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Neurocrine(NBIX) - 2025 Q3 - Earnings Call Transcript
2025-10-28 21:30
Financial Data and Key Metrics Changes - Neurocrine Biosciences reported $790 million in net product sales for Q3 2025, reflecting a 28% year-over-year growth driven by INGREZZA and CRENESSITY [6][10] - CRENESSITY's sales grew from $53 million in Q2 to $98 million in Q3, indicating strong early adoption and persistency rates [6][7] - INGREZZA achieved net sales of $687 million in Q3, marking the third consecutive quarter of record new patient additions [7][10] Business Line Data and Key Metrics Changes - INGREZZA's performance has been exceptional, with a prescriber base that has expanded by 30% over the past two years, reflecting the strong clinical profile and unmet need for tardive dyskinesia treatment [10][11] - CRENESSITY has seen 540 new patients initiate therapy in Q3, bringing the total to over 1,600 since its launch [13][15] - The company anticipates continued growth for both products, with plans for further sales force expansion to maximize patient share [8][16] Market Data and Key Metrics Changes - The tardive dyskinesia market is expected to grow significantly, with only about 10% of diagnosed patients currently treated with a VMAT2 inhibitor, indicating substantial growth potential for INGREZZA [10][11] - The congenital adrenal hyperplasia (CAH) community has shown favorable feedback towards CRENESSITY, with 80% of dispensed prescriptions now being reimbursed [6][15] Company Strategy and Development Direction - Neurocrine Biosciences is focused on expanding its sales force for both INGREZZA and CRENESSITY to accelerate growth into 2026 and beyond [4][8] - The company aims to drive revenue growth, advance R&D programs, enable business development, and return capital to shareholders, with a strong financial profile of over $2.1 billion in cash [9][80] - The strategic expansion of the sales force is intended to maximize patient share and prepare for anticipated launches of investigational psychiatric medicines [8][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing momentum for both products and the potential for sustained long-term growth driven by their science and commitment to patients [5][9] - The company remains on track for its clinical programs, with anticipated top-line results for key studies in the near future [18][19] - Management acknowledged the potential impacts of the Inflation Reduction Act (IRA) on the market and emphasized the importance of maximizing patient share before 2027 [8][30] Other Important Information - The company is fully cooperating with a Department of Justice investigation related to the sales and marketing of INGREZZA, maintaining a robust compliance program [40][41] - The sales force expansion is expected to result in an increase in SG&A expenses of around $150 million in 2026 [9][79] Q&A Session Summary Question: Insights on patient dynamics and starts for CRENESSITY - Management noted that the adoption of CRENESSITY has been strong, with 540 new treatment forms in Q3, and they do not believe there are significant seasonal dynamics affecting enrollment [22][23] Question: Implications of the IRA on pricing and reimbursement - Management is monitoring the upcoming Oscado pricing and its potential effects on INGREZZA, emphasizing the importance of maximizing patient numbers before the IRA impacts [28][30] Question: Status of reimbursement requirements for CRENESSITY - Management indicated that reimbursement has been smooth, with no specific requirements for steroid tapering to continue coverage [34] Question: Sales force expansion details - The expansion is characterized as a 30% increase in overall sales footprint, primarily targeting psychiatry and neurology for INGREZZA, while also expanding the team for CRENESSITY [46][48] Question: Update on the Department of Justice investigation - Management confirmed they are cooperating with the DOJ regarding a civil investigative demand related to INGREZZA's sales and marketing practices [40][41] Question: Progress with CRENESSITY at centers of excellence - All centers of excellence have started adopting CRENESSITY, with varying rates of adoption, and there is optimism about community endocrinologists' engagement [43][44]
Neurocrine Biosciences, Inc. 2025 Q3 - Results - Earnings Call Presentation (NASDAQ:NBIX) 2025-10-28
Seeking Alpha· 2025-10-28 21:02
Group 1 - The article does not provide any specific content related to a company or industry [1]
Neurocrine(NBIX) - 2025 Q3 - Earnings Call Presentation
2025-10-28 20:30
