ACAD earnings call transcript, November 4, 2026

After the speaker's remarks there will be a question and answer session. If you would like to ask a question during this time, please press star one on your telephone keypad. I would now like to turn the conference over to Al Kildani, Senior Vice President, Investor Relations and Corporate Communications. You may begin.

Good afternoon and thank you for joining us on today's call to discuss Acadia's third quarter 2026 financial results. Joining me on the call today from Acadia are Catherine Owen-Adams, our Chief Executive Officer, who provides some opening remarks, followed by Tom Garner, our Chief Commercial Officer, who will discuss our commercial brand's debut in New Plaza. Also joining us today is Dr. Sanji. Chief Fatback, SVP and Head of Clinical Development, who will provide an update on our pipeline programs, and Mark Schneier, our Chief Financial Officer, who will review the financial highlights. Catherine will then provide some closing remarks before we open up the call for your questions. We are using supplemental slides, which are available on our website in the Events and Presentations section. On today's call, both GAAP and non-GAAP financial measures will be discussed, including non-GAAP New Plaza Net Sales and non-GAAP Total Revenues. A non-GAAP financial... ...measures that are also referred to as adjusted financial measures pertain only to New Plaza sales in 2025 and their impact on total revenues. All references to non-GAAP are reconciled with the most directly comparable... ...GAAP financial measures in our earnings press release and slide presentation, which has been posted on the investors page of the company's website. Before proceeding, I would like to remind you that during our call today, we will be making several forward-looking...

Thank you, Al, and good afternoon, everyone. Quarter 3 was another strong quarter for Acadia, one that demonstrates the strength of our commercial foundation and... the progress we are making to translate that strength into our next chapter of growth. In the third quarter, we delivered total revenues of $342 million, representing 22% year-over-year growth on an adjusted basis. DEBU delivered record net sales of $140 million, up 39% year-over-year. DEBU STIX is expanding our opportunity in several different ways. Current patients who want to switch to STIX new patients who are trying DEBU for the first time and patients who previously stopped treatment and are coming back to try again with STIX. Given this momentum, we are raising our 2026 DEBU guidance and we remain confident that we can reach 700 million in DEBU sales by the end of 2028. We also achieved an important IP milestone during the quarter, receiving a USPTO notice of allowance for an important new patent covering the weight band dosing regimen used in both DEBU oral solution and DEBU sticks. Following issuance with pediatric exclusivity, the patent is expected to provide US protection for both formulations of DEBU. through March 2041, extending patent protections by nearly five years. Following the successful completion of our phase three trial for DEBU in Japan, we are focused on identifying the right distribution partner while preparing for an

in detail.

Thank you, Catherine, and good afternoon, everyone. I'm pleased to walk you through what was another strong quarter for the commercial business. Starting with debut, Q3 mark yesterday. It's another record quarter for the brand with $140 million in net sales, representing 39% growth year over year, with almost all of that being driven by volume. That's the result that we're particularly proud of, as it not only reflects the... ...continued execution of our commercial team, but also the deepening position Debut holds as the foundational standard of care for Rett syndrome. Debut sticks continue to be an important contributor to growth in Q3. Now, with approximately six months of commercial experience, we're seeing increasing utilization across the patient base and continued adoption in both sense of excellence and community practices. Over 50% of the patients are working with the patient base. Most of all U.S. debut patients were receiving sticks by the end of Q3, with these patients generally utilizing doses consistent with or somewhat higher than what we have seen historically with debut liquid. We're also encouraged by the early experience with patient restarts, which expands the growth opportunity for debut beyond naive patients alone. Patients who previously discontinued therapy represent an opportunity for re-engagement. And STICS provides caregivers with a compelling reason to reconsider treatment with a different formulation.

