This performance underscores our ability to execute on multiple fronts while building for future growth. I'm excited to share that we achieved our largest sequential increase in referrals since launch. This meaningful sequential growth reflects the impact of our expanded team into the community setting, giving us confidence that we will continue to see benefits from our broadened physician reach. The momentum we are now driving gives us tremendous confidence in NUPLAZID's potential to unlock higher growth in the coming years.

The impact of this sales team expansion, combined with our direct-to-consumer campaigns, creates a powerful combination that we believe will drive sustained growth and value maximization for NUPLAZID. We're looking to build on our commercial success by advancing our pipeline of novel product candidates, including the recent initiation of one phase II and one phase III trials. DAYBUE sales were $101.1 million in Q3, representing our highest revenue and total prescription volume in any quarter to date since launch. Referrals are leading the way, with the highest quarter-over-quarter increase since DAYBUE's launch in 2023.

Supported by a similar increase in the number of educational programs we delivered, both of which are important levers in helping to educate prescribers on the benefits that DAYBUE has to offer. As we expand our reach beyond COEs, we see this segment as a significant growth driver for 2026 and beyond. The strength of these metrics is important, as they further reinforce not only our confidence in DAYBUE's therapeutic value, but also our outlook for sustainable long-term growth in the U.S. Looking ahead, we remain confident in DAYBUE's growth outlook, driven by sustained demand generation supported by our strategic field force investments, strong persistency metrics, and expanding global access.

What went well
  • Total revenue reached $278.6 million, up 11% year over year, on strength across the commercial portfolio.
  • NUPLAZID delivered its strongest sales quarter ever at $177.5 million, up 12% year over year (9% volume), with new prescriptions up 23% year over year — the strongest year-over-year increase since 2019 — and referrals up 21%.
  • DAYBUE generated $101.1 million in net sales, up 11% year over year and entirely volume-driven, its highest revenue and prescription volume in any quarter since launch, with more than 1,000 unique patients (1,006) receiving therapy globally for the first time.
  • DAYBUE's community expansion is working: 956 physicians have now prescribed the drug, community-based physicians accounted for 74% of new prescriptions, and persistency held above 50% at 12 months and above 45% at 18 months.
  • The company raised the low and high ends of its full-year NUPLAZID guidance and reaffirmed its ambition to exceed $1 billion in total revenue for 2025.
  • The balance sheet strengthened to $847 million in cash, up from $762 million at the end of Q2, and the pipeline advanced with initiation of the Phase II ACP-204 study in Lewy body dementia psychosis and the Phase III trofinetide study in Japan.
What went wrong
  • The COMPASS Prader-Willi syndrome study of ACP-101 failed, and management is winding the program down while sharing learnings with the Prader-Willi community.
  • The EU regulatory path for trofinetide slipped: EMA indicated the earliest a scientific advisory group could convene was January, pushing the anticipated CHMP opinion into Q1 2026.
  • DAYBUE market penetration remains low at roughly 40% in the U.S. and only 27% in the community setting, and penetration among patients older than 11 lags despite growing real-world evidence of benefit.
  • R&D expense rose to $87.8 million from $66.6 million a year earlier on higher ACP-204, LBDP and ACP-101 clinical costs, and management flagged a further step-up in commercial spend from a planned 30% NUPLAZID field-force expansion in Q1 2026.

Guidance Changes

MetricPeriodCurrent guidance
NUPLAZID net salesFY2025$685M-$695M (raised)
DAYBUE net salesFY2025$385M-$400M (now includes named patient supply programs)
R&D expenseFY2025$335M-$345M
SG&A expenseFY2025$540M-$555M
Total revenueFY2025On track to exceed $1 billion for the first time in company history

Performance Breakdown

MetricYoYNote
Total revenue +11% Broad-based strength across NUPLAZID and DAYBUE.
NUPLAZID net sales +12% (9% volume) Record quarter; new prescriptions +23% YoY (strongest since 2019) and referrals +21% as awareness and earlier treatment of Parkinson's disease psychosis improved.
DAYBUE net sales +11% (all volume) Highest quarter since launch; >1,000 unique patients globally, community physicians 74% of new Rx, and contributions from ex-U.S. named patient supply programs.
R&D expense $87.8M vs $66.6M Higher clinical trial spend on ACP-204, LBDP and ACP-101 plus personnel, partly offset by completed programs.
SG&A expense $133.4M (roughly flat) Essentially flat with the prior-year quarter.
Cash and investments $847M (up from $762M in Q2) Strong operating cash generation from the commercial portfolio.

Earnings Call Themes & Trends

TopicPrevious mentionCurrent periodTrend
NUPLAZID field-force expansionReach-and-frequency model with DTC campaignsAnnounced a 30% increase in the customer-facing team starting Q1 2026 to reach newly activated prescribers (including primary care, NPs and PAs) and improve pull-through; ~26% of Q3 prescriptions came from new writers.—
DAYBUE community expansionField-force expansion earlier in 2025Community physicians drove 74% of new prescriptions and referrals hit their highest level since launch, with benefits expected to accelerate through Q4 and into 2026.—
Pipeline cadenceEight disclosed programsInitiated Phase II ACP-204 (LBDP) and Phase III trofinetide (Japan); next up ACP-211 in MDD (Q4 2025) and first-in-human ACP-271 (GPR88 agonist) in Q1 2026; four Phase II/III readouts expected across 2026-2027, led by ACP-204 in Alzheimer's disease psychosis in mid-2026.—

Q&A Summary

Ritu Baral (TD Cowen) asked how the expanded NUPLAZID customer-facing force is organized and whether community or long-term care offers more growth.
Tom Garner said ~26% of Q3 prescription volume came from new writers, giving confidence to pull the expansion into Q1 2026; the company is investing in both channels, with slightly more emphasis on the community while modestly increasing the LTC team, aiming to pull through every NUPLAZID script.
Yigal Nochomovitz (Citigroup) asked what a clinically meaningful SAPS-H&D score would be for ACP-204 and why that scale was chosen.
Elizabeth Thompson said SAPS-H&D was used in the pivotal PDP study and Harmony, is well suited to the domains that matter, and the trial is sized on effect size — a moderate ~0.4 — while the team holistically assesses the target product profile including cognition sparing and avoidance of sedation, falls and motor effects.
Tessa Romero (JPMorgan) asked about the trajectory of DAYBUE new patient starts and when ACP-204 Phase II enrollment finishes.
Tom Garner cited the highest referral rate since launch and expected patient counts to keep growing through Q4 into 2026; Elizabeth Thompson said final enrollment was anticipated around the Q2 timeframe to support a mid-2026 top-line readout.
Sean Lyman (Morgan Stanley) asked how many new prescribers the 30% NUPLAZID investment reaches and its cost.
Tom Garner noted NUPLAZID share remains in the mid-20% range (MBRx) with significant headroom given the large PDP population; Mark Schneyer said it is about 50 customer-facing reps plus home-office support, folded into 2026 SG&A guidance.
Sumant Kulkarni (Canaccord Genuity) asked how a larger player's Parkinson's sales-force expansion might affect PDP diagnosis and the market.
Catherine Owen Adams noted NUPLAZID is the only branded PDP therapy and that broader Parkinson's activity tends to raise disease awareness; Tom Garner estimated ~130,000 diagnosed PDP patients and stressed the call to action to treat hallucinations and delusions earlier.

More on Acadia Pharmaceuticals Inc

Reported 2025-11-05 · figures from the Acadia Pharmaceuticals Inc Q3 2025 earnings call.

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