Financial Data and Key Metrics Changes - The company reported first quarter product sales of $545 million for INGREZZA, with a reaffirmed sales guidance range for 2025 of $2.5 billion to $2.6 billion, reflecting expected acceleration in new patient additions despite gross to net impacts from contracting activities [8][9][10] - The company has approximately $1.8 billion in cash, supporting its commercial and clinical development strategies for continued growth [11] Business Line Data and Key Metrics Changes - INGREZZA achieved record new patient starts in the first quarter, indicating strong demand and unmet medical needs [9][12] - KRONESITY generated $15 million in net revenue during its first full quarter of launch, with 70% of dispensations receiving reimbursement [10][16] Market Data and Key Metrics Changes - The formulary coverage for INGREZZA in Medicare Part D expanded from less than half to approximately two-thirds, improving patient access [14] - The company noted that 70% of the dispensers for KRONESITY were reimbursed, although most reimbursement was through the exceptions process rather than formal reviews [40] Company Strategy and Development Direction - The company aims to evolve from a single blockbuster to a multiple blockbuster neuroscience company, focusing on both near and long-term revenue growth [5][7] - The R&D portfolio is advancing, with ongoing Phase III studies for osevampatore and MBI-568, and plans to expand the muscarinic portfolio into new Phase II studies later this year [6][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum from record new patient starts and the potential for growth in the second quarter and beyond, despite challenges in the reauthorization process and market dynamics [31][32] - The management team highlighted the importance of continued investment in sales force expansion and marketing initiatives to strengthen INGREZZA's market position [15][16] Other Important Information - The company is transitioning leadership, with Dr. Eiry Roberts moving to a strategic advisory role and Dr. Sanjay Keswani set to become the new Chief Medical Officer [6][25] - The company is focused on increasing awareness and reducing stigma around tardive dyskinesia, collaborating with various organizations to improve patient access to treatment [12][14] Q&A Session Summary Question: Insights on INGREZZA's performance and future growth - Management acknowledged challenges in Q1 but noted record new patient starts, indicating strong momentum going into Q2 and the rest of the year [31][32] Question: Expectations for KRONESITY's adoption and reimbursement dynamics - Management indicated that while initial adoption exceeded expectations, it is too early to define long-term trends, and they will continue to monitor reimbursement patterns [35][40] Question: Share dynamics between INGREZZA and competitors - Management stated that INGREZZA continues to hold a majority share in the tardive dyskinesia market, with ongoing efforts to differentiate from competitors [44] Question: Insights on patient demographics for KRONESITY - Management noted an early trend towards greater uptake in pediatric and adolescent patients compared to adults, aligning with pre-launch expectations [46][69] Question: Contracting strategies and pricing trends for INGREZZA - Management emphasized a focus on maximizing patient access through prudent contracting, with no immediate changes anticipated but ongoing monitoring of the environment [59][82]

Financial Data and Key Metrics Changes - Neurocrine Biosciences reported $545 million in product sales for INGREZZA in Q1 2025, impacted by one less order week and patient reauthorization processes [9] - The company reaffirmed its 2025 sales guidance range for INGREZZA at $2.5 billion to $2.6 billion, factoring in expected acceleration of new patient additions [10][11] - The company has approximately $1.8 billion in cash to support its commercial and clinical development strategies [12] Business Line Data and Key Metrics Changes - INGREZZA achieved record new patient starts in Q1 2025, indicating strong demand despite market challenges [10][14] - KRONESITY generated $15 million in net revenue in its first full quarter of launch, with 70% of dispensers receiving reimbursement [11][19] - The company expanded formulary coverage in Medicare Part D, increasing patient access for INGREZZA [10][16] Market Data and Key Metrics Changes - The payer environment has been influenced by the Inflation Reduction Act, affecting prior authorization processes for both new and continuing patients [16] - Approximately 40% of patients with tardive dyskinesia (TD) have been diagnosed, with less than 10% receiving standard care treatment [15] Company Strategy and Development Direction - The company aims to evolve from a single blockbuster to a multiple blockbuster neuroscience company, focusing on both near and long-term revenue growth [6] - Neurocrine is advancing its R&D portfolio, with ongoing Phase III studies for osevampatore and MBI-568, and plans to expand its muscarinic portfolio into new Phase II studies [7][23] - The leadership transition includes welcoming Dr. Sanjay Keswani as the new Chief Medical Officer [7][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum from record new patient starts and the potential for growth in Q2 and beyond [35][36] - The company is optimistic about the early adoption of KRONESITY and expects continued growth in the pediatric and adolescent segments [19][70] Other Important Information - The company has retired 3.6 million shares over the past two quarters, reflecting a commitment to returning capital to shareholders [12] - The transition of Dr. Eiry Roberts to a strategic advisory role marks a significant change in leadership, with a focus on maintaining the momentum in the company's pipeline [27] Q&A Session Summary Question: What are the expectations for INGREZZA in Q2? - Management noted that Q1 challenges were anticipated, but record new patient starts provide confidence for Q2 growth [34][35] Question: How should KRONESITY's initial numbers be interpreted? - Management indicated that it is too early to define a trend for KRONESITY, but initial adoption has exceeded expectations [37][38] Question: What are the reimbursement dynamics for KRONESITY moving forward? - The company expects some health plans to conduct formal reviews of KRONESITY, but initial reimbursement metrics are favorable [41][44] Question: Can you provide insights on the share split between INGREZZA and Teva? - Management stated that INGREZZA continues to hold the majority share in TD prescriptions, with trends aligning with expectations [48] Question: What is the expected growth for INGREZZA in Q2? - Management anticipates a nice step up in sales due to one additional order week and record new patient starts, despite some gross to net impacts [53][54] Question: What is the timeline for KRONESITY data from ongoing studies? - Management plans to release one-year data on KRONESITY at upcoming medical meetings, with a focus on various clinical endpoints [99]

