Today's Spotlight BREAKING: Carvana, Comfort Systems, CRH To Join S&P 500 Neurocrine Biosciences (NBIX) is this week's Big Cap 20 pick to watch, as the drug stock is back inside a 5% buy zone from a recent entry. The biotech has a few flagship drugs. Among them are Crenessity, which treats classic congenital adrenal hyperplasia. It also has Ingrezza, a treatment for the movement disorders known as tardive dyskinesia and chorea,… MarketSurge Cyber Week Sale This week, save over 80% on MarketSurge—get 2 month ...

Neurocrine Biosciences (NasdaqGS:NBIX) FY Conference December 02, 2025 09:30 AM ET Company ParticipantsEric Benevich - CCOMatt Abernethy - CFOConference Call ParticipantsDavid Amsellem - AnalystDavid AmsellemAll right.Matt AbernethyOkay, we're live now.David AmsellemWe are live.Matt AbernethyThat's awesome.David AmsellemAll right.Matt AbernethyOutside chat.David AmsellemLet's kick things off. This is David Amsellem from the Piper Sandler Biopharma Research Team. We're delighted to have Neurocrine here. We h ...

Core Insights - Novo Nordisk's stock rose due to a lighter-than-expected discount for its semaglutide-based products, Ozempic and Wegovy, under the Inflation Reduction Act, with discounts ranging from 38% to 85% [1][3] - The Centers for Medicare and Medicaid Services (CMS) estimates that price negotiations will save patients $685 million in out-of-pocket costs, focusing on the 15 most expensive drugs in Medicare [2] - Teva Pharmaceutical's Austedo received a 38% discount, with projected sales of $2.5 billion in 2027, contributing to a 4% rise in its stock [5][6] Novo Nordisk - Semaglutide will face a 71% discount, reducing its Medicare price to $274 per month in 2027 from a list price of $959 in 2024 [3] - The discount aligns with a Most Favored Nation deal, allowing Medicare to cover obesity drugs for the first time [4] - Novo Nordisk's stock is currently trading below key moving averages, indicating potential pressure [9] Teva Pharmaceutical - Teva's Austedo will see its price drop from $6,623 to $4,093 by 2027, leading to a positive outlook for the drug [5] - Teva's stock increased by over 4% following the news, reflecting investor confidence [6] AstraZeneca and BeOne Medicines - AstraZeneca's Calquence faces a 40% discount, dropping from $14,228 to $8,600 per month by 2027, but is not expected to significantly impact its market position against BeOne's Brukinsa [7][8] - BeOne's stock rose more than 2%, indicating a favorable market response despite AstraZeneca's discount [8]

Neurocrine Biosciences Conference Call Summary Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Key Products**: - Ingrezza: Approved for tardive dyskinesia (TD) in 2017 and for chorea associated with Huntington's disease - Crinecerfont: Recently approved for congenital adrenal hyperplasia (CAH) in December 2024 - **R&D Pipeline**: Focus on developing a deep and sustainable research and development pipeline Core Points and Arguments Financial Performance - **Q3 Revenue**: $790 million, representing nearly 30% year-over-year growth and double-digit quarter-to-quarter growth [4][5] - **Ingrezza Revenue**: $687 million in Q3, with 12% year-over-year growth and 10% quarter-to-quarter growth [5][6] - **Full Year Guidance**: Reaffirmed guidance of $2.5-$2.55 billion for the year [5][6] Ingrezza Insights - **Market Potential**: 800,000 patients in the U.S. with 90% not on a VMAT2 inhibitor, indicating significant growth potential [6][20] - **Efficacy**: Ingrezza has best-in-class efficacy and a novel formulation for patients with dysphagia, with intellectual property protection until 2038 [6][7] - **Sales Strategy**: Expansion of the sales force and improved market access have driven new patient starts and market share gains [16][20] Crinecerfont Launch - **Initial Performance**: Exceeded expectations with $98 million in revenue and 540 enrollment forms in Q3 [7][33] - **Patient Adoption**: 1,600 new patient starts in the first year, aiming for 2,000 by year-end, representing 10% of the prevalent population [9][34] - **Reimbursement Success**: High reimbursement rate of 80% for dispensed scripts [7][33] R&D Pipeline and Future Growth - **R&D Goals**: Aim to offer one new medicine every other year by the end of the decade, with a focus on validated targets and expanding capabilities into peptides and biologics [10][11] - **Upcoming Programs**: Multiple phase one and phase two starts planned, with a focus on neuroscience and psychiatry [12][43] Market Dynamics and Competitive Landscape - **Pricing Strategy**: Anticipated price decline of 5-7% for Ingrezza due to market access gains and competitive dynamics [18][27] - **Market Growth**: TD market is growing faster than the general population due to increased use of antipsychotics [25][26] - **Competitor Analysis**: Ingrezza is priced significantly lower than competitors like Austedo, which may impact market share dynamics [30][29] Regulatory and Strategic Considerations - **IRA Impact**: Anticipation of the Inflation Reduction Act (IRA) influencing pricing and access strategies [21][24] - **Formulary Coverage**: Increased Medicare formulary coverage from under 50% to over 70% [20][19] Pipeline Developments - **NBI-770**: Did not meet primary endpoint but showed safety and efficacy signals; next steps are under consideration [42][43] - **Ozevampitor**: Phase three program for major depressive disorder (MDD) showing promising results with a significant effect size [44][45] Additional Important Insights - **Sales Force Expansion**: Investment in expanding the sales team for both Ingrezza and Crinecerfont to drive patient adoption [40][41] - **Data-Driven Approach**: Utilizing machine learning and data analytics to identify potential patients for Crinecerfont [40][41] This summary encapsulates the key points discussed during the Neurocrine Biosciences conference call, highlighting the company's financial performance, product insights, market dynamics, and future growth strategies.

