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 Viewpoint - Neurocrine Biosciences (NBIX) is a biopharmaceutical company focused on developing treatments for neurology and neuroendocrinology, with a strong commercial portfolio and an expanding pipeline [1] Group 1: Commercial Portfolio - The two most important commercial drugs for Neurocrine Biosciences are Ingrezza and another unnamed product [1]

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]

Core Viewpoint - Neurocrine Biosciences reported quarterly earnings of $1.06 per share, exceeding the Zacks Consensus Estimate of $0.98 per share, and showing a significant increase from $0.63 per share a year ago, indicating strong performance in the biopharmaceutical sector [1][2] Financial Performance - The company achieved revenues of $687.5 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 5.72% and reflecting a year-over-year increase from $590.2 million [2] - Over the last four quarters, Neurocrine has exceeded consensus revenue estimates three times, showcasing its ability to perform well in a competitive market [2] Stock Performance and Outlook - Neurocrine shares have declined approximately 1.7% since the beginning of the year, contrasting with the S&P 500's gain of 8.3%, indicating underperformance relative to the broader market [3] - The current consensus EPS estimate for the upcoming quarter is $1.31 on revenues of $705.5 million, while for the current fiscal year, the estimate is $3.77 on revenues of $2.66 billion [7] Industry Context - The Medical - Drugs industry, to which Neurocrine belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable environment for companies within this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Neurocrine's stock performance [5][6]

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 NEUROCRINE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 6027 Edgewood Bend Court San Diego ...

Financial Performance - Total net product sales for Q2 2025 reached $682 million, representing a 17% year-over-year growth[1] - INGREZZA net product sales were $624 million, reflecting 15% sequential growth and 8% year-over-year growth[5] - CRENESSITY net product sales for Q2 2025 were $53 million, with 664 new patient enrollment start forms indicating strong demand[5] - Net product sales for Q2 2025 reached $682.0 million, a 16.8% increase from $583.8 million in Q2 2024[18] - Total revenues for the first half of 2025 were $1,260.1 million, up 14.0% from $1,105.5 million in the same period of 2024[18] Income and Earnings - GAAP net income for Q2 2025 was $107.5 million, compared to $65 million in Q2 2024, with diluted earnings per share of $1.06[9] - Non-GAAP net income for Q2 2025 was $166.2 million, slightly down from $168.9 million in Q2 2024, with diluted earnings per share of $1.65[9] - Net income for Q2 2025 was $107.5 million, a 65.4% increase from $65.0 million in Q2 2024[18] - The company reported a diluted earnings per share of $1.06 for Q2 2025, compared to $0.63 in Q2 2024[22] Cash and Assets - Total cash, cash equivalents, and marketable securities as of June 30, 2025, amounted to approximately $1.8 billion[9] - Cash, cash equivalents, and marketable securities totaled $975.6 million as of June 30, 2025, down from $1,076.1 million at the end of 2024[20] - Total assets increased to $3,889.8 million as of June 30, 2025, compared to $3,718.7 million at the end of 2024[20] Guidance and Projections - The company narrowed its 2025 net product sales guidance for INGREZZA to $2.5 - $2.55 billion[5] - R&D expenses for 2025 are guided to be between $960 million and $1.010 billion[10] - SG&A expenses for 2025 are projected to be between $1.135 billion and $1.155 billion, supporting ongoing commercial initiatives[10] Research and Development - The company initiated a Phase 3 registrational program for NBI-'568, targeting schizophrenia treatment[5] - Research and development expenses for Q2 2025 were $244.3 million, compared to $191.1 million in Q2 2024, reflecting a 27.8% increase[18] Strategic Focus and Risks - The company plans to successfully launch CRENESSITY and continue the success of INGREZZA, focusing on future clinical and regulatory milestones[15] - Neurocrine Biosciences is facing risks related to the commercialization of its products and potential adverse regulatory decisions[15]

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]