Neurocrine Biosciences FY Conference Summary Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Event**: 44th Annual J.P. Morgan Healthcare Conference - **Date**: January 12, 2026 - **Key Speaker**: Kyle Gano, CEO Core Themes 1. **Strong and Building Momentum** - Neurocrine has a workforce of 2,000 and a proven track record in discovering, developing, and commercializing medicines for patients [2][3] - The company has four FDA-approved medicines, including Ingrezza and Crinecerfont, which are marketed in the U.S. [3] - In 2025, Ingrezza is projected to generate $2.5-$2.55 billion in net sales, while Crinecerfont achieved $166 million in net sales in its first nine months [4] 2. **Strategic Balanced Diversification** - Transitioned from a single product company focused on small molecules to a diversified biopharmaceutical company [5][6] - Crinecerfont is expected to be a significant contributor to revenue diversification alongside Ingrezza [6] - The company is expanding its R&D efforts into new therapeutic areas, including peptides, antibodies, and gene therapies [7][8] Financial Performance - **Ingrezza**: Projected net sales of $2.5-$2.55 billion for 2025 [4] - **Crinecerfont**: $166 million in net sales for the first nine months of commercialization [4] R&D Pipeline - **Current Pipeline**: 12 programs in clinical development (8 in phase one, 2 in phase two, 2 in phase three) [35] - **Goals**: Targeting four new phase one programs and advancing two new phase two programs annually [11] - **Focus Areas**: Neurology, psychiatry, endocrinology, with a strong emphasis on validated biology [35] Key Products and Programs 1. **Crinecerfont**: - First approved treatment for classic congenital adrenal hyperplasia (CAH) [41] - Positive two-year data showing robust efficacy and safety, with an 80% retention rate in the open-label extension study [24][45] - 40% of patients experienced a 5% or greater weight loss during the two-year period [25] 2. **Neuropsychiatry Portfolio**: - Includes first-in-class AMPA PAM for major depressive disorder and Derecladine for schizophrenia [13][14] - Both programs are in phase three trials, with potential to change the standard of care [37] 3. **Emerging Endocrinology Pipeline**: - Focused on CRF biology, with programs targeting obesity and metabolic disorders [17][19] - New molecule MBIP2118 for obesity is set to be a once-weekly injectable with a differentiated product profile [19] Market Strategy - **Sales Force Expansion**: Aiming to deepen engagement with endocrinologists and reach patients not currently under specialized care [48] - **Reimbursement Success**: Patients have been able to secure commercial reimbursement within a week, exceeding initial expectations [43] Safety and Efficacy - Crinecerfont has shown a favorable safety profile with no new safety warnings and a low rate of adrenal insufficiency [49][50] - Long-term steroid reduction has led to improvements in weight loss and insulin resistance, critical for patients with CAH [50] Future Outlook - Anticipated data flow from various programs, including gene therapy for Friedreich's Ataxia and weight loss data from CRF2 peptide studies [38] - Continued focus on building a robust R&D engine to support future growth and innovation [36] Conclusion - Neurocrine is positioned for significant growth in 2026 and beyond, with a strong pipeline and strategic diversification efforts aimed at enhancing patient care and expanding market reach [9][10]

