ACADIA PHARMACEUTICALS INC Q1 2026 earnings call

Good afternoon, and thank you for joining us on today's call to discuss ACADIA Pharmaceuticals' first quarter 2026 financial results. Joining me on the call today from ACADIA Pharmaceuticals are Catherine Owen Adams, our Chief Executive Officer, who will provide some opening remarks, followed by Tom Garner, our Chief Commercial Officer, who will discuss our commercial brands, DAYBUE and NUPLAZID. Also joining us today are 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. Catherine will 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 Presentation section.

On today's call, both GAAP and non-GAAP financial measures will be discussed, including non-GAAP NUPLAZID net sales and non-GAAP total revenues. The non-GAAP financial measures that are also referred to as adjusted financial measures pertain only to NUPLAZID 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 statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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

Thank you, Al. Good afternoon, everyone, and thank you for joining us today to discuss our first quarter 2026 results. ACADIA delivered a solid start to the year with total revenue of $268 million in the first quarter, representing 11% year-over-year growth on an adjusted basis. DAYBUE had an especially strong quarter with sales of $101 million, up an impressive 20%, our highest year-over-year growth since the third quarter of 2024, marking an excellent start to the year. We are excited about the successful launch of DAYBUE STIX with strong feedback from both caregivers and healthcare providers. As announced now last month, DAYBUE STIX is now broadly available across the United States, we're seeing strong early uptake from both new and previously discontinued patients that gives us confidence in our growth outlook.

NUPLAZID sales were $167 million in the first quarter, up 6% year-over-year on an adjusted basis. The first quarter performance reflects that some patients were slower to refill than in prior years. We are pleased to report that these refill dynamics have since normalized. Importantly, we saw double-digit referral growth in the first quarter and robust demand growth at 8% even prior to the expected impact of the recent sales force expansion. I'm pleased to share that we are reaffirming our 2026 net sales guidance for both DAYBUE and NUPLAZID. Looking at our pipeline, we have several significant catalysts on the horizon. Most notably, we are approaching the highly anticipated phase II readout for remlifanserin in Alzheimer's disease psychosis, which we continue to expect to share results from in the August to October timeframe.

This represents a key inflection point for our company and could unlock substantial value given the significant unmet medical need in this indication. The timing of our phase III study in Japan for trofinetide has accelerated, and we now expect results in the September to November timeframe of this year. I want to remind everyone of the tremendous opportunity we have across our pipeline. We have four molecules targeting large markets with a combined full peak sales potential of $11 billion, with approximately $4 billion of that specifically attributable to remlifanserin across the ADP and Lewy body dementia psychosis indications. This underscores the transformative potential of our research and development efforts. With that, I'll now turn the call over to Tom to provide a more detailed insight into our commercial performance.

Thank you, Catherine. Let me dive into the details of our first quarter performance. Starting with DAYBUE, I'm pleased to report another excellent quarter with revenue of $101 million, representing 20% year-over-year growth.

This was another record quarter for unique patients receiving shipments, highlighting the continued momentum and durability of the DAYBUE franchise. Growth was fueled by robust referral volumes driven by new patient starts alongside meaningful re-engagement of previously discontinued patients following the recent approval and launch of the new powder for oral solution formulation of trofinetide DAYBUE STIX. During the first quarter, we launched DAYBUE STIX with a focus on Centers of Excellence to ensure optimal launch execution while gathering valuable real-world feedback. We've been extremely pleased with both the initial uptake and positive experiences we've received from both caregivers and healthcare providers. Through Q1, we received DAYBUE STIX prescriptions for more than 250 individual patients, demonstrating strong early demand for the new formulation. Notably, nearly 30% of these patients were either treatment naive or restarting therapy, aligning with our expectations and further supporting DAYBUE's growth outlook.

We're also seeing strong interest from existing patients in switching to the STIX formulation. Collectively, this early experience demonstrates how DAYBUE STIX can help retain current patients, bring discontinued patients back into therapy, and grow the treated patient population, aligning closely with our long-term growth strategy for DAYBUE. From a patient and caregiver perspective, DAYBUE STIX offers meaningful advantages, including flexible dosing volume, potentially shorter dosing time, a preservative-free formulation, no requirement for refrigeration, and enhanced portability. These attributes are resonating strongly with early feedback reinforcing the value of the new formulation, as you can see on this slide. Caregiver response has been particularly positive, with more than 80% of those who have tried STIX reporting high satisfaction, complemented by strong endorsement from healthcare providers across Rett centers of excellence where the product was available through the first quarter.

Following the focus launch we announced in early April that DAYBUE STIX is now fully available in the U.S. We look forward to seeing the continued impact of this broader rollout for patients and caregivers. Outside of the U.S., our global named patient supply programs continued to contribute meaningfully to our growth through the first quarter. The number of patients receiving product through our NPS programs continues to increase over time, providing important access to patients. The recent Delphi expert consensus reinforces DAYBUE's position as the standard of care for Rett syndrome, reflecting broad adoption across centers of excellence and accelerating uptake among clinicians treating Rett patients. This important publication demonstrates that Rett syndrome experts agree that DAYBUE plays a crucial role in patient care, including the importance of initiating treatment early and dosing individualized to the patient's needs.

