Group 1: Earnings Performance - Neurocrine Biosciences reported quarterly earnings of $0.63 per share, missing the Zacks Consensus Estimate of $1.15 per share, and down from $0.95 per share a year ago, representing an earnings surprise of -45.22% [1] - Over the last four quarters, the company has surpassed consensus EPS estimates only once [2] - The company posted revenues of $590.2 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 7.56%, and up from $452.7 million year-over-year [2] Group 2: Stock Performance and Outlook - Neurocrine shares have increased approximately 7.5% since the beginning of the year, compared to the S&P 500's gain of 15.8% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to those expectations [4] - The current consensus EPS estimate for the coming quarter is $1.31 on revenues of $571.55 million, and for the current fiscal year, it is $4.22 on revenues of $2.23 billion [7] Group 3: Industry Context - The Medical - Drugs industry, to which Neurocrine belongs, is currently in the top 40% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The estimate revisions trend for Neurocrine is currently favorable, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6]

Financial Performance - INGREZZA (valbenazine) second quarter 2024 net product sales reached $580 million, representing a 32% year-over-year growth[1]. - The company raised its 2024 net product sales guidance for INGREZZA to a range of $2.25 billion to $2.3 billion[1]. - GAAP net income for the second quarter 2024 was $65 million, with diluted earnings per share of $0.63, compared to $96 million and $0.95 in the same quarter of 2023[4]. - Non-GAAP net income for the second quarter 2024 was $169 million, with diluted earnings per share of $1.63, compared to $126 million and $1.25 in the same quarter of 2023[4]. - Net product sales for Q2 2024 reached $583.8 million, a 30.8% increase from $446.3 million in Q2 2023[14]. - Total revenues for the first half of 2024 were $1,105.5 million, up 26.6% from $873.1 million in the same period of 2023[14]. - The company reported a net income of $65.0 million for Q2 2024, down from $95.5 million in Q2 2023, representing a decrease of 31.9%[14]. - Non-GAAP net income for Q2 2024 was $168.9 million, compared to $125.7 million in Q2 2023, indicating a 34.4% increase[16]. Research and Development - The company initiated several Phase 1 and Phase 2 studies for new investigational drugs targeting major depressive disorder and other CNS indications[6][8]. - The company is focused on expanding its pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas[10]. - Research and development expenses for Q2 2024 were $191.1 million, compared to $145.8 million in Q2 2023, reflecting a 31.0% increase[14]. - Non-GAAP R&D expenses for Q2 2024 were $175.3 million, up from $122.0 million in Q2 2023, an increase of 43.7%[18]. Cash and Assets - The company reported cash, cash equivalents, and marketable securities totaling approximately $1.7 billion as of June 30, 2024[4]. - The total assets as of June 30, 2024, were $3,305.0 million, a slight increase from $3,251.4 million at the end of 2023[15]. - The company’s cash, cash equivalents, and marketable securities totaled $1,038.9 million as of June 30, 2024, compared to $1,031.6 million at the end of 2023[15]. Product Development and Sales Strategy - A new sprinkle formulation of INGREZZA was launched for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease[7]. - The company plans to expand the INGREZZA salesforce and build its endocrinology team to support growth[2]. - The FDA granted Priority Review for crinecerfont to treat congenital adrenal hyperplasia, with PDUFA target action dates set for December 29 and 30, 2024[6]. Expenses and Financial Metrics - GAAP cost of revenues for Q2 2024 was $9.2 million, down from $11.5 million in Q2 2023, representing a decrease of 20%[17]. - Non-GAAP cost of revenues for Q2 2024 was $8.3 million, compared to $10.6 million in Q2 2023, a decline of 21.7%[17]. - GAAP SG&A expenses for Q2 2024 were $242.0 million, compared to $221.8 million in Q2 2023, a rise of 9.6%[19]. - Non-GAAP SG&A expenses for Q2 2024 were $200.7 million, up from $177.1 million in Q2 2023, an increase of 13.3%[19]. - Stock-based compensation expense in Q2 2024 was $15.8 million, down from $23.8 million in Q2 2023, a decrease of 33.5%[18]. - Charges associated with convertible senior notes in Q2 2024 amounted to $49.7 million, with no charges reported in Q2 2023[20]. Collaborations and Future Outlook - Neurocrine Biosciences is actively pursuing collaborations to enhance its product offerings and market reach[12]. - The company anticipates continued growth driven by the success of its existing products and the advancement of its clinical pipeline[12].