Alnylam Pharmaceuticals - Alnylam's market worth exceeded many large-cap drugmakers, indicating a challenging position due to high expectations from investors [1] - The company reported quarterly revenues of approximately $1.25 billion, surpassing analyst estimates by nearly $300 million, and boosted its financial forecasts [4] - Amvuttra generated $685 million in sales, exceeding the expected $622 million, indicating growing demand among patients with transthyretin amyloidosis [4] - Despite strong earnings, Alnylam shares fell nearly 7%, attributed to high share prices and elevated investor expectations [3] Biogen - Biogen's latest earnings report showed revenues just above $2.5 billion, narrowly exceeding Wall Street expectations [7] - The company’s aging multiple sclerosis drugs accounted for about 40% of total revenue, while new product launches showed muted performance [8] - Biogen revised its revenue forecast for the year to flat to up 1%, but lowered annual earnings per share estimates to $14.50 to $15 [9] Neurocrine Biosciences - Neurocrine reported a 28% year-over-year increase in net sales, totaling $785 million, but shares fell by 9% following the announcement [11] - The company plans to invest an additional $150 million in expanding sales teams, raising concerns about future margins [12] - Neurocrine received a civil investigative demand from the DOJ regarding Ingrezza, which may have unsettled investors despite a solid quarterly performance [13][14] Bristol Myers Squibb - Bristol Myers' earnings report was positive overall, but the performance of its schizophrenia drug Cobenfy was seen as underwhelming compared to other products [15][16] - Cobenfy sales reached $43 million in the third quarter, with ongoing trials testing its efficacy in treating Alzheimer's-related psychosis [18] - Despite uncertainties surrounding Cobenfy, Bristol Myers' shares rose 7% due to improved financial guidance and quarterly revenue performance [20]

Core Insights - Neurocrine Biosciences reported strong third-quarter sales, exceeding analyst expectations for both Ingrezza and Crenessity, with total sales reaching $790 million, a 28% increase year-over-year [5] - Ingrezza sales were $687 million, up 12% year-over-year, while Crenessity generated $98 million, significantly surpassing forecasts of $68 million [1][2] - Despite the strong performance, Neurocrine's stock faced pressure due to concerns over salesforce expansion, slow uptake of Crenessity, and ongoing investigations by the Department of Justice [3] Financial Performance - Total sales for Neurocrine Biosciences were $790 million, exceeding the projected $747 million, with adjusted earnings of $2.17 per share, beating forecasts by $0.10 [5] - The company reaffirmed its guidance for Ingrezza sales between $2.5 billion and $2.55 billion for the year, with analysts predicting $2.53 billion [5] Product Dynamics - Ingrezza is experiencing pricing pressure, with a projected 6% to 7% year-over-year decline in net pricing for the third and fourth quarters [6] - Crenessity's launch has been strong, with about 80% of insurers reimbursing for the drug, contributing to its sales success [10] - However, there was a sequential drop in new patient starts for Crenessity, with only 540 patients starting treatment in Q3, down from 644 in Q2 [11] Market Reactions - Neurocrine's stock fell over 2% to $143.76, currently resting at its 50-day moving average, despite a strong Composite Rating of 94, indicating it ranks in the top 6% of stocks based on fundamental and technical measures [4] - Analysts have mixed views, with some expressing confidence in the company's growth trajectory while others highlight potential risks related to pricing and market competition [3][9][12]

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.

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 - Biotechnology stocks, with exceptions like Novo Nordisk and Eli Lilly, faced challenges in attracting investment capital in 2024 due to a high interest rate environment [1] - The FDA's cautious approach to drug approvals, particularly in breakthrough areas like gene therapy, has impacted large-cap drug companies [2] - The biotech industry is leveraging AI to enhance efficiencies and accelerate drug development, particularly in precision medicine [3] Company-Specific Insights - **Iovance Biotherapeutics**: Received FDA approval for Amtagvi, the first TIL therapy for solid tumors, transitioning from clinical stage to revenue generation. However, the stock is down 75.8% in 2025, with concerns over slow sales and cash burn projected at $300 million for the year [5][6][8] - **Neurocrine Biosciences**: Projecting revenue between $2.5 billion and $2.6 billion in 2025 from its Ingrezza therapy. The approval of Crenessity for congenital adrenal hyperplasia could boost revenue significantly, with peak U.S. sales estimated at $800 million to $1 billion [9][10][11] - **Viking Therapeutics**: Stock is down 33% as it awaits Phase 2 results for its GLP-1 candidate VK2735. The company faces competition from Eli Lilly and has significant short interest, but claims of durable weight loss could provide a competitive edge [13][14][15]

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]