Q1 2025 ACADIA Pharmaceuticals Inc Earnings Call
Lauren Cannon: Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals conference call. My name is Lauren Cannon and I'll be your coordinator for today.
Lauren Cannon: After the speaker's presentation, there will be a question and answer session.
Lauren Cannon: To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised.
Speaker Change: To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the presentation over to Al Kildani, Senior Vice President of Investor Relations and Corporate Communications at ACADIA. Please proceed.
Al Kildani: Good afternoon, and thank you for joining us on today's call to discuss ACADIA's first quarter 2025 financial results.
Speaker Change: Joining me on the call today from ACADIA are Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks followed by Tom Garner, our Chief Commercial Officer, who will discuss our strong commercial brand's debut and new plazit
Speaker Change: 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 Change: Catherine will then provide some closing thoughts before we open up to call for your questions.
Speaker Change: 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 Security's litigation reform act of 1995 .
These forward-looking statements, including goals, expectations, plans.
Speaker Change: 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.
Speaker Change: These factors and other risks associated with our business can be found in our filings made with the SEC.
Speaker Change: Your caution is 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 Change: I'll now turn the call over to Catherine for opening remarks.
Catherine: Thank you all. Good afternoon everyone and thank you for joining us.
Catherine: We're off to a strong start in 2025. Our performance this quarter reflects solid execution across the business and continued momentum behind our strategic priorities. Thank you.
Catherine: From commercial progress to pipeline advancement, we're delivering an arch-commitment spot positioning in the ACADIA for long-term growth.
Catherine: Let me walk you through the key highlight, starting with our commercial performance.
Catherine: The police report that our commercial business has had a strong first quarter, we're holding on the solid foundation we established in 2024 with first quarter revenues of 244.3 million at 19% from a year ago.
Catherine: Starting with Davis, this quarter represents a meaningful inflection point in the Browns trajectory. Over the past few quarters, we've successfully stabilized the business and established a solid base of growth to build on. [inaudible]
Catherine: Today our focus is shifting towards accelerating that growth through deeper patient and provider engagement and by broadening our overall reach into the community.
Catherine: We generated 84.6 million in debut sales in the first quarter up 11% from a year ago.
Catherine: Importantly, the number of unique patients receiving shipments was 954, up meaningfully from Q4 and in fact an all-time record for the brand.
Catherine: This gives us confidence in the sustainability of David's growth and we reiterate our four-year sales guidance.
Catherine: Turning to new plazard, we reported 159.7 million in revenue for the quarter, up 23% from the prior year. As Mark will detail, that growth included 6% growth in volume, and the remainder was largely attributable to one time change of growth in that.
Catherine: We continue to see strong performance driven by our direct consumer effort, which are helping drive patient awareness and pull through in the form of physician visits.
Catherine: As with Davey, we are reiterating our full-year guidance for New Plaza and expect continued solid
Catherine: On the R&D front, we're making great progress and a thrilled to update you that it's our timeline for last patient in and therefore top-line results from our Compass PWS Phase 3 study in Prada Willie syndrome and now both expected to happen before the end of 2025
Catherine: We're also excited to host our first ever R&D Day next month. This event will offer a deeper look into our development strategy and allow us to showcase some of the promising innovation that's taking shape across our pipeline.
Catherine: We look forward to introducing you to more members of our team and sharing how we're thinking about the next wave of growth.
Tom Garner: With that, I'd like to turn the call over to Tom to discuss our commercial performance in the first quarter.
Tom Garner: Thank you, Catherine. I'll begin with a review of Davey where we have made exciting progress.
Tom Garner: First quarter sales were 84.6 million, up 11% from a year ago. [inaudible]
Tom Garner: Although sales were down sequentially, as we were explained would be the case on our last call, the underlying patient dynamics were positive.
During the quarter, 954 unique patients received page shipments. [inaudible]
Up from 920 in the fourth quarter. [inaudible]
Tom Garner: In fact, as Catherine said, this was the highest number of patients served in a quarter since the launch of debut over two years ago [inaudible]
Catherine: While we continue to add new patients, a key driver of this performance was a significant reduction in discontinuations and improvements in persistency.
Overall, our persistency rate remains above 15% after 12 months. [inaudible]
Catherine: Driving a growing, stable base of patients remain on therapy long term, with 65% of our active patients now having been on therapy for 12 months or longer.
Catherine: With regard to patient mix, our strategy is playing out as intended.
Catherine: In the first quarter, we saw more new scripts from the community setting, including a higher number of prescriptions from pediatricians.
Catherine: This was particularly encouraging as it occurred ahead of the Field Force expansion which we announced in the first quarter.
Catherine: I'm pleased to share that all plant hires for the expansion have now been completed and I'm confident our expanded customer model and refined strategy will begin contributing to further debut sales growth in the second half of the year.
Catherine: As a reminder, to date, roughly two-thirds of diagnosed ret syndrome patients have yet to try
Catherine: Turning to our plans outside of the US, we continue to lay the foundation for a strong launch outside the US once we obtain approval from the EMA, which we anticipate in the first quarter of 2026.
As a reminder, the opportunity in Europe is substantial.
Catherine: with an estimated 9 to 12,000 individuals affected by Retson Drone.
Catherine: We have now hired an experienced general manager for Europe and continue to build out the commercial team behind him.
Catherine: We have also initiated managed access programs and in April have already served the first reps syndrome patient under this program in Germany.
Catherine: We continue to see strong interest in access to trophinatide prior to approval.
Catherine: For the rest of the world, we recently entered into distribution agreements for named patient access in geographies including Latin America, the Middle East, Asia Pacific, and other countries around the world and are already receiving inquiries.
Catherine: In summary, I'm very pleased with the progress we have made with debut. As you can see from the first quarter results, we have now started to see renewed growth in patients.
Catherine: We believe we now have the strategy, structure and resources available to maximize growth through 2025 and into 2026.
Catherine: Turning to New Pazid, we were pleased to see the strong momentum built throughout 2024, continue into 2025.
