Neurocrine Biosciences

Neurocrine Biosciences, Inc. is a neuroscience-focused, biopharmaceutical company. It discovers, develops and intends to commercialize drugs for the treatment of neurological and endocrine related diseases and disorders. The firm's product includes INGREZZA. The company was founded by Kevin C. Gorman and Wylie W. Vale in January 1992 and is headquartered in San Diego, CA.

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Earnings data Q3 2023

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Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Neurocrine Biosciences reports strong Q4 performance and eyes growth

Neurocrine Biosciences delivered strong performance in Q4 2022, with robust INGREZZA sales and a positive outlook for 2023, supported by significant investments in SG&A and R&D.
The company's focus on expanding into long-term care, advancing pipeline assets, and collaborations for innovative treatments positions it well for growth and addressing unmet needs.
While facing challenges in managing increased spending and market dynamics, Neurocrine remains optimistic about opportunities in expanding treatment reach, market penetration, and advancing clinical programs.

Neurocrine Biosciences reports strong Q1 performance and eyes international expansion

Neurocrine Biosciences had a strong Q1 performance with record sales, upcoming milestones, and disciplined expense management.
The company faces challenges in certain therapeutic categories but is optimistic about addressing unmet needs and expanding internationally.
Opportunities lie in innovative science, market positioning, and portfolio expansion, positioning Neurocrine for future growth.
Addressing concerns around drug interactions, dosing strategies, and trial risks will be crucial for maintaining clinical success and patient safety.

Neurocrine Biosciences excels in Q2, eyes growth opportunities ahead

Neurocrine Biosciences shows strong financial performance and growth prospects.
Focus on INGREZZA's persistency and pipeline advancements drives optimism.
Challenges include market dynamics and clinical trial complexities.
Opportunities lie in new indications, long-term care expansion, and telemedicine.

Neurocrine Biosciences excels in Q3, eyes growth in LTC segment

Neurocrine Biosciences delivered a strong Q3 performance with robust sales, positive regulatory developments, and promising pipeline advancements.
The company's focus on expanding indications, exploring combination therapies, and addressing market opportunities positions it for future growth.
While facing challenges in market evaluation and competition, Neurocrine Biosciences has opportunities to leverage its strengths and drive innovation.
Investors can look forward to upcoming events like the Analyst Day and R&D Day for deeper insights into the company's strategic direction and growth potential.

Neurocrine Biosciences excels in 2023, eyes Crinecerfont launch success

Neurocrine Biosciences had a strong 2023 with notable achievements in sales growth and pipeline advancements. While facing challenges in market dynamics and pricing negotiations, the company is well-positioned to leverage opportunities in upcoming launches and strategic growth initiatives.

Neurocrine Biosciences excels in Q1 with strong sales and pipeline advancements

Neurocrine Biosciences delivered a strong performance in Q1 2024, driven by robust INGREZZA sales, promising Phase II results for NBI-845, and advancements in Crinecerfont development.
The company's strengths lie in its diverse pipeline, financial stability, and strategic focus on chronic therapy and tolerability, positioning it for future growth and innovation.
While facing challenges in dosing optimization and revenue management, Neurocrine has opportunities to leverage its pipeline, explore new treatments, and differentiate its offerings in the market.

Neurocrine Biosciences excels in Q3, poised for growth ahead

Neurocrine Biosciences showcased robust performance in Q3, with strong INGREZZA sales and pipeline success, positioning for future growth.
The company's strengths lie in its expanded sales team, leadership quality, and commitment to innovation and value creation for shareholders.
Challenges include potential payer reimbursement issues, FDA interactions for Phase III strategy, and competitive pressures in the market.
Opportunities abound with upcoming regulatory approvals, pipeline advancements, and targeted commercial strategies for new product launches.

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Neurocrine Biosciences, Inc. is a neuroscience-focused, biopharmaceutical company, which engages in the research, development, and commercialization of pharmaceuticals for the treatment of neurological, neuroendocrine, and neuropsychiatric disorders. The company was founded by Kevin C. Gorman and Wylie W. Vale in January 1992 and is headquartered in San Diego, CA.

As new schizophrenia drugs move toward approval, Neurocrine Biosciences reports a subpar outcome for its phase 2 trial.

Neurocrine Bio Dives As Schizophrenia Trial Results Lag Peers

Tokyo, Japan and Cambridge, UK, 28 August 2024 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – formerly known as Sosei Group or Sosei Heptares – notes the announcement by its partner Neurocrine Biosciences Inc. (“Neurocrine”; Nasdaq: NBIX) that NBI-1117568 (NBI-‘568) has delivered positive topline results from its Phase 2 clinical study in adults with schizophrenia. NBI-'568 is the first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia.

Nxera Pharma Notes Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568

Neurocrine Biosciences said on Wednesday its experimental drug to treat adults with schizophrenia met the main goal in a mid-stage study.

