Core Insights - Neurocrine Biosciences, Inc. will participate in two investor conferences in May 2025, showcasing its commitment to engaging with investors and stakeholders [1][5]. Company Overview - Neurocrine Biosciences is a leading biopharmaceutical company focused on neuroscience, 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, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids, along with a robust pipeline of compounds in mid- to late-phase clinical development [3]. Upcoming Events - CEO Kyle Gano and VP of Investor Relations Todd Tushla will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 11:20 AM Pacific Time in Las Vegas [5]. - CFO Matt Abernethy and CCO Eric Benevich will present at the RBCCM Global Healthcare Conference on May 20, 2025, at 11:30 AM Eastern Time in New York [5].

Core Insights - Neurocrine Biosciences Inc. reported better-than-expected first-quarter 2025 earnings, with adjusted EPS of 70 cents, surpassing the consensus estimate of 54 cents, but lower than the $1.20 reported a year ago [1] - The company reported sales of $572.6 million, an increase from $515.3 million a year ago, but missed the consensus of $559.3 million [1] Ingrezza Performance - Ingrezza's first-quarter 2025 net product sales were $545 million, reflecting an 8% year-over-year growth driven by strong patient demand and improved gross-to-net dynamics [2] - Neurocrine reaffirmed its 2025 Ingrezza sales guidance of $2.5 billion to $2.6 billion [3] Analyst Commentary - Analysts view Ingrezza as a leading treatment for tardive dyskinesia (TD), highlighting its once-daily dosing and lack of severe FDA warnings, along with 14 years of potential patent protection [4] - The positive performance of Crenessity indicates strong sales efforts, with early metrics showing significant interest in the orphan disease therapy [5] - Stock price for Neurocrine Biosciences increased by 14% to $125.07 following the earnings report [5] Analyst Ratings and Price Targets - Needham maintains a Buy rating, raising the price target from $138 to $139 [6] - Canaccord Genuity also maintains a Buy rating, increasing the price target from $158 to $160 [6] - UBS keeps a Buy rating, raising the price target from $137 to $152 [6] - BMO Capital maintains a Market Perform rating, increasing the price target from $96 to $115 [6] - Guggenheim maintains a Buy rating, raising the price target from $155 to $165 [6]

Company Overview - Neurocrine Biosciences, Inc. is a neuroscience-focused biopharmaceutical company dedicated to developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders [21] - The company has a diverse portfolio that includes FDA-approved treatments for tardive dyskinesia (TD) and other conditions, along with a robust pipeline of compounds in clinical development [21] Campaign Launch - The company launched the "ConnectING with Carnie™" multimedia awareness campaign in partnership with Carnie Wilson to raise awareness about tardive dyskinesia [1][5] - The campaign aims to combat stigma, promote diagnosis, and empower patients to seek treatment options, including INGREZZA® (valbenazine) capsules [5] Tardive Dyskinesia (TD) Awareness - Tardive dyskinesia is characterized by uncontrolled, abnormal movements and is associated with the use of certain antipsychotic medications [6][7] - It is estimated that at least 800,000 adults in the U.S. are affected by TD [7] INGREZZA® (valbenazine) Capsules - INGREZZA is an FDA-approved treatment for adults with tardive dyskinesia and is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor [8][9] - The medication is available in 40 mg, 60 mg, and 80 mg capsules and can be taken once daily without the need for titration [10] Campaign Goals - The ultimate goal of the "ConnectING with Carnie" campaign is to encourage individuals living with TD to seek the help they deserve and to reduce stigma surrounding the condition [2][4] - The campaign will feature personal stories and resources for those affected by TD, aiming to foster open discussions about symptoms and treatment options [3][4]

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]

