分组1 - Neurocrine Biosciences reported quarterly earnings of $1.88 per share, missing the Zacks Consensus Estimate of $2.25 per share, representing an earnings surprise of -16.55% [1] - The company posted revenues of $805.5 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 2.89%, compared to year-ago revenues of $627.7 million [2] - Neurocrine has surpassed consensus revenue estimates four times over the last four quarters [2] 分组2 - The stock has underperformed the market, losing about 3% since the beginning of the year, while the S&P 500 gained 1.4% [3] - The current consensus EPS estimate for the coming quarter is $1.75 on revenues of $736.77 million, and for the current fiscal year, it is $8.70 on revenues of $3.35 billion [7] - The Zacks Industry Rank for Medical - Drugs is currently in the bottom 42% of over 250 Zacks industries, indicating potential underperformance compared to the top 50% of ranked industries [8]

Financial Data and Key Metrics Changes - Neurocrine's 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 [11][12] - INGREZZA generated just over $2.5 billion in revenue, up 9% year-over-year, with expectations of sales in the range of $2.7 billion to $2.8 billion in 2026, indicating 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, reflecting 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 sales force expansion [5][11] - CRENESSITY achieved over $300 million in net product sales in its first full year, with prescriptions covering over 10% of the classic congenital adrenal hyperplasia patient population [12][13] - The company expects double-digit volume-driven growth for INGREZZA, supported by continued demand from patients not currently taking a VMAT2 inhibitor [6][11] Market Data and Key Metrics Changes - Approximately 10% of the classic CAH population in the U.S. has been prescribed CRENESSITY, with the potential for further growth as the company expands its reach beyond endocrinologists [22][82] - The market for VMAT2 inhibitors, including INGREZZA, remains underpenetrated, with only about 10% of the prevalent TD population currently taking a VMAT2 inhibitor [23] Company Strategy and Development Direction - Neurocrine aims to lead the VMAT2 category by leveraging its experience with INGREZZA to advance next-generation VMAT2 inhibitors [8] - The company is focused on expanding its pipeline, with late-stage programs in neuropsychiatry and ongoing investments in R&D to support future growth [9][27] - The strategy includes expanding the CRENESSITY sales force and leveraging technology to identify and engage potential prescribers [21][83] 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 its strategies [10][16] - The management team highlighted the importance of ongoing education for prescribers and patients regarding the benefits of CRENESSITY and the limitations of existing treatments [88] Other Important Information - The company achieved its phase I through phase III objectives for the first time in 2025, marking it as the most productive clinical year in its history [9] - Neurocrine's R&D expenses are expected to increase in 2026 due to investments in phase III programs, with a focus on delivering one new medicine every two years at steady state [15][47] Q&A Session Summary Question: Insights on CRENESSITY's early performance and patient dynamics - Management noted that while they are not providing specific guidance for CRENESSITY, they anticipate steady new patient additions and a strong growth year based on positive feedback and demand dynamics [34][51] Question: Impact of receptor occupancy data on future VMAT2 inhibitors - The management highlighted that INGREZZA demonstrated nearly double the VMAT2 target occupancy compared to Austedo XR, indicating superior efficacy, which will inform the development of next-generation VMAT2 inhibitors [38] Question: Barriers to further adoption of CRENESSITY - Management identified lack of knowledge among endocrinologists as a barrier and emphasized the importance of educational efforts to inform prescribers about the benefits of CRENESSITY over traditional glucocorticoid treatments [86]

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 ...