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]

Summary of Neurocrine Biosciences (NBIX) 2025 Conference Call Company Overview - **Company**: Neurocrine Biosciences (NBIX) - **Key Products**: INGREZZA, Chrinesity - **Market Focus**: Tardive Dyskinesia (TD), Congenital Adrenal Hyperplasia (CAH), Major Depressive Disorder, Schizophrenia Key Highlights 1. **Sales Performance**: Expected sales for INGREZZA in 2025 are projected at $2.5 billion, indicating strong market performance [3] 2. **Product Launch**: Chrinesity has had a successful launch, being the first new medicine for congenital adrenal hyperplasia in over 70 years, with strong initial uptake [4] 3. **Clinical Trials**: Two major Phase 3 programs are ongoing: one for osavampitur in major depressive disorder and another for a muscarinic program in schizophrenia, with plans to initiate a bipolar mania trial later this year [5] Financial and Market Strategy 1. **Sales Force Expansion**: The company is focusing on expanding its sales force for INGREZZA and enhancing contracting strategies to improve market access [6] 2. **Contracting Strategy**: The contracting strategy for INGREZZA has evolved, with a focus on increasing formulary coverage in the Medicare segment, moving from less than half to over 70% coverage [12][14] 3. **Impact of IRA**: The Inflation Reduction Act (IRA) is influencing payer behavior, leading to tighter management of specialty drugs, which has necessitated adjustments in contracting strategies [15][16] Market Dynamics 1. **Patient Access**: The company has seen record new patient starts in Q1 and Q2, attributed to improved formulary coverage and reduced friction in patient access [12][13] 2. **Competitor Landscape**: AUSTEDO, a competitor, is negotiating with CMS for its price, which could impact Neurocrine's strategy and pricing for INGREZZA [21][22] 3. **Long-term Growth Potential**: There is a significant opportunity for INGREZZA, with a large portion of the TD market still untreated, and exclusivity extending until February 2038 [23] Pipeline Updates 1. **Osavampitur**: Phase II data is expected soon, with promising efficacy results indicated by a placebo-adjusted score improvement of 7.5 points [50][51] 2. **Cerebral Palsy**: There is ongoing research into the efficacy of VMAT2 inhibition for patients with dyskinetic cerebral palsy, although there are clinical risks associated with this patient population [48][49] Additional Insights 1. **Market Segmentation for Chrinesity**: The company estimates around 20,000 classic CAH patients in the U.S., with a focus on pediatric endocrinologists and centers of excellence for treatment [35][36] 2. **Educational Efforts**: Neurocrine is actively educating healthcare providers on the distinctions between classic and non-classic CAH to enhance patient identification and treatment [41][42] 3. **Patient Feedback**: Positive anecdotal feedback from patients and clinicians regarding the effectiveness of new therapies has been noted, contributing to a rewarding launch experience [45][46] Conclusion Neurocrine Biosciences is positioned for growth with strong sales performance from INGREZZA and a successful launch of Chrinesity. The company is navigating a complex market influenced by regulatory changes and competitive dynamics while advancing its clinical pipeline.

Summary of Neurocrine Biosciences (NBIX) FY Conference Call - August 13, 2025 Company Overview - Neurocrine Biosciences specializes in neuro and endocrine disorders, with a strong focus on commercialization and a robust pipeline of products [2][5] Key Points on Commercialization and Product Launches - The company successfully launched KRONESTY, a treatment for congenital adrenal hyperplasia (CAH), which has exceeded internal expectations due to pre-launch disease state education efforts [6][10] - KRONESTY's uptake has been strong among healthcare providers, with a focus on patient identification and education to ensure ongoing treatment adherence [11][12] - The reimbursement rate for KRONESTY was reported at 76% in Q2, indicating strong market access compared to previous products [15][16] Financial Performance - Q2 revenue for INGREZZA reached $624 million, reflecting a 15% quarter-over-quarter growth and an 8% year-over-year increase [24] - The company narrowed its sales guidance for INGREZZA to between $2.5 billion and $2.55 billion for the year, anticipating double-digit growth [27][28] Pipeline and Research Development - Neurocrine aims to initiate four new Phase I trials and two new Phase II trials annually, with a goal of introducing one new medicine every two years [8] - The company is advancing its lead muscarinic program, dereclidine, in Phase III trials for schizophrenia and plans to explore bipolar mania later this year [39][46] - The company is also investigating opportunities in Alzheimer's disease psychosis, leveraging its diverse muscarinic portfolio [47] Competitive Landscape - Neurocrine acknowledges competition in the CAH space but emphasizes its history of being first in various disease states and its commitment to patient safety and tolerability [17][18] - The company is preparing for potential impacts from the Inflation Reduction Act (IRA) on its competitors, particularly regarding pricing negotiations starting in 2027 [30][33] Future Outlook - The focus remains on the U.S. market for KRONESTY, with plans for international expansion being evaluated but not imminent [23] - The company is optimistic about the long-term growth potential of INGREZZA, supported by a strong intellectual property position extending to 2038 [34] Additional Insights - Neurocrine's approach to patient engagement and education is critical for the success of its products, particularly in rare diseases where awareness is low [12][13] - The company is committed to maintaining high standards in its research and development efforts, ensuring a balanced portfolio of validated and unvalidated targets [7][8] This summary encapsulates the key insights from the Neurocrine Biosciences FY Conference Call, highlighting the company's strategic focus, financial performance, and future growth potential in the biopharmaceutical landscape.

