ACADIA Pharmaceuticals Q1 2025 Earnings Call Transcript

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May 7, 2025
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Operator

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals conference call. My name is Lauren Cannon, and I'll be your coordinator for today. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised.

Operator

To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to turn the presentation over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at Acadia. Please proceed.

Al Kildani
Al Kildani
Senior VP of Investor Relations & Corporate Communications at ACADIA Pharmaceuticals

Good afternoon, and thank you for joining us on today's call to discuss Acadia's first quarter twenty twenty five financial results. Joining me on the call today from Acadia are Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks followed by Tom Garner, our Chief Commercial Officer, who will discuss our strong commercial brands, Debut and NUPLAZID. Also joining us today is Elizabeth Thompson, PhD, Executive Vice President, Head of Research and Development, who will provide an update on our pipeline programs, and Mark Schneier, our Chief Financial Officer, will review the financial highlights. Kathryn will then provide some closing thoughts before we open up the call for your questions. We are using supplemental slides, which are available on our website Events and Presentations section.

Al Kildani
Al Kildani
Senior VP of Investor Relations & Corporate Communications at ACADIA Pharmaceuticals

Before proceeding, I would like to remind you that during our call today, we will be making several forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements, including goals, expectations, plans, prospects, growth potential, timing of events, future results and 2025 financial guidance are based on current information, assumptions and expectations that are inherently subject to change and involve several risks and uncertainties that may cause results to differ materially. These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are made only as of today's date, and we assume no obligation to update or revise these forward looking statements as circumstances change, except as required by law. I'll now turn the call over to Kathryn for opening remarks.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thank you, Al. Good afternoon, everyone, and thank you for joining us. We're off to a strong start in 2025. Our performance this quarter reflects solid execution across the business and continued momentum behind our strategic priorities. From commercial progress to pipeline advancement, we're delivering on our commitments whilst positioning Acadia for long term growth.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Let me walk you through the key highlights, starting with our commercial performance. We're pleased to report that our commercial business has had a strong first quarter, building on the solid foundation we established in 2024, with first quarter revenues of $244,300,000 up 19% from a year ago. Starting with debut, this quarter represents a meaningful inflection point in the brand's trajectory. Over the past few quarters, we've successfully stabilized the business and established a solid base of growth to build on. Today, our focus is shifting towards accelerating that growth through deeper patient and provider engagement and by broadening our overall reach into the community.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

We generated $84,600,000 in debut sales in the first quarter, up 11% from a year ago. Importantly, the number of unique patients receiving shipments was nine fifty four, up meaningfully from Q4 and in fact an all time record for the brand. This gives us confidence in the sustainability of Debut's growth and we reiterate our full year sales guidance. Turning to NUPLAZID, we reported $159,700,000 in revenue for the quarter, up 23% from the prior year. As Mark will detail, that growth included 6% growth in volume and the remainder was largely attributable to one time changes in gross to net.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

We continue to see strong performance driven by our direct to consumer efforts, which are helping drive patient awareness and pull through in the form of physician visits. As with debut, we are reiterating our full year guidance for NUPLAZID and expect continued solid execution throughout the year. On the R and D front, we're making great progress and are thrilled to update you that our timeline for last patient in and therefore top line results from our COMPASS PWS Phase III study in Prader Willi syndrome are now both expected to happen before the end of twenty twenty five. We're also excited to host our first ever R and D Day next month. This event will offer a deeper look into our development strategy and allow us to showcase some of the promising innovation that's taking shape across our pipeline.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

We look forward to introducing you to more members of our team and sharing how we're thinking about the next wave of growth. With that, I'd like to turn the call over to Tom to discuss our commercial performance in the first quarter.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

Thank you, Catherine. I'll begin with a review of Dayview, where we have made exciting progress. First quarter sales were $84,600,000 up 11% from a year ago. Although sales were down sequentially, as we explained would be the case on our last call, the underlying patient dynamics were positive. During the quarter, nine fifty four unique patients received paid shipments, up from nine twenty in the fourth quarter.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

In fact, as Kathryn said, this was the highest number of patients served in a quarter since the launch of DayView over two years ago. While we continue to add new patients, a key driver of this performance was a significant reduction in discontinuations and improvements in persistency. Discontinuations were down 35 sequentially from the fourth quarter of twenty twenty four and declined 66% compared to the first quarter of twenty twenty four. Overall, our persistency rate remains above 50% after twelve months, driving a growing stable base of patients who remain on therapy long term, with sixty five percent of our active patients now having been on therapy for twelve months or longer. With regard to patient mix, our strategy is playing out as intended.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

In the first quarter, we saw more new scripts from the community setting, including a higher number of prescriptions from pediatricians. This is particularly encouraging as it occurred ahead of the field force expansion, which we announced in the first quarter. I'm pleased to share that all planned hires for the expansion have now been completed, and I'm confident our expanded customer model and refined strategy will begin contributing to further Dayview sales growth in the second half of the year. As a reminder, to date, roughly two thirds of diagnosed Rett syndrome patients have yet to try Dayview. Turning to our plans outside of The U.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

S. We continue to lay the foundation for a strong launch outside The U. S. Once we obtain approval from the EMA, which we anticipate in the first quarter of twenty twenty six. As a reminder, the opportunity in Europe is substantial, with an estimated nine thousand to twelve thousand individuals affected by Rett syndrome.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

We have now hired an experienced general manager for Europe and continue to build out the commercial team behind him. We have also initiated managed access programs and, in April, have already served the first Rett syndrome patient under this program in Germany. We continue to see strong interest in access to trofinetide prior to approval. For the rest of the world, we recently entered into distribution agreements for named patient access in geographies including Latin America, The Middle East, Asia Pacific, and other countries around the world and are already receiving inquiries. In summary, I'm very pleased with the progress we have made with Debut.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

As you can see from the first quarter results, we have now started to see renewed growth in patients, and this gives us confidence that we will be able to accelerate growth in the second half of the year with our broadened field footprint as we expand penetration into the community setting. We believe we now have the strategy, structure and resources available to maximize growth through 2025 and into 2026. Turning to Newplazid, we were pleased to see the strong momentum built throughout 2024 continue into 2025. Newplazid achieved first quarter sales of 159,700,000 representing 23% revenue growth year over year, of which 6% came from volume. In fact, the first quarter of twenty twenty five was the best quarter in terms of new to brand prescriptions since 2020.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

