Neurocrine(NBIX)

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Neurocrine(NBIX) - 2022 Q2 - Quarterly Report
2022-08-04 20:08
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 June 30, 2022 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 of ...
Neurocrine(NBIX) - 2022 Q1 - Earnings Call Presentation
2022-05-06 12:41
| --- | --- | --- | --- | --- | |---------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | Advancing | | | | | | Life-Changing Discoveries in Neuroscience | | | | | | Q1 2022 Corporate Presentation | | | | | | May 4, 2022 Nasdaq: NBIX | | | | | | | | | | | Safe Harbor Statement and Non-GAAP Financial Measures 2 In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncert ...
Neurocrine(NBIX) - 2022 Q1 - Earnings Call Transcript
2022-05-04 16:30
Financial Data and Key Metrics Changes - Neurocrine Biosciences reported strong Q1 performance with INGREZZA sales totaling $303 million, marking a significant achievement in a typically challenging quarter [11] - The company exited Q1 with a record number of new patients, reflecting an improving external environment and benefits from commercial initiatives [12] - The gross to net guidance for Q1 was around $5,300 per script, with an expectation of $5,400 per TRx for the full year, indicating a 2% headwind in Q1 [30] Business Line Data and Key Metrics Changes - The INGREZZA franchise experienced over 30% year-over-year growth in Q1, driven by improved healthcare professional access and effective execution by field teams [14] - The company expanded its sales force by 140 representatives, which is expected to benefit growth in the latter half of the year [14][15] - The management noted that while Q2 is expected to show sequential growth, the percentage increase may be lower than in previous years due to the strong performance in Q1 [12][15] Market Data and Key Metrics Changes - The company highlighted that approximately 85% of the estimated 600,000 people living with tardive dyskinesia (TD) remain undiagnosed or untreated, indicating a significant market opportunity [17] - The external environment has improved, but challenges remain, particularly in adapting to remote healthcare delivery [7] Company Strategy and Development Direction - Neurocrine is focused on expanding the INGREZZA franchise and advancing its clinical pipeline, including filing a supplemental NDA for INGREZZA in Huntington's disease [8][20] - The company is committed to increasing awareness and treatment of TD through significant commercial investments and an expanded sales force [17] - The management emphasized the importance of adapting to the evolving healthcare landscape, including the integration of telemedicine [56] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the trajectory of INGREZZA and the ability to treat more TD patients, despite the challenges posed by the conflict in Ukraine [110] - The company is looking forward to a wealth of data readouts in 2023, indicating a strong pipeline and growth potential [111] Other Important Information - The company received regulatory approval for valbenazine in Japan for the treatment of tardive dyskinesia, which is expected to support its launch plans [20] - The humanitarian crisis in Ukraine has impacted some clinical programs, but the company is implementing contingency plans to mitigate these effects [24][110] Q&A Session Summary Question: Can you provide context around compliance improvement this quarter? - Management noted a less significant decline in refill rates from Q4 to Q1, attributed to improved management of the reauthorization process and a better access environment [30] Question: Was there any impact from inventory during the quarter? - Management reported no significant swings in inventory and described the quarter as clean from that regard [32] Question: How is the split between psychiatrists and neurologists in terms of scripts? - Historically, the split has been about 80% psychiatry and 20% neurology, with efforts to better penetrate the neurology segment through an expanded sales team [35] Question: What are the plans for ONGENTYS given its commercial performance? - Management acknowledged lower-than-expected sales for ONGENTYS but emphasized positive feedback from prescribers and plans to continue focusing on neurologists [41][44] Question: What are the key drivers for new patient starts? - The company identified increased awareness, improved healthcare professional access, and direct-to-consumer campaigns as key drivers for new patient starts [71] Question: How does the company differentiate its M4 program from competitors? - The M4 program is a highly selective orthosteric agonist, with potential advantages over competitors, and the company is considering a range of other indications [107]
Neurocrine(NBIX) - 2022 Q1 - Quarterly Report
2022-05-04 11:39
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, 2022 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 ...
Neurocrine(NBIX) - 2021 Q4 - Annual Report
2022-02-11 22:11
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, 2021 ☐ 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 33-0525145 (State or other jur ...
