Core Insights - Neurocrine Biosciences reported quarterly earnings of $2.04 per share, exceeding the Zacks Consensus Estimate of $1.58 per share, and showing an increase from $1.24 per share a year ago, resulting in an earnings surprise of +29.11% [1] - The company achieved revenues of $794.9 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 6.73% and up from $622.1 million year-over-year [2] - Neurocrine shares have increased approximately 9.1% year-to-date, while the S&P 500 has gained 16.9% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $1.71 on revenues of $785.17 million, and for the current fiscal year, it is $4.49 on revenues of $2.79 billion [7] - The estimate revisions trend for Neurocrine was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which Neurocrine belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting that stocks in the top 50% outperform those in the bottom 50% by more than 2 to 1 [8] - Amneal Pharmaceuticals, another company in the same industry, is expected to report quarterly earnings of $0.13 per share, reflecting a year-over-year decline of -18.8%, with revenues projected at $773.6 million, up 10.1% from the previous year [9][10]

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]

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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]

Financial Performance - INGREZZA net product sales totaled $1.9 billion for the first nine months of 2025, compared to $1.7 billion for the same period in 2024, reflecting a significant increase in demand [101]. - CRENESSITY, launched in December 2024, generated net product sales of $165.8 million in the first nine months of 2025 [101]. - Total net product sales for the first nine months of 2025 reached $2.04 billion, up from $1.71 billion in 2024, indicating a growth of approximately 19% [106]. - Net income for the first nine months of 2025 was $324.9 million, compared to $238.2 million in the same period of 2024, representing a 36.3% increase [123]. - Total collaboration revenues for the first nine months of 2025 were $19.4 million, compared to $18.2 million in 2024, driven by royalties from AbbVie and MTPC [107]. Research and Development - The company initiated two Phase 3 clinical studies for direclidine and osavampator, targeting schizophrenia and major depressive disorder, respectively [108]. - Research and development expenses for the first nine months of 2025 amounted to $757.5 million, an increase from $545.5 million in 2024, primarily due to investments in late-stage programs [111]. Expenses and Costs - Selling, general, and administrative expenses for Q3 2025 were $291.6 million, up from $234.3 million in Q3 2024, reflecting a 24.4% increase [120]. - The cost of revenues for the first nine months of 2025 was $34.5 million, up from $24.7 million in 2024, reflecting increased sales of INGREZZA and CRENESSITY [109]. - The provision for income taxes for Q3 2025 was $82.3 million, up from $60.5 million in Q3 2024, reflecting a 36.5% increase [122]. Cash and Capital Resources - Total cash, cash equivalents, and marketable securities increased to $2,113.3 million as of September 30, 2025, from $1,815.6 million at the end of 2024, a growth of 16.4% [125]. - Cash flows from operating activities for the first nine months of 2025 were $394.3 million, compared to $352.9 million in the same period of 2024, indicating an increase of 11.7% [126]. - Total working capital as of September 30, 2025, was $1,520.4 million, compared to $1,217.0 million at the end of 2024, a rise of 24.9% [125]. - The company anticipates that existing capital resources and projected revenues will be sufficient for at least the next 12 months, but future funding may be required [124]. - Future capital requirements may include potential payments of up to $14.0 billion upon achieving certain milestones in collaboration and license agreements [132]. Shareholder Actions - The company authorized a new share repurchase program of up to $500 million in February 2025, in addition to a completed $300 million program [103]. - The company repurchased 1.5 million shares for $167.7 million under the 2025 Repurchase Program, with $332.3 million remaining for future repurchases [134]. Commercial Strategy - The expansion of the INGREZZA and CRENESSITY sales teams is planned to be completed by the end of Q1 2026 to enhance commercial momentum [104]. - The company received CMS notification that INGREZZA qualifies for the small biotech exception under the Medicare Drug Price Negotiation Program, providing exemption until 2027 [103]. Investment Performance - Unrealized gains on equity investments for Q3 2025 were $30.6 million, compared to a loss of $16.9 million in Q3 2024 [121].