Financial Performance - Total Neurocrine net product sales reached $790 million, representing a 16% quarter-over-quarter (QoQ) growth and a 28% year-over-year (YoY) growth compared to Q2 2025 and Q3 2024, respectively[11] - INGREZZA net product sales were $687 million, showing a 10% QoQ growth and a 12% YoY growth compared to Q2 2025 and Q3 2024, respectively[11] - CRENESSITY net product sales amounted to $98 million, including 540 total new patient enrollment forms[11] - The company reaffirmed INGREZZA net sales guidance at $2500 million - $2550 million for the full year 2025[11] - Cash and investments totaled approximately $2100 million as of September 30, 2025[7] Research and Development - The company initiated all Phase 3 registrational studies for osavampator (AMPA PAM) as an adjunctive therapy for the treatment of MDD in adults and direclidine (Selective M4 Agonist) for the treatment of Schizophrenia[11] - The company expects to report top-line data 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] - The company plans to initiate Phase 2 studies in Q4 2025 for direclidine for Bipolar Mania and NBI-'570 (Selective Dual M1 / M4 Agonist) for Schizophrenia[11] Commercial Strategy - The company plans to expand INGREZZA and CRENESSITY sales teams in Q4 2025, with completion expected by the end of Q1 2026, to maximize commercial momentum[11] - CRENESSITY has achieved approximately 80% reimbursement coverage for dispensed scripts[11] Pipeline Development - The company has a pipeline of 12 programs, including the first biologic program NBIP-'1435[8] - The company is advancing additional internally developed pre-clinical programs, including biologics, into first-in-human studies[11]
Neurocrine(NBIX) - 2025 Q3 - Quarterly Report
2025-10-28 20:03
Financial Performance - INGREZZA net product sales totaled $1.9 billion for the first nine months of 2025, compared to $1.7 billion for the same period in 2024, reflecting a significant increase in demand [101]. - CRENESSITY, launched in December 2024, generated net product sales of $165.8 million in the first nine months of 2025 [101]. - Total net product sales for the first nine months of 2025 reached $2.04 billion, up from $1.71 billion in 2024, indicating a growth of approximately 19% [106]. - Net income for the first nine months of 2025 was $324.9 million, compared to $238.2 million in the same period of 2024, representing a 36.3% increase [123]. - Total collaboration revenues for the first nine months of 2025 were $19.4 million, compared to $18.2 million in 2024, driven by royalties from AbbVie and MTPC [107]. Research and Development - The company initiated two Phase 3 clinical studies for direclidine and osavampator, targeting schizophrenia and major depressive disorder, respectively [108]. - Research and development expenses for the first nine months of 2025 amounted to $757.5 million, an increase from $545.5 million in 2024, primarily due to investments in late-stage programs [111]. Expenses and Costs - Selling, general, and administrative expenses for Q3 2025 were $291.6 million, up from $234.3 million in Q3 2024, reflecting a 24.4% increase [120]. - The cost of revenues for the first nine months of 2025 was $34.5 million, up from $24.7 million in 2024, reflecting increased sales of INGREZZA and CRENESSITY [109]. - The provision for income taxes for Q3 2025 was $82.3 million, up from $60.5 million in Q3 2024, reflecting a 36.5% increase [122]. Cash and Capital Resources - Total cash, cash equivalents, and marketable securities increased to $2,113.3 million as of September 30, 2025, from $1,815.6 million at the end of 2024, a growth of 16.4% [125]. - Cash flows from operating activities for the first nine months of 2025 were $394.3 million, compared to $352.9 million in the same period of 2024, indicating an increase of 11.7% [126]. - Total working capital as of September 30, 2025, was $1,520.4 million, compared to $1,217.0 million at the end of 2024, a rise of 24.9% [125]. - The company anticipates that existing capital resources and projected revenues will be sufficient for at least the next 12 months, but future funding may be required [124]. - Future capital requirements may include potential payments of up to $14.0 billion upon achieving certain milestones in collaboration and license agreements [132]. Shareholder Actions - The company authorized a new share repurchase program of up to $500 million in February 2025, in addition to a completed $300 million program [103]. - The company repurchased 1.5 million shares for $167.7 million under the 2025 Repurchase Program, with $332.3 million remaining for future repurchases [134]. Commercial Strategy - The expansion of the INGREZZA and CRENESSITY sales teams is planned to be completed by the end of Q1 2026 to enhance commercial momentum [104]. - The company received CMS notification that INGREZZA qualifies for the small biotech exception under the Medicare Drug Price Negotiation Program, providing exemption until 2027 [103]. Investment Performance - Unrealized gains on equity investments for Q3 2025 were $30.6 million, compared to a loss of $16.9 million in Q3 2024 [121].
