ACADIA Pharmaceuticals (ACAD) Stifel 2025 Virtual CNS Forum summary

Commercial performance and strategy

• Two commercialized neuroscience products are expected to generate over $1 billion in 2024, with Daybue for Rett syndrome and Nuplazid for Parkinson's disease psychosis leading the portfolio.

• Daybue's initial launch saw strong uptake in Centers of Excellence, but growth plateaued as outreach expanded to community physicians; 65% of Rett patients are treated outside these centers.

• Expansion of the field force and customer-facing teams aims to reach more community physicians, with anticipated growth in Daybue prescriptions expected in the latter half of 2024.

• Persistence rates for Daybue remain high, with over 50% of patients on therapy at 12 months and 62% on for more than a year, indicating a stable and growing patient base.

• Nuplazid's growth has been reinvigorated through renewed direct-to-consumer campaigns, increased awareness, and real-world evidence, achieving a 25% market share.

International expansion and pricing

• Approval for Daybue has been secured in Canada, with reimbursement discussions ongoing; European launch preparations are underway, focusing on major markets like Germany, France, Spain, and Italy.

• European pricing is expected to be lower than in the US, with price erosion anticipated over time, but strong demand supports a positive outlook.

• A named patient program is being opened to meet international demand for Daybue.

Pipeline and R&D updates

• Late-stage pipeline includes ACP-204 for Alzheimer's disease psychosis and Lewy body dementia, and ACP-101 (intranasal carbetocin) for Prader-Willi syndrome, both in phase 2/3 trials.

• ACP-204 is designed to improve on Nuplazid by reducing QT prolongation, achieving higher exposures, and faster steady state; trial design incorporates learnings from previous studies to maximize efficacy.

• ACP-101 is being tested at a lower dose after prior phase 3 data suggested efficacy at this level, with the new trial designed to address previous shortcomings.