ACADIA Pharmaceuticals(ACAD) - 2024 Q3 - Earnings Call Transcript

Financial Data and Key Metrics - Total net sales for Q3 2024 were $250.4 million, up 18$91.2 million in Q3, up 36% YoY and 8% sequentially [49] - NUPLAZID net product sales were $159.2 million in Q3, up 10$66.6 million in Q3 2024 from 157 million in Q3 2023 [51] - SG&A expenses increased to 133.3 million in Q3 2024 from $97.9 million in Q3 2023 [52] - Cash balance at the end of Q3 was$565.3 million, up $64.4 million from the prior quarter [52] Business Line Performance - DAYBUE sales were driven by continued penetration of the prevalent population and increased demand among continuing patients, with 923 patients receiving paid shipments in Q3 [21][22] - NUPLAZID achieved its highest-ever quarterly sales of$159.2 million, driven by increased active patients across all market segments [33] - DAYBUE has over 60% of active patients on treatment for 10 months or more, with persistency rates at 50% or higher beyond 12 months [23] - NUPLAZID's growth was supported by real-world evidence studies and label clarification, leading to higher demand and market share [34] Market Performance - DAYBUE has expanded its prescriber base to approximately 800 unique prescribers, with increasing penetration outside of RETT centers of excellence [24][25] - NUPLAZID benefited from a stable Parkinson's disease psychosis market and the launch of direct-to-consumer campaigns, which are expected to drive growth in 2025 [35][37] - DAYBUE received approval in Canada and is targeting a marketing authorization application submission in the EU in Q1 2025 [39][40] Company Strategy and Industry Competition - The company is focused on growing its commercial franchises (DAYBUE and NUPLAZID) and advancing its pipeline, including late-stage assets for Prader-Willi Syndrome and Alzheimer's disease psychosis [9][10] - Acadia is actively pursuing business development opportunities to expand its pipeline and set its growth trajectory for the future [20] - The company is leveraging real-world evidence and caregiver-reported benefits to drive adoption of DAYBUE and NUPLAZID [26][27] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong foundation of the business and the potential for future growth in both DAYBUE and NUPLAZID [57] - The company expects to see growth in both franchises in 2025, with DAYBUE sales guidance narrowed to $340-$350 million and NUPLAZID sales guidance narrowed to $600-$610 million [54] - The company is confident in its growth outlook based on the current rate of new patient starts and a growing base of enduring patients [32] Other Important Information - The company sold its rare pediatric disease priority review voucher for $150 million, with$50 million to be paid to Neuren as part of a licensing agreement [53] - Acadia is preparing for the European launch of DAYBUE, with plans to build out its team and expertise in Europe [39][94] Q&A Session Summary Question: Business Development and Early-Stage Pipeline - The company is focused on business development to complement its strong neuropsychiatry and rare disease franchises, with a strong financial position to support future deals [62][64] Question: DAYBUE Patient Dynamics and Holiday Season Impact - The company has a better understanding of the reverification process and a more mature patient base heading into 2025, which provides a dependable base for Q1 demand [66][67] Question: NUPLAZID Patient Profile and Label Change Impact - The mix of prescribers and patient age has remained consistent post-campaign launch, with no substantial change in patient demographics [71][72] Question: DAYBUE Sales and Patient Persistency - Over 60% of DAYBUE patients are on treatment for 10 months or more, with persistency rates flattening beyond 10 months, indicating a strong enduring patient base [76] - Discontinuations are primarily due to tolerability issues (diarrhea or vomiting) rather than lack of treatment effect [77] Question: DAYBUE Launch Strategy and Growth Focus - The company is focusing on enhancing efficacy messaging, managing the patient journey, and driving growth outside of centers of excellence to recharge DAYBUE growth [79][80][81] Question: DAYBUE Prescriber Dynamics - The company is focused on driving depth of prescribing among HCPs who have prescribed DAYBUE to one or two patients, with additional patients under their care [86][87] Question: DAYBUE International Expansion - The company is preparing for the Canadian launch of DAYBUE, with limited coverage expected in 2025 through private payers, and is targeting EU and Japan for future expansion [90][94] Question: European Rare Disease Launch Strategy - The company plans to launch DAYBUE in Europe post-registrational approval, with a focus on national HTA negotiations and leveraging its experience in managing rare disease launches [97][98] Question: ACP-204 Master Protocol and Data Release - The company plans to release Phase 2 data for ACP-204 at an appropriate time, with the potential to use the data to modify Phase 3 studies [102][113] Question: CEO's Vision for Acadia - The new CEO is focused on growing the commercial base, advancing the pipeline, and leveraging the company's strong financial position for future growth [114][115] Question: DAYBUE Growth Bottlenecks - The company is focused on educating physicians and caregivers about DAYBUE's real-world efficacy and clinical benefits to drive further adoption [119][120] Question: DAYBUE Patient Restarts - The company is working on strategies to address tolerability challenges and encourage restarts among patients who discontinued treatment, with restarts currently representing less than 10% of the patient base [125][126]