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    ACAD
    Earnings call· Dec 2025(Q4 FY25)

    ACADIA PHARMACEUTICALS Q4 FY25 earnings call ACAD

    Feb 25, 2026 Source

    Executive summary

    ACADIA Q4 FY25 — Strong Commercial Performance and Pipeline Progress

    ACADIA Pharmaceuticals closed FY25 with strong commercial execution for both NUPLAZID and DAYBUE, exceeding $1 billion in annual adjusted revenues for the first time. The company is making foundational SG&A investments to support continued growth towards 2028 targets, while navigating higher-than-anticipated IRA rebates and a negative EU regulatory trend vote for DAYBUE. The R&D pipeline is advancing, with a key Phase II readout for remlifanserin expected later in 2026.

    Highlights

    5

    • Achieved adjusted total revenues of $298 million in Q4 FY25, up 16% from the prior year, with annual revenues exceeding $1.08 billion for FY25.

    • NUPLAZID delivered adjusted net sales of $189 million in Q4 FY25, growing 17% year-over-year, driven by 13% volume growth and 18% increase in new prescriptions.

    • DAYBUE net sales reached $110 million in Q4 FY25, up 13% year-over-year, with 1,070 patients receiving shipments globally and 76% of new prescriptions from community physicians.

    • Launched DAYBUE STIX, a new powder formulation, approved by the FDA in December, expected to unlock over 400 incremental patients over the next 2-3 years.

    • Advanced a robust R&D pipeline with a key Phase II readout for remlifanserin in Alzheimer's disease psychosis expected August-October 2026, targeting a $4 billion peak sales potential.

    Concerns

    3

    • Received higher than anticipated Inflation Reduction Act (IRA) invoices from CMS for NUPLAZID, resulting in a nonrecurring $20 million reduction in net sales due to an accounting change in estimate.

    • Received a negative trend vote from the CHMP for the trofinetide marketing application in the EU, with a negative final opinion anticipated, leading to a reexamination process.

    • 2026 DAYBUE guidance of $460 million to $490 million does not include potential EU commercial sales due to the uncertain regulatory status.

    Guidance & targets

    12
    CategoryTargetConfidence
    NUPLAZID Net Sales
    $760 million to $790 million
    high materiality
    High
    NUPLAZID Net Sales (Midpoint)
    $775 million
    high materiality
    High
    NUPLAZID Net Sales
    $1 billion
    high materiality
    High
    DAYBUE Global Net Sales
    $460 million to $490 million
    high materiality
    High
    DAYBUE Global Net Sales
    $700 million
    high materiality
    High
    Total Revenues
    $1.22 billion to $1.28 billion
    high materiality
    High
    NUPLAZID Gross to Net
    22% to 24%
    medium materiality
    High
    DAYBUE Gross to Net
    22% to 24%
    medium materiality
    High
    R&D Expense
    $385 million to $410 million
    medium materiality
    High
    SG&A Expense
    $660 million to $700 million
    medium materiality
    High
    Operating Margin (no attrition)
    mid-teens
    medium materiality
    Medium
    Operating Margin (normal attrition)
    low 20%
    medium materiality
    Medium

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    NUPLAZID
    Adjusted net sales. Growth was broad-based across all channels, reflecting continued traction and effectiveness of commercial strategy.
    Volume Growth Q4: 13%Volume Growth FY25: 9%New Prescriptions Growth Q4 YoY: 18%New Prescribers FY25: 40% new to brand
    		$189M17%——
    DAYBUE
    Net sales. Driven by strong U.S. performance and growing contributions from rest of world programs. Core business fundamentals remain strong with low discontinuation rates.
    Volume Growth Q4: 12%Patients Receiving Shipments Q4: 1,070 globallyNew Prescriptions from Community Physicians Q4: 76%
    		$110M13%——

    Operational metrics

    28
    Adjusted Total Revenues
    $298 millionup 16% YoY
    Q4 FY25

    Achieved adjusted total revenues.

    Adjusted Total Revenues
    $1.08 billionup 14% YoY
    FY25

    First time annual revenues exceeded $1 billion.

    NUPLAZID Gross to Net
    29.4%
    Q4 FY25

    Reported basis.

    NUPLAZID Gross to Net (Adjusted)
    23.6%
    Q4 FY25

    Adjusted basis, accounting for IRA impact.

    NUPLAZID Gross to Net
    25.9%
    FY25

    Reported basis.

    NUPLAZID Gross to Net (Adjusted)
    24.6%
    FY25

    Adjusted basis, accounting for IRA impact.

