Core Points - Neurocrine Biosciences announced the retirement of CEO Kevin Gorman, effective October 11, 2024, with Kyle Gano appointed as CEO-elect [1][2] - Under Dr. Gorman's leadership since 2008, Neurocrine has developed a strong financial position and a mature pipeline, including the successful commercial product INGREZZA® [2][3] - The company has submitted two New Drug Applications for crinecerfont to the FDA for treating classic congenital adrenal hyperplasia [2] - Neurocrine currently has 17 clinical development programs focusing on neurology, neuroendocrinology, and neuropsychology [2] Company Overview - Neurocrine Biosciences is a neuroscience-focused biopharmaceutical company dedicated to developing treatments for under-addressed neurological, neuroendocrine, and neuropsychiatric disorders [6] - The company has a diverse portfolio that includes FDA-approved treatments for tardive dyskinesia and chorea associated with Huntington's disease, as well as a robust pipeline in mid- to late-phase clinical development [6] - INGREZZA is the only once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved for treating adults with tardive dyskinesia and chorea associated with Huntington's disease [7][8] Leadership Transition - Dr. Gorman expressed confidence in Dr. Gano's ability to lead the company into its next growth phase, highlighting their long-standing collaboration [3] - Dr. Gano has over 23 years of experience at Neurocrine, with a focus on business and corporate development, and has played a key role in the company's strategic collaborations and FDA-approved medicines [4][5] - The Board of Directors is optimistic about Dr. Gano's leadership and vision for the future of Neurocrine [3]

- CAHtalyst™ Phase 3 Baseline Characteristics Highlight Limitations of Current CAH Treatment Paradigm in Children, Adolescents and Adults - Phase 2 Study for Modified-Release Hydrocortisone in Adults with Adrenal Insufficiency Demonstrated Participants Achieved Physiological Morning Cortisol Levels after 4 Weeks - Phase 3 Extension Study Data for Modified-Release Hydrocortisone in Adults with CAH Demonstrated Reduction in Median Daily Hydrocortisone Dose and an Increase in Responders at Levels ≤ 25 mg/day S ...

CAHtalyst™ Study Baseline Characteristics Highlight the Need for New Treatment Options to Reduce Adrenal Androgens and Supraphysiologic Glucocorticoid Dosing in CAH Adult Patients Comprehensive Literature Review Identified Potential Psychological and Cognitive Impact of High Glucocorticoid Doses in CAH Patients SAN DIEGO, May 9, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present CAHtalyst™ Adult Phase 3 clinical study baseline characteristics for adults w ...

SAN DIEGO, May 9, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1076986 in healthy adult participants. NBI-1076986 is an investigational, oral, M4 subtype-selective muscarinic acetylcholine receptor antagonist for the potential treatment of movement disorders that was discovered and developed by Neurocrine ...

Tokyo, Japan and Cambridge, UK, 9 May 2024 – Nxera Pharma ("the Company" or "Nxera"; TSE: 4565) notes that its partner Neurocrine Biosciences Inc. (("Neurocrine", NASDAQ:NBIX), a leading neuroscience-focused biopharmaceutical company, announced that it has initiated its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants – see Neurocrine press announcement here. NBI-1117567 is ...

SAN DIEGO, May 8, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions. "Neurocrine Biosciences has the lar ...

Approximately 600,000 people in the United States live with tardive dyskinesia (TD), and about 65% have not yet been diagnosed1-3 The diagnosis rate can be improved by increasing routine TD screenings in people treated with antipsychotic medication4   SAN DIEGO, May 6, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today renewed its commitment to increasing awareness and advancing care for people living with TD during Tardive Dyskinesia Awareness Week, May 5-11. TD is a persistent, invol ...

CAHtalyst™ Pediatric Study Baseline Characteristics Data Highlight Need for Novel Treatments in Children and Adolescents with Congenital Adrenal Hyperplasia (CAH) CAHtalog™ Registry Data of Glucocorticoid Treatment Patterns in Pediatric and Adult Patients Illustrates the Challenges of Long-Term CAH Management SAN DIEGO, May 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today presented the CAHtalyst™ Pediatric Phase 3 clinical study baseline characteristics data for children and ado ...

Financial Data and Key Metrics Changes - The company reported Q1 sales of $506 million, reflecting over 20% year-over-year growth and marking the third consecutive year of sequential growth from Q4 to Q1 [35][38] - The company ended Q1 with over $1.9 billion in cash, demonstrating significant cash flow generation [5] - Operating leverage on a non-GAAP basis increased by over 1,000 basis points when excluding IT R&D investments made in the prior year [35] Business Line Data and Key Metrics Changes - The INGREZZA franchise continues to show strength, with Q1 sales reaching $506 million, representing a 23% year-over-year increase despite seasonal payer challenges [38] - The company is focusing on the commercialization of Crinecerfont and has submitted a new drug application for its treatment of congenital adrenal hyperplasia [16][39] - Positive Phase 2 results were reported for NBI-845, an AMPA potentiator for major depressive disorder, indicating strong efficacy and tolerability [43] Market Data and Key Metrics Changes - The company is actively expanding its presence in the long-term care market, which remains a significant growth area for INGREZZA [129] - The new sprinkle formulation of INGREZZA is expected to benefit 5% to 10% of patients with swallowing difficulties, already integrated into sales forecasts [49] Company Strategy and Development Direction - The company prioritizes the growth of INGREZZA, preparation for Crinecerfont commercialization, and advancing its pipeline while assessing external opportunities [5] - The company aims to enhance awareness and treatment of tardive dyskinesia (TD) and Huntington's chorea, with a focus on educating the CAH community regarding Crinecerfont [39][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the robustness of the data from recent studies and the potential for significant impact on patient lives [33] - The company is optimistic about the likelihood of priority review for Crinecerfont due to the significant unmet need and the breakthrough designation granted [58][60] Other Important Information - The company has reduced its convertible debt from approximately $518 million to $170 million, managing dilution effectively [11] - The FDA approved the new sprinkle formulation of INGREZZA, providing a valuable treatment option for patients with difficulty swallowing [14] Q&A Session Summary Question: On NBI-845, is there any reason mechanistically for not seeing a dose response? - Management indicated that they are encouraged by the positive results and are exploring the data further before making definitive comments [23][48] Question: What percent of patients have trouble swallowing with INGREZZA and the expected impact of the new formulation? - It is estimated that 5% to 10% of patients experience difficulty swallowing, and the impact on sales is already integrated into guidance [49] Question: Can you speak to the likelihood of a priority review for Crinecerfont? - Management expressed hope for a priority review based on the breakthrough designation and robust Phase 3 data submitted [58][60] Question: What are the benefits of having an adaptive trial design for NBI-568? - The adaptive trial design allows for exploring a broader range of doses in a limited number of patients, which is critical for understanding the benefit-risk perspective [62] Question: How does the company plan to manage multiple Phase 3 studies? - The company is prioritizing programs and closely monitoring spending, indicating a willingness to invest in promising data while managing resources effectively [90][91]

Neurocrine Biosciences (NBIX) reported $515.3 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 22.6%. EPS of $0.42 for the same period compares to -$0.79 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $512.21 million, representing a surprise of +0.60%. The company delivered an EPS surprise of -59.62%, with the consensus EPS estimate being $1.04.While investors closely watch year-over-year changes in headline numbers -- revenue and ea ...