We believe this gives us strong momentum for the rest of the year, even as we have a significant opportunity to further expand our share of the Parkinson's disease psychosis market. We continue to see the benefits from both our unbranded disease awareness campaign as well as our branded campaign. These efforts led to higher engagement across our unbranded disease awareness and NUPLAZID websites, helping to spark more meaningful conversations between patients and their physicians, with a nearly 30% increase in awareness of Parkinson's related hallucinations and delusions since the launch of the More to Parkinson's campaign. Our consumer activation campaigns have complemented and enhanced the core growth drivers that have supported the Nuplazid brand for over two years, including leveraging of our published real world evidence showing an association of pimavanserinus compared with other atypical antipsychotics in important outcomes like all cause mortality. From a brand perspective, our primary focus is on identifying PDP patients earlier in their Parkinson's journey and ensuring they're aware of available treatments upon diagnosis.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

It's crucial to remember that while approximately fifty percent of Parkinson's disease patients will experience hallucinations and delusions, it's estimated that only ten percent will ever self report these symptoms. Therefore, we will continue to actively engage with the Parkinson's disease community across both HCP and consumer audiences to drive earlier awareness, diagnosis, and treatment of Parkinson's disease psychosis, and to help ensure that NUPLAZID is recognized as a first line therapy for this challenging condition. Overall, we remain highly confident in our ability to drive meaningful growth for the brand through 2025 and beyond. I'll now turn this over to Liz.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Thanks, Tom. I'm delighted to start out today with an important update for our pipeline. As Kathryn mentioned in her opening remarks, due to the diligence of our team and support of the community, the timeline for our COMPASS PWS phase three trial for ACP101 has accelerated. As a result, we now expect closed screening within the coming days, which should allow us to complete enrollment this quarter. With that, we're now expecting top line results by early fourth quarter of this year.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Assuming positive data, we believe that sets us up for a potential regulatory submission in The U. S. In the first quarter of twenty twenty six. As a quick reminder, ACP101 is an intranasal delivery of carbitocin, a long lasting analog of human oxytocin. Carbitocin was developed to more selectively bind to the oxytocin receptor.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

We're developing it for the treatment of hyperphagia in Prader Willi, which is a rare genetic neurobehavioral disorder. Hyperphagia, an intense persistent sensation of hunger, is a defining characteristic of Prader Willi. Again, we are pleased to pull these important milestones into 2025 and look forward to reporting results later this year. Next, I will turn to our second late stage clinical program, ACP-two zero four, our new five HT2A inverse agonist that we designed based on learnings from pimavanserin. We continue to make important progress with ACP-two zero four as well, now moving it forward in two indications.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

First, we're currently conducting a global double blind placebo controlled phase two study in Alzheimer's disease psychosis or ADP. We've designed the program for seamless enrollment from phase two to phase three. For this program, we continue to expect last patient in during the first quarter of twenty twenty six, followed by top line results around mid-twenty twenty six. We're also advancing ACP-two zero four into a second indication, Lewy body dementia psychosis, a serious neurodegenerative condition linked to alpha synuclein buildup and marked by cognitive, behavioral, and motor symptoms. Affecting over one million people in The US, LVD is one of the most common forms of dementia.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Prior data with pimavanserin showed encouraging signals in this population supporting the potential of ACP-two zero four to address hallucinations and delusions. For Lewy body dementia psychosis, we remain on track to initiate a phase two study in the third quarter of this year. Now I'd like to turn to our updated pipeline and provide a few additional updates. First, I am looking forward to sharing more details on these programs at our R and D Day next month. In particular, I am excited to share additional insight into our plans and the supportive data regarding some of our most newly disclosed programs.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

The event is intended

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

to provide a bit of

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

a deep dive into each of these programs as well as to allow you an opportunity to meet some of the senior members of our R and D team. We're also looking to give you an understanding of how we think about drug development here at Acadia and the high bars we put on our potential medicines at every step along the way. You'll hear that from us as well as through input from KOLs, caregivers, and patient advocates who are our true north as we make tough decisions about what innovation to continue to pursue and where to focus our resources. At this time, I want to share an update related to our collaboration with Stokes Therapeutics. We continue to be excited by the data we are seeing from the Syngap1 program and look forward to getting to the next decision enabling data early next year.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

With respect to the other discovery programs in the collaboration, ACADIA has reached the conclusion that there is not a viable path forward for the RET or the undisclosed program. Accordingly, we will be winding down our efforts for both of these programs. Finally, I wanted to provide a brief update on trofinetide. Our marketing authorization application for trofinetide in The EU remains under review and we continue to anticipate approval in the first quarter of twenty twenty six. In Japan, our engagement with the PMDA remains productive.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

I'm pleased to share that we have officially received orphan drug designation. This has various benefits but importantly offers the potential for priority review. And we remain on track to initiate a phase three trial in Japanese patients with Rett syndrome in the third quarter of this year. And now, I'll turn it over to Mark for financial updates.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

Thank you, Liz. Let's now review our first quarter twenty twenty five financial results. In the first quarter of twenty twenty five, we recorded two hundred and forty four point three million dollars in total revenue, up 19% from the first quarter of last year. First quarter debut net product sales were $84,600,000 up 11% year over year on the strength of achieving an all time high in terms of number of unique patients receiving shipments. As we signaled on our Q4 call in February, we expected Dayview net sales to be down sequentially.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

Factors contributing to this included the fourth quarter pull forward of approximately $3,500,000 in net sales, typical beginning of year seasonality impacting both volume and net price, and a sequential decline in net price per bottle of Debut attributable to the impact of the Medicare Part D redesign. The Dayview gross to net adjustment for the quarter was 24.9%. Importantly, we continue to expect all the key metrics that drive Dayview net sales to increase throughout the remainder of the year, including unique patients served, bottle volumes and net price. Turning next to NUPLAZID. First quarter NUPLAZID net product sales were $159,700,000 up 23% year over year with 6% attributable to volume.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

