Q3 2025 ACADIA Pharmaceuticals Inc Earnings Call

Speaker #2: Good day , ladies and gentlemen , and thank you for standing by . Welcome to Acadia Pharmaceuticals . Third quarter 2020 financial Results conference call .

Speaker #2: At this time , all participants are in a listen only mode . After the speakers presentation , there will be a question and answer session .

Speaker #2: To ask a question during the session , you will need to press star one one on your telephone . Please be advised that today's conference is being recorded .

Speaker #2: I would now like to hand the conference over to Al Kildani Senior Vice President of Investor Relations and Corporate Communications at Acadia . Please go ahead .

Speaker #3: Good afternoon , and thank you for joining us on today's call to discuss Acadia's third quarter 2020 financial results . Joining me on the call today from Acadia are Katherine 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 brands , debut a new plasmid .

Speaker #3: 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 Schneyer , our chief financial officer , who will review the financial highlights .

Speaker #3: Katherine will then provide some closing thoughts before we open up the call to your questions . We are using supplemental slides , which are available on our website , events and presentations section .

Speaker #3: 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 .

Speaker #3: These forward looking statements , including goals , expectations , plans , prospects , growth , potential , timing of events , future results and 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 .

Speaker #3: 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 .

Speaker #3: I'll now turn the call over to Katherine for opening remarks .

Speaker #4: Thank you al . Good afternoon , everyone , and thank you for joining us today . I'm pleased to report another strong quarter for Acadia with solid execution across our commercial portfolio .

Speaker #4: And continued momentum positions us well for a strong finish to 2025 as we lay the foundation for sustained growth into 2026 and beyond .

Speaker #4: We delivered total revenues of $278.6 million this quarter , up 11% from a year ago . Reflecting the strength of our commercial portfolio .

Speaker #4: This performance underscores our ability to execute on multiple fronts while building for future growth . Starting with debut , we're very pleased with our progress following the expansion of our earlier this year .

Speaker #4: The benefits of which are now starting to materialize . I'm excited to share that we achieved our largest sequential increase in referrals since launch .

Speaker #4: This meaningful sequential growth reflects the impact of our expanded team into the community setting , giving us confidence that we will continue to see benefits from our broadened physician reach .

Speaker #4: During the third quarter , Deb generated 101.1 million in net sales , including contributions from both US sales and Maine patient supply programs .

Speaker #4: Outside the US . We shipped the highest number of daily bottles ever in a single quarter . In total , we've shipped to over 1000 unique patients globally and exciting milestone for the company .

Speaker #4: Importantly , patient persistency remains stable . Underscoring the sustained benefit debut delivers to patients and their families . Moving to new Placid . We delivered an exceptional quarter with net sales of 177.5 million , marking our strongest sales quarter ever .

Speaker #4: The momentum we are now driving gives us tremendous confidence in new plasmids potential to unlock higher growth in the coming years . To ensure we capture this opportunity , we're making strategic investments in a meaningful field force expansion .

Speaker #4: The impact of this field team expansion , combined with our direct to consumer campaigns , creates a powerful combination that we believe will will drive sustained growth and value maximization for new hazard .

Speaker #4: We're looking to build on our commercial success by advancing our pipeline of novel product candidates , including the recent initiation of one phase two and one phase three trials .

Speaker #4: I'll now turn the call over to Tom to cover our commercial performance .

Speaker #5: Thank you . Katherine . I'll begin with debut , where we delivered another strong quarter of commercial execution . Debut sales were $101.1 million in Q3 , representing our highest revenue and total prescription volume in any quarter to date .

Speaker #5: Since launch . As Katherine noted , for the first time since approval , the number of unique patients receiving debut worldwide exceeded 1000 in a single quarter for an actual count of 1006 .

Speaker #5: This achievement reflects not only our progress in the US , but also from patients now starting to access debut through our named patient supply programs internationally .

Speaker #5: We're seeing strong early indicators from our field force expansion . Referrals are leading the way with the highest quarter over quarter increase since debut launch in 2023 .

Speaker #5: This momentum is translating into other key performance indicators , such as broadening prescriber reach . With 956 physicians having now written at least one prescription for debut .

Speaker #5: Our sales teams are now gaining real traction with call volumes on our expanded target customer base , increasing over 20% versus Q2 , supported by a similar increase in the number of educational programs we delivered , both of which were important levers in helping to educate prescribers on the benefits that debut has to offer .

Speaker #5: Importantly , adoption is broadening beyond centers of excellence or Coes with community based physicians accounting for 74% of new prescriptions in Q3 . We're also seeing a meaningful uptick in scripts from nurse practitioners and physician assistants , reinforcing that our strategy to expand in-person efforts into the wider treating community is working .

Speaker #5: These trends position us well to reach more patients who could benefit from debut . Even with this progress , overall market penetration remains relatively low , at about 40% in the US and only 27% in the community setting , where the majority of patients are treated .

Speaker #5: This continues to represent a substantial growth opportunity for the brand . Looking at age demographics , penetration among patients under the age of 11 is over 60% , but amongst older patients is significantly lower .

Speaker #5: Despite growing real world evidence of Debut's positive impact in this group . As we expand our reach beyond CEOs , we see this segment as a significant growth driver for 2026 and beyond .

Speaker #5: Long term persistency remains a key strength for debut , reflecting its sustained clinical benefit and strong patient engagement , with another quarter of maturity in our data .

Speaker #5: Persistency rates remain above 50% at 12 months and greater than 45% at 18 months . The strength of these metrics are important as they further reinforce not only our confidence in debuts therapeutic value , but also our outlook for sustainable long term growth in the US .

Speaker #5: Internationally, our name, Patient Supply Programs, continues to gain traction. All three distribution partners are now actively shipping to patients in the EU.

Speaker #5: Israel, Middle East, and Latin America. Looking ahead, we remain confident in Debut's growth outlook, driven by sustained demand generation supported by our Strategic Field Force investments.

Speaker #5: Strong persistency metrics and expanding global access . These factors are critical because they are not only validate the long term value of debut for patients , but also create a durable foundation for revenue growth .

