Core Insights - Neurocrine Biosciences is advancing a diversified pipeline of first- and best-in-class medicines across therapeutic modalities, including two Phase 3 programs targeting major depressive disorder and schizophrenia, with expectations to deliver an approved medicine every two years by the end of the decade [2][4] R&D Strategy - The company has unveiled a transformed R&D engine aimed at delivering at least four new Phase 1 and two Phase 2 programs annually, focusing on genetically or clinically validated mechanisms of action [4] - The R&D strategy is designed to create long-term value and accelerate the delivery of new medicines for patients [3][4] Pipeline Highlights - Osavampator is a potential first-in-class AMPA positive allosteric modulator for major depressive disorder, with topline data from three ongoing Phase 3 studies expected in 2027 [5] - Direclidine is an M4 muscarinic agonist for psychiatric disorders, with topline data from ongoing studies expected in 2027 and 2028 [5] - The pipeline includes next-generation VMAT2 inhibitors and a suite of differentiated assets for better quality weight loss, including a CRF2 agonist expected to enter Phase 1 development in the first half of 2026 [5] Leadership and Vision - The CEO emphasized the company's commitment to developing novel therapies across metabolic diseases, starting with obesity, aiming for superior weight loss while preserving muscle mass [3] - The company has a proven track record in drug development and commercialization, positioning it uniquely to advance its pipeline and create sustained value for stakeholders [3]

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]

Core Insights - Neurocrine's growth strategy is centered around three key pillars: INGREZZA, CRENESSITY, and a robust R&D pipeline [3] Group 1: Product Overview - INGREZZA is Neurocrine's primary product for treating tardive dyskinesia, approved in 2017, and later for chorea associated with Huntington's Disease [3] - CRENESSITY, a recently approved medication for congenital adrenal hyperplasia, was launched in December 2024, marking its first full year in the market [3] Group 2: Company Positioning - The company emphasizes its commitment to maintaining a deep and sustainable research and development pipeline to support future growth [3]

Core Insights - Allworth Financial LP significantly increased its position in Neurocrine Biosciences by 2,107.4% in Q2, owning 2,980 shares valued at $375,000 [2] - Other institutional investors also increased their stakes, with Dodge & Cox raising its position by 83.5% and Los Angeles Capital Management by 19,454.9% in Q2 [3] - Analysts have a positive outlook on Neurocrine Biosciences, with multiple firms raising their price targets and maintaining buy ratings [4] Institutional Investment - Allworth Financial LP acquired an additional 2,845 shares in Q2, bringing its total to 2,980 shares [2] - Dodge & Cox now owns 5,534,624 shares worth $612.13 million after acquiring 2,518,199 shares [3] - Los Angeles Capital Management LLC increased its holdings to 744,650 shares valued at $93.60 million after purchasing 740,842 shares [3] Analyst Ratings - Wedbush maintains an "outperform" rating for Neurocrine Biosciences [4] - Canaccord Genuity raised its target price from $160.00 to $164.00, while Citigroup increased its target from $175.00 to $203.00 [4] - The consensus rating for Neurocrine Biosciences is "Moderate Buy" with a target price of $170.53 [4] Financial Performance - Neurocrine Biosciences reported Q3 earnings of $2.17 per share, exceeding estimates by $0.59, with revenue of $794.90 million, up 27.8% year-over-year [6] - The company has a market capitalization of $14.44 billion and a P/E ratio of 34.66 [5] Insider Activity - CEO Kyle Gano sold 300 shares at an average price of $141.97, reducing his ownership by 0.21% [7] - Director William H. Rastetter sold 18,000 shares at an average price of $151.82, representing a 30.84% decrease in ownership [7] Company Overview - Neurocrine Biosciences focuses on pharmaceuticals for neurological and neuropsychiatric disorders, with products including INGREZZA and ALKINDI [8]

