- Earnings Miss: ACADIA Pharmaceuticals Inc. Missed EPS By 58% And Analysts Are Revising Their Forecasts
May 11, 2026
It's shaping up to be a tough period for ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), which a week ago released some disappointing first-quarter results that could have a notable impact on how the market views the stock. Results showed a clear earnings miss, with US$268m revenue coming in 4.6% lower than what the analystsexpected. Statutory earnings per share (EPS) of US$0.02 missed the mark badly, arriving some 58% below what was expected. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year.
We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free.NasdaqGS:ACAD Earnings and Revenue Growth May 11th 2026
Taking into account the latest results, the current consensus from ACADIA Pharmaceuticals' 21 analysts is for revenues of US$1.24b in 2026. This would reflect a solid 13% increase on its revenue over the past 12 months. Statutory earnings per share are expected to plunge 82% to US$0.39 in the same period. Before this earnings report, the analysts had been forecasting revenues of US$1.25b and earnings per share (EPS) of US$0.44 in 2026. So there's definitely been a decline in sentiment after the latest results, noting the real cut to new EPS forecasts.
See our latest analysis for ACADIA Pharmaceuticals
It might be a surprise to learn that the consensus price target was broadly unchanged at US$31.65, with the analysts clearly implying that the forecast decline in earnings is not expected to have much of an impact on valuation. It could also be instructive to look at the range of analyst estimates, to evaluate how different the outlier opinions are from the mean. The most optimistic ACADIA Pharmaceuticals analyst has a price target of US$45.00 per share, while the most pessimistic values it at US$17.00. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business.
These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the ACADIA Pharmaceuticals' past performance and to peers in the same industry. We can infer from the latest estimates that forecasts expect a continuation of ACADIA Pharmaceuticals'historical trends, as the 18% annualised revenue growth to the end of 2026 is roughly in line with the 21% annual growth over the past five years. Compare this with the broader industry, which analyst estimates (in aggregate) suggest will see revenues grow 22% annually. It's clear that while ACADIA Pharmaceuticals' revenue growth is expected to continue on its current trajectory, it's only expected to grow in line with the industry itself.
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The Bottom Line
The most important thing to take away is that the analysts downgraded their earnings per share estimates, showing that there has been a clear decline in sentiment following these results. Happily, there were no real changes to revenue forecasts, with the business still expected to grow in line with the overall industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates.
Keeping that in mind, we still think that the longer term trajectory of the business is much more important for investors to consider. We have estimates - from multiple ACADIA Pharmaceuticals analysts - going out to 2028, and you can see them free on our platform here.
It is also worth noting that we have found 1 warning sign for ACADIA Pharmaceuticals that you need to take into consideration.
Have feedback on this article? Concerned about the content?Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
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- What ACADIA Pharmaceuticals (ACAD)'s Earnings Miss, EU Setback and R&D Transition Means For Shareholders
May 9, 2026
In early May 2026, ACADIA Pharmaceuticals Inc. reported first-quarter revenue of US$268.06 million with net income of US$3.64 million, while also disclosing a negative regulatory opinion on trofinetide in Europe and reaffirming its full-year outlook. At the same time, the company announced the planned retirement of its Head of Research and Development, Elizabeth H.Z. Thompson, Ph.D., who will remain as a consultant through at least the end of 2026 to support key late-stage clinical milestones. With earnings missing expectations and a setback for trofinetide in Europe, we’ll now examine how this affects ACADIA’s longer-term investment narrative.
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ACADIA Pharmaceuticals Investment Narrative Recap
To own ACADIA, you need to believe its core neurology and rare disease franchise, led by NUPLAZID and DAYBUE, can offset pipeline and regulatory bumps. The recent earnings miss and negative European opinion on trofinetide may weigh on sentiment, but they do not change that the key near term catalyst is the late 2026 remlifanserin readout, while the biggest risk remains concentrated dependence on a few products and rising development costs.
The most relevant update here is the planned retirement of Head of R&D Elizabeth Thompson, who will stay on as a consultant through at least the end of 2026. Her continued involvement during the crucial remlifanserin Phase 2 readout and early Phase 3 work helps support continuity in ACADIA’s development plans at a time when investors are already weighing the impact of the EU trofinetide setback and softer quarterly profitability.
But investors should also be aware that growing R&D spend and any further regulatory pushback could...
Read the full narrative on ACADIA Pharmaceuticals (it's free!)
ACADIA Pharmaceuticals' narrative projects $1.6 billion revenue and $286.9 million earnings by 2029. This requires 13.6% yearly revenue growth and a $104.1 million earnings decrease from $391.0 million today.
Uncover how ACADIA Pharmaceuticals' forecasts yield a $31.80 fair value, a 41% upside to its current price.
Exploring Other PerspectivesACAD 1-Year Stock Price Chart
Before this quarter, the most bearish analysts were already assuming revenue of about US$1.4 billion and earnings falling to roughly US$113.6 million by 2029, so if you are worried about trofinetide setbacks and execution risk around DAYBUE, their more pessimistic view shows just how differently people can interpret the same story and why it is worth comparing several viewpoints before deciding what you believe.
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Explore 8 other fair value estimates on ACADIA Pharmaceuticals - why the stock might be worth over 4x more than the current price!
Decide For Yourself
Don't just follow the ticker - dig into the data and build a conviction that's truly your own.
A great starting point for your ACADIA Pharmaceuticals research is our analysis highlighting 4 key rewards that could impact your investment decision. Our free ACADIA Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate ACADIA Pharmaceuticals' overall financial health at a glance.
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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include ACAD.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com
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- ACAD Q1 Earnings & Revenues Miss Estimates Despite Y/Y Sales Growth
May 7, 2026
Acadia Pharmaceuticals ACAD reported first-quarter 2026 earnings per share (EPS) of 2 cents, which missed the Zacks Consensus Estimate of 4 cents. In the year-ago quarter, the company had reported EPS of 11 cents.
In the first quarter, Acadia recorded total revenues of $268.1 million, which missed the Zacks Consensus Estimate of $282 million. ACAD’s net product revenues comprise sales of its two marketed products, Nuplazid (pimavanserin) and Daybue (trofinetide).