The anticipated net price benefit of 16% was largely attributable to a one time change in gross to net as a result of the Medicare Part D redesign as part of the inflation reduction act. Moving forward, we expect our gross to net to stabilize without significant quarterly fluctuations. And to remind you, Acadia is benefiting from qualifying as a small company manufacturer under the inflation reduction. As a point of reference, our gross price for NUPLAZID in the quarter was up just over 2% year over year. The NUPLAZID gross to net adjustment for the quarter was 24.1%.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

R and D expenses were $78,300,000 in the first quarter, up from $59,700,000 from the first quarter of twenty twenty four due to increased spend on clinical stage programs. SG and A expenses for the quarter were $126,400,000 up from $108,000,000 in the first quarter of twenty twenty four. The increase was primarily driven by the continuation of our NUPLAZID consumer activation campaigns, as well as higher commercial operation expenses for our planned expansion of the debut team. Our cash balance as of March 31 was $681,600,000,000 While cash flow from operating activities was positive in the quarter, cash declined sequentially, primarily as a result of 98,800,000 in payments made to Nurin reflecting payments of a sales milestone and their share of the net proceeds from the sale of our PRV, as I explained on our last call. Let's turn to our 2025 guidance.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

As you can see on this slide, we are reiterating the full year 2025 financial guidance first provided on February 26, with the exception of R and D expense. We now expect to spend $330,000,000 to $350,000,000 up from our prior range of $310,000,000 to $330,000,000 The increase is primarily related to the acceleration of the timeline for HCP-one hundred one, which is pulling forward spend from 2026. And to conclude, regarding uncertainty around the potential tariffs, it's important to note that for both NUPLAZID and Debut, we have substantial inventory on hand in The United States. For NUPLAZID, we have enough inventory to meet anticipated demand into the mid to late 2030s, and for Debut, we have a few years' worth of inventory. And now I'll turn the call over to Katherine for closing remarks.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks, Mark. Our first quarter results reflect a strong start to 2025 and we are well positioned to build on this momentum. We are eager to deliver on the value creating milestones you see on this slide in 2025 and 2026. I'm pleased that one of those significant milestones has been accelerated, with top line results from Compass PWS now expected in the fourth quarter of this year. We have delivered on key commitments from our Q4 call, including expanding the debut field force and launching a global managed access program.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

We remain sharply focused on executing against our strategic priorities, accelerating debut commercial trajectory, capitalizing on the continued momentum of NUPLAZID, expanding our global presence, and advancing a pipeline designed to deliver innovative therapies to underserved patient populations. In line with this strategy, we're pleased to invite you to our inaugural R and D Day on June 25, which will be broadcast live. I look forward to keeping you updated as we execute through the remainder of the year, And with that, I'll turn the call over to the operator. Operator?

Operator

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press 11 on your telephone and wait for your name to be announced. Our first question comes from the line of Ritu Baral with TD Cowen. Your line is now open.

Ritu Baral
MD & Senior Biotechnology Analyst at TD Cowen

Good afternoon, guys. Thanks for taking the question. I wanted to ask about, I guess, one question on 101 and then one question about debut for Europe. 1, what does good 101 data look like? And can you discuss how that may relate to your last discussions with FDA on the filing strategy?

Ritu Baral
MD & Senior Biotechnology Analyst at TD Cowen

And then as far as Europe, how should we be thinking about modeling a European price for debut? And then just balancing the pricing risk from a potential most favored nation drug pricing development that I think we're all sort of watching. Thanks for taking the questions.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks, Ritu. Appreciate those two part questions. So, I'm going to ask Liz to kick us off on 01/2001 and then I'll talk about the EU strategy.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Thanks, Katherine. Hi, Ritu, thanks for the question. First off, I do want to reiterate how very pleased we are to find ourselves ahead of schedule with respect to 01/2001 and looking to have data out of this study by the end of the year which we think is going be a pretty important milestone for Acadia as a company and really reflects both great effort by the team as well as I think good enthusiasm from the community, so positive all the way around. In terms of your question about what a good outcome would look like here, you know, the nature of the trial is such that I'm going to be very pleased if what we have is a statistically significant result, we've powered this such that we think that if we have statistical significance we're going to have demonstrated a clinically meaningful impact on hyperphagia which really is a defining and truly terrible symptom for these patients to be living with. There are a number of other things that we're looking at in this trial that we think are interesting, but that outcome on hyperphagia is really what's going to drive us here.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

And I'll start on the EU. You know, a two part question, Ritu, about the price in terms of modeling and then the most favored nation. Let me maybe start with most favored nation first. You know, I think as we all look out into the unknown of the future of whatever might happen with the decisions on that, we're looking really to focus on the approval of Debut in Europe, and then after that, as you know, reimbursement takes quite a period of time across the different member states and the countries, and we'll assess any specific recommendations that come out of the administration with respect to, most favored nation as we are able to sort of understand it and make decisions as we move forward on pricing and reimbursement in individual countries. With respect to EU price, I think we've spoken before about a number of rare analogues that are out there, that you can probably use for your modeling.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

What I will say is that we are confident in getting a strong EU price that allows us to display the value that we believe we're bringing with debut to our patients in the Rett community, and we will continue to update you as we have those discussions moving forward. Thanks, Ritu.

Ritu Baral
MD & Senior Biotechnology Analyst at TD Cowen

Thank you.

Operator

Thank you. Our next question comes from the line of Tess Romero with JPMorgan. Your line is now open.

