Acadia Pharmaceuticals at BofA Conference: Strategic Growth Plans

On Tuesday, 13 May 2025, Acadia Pharmaceuticals (NASDAQ:ACAD) presented its strategic outlook at the BofA Securities 2025 Healthcare Conference. The company discussed its commercial performance, pipeline development, and strategies for growth. While there are challenges, such as seasonality and competition, Acadia remains optimistic about its prospects, particularly with its key products, NUPLAZID and DAYBUE.

Key Takeaways

• Acadia is expanding its commercial strategy for DAYBUE, aiming to reach more physicians and patients.
• The company anticipates a steady increase in NUPLAZID sales due to heightened awareness.
• Acadia is progressing with its pipeline, expecting significant data readouts for ACP-101 and ECP-204.
• Leadership is confident in the company’s growth strategy and has reaffirmed financial guidance.
• No immediate material risks from macroeconomic factors, such as tariffs and executive orders, were identified.

Financial Results

• Seasonal Impact: Q1 is typically a low season for Acadia, affecting price and volume. This is expected to improve in Q2.
• Revenue Guidance: The company reaffirmed its existing revenue guidance for NUPLAZID, highlighting a large potential market due to late diagnosis.
• Sales Consistency: Acadia expects more consistent net sales from Q1 to Q4.

Operational Updates

• DAYBUE Launch:

- Acadia increased its field sales team by 30% to enhance outreach to community physicians.

- The company is emphasizing DAYBUE’s efficacy through peer interactions and patient testimonials.

- 65% of RET patients have yet to try DAYBUE, indicating significant growth potential.

• NUPLAZID:

- Acadia launched awareness campaigns to educate patients and physicians about psychosis in Parkinson’s disease.

- The company recorded its best quarter in five years for new patient starts on NUPLAZID.

- Efforts are focused on encouraging earlier diagnosis and treatment.

Pipeline Developments

• ACP-101 for Prader-Willi Syndrome:

- Full enrollment in the phase three trial is expected this quarter, with data anticipated in early Q4.

- The trial involves approximately 170 patients and focuses on the Hyperphagia Questionnaire as the primary endpoint.

• ECP-204 for Alzheimer’s Disease Psychosis:

- A phase two study is set to start in Q3, with data expected mid-year.

- Acadia is also initiating a Lewy body dementia psychosis program.

Future Outlook

• DAYBUE Growth: New patient growth is expected throughout the year, with a notable increase in Q3 due to sales force expansion.
• NUPLAZID Growth: A steady increase in sales is anticipated as awareness continues to rise.
• R&D Day: Acadia plans to share more about its pipeline on June 25.
• Europe Launch: The company is implementing a name patient program to prepare for DAYBUE’s European launch.

Q&A Highlights

• Tariffs: Acadia reported no significant exposure to tariffs due to existing inventory.
• FDA Interactions: Routine interactions with the FDA are proceeding without delays.
• Prader-Willi Syndrome Differentiation: Acadia believes there’s room for multiple drugs in this complex patient population.

In conclusion, Acadia Pharmaceuticals presented a comprehensive strategy for growth at the BofA Securities 2025 Healthcare Conference. For more details, please refer to the full transcript.

Full transcript - BofA Securities 2025 Healthcare Conference:

Unidentified speaker, Moderator, BofA: Thanks for continuing to participate in the BofA Healthcare Conference. Our next presenting company is Acadia Pharmaceuticals. We have several members from the management team up here with me. I will introduce each of them. There’s Catherine Owen Adams, who is, of course, chief executive officer, Mark Schnaier, who is chief financial officer, and Elizabeth Thompson, who is head of r and d.

Team Acadia, thank you so much for coming to Las Vegas to see us today. Thanks for having us. So we’ve been starting all conversations with macro questions. I’m sure these these are all things that are not going to be new to you. We’ll start in the in the most recent of of updates, which was yesterday’s executive order as it relates to most favored nation.

Can you talk about, just in general, what you think the interpretation of that announcement is and what the implications are specifically for Acadia?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Yeah. So, as we know, most favored nation, is not a new idea from this administration. It came around during the first administration, and so it’s it’s certainly not a surprise that it’s back on the agenda. I think for Acadia, for right now, we don’t sell products outside The US. So for right now, no immediate impact of of MFN.