Speaker #5: While we began to see the initial positive impact from the field force expansion in Q3 , we expect meaningful benefits to accelerate through Q4 and into 2026 .

Speaker #5: In summary , debut is well positioned to capture significant market opportunities in the US and internationally , reinforcing our commitment to delivering both patient impact and shareholder value .

Speaker #5: Now , turning to Nuplazid , where we delivered record performance with net sales of $177.5 million , representing 12% year over year growth , driven by 9% volume growth .

Speaker #5: This reflects strong underlying demand for Nuplazid among patients with Parkinson's disease , psychosis or PDP , and the success of our commercial strategy , coupled with the unwavering focus of our customer facing teams on Executional excellence .

Speaker #5: Referrals were a key driver of this momentum , increasing 21% year over year . This growth signals increasing awareness and confidence among healthcare providers in identifying and treating Parkinson's related hallucinations and delusions .

Speaker #5: Earlier in the course of the disease . New prescription volumes grew 23% in Q3 compared to the same quarter last year , representing the strongest year over year increase since 2019 , and were up 9% sequentially .

Speaker #5: This inflection point demonstrates that our patient engagement campaigns and HCP outreach are translating into tangible prescribing behavior . It also underscores their belief in new plasmids , differentiated profile as the first and only FDA , FDA approved therapy for PDP with a well-established safety and efficacy record .

Speaker #5: Taken together , we believe these trends are an important leading indicator of future prescribing behavior and reinforce the strength of new Placid in meeting a critical unmet medical need .

Speaker #5: As a reminder, the U.S. PDP market represents a significant opportunity. There are approximately 1 million Parkinson's patients, with an estimated 50% experiencing hallucinations and delusions at some point during the course of the disease.

Speaker #5: This translates into a substantial number of patients who could benefit from nuplazid , underscoring the long runway for growth . Looking ahead , we see significant opportunity to build on this momentum .

Speaker #5: Our reach and frequency model is driving broader prescribing patterns across a wide range of hcp's , and our direct consumer campaigns are raising awareness of PDP symptoms while highlighting Nuplazid as the first and only approved treatment to fully realize Nuplazid long term potential and capitalize on the brand's strong momentum .

Speaker #5: We are making strategic investments , including a 30% increase in our customer facing team starting in the first quarter of 2026 . This expansion will allow us to reach newly activated physicians and improve pull through .

Speaker #5: We are approaching this expansion thoughtfully to maximize near-term efficiency and long term impact . Our various consumer initiatives are driving awareness and creating demand with our expanded field force , ensuring we efficiently convert that demand into prescriptions .

Speaker #5: In summary , the new plasmid fundamentals are strong . The market opportunity is substantial , and we have a proven strategy designed to capture it with a differentiated product profile , accelerating demand indicators and targeted investments in our commercial model .

Speaker #5: Our ambition is not just to grow , but to become standard of care for these patients . I'll now turn the call over to Liz .

Speaker #6: Thank you . Tom . I'm pleased to share some updates on our pipeline , where we continue to make encouraging progress across multiple programs that hold meaningful potential for the future .

Speaker #6: We've achieved some important milestones recently, including the successful initiation of our Phase 2 study for ACP 204 in Lewy Body dementia, psychosis, and the initiation of our Phase 3 study of Trofinetide in Japan.

Speaker #6: Looking ahead, our next expected milestone is the initiation of a Phase 2 study for ACP-211 in the fourth quarter of this year.

Speaker #6: We are developing ACP 211 in major depressive disorder , a common condition with significant unmet need . Then , in Q1 2026 , we expect to initiate our first in human study of ACP 271 in healthy volunteers .

Speaker #6: To our knowledge , this will be the first time a GPR 88 agonist enters the clinic , and it moves us along the path of development , targeting the indications of tardive dyskinesia and Huntington's disease .

Speaker #6: We also have important projected study readouts coming . We anticipate reporting results from four phase two or phase three studies between now and the end of 2027 , underscoring both the breadth of our pipeline and the momentum behind our R&D strategy .

Speaker #6: Our next major readout is expected to be ACP 204 . In Alzheimer's disease , psychosis in mid 2026 . We're particularly excited about this opportunity and what success could mean for the future trajectory of our company .

Speaker #6: The unmet need here is substantial . The market opportunity is large , and we have built this program based on a substantial body of learnings from Pimavanserin at both the molecule and the trial level .

Speaker #6: Now , switching gears to our international expansion efforts . First , I wanted to provide an update on the regulatory process in the EU for Trofinetide .

Speaker #6: We've been informed by EMA that the earliest a scientific advisory group could be held would be in January. Given this, we now anticipate a CHMP opinion in the first quarter and the regulatory decision following the standard regulatory timeline.

Speaker #6: Meanwhile , in Japan , we've successfully initiated our phase three study representing a key step towards potentially bringing to patients in this important market .

Speaker #6: Now , before I close , I wanted to take a moment to acknowledge and thank everyone involved in our compass Praderwilli syndrome study and the ACP 101 Clinical Development Program .

Speaker #6: We are so grateful for the dedication and contributions of the patients families . Study site personnel , and physicians who participated . While the outcome wasn't what we hoped for , we hoped that learnings from the trial will benefit the Praderwilli community and we're actively sharing our insights while we work to add the findings to the scientific literature .

Speaker #6: Our pipeline continues to represent a powerful engine for future growth as we look to advance therapies for underserved neurologic , neurological disorders and rare disease communities .

Speaker #6: We anticipate continued activity across our pipeline over the coming years with multiple programs progressing through key stages of development . As a reminder , across our eight disclosed programs , we anticipate initiating five additional phase two or phase three studies between now and the end of 2026 , demonstrating the depth and diversity of our development portfolio .

Speaker #6: And , of course , we anticipate reporting for phase two or phase three study results in 2026 and 2027 . And now I'll pass over to Mark for a review of our financial .

Speaker #7: Thank you Liz . Let me walk you through our third quarter financial results . We delivered an excellent quarter that underscores the robustness of our commercial portfolio , which enables us to generate strong revenue and cash flows while continuing to invest strategically in growth opportunities .

