Core Insights - Neurocrine Biosciences is advancing a diversified pipeline of first- and best-in-class medicines across therapeutic modalities, including two Phase 3 programs targeting major depressive disorder and schizophrenia, with expectations to deliver an approved medicine every two years by the end of the decade [2][4] R&D Strategy - The company has unveiled a transformed R&D engine aimed at delivering at least four new Phase 1 and two Phase 2 programs annually, focusing on genetically or clinically validated mechanisms of action [4] - The R&D strategy is designed to create long-term value and accelerate the delivery of new medicines for patients [3][4] Pipeline Highlights - Osavampator is a potential first-in-class AMPA positive allosteric modulator for major depressive disorder, with topline data from three ongoing Phase 3 studies expected in 2027 [5] - Direclidine is an M4 muscarinic agonist for psychiatric disorders, with topline data from ongoing studies expected in 2027 and 2028 [5] - The pipeline includes next-generation VMAT2 inhibitors and a suite of differentiated assets for better quality weight loss, including a CRF2 agonist expected to enter Phase 1 development in the first half of 2026 [5] Leadership and Vision - The CEO emphasized the company's commitment to developing novel therapies across metabolic diseases, starting with obesity, aiming for superior weight loss while preserving muscle mass [3] - The company has a proven track record in drug development and commercialization, positioning it uniquely to advance its pipeline and create sustained value for stakeholders [3]

Neurocrine Biosciences (NasdaqGS:NBIX) 2025 R&D Day December 16, 2025 12:00 PM ET Speaker0Good morning and good afternoon. My name is Todd Tushla. I'm the Vice President of Investor Relations at Neurocrine Biosciences, and on behalf of our entire company, welcome to our 2025 R&D Day. Whether you're here in person, on the webcast, or reading the transcript, we're grateful for your time. We will be making forward-looking statements today to refer you to our latest SEC disclosures. Our speakers for today from ...

Company Strategy & R&D Transformation - Neurocrine Biosciences is positioned as a diversified neuroscience and endocrinology leader aiming for sustainable growth and value creation[12] - The company aims to deliver a new medicine every two years, driven by a redesigned R&D organization[30, 31, 132] - R&D transformation includes a goal to advance 20 development candidates in 5 years, focusing on clinically or genetically validated targets[94, 99, 101] - The company is diversifying its therapeutic areas beyond neurology and psychiatry to include endocrinology and immunology[23, 94, 100] - New modalities, including peptides, antibodies, and gene therapy, now represent approximately 60% of the portfolio across therapeutic areas[105] Neuropsychiatry Pipeline - The neuropsychiatry pipeline is positioned to deliver multiple first- and best-in-class medicines this decade[12] - Osavampator, an AMPA PAM, is in Phase 3 development for Major Depressive Disorder (MDD), with data expected in 2027[23, 59] - Phase 2 SAVITRI study results showed statistically significant improvements in depression severity with osavampator, with an effect size of 0.53 at day 28 and 0.73 at day 56 for the 1mg dose[52, 55] - Direclidine, an M4 agonist, is in Phase 3 development for schizophrenia, with initial topline data expected in 2027[23, 77] - Phase 2 data for direclidine showed a PANSS total score change from baseline of -18.2 at week 6, with a change vs placebo of -7.5 (p=0.011) and an effect size of 0.61[73] Endocrinology Pipeline - The company is leveraging its Corticotropin Releasing Factor (CRF) biology expertise to expand in endocrinology and metabolic disease[12, 137] - NBIP-'2118, a CRF2 agonist, is being developed for obesity, with a Phase 1 study planned for the first half of 2026[159]

Core Viewpoint - Nxera Pharma is undergoing a focused restructuring to concentrate investments on high-value programs and reduce operating expenses, aiming for net sales of ≥JPY50 billion and an operating profit margin of ≥30% by 2030 [1][5] Restructuring Objectives - The restructuring aims to prioritize high-probability, high-return programs and streamline operations to enhance efficiency and accelerate program progression [5][6] - A portfolio review has identified non-priority programs for potential partnership or termination, focusing on next-generation therapies for obesity and metabolic disorders [6][12] Financial Strategy - Nxera plans to reduce cash R&D expenditure by approximately JPY3.5 billion in FY2026 and expects a minimum of JPY1.0 billion in year-on-year savings [6][11] - The company maintains a strong cash position with current cash and liquid investments of JPY30.9 billion, allowing flexibility in executing its strategy [6][11] Leadership Changes - Dr. Patrick Foerch has been appointed as Chief Scientific Officer and President of Nxera Pharma UK, bringing significant experience to enhance R&D focus [5][9] - The executive team will be reduced from ten to seven members by March 2026, and a workforce reduction of approximately 15% will occur across Japan and UK operations [6][11] R&D Focus - Nxera will leverage its NxWave™ platform, utilizing AI technology to enhance drug discovery and development, particularly in GPCR-targeted programs [6][12] - The company has an extensive pipeline of over 30 active programs, with several partnered programs progressing through clinical development [12]