Acadia’s first drug, Nuplazid, is approved in the United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. ACAD’s second product, Daybue, received approval in 2023 for treating Rett syndrome in adult and pediatric patients aged two years and older. The drug was launched in the United States in April 2023.
Total revenues increased 10% year over year, driven by contributions from Daybue and continued growth in Nuplazid's market share.
Year to date, Acadia shares have plunged 19.6% compared with the industry’s 1.6% decline.Zacks Investment Research
Image Source: Zacks Investment Research
ACAD’s Q1 Earnings in Detail
Revenues from Nuplazid increased 5% year over year to $167 million in the first quarter of 2026, driven primarily by volume growth. Nuplazid sales missed the Zacks Consensus Estimate of $179.7 million.
Daybue recorded net product sales of $101 million in the reported quarter, up 20% year over year, driven by the growth in the drug’s unit sales as Acadia shipped to more unique patients. The reported figure, however, missed the Zacks Consensus Estimate of $105.6 million.
Research and development (R&D) expenses were $76.9 million, down 2% year over year.
Selling, general and administrative (SG&A) expenses were $171 million, up 35% year over year, due to increased marketing investments to support the continued growth of Nuplazid and Daybue.
Acadia had cash, cash equivalents and investments worth $851 million as of March 31, 2026, compared with $820 million as of Dec. 31, 2025.
ACAD Reaffirms 2026 Financial Outlook
Acadia continues to expect total revenues from the U.S. sales of its products to be in the range of $1.22-$1.28 billion in 2026. Nuplazid net product sales are expected to be in the range of $760-$790 million, while U.S. sales of Daybue are expected to be between $460 million and $490 million.
R&D expenses in 2026 are projected to be in the range of $385-$410 million, while SG&A expenses are expected to be between $660 million and $700 million.
ACAD's Recent Pipeline Updates
In early March, Acadia announced that the advisory committee to the regulatory body in the EU had formally adopted a negative opinion recommending against the approval of trofinetide for the treatment of Rett syndrome in patients aged two years and older.
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The decision was expected as the advisory committee had informed ACAD of a negative trend vote on its marketing application for trofinetide to treat Rett syndrome in February. Following the formal adoption of the opinion, Acadia reviewed the grounds for refusal in detail and plans to request a re-examination. The regulatory setback has delayed the potential approval of trofinetide in the EU.
In late 2025, the FDA approved Daybue Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation for the treatment of Rett syndrome in adults and pediatric patients aged two years and older. The new product expands the Daybue franchise, which remains the only FDA-approved treatment option for this indication.
Per Acadia, the full U.S. launch of Daybue STIX is underway, with nearly 30% of patients using STIX either new to treatment or resuming therapy after previously discontinuing the liquid formulation. The company will continue to offer both formulations in the United States, strengthening its positioning in the Rett syndrome treatment market.
Acadia also anticipates a data readout from the phase II RADIANT study of ACP-204 (remlifanserin) for Alzheimer’s disease psychosis, which is on track for the August to October 2026 timeframe and represents a potential catalyst for the company this year.
ACADIA Pharmaceuticals Inc. Price, Consensus and EPS SurpriseACADIA Pharmaceuticals Inc. Price, Consensus and EPS Surprise
ACADIA Pharmaceuticals Inc. price-consensus-eps-surprise-chart | ACADIA Pharmaceuticals Inc. Quote
ACAD's Zacks Rank & Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals CPRX, Immatics IMTX and Inovio Pharmaceuticals INO, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have declined from $2.82 to $2.79. CPRX shares have gained 30.8% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Immatics’ 2026 loss per share have narrowed from $1.61 to $1.49. IMTX shares have gained 9.6% year to date.
Immatics’ earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average negative surprise of 8.06%.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.06. INO shares have plunged 28.8% year to date.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.
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This article originally published on Zacks Investment Research (zacks.com).
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- ACAD Q1 Earnings & Revenues Miss Estimates Despite Y/Y Sales Growth
May 7, 2026 · zacks.com
Acadia's first-quarter earnings and revenues miss estimates despite 10% sales growth, driven by Nuplazid and Daybue demand.
- ACADIA Pharmaceuticals Inc. (ACAD) Q1 2026 Earnings Call Transcript
May 7, 2026 · seekingalpha.com
ACADIA Pharmaceuticals Inc. (ACAD) Q1 2026 Earnings Call Transcript
- ACADIA Pharmaceuticals Q1 Earnings Call Highlights
May 6, 2026
ACADIA Pharmaceuticals logo
Key Points
ACADIA reported Q1 revenue of $268 million$1.22–$1.28 billion; DAYBUE sales rose to $101 million (up 20%) and NUPLAZID to $167 million (up 6%), with early uptake of the new DAYBUE STIX formulation (over 250 prescriptions, >220 shipped, ~30% new/restarting and >80% caregiver satisfaction). The near-term clinical catalyst is the phase II readout for remlifanserin in Alzheimer’s disease psychosis expected in Aug–Oct 2026 (biomarker-confirmed enrollment, trial powered for ~0.4 effect size); trofinetide enrollment in Japan should complete this quarter with top-line results in Sep–Nov 2026 and a European reexamination expected by late June. NUPLAZID saw a temporary refill-timing headwind but underlying demand grew (~8%) with physician referrals up ~11%; ACADIA expanded customer-facing teams by 30%, increased SG&A to $171 million to support commercial growth, and ended the quarter with $851 million in cash while targeting ~$1 billion annual sales by 2028. Interested in ACADIA Pharmaceuticals Inc.? Here are five stocks we like better.
Acadia Pharmaceuticals: A Mid-Cap Biotech Making Large Moves
ACADIA Pharmaceuticals (NASDAQ:ACAD) reported first-quarter 2026 total revenue of $268 million, and executives said the company is maintaining its full-year outlook as it advances a pipeline led by remlifanserin in Alzheimer’s disease psychosis and trofinetide in Japan.
Chief Executive Officer Catherine Owen Adams said the quarter represented “a solid start to the year,” with total revenue up 11% year over year on an adjusted basis. The company posted DAYBUE sales of $101 million, up 20%, and NUPLAZID sales of $167 million, up 6% year over year on an adjusted basis. Adams said ACADIA is reaffirming 2026 net sales guidance for both brands and reiterated total revenue guidance of $1.22 billion to $1.28 billion.