Speaker #7: The third quarter was strong across the board , with $278.6 million in total revenues , up 11% year over year . Debut achieved net sales of $101.1 million , up 11% year over year .

Speaker #7: All of which is attributable to volume growth . The gross to net adjustment for debut in the quarter was 22% . Nuplazid delivered net sales of $177.5 million , up 12% year over year , with 9% of that growth attributable to volume .

Speaker #7: The gross to net adjustment for new Placid was 25% . Turning to operating expenses , R&D expenses were $87.8 million in the third quarter , up from $66.6 million in the third quarter of 2020 .

Speaker #7: Four . With the increase primarily attributable to higher clinical trial expenses from our ACP 204 LBP and ACP 101 programs and personnel expenses , partially offset by lower clinical spend from programs that have completed SG&A expenses .

Speaker #7: For the third quarter were $133.4 million , essentially flat with the prior year . Turning to the balance sheet . We ended the quarter with $847 million in cash , compared with $762 million at the end of the second quarter .

Speaker #7: Looking ahead to our full year 2025 guidance , we're making targeted updates that reflect our strong performance and outlook for new plasmid . We're raising the lower end of our guidance range and increasing at the high end to 685 to $695 million , up from 665 to $690 million , reflecting the momentum we're seeing in the business for debut .

Speaker #7: We're modifying to include contribution from our named patient supply programs and narrowing our prior guidance range . And now expect 385 to $400 million compared with prior guidance of 380 to $405 million .

Speaker #7: For us , only . Regarding operating expenses , we now expect R&D expenses of 335 to $345 million , compared with prior guidance of 330 to $350 million .

Speaker #7: For G&A expenses . We now expect 540 to $555 million , compared with prior guidance of 535 to $565 million . Our financial strength positions us exceptionally well to finish 2025 strong while making the investments necessary to drive sustained growth in 2026 and beyond .

Speaker #7: I'll now turn the call back to Kathryn for closing remarks .

Speaker #4: Thank you . Mark . As we wrap up , today's call , I wanted to emphasize our commitment to finishing 2025 , hitting over $1 billion in total revenues , positioning Acadia for continued growth in 2026 and beyond .

Speaker #4: We continue to be confident in the stability and growth trajectory driven by our new sales teams . For debut , reflected by the over 1000 patients globally who are now on treatment .

Speaker #4: We're focused on unlocking new plasmids for potential with our strategic field force expansion and proven patient engagement campaigns , and we now have the elements in place to further accelerate that growth .

Speaker #4: We are dedicated to advancing our robust pipeline , as Liz has described , and look forward to the four major readouts expected in 2026 and 2027 .

Speaker #4: We also continue to focus on expanding our portfolio through business development , with our strong balance sheet providing flexibility to pursue partnerships and acquisitions .

Speaker #4: Ultimately , our mission drives everything we do to turn scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world .

Speaker #4: We are here to be their difference . I'm excited about what lies ahead for Acadia , and I'm confident that our strategic investments and unwavering focus on our patients will deliver value for all of our stakeholders .

Speaker #4: And with that , I'll turn the call back to the operator for questions .

Speaker #2: Yes . Thank you . Ladies and gentlemen , if you wish to ask a question , please press Star followed by one . One on your touchtone telephone .

Speaker #2: It's been answered . Or if you wish to withdraw your question , press star one one again . Please limit yourself to one question .

Speaker #2: I'll repeat , please limit yourself to one question . Press star one one to begin and stand by for your first question . That first question comes from the line of Ritu Baral with TD Cowen .

Speaker #2: Your line is now open .

Speaker #8: Good afternoon guys . Thanks for taking the question . This afternoon . I wanted to ask about the expanded new pleased client facing force .

Speaker #8: Catherine , how is that organized ? Is it along the lines of focus on the newly activated prescribers ? How should we think about it in terms of community versus long term care facilities , which is a way that historically , Acadia has broken up the population for new pleased and you know which of those two has the most likelihood for continued growth ?

Speaker #8: As you see , the market right now ? Thank you .

Speaker #4: Thanks , Ritu . Appreciate the question . I'm going to ask Tom to explain . He's been leading this charge for us . So Tom .

Speaker #5: Good afternoon . Thank you for the thank you for the question . So as we think about the expansion that as we mentioned , we plan on executing in Q1 of next year , you know , there's a few different factors .

Speaker #5: I would say are playing into our thinking . So as you you think about kind of the new writer base , if we look at kind of dynamics during Q3 , we actually saw that in terms of our overall prescription volume , 26% actually came from new writers .

Speaker #5: So I think this really talks to , you know , the way that our campaigns are working , the execution of the field force .

Speaker #5: And it's been that kind of underlying dynamic that we've actually seen throughout the year, but actually accelerated in Q3. That's really given us the confidence to pull forward this investment into Q1 of next year.

Speaker #5: In relation to your question regarding community versus LTC , actually we're seeing growth across all channels . We're seeing growth both in the community setting and in the LTC setting , as well .

Speaker #5: And you know , there are various channels that we see the new scripts being pulled through . So in essence , you know , we're investing in both .

Speaker #5: If you're looking at it from an absolute kind of percentage terms , we're actually investing slightly more on a percentage basis in the community .

Speaker #5: But at the same time , we are going to be modestly increasing our LTC team , just given the the dynamics that we're seeing in that space as well .

Speaker #5: So long story short , we're investing in both and at the same time , making sure that wherever we see a new script , we're able to pull that through as optimally as possible .

Speaker #8: Thank you .

Speaker #2: Thank you . Your next question comes from the line of Yigal . Not with Citigroup . Group is now open .

Speaker #9: Hi. Great. Thank you very much for taking the questions. I have one on ACP-204, with the top-line data for Phase 2 coming out in the middle of next year.

Speaker #9: I'd be curious if you could comment briefly on what you would see as a clinically meaningful score on the SAP HD score , and also , if you could just discuss related to that , why that that particular scale is a good one to use in this context .

Speaker #9: Thank you .

Speaker #4: Thank you . Gol . This is leading that for us . So I'm going to ask her to comment on the scales and the confidence around both of them .

Speaker #10: So .