While the initial pace of STICS conversion will naturally moderate as the launch matures, we believe continued new patient uptake. And restarts provide two distinct opportunities to drive sustained growth going forward. Turning to debut outside the US, Q3 was a landmark quarter. We received European Commission approval to debut. Making it the first and only approved treatment for the neurobehavioral symptoms of Rett syndrome in the EU. This is an important milestone for patients, families and treating physicians who previously had no approved. treatment options available. We launched commercially in Germany in early October, and the early response from Rett treating physicians has been encouraging. We're already seeing that initial interest translate into new patients receiving commercial product. In addition to those patients converting from our compassionate use program. As a reminder, Germany allows us to launch at a freely set price while reimbursement negotiations are completed. So we were able to move quickly. to make debut available to these patients. Looking across the rest of the EU, we plan to submit reimbursement dossiers for our key planned launch countries before year end to drive additional commercial access to date. In addition, our main patient supply programs have been important in markets where we do not yet have regulatory approval and the continued momentum across those programs reinforces the breadth of interest in this therapy.

As we look to the remainder of the year, we feel good about where we stand. The momentum with Debut Sticks is real and building, and the EU launch adds a new dimension to the growth story that we're just beginning to realise. As Catherine noted, we are raising our full year guidance for Debut and reiterating our confidence in our previously stated $700 million sales ambition for 2028. We see 2028 as a milestone on a much longer growth. Because of the recently announced patent allowance extends our US exclusivity runway into 2041. That confidence is supported by multiple growth drivers beyond the US are expansion into Europe. and other international markets as another meaningful source of future growth. Together, these drivers and our long-term exclusivity support sustained growth for DEBU as the standard of care for patients living with Rett Syndrome. Turning now to New Placid, net sales in the third quarter were $202 million, representing 12% growth year-over-year on an adjusted basis, with 11% of that growth coming from volume. Due to brand prescription trends remain healthy, with MBRX growth continuing to at pace the prior year period, reflecting the underlying demand we're building in the Parkinson's disease psychosis market. Earlier this year, we made a significant investment in our New Placid field force. to increase the reach and frequency of our engagement with neurologists, psychiatrists, movement disorder specialists, and PCPs.

That investment has more than doubled our reach. We now engage a customer universe of over 10,000 physicians. Including more than 5,000 that we are calling on for the first time. The results thus far are encouraging. Call volume and rep productivity have increased as expected. And when our highest value customers are called on, they're. Intent to prescribe new Plasid increases. It is now at its highest level in years. Our focus now is on converting this positive momentum into new to brand prescriptions through focused execution. As expected with a new group of physicians, building those relationships takes a few more calls, and our reps are moving up the productivity curve. We are confident in the trajectory, and we expect to realize the full benefit of the expansion through the back end of the... this year, and into 2027. With one quarter remaining, we have narrowed our new plastic guidance within our prior range to reflect that timing. At the same time, our direct consumer investment is expanding awareness of PDP, and... ...encouraging patients and caregivers to talk about symptoms and treatment. An aided awareness of new plastic is at an all-time high, and awareness of hallucinations and delusions associated with Parkinson's disease has also... ...increased significantly. That awareness is turning into action. Through September, our branded and unbranded campaigns reached more than 1.3 million qualified Parkinson's patients.

Approximately one in 10 subsequently visited a neurologist, with more than 1,500 having since initiated New Placid as a result. These campaigns complement our expanded field organization. They build... ...awareness and intent among patients and caregivers, while our teams increase engagement with the healthcare professionals who diagnose and treat them. Together, they are building momentum towards sustained New Placid growth. Looking ahead, our confidence in reaching approximately $1 billion in net sales by the end of 2028 remains unchanged. The path to that ambition is clear. Expand awareness and diagnosis of PEDP among treating ACPs and people living... ...with Parkinson's disease, increase the number of appropriate patients who initiate treatment, and support patients in remaining on therapy. With a larger and more productive field force now in place, we are well positioned to deliver... on each of these priorities and drive sustained growth for New Placid. With that, I'll hand the call over to Dr. Sanjeev Patak to walk through our pipeline programs.

Thank you, Tal.