New pleasure to achieve first quarter sales of $159.7 million.
Catherine: Representing 23% revenue growth year over year, of which 6% came from volume [inaudible]
Catherine: In fact, the first quarter of 2025 was the best quarter in terms of new to brand prescriptions since 2020 2020.
Catherine: We believe this gives us strong momentum for the rest of the year, even as we have a significant opportunity to further expand our share of the Parkinson's disease psychosis market.
Catherine: We continue to see the benefits from both our unbranded disease awareness campaign as well as our branded campaign.
Catherine: These efforts led to higher engagement across our unbranded disease awareness and new plazid websites.
Catherine: Helping to spark more meaningful conversations between patients and their physicians [inaudible]
Catherine: with a nearly 30% increase in awareness of Parkinson's related hallucinations and delusions since the launch of the Mortar Parkinson's campaign.
Catherine: Our consumer activation campaigns have complemented and enhanced the core growth drivers that have supported the new plurid brand for over two years.
Catherine: including leveraging of our published Rear-World Evidence, showing an association of film events renewed with other atypical and psychotics in important outcomes like fall cause mortality.
Catherine: From a brand perspective, our primary focus is identifying PDP patients earlier in their Parkinson's journey and ensuring they're aware of available treatments upon diagnosis.
Catherine: It's crucial to remember that while approximately 50% of Parkinson's disease patients will experience Parkinson's and hallucinations and delusions, it's estimated that only 10% will ever self-report these symptoms.
Catherine: Therefore, we will continue to actively engage with the Parkinson's disease community.
Catherine: across both HCP and consumer audiences to drive earlier awareness, diagnosis, and treatment of Parkinson's disease psychosis, and to help ensure that new pleasure is recognised as a first line therapy for this challenging condition.
Catherine: Overall, we remain highly confident in our ability to drive meaningful growth for the brand through 2025 and beyond.
I'll now turn this over to Liz.
Thanks Tom.
Liz: I'm delighted to start out today with an important update for our pipeline.
Liz: As Catherine mentioned in her opening remarks, due to the diligence of our team and support of the community, the timeline for our Compass PWS Phase 3 trial for ACP 101 has accelerated
Liz: As a result, we now expect close screening within the coming days, which would allow us to complete enrollment this quarter.
Liz: With that, we're now expecting top-line results by early fourth quarter of this year Assuming positive data, we believe that sets us up for a potential regulatory submission in the US in the first quarter of 2026 We're now expecting top-line results by early fourth quarter of this year Assuming positive data, we're now expecting top-line results by early fourth quarter of 2026
Liz: As a quick reminder, ACP 101 is an intranasal delivery of Carvitosan, a long-lasting analog of human oxytocin. Carvitosan was developed to more selectively bind to the oxytocin receptor.
Liz: We're developing it for the treatment of Hyperfasia and Prater Willie, which is a rare genetic neurobehavioral disorder. Hyperfasia and intense persistent sensation of hunger is a defining characteristic of Prater Willie. Dr. Prater Willie, Dr. Prater Willie, Dr. Prater Willie, Dr. Prater
Liz: Again, we're pleased to pull these important milestones into 2025 and look forward to reporting results later this year.
Liz: Next, I'll turn to our second late-stage clinical program, ACP 204, our new 5-HT2A inverse agonist that we designed based on learning from Pimm of Answering
Liz: We continue to make important progress with ACP204 as well. Now moving it forward into indications.
Liz: First, we're currently conducting a global double-blind placebo-controlled phase two study in Alzheimer's disease psychosis or ADP. We've designed the program for seamless enrollment from phase two to phase three. [inaudible]
Liz: For this program, we continue to expect last patient in during the first quarter of 2026, followed by Healthline Results around mid-2026.
Liz: We're also advancing ACP 204 into a second indication, Louis body dementia psychosis, a serious neurodegenerative condition linked to alpha-synuclein buildup, and marked by cognitive, behavioral, and motor symptoms
Liz: Effecting over 1 million people in the US, LBD is one of the most common forms of dementia. This is one of the most common forms of dementia.
Liz: Prior data with Tim Evancerin showed encouraging signals in this population, supporting the potential of ACP 204 to address hallucinations and illusions.
Liz: For Louis Body Dementia Psychosis, we remain on track to initiate a phase two study in the third quarter of this year.
Liz: Now I'd like to turn to our updated pipeline and provide a few additional updates.
Liz: First, I'm looking forward to sharing more details on these programs at our R&D Day next month. In particular, I'm excited to share additional insight into our plans and the supportive data regarding some of our most newly disclosed programs.
Liz: The event is intended to provide a bit of a deep dive into each of these programs, as well as to allow you an opportunity to meet some of the senior members of our R&D team.
Liz: We're also looking to give you an understanding of how we think about drug development here at Acadia, and the high bars we put on our potential medicines at every step along the way.
Liz: At this time, I want to share an update related to our collaboration with Stoke Therapeutics. We continue to be excited by the data we are seeing from the SynGap 1 program, and look forward to getting to the next decision-enabling data, early next year.
Liz: With respect to the other discovery programs in the collaboration, ACADIA has reached the conclusion that there's not a viable path forward for the RET or the undisclosed program. Accordingly, we'll be winding down our efforts for both of these programs. Thank you very much.
Liz: In Japan, our engagement with the PMDA remains productive. I'm pleased to share that we have officially received orphan drug designation. This has various benefits but importantly offers the potential for priority review.
Liz: and we remain on track to initiate a phase three trial in Japanese patients with red syndrome in the third quarter of this year.
Mark Schneyer: And now, I'll turn it over to Marc for a financial update.
Mark Schneyer: Thank you Liz. Let's now review our first quarter of 2025 financial results.
Mark Schneyer: In the first quarter of 2025, we recorded $244.3 million in total revenue, up 19% from the first quarter of last year.
Mark Schneyer: First quarter debut net product sales were $84.6 million, up 11% year over year on the strength of achieving an all-time high in terms of number of unique patients receiving shipments.