Speaker #6: Yeah absolutely . Thank you . So I'll go in reverse order I suppose and start with SAPs and why we landed there for Alzheimer's disease .

Speaker #6: So sass is actually an endpoint that we do have some experience with in our prior Pimavanserin trials . It was involved in the pivotal study for PDP , and it was also part of the relapse criterion in harmony .

Speaker #6: And so overall , we feel like we have a good understanding of that endpoint . And it's responsiveness . It is well set to measure the domains that we think are important in this patient population , and it's one of several endpoints that are in the literature that are supported as being relevant for this patient population .

Speaker #6: We are measuring other things as well . So that is how we landed on this as the primary endpoint for the phase two portion of this study .

Speaker #6: In terms of how we're looking at this , I'll first , I'll note the powering piece and then I'll talk a little bit about what we're looking for in this trial in terms of how we size the trial .

Speaker #6: We actually did this on effect size . And so we're looking for roughly a moderate effect size a 0.4 effect size on SAPs H .

Speaker #6: And but really what we're looking for in the phase two is to continue to understand how we progress towards our overall target product profile for 204 .

Speaker #6: And that certainly has an efficacy component to it . But it also is about making sure that this is appropriate for use in this patient population .

Speaker #6: I think there are a number of important unmet needs here . Sparing cognition , avoiding daytime sleepiness or sedation , avoiding increasing risk of falls or fractures , avoidance of motoric adverse effects .

Speaker #6: So there's a number of things we're going to be looking for that we feel good about based on what we know about the 204 profile.

Speaker #6: But we're sort of holistically going to be looking at the profile of the drug in this trial .

Speaker #4: Thanks so much .

Speaker #9: Great . Thank you .

Speaker #2: Thank you . Your next question comes to the line of Tess Romero with J.P. Morgan . Your line is now open .

Speaker #10: Hey , Catherine and team , good afternoon . Thanks for taking our question . So for debut , you cited the highest quarter over quarter referral growth since launch this quarter .

Speaker #10: Double clicking . How do you think patient starts will look sequentially here over the next few quarters in light of the growth you are seeing ?

Speaker #10: new

Speaker #10: And second one is just a quick housekeeping . When do you think you will finish enrollment in the phase two trial in . Thank you .

Speaker #4: Thanks , Tess . I'll ask Tom to kick off about the referral dynamics we're seeing . And we saw in the quarter that led to about 204 .

Speaker #5: Yeah . Good afternoon sir . Thank you for the question . In terms of debut and referral dynamics , we're really encouraged by what we saw in Q3 .

Speaker #5: We saw actually our highest rate of referrals since essentially launch . And if you look over the last 12 months , you know , we're really growing at a pretty decent rate now , which is very encouraging in terms of pull through , you know , just given standard dynamics that you would expect .

Speaker #5: It does take some time for a referral to then become a actual new to brand prescription . Given the dynamics that we saw during Q3 in the acceleration that we saw , we would anticipate that we'll continue to see growth in actual active patient counts through Q4 into 2026 and beyond .

Speaker #4: Unless you .

Speaker #6: Want to touch on . Oh , right . Sorry . 2 or 4 . So again just reiterating the predicting midyear for top line results here .

Speaker #6: We're really keeping a careful eye on enrollment for the right patient populations . I don't have an exact date of final enrollment here , but we anticipate that that would be occurring sort of in the Q2 ish time frame to enable that mid-year .

Speaker #10: Thank you .

Speaker #4: Okay, thanks, Tom.

Speaker #2: Thank you . Your next question comes to the line of Brian Abrahams with RBC Capital Markets . Your line is now open .

Speaker #11: Hey . Good afternoon . Thanks for taking my question and congrats on the on the quarter . Maybe another question on on 204 .

Speaker #11: Can you talk a little bit about maybe the overall study conduct , how you're feeling about that and are there any I guess , any have there been any or will there be any looks at the blinded safety data that might inform the potential around having the QTc prolongation advantage or anything you could learn about things like risk of falls or some of the other aspects of the profile that you talked about that could give you kind of an early read into that .

Speaker #11: Thanks .

Speaker #6: So the first overall . Pleased with how the study is progressing thus far in terms of , you know , behavior of sites , investigators , the patient population that we're getting in there , we are laser focused on making sure that we are getting the right patients in here , trying to trying to we are verifying them with biomarkers to make sure that this is a biologically confirmed Alzheimer's diagnosis , which we think is going to be important , you know , from a blinded safety perspective , I'd say a couple of things .

Speaker #6: You know , we do have a Dsm-v that looks after this on an ongoing basis . So we would get , you know , any indication of anything that is concerning from that perspective .

Speaker #6: And thus far , they've been supportive of continuing the study on as planned . And we do monitor on an ongoing basis from just sort of medical monitoring perspective , that said , I don't like to comment on data from ongoing blinded trials because you never really know how that's going to sort out across arms .

Speaker #4: Excellent .

Speaker #11: Thanks .

Speaker #2: Thank you. Your next question comes from Ash Verma with UBS. Your line is now open.

Speaker #12: Hi . This is for ash . Thank you for taking our question . Just wanted to get back to the risk adjusted T sales guide that you had provided at your R&D day .

Speaker #12: What is your latest thought on the 2.5 billion and 12 billion peak sales ? You provided on risk adjusted and nominal basis ?

Speaker #4: There was a little bit difficult to hear, but I think what you asked was how we’re commenting on our peak potential that we talked about at R&D Day and our expectations for the commercial portfolio within that same discussion.

Speaker #4: So let me talk about the overall aspirations for Acadia R&D day . We we shared that we aspire to achieve a $12 billion top line .

Speaker #4: Should all of our pipeline programs hit during the next 2 to 3 years . And as you know , unfortunately , our 1 to 1 program did not hit .

Speaker #4: And so we've we would take about 800 to 1 billion from that top line expectation . So we would now if we were speaking about the same thing , aspire to achieve the $11 billion total peak sales of our currently shared portfolio within that same group of of compounds in terms of our commercial aspirations , we shared the 1.5 to 2 billion for our commercial brands and debut , and we are still absolutely committed to deliver on that .

