SAN DIEGO, June 9, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the appointment of Lewis Choi as Chief Information Officer, effective June 9, 2025. Choi, an accomplished leader with 25 years of experience in information technology and artificial intelligence, will be responsible for driving the vision and long-term strategic direction of the company's technology initiatives. "Lewis is a proven global healthcare leader with a track record of utilizing technology to drive ...

KINECT-PRO is the first and only study to specifically evaluate and demonstrate patient-reported improvement with vesicular monoamine transporter 2 inhibitor treatment on tardive dyskinesia using multiple clinically validated scales Patients taking INGREZZA reported robust and clinically meaningful improvements in physical, social and emotional functioning Improvements were seen as early as Week 4 after initial treatment with the lowest INGREZZA dose and sustained through Week 24 Even patients with milder ...

SAN DIEGO, May 28, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of data from the Phase 2 study of NBI-1117568 in adults with schizophrenia, which showed a significant improvement in symptoms and overall severity and highlighted new data on the safety and tolerability of the treatment. NBI-1117568 is the first and only investigational oral muscarinic M4 selective orthosteric agonist in clinical development as a potential treatment for schizophrenia. These ...

Summary of Neurocrine's Conference Call Company Overview - **Company**: Neurocrine Biosciences - **Key Products**: Pranesity, INGREZZA - **Financial Guidance**: Expected revenue of $2.5 to $2.6 billion for the year [5][41] Core Insights and Arguments Product Launch and Performance - **Pranesity Launch**: Launched in December, first treatment for congenital adrenal hyperplasia in over 70 years; exceeded expectations with over 400 treatment forms submitted in Q1 [6][16] - **INGREZZA Performance**: Despite a challenging environment, INGREZZA showed better-than-expected performance in Q1, with a record number of new patient starts [33][41] Market Dynamics - **Diagnosis Rates**: For INGREZZA, diagnosis rates have increased from 2% at launch to 40% currently, but only 10% of diagnosed patients are being treated [5][34] - **Patient Population**: Estimated 20,000 classic congenital adrenal hyperplasia patients in the U.S., primarily treated by endocrinologists [14][15] Financial Position - **Cash Reserves**: Neurocrine has $1.8 billion in cash, reflecting financial flexibility despite using $750 million to retire convertible debt [9] - **Reimbursement Success**: 70% of Pranesity prescriptions were commercially reimbursed in Q1, exceeding expectations [31] Additional Important Points Clinical Trials and Pipeline - **Osvampir and M4 Agonist Programs**: Two major phase three programs underway, focusing on major depressive disorder and schizophrenia [7][9] - **Patient Engagement**: Early patient engagement and education efforts contributed to the successful launch of Pranesity [13][21] Market Challenges - **Competitive Dynamics**: The market for INGREZZA faced challenges due to competitive pressures and payer dynamics, leading to a slowdown in new patient starts in late 2022 [34][36] - **Reauthorization Process**: Many existing patients require reauthorization at the beginning of the year, impacting Q1 performance [37] Future Outlook - **Growth Expectations**: Anticipated continued growth in new patient starts and overall revenue, with confidence in the sales team's productivity [41][42] - **Contracting Strategy**: Entering into contracts with payers to ensure patient retention and facilitate new patient additions [39][40]

One-Year Data Show Lasting Reductions in Glucocorticoid Doses and Improvements in Clinical Outcomes with CRENESSITY™ (crinecerfont) in Pediatric Patients with Classic Congenital Adrenal Hyperplasia SAN DIEGO, May 16, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced it will present new data from the Phase 3 CAHtalyst™ Pediatric study showing lasting reductions in glucocorticoid doses in pediatric patients with classic congenital adrenal hyperplasia who received CRENESSITY™ (cr ...

Patients Treated with INGREZZA® (valbenazine) Capsules Reported Continued Improvements in Functional and Health-Related Quality of Life Measures Findings Presented at 2025 International Society for Pharmacoeconomics and Outcomes Research ConferenceSAN DIEGO, May 16, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new analyses from a Phase 4 randomized withdrawal study (NCT03891862) showing patients with tardive dyskinesia who received continued treatment ...

90% of Pediatric Participants on CRENESSITY versus 21% on Placebo Achieved ≥1 Threshold for Androstenedione Reduction or Glucocorticoid Reduction Observed Rates of Select Reproductive Hormone Normalization in Adult Males Taking CRENESSITY with Substantial Glucocorticoid Dose Reductions Findings Presented at the 2025 American Association of Clinical Endocrinology Annual MeetingSAN DIEGO, May 15, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data from the Phase 3 CAHtal ...

Summary of Neurocrine's Conference Call Company Overview - **Company**: Neurocrine Biosciences - **CEO**: Kyle Gano, appointed in October 2023 Macro Issues - **Executive Order on Most Favored Nation**: - Uncertainty regarding the impact on Neurocrine due to lack of details on the executive order [3][4][5][6] - Focus on building a resilient business amidst evolving regulations [6][7] - **Tariffs**: - Tariffs are not expected to significantly impact the cost of goods for Neurocrine's products [9][10] - **FDA Interactions**: - No current NDA reviews; recent interactions focused on Phase II discussions for upcoming Phase III programs [11][12] Product Launch: Crinesity (Canestrafont) - **Sales Performance**: - Recognized $14.5 million in sales with over 400 new patient starts in the last quarter [16] - Impressive reimbursement rate of approximately 70% [16][18] - **Launch Strategy**: - The launch is described as "measured" due to the need for physician education and patient awareness [18][20] - Patients must navigate insurance processes, which may delay prescriptions [20][21] - **Patient Demographics**: - Initial patient population is skewed towards pediatrics due to more frequent physician visits [27][32] - Adult women are expected to show more motivation for treatment compared to men [49] - **Direct-to-Consumer Advertising**: - Traditional advertising may be less effective due to the smaller patient population for congenital adrenal hyperplasia (CAH) [34][36] - **Market Potential**: - Crinesity is viewed as a potential blockbuster, with expectations of significant market uptake [38][39] Competitive Landscape - **Differentiation**: - Neurocrine's approach with Crinesity is based on efficacy, safety, and tolerability, which are critical for patient adoption [43][46] - The company aims to treat the majority of patients with CAH before competitors enter the market [45][46] Pipeline Developments - **Upcoming Data Readouts**: - Phase III trials for osavapitur and MBI-568 are anticipated [52] - Studies on valbenazine for dyskinesia associated with cerebral palsy and adjunctive treatment for schizophrenia are ongoing [56][60] - **Muscarinic Agonists**: - Neurocrine is developing multiple muscarinic agonists, focusing on selective activation to improve efficacy and safety [70][72] Financial Outlook - **Investment in Growth**: - The company is prioritizing growth over immediate profitability, with significant investments in sales and marketing for Crinesity and INGREZZA [77][78] - R&D spending is projected to be in the mid-30% range of net revenue due to ongoing Phase III trials [79] Conclusion - Neurocrine is navigating a complex regulatory environment while launching Crinesity, which shows promising early sales. The company is focused on educating physicians and patients, with a strong pipeline and strategic investments aimed at long-term growth and market leadership in the treatment of CAH and other conditions.

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes U.S. FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometri ...

Advancing Life-Changing Discoveries in Neuroscience Neurocrine Biosciences (Nasdaq: NBIX) Q1 2025 Earnings Presentation May 5,2025 Safe Harbor and Forward-Looking Statements In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may br ...