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Good afternoon, Catherine and team. Thanks so much for taking our question. So for each of your brands, NUPLAZID and Debut, what is the right way for us to be thinking about what we are likely to see sequentially from 1Q to 2Q from a growth perspective? What are the key factors and drivers we should be thinking about from a quarter to quarter basis as we are trying to model this out? Thank you.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks, Tess. I'm going to ask Tom to talk about maybe patient demand, then Mark to talk about more of the sequential financials, if that's okay. So, Tom, why don't you kick

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

thank you for the question. So, I'll maybe start with debut. So, as we shared, we had a good first quarter in terms of active patients, and we believe that that's going to continue. Q2, obviously, we'll begin to see the full impact of our expanded customer model, which as a reminder, the primary goal behind that is making sure that we can really meet patients where they're seeing their treaters. As a reminder, we are pretty underpenetrated outside of the COEs, and outside of the COEs represents 65% of the overall Rett patient volume.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

So significant headroom for growth. I think with the expansion of our field model, which again, we've increased our field footprint across all functions by about 30%, We do anticipate that we will continue to see new patient adds at the top of the funnel, which is our primary focus. And at the same time, as we shared, we continue to see really encouraging data regarding ongoing persistency and discontinuations continuing to decline. And I think that that reflects just the continued learning we've had around the product, sure that we really support the rep families as they start debut. And encouragingly, as you look at the discontinuation data, we're seeing it across all of the cohorts that we've had since launch, including those who have been on treatment for less than three months, which is critically important as you think about modeling out the rest of the year, because we want to ensure that every single new patient start is able to continue for the long term.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

So that kind of touches upon debut. I think for NUPLAZID, we continue to be pleased with the impact that our unbranded and branded campaigns are having. We're seeing good momentum around referrals. Our NBRxs are looking positive. And as we mentioned, Q1 of 'twenty five was actually the best quarter that we've had in nearly five years for New Plaza, and we believe that encouraging momentum is something we will continue to pull on as we head through the rest of the year.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

Mark?

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

Yeah. Thanks, Tom. I think from a financial perspective, starting with Debut, I think both brands it's really going to be a volume story throughout the rest of the year and Tom explains the operational dynamics. On Debut from a kind of a net sales standpoint, we do expect kind of price to gradually increase over time as we benefit from kind of Medicaid. As you remember, Debut is largely Medicaid patient population, so the Medicaid pricing resets on a quarterly basis, so we should benefit from some price benefit over time about the inflation level.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

And then in Q1 for Debut, we do tend to have higher Medicaid rebates because we have a segment of our patient population are dual eligible Medicaid commercial payment patients, and those patients, as they get through their out of pocket maximums tend to shift towards commercial payments over time, and so that also is a tailwind from a little bit of price. As we've talked about on our last call and Tom mentioned, we've initiated our expansion of our debut field team and that we expect operationally to have a greater impact in the second half of the year. On NUPLAZID, I think it's probably more consistent our volume will drive the quarter to quarter performance. You don't have the same level of dynamics on changes in price over time. NUPLAZID is largely a Medicare patient population, so the pricing doesn't reset on a quarterly basis.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

So it's really a one time reset towards the end of the year. So our gross to net subject to what anything can happen on a quarterly basis due to patient mix should be, you know, mostly stable throughout the remainder of the year. We did have the big time one time adjustment, as we mentioned, comparing Q1 last year to this year, but going forward probably pricing should be relatively consistent and volume will drive the performance over the quarters.

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Great. Thank you.

Operator

Thank you. Our next question comes from the line of Ash Verma with UBS. Your line is now open.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Hi. Congrats on the progress. I wanted to ask about the pipeline. So maybe just on carbidosin. So the prior attempt by Levothyroxine, I had failed on the high dose, but successful on the low dose?

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

And typically, you generally don't see inverse dose relationship. Like, what makes you confident that low dose can generate positive data and be accepted by the FDA? And then just secondly, any thoughts on GLP one using pridoviri? Thanks.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks, Ash. I think Liz is going to answer both of those for you.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Yes, indeed. Thanks, Ash. So, you know, exactly as you say, there was a prior phase three trial that was run that had two doses, a three 3.2mg dose and a 9.6mg dose and the 9.6mg dose didn't show statistical separation from placebo, the 3.2mg dose did appear to separate from placebo, though of course that was only statistically significant. You know, as you take a step back, when we think about this, there are a few things that give us confidence in the need to run a second trial with a three point two mg dose and why that's a sensible thing to do. You know, the first of this is that there is mechanistic reason to think that oxytocin and therefore carbitocin is going to be relevant in prodder willie.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

The second piece is that as we look at that three point two mg dose dataset, we do see some signs of internal consistency, so positivity at more than one time point and positivity on more than one end point. That helps give some additional reassurance about the consistency of that data set and the likelihood that it represents truth. And then finally, I'm always looking for an alternative explanation, exactly as you say, the inverse dose response is not your typical thing, but it does happen and there needs to be an explanation as to why that might be the case. You know, it's not possible to prove ultimately with the data that we currently have in hand, but there is a good rationale for the idea that off target impact of the vasopressin receptor could have the effect of essentially obscuring the ability to see an improvement on hyperphagia and that you get more of that at the higher dose. It's a plausible hypothesis as to how we could have gotten that dose response and we take all those other pieces of information to pull together to give us some confidence in running this trial and in the likelihood that three point two milligrams is going to be useful.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

And then I apologize, I forgot to write down what the second oh, GLP-1s. So, you know, the data on GLP-1s, there is some use of it within Prader Willi. There certainly aren't definitive studies that make it clear that it is useful in this patient population, so I would say the jury is still pretty out on whether GLP-1s are helpful for patients with Prader Willi.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thank

Operator

you. You. Our next question comes from the line of Charles Duncan with Cantor. Your line is now open.

Elaine Kim
Analyst at Cantor Fitzgerald

Hi. This is Yingying Kim on for Charles. Thank you for taking our questions. I just wanted to ask for the Phase III COMPASS trial. Are there any phenotypic behaviors or patient subsets, you know, like genetic subtypes or age groups that are more likely to respond to treatment?

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thank you. I'll let Liz talk to that as well.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Sure. So, you know, I do have to give the caveat here that, of course, the data set we have based on right now is really the prior data set, which is relatively small. That said, with the data that we have to date, we haven't been able to identify subsets that are more or less likely to respond to carbitocin. We will get some more information out of this out of the COMPASS trial but of course that is a currently enrolling and currently blinded trial so I'm not able to answer that right now, but thus far nothing that clearly identifies for us patients who are more likely or less likely to respond.

Elaine Kim
Analyst at Cantor Fitzgerald

That makes sense and congrats on the accelerated enrollment. I just wanted to ask a quick follow-up regarding the R and D Day next month. I understand that you're giving additional details and data across the pipeline programs, but will you be going through each clinical programs individually? Like I understand that Essential Tremors joined recently. So what are your could you provide additional color on your plans?

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

So let's just go ahead

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

and jump in here, Kathleen.