Neurocrine Biosciences Non-GAAP EPS of $2.17 beats by $0.10, revenue of $794.9M beats by $47.68M (NASDAQ:NBIX)
Seeking Alpha· 2025-10-28 20:03
Core Insights - The article discusses the importance of enabling Javascript and cookies in browsers to prevent access issues [1] - It highlights that ad-blockers may interfere with website functionality, suggesting users disable them for a better experience [1] Group 1 - The article emphasizes the need for proper browser settings to ensure seamless access to content [1] - It warns that ad-blockers can lead to blocked access, recommending their temporary disablement [1]
Neurocrine(NBIX) - 2025 Q3 - Quarterly Results
2025-10-28 20:02
Financial Performance - Total net product sales for Q3 2025 were $790 million, reflecting a 28% year-over-year growth[5] - INGREZZA net product sales for Q3 2025 were $687 million, representing a 12% year-over-year growth[5] - CRENESSITY net product sales for Q3 2025 were $98 million, with 540 total new patient enrollment start forms[5] - GAAP net income for Q3 2025 was $209.5 million, compared to $129.8 million in Q3 2024, marking a 62% increase[10] - Non-GAAP net income for Q3 2025 was $222.1 million, up from $189.2 million in Q3 2024, reflecting a 17% increase[10] - Net product sales for Q3 2025 reached $789.9 million, a 28.1% increase from $616.6 million in Q3 2024[20] - Total revenues for the nine months ended September 30, 2025, were $2,055.0 million, up 19.0% from $1,727.6 million in the same period of 2024[20] - Operating income for Q3 2025 was $239.0 million, a 30.0% increase from $183.8 million in Q3 2024[20] - Net income for Q3 2025 was $209.5 million, up 61.5% from $129.8 million in Q3 2024[20] - Diluted earnings per share for Q3 2025 were $2.04, compared to $1.24 in Q3 2024, representing a 64.5% increase[20] - Non-GAAP net income for Q3 2025 was $222.1 million, compared to $189.2 million in Q3 2024, reflecting a 17.4% increase[24] Cash and Assets - Total cash, cash equivalents, and marketable securities as of September 30, 2025, were approximately $2.1 billion[10] - Cash, cash equivalents, and marketable securities totaled $1,114.8 million as of September 30, 2025, an increase from $1,076.1 million at the end of 2024[22] - Total assets increased to $4,265.7 million as of September 30, 2025, compared to $3,718.7 million at the end of 2024[22] - Stockholders' equity rose to $3,003.6 million as of September 30, 2025, up from $2,589.7 million at the end of 2024[22] Research and Development - The company initiated a second Phase 3 registrational clinical trial for direclidine as a potential treatment for schizophrenia[5] - Research and development expenses for Q3 2025 were $250.0 million, compared to $195.0 million in Q3 2024, reflecting a 28.2% increase[20] Sales and Marketing Strategy - The company plans to expand the INGREZZA and CRENESSITY sales teams by the end of Q1 2026 to maximize commercial momentum[8] Awards and Recognition - The company was honored with the 2025 Poster Award at the 38th annual Psych Congress for new data presented from the Phase 2 SAVITRI™ study[5] Guidance - Full year 2025 guidance for INGREZZA net product sales is expected to be between $2.5 billion and $2.55 billion[11]
Neurocrine Biosciences Reports Third Quarter 2025 Financial Results
Prnewswire· 2025-10-28 20:01
Core Insights - Neurocrine Biosciences reported strong financial results for Q3 2025, with INGREZZA achieving net product sales of $687 million, reflecting a 12% year-over-year growth, while CRENESSITY generated $98 million in net product sales [1][6][13] - The company highlighted the positive impact of its products on patients and emphasized its commitment to advancing innovative therapies in neuroscience [2][4] Financial Performance - Total revenues for Q3 2025 were $794.9 million, up from $622.1 million in Q3 2024, marking a 28% year-over-year increase [4][16] - GAAP net income for Q3 2025 was $209.5 million, compared to $129.8 million in Q3 2024, with diluted earnings per share increasing from $1.24 to $2.04 [13][16] - Non-GAAP net income for Q3 2025 was $222.1 million, up from $189.2 million in Q3 2024, with diluted earnings per share rising from $1.81 to $2.17 [13][19] Product Sales Highlights - INGREZZA's net product sales for Q3 2025 were $687 million, showing a 10% sequential growth over Q2 2025 and a 12% year-over-year growth [6][8] - CRENESSITY's net product sales reached $98 million, with 540 new patient enrollment start forms, indicating strong demand and 80% reimbursement coverage for dispensed scripts [6][8] Research and Development - The company initiated a second Phase 3 registrational