Neurocrine's schizophrenia drug meets main goal in mid-stage study

The Once-Daily 20 mg Dose Met the Primary Endpoint, Demonstrating a Statistically Significant 7.5-Point Improvement (p=0.011, 0.61 Effect Size) in the PANSS Total Score Compared to Placebo at Week 6 with an 18.2-Point PANSS Total Score Improvement from Baseline The Once-Daily 20 mg Dose Met Additional Endpoints, Demonstrating Statistically Significant Improvements in Clinical Global Impression of Severity Scale and Marder Factor Score Positive Symptom Change and Negative Symptom Change NBI-'568 Was Generally Safe and Well Tolerated at All Doses Studied The Once-Daily 20 mg Dose Efficacy, Safety and Tolerability Phase 2 Results Support Advancement to Phase 3 in Schizophrenia in Early 2025 Company to Host Conference Call with Management at 8 a.m. EDT SAN DIEGO , Aug. 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced positive top-line data for its Phase 2 clinical study of NBI-1117568 (NBI-'568) in adults with schizophrenia.

Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1117568 in Adults with Schizophrenia

SAN DIEGO , Aug. 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) will present at the Canaccord Genuity 44th Annual Growth Conference in Boston at 3:30 p.m. Eastern Time on Wednesday, August 14, 2024.

Neurocrine Biosciences to Present at the Canaccord Genuity 44th Annual Growth Conference

Neurocrine (NBIX) is well positioned to outperform the market, as it exhibits above-average growth in financials.

Is Neurocrine (NBIX) a Solid Growth Stock? 3 Reasons to Think "Yes"

Ingrezza sales are on the rise, with a 32% increase in sales in Q2'24, and there is still an attractive runway of growth ahead for the drug. The Phase II results of '845 in major depressive disorder exceeded expectations, potentially adding over $1B to the revenue pool and positioning it as a potential future rival to Spravato. The upcoming Phase II readout for '568 (an M4 agonist) in schizophrenia is a potentially significant value-creation opportunity, but it will likely require a double-digit improvement in PANSS.

Neurocrine Biosciences Delivering Strong Core Results, And Significant Pipeline Value Could Be On The Way

Neurocrine Biosciences, Inc. (NASDAQ:NBIX ) Q2 2024 Earnings Conference Call August 1, 2024 8:00 AM ET Company Participants Todd Tushla - VP, IR Kevin Gorman - CEO Matt Abernethy - CFO Eric Benevich - Chief Commercial Officer Eiry Roberts - Chief Medical Officer Kyle Gano - Chief Business Development & Strategy Officer Conference Call Participants Philip Nadeau - TD Cowen Paul Matteis - Stifel Tazeen Ahmad - Bank of America Anupam Rama - JPMorgan Akash Tewari - Jefferies Jay Olson - Oppenheimer Cameron Bradshaw - Goldman Sachs Brian Skorney - Baird Mohit Bansal - Wells Fargo Marc Goodman - Leerink Carter Gould - Barclays Myles Minter - William Blair Cory Kasimov - Evercore ISI Laura Chico - Wedbush Securities Operator Good day everyone and welcome to today's Neurocrine Biosciences' reports Second Quarter Results. At this time, all participants are in a listen-only mode.

Neurocrine Biosciences, Inc. (NBIX) Q2 2024 Earnings Call Transcript

Revenue reached $590.2 million, a 30% increase from Q2 2023. Net product sales for Ingrezza hit $580 million, up 32% year over year.

Neurocrine Biosciences' Revenue and Adjusted Income Surge

While the top- and bottom-line numbers for Neurocrine (NBIX) give a sense of how the business performed in the quarter ended June 2024, it could be worth looking at how some of its key metrics compare to Wall Street estimates and year-ago values.

Compared to Estimates, Neurocrine (NBIX) Q2 Earnings: A Look at Key Metrics

Neurocrine Biosciences (NBIX) came out with quarterly earnings of $0.63 per share, missing the Zacks Consensus Estimate of $1.15 per share. This compares to earnings of $0.95 per share a year ago.

Neurocrine Biosciences (NBIX) Lags Q2 Earnings Estimates

INGREZZA® (valbenazine) Second Quarter Net Product Sales of $580 Million Representing 32% Year-Over-Year Growth INGREZZA ® (valbenazine) 2024 Net Product Sales Guidance Raised to $2.25 - $2.3 Billion Top-Line Phase 2 Data Readouts for NBI-'568 and Luvadaxistat Remain On Track in Q3 SAN DIEGO , Aug. 1, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter ended June 30, 2024 and provided an update on its 2024 financial guidance. "At Neurocrine, we are energized by the tremendous opportunity we see to help many more patients, and we are encouraged by our recent progress, including INGREZZA's continued success in treating tardive dyskinesia and Huntington's disease chorea and the FDA's decision to grant Priority Review for crinecerfont to treat congenital adrenal hyperplasia," said Kevin Gorman, Ph.D.

Neurocrine Biosciences Reports Second Quarter 2024 Financial Results and Raises 2024 INGREZZA Sales Guidance

Evaluate the expected performance of Neurocrine (NBIX) for the quarter ended June 2024, looking beyond the conventional Wall Street top-and-bottom-line estimates and examining some of its key metrics for better insight.