The Delphi publication adds to the growing body of real-world experience supporting DAYBUE, complementing our robust clinical trial programs that support the meaningful impact that trofinetide can make for patients living with Rett syndrome. Taken together, the successful launch of DAYBUE STIX, combined with sustained referral strength and durable patient persistence, positions DAYBUE for continued growth through 2026 and beyond. Turning to NUPLAZID. We delivered sales of $167 million in the first quarter, representing 6% growth year-over-year on an adjusted basis. I'd like to walk through the dynamics behind the quarter and explain why our confidence in full year performance remains strong. Starting at the top of the funnel, physician referral growth was strong at approximately 11% year-over-year, even ahead of the anticipated impact of our sales force expansion, which was completed in the quarter.

This level of referral growth reflects continued physician confidence in NUPLAZID, driving strong underlying demand. However, as Catherine noted, first quarter performance was impacted by a temporary increase in patients taking longer than expected to refill their prescriptions. This dynamic emerged in January and extended into early February as refill timing lagged historical first quarter patterns. Importantly, these delays proved temporary. Patients who were late to fill returned in the latter part of the quarter, and we have now returned to normal patterns. Despite the short-term timing impact, NUPLAZID delivered 8% year-over-year demand growth in the quarter, reinforcing our confidence in the full year outlook. As a reminder, our commercial strategy is focused on driving earlier awareness and use of NUPLAZID in the Parkinson's disease psychosis journey through smart, disciplined execution.

We're sharpening prescriber reach, improving call quality, and maintaining tight segmentation while strengthening field and digital engagement in order to engage physicians earlier and convert strong referral momentum into improved pull-through. Building on this foundation, we expect to realize the full impact of the recent 30% expansion of our customer-facing teams by late 2026 and into next year as we extend these capabilities across a broader target universe. In addition, we anticipate further benefits from our direct-to-consumer efforts. We've recently renewed our partnership with Ryan Reynolds for the unbranded More to Parkinson's campaign, reflecting its strong resonance with patients and caregivers, enabling us to introduce new content and creative to further raise awareness of Parkinson's disease psychosis. Since launching the campaign, awareness of hallucinations and delusions amongst the Parkinson's disease community has increased from 8% to over 30%, underscoring the campaign's significant impact.

We're complementing this with refreshed branding creative on nuplazid.com to engage patients earlier in their journey and clearly reinforce NUPLAZID as the only FDA-approved treatment for Parkinson's disease psychosis. I'd also like to highlight a significant milestone for NUPLAZID. This year marks the 10-year anniversary of its FDA approval. Over the past decade, nearly 100,000 patients, along with their families and caregivers, have benefited from this therapy. This milestone underscores both the durability of the NUPLAZID franchise and its meaningful impact on the Parkinson's disease community. In summary, NUPLAZID remains firmly on track for another strong year, with continued referral momentum, the scaling impact of our expanded sales force, and ongoing market development supporting our path towards approximately $1 billion in annual sales by 2028. With that, I'll now turn the call over to Liz to provide an update on our pipeline developments.

Thank you, Tom. Before turning to pipeline updates, I want to briefly address the retirement announcement we shared last week. For personal reasons, I've decided to retire by year-end. While we seek the right next head of R&D, I remain fully engaged in driving our pipeline forward. We will ensure continuity through this transition, including supporting the upcoming phase II readouts and early phase III planning for remlifanserin. With that context, I'll now walk through the key R&D progress for the quarter. I'm pleased to share updates on our pipeline, which continues to offer meaningful opportunity with real momentum building across multiple programs. Across our eight disclosed programs, we continue to anticipate initiating five additional phase II or phase III studies by the end of 2027, demonstrating the breadth and depth of our development portfolio.

Most recently, we successfully initiated our first in-human study of ACP-271 in healthy volunteers, and I'm pleased to report that the study is going well to date. We continue to advance enrollment across several key studies. Our phase II study of ACP-211 in major depressive disorder is progressing, as is our phase II study of remlifanserin in Lewy body dementia psychosis. Of course, both of these programs represent significant opportunities to address substantial unmet medical needs. Looking ahead, we currently anticipate reporting four phase II or phase III study readouts by the end of 2027. Of course, the closest to these is the top-line results from our phase II study of remlifanserin in Alzheimer's disease psychosis. The Alzheimer's study is still enrolling, and the enrollment dynamics continue to support our expectation for top-line results in the August through October 2026 timeframe.

As a reminder, throughout this study, we've focused on ensuring our patient population has biomarker-confirmed Alzheimer's disease, which we think could be an important component of both technical and regulatory success. We're excited for this readout and what it could mean for the future of the company if successful. Most importantly, as a step towards relief for the patients and families affected by this challenging condition. Turning to regulatory and international developments, the trofinetide reexamination process in Europe remains ongoing, and we continue to expect that process to conclude by late June. We remain focused on working closely with European regulators to address their questions and support the positive benefit risk profile of trofinetide for patients with Rett syndrome. In Japan, enrollment in our phase III trial with trofinetide has been progressing exceptionally well, and I'm pleased to share that we now anticipate completing enrollment this quarter.