Al Kildani
Al Kildani
Senior VP of Investor Relations & Corporate Communications at ACADIA Pharmaceuticals

No, you

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

can do So, we do anticipate touching on all of the certainly all of the currently clinically staged programs, so we would have a touch on essential tremor in there as well, and we do have some new data that I'm looking forward to sharing on that program in particular.

Elaine Kim
Analyst at Cantor Fitzgerald

Fantastic. Thank you for taking our questions.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thank you.

Operator

Thank you. Our next question comes from the line of Mark Goodman with Leerink Partners. Your line is now open.

Basma Radwan
Equity Research Associate at Leerink Partners

Hi. Good afternoon. This is Basma on for Mark. Thank you for taking our question. We have a question on debut.

Basma Radwan
Equity Research Associate at Leerink Partners

Can you provide some color on the utilization rate or the compliance in the quarter? And also if you can provide some color on the average age and weight of the patient on therapy to date and whether you see correlation between the age and the discontinuation rate. That's it for us. Thank you.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

I'm going to let Tom talk to the compliance and any insight on the weight age correlation.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

So, in terms of compliance, if you recall in the fourth quarter, we said that our compliance rate was in the low 70% range. It was marginally down in Q1 in the very high 60s. We believe that this is down to primarily customers just becoming more confident in their titration strategies. We are seeing that some patients are actually starting on a lower dose and then moving upwards as they continue with therapy. We think that this may actually be contributing to the just ongoing persistency that we're now seeing with new patient starts as well.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

Encouraging is nothing that we are overly concerned about, because our goal is to make sure that every single new patient start that we have is able to continue for the long term and truly see the benefits that we know that Debut offers. So that's what I would say around that. In terms of our broader patient mix, I mean, it continues to be across a broad range of patients. We have started to see over time some older patients, more mature patients who may not have necessarily been there at the beginning come online. And obviously they would be slightly heavier in terms of weight banding.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

But generally speaking, I think the dynamics that we've seen since launch relatively stable.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

I think the other part of that question was do we see a dynamic between persistency and age? And I think the answer is we don't actually see anything across the age range in terms of a link between age and persistency.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

As I mentioned, encouragingly, I think all of the cohorts that we saw throughout 2024, we've seen improvements in persistency across them all. I think that again, that gives us great confidence as we move into 2025, we'll be able to continue with that kind of dynamic into the rest of the year.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Great. Thanks, Tom. Cosmos, does that answer your question?

Operator

Thank you.

Basma Radwan
Equity Research Associate at Leerink Partners

Yeah, thank you very much.

Operator

Thank you. Our next question comes from the line of Paul Matteis with Stifel. Your line is now open.

Julian Pino
Julian Pino
Senior Associate - Biotechnology Equity Research at Stifel Financial Corp

Hey there.

Julian Pino
Julian Pino
Senior Associate - Biotechnology Equity Research at Stifel Financial Corp

This is Julian on for Paul. Thanks so much for taking our question. I guess another one on trofinetide for ex U. S. Approvals.

Julian Pino
Julian Pino
Senior Associate - Biotechnology Equity Research at Stifel Financial Corp

I guess, do you guys sort of see as maybe the biggest risk to the approval process? I guess, could you just speak to your confidence in getting EMA approval and eventual reimbursement there? And then, I guess a second quick one is just where does BD fit on your list of priorities this year? Is this mainly about execution you know, under new management, or, you know, are you interested in transacting as other executives have have mentioned that, you know, valuations have come down and, you know, biotechs have sort of, you know, been been reaching out to to pharmas for partnership? Thank you.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Hey. Thanks, Jillian. I'll I'll start on both of those and if Liz wants to add in. You know, in terms of our EMA, time clock, it's proceeding We're coming up to our one hundred and twenty day questions.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

As you know, we've got approval in both The US and Canada now, so regulatory team is fairly well apprised of the questions, and we had nothing, different or any communication to suggest that we're not proceeding according to the time clock. As and when we get off day 120 questions, we may share a little bit more, but for right now we're feeling very confident that we're proceeding down the right path. You know, in terms of BD, the question was, are we just going to execute or are we interested in transacting? I think, you know, we are very interested in, transacting according to our principles, and as we've shared before, we're looking for exciting assets in areas of higher met medical need where we can bring the, the, Acadia team into the space with confidence that we could commercially launch, and so we're looking for those assets right now. We're actively out there.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

We remain disciplined in terms of our P and L management and ensuring that we are keeping our P and Ls, as Mark likes to say, pristine, but we are very much looking actively, not only in our core spaces of neuro and neuro rare, but also to reinforce our direction at JPMorgan where we explained that we're now opened our aperture and are actively looking at rare diseases outside the neuro space, including endocrine, metabolic, cardiovascular, immunology, and other space. So we're excited to continue to look at that and are diligently doing that right now. The market is what the market is, and we're actively looking at those compounds against the criteria I've

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

just shared.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Tom, do you want add anything to that?

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

Yeah, I think for us, we're well positioned to act in the current environment. Think for us, question when you have kind of swings in valuations, do people on the other side of the table have their expectations reset? And I think for us, if that happens, we're able to get good strategic deals at good financial value for the company, we're ready to transact and expand the portfolio. And if that hasn't happened, we can stay patient till the right time.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks. Hope that answers your questions, Julie.

Operator

Thank you.

Julian Pino
Julian Pino
Senior Associate - Biotechnology Equity Research at Stifel Financial Corp

Absolutely.

Operator

Our next question comes from the line of David Huang with Deutsche Bank. Your line is now open.

David Huang
David Huang
Vice President Equity Research at Deutsche Bank

Hi, there. Thanks so much for taking my questions. So first on, Dave, I just wanted to ask about the persistency you're seeing here long term at twelve months. I think you mentioned it was a little bit north of 50%. Is there more work to do there?