As we look at Debut, our aspiration is to commercialize Debut outside of The US. We have ongoing regulatory approval process in Europe, looking to get Debut approved in q one of next year. As you know, it takes then a number of months and years to get each product reimbursed in each individual of the 27 member states. But the first country we can launch is Germany, and we have free pricing for the first six months. All to say that we’ve got about eighteen months to see how this plays out and make differential decisions according to where it lands.

So for right now, keeping a strong eye on it, joining the forces at Bio to ensure that our voices are heard on the hill and actively participating in the discussion. But for right now, no immediate impact on Acadia. As we move into Europe, we will make those strategic decisions depending on what eventually happens.

Unidentified speaker, Moderator, BofA: Okay. And then next question is is on tariffs in general.

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Yeah. And I’m gonna go ask mom

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: Yeah. I would say tariffs. From where we stand today, we don’t believe we have a meaningful exposure to tariffs. I’ll explain why in a couple of points. On NUPLAZID for pimavanserin, you know, we have inventory in The US that could last us from a volume standpoint to the mid to late twenty thirties, really because of investments the company made on the, you know, r and d portfolio or in in the indication expansion strategy previously.

So we have that, and that’s here already. Debut, we have a couple of years of inventory in The US, and so there’s no immediate exposure there. You know, we don’t own manufacturing facilities, so there’s no kind of physical investment we would need to make to make any changes. You know, with manufacturing, any company, we wanna make sure we’re working with high quality suppliers, have redundancies, have low cost. And over time, anything in manufacturing can change.

So if something needs to be changed because of some future issue with tariffs or cost imposed upon us, that’s something we can evaluate over time, but no meaningful exposure today and certainly on pimavanserin for a very long time.

Unidentified speaker, Moderator, BofA: Okay. And where does your IP reside?

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: So the IP for pimavanserin is in Switzerland, and the IP for everything else in the portfolio except for maybe one small early stage asset is all in The US.

Unidentified speaker, Moderator, BofA: Okay. And so how would that IP in Switzerland impact, the company?

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: Well, I think for again, going back to the tariff question, the inventory is already the product’s already here.

Unidentified speaker, Moderator, BofA: Okay. So even though the IP resides

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: So even though the IP resides there, the product is already here.

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Okay.

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: And if there’s anything that comes up there, again, there’s no physical plant or infrastructure along with the IP. So if anything in the future came up related to the IP, that’s also something we can consider unwinding.

Unidentified speaker, Moderator, BofA: Okay. Got it. And then last question is on FDA interaction. So maybe, Elizabeth, you can talk about that.

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: Sure. I think what you’ll get here is a sort of theme of no clear immediate negative impacts to Acadia. You know, obviously, we are watching the news like everybody else is. There are a number of dynamics at play in terms of FDA, and certainly we do know that there are companies that have reported delays in their interaction. To date, in the routine interactions we’ve had with FDA, we’re getting the kind of feedback and and communication that we expect in the timeline that we expect.

So so far, so good from that perspective.

Unidentified speaker, Moderator, BofA: Okay. And the the people that you’ve been interacting with, have they stayed the same? Have there been any changes?

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: Thus far, they’ve stayed the same, so it’s been pretty consistent.

Unidentified speaker, Moderator, BofA: Okay. Alright. So enough about the macro. Let’s get into specifics about the company. So I think a topic that’s been front and center for the better part of the last year and a half to two years has been the debut launch.

So, Catherine, as you continue to adjust to being CEO, how long has it been now? Seven months. Seven months. No one’s counting. Right?

No. What have you, you know, learned about the debut launch that’s enabled you to kind of figure out what’s needed as next steps in order to kind of, have the growth curve go back to being close to the steepness that they saw initially?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Right. So as you know, just to rewind, came out the gate very strong, bolus of patients with pent up demand. And then after two quarters of of fairly strong numbers, we saw some flattening, and the last three quarters of last year were were flat. As I came in and at the September, beginning of October, the commitment was to look at this with fresh eyes, commercial eyes, and to think about things we could enhance or evolve, as the team had, had seen this stagnation. So I think the immediate, decision I took was to bring in a new chief commercial officer.