This accelerated timeline positions us for top-line results in the September through November timeframe this year, which represents an earlier completion than we previously anticipated. As a reminder, this is a small study that was designed with regulators to provide descriptive information on Japanese patients receiving trofinetide. We expect this study to provide the remaining new data needed for our Japanese filing package, which will rely largely on the Lavender trial to establish trofinetide's efficacy and safety with an expected regulatory submission in 2027. These pipeline developments underscore our commitment to advancing innovative treatments across neurological and rare diseases, and we look forward to sharing more updates as these programs continue to progress. With that, I'll turn the call over to Mark.

Thank you, Liz. I'll now walk you through our first quarter 2026 financial results. Starting with our revenue performance, total revenue for the quarter was $268 million, up 11% compared to adjusted total revenue in the first quarter of 2025. NUPLAZID generated $167 million of net product sales in the first quarter, representing 6% growth year-over-year on an adjusted basis. As Tom discussed, we are very encouraged by the strong demand growth and referral growth in the quarter, which we saw even before the anticipated impact from the field force expansion that was completed in the quarter. The gross to net adjustment for NUPLAZID in the quarter was 22.1%.

As stated in our press release, NUPLAZID year-over-year growth metrics are derived by comparing our Q1 2026 GAAP NUPLAZID net sales to our Q1 2025 non-GAAP NUPLAZID adjusted net sales. DAYBUE delivered strong performance with $101 million in net sales, up 20% year-over-year. Our DAYBUE results reflect the robust momentum Tom described in both the U.S. market and through our international programs. The gross to net adjustment for DAYBUE in the quarter was 25.8%. Turning to our operating expenses, research and development expenses were $76.9 million compared to $78.3 million in the first quarter of 2025.

Our SG&A expenses were $171 million compared to $126.4 million in the first quarter of 2025, reflecting our continued investments in our commercial franchises with increased marketing investments for NUPLAZID and the expanded field footprint for both NUPLAZID and DAYBUE, which both took place after the first quarter of 2025, which is an important consideration in any year-over-year comparison. Our cash position remains exceptionally strong with $851 million at the end of the first quarter as compared to $820 million at the end of the fourth quarter. This increase reflects our positive operating cash flow generation and positions us well to execute on our strategic priorities. Moving to guidance, I'm pleased to reaffirm our full year 2026 guidance for net sales and expenses.

In terms of quarterly progression, we expect total revenue to be back-end loaded as the year progresses, with a greater sales contribution from both brands in the second half of the year, driven by the expected productivity ramp from our expanded NUPLAZID field force, coupled with broader availability and adoption of DAYBUE STIX. With that financial overview, I'll turn the call back to Catherine for her closing remarks.

Thank you, Mark. As we wrap up today's call, I want to highlight the key milestones and catalysts that make 2026 such an exciting and potentially transformative year for ACADIA. First and foremost, we're approaching our highly anticipated top-line results for remlifanserin in Alzheimer's disease psychosis, which we expect to report in the August to October timeframe. This represents the most significant near-term catalyst for our company, with the potential to unlock tremendous value and address a massive unmet medical need affecting millions of patients and their families. The ADP market represents a substantial opportunity with no currently approved therapies, and successful results could position remlifanserin as a cornerstone therapy in this underserved patient population. We also anticipate top-line results from our Japan phase III trial with trofinetide later this year, which could establish an important new market for DAYBUE.

This accelerated timeline reflects strong international engagement and our commitment to bringing innovative treatments to patients worldwide. Importantly, as we head into these upcoming data readouts, while Liz has announced her intention to retire at the end of the year, we are grateful that she will continue to lead R&D to provide continuity and leadership while we look to find a strong replacement. Beyond these clinical and regulatory milestones, we have a strong commercial foundation. We're pleased to reaffirm our 2026 financial guidance for total revenues of $1.22 billion-$1.28 billion. Our cash balance of $851 million provides us with significant strategic flexibility, enabling us to pursue business development opportunities, including potential acquisitions, licenses, and partnerships that could complement our existing portfolio and further accelerate our growth trajectory.

We remain actively engaged in evaluating opportunities that align with our strategic focus on neurological and rare disease with significant unmet need. Throughout all of these initiatives, we remain steadfast in our mission to turn scientific promise into meaningful innovation for underserved communities. Every program in our pipeline, every commercial initiative we undertake, and every strategic decision we make is guided by our commitment to bring life-changing treatments to patients and families who need them most. The combination of our strong commercial performance, robust pipeline, and solid financial foundation positions ACADIA exceptionally well for both near-term catalysts and long-term sustainable growth. We're excited about the opportunities ahead and look forward to sharing our progress with you throughout the year. With that, we're happy to take your questions. Operator?