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 ...

Financial Data and Key Metrics Changes - INGREZZA net sales for Q3 2023 reached approximately $1.34 billion, reflecting a 29% year-over-year growth, with an updated guidance range of $1.82 billion to $1.84 billion for the full year [83][101] - Non-GAAP diluted earnings per share for the quarter were reported at $1.54, with over $1.5 billion in cash at the end of the quarter [83] Business Line Data and Key Metrics Changes - The diagnosis rate for tardive dyskinesia (TD) has increased from low single digits to around 35% of the prevalent population, indicating significant progress but still leaving about two-thirds of the estimated 600,000 TD patients undiagnosed [85][114] - The initial rollout of INGREZZA for Huntington's disease (HD) Chorea has shown encouraging early feedback, although it is still in the early stages of market introduction [86][104] Market Data and Key Metrics Changes - Approximately 20% of the eligible patient population for VMAT2 inhibitors are currently being treated, with half of the diagnosed patients not receiving any treatment [3][114] - The addressable population for Huntington's disease and Chorea is estimated at around 20,000 to 25,000, with only about 20% currently treated with a VMAT2 inhibitor [125] Company Strategy and Development Direction - The company is focusing on expanding its pipeline and investing in research and development, particularly in areas such as neuroscience, neuropsychiatry, and congenital adrenal hyperplasia (CAH) [2][24] - The upcoming Analyst Day on December 5th will focus on R&D strategy and the burden of disease in CAH, highlighting the potential of crinecerfont as a new standard of care [66][134] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued strong growth driven by the expanded sales team and ongoing marketing efforts for INGREZZA, particularly in the long-term care segment [93][136] - The company is optimistic about the potential of crinecerfont to change the treatment paradigm for congenital adrenal hyperplasia, with plans for NDA submission next year [130][134] Other Important Information - The company has developed a new INGREZZA sprinkles formulation to cater to patients who have difficulty swallowing capsules, which has been accepted as a new drug application by the FDA [133] - The company is committed to maintaining its leadership in movement disorders and tardive dyskinesia while exploring additional indications for INGREZZA [162][192] Q&A Session Summary Question: Can you discuss the dynamics of the long-term care facility effort and its contribution to revenue? - Management noted that the long-term care segment is growing nicely and is becoming a meaningful contributor to revenue, with the sales team effectively driving diagnosis and treatment [9][185] Question: What are the expectations for the upcoming R&D Day? - The R&D Day will focus on the company's strategy and vision, with no new data expected to be unveiled during the event [66][67] Question: How is the company planning to address the market opportunity for Huntington's disease? - The company is targeting neurology specialists and centers of excellence for Huntington's disease to drive treatment rates, with a focus on both newly diagnosed and previously untreated patients [148][178]

Open-Label Treatment (one year) OpenLabel Extension* Participants randomized to placebo will receive crinecerfont during open-label treatment Objective Evaluate the efficacy, safety and tolerability of crinecerfont in adults with classic CAH Crinecerfont is investigational and not approved in any country *The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per participant for the open-label extension CAHtalystTM Adult and Pediatric S ...