David Huang
David Huang
Vice President Equity Research at Deutsche Bank

Do you think that can materially improve? Or are we kind of more at steady state and it would be more beneficial to focus on net patient adds? And then just with Prader Willi, your asset versus commercial positioning of Celeno's product, which is now on the market, how do you kind of think about that? Thanks a lot.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Great. Thank you for the two parted, David. I'll let Tom start on that one.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

Yep. Thanks, David. So, as we mentioned, yeah, our persistency is around 50% after twelve months. We expect that that's going to kind of stay within that ballpark moving forward. So, we don't anticipate there's going to be big swings up or down, given the data that we're seeing come through.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

Just as a reminder as to how we're getting there, I mean, we mentioned we've seen a nice continuation in terms of the discontinuation story that we showed in Q4 with a 35% improvement in quarter. We believe that that's important as we now really focus all of our efforts on driving new patient starts. And that's been the primary angle and primary focus of the expanded customer model that we mentioned as well. So absolutely, I think you should be thinking about two main factors new patient starts and active patients, because it's going to be the active patients that we believe that we can continue to grow over time that are really going to be meaningful for the ongoing revenue uptick for this brand into the long term.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Liz, do want to touch on our positioning versus the new Solana product?

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Sure. I'll start out with the fact that we're delighted for the PWS community that there is now a first therapy available for them. That said, I think we see this as an area of significant high unmet need and complex patients who are dealing with a number of different challenges. It's the kind of space where we think that it's likely that there is going to be absolutely room for multiple agents that are used with different MOAs, with different benefit risk profiles that physicians can use according to the patient that's in front of them. I don't know if there's anything you want to add here, Tom?

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

Well, the only thing I would add is we know that the Prader Willi population, they have very complex and distinct needs, and we actually believe that there's going be an opportunity for more than one product to play here. And I think with therapeutic areas like this, the notion of combination therapy could also be something that plays out into the future as well. So a pretty substantial patient population here in The US, plenty of opportunity for more than one player to play, and we will be ready to launch should the data be positive.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Yeah, and we do spend a lot of time, of course, talking to caregivers, advocacy organizations, and we hear pretty robustly that, again, they are delighted that there is something available for their family members now and they absolutely think that there needs to be continued therapies and the ability to treat an individual patient for their individual services.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks, guys. Hopefully that answers your question, David.

David Huang
David Huang
Vice President Equity Research at Deutsche Bank

Yes, thank you.

Operator

Thank you. Our next question comes from the line of Sean Lehman with Morgan Stanley. Your line is now open. Hi. Good afternoon.

Katherine Delahunt
Katherine Delahunt
Equity Research Senior Associate at Morgan Stanley

This is Katherine on for Sean. Thank you so much for taking our question. Just one from us on your earlier pipeline. For ACP seven eleven, you announced the successful completion of the Phase I MAD cohorts earlier this year. We're just curious if you can provide any color on what you observed here and if you have an update on the status of that study.

Katherine Delahunt
Katherine Delahunt
Equity Research Senior Associate at Morgan Stanley

Thank you.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Yes, so I think what I'd share there is consistent with what we put out at the time, we were pleased with the safety and tolerability profile we were seeing in that study. There are some interesting pieces on, the biomarker side that we'll be sharing at R and D Day, so please feel free to, come in and look for that. Status wise, we're continuing forward with additional explorations that we think are necessary to get us lined up for the phase two that we're planning to start in 2026, so continued good progress there.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks, Kathryn.

Katherine Delahunt
Katherine Delahunt
Equity Research Senior Associate at Morgan Stanley

Thank you.

Operator

Our next question comes from the line of Tazeen Ahmad with BofA Securities. Your line is now open.

Tazeen Ahmad
Tazeen Ahmad
MD - US Equity Research at Bank of America

Hi, good afternoon. Thanks for taking my question. For trozanatide in EU, can you maybe, Kathryn, give us

Tazeen Ahmad
Tazeen Ahmad
MD - US Equity Research at Bank of America

a sense on in what ways the launch could be different from the trajectory that Debut has seen in The U. S? I know you bring a lot of experience from launching products outside of The US. What kind of, I guess, to specifics should we be paying as we think about how to model out European launches for your drugs and how we think about DABU in general?

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Yeah, thanks Tazeen. So let me start with the European overall population being larger than The U. S, so we are, but that is sort of in line with country size, so there's no specific country that has more or less patients. So, as you know, Germany being the largest, country in the EU, we will launch first into Germany, as you know, as a period of free pricing and then after that we start to negotiate with AmNOG, and then beyond that we'll look at each of the countries and start those negotiations with the national payers. Yes, both Tom and I have very experienced at launching in Europe.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

We also have now put in place a really great team who have a lot of rare experience in Europe, and we're building up our dossiers, we're building up our value story, and we're ready to, start those discussions with the authorities as soon as we get that regulatory approval. I think to your point about learning from The US launch, as with all global launches, the launch country, which generally tends to be The US, is the one where we can learn a lot, and I think we have learned about, the importance of working with families and the importance of making sure that we really are sharing the titration strategies that have been put in place here, so there's a lot of work going on right now with the KOL communities, with the advocacy groups. You know, we had a big bolus of patients in The U. S. That came out of the gate pretty strong.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

We're also getting a lot of inquiries from patients in the European Union, and that's why we've put in place our named patient program and managed access program for those physicians that want to set trofinetide in the countries where it is legally and regulatory allowed. Those processes will be in place. We don't expect sort of the same sort of massive bolus of patient dynamics, but each country is going to be slightly different depending on how many of their patients are on those managed access programs. We feel very confident that we understand what we're doing, we understand how to get our product into the market, and we're also investing appropriately. We're not investing all over the place, we're being very strategic about where we build our teams, about where we put our people, and we will take into account any future administration, directives that affect that too.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

So, you know, we're very conscious about it, but also very excited and mostly excited by the advocacy groups who are very, very interested in accessing trofinetide for the loved ones. Thanks Tazeen for the question.

Operator

Thank you. Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is now open.

Anish Nikhanj
Anish Nikhanj
Senior Associate - Biotechnology Equity Research at RBC Capital Markets

Hi, Catherine and team. It's Anish on for Greg. Congrats on the progress this quarter and thanks for taking our questions. Firstly, as a follow on to David's previous question, what unique aspects of your commercial engine or priorities within the target market do you believe you'll be able to leverage to rise above competitors in the PWS market with both with respect to Seleno and other therapies in development? And secondly, obviously, there's a lot of concern across the sector on macro and policy exposure for companies.