Mark Schneyer: As we signaled on our Q4 call in February , we expected debut net sales to be down to budgetary factors contributing to this included the fourth quarter pull forward of approximately $3.5 million in net sales.
Mark Schneyer: Typical beginning of year seasonality, impacting both volume and net price, and a sequential decline in net price per bottle of debut, attributable to the impact of the Medicare Part D redesign.
Mark Schneyer: The day view grossed an antichessment for the quarter was 24.9 percent. [inaudible]
Mark Schneyer: Importantly, we continue to expect all the key metrics that drive debut net sales to increase throughout the remainder of the year, including unique patient served, bottle volumes, and net price.
Turning next to new closet.
Mark Schneyer: First quarter new class in net product sales were $159.7 million, up 23% year-over-year, with 6%
Mark Schneyer: The anticipated net price benefit of 16% was largely attributable to a one-time change in growth net as a result of the Medicare Part D redesign as part of the inflation reduction net.
Mark Schneyer: Moving forward, we expect our growth to net to stabilize without significant quarterly fluctuations.
Mark Schneyer: and to remind you, ACADIA's benefiting from qualifying as a small company manufacturer under the inflation reduction.
Mark Schneyer: As a point of reference, our gross price for new closet in the quarter was up just over 2% year over year.
Mark Schneyer: The new classes grossed an adjustment for the quarter was 24.1%. [inaudible]
Mark Schneyer: R&D expenses were $78.3 million in the first quarter up from $59.7 million from the first quarter of 2024 due to increased spend on clinical stage programs.
Mark Schneyer: SNA expenses for the quarter were $126.4 million up from $1008 million in the first quarter of 2024.
Mark Schneyer: The increase was primarily driven by the continuation of our new plazas consumer activation campaigns, as well as higher commercial operation expenses for our planned expansion of the Dave UT.
Our cash balance as of March 31 was $681.6 billion.
Mark Schneyer: while Cashwell from operating activities was positive in the quarter. [inaudible]
Mark Schneyer: Cash declines sequentially, primarily as a result of $98.8 million in payments made to Niren reflecting payments of a sales milestone and their share of the net proceeds from the sale of RPRB as I explained on our last call.
Let's turn to our 2025 Guide.
Mark Schneyer: As you can see on this slide, we are reiterating the full year 2025 financial guidance first provided on February 26th with the exception of R&D expects.
We now expect to spend...
Mark Schneyer: $330 to $350 million up from our prior range of $310 to $330 million.
Mark Schneyer: The increase is primarily related to the acceleration of the timeline for HCP 101, which is pulling forward spend from 2026.
and to include regarding uncertainty around potential tariffs. [inaudible]
Mark Schneyer: It's important to note that for both duplas and in-day view, we have substantial inventory on hand in the United States.
Mark Schneyer: For New Plaza, we have enough inventory to meet anticipated demand into the mid to late 2030s, and for a day view, we have a few years worth of inventory.
Catherine: And now I'll turn the call over to Catherine for closing remarks.
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Catherine: Thanks, Marc. Our first quarter results reflect us from start to 2025, and we are well positioned to build on this momentum. We are eager to deliver on the value of creating milestones you see on this slide in 2025 and 2026.
Catherine: And please that one of those significant milestones has been accelerated with top-line results from Compass PWS now expected in the fourth quarter of this year.
Catherine: We have delivered on key commitments from our Q4 call, including expanding the debut feel force and launching a global managed access program.
We remain sharply focused on executing against all strategic priorities.
Catherine: Accelerating Davis commercial trajectory, capitalising on the continued momentum of new plazard, expanding our global presence, and advancing our pipeline designed to deliver innovative therapies to underserved patient populations.
Catherine: In line with this strategy, we're pleased to invite you to our inaugural R&D Day on June 25th, which will be broadcast live.
Catherine: I look forward to keeping you updated as we execute through the remainder of the year. And with that, I'll turn the call over to the operator. Operator? Thank you.
Speaker Change: Thank you. At this time we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Ritu Baral with TD Cohen. Your line is now open.
Ritu Baral: Good afternoon, guys. Thanks for taking the question. I wanted to ask about, I guess, one question on 101 and then one question about debut for Europe . One, what does good 101 data look like? And can you discuss how that may relate to your last discussions with FDA on the filing strategy? And then as far as Europe , I'm not sure if you have any questions, but I would like to ask you a question. I would like to ask you a question.
Ritu Baral: How should we be thinking about modeling a European price for debut and then, you know, just...
Speaker Change: Balancing the pricing risk from a potential most favored nation drug pricing.
Speaker Change: Development that I think we're all sort of watching. Thanks for taking the questions.
Speaker Change: Thanks Ritu, appreciate those two part questions, so I'm going to ask Liz to kick us off on 101 and then I'll talk about the EU strategy.
Speaker Change: Thanks, Catherine. Hi, Ritu, and thanks for the question. First off, I do want to reiterate how very pleased we are to find ourselves ahead of schedule with respect to 101 and looking to have data out of this study by the end of the year, which we think is going to be a pretty important milestone for ACADIA as a company and really reflects.
Speaker Change: You know, both great effort by the team, as well as I think good enthusiasm from the community, so pause them all the way around.
Speaker Change: In terms of your question about what a good outcome would look like here, the nature of the trial is such that I'm going to be very pleased with what we have as a statistically significant result. We've powered this such that we think that if we have statistical significance, we're going to have demonstrated a clinically meaningful impact on hyperfagia, which really is a defining and truly terrible symptom for these patients to be living with. There are a number of other things that we're looking at in this trial that we think are interesting, but that I'll come on hyperfagia. And that's really what we're looking at here.
Let's go in to drive us here.
Speaker Change: And then I'll start on the EU. It was a two-part question Ritu about the prize in terms of modeling and then the most favored nation. Let me maybe start with the most favored nation, but...
Speaker Change: And we'll assess the any specific recommendations that come out of the administration with respect to our most favored nation as we are able to sort of understand it and make decisions as we move forward on pricing and reimbursement in individual countries.