Insights Into Neurocrine (NBIX) Q2: Wall Street Projections for Key Metrics

Neurocrine (NBIX) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Neurocrine Biosciences (NBIX) Earnings Expected to Grow: What to Know Ahead of Next Week's Release

Sales and profits have been rocketing upwards for Neurocrine Biosciences, Inc. (NBIX), and a recent regulatory approval should continue that trend.

Neurocrine's Growing Sales, Profits Attracting Big Money

SAN DIEGO , July 18, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the launch of a new sprinkle formulation of INGREZZA® (valbenazine) capsules, the #1 prescribed vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA® SPRINKLE (valbenazine) capsules is now available through the same network of specialty and local affiliated pharmacies that distribute INGREZZA. "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.

Neurocrine Biosciences Launches INGREZZA® SPRINKLE (valbenazine) Capsules to Ease Administration for Patients Experiencing Dysphagia or Difficulty Swallowing

Conference Call and Webcast Scheduled for Thursday, August 1 SAN DIEGO , July 11, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its second quarter 2024 financial results conference call and webcast for 5:00 a.m. Pacific Time (8:00 a.m.

Neurocrine Biosciences Announces Conference Call and Webcast of Second Quarter 2024 Financial Results

Neurocrine Biosciences develops treatments for neurological, neuroendocrine, and neuropsychiatric conditions with leading products Ingrezza and Orilissa. NBIX's diverse pipeline includes promising candidates like CAH in phase 3 clinical trials. The company's revenue is highly concentrated in Ingrezza, but efforts are ongoing to diversify through pipeline development.

Neurocrine Biosciences: Diverse Pipeline, High Margins, And Growth Potential In Biotech

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Ingrezza Sprinkle, granules, has been recently granted with the FDA approval. Supporting $2.1-2.2 billion in 2024 sales for the whole Ingrezza franchise guided by Neurocrine's management. Neurocrine Biosciences, Inc. has two new drug applications for Crinecerfont accepted by the FDA with a priority review, potentially leading to regulatory approval by the end of 2024. Positive results from Crinecerfont trials show efficacy in controlling androgen hormones in patients with congenital adrenal hyperplasia, supporting potential regulatory approval.

Neurocrine's Pipeline, Including Crinecerfont's Priority Review, Drives Long-Term Growth

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 would be the first new treatment option for CAH in 70 years and a first-in-class therapy, with a novel approach for the treatment of this rare and serious endocrine disorder.

Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Applications and Grants Priority Review for Crinecerfont for Pediatric and Adult Patients with CAH

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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.

Neurocrine Biosciences Presented CAHtalyst™ Phase 3 Pediatric and Adult Studies, CAHtalog™ Registry and Disease- and Glucocorticoid-Related Comorbidities Data in CAH at ENDO 2024

-          CAHtalyst™ Pediatric Study Met Primary and Key Secondary Endpoints, with Crinecerfont Treatment Decreasing Androstenedione Levels and Enabling Glucocorticoid Dose Reduction While Maintaining Androstenedione Control     -          30% of Crinecerfont Participants Achieved a Physiologic Glucocorticoid Dose at Week 28 while Maintaining Androgen Control versus 0% of Placebo Participants     -          Favorable Trends in Endpoints Reflecting Supraphysiologic Glucocorticoid Dosing and Androgen Excess     -          Crinecerfont was Generally Well Tolerated SAN DIEGO , June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the primary study results from its CAHtalyst™ Pediatric Phase 3 study investigating crinecerfont for the treatment of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine online edition and will appear in a future print issue of the journal. The CAHtalyst Pediatric Phase 3 study met the primary and key secondary endpoints related to androgen reduction (during an initial glucocorticoid-stable period) and glucocorticoid (GC) dose reduction while maintaining androgen control.

Neurocrine Biosciences Announces Publication of Primary CAHtalyst™ Pediatric Phase 3 Study Results of Crinecerfont for the Treatment of CAH in The New England Journal of Medicine

-          CAHtalyst™ Adult Phase 3 Study Met Primary and Important Key Secondary Endpoints, with Crinecerfont Treatment Decreasing Androstenedione Levels and Enabling Glucocorticoid Dose Reduction While Maintaining Androstenedione Control        -          62.7% of Crinecerfont Participants Achieved a Physiologic Glucocorticoid Dose while Maintaining Androstenedione Control versus 17.5% of Placebo Participants     -          Favorable Trends in Endpoints Reflecting Consequences of Supraphysiologic Glucocorticoid Dosing     -          Crinecerfont was Generally Well Tolerated SAN DIEGO , June 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the primary study results from its CAHtalyst™ Phase 3 study investigating crinecerfont for the treatment of adults ages 18 and older with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine online edition and will appear in a future print issue of the journal. The study met the primary and important key secondary endpoints related to androgen reduction (during an initial glucocorticoid-stable period) and glucocorticoid (GC) dose reduction while maintaining androgen control.

Neurocrine Biosciences Announces Publication of Primary CAHtalyst™ Adult Phase 3 Study Results of Crinecerfont for the Treatment of CAH in The New England Journal of Medicine

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