Neurocrine(NBIX)2022-02-11 18:19Financial Data and Key Metrics Changes - The 2022 net sales guidance for INGREZZA is projected to be between $1.25 billion and $1.35 billion, marking the first time the company has provided annual sales guidance [14][19] - The GAAP operating expense range for 2022 is estimated to be between $1.1 billion and $1.15 billion, with a significant increase in sales force expansion and direct-to-consumer advertising [19][20] Business Line Data and Key Metrics Changes - INGREZZA's Q4 performance showed a total prescription growth of 8% sequentially and 32% year-over-year, marking the third consecutive quarter of growth during the pandemic [23][27] - The company has expanded its sales force to over 350 members, focusing on psychiatry, neurology, and long-term care [29] Market Data and Key Metrics Changes - The total addressable market for tardive dyskinesia (TD) in the U.S. is estimated at 600,000 patients, with only about 25% currently diagnosed [108][110] - The use of antipsychotics continues to grow, leading to an increase in the TD patient population, with 70 million prescriptions written in the past year [115][116] Company Strategy and Development Direction - The company aims to accelerate growth through a combination of expanding its sales force and enhancing its commercial initiatives, including a direct-to-consumer advertising campaign [17][29] - The R&D pipeline includes 12 mid- to late-stage clinical programs, with plans to submit a supplemental new drug application for valbenazine for Huntington's disease in the second half of 2022 [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the external environment improving, which is expected to positively impact patient access and sales [28][69] - The company acknowledges the challenges posed by COVID-19 but believes that the reopening of clinics and increased patient visits will drive growth in the latter half of 2022 [9][16] Other Important Information - The company is focused on addressing the unmet medical needs in neurology and psychiatry, with a strong emphasis on innovative therapies [42][100] - The company plans to continue exploring business development opportunities to enhance its pipeline and market presence [99] Q&A Session Summary Question: Can you give us some sense of what would be proof of concept for essential tremor? - The proof-of-concept study includes several endpoints, with a primary focus on tremor amplitude measured by accelerometer, and a statistically significant difference is sought [48] Question: How does the demand growth for INGREZZA compare to pre-COVID levels? - Prior to the pandemic, the company experienced a growth trajectory of a couple of hundred million dollars per year, and a 20% midpoint growth in guidance aligns with that performance [51][52] Question: Is your guidance impacted by inventory stocking for INGREZZA? - The guidance reflects underlying demand for INGREZZA sales, and inventory fluctuations are expected to net out over the year [56][58] Question: What are the expectations for long-term care opportunities? - Long-term care represents a significant incremental opportunity, with several million people in facilities potentially treated with antipsychotics that cause TD [103][104] Question: How fast is the total addressable TD market growing? - The TD population is growing due to the increased use of antipsychotics, with estimates rising from around 500,000 to 600,000 patients over the past five years [116]