Speaker Change: and we will continue to update you as we have those discussions moving forward. Thanks, Ritu. Thank you.
Thank you
Speaker Change: Our next question comes from the line of Tess Romero with JP Morgan. Your line is now open. Thank you very much.
Speaker Change: Good afternoon, Catherine and Tim, thanks so much for taking our question.
Speaker Change: So, for each of your brands, new plasid and debut, what is the right way for us to be thinking about?
Speaker Change: What are the key factors and drivers we should be thinking about from a quarter to quarter basis as we are trying to model this out? Thank you
Speaker Change: And we believe that that's going to continue. Q2 obviously will begin to see the full impact of our expanded customer model which as a reminder, the primary goal behind that is making sure that we can really meet patients where they're
Speaker Change: Seeing their treaters, as a reminder, we are pretty under penetrated outside of the COEs and outside of the COEs, represents around 65% of the overall rat patient volume, so significant headroom for growth.
Speaker Change: I think with the expansion of our field model, which again we've increased our field footprints across all functions by about 30% . . . .
Speaker Change: We do anticipate that we will continue to see new patient ads at the top of the funnel, which is our primary focus and at the same time as we shared, you know, we continue to see really encouraging data regarding ongoing persistency and discontinuations continuing to decline and I think that that reflects.
Speaker Change: Just the continued learning we've had around the product, making sure that we really support the rep families as they start debut. And encouragingly, as you look at the discontinuation data, we're seeing it across all of the cohorts that we've had since launch.
Speaker Change: including those who have been on treatment for less than three months, which is critically important as you think about modeling out the rest of the year, because we want to ensure that every single new patient's start is able to continue for the long term. Thank you very much.
Speaker Change: We're seeing good momentum around referrals, R&BRXs, looking positive and as we mentioned.
Speaker Change: Q-1 of 25 was actually the best quarter that we've heard in nearly five years for new plaza and we believe that encouraging momentum is something we will continue to pull on as we head through the rest of the year
Thanks, Tom. I think from a financial perspective.
Speaker Change: Starting with the ABU, both brands, it's really going to be a volume story throughout the rest of the year and how it explains the operational dynamics.
Speaker Change: On debut from a kind of a net sales standpoint, we do expect kind of price to gradually increase.
Speaker Change: over time, as we benefit from kind of Medicaid, you know, as you remember, debut is largely a Medicaid patient population, so the Medicaid pricing resets on a quarterly basis, so we should benefit from some price benefit. Thank you very much.
and Unknown Speaker 0.0.0. Okay. Thanks a lot.
Speaker Change: over time, you know, about the inflation level. And then in Q1 for a debut, we do tend to have higher Medicaid rebates because we have a segment of our patient population, our dual eligible Medicaid commercial patients. And those patients, as they get through there, out of pocket, maximums tend to shift towards commercial payments over time. And so that also is a tailwind from a little bit of price.
Speaker Change: As we've talked about on our last call and mention, we've initiated our expansion of our debut field team and that we expect operationally to have a greater impact in the second half of the year.
Speaker Change: On New Plaza, I think it's probably more consistent. Our volume will drive the quarter to quarter performance.
Speaker Change: You don't have the same level of dynamics on changes in price over time, new plazits, largely a Medicare patient population, so the pricing doesn't reset on a quarterly basis, so it's really a one-time reset towards the end of the year. So our growth in that subject to...
Speaker Change: What anything can happen on a quarterly basis due to patient mix should be mostly stable throughout the remainder of the year. We did have the big time, one time adjustment as we mentioned comparing Q1 last year to this year but going forward probably pricing should be relatively consistent and volume will drive the performance over the quarters.
Great, thank you! [inaudible]
Thank you [inaudible]
Speaker Change: Our next question comes from the line of Ash Verma with UBS. Your line is now open. Thank you very much.
Ash Verma: Connection with Thomas, I wanted to ask about the pipeline, maybe just on Carvedos scene, so the private [inaudible]
Ash Verma: Successful on the low-dose, and particularly, generally don't see inverse-dose relationship. Like what makes you confident that the low-dose can generate positive data and be accepted by the FDA? And then just secondly, any thoughts on GLD1 using predictably? No.
Thanks.
Tom Garner: Thanks, Ash. I think this has been once both of those for you.
Yes indeed, thanks Ash.
Tom Garner: So, you know, exactly as you say, there was a prior phase three trial that was run that had two doses of 3.2 milligrams dose and the 9.6 milligrams dose. And the 9.6 milligrams dose didn't show statistical separation from placebo with 3.2 milligrams dose did appear to separate from placebo, though of course that was only normally statistically significant. So, you know, as you take a step back, when we think about this, there are few things that give us confidence in the need to run. And that's our control.
Tom Garner: with a 3.2mg dose and what that's a sensible thing to do. You know, the first of this is that there is mechanistic reason to think that oxytocin and therefore carbitose and is going to be relevant in
Tom Garner: The second piece is that as we look at that 3.2 milligram dose data set, we do see some signs of internal consistency, so positivity at more than one time point and positivity on more than one endpoint. That helps give some additional reassurance about the consistency of that data set and the likelihood that it represents truth. [inaudible]
Tom Garner: And then finally, I'm always looking for an alternative explanation, exactly as you say the inverse dose response is not your typical thing, but it does happen. And there needs to be an explanation as to why that might be the case.
Tom Garner: You know, it's not possible to prove ultimately with the data that we currently have in hand, but there is a good rationale for the idea that off-target impact at the Bay of the Press and Receptor could have the effect of essentially obscuring the ability to see an improvement on a hyperphasia and that you get more of that at the higher dose. [inaudible]
Tom Garner: It's a plausible hypothesis as to how we could have gotten that dose response and we take all those other pieces of information to told together to give us some confidence in running this trial and in the likelihood that 3.2 milligrams is going to be useful. And then I apologize, I forgot to write down what the fact. Oh, GLT ones. [inaudible]
So, you know,
Tom Garner: You know, the data on GLP1s, there is some use of it within Prater Relie. There certainly aren't definitive studies, but make it clear that it is youthful in this patient population. So, I would say the jury is still pretty out on whether GLP1s are helpful for patients with Prater Relie.
