Neurocrine(NBIX)

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Neurocrine(NBIX) - 2024 Q4 - Earnings Call Transcript
2025-02-07 03:52
Financial Data and Key Metrics Changes - Neurocrine reported record sales growth for INGREZZA in 2024, increasing annual sales by approximately $475 million, driven by increased volume and improved gross-to-net dynamics [22] - The guidance for INGREZZA sales in 2025 is projected to be between $2.5 billion and $2.6 billion, reflecting a growth of $250 million at the midpoint [14][24] - The company anticipates a slower growth trajectory for INGREZZA due to increased competitive pressure and utilization management by payers [14][24] Business Line Data and Key Metrics Changes - INGREZZA continues to show strong performance with expectations of double-digit year-over-year growth, although moderated compared to 2024 [7][14] - Quinicity, the newly launched treatment for congenital adrenal hyperplasia, is expected to have measured early revenues due to factors such as delayed reimbursement and patient flow [16][27] - The sales organization has been expanded to better address the needs of the approximately 90% of untreated tardive dyskinesia patients in the US [9][24] Market Data and Key Metrics Changes - The market for tardive dyskinesia is estimated to have around 800,000 patients in the US, with less than 10% currently treated with VMAT2 inhibitors, indicating substantial growth potential [22][24] - The competitive landscape is evolving, with increased utilization management impacting access to INGREZZA [80][82] Company Strategy and Development Direction - Neurocrine aims to diversify its revenue profile with Quinicity and anticipates it could become a second blockbuster therapy [10][21] - The company plans to enhance its R&D productivity, expecting to launch a new commercial product every two years at steady state [11] - The focus will be on expanding into new therapeutic areas and advancing biologics, with a robust neuroscience pipeline expected to grow from 12 to 18 programs by year-end [11][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of INGREZZA despite current headwinds, emphasizing the unmet medical need in the tardive dyskinesia market [14][56] - The early feedback from the CAH community regarding Quinicity has been positive, with expectations for broad reimbursement in the future [75] - Management acknowledged the challenges of launching a new treatment but remains optimistic about Quinicity's potential to transform care for CAH patients [10][28] Other Important Information - The company is investing in both revenue growth and R&D programs, with a significant focus on the launch of Quinicity and the expanded INGREZZA sales force [18][19] - The anticipated increase in operating expenses for 2025 aligns with the investment behind the Quinicity launch and sales force expansion [18][19] Q&A Session Summary Question: Expectations for Quinicity launch revenue trajectory - Management indicated that early launch dynamics for Quinicity are promising, with 11 new patient start forms received shortly after approval, but refrained from providing specific ramp expectations [41][44] Question: Clarification on INGREZZA guidance and market dynamics - Management reiterated that the guidance reflects continued growth despite external factors like payer dynamics and competitive pressures, emphasizing proactive steps to address these challenges [49][52] Question: Insights on payer traction and free drug program for Quinicity - The company has implemented a fast start program to provide free product to patients while reimbursement is secured, with expectations that most patients will require this for one to two months [73][75] Question: Utilization management impact on INGREZZA - Management noted that utilization management has tightened, impacting access, but they are actively working to maximize patient access through a sophisticated infrastructure [80][82] Question: Growth levers among segments for INGREZZA - The greatest growth is expected to come from the psychiatry segment, with ongoing efforts to address telemedicine challenges and high turnover in healthcare providers [85][86] Question: Feedback from end of phase two meetings for osuvamphetor and 568 - Management reported positive feedback and alignment from the agency regarding the registration programs for both osuvamphetor and 568, with support for the planned dose selection [106][107]
Neurocrine Biosciences (NBIX) Q4 Earnings and Revenues Lag Estimates
ZACKS· 2025-02-06 23:15
Neurocrine Biosciences (NBIX) came out with quarterly earnings of $1 per share, missing the Zacks Consensus Estimate of $1.56 per share. This compares to earnings of $1.44 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -35.90%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $1.47 per share when it actually produced earnings of $1.24, delivering a surprise of -15.65%.Over the last fou ...