Financial Data and Key Metrics Changes - The company reported first quarter product sales of $545 million for INGREZZA, with a reaffirmed sales guidance range for 2025 of $2.5 billion to $2.6 billion, reflecting expected acceleration in new patient additions despite gross to net impacts from contracting activities [8][9][10] - The company has approximately $1.8 billion in cash, supporting its commercial and clinical development strategies for continued growth [11] Business Line Data and Key Metrics Changes - INGREZZA achieved record new patient starts in the first quarter, indicating strong demand and unmet medical needs [9][12] - KRONESITY generated $15 million in net revenue during its first full quarter of launch, with 70% of dispensations receiving reimbursement [10][16] Market Data and Key Metrics Changes - The formulary coverage for INGREZZA in Medicare Part D expanded from less than half to approximately two-thirds, improving patient access [14] - The company noted that 70% of the dispensers for KRONESITY were reimbursed, although most reimbursement was through the exceptions process rather than formal reviews [40] Company Strategy and Development Direction - The company aims to evolve from a single blockbuster to a multiple blockbuster neuroscience company, focusing on both near and long-term revenue growth [5][7] - The R&D portfolio is advancing, with ongoing Phase III studies for osevampatore and MBI-568, and plans to expand the muscarinic portfolio into new Phase II studies later this year [6][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum from record new patient starts and the potential for growth in the second quarter and beyond, despite challenges in the reauthorization process and market dynamics [31][32] - The management team highlighted the importance of continued investment in sales force expansion and marketing initiatives to strengthen INGREZZA's market position [15][16] Other Important Information - The company is transitioning leadership, with Dr. Eiry Roberts moving to a strategic advisory role and Dr. Sanjay Keswani set to become the new Chief Medical Officer [6][25] - The company is focused on increasing awareness and reducing stigma around tardive dyskinesia, collaborating with various organizations to improve patient access to treatment [12][14] Q&A Session Summary Question: Insights on INGREZZA's performance and future growth - Management acknowledged challenges in Q1 but noted record new patient starts, indicating strong momentum going into Q2 and the rest of the year [31][32] Question: Expectations for KRONESITY's adoption and reimbursement dynamics - Management indicated that while initial adoption exceeded expectations, it is too early to define long-term trends, and they will continue to monitor reimbursement patterns [35][40] Question: Share dynamics between INGREZZA and competitors - Management stated that INGREZZA continues to hold a majority share in the tardive dyskinesia market, with ongoing efforts to differentiate from competitors [44] Question: Insights on patient demographics for KRONESITY - Management noted an early trend towards greater uptake in pediatric and adolescent patients compared to adults, aligning with pre-launch expectations [46][69] Question: Contracting strategies and pricing trends for INGREZZA - Management emphasized a focus on maximizing patient access through prudent contracting, with no immediate changes anticipated but ongoing monitoring of the environment [59][82]

Financial Data and Key Metrics Changes - Neurocrine Biosciences reported $545 million in product sales for INGREZZA in Q1 2025, impacted by one less order week and patient reauthorization processes [9] - The company reaffirmed its 2025 sales guidance range for INGREZZA at $2.5 billion to $2.6 billion, factoring in expected acceleration of new patient additions [10][11] - The company has approximately $1.8 billion in cash to support its commercial and clinical development strategies [12] Business Line Data and Key Metrics Changes - INGREZZA achieved record new patient starts in Q1 2025, indicating strong demand despite market challenges [10][14] - KRONESITY generated $15 million in net revenue in its first full quarter of launch, with 70% of dispensers receiving reimbursement [11][19] - The company expanded formulary coverage in Medicare Part D, increasing patient access for INGREZZA [10][16] Market Data and Key Metrics Changes - The payer environment has been influenced by the Inflation Reduction Act, affecting prior authorization processes for both new and continuing patients [16] - Approximately 40% of patients with tardive dyskinesia (TD) have been diagnosed, with less than 10% receiving standard care treatment [15] Company Strategy and Development Direction - The company aims to evolve from a single blockbuster to a multiple blockbuster neuroscience company, focusing on both near and long-term revenue growth [6] - Neurocrine is advancing its R&D portfolio, with ongoing Phase III studies for osevampatore and MBI-568, and plans to expand its muscarinic portfolio into new Phase II studies [7][23] - The leadership transition includes welcoming Dr. Sanjay Keswani as the new Chief Medical Officer [7][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum from record new patient starts and the potential for growth in Q2 and beyond [35][36] - The company is optimistic about the early adoption of KRONESITY and expects continued growth in the pediatric and adolescent segments [19][70] Other Important Information - The company has retired 3.6 million shares over the past two quarters, reflecting a commitment to returning capital to shareholders [12] - The transition of Dr. Eiry Roberts to a strategic advisory role marks a significant change in leadership, with a focus on maintaining the momentum in the company's pipeline [27] Q&A Session Summary Question: What are the expectations for INGREZZA in Q2? - Management noted that Q1 challenges were anticipated, but record new patient starts provide confidence for Q2 growth [34][35] Question: How should KRONESITY's initial numbers be interpreted? - Management indicated that it is too early to define a trend for KRONESITY, but initial adoption has exceeded expectations [37][38] Question: What are the reimbursement dynamics for KRONESITY moving forward? - The company expects some health plans to conduct formal reviews of KRONESITY, but initial reimbursement metrics are favorable [41][44] Question: Can you provide insights on the share split between INGREZZA and Teva? - Management stated that INGREZZA continues to hold the majority share in TD prescriptions, with trends aligning with expectations [48] Question: What is the expected growth for INGREZZA in Q2? - Management anticipates a nice step up in sales due to one additional order week and record new patient starts, despite some gross to net impacts [53][54] Question: What is the timeline for KRONESITY data from ongoing studies? - Management plans to release one-year data on KRONESITY at upcoming medical meetings, with a focus on various clinical endpoints [99]