Tom started with us in December and has made immediate impact on both brands, and we can talk about that in a second. But in terms of debut, we really relooked at the the fundamentals, and that’s where I start with commercial execution. Do we have the right people? Are they calling on the right customers at the right frequency? It’s fairly fundamental in sales, and I I felt that the team was was underpowered.

In rare, it’s important to get to the centers of excellence, and, there are 21 of those for rare in The US, and we were proud to get to those centers. But the most important part of RET is that you can get to the tail, and you can get to the patients that are being treated in the communities who, over time, become the strength of your numbers. And so 65% of RET patients are treated outside the centers of excellence in, local pediatric neurology centers, PCPs, etcetera. We were not powered to get to the right number of physicians in the community. So we took the decision to upsize the field by thirty percent, immediately, and those people were put in place last month.

And so that we will start to see the impact of them probably, from the second half onwards, hopefully. In addition to that, we really doubled down on the efficacy message. I felt that the efficacy message had got a little bit out outvoiced with the focus on side effect management. And so bringing to life the efficacy in terms of, peer to peer interactions, in terms of, families going on video talking about the impact that Rhett has had on their loved one and bringing that data to life in a way that people and families could relate to. We’ve really doubled down on that.

And then in addition to that, we’ve had a focus on managing the titration and the side effects to the point where each doctor now feels comfortable with their own approach to it, and we’re also ensuring that the patients are interacting with Acadia with the same person. Last year, they had two or three people that they were interacting with. We’ve now gone that to one to one relationship, So they have one person they they can go to with every single issue that they might have. That might sound like a small change, but, again, in rare, it’s very important to have that one to one interaction. So those are the things that we put in prey place almost immediately in addition to thinking about, predictive analytics in the field.

So the other thing that we’ve put in place is a more, analytically driven field so that now they have data to say where the rep patients are, where they’re likely to turn up, which doctors are seeing them so that they they can get there and have those precious conversations at the right time. So those are a number of things that we’ve done differently. And as you saw from first quarter, we’ve seen the first large jump in in net new patients for the last three quarters. So we’re we’re pleased with the progress, but we hope to continue to drive that.

Unidentified speaker, Moderator, BofA: And where, would you say these patients are being found? So you’ve put in a lot of effort to to really expand, you know, awareness about the efficacy of the drug, for example. Is it with doctors who had never, prescribed AV before, or are you seeing reinvigoration of doctors who would have prescribed it for a couple of patients and are trying it again on on others?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: I would say the encouraging news is we’ve seen a lot of new writers in the last quarter, many of whom have come from the community, and, we’re seeing that sort of strategy start to play out. So it’s a little bit

Unidentified speaker, Moderator, BofA: of a blend, but, definitely new writers coming in to to to experience debut. And just remind everybody, what type of physician is treating, a rep patient?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: A pediatric neurologist in the main.

Unidentified speaker, Moderator, BofA: And how many of them are there?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: There are, within our focused universe, there are about 5,000, physicians in The US who are treating rep patients on regular basis.

Unidentified speaker, Moderator, BofA: So of those, on average, how many, I guess, touch points does a a sales rep need in order to Yeah. Motivate a doctor to write a script?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: So back to the basic numbers. Right? So we’ve from what we’ve learned over time is that each doctor, it obviously depends, but they need about four to five interactions to feel confident to prescribe Debut for the first time. And, again, back to the underpowering of the field, we weren’t able to have those conversations in a reasonable time frame. So, again, by increasing the amount of people in the field, you can have those conversations more quickly and therefore stimulate that growth in in new patient demand.

Just to say that year to or launch to date, thirty five percent of rep patients have ever tried Debut, and so there’s sixty five percent still to go. And so that’s the belief in terms of that ability to drive that growth further now that we can get to these doctors more regularly.

