Summary of Neurocrine Biosciences FY Conference Call Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Date**: September 17, 2025 - **Key Speakers**: Kyle Gano (CEO), Sanjay Keswani (CMO), Todd Tushla (VP of Investor Relations) Key Points R&D Strategy and Pipeline - Neurocrine is shifting its R&D strategy to focus on internal drug discovery rather than solely in-licensing programs, aiming to enhance R&D productivity [2][3] - The company plans to initiate four new phase 1 programs, two new phase 2 programs, and maintain at least three programs in phase 3 development annually, potentially leading to one new medicine every two years [4] - Therapeutic areas of focus include neurology, psychiatry, endocrinology, and immunology, with a particular emphasis on CNS-related targets [5][6] Portfolio Risk Management - The current portfolio is weighted more towards psychiatry due to recent successes, with future expectations of a balanced distribution: 40-50% neurology, 20-30% psychiatry, 10-20% endocrinology, and 10-20% immunology [8][9] Specific Programs - **NBI-770**: An NMDA negative allosteric modulator for major depressive disorder (MDD), aiming for efficacy similar to Spravato but with fewer side effects. Phase 2 data expected by late 2025 [10][11] - The study involves 72 patients, focusing on changes in MADRS scores by day five [11][12] - **Osavampator**: An AMPA potentiator with positive phase 2 data, showing significant efficacy and a favorable safety profile. Phase 3 trials are ongoing, with data expected in 2027 [16][19] - The most effective dose showed a MADRS effect size of 0.55 to 0.75, indicating strong efficacy [19][20] - **NBI-568**: A treatment for schizophrenia, with phase 2 results showing a significant improvement in PANSS scores. The best-performing dose was 20 mg once daily, with a placebo-corrected improvement of 7.5 points and an effect size of 0.61 [35][37] Market Performance and Financials - In Q2, Neurocrine reported $682 million in revenue, a 17% year-over-year growth, driven by Ingrezza and CRENESSITY [54][55] - Ingrezza achieved record back-to-back NRX quarters and a record TRX quarter in Q2, indicating strong market performance [54] Future Outlook - The company is optimistic about its evolving R&D strategy and the potential of its pipeline to address significant unmet needs in neuropsychiatric conditions [6][55] - The focus on validated biological pathways and diverse mechanisms of action aims to enhance treatment options for patients with major depressive disorder and schizophrenia [27][50] Additional Insights - The company emphasizes the importance of safety and tolerability in its drug development, particularly for chronic psychiatric conditions [50] - Neurocrine's approach to managing clinical trials aims to simplify processes and enhance the likelihood of positive outcomes, learning from past industry experiences [43][45] This summary encapsulates the key discussions and insights from the Neurocrine Biosciences FY Conference Call, highlighting the company's strategic direction, pipeline developments, and market performance.

Company Highlights - Neurocrine expects $2.5 billion in sales for INGREZZA this year, indicating strong market performance [3] - The launch of CRENESSITY, the first new medicine in over 70 years for congenital adrenal hyperplasia, has started off strongly [3] - Neurocrine has initiated two major Phase III programs: one for osavampator targeting major depressive disorder and another for a muscarinic program related to schizophrenia [4]