Sales Performance - INGREZZA net product sales reached $545.2 million in Q1 2025, up from $506.0 million in Q1 2024, reflecting strong patient demand and improved gross-to-net dynamics [97]. - CRENESSITY, launched in December 2024, generated $14.5 million in net product sales for Q1 2025 [93]. - Total net product sales for Q1 2025 were $563.7 million, compared to $509.0 million in Q1 2024, marking an increase of approximately 10.5% [97]. - Collaboration revenues increased to $8.9 million in Q1 2025 from $6.3 million in Q1 2024, primarily due to higher royalties from AbbVie and MTPC [98]. Expenses - Total research and development expenses for Q1 2025 were $263.2 million, up from $159.4 million in Q1 2024, driven by increased investment in late-stage programs [102]. - Selling, general, and administrative expenses rose to $276.5 million in Q1 2025 from $243.1 million in Q1 2024, reflecting investments in the commercial organization [110]. - Net income for Q1 2025 was $7.9 million, a decrease from $43.4 million in Q1 2024, attributed to higher development milestone expenses and increased operational costs [113]. Share Repurchase Program - The company authorized a new share repurchase program of up to $500.0 million in February 2025, in addition to a completed $300.0 million repurchase program [95]. - The 2025 Repurchase Program allows for the repurchase of up to $500.0 million of common stock, in addition to the completed $300.0 million program from 2024 [123]. - Cash flows from financing activities included $150.0 million in common stock repurchases under the 2025 Repurchase Program, with $350.0 million remaining available for future repurchases [123]. Cash Flow and Working Capital - Total cash, cash equivalents, and marketable securities decreased from $1,815.6 million on December 31, 2024, to $1,758.8 million on March 31, 2025, a decline of approximately 3.1% [115]. - Cash flows from operating activities fell significantly from $130.3 million in Q1 2024 to $64.8 million in Q1 2025, representing a decrease of about 50.2% [116]. - Cash flows from investing activities showed a positive change of $14.2 million in Q1 2025, compared to a negative $55.0 million in Q1 2024 [116]. - Total working capital decreased from $1,217.0 million on December 31, 2024, to $1,115.0 million on March 31, 2025, a reduction of approximately 8.4% [115]. Clinical Development - The company initiated a Phase 3 clinical study for osavampator in major depressive disorder, incurring a $37.5 million milestone expense in Q1 2025 [100]. Future Commitments - The company has potential future payments of up to $14.8 billion related to existing collaboration and license agreements upon achieving certain milestones [121]. Investment Portfolio - The company maintains a diversified investment portfolio with low-risk, investment-grade debt securities, and a 1% unfavorable change in interest rates would not materially affect the fair value of this portfolio [125]. Operational Focus - The company is focused on expanding its commercial organization, including the psychiatry and long-term care sales team, which was completed in September 2024 [117]. - The company experienced an increase in accounts receivable due to timing impacts of customer orders and cash collections [117]. Regulatory Status - INGREZZA qualifies for the small biotech exception under the Medicare Drug Price Negotiation Program, providing exemption from selection until 2027 [95].

