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koto_feja The arrow is pointing up these days for Neurocrine Biosciences (NASDAQ:NBIX) as this neuro- and neuropsych-focused biotech continues to report healthy sales of its core commercial product Ingrezza, while also delivering clinical wins and a deepening pipeline of high-potential drugs. Neurocrine shares are up about 15% since my last update, which is a little better than the overall biotech sector over that time period. With healthy sales growth from Ingrezza, a likely launch of crinecerfont in 2025, ...

Financial Data and Key Metrics Changes - Q2 2024 gross sales reached $580 million, a 32% increase from $440 million in the prior year [6][4] - The company raised its 2024 gross and net sales guidance to a range of $2.25 billion to $2.3 billion, up from the previous range of $2.1 billion to $2.2 billion [6][7] - GAAP SG&A expense guidance was updated by approximately $35 million, with $20 million allocated for the growth of ININGREZZA and $15 million for a non-GAAP impairment charge [6][7] Business Line Data and Key Metrics Changes - ININGREZZA experienced over 30% year-over-year growth, with sales approaching $1.1 billion in the first half of 2024 [8][9] - The company is expanding its sales force to enhance the reach and education of healthcare providers regarding ININGREZZA [10][11] - A new sprinkle formulation of ININGREZZA was launched to cater to patients with swallowing difficulties [12][13] Market Data and Key Metrics Changes - The TD market has grown significantly, with more healthcare providers diagnosing and treating tardive dyskinesia (TD) [10][11] - The company plans to increase its psychiatry and long-term care sales teams to better serve the growing number of TD treaters [11][34] - The CAH market is expected to see significant changes with the potential approval of Crinecerfont, which has been granted priority review by the FDA [18][19] Company Strategy and Development Direction - The company aims to maintain its leadership in neuroscience by investing in its R&D pipeline and expanding its commercial footprint [6][8] - Neurocrine is focused on organic growth, moving towards internally discovered programs and exploring gene therapy [47][48] - The strategic plan includes launching Crinecerfont and advancing the clinical programs for NBI-'845 and NBI-'568 [46][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of ININGREZZA and the upcoming launch of Crinecerfont, highlighting the significant unmet needs in the CAH community [18][19] - The company is well-positioned financially, with $1.7 billion in cash, allowing for continued investment in R&D and potential new therapies [48] - Management emphasized the importance of evolving their approach to meet the needs of healthcare providers and patients [10][34] Other Important Information - The company has a robust clinical pipeline, with multiple new compounds entering the clinic and significant progress in ongoing studies [21][22] - The FDA has granted breakthrough therapy designation and orphan drug designation to Crinecerfont, enhancing its potential market position [18][19] Q&A Session Summary Question: Insights on NBI-'568 data and Phase I study - Management confirmed that data from the Phase I proof-of-concept study will be delivered soon, emphasizing confidence in the safety and tolerability of the doses chosen for the study [22][23] Question: Sales force expansion rationale - The company is expanding its sales force to meet the growing needs of the psychiatry segment and long-term care, expecting positive ROI from this investment [34][35] Question: Growth drivers for ININGREZZA - All three business segments (psychiatry, neurology, long-term care) are experiencing growth, with continued efforts to raise awareness and educate healthcare providers [37][38] Question: Future opportunities for M4 beyond schizophrenia - Management indicated that while there are many potential opportunities, the focus remains on the data from the Phase II study before considering expansions into other indications [71]

For the quarter ended June 2024, Neurocrine Biosciences (NBIX) reported revenue of $590.2 million, up 30.4% over the same period last year. EPS came in at $0.63, compared to $0.95 in the year-ago quarter. The reported revenue represents a surprise of +7.56% over the Zacks Consensus Estimate of $548.7 million. With the consensus EPS estimate being $1.15, the EPS surprise was -45.22%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to d ...

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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