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]

Summary of Neurocrine's Conference Call Company Overview - **Company**: Neurocrine Biosciences - **CEO**: Kyle Gano, appointed in October 2023 Macro Issues - **Executive Order on Most Favored Nation**: - Uncertainty regarding the impact on Neurocrine due to lack of details on the executive order [3][4][5][6] - Focus on building a resilient business amidst evolving regulations [6][7] - **Tariffs**: - Tariffs are not expected to significantly impact the cost of goods for Neurocrine's products [9][10] - **FDA Interactions**: - No current NDA reviews; recent interactions focused on Phase II discussions for upcoming Phase III programs [11][12] Product Launch: Crinesity (Canestrafont) - **Sales Performance**: - Recognized $14.5 million in sales with over 400 new patient starts in the last quarter [16] - Impressive reimbursement rate of approximately 70% [16][18] - **Launch Strategy**: - The launch is described as "measured" due to the need for physician education and patient awareness [18][20] - Patients must navigate insurance processes, which may delay prescriptions [20][21] - **Patient Demographics**: - Initial patient population is skewed towards pediatrics due to more frequent physician visits [27][32] - Adult women are expected to show more motivation for treatment compared to men [49] - **Direct-to-Consumer Advertising**: - Traditional advertising may be less effective due to the smaller patient population for congenital adrenal hyperplasia (CAH) [34][36] - **Market Potential**: - Crinesity is viewed as a potential blockbuster, with expectations of significant market uptake [38][39] Competitive Landscape - **Differentiation**: - Neurocrine's approach with Crinesity is based on efficacy, safety, and tolerability, which are critical for patient adoption [43][46] - The company aims to treat the majority of patients with CAH before competitors enter the market [45][46] Pipeline Developments - **Upcoming Data Readouts**: - Phase III trials for osavapitur and MBI-568 are anticipated [52] - Studies on valbenazine for dyskinesia associated with cerebral palsy and adjunctive treatment for schizophrenia are ongoing [56][60] - **Muscarinic Agonists**: - Neurocrine is developing multiple muscarinic agonists, focusing on selective activation to improve efficacy and safety [70][72] Financial Outlook - **Investment in Growth**: - The company is prioritizing growth over immediate profitability, with significant investments in sales and marketing for Crinesity and INGREZZA [77][78] - R&D spending is projected to be in the mid-30% range of net revenue due to ongoing Phase III trials [79] Conclusion - Neurocrine is navigating a complex regulatory environment while launching Crinesity, which shows promising early sales. The company is focused on educating physicians and patients, with a strong pipeline and strategic investments aimed at long-term growth and market leadership in the treatment of CAH and other conditions.