Thanks, thank you
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Thank you
Speaker Change: Our next question comes from the line of Charles Duncan with Cantor. Your line is now open.
Speaker Change: Hi, this is Emily and Kim on for Charles. Thank you for taking our questions. I just wanted to ask for the Phase 3 Compass trial. Are there any phenotypic behaviors or patient subsets?
Speaker Change: Subsets, you know, like genetic subtypes or age groups that are more likely to respond to treatment.
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Speaker Change: You know, I do have to give the caveat here that, of course, the data set we have based on right now is really the prior data set, which is relatively small. That said, with the data that we have to date, we haven't been able to identify patient subsets that are more or less likely to respond to Carbotosan. We will get some more information about this out of the compass trial, but, of course, that is a currently enrolling and currently blinded trial, so I'm not able to answer that right now. But best bar, nothing that clearly.
Speaker Change: Identifies for a patient who are more likely or left likely to respond.
Speaker Change: That makes sense, and you know, congrats on the solidarity and enrollment. I just wanted to ask a quick follow-up regarding the R&D day next month. I understand that you're getting additional details and data across the pipeline programs, but will you be going through each?
Speaker Change: So let's just go ahead and jump in here. So we do anticipate touching on all of the, certainly all of the currently clinically staged programs. So we would have a touch on the central trimmer in there as well. And we do have some new data that I'm looking forward to sharing on that program in particular. Thank you very much.
Fantastic. Thank you for taking our questions.
Thank you Thank you [inaudible]
Mark Goodman: Our next question comes from the line of Marc Goodman with Learing Partners, your line is now open.
Speaker Change: Hi, good afternoon. This is Basma on for Marc. Thank you for taking our question. We have a question on debut. Can you provide some color on the utilization rate or the compliance in the quarter? And also, if you can provide some color on the average age and weight of the patient on therapy to date, and whether you see color relation between the age and this configuration rate, that's it for us. Thank you. Thank you.
Speaker Change: I'm going to let Tom talk to the compliance that any insight on the white age correlation.
Tom Garner: So in terms of compliance, if you recall, in the fourth quarter, we said that our compliance rate was in the low 70% range. It was marginally down in Q1 in the very high 60s.
Tom Garner: We believe that this is down to primarily customers just becoming more confident in their titration strategies. We are seeing that some patients are actually starting on a lower dose and then moving upwards as they um...
Tom Garner: as they continue with therapy and we think that this may actually be contributing to the just ongoing persistency that we're now seeing. Thank you.
with new patient starts as well.
Tom Garner: Encouraging is nothing that we are overly concerned about because our goal is to make sure that every single new patient start that we have.
Tom Garner: is able to continue for the long term and truly see the benefits that we know that debut offers. So that's what I would say around that. In terms of our broader patient mix, I mean it continues to be. Thank you.
Tom Garner: across a broad range of patients. We have started to see over time.
Tom Garner: Some older patients, more mature patients who may not have necessarily been there at the beginning come online and obviously they would be slightly heavy in terms of weight banding but generally speaking I think the dynamics that we've seen since launch have kind of held relatively, relatively stable.
Tom Garner: And I think the other part of that question was, do we see a dynamic between persistency and age? And I think the answer is we don't actually see anything across the age range in terms of a link between age and persistency. So yeah.
Tom Garner: And as I mentioned, you know, we're encouragingly, I think all of the cohorts that we saw throughout 2024, we've seen improvements in persistency across them all. And I think that, again, that gives us great confidence as we move into 25, we'll be able to continue, continue with that kind of dynamic into the rest of the year.
Thanks, Charles. Thanks for that. I'll see you questions. Thank you.
Yeah, thank you very much [inaudible]
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Thank you
Speaker Change: Our next question comes from the line of Paul Matisse with Steeple. Your line is now open.
[inaudible]
Speaker Change: This is Julian on for Paul, thanks so much for taking our question. I guess another one on
for XUS approvals, I guess.
Speaker Change: What do you guys sort of see as maybe the biggest risk? [inaudible]
Speaker Change: to the approval process, I guess. Could you just speak to your confidence and
and getting the EMA approval and an eventual reimbursement there and then...
Speaker Change: As other executives have mentioned that, you know, valuations have come down and, you know, biotechs have sort of, you know, been, been reaching out to, to pharmaceuticals for partnership. Thank you.
Speaker Change: Thanks Julian, I'll start on both of those and if Liz wants to add in.
Speaker Change: You know, in terms of our EMA time clock, it's proceeding as per expectations were coming up to all 120 day questions. As you know, we've got approval of both the US and Canada now. And also,
Speaker Change: Regulatory team is fairly well-apprised of the questions and we have had nothing different or any communication to suggest that we're not.
Proceeding according to the time clock. [inaudible]
Speaker Change: As a mummy, get our day 120 questions, we may share a little bit more, but for right now we're feeling very confident that we're proceeding down the right path.
Speaker Change: You know, in terms of BD, the question was, are we just going to execute or are we interested in transacting? I think, you know, we are very interested in transacting according to our principles. And as we've shared before, we're looking for exciting assets in areas of higher medical need where we can bring the
Speaker Change: The ACADIA team entered the space with confidence that we could commercially launch. And so we're looking for those assets right now. We're actively out there.
Speaker Change: We have, we remain disciplined in terms of our P&L management and ensuring that we are keeping our P&L as much lights to say pristine, but we are very much looking actively, not only in our core spaces of euro and euro rare, but also to reinforce our direction at JP Morgan, where we explain that we're now opened our aperture and are actively looking at rare diseases. Thank you very much.
Speaker Change: outside the Neuro Space, including Endocrine, Mathabolic, Cardiovascular Immunology and other spaces. So, we're excited to continue to look at that and are diligently doing that right now. The market is what the market is. We're actively looking at those compounds against the criteria. That's irractive.
