Financial Data and Key Metrics Changes - Neurocrine's total product sales grew to over $2.8 billion in 2025, representing a 22% year-over-year growth, driven by INGREZZA and the successful launch of CRENESSITY [11][12] - INGREZZA generated over $2.5 billion in revenue, up 9% year-over-year, with expectations of sales in the range of $2.7-$2.8 billion in 2026, reflecting approximately 10% growth [11][12] - 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 [14] 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 [5][11] - 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 [12][13] - The company expects double-digit volume-driven growth for INGREZZA in 2026, supported by continued demand from patients not currently taking a VMAT2 inhibitor [6][11] Market Data and Key Metrics Changes - Neurocrine estimates that only about 10% of the prevalent tardive dyskinesia (TD) population is currently taking a VMAT2 inhibitor, indicating substantial growth opportunities [23] - The company has reached approximately 10% of the classic CAH population on therapy in the first year, with a focus on expanding beyond the endocrinology prescriber base [22][82] Company Strategy and Development Direction - Neurocrine aims to lead the VMAT2 category by leveraging its experience with INGREZZA and advancing next-generation VMAT2 inhibitors [8] - The company is focused on maximizing its evolving pipeline, with late-stage programs in neuropsychiatry and ongoing investments in R&D and Salesforce expansion [9][15] - Neurocrine plans to deliver one new medicine every two years at steady state, with a strong pipeline and a commitment to patient and shareholder value [10][15] 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 and successful execution of strategies [5][10] - The management team highlighted the importance of ongoing education for prescribers and patients to drive adoption of CRENESSITY and improve treatment outcomes [88] - There is optimism regarding the potential for CRENESSITY to become a second blockbuster product, similar to INGREZZA, as the company continues to learn from the market dynamics [17][19] Other Important Information - The company is expanding its Salesforce for CRENESSITY to deepen engagement with existing prescribers and reach new potential prescribers [20][77] - Neurocrine is leveraging AI and technology tools to identify and engage providers likely to care for classic CAH patients, enhancing its market reach [21][83] Q&A Session Summary Question: Insights on CRENESSITY's early performance and revenue expectations - Management anticipates steady new patient additions each quarter for CRENESSITY, with a strong growth outlook for year two [34] Question: Implications of receptor occupancy data for INGREZZA - The data showed INGREZZA's superior efficacy compared to Austedo XR, which will inform the development of next-generation VMAT2 inhibitors [38] Question: Patient dynamics and potential seasonality for CRENESSITY - Management noted that it is too early to determine seasonality effects, emphasizing the need for further data collection [44] Question: R&D expense increases and their components - The increase in R&D expenses is primarily due to ongoing phase 3 trials, with minimal investment in earlier-stage programs like obesity [47] Question: Barriers to further adoption of CRENESSITY - The main barrier is a lack of knowledge among endocrinologists about classic CAH and the benefits of CRENESSITY, which the company is addressing through educational efforts [86]

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]

Advancing Life-Changing Discoveries in Neuroscience Neurocrine Biosciences (Nasdaq: NBIX) Q4 and Year-End 2025 Earnings Presentation February 1 1, 2026 Safe Harbor and Forward-Looking Statements In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our business strategy, objectives, and future development plans; the benefits to be derived from our produc ...