clinical trial for direclidine, targeting adults with schizophrenia, and presented promising data from the Phase 2 SAVITRI study for osavampator in major depressive disorder [5][6] - R&D expenses for Q3 2025 were $250 million, up from $195 million in Q3 2024, reflecting increased investment in clinical programs [4][16] Corporate Developments - Neurocrine announced the appointment of Mike Sibley as Senior Vice President and General Manager of the Neuropsychiatry franchise, aiming to enhance the sales and marketing strategy for its neuropsychiatry products [5][6] - The company plans to expand its INGREZZA and CRENESSITY sales teams to maximize commercial momentum, with completion expected by the end of Q1 2026 [5][6]
Are You Looking for a Top Momentum Pick? Why Neurocrine Biosciences (NBIX) is a Great Choice
ZACKS· 2025-10-24 17:01
Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Neurocrine Biosciences (NBIX) - Neurocrine Biosciences currently holds a Momentum Style Score of B, indicating a favorable momentum outlook [3] - The company has a Zacks Rank of 2 (Buy), suggesting strong potential for outperformance in the market [4] Performance Metrics - Over the past week, NBIX shares increased by 2.53%, while the Zacks Medical - Drugs industry remained flat [6] - In the last month, NBIX's price change was 1.97%, outperforming the industry's 1.66% [6] - Over the past quarter, NBIX shares rose by 12.04%, and over the last year, they increased by 24.37%, compared to the S&P 500's gains of 6.22% and 17.55%, respectively [7] Trading Volume - The average 20-day trading volume for NBIX is 815,114 shares, which serves as a bullish indicator when combined with rising stock prices [8] Earnings Outlook - In the last two months, three earnings estimates for NBIX have been revised upward, while none have been revised downward, increasing the consensus estimate from $4.41 to $4.49 [10] - For the next fiscal year, two estimates have moved up, while one has been revised down [10] Conclusion - Considering the positive momentum indicators and earnings outlook, NBIX is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [12]
3 Reasons Why Growth Investors Shouldn't Overlook Neurocrine (NBIX)
ZACKS· 2025-10-23 17:46
Core Viewpoint - Growth investors seek stocks with above-average financial growth, but identifying such stocks can be challenging due to their inherent risks and volatility [1] Group 1: Company Overview - Neurocrine Biosciences (NBIX) is highlighted as a recommended stock with a favorable Growth Score and a top Zacks Rank [2] - The company has a historical EPS growth rate of 12.9%, with projected EPS growth of 36.4% this year, significantly surpassing the industry average of 19% [5] Group 2: Financial Metrics - Cash flow growth for Neurocrine is currently at 35.4%, well above the industry average of 3.2% [6] - The annualized cash flow growth rate over the past 3-5 years is 39.5%, compared to the industry average of 6.9% [7] Group 3: Earnings Estimates - There has been a positive trend in earnings estimate revisions for Neurocrine, with the Zacks Consensus Estimate for the current year increasing by 1.7% over the past month [8] - Neurocrine holds a Zacks Rank of 2 (Buy) and a Growth Score of B, indicating its potential as a solid choice for growth investors [10]
Neurocrine Biosciences: Buy Rated As Q3 2025 Earnings Catalyst Approaches (NASDAQ:NBIX)
Seeking Alpha· 2025-10-18 08:47
Core Insights - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) has experienced a strong six-month performance with double-digit gains, recovering from 52-week lows recorded in April 2025, although the past month has seen marginal losses of less than one percent [1] Company Performance - The stock of Neurocrine Biosciences, Inc. has shown significant recovery over the last six months, indicating positive market sentiment and potential growth opportunities [1] Analyst Background - Gamu Dave Innocent Pasi is a seasoned financial professional with extensive experience in financial analysis and investment research, contributing to reputable publications and focusing on actionable trading ideas and investment recommendations [1] Investment Philosophy - Gamu emphasizes the importance of Responsible Investment and actively promotes Environmental, Social, and Governance (ESG) principles in investment decision-making, reflecting a growing trend in the investment community towards sustainability and social impact [1] Future Focus - The company is currently focused on building a new international investment portfolio, indicating a strategic move towards global market engagement and diversification [1]