Speaker Change: Shad, but you won't add anything to it? Yeah, I think for us, we're well positioned to act in the current environment, I think for us.
The question when you have kind of swings and valuations. [inaudible]
Speaker Change: You know, do people on the other side of the table have their expectations reset? Check.
Speaker Change: and I think for us, if that happens, we're able to get good strategic deals and good financial value for the company. We're ready to transact and expand the portfolio. And if that hasn't happened, we can stay patient till the right time.
Thanks.
Albert Ansley, go fast and get it.
Thank you. Absolutely.
Speaker Change: Our next question comes from the line of David Hoang with Deutsche Bank. Your line is now open! David Hoang, David Hoang, David Hoang, David Hoang,
David Huang: Hi there, thanks so much for taking my questions. So first on debut, I just wanted to ask about the the persistency you're seeing here long term at 12 months. I think you mentioned it was a little bit north of 50%
David Huang: The more beneficial to focus on that patient ad, and then just with Prater Willie, your asset versus commercial positioning of Soleno's product which is now on the market. How do you kind of think about that? Thanks a lot. Thanks a lot.
Tom Garner: Great, thank you for the too far to David, I'll talk about that one. Yeah, thanks David. So as we mentioned, yeah our persistency is around 50% after 12 months, we expect that that's going to kind of stay within that ballpark moving forwards. We don't anticipate there's going to be big swings.
Tom Garner: Up all down, given the data that we're seeing come through, just as a reminder as to how we're getting there, I mean obviously we've mentioned we've seen a...
Tom Garner: A nice continuation in terms of the discontinuation story that we showed in Q4 where the 35% improvement in the quarter
Tom Garner: We believe that that's important as we now really focus all of our efforts on driving new patient starts and that's been the primary angle and primary focus of the expanded customer model that we mentioned as well so...
Tom Garner: Absolutely, I think you should be thinking about two main factors, you know, new patient starts and active patients because it's going to be the active patients that we believe that we can continue to grow over time that are really going to be meaningful for the ongoing revenue, but tick for this brand, it's the long term. Thank you very much.
Tom Garner: As you're in touch on opposition, Russ is the new Salina product. Sure. I'll start out with the fact that, I mean, we're delighted for the PWS community that there is now a first there be available for them.
Tom Garner: That said, I think we see this as an area of significant, high unmet need and complex patients who are dealing with a number of different challenges. It's the kind of space where we think that it's likely that there is going to be absolutely room for multiple agents that are used. [inaudible]
Tom Garner: with different MOAs, with different benefit risk profiles that physicians can use according to the patient that's in front of them. I don't know if there's anything you want to add to your talk.
Tom Garner: Well, the only thing I would add is we know that the Prada Willie population, you know, they have very complex and distinct needs and we actually believe that there's going to be an opportunity for more of them one product to play here and I think with therapeutic areas like this, you know, the notion of combination therapy could also be something that plays out into the future as well. So,
Tom Garner: A pretty substantial patient population here in the US. [inaudible]
Tom Garner: Plenty of opportunity for more than one player to play and we will be ready to launch the DATP positive.
Tom Garner: Yeah, and we do spend a lot of time of course talking to caregivers, advocacy organizations, and we hear pretty robustly that again they are delighted that there is something available for their family members now, and they absolutely think that there needs to be continued therapies and the ability to treat an individual patient for their individuals.
and Mark.
Thanks guys, hopefully not answered the question, David. [inaudible]
Yes, thank you.
Thank you.
Sean Layman: Our next question comes from the line of Sean Lehman with Morgan Stanley . Her line is now open. [inaudible]
Sean Layman: Hi, good afternoon. This is Catherine on for Sean. Thank you so much for taking our questions. I'm just one from us on your earlier pipeline for ACP 711. You announced the successful completion of the phase one Mad Cole Horits earlier this year. We're just curious. You can provide any color on what you observed here. And if you have an update on the status of that study, thank you. Thank you.
Speaker Change: Yeah, so I think what I'd share there is, you know, consistent with what we put out at the time. We were pleased with the Safety and Tolerability Profile. We were seeing in that study. There are some interesting pieces on the biomarker side that we'll be sharing at R&D Day. So please feel free to come in and look for that. Status wise, we're continuing forward with additional explorations that we think are necessary to get us lined up for the phase two that we're planning to start in 2026. So continue good progress.
Thanks, Catherine. [inaudible]
Thank you.
Speaker Change: Our next question comes from the line of Tazeen Ahmad with BLA Securities. Your line is now open.
Speaker Change: Hi, good afternoon. Thanks for taking my question. Four percent of time in EU, can you maybe Catherine give us a sense on in what ways the launch could be different from the trajectory that they view has seen in the US?
Speaker Change: I know you bring a lot of experience from launching products outside of the US. What kind of...
Speaker Change: You know, I guess attention that to specifics should we be paying as we think about how to model out European launches for your drugs and how we think about debut in general.
Yeah, thanks Tazeen, so let me start with...
Speaker Change: The European overall population being larger than the US, so we are...
Speaker Change: But that is sort of in line with country size. So there's no specific country that has more or less patients. So as you know, Germany being the largest country in the EU, we will launch first into Germany as you know there's a period of free pricing and then after that we start to negotiate with Amnog.
Speaker Change: and then beyond that we'll look at each of the countries and start those negotiations with the national payers.
Speaker Change: Yes, both Tom and I have our experience at launching in Europe . We also have now put in place a really great team who have a lot of rare experience in Europe .
Speaker Change: and we're building up our dossiers, we're building up our value story and we're ready to start those discussions with the authorities as soon as we get that regulatory approval.
Speaker Change: I think to a point about learning from the US launch, you know, as with all global launches, the launch country, which generally tends to be the US, is the one we can learn a lot. And I think we have learned about the importance of working with families and we, the importance of
Speaker Change: You know, we had a big prolific patient in the U.S. that came out the gate pretty strong.