Anish Nikhanj
Anish Nikhanj
Senior Associate - Biotechnology Equity Research at RBC Capital Markets

I know you commented on inventory already, but maybe if you could just share some thoughts around where Debut and NUPLAZID might be impacted along their respective supply chains and how you're navigating that. Thanks so much.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Great. Thanks, Anisha. Quite a few different subsets of questions there. So let me start, by just giving you an overview of my thoughts around the commercial engine. I'll ask Tom to add and then we'll throw it to Mark to talk about supply chain, and tariffs.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

In terms of commercial engine, you know, have a very strong team now both in neuropsych and in rare, who understand the subtleties of launching within a rare space, and we've learned a lot through the debut launch. So, we feel very well prepared as a company to work within the Prader Willi community. We have strong, associations with them already. We have our teams out there right now, and as Liz has already outlined, we feel very strongly that the community is asking for as many options as possible for their patients. These are complicated, complex patients, and, we'll see over time the need, I believe, for more than one therapy option for sure.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

So, we feel very confident in our ability to go out there and compete, but also offer patients choices, which we believe are very important. Tom, is there anything you'd bring from that, your previous experience in RARE?

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

I would say that clearly we have already launched a RARE product in very recent history with Debut. I think we've learned a great deal as we've gone through that launch. As Catherine mentioned, I think both Catherine and I have had the privilege of launching products in other rare spaces. And I think being able to continue to build that muscle, make sure that we're pulling through the experiences that we have, and really make making sure that as the 101 data reads out, that we're able to leverage the product profile in an appropriate way as quickly as possible, taking all of the learnings that we already have, but also thinking about some of the unique aspects that we bring at Acadia with a true focus on the patient and on patient advocacy, I think we will have a significant leg up in making sure that we can be highly competitive even as a fast follow.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Mike, do want talk about supply On

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

the supply chain standpoint,

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

obviously we're monitoring all the events of the day as it relates potentially to tariffs that may come forth for the industry. I think as our supply chain set up today, our API for both products is manufactured outside The US. ABU has drug product manufacturing in Canada and The US. The drug product manufacturing for NUPLAZID is all in The US. I think what we've done thus far in recent months, as I mentioned on the call, was onshore as much inventory as possible due to investments that the company had made previously in advance of a potential DRP approval.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

The company did make investments in inventory for supply for Covanserin, which is why we have the supply. All of that's on, you know, in The United States today and can last us into the mid to late 2030s. And we don't own any manufacturing sites, so we don't have any infrastructure that's set up with our supply. Like everybody, we look at our supply chain to make sure we have assurances of supply, redundancy, high quality suppliers, appropriate price, you know, if there are tariffs, you know, that's one cost that will be considered in the overall supply chain. But from a manufacturing standpoint, you know, time and investment can change everything.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

So nothing's permanent, but nothing changes overnight. I think we feel very comfortable in the position that we are today with our inventories, and we'll keep the supply chain as is until there's a appropriate reason, whatever that may be, change it, we can do that in the future.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

I thought.

Operator

Thank

Operator

you. Our next question comes from the line of Yatin Suneja with Guggenheim. Your line is now open.

Yatin Suneja
Senior Managing Director, Biotechnology Analyst at Guggenheim Partners

Hey, guys. Thank you for taking my question. Question on the Prader Willi study. Are you able to talk about the powering of the study? I understand the size of the study is pretty robust.

Yatin Suneja
Senior Managing Director, Biotechnology Analyst at Guggenheim Partners

What effect size are you powered for? What is the minimum delta you are able achieve? Thank you.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Yeah, I'll ask Liz to talk about the effect size and the powering for our study.

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

Yeah, so I think probably the most important thing to orient here is that we have a study that is substantially larger than the prior study where there was nominal significance but where if 3.2 had been run by itself we would have anticipated having a significant p value, so that is a check-in our column. As far as we think about the specifics of the powering that underlies this, we actually looked at a number of different potential powering scenarios to make sure that we were adequately covered for a few possibilities. The one that is, most obviously disclosed is a slight increase in terms of the delta between placebo and active and that's reflective of

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

the fact that we have

Elizabeth Thompson
Elizabeth Thompson
Executive VP and Head of Research & Development at ACADIA Pharmaceuticals

a slightly longer time point in this trial than we did in the prior study. But I think broadly consistent expectations with what we've seen historically and a number of different scenarios that get us with, you know, strong 80 plus percent powering.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Thanks, Liz. Thanks for the question.

Operator

Thank you. Our next question comes from the line of Joel Beatty with Baird. Your line is now open.

Joel Beatty
Senior Research Analyst at Baird

Hi. Thanks for taking the question. It's a little bit of a math question on DayView and the ability to find new patient starts faster than patients discontinue. And I guess it's in the context of getting close to one thousand patients on therapy in a quarter now, and then a discontinuation or persistency rate at twelve months of about fifty percent. So putting those numbers together, I guess the question is, would that mean to expect about five hundred patients dropping off over the course of a year?

Joel Beatty
Senior Research Analyst at Baird

Then if so, how realistic is it to be able to find 500 plus patients of new starts to be able to replace that?

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Let me try and reorient the math a bit, and if I get convoluted, somebody can help simplify. But you're right, in terms of the patients actively shipped in the quarter, nine fifty four. Now, of those patients, sixty five percent of them, just above actually, have been on therapy for more than a year, so it's important to understand that within that nine fifty four there are different cohorts of patient start times, but, more than sixty five have been on the product for over a year. We continue to see strong persistency beyond a year, so we're not seeing sort of a sudden drop off beyond that either, So, it's really a cohort question, if I may, in terms of the math job, and in terms of new stuff added every quarter and the expected time that that patient stays on therapy. Again, we've given you the twelve month, if you like, persistency rate however, we are seeing patients stay on therapy for much longer than that, so that's sort of maybe a way to think about it.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Mark or Tom, if

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

I could

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

we talk about twelve months, that's the first twelve months of therapy. It's not each twelve months of therapy. So the persistency rates are very high kind of after, know, the curve is like plateauing after as you get out in time. So it's really in that first twelve months that we keep more than fifty percent of our patients. And then beyond that time, it's a very high rate of persistency.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

So as Catherine mentioned, we have that stable base of patients that are on therapy more than twelve months, sixty five percent of our current patients. And so then we're adding patients on top of that, and that's how the patient count grows over time.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Maybe I'll just give you one statistic that gives you maybe a thought. As we went through 2024, we started sort of with eight seventy or so patients shipped per quarter and now we're at nine fifty four, so again they don't drop off at the end of the year they They continue to stay on therapy. Hoping that helps you out, Joel. If you need some more follow-up, I'm happy to do that too.