DAYBUE growth boosted by early DAYBUE STIX adoption
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Chief Commercial Officer Thomas Garner attributed DAYBUE’s performance to strong referral volumes, new patient starts, and “meaningful re-engagement of previously discontinued patients” following the launch of DAYBUE STIX, a powder for oral solution formulation of trofinetide.
During the quarter, ACADIA initially launched DAYBUE STIX with a focus on Rett syndrome Centers of Excellence (COEs), then broadened availability in early April. Garner said that through Q1 the company received DAYBUE STIX prescriptions for more than 250 individual patients and shipped over 220 of those prescriptions during the quarter. He added that nearly 30% of patients receiving STIX prescriptions were “either treatment naive or restarting therapy.”
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Garner said caregivers and providers have responded positively to the new formulation, citing features including flexible dosing volume, potentially shorter dosing time, no refrigeration requirement, and improved portability. He also pointed to caregiver feedback, stating that more than 80% of caregivers who tried STIX reported high satisfaction.
ACADIA also highlighted international access efforts. Garner said global named patient supply programs continued to contribute to growth, with the number of patients receiving product through the company’s programs increasing over time. He cited a Delphi expert consensus publication that “reinforces DAYBUE’s position as the standard of care for Rett syndrome,” including support for early initiation and individualized dosing.
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On questions about persistence, Garner said the company continues to monitor whether STIX can improve persistence versus the liquid formulation. He reported that for the liquid formulation, persistence is “north of 55% remaining on treatment through 12 months,” with “about 50% of patients through 18 months,” and noted that “74% of our active patients have actually been on treatment for 12 months or longer.”
NUPLAZID demand growth offset by temporary refill timing headwind
NUPLAZID’s first-quarter sales were affected by a temporary shift in refill timing, executives said, though they emphasized that underlying demand indicators were positive. Adams said some patients were slower to refill than in prior years, but that the dynamics “have since normalized.”
Garner said physician referral growth was approximately 11% year over year and that NUPLAZID delivered 8% year-over-year demand growth in the quarter. The company completed a 30% expansion of its customer-facing teams during the quarter, and Garner said ACADIA expects to realize the “full impact” of that expansion “by late 2026 and into next year.”
He also discussed direct-to-consumer marketing, including a renewed partnership with Ryan Reynolds for the unbranded “More to Parkinson’s” campaign. Garner said awareness of hallucinations and delusions among the Parkinson’s disease community has increased from 8% to over 30% since the campaign launched. He added that ACADIA refreshed branding creative on nuplazid.com to reinforce NUPLAZID as “the only FDA-approved treatment for Parkinson’s disease psychosis.”
Garner also marked the brand’s milestone, noting that 2026 is the 10-year anniversary of NUPLAZID’s FDA approval and that nearly 100,000 patients have used the therapy over the past decade. He said the company remains on a path toward “approximately $1 billion in annual sales by 2028.”
In the Q&A, management said the late refills did not necessarily imply a simple revenue “make-up” in Q2. CFO Mark Schneyer said the delayed refills meant some patients “essentially missed a script in the year,” calling it “kind of a lost revenue,” though “not a lost patient.”
Pipeline: Remlifanserin phase II Alzheimer’s psychosis readout expected Aug.–Oct.
Executive Vice President and Head of R&D Elizabeth H.Z. Thompson said she plans to retire by year-end for personal reasons but will remain engaged through the transition and upcoming readouts. Thompson provided updates across the company’s R&D portfolio, stating ACADIA has “eight disclosed programs” and expects to initiate “five additional phase II or phase III studies by the end of 2027.”
ACADIA’s most closely watched near-term catalyst is the phase II readout for remlifanserin in Alzheimer’s disease psychosis. Adams and Thompson reiterated expectations to report top-line results in the August to October 2026 timeframe. In response to analyst questions, Thompson said the ADP study is still enrolling but “getting to the last phases of enrollment,” adding she could not narrow the timing further.
Thompson emphasized that the ADP trial requires biomarker-confirmed Alzheimer’s disease, describing it as part of the diagnostic pathway and a way to “future-proof the program.” She added that biomarker confirmation could also reduce heterogeneity and potentially improve technical success.
On what could define success in the phase II trial, Thompson said ACADIA is looking for phase III-enabling data and would be “pleased with an effect size that’s in line of what we’re powered for, which is a 0.4 or a moderate effect size.” She said there is not a well-established minimal clinically important difference for SAPS-H&D and noted the company will also evaluate responder thresholds such as 30% and 50% improvement.
Thompson also addressed questions about whether remlifanserin would carry a black box warning similar to antipsychotics in elderly patients, saying it will “depend on the data,” but that ACADIA believes there is “good reason to think that this could be a path forward without a black box.”
For the phase II Lewy body dementia psychosis study of remlifanserin, Thompson said enrollment is progressing and that she is “pleased,” though she said the company has not yet publicly shared an expected data timing. She also said the SAPS-H&D and SAPS-LBDP endpoints have “a fair amount of overlap,” with SAPS-LBDP derived from SAPS elements that appeared most impacted in prior Parkinson’s disease psychosis studies.
Trofinetide in Japan and Europe: timing updates
ACADIA also discussed international regulatory and clinical progress for trofinetide. Thompson said the trofinetide reexamination process in Europe remains ongoing and is expected to conclude by late June. She later added the company has submitted its grounds for reexamination and that upcoming steps include an anticipated SAG meeting and a possible oral examination meeting.
In Japan, Thompson said enrollment in the phase III trofinetide trial is progressing “exceptionally well,” and ACADIA now expects to complete enrollment this quarter. The updated timeline positions the company for top-line results in the September to November timeframe this year, earlier than previously expected. Thompson said the study is a small trial designed with regulators to provide descriptive information on Japanese patients and is expected to support a Japanese filing package that will rely largely on the Lavender trial, with an expected regulatory submission in 2027.
Financial results: higher SG&A reflects commercial investment
Schneyer reported R&D expenses of $76.9 million versus $78.3 million a year earlier, while SG&A expenses increased to $171 million from $126.4 million, reflecting increased marketing investment for NUPLAZID and the expanded field footprint for both brands.