Unidentified speaker, Moderator, BofA: And then going back to patients who have tried it and from you tell me the reason that they have dropped out of taking or discontinued taking therapy. What percent or can you track, of those patients have come

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: back on? So we track all of them. Relatively, you have come back on. I think we’re seeing every month, we see patient restarts. They may have stopped because of side effects.

They may have stopped because of other things that are happening in the family dynamic or in the child’s life. So there’s there’s variable reasons. The majority of the reasons to stop are side effects. So for right now, a lot of those families don’t feel like they can they can come back on. But the ones that are restarting are hear hearing about the titration Mhmm.

Schedules and are coming back and starting the dose slightly differently, and we’re now seeing those patients come back. So it’s still a relatively small number, but they’re there.

Unidentified speaker, Moderator, BofA: Okay. So how should we be thinking about the cadence between what you saw in the first quarter and how to think about, you know, each successful quarter this year, for example?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: So then Mark can talk to sort of the financial cadence. But if we just look at new patient starts, we’re expecting new patient growth, in subsequent quarters throughout the year. But as I’ve already said, the inflection point that I believe will happen, we’ll start to see in the third quarter as that sales force increase starts to have impact. Now why do you have to wait those three or four months? Because they have to have those three or four calls.

And so that’s the reason for waiting for

Unidentified speaker, Moderator, BofA: the impact. Would you expect February to be a stronger quarter than January?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: I expect February to be a a strong quarter, but I think the inflection point will come in the back half of the year.

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: I think from a financial perspective, I think Catherine’s right. Operationally, the investment we’re making and the time frame we expect that investment to come is more of an inflection in the second half. But just remember, our first quarter is a low seasonal quarter both in terms of price and volume. So we’ll expect that seasonality to unwind in the second quarter. So if you’re looking at a net sales standpoint over the course of the year, it should be more consistent q one, q ’2, q ’3, q ’4.

Unidentified speaker, Moderator, BofA: Okay. And with these, interactions that your sales force is having with the physicians, what are the questions that they feel need to be, addressed a few times before the doctor

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Now that we’ve got the balance back to efficacy, it’s understanding which of the domains, the the child might see, improvements in. They like to see the long term LOTUS data where we we, look at the eight domains that, that the original trial endpoints cover, and we talk about the, possibilities within each of those domains. They like to talk to other clinicians about how they have started their patients on debut. So it’s a it’s a variety of of needs. They like to speak to the MSLs about maybe some of the publications that have have just recently come out.

So it’s it’s overall I think the real the real focus is why should my patient go through two or three months of titration and and understanding the side effect profile? What’s in it for them to believe that it’s worth the journey? Sort of back to the old L’Oreal commercial of what’s in it for me, or am I worth it? And so it’s really having that conversation with the families and bringing that to life.

Unidentified speaker, Moderator, BofA: Okay. And do you think that your Salesforce is now right sized to do that?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: I do. They’re right sized, and they’re highly motivated, and we’ve brought some new people in with real skill sets and passion around this space, and I’m excited to see what they can achieve.

Unidentified speaker, Moderator, BofA: Let’s switch over to Europe. Sure. Part of your area of expertise in your previous jobs has been to manage launches ex US.

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Mhmm.

Unidentified speaker, Moderator, BofA: How would a launch like debut need to be managed differently than what’s been done in The US, if at all?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: So the first thing about Europe is is, ensuring that the physicians there feel comfortable with prescribing. Otherwise, you have to go a similar learning curve as we would do here. That’s the reason why we put in in place in countries where we’re where we’re able to a name patient program. That allows physicians who are motivated and have patients who are asking for Debut to, source it from us and start using Debut prior to approval. Now that will be a modest number of patients, but it still allows the European community to talk to each other about managing a patient within a European health care system, which is different to a US health care system.

So in a single payer space where you’ve got sort of patients that are much less likely to be moving between doctors, you’ve got a much more sort of consistent theme. You’ve got health records that are longitudinal and can be tracked over time. These physicians want to see progress. They want to understand how the patients are improving over time, so having that experience is important. I think overall, Tazeen, the importance is that we learn from the lessons in The US and we apply them in in the EU, and we will do that.

