Neurocrine(NBIX)2025-02-07 03:52Financial Data and Key Metrics Changes - Neurocrine reported record sales growth for INGREZZA in 2024, increasing annual sales by approximately 2.5 billion and 250 million at the midpoint [14][24] - The company anticipates a slower growth trajectory for INGREZZA due to increased competitive pressure and utilization management by payers [14][24] Business Line Data and Key Metrics Changes - INGREZZA continues to show strong performance with expectations of double-digit year-over-year growth, although moderated compared to 2024 [7][14] - Quinicity, the newly launched treatment for congenital adrenal hyperplasia, is expected to have measured early revenues due to factors such as delayed reimbursement and patient flow [16][27] - The sales organization has been expanded to better address the needs of the approximately 90% of untreated tardive dyskinesia patients in the US [9][24] Market Data and Key Metrics Changes - The market for tardive dyskinesia is estimated to have around 800,000 patients in the US, with less than 10% currently treated with VMAT2 inhibitors, indicating substantial growth potential [22][24] - The competitive landscape is evolving, with increased utilization management impacting access to INGREZZA [80][82] Company Strategy and Development Direction - Neurocrine aims to diversify its revenue profile with Quinicity and anticipates it could become a second blockbuster therapy [10][21] - The company plans to enhance its R&D productivity, expecting to launch a new commercial product every two years at steady state [11] - The focus will be on expanding into new therapeutic areas and advancing biologics, with a robust neuroscience pipeline expected to grow from 12 to 18 programs by year-end [11][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of INGREZZA despite current headwinds, emphasizing the unmet medical need in the tardive dyskinesia market [14][56] - The early feedback from the CAH community regarding Quinicity has been positive, with expectations for broad reimbursement in the future [75] - Management acknowledged the challenges of launching a new treatment but remains optimistic about Quinicity's potential to transform care for CAH patients [10][28] Other Important Information - The company is investing in both revenue growth and R&D programs, with a significant focus on the launch of Quinicity and the expanded INGREZZA sales force [18][19] - The anticipated increase in operating expenses for 2025 aligns with the investment behind the Quinicity launch and sales force expansion [18][19] Q&A Session Summary Question: Expectations for Quinicity launch revenue trajectory - Management indicated that early launch dynamics for Quinicity are promising, with 11 new patient start forms received shortly after approval, but refrained from providing specific ramp expectations [41][44] Question: Clarification on INGREZZA guidance and market dynamics - Management reiterated that the guidance reflects continued growth despite external factors like payer dynamics and competitive pressures, emphasizing proactive steps to address these challenges [49][52] Question: Insights on payer traction and free drug program for Quinicity - The company has implemented a fast start program to provide free product to patients while reimbursement is secured, with expectations that most patients will require this for one to two months [73][75] Question: Utilization management impact on INGREZZA - Management noted that utilization management has tightened, impacting access, but they are actively working to maximize patient access through a sophisticated infrastructure [80][82] Question: Growth levers among segments for INGREZZA - The greatest growth is expected to come from the psychiatry segment, with ongoing efforts to address telemedicine challenges and high turnover in healthcare providers [85][86] Question: Feedback from end of phase two meetings for osuvamphetor and 568 - Management reported positive feedback and alignment from the agency regarding the registration programs for both osuvamphetor and 568, with support for the planned dose selection [106][107]