ACADIA Pharmaceuticals (ACAD) investor relations material

Remlifanserin development and clinical strategy

• Remlifanserin eliminates QTc prolongation seen with pimavanserin, allowing higher dosing and potentially better efficacy in Alzheimer's disease psychosis (ADP).

• The program targets more severe psychosis, uses sensitive endpoints (SAPS-H+D), and leverages biomarker-confirmed AD diagnosis to reduce placebo response.

• The trial is powered at 80% for a moderate effect size (Cohen's d = 0.4), with strategies to maintain effect size from phase II to phase III by enriching patient selection and endpoint sensitivity.

• Lessons from prior programs and competitor trials are being considered, but direct cross-study comparisons are limited by differences in design and patient populations.

• Remlifanserin's shorter half-life allows for faster steady-state and potentially earlier efficacy.

Commercial performance and product expansion

• Sales force for NUPLAZID expanded by 30% in Q1, increasing reach to 10,000 customers, with 45% being neurologists.

• 25% of Q1 writers were new to brand, indicating successful outreach, though full impact is expected later in the year due to ramp-up time.

• Q1 script refill delays attributed to Medicare re-verification, not ongoing issues.

DAYBUE market penetration and formulation updates

• Expansion beyond Centers of Excellence targets the under-penetrated community segment, with persistence rates at 12 and 18 months now above 50%.

• DAYBUE STIX, a new powder formulation, launched in Q1, has seen strong uptake among naive, returning, and switch patients, with positive feedback on portability and reduced excipients.

• Direct consumer outreach and Family Support Educators have helped reengage patients who discontinued due to formulation concerns.

• IP for DAYBUE covers both liquid and STIX formulations under trofinetide use in Rett syndrome.