Sales Performance - INGREZZA net product sales were $2.51 billion for 2025, $2.31 billion for 2024, and $1.84 billion for 2023, significantly contributing to total net product sales [18]. - CRENESSITY net product sales were $301.2 million for 2025 during its first full year of launch [18]. - The planned expansion of the INGREZZA and CRENESSITY sales teams is expected to be completed by the end of Q1 2026 [115]. - Over 90% of total gross product sales for INGREZZA and CRENESSITY come from four specialty pharmacy providers, indicating a significant customer concentration risk [174]. Market and Competition - Approximately 800,000 people in the U.S. are estimated to be affected by tardive dyskinesia, with 90% of 40,000 Huntington's disease patients expected to develop chorea, and at least 20,000 people affected by classic congenital adrenal hyperplasia [18]. - The company faces competition from various pharmaceutical companies and academic institutions in the biotechnology sector [49]. - The successful commercialization of CRENESSITY depends on physician and patient acceptance, as well as adequate reimbursement coverage [125]. - The company faces intense competition from existing products and potential generic equivalents, which may impact market demand for INGREZZA and CRENESSITY [129]. Research and Development - A comprehensive Phase 3 clinical program for osavampator in major depressive disorder has been initiated, with initial topline data expected in 2027 [29]. - Direclidine, targeting schizophrenia and bipolar mania, has also entered a comprehensive Phase 3 clinical program, with initial topline data expected in 2027 [30]. - The company aims to launch approximately one new medicine every two years, leveraging its diversified pipeline [25]. - NBIP-01435, a long-acting CRF-1 receptor antagonist peptide for CAH, is currently in Phase 1 development, building on the success of CRENESSITY [40]. - The company aims to advance at least four new programs into Phase 1 and two into Phase 2 each year, supported by internal investments in discovery [42]. - The clinical development pipeline includes multiple late-stage opportunities with near-term registration potential, designed to drive growth into the next decade [43]. Regulatory Environment - The company is subject to extensive regulations, including compliance with federal and state healthcare laws, which can significantly affect operations [52]. - The FDA has a review goal of 10 months for standard NDAs and 6 months for priority NDAs, impacting the timeline for product commercialization [67]. - The FDA may require additional information before accepting an NDA for filing, and once accepted, it begins an in-depth review to assess safety and effectiveness [70]. - Approval of an NDA may involve inspections of manufacturing facilities and clinical trial sites to ensure compliance with regulatory standards [72]. - The FDA may issue a complete response letter detailing conditions that must be met for final approval, which may include additional clinical testing [73]. - Orphan drug designation can provide a seven-year marketing exclusivity period if approved for a rare disease, but does not shorten the regulatory review process [77]. - Post-approval, drugs are subject to ongoing FDA regulation, including requirements for recordkeeping, reporting, and potential post-marketing studies [78]. Financial Considerations - The company may need to raise additional capital to fund its business plan and future research, development, and commercialization efforts, influenced by the success of INGREZZA and CRENESSITY [175]. - The company anticipates significant operating and capital expenditures as it seeks to commercialize INGREZZA and CRENESSITY, and develop new product candidates [180]. - The market price of the company's common stock has fluctuated between approximately $84 and $160 per share over the last 12 months, indicating high volatility [191]. - The company may not achieve sustained profitability, as significant revenue generation is required to maintain positive cash flow [178]. - The company is subject to changes in tax laws that could adversely affect its financial condition and results of operations [187]. Employee and Organizational Growth - The number of full-time employees has grown from approximately 200 in 2017 to approximately 2,000 as of December 31, 2025 [115]. - The company has been recognized as one of the Fortune "Best Workplaces in Biopharma" Top 10 for three consecutive years (2023-2025) [117]. - The company is making substantial investments in research and development personnel to support the expansion into biologics, including peptides, proteins, antibodies, conjugates, and gene therapies [115]. - The company conducts an annual confidential employee engagement survey to assess engagement and identify key drivers of attrition and retention [116]. Compliance and Legal Risks - The company is cooperating with a civil investigative demand from the U.S. Department of Justice regarding its sales and marketing of INGREZZA [62]. - Regulatory compliance issues with third-party manufacturers could significantly impair the company's ability to develop and commercialize its products [171]. - The company faces risks related to intellectual property protection, including potential challenges to patent validity and competition from generic drug applications [212][215]. Strategic Collaborations and Supply Chain - The company relies on third-party manufacturers for the production of its products, ensuring adequate supply through long-term agreements [22]. - The company relies on a limited number of third-party suppliers, and any disruptions could adversely affect product commercialization [123]. - The company relies on independent clinical investigators and contract research organizations for clinical trials, which may impact the approval of product candidates if performance is substandard [179]. - The company is highly dependent on a limited number of third-party suppliers for the production of INGREZZA and CRENESSITY, which poses risks to successful development and commercialization [162].

