Neurocrine(US:NBIX)2023-02-06 19:52Financial Data and Key Metrics Changes - Neurocrine reported INGREZZA sales growth of over $350 million in 2022, with expectations for 2023 sales between $1.67 billion to $1.77 billion, reflecting approximately 20% year-over-year growth at the midpoint [11][12][16] - The company ended 2022 with over $1.2 billion in cash and used $280 million to retire a significant portion of its convertible debt [12] - SG&A and R&D expenses are projected to exceed $1.4 billion in 2023, with an anticipated SG&A leverage of around 300 basis points [12][13] Business Line Data and Key Metrics Changes - INGREZZA's performance in 2022 showed year-over-year growth exceeding 30% for four consecutive quarters, indicating strong execution by commercial and medical affairs teams [15] - The majority of growth in 2023 is expected to come from the psychiatry and neurology business segments, which are more developed compared to other segments [16] Market Data and Key Metrics Changes - Approximately 600,000 people in the U.S. are living with tardive dyskinesia (TD), with seven out of ten remaining undiagnosed [15][82] - The long-term care (LTC) segment is a new area for INGREZZA, with an estimated 10% to 15% of TD patients in LTC settings, but tangible sales impact is expected to take a few more quarters [18][63] Company Strategy and Development Direction - The company plans to continue expanding its sales force and direct-to-consumer advertising to increase awareness and treatment of TD [7][8] - Neurocrine has a diversified pipeline with multiple mid and late-stage clinical programs, including treatments for Huntington's disease and congenital adrenal hyperplasia [9][20][21] - The company is focused on advancing its research and development efforts to ensure a consistent flow of new products [9][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2023, driven by an underdeveloped TD market and ongoing marketing initiatives [12][19] - The company is preparing for the potential launch of valbenazine for Huntington's disease, with a PDUFA date set for August 2023 [20] - Management acknowledged the challenges in the LTC segment but remains confident in the potential for growth as education and awareness improve [63] Other Important Information - The company is investing in a range of modalities, including small molecules and gene therapy, to provide treatments for serious diseases in neuroscience [25] - Neurocrine is actively working with partners to navigate legislative changes affecting Medicare price negotiations, which could impact long-term strategies [73] Q&A Session Summary Question: Guidance assumptions for 2023 - Management expects over $300 million in year-over-year growth for INGREZZA, with the top end of guidance reflecting acceleration in new patients [28] Question: Net price per script for INGREZZA - The net revenue per script in Q4 was in the $5,400 range, with expectations for a net price increase of 3% to 4% in 2023 [36] Question: Impact of COVID-19 telemedicine mandates - Telemedicine mandates will last for two years post-emergency health order expiration, with no expected changes in 2023 [41] Question: Market opportunity in congenital adrenal hyperplasia (CAH) - There are approximately 20,000 to 30,000 people in the U.S. with CAH, and the company sees significant potential for its investigational treatment crinecerfont [47] Question: Differentiation of valbenazine in Huntington's disease - Valbenazine is expected to have a differentiated profile due to its simpler dosing regimen and lack of food effect compared to competitors [77][78] Question: Long-term care segment operational hurdles - The LTC segment presents unique challenges, requiring close collaboration with care centers to educate staff on TD [63] Question: Insights on tardive dyskinesia treatment duration - Compliance with INGREZZA has been better than expected, with ongoing efforts to improve diagnosis and treatment rates among TD patients [82]