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Financial Performance - Total net product sales for Q3 2025 were $790 million, reflecting a 28% year-over-year growth[5] - INGREZZA net product sales for Q3 2025 were $687 million, representing a 12% year-over-year growth[5] - CRENESSITY net product sales for Q3 2025 were $98 million, with 540 total new patient enrollment start forms[5] - GAAP net income for Q3 2025 was $209.5 million, compared to $129.8 million in Q3 2024, marking a 62% increase[10] - Non-GAAP net income for Q3 2025 was $222.1 million, up from $189.2 million in Q3 2024, reflecting a 17% increase[10] - Net product sales for Q3 2025 reached $789.9 million, a 28.1% increase from $616.6 million in Q3 2024[20] - Total revenues for the nine months ended September 30, 2025, were $2,055.0 million, up 19.0% from $1,727.6 million in the same period of 2024[20] - Operating income for Q3 2025 was $239.0 million, a 30.0% increase from $183.8 million in Q3 2024[20] - Net income for Q3 2025 was $209.5 million, up 61.5% from $129.8 million in Q3 2024[20] - Diluted earnings per share for Q3 2025 were $2.04, compared to $1.24 in Q3 2024, representing a 64.5% increase[20] - Non-GAAP net income for Q3 2025 was $222.1 million, compared to $189.2 million in Q3 2024, reflecting a 17.4% increase[24] Cash and Assets - Total cash, cash equivalents, and marketable securities as of September 30, 2025, were approximately $2.1 billion[10] - Cash, cash equivalents, and marketable securities totaled $1,114.8 million as of September 30, 2025, an increase from $1,076.1 million at the end of 2024[22] - Total assets increased to $4,265.7 million as of September 30, 2025, compared to $3,718.7 million at the end of 2024[22] - Stockholders' equity rose to $3,003.6 million as of September 30, 2025, up from $2,589.7 million at the end of 2024[22] Research and Development - The company initiated a second Phase 3 registrational clinical trial for direclidine as a potential treatment for schizophrenia[5] - Research and development expenses for Q3 2025 were $250.0 million, compared to $195.0 million in Q3 2024, reflecting a 28.2% increase[20] Sales and Marketing Strategy - The company plans to expand the INGREZZA and CRENESSITY sales teams by the end of Q1 2026 to maximize commercial momentum[8] Awards and Recognition - The company was honored with the 2025 Poster Award at the 38th annual Psych Congress for new data presented from the Phase 2 SAVITRI™ study[5] Guidance - Full year 2025 guidance for INGREZZA net product sales is expected to be between $2.5 billion and $2.55 billion[11]

Core Insights - Neurocrine Biosciences reported strong financial results for Q3 2025, with INGREZZA achieving net product sales of $687 million, reflecting a 12% year-over-year growth, while CRENESSITY generated $98 million in net product sales [1][6][13] - The company highlighted the positive impact of its products on patients and emphasized its commitment to advancing innovative therapies in neuroscience [2][4] Financial Performance - Total revenues for Q3 2025 were $794.9 million, up from $622.1 million in Q3 2024, marking a 28% year-over-year increase [4][16] - GAAP net income for Q3 2025 was $209.5 million, compared to $129.8 million in Q3 2024, with diluted earnings per share increasing from $1.24 to $2.04 [13][16] - Non-GAAP net income for Q3 2025 was $222.1 million, up from $189.2 million in Q3 2024, with diluted earnings per share rising from $1.81 to $2.17 [13][19] Product Sales Highlights - INGREZZA's net product sales for Q3 2025 were $687 million, showing a 10% sequential growth over Q2 2025 and a 12% year-over-year growth [6][8] - CRENESSITY's net product sales reached $98 million, with 540 new patient enrollment start forms, indicating strong demand and 80% reimbursement coverage for dispensed scripts [6][8] Research and Development - The company initiated a second Phase 3 registrational clinical trial for direclidine, targeting adults with schizophrenia, and presented promising data from the Phase 2 SAVITRI study for osavampator in major depressive disorder [5][6] - R&D expenses for Q3 2025 were $250 million, up from $195 million in Q3 2024, reflecting increased investment in clinical programs [4][16] Corporate Developments - Neurocrine announced the appointment of Mike Sibley as Senior Vice President and General Manager of the Neuropsychiatry franchise, aiming to enhance the sales and marketing strategy for its neuropsychiatry products [5][6] - The company plans to expand its INGREZZA and CRENESSITY sales teams to maximize commercial momentum, with completion expected by the end of Q1 2026 [5][6]