Speaker Change: We're also getting a lot of inquiries from patients in the European Union and that's why we put in place our name patient program and manage access program for those physicians that want to. I'm.
Speaker Change: Seth Trefinitide in the countries where it is legally unregulatory allowed.
Dose,
Processes will be in place.
We don't expect for the same.
Speaker Change: sort of massive, both a patient dynamic, but each country is going to be slightly different depending on how many of their patients are on those managed access programs.
Speaker Change: We feel very confident that we understand what we're doing. We understand how to get our product into the markets. And we're also investing appropriately. We're not investing all over the place. We're being very strategic about while we build our teams. [inaudible]
Speaker Change: about where we put our people and we will take into account any future administration directives that affect that too. So, you know, we're very, we're very conscious about it, but also very excited and mostly excited by the advocacy groups who are very, very interested in accessing Trafinatide for the...
Speaker Change: sort of loved one, so thanks Tazeen to the question.
Thank you [inaudible]
Speaker Change: Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is now open.
Speaker Change: Hi Catherine and team, it's Anish on for Greg. Congrats on the progress this quarter and thanks for taking our questions.
Speaker Change: Firstly, as a follow on to David's previous question, what unique aspects of your commercial engine or priorities within the target market?
Speaker Change: Do you believe you'll be able to leverage to rise above competitors in the PWS market, with respect to both reserves? Respect to you.
Speaker Change: Solino, and other therapies in development. And secondly, obviously there's a lot of concern across the sector on macro and policy exposure for companies. I know you commented on inventory already, but maybe if you could just share some thoughts around where debut and new plazid might be impacted along the respective supply chains and how you're navigating that. Thanks so much. Thank you very much.
Speaker Change: Great, thanks Anisha, quite a few different subsets of questions there, so let me start. We're just giving you an overview of my thoughts around the commercial engine our last time to add, and then we'll throw it to Mark to talk about supply chain.
Speaker Change: and tariff. So just in terms of commercial engine, you know, we have a very strong team now, both in neuropsych and in rare, who understand the...
The subtleties of launching within a rare space.
Speaker Change: and we've learned a lot through the Davey launch. So we feel very well prepared as a company to work within the Prada Willie community. We have strong associations with them already, we have our teams out there right now.
Speaker Change: And as Liz has already outlined, we feel very strongly that the community is asking for as many options as possible for their patients. These are complicated, complex patients.
Speaker Change: and we'll see over time the need I believe for more than one therapy option for sure. So we feel very confident in our ability to go out there and compete, but also offer patient's choices which we believe are very important.
Speaker Change: Thomas, are there anything you'd bring from that your previous experience in rare? Yeah, I mean, I would say that clearly we have already launched a rare product in very recent history of the day view. I think we've learned a great deal as we've gone through that launch. And as Catherine mentioned, I think both.
Speaker Change: Catherine and I have had the privilege of launching products in other rare spaces and I think being able to continue to kind of build that muscle make sure that we're pulling through the experiences that we have.
Speaker Change: And really making sure that as the 101 day to reach out that we're able to leverage the product profile in an appropriate way as quickly as possible.
Speaker Change: Taking all of the learnings that we already have, but also thinking about some of the...
kind of unique aspects that we bring.
Speaker Change: As ACADIA, you know, with a true kind of focus on the patient and on patient advocacy, I think we will have a...
Speaker Change: A significant leg up in making sure that we can be highly competitive, even as a fast follow . . .
Speaker Change: Do you want to talk better about flight change? Obviously, we're monitoring in all the events of the day.
as it relates potentially to tariffs that may come.
Speaker Change: for the industry. I think as our supply chain set up today, our API for both products is manufactured outside the U.S.
Dabiu has drug product manufacturing in Canada and the US
Speaker Change: The Drug Product Manufacturing for New Plaza is all in the U.S. I think what we've done thus far in recent months, as I mentioned in the call, is on shore as much inventory as possible due to investments that the company had made previously in advance. And so,
Speaker Change: Potential DRP approval. The company did make investments in inventory for supply for a kind of answering, which is why we have to supply. All of that's on, you know, in the United States today and can last us into the mid to late 2030s.
Speaker Change: and we don't own any manufacturing sites, so we don't have any infrastructure that's set up with our supply. Like everybody, we look at our supply chain to make sure we have assurances of supply. Thank you very much.
Speaker Change: redundancy, high quality suppliers, appropriate price, you know, if there are tariffs, you know, that's one cost that's...
Speaker Change: will be considered in the overall supply chain but from a manufacturing standpoint you know time and investment can change everything so nothing's permanent but nothing changes overnight
Speaker Change: I think we feel very comfortable in the position that we are today with our inventories, and we'll keep the supply chain as is, until there's a tough appropriate reason, whatever that may be to change it, we can do that in the future.
Thank you.
Speaker Change: Our next question comes from a line of Yatin Suneja with Guggenheim. Your line is now open.
Speaker Change: Hey guys, thank you for taking my question. Question on the greater valley study. Are you able to talk about the powering of the study and the size of the study is pretty robust? What effect size are you powered for? What is the minimum delta you are able to achieve?
Technology, thank you.
Speaker Change: Get lost, let's talk about the effect size and the power in for our study.
Speaker Change: Yeah, so I think probably the most important thing to orient here is that we have a study that is substantially larger than the prior study where there was normal significance, but where if 3.2 had been run by itself, we would have anticipated having a significant p-value, so that is a check in our column. As far as we think about the specifics of the powering that underlies this, we actually looked at a number of different potential powering scenarios to make sure that we were adequately covered for a few possibilities. [inaudible]
Speaker Change: One that is most obviously disclosed is a slight increase in terms of the delta between placebo and active and that's reflective of the fact that we have a slightly longer time point in this trial than we did in the prior study. But I think broadly consistent expectations with what we've seen historically and a number of different scenarios that get us with, you know, from 80 plus percent powering. And I think we're going to be able to do that in the next few years, but I think we're going to be able to do that in the next few years.
