Neurocrine(NBIX)2024-08-01 19:24Financial Data and Key Metrics - Q2 2024 gross sales were $580 million, up 32% YoY from $440 million in Q2 2023 [6] - Full-year 2024 gross and net sales guidance raised to $2.25 billion - $2.3 billion, up from previous guidance of $2.1 billion - $2.2 billion [6] - INGREZZA sales grew over 30% YoY in Q2 2024, approaching $1.1 billion in the first half of 2024 [8] - Midpoint of 2024 sales guidance implies ~24% growth vs 2023 [9] Business Line Performance - INGREZZA continues strong growth momentum, with expanded sales force and new sprinkle formulation driving adoption [4][12] - Crinecerfont granted priority review by FDA, with PDUFA date set for late December 2024 [17][18] - NBI-845 AMPA modulator showed statistically significant reduction in MADRS scores in Phase 2 MDD study [16] - Two new Phase 1 molecules entered clinic: NBI-986 (M4 antagonist) and NBI-567 (M1 preferring agonist) [20] Market and Strategic Focus - Company sees significant growth opportunities in TD and HD chorea markets, with ~70-80% of patients still untreated [35][77] - Investing $125 million incremental in 2025 to support Crinecerfont launch and INGREZZA growth [7] - Focus on expanding commercial footprint and educating HCPs in psychiatry and long-term care segments [11][34] - Building rare endocrinology team for Crinecerfont launch, with average 20+ years biopharma experience [14] R&D Pipeline Progress - NBI-568 (M4 agonist) Phase 2 schizophrenia data expected in Q3 2024 [19] - Luvadaxistat Phase 2 cognitive impairment in schizophrenia data also expected in Q3 2024 [20] - Crinecerfont Phase 3 data published in NEJM, showing strong efficacy and tolerability [17] - Robust preclinical and clinical pipeline, with biologics expected to enter clinic next year [5] Management Commentary - Company believes it has the most robust neuroscience pipeline globally [5] - INGREZZA investments have consistently shown positive ROI through sales force expansions [4] - Crinecerfont expected to change treatment paradigm for CAH patients [5] - Focus on advancing high-value preclinical programs and investing behind positive proof-of-concept data [8] Q&A Session Highlights INGREZZA Growth and Market Opportunity - Sales force expansion justified by continued market growth and need to educate more HCPs [33] - All three business segments (psychiatry, neurology, LTC) showing strong growth [37] - ~70-80% of TD patients still untreated, indicating significant remaining opportunity [35][77] Pipeline Updates - NBI-568 adaptive trial design focuses on safety, with independent DMC guiding dose escalation [24][25] - Luvadaxistat cognitive benefits in schizophrenia represent significant unmet need if replicated [54][55] - NBI-845 focused on MDD initially, with potential to expand to other indications later [66] Crinecerfont Launch Preparation - Market education key focus, with "What the C@H?" initiative targeting endocrinologists and patients [73][74] - Centers of excellence important but majority of patients treated by community endocrinologists [73] - Strong Phase 3 data and >95% rollover rate into extension studies support favorable profile [61][62] Strategic Vision - Focus on organic growth and internal R&D transformation [47] - Moving from symptomatic to disease-modifying and curative therapies [47] - Strong financial position with $1.7 billion cash to support pipeline advancement [48]