Speaker #4: And look forward next year to share a little bit more clarity about both of those brands and our expectations for each of them , so that you can understand where we see both of those in the next 2 to 3 years .

Speaker #12: Thank you .

Speaker #2: Thank you. Your next question comes from the line of Sam Beck with Deutsche Bank. Your line is now open.

Speaker #13: Hey , Team Sam on for David Wong . Thanks for taking the question . Just a quick one from us on Nuplazid . If you could just provide a little bit more detail on any drivers you're seeing behind the higher average net selling price in the quarter , that'd be great .

Speaker #13: Thanks .

Speaker #4: Yeah , not to take the net selling price question around neoplasm .

Speaker #7: Yeah , I think at this point , you know , I think when you take all the puts and takes that go into pricing and the fact that , you know , the majority or the supermajority of sales for neoplasm are for Medicare based patients , kind of our year over year pricing , you know , is about the rate of inflation .

Speaker #7: That's been our expectation the whole year , except for the kind of one time pricing benefit in the first quarter . And that's really what we saw in this quarter .

Speaker #4: Thank you . Sam .

Speaker #2: Thank you . Your next on the line of Evan Seggerman with BMO Capital Markets . Your line is now open .

Speaker #14: Hi , Mark Hoffman on for Evan . Thanks for taking our question for debut with the opinion expected in the first quarter next year .

Speaker #14: How can you make sure scripts kind of get off the ground quickly after ? What could be a positive opinion there ? Thanks .

Speaker #4: I'll let Tom take that . He's leading our European team . We're all getting ready for that right now . So why don't you share our plans ?

Speaker #5: Absolutely . So thank you for the question , Matt . So as you would imagine , that's a amount of energy being put behind our launch readiness planning in Europe .

Speaker #5: We're going to be following the kind of the standard track that you see for any approval in Europe . So we will be out the gate first in significant Germany .

Speaker #5: And I can tell you we're already gearing up to make sure that the team is ready to go there . So we already have a small group of key account managers .

Speaker #5: We have a handful of folks working on the medical side of the organization , and they've been very actively engaged already with prescribers .

Speaker #5: Well , actually , with treaters from across the universe . I mean , as you would imagine , each of the European markets looks very different to the US .

Speaker #5: But , you know , we are making sure that we have the right infrastructure in place , the right focus in place . And I'm pleased to announce that actually , in this quarter , we opened our compassionate use program in Germany and have already had a number of requests from German HCPs to enroll their patients in that program , which we think is a very nice kind of early indicator of enthusiasm to use the product .

Speaker #5: And obviously , we'll be making sure that that experience is positive as we build out towards the launch .

Speaker #4: Do you want to share a little bit more about the other countries who have also opened their programs in the last quarter ?

Speaker #5: Sure . So I also pleased to announce that we have just opened programs in Italy and France . You know , again , we're pursuing wherever the regulatory and legal frameworks allow us to do so , you know , and early engagements programs .

Speaker #5: And as we mentioned on the call , you know , we also have our ongoing rest of world patient access programs as well , which , again , encouragingly , we continue to see ad hoc requests in an unsolicited fashion coming through to the company .

Speaker #4: Thanks , John . Thanks for the question .

Speaker #14: Thank you .

Speaker #2: Your next question comes from the line of Sean Lehman with Morgan Stanley . Your line is now open .

Speaker #15: Good afternoon , Catherine and team hope everyone's well . I have a question on the 30% increase investment to new . I guess .

Speaker #15: Could you describe in percentage terms how many new prescribers you might be reaching with that investment ? And what's the headroom there before you get near saturation ?

Speaker #15: And if you can provide any guide on quantifying what the costs of that investment is , it would be really useful . Thank you .

Speaker #16: Yeah , I'm going to let Tom .

Speaker #4: Talk about the the increase and we'll go from that .

Speaker #5: So you know , as I mentioned , a few minutes ago , you know , we actually saw a very nice uptick during the quarter in terms of new prescriptions increasing through actual new writers , which was , you know , over 25% in the quarter .

Speaker #5: As we look ahead to kind of opportunities for growth . And as we really kind of done a deep dive on what that assessment looks like and where we see the opportunity , you know , we see a ton of opportunity across a wider group of customers that we've been actually calling on to date .

Speaker #5: Just for reference , you know , historically speaking , we generally called on neurologists . We've called on some movement disorder specialists and some psychiatrists .

Speaker #5: But as we look at that , 26% who are new to writing prescriptions for nuplazid , you know , a ton of those are now coming from primary care .

Speaker #5: They're often nurse practitioners or advanced . Practitioners that are now writing new flaccid and and in reality , we want to ensure that wherever that prescription is written , whether it be for a patient in the community or in the LTC setting , that we're really highlighting the benefit that Nuplazid can offer .

Speaker #5: And just as a reminder , in terms of , you know , our share in terms of NBC's remains in the mid 20% range .

Speaker #5: So if you just think about the upside of opportunity that we have , given the size of the overall PDP population in the US , there is still significant headroom for growth .

Speaker #5: And that's what we're aiming to tap into in 2026 .

Speaker #4: And I'll let Mark share a little bit more about how we plan to make that investment .

Speaker #7: Yeah , I think in terms of people , it's about 50 customer facing reps . I think you can certainly use standard benchmarks for what that cost is .

Speaker #7: We don't dive into exact cost at this level of detail , but consider 50 reps plus some Home Office support and other things that go around that for the kind of overall investment .

Speaker #7: And , you know , we'll just share this kind of within , you know , our guidance for SG&A expenses next year .

Speaker #15: Okay . Thank you everyone .

Speaker #16: Thank you . Thanks a lot .

Speaker #2: Thank you . Your next question comes to the line of Tazeen Ahmad with Bank of America . Your line is now open .

Speaker #17: Hi . Good evening . Thanks for taking my question . Maybe just wanted to ask about why you think now is the right time to add to the field force for new plasmid ?

Speaker #17: And how were you deciding what is the right size ? Is this the final change ? Or final increase that you think you need to make ?