Financial Performance - Total net product sales for Q4 2025 reached $798.3 million, representing a year-over-year growth of 29%[5] - Full-year 2025 net product sales totaled $2.83 billion, reflecting a year-over-year growth of 22%[5] - INGREZZA net product sales for Q4 2025 were $657.5 million, with a year-over-year growth of 7%[5] - CRENESSITY net product sales for Q4 2025 were $135.3 million, driven by 431 new patient enrollments[5] - Total revenues for the three months ended December 31, 2025, were $805.5 million, a 28.4% increase from $627.7 million in the same period of 2024[19] - Net product sales reached $798.3 million for the three months ended December 31, 2025, compared to $621.2 million in the prior year, reflecting a 28.5% growth[19] - Operating income for the twelve months ended December 31, 2025, was $619.1 million, up from $570.5 million in 2024, representing an 8.5% increase[19] - Net income for the three months ended December 31, 2025, was $153.7 million, compared to $103.1 million in the same period of 2024, marking a 48.9% increase[19] Income and Earnings - GAAP net income for Q4 2025 was $153.7 million, compared to $103.1 million in Q4 2024[10] - Non-GAAP net income for Q4 2025 was $194.6 million, up from $173.4 million in Q4 2024[10] - Non-GAAP net income for the twelve months ended December 31, 2025, was $654.5 million, slightly down from $656.3 million in 2024[23] - Diluted earnings per share (GAAP) for the three months ended December 31, 2025, were $1.48, compared to $1.00 in the same period of 2024, representing a 48% increase[23] Cash and Assets - The company had cash, cash equivalents, and marketable securities totaling approximately $2.54 billion as of December 31, 2025[10] - Cash, cash equivalents, and marketable securities totaled $1,480.4 million as of December 31, 2025, up from $1,076.1 million in 2024, indicating a 37.4% increase[21] - Total assets increased to $4,631.5 million as of December 31, 2025, compared to $3,718.7 million in 2024, reflecting a 24.5% growth[21] Expenses - R&D expenses for full-year 2026 are expected to be between $1.2 billion and $1.25 billion[11] - SG&A expenses for full-year 2026 are projected to be between $1.375 billion and $1.4 billion[11] - Research and development expenses for the twelve months ended December 31, 2025, were $1,015.7 million, up from $731.1 million in 2024, a 38.9% increase[19] - Selling, general, and administrative expenses for the twelve months ended December 31, 2025, were $1,156.2 million, compared to $1,007.2 million in 2024, reflecting a 14.8% increase[19] - GAAP cost of revenues for Q4 2025 was $17.6 million, up from $9.3 million in Q4 2024, representing an increase of 89.2%[27] - GAAP SG&A expenses for Q4 2025 were $301.8 million, compared to $287.8 million in Q4 2024, indicating a rise of 4.0%[27] - Non-GAAP R&D expenses for the twelve months ended December 31, 2025, reached $924.7 million, a significant increase from $662.3 million in 2024, reflecting a growth of 39.5%[27] - Non-GAAP SG&A expenses for the twelve months ended December 31, 2025, totaled $1,024.9 million, up from $862.5 million in 2024, marking an increase of 18.8%[27] Other Income and Adjustments - GAAP other income for the twelve months ended December 31, 2025, was $86.3 million, a recovery from a loss of $84.5 million in 2024[27] - Non-GAAP other income for Q4 2025 was $25.7 million, compared to $22.5 million in Q4 2024, showing an increase of 14.2%[27] - The amortization of acquired intangible assets for Q4 2025 was $1.1 million, slightly up from $0.9 million in Q4 2024[27] - Stock-based compensation expense in GAAP R&D for Q4 2025 was $24.4 million, compared to $21.2 million in Q4 2024, reflecting a rise of 15.1%[27] - Charges associated with convertible senior notes were not reported in the current period, contrasting with $138.4 million in the previous year[27] - Changes in fair values of equity investments resulted in a loss of $2.7 million in Q4 2025, compared to a gain of $1.9 million in Q4 2024[27]

