PresentationSean LaamanHead of Healthcare Research & Equity Analyst Good morning, everyone, and welcome to Morgan Stanley's Global Healthcare Conference. I'm Sean Laaman, Head of U.S. mid-cap biotech equity research here at the firm. Before we commence, for important disclosures, go to our research disclosure website at www.morganstanley.com/researchdisclosures. And if you have any questions, please reach out to your Morgan Stanley sales representative. For this session, we have Neurocrine Biosciences, with ...

Neurocrine Biosciences (NasdaqGS:NBIX) FY Conference September 09, 2025 10:45 AM ET Company ParticipantsSean Laaman - Executive DirectorKyle Gano - President, CEO & DirectorSanjay Keswani - Chief Medical OfficerSean LaamanGood morning, everyone, and welcome to Morgan Stanley's Global Healthcare Conference. I'm Sean Lamm, Head of US Midcap Biotech Equity Research here at the firm. Before we commence, for important disclosures, go to our research disclosure website at www.morganstanley.com/researchdisclosures ...

Question-and-Answer SessionBut a lot going on at Neurocrine, Matt, can you give us a quick snapshot of the highlights of 2025 that we've passed or are yet to come.Matthew AbernethyChief Financial Officer Well, thanks, Josh, and we will be making forward-looking statements, so I'll get that out there. Yes, happy to be here. A lot going on for Neurocrine. And hopefully, this is Eric. We have an open chair here. A lot going on for Neurocrine. INGREZZA is going quite well, $2.5 billion in sales is what we expec ...

Summary of Neurocrine Biosciences (NBIX) 2025 Conference Call Company Overview - **Company**: Neurocrine Biosciences (NBIX) - **Key Products**: INGREZZA, Chrinesity - **Market Focus**: Tardive Dyskinesia (TD), Congenital Adrenal Hyperplasia (CAH), Major Depressive Disorder, Schizophrenia Key Highlights 1. **Sales Performance**: Expected sales for INGREZZA in 2025 are projected at $2.5 billion, indicating strong market performance [3] 2. **Product Launch**: Chrinesity has had a successful launch, being the first new medicine for congenital adrenal hyperplasia in over 70 years, with strong initial uptake [4] 3. **Clinical Trials**: Two major Phase 3 programs are ongoing: one for osavampitur in major depressive disorder and another for a muscarinic program in schizophrenia, with plans to initiate a bipolar mania trial later this year [5] Financial and Market Strategy 1. **Sales Force Expansion**: The company is focusing on expanding its sales force for INGREZZA and enhancing contracting strategies to improve market access [6] 2. **Contracting Strategy**: The contracting strategy for INGREZZA has evolved, with a focus on increasing formulary coverage in the Medicare segment, moving from less than half to over 70% coverage [12][14] 3. **Impact of IRA**: The Inflation Reduction Act (IRA) is influencing payer behavior, leading to tighter management of specialty drugs, which has necessitated adjustments in contracting strategies [15][16] Market Dynamics 1. **Patient Access**: The company has seen record new patient starts in Q1 and Q2, attributed to improved formulary coverage and reduced friction in patient access [12][13] 2. **Competitor Landscape**: AUSTEDO, a competitor, is negotiating with CMS for its price, which could impact Neurocrine's strategy and pricing for INGREZZA [21][22] 3. **Long-term Growth Potential**: There is a significant opportunity for INGREZZA, with a large portion of the TD market still untreated, and exclusivity extending until February 2038 [23] Pipeline Updates 1. **Osavampitur**: Phase II data is expected soon, with promising efficacy results indicated by a placebo-adjusted score improvement of 7.5 points [50][51] 2. **Cerebral Palsy**: There is ongoing research into the efficacy of VMAT2 inhibition for patients with dyskinetic cerebral palsy, although there are clinical risks associated with this patient population [48][49] Additional Insights 1. **Market Segmentation for Chrinesity**: The company estimates around 20,000 classic CAH patients in the U.S., with a focus on pediatric endocrinologists and centers of excellence for treatment [35][36] 2. **Educational Efforts**: Neurocrine is actively educating healthcare providers on the distinctions between classic and non-classic CAH to enhance patient identification and treatment [41][42] 3. **Patient Feedback**: Positive anecdotal feedback from patients and clinicians regarding the effectiveness of new therapies has been noted, contributing to a rewarding launch experience [45][46] Conclusion Neurocrine Biosciences is positioned for growth with strong sales performance from INGREZZA and a successful launch of Chrinesity. The company is navigating a complex market influenced by regulatory changes and competitive dynamics while advancing its clinical pipeline.