Neurocrine(NBIX) - 2024 Q4 - Annual Results
2025-02-06 21:04
Exhibit 99.1 Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2024 Financial Results and Provides Financial Expectations for 2025 INGREZZA (valbenazine) Fourth Quarter and Full Year 2024 Net Product Sales of $615 Million and $2.3 Billion, Representing Year-Over-Year Growth of 23% and 26% Respectively ® • INGREZZA fourth quarter and fiscal 2024 net product sales were $615 million and $2.3 billion, respectively • INGREZZA fourth quarter net product sales grew 23% compared to fourth quarter 2023, drive ...
Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2024 Financial Results and Provides Financial Expectations for 2025
Prnewswire· 2025-02-06 21:01
INGREZZA® (valbenazine) Fourth Quarter and Full Year 2024 Net Product Sales of $615 Million and $2.3 Billion, Representing Year-Over-Year Growth of 23% and 26% Respectively INGREZZA® (valbenazine) Full Year 2025 Net Product Sales Guidance of $2.5 - $2.6 Billion CRENESSITYTM (crinecerfont), a First-in-Class Treatment for Children and Adults with Classic Congenital Adrenal Hyperplasia, Approved and Launched in the United States Phase 3 Programs for Osavampator in Major Depressive Disorder and NBI-'568 in Schi ...
Neurocrine (NBIX) Q4 Earnings on the Horizon: Analysts' Insights on Key Performance Measures
ZACKS· 2025-02-04 15:20
The upcoming report from Neurocrine Biosciences (NBIX) is expected to reveal quarterly earnings of $1.58 per share, indicating an increase of 9.7% compared to the year-ago period. Analysts forecast revenues of $630.72 million, representing an increase of 22.4% year over year.The current level reflects a downward revision of 9.4% in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their initial projections ov ...
Neurocrine Biosciences Q4 Earnings Preview: What To Expect After The New Drug Approval
Seeking Alpha· 2025-02-04 12:52
Brendan, a Pennsylvanian by birth:-Completed a Ph.D. at Stanford University in the field of organic synthesis (2009). -Worked for a major pharmaceutical company (Merck, 2009-2013).-Worked in biotech including start-ups (Theravance/Aspira) prior to securing employment at Caltech.-First employee and co-founder of 1200 Pharma as it spun out of Caltech garnering major investment (into the 8 figures).-Remains an avid investor, focused on market trends and especially biotechnology stocks.Analyst’s Disclosure: I/w ...
Neurocrine Biosciences Announces Conference Call and Webcast of Fourth Quarter and Year-End 2024 Financial Results
Prnewswire· 2025-01-30 21:01
Conference Call and Webcast Scheduled for Thursday, February 6SAN DIEGO, Jan. 30, 2025 /PRNewswire/ --Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has scheduled its fourth quarter and year-end 2024 financial results conference call and webcast for 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time) on February 6, 2025.The schedule for the press release and conference call / webcast is as follows: Q4 & Year-End 2024 Press Release: February 6, 2025 at 1:00 p.m. PT / 4:00 p.m. ET Q4 & Year-E ...
Neurocrine Biosciences (NBIX) Earnings Expected to Grow: What to Know Ahead of Q4 Release
ZACKS· 2025-01-29 16:06
Neurocrine Biosciences (NBIX) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended December 2024. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, ...
Neurocrine Biosciences Announces Initiation of Phase 3 Registrational Program for Osavampator as an Adjunctive Therapy for the Treatment of Major Depressive Disorder in Adults
Prnewswire· 2025-01-28 13:30
SAN DIEGO, Jan. 28, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 3 registrational study to evaluate the efficacy, safety and tolerability of osavampator (formerly NBI-1065845), an investigational drug under development as an adjunctive treatment to antidepressants for major depressive disorder (MDD). Positive topline data for the Phase 2 SAVITRI™ study of osavampator in adult subjects with MDD were announced in April 2024. "Osavampator has the po ...
Andrew Ratz, Ph.D., Joins Neurocrine Biosciences as Senior Vice President of Drug Development, Delivery and Device
Prnewswire· 2025-01-23 21:05
Dr. Ratz joins Neurocrine after a 28-year career at Eli Lilly and Company, where he contributed to the development and successful registration of more than 25 products across multiple therapeutic areas and molecule modalities. Most recently, he served as Lilly's Senior Vice President and Head of the Drug Delivery, Device and Connected Solutions organization. He led the integrated design and development of devices, drug-device combination products, and packaging systems for both the biotech and small molecul ...