Core Insights - Neurocrine Biosciences reported strong financial results for Q4 and full-year 2025, with net product sales of $798.3 million for Q4 and $2.83 billion for the full year, reflecting year-over-year growth of 29% and 22% respectively [1][2] - The company anticipates 2026 net product sales for INGREZZA to be between $2.7 billion and $2.8 billion, indicating continued growth potential [1][2] - The CEO emphasized the company's focus on sustainable growth and advancing its pipeline, including Phase 3 programs for osavampator and direclidine [1][2] Financial Performance - Q4 2025 net product sales for INGREZZA were $657.5 million, a 7% increase year-over-year, while full-year sales reached $2.51 billion, up 9% [1][2] - CRENESSITY's Q4 and full-year 2025 net product sales were $135.3 million and $301.2 million, respectively, with significant new patient enrollments [1][2] - Total revenues for Q4 2025 were $805.5 million, compared to $627.7 million in Q4 2024, and full-year revenues were $2.86 billion, up from $2.36 billion in 2024 [3][4] Research and Development Updates - The company initiated a Phase 2 clinical study for NBI-1065890, targeting tardive dyskinesia, leveraging its expertise in VMAT2 inhibition [1][2] - Neurocrine's R&D Day highlighted ongoing Phase 3 programs for osavampator in major depressive disorder and direclidine in schizophrenia, indicating a robust pipeline [1][2] - The company is expanding its corticotropin releasing factor (CRF) platform to target metabolic diseases, including obesity [1][2] Market Position and Strategy - Neurocrine's strategic investments in R&D and commercial initiatives are aimed at supporting the growth of INGREZZA and the launch of CRENESSITY [2][3] - The company reported over 80% reimbursement coverage for CRENESSITY prescriptions, indicating strong market acceptance [1][2] - The financial guidance for 2026 reflects ongoing commercial initiatives and expansion of sales teams to support product growth [2][3]

Core Insights - Neurocrine Biosciences has initiated a Phase 2 clinical study for NBI-1065890, a selective VMAT2 inhibitor aimed at treating tardive dyskinesia (TD) [1][2] - The study will involve approximately 100 adult subjects and will evaluate the efficacy, safety, and tolerability of NBI-1065890 compared to a placebo, with the primary endpoint being the change in AIMS dyskinesia total score at Week 8 [2] Company Overview - Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological, psychiatric, endocrine, and immunological disorders, with a history of successful drug development including valbenazine for TD [3][6] - The company has a robust pipeline with multiple compounds in mid- to late-phase clinical development, reflecting its commitment to addressing under-treated conditions [6] Tardive Dyskinesia (TD) Context - TD is a movement disorder characterized by uncontrolled and repetitive movements, often resulting from the use of certain antipsychotic medications, affecting an estimated 800,000 adults in the U.S. [4][5] - The condition can lead to significant disruption in patients' lives, highlighting the need for effective treatment options [4]

Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? Neurocrine Biosciences (NBIX) , which belongs to the Zacks Medical - Drugs industry, could be a great candidate to consider.This biopharmaceutical company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 18.64%.For the most recent quarter, Neuro ...

Core Insights - Neurocrine Biosciences, Inc. has scheduled its fourth quarter and year-end 2025 financial results conference call and webcast for February 11, 2026, at 1:30 p.m. Pacific Time [1][4] - The company is focused on developing treatments for neurological, psychiatric, endocrine, and immunological disorders, with a diverse portfolio that includes FDA-approved treatments and a robust pipeline [2] Company Overview - Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed conditions [2] - The company's portfolio includes treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids, with some products developed in collaboration with AbbVie [2] - The company has been applying its insights into neuroscience for three decades to address complex conditions and aims to ease the burden of debilitating diseases [2]

These data are consistent with our integrated understanding of the TO of INGREZZA and drug exposure concentrations observed from INGREZZA in pivotal clinical trials. The superior target engagement observed with INGREZZA may be related to its single high affinity metabolite, compared with AUSTEDO XR, which generates multiple metabolites, including those with lower VMAT2 affinity. SAN DIEGO, Jan. 15, 2026 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of the first ...