Core Insights - Neurocrine Biosciences reported strong Q2 2025 earnings, with Non-GAAP diluted EPS of $1.65, exceeding analyst expectations of $0.96, and GAAP revenue of $687.5 million, surpassing estimates of $653.9 million [1][2][7] Financial Performance - Non-GAAP diluted EPS increased by 1.2% year-over-year from $1.63 [2] - GAAP revenue rose 16.5% year-over-year from $590.2 million [2] - INGREZZA net product sales were $624.4 million, up 7.7% year-over-year [2] - CRENESSITY generated $53.2 million in its first full quarter post-launch [2] - Non-GAAP R&D expenses increased by 27.1% to $222.7 million year-over-year [2] Product Highlights - INGREZZA continued to drive financial health with a 15% sequential increase in sales over Q1 2025, supported by robust patient demand and expanded Medicare coverage [5] - CRENESSITY showed strong initial demand with 664 new patient start forms and 76% reimbursement coverage, particularly among pediatric patients [6] Company Background - Neurocrine specializes in pharmaceuticals for neurological and endocrine diseases, with INGREZZA as its primary revenue driver for tardive dyskinesia and chorea associated with Huntington's disease [3] - The launch of CRENESSITY for congenital adrenal hyperplasia (CAH) enhances the company's commercial portfolio [3] Strategic Focus - Future success relies on the sustained performance of INGREZZA, the launch trajectory of CRENESSITY, and advancing the drug pipeline through late-stage clinical trials [4] - The company emphasizes diversification beyond INGREZZA and is investing in several neuroscience programs [10] Operational Metrics - Total GAAP operating expenses increased by 21.9% year-over-year, reflecting higher spending on new product launches and pipeline advancements [12] - The company ended the quarter with $1.85 billion in cash and investments, supporting share repurchases and future investments [9][13] Outlook - Management updated the sales outlook for INGREZZA to $2.5–$2.55 billion for FY2025, reflecting expectations for continued double-digit volume growth [14] - R&D expense guidance for FY2025 is set at $960–1,010 million (GAAP) and $890–940 million (Non-GAAP) [14]

Core Insights - Neurocrine Biosciences reported $687.5 million in revenue for Q2 2025, a 16.5% year-over-year increase, with an EPS of $1.06 compared to $0.63 a year ago, exceeding both revenue and EPS consensus estimates [1][4] Revenue Breakdown - Product sales, net reached $682 million, surpassing the estimated $635.87 million, reflecting a 16.8% increase year-over-year [4] - Collaboration revenue was reported at $5.5 million, below the estimated $6.04 million, marking a 14.1% decline year-over-year [4] - Product sales for INGREZZA were $624.4 million, slightly above the $620.8 million estimate, with a year-over-year growth of 7.8% [4] - CRENESSITY product sales were reported at $53.2 million, significantly exceeding the $19.82 million estimate [4] - Other product sales amounted to $4.4 million, slightly above the $4 million estimate [4] - Royalty collaboration revenue was $5.1 million, slightly below the $5.35 million estimate [4] Stock Performance - Neurocrine's shares have returned +4.8% over the past month, outperforming the Zacks S&P 500 composite's +3.4% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market [3]

Financial Performance - Total Neurocrine net product sales reached $682 million in Q2 2025, representing a 21% quarter-over-quarter (QoQ) growth and a 17% year-over-year (YoY) growth compared to Q1 2025 and Q2 2024, respectively [11] - INGREZZA net product sales were $624 million in Q2 2025, reflecting a 15% QoQ growth and an 8% YoY growth compared to Q1 2025 and Q2 2024, respectively [11] - CRENESSITY net product sales amounted to $53 million in Q2 2025, including 664 total new patient enrollment forms [11] - The company narrowed INGREZZA net sales guidance for 2025 to $2.50 - $2.55 billion, reflecting double-digit volume growth partially offset by a lower net price due to expanded access [7, 11] - Cash and investments totaled approximately $1.8 billion as of June 30, 2025 [7] Research and Development - The company initiated all Phase 3 registrational programs for osavampator (AMPA PAM) for MDD and NBI-'568 (Selective M4 Agonist) for schizophrenia [11] - A Phase 1 study was initiated for NBIP-'1435, a long-acting CRF-1 receptor antagonist, for the potential treatment of classic CAH [11] - Phase 2 studies are expected to be initiated for NBI-'568 in bipolar mania and NBI-'570 (Selective Dual M1 / M4 Agonist) for schizophrenia [11] - Top-line data is expected to be reported in Q4 2025 for the Phase 3 study of valbenazine for dyskinetic cerebral palsy and the Phase 2 study of NBI-'770 (NMDA NR2B NAM) for the treatment of MDD [11] Pipeline and Portfolio - The company has a pipeline of 12 programs, including the first biologic program NBIP-'1435 [8] - The company expects Phase 1 muscarinic agonist results for NBI-'567 (Selective M1 Agonist), NBI-'569 (Selective M4 Agonist), and NBI-'570 [11]

