NASDAQ:ACAD ACADIA Pharmaceuticals Q2 2025 Earnings Report $25.33 +0.80 (+3.26%) Closing price 08/15/2025 04:00 PM EasternExtended Trading$25.33 0.00 (0.00%) As of 08/15/2025 07:55 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast ACADIA Pharmaceuticals EPS ResultsActual EPS$0.16Consensus EPS $0.14Beat/MissBeat by +$0.02One Year Ago EPS$0.20ACADIA Pharmaceuticals Revenue ResultsActual Revenue$264.57 millionExpected Revenue$263.07 millionBeat/MissBeat by +$1.49 millionYoY Revenue Growth+9.40%ACADIA Pharmaceuticals Announcement DetailsQuarterQ2 2025Date8/6/2025TimeAfter Market ClosesConference Call DateWednesday, August 6, 2025Conference Call Time4:30PM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by ACADIA Pharmaceuticals Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 6, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Q2 total revenue reached $264.6 million, up 9% year-over-year, driven by 14% growth in Debut sales and 7% growth in NUPLAZID sales. Positive Sentiment: Raised the low end of 2025 NUPLAZID guidance to $665 million–$690 million in expected net sales, citing disciplined execution and strong DTC momentum. Positive Sentiment: Debut’s commercial expansion delivered 987 unique patients in Q2, achieved over 45% 18-month persistency, added 900 community HCP writers, and saw early DTC engagement. Positive Sentiment: Robust pipeline showcased at R&D Day with nine disclosed programs—ACP-211 and ACP-271 among them—planning seven Phase II/III starts by 2026 and five readouts by 2027. Neutral Sentiment: Second-quarter R&D expenses were $78 million and SG&A expenses were $133.5 million, reflecting increased investments in commercial team expansion and ongoing development. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallACADIA Pharmaceuticals Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals Conference Call. My name is Gerald, I'll be your host for today. I would now like to turn the conference over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at Acadia. Please proceed. Al KildaniSVP of IR & Corporate Communications at ACADIA Pharmaceuticals00:00:21Thank you. Good afternoon and thank you for joining us on today's call to discuss Acadia's second 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 commercial brand debut in 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 Schneider, our Chief Financial Officer, who will review the financial highlights. Kathryn will then provide some closing thoughts before we open up the call for your questions. Al KildaniSVP of IR & Corporate Communications at ACADIA Pharmaceuticals00:01:03We are using supplemental slides, which are available on our website's Events and Presentations section. 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. Al KildaniSVP of IR & Corporate Communications at ACADIA Pharmaceuticals00:02:03I'll now turn the call over to Kathryn for opening remarks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:02:06Thank you, Al, and good afternoon, everyone. Our second quarter performance reinforces the momentum we're building across all facets of our business, from commercial strength to our clinical pipeline and global expansion. We delivered total revenue of $264,600,000 this quarter, driven by strong growth across our portfolio. This includes $96,100,000 from Debut, with patient uptake continuing to grow for the second successive quarter and $168,500,000 from MUPLAZID, fostered by new patient starts and commercial execution. Dayview has now passed stabilization, moved into growth, and is entering a new phase, expansion and acceleration. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:02:55Our investments in patient support, community engagement, and field expansion are starting to make a positive impact, as Tom will highlight in more detail. On Neuclazid, we're encouraged by continued growth across all leading indicators, bolstered by recent litigation wins enforcing our intellectual property. These victories validate our long term strategy and reinforce our ability to deliver Neuclazid to patients through 02/1938. Our full year revenue guidance reflects this confidence. We are raising the low end of our NUPLAZID guidance based upon a foundation of disciplined execution and momentum delivered by our DTC campaigns. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:03:42We also hosted our first R and D Day, a milestone event that showcased our exciting and expanding pipeline With nine disclosed programs in development and five Phase II or Phase III data readouts expected through 2027, the excitement within Acadia is palpable. Liz will walk you through that shortly. First, let's start with commercial. Over to Tom. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:04:07Thanks, Kathryn. Let's begin with Dayview. Q2 sales were $96,100,000 up 14% from a year ago. We observed steady progress across key performance metrics in the quarter. In Q2, nine eighty seven unique patients in The U. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:04:26S. Received paid shipments, increasing from nine fifty four in Q1 and nine twenty in Q4 twenty twenty four. The upward trend reflects encouraging signs of growth in both new patient starts and persistency. Long term persistency remains a key strength for DayView. Our twelve month persistency rate continues to exceed 50%, and we're now pleased to report that our eighteen month persistency rate is above forty five percent. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:04:59This trend reflects the growing and stable base of patients who remain on therapy over time. When we look at length of treatment among patients currently on therapy, seventy percent have been on treatment for at least twelve months, highlighting the sustained benefits that Debut continues to deliver and the durability of our growing patient base. Notably, we're seeing more new prescriptions from the community setting, signaling progress in broadening reach beyond academic centers, which was a key element of our field force expansion, which is now complete. We finished hiring and training earlier this quarter, and we're already seeing encouraging signs that the new customer model is gaining traction. One of the most promising indicators in the second quarter is a meaningful uptick in our proportion of new referrals coming outside of centers of excellence, where a majority of Rett patients receive their primary treatment. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:05:56Encouragingly, this increase was underpinned by a further increase in the number of new community based writers for Debut, with 900 total HCPs now having written. Additionally, we launched a direct to consumer campaign for Debut in July, and we are already seeing positive signs of early engagement from the Rett community. During Q2, we welcomed Alison McMillan Youngblood, a senior vice president of our rare disease franchise. Alison brings a breadth of commercial experience across The U. S. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:06:29Biopharma business, including many launches. Her leadership will help to drive this critical business forward. As we look ahead with the expanded team now in place, we're continuing to execute against our strategy to drive long term sustainable growth for Dayview. We expect this will translate into an increase in new patient starts towards the back end of the year. At the International Rett Syndrome Foundation meeting in June, our presence as a leader in the Rett therapy field was felt. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:07:02As Liz will detail, we shared multiple compelling posters that add to the body of evidence for DayView. Let's now turn our plans to trofinetide outside The U. S. In The EU, where the prevalent population is estimated to be between nine thousand to 12,000 Rett patients, named patient supply as requested by local HCPs is available through Clinigen. We've received requests from multiple countries and are continuing to support patients where regulatory frameworks allow. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:07:35Named patient supply based upon HCP requests is also in place in Israel through Rafa and in select rest of world countries through Pharmamunda. Overall, we're pleased with the continued momentum of DABU in The U. S. And with the global interest in trofinetide, where we have already started serving patients through these programs. Now, turning to New Blazid. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:08:00Our commercial team delivered another strong quarter with revenue of $168,500,000 up 7% from a year ago, driven primarily by volume. We saw strength across all key metrics in Q2. Referrals were up 17% year over year, driven by continued momentum in our direct to consumer campaign. As a result, for the first time ever, both referrals and new prescriptions increased sequentially from Q1 to Q2. Another of the quarter's highlights was shipping the highest number of new Puzzet bottles since launch, a strong indicator of growing demand as we continue educating both healthcare providers and patients with PDP about the product's unique and differentiated profile. The DTC campaigns are doing exactly as we intended, sparking meaningful conversations with healthcare providers and reinforcing our commitment to educating caregivers about the symptoms of hallucinations and delusions related to Parkinson's disease. Visits to newplazit.com have surged, with a 17 fold increase in consumer traffic year over year, helping to drive more patients to speak with their physicians. To carry this momentum forward, we're pleased to extend our agreement with Ryan Reynolds and the Molt to Parkinson's campaign through February 2026. The campaign continues to drive meaningful awareness of hallucinations and delusions in Parkinson's disease, and we believe a strong push through year end is essential to build on that success. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:09:42This quarter's NUPLAZID results reflect the strong executional focus of our field teams, coupled with the ongoing positive impact of our DTC efforts. Taken together, we expect to see sustained growth through the second half of the year and beyond. And with that, I'll hand it to Liz to review our pipeline progress. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:10:03Thank you, Tom. Let me begin by revisiting the highlights from our inaugural R and D Day held in New York on June 25, where we showcased the strength and breadth of our pipeline. We were pleased with how the event came together and I want to thank many of you on this call who were able to join us. While we had already disclosed all the programs on this chart, R and D Day gave us great opportunity to provide more details, particularly for two newer molecules. The first is ACP-two eleven, an orally administered, selectively deuterated form of R nortetamine, which we're developing for the potential treatment of major depressive disorder. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:10:44Dated state support the potential for efficacy without significant sedation or dissociation, a profile we will continue to explore in phase two and beyond. The second is ACP271, a GPR-eighty eight agonist with potential applications in tardive dyskinesia and Huntington's disease. This is some of the most novel biology in our pipeline and we believe it to be the first GPR-eighty eight agonist that will enter clinical trials. If you weren't able to participate in our R and D Day, I highly encourage you to visit our website where you can access the webcast and the full set of presentation slides. The event was a clear demonstration of the momentum building across our pipeline. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:11:30We're advancing with purpose and clarity and the progress is tangible. Across our nine disclosed programs, we anticipate initiating seven phase two or phase three studies over the course of 2025 and 2026. Moreover, between 2025 and 2027, we expect five phase two or phase three readouts. These milestones underscore both the breadth of our pipeline and the strength of our R and D strategy. Specifically, we have several important trial initiations and data readouts on the horizon. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:12:06In Q3 twenty twenty five, we plan to initiate a Phase II study of ACP-two zero four in Lewy body dementia psychosis. Also in the third quarter, we expect to initiate our Phase III study of trofinetide in patients with Rett syndrome in Japan. In early Q4 twenty twenty five, we expect to report top line results from the COMPASS PWS Phase III study of ACP101 in Prader Willi syndrome following the completion of enrollment in Q2. Also in Q4 twenty twenty five, we anticipate initiating a Phase II study of ACP211 in major depressive disorder. Wrapping up the year, we plan to begin a first in human study of ACP-two seventy one in healthy volunteers before year end. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:12:54And finally, we also continue to progress through the review process with EMA for trofinetide with agency decision expected in the 2026. In addition to these upcoming milestones, we continue to make meaningful contributions to the scientific literature for our marketed and pipeline products. The second quarter was a busy one for Acadia relevant medical meetings with major conferences for Rett syndrome, Prader Willi syndrome, and Alzheimer's. First, there were multiple Dayview related presentations at the International Rett Syndrome Foundation meeting continuing to expand the body of evidence describing Dayview's long term impact in the Rett community. Several posters focused on caregiver reported outcomes and real world data, which importantly continue to align with what we have observed in clinical trials. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:13:48Additionally, there were analyses evaluating treatment utilization in less commonly studied populations, such as males and older patients. And finally, Acadia shared an analysis of our clinical trial data suggesting that most patients who are going to benefit from Dayview show a response within six months, reinforcing our guidance to providers and caregivers. Together, these data points reflect a growing and maturing evidence base that continues to shape how Dayview is understood and used in the real world. In the pipeline, both ACP101 and ACP204 teams had important meetings in the quarter. In Prader Willi Syndrome, the June marked the United and Hope meeting, the joining together of three separate PWS organizations in a combined meeting. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:14:40Those of you who tuned in to R and D Day will recall that our PWS panel in part was live from United and Hope. As we await data out of our phase three trial, we nevertheless are contributing to the knowledge and understanding of PWS with posters about the experience of patients and families exploring comorbidities and the associated burden. In the Alzheimer's space, I'm also pleased to report multiple ACP two zero four presentations at the Alzheimer's Association International Conference held last week in Toronto. This meeting represented a significant step in our public disclosure of detailed data from nonclinical and early stage clinical studies supporting ACP-two zero four's attainment to date of its desired profile. Presented data included the specificity for five HT2A and the supported PK profile indicating a faster time to steady state, support for daily dosing, the lack of QT prolongation, and the ability to dose with and without food. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:15:42We also shared clinical data primarily focused on the sixty milligram dose across several phase one trials with supportive safety and tolerability profiles to date, including in healthy elderly subjects. Collectively, the data provides support for the potential utility of ACP two zero four and key aspects of its target profile. Lastly, I'll touch briefly on ACP 101, where we continue to expect top line results in early Q4. Just as a reminder, this is a twelve week placebo controlled parallel group study. That design is important because, if successful, it would allow us to clearly describe for physicians and patients what to expect upon initiating therapy in a Prader Willi syndrome patient population. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:16:31Should the data be positive, we anticipate being in a position to file in the 2026, and we continue to anticipate that this will qualify as a resubmission with the FDA with the associated shorter potential review clock with a potential PDUFA date in the 2026. And now, I'll pass over to Mark for a financial overview of the quarter. Mark SchneyerCFO at ACADIA Pharmaceuticals00:16:54Thanks, Liz. Let's now review our second quarter twenty twenty five financial results. The second quarter was strong across the board with $264,600,000 in total revenues, up 9% year over year. Second quarter debut net product sales of $96,100,000 represented 14% year over year growth, including 12% volume growth, primarily reflecting the increase in unique patients receiving shipments in the quarter. The debut gross to net adjustment for the quarter was 23.3%. Mark SchneyerCFO at ACADIA Pharmaceuticals00:17:33Turning next to NUPLAZID, second quarter net product sales were $168,500,000 up 7% year over year with 5% of that growth attributable to volume. The NUPLAZID gross to net adjustment for the quarter was 24.6%. R and D expenses were $78,000,000 in the second quarter, up slightly from $76,200,000 in the 2024. SG and A expenses for the second quarter were $133,500,000 up from $117,100,000 in the 2024. The increase was primarily driven by increased expenditures for both debut and NUPLAZID in The US, including the planned expansion of the debut commercial team. Mark SchneyerCFO at ACADIA Pharmaceuticals00:18:26We ended the quarter with a cash balance of $762,000,000 up from $681,600,000 at the end of Q1 and $756,000,000 at the 2024. Let's turn to our 2025 guidance. We are raising the low end of our NUPLAZID guidance range, reflecting the strength of the business and its performance to date. We now expect NUPLAZID net product sales for the year to be between $665,000,000 and $690,000,000 This compares with our prior guidance range of $650,000,000 to $690,000,000 Accordingly, we are also adjusting our U. S. Mark SchneyerCFO at ACADIA Pharmaceuticals00:19:11Only total revenue guidance to reflect this change. As you can see on the slide, we are reiterating all other prior guidance ranges from our Q1 call. We're confident in our ability to execute against these targets and to continue creating value for patients and shareholders. I'd now like to hand it back to Kathryn for closing remarks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:19:35Thanks, Mark. As you've heard, quarter two was a quarter of progress and momentum. Our teams are executing with urgency and precision, and we remain focused on accelerating debut commercial trajectory, sustaining long term growth and differentiation for NUPLAZID, advancing a deep pipeline through rigorous clinical development, and continuing to build the pipeline through business development, and expanding globally to reach more patients in need. The next major milestone is ACP101's data readout in early Q4, and we're hopeful for what that could mean for families living with Prader Willi syndrome. Thanks for joining today's call, and thank you for your continued support of Acadia. I'll now open it up for questions. Operator? Operator00:20:26Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star, one, one on your telephone and wait for your name to be announced. To withdraw your question, press 11 again. Please stand by while we compile the Q and A roster. Operator00:20:49Our first question comes from Tess Romero from JPMorgan. The floor is yours. Tessa RomeroEquity Analyst - Biotechnology at J.P. Morgan00:20:57Good afternoon, team. Thanks so much for taking our questions. So I actually wanted to ask about ACP101 today. Liz, maybe could you orient us to the approach you plan to take with your top line? How much detail will you provide and will this be more qualitative or quantitative in nature? Tessa RomeroEquity Analyst - Biotechnology at J.P. Morgan00:21:18And are there any secondary or other endpoints that you will think will matter beyond HQCT? And then as a follow-up, where are you really most focused from a clinical trial conduct perspective to manage any key risks? Thanks. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:21:36Thanks Tess, great question. So in terms of our approach to top line, and for that matter in terms of our approach to how we're thinking about this trial, first and foremost is the primary endpoint and success there. We will be looking at our secondary endpoints which are of clinician assessments as well as a responder bar for the, HQCT as well. In terms of what we're going to release, certainly I would anticipate that there would be a focus on the primary endpoint and key overview of safety and tolerability and that's what you should anticipate out of our top line announcement. In terms of the areas that we are focusing on in terms of clinical trial conduct, We have been, you know, throughout, we have been robustly keeping on top of how the, assessments appear to be performed and whether variability was within our expected ranges. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:22:37So those are the areas that we've been focusing on in terms of conduct and making sure that we have as consistent a behavior as possible across the sites. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:22:46Thanks, Liz. Thanks for the question, Tess. Operator00:22:51Thank you for your question. Our next question comes from Ritu Baral from TD Cowen. The floor is yours. Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:23:02Good afternoon. Thanks for taking the question. I wanted to talk a little bit or ask a little bit about the new momentum in Dabu. Could you tell us what percentage of patients, or new patients specifically, came from the community setting? And, you mentioned the new number of 900 HCP riders. Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:23:30What percentage, or at least movement of those riders were in the community setting on, a quantitative basis? And then I have a Prader Willi follow-up as well. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:23:42Thanks, Ritu. We'll take the daily question first. I'll ask Tom to give you some more details on that. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:23:47Perfect. Good afternoon, Ritu. Hope you're doing well. So, in terms of your first question regarding the penetration that we've seen as a result of the increase in the sales force, which as a reminder, that went live through May. So, we're fairly early on in terms of seeing the impact, but we're pleased with what we're seeing already. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:24:06In the quarter, we actually saw that the number of referrals that were coming directly from our non COE accounts actually grew to about three quarters of our overall number. So that was up from about two thirds the quarter before, which I think is a nice increase in terms of being able to penetrate that large group of patients that we know exist that fall outside of our COEs. So just as a reminder, roughly 65 of our patients fall outside the direct care of one of the COE designated centers. With regards to your second question as to the additional writers that we saw through Q2, the vast majority of those new writers fell outside of the COEs, which given the fact that we saw this nice uptick in terms of penetration through the quarter, I think again is a nice leading indicator that the new model that we have in place is beginning to pay dividends for us. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:25:07Thanks, Tom. Do you want to ask your one on one question, Ritu? Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:25:10Yes, and just mopping up after Tess' questions, can you talk to how the conduct, specifically dropouts, of the Phase III pre or willy have gone? Are they within expectations? And are all the DSMB looks, for the trial completed and if the SAP has been finalized with FDA? Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:25:34So I am not going to comment on data from a currently ongoing trial aside from to say that generally speaking we are continuing to see this trial, unfolding in an acceptable way, but obviously it's blinded and I'm not going to comment any further on that at this point. We do have an SAP in place. I do consider that we have the right to continue to modify until before we unblind the trial, but we do have our planned analyses established at this point. Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:26:06Great, thank you. Operator00:26:07Thank you for your question. Our next question comes from Sean Lammond from Morgan Stanley. The floor is yours. Michael RiadEquity Research Associate at Morgan Stanley00:26:20Hi, this is Mike Riyadh on for Sean. Thank you for taking our questions and congratulations on the quarter. So thinking about debut, the nine eighty seven new patient adds, suggest a good steady growth rate quarter over quarter. How should we be thinking about this trajectory? Given the relative lower prevalence, is it reasonable to expect that this would ever accelerate and doesn't need to? Michael RiadEquity Research Associate at Morgan Stanley00:26:43Or how should we be just thinking about that trajectory? Thanks so much. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:26:49So, it's Tom here. I'll take that one. Thank you for the question. So, we're pleased with the steady growth that we've seen over the last three quarters. I think as we mentioned in the call, if you look at Q4, we had around nine twenty patients that increased close to nine fifty four in Q1 and we're pleased with the continued growth that we saw through Q2 with nine eighty seven active patients on therapy. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:27:13Obviously, the plan that we have moving forward is that that will continue to accelerate as we see the impact of our new customer model. And our goal is to make sure that we have more new patient starts continuing week over week and month over month and quarter over quarter. And I think now we have this very stable and growing group of persistent patients, many of whom have now been on treatment for twelve months or longer, I think gives us a real sense that we can really continue to grow this brand and take it to new heights. Michael RiadEquity Research Associate at Morgan Stanley00:27:46Thanks so much. Operator00:27:48Thank you for your question. Our next question comes from Jason Butler from Citizens JMP. The floor is yours. Jason ButlerMD & Biotechnology Equity Research at JMP Group LLC00:28:01Hi, thanks for taking the questions. Just one on Neplazid. Given that you're seeing a return on investment on, for example, DTC activities and now that you have the greater visibility with intellectual property, are there more investments or longer term investments that you're considering for the franchise? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:28:22Hi, Jason. Thanks for the question. You know, I think as as we think about our strategy with Newfoundland, I tried I encourage us to sort of bifurcate, the commercial strategy that we're putting in place now with the longer term ability to now maximize the brand. Direct to consumer decisions that we're making are sort of relative to the 2038 shorter term. We're seeing, impact of the DTC. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:28:45We would have continued to invest regardless of the outcome of the IP trial because it has a strong momentum for the next sort of two to three years potentially depending on how long we continue to invest. Beyond that now, what we have been able to do is think about the longer term strategy for Neoplasm. I'm looking forward to sharing a little bit more about that as we talk as we head towards the back end of the year in terms of how we now think about the investment longer term, but for right now the DTC campaign is certainly paying dividends as you point out, and we're excited about the continued momentum and indeed in terms of the, more to Parkinson's campaign and raising awareness of hallucinations and delusions, we're delighted that Ryan Reynolds has agreed to continue supporting that campaign, because we believe that's been one of the main drivers of increased awareness, and once a caregiver is aware, they're encouraged to go in and talk to their doctor. It's been a very strong impact to caregivers and we're excited to continue that. Thanks for the question. Jason ButlerMD & Biotechnology Equity Research at JMP Group LLC00:29:44Thank you. Operator00:29:47Thank you for the question. Our next question comes from Brian Abrahams from RBC Capital Markets. The floor is yours. Brian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital Markets00:29:59Hey, guys. Congrats on the quarter. Thanks for taking my questions. Just two for me, guess, both on debut. As you've expanded the sales force, can you talk a little bit more, I guess, qualitatively around your learnings from patients outside of the centers of excellence, just in terms of physician receptivity, number of prescriptions per physician, any early persistent signals and how well educated the docs are around the titration? Brian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital Markets00:30:26And then can you also maybe talk about any hints of changes you may be seeing in overall debut persistence both quarter over quarter and bigger picture trends? Just how much the education around AE management and the efficacy message and importance of staying on therapy is resonating? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:30:43Thanks, Brian. I'll let Tom come up with his thoughts on that. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:30:47Yeah, thanks for the question. So, yeah, we've already had a number of learnings as we've expanded beyond the COEs. One of the key things is there is clearly receptivity to debut outside of the COEs. We know that there are physicians who are treating rep patients who won't necessarily have been called on yet, and we're appreciating that they require ongoing education to make sure that they fully understand the profile of the product, they fully understand how to utilize the product, and we're utilizing the full mechanics of the system that we've built to make sure that we can educate all of those prescribers as quickly as possible. So, I think one thing that you probably need to be thinking about as you look at modeling is that the buying process, the number of calls, may be slightly longer for this group of prescribers versus those that we see for COEs. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:31:42And that's purely because they just don't see Rett patients as frequently. As you talk about persistency, we're really pleased with the persistency that we're seeing. So as I mentioned on the call, twelve month persistency remains well above 50%. And as we also mentioned mentioned for the first time, our eighteen month persistency, although not yet fully mature, is above 45%. So I think that that gives us a real good sense that we've kind of reached a nice kind of plateau as we go into the longer term outlook for the product. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:32:14And that gives us, with this growing group of patients who are now receiving therapy, a sense that we can continue to grow JBU to newer heights, as I've mentioned, as we get new patients started. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:32:28Thanks, Tom. Thanks for the question, Brian. Brian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital Markets00:32:30Thanks a lot. Operator00:32:31Thank you for your question. Our next question comes from Ami Fadia from Needham and Company. The floor is yours. Ami FadiaSenior Analyst at Needham & Company00:32:45Good evening. Thanks for taking my question. I have two quick ones. Firstly, just with regards to NUPLAZID. It continues to remain really strong with the number of ship bottles that you mentioned. Ami FadiaSenior Analyst at Needham & Company00:33:00Can you give us some sense of what's driving the strength and maybe give us some color around where the growth is coming from across channels? And then with regards to debut as you see increased adoption outside the COE setting, can you give us a sense of what you saw in your open label study in terms of persistency out you know, at twelve or eighteen months in, you know, with regards to patients that are being treated outside the COE study, if you have that? Thank you. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:33:34Ami, thanks. I'm going to let Tom answer both of those and Liz maybe in terms of the longer term in the trial. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:33:41So, in terms NUPERTID, we're seeing a nice uptick in terms of referrals, NBRxs, and ongoing TRx volume. I think if you look at the second quarter and the impact that we saw, we were pleased with the fact that our NBRx volume was reflected across all channels. So, we saw it both within the community setting, but we also saw nice increases across the LTC setting as well. As a reminder, the vast majority of patients do sit within the community setting, but the fact that we have a group of patients that sit within long term care where we also promote showed just continued strength across the breadth of patients that we serve for New Plasmid. So, very pleased with that ongoing uptick and the strength that we have now going into the second half of the year. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:34:36In terms of the question around Dayview and the real world data, I think the real world data that we have and we had a recent publication, I think at IRSF, that showed that at eighteen months we had about a 40% persistency rate. So I think the real world data that we're now seeing through the latest data with a 45% persistency rate through eighteen months, I think really kind of begins to match up with that very, very nicely. And I think, again, gives us a real sense that this drug is performing as we've seen in clinical studies and moving forward. We don't expect to see any significant deviation versus this very stable plateau that we're now seeing. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:35:16And I'll just add on that in our actual clinical trial experience, we really only have about nine months of data that you can count on from a persistency perspective, because in the later part of the open label extension we had, patients going off to market a drug and so coming off of the program. If you look to that nine month experience at that point you've got something like forty five percent persistency, so I think what we continue to see and what we've seen sort of all along is that actually the real world persistency is a little bit better than we're seeing in the clinical trials. Ami FadiaSenior Analyst at Needham & Company00:35:52Thanks, Liz. Operator00:35:54Thank you for your question. Our next question comes from Mark Goodman from Leerink. The floor is yours. Marc GoodmanSenior MD - Neuroscience at Leerink Partners00:36:07Can you talk about discontinuations for Dayview and what you saw in the quarter? And was there any inventory changes that were of any significance for either product? Thank you. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:36:20Thanks, Mark. I'll let Tom talk to that. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:36:22Yes. Discontinuations, Mark, we were very pleased that we had another quarter where discontinuations remained well below 10%. Again, I think as you think about discontinuations as part of the overall story that we're now telling in terms of debut, very stable but growing group of active patients, discontinuations remaining relatively low, and I think that this all speaks to the fact that we really now have a very good understanding as to the profile of the product, how we can engage with the patient community, and ensuring that as we move forward, again with a real focus on the efficacy profile of the product, which continues to be strengthened, thanks to the work of Liz and team, that we feel very good about with the direction of travel for debut as a whole. I'll ask Mark to answer the question. Mark SchneyerCFO at ACADIA Pharmaceuticals00:37:10Yeah, there's nothing to report on in channel inventory. MUPLAZID's consistent quarter over quarter. And then just as a reminder, that concept really doesn't exist for debut as our single specialty pharmacy really only takes control of the inventory for like a nanosecond before it goes directly to patients. The debut model has always been really a sell through model. Marc GoodmanSenior MD - Neuroscience at Leerink Partners00:37:35Fair enough. Mark, can you also comment on just the tax rate and how to think about it this year and going forward? Mark SchneyerCFO at ACADIA Pharmaceuticals00:37:42Yes, so our tax so right, I guess if you look at our P and L, our book tax rate year over year is a little higher because for GAAP accounting, we're not able to account for all the credits and NOLs that we're actually using. For modeling purposes, our cash tax rate remains currently in kind of the mid teens rate. Long term we guide more towards mid-20s and that's before considering anything for OB3 which will start to be implemented from our standpoint in the next quarter. And with that, we have about $400,000,000 of kind of US based activity R and D expense that had been capitalized and that in the near term will be able to have some accelerating expensing for US tax purposes. So in the next year or two, our tax rate will actually go down. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:38:40Maybe three is our internal vernacular for one big useful bill just in case. Thanks, Mark. Next question. Operator00:38:51Thank you for your question. Our next question comes from Ash Verma from UBS. The floor is yours. Ashwani VermaExecutive Director - SMID Biotech & Biopharma at UBS Group00:39:04Yeah. Hi. Thanks for taking my question. So for NUPLAZID, I know, like, you've outlined that this is a largely Medicare patient population. Roughly, by when do you think that it'll be eligible for IRA price negotiation and implementation? Ashwani VermaExecutive Director - SMID Biotech & Biopharma at UBS Group00:39:19And then secondly, on the ECP one zero one, I I wanted to ask, like, is this the same formulation from setting that required refrigeration, and do you think that could potentially become a hindrance at all in terms of thrice daily administration for this patient population? And then is there a plan for a room temperature stable variant here? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:39:43Thanks, Ash. I'm going to let, Mark answer the IRA question and then Liz on 101, and some of that was a little bit unclear. You broke up for a little bit, so you might have to say your 101 question again for Liz so she can make sure she answers it correctly. But let's start with the IRA. Mark SchneyerCFO at ACADIA Pharmaceuticals00:39:57Yeah, in terms of potential timing for negotiation under the IRA, 2029 would be the first year that New Plaza is eligible for negotiation unless there's changes in the legislation like getting rid of the pill penalty. That's probably the year we anticipate we potentially be subject to negotiation. Just to remind you as a small company, we have a limit on the discount we have to offer. It's in the range of 25 to 34% as outlined in the legislation. Then after that would be subject to negotiation like any other drug. Mark SchneyerCFO at ACADIA Pharmaceuticals00:40:34From our standpoint, just due to the launch timing of NUPLAZID, if the pill penalty is removed, that could add another year before negotiation would likely be expected. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:40:46Great. And the small company is the two year, right, two years of Mark SchneyerCFO at ACADIA Pharmaceuticals00:40:51Two years, yes. Yeah. Great. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:40:53And with respect to ACP 101 and the question there, and that obviously tell me if there's anything that I didn't catch about your question that I neglect here, but we are using the same formulation as Levo used and an important thing to remember is that part of what we're doing here is a resubmission to the complete response letter and so the intent is to provide the new information that FDA requires, which is an additional study to demonstrate efficacy, while changing as few things as possible about the overall, initial presentation. You know, we have seen that to be acceptable and usable in our clinical trials, have not found it to be a concern. Terms of your question about next generation, you know, we're always considering whether there are things that we can do to our products to make them more patient friendly, and so I anticipate that we'll be thinking about that for 01/2001 as well as we do for other things. Ashwani VermaExecutive Director - SMID Biotech & Biopharma at UBS Group00:41:46Thanks, Josh. Operator00:41:52Thank you for your question. Our next question comes from David Huang from Deutsche Bank. The floor is yours. David HoangDirector & Senior Analyst - Biotechnology at Deutsche Bank00:42:04Hi there. Congrats on the quarter and thanks for taking my question. I just wanted to ask on ACP-one 101. Can you comment or say anything on the, I guess, open label extension for the Phase III study, like what you're seeing in terms of rollover rate? And would you ever consider adding a randomized withdrawal portion to the plan that I think was used by a competitor with approved products in the market to get that product approved? Thanks. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:42:36Great questions. So, first off, on the OLE, I'm not going to comment too specifically at this point, but I will say that we have seen generally good interest in our open label extension and are continuing to collect, information on patients who are enrolling into that. To the question about the randomized withdrawal, it's an interesting question. At this point, we really are focused on the results of our current, parallel arm study that we're looking at those data coming in, in early Q4. We think a real advantage of that is that that's going to be able to give a clear, if it's positive and turns out the way we hope, it's going to give a clear demonstration for regulators, for physicians and for patients and families of what you could expect upon initiation of therapy. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:43:23A randomized withdrawal study could be something that we might consider in the future, but at this point we think the most important data set really is this, parallel group study that we're currently running and eagerly anticipating the data. David HoangDirector & Senior Analyst - Biotechnology at Deutsche Bank00:43:36Thanks, David. Operator00:43:42Thank you for your question. Our next question comes from Oi Eer from Mizuho. The floor is yours. Analyst00:43:56Hi, thanks for taking our question. Analyst00:43:57This is Leo on for Oi and congrats on the quarter. For each of your brands, Neoplasma and Debut, what is the right way for us to be thinking about 2026 from a growth perspective? What are the key factors and drivers we should be thinking about? And maybe on the heels of the recent R and D Day, excitement is clearly growing in the pipeline. Which pipeline programs is the team most excited about? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:44:20Thanks, Leah. I'm gonna ask Tom to comment on how to think about growth in '26 with Graham. Analyst00:44:26Mhmm. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:44:27And then Liz to tell us which is her favorite child in her pipeline. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:44:32Yeah, thanks for the question. So, let me start with Dave Hughes. As we've mentioned during the call, we've seen very nice continued growth for the last three quarters in terms of active patients. We do anticipate through the second half of the year that the rate that we are growing that number will accelerate as we see the impact of our new field force model really begin to pull through. As a reminder, our penetration rate in general across the entire rec community remains in the low 30%. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:45:04So we've still got a significant opportunity here for this brand to continue to grow, and that's our goal through 2026 and beyond is to really make sure that we engage with the patient community in the right way. We really meet patients where they are, which is what we are doing with our new customer model. We can really make sure that we take Debut to the height that we know it can be. So, that's our goal for '26. So, it's really a story of continued and we plan for accelerating growth through the year. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:45:34As it relates to NUPLAZID, it's a similar story in a way. I think we've seen this year and this quarter in particular some very nice numbers in terms of leading metrics. The team in the field continued to execute very well. Our campaigns are working for us very well and are giving us a nice tailwind as we think about the second half of this year, and we believe that that sets us very nicely up for 2026. So, I think the outlook for both brands from a commercial point of view is one of strength, and we really look forward to really capitalizing on that as we head into 2026. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:46:08I love that Katherine teed this up as my favorite child, because what I was going to say is I would never say who my favorite child is. You know, I think that across our pipeline we have a nice mix of assets that are relatively de risked from a mechanistic perspective, things like ACP two zero four where we are following in learnings that we have from NUPLAZID, as well as some areas really novel biology like ACP two seventy one. I think that we are excited about the fact that we've got a number of different ways we could potentially serve patients living with rare neurological diseases. So there's a lot in our pipeline that we're very enthused about, and I'm not going pick a favorite child today. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:46:49Maybe I'll just come on top of that with, you know, I think what was exciting for us at R and D Day was to be able to share our expectations on the market opportunity that these brands, these new brands potentially disapproved offer to Acadia in terms of potential expansion, and we shared at R and D Day that we believe all five of the new products could hit blockbuster potential, and we believe three of them have the ability to achieve over $2,000,000,000 should they be successfully approved. We're moving into bigger markets with still high unmet medical need, and we're excited to continue to focus our development on really differentiated assets and ensuring that we're developing a pipeline of valuable innovation that patients from those underserved communities will really feel adds to that opportunity to see more memorable moments with their families, so we're excited for that. Analyst00:47:49Awesome. Thanks. Operator00:47:51Thank you for your question. Our next question comes from Tazeen Hamed from Bank of America. The floor is yours. Tazeen AhmadMD - US Equity Research at Bank of America00:48:03Hi, good afternoon. Thanks for taking my question. I wanted to ask about whether the 02/2004 study in Lewy Body and Dementia has started. I think your guidance has been that it's supposed to start soon or this quarter. And then I also wanted to get your thoughts about the ADP data that's expected in the middle of next year. Tazeen AhmadMD - US Equity Research at Bank of America00:48:22If that's positive, what's your view about the likelihood of the Lewy Body study working, you know, knowing that you had the company had looked at Lewy Body as part of a previous study with Pima a few years ago. Thanks. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:48:40Okay, the first easy one, which is we do continue to anticipate that the Lewy Body study will get started this quarter. So, hasn't gotten first patient randomized yet, but we are confident we'll get it in the quarter. In terms of ADP and potential for read through, you know, I guess what I'll say is that I think that the data, while limited in terms of its numbers that we have from NUPLAZID is pretty supportive of Lewy Body. Again, there's a relatively small number of patients in that study, but roughly 20 patients in the active arm and 20 patients in the placebo arm and there was a marked difference in relapse rate of patients on placebo versus patients who continued on drug. So, I think we have some good reason to believe just based on the existing NUPLAZID dataset. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:49:31A positive ABPD, as I said, is certainly going to make me feel better, in particular because that gives you clear evidence that this particular molecule is active, though we, of course, expect it to be based on all the nonclinical and phase I works that we've done to date. So, certainly we are anticipating that ADP readout with a great deal of anticipation and feel good about Lewy Body and its potential for success. Tazeen AhmadMD - US Equity Research at Bank of America00:49:57Thanks, Liz. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:49:58Thanks, Justine. Operator00:50:00Thank you for your question. Our next question comes from Sumat Tulkami from Canaccord. The floor is yours. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:50:12Good afternoon. Nice to see the progress this quarter, and thanks for taking our questions. Could you give us some specifics on how ACP 2591 fits into your plans for Rett syndrome relative to your current efforts with Debut? Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:50:24Thanks for the question. We haven't had a 2,591 question for a while, so I'll let Liz answer that. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:50:31Yeah. As excuse me. As we think about ACP 2,591, I mean, I think what originally attracted us to the program was the fact that there are some similarities mechanistically speaking to debut and so that derisks it with a potential for a differential penetration from perspective, so there's a possibility that you've got a difference on the benefitrisk profile there. Obviously, that's going to have to play its way out in RET patients in order to know how we would use that in the context of DayView. What we're doing right now on this one is some additional work to verify the information we need to specifically take forward in RET, and I look forward to providing some additional updates on that at an appropriate time. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:51:19Thanks. Operator00:51:22Thank you for your question. Our next question comes from Salveen Richter from Goldman Sachs. The floor is yours. Salveen RichterBiotechnology Equity Research at Goldman Sachs00:51:34Good afternoon. Thanks for taking my question. For PWS here beyond HQCT and CGIS and CGIC, do you plan to evaluate functional endpoints such as hyperglycemia control and weight loss in the phase three trial? And what would be a clinically meaningful bar for success in this study? Thank you. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:51:58In terms of clinically meaningful bar of success, I'll be very pleased if what I see out of this study is similar to the magnitude that was demonstrated with the three point two milligram dose in the prior study. That would be, I think we feel confident that that's going to be a meaningful change and we feel confident not just from ourselves but from talking to physicians as well as patient advocacy organizations. We think that that would be a meaningful note. I mean, I will say that the, I think your other question was about things like weight circumference, we aren't specifically looking at that. We do think that this is a complex interplay of the disease itself as well as the mechanisms that families have put in place to manage their children and their access to food, so that hasn't been a focus here. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:52:47We are looking at adverse events and typically at blood profiles and at least based on the data that we saw in the prior study we have no reason to anticipate that routine monitoring is going to be necessary. That's going be subject to the data we see in this study, of course. Thanks, Salveen. Operator00:53:09Thank you for the question. Our next question comes from Yatin Sanjeev from Guggenheim. The floor is yours. Yatin SunejaBiotechnology Research Analyst at Guggenheim Partners00:53:20Hey, guys. Thank you for taking my question. Question is on 204, ACP two zero four. Could you just comment on the pharmacology that you think is better addressed with this molecule, which was not addressed with Niplasid specifically as it relates to this ADP population? Just trying to get a sense in terms of how the setup is or how different the setup is into this ADP readout versus the DRP study that you ran with NUPLAZID? Thank you. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:53:53So I think, so thank you for the question. As I think about the differences with two zero four, they kind of go into a couple different categories. There's the molecule differences and then there's program design differences and I do think both of those play into what we could be looking at at the ADP study. So on a molecule perspective, just hitting on this really briefly, NUPLAZID does have that QT prolongation, it's not significant, it's not clinically impactful, but in an elderly and frail patient population you do need to think about it, but also it limited our ability to dose range and we do see some differences in the exposure response that suggest that higher levels of exposure could get us to higher efficacy. We think that this is a reason to think that we've got increasing reason to believe LIS two zero four in our ADP program. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:54:42And then on the design of the program itself, you know, think one of the biggest things that we learned from our prior experience was the importance of having our program specifically focused on the disease that we are studying. I don't want to go through the whole history of DRP, but obviously that was one of the challenges that we had there. So the program that we've designed with ADP is very specifically identifying that patient population, specifically looking at a patient population that's a little more severe in their psychosis, which we also found to be more responsive, and were biomarker confirming that patient population. So if we take all of these things together, we think that we have a good setup for ACT two zero four to show what it can do and some good reasons to think that it might be more likely to be successful. Successful. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:55:28Thanks, Liz. Thank you for the question. Operator00:55:31Thank you for your question. Next question comes from Evan Seigerman from BMO Capital. The floor is yours. Evan SeigermanMD & Senior Research Analyst at BMO Capital Markets00:55:42Malcolm Hoffman on for Evan. Thanks for taking our question. Back to debut, I noticed improvement in the percent of active patients who have been on therapy for twelve months or longer from sixty five percent to seventy percent this quarter. Can you just expand on this a little bit further? Is this more a factor again of just providers handling treatment, becoming more comfortable with the GI profile and how to manage it over time? Just would appreciate any color there. Thanks. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:56:06Yeah, I'll take that question. So, thank you. Think it's a few different factors. I mentioned a few minutes ago, we are learning more about the product as we go. We are clearly educating both the patient community and the caregivers and the HCPs regarding how they should go about utilizing the product. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:56:27If you look at the overall usage that we see, our percentage to dose remains in the 70% range, which I think also just towards the fact that our user base is just getting more comfortable in terms of titration as well. And I think over time, as they see the benefits of the product and as we lean in more in terms of the efficacy profile, I think that there is more that we can pull through there as we think about debut for the long term. So I think it's a story of continued knowledge. I think we continue to educate in the right way. We make sure that all of the learnings that we have from our COEs are now being amplified into the community as well, and I think that this is all being reinforced with our updated customer model and strategy as we think about Dayview moving forward. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:57:16And I think just finally, persistency that we continue to see sort of amplifies that, so the 65 to 70 is really a recognition of everything that Tom just talked to. Just a much more stable base than we were a quarter ago and than we were a year ago, so again, lots of steadiness and now we're driving the momentum into debut. Thank you for the question. Evan SeigermanMD & Senior Research Analyst at BMO Capital Markets00:57:40Appreciate it. Thanks, guys. Operator00:57:42Thank you for the question. Our final question comes from Paul Matteis from Stifel. The floor is yours. Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:57:54Hey, there. This is Julian on for Paul. Thanks so much for taking our question, and congrats on the progress. Just want to circle back to something that was mentioned earlier in the Q and A about the SAP for SAP for ACP101 and how you guys quote unquote retain the right to modify SAP while you remain blinded. Just curious, you know, what what types of modifications could, you know, potentially qualify or could be sort of, you know, in the realm of of possibilities? Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:58:26Just curious if you could expand on that. And I have one quick follow-up as well on Debut. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:58:34Yeah, no planned modifications. I purely meant that as a just from a practical point of view, until you have unblinded your database, you can consider your SAP subject to the possibility to change. But, no, there are no plans, modifications. Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:58:49Got it. That's helpful. Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:58:50Thank you for clarifying. And then on Debut, it just sounds like, you know, things are going well. You're starting to see, you know, increased scripts in the community in addition to higher persistence or, I guess, greater line of sight to the persistence of your patient population. I guess just thinking about the second half of the year, you've sort of messaged how you expect to see greater growth. Why the decision to not narrow guidance this quarter? Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:59:24It just seems like you'd kind of easily hit if you continue to add the patients that you have this year. Just curious if that's being conservative out of sake for being conservative or if there's anything else to that. Thank you. Mark SchneyerCFO at ACADIA Pharmaceuticals00:59:42Yeah, I wouldn't read anything in the guidance. I think what I would say maybe on the reason why we adjusted NUPLAZID is we started the year with a wider range than we normally do, kind of coming into the year, not knowing all the puts and takes for the Medicare Part D redesign. So when we looked at the NUPLAZID range, we just thought it was just too wide kind of halfway through the year. As we looked at all the other ranges, we left them including Debut, and we'll revisit those in the third quarter as we would typically it would be a typical point to start narrowing. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals01:00:20Thanks, Bob. Everybody, for the questions, and thank you, operator. We really appreciate everybody joining us today, and we look forward to updating you on our progress next quarter. Operator01:00:33Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read moreParticipantsExecutivesAl KildaniSVP of IR & Corporate CommunicationsCatherine Owen AdamsCEO & DirectorThomas GarnerChief Commercial OfficerElizabeth ThompsonEVP - Head of Research & DevelopmentMark SchneyerCFOAnalystsTessa RomeroEquity Analyst - Biotechnology at J.P. MorganRitu BaralMD & Senior Biotechnology Analyst at TD CowenMichael RiadEquity Research Associate at Morgan StanleyJason ButlerMD & Biotechnology Equity Research at JMP Group LLCBrian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital MarketsAmi FadiaSenior Analyst at Needham & CompanyMarc GoodmanSenior MD - Neuroscience at Leerink PartnersAshwani VermaExecutive Director - SMID Biotech & Biopharma at UBS GroupDavid HoangDirector & Senior Analyst - Biotechnology at Deutsche BankAnalystTazeen AhmadMD - US Equity Research at Bank of AmericaSumant KulkarniManaging Director at Canaccord Genuity IncSalveen RichterBiotechnology Equity Research at Goldman SachsYatin SunejaBiotechnology Research Analyst at Guggenheim PartnersEvan SeigermanMD & Senior Research Analyst at BMO Capital MarketsJulian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial CorpPowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) ACADIA Pharmaceuticals Earnings HeadlinesHigh Growth Tech Stocks To Watch In The US August 2025August 15 at 7:15 PM | uk.finance.yahoo.comShareholders In ACADIA Pharmaceuticals (NASDAQ:ACAD) Should Look Beyond Earnings For The Full StoryAugust 14 at 9:14 AM | finance.yahoo.comJPMorgan: Gold to $4,250—Here’s the Real PlayGold Surges And Some Investors Are Getting Paid, But Most Are Not. Which One Do You Want to Be? Gold prices are breaking records and some people are earning up to $1,152/month from the rally. Click here to discover the income ETF behind it all.August 16 at 2:00 AM | Investors Alley (Ad)Analysts Are Bullish on Top Healthcare Stocks: Vertex Pharmaceuticals (VRTX), AMN Healthcare Services (AMN)August 13 at 2:00 AM | theglobeandmail.comNeedham Keeps Their Buy Rating on Avadel Pharmaceuticals (AVDL)August 12, 2025 | theglobeandmail.comResults: ACADIA Pharmaceuticals Inc. Exceeded Expectations And The Consensus Has Updated Its EstimatesAugust 11, 2025 | finance.yahoo.comSee More ACADIA Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like ACADIA Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on ACADIA Pharmaceuticals and other key companies, straight to your email. Email Address About ACADIA PharmaceuticalsACADIA Pharmaceuticals (NASDAQ:ACAD), a biopharmaceutical company, focuses on the development and commercialization innovative medicines that address unmet medical needs in central nervous system (CNS) disorders and rare diseases in the United States. The company offers NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis; and DAYBUE, a novel synthetic analog of the amino-terminal tripeptide of insulin-like growth factor 1 for treatment of Rett Syndrome. It also develops Pimavanserin that is in Phase III ADVANCE-2 study to treat the negative symptoms of schizophrenia; ACP-101 whixh is in Phase III for the treatment of hyperphagia in Prader-Willi syndrome; ACP-204 which is in Phase II for the treatment of Alzheimer's disease psychosis; ACP-2591 that is in Phase I for Rett syndrome and Fragile X syndrome; preclinical antisense oligonucleotide programs; and other programs for neuropsychiatric symptoms. It has a license agreement with Neuren Pharmaceuticals Limited to develop and commercialize trofinetide for Rett syndrome and other indications; and a license and collaboration agreement with Stoke Therapeutics, Inc. to discover, develop and commercialize novel RNA-based medicines for the potential treatment of severe and rare genetic neurodevelopmental diseases of the CNS. The company was formerly known as Receptor Technologies, Inc. and changed its name ACADIA Pharmaceuticals Inc. in 1997. 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PresentationSkip to Participants Operator00:00:00Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals Conference Call. My name is Gerald, I'll be your host for today. I would now like to turn the conference over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at Acadia. Please proceed. Al KildaniSVP of IR & Corporate Communications at ACADIA Pharmaceuticals00:00:21Thank you. Good afternoon and thank you for joining us on today's call to discuss Acadia's second 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 commercial brand debut in 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 Schneider, our Chief Financial Officer, who will review the financial highlights. Kathryn will then provide some closing thoughts before we open up the call for your questions. Al KildaniSVP of IR & Corporate Communications at ACADIA Pharmaceuticals00:01:03We are using supplemental slides, which are available on our website's Events and Presentations section. 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. Al KildaniSVP of IR & Corporate Communications at ACADIA Pharmaceuticals00:02:03I'll now turn the call over to Kathryn for opening remarks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:02:06Thank you, Al, and good afternoon, everyone. Our second quarter performance reinforces the momentum we're building across all facets of our business, from commercial strength to our clinical pipeline and global expansion. We delivered total revenue of $264,600,000 this quarter, driven by strong growth across our portfolio. This includes $96,100,000 from Debut, with patient uptake continuing to grow for the second successive quarter and $168,500,000 from MUPLAZID, fostered by new patient starts and commercial execution. Dayview has now passed stabilization, moved into growth, and is entering a new phase, expansion and acceleration. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:02:55Our investments in patient support, community engagement, and field expansion are starting to make a positive impact, as Tom will highlight in more detail. On Neuclazid, we're encouraged by continued growth across all leading indicators, bolstered by recent litigation wins enforcing our intellectual property. These victories validate our long term strategy and reinforce our ability to deliver Neuclazid to patients through 02/1938. Our full year revenue guidance reflects this confidence. We are raising the low end of our NUPLAZID guidance based upon a foundation of disciplined execution and momentum delivered by our DTC campaigns. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:03:42We also hosted our first R and D Day, a milestone event that showcased our exciting and expanding pipeline With nine disclosed programs in development and five Phase II or Phase III data readouts expected through 2027, the excitement within Acadia is palpable. Liz will walk you through that shortly. First, let's start with commercial. Over to Tom. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:04:07Thanks, Kathryn. Let's begin with Dayview. Q2 sales were $96,100,000 up 14% from a year ago. We observed steady progress across key performance metrics in the quarter. In Q2, nine eighty seven unique patients in The U. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:04:26S. Received paid shipments, increasing from nine fifty four in Q1 and nine twenty in Q4 twenty twenty four. The upward trend reflects encouraging signs of growth in both new patient starts and persistency. Long term persistency remains a key strength for DayView. Our twelve month persistency rate continues to exceed 50%, and we're now pleased to report that our eighteen month persistency rate is above forty five percent. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:04:59This trend reflects the growing and stable base of patients who remain on therapy over time. When we look at length of treatment among patients currently on therapy, seventy percent have been on treatment for at least twelve months, highlighting the sustained benefits that Debut continues to deliver and the durability of our growing patient base. Notably, we're seeing more new prescriptions from the community setting, signaling progress in broadening reach beyond academic centers, which was a key element of our field force expansion, which is now complete. We finished hiring and training earlier this quarter, and we're already seeing encouraging signs that the new customer model is gaining traction. One of the most promising indicators in the second quarter is a meaningful uptick in our proportion of new referrals coming outside of centers of excellence, where a majority of Rett patients receive their primary treatment. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:05:56Encouragingly, this increase was underpinned by a further increase in the number of new community based writers for Debut, with 900 total HCPs now having written. Additionally, we launched a direct to consumer campaign for Debut in July, and we are already seeing positive signs of early engagement from the Rett community. During Q2, we welcomed Alison McMillan Youngblood, a senior vice president of our rare disease franchise. Alison brings a breadth of commercial experience across The U. S. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:06:29Biopharma business, including many launches. Her leadership will help to drive this critical business forward. As we look ahead with the expanded team now in place, we're continuing to execute against our strategy to drive long term sustainable growth for Dayview. We expect this will translate into an increase in new patient starts towards the back end of the year. At the International Rett Syndrome Foundation meeting in June, our presence as a leader in the Rett therapy field was felt. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:07:02As Liz will detail, we shared multiple compelling posters that add to the body of evidence for DayView. Let's now turn our plans to trofinetide outside The U. S. In The EU, where the prevalent population is estimated to be between nine thousand to 12,000 Rett patients, named patient supply as requested by local HCPs is available through Clinigen. We've received requests from multiple countries and are continuing to support patients where regulatory frameworks allow. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:07:35Named patient supply based upon HCP requests is also in place in Israel through Rafa and in select rest of world countries through Pharmamunda. Overall, we're pleased with the continued momentum of DABU in The U. S. And with the global interest in trofinetide, where we have already started serving patients through these programs. Now, turning to New Blazid. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:08:00Our commercial team delivered another strong quarter with revenue of $168,500,000 up 7% from a year ago, driven primarily by volume. We saw strength across all key metrics in Q2. Referrals were up 17% year over year, driven by continued momentum in our direct to consumer campaign. As a result, for the first time ever, both referrals and new prescriptions increased sequentially from Q1 to Q2. Another of the quarter's highlights was shipping the highest number of new Puzzet bottles since launch, a strong indicator of growing demand as we continue educating both healthcare providers and patients with PDP about the product's unique and differentiated profile. The DTC campaigns are doing exactly as we intended, sparking meaningful conversations with healthcare providers and reinforcing our commitment to educating caregivers about the symptoms of hallucinations and delusions related to Parkinson's disease. Visits to newplazit.com have surged, with a 17 fold increase in consumer traffic year over year, helping to drive more patients to speak with their physicians. To carry this momentum forward, we're pleased to extend our agreement with Ryan Reynolds and the Molt to Parkinson's campaign through February 2026. The campaign continues to drive meaningful awareness of hallucinations and delusions in Parkinson's disease, and we believe a strong push through year end is essential to build on that success. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:09:42This quarter's NUPLAZID results reflect the strong executional focus of our field teams, coupled with the ongoing positive impact of our DTC efforts. Taken together, we expect to see sustained growth through the second half of the year and beyond. And with that, I'll hand it to Liz to review our pipeline progress. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:10:03Thank you, Tom. Let me begin by revisiting the highlights from our inaugural R and D Day held in New York on June 25, where we showcased the strength and breadth of our pipeline. We were pleased with how the event came together and I want to thank many of you on this call who were able to join us. While we had already disclosed all the programs on this chart, R and D Day gave us great opportunity to provide more details, particularly for two newer molecules. The first is ACP-two eleven, an orally administered, selectively deuterated form of R nortetamine, which we're developing for the potential treatment of major depressive disorder. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:10:44Dated state support the potential for efficacy without significant sedation or dissociation, a profile we will continue to explore in phase two and beyond. The second is ACP271, a GPR-eighty eight agonist with potential applications in tardive dyskinesia and Huntington's disease. This is some of the most novel biology in our pipeline and we believe it to be the first GPR-eighty eight agonist that will enter clinical trials. If you weren't able to participate in our R and D Day, I highly encourage you to visit our website where you can access the webcast and the full set of presentation slides. The event was a clear demonstration of the momentum building across our pipeline. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:11:30We're advancing with purpose and clarity and the progress is tangible. Across our nine disclosed programs, we anticipate initiating seven phase two or phase three studies over the course of 2025 and 2026. Moreover, between 2025 and 2027, we expect five phase two or phase three readouts. These milestones underscore both the breadth of our pipeline and the strength of our R and D strategy. Specifically, we have several important trial initiations and data readouts on the horizon. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:12:06In Q3 twenty twenty five, we plan to initiate a Phase II study of ACP-two zero four in Lewy body dementia psychosis. Also in the third quarter, we expect to initiate our Phase III study of trofinetide in patients with Rett syndrome in Japan. In early Q4 twenty twenty five, we expect to report top line results from the COMPASS PWS Phase III study of ACP101 in Prader Willi syndrome following the completion of enrollment in Q2. Also in Q4 twenty twenty five, we anticipate initiating a Phase II study of ACP211 in major depressive disorder. Wrapping up the year, we plan to begin a first in human study of ACP-two seventy one in healthy volunteers before year end. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:12:54And finally, we also continue to progress through the review process with EMA for trofinetide with agency decision expected in the 2026. In addition to these upcoming milestones, we continue to make meaningful contributions to the scientific literature for our marketed and pipeline products. The second quarter was a busy one for Acadia relevant medical meetings with major conferences for Rett syndrome, Prader Willi syndrome, and Alzheimer's. First, there were multiple Dayview related presentations at the International Rett Syndrome Foundation meeting continuing to expand the body of evidence describing Dayview's long term impact in the Rett community. Several posters focused on caregiver reported outcomes and real world data, which importantly continue to align with what we have observed in clinical trials. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:13:48Additionally, there were analyses evaluating treatment utilization in less commonly studied populations, such as males and older patients. And finally, Acadia shared an analysis of our clinical trial data suggesting that most patients who are going to benefit from Dayview show a response within six months, reinforcing our guidance to providers and caregivers. Together, these data points reflect a growing and maturing evidence base that continues to shape how Dayview is understood and used in the real world. In the pipeline, both ACP101 and ACP204 teams had important meetings in the quarter. In Prader Willi Syndrome, the June marked the United and Hope meeting, the joining together of three separate PWS organizations in a combined meeting. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:14:40Those of you who tuned in to R and D Day will recall that our PWS panel in part was live from United and Hope. As we await data out of our phase three trial, we nevertheless are contributing to the knowledge and understanding of PWS with posters about the experience of patients and families exploring comorbidities and the associated burden. In the Alzheimer's space, I'm also pleased to report multiple ACP two zero four presentations at the Alzheimer's Association International Conference held last week in Toronto. This meeting represented a significant step in our public disclosure of detailed data from nonclinical and early stage clinical studies supporting ACP-two zero four's attainment to date of its desired profile. Presented data included the specificity for five HT2A and the supported PK profile indicating a faster time to steady state, support for daily dosing, the lack of QT prolongation, and the ability to dose with and without food. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:15:42We also shared clinical data primarily focused on the sixty milligram dose across several phase one trials with supportive safety and tolerability profiles to date, including in healthy elderly subjects. Collectively, the data provides support for the potential utility of ACP two zero four and key aspects of its target profile. Lastly, I'll touch briefly on ACP 101, where we continue to expect top line results in early Q4. Just as a reminder, this is a twelve week placebo controlled parallel group study. That design is important because, if successful, it would allow us to clearly describe for physicians and patients what to expect upon initiating therapy in a Prader Willi syndrome patient population. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:16:31Should the data be positive, we anticipate being in a position to file in the 2026, and we continue to anticipate that this will qualify as a resubmission with the FDA with the associated shorter potential review clock with a potential PDUFA date in the 2026. And now, I'll pass over to Mark for a financial overview of the quarter. Mark SchneyerCFO at ACADIA Pharmaceuticals00:16:54Thanks, Liz. Let's now review our second quarter twenty twenty five financial results. The second quarter was strong across the board with $264,600,000 in total revenues, up 9% year over year. Second quarter debut net product sales of $96,100,000 represented 14% year over year growth, including 12% volume growth, primarily reflecting the increase in unique patients receiving shipments in the quarter. The debut gross to net adjustment for the quarter was 23.3%. Mark SchneyerCFO at ACADIA Pharmaceuticals00:17:33Turning next to NUPLAZID, second quarter net product sales were $168,500,000 up 7% year over year with 5% of that growth attributable to volume. The NUPLAZID gross to net adjustment for the quarter was 24.6%. R and D expenses were $78,000,000 in the second quarter, up slightly from $76,200,000 in the 2024. SG and A expenses for the second quarter were $133,500,000 up from $117,100,000 in the 2024. The increase was primarily driven by increased expenditures for both debut and NUPLAZID in The US, including the planned expansion of the debut commercial team. Mark SchneyerCFO at ACADIA Pharmaceuticals00:18:26We ended the quarter with a cash balance of $762,000,000 up from $681,600,000 at the end of Q1 and $756,000,000 at the 2024. Let's turn to our 2025 guidance. We are raising the low end of our NUPLAZID guidance range, reflecting the strength of the business and its performance to date. We now expect NUPLAZID net product sales for the year to be between $665,000,000 and $690,000,000 This compares with our prior guidance range of $650,000,000 to $690,000,000 Accordingly, we are also adjusting our U. S. Mark SchneyerCFO at ACADIA Pharmaceuticals00:19:11Only total revenue guidance to reflect this change. As you can see on the slide, we are reiterating all other prior guidance ranges from our Q1 call. We're confident in our ability to execute against these targets and to continue creating value for patients and shareholders. I'd now like to hand it back to Kathryn for closing remarks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:19:35Thanks, Mark. As you've heard, quarter two was a quarter of progress and momentum. Our teams are executing with urgency and precision, and we remain focused on accelerating debut commercial trajectory, sustaining long term growth and differentiation for NUPLAZID, advancing a deep pipeline through rigorous clinical development, and continuing to build the pipeline through business development, and expanding globally to reach more patients in need. The next major milestone is ACP101's data readout in early Q4, and we're hopeful for what that could mean for families living with Prader Willi syndrome. Thanks for joining today's call, and thank you for your continued support of Acadia. I'll now open it up for questions. Operator? Operator00:20:26Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star, one, one on your telephone and wait for your name to be announced. To withdraw your question, press 11 again. Please stand by while we compile the Q and A roster. Operator00:20:49Our first question comes from Tess Romero from JPMorgan. The floor is yours. Tessa RomeroEquity Analyst - Biotechnology at J.P. Morgan00:20:57Good afternoon, team. Thanks so much for taking our questions. So I actually wanted to ask about ACP101 today. Liz, maybe could you orient us to the approach you plan to take with your top line? How much detail will you provide and will this be more qualitative or quantitative in nature? Tessa RomeroEquity Analyst - Biotechnology at J.P. Morgan00:21:18And are there any secondary or other endpoints that you will think will matter beyond HQCT? And then as a follow-up, where are you really most focused from a clinical trial conduct perspective to manage any key risks? Thanks. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:21:36Thanks Tess, great question. So in terms of our approach to top line, and for that matter in terms of our approach to how we're thinking about this trial, first and foremost is the primary endpoint and success there. We will be looking at our secondary endpoints which are of clinician assessments as well as a responder bar for the, HQCT as well. In terms of what we're going to release, certainly I would anticipate that there would be a focus on the primary endpoint and key overview of safety and tolerability and that's what you should anticipate out of our top line announcement. In terms of the areas that we are focusing on in terms of clinical trial conduct, We have been, you know, throughout, we have been robustly keeping on top of how the, assessments appear to be performed and whether variability was within our expected ranges. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:22:37So those are the areas that we've been focusing on in terms of conduct and making sure that we have as consistent a behavior as possible across the sites. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:22:46Thanks, Liz. Thanks for the question, Tess. Operator00:22:51Thank you for your question. Our next question comes from Ritu Baral from TD Cowen. The floor is yours. Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:23:02Good afternoon. Thanks for taking the question. I wanted to talk a little bit or ask a little bit about the new momentum in Dabu. Could you tell us what percentage of patients, or new patients specifically, came from the community setting? And, you mentioned the new number of 900 HCP riders. Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:23:30What percentage, or at least movement of those riders were in the community setting on, a quantitative basis? And then I have a Prader Willi follow-up as well. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:23:42Thanks, Ritu. We'll take the daily question first. I'll ask Tom to give you some more details on that. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:23:47Perfect. Good afternoon, Ritu. Hope you're doing well. So, in terms of your first question regarding the penetration that we've seen as a result of the increase in the sales force, which as a reminder, that went live through May. So, we're fairly early on in terms of seeing the impact, but we're pleased with what we're seeing already. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:24:06In the quarter, we actually saw that the number of referrals that were coming directly from our non COE accounts actually grew to about three quarters of our overall number. So that was up from about two thirds the quarter before, which I think is a nice increase in terms of being able to penetrate that large group of patients that we know exist that fall outside of our COEs. So just as a reminder, roughly 65 of our patients fall outside the direct care of one of the COE designated centers. With regards to your second question as to the additional writers that we saw through Q2, the vast majority of those new writers fell outside of the COEs, which given the fact that we saw this nice uptick in terms of penetration through the quarter, I think again is a nice leading indicator that the new model that we have in place is beginning to pay dividends for us. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:25:07Thanks, Tom. Do you want to ask your one on one question, Ritu? Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:25:10Yes, and just mopping up after Tess' questions, can you talk to how the conduct, specifically dropouts, of the Phase III pre or willy have gone? Are they within expectations? And are all the DSMB looks, for the trial completed and if the SAP has been finalized with FDA? Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:25:34So I am not going to comment on data from a currently ongoing trial aside from to say that generally speaking we are continuing to see this trial, unfolding in an acceptable way, but obviously it's blinded and I'm not going to comment any further on that at this point. We do have an SAP in place. I do consider that we have the right to continue to modify until before we unblind the trial, but we do have our planned analyses established at this point. Ritu BaralMD & Senior Biotechnology Analyst at TD Cowen00:26:06Great, thank you. Operator00:26:07Thank you for your question. Our next question comes from Sean Lammond from Morgan Stanley. The floor is yours. Michael RiadEquity Research Associate at Morgan Stanley00:26:20Hi, this is Mike Riyadh on for Sean. Thank you for taking our questions and congratulations on the quarter. So thinking about debut, the nine eighty seven new patient adds, suggest a good steady growth rate quarter over quarter. How should we be thinking about this trajectory? Given the relative lower prevalence, is it reasonable to expect that this would ever accelerate and doesn't need to? Michael RiadEquity Research Associate at Morgan Stanley00:26:43Or how should we be just thinking about that trajectory? Thanks so much. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:26:49So, it's Tom here. I'll take that one. Thank you for the question. So, we're pleased with the steady growth that we've seen over the last three quarters. I think as we mentioned in the call, if you look at Q4, we had around nine twenty patients that increased close to nine fifty four in Q1 and we're pleased with the continued growth that we saw through Q2 with nine eighty seven active patients on therapy. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:27:13Obviously, the plan that we have moving forward is that that will continue to accelerate as we see the impact of our new customer model. And our goal is to make sure that we have more new patient starts continuing week over week and month over month and quarter over quarter. And I think now we have this very stable and growing group of persistent patients, many of whom have now been on treatment for twelve months or longer, I think gives us a real sense that we can really continue to grow this brand and take it to new heights. Michael RiadEquity Research Associate at Morgan Stanley00:27:46Thanks so much. Operator00:27:48Thank you for your question. Our next question comes from Jason Butler from Citizens JMP. The floor is yours. Jason ButlerMD & Biotechnology Equity Research at JMP Group LLC00:28:01Hi, thanks for taking the questions. Just one on Neplazid. Given that you're seeing a return on investment on, for example, DTC activities and now that you have the greater visibility with intellectual property, are there more investments or longer term investments that you're considering for the franchise? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:28:22Hi, Jason. Thanks for the question. You know, I think as as we think about our strategy with Newfoundland, I tried I encourage us to sort of bifurcate, the commercial strategy that we're putting in place now with the longer term ability to now maximize the brand. Direct to consumer decisions that we're making are sort of relative to the 2038 shorter term. We're seeing, impact of the DTC. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:28:45We would have continued to invest regardless of the outcome of the IP trial because it has a strong momentum for the next sort of two to three years potentially depending on how long we continue to invest. Beyond that now, what we have been able to do is think about the longer term strategy for Neoplasm. I'm looking forward to sharing a little bit more about that as we talk as we head towards the back end of the year in terms of how we now think about the investment longer term, but for right now the DTC campaign is certainly paying dividends as you point out, and we're excited about the continued momentum and indeed in terms of the, more to Parkinson's campaign and raising awareness of hallucinations and delusions, we're delighted that Ryan Reynolds has agreed to continue supporting that campaign, because we believe that's been one of the main drivers of increased awareness, and once a caregiver is aware, they're encouraged to go in and talk to their doctor. It's been a very strong impact to caregivers and we're excited to continue that. Thanks for the question. Jason ButlerMD & Biotechnology Equity Research at JMP Group LLC00:29:44Thank you. Operator00:29:47Thank you for the question. Our next question comes from Brian Abrahams from RBC Capital Markets. The floor is yours. Brian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital Markets00:29:59Hey, guys. Congrats on the quarter. Thanks for taking my questions. Just two for me, guess, both on debut. As you've expanded the sales force, can you talk a little bit more, I guess, qualitatively around your learnings from patients outside of the centers of excellence, just in terms of physician receptivity, number of prescriptions per physician, any early persistent signals and how well educated the docs are around the titration? Brian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital Markets00:30:26And then can you also maybe talk about any hints of changes you may be seeing in overall debut persistence both quarter over quarter and bigger picture trends? Just how much the education around AE management and the efficacy message and importance of staying on therapy is resonating? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:30:43Thanks, Brian. I'll let Tom come up with his thoughts on that. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:30:47Yeah, thanks for the question. So, yeah, we've already had a number of learnings as we've expanded beyond the COEs. One of the key things is there is clearly receptivity to debut outside of the COEs. We know that there are physicians who are treating rep patients who won't necessarily have been called on yet, and we're appreciating that they require ongoing education to make sure that they fully understand the profile of the product, they fully understand how to utilize the product, and we're utilizing the full mechanics of the system that we've built to make sure that we can educate all of those prescribers as quickly as possible. So, I think one thing that you probably need to be thinking about as you look at modeling is that the buying process, the number of calls, may be slightly longer for this group of prescribers versus those that we see for COEs. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:31:42And that's purely because they just don't see Rett patients as frequently. As you talk about persistency, we're really pleased with the persistency that we're seeing. So as I mentioned on the call, twelve month persistency remains well above 50%. And as we also mentioned mentioned for the first time, our eighteen month persistency, although not yet fully mature, is above 45%. So I think that that gives us a real good sense that we've kind of reached a nice kind of plateau as we go into the longer term outlook for the product. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:32:14And that gives us, with this growing group of patients who are now receiving therapy, a sense that we can continue to grow JBU to newer heights, as I've mentioned, as we get new patients started. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:32:28Thanks, Tom. Thanks for the question, Brian. Brian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital Markets00:32:30Thanks a lot. Operator00:32:31Thank you for your question. Our next question comes from Ami Fadia from Needham and Company. The floor is yours. Ami FadiaSenior Analyst at Needham & Company00:32:45Good evening. Thanks for taking my question. I have two quick ones. Firstly, just with regards to NUPLAZID. It continues to remain really strong with the number of ship bottles that you mentioned. Ami FadiaSenior Analyst at Needham & Company00:33:00Can you give us some sense of what's driving the strength and maybe give us some color around where the growth is coming from across channels? And then with regards to debut as you see increased adoption outside the COE setting, can you give us a sense of what you saw in your open label study in terms of persistency out you know, at twelve or eighteen months in, you know, with regards to patients that are being treated outside the COE study, if you have that? Thank you. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:33:34Ami, thanks. I'm going to let Tom answer both of those and Liz maybe in terms of the longer term in the trial. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:33:41So, in terms NUPERTID, we're seeing a nice uptick in terms of referrals, NBRxs, and ongoing TRx volume. I think if you look at the second quarter and the impact that we saw, we were pleased with the fact that our NBRx volume was reflected across all channels. So, we saw it both within the community setting, but we also saw nice increases across the LTC setting as well. As a reminder, the vast majority of patients do sit within the community setting, but the fact that we have a group of patients that sit within long term care where we also promote showed just continued strength across the breadth of patients that we serve for New Plasmid. So, very pleased with that ongoing uptick and the strength that we have now going into the second half of the year. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:34:36In terms of the question around Dayview and the real world data, I think the real world data that we have and we had a recent publication, I think at IRSF, that showed that at eighteen months we had about a 40% persistency rate. So I think the real world data that we're now seeing through the latest data with a 45% persistency rate through eighteen months, I think really kind of begins to match up with that very, very nicely. And I think, again, gives us a real sense that this drug is performing as we've seen in clinical studies and moving forward. We don't expect to see any significant deviation versus this very stable plateau that we're now seeing. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:35:16And I'll just add on that in our actual clinical trial experience, we really only have about nine months of data that you can count on from a persistency perspective, because in the later part of the open label extension we had, patients going off to market a drug and so coming off of the program. If you look to that nine month experience at that point you've got something like forty five percent persistency, so I think what we continue to see and what we've seen sort of all along is that actually the real world persistency is a little bit better than we're seeing in the clinical trials. Ami FadiaSenior Analyst at Needham & Company00:35:52Thanks, Liz. Operator00:35:54Thank you for your question. Our next question comes from Mark Goodman from Leerink. The floor is yours. Marc GoodmanSenior MD - Neuroscience at Leerink Partners00:36:07Can you talk about discontinuations for Dayview and what you saw in the quarter? And was there any inventory changes that were of any significance for either product? Thank you. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:36:20Thanks, Mark. I'll let Tom talk to that. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:36:22Yes. Discontinuations, Mark, we were very pleased that we had another quarter where discontinuations remained well below 10%. Again, I think as you think about discontinuations as part of the overall story that we're now telling in terms of debut, very stable but growing group of active patients, discontinuations remaining relatively low, and I think that this all speaks to the fact that we really now have a very good understanding as to the profile of the product, how we can engage with the patient community, and ensuring that as we move forward, again with a real focus on the efficacy profile of the product, which continues to be strengthened, thanks to the work of Liz and team, that we feel very good about with the direction of travel for debut as a whole. I'll ask Mark to answer the question. Mark SchneyerCFO at ACADIA Pharmaceuticals00:37:10Yeah, there's nothing to report on in channel inventory. MUPLAZID's consistent quarter over quarter. And then just as a reminder, that concept really doesn't exist for debut as our single specialty pharmacy really only takes control of the inventory for like a nanosecond before it goes directly to patients. The debut model has always been really a sell through model. Marc GoodmanSenior MD - Neuroscience at Leerink Partners00:37:35Fair enough. Mark, can you also comment on just the tax rate and how to think about it this year and going forward? Mark SchneyerCFO at ACADIA Pharmaceuticals00:37:42Yes, so our tax so right, I guess if you look at our P and L, our book tax rate year over year is a little higher because for GAAP accounting, we're not able to account for all the credits and NOLs that we're actually using. For modeling purposes, our cash tax rate remains currently in kind of the mid teens rate. Long term we guide more towards mid-20s and that's before considering anything for OB3 which will start to be implemented from our standpoint in the next quarter. And with that, we have about $400,000,000 of kind of US based activity R and D expense that had been capitalized and that in the near term will be able to have some accelerating expensing for US tax purposes. So in the next year or two, our tax rate will actually go down. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:38:40Maybe three is our internal vernacular for one big useful bill just in case. Thanks, Mark. Next question. Operator00:38:51Thank you for your question. Our next question comes from Ash Verma from UBS. The floor is yours. Ashwani VermaExecutive Director - SMID Biotech & Biopharma at UBS Group00:39:04Yeah. Hi. Thanks for taking my question. So for NUPLAZID, I know, like, you've outlined that this is a largely Medicare patient population. Roughly, by when do you think that it'll be eligible for IRA price negotiation and implementation? Ashwani VermaExecutive Director - SMID Biotech & Biopharma at UBS Group00:39:19And then secondly, on the ECP one zero one, I I wanted to ask, like, is this the same formulation from setting that required refrigeration, and do you think that could potentially become a hindrance at all in terms of thrice daily administration for this patient population? And then is there a plan for a room temperature stable variant here? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:39:43Thanks, Ash. I'm going to let, Mark answer the IRA question and then Liz on 101, and some of that was a little bit unclear. You broke up for a little bit, so you might have to say your 101 question again for Liz so she can make sure she answers it correctly. But let's start with the IRA. Mark SchneyerCFO at ACADIA Pharmaceuticals00:39:57Yeah, in terms of potential timing for negotiation under the IRA, 2029 would be the first year that New Plaza is eligible for negotiation unless there's changes in the legislation like getting rid of the pill penalty. That's probably the year we anticipate we potentially be subject to negotiation. Just to remind you as a small company, we have a limit on the discount we have to offer. It's in the range of 25 to 34% as outlined in the legislation. Then after that would be subject to negotiation like any other drug. Mark SchneyerCFO at ACADIA Pharmaceuticals00:40:34From our standpoint, just due to the launch timing of NUPLAZID, if the pill penalty is removed, that could add another year before negotiation would likely be expected. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:40:46Great. And the small company is the two year, right, two years of Mark SchneyerCFO at ACADIA Pharmaceuticals00:40:51Two years, yes. Yeah. Great. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:40:53And with respect to ACP 101 and the question there, and that obviously tell me if there's anything that I didn't catch about your question that I neglect here, but we are using the same formulation as Levo used and an important thing to remember is that part of what we're doing here is a resubmission to the complete response letter and so the intent is to provide the new information that FDA requires, which is an additional study to demonstrate efficacy, while changing as few things as possible about the overall, initial presentation. You know, we have seen that to be acceptable and usable in our clinical trials, have not found it to be a concern. Terms of your question about next generation, you know, we're always considering whether there are things that we can do to our products to make them more patient friendly, and so I anticipate that we'll be thinking about that for 01/2001 as well as we do for other things. Ashwani VermaExecutive Director - SMID Biotech & Biopharma at UBS Group00:41:46Thanks, Josh. Operator00:41:52Thank you for your question. Our next question comes from David Huang from Deutsche Bank. The floor is yours. David HoangDirector & Senior Analyst - Biotechnology at Deutsche Bank00:42:04Hi there. Congrats on the quarter and thanks for taking my question. I just wanted to ask on ACP-one 101. Can you comment or say anything on the, I guess, open label extension for the Phase III study, like what you're seeing in terms of rollover rate? And would you ever consider adding a randomized withdrawal portion to the plan that I think was used by a competitor with approved products in the market to get that product approved? Thanks. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:42:36Great questions. So, first off, on the OLE, I'm not going to comment too specifically at this point, but I will say that we have seen generally good interest in our open label extension and are continuing to collect, information on patients who are enrolling into that. To the question about the randomized withdrawal, it's an interesting question. At this point, we really are focused on the results of our current, parallel arm study that we're looking at those data coming in, in early Q4. We think a real advantage of that is that that's going to be able to give a clear, if it's positive and turns out the way we hope, it's going to give a clear demonstration for regulators, for physicians and for patients and families of what you could expect upon initiation of therapy. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:43:23A randomized withdrawal study could be something that we might consider in the future, but at this point we think the most important data set really is this, parallel group study that we're currently running and eagerly anticipating the data. David HoangDirector & Senior Analyst - Biotechnology at Deutsche Bank00:43:36Thanks, David. Operator00:43:42Thank you for your question. Our next question comes from Oi Eer from Mizuho. The floor is yours. Analyst00:43:56Hi, thanks for taking our question. Analyst00:43:57This is Leo on for Oi and congrats on the quarter. For each of your brands, Neoplasma and Debut, what is the right way for us to be thinking about 2026 from a growth perspective? What are the key factors and drivers we should be thinking about? And maybe on the heels of the recent R and D Day, excitement is clearly growing in the pipeline. Which pipeline programs is the team most excited about? Thanks. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:44:20Thanks, Leah. I'm gonna ask Tom to comment on how to think about growth in '26 with Graham. Analyst00:44:26Mhmm. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:44:27And then Liz to tell us which is her favorite child in her pipeline. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:44:32Yeah, thanks for the question. So, let me start with Dave Hughes. As we've mentioned during the call, we've seen very nice continued growth for the last three quarters in terms of active patients. We do anticipate through the second half of the year that the rate that we are growing that number will accelerate as we see the impact of our new field force model really begin to pull through. As a reminder, our penetration rate in general across the entire rec community remains in the low 30%. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:45:04So we've still got a significant opportunity here for this brand to continue to grow, and that's our goal through 2026 and beyond is to really make sure that we engage with the patient community in the right way. We really meet patients where they are, which is what we are doing with our new customer model. We can really make sure that we take Debut to the height that we know it can be. So, that's our goal for '26. So, it's really a story of continued and we plan for accelerating growth through the year. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:45:34As it relates to NUPLAZID, it's a similar story in a way. I think we've seen this year and this quarter in particular some very nice numbers in terms of leading metrics. The team in the field continued to execute very well. Our campaigns are working for us very well and are giving us a nice tailwind as we think about the second half of this year, and we believe that that sets us very nicely up for 2026. So, I think the outlook for both brands from a commercial point of view is one of strength, and we really look forward to really capitalizing on that as we head into 2026. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:46:08I love that Katherine teed this up as my favorite child, because what I was going to say is I would never say who my favorite child is. You know, I think that across our pipeline we have a nice mix of assets that are relatively de risked from a mechanistic perspective, things like ACP two zero four where we are following in learnings that we have from NUPLAZID, as well as some areas really novel biology like ACP two seventy one. I think that we are excited about the fact that we've got a number of different ways we could potentially serve patients living with rare neurological diseases. So there's a lot in our pipeline that we're very enthused about, and I'm not going pick a favorite child today. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:46:49Maybe I'll just come on top of that with, you know, I think what was exciting for us at R and D Day was to be able to share our expectations on the market opportunity that these brands, these new brands potentially disapproved offer to Acadia in terms of potential expansion, and we shared at R and D Day that we believe all five of the new products could hit blockbuster potential, and we believe three of them have the ability to achieve over $2,000,000,000 should they be successfully approved. We're moving into bigger markets with still high unmet medical need, and we're excited to continue to focus our development on really differentiated assets and ensuring that we're developing a pipeline of valuable innovation that patients from those underserved communities will really feel adds to that opportunity to see more memorable moments with their families, so we're excited for that. Analyst00:47:49Awesome. Thanks. Operator00:47:51Thank you for your question. Our next question comes from Tazeen Hamed from Bank of America. The floor is yours. Tazeen AhmadMD - US Equity Research at Bank of America00:48:03Hi, good afternoon. Thanks for taking my question. I wanted to ask about whether the 02/2004 study in Lewy Body and Dementia has started. I think your guidance has been that it's supposed to start soon or this quarter. And then I also wanted to get your thoughts about the ADP data that's expected in the middle of next year. Tazeen AhmadMD - US Equity Research at Bank of America00:48:22If that's positive, what's your view about the likelihood of the Lewy Body study working, you know, knowing that you had the company had looked at Lewy Body as part of a previous study with Pima a few years ago. Thanks. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:48:40Okay, the first easy one, which is we do continue to anticipate that the Lewy Body study will get started this quarter. So, hasn't gotten first patient randomized yet, but we are confident we'll get it in the quarter. In terms of ADP and potential for read through, you know, I guess what I'll say is that I think that the data, while limited in terms of its numbers that we have from NUPLAZID is pretty supportive of Lewy Body. Again, there's a relatively small number of patients in that study, but roughly 20 patients in the active arm and 20 patients in the placebo arm and there was a marked difference in relapse rate of patients on placebo versus patients who continued on drug. So, I think we have some good reason to believe just based on the existing NUPLAZID dataset. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:49:31A positive ABPD, as I said, is certainly going to make me feel better, in particular because that gives you clear evidence that this particular molecule is active, though we, of course, expect it to be based on all the nonclinical and phase I works that we've done to date. So, certainly we are anticipating that ADP readout with a great deal of anticipation and feel good about Lewy Body and its potential for success. Tazeen AhmadMD - US Equity Research at Bank of America00:49:57Thanks, Liz. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:49:58Thanks, Justine. Operator00:50:00Thank you for your question. Our next question comes from Sumat Tulkami from Canaccord. The floor is yours. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:50:12Good afternoon. Nice to see the progress this quarter, and thanks for taking our questions. Could you give us some specifics on how ACP 2591 fits into your plans for Rett syndrome relative to your current efforts with Debut? Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:50:24Thanks for the question. We haven't had a 2,591 question for a while, so I'll let Liz answer that. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:50:31Yeah. As excuse me. As we think about ACP 2,591, I mean, I think what originally attracted us to the program was the fact that there are some similarities mechanistically speaking to debut and so that derisks it with a potential for a differential penetration from perspective, so there's a possibility that you've got a difference on the benefitrisk profile there. Obviously, that's going to have to play its way out in RET patients in order to know how we would use that in the context of DayView. What we're doing right now on this one is some additional work to verify the information we need to specifically take forward in RET, and I look forward to providing some additional updates on that at an appropriate time. Sumant KulkarniManaging Director at Canaccord Genuity Inc00:51:19Thanks. Operator00:51:22Thank you for your question. Our next question comes from Salveen Richter from Goldman Sachs. The floor is yours. Salveen RichterBiotechnology Equity Research at Goldman Sachs00:51:34Good afternoon. Thanks for taking my question. For PWS here beyond HQCT and CGIS and CGIC, do you plan to evaluate functional endpoints such as hyperglycemia control and weight loss in the phase three trial? And what would be a clinically meaningful bar for success in this study? Thank you. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:51:58In terms of clinically meaningful bar of success, I'll be very pleased if what I see out of this study is similar to the magnitude that was demonstrated with the three point two milligram dose in the prior study. That would be, I think we feel confident that that's going to be a meaningful change and we feel confident not just from ourselves but from talking to physicians as well as patient advocacy organizations. We think that that would be a meaningful note. I mean, I will say that the, I think your other question was about things like weight circumference, we aren't specifically looking at that. We do think that this is a complex interplay of the disease itself as well as the mechanisms that families have put in place to manage their children and their access to food, so that hasn't been a focus here. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:52:47We are looking at adverse events and typically at blood profiles and at least based on the data that we saw in the prior study we have no reason to anticipate that routine monitoring is going to be necessary. That's going be subject to the data we see in this study, of course. Thanks, Salveen. Operator00:53:09Thank you for the question. Our next question comes from Yatin Sanjeev from Guggenheim. The floor is yours. Yatin SunejaBiotechnology Research Analyst at Guggenheim Partners00:53:20Hey, guys. Thank you for taking my question. Question is on 204, ACP two zero four. Could you just comment on the pharmacology that you think is better addressed with this molecule, which was not addressed with Niplasid specifically as it relates to this ADP population? Just trying to get a sense in terms of how the setup is or how different the setup is into this ADP readout versus the DRP study that you ran with NUPLAZID? Thank you. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:53:53So I think, so thank you for the question. As I think about the differences with two zero four, they kind of go into a couple different categories. There's the molecule differences and then there's program design differences and I do think both of those play into what we could be looking at at the ADP study. So on a molecule perspective, just hitting on this really briefly, NUPLAZID does have that QT prolongation, it's not significant, it's not clinically impactful, but in an elderly and frail patient population you do need to think about it, but also it limited our ability to dose range and we do see some differences in the exposure response that suggest that higher levels of exposure could get us to higher efficacy. We think that this is a reason to think that we've got increasing reason to believe LIS two zero four in our ADP program. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:54:42And then on the design of the program itself, you know, think one of the biggest things that we learned from our prior experience was the importance of having our program specifically focused on the disease that we are studying. I don't want to go through the whole history of DRP, but obviously that was one of the challenges that we had there. So the program that we've designed with ADP is very specifically identifying that patient population, specifically looking at a patient population that's a little more severe in their psychosis, which we also found to be more responsive, and were biomarker confirming that patient population. So if we take all of these things together, we think that we have a good setup for ACT two zero four to show what it can do and some good reasons to think that it might be more likely to be successful. Successful. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:55:28Thanks, Liz. Thank you for the question. Operator00:55:31Thank you for your question. Next question comes from Evan Seigerman from BMO Capital. The floor is yours. Evan SeigermanMD & Senior Research Analyst at BMO Capital Markets00:55:42Malcolm Hoffman on for Evan. Thanks for taking our question. Back to debut, I noticed improvement in the percent of active patients who have been on therapy for twelve months or longer from sixty five percent to seventy percent this quarter. Can you just expand on this a little bit further? Is this more a factor again of just providers handling treatment, becoming more comfortable with the GI profile and how to manage it over time? Just would appreciate any color there. Thanks. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:56:06Yeah, I'll take that question. So, thank you. Think it's a few different factors. I mentioned a few minutes ago, we are learning more about the product as we go. We are clearly educating both the patient community and the caregivers and the HCPs regarding how they should go about utilizing the product. Thomas GarnerChief Commercial Officer at ACADIA Pharmaceuticals00:56:27If you look at the overall usage that we see, our percentage to dose remains in the 70% range, which I think also just towards the fact that our user base is just getting more comfortable in terms of titration as well. And I think over time, as they see the benefits of the product and as we lean in more in terms of the efficacy profile, I think that there is more that we can pull through there as we think about debut for the long term. So I think it's a story of continued knowledge. I think we continue to educate in the right way. We make sure that all of the learnings that we have from our COEs are now being amplified into the community as well, and I think that this is all being reinforced with our updated customer model and strategy as we think about Dayview moving forward. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals00:57:16And I think just finally, persistency that we continue to see sort of amplifies that, so the 65 to 70 is really a recognition of everything that Tom just talked to. Just a much more stable base than we were a quarter ago and than we were a year ago, so again, lots of steadiness and now we're driving the momentum into debut. Thank you for the question. Evan SeigermanMD & Senior Research Analyst at BMO Capital Markets00:57:40Appreciate it. Thanks, guys. Operator00:57:42Thank you for the question. Our final question comes from Paul Matteis from Stifel. The floor is yours. Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:57:54Hey, there. This is Julian on for Paul. Thanks so much for taking our question, and congrats on the progress. Just want to circle back to something that was mentioned earlier in the Q and A about the SAP for SAP for ACP101 and how you guys quote unquote retain the right to modify SAP while you remain blinded. Just curious, you know, what what types of modifications could, you know, potentially qualify or could be sort of, you know, in the realm of of possibilities? Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:58:26Just curious if you could expand on that. And I have one quick follow-up as well on Debut. Elizabeth ThompsonEVP - Head of Research & Development at ACADIA Pharmaceuticals00:58:34Yeah, no planned modifications. I purely meant that as a just from a practical point of view, until you have unblinded your database, you can consider your SAP subject to the possibility to change. But, no, there are no plans, modifications. Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:58:49Got it. That's helpful. Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:58:50Thank you for clarifying. And then on Debut, it just sounds like, you know, things are going well. You're starting to see, you know, increased scripts in the community in addition to higher persistence or, I guess, greater line of sight to the persistence of your patient population. I guess just thinking about the second half of the year, you've sort of messaged how you expect to see greater growth. Why the decision to not narrow guidance this quarter? Julian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial Corp00:59:24It just seems like you'd kind of easily hit if you continue to add the patients that you have this year. Just curious if that's being conservative out of sake for being conservative or if there's anything else to that. Thank you. Mark SchneyerCFO at ACADIA Pharmaceuticals00:59:42Yeah, I wouldn't read anything in the guidance. I think what I would say maybe on the reason why we adjusted NUPLAZID is we started the year with a wider range than we normally do, kind of coming into the year, not knowing all the puts and takes for the Medicare Part D redesign. So when we looked at the NUPLAZID range, we just thought it was just too wide kind of halfway through the year. As we looked at all the other ranges, we left them including Debut, and we'll revisit those in the third quarter as we would typically it would be a typical point to start narrowing. Catherine Owen AdamsCEO & Director at ACADIA Pharmaceuticals01:00:20Thanks, Bob. Everybody, for the questions, and thank you, operator. We really appreciate everybody joining us today, and we look forward to updating you on our progress next quarter. Operator01:00:33Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.Read moreParticipantsExecutivesAl KildaniSVP of IR & Corporate CommunicationsCatherine Owen AdamsCEO & DirectorThomas GarnerChief Commercial OfficerElizabeth ThompsonEVP - Head of Research & DevelopmentMark SchneyerCFOAnalystsTessa RomeroEquity Analyst - Biotechnology at J.P. MorganRitu BaralMD & Senior Biotechnology Analyst at TD CowenMichael RiadEquity Research Associate at Morgan StanleyJason ButlerMD & Biotechnology Equity Research at JMP Group LLCBrian AbrahamsMD & Co-Head - Biotechnology Research at RBC Capital MarketsAmi FadiaSenior Analyst at Needham & CompanyMarc GoodmanSenior MD - Neuroscience at Leerink PartnersAshwani VermaExecutive Director - SMID Biotech & Biopharma at UBS GroupDavid HoangDirector & Senior Analyst - Biotechnology at Deutsche BankAnalystTazeen AhmadMD - US Equity Research at Bank of AmericaSumant KulkarniManaging Director at Canaccord Genuity IncSalveen RichterBiotechnology Equity Research at Goldman SachsYatin SunejaBiotechnology Research Analyst at Guggenheim PartnersEvan SeigermanMD & Senior Research Analyst at BMO Capital MarketsJulian PinoSenior Associate - Biotechnology Equity Research at Stifel Financial CorpPowered by