He said the company ended the quarter with $851 million in cash, up from $820 million at the end of the fourth quarter, citing positive operating cash flow generation. Schneyer said ACADIA expects 2026 revenue to be “back-end loaded,” with greater sales contribution in the second half driven by the expected productivity ramp from the expanded NUPLAZID field force and broader availability and adoption of DAYBUE STIX.
In closing remarks, Adams said the company’s cash provides “significant strategic flexibility,” including potential acquisitions, licenses, and partnerships, and that ACADIA remains actively evaluating business development opportunities aligned with neurological and rare diseases.
About ACADIA Pharmaceuticals (NASDAQ:ACAD)
ACADIA Pharmaceuticals Inc is a biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders. Established in 1993 and headquartered in San Diego, California, ACADIA's research centers concentrate on conditions with significant unmet medical needs, including Parkinson's disease psychosis, Alzheimer's disease psychosis, and schizophrenia. The company utilizes a range of scientific platforms, including selective receptor modulation and precision-targeted compounds, to advance its portfolio of small-molecule therapeutics.
The company's flagship product, NUPLAZID® (pimavanserin), received U.S.
The article "ACADIA Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat.
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- Acadia (ACAD) Q1 2026 Earnings Transcript
May 6, 2026
Image source: The Motley Fool.
Date
Wednesday, May 6, 2026 at 4:30 p.m. ET
Call participants
Chief Executive Officer — Catherine Owen Adams Chief Commercial Officer — Thomas Garner Executive Vice President, Head of Research and Development — Elizabeth Thompson, PhD Chief Financial Officer — Mark C. Schneyer Vice President, Investor Relations — Albert Kildani
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Full Conference Call Transcript
Albert Kildani: Good afternoon, and thank you for joining us on today's call to discuss ACADIA Pharmaceuticals Inc.'s First Quarter 2026 Financial Results. Joining me on the call today from ACADIA Pharmaceuticals Inc. are Catherine Owen Adams, our Chief Executive Officer, who will provide opening remarks; followed by Thomas Garner, our Chief Commercial Officer, who will discuss our commercial brands, DAYBUE and NUPLAZID. Also joining us are Elizabeth Thompson, PhD, Executive Vice President, Head of Research and Development, who will provide an update on our pipeline programs; and Mark C. Schneyer, our Chief Financial Officer, who will review the financial highlights. Catherine will then provide closing remarks before we open the call for your questions.
We are using supplemental slides 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 NUPLAZID net sales and non-GAAP total revenues. The non-GAAP financial measures, 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 have 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 will now turn the call over to Catherine for opening remarks.
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Catherine Owen Adams: Thank you, Albert. Good afternoon, everyone, and thank you for joining us today to discuss our first quarter 2026 results. ACADIA Pharmaceuticals Inc. 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% year-over-year, our highest year-over-year growth since 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 health care providers.
As announced last month, DAYBUE STIX is now broadly available across the United States, and we are 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 am 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 remifanserin in Alzheimer's disease psychosis, which we continue to expect 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. Additionally, the timing of our Phase III study in Japan for trofinetide has accelerated. 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 remifanserin across the Alzheimer's disease psychosis and Lewy body dementia psychosis indications. This underscores the transformative potential of our research and development efforts. With that, I will now turn the call over to Thomas to provide more detailed insight into our commercial performance.
Thomas Garner: Thank you, Catherine. Let me dive into the details of our first quarter performance. Starting with DAYBUE, I am 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 reengagement of previously discontinued patients following the recent approval and launch of the new powder-for-oral-solution formulation, 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 have been extremely pleased with both the initial uptake and positive experiences we have received from both caregivers and health care 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. In addition, we are 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. Caregiver response has been particularly positive, with more than 80% of those who have tried STIX reporting high satisfaction, complemented by strong endorsement from health care providers across our centers of excellence where the product was available through the first quarter. Following the focused 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 to 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. Now turning to NUPLAZID. We delivered sales of $167 million in the first quarter, representing 6% growth year-over-year on an adjusted basis. 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 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.
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 are 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 have 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 disease community increased from 8% to over 30%, underscoring the campaign's significant impact. We are complementing this with refreshed branding and creative on nplazid.com to engage patients earlier in their journey and clearly reinforce NUPLAZID as the only FDA-approved treatment for Parkinson's disease psychosis. I would 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 thousand 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 toward approximately $1 billion in annual sales by 2028. With that, I will now turn the call over to Elizabeth to provide an update on our pipeline developments.
Elizabeth Thompson: Thank you, Thomas. Before turning to pipeline updates, I want to briefly address the retirement announcement we shared last week. For personal reasons, I have 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 remifanserin. With that context, I will now walk through the key R&D progress for the quarter. I am 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 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 am 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 remifanserin in Lewy body dementia psychosis, and 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 2027. The closest of these is the top-line results from our Phase II study of remifanserin 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 have 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 are excited for this readout and what it could mean for the future of the company if successful, but most importantly, as a step toward relief for the patients and families affected by this challenging condition. Turning to regulatory and international developments, the trofinetide re-examination 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 with trofinetide has been progressing exceptionally well, and I am 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. Thank you.
Mark C. Schneyer: I will 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 2025. NUPLAZID generated $167 million of net product sales in the first quarter, representing 6% growth year-over-year on an adjusted basis. As Thomas 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 Thomas 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 2025.
Our SG&A expenses were $171 million compared to $126.4 million in 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 2025 and are 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 am 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 will turn the call back to Catherine for her closing remarks.
Catherine Owen Adams: 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 transformative year for ACADIA Pharmaceuticals Inc. First and foremost, we are approaching our highly anticipated top-line results for remifanserin 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 Alzheimer's disease psychosis market represents a substantial opportunity with no currently approved therapies, and successful results could position remifanserin 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 Elizabeth 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, and we are pleased to reaffirm our 2026 financial guidance for total revenues of $1.22 billion to $1.28 billion.
Furthermore, 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. The combination of our strong commercial performance, robust pipeline, and solid financial foundation positions ACADIA Pharmaceuticals Inc. exceptionally well for both near-term catalysts and long-term sustainable growth. We are excited about the opportunities ahead and look forward to sharing our progress with you throughout the year. We will now open the call for questions.
Operator: Your first question comes from Tessa Thomas Romero with JPMorgan. Please go ahead.