    DAYBUE Gross to Net
    19.5%
    Q4 FY25
    DAYBUE Gross to Net
    22.3%
    FY25
    R&D Expenses
    $85 milliondown from $101 million in Q4 2024
    Q4 FY25

    Decrease primarily due to $28 million upfront payment for ACP-711 in Q4 2024.

    SG&A Expenses
    $156 millionup from $130 million in Q4 2024
    Q4 FY25

    Primarily driven by increased marketing investments for NUPLAZID and DAYBUE field expansion and marketing.

    Cash Balance
    $820 million
    End of FY25
    Noncash Income Tax Benefit
    $250 million
    Q4 FY25

    Resulting from the release of valuation allowance on deferred tax assets.

    IRA Rebate Payment
    $108 million
    First 2 years of program

    Payment for first 2 years of the program, paid in Q4 FY25.

    IRA Net Cash Flow Impact
    ~$30 million
    FY25

    Net cash flow over the year, factoring in payment and additional accruals.

    NUPLAZID Field Team Expansion
    30%
    FY25

    Expansion completed, representatives fully deployed in the field.

    NUPLAZID Field Team Ramp-up
    6-9 months
    Starting Q1 FY26

    Expected ramp before full impact of investment is reflected in results.

    NUPLAZID Target Prescriber Universe
    11,000increased from 7,000
    Ongoing

    Expanded to meet needs of broader prescriber base.

    DAYBUE STIX Incremental Patient Opportunity
    >400
    Next 2-3 years

    Includes treatment-naive and those who previously discontinued due to formulation concerns.

    R&D Pipeline Peak Sales Potential
    $11 billion
    Long-term

    Combined full peak sales potential across 4 unique molecules targeting large addressable markets.

    Remlifanserin Peak Sales Potential
    ~$4 billion
    Long-term

    Specifically attributable to remlifanserin across Alzheimer's disease psychosis and Lewy body dementia psychosis indications.

    DAYBUE EU Sales Contribution to 2028 Target
    <15%
    FY28

    Represents less than 15% of the projected $700 million in 2028 global sales.

    EU Reexamination Success Rate
    20-30%
    Last 5 years

    Precedent for reexaminations turning a negative opinion into a positive one.

    NUPLAZID Discontinuation Rate
    low single-digit rangestabilized
    Ongoing

    Consistent with previous quarters.

    DAYBUE Discontinuation Rate
    low single-digit rangestabilized
    Ongoing

    Consistent with previous quarters.

    DAYBUE Consumption Rate
    high 60%
    FY25

    Remains as shared before.

    Company Revenue CAGR
    ~16%
    2026-2028

    Overall company compound annual growth rate.

    NUPLAZID Revenue Growth Rate
    low to mid-teens
    2026-2028

    Expected growth rate to reach $1 billion by 2028.

    DAYBUE Revenue Growth Rate
    low 20%
    2026-2028

    Expected growth rate to reach $700 million by 2028.

    Industry KPIs

    8
    MetricValueDetails
    Launch access metrics>400patients
    Pipeline read out calendarremlifanserin ADP Phase II: August-October 2026; trofinetide Japan Phase III results: Q4 2026 - Q1 2027
    Product franchise net salesNUPLAZID: $189M (adjusted Q4), $692M (adjusted FY25); DAYBUE: $110M (Q4), $391M (FY25)USD
    Regulatory approvals filingsDAYBUE STIX FDA approval; DAYBUE liquid Israel approval; trofinetide EU CHMP negative trend vote
    Peak long term sales guidanceNUPLAZID: $1B; DAYBUE: $700M; Remlifanserin: ~$4BUSD
    Prescription volume new startsNUPLAZID new prescriptions: +18%; DAYBUE new prescriptions from community: 76%%
    Clinical trial efficacy safety data0.4 effect size
    Cumulative patients uptake since launch1,070patients

    Product announcements

    2
    ProductTypeDetails
    DAYBUE STIXlaunch
    DAYBUE liquidexpansion

    Risks & headwinds

    3
    Higher-than-anticipated Inflation Reduction Act (IRA) invoices from CMS for NUPLAZIDQ4 FY25 (impact), first 2 years of program (payment)

    Nonrecurring $20 million reduction in net sales due to accounting change in estimate. $108 million payment for first 2 years of program.

    Mitigation: Adjusted net sales methodology apportions the change in estimate to applicable years. Company will continue to monitor Medicare volume mix.