Core Insights - Neurocrine Biosciences reported second quarter net product sales of INGREZZA® (valbenazine) at $580 million, reflecting a 32% year-over-year growth driven by strong patient demand and improved gross-to-net dynamics [3][4] - The company raised its 2024 net product sales guidance for INGREZZA to a range of $2.25 billion to $2.3 billion [7] - Recent developments include positive Phase 2 data for NBI-1065845 and FDA's Priority Review for crinecerfont, indicating ongoing progress in the company's pipeline [2][5] Financial Highlights - Total revenues for the second quarter of 2024 were $590.2 million, compared to $452.7 million in the same period of 2023 [3][4] - GAAP net income for the second quarter was $65 million, down from $95.5 million year-over-year, while Non-GAAP net income increased to $168.9 million from $125.7 million [4][17] - The company had cash, cash equivalents, and marketable securities totaling approximately $1.7 billion as of June 30, 2024 [4][16] Research and Development - Increased R&D expenses in the second quarter of 2024 were attributed to investments in an expanded clinical portfolio, including muscarinic compounds and gene therapy programs [4][12] - The company initiated several Phase 1 and Phase 2 studies for new investigational compounds targeting major depressive disorder and other neurological conditions [6][10] Leadership Changes - Kevin Gorman, Ph.D., announced his planned retirement as CEO on October 11, 2024, with Kyle Gano, Ph.D., set to succeed him [5][11] Pipeline Developments - The company is advancing multiple compounds in its pipeline, with key milestones expected in the coming quarters, including top-line data for NBI-1117568 in schizophrenia and NBI-1070770 in major depressive disorder [8][10]

The upcoming report from Neurocrine Biosciences (NBIX) is expected to reveal quarterly earnings of $1.15 per share, indicating an increase of 21.1% compared to the year-ago period. Analysts forecast revenues of $548.7 million, representing an increase of 21.2% year over year. Before a company announces its earnings, it is essential to take into account any changes made to earnings estimates. This is a valuable factor in predicting the potential reactions of investors toward the stock. Empirical research has ...

The market expects Neurocrine Biosciences (NBIX) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to b ...

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"Only INGREZZA offers a sprinkle formulation to ease administration for individuals living with tardive dyskinesia or Huntington's disease chorea, who often have difficulty swallowing pills," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "We wanted to provide this new option to patients and their caregivers who want the benefit of treatment with INGREZZA without the challenge of swallowing a capsule." INGREZZA and INGREZZA SPRINKLE offer simple dosing that's always one capsule, ...

Conference Call and Webcast Scheduled for Thursday, August 1 The schedule for the press release and conference call / webcast is as follows: The webcast can also be accessed on Neurocrine Biosciences' website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple pu ...

PDUFA Target Action Dates in Late December 2024 Highly Selective CRF1 Antagonist is the Potential First New Treatment for CAH in 70 Years SAN DIEGO, July 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has accepted its two New Drug Applications (NDA) with Priority Review designations for crinecerfont in the treatment of children, adolescents and adults with classic congenital adrenal hyperplasia (CAH). If approved, crinecerfont ...

SAN DIEGO, June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Diurnal Ltd., a Neurocrine Biosciences company, presented information from its neuroendocrinology pipeline at the Endocrine Society Annual Meeting, ENDO 2024, including primary data just published in The New England Journal of Medicine from its CAHtalyst™ Phase 3 registrational studies of crinecerfont in pediatric and adult patients with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. In addition, ...