Speaker #17: Or are there certain targets that you might be monitoring ? And if so , can you ? Can you kind of share a little bit about how you how you were thinking about needing more or less people as this launch matures ?

Speaker #17: Thanks .

Speaker #16: Yeah .

Speaker #4: Let me start and then I'll let Tom dive into a little bit more of the details . You know , I think as I came on board last year in September , the team had just started their DTC communications .

Speaker #4: Both the branded and the branded , and we weren't sure how impactful that was going to be . We knew it probably would have some traction , but again , we hadn't really been in the DCC space for a while since pre-COVID , and we wanted to understand the impact of that type of DTC investment .

Speaker #4: We've now got a year under our belt and we can see and you can see in the numbers , real traction in terms of carers and their families being made aware of what the symptoms of Parkinson's disease can be .

Speaker #4: Beyond motor . And then those sort of awareness levels now translating into moving into the physician office and physicians now also with our increasing real world evidence and data generation around neoplasms being confident in prescribing it for the right patient to treat their hallucinations and delusions .

Speaker #4: So all of those metrics have come together . And with the important IP win that we had for neoplasm , allowing us to continue to feel confident about our IP runway in the US , we felt it was time to reassess the opportunity for new closet .

Speaker #4: Tom's been leading that reassessment , and from that he has made the decision and we have , as as a management team that it's right to invest now .

Speaker #4: And so maybe Tom , you can talk a little bit more about some of those investment decisions .

Speaker #5: Yeah . I mean , I think Katherine captured it really well . I mean , it's really been a story of momentum this year for new players .

Speaker #5: And Q3 in particular has really seen this kind of step change in how we're seeing referrals across the board . And , you know , I think given that momentum that gave us the opportunity in the lens to really have another look at what our customer model looked like , especially as you think about a world where we're seeing a number of new prescribers outside of our core kind of target base , really beginning to latch on to the benefit that you can offer and really engaging with this community in terms of where their where they're engaging with , with healthcare professionals , which , as a reminder , you know , it can be quite challenging to get time with the neurologist or with a , you know , a PDP specialist .

Speaker #5: And , you know , we think that with this expanded reach , we'll be able to actually help these patients really understand the benefit that they can afford and see with new closet beyond what we're doing today .

Speaker #5: So it's about it's about really capitalizing on momentum . And then ensuring that we have the right structure in place for both . Today and tomorrow .

Speaker #5: To your question that we believe will put us in a really very strong position to maximize the opportunity ahead .

Speaker #4: And just a final thought . You know , we've been very focused at Acadia on ensuring that we are building a company that's built on a foundation of analytics and insights and data .

Speaker #4: And within the new expansion , it's been fueled by analytics , data and insights . And we'll be using both that and our AI on top of it to ensure that we really efficiently now find our patients and target them .

Speaker #4: And so I think the combination of of the new data being sort of driven by a focus on analytics technology , we have a new CIO in place to help us drive that .

Speaker #4: And so I feel very confident that it will not only be an efficient focus , but also very effective . One . Thanks for the question .

Speaker #2: Thank you . The next question comes from the line of Jack Allen with Baird . Your line is now open .

Speaker #18: Great . Thank you so much for taking the questions . And congrats to the team on the progress made over the course of the quarter .

Speaker #18: I wanted to ask on the European opportunity for for debut . I just wanted to gauge opinion on how about reimbursement in Europe , Canada ?

Speaker #4: Just cut out . You just cut out the end . I heard reimbursement in Europe . Could you just maybe just repeat the question for us ?

Speaker #18: Yeah , sorry about that . I hope you have me better now . Yeah , I wanted to ask about reimbursement in Europe .

Speaker #18: I know there was . In in Canada over the summer . What your thoughts are and your early conversations are around payers in Europe ahead of a potential European launch for debut .

Speaker #4: Thanks , Jack . So yes , we we are obviously in in the middle of discussions and thinking right now around reimbursement in Europe .

Speaker #4: And you're right , we did have a disappointing decision in Canada . Tom , do you want to share a little bit more about how we're thinking about reimbursement in terms of the sequential approach to that in Europe ?

Speaker #5: Absolutely . So , you know , as I mentioned a few minutes ago , our plan would be that we launch first in Germany .

Speaker #5: And as a reminder , in Germany , as we launch , we have six months of repricing , which we will obviously think very carefully about what that looks like , especially just given some of the other dynamics that we continue to monitor across the board , such as MFN .

Speaker #5: But , you know , I think given the engagement that we've already started with payers and clinicians , we remain pretty confident , actually , that , you know , our European clinicians and the broader environment are seeing the benefit that debut can have , and can offer .

Speaker #5: And I think as we continue to generate new real world evidence in the US , you know , we're going to ensure that we leverage that as we go into discussions with European payers and beyond , as well , to really ensure that the value of debut is fully understood and realized across the markets where we're where we're launching .

Speaker #5: So more to come . But again , I think we're excited about the opportunity in Europe and look forward to putting debut into the hands of many more patients who clearly deserve this treatment .

Speaker #4: Thanks , Jack .

Speaker #2: Thank you . Your next question comes to the line of Paul Mathias with Stifel . Your line is now open .

Speaker #14: Hi there .

Speaker #19: This is Julien on for Paul . Thanks very much for taking our question . I guess just on ACP 204 , I was wondering if you guys could clarify the exposure response relationship .

Speaker #19: You've sort of seen from Pimavanserin and the work you've done on ACP 204 . You you often allude to , you know , like your , your learnings that that you've , you know , learnings that you've had from development as well .

Speaker #19: You know , from an execution perspective as well as from a scientific and biological perspective and why you believe greater potency with ACP 204 will translate to greater clinical benefit .

Speaker #19: Thanks very much .

Speaker #6: All right . I'll try and get all the things that were in there . So starting with the exposure response . So both in both in the old timer's disease population as well as in Lewy body .

Speaker #6: We do have some information from Pimavanserin suggesting that with higher levels of exposure , you are able to get to higher levels of improvement on the clinical end points and that the median exposure that we're able to achieve with Tim Aventurine leave some of that efficacy on the table .