Core Insights - Neurocrine Biosciences reported revenue of $794.9 million for the quarter ended September 2025, reflecting a year-over-year increase of 27.8% and surpassing the Zacks Consensus Estimate by 6.73% [1] - The company's EPS for the quarter was $2.04, up from $1.24 in the same quarter last year, resulting in an EPS surprise of 29.11% compared to the consensus estimate of $1.58 [1] Revenue Breakdown - Product sales from INGREZZA reached $686.6 million, exceeding the average estimate of $664.3 million, marking a 12% year-over-year increase [4] - Total product sales amounted to $789.9 million, surpassing the nine-analyst average estimate of $736.39 million, with a year-over-year change of 28.1% [4] - CRENESSITY generated $98.1 million in product sales, exceeding the average estimate of $67.22 million [4] - Collaboration revenue was reported at $5 million, slightly below the estimated $5.69 million, representing a decline of 9.1% year-over-year [4] - Royalty collaboration revenue was $4.8 million, compared to the average estimate of $5.1 million [4] - Other product sales reached $5.2 million, exceeding the average estimate of $4.25 million [4] Stock Performance - Neurocrine's shares have returned 6.2% over the past month, outperforming the Zacks S&P 500 composite's 3.6% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market in the near term [3]

Core Insights - Neurocrine Biosciences reported a strong Q3 performance, driven by significant sales growth from its products INGREZZA and CRENESSITY, achieving a 28% increase in product sales [1] Product Performance - INGREZZA and CRENESSITY were the primary contributors to the sales growth, indicating robust market demand and effective commercialization strategies [1] - The company’s product sales reached a notable milestone, reflecting the successful execution of its business model [1] Financial Highlights - The Q3 results exceeded market expectations, showcasing the company's strong financial health and operational efficiency [1] - The growth in product sales is a positive indicator for future revenue streams and overall company performance [1]

Financial Data and Key Metrics Changes - The company reported $790 million in net product sales for Q3 2025, reflecting a 28% year-over-year growth driven by INGREZZA and CRENESSITY [8][10] - CRENESSITY sales grew from $53 million in Q2 to $98 million in Q3, indicating strong early adoption [8][10] - INGREZZA achieved net sales of $687 million, marking the third consecutive quarter of record new patient additions [8][10] Business Line Data and Key Metrics Changes - INGREZZA's performance has been exceptional, with a prescriber base 30% larger than two years ago, and only about 10% of the estimated 800,000 patients with tardive dyskinesia currently treated with a VMAT2 inhibitor [12][13] - CRENESSITY has seen 540 new patients initiate therapy in Q3, bringing the total to over 1,600 since launch, with 80% of dispensed prescriptions now reimbursed [8][10][15] Market Data and Key Metrics Changes - The company noted a significant organic growth opportunity in the tardive dyskinesia market, with only 10% of diagnosed patients currently receiving treatment [12][13] - The pediatric population showed modestly higher demand for CRENESSITY compared to adults, with strong reimbursement rates observed [16][17] Company Strategy and Development Direction - The company plans to expand its sales force for both INGREZZA and CRENESSITY to accelerate growth into 2026 and beyond, focusing on maximizing patient share and preparing for future product launches [9][10][17] - The capital allocation priorities include driving revenue growth, advancing R&D programs, enabling business development, and returning capital to shareholders [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum for both INGREZZA and CRENESSITY, highlighting the potential for sustained long-term growth driven by their science and commitment to patients [6][7] - The company is on track to meet its R&D productivity goals, with plans for four new Phase I study initiations and two new Phase II initiations [6][10] Other Important Information - The company is fully cooperating with a Department of Justice investigation regarding the sales and marketing of INGREZZA, maintaining a robust compliance program [49][50] - The company has $2.1 billion in cash with no debt, allowing for flexibility in capital allocation [94] Q&A Session Summary Question: Insights on CRENESSITY patient dynamics and enrollment trends - Management noted that the adoption of CRENESSITY has been consistent, with no significant seasonal dynamics affecting enrollment [24][25] Question: Implications of the Inflation Reduction Act on pricing - Management discussed the upcoming Oscado pricing and its potential impact on INGREZZA, emphasizing the need to maximize patient share before the IRA takes effect [31][32] Question: Reimbursement requirements for CRENESSITY - Management clarified that there are no specific steroid tapering requirements for reimbursement, and the process has been smooth [39] Question: Sales force expansion details - The company plans a 30% increase in its sales footprint, primarily focusing on INGREZZA, with a smaller expansion for CRENESSITY [58][60] Question: Persistence and compliance of CRENESSITY - Management reported strong persistence and compliance rates for CRENESSITY, with positive feedback from healthcare providers regarding treatment outcomes [78][79] Question: Future growth outlook for INGREZZA - Management indicated that INGREZZA is growing faster than the overall market, with expectations for continued robust growth into 2026 and beyond [103]