Summary of Neurocrine Biosciences (NBIX) FY Conference Call - August 13, 2025 Company Overview - Neurocrine Biosciences specializes in neuro and endocrine disorders, with a strong focus on commercialization and a robust pipeline of products [2][5] Key Points on Commercialization and Product Launches - The company successfully launched KRONESTY, a treatment for congenital adrenal hyperplasia (CAH), which has exceeded internal expectations due to pre-launch disease state education efforts [6][10] - KRONESTY's uptake has been strong among healthcare providers, with a focus on patient identification and education to ensure ongoing treatment adherence [11][12] - The reimbursement rate for KRONESTY was reported at 76% in Q2, indicating strong market access compared to previous products [15][16] Financial Performance - Q2 revenue for INGREZZA reached $624 million, reflecting a 15% quarter-over-quarter growth and an 8% year-over-year increase [24] - The company narrowed its sales guidance for INGREZZA to between $2.5 billion and $2.55 billion for the year, anticipating double-digit growth [27][28] Pipeline and Research Development - Neurocrine aims to initiate four new Phase I trials and two new Phase II trials annually, with a goal of introducing one new medicine every two years [8] - The company is advancing its lead muscarinic program, dereclidine, in Phase III trials for schizophrenia and plans to explore bipolar mania later this year [39][46] - The company is also investigating opportunities in Alzheimer's disease psychosis, leveraging its diverse muscarinic portfolio [47] Competitive Landscape - Neurocrine acknowledges competition in the CAH space but emphasizes its history of being first in various disease states and its commitment to patient safety and tolerability [17][18] - The company is preparing for potential impacts from the Inflation Reduction Act (IRA) on its competitors, particularly regarding pricing negotiations starting in 2027 [30][33] Future Outlook - The focus remains on the U.S. market for KRONESTY, with plans for international expansion being evaluated but not imminent [23] - The company is optimistic about the long-term growth potential of INGREZZA, supported by a strong intellectual property position extending to 2038 [34] Additional Insights - Neurocrine's approach to patient engagement and education is critical for the success of its products, particularly in rare diseases where awareness is low [12][13] - The company is committed to maintaining high standards in its research and development efforts, ensuring a balanced portfolio of validated and unvalidated targets [7][8] This summary encapsulates the key insights from the Neurocrine Biosciences FY Conference Call, highlighting the company's strategic focus, financial performance, and future growth potential in the biopharmaceutical landscape.

Summary of Earnings Call Records Industry Overview - **Industry**: Pharmaceuticals and Biotech Sectors - **Companies Discussed**: AbbVie, Biogen, Bristol Myers Squibb, Bio-Rad Laboratories, Neurocrine Biosciences, Takeda Pharmaceutical, Chugai Pharmaceutical, PeptiDream, Nxera Pharma Key Points by Company AbbVie - **Sales Performance**: Humira sales decreased by 58.1% year-over-year due to biosimilar competition, but this was offset by strong sales of Skyrizi, which increased by 62.2% to $4.4 billion, driven by market share growth in psoriasis and inflammatory bowel disease [1] - **Product Strategy**: Many patients switched from Humira to Skyrizi and Rinvoq instead of biosimilars. AbbVie plans to increase production capacity for Skyrizi in the long term [1] - **New Developments**: The obesity treatment ABBV-295 may address muscle and bone loss when used with other AbbVie drugs [1] Biogen - **Market Share**: Leqembi, an Alzheimer's treatment, maintains a 70% market share despite competition from Eli Lilly's Kisunla [3] - **Testing Growth**: Monthly PET testing for Alzheimer's has increased fivefold, and blood-based biomarker testing has tripled in the past year [3] - **Future Expectations**: Biogen anticipates interim data readout for the AHEAD 3-45 study in 2028 [3] Bristol Myers Squibb - **Sales Growth**: Sales of Opdivo's subcutaneous formulation increased by 7% year-over-year to $30 million, while the intravenous formulation rose to $2.56 billion [6] - **New Product Launch**: Cobenfy, a schizophrenia treatment, generated $35 million in sales with over 2,000 weekly prescriptions [6] - **Direct-to-Patient Model**: The company plans to sell Eliquis directly to patients at a discount of over 50% below the list price [6] Bio-Rad Laboratories - **Sales Performance**: Reported sales of $652 million, up 2% year-over-year, but operating profits fell by 24% to $77 million due to weak demand in biotech and academic research markets [8] - **Market Challenges**: The demand for instruments has been particularly weak, impacting overall sales [8] Neurocrine Biosciences - **Sales Growth**: Total sales reached $688 million, up 16% year-over-year, with operating profits flat at $146 million [10] - **Future Studies**: Plans to initiate a Phase 2 study of NBI-570 in H2 2025, with Phase 1 data readouts expected for NBI-567 and NBI-569 [10] - **Market Positioning**: Neurocrine is exploring differentiation opportunities in muscarinic receptor agonists, which may be better suited for elderly patients [10] Implications for Japanese Companies - **Takeda Pharmaceutical**: Entyvio retains a top share among first-line therapies for ulcerative colitis but is losing market share in second-line settings due to competition [2] - **Chugai Pharmaceutical and PeptiDream**: Both companies are developing myostatin inhibitors to counteract muscle mass loss associated with long-term GLP-1 receptor agonist use [2] - **Nxera Pharma**: The company is positioned positively due to its licensing of muscarinic receptor agonists to Neurocrine, although earnings contributions may not be reflected in share prices until Phase 3 study results are available [11] Additional Insights - **Market Trends**: The aggressive advertising by competitors is impacting market shares of established products like Entyvio [2] - **Direct Sales Models**: There is a growing trend among overseas pharmaceutical companies to adopt direct-to-patient sales models, which Japanese companies have yet to fully embrace [7] This summary encapsulates the key insights and data from the earnings calls of the discussed companies, highlighting their performance, strategies, and implications for the broader industry.

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]

The reported revenue represents a surprise of +5.72% over the Zacks Consensus Estimate of $650.3 million. With the consensus EPS estimate being $0.98, the EPS surprise was +8.16%. Neurocrine Biosciences (NBIX) reported $687.5 million in revenue for the quarter ended June 2025, representing a year-over-year increase of 16.5%. EPS of $1.06 for the same period compares to $0.63 a year ago. Here is how Neurocrine performed in the just reported quarter in terms of the metrics most widely monitored and projected ...

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]