Financial Data and Key Metrics Changes - Neurocrine Biosciences reported $790 million in net product sales for Q3 2025, reflecting a 28% year-over-year growth driven by INGREZZA and CRENESSITY [6][10] - CRENESSITY's sales grew from $53 million in Q2 to $98 million in Q3, indicating strong early adoption and persistency rates [6][7] - INGREZZA achieved net sales of $687 million in Q3, marking the third consecutive quarter of record new patient additions [7][10] Business Line Data and Key Metrics Changes - INGREZZA's performance has been exceptional, with a prescriber base that has expanded by 30% over the past two years, reflecting the strong clinical profile and unmet need for tardive dyskinesia treatment [10][11] - CRENESSITY has seen 540 new patients initiate therapy in Q3, bringing the total to over 1,600 since its launch [13][15] - The company anticipates continued growth for both products, with plans for further sales force expansion to maximize patient share [8][16] Market Data and Key Metrics Changes - The tardive dyskinesia market is expected to grow significantly, with only about 10% of diagnosed patients currently treated with a VMAT2 inhibitor, indicating substantial growth potential for INGREZZA [10][11] - The congenital adrenal hyperplasia (CAH) community has shown favorable feedback towards CRENESSITY, with 80% of dispensed prescriptions now being reimbursed [6][15] Company Strategy and Development Direction - Neurocrine Biosciences is focused on expanding its sales force for both INGREZZA and CRENESSITY to accelerate growth into 2026 and beyond [4][8] - The company aims to drive revenue growth, advance R&D programs, enable business development, and return capital to shareholders, with a strong financial profile of over $2.1 billion in cash [9][80] - The strategic expansion of the sales force is intended to maximize patient share and prepare for anticipated launches of investigational psychiatric medicines [8][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum for both products and the potential for sustained long-term growth driven by their science and commitment to patients [5][9] - The company remains on track for its clinical programs, with anticipated top-line results for key studies in the near future [18][19] - Management acknowledged the potential impacts of the Inflation Reduction Act (IRA) on the market and emphasized the importance of maximizing patient share before 2027 [8][30] Other Important Information - The company is fully cooperating with a Department of Justice investigation related to the sales and marketing of INGREZZA, maintaining a robust compliance program [40][41] - The sales force expansion is expected to result in an increase in SG&A expenses of around $150 million in 2026 [9][79] Q&A Session Summary Question: Insights on patient dynamics and starts for CRENESSITY - Management noted that the adoption of CRENESSITY has been strong, with 540 new treatment forms in Q3, and they do not believe there are significant seasonal dynamics affecting enrollment [22][23] Question: Implications of the IRA on pricing and reimbursement - Management is monitoring the upcoming Oscado pricing and its potential effects on INGREZZA, emphasizing the importance of maximizing patient numbers before the IRA impacts [28][30] Question: Status of reimbursement requirements for CRENESSITY - Management indicated that reimbursement has been smooth, with no specific requirements for steroid tapering to continue coverage [34] Question: Sales force expansion details - The expansion is characterized as a 30% increase in overall sales footprint, primarily targeting psychiatry and neurology for INGREZZA, while also expanding the team for CRENESSITY [46][48] Question: Update on the Department of Justice investigation - Management confirmed they are cooperating with the DOJ regarding a civil investigative demand related to INGREZZA's sales and marketing practices [40][41] Question: Progress with CRENESSITY at centers of excellence - All centers of excellence have started adopting CRENESSITY, with varying rates of adoption, and there is optimism about community endocrinologists' engagement [43][44]
Neurocrine(NBIX) - 2025 Q3 - Earnings Call Transcript