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    ACAD
    Earnings call· Jun 2026(Q2 FY26)

    ACADIA PHARMACEUTICALS Q2 FY26 earnings call ACAD

    Aug 4, 2026 Source

    Executive summary

    ACADIA Q2 FY26 — Strong DAYBUE and NUPLAZID Performance, Remlifanserin ADP Readout Expected

    ACADIA delivered a strong second quarter, driven by robust commercial execution for both DAYBUE and NUPLAZID, leading to an upward revision of DAYBUE's full-year guidance. The company is advancing its pipeline, with the highly anticipated Phase II readout for remlifanserin in Alzheimer's disease psychosis expected in September to October, and preparations underway for DAYBUE's European launch.

    Highlights

    5

    • Total revenues reached $308 million, representing 17% year-over-year growth on an adjusted basis.

    • DAYBUE net sales were $125 million, up 30% year-over-year, driven by strong uptake of DAYBUE STIX.

    • DAYBUE full-year 2026 net sales guidance raised to $480 million to $510 million.

    • NUPLAZID net sales were $183 million, up 10% year-over-year on an adjusted basis, with new patient prescriptions increasing 20% year-over-year.

    • Received positive CHMP opinion for DAYBUE in Europe, enabling planned launch in Germany in early Q4.

    Concerns

    1

    • R&D expense guidance lowered to $355 million to $380 million from $385 million to $410 million, primarily due to a BD milestone shift to 2027 and portfolio prioritization.

    Guidance & targets

    16
    CategoryTargetConfidence
    Total revenues
    $1.24 billion to $1.3 billion
    high materiality
    High
    DAYBUE net sales
    $480 million to $510 million
    high materiality
    High
    NUPLAZID net sales
    $760 million to $790 million
    high materiality
    High
    R&D expenses
    $355 million to $380 million
    medium materiality
    High
    DAYBUE gross to net adjustment
    23% to 25%
    low materiality
    High
    DAYBUE sales
    $700 million
    high materiality
    High
    NUPLAZID net sales
    approximately $1 billion
    high materiality
    High
    Remlifanserin peak sales potential
    estimated $4 billion
    high materiality
    Medium
    Remlifanserin Phase II ADP top-line results
    September to October
    high materiality
    High
    Trofinetide Japan Phase III readout
    between September and November
    medium materiality
    High
    Trofinetide Japan regulatory submission
    2027
    medium materiality
    High
    DAYBUE EU commercial sales
    initial EU commercial sales in Q4
    medium materiality
    High
    DAYBUE Germany launch
    early Q4
    medium materiality
    High
    DAYBUE EU pricing and market access submissions
    this year
    low materiality
    High
    Additional Phase II or Phase III studies initiated
    3
    medium materiality
    High
    Phase II or Phase III readouts
    4
    medium materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    DAYBUE
    Strong performance driven by volume growth and significant uptake of the newly launched DAYBUE STIX formulation in the U.S. Positive CHMP opinion received in Europe, with Germany launch expected in early Q4.
    Volume growth: 27%DAYBUE STIX patients: 40% of all U.S. DAYBUE patientsSTIX referrals (June): 60% of all referralsSTIX existing patient switch: 55%STIX new or returning patients: 45%Naive patient referrals: 60%Returning patient referrals: 40%Gross to net adjustment: 24.4%
    		$125 million30%——
    NUPLAZID
    Continued strong performance driven by volume growth and increased new patient prescriptions. Expanded field force and direct-to-consumer investments are contributing to momentum.
    Volume growth: 8%New patient prescriptions increase: 20% year-over-yearPriority healthcare providers reached by expanded field force: over 12,000 since FebruaryGross to net adjustment: 23.9%
    		$183 million10% (adjusted basis)——

    Operational metrics

    7
    Total revenues (adjusted basis)
    $308 million17% year-over-year growth
    Q2 FY26

    Total revenues for the second quarter on an adjusted basis.

    Research and development expenses
    $82 millionvs $78 million a year ago
    Q2 FY26

    R&D expenses for the quarter, reflecting investments in pipeline advancement.

    Selling, General and Administrative expenses
    $160 millionvs $134 million a year ago
    Q2 FY26

    SG&A expenses for the quarter, reflecting investments in expanding field forces and marketing for both brands.

    Cash position
    $956 million
    Q2 FY26 end

    Cash balance at the end of the quarter, providing financial flexibility.

    Remlifanserin Phase II ADP enrollment
    363
    Phase II

    Number of patients enrolled in the Phase II portion of the remlifanserin ADP program.

    DAYBUE Europe sales contribution to 2028 target
    <15%
    FY28

    Estimated contribution of European sales to the $700 million DAYBUE sales target for 2028.