Good afternoon, everyone. I'm Sanjeev Patak, and I'm very pleased to be speaking with you today in my role as Senior Vice President and Head of Clinical Development here at Acadia. By way of background, I'm board-certified in both psychiatry and pediatric psychiatry and maintain an active medical license. In my clinical practice, I have treated children with Rett syndrome and related disorders, as well as patients with Alzheimer's disease. and other dementias. That experience continues to shape my work and reinforces the importance of getting the science right. I've led development programs across pharma and biotech and joined Acadia five years ago. Remnifazarin sits at the intersection of my clinical background and the leaders I have focused on throughout my career. I'm honored to share leadership responsibilities for our R&D. organization during this transition and look forward to engaging with many of you. As you can see on this slide, it's a great privilege to lead clinical development at a time when Acadia has such a broad and promising pipeline. across neurological and rare diseases. Let me now turn to remblufanserin and the phase two radiant study results in ADP. The phase two portion of the scene seamless phase two phase three radiant study had two important goals. First, to establish the appropriate dose to advance into phase three. And second, to generate the data and insights needed to optimize the design and execution of our ongoing registration studies. The study achieved both of these goals. While it narrowly missed statistical significance on the prime

to walk through our financial results.

Thank you, Sanjeev.

Good afternoon, everyone. I'll now walk you through our financial results for the third quarter of 2026 and provide an update on our full year outlook. Total revenues for the third quarter came in at $342 million, representing 22% year-over-year growth on an adjusted basis. Debut net sales were $140 million in the quarter, up 39% year-over-year. Driven almost entirely by volume. The gross to net adjustment for Debut in the quarter was 23.2%. As Tom described, the continued uptake of Debut sticks in the U.S. was the predominant contribution.

New Plaza net sales were $202 million in the quarter, up 12% year-over-year on an adjusted basis, with 11% of that growth attributable to volume. This volume-driven growth reflects... ...continued expansion in underlying demand. The gross to net adjustment for New Plaza in the quarter was 22.7%. Turning to operating expenses, research and development expenses for the quarter... ...were $76 million, compared to $88 million a year ago. The decrease was primarily related to reduced expenditures for ending studies that took place in 2025, partially offset by increased expenditure... ...for remlefanserin and ACP-211. SG&A expenses were $159 million for the quarter, compared to $133 million a year ago. This increase reflects our investment... ...to expand both the New Placid and Debut Field Forces and increased marketing investments supporting both brands. We continue to manage our cost base with discipline while ensuring we are making the right investments to support... ...both near-term commercial execution and the longer-term pipeline programs Sanjeev described earlier. Our cash position at the end of the quarter was $976 million. We believe our balance sheet is a genuine strategic asset. It provides a... ...the flexibility to invest behind the strongest evidence in our pipeline, pursue business development where strategic fit and expected returns are compelling, and to continue to execute against our commercial ambitions from a position of strength.

Turning to our full year outlook, now that we are three quarters into the year, we are narrowing our guidance ranges and providing several updates. We now expect total revenues of $1.265 to $1.295 billion. For DEBU, we are raising and narrowing our full year global net sales guidance to $505 to $520 million. This reflects the strong performance we've seen from DEBU stick. In the U.S. and the momentum Tom described earlier. For New Placid, we are narrowing our full year net sales guidance to $760 to $775 million, reflecting the timing of the field force impact Tom described. For gross to net, we now expect debut to be approximately 23% to 24% and New Placid to be approximately 22% to 23% for the full year. Turning to operating expenses, we now expect full year. R&D expenses of $325 to $340 million. This reduced updated outlook reflects the timing of development spend, portfolio prioritization decisions, and reduced personnel costs. For SG&A, we now expect full-year expenses of $665 to $685 million. Overall, these updates reflect our latest expectations as we enter the- final quarter of the year. We remain focused on executing against the continued growth opportunities for both commercial brands while maintaining disciplined investment across our pipeline. With that, I'll hand the call back to Catherine.

for her closing remarks.

Thank you, Mark.

Before we open the call for questions, let me briefly step back and highlight what this quarter says about the cages trajectory. We had an excellent quarter commercially and expect to finish the year with continued momentum across both debut and new plaza. At the same time, we are making important progress across our pipeline, creating multiple opportunities to drive our next phase of growth. Remlifancerin is central to that opportunity. The phase two radiant results show a clear efficacy signal at 60 milligrams and a favorable safety and tolerability profile while providing important insights into how to optimize phase three. We are moving forward with conviction in ADP and will present more data at CTAD later this month. Results have also reinforced our confidence in the LBD. opportunity. Where phase two results from Lumera are expected in the fourth quarter of 2027. Beyond Ramla Fanseren, we are advancing additional programs that can broaden our portfolio and create. new growth opportunities led by ACP 211, with phase two results in MDD expected in the second half of 2027. Together, these programs give us multiple potential paths to value creation in large, high unmet need markets. With a strong commercial foundation and the financial flexibility to invest behind the opportunities where the evidence and our conviction is strongest, we are well positioned to advance this pipeline and build momentum.