Neurocrine(NBIX) - 2021 Q4 - Earnings Call Transcript
2022-02-11 18:19
Financial Data and Key Metrics Changes - The 2022 net sales guidance for INGREZZA is projected to be between $1.25 billion and $1.35 billion, marking the first time the company has provided annual sales guidance [14][19] - The GAAP operating expense range for 2022 is estimated to be between $1.1 billion and $1.15 billion, with a significant increase in sales force expansion and direct-to-consumer advertising [19][20] Business Line Data and Key Metrics Changes - INGREZZA's Q4 performance showed a total prescription growth of 8% sequentially and 32% year-over-year, marking the third consecutive quarter of growth during the pandemic [23][27] - The company has expanded its sales force to over 350 members, focusing on psychiatry, neurology, and long-term care [29] Market Data and Key Metrics Changes - The total addressable market for tardive dyskinesia (TD) in the U.S. is estimated at 600,000 patients, with only about 25% currently diagnosed [108][110] - The use of antipsychotics continues to grow, leading to an increase in the TD patient population, with 70 million prescriptions written in the past year [115][116] Company Strategy and Development Direction - The company aims to accelerate growth through a combination of expanding its sales force and enhancing its commercial initiatives, including a direct-to-consumer advertising campaign [17][29] - The R&D pipeline includes 12 mid- to late-stage clinical programs, with plans to submit a supplemental new drug application for valbenazine for Huntington's disease in the second half of 2022 [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the external environment improving, which is expected to positively impact patient access and sales [28][69] - The company acknowledges the challenges posed by COVID-19 but believes that the reopening of clinics and increased patient visits will drive growth in the latter half of 2022 [9][16] Other Important Information - The company is focused on addressing the unmet medical needs in neurology and psychiatry, with a strong emphasis on innovative therapies [42][100] - The company plans to continue exploring business development opportunities to enhance its pipeline and market presence [99] Q&A Session Summary Question: Can you give us some sense of what would be proof of concept for essential tremor? - The proof-of-concept study includes several endpoints, with a primary focus on tremor amplitude measured by accelerometer, and a statistically significant difference is sought [48] Question: How does the demand growth for INGREZZA compare to pre-COVID levels? - Prior to the pandemic, the company experienced a growth trajectory of a couple of hundred million dollars per year, and a 20% midpoint growth in guidance aligns with that performance [51][52] Question: Is your guidance impacted by inventory stocking for INGREZZA? - The guidance reflects underlying demand for INGREZZA sales, and inventory fluctuations are expected to net out over the year [56][58] Question: What are the expectations for long-term care opportunities? - Long-term care represents a significant incremental opportunity, with several million people in facilities potentially treated with antipsychotics that cause TD [103][104] Question: How fast is the total addressable TD market growing? - The TD population is growing due to the increased use of antipsychotics, with estimates rising from around 500,000 to 600,000 patients over the past five years [116]
Neurocrine Biosciences (NBIX) Presents At 40th Annual J.P. Morgan Virtual Healthcare Conference
2022-01-24 16:35
J.P. Morgan Healthcare Conference January 2022 Safe Harbor Statement 2 In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, including ...
Neurocrine(NBIX) - 2021 Q3 - Earnings Call Transcript
2021-11-02 03:25
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q3 2021 Earnings Conference Call November 1, 2021 4:30 PM ET Company Participants Todd Tushla - Vice President, Investor Relations Kevin Gorman - Chief Executive Officer and Director Matt Abernethy - Chief Financial Officer Eric Benevich - Chief Commercial Officer Eiry Roberts - Chief Medical Officer Conference Call Participants Neena Garg - Citi Paul Matteis - Stifel Carter Gould - Barclays Tazeen Ahmad - Bank of America Phil Nadeau - Cowen Company Anupam Rama - J ...
Neurocrine(NBIX) - 2021 Q3 - Quarterly Report
2021-11-01 20:05
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 September 30, 2021 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 jurisdictio ...
Neurocrine(NBIX) - 2021 Q2 - Earnings Call Presentation
2021-08-04 08:41
| --- | --- | --- | --- | |----------------|------------------------------------------------------|-------|--------------------------------| | | | | | | | Advancing Life-Changing Discoveries in Neuroscience | | Q2 2021 Corporate Presentation | | neurocrine.com | | | August 3, 2021 Nasdaq: NBIX | Safe Harbor Statement and Non-GAAP Financial Measures In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncertainties. These statements include ...