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. 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. 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. I want to remind everyone of the tremendous opportunity we have across our pipeline. 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. 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. 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.

What went well
  • Total revenue was $268 million, up 11% year over year on an adjusted basis, a solid start to the year.
  • DAYBUE had a standout quarter at $101 million, up 20% year over year — its highest year-over-year growth since Q3 2024 — with another record for unique patients receiving shipments.
  • The DAYBUE STIX launch exceeded expectations: more than 250 patients received prescriptions in a COE-focused rollout (220 shipped), nearly 30% treatment-naive or restarting, with more than 80% caregiver satisfaction; the formulation went fully available in the U.S. in early April.
  • NUPLAZID demand remained healthy with ~11% referral growth and 8% year-over-year demand growth even before the field-force expansion ramp, and a temporary refill delay from January-early February normalized during the quarter.
  • The company reaffirmed full-year 2026 guidance (total revenue $1.22-$1.28 billion) and grew cash to $851 million from $820 million on positive operating cash flow.
  • The pipeline advanced: ACADIA initiated the first-in-human study of ACP-271, accelerated the Japan trofinetide Phase III (results now expected September-November 2026), and remained on track for the remlifanserin ADP Phase II readout in August-October 2026.
What went wrong
  • NUPLAZID growth slowed to 6% year over year (adjusted) as some Medicare patients were slower than usual to refill in January and early February — a temporary, since-normalized dynamic that cost a missed script (lost revenue, though not lost patients).
  • SG&A jumped to $171 million from $126.4 million a year earlier, reflecting the annualized NUPLAZID and DAYBUE field-force expansions and higher marketing.
  • Head of R&D Elizabeth Thompson announced her intention to retire by year-end for personal reasons, initiating a leadership transition (she will remain engaged through the key readouts).
  • The trofinetide EU reexamination remained unresolved, expected to conclude by late June, keeping EU commercialization uncertain.
  • Management reiterated that 2026 revenue will be back-end loaded, implying continued softer first-half optics as the expanded field force ramps.

Guidance Changes

MetricPeriodCurrent guidance
Total revenueFY2026$1.22B-$1.28B (reaffirmed)
NUPLAZID net salesFY2026$760M-$790M (reaffirmed)
DAYBUE net salesFY2026$460M-$490M (reaffirmed)
Revenue phasingFY2026Back-end loaded; greater second-half contribution from the NUPLAZID field-force ramp and broader DAYBUE STIX adoption
Remlifanserin ADP Phase II readout2026August-October 2026 (reaffirmed)
Japan trofinetide Phase III readout2026Accelerated to September-November 2026

Performance Breakdown

MetricYoYNote
Total revenue +11% (adjusted) Strong DAYBUE growth partly offset by softer NUPLAZID refills.
DAYBUE net sales +20% to $101M Highest YoY growth since Q3 2024; DAYBUE STIX uptake plus community expansion and named patient supply; gross-to-net 25.8%.
NUPLAZID net sales +6% to $167M (adjusted) ~11% referral growth and 8% demand growth offset by a temporary refill delay in January-early February; gross-to-net 22.1%.
R&D expense $76.9M vs $78.3M Roughly flat year over year.
SG&A expense $171M vs $126.4M Annualized NUPLAZID and DAYBUE field expansions and higher marketing investments.
Cash and investments $851M (up from $820M) Positive operating cash flow.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
DAYBUE STIX rampDecember 2025 FDA approval; broad launch planned early Q2COE-focused Q1 launch drew >250 prescriptions (~30% naive/restart), >80% caregiver satisfaction, and full U.S. availability from early April; ~450-patient opportunity may be captured faster than the original three-year assumption.
NUPLAZID refill dynamicsStrong Q4 2025 momentumA temporary Q1 refill delay (Jan-early Feb) normalized; ~11% referral and 8% demand growth support the reaffirmed full-year outlook, with field-force benefits building later in 2026.
R&D leadership transitionStable R&D leadershipElizabeth Thompson announced retirement by year-end; she remains fully engaged through the remlifanserin readouts and early Phase III planning while a successor is sought.
NUPLAZID demand generationDTC campaigns launchedRenewed Ryan Reynolds 'More to Parkinson's' campaign lifted awareness of hallucinations/delusions from 8% to over 30%; 10-year FDA-approval anniversary with nearly 100,000 patients treated.

Q&A Summary

Tessa Romero (JPMorgan) asked how far along RADIANT (remlifanserin ADP) enrollment is and about the ILLUMERA LBDP study timeline.
Elizabeth Thompson reaffirmed confidence in the August-October ADP readout, saying the study was in its last phases of enrollment, and noted LBDP enrollment was progressing in line with expectations though a data timeline had not yet been shared.
Ashwani Verma (UBS) asked why biomarker confirmation of Alzheimer's matters and whether remlifanserin would carry a black-box warning.
Elizabeth Thompson said biomarker confirmation is now part of the Alzheimer's diagnostic pathway and helps 'future-proof' the program and reduce population heterogeneity; whether a class boxed warning applies will depend on the data ACADIA is collecting to support an agent-specific FDA decision.
Marc Goodman (Leerink) asked why Q2 would not simply rebound strongly from the delayed Q1 NUPLAZID refills.
Catherine Owen Adams said a strong Q2 is expected from the current sales force, with the back-end loading driven by the expansion ramp; Mark Schneyer clarified the late refills were a missed script (lost revenue) among existing patients, not lost patients, so it is not a simple recoupment.
Caroline DePaul (Citigroup) asked whether DAYBUE STIX's 30% naive/returning mix met expectations and if the 400-plus patient opportunity still holds.
Tom Garner said 250 prescriptions were received and 220 shipped in a COE-focused quarter, the ramp was faster than anticipated, and the ~450-patient opportunity (modeled over three years) still holds, with STIX possibly becoming the dominant SKU sooner.
Yatin Suneja (Guggenheim) asked where the trofinetide EU reexamination process stands.
Elizabeth Thompson said ACADIA had requested reexamination shortly after the negative opinion, new rapporteurs were assigned, the grounds for reexamination were submitted, and an upcoming scientific advisory group meeting (and possibly an oral explanation) remained ahead.

More on Acadia Pharmaceuticals Inc

Reported 2026-05-06 · figures from the Acadia Pharmaceuticals Inc Q1 2026 earnings call.

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