Sales Performance - INGREZZA (valbenazine) first-quarter 2025 net product sales reached $545 million, an 8% increase compared to the first quarter of 2024[5] - CRENESSITY (crinecerfont) first-quarter 2025 net product sales were $14.5 million, with 413 total patient enrollment start forms indicating strong initial demand[5] - The company reaffirms 2025 net product sales guidance for INGREZZA in the range of $2.5 billion to $2.6 billion[2] - Total revenues for the first quarter of 2025 were $572.6 million, compared to $515.3 million in the first quarter of 2024[6] - Total revenues for the three months ended March 31, 2025, were $572.6 million, a 11.1% increase from $515.3 million in the same period of 2024[18] - Net product sales increased to $563.7 million, up 10.7% from $509.0 million year-over-year[18] Income and Earnings - GAAP net income for the first quarter of 2025 was $7.9 million, down from $43 million in the same period of 2024[9] - Non-GAAP net income for the first quarter of 2025 was $71.5 million, compared to $124.8 million in the first quarter of 2024[9] - Operating income decreased to $23.6 million, down 76.2% from $99.3 million in the same quarter of 2024[18] - Net income for the quarter was $7.9 million, a decline of 81.8% from $43.4 million in the previous year[18] - Non-GAAP net income was reported at $71.5 million, down 42.7% from $124.8 million in the same quarter of 2024[22] - Diluted earnings per share (EPS) on a GAAP basis was $0.08, compared to $0.42 in the prior year, reflecting an 81.0% decrease[22] Research and Development - The company initiated Phase 3 registrational programs for osavampator in major depressive disorder and NBI-'568 in schizophrenia[7] - Research and development expenses rose significantly to $263.2 million, a 65.1% increase compared to $159.4 million in the prior year[18] - The company plans to invest $960 million to $1.010 billion in GAAP R&D expenses for the full year 2025[10] Financial Position - The company has approximately $1.8 billion in cash, cash equivalents, and marketable securities as of March 31, 2025[9] - Cash, cash equivalents, and marketable securities totaled $943.5 million as of March 31, 2025, down from $1,076.1 million at the end of 2024[20] - Total assets decreased to $3,687.7 million from $3,718.7 million at the end of 2024[20] - Stockholders' equity declined to $2,535.7 million, down from $2,589.7 million at the end of the previous year[20] Share Repurchase - A second share repurchase program was announced to repurchase up to $500 million of outstanding common stock, with $150 million already repurchased as of March 31, 2025[9]

Financial Performance - Neurocrine Biosciences reported first-quarter 2025 net product sales of INGREZZA at $545 million, an 8% increase compared to the same period in 2024, driven by record new patient starts and improved gross-to-net dynamics [6][8] - CRENESSITY generated first-quarter net product sales of $14.5 million, with 413 total patient enrollment start forms, indicating strong initial demand and approximately 70% reimbursement coverage for dispensed scripts [6][8] - Total revenues for the first quarter of 2025 reached $572.6 million, compared to $515.3 million in the first quarter of 2024 [8][19] Research and Development - The company initiated two Phase 3 registrational programs: osavampator for major depressive disorder and NBI-1117568 for schizophrenia, positioning itself for future growth [4][6] - A Phase 4 study, KINECT-PRO™, demonstrated clinically meaningful effects of INGREZZA on patients with tardive dyskinesia, regardless of severity [6][8] Financial Guidance - Neurocrine reaffirmed its 2025 financial guidance for INGREZZA net product sales between $2.5 billion and $2.6 billion [2][10] - The company expects GAAP R&D expenses to be in the range of $960 million to $1.010 billion and GAAP SG&A expenses between $1.110 billion and $1.130 billion for the full year 2025 [10][11] Corporate Developments - Sanjay Keswani, M.D., was appointed as Chief Medical Officer effective June 2, 2025, enhancing the executive management team [6][8] - The company completed a $300 million accelerated share repurchase program and announced a second program to repurchase up to $500 million of outstanding common stock [9][10]