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 Data and Key Metrics Changes - Neurocrine Biosciences reported net product sales of $682 million for Q2 2025, reflecting a 17% year-over-year growth [11] - The company refined its net sales guidance for INGREZZA to a range of $2.5 billion to $2.55 billion, accounting for anticipated double-digit volume gains [14] - The company has $1.8 billion in cash and a strong balance sheet to support its commercial and clinical development strategies [15] Business Line Data and Key Metrics Changes - INGREZZA sales reached $624 million in Q2 2025, with a record number of new patient starts, representing 15% sequential growth and 8% year-over-year growth [16] - KRONESTIV achieved net sales of $53 million in Q2 2025, growing from $15 million in Q1 2025, indicating strong early adoption [12][19] Market Data and Key Metrics Changes - The company has expanded Medicare formulary coverage for INGREZZA to approximately 70% of Medicare beneficiary lives in the TD market, improving patient access [17] - Over 75% of all dispensed prescriptions for KRONESTIV in Q2 were reimbursed, indicating strong market acceptance [19] Company Strategy and Development Direction - Neurocrine aims to solidify its position as a leading neurology-focused enterprise by investing in advancing and expanding its pipeline [10] - The company is focused on enhancing payer access and market share for INGREZZA through strategic investments [6][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of both INGREZZA and KRONESTIV, driven by strong market access initiatives [6][10] - The company anticipates continued revenue contribution from both products, enabling further investment in R&D and patient support [10] Other Important Information - The company has initiated multiple Phase III programs within a single calendar year, showcasing a robust clinical pipeline [9] - The recent ENDO conference highlighted the company's progress and the positive reception of its products among clinicians [7][20] Q&A Session Summary Question: Guidance adjustment and pricing dynamics - Management explained that the adjustment in guidance was primarily due to a change in pricing assumptions, moving from flat pricing expectations to a projected 5% price decline for the year [30][32] Question: KRONESTIV launch dynamics - Management noted that the adoption of KRONESTIV has been steady and consistent, with no significant bolus effect from prior clinical trials [36][40] Question: Prescribing concentration and treatment dynamics - Management indicated that the patient population for CAH is not highly concentrated, allowing for broader adoption across various prescribers [44][46] Question: Transition to formulary-driven reimbursement - Management stated that while some health plans may conduct formulary reviews, many will continue to reimburse KRONESTIV as a non-formulary product [94] Question: Reauthorization and patient authorization patterns - Management reported that patients typically receive authorization for six or twelve prescriptions, with a pattern emerging for reauthorization [108]

Financial Data and Key Metrics Changes - The company reported net product sales of $682 million for Q2 2025, representing a 17% year-over-year growth [9] - INGREZZA sales reached $624 million in Q2, showing a 15% sequential growth and an 8% year-over-year increase [14] - KRONESTIV sales grew from $15 million in Q1 2025 to $53 million in Q2 2025, reflecting strong early adoption [10] - The company has refined its net sales guidance for INGREZZA to a range of $2.5 billion to $2.55 billion, accounting for anticipated double-digit volume gains [12] Business Line Data and Key Metrics Changes - The INGREZZA franchise continues to show solid growth, with record new patient starts and total prescriptions [14] - KRONESTIV has been well received, with over 75% of all dispensed prescriptions reimbursed in Q2 [18] - The company has seen a significant increase in Medicare formulary coverage for INGREZZA, now covering approximately 70% of Medicare beneficiary lives in the TD market [15] Market Data and Key Metrics Changes - The company noted that less than half of the estimated 800,000 TD patients have been diagnosed, indicating a substantial market opportunity [16] - The adoption of KRONESTIV is widespread across both pediatric and adult patients, with a slight trend towards pediatric patients [19] Company Strategy and Development Direction - The company aims to solidify its position as a leading neurology-focused enterprise by investing in advancing and expanding its pipeline [9] - The strategic investments in market access and sales force expansion are expected to drive long-term growth for both INGREZZA and KRONESTIV [11][14] - The company is focused on diversifying its neuroscience pipeline, with multiple Phase III programs initiated within a single calendar year [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the INGREZZA franchise due to market access initiatives [5] - The company anticipates that the strong performance in the first half of the year will enable further investments in R&D and commercial strategies [9] - Management acknowledged the dynamic nature of the business and the need to adjust guidance based on pricing and volume expectations [30] Other Important Information - The company has a strong balance sheet with $1.8 billion in cash, positioning it well for continued growth [13] - The clinical pipeline includes multiple Phase III programs, with anticipated data readouts in 2027 and 2028 [22] Q&A Session Summary Question: How is the company triangulating the guidance adjustments? - The company adjusted the top end of guidance due to a change in pricing assumptions, moving from flat pricing expectations to a negative 5% price decline for the year [30] Question: Can you discuss the dynamics at clinics regarding KRONESTIV? - The company noted steady and consistent adoption of KRONESTIV, with no significant bolus effect from prior clinical trials [36][40] Question: What metrics can be shared regarding prescribing concentration for KRONESTIV? - The company estimates that around 15% of the total CAH patient population flows through a small number of accredited centers, indicating room for growth in community endocrinologists [44][46] Question: What is the reimbursement process for KRONESTIV? - The company reported a high rate of reimbursement for KRONESTIV, with over 75% of dispensed prescriptions reimbursed, and noted that many patients do not need to go on free goods programs [93] Question: How does the company view the implications of the IRA? - The company aims to maximize patient access to INGREZZA and is preparing for the new pricing environment that will come with the IRA [82][84]

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]