Neurocrine Biosciences 2025 R&D Day Summary Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Event**: 2025 R&D Day held on December 16, 2025 - **Key Speakers**: - Kyle Gano, Chief Executive Officer - Sanjay Keswani, Chief Medical Officer - Jude Onyia, Chief Scientific Officer - Dr. John Krystal, expert in neurology and psychiatry Core Industry Insights - **Transition**: Neurocrine is evolving from a single-product biotech to a multi-product diversified biopharmaceutical company with scale [11] - **Employee Base**: The company has grown to 2,000 employees, consolidating all departments under one roof for enhanced collaboration [11][6] - **R&D Focus**: Emphasis on innovative science and pipeline development, particularly in neuropsychiatry [8] Key Products and Pipeline - **Current Products**: - Ingrezza (for tardive dyskinesia) - Krenesti (for CAH) - **Future Products**: - Osirvampetor (for major depressive disorder) - Direclidine (for schizophrenia) - **Pipeline Strategy**: Focus on delivering multiple best-in-class medicines by 2030, leveraging a transformed R&D engine [12][16] R&D Transformation - **R&D Engine**: Fully operational and over-delivering on innovative science, with a focus on high-quality programs across various modalities [12][13] - **CRF Biology**: Leveraging 30 years of expertise in corticotropin-releasing factor (CRF) biology to expand into metabolic disorders, including obesity [14] - **Clinical Trials**: Anticipated phase three trials for Osirvampetor and Direclidine to start reading out in 2027 [16] Market Opportunity - **Mental Health Crisis**: Over one-third of individuals with depression do not respond to current treatments, highlighting a significant unmet need [45] - **Safety and Tolerability**: Osirvampetor aims to provide ketamine-like efficacy without the associated safety issues, such as psychotomimetic effects [40][46] Competitive Advantages - **Institutional Knowledge**: Deep expertise in neurology, psychiatry, endocrinology, and immunology, providing a competitive edge in drug development [19][20] - **Business Development**: Active role in partnerships to enhance R&D capabilities and fill pipeline gaps [31] Future Outlook - **Investment in R&D**: Strong financial profile allows for continued investment in R&D across therapeutic areas [26] - **Execution and Innovation**: Commitment to execution and repeatable innovation as key drivers for future success [36][37] Conclusion Neurocrine Biosciences is positioned for significant growth and innovation in the biopharmaceutical space, particularly in neuropsychiatry, with a robust pipeline and a commitment to addressing unmet medical needs in mental health. The company's strategic focus on leveraging its institutional knowledge and transforming its R&D capabilities is expected to yield multiple new therapies by the end of the decade [11][12][16].

Summary of Neurocrine Biosciences FY Conference Call Company Overview - **Company**: Neurocrine Biosciences (NasdaqGS:NBIX) - **Date**: December 02, 2025 - **Key Speakers**: Matt Abernethy (CFO), Eric Benevich (Chief Commercial Officer), Todd Tushla (Director of Investor Relations) Core Industry Insights - The biotech industry has faced significant challenges over the past year, but Neurocrine has executed well despite these difficulties [8][10][26] - The company is focused on helping patients with conditions like tardive dyskinesia and congenital adrenal hyperplasia (CAH) [10][14] Key Products and Financial Performance - **Ingrezza**: - Generated approximately $2.5 billion in revenue this year [11] - Only 10% of patients with tardive dyskinesia are currently treated with VMAT2 inhibitors, indicating substantial growth potential [12][62] - **Crinecerfont**: - Approved for CAH, with no approved treatment options for over 70 years [14] - One year post-launch, the company has reached 10% of the CAH patient population [16][94] Strategic Challenges and Responses - The company is navigating the implications of the Inflation Reduction Act (IRA) and believes it can manage the impact on Ingrezza from 2027 to 2029 [22][61] - Neurocrine aims to increase its market cap beyond $20 billion, currently positioned between $10-$20 billion [26][28] Market Position and Competitive Landscape - The company has a strong cash position of $2 billion with no debt, allowing for potential business development opportunities [28] - The competitive landscape includes recent acquisitions in the psych space, but Neurocrine is focused on internal development and leveraging its commercial infrastructure [56][58] Sales and Marketing Strategy - The company is expanding its sales force to include advanced practice providers, which are now the largest group of prescribers for VMAT2 medications [90][92] - The expansion is driven by double-digit growth in the VMAT2 category, with Ingrezza growing faster than the overall category [89] Future Outlook - The company is optimistic about the continued growth of Ingrezza and Crinecerfont, with plans to maintain formulary coverage and negotiate favorable pricing with Medicare [62][67] - Upcoming R&D day is anticipated to provide further insights into the company's pipeline and strategic direction [108][111] Additional Considerations - The company emphasizes patient-centric approaches and aims to increase awareness and treatment rates for tardive dyskinesia and CAH [62][90] - The management team is committed to maximizing the value of existing products while exploring new opportunities in neuro and endocrine spaces [58][44]

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.