Core Insights - The survey conducted by The Harris Poll highlights the significant negative impact of tardive dyskinesia (TD) on patients' daily lives, emphasizing the need for routine screening, earlier diagnosis, and treatment [1][2][3] Functional Impact - 80% of patients with TD wished they had been screened earlier, and 86% wanted their healthcare providers to discuss treatment options sooner [1][4] - 43% of all patients and 40% of those with mild/moderate TD required assistance with daily activities due to their symptoms [4] - 41% of all patients and 40% of those with mild/moderate TD were unable to perform their job functions because of their symptoms [4] Psychological Impact - 86% of patients felt judged or stared at due to their movements, and 82% agreed that their uncontrolled movements brought unwanted attention to their mental health condition [4] - 80% of patients felt that others made incorrect assumptions about them because of their movements [4] Social Impact - 56% of all patients and 55% of those with mild/moderate TD avoided going out in public [4] - 44% of all patients and 46% of those with mild/moderate TD avoided leaving home [4] - 40% of all patients and 43% of those with mild/moderate TD experienced limited professional interactions [4] - 40% of all patients and 34% of those with mild/moderate TD missed work or school due to their symptoms [4] Awareness and Education - The survey results indicate a need for continued education about TD, especially among individuals taking antipsychotic medications [3][5] - Only 47% of patients were informed by their providers about the potential contribution of their mental health medications to their symptoms prior to diagnosis [10] - 83% of people with TD wished they had been encouraged to discuss their uncontrolled movements with healthcare providers earlier [10] Company Commitment - Neurocrine Biosciences is dedicated to improving awareness and education regarding TD, providing resources for patients and healthcare professionals [8][12]

Core Viewpoint - Nxera Pharma's partner Neurocrine Biosciences has initiated a Phase 3 clinical trial for NBI-1117568, an investigational treatment for schizophrenia, following positive Phase 2 results [1][6]. Company Overview - Nxera Pharma is a biopharma company focused on developing specialty medicines for unmet medical needs, leveraging its NxWave™ discovery platform [11][12]. - The company has a pipeline of over 30 active programs targeting neurology, neuropsychiatry, metabolic diseases, and immunology [12]. Clinical Development - NBI-1117568 is the first oral muscarinic M4 selective orthosteric agonist in clinical development for schizophrenia, with a unique mechanism aimed at improving safety and efficacy [5][8]. - The Phase 3 study will enroll approximately 280 patients and will evaluate the drug's efficacy using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression of Severity (CGI-S) scale [2][6]. Financial Aspects - No milestone payment is due from Neurocrine to Nxera at the start of the Phase 3 trial, but a US$15 million milestone payment is expected upon dosing the first patient [3]. Market Context - Schizophrenia affects approximately 24 million people globally, with annual costs exceeding $150 billion in the U.S., highlighting the significant need for effective treatments [10].

Core Insights - Neurocrine Biosciences has initiated a Phase 3 registrational program for NBI-1117568, an investigational oral muscarinic M4 selective orthosteric agonist aimed at treating schizophrenia, following positive Phase 2 data reported in August 2024 [1][2][3] Company Overview - Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a diverse portfolio including FDA-approved treatments and a robust pipeline [8] Clinical Development - The Phase 3 study is a global double-blind, placebo-controlled trial targeting approximately 280 patients with schizophrenia experiencing acute exacerbation or relapse of symptoms, with primary and secondary endpoints focused on PANSS and CGI-S scale improvements [2][3] - NBI-1117568 is the first oral muscarinic M4 selective orthosteric agonist in clinical development for schizophrenia, potentially offering a novel mechanism with an improved safety profile [3][4] Market Need - Schizophrenia affects approximately 24 million people globally, with annual costs exceeding $150 billion in the U.S., highlighting the significant need for innovative treatment options [6][7] Clinical Results - The Phase 2 study demonstrated a statistically significant reduction in PANSS total score with a placebo-adjusted mean reduction of 7.5 points and an 18.2-point reduction from baseline, indicating the efficacy of NBI-1117568 [6]

Group 1 - The article discusses Neurocrine Biosciences (NASDAQ: NBIX) and highlights a previous analysis regarding a buying opportunity following a stock price drop related to schizophrenia data [2] - The author operates the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and includes a library of over 600 biotech investing articles [2] - The service offers a model portfolio of more than 10 small and mid-cap stocks, along with live chat and various analysis and news reports to assist healthcare investors [2] Group 2 - The article does not contain any specific financial data or performance metrics related to Neurocrine Biosciences or the broader biotech industry [1][3][4]

Company Overview - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) is a San Diego-based drug developer that completed its initial public offering (IPO) in 1996, raising $36.75 million [2]. Investment Insights - The investment group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including catalysts to watch for, buy and sell ratings, product sales forecasts, and integrated financial statements [2]. Analyst Background - The article is authored by a biotech consultant with over 5 years of experience covering biotech, healthcare, and pharma, having prepared detailed reports on over 1,000 companies [2].