Tessa Thomas Romero: Hey, thanks so much for taking our questions this afternoon. A pipeline one here. Where are you more precisely in terms of enrollment of the Phase II RADIANCE study of remifanserin in Alzheimer's disease psychosis, and how confident are you in your August to October 2026 timeline? When might you see the last patient in? And then, how is enrollment going in your Phase II study in Lewy body dementia psychosis, and what is the right way to think about the potential timeline to data there as well?
Catherine Owen Adams: Thank you. I am going to ask Elizabeth to take us through the timelines for remifanserin.
Elizabeth Thompson: Hi, Tessa, thanks for the question. For the Alzheimer's disease psychosis program, we continue to feel very good about the August to October 2026 timeframe. The study is still enrolling, but we are getting to the last phases of enrollment, so we feel confident about that timeline. That said, I am not yet able to narrow it further. As we look at Lewy body dementia psychosis, I am pleased with the enrollment progress. I do not think we have yet shared publicly our expectations around timing of data; we want to get further into enrollment before guiding. I look forward to sharing more in the future, but so far we are pleased and on track.
Operator: Your next question comes from the line of Ashwani Verma with UBS. Please go ahead.
Catherine Owen Adams: Thanks for the questions. Elizabeth will take the biomarker and black box topics.
Elizabeth Thompson: There was a lot in there, so hopefully I captured everything. On the biomarker basis, this has been an important evolution in the Alzheimer's field. Biomarkers are now considered part of the diagnostic pathway for Alzheimer's disease. I fully anticipate that by the time we would make it to the FDA with a potential package for remifanserin, there would be an expectation that Alzheimer's disease is biologically confirmed. We put this in place to future-proof the program. Regarding real world, practice is moving that way as well. Biomarker confirmation may also improve technical success by reducing heterogeneity and ensuring we are studying true Alzheimer's disease patients.
On the black box warning question, the FDA held a workshop about a year and a half ago discussing the mortality boxed warning for elderly patients with dementia-related psychosis and what data might allow agent-specific decisions. We attended, learned from it, and have incorporated feedback into our data collection to enable the FDA to make a decision specific to remifanserin. We do not know the outcome yet, but we know what data are needed and believe there is a path forward without a boxed warning, depending on the totality of the data.
Operator: Your next question comes from the line of Ritu Subhalaksmi Baral with TD Cowen. Please go ahead.
Ritu Subhalaksmi Baral: Thanks for taking the question. More remifanserin questions, extending from clinical into commercial. As we think about the upcoming Phase II data, what should our expectations be around effect size or delta on the SAPS-H+D? Is there an accepted minimal clinically important difference? What frames success statistically? And from a market perspective, given the recent approval of an Alzheimer's agitation drug, how should we think about differential diagnosis between agitation and psychosis, accurate diagnosis, and treatment decisions between the two?
Catherine Owen Adams: Given all the interest in remifanserin, Elizabeth will kick off, and then Thomas can add market context.
Elizabeth Thompson: On what to look for and what defines Phase II success: Phase II should be Phase III-enabling. We are looking for information that informs Phase III design and any needed modifications. We will look for data consistent with our target product profile: once-daily dosing, ease with concomitant meds and food, patient-friendly administration, efficacy with an effect size in line with what we are powered for (0.4, a moderate effect size), and a safety profile similar to pimavanserin. We will also monitor for any signals on movement or cognition; based on the pimavanserin dataset, we feel good there but will look for directional signals. There is not a well-established MCID on SAPS-H+D at this point.
For a future FDA dossier, we would establish MCID in part based on the Phase II data. We are also looking at responder analyses (≥30% and ≥50% improvement) to contextualize meaningfulness. Regarding the recent agitation approval, agitation and psychosis are distinct. Agitation is multifactorial (pain, cognitive challenges, psychosis). Pimavanserin data suggest that in patients with both significant agitation and psychosis, improvement in psychosis may be associated with improvement in agitation. We would not expect to impact agitation due to non-psychosis drivers like pain. Conversely, agents effective for agitation may not impact underlying drivers such as psychosis, and some components can be associated with increased psychosis.
We believe there is room for multiple players, and agitation treatments should not be meaningfully impactful to the psychosis opportunity we see for remifanserin.
Operator: Your next question comes from the line of Yigal Nochomovitz with Citigroup. Please go ahead.
Analyst: Hi, this is Caroline DePaul on for the team. Switching gears to DAYBUE STIX, you disclosed that 30% of patients are either treatment-naive or returning after previously discontinuing the liquid formulation. How does this compare to your expectations for the launch? Do you still expect to capture over 400 incremental patients with STIX, and what is the anticipated cadence?
Thomas Garner: Thanks for the question. Our launch strategy focused on centers of excellence in the first quarter, so we have not yet gone broadly into the community. We have been very pleased with initial uptake. Of roughly 250 STIX prescriptions, about 220 were shipped in the quarter, showing we can get drug to patients quickly. The ramp is tracking faster than anticipated. The 450 incremental patients we referenced earlier this year still holds, modeled over a three-year period to make STIX the dominant SKU by the end of that time. It may go slightly quicker.
The ~30% mix of naive and restart patients is broadly in line with expectations, and we are also seeing significant interest from existing liquid patients switching to STIX. This gives us real optimism for DAYBUE growth and the role of STIX in fueling that growth.
Operator: Your next question comes from the line of Brian Corey Abrahams with RBC Capital Markets. Please go ahead.
Brian Corey Abrahams: On remifanserin, what are the key differences on potency, saturation, and receptor binding you might expect from 60 mg remifanserin compared to the marketed and previously tested dose of pimavanserin? Or should we think of success as being driven more by a more homogeneous population and a design leveraging prior learnings with more sensitive endpoints?
Elizabeth Thompson: It is a bit of both. From prior pimavanserin work, exposure-response analyses suggest that exposures higher than achievable with the currently marketed pimavanserin dose may yield greater efficacy. With the 60 mg dose of remifanserin, we can potentially achieve higher exposures and move further up the exposure-response curve. Independently, the study design is tailored to Alzheimer's disease: biomarker-confirmed AD, slightly more severe baseline psychosis (based on PIM data indicating better responses at higher baseline severity), and endpoints we believe are better suited, like SAPS-H+D and the NPI-C, versus the NPI-NH used in older studies. All of the above should help.
