CAHtalyst™ Pediatric Study Baseline Characteristics Data Highlight Need for Novel Treatments in Children and Adolescents with Congenital Adrenal Hyperplasia (CAH) CAHtalog™ Registry Data of Glucocorticoid Treatment Patterns in Pediatric and Adult Patients Illustrates the Challenges of Long-Term CAH Management SAN DIEGO, May 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today presented the CAHtalyst™ Pediatric Phase 3 clinical study baseline characteristics data for children and ado ...

Financial Data and Key Metrics Changes - The company reported Q1 sales of $506 million, reflecting over 20% year-over-year growth and marking the third consecutive year of sequential growth from Q4 to Q1 [35][38] - The company ended Q1 with over $1.9 billion in cash, demonstrating significant cash flow generation [5] - Operating leverage on a non-GAAP basis increased by over 1,000 basis points when excluding IT R&D investments made in the prior year [35] Business Line Data and Key Metrics Changes - The INGREZZA franchise continues to show strength, with Q1 sales reaching $506 million, representing a 23% year-over-year increase despite seasonal payer challenges [38] - The company is focusing on the commercialization of Crinecerfont and has submitted a new drug application for its treatment of congenital adrenal hyperplasia [16][39] - Positive Phase 2 results were reported for NBI-845, an AMPA potentiator for major depressive disorder, indicating strong efficacy and tolerability [43] Market Data and Key Metrics Changes - The company is actively expanding its presence in the long-term care market, which remains a significant growth area for INGREZZA [129] - The new sprinkle formulation of INGREZZA is expected to benefit 5% to 10% of patients with swallowing difficulties, already integrated into sales forecasts [49] Company Strategy and Development Direction - The company prioritizes the growth of INGREZZA, preparation for Crinecerfont commercialization, and advancing its pipeline while assessing external opportunities [5] - The company aims to enhance awareness and treatment of tardive dyskinesia (TD) and Huntington's chorea, with a focus on educating the CAH community regarding Crinecerfont [39][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the robustness of the data from recent studies and the potential for significant impact on patient lives [33] - The company is optimistic about the likelihood of priority review for Crinecerfont due to the significant unmet need and the breakthrough designation granted [58][60] Other Important Information - The company has reduced its convertible debt from approximately $518 million to $170 million, managing dilution effectively [11] - The FDA approved the new sprinkle formulation of INGREZZA, providing a valuable treatment option for patients with difficulty swallowing [14] Q&A Session Summary Question: On NBI-845, is there any reason mechanistically for not seeing a dose response? - Management indicated that they are encouraged by the positive results and are exploring the data further before making definitive comments [23][48] Question: What percent of patients have trouble swallowing with INGREZZA and the expected impact of the new formulation? - It is estimated that 5% to 10% of patients experience difficulty swallowing, and the impact on sales is already integrated into guidance [49] Question: Can you speak to the likelihood of a priority review for Crinecerfont? - Management expressed hope for a priority review based on the breakthrough designation and robust Phase 3 data submitted [58][60] Question: What are the benefits of having an adaptive trial design for NBI-568? - The adaptive trial design allows for exploring a broader range of doses in a limited number of patients, which is critical for understanding the benefit-risk perspective [62] Question: How does the company plan to manage multiple Phase 3 studies? - The company is prioritizing programs and closely monitoring spending, indicating a willingness to invest in promising data while managing resources effectively [90][91]

Neurocrine Biosciences (NBIX) reported $515.3 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 22.6%. EPS of $0.42 for the same period compares to -$0.79 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $512.21 million, representing a surprise of +0.60%. The company delivered an EPS surprise of -59.62%, with the consensus EPS estimate being $1.04.While investors closely watch year-over-year changes in headline numbers -- revenue and ea ...

Neurocrine Biosciences (NBIX) came out with quarterly earnings of $0.42 per share, missing the Zacks Consensus Estimate of $1.04 per share. This compares to loss of $0.79 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -59.62%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.13 per share when it actually produced earnings of $1.44, delivering a surprise of 27.43%.Over the last four ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0-22705 NEUROCRINE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction o ...

Exhibit 99.1 Neurocrine Biosciences Reports First Quarter 2024 Financial Results INGREZZA (valbenazine) First Quarter Net Product Sales of $506 Million Representing 23% Year-Over- Year Growth ® INGREZZA SPRINKLE (valbenazine) Capsules Approved by the U.S. FDA ® Crinecerfont New Drug Applications for the Treatment of Congenital Adrenal Hyperplasia Submitted to the U.S. FDA Positive Phase 2 Top-Line Data for NBI-1065845, a Potential First-In-Class AMPA Positive Allosteric Modulator, in Adults with Major Depre ...

SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing. Like ...

Wall Street analysts forecast that Neurocrine Biosciences (NBIX) will report quarterly earnings of $1.04 per share in its upcoming release, pointing to a year-over-year increase of 231.7%. It is anticipated that revenues will amount to $512.21 million, exhibiting an increase of 21.8% compared to the year-ago quarter.Over the past 30 days, the consensus EPS estimate for the quarter has been adjusted downward by 3.8% to its current level. This demonstrates the covering analysts' collective reassessment of the ...

WHAT THE C@H?! provides a platform for the congenital adrenal hyperplasia (CAH) community to find educational information, share experiences and learn about current research. SAN DIEGO, April 24, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the launch of WHAT THE C@H?!, an educational initiative that aims to close the gap in the need for helpful information about congenital adrenal hyperplasia (CAH) and acknowledges the frustrations and challenges experienced by the co ...

For the transition period from __________to__________ Commission file number 0-22705 NEUROCRINE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 33-0525145 (State or other jur ...