Operator

Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord Genuity. Your line is now open.

Sumant Kulkarni
Sumant Kulkarni
Managing Director at Canaccord Genuity Group

Good afternoon. Thanks for taking my questions. I have two quick ones. Given post trial briefing is done on the pimavanserin two case, could you remind us of your latest assumptions on when you might expect generic competition on lenoplazib? And second, on trofinetide, do you expect to start recognizing European revenue from France via the paid early access program that country allows?

Sumant Kulkarni
Sumant Kulkarni
Managing Director at Canaccord Genuity Group

And how important might that type of initiative be to give you a good sense of how the product might launch in the rest of Europe?

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Okay, I'm going to ask Mark to update you on MUPLAZID and then I'll take the France question.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

Yes, on PIVVANSAR and IP, we remain kind of in the view that we have bookends, The short end of the bookend would be October 2030, the long end of the bookend is February 2038. Really nothing has changed with our reasoning behind that as we've been talking over the last months and year, whatever the timeframe would be. Really the only update since the last time we've talked publicly is that oral arguments for the appeal on our composition of matter is now scheduled for June sixth of this year.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

In terms of France, I'll start and Tom can add color. I think you're referring to the ATU program in France, which has now got a different acronym that's currently escaping me, but essentially it's the early access program where the French government pays for product. We putting in place mechanisms for that program to be activated in France for debut. There are a number of regulatory and legal considerations we need to put in place before that action, but that's actively going on right now. As you know, once you then get reimbursement through the Transparency Commission, those patients switch over to, paid product from the French government, and that's our current plan.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Again, you know, we have to understand what the French, situation is nearer to the time, but we are planning for the ATU to be activated this year and we're planning for those patients to transition over to commercial product once those negotiations have completed. Tom, did I miss anything?

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

No, think as it relates to France, that's entirely true. The other thing I would say is obviously Germany, we will be having a managed access program there as well. Actually Germany, if you recall, will be out of the gates pretty significantly ahead of where we are in France. So I think if you want to have a good barometer as to what's going to be happening in Europe, the German launch will be the one to watch because we do anticipate having patients enrolled in that early access program. As a reminder, on day one, once we have a European approval, they will be able to be switched over to commercial drug with free drug pricing as well.

Thomas Garner
Thomas Garner
Chief Commercial Officer at ACADIA Pharmaceuticals

So more to come, but that's how we expect to see things playing out.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Hopefully that answers the question. Take the next one.

Operator

Thank you. Our next question comes from the line of Malcolm Hoffman with BMO Capital Markets. Your line is now open.

Malcolm Hoffman
Malcolm Hoffman
Senior BioPharma Equity Research Associate at BMO Capital Markets

Hi. Malcolm on for Evan from BMO. I wanted to touch on Neuplaza gross to net. I believe you said gross to net for the quarter was roughly 24% and the guide suggests a range for the year of 22.5% to 25.5%. Can you just talk through what pushes and pulls you expect can move this gross to net one side or another of the guide?

Malcolm Hoffman
Malcolm Hoffman
Senior BioPharma Equity Research Associate at BMO Capital Markets

Thank you.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Yeah, I'll let Mark take the gross net question.

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

Yeah, I

Mark Schneyer
Mark Schneyer
CFO at ACADIA Pharmaceuticals

think right now we're at least the first quarter is kind of right in the middle of our guidance. It really is just patient mix, which we don't control, it's just the payers for our patient base can change over time and that can influence quarterly fluctuations in what the gross to net is on the year. The other thing does is that influences it, is that we take any pricing action. We had a small modest price increase at the beginning of the year, we don't foreshadow when we may or may not take pricing action, we price our medicines to value and we just announce that when and if we do it over time.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Great. Thanks, Mark.

Operator

Thank you. I'm showing no further questions at this time. I would now like to turn it back to Kathryn Owen Adams for closing remarks.

Catherine Owen Adams
Catherine Owen Adams
CEO at ACADIA Pharmaceuticals

Well, just thanks, everybody, for your questions this quarter. We look forward to continuing to deliver on our commitments to our patients and updating you on our progress next quarter. Thanks again for your questions.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Executives
    • Al Kildani
      Al Kildani
      Senior VP of Investor Relations & Corporate Communications
    • Catherine Owen Adams
      Catherine Owen Adams
      CEO
    • Thomas Garner
      Thomas Garner
      Chief Commercial Officer
    • Elizabeth Thompson
      Elizabeth Thompson
      Executive VP and Head of Research & Development
    • Mark Schneyer
      Mark Schneyer
      CFO
Analysts
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Key Takeaways

  • Acadia delivered Q1 2025 revenues of $244.3M, up 19% year-over-year, driven by Debut sales of $84.6M (+11%) and NUPLAZID sales of $159.7M (+23%), and reiterated full-year guidance.
  • Debut achieved a record 954 unique patients receiving shipments in Q1, with a 35% sequential drop in discontinuations and over 50% 12-month persistency, supported by a completed 30% field-force expansion to boost community penetration.
  • NUPLAZID saw its best quarter for new-to-brand prescriptions since 2020, with 6% volume growth and enhanced by unbranded and branded consumer campaigns lifting patient and physician awareness of Parkinson’s disease psychosis.
  • The R&D pipeline gained momentum, with COMPASS PWS Phase III topline results now expected in Q4 2025 (potential U.S. submission in Q1 2026), ACP-204 advancing in Alzheimer’s and Lewy body dementia psychosis, and an inaugural R&D Day on June 25.
  • Acadia reaffirmed 2025 revenue guidance, raised R&D investment to $330–350M due to accelerated HCP-101 spending, and cited a strong cash balance ($681.6M) plus ample inventory to mitigate potential tariff risks.
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Earnings Conference Call
ACADIA Pharmaceuticals Q1 2025
00:00 / 00:00

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