And it’s all about setting expectations, managing the patients appropriately, but also talking about the possibilities of debut.

Unidentified speaker, Moderator, BofA: Okay. So, let’s move on to NUPLAZID. Yeah. And, this is a, you know, a mature launch. But what do you think, you know, is is an area that hasn’t been touched yet, and what’s giving you confidence that, you know, it’s worth investing, more resources into it at this particular stage?

So

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: I think what the team had started before I arrived was a refocus on awareness campaign. What the team had seen prior is that if you educate patients around Parkinson’s disease, one of the areas that they are very unaware of is the possibility of a psychosis in terms of hallucinations and delusions in a patient with Parkinson’s. Very well aware of motor symptoms, very unaware of anything else. So the the ability to educate and make patients aware is highly impactful, and it’s a it’s a promotionally sensitive market. The fact that we’ve had Ryan Reynolds on board in terms of an unbranded campaign has been amazing in terms of the impact it’s had on awareness.

We’ve seen very significant increases in the awareness that patients and their families now have about the possibility of hallucinations and delusions. And what we’ve seen that translate into is a very strong increase in patients going to their doctors and having conversations about treatment for hallucinations and dilutions. We’ve now had the first, the best quarter in five years for new patient starts on debut oh, sorry, on Neuplazib. So joining the dots, the awareness campaign has had an impact. The patients have gone into their physicians, and they’ve now been prescribed NUPLAZID.

We believe now that the team can really focus on the efficacy messages and the story around NUPLAZID and really underlining the great data that we now have, including, you know, an impact on all cause mortality versus what’s normally used in these patients, which is off label unapproved antipsychotics. And so having a clinical argument which is able to talk to that and now encouraging physicians to have conversations about earlier diagnosis of of symptoms. And so there’s there’s lots going on to try and really stimulate the growth that I believe is truly possible for NUPLAZID. Yeah. So where would you say the the next range of of profile of patients is?

So what we’re what we’re working with the medical team on is is generating information, publications, data around the use of, NUPLAZID earlier in the treatment diagnosis journey and ensuring that doctors are aware that, you can use NUPLAZID earlier in the treatment diagnosis journey. And so there’s a strong focus on on that right now. So the earlier diagnosis of patients is a very strong focus, as well as the the other data that we have on on efficacy.

Unidentified speaker, Moderator, BofA: Okay. Now is this, is the diagnosis of this something that requires family members to also be involved as opposed to, obviously, the patient may not be aware even that this is happening to them in certain cases? I mean, I

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: I think a lot of our patients do have insight into the fact that they are thinking things that may or may not be true. Mhmm. So there is definitely, depending on the age of diagnosis, insight. More often than not, though, it’s the family And so it is really the family that is required to be educated around this.

And even if patients know that they’re having these thoughts, they’re very reluctant often to share them because it’s scary, and they don’t know why it’s happening. And, again, a lot of patients are unaware unaware of that as well. I don’t if you wanna add anything to that, Liz. No. I mean, I

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: think that that’s you know, we know that something like fifty percent of Parkinson’s disease patients will develop psychosis, and we also know that something like ten percent of them will self report. There is an aspect to that that is about sort of the stigma and the shame and the confusion. There is an aspect, in some cases, I’m sure, of inability for patients to recognize that about themselves. So I think that both increasing the awareness within patients, decreasing the stigma through talking about how this is a normal part of the course of the disease, and educating patients’ families as well so they can keep an eye out for things with their loved ones, all of these I think are pretty important.

Unidentified speaker, Moderator, BofA: So if you had to kind of talk about the the cadence of of impacts of the efforts you’re making here with NUPLAZID, it’s a much more mature launch relative to the efforts you’re making with Debut, how should we be thinking about those?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: I think this is a much more steady increase over time. I mean, I don’t know if you wanna talk about the financials as well, Mark, but, you know, Nuclazid this year, as you know, we’ve guided to June to June. We still reiterated that guidance in our q one call, and, we’re seeing that growth come now. So it’s a much more steady increase as that awareness increases.

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: Yeah. I think if you maybe you just look you look at the patient population. The size is very different. Right? And so, you you know, debut two years into launch, we’re still penetrating the existing patient population.