Sales Performance - INGREZZA net product sales reached $545.2 million in Q1 2025, up from $506.0 million in Q1 2024, reflecting strong patient demand and improved gross-to-net dynamics [97]. - CRENESSITY, launched in December 2024, generated $14.5 million in net product sales for Q1 2025 [93]. - Total net product sales for Q1 2025 were $563.7 million, compared to $509.0 million in Q1 2024, marking an increase of approximately 10.5% [97]. - Collaboration revenues increased to $8.9 million in Q1 2025 from $6.3 million in Q1 2024, primarily due to higher royalties from AbbVie and MTPC [98]. Expenses - Total research and development expenses for Q1 2025 were $263.2 million, up from $159.4 million in Q1 2024, driven by increased investment in late-stage programs [102]. - Selling, general, and administrative expenses rose to $276.5 million in Q1 2025 from $243.1 million in Q1 2024, reflecting investments in the commercial organization [110]. - Net income for Q1 2025 was $7.9 million, a decrease from $43.4 million in Q1 2024, attributed to higher development milestone expenses and increased operational costs [113]. Share Repurchase Program - The company authorized a new share repurchase program of up to $500.0 million in February 2025, in addition to a completed $300.0 million repurchase program [95]. - The 2025 Repurchase Program allows for the repurchase of up to $500.0 million of common stock, in addition to the completed $300.0 million program from 2024 [123]. - Cash flows from financing activities included $150.0 million in common stock repurchases under the 2025 Repurchase Program, with $350.0 million remaining available for future repurchases [123]. Cash Flow and Working Capital - Total cash, cash equivalents, and marketable securities decreased from $1,815.6 million on December 31, 2024, to $1,758.8 million on March 31, 2025, a decline of approximately 3.1% [115]. - Cash flows from operating activities fell significantly from $130.3 million in Q1 2024 to $64.8 million in Q1 2025, representing a decrease of about 50.2% [116]. - Cash flows from investing activities showed a positive change of $14.2 million in Q1 2025, compared to a negative $55.0 million in Q1 2024 [116]. - Total working capital decreased from $1,217.0 million on December 31, 2024, to $1,115.0 million on March 31, 2025, a reduction of approximately 8.4% [115]. Clinical Development - The company initiated a Phase 3 clinical study for osavampator in major depressive disorder, incurring a $37.5 million milestone expense in Q1 2025 [100]. Future Commitments - The company has potential future payments of up to $14.8 billion related to existing collaboration and license agreements upon achieving certain milestones [121]. Investment Portfolio - The company maintains a diversified investment portfolio with low-risk, investment-grade debt securities, and a 1% unfavorable change in interest rates would not materially affect the fair value of this portfolio [125]. Operational Focus - The company is focused on expanding its commercial organization, including the psychiatry and long-term care sales team, which was completed in September 2024 [117]. - The company experienced an increase in accounts receivable due to timing impacts of customer orders and cash collections [117]. Regulatory Status - INGREZZA qualifies for the small biotech exception under the Medicare Drug Price Negotiation Program, providing exemption from selection until 2027 [95].

