ACADIA Pharmaceuticals (NasdaqGS:ACAD) FY Conference Transcript

Summary of ACADIA Pharmaceuticals FY Conference Call Company Overview - Company: ACADIA Pharmaceuticals (NasdaqGS:ACAD) - Date of Conference: March 02, 2026 Key Financial Projections - Revenue Guidance for 2028: Projected net sales of $1.7 billion - NUPLAZID: $1 billion - Daybue: $700 million - Growth Rate for NUPLAZID: Expected 12% growth in 2026 and similar in 2027 - Growth Rate for Daybue: Expected 20% growth in the current year [7][13][15] Product Performance and Strategies NUPLAZID - Fourth Quarter Growth: Reported 18% growth in MBRXs (monthly active patients) [13] - Marketing Strategy: Focused on direct consumer campaigns and an expanded field force, increasing targets from 7,000 to 11,000 physicians [13][21] - Field Force Expansion: Increased by 30%, expected to impact growth in the latter half of the year [13][14] Daybue - Current Market Penetration: Approximately 27% in the community setting, expected to rise to the early 30s by year-end [15][198] - New Product Launch: DAYBUE STIX, a new formulation aimed at improving patient adherence and flexibility [15][16] - Expected Incremental Patients: Approximately 400 additional patients expected to be unlocked through the new formulation by 2028 [212] Pipeline Developments Remlifanserin (204) - Phase 2 Data Timeline: Expected between August and October [37] - Study Design: Focused on Alzheimer's disease psychosis with a primary endpoint of SAPS H&D at week 6 [51][52] - Patient Population: Enrolling around 300 patients [53] Clinical Rationale - Biological Rationale: Targeting serotonin signaling disruption in Lewy body dementia and Alzheimer's disease psychosis [182] - Clinical Evidence: Previous studies with pimavanserin support the mechanism for remlifanserin [183][194] Regulatory and Market Challenges - CHMP Negative Opinion: Received a negative trend vote regarding Daybue, citing concerns over the clinical meaningfulness of endpoints [225][226] - Reexamination Process: Plans to apply for reexamination within the next few weeks, with a timeline of about 120 days for review and decision [257][258] Other Pipeline Programs ACP-211 - Differentiation from IV Ketamine: ACP-211 is orally bioavailable and aims to provide a better patient experience with lower dissociation levels [275] - Phase 2 Study Design: Double-blind, randomized, placebo-controlled trial with a primary endpoint of MADRS scale at 4 weeks [288][289] Conclusion - ACADIA Pharmaceuticals is positioning itself for significant growth through its existing products and pipeline developments, while navigating regulatory challenges and expanding its market reach through innovative formulations and strategic marketing efforts.