Speaker #6: So it's sort of midway through that exposure response downward curve . And the reason for that , of course , is that unfortunately with Pimavanserin , there was a tendency towards QT prolongation , which limited the ability that we could dose range .

Speaker #6: So, we were not able to push the average patient up to the near-maximal efficacy that you could get with a higher exposure level.

Speaker #6: With 204 . We don't have that problem . So thus far , our non-clinical and our clinical data are supportive of the fact that there is not a signal of QT prolongation here .

Speaker #6: And our overall , our experience has been such that it is supportive of moving to our current clinical doses , which we're looking at in our Alzheimer's and Lewy body programs , where the lower dose is roughly equivalent to the exposure with the marketed dose , and the higher dose is roughly twice that .

Speaker #6: So those are the pieces that give us some optimism that we have the possibility of exploring higher levels of efficacy . But even if we are not able to actually achieve higher levels of efficacy with a higher doses , we do think that there are some program learnings that we're able to apply here , certainly in both cases , we have programs that are focused specifically on the disease under study .

Speaker #6: The Pimavanserin data in Lewy body is promising , but it's a limited number of patients . And the Alzheimer's program had a single dedicated study .

Speaker #6: And then a subgroup in an overall study . So here we're going to be able to bring to bear much more robust data evaluating both of these disease states .

Speaker #6: So those are the things that we take together to give us some real enthusiasm . About 204 , which again , we see as potentially having the possibility of really changing the trajectory of this company .

Speaker #4: Excellent .

Speaker #2: Thank you . Your next question comes from the line of Mark with Leerink Partners . Your line is now open .

Speaker #20: Hi . Good afternoon . This is Basma On for Mark . We have a question on debut . You mentioned that the penetration is lower in the patients older than 11 years old .

Speaker #20: Do you believe that the slower penetration is driven by the higher discontinuation in this age , in this older age group ? The reason why we asking this question is we would expect that the improvement in communication skills and other effects may be minimal in the older patients .

Speaker #20: And maybe that's a lack of effect to drive greater discontinuations . And also , could you clarify whether the age of patients in general seeking treatment is is is skewed to the younger age group or it's basically uniform across the different age ?

Speaker #20: Thank you . That's it for us .

Speaker #4: Thank you . I think there's some some important opportunities there to clarify what the data actually says about debut efficacy across the age groups .

Speaker #4: And to share a little bit more about what we're seeing in the field . So , Tom , do you want to answer it ?

Speaker #4: And if you've got any efficacy points to add on top , that would be good .

Speaker #5: Absolutely . So thank you for the question . So I mean going back to the the original premise , you know , do we think that the reason that we are slightly lower penetrated in patients greater than 11 years and older is , is due to discontinuation ?

Speaker #5: I don't think that that's the case . I mean , essentially what we have to remember is the vast majority of patients who have been treated so far .

Speaker #5: Again , if we look at penetration by age , are those in the 2 to 4 age bracket , you know , newly diagnosed patients , they're easy to identify .

Speaker #5: And they generally fall under the the focus of the Center of excellence . And I think that that's a group that we've been able to penetrate very early on .

Speaker #5: If you look at the last quarter . Interestingly , 65% of our patients were actually older than the age of 11 . So it's a group of patients that we believe that we can really begin to penetrate further still .

Speaker #5: And , you know , especially with our lotus real world evidence generation , which as a reminder , has patients as old as 60 included in it .

Speaker #5: You know , we do continue to see a group of , well , we continue to see patients seeing benefit irrespective of age .

Speaker #5: And this is this has been part of the strategy as we've extended our reach beyond center of excellence because many of these patients who are slightly older , unfortunately , you know , they sit within the community setting , they may not be under the care of a Co , and they may not even be aware of debut .

Speaker #5: In fact , we just heard about a patient story yesterday for a patient in Kansas who was receiving Rep . Sorry , debut for the first time .

Speaker #5: But before they came into this center had never even been made aware of debut . So I think it really does talk to the fact that we have more work to be done .

Speaker #5: Both in terms of educating the community about what RET is and what to look for . And at the same time ensuring that they understand the benefit that debut can offer to these patients , irrespective of their age .

Speaker #4: Do you want to enhance a little bit on that , or is there anything you wanted to add about the data that we've shared ?

Speaker #6: Sure . I mean , so , you know , agree with everything that Tom said there . I think that , you know , going back even to the original clinical trials , there is supportive data suggesting that there's efficacy in patients above 11 , as well as below 11 , though , you know , it is a somewhat smaller proportion of our overall patient population .

Speaker #6: But exactly as Tom said , we've also been tracking these patients in in Lotus as well and see evidence of improvement in those patients as well .

Speaker #6: So I think that there is an increasing body of evidence that supports the fact that debut does bring benefit to patients in line with the indication, which is not restricted in terms of age.

Speaker #6: need .

Speaker #4: Yeah , I think that's the key . We see a debut efficacy across age ranges and we want to ensure that neurologists and treating physicians are educated about the data and don't have preconceived notions about specific efficacy and specific age groups .

Speaker #4: And that's a big focus of Tom and Allison and the team . As we move into next year to really ensure that that that data is shared specifically to encourage the physicians that aren't so well versed in to really look at the data and think about it for all patients , not just younger patients .

Speaker #4: So with that , it's a good question . Okay . The next one .

Speaker #2: Thank you . Your next question comes from the line of Amy Fadia with Needham and Company . Your line is now open .

Speaker #12: Hi . This is Purna on for Amy . Thank you for taking my question and congratulations on the quarter . My first question is we're seeing some IRA impact feedback coming from therapies such as Austedo .

Speaker #12: Is there any read through for new based on this ? Is this more positive than you expected ? And my second question is how is ACP 211 differentiated from Spravato and the emerging psychedelic class in depression ?

Speaker #12: Thank you .

Speaker #4: I'm going to ask Mark to answer the question first , and then we'll ask Liz to talk about the differentiation of ACP .

Speaker #7: 211 I think on the on the IRA , there's not a great comp yet for neoplasm as new plasmid is the first and only approved therapy for its indication .

Speaker #7: And so it doesn't have , you know , competition with other branded agents as well as we haven't seen a comp like that go through the IRA negotiation .