Operator: Your next question comes from the line of Tazeen Ahmad with Bank of America. Please go ahead.
Tazeen Ahmad: How are you thinking about read-through from the Alzheimer's Phase II to the Lewy body study? Pimavanserin showed a strong signal in Lewy body previously. Regardless of how ADP turns out, how should we think about de-risking for Lewy body next year?
Elizabeth Thompson: Great question. While the numbers were small, I have always found the Lewy body data with pimavanserin striking. In HARMONY’s withdrawal design, about 20 patients per arm with Lewy body dementia were included; roughly 55% of those withdrawn relapsed versus about 5% who continued therapy. Regardless of the ADP outcome—though we have high hopes for it—we remain very optimistic about the Lewy body study. The only possible read-through that could negatively impact both would be an unexpected safety signal; we are not anticipating that, but we will know when we see the ADP data. We also believe our remifanserin formulation and dosing approach should suit this frailer population, emphasizing safety and ease of administration.
Operator: Your next question comes from the line of Marc Harold Goodman with Leerink. Please go ahead.
Marc Harold Goodman: On NUPLAZID, if patients were delayed in refilling in January and February, why would we not have a great second quarter that makes up for the low first quarter? Your guidance talks about back-end loading.
Catherine Owen Adams: We are expecting a strong second quarter. The back-half weighting we referenced is primarily tied to the incremental impact of our additional sales force expansion. Thomas will add detail.
Thomas Garner: We executed a 30% expansion of our sales team in Q1. By quarter-end, the new team had been in the field for about six weeks, so we did not see a full-quarter productivity impact. Referral volumes were up 11% year-over-year and demand growth was solid, but late refills, coupled with typical Q1 Medicare dynamics, affected the quarter. We expect the productivity ramp to continue through Q2 and beyond. We are also pushing on DTC efforts (both unbranded and branded) and have expanded our target universe to just over 10 thousand HCPs, which should support further share growth over coming quarters.
Mark C. Schneyer: From a financial perspective, the delay was largely late refills from existing patients, not new starts. Those late refills effectively missed a script in the quarter—so lost revenue in Q1—but not a lost patient. Those patients returned and refilled later in the quarter, positioning us well going forward, but not necessarily resulting in a full rebound that recoups all January/early February revenue.
Operator: Your next question comes from the line of Jack Allen with Baird. Please go ahead.
Jack Allen: Two quick ones on remifanserin and DAYBUE. First, the ADP study is placebo-controlled, and FDA has discussed potential single-trial filings in certain settings. Thoughts on filing on a single positive placebo-controlled trial? Second, on DAYBUE, you have referenced $700 million as an aspirational sales number for 2027/2028. How do you factor potential gene therapy for Rett into that longer-term guidance?
Elizabeth Thompson: On single-trial approvals, we are all awaiting formal guidance to better understand FDA’s thinking. Key considerations like the size of the safety database likely still apply. Our base case remains that we will need the current Phase II and at least one Phase III. If we were to see truly striking results, we would certainly discuss options with FDA, but our planning assumes more than a single study given exposure requirements.
Catherine Owen Adams: At a top-line level, we remain confident in our $700 million DAYBUE sales target by 2028. We have of course considered competitive dynamics, including gene therapy.
Thomas Garner: We are very pleased with early STIX progress, which complements our liquid formulation and community expansion. Our penetration across COEs and community physicians is still around 40%, leaving significant headroom. We also have roughly 1 thousand patients who have tried DAYBUE but are no longer on treatment; we believe STIX can help reengage many of them, and we have already begun to see this in Q1. Regarding gene therapy, the Delphi consensus positioned DAYBUE as standard of care for Rett syndrome. We welcome more treatment options for the Rett population and will evaluate gene therapy data as they emerge. Irrespective, we believe DAYBUE will have a role across these patients. We feel really good about the $700 million by 2028.
Operator: Your next question comes from the line of Ami Fadia with Needham. Please go ahead.
Ami Fadia: On remifanserin, you mentioned powering for a 0.4 effect size. What is the minimum effect size needed for statistical significance? Also, as we expect data from other trials that use the NPI-C, will you provide NPI-C data at top line, and at what time point, to enable cross-trial comparisons?
Elizabeth Thompson: A brief caution that cross-study comparisons require care. NPI-C was added to our Phase II ADP study after it had started—one of the earlier changes I made—so we will not have NPI-C on all patients. It is an exploratory endpoint on a subset; I would not expect it to be part of the formal top line. In terms of powering, we are 80% powered for an effect size of 0.4. There is some flexibility around that with scenarios that could still be statistically significant, but that is generally what we are targeting.
Operator: Your next question comes from the line of Sean Laaman with Morgan Stanley. Please go ahead.
Analyst: Hi, this is Catherine on for Sean. As DAYBUE STIX adoption scales, do you expect any meaningful change in persistency versus the liquid formulation, or is the primary benefit reengaging discontinued patients?
Thomas Garner: We are monitoring persistency closely. Improving persistency over liquid would be a significant advantage. For context, with liquid DAYBUE, more than 55% of patients remain on treatment through 12 months, and about 50% through 18 months. Persistency continues to improve over time, and 74% of our active patients have been on treatment for 12 months or longer. For STIX, we believe it can help reduce initial friction and improve convenience. It is early to be definitive on real-world persistency versus liquid, and we will share more in due course. As for recapturing discontinued patients, of the ~450 incremental STIX patients we discussed earlier in the year, we estimate roughly three-quarters would be naive and one-quarter restarts.
In Q1 STIX experience, among the ~30% naive/returning share, it is roughly a 50/50 split, and we are also seeing significant interest from existing patients switching from liquid. On logistics and refills, we supply via a single specialty pharmacy on a patient-by-patient basis, so there is very limited stocking. Of the ~250 prescriptions written, over ~220 were filled in the quarter. We are not seeing payer or formulary issues; the limited COE-focused launch approach has worked well and should support ongoing refill momentum.
Operator: Your next question comes from the line of Analyst with Wolfe Research. Please go ahead.
Analyst: Thanks for taking my question. On diagnostics and endpoints for the Lewy body dementia psychosis study: you have biomarker confirmation for Alzheimer's disease entry. The Lewy body field is more exploratory; are you including alpha-synuclein measures? And can you comment on endpoint overlap between SAPS-H+D and SAPS-Lewy body?