Core Insights - Neurocrine Biosciences reported total net product sales of $682 million for Q2 2025, reflecting a 17% year-over-year growth, with INGREZZA sales at $624 million and CRENESSITY sales at $53 million [1][5][17] - The company narrowed its 2025 net product sales guidance for INGREZZA to a range of $2.5 billion to $2.55 billion [1][6] Financial Performance - Q2 2025 revenues totaled $687.5 million, compared to $590.2 million in Q2 2024, marking a significant increase [5][17] - INGREZZA net product sales grew by 8% year-over-year and 15% sequentially, driven by strong patient demand and a record in new prescriptions [6][17] - CRENESSITY achieved $53 million in net product sales with 664 new patient enrollment forms, indicating robust demand and 76% reimbursement coverage [6][17] R&D and Pipeline Developments - The company initiated a Phase 3 registrational program for NBI-'568, targeting schizophrenia, and presented one-year data on CRENESSITY's efficacy at ENDO 2025 [6][10] - Neurocrine is advancing its neuropsychiatry pipeline, including ongoing programs for major depressive disorder with osavampator [2][6] Operating Expenses and Income - GAAP net income for Q2 2025 was $107.5 million, up from $65 million in Q2 2024, with diluted earnings per share increasing to $1.06 [7][17] - R&D expenses rose to $244.3 million in Q2 2025, reflecting investments in expanding the clinical portfolio [7][10] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling approximately $1.8 billion [10][19]

Core Insights - Neurocrine Biosciences appointed Lewis Choi as Chief Information Officer, effective June 9, 2025, to lead the company's technology initiatives [1][2] - Choi brings 25 years of experience in information technology and artificial intelligence, previously serving at Thermo Fisher Scientific [2] - The company is focused on advancing its technology to support the launch of CRENESSITY, growth of INGREZZA, and development of its pipeline [2] Company Overview - Neurocrine Biosciences is a biopharmaceutical company dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders [3] - The company has a diverse portfolio that includes FDA-approved treatments for conditions such as tardive dyskinesia and Huntington's disease, along with a robust pipeline in mid- to late-phase clinical development [3] - The mission of the company is to relieve suffering for patients with significant unmet medical needs through innovative neuroscience [3]

Financial Performance & Guidance - INGREZZA net product sales reached $545 million in Q1 2025, representing an 8% year-over-year growth[12] - CRENESSITY net product sales were $145 million in Q1 2025, including 413 total patient enrollment forms[11] - The company reaffirms INGREZZA net sales guidance of $250 billion to $260 billion for 2025[6, 11] - Cash and investments totaled approximately $18 billion as of March 31, 2025[6] - Non-GAAP R&D expense was $2402 million in Q1 2025, an increase from $1424 million in Q1 2024[12] - Non-GAAP SG&A expense was $245 million in Q1 2025, compared to $216 million in Q1 2024[12] Pipeline Development - Phase 3 registrational program initiated for osavampator as an adjunctive therapy for the treatment of MDD in adults[11] - Phase 1 studies initiated for NBI-'355 (Nav12 / 16 Inhibitor) for Epilepsy and NBI-'675 (VMAT2 Inhibitor) for Movement Disorders[11] Market & Product - Approximately 800000 people in the US are estimated to be affected by Tardive Dyskinesia[21] - Chorea affects approximately 90% of the 40000 patients with Huntington's Disease in the US[24] - CRENESSITY is the first new treatment available for Classic CAH in 70 years, targeting approximately 20000 pediatric and adult patients in the US[30, 31]