They have a long ways to go. NUPLAZID is much bigger market, and it’s a market where, you know, patients are getting diagnosed late in their disease progression for the most part. Mhmm. Right? So it’s a patient population that’s kinda ever churning, and that’s why awareness is important because the patients and caregivers today are different than patient and caregivers five years ago.

We also lived through a global pandemic. So a lot’s changed, which is why the investment today makes sense, and it’s starting to pay off.

Unidentified speaker, Moderator, BofA: Okay. So let’s move on to pipeline because you do have some updates coming up. And, Elizabeth, your turn to talk now. So Excellent. For ACP one zero one, for Peter Willey, can you talk to us about that phase three trial design and, what would be good data?

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: Absolutely. So first off, I do wanna recognize that we were very pleased that we were able to accelerate timing on this. So we’re now expecting full enrollment in the trial in this quarter, which leads us towards top line data roughly early fourth quarter this year. So really pleased with that combination of good hard work by the R and D team as well as I think a real groundswell of support from the community. We work closely with patient advocacy organizations and we were really pleased with the uptake we saw that.

So as far as the clinical trial design is concerned, we’ve got a phase three trial that’s currently ongoing. It is roughly 170 patients that we’re looking to have enrolled in total. Two arms parallel group, so at baseline patients are randomized to start either getting 101 at three point two milligrams or placebo. Our primary endpoint’s at week twelve. We’re looking at the hyperphagia questionnaire for clinical trials.

This is pretty standard endpoint that is used in trials in this space. And in terms of what good data look like there, there are a couple of things that I’m looking for that I’d be pleased to see. The first of these is a magnitude of effect that’s similar to what we saw in the three point two milligram arm in the prior, phase three trial. And the second thing is to see a safety tolerability profile that’s fairly consistent with what we saw there, where I at least don’t see any clear reasons where we would need to exclude parts of the patient population, have significant burden of monitoring, anything like that. Obviously, we’ll see what comes out of this trial, but those are the things that I’m looking for here.

Unidentified speaker, Moderator, BofA: What are the most common side effects?

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: So the most common side effects that we saw, again, I don’t know in the phase three that we’re currently running, but in terms of what was seen historically, most common was flushing, and even that was only seen by something like twenty percent of patients. Generally, it was fairly transient. So this is thus far, I think, a safety profile that, again, doesn’t seem as though it’s going to lend itself to needing to exclude significant groups of patients or anything like that.

Unidentified speaker, Moderator, BofA: Okay. This is an area of unmet need, but it looks like it’s becoming crowded at kind of the same time. So that’s good for the patients. Yep. So Solido is launching its its product.

Can you talk about the differences mechanistically, for your product? It seems like it’s a big enough market where there’s room for multiple players.

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Yeah.

Unidentified speaker, Moderator, BofA: But if you were to try to, let’s say, speak to a physician about differentiation, what would you, without knowing the phase three data, be talking about?

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: Yeah. So I’d I’d make a couple of comments. I do wanna start with the I mean, we and I think the the Prader Willi community, again, we are thrilled that there is actually something available for them now. This has been a patient population that has been waiting for a very long time. That said, entirely consistent with what you say, this is a larger, certainly compared with Rett population, something like eight to 10,000 patients in The US.

And I think these are patients with truly complex medical situations. So I think we firmly believe this is the kind of space where there is, you know, one agent is not going be the solution for everyone. We think there’s ample room for multiple drugs to come forward and make meaningful differences for patients. You know, in terms of differentiation, it is awfully hard for me to be too specific in the absence of the phase three data. I will say we are really, you know, I think that the study design that we have, if we have a positive outcome of that trial, we’re gonna have a pretty clear clinical story for physicians and for patients.

Here’s what you can expect when you start on our drug. You know, the VICAT approval was based on a randomized withdrawal trial. Typically that’s a little bit more informative for things like maintenance or rebound. It makes it a little harder to set expectations and Catherine may want to comment on that from a commercial point of view. But I think that’s going to be an important part of the story.

