CRF-based therapies
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Neurocrine(NBIX) - 2025 Q4 - Earnings Call Transcript
2026-02-11 22:30
Financial Data and Key Metrics Changes - In 2025, total product sales grew to over $2.8 billion, representing a 22% year-over-year growth, driven by INGREZZA and the successful launch of CRENESSITY [9][10] - INGREZZA generated over $2.5 billion in revenue, up 9% year-over-year, with expectations for 2026 sales in the range of $2.7-$2.8 billion, reflecting approximately 10% growth [9][10] - The company's cash position increased by approximately $700 million, from $1.8 billion at the end of 2024 to $2.5 billion at the end of 2025, indicating strong operating performance [11] Business Line Data and Key Metrics Changes - INGREZZA's performance continues to impress, with record levels of new and total prescriptions, supported by strategic investments in access and Salesforce expansion [3][9] - CRENESSITY achieved over $300 million in net product sales in its first full year, capturing approximately 10% of the classic congenital adrenal hyperplasia patient population [10][15] - The company expects double-digit volume-driven growth for INGREZZA in 2026, supported by an expanded Salesforce and continued demand [10][20] Market Data and Key Metrics Changes - The company estimates that only about 10% of the prevalent tardive dyskinesia (TD) population is currently taking a VMAT2 inhibitor, indicating significant growth potential [20] - For CRENESSITY, the company is focused on expanding its reach beyond endocrinologists to include primary care providers and OB/GYNs, leveraging technology to identify potential prescribers [17][81] Company Strategy and Development Direction - Neurocrine aims to lead the VMAT2 category by advancing next-generation VMAT2 inhibitors and expanding its CRF platform [5][6] - The company is committed to delivering one new medicine every two years at steady state, with a strong pipeline including late-stage neuropsychiatry programs [7][8] - The strategy includes expanding the CRENESSITY sales force and enhancing medical education to improve understanding of classic CAH [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong foundation and momentum entering 2026, with expectations for continued growth in both INGREZZA and CRENESSITY [3][13] - The management team highlighted the importance of ongoing investments in R&D and sales to drive future growth, despite not prioritizing near-term profitability [11][12] - Positive feedback from prescribers and stakeholders reinforces the belief that CRENESSITY will become a standard of care for patients with classic CAH [19][86] Other Important Information - The company achieved its phase 1 through phase 3 objectives for the first time in 2025, marking it as the most productive clinical year in its history [7] - The management team emphasized the importance of safety and tolerability in the adoption of CRENESSITY, with a strong retention rate observed in clinical trials [24][66] Q&A Session Summary Question: Insights on CRENESSITY's early performance and patient dynamics - Management indicated that they anticipate steady new patient additions each quarter for CRENESSITY, with a focus on learning from the launch experience [31][41] Question: Impact of receptor occupancy data on future products - The company highlighted the superior efficacy of INGREZZA compared to Austedo XR, which will inform the development of next-generation VMAT2 inhibitors [35] Question: Barriers to further adoption of CRENESSITY - Management noted that lack of knowledge among endocrinologists is a significant barrier, and they are focused on educational efforts to improve understanding of classic CAH and CRENESSITY's benefits [84][86]
Neurocrine Biosciences (NasdaqGS:NBIX) 2025 Earnings Call Presentation
2025-12-16 17:00
Company Strategy & R&D Transformation - Neurocrine Biosciences is positioned as a diversified neuroscience and endocrinology leader aiming for sustainable growth and value creation[12] - The company aims to deliver a new medicine every two years, driven by a redesigned R&D organization[30, 31, 132] - R&D transformation includes a goal to advance 20 development candidates in 5 years, focusing on clinically or genetically validated targets[94, 99, 101] - The company is diversifying its therapeutic areas beyond neurology and psychiatry to include endocrinology and immunology[23, 94, 100] - New modalities, including peptides, antibodies, and gene therapy, now represent approximately 60% of the portfolio across therapeutic areas[105] Neuropsychiatry Pipeline - The neuropsychiatry pipeline is positioned to deliver multiple first- and best-in-class medicines this decade[12] - Osavampator, an AMPA PAM, is in Phase 3 development for Major Depressive Disorder (MDD), with data expected in 2027[23, 59] - Phase 2 SAVITRI study results showed statistically significant improvements in depression severity with osavampator, with an effect size of 0.53 at day 28 and 0.73 at day 56 for the 1mg dose[52, 55] - Direclidine, an M4 agonist, is in Phase 3 development for schizophrenia, with initial topline data expected in 2027[23, 77] - Phase 2 data for direclidine showed a PANSS total score change from baseline of -18.2 at week 6, with a change vs placebo of -7.5 (p=0.011) and an effect size of 0.61[73] Endocrinology Pipeline - The company is leveraging its Corticotropin Releasing Factor (CRF) biology expertise to expand in endocrinology and metabolic disease[12, 137] - NBIP-'2118, a CRF2 agonist, is being developed for obesity, with a Phase 1 study planned for the first half of 2026[159]