Speaker #7: So , so simply speaking , I think we'll we'll see how this evolves as , as , as an if new plasmid goes through negotiations or others in a more comparable situation .

Speaker #7: And that may or may not have read through for what a new plaza negotiation may look like.

Speaker #6: And as far as switching gears , quite a lot to 211 as far as 211 is concerned , so we've designed 211 as an oral therapy .

Speaker #6: And what we're hoping for here is the potential for ketamine like efficacy or spravato like efficacy with a very different patient experience in terms of the degree of required in-office monitoring and the data that we have so far supports that , both in terms of animal models that suggest efficacy as well as lacking sedative impacts or dissociation .

Speaker #6: And in healthy volunteers in our phase one study , we've demonstrated the ability to reach high doses with no sedation and minimal dissociation .

Speaker #6: We think if this reads through in our upcoming clinical trials , we are looking to start this phase two and 211 before the end of this year .

Speaker #6: And we designed this , of course , to look at efficacy , but also very importantly , to rule out unacceptable levels of sedation and dissociation .

Speaker #6: So we think that there is a potential for a really appealing product here .

Speaker #4: Thanks so much .

Speaker #21: Thank you .

Speaker #2: Thank you . Your next question comes to the line of Salveen Richter with Goldman Sachs . Your line is now open .

Speaker #22: Good afternoon . Thanks for taking my question . On the LBD psychosis study , can you just help us understand the rationale for enrichment of the phase two with the additional patient groups , including LBP and the PDP population , instead of just focused on Lewy body dementia , psychosis specifically .

Speaker #23: So Lewy body dementia .

Speaker #6: Psychosis is is sort of an umbrella term that actually encapsulates encapsulates dementia with Lewy bodies as well as Parkinson's disease , dementia , psychosis .

Speaker #6: And so what we're looking to do in our Lewy body program is actually ensure that we're looking at roughly equivalent numbers of both of those two patient populations to understand any similarities and differences in terms of how they behave.

Speaker #6: This will help us in terms of designing what future studies could look like when we look at the population in the Pimavanserin data set , that is specifically that Lewy body dementia psychosis , you know , the numbers are relatively small , but it is very promising data .

Speaker #6: And that's part of what had us move this program forward . And part of what makes us enthused about it .

Speaker #4: Thanks , Salveen .

Speaker #2: Okay . Thank you . Your last question comes to the line of Sumant Kulkarni with Canaccord Genuity . Your line is now open .

Speaker #24: Good afternoon . Thanks for taking our question . You're investing more on neoplasm and there have been some questions already about that . But we're finally seeing some excitement in the Parkinson's market .

Speaker #24: And AbbVie recently announced a Salesforce expansion on the strength they're seeing for you and a potential approval for Teva . So how do you think this additional focus on Parkinson's market from a relatively large player might influence the market or diagnosis rates for psychosis associated with Parkinson's ?

Speaker #4: Charles I'll start and then maybe give a perspective from Tom . I think . So let's just start by reminding everybody that neoplasm is the only branded product approved for Parkinson's disease psychosis .

Speaker #4: But as we see more activity in an overall Parkinson's market , I think what history would tell us is that once more , once larger companies are in the market , are talking about Parkinson's disease , more forcefully with with more people .

Speaker #4: That does tend to be an increase in terms of awareness of different elements of the of the disease . And as Tom has already alluded to , 50% of patients suffer from psychosis or suffer from the hallucinations and delusions Parkinson's .

Speaker #4: At some point during their journey . And so it wouldn't be unsurprising to to sort of see that that rate increase . What we do know right now is that there's a relatively low level of awareness amongst families and caregivers .

Speaker #4: Of those symptoms , which is why we've been putting effort behind the unbranded campaign . And that would still have to be true , because those sort of non-motor related symptoms generally go undiscussed and .

Speaker #4: Unfocused on by the physicians and their families . And what we have understood is that we need to continue to talk about them to ensure that those questions are raised as we continue to educate physicians with our expansion .

Speaker #4: So I think we probably hope to see that the physicians are starting to learn more about it themselves . But I don't think without us , it's going to be a sort of a natural place for them to go with other companies .

Speaker #4: What would you say on that ?

Speaker #5: No , I mean , one thing I would say , I mean , I think it's well recognized that Parkinson's in general is one of the , you know , the fastest growing neurological , you disease types in the United States .

Speaker #5: You know , as a reminder , there's estimated to be about a million patients with with Parkinson's in the US . And as we kind of then take a step down into those patients who actually diagnosed with hallucinations , delusions , it's somewhere between 40 and 50% of that population at any given time .

Speaker #5: By our estimate, there are about 130,000 of those patients who are actually diagnosed with atypical antipsychotics and antipsychotics. Pardon me? During the course of the disease.

Speaker #5: That's not to say , you know , there's more work to be done here , because I think if you look at most patients as they go through their Parkinson's journey to begin with , they are fully focused on , you know , the movement elements of the disease .

Speaker #5: And unfortunately , not everybody is educated on the hallucinations and delusions that can commonly concur . And I think one of the key calls to action that we're trying to drive at the moment , that if if a patient even if early in their disease course is experiencing hallucinations or delusions , that that is a trigger point to start treatment , that's a trigger point to make sure that they're engaging with an HCP , whether it be a neuro or it be their primary care physician , to make sure that they're having that dialogue to ensure that appropriate action can be taken .

Speaker #5: And we believe that that's where , quite honestly , Nuplazid can play a really critical role just given his profile , given its safety profile and given the the growing body of evidence that Catherine mentioned earlier on .

Speaker #5: So I think taken together , you know , clearly more upside . And I think that that's one of the reasons that we have decided that now is the time to really invest in our customer facing approach for New Placid .

Speaker #5: As we look forward .

Speaker #4: , now is the time is a great way , I think , to end that , that that question . Thanks very much .

Speaker #2: Thank you . Since there are no further questions , I'll pass it along to Mrs. Owen Adams to proceed to closing remarks .

Speaker #4: Thanks , everybody , for your questions . We're really excited about what lies ahead for Acadia , and we look forward to our next call .