Elizabeth Thompson: For Lewy body dementia psychosis, we are indeed exploring alpha-synuclein assessments to inform future design and contribute to the science, but it is not required for trial entry. Regarding endpoints, there is meaningful overlap between SAPS-H+D and the SAPS-Lewy body scales; both derive from the broader SAPS and focus on relevant subsets of symptoms, though they are not identical. Our endpoint strategy is intended to be sensitive to changes most characteristic of Lewy body psychosis while maintaining consistency with our broader program.
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Acadia (ACAD) Q1 2026 Earnings Transcript was originally published by The Motley Fool
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- Acadia Pharmaceuticals (ACAD) Lags Q1 Earnings and Revenue Estimates
May 6, 2026
Acadia Pharmaceuticals (ACAD) came out with quarterly earnings of $0.02 per share, missing the Zacks Consensus Estimate of $0.04 per share. This compares to earnings of $0.11 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of -54.23%. A quarter ago, it was expected that this drugmaker would post earnings of $0.12 per share when it actually produced earnings of $0.16, delivering a surprise of +33.33%.
Over the last four quarters, the company has surpassed consensus EPS estimates three times.
Acadia, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $268.06 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 5%. This compares to year-ago revenues of $244.32 million. The company has topped consensus revenue estimates two times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Acadia shares have lost about 16.3% since the beginning of the year versus the S&P 500's gain of 6%.
What's Next for Acadia?
While Acadia has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Acadia was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.11 on $305.7 million in revenues for the coming quarter and $0.45 on $1.25 billion in revenues for the current fiscal year.
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Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
BioHarvest Sciences Inc. (BHST), another stock in the same industry, has yet to report results for the quarter ended March 2026. The results are expected to be released on May 14.
This company is expected to post quarterly loss of $0.13 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 9.1% higher over the last 30 days to the current level.
BioHarvest Sciences Inc.'s revenues are expected to be $8.51 million, up 8.2% from the year-ago quarter.
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- Acadia Pharmaceuticals Reports First Quarter 2026 Financial Results and Reaffirms 2026 Financial Guidance
May 6, 2026
- First quarter DAYBUE® GAAP net sales of $101 million, up 20% year-over-year; successful launch of DAYBUE STIX underway
- First quarter NUPLAZID® GAAP net sales of $167 million, up 6% year-over-year on a non-GAAP adjusted basis
- Reaffirms expectation for topline results from the Phase 2 remlifanserin study in Alzheimer’s disease psychosis between August and October 2026
SAN DIEGO, May 06, 2026--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the first quarter ended March 31, 2026.
"Acadia delivered a solid first quarter of 2026 with total revenues of $268 million, driven by a strong start from DAYBUE, which generated sales of $101 million," said Catherine Owen Adams, Chief Executive Officer. "We are very encouraged by the early enthusiasm for DAYBUE STIX, which is now broadly available in the U.S., and by the initial uptake during our focused launch. NUPLAZID generated sales of $167 million, supported by strong new referrals and underlying demand, with performance strengthening as the quarter progressed. As we look ahead, we remain focused on advancing our deep, differentiated pipeline, with remlifanserin representing a key value driver as we approach expected Phase 2 topline data in Alzheimer’s disease psychosis later this year. We are reaffirming our full year guidance and remain confident in our ability to deliver long‑term value for both patients and shareholders."
Company Updates
Full launch of DAYBUE STIX (trofinetide) in the U.S. is underway, with ~30% of STIX patients being either treatment-naive or returning after previously discontinuing the liquid formulation. Phase 2 topline results readout from the remlifanserin Alzheimer’s disease psychosis study remains on track for August to October 2026 timeframe. Accelerated enrollment in the trofinetide clinical trial in Japan, with topline results now anticipated in the September to November 2026 timeframe. Delphi expert consensus panel recently recommended DAYBUE as part of the standard of care for eligible patients with Rett syndrome.1
Financial Results
Revenues
GAAP total revenues, comprised of net product sales from NUPLAZID and DAYBUE, were $268 million for the first quarter of 2026, up 10% as compared to GAAP total revenues of $244 million in the first quarter of 2025, and up 11% as compared to non-GAAP adjusted total revenues of $242 million in the first quarter of 2025.
GAAP net product sales of NUPLAZID were $167 million for the first quarter of 2026, up 5% compared to GAAP net product sales of $160 million for the first quarter of 2025, and up 6% as compared to non-GAAP adjusted net product sales of $157 million for the first quarter of 2025.
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Net product sales of DAYBUE were $101 million for the first quarter of 2026, an increase of 20% as compared to $85 million for the first quarter of 2025.
A reconciliation of NUPLAZID non‑GAAP adjusted net sales and non‑GAAP adjusted total revenues is provided in Table 1. A description of these adjustments is included under ‘Non-GAAP Financial Measures.’
Research and Development
Research and development expenses for the first quarter of 2026 were $77 million, compared to $78 million for the same period of 2025.
Selling, General and Administrative
Selling, general and administrative expenses for the first quarter of 2026 were $171 million, compared to $126 million for the same period of 2025. The increase in selling, general and administrative expenses during the first quarter was primarily driven by increased investments to support continued growth of NUPLAZID and DAYBUE.
Net Income
For the first quarter of 2026, Acadia reported net income of $4 million, or $0.02 per diluted share, compared to a net income of $19 million, or $0.11 per diluted share, for the same period in 2025.
Cash and Investments
At March 31, 2026, Acadia’s cash, cash equivalents, and investment securities totaled $851 million, compared to $820 million at December 31, 2025.
Full Year 2026 Financial Guidance (GAAP):
Acadia is reaffirming its 2026 guidance as first provided on February 25, 2026:
Total revenues in the range of $1.22 to $1.28 billion. NUPLAZID net product sales in the range of $760 to $790 million. DAYBUE net product sales in the range of $460 to $490 million. R&D expense in the range of $385 to $410 million. SG&A expense in the range of $660 to $700 million.
Conference Call and Webcast Information
Acadia will host a conference call to discuss the first quarter 2026 results today, Wednesday, May 6, 2026 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed by registering for the call here. Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call.
About NUPLAZID® (pimavanserin)
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID.