Certainly there are going to be aspects about different administration profiles that are going to be relevant to different patients. There are going to be patients that will prefer one versus the other. And, you know, again, I’m sure there will be things on the safety and tolerability in terms of what’s appropriate for a given patient. Anything you wanna expand on with the commercial case, Catherine?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Well, I think while two product sounds crowded, for me, it’s not very crowded. So I think, you know, to Liz’s point, it’s gonna be potentially very exciting to offer a different alternative mechanism, with different data, different profile. And as she said, you know, talking to the community, they welcome that opportunity. I I think for us commercially, there’s plenty of space for us both to play, and we look forward to a successful trial in order to achieve that.

Unidentified speaker, Moderator, BofA: Yeah. And I I guess, the best compliment is is if someone else wants to pursue the indication. So so Rhythm is actually trying

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: to Exactly. And there’s different aspects people are looking at. Right? And, again, I think it points out how complex these these these patients are. So, again, each of these drugs seems to be having taking a slightly different spin, and and that’s that’s great because each patient has very different needs.

Unidentified speaker, Moderator, BofA: Okay. And then as you think about how to integrate, let’s say that that all good things happen with this program, you apply and you get approval, how would that fit in with the launches that you would already have been managing at that point, the two other launches?

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Yes. So I think this this fits very nicely into our rare disease team. The call points are very similar in terms of the physicians that treat. There’s definitely an overlap. There’s obviously in all spaces, there’s there’s different physicians in different hospitals that have very specific focuses.

But roughly, you know, neurologists treat both patients. So our expertise in rare and neurology, patient support, commercialization, I think that will all come to bear when we hopefully, when we can launch, one zero one. Okay.

Unidentified speaker, Moderator, BofA: And then, last question is on ECP two zero four. So back to Elizabeth. Can you just talk to us about where you are on that?

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: Sure. Really quickly, ECP 204 is our new five HT2A. We, inverse agonist, we designed this based on learning from pimavanserin. We were looking for a few things. First is that NUPLAZID is associated with QT prolongation.

While it’s not massive, it is something that you need to think about in an elderly, frail patient population. So important in and of itself and we were looking to reduce or eliminate that, but it’s also important because it limited our ability to dose range with NUPLAZID and there is indication in a number of disease states, is some suggestion of an exposure response relationship suggesting we haven’t gotten as much efficacy out of this mechanism as we could. So we think the ability to dose range here is going to be important. And finally, we were looking for a faster time to study states with potential better onset of action. We’re currently in a study in Alzheimer’s disease psychosis.

We’re in the phase two portion of a phase two, three overall program. We’re looking to have that completely enrolled in the first quarter of next year and get data roughly mid year. We are also starting a Lewy body dementia psychosis program and we’re looking to get that started in phase two in the third quarter, so a lot of activity going on with two zero four.

Unidentified speaker, Moderator, BofA: So how does Alzheimer’s psychosis different from Parkinson’s psychosis manifestation wise?

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: So there certainly is some overlap in terms of hallucinations and delusions but there can be some differences in terms of the relative relative proportion of those and certainly, sort of when you see that in the disease course and the number of patients who suffer from it. We do have some data with pimavanserin Alzheimer’s disease psychosis. Obviously, that would take us more than the forty seconds I think we have left to go through. But what I will say is that there some, you know, there’s signals of efficacy there that I think we can build on both from a potentially better molecule perspective as well as some study design learnings that I think give us opportunity to, you know, maximize success for 02/2004 and ADP.

Unidentified speaker, Moderator, BofA: Okay. We’ll continue this. We’ll schedule this here.

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: Sounds good.

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: Sounds good. And if I could just say we have a r and d day on June 25.

Unidentified speaker, Moderator, BofA: Yes. Yes. And you

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: can hear more about all of

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: what Liz has Do

Unidentified speaker, Moderator, BofA: that live. Yep. Guys. Thanks for

Catherine Owen Adams, Chief Executive Officer, Acadia Pharmaceuticals: your time.

Mark Schnaier, Chief Financial Officer, Acadia Pharmaceuticals: Thanks for

Elizabeth Thompson, Head of R&D, Acadia Pharmaceuticals: joining us.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.