Across several important clinical programs.

Thank you all for your continued support of Acadia. And with that, we're happy to take your questions. Operator. Thank you. If you would like to ask a question, please press star one on your telephone keypad. If you would like to withdraw your question, simply press star one again.

Your next question comes from Tessa Romero with J.P. Morgan. Your line is open.

Your next question comes from Brian Abrahams of RBC Capital Markets. Your line is open.

Your next question comes from Yegel Nachomovic with Citi. Your line is open. All right. Thank you.

Your next question comes from...

Hi, good evening.

Thanks for taking my question.

I wanted to sort of go back to the comment that you made that as you... Analyze the data for the REN-Li study, you found some patient characteristics that you're going to reflect in the new statistical modifications. Can you elaborate... A little bit about that is that, you know, kind of the baseline patient severity based on which you might modify the statistical analysis. And then also, you know, given the modifications that you're making... to your approach here for this indication, are there any implications for the Lewy body dementia trial analysis? Thank you.

Thanks, Ami.

I'll let Sanjeev... answer further on those characteristics that we're looking at? Great question. Yes, we have looked at several patient characteristics. Of course, disease severity remains one of the key ones. And this is a finding not only in our trial, but... Also studies with other active medications. So we would likely incorporate that into our statistical modifications. There are other characteristics that we have identified, which... We are not sharing for...we are keeping these confidential, as I said, to maintain the integrity of the tribe. In regards to Lewy body dementia psychosis program, it has increased our... Confidence in that program, as I shared in the prepared remarks, that when we looked at the Pimavansarin program, despite small sample size, we had seen greater efficacy. In subpopulations of LBDP. Now, rembryphansarin is a distinct molecule, but it does give us greater confidence, and we will be... Looking at the LBDP study design, and if there's an opportunity to optimize, we will do so. So, so far, we are progressing as planned. I think this might be a good... place to hit the 30 milligram, but that will continue in the LBD program. Yes. So, we are studying 30 milligrams and 60 milligram doses in the LBDP program. And as you know, LBDP is distinct. disease state and also has distinct efficacy and safety outcomes with off-label treatment. These patients are very sensitive to adverse effects. So,

therefore, we are studying both these doses. And also, given that the Pimavanserin data is with 34 milligrams, which is deemed equivalent to 30 milligrams of Remlifanserin, it, um, makes sense to continue the experiment with both the doses in the LBTP study.

Thanks, Sanjeev.

Thanks for your question, Ami.

Your next question comes from

Your next question comes from Rudy Lee with Wolf Research. Your line is open.

Your next question comes from Ash Verma with UBS. Your line is open.

Your next question comes...

Thanks so much for taking the questions and congrats on the progress made over the course of the quarter. I wanted to ask one real briefly on the upcoming CTAD update. I know you guys had... in the phase two from both the 30 and the 60 milligram. And I'm just curious if you're going to have any exposure related analyses at CTAD so we can better understand the underlying drug exposures within those two arms and how it correlates with effect. I thought somebody might ask about exposure. So Sanji, why don't you share a little bit more? Yeah, we are working on the exposure response analysis but it will not be ready for CTAD. This is to inform our future thinking for the entire program and perhaps it will be available in 2027. Yeah, CTAD will really be sharing a little bit more around the overall effect size that we've seen. across the four psychosis scales. We were showing you a little bit more data around the efficacy over time and some other sub cuts of data, but the exposure response to Sanjeev's point is just going to take us a little bit more time to work through. We look forward to sharing that data when we have a good summary of that that we can share with you with a focus on the meaningfulness behind it. What I will underscore is that we have seen a dose response and which gives us confidence in the activity of the monitor.

Thanks, Angie.

Okay. That is all the time we have for questions. Sorry, I'll turn it back to you, Catherine. No, that's fine.

Thank you so much, operator.

This concludes today's conference call.

Thank you for joining.

You may now disconnect.