Acadia Pharmaceuticals Conference Call Summary Company Overview - **Company**: Acadia Pharmaceuticals (ACAD) - **Event**: BofA Healthcare Conference - **Date**: May 13, 2025 Key Industry Insights - **Most Favored Nation (MFN) Executive Order**: - No immediate impact on Acadia as it currently does not sell products outside the US [3] - Plans to commercialize Debut in Europe, with regulatory approval expected in Q1 2026 [4] - Initial launch in Germany with free pricing for the first six months [4] - **Tariffs**: - Acadia does not foresee meaningful exposure to tariffs due to existing inventory in the US that can last until the mid to late 2030s [7][9] - No manufacturing facilities owned, allowing flexibility in response to future tariff changes [8] - **FDA Interactions**: - No immediate negative impacts reported; routine interactions with the FDA are proceeding as expected [17][18] Company-Specific Developments - **Debut Launch**: - Initial strong demand followed by stagnation; new Chief Commercial Officer hired to enhance commercial execution [21][22] - Field force increased by 30% to improve outreach to physicians, particularly in local pediatric neurology centers [23] - Focus on efficacy messaging and one-to-one patient interactions to improve patient retention [24][25] - New patient starts have shown a significant increase in Q1 2025, with expectations for continued growth [26][36] - **NUPLAZID**: - Awareness campaigns have led to the best quarter in five years for new patient starts [49] - Focus on educating patients and families about Parkinson's disease psychosis, with a strong emphasis on early diagnosis [50][52] - Steady growth expected as awareness increases, with a larger patient population compared to Debut [55] Pipeline Updates - **ACP-101**: - Phase 3 trial expected to complete enrollment in Q2 2025, with top-line data anticipated in early Q4 2025 [58][60] - Primary endpoint focuses on the hyperphagia questionnaire, with a safety profile similar to previous trials [61][62] - **ECP-204**: - New inverse agonist targeting 5-HT2A receptors, currently in phase 2/3 trials for Alzheimer's disease psychosis [73] - Aiming for faster onset of action and reduced QT prolongation compared to NUPLAZID [74] Additional Considerations - **Market Dynamics**: - The rare disease market is seen as having room for multiple therapies, with Acadia's products positioned to meet diverse patient needs [66][70] - The company is focused on leveraging its expertise in rare diseases and neurology for successful product launches [71] - **Future Events**: - R&D Day scheduled for June 25, 2025, to provide further updates on pipeline developments [79]