    Remlifanserin peak sales split
    60% ADP / 40% Lewy body
    Peak sales

    Directional split of the estimated $4 billion peak sales potential for remlifanserin between Alzheimer's disease psychosis and Lewy body dementia psychosis.

    Industry KPIs

    3
    MetricValueDetails
    Peak long term sales guidance$4 billionUSD
    Prescription volume new starts20%%
    Clinical trial efficacy safety data0.4effect size

    Deals & partnerships

    1
    nullCommercialization partnership for trofinetide in Japan

    The company plans to select a commercialization partner for the Japanese market after the Phase III readout and before regulatory submission in 2027.

    Risks & headwinds

    3
    R&D expense reduction due to BD milestone shift and portfolio prioritizationFY26

    R&D guidance lowered by $30 million to $35 million (from $385M-$410M to $355M-$380M)

    Mitigation: Shifted BD milestone to 2027; selected portfolio prioritization decisions.

    Potential impact of gene therapies on Rett syndrome marketShort or long term

    No impact to commercial forecast

    Mitigation: DAYBUE is expected to remain the standard of care, usable pre or post gene therapy, offering flexibility and reversibility. DAYBUE STIX further strengthens this position.

    NUPLAZID Q1 2026 refill rate phenomenonQ1 FY26

    One-off event

    Mitigation: Refill and restart rates are back to expected levels in Q2 2026, showing a good rebound versus prior year.

    What to watch in Q3 FY26

    5

    Remlifanserin Phase II ADP top-line results

    September to October
    CurrentEnrollment complete
    TargetTop-line data release

    Why it matters

    This is the most important near-term pipeline catalyst and will determine the future development path for remlifanserin in Alzheimer's disease psychosis.

    We now expect to report top line results from this study in September to October of this year.

    Q&A highlights

    6

    What effect size on SAPS-H+D is considered Phase III enabling, and what other factors are being considered for success?

    The Phase II study is 80% powered for a 0.4 effect size on SAPS-H+D, which is considered a moderate effect. While there's some flexibility, a lower level might raise concerns about replication. Beyond SAPS-H+D, the company will look at responder analyses, safety profile (avoiding negative cognitive/motor impact), and overall meaningfulness for patients, including ease of use.

    “There is a lower level beyond which you start worrying about whether you'd be able to replicate the effect. But I think we've got a ways there.”

    asked by Tess Romero (JPMorgan) · answered by Elizabeth Thompson

    2 min read5 chapters

    Detailed Narrative

    01

    DAYBUE Commercial Performance and European Expansion

    DAYBUE delivered strong Q2 net sales of $125 million, a 30% year-over-year increase, primarily driven by volume and the successful launch of DAYBUE STIX. Approximately 40% of all U.S. DAYBUE patients were receiving STIX by quarter-end, with 60% of June referrals for the STIX formulation. The company received a positive CHMP opinion for trofinetide in Europe, paving the way for an expected European Commission decision in Q3 and a planned launch in Germany in early Q4, with other European market access submissions ongoing.

    02

    NUPLAZID Continued Momentum

    NUPLAZID achieved $183 million in net sales, growing 10% year-over-year on an adjusted basis, driven by 8% volume growth. New patient prescriptions increased 20% year-over-year, reaching the highest quarterly volume since Q1 2018. The expanded field force has reached over 12,000 priority healthcare providers since February, and direct-to-consumer campaigns are driving awareness and patient conversion, reinforcing sustainable growth.

    03

    Remlifanserin in Alzheimer's Disease Psychosis (ADP)

    Enrollment for the Phase II portion of the remlifanserin ADP program is complete, with top-line results expected in September to October. The program received Fast Track designation from the FDA, highlighting the significant unmet need. Phase III studies have commenced screening and enrollment, designed to be operationally seamless with the Phase II, allowing for potential modifications based on Phase II data. The study is powered for a 0.4 effect size on SAPS-H+D, aiming for a meaningful clinical impact.

    04

    Broader Pipeline Progress

    Beyond remlifanserin, ACADIA's pipeline includes a Phase III study of trofinetide in Japan, with a readout expected between September and November and a regulatory submission planned for 2027. A Phase II study for remlifanserin in Lewy body dementia psychosis is underway, alongside Phase II for ACP-211 in major depressive disorder and Phase I programs for ACP-711 and ACP-271. The company anticipates initiating 3 additional Phase II/III studies and reporting 4 Phase II/III readouts by the end of 2027.

    05

    Financial Position and Capital Allocation

    ACADIA ended the quarter with a strong cash position of $956 million, providing financial flexibility for commercial plans, pipeline advancement, and business development. The company lowered its full-year R&D expense guidance to $355 million to $380 million, primarily due to a BD milestone shift to 2027 and portfolio prioritization decisions, while other guidance ranges remain unchanged.

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