Sales Performance - INGREZZA (valbenazine) first-quarter 2025 net product sales reached $545 million, an 8% increase compared to the first quarter of 2024[5] - CRENESSITY (crinecerfont) first-quarter 2025 net product sales were $14.5 million, with 413 total patient enrollment start forms indicating strong initial demand[5] - The company reaffirms 2025 net product sales guidance for INGREZZA in the range of $2.5 billion to $2.6 billion[2] - Total revenues for the first quarter of 2025 were $572.6 million, compared to $515.3 million in the first quarter of 2024[6] - Total revenues for the three months ended March 31, 2025, were $572.6 million, a 11.1% increase from $515.3 million in the same period of 2024[18] - Net product sales increased to $563.7 million, up 10.7% from $509.0 million year-over-year[18] Income and Earnings - GAAP net income for the first quarter of 2025 was $7.9 million, down from $43 million in the same period of 2024[9] - Non-GAAP net income for the first quarter of 2025 was $71.5 million, compared to $124.8 million in the first quarter of 2024[9] - Operating income decreased to $23.6 million, down 76.2% from $99.3 million in the same quarter of 2024[18] - Net income for the quarter was $7.9 million, a decline of 81.8% from $43.4 million in the previous year[18] - Non-GAAP net income was reported at $71.5 million, down 42.7% from $124.8 million in the same quarter of 2024[22] - Diluted earnings per share (EPS) on a GAAP basis was $0.08, compared to $0.42 in the prior year, reflecting an 81.0% decrease[22] Research and Development - The company initiated Phase 3 registrational programs for osavampator in major depressive disorder and NBI-'568 in schizophrenia[7] - Research and development expenses rose significantly to $263.2 million, a 65.1% increase compared to $159.4 million in the prior year[18] - The company plans to invest $960 million to $1.010 billion in GAAP R&D expenses for the full year 2025[10] Financial Position - The company has approximately $1.8 billion in cash, cash equivalents, and marketable securities as of March 31, 2025[9] - Cash, cash equivalents, and marketable securities totaled $943.5 million as of March 31, 2025, down from $1,076.1 million at the end of 2024[20] - Total assets decreased to $3,687.7 million from $3,718.7 million at the end of 2024[20] - Stockholders' equity declined to $2,535.7 million, down from $2,589.7 million at the end of the previous year[20] Share Repurchase - A second share repurchase program was announced to repurchase up to $500 million of outstanding common stock, with $150 million already repurchased as of March 31, 2025[9]

Financial Performance - Neurocrine Biosciences reported first-quarter 2025 net product sales of INGREZZA at $545 million, an 8% increase compared to the same period in 2024, driven by record new patient starts and improved gross-to-net dynamics [6][8] - CRENESSITY generated first-quarter net product sales of $14.5 million, with 413 total patient enrollment start forms, indicating strong initial demand and approximately 70% reimbursement coverage for dispensed scripts [6][8] - Total revenues for the first quarter of 2025 reached $572.6 million, compared to $515.3 million in the first quarter of 2024 [8][19] Research and Development - The company initiated two Phase 3 registrational programs: osavampator for major depressive disorder and NBI-1117568 for schizophrenia, positioning itself for future growth [4][6] - A Phase 4 study, KINECT-PRO™, demonstrated clinically meaningful effects of INGREZZA on patients with tardive dyskinesia, regardless of severity [6][8] Financial Guidance - Neurocrine reaffirmed its 2025 financial guidance for INGREZZA net product sales between $2.5 billion and $2.6 billion [2][10] - The company expects GAAP R&D expenses to be in the range of $960 million to $1.010 billion and GAAP SG&A expenses between $1.110 billion and $1.130 billion for the full year 2025 [10][11] Corporate Developments - Sanjay Keswani, M.D., was appointed as Chief Medical Officer effective June 2, 2025, enhancing the executive management team [6][8] - The company completed a $300 million accelerated share repurchase program and announced a second program to repurchase up to $500 million of outstanding common stock [9][10]

Core Insights - The survey conducted by The Harris Poll highlights the significant negative impact of tardive dyskinesia (TD) on patients' daily lives, emphasizing the need for routine screening, earlier diagnosis, and treatment [1][2][3] Functional Impact - 80% of patients with TD wished they had been screened earlier, and 86% wanted their healthcare providers to discuss treatment options sooner [1][4] - 43% of all patients and 40% of those with mild/moderate TD required assistance with daily activities due to their symptoms [4] - 41% of all patients and 40% of those with mild/moderate TD were unable to perform their job functions because of their symptoms [4] Psychological Impact - 86% of patients felt judged or stared at due to their movements, and 82% agreed that their uncontrolled movements brought unwanted attention to their mental health condition [4] - 80% of patients felt that others made incorrect assumptions about them because of their movements [4] Social Impact - 56% of all patients and 55% of those with mild/moderate TD avoided going out in public [4] - 44% of all patients and 46% of those with mild/moderate TD avoided leaving home [4] - 40% of all patients and 43% of those with mild/moderate TD experienced limited professional interactions [4] - 40% of all patients and 34% of those with mild/moderate TD missed work or school due to their symptoms [4] Awareness and Education - The survey results indicate a need for continued education about TD, especially among individuals taking antipsychotic medications [3][5] - Only 47% of patients were informed by their providers about the potential contribution of their mental health medications to their symptoms prior to diagnosis [10] - 83% of people with TD wished they had been encouraged to discuss their uncontrolled movements with healthcare providers earlier [10] Company Commitment - Neurocrine Biosciences is dedicated to improving awareness and education regarding TD, providing resources for patients and healthcare professionals [8][12]