Financial Data and Key Metrics Changes - The company reported $790 million in net product sales for Q3 2025, reflecting a 28% year-over-year growth driven by INGREZZA and CRENESSITY [8][10] - CRENESSITY sales grew from $53 million in Q2 to $98 million in Q3, indicating strong early adoption [8][10] - INGREZZA achieved net sales of $687 million, marking the third consecutive quarter of record new patient additions [8][10] Business Line Data and Key Metrics Changes - INGREZZA's performance has been exceptional, with a prescriber base 30% larger than two years ago, and only about 10% of the estimated 800,000 patients with tardive dyskinesia currently treated with a VMAT2 inhibitor [11][12] - CRENESSITY has seen 540 new patients initiate therapy in Q3, bringing the total to over 1,600 since launch, with 80% of dispensed prescriptions now reimbursed [8][15] Market Data and Key Metrics Changes - The company estimates that only half of the patients living with tardive dyskinesia have received a diagnosis, indicating significant growth potential in the market [11][12] - The pediatric population has shown modestly higher demand for CRENESSITY compared to adults, with strong reimbursement rates observed [15] Company Strategy and Development Direction - The company plans to expand its sales force for both INGREZZA and CRENESSITY to accelerate growth and maximize patient share [9][16] - The capital allocation priorities include driving revenue growth, advancing R&D programs, enabling business development, and returning capital to shareholders [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum for both INGREZZA and CRENESSITY, with expectations for continued growth into 2026 and beyond [6][10] - The company is on track to achieve its R&D productivity goals, with multiple Phase I and II study initiations planned [6][10] Other Important Information - The company is fully cooperating with a Department of Justice investigation related to the sales and marketing of INGREZZA, maintaining a robust compliance program [49][50] - The company has $2.1 billion in cash with no debt, allowing for flexibility in capital allocation [94] Q&A Session Summary Question: Insights on patient dynamics and starts for CRENESSITY - Management noted that the adoption of CRENESSITY has been strong, with 540 new treatment forms in Q3, and they do not see significant seasonality affecting the launch [23][24] Question: Implications of the Inflation Reduction Act (IRA) on pricing - Management is awaiting pricing information for Oscado and is preparing to maximize patient numbers on INGREZZA before the IRA impacts begin [31][33] Question: Reimbursement requirements for CRENESSITY - Reimbursement has been smooth, with no specific steroid tapering required for coverage, focusing instead on the underlying disease [39] Question: Sales force expansion details - The sales force expansion is expected to increase overall coverage by about 30%, primarily targeting psychiatry and neurology [58][60] Question: Persistence and compliance of CRENESSITY - Persistence and compliance for CRENESSITY have been strong, with positive feedback on disease control and androgen reduction from healthcare providers [77][78] Question: Future product launches and sales force readiness - The expanded sales force is positioned to support potential launches of new products in the pipeline, including osavampator and Directlidine [109]