Thanks, Liz. Thanks for the question.
Thank you.
Speaker Change: Our next question comes from the line of Joel Beatty with Baird. Your line is now open.
Joel Beattie: Hi, thanks for taking a question. It's a little bit of a math question on debut and the ability to find new patients starts.
Joel Beattie: Faster Than Patients Discontinue, and I guess it's in the context of getting close to 1000 patients on therapy in the quarter now, and then a discontinuation or persistency rate at 12 months of about 50%.
Joel Beattie: So, putting those numbers together, I guess the question is would that mean to expect about 500 patients dropping off over the course of a year? And then it's so, how realistic is it to be able to find 500 plus patients of new starts to be able to replace that?
Joel Beattie: Let me try and reorient the math a bit, and if I get convoluted, somebody can help simplify.
Joel Beattie: But you're right, in terms of their patients actively stepped in the quarter, 954. [inaudible]
Joel Beattie: Now, of those patients, 65% of them, just above actually, have been on therapy for more than a year. So it's important to understand that within that 954, there are different cohorts of patients start times, but more than 65 have been on the product for over a year.
Joel Beattie: We continue to see strong persistency beyond the year, so we're not seeing sort of a sudden drop off beyond that either. So it's really a cohort question, if I may, in terms of the match-all. And in terms of new steps added every quarter and the expected time that that patient stays on therapy.
Joel Beattie: Again, we've given you the 12 months if you like persistency rates. However, we are seeing patients stay on therapy for much longer than that.
Joel Beattie: So that's sort of maybe a way to think about it, Marc, or Thomas, I mean it's not a big issue. We talked about 12 months. That's the first 12 months of therapy. It's not each 12 months of therapy.
Joel Beattie: So the rate of the persistency rates are very high kind of after the curve is like plateauing after as you get out in time.
Joel Beattie: So it's really in that first 12 months that we keep more than 50% of our patients and beyond that time it's a very high rate of persistence.
Speaker Change: So, as Catherine mentioned, we have that stable base of patients that are on therapy more than 12 months, 65% of our current patients And so then we're adding patients on top of that, and that's how the patient counts grows overhead [inaudible]
Speaker Change: As we went through 2024, we started sort of with 870s or so patients ship a quarter and now we're at 954. So again, they don't drop off at the end of the year. They continue to stay on therapy. [inaudible]
Speaker Change: Hoping that that helps you out, Joel, if you need some more follow-up, I'm happy to do that too. Thank you.
Thank you.
http://TheBusinessProfessor.com
Speaker Change: Our next question comes from the line of Sumant Kulkarni with Canaccord Genuity. Your line is now open.
Speaker Change: Good afternoon, thanks for taking our questions, I have two quick ones...
Speaker Change: Gibbon Postrial Briefing is done on the Pimovancer in two cases. Could you remind us of your latest assumptions on when you might expect generic competition on a new closet?
Speaker Change: And second, on Profinitide, do you expect to start recognizing European revenue from France? Why are the paid early access program that country allows? And how important might that type of initiative be to give you a good sense of how the product might launch in the rest of Europe ? Thank you.
Speaker Change: Okay, I'm going to ask Mark to update you on your plazard and then I'll take the France question.
Speaker Change: I think youre, referring to the ICU program in France, which is now going to a different acronym. That's currently escaping me, but essentially it's the it's the early access program, where the French government pay for product, we're putting in place mechanisms for that program to be activated in France for <unk> and there are a number of regulatory and legal considerations, we need to put in place before the ACA.
Speaker Change: <unk>, but that's actively going on right now as you know once you then get reimbursement through the transparency Commission those patients switched over to paid products from the French government.
Speaker Change: That's up.
Speaker Change: Again, you know.
Speaker Change: We have to understand what the French situation has narrowed to the time, but we are planning for the <unk> used to be activated this year and we're planning for those patients to transition over to commercial product once those negotiations have completed some.
Speaker Change: Tom did I Miss anything I don't know I think I think as it relates to friends that's entirely true.
Speaker Change: The other thing I would say is obviously, Germany, we will be having a managed access program there as well and actually Germany. If you recall, we will be out of the gates pretty significantly ahead of where we are in France. So I think I think if you want to kind of have a good kind of.
Speaker Change: Barometer as to what's going to be happening in Europe, Jim The German loan should we go onto awash, because we do anticipate having patients enrolled in the early access program.
Speaker Change: On day, one once we have a European approval date, we will be able to space switched over to commercial drug with free drug pricing as well so.
Speaker Change: Most come.
Speaker Change: We expect to see things playing out.
Speaker Change: I would say that asked the question.
Speaker Change: Okay.
Speaker Change: Thank you.
Our next question comes from the line of Malcolm Hoffman with BMO capital markets. Your line is now open.
Speaker Change: Hi, Marc Maun for Evan from BMO I wanted to touch on NUPLAZID gross to net I believe you said gross to net for the quarter was roughly 24% in the guide suggests a range for the year of $22 525, and a half can you just talk through what pushes and pulls you expect can move this Chris Smith, one side or another of the guide. Thank you.
Speaker Change: Yes, I'll, let mark take the gross Nicholson.
Speaker Change: Yes, I think right now or at least the first quarter is kind of right in the middle of our guidance. It really is just patient mix, which we don't control. It is just.
Speaker Change: The payers for our patient base can change over time and that can influence quarterly fluctuations and what the gross to net is on the year. The other thing does that influences. It is if we take any pricing action.
Speaker Change: We took we had a small modest price increase at the beginning of the year. We don't foreshadow when we may or may not take pricing action, we price our medicines to value and we just announced that when and if we do it over time.
Mark: Great. Thanks, Mark thank.
Speaker Change: Thank you.
Speaker Change: No further questions at this time I would now like to turn it back to Katherine Owen Adams for closing remarks.
Speaker Change: Well thanks, everybody for your questions. This quarter, we look forward to continuing to deliver on our commitments to our patients and updating you on our progress next quarter. Thanks again for your questions.
Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.