About DAYBUE® (trofinetide)
Trofinetide is a synthetic version of a naturally occurring molecule known as the tripeptide glycine-proline-glutamate (GPE). The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown. Trofinetide was approved for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older by the U.S. Food and Drug Administration in March 2023 under the trade name DAYBUE or DAYBUE STIX.
About Acadia Pharmaceuticals
Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X.
Non-GAAP Financial Measures
This press release contains the following financial measures that do not comply with U.S. generally accepted accounting principles (GAAP): non-GAAP adjusted net sales for NUPLAZID for the first quarter of 2025 and non-GAAP adjusted total revenues for the first quarter of 2025. In preparing these non-GAAP financial results, the Company includes adjustments made to reflect the impact of a change in estimate related to NUPLAZID IRA rebate accruals. Please refer to our press release dated February 25, 2026, for additional details. These non-GAAP financial measures complement GAAP results and are used by management to analyze financial performance and evaluate period-to-period changes. Management believes these non-GAAP financial measures are useful to investors and other users of the Company’s financial statements to facilitate period-to-period comparability. These non-GAAP financial measures are not meant to be considered as a substitute for comparable GAAP measures; should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are unlikely to be comparable with non-GAAP disclosures released by other companies.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential," "guidance," "continue" and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) our business strategy, objectives and opportunities, including support for and innovations in our pipeline assets and business development opportunities, DAYBUE sales growth, interest in DAYBUE STIX, and potential for enhanced shareholder value; (ii) plans for, including timing, development and progress of commercialization or regulatory timelines for our products, including NUPLAZID and DAYBUE, and our product candidates; (iii) benefits to be derived from and efficacy of our products, including the potential advantages of our products; (iv) the timing and conduct of our clinical trials; and (v) our estimates regarding our future financial performance, profitability, capital requirements or expenses, including our full year 2026 financial guidance. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our dependency on the continued successful commercialization of our products and our ability to maintain or increase sales of our products; our plans to continue commercial growth; the costs of our commercialization plans and development programs, and the financial impact or revenues from any commercialization we undertake; our ability to obtain necessary regulatory approvals for our product candidates and, if and when approved, market acceptance of our products; the risks associated with clinical trials and their outcomes, including risks of unsuccessful enrollment and negative or inconsistent results; our dependence on third-party collaborators, clinical research organizations, manufacturers, suppliers and distributors; the impact of competitive products and therapies; our ability to generate or obtain the necessary capital to fund our operations; our ability to grow, equip and train our specialized sales forces; our ability to manage the growth and complexity of our organization; our ability to maintain, protect and enhance our intellectual property; and our ability to continue to stay in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our annual report on Form 10-K for the year ended December 31, 2025 as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited) Three Months Ended March 31, 2026 2025 Revenues Product sales, net $ 268,062 $ 244,317 Total revenues 268,062 244,317 Operating expenses Cost of product sales (1)(2) 24,791 20,392 Research and development (2) 76,868 78,265 Selling, general and administrative (2) 171,019 126,370 Total operating expenses 272,678 225,027 (Loss) income from operations (4,616 ) 19,290 Interest income, net 8,055 7,901 Other income 542 588 Income before income taxes 3,981 27,779 Income tax expense 344 8,792 Net income $ 3,637 $ 18,987 Earnings per share: Basic $ 0.02 $ 0.11 Diluted $ 0.02 $ 0.11 Weighted average common shares outstanding: Basic 170,517 166,808 Diluted 172,706 167,668 (1) Includes license fees and royalties (2) Includes the following stock-based compensation expense Cost of product sales $ 328 $ 334 Research and development $ 4,142 $ 3,433 Selling, general and administrative $ 10,228 $ 7,613
ACADIA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(Unaudited) March 31,
2026 December 31,
2025 (unaudited) Assets Cash, cash equivalents and investment securities $ 851,458 $ 819,686 Accounts receivable, net 135,350 121,457 Interest and other receivables 13,034 26,774 Inventory 31,574 34,670 Prepaid expenses 64,600 59,526 Total current assets 1,096,016 1,062,113 Property and equipment, net 14,652 7,511 Operating lease right-of-use assets 46,274 47,354 Intangible assets, net 106,171 108,893 Restricted cash 7,846 7,845 Long-term inventory 80,719 76,704 Deferred tax assets 249,624 249,879 Other assets 3,928 3,896 Total assets $ 1,605,230 $ 1,564,195 Liabilities and stockholders’ equity Accounts payable $ 12,246 $ 10,903 Accrued liabilities 293,278 266,211 Total current liabilities 305,524 277,114 Operating lease liabilities 39,003 40,554 Other long-term liabilities 12,637 19,137 Total liabilities 357,164 336,805 Total stockholders’ equity 1,248,066 1,227,390 Total liabilities and stockholders’ equity $ 1,605,230 $ 1,564,195
Table 1. ACADIA PHARMACEUTICALS INC.
NON-GAAP RECONCILIATION
(in millions)
(Unaudited) 1Q25 1Q26 GAAP NUPLAZID Net Sales $ 159.7 $ 166.9 Allocation of 2025 Amount $ (2.3 ) $ — Non-GAAP Adjusted NUPLAZID Net Sales $ 157.4 $ 166.9 DAYBUE Net Sales $ 84.6 $ 101.2 Non-GAAP Adjusted Total Revenues $ 242.0 $ 268.1
References
Prange EO, Beisang A, Pehlivan D, et al. Expert Consensus on Real-World Use of Trofinetide for Rett Syndrome Using a Modified Delphi Method. Ann Child Neurol. 2026; 4:38-51.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260506206885/en/
Contacts
Investor Contact:
Acadia Pharmaceuticals Inc.
Al Kildani
(858) 261-2872
ir@acadia-pharm.com
Acadia Pharmaceuticals Inc.
Jessica Tieszen
(858) 261-2950
ir@acadia-pharm.com
Media Contact:
Acadia Pharmaceuticals Inc.
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com
View Comments
- Acadia Pharmaceuticals (ACAD) Lags Q1 Earnings and Revenue Estimates
May 6, 2026 · zacks.com
Acadia Pharmaceuticals (ACAD) came out with quarterly earnings of $0.02 per share, missing the Zacks Consensus Estimate of $0.04 per share. This compares to earnings of $0.11 per share a year ago.