    Negative trend vote from CHMP for trofinetide marketing application in EUFinal opinion expected this week; reexamination process approximately 120 days, new final opinion around end of Q2.

    Anticipated negative final opinion from CHMP. EU sales represent less than 15% of DAYBUE's projected $700 million 2028 sales.

    Mitigation: Company plans to request a reexamination. Named patient supply programs remain active in the EU. EU sales are a small portion of long-term DAYBUE sales target.

    Potential for placebo effect in clinical trialsOngoing for clinical trials

    null

    Mitigation: Good training of investigators, looking for outliers, commitment to good clinical practice.

    What to watch in Q1 FY26

    4

    DAYBUE STIX Commercial Launch Progress

    Early Q2 2026
    CurrentEarly response very encouraging, initial product in channel, first patients receiving shipments.
    TargetBroader commercial launch in early Q2, continued positive patient mix and uptake.

    Why it matters

    Successful launch of DAYBUE STIX is a key driver for DAYBUE's 2026 growth and unlocking incremental patient opportunity.

    Early patient mix is tracking in line with our expectations, and we remain on track for a broader commercial launch in early Q2 as we ensure appropriate inventory levels and a smooth transition for patients.

    Q&A highlights

    5

    How should investors think about the ramp from 2026 guidance to the 2028 targets for both brands, and what gives management confidence?

    Catherine explained that NUPLAZID's midpoint 2026 guidance implies low to mid-teens growth to reach $1 billion by 2028, while DAYBUE's midpoint implies low 20% growth to reach $700 million by 2028. Tom added that NUPLAZID's Q4 acceleration and expanded field force (30% increase, 6-9 month ramp) support continued demand, targeting 11,000 prescribers. DAYBUE STIX is expected to unlock additional growth, with early positive feedback.

    “So if we take NUPLAZID and we look at our midpoint guidance for '26 at $775 million, that's about 12% above this year's growth on the adjusted basis. And so would indicate we're expecting low to mid-teens growth out to the $1 billion.”

    asked by Tessa Romero · answered by Catherine Owen Adams

    2 min read5 chapters

    Detailed Narrative

    01

    Commercial Momentum and Strategic Investments

    ACADIA reported strong Q4 and FY25 results, with adjusted total revenues exceeding $1 billion for the first time. Both NUPLAZID and DAYBUE demonstrated robust growth, driven by commercial execution and strategic investments. The company expanded its customer-facing teams by 30% for NUPLAZID and made significant marketing investments for both brands, expecting a 6-9 month ramp for the full impact of these investments. This expansion aims to capitalize on underlying demand and penetrate the market further.

    02

    DAYBUE STIX Launch and Global Expansion

    The FDA approval and early launch of DAYBUE STIX, a new powder formulation, is generating significant interest and is expected to unlock an incremental opportunity of over 400 patients over the next 2-3 years. This new formulation offers flexibility and portability, addressing caregiver feedback. Globally, DAYBUE liquid is now approved in three markets, including Israel, and named patient supply programs continue to expand access outside the U.S., contributing to continued growth.

    03

    R&D Pipeline Progress and Key Catalysts

    ACADIA's R&D pipeline is advancing with multiple programs, targeting large addressable markets with a combined peak sales potential of $11 billion. Key upcoming milestones include the Phase II readout of remlifanserin in Alzheimer's disease psychosis (ADP) between August and October 2026, and the initiation of a first-in-human study for ACP-271. The company anticipates initiating 5 additional Phase II or Phase III studies and delivering 4 readouts by the end of 2027, highlighting the breadth and depth of its development portfolio.

    04

    Regulatory Headwinds for DAYBUE in EU

    The company received a negative trend vote from the CHMP for its trofinetide marketing application in the EU and anticipates a negative final opinion. ACADIA plans to request a reexamination, a process expected to take approximately 120 days, with a new final CHMP opinion around the end of Q2. Despite this, named patient supply programs in the EU remain active, ensuring patients maintain access to treatment during the regulatory process.

    05

    Financial Performance and IRA Impact

    ACADIA reported adjusted total revenues of $298 million in Q4, up 16% YoY, and $1.08 billion for FY25, up 14% YoY. The company recorded a nonrecurring $20 million reduction in NUPLAZID net sales due to higher-than-anticipated Inflation Reduction Act (IRA) invoices from CMS, requiring an accounting change in estimate. A one-time📎 noncash income tax benefit of $250 million was recognized in Q4, strengthening the balance sheet.

    AI-generated summary of the company’s earnings call. Not investment advice.