Financial Data and Key Metrics Changes - Neurocrine Biosciences reported $790 million in net product sales for Q3 2025, reflecting a 28% year-over-year growth driven by INGREZZA and CRENESSITY [6][10] - CRENESSITY's sales grew from $53 million in Q2 to $98 million in Q3, indicating strong early adoption and persistency rates [6][7] - INGREZZA achieved net sales of $687 million in Q3, marking the third consecutive quarter of record new patient additions [7][10] Business Line Data and Key Metrics Changes - INGREZZA's performance has been exceptional, with a prescriber base that has expanded by 30% over the past two years, reflecting the strong clinical profile and unmet need for tardive dyskinesia treatment [10][11] - CRENESSITY has seen 540 new patients initiate therapy in Q3, bringing the total to over 1,600 since its launch [13][15] - The company anticipates continued growth for both products, with plans for further sales force expansion to maximize patient share [8][16] Market Data and Key Metrics Changes - The tardive dyskinesia market is expected to grow significantly, with only about 10% of diagnosed patients currently treated with a VMAT2 inhibitor, indicating substantial growth potential for INGREZZA [10][11] - The congenital adrenal hyperplasia (CAH) community has shown favorable feedback towards CRENESSITY, with 80% of dispensed prescriptions now being reimbursed [6][15] Company Strategy and Development Direction - Neurocrine Biosciences is focused on expanding its sales force for both INGREZZA and CRENESSITY to accelerate growth into 2026 and beyond [4][8] - The company aims to drive revenue growth, advance R&D programs, enable business development, and return capital to shareholders, with a strong financial profile of over $2.1 billion in cash [9][80] - The strategic expansion of the sales force is intended to maximize patient share and prepare for anticipated launches of investigational psychiatric medicines [8][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum for both products and the potential for sustained long-term growth driven by their science and commitment to patients [5][9] - The company remains on track for its clinical programs, with anticipated top-line results for key studies in the near future [18][19] - Management acknowledged the potential impacts of the Inflation Reduction Act (IRA) on the market and emphasized the importance of maximizing patient share before 2027 [8][30] Other Important Information - The company is fully cooperating with a Department of Justice investigation related to the sales and marketing of INGREZZA, maintaining a robust compliance program [40][41] - The sales force expansion is expected to result in an increase in SG&A expenses of around $150 million in 2026 [9][79] Q&A Session Summary Question: Insights on patient dynamics and starts for CRENESSITY - Management noted that the adoption of CRENESSITY has been strong, with 540 new treatment forms in Q3, and they do not believe there are significant seasonal dynamics affecting enrollment [22][23] Question: Implications of the IRA on pricing and reimbursement - Management is monitoring the upcoming Oscado pricing and its potential effects on INGREZZA, emphasizing the importance of maximizing patient numbers before the IRA impacts [28][30] Question: Status of reimbursement requirements for CRENESSITY - Management indicated that reimbursement has been smooth, with no specific requirements for steroid tapering to continue coverage [34] Question: Sales force expansion details - The expansion is characterized as a 30% increase in overall sales footprint, primarily targeting psychiatry and neurology for INGREZZA, while also expanding the team for CRENESSITY [46][48] Question: Update on the Department of Justice investigation - Management confirmed they are cooperating with the DOJ regarding a civil investigative demand related to INGREZZA's sales and marketing practices [40][41] Question: Progress with CRENESSITY at centers of excellence - All centers of excellence have started adopting CRENESSITY, with varying rates of adoption, and there is optimism about community endocrinologists' engagement [43][44]

Financial Performance - Total Neurocrine net product sales reached $790 million, representing a 16% quarter-over-quarter (QoQ) growth and a 28% year-over-year (YoY) growth compared to Q2 2025 and Q3 2024, respectively[11] - INGREZZA net product sales were $687 million, showing a 10% QoQ growth and a 12% YoY growth compared to Q2 2025 and Q3 2024, respectively[11] - CRENESSITY net product sales amounted to $98 million, including 540 total new patient enrollment forms[11] - The company reaffirmed INGREZZA net sales guidance at $2500 million - $2550 million for the full year 2025[11] - Cash and investments totaled approximately $2100 million as of September 30, 2025[7] Research and Development - The company initiated all Phase 3 registrational studies for osavampator (AMPA PAM) as an adjunctive therapy for the treatment of MDD in adults and direclidine (Selective M4 Agonist) for the treatment of Schizophrenia[11] - The company expects to report top-line data in Q4 2025 for the Phase 3 study of valbenazine for Dyskinetic Cerebral Palsy and the Phase 2 study of NBI-'770 (NMDA NR2B NAM) for the treatment of MDD[11] - The company plans to initiate Phase 2 studies in Q4 2025 for direclidine for Bipolar Mania and NBI-'570 (Selective Dual M1 / M4 Agonist) for Schizophrenia[11] Commercial Strategy - The company plans to expand INGREZZA and CRENESSITY sales teams in Q4 2025, with completion expected by the end of Q1 2026, to maximize commercial momentum[11] - CRENESSITY has achieved approximately 80% reimbursement coverage for dispensed scripts[11] Pipeline Development - The company has a pipeline of 12 programs, including the first biologic program NBIP-'1435[8] - The company is advancing additional internally developed pre-clinical programs, including biologics, into first-in-human studies[11]