Neurocrine (NASDAQ:NBIX) Biosciences (NASDAQ:NBIX), in its third quarter earnings call of 2023, reported robust results with INGREZZA sales climbing 29% year-over-year (YoY) to $486 million. The company raised its net sales guidance for the year between $1.82 billion and $1.84 billion. The pharmaceutical firm also announced FDA approval for INGREZZA to treat Chorea associated with Huntington's disease and shared promising Phase III results for crinecerfont, a drug for congenital adrenal hyperplasia.
Key takeaways from the call include:
- INGREZZA sales showed a 29% YoY growth, reaching $486 million.
- The company raised its net sales guidance to a range of $1.82 billion to $1.84 billion.
- FDA approval has been granted for INGREZZA for the treatment of Chorea associated with Huntington's disease.
- Positive Phase III results have been achieved for crinecerfont in pediatric and adult patients with congenital adrenal hyperplasia.
Neurocrine Biosciences stated that the diagnosis rate for tardive dyskinesia (TD (TSX:TD)) has increased from 30% to 35% of the overall population. However, the company believes there is still significant room for growth, as approximately two-thirds of patients remain undiagnosed. Moreover, only about half of the diagnosed patients receive treatment with the INGREZZA VMAT2 inhibitor. The company sees opportunities for improvement in both the diagnosis rate and the frequency of INGREZZA usage.
Neurocrine Biosciences also discussed their future plans, including the release of data on the focal onset seizure study for 352 this quarter. The company expressed excitement about the potential benefits of this asset and is aiming for a robust efficacy signal in the study. The company expects the opportunity for INGREZZA in Huntington's Chorea to be smaller compared to TD, as only about 20% of the eligible patient population currently receives treatment with a VMAT2 inhibitor.
The company remains focused on investing in INGREZZA's commercial growth and internal pipeline, with upcoming readouts and the submission of crinecerfont next year. Neurocrine Biosciences also mentioned that they are on track to release data from a Phase II study on an anhedonia asset in the fourth quarter.
During the call, the company announced plans to host an Analyst Day on December 5th to discuss its R&D strategy and pipeline updates. They also provided an update on a dual agonist in a Phase I clinical program and the progress of INGREZZA's sales in long-term care facilities, stating that it is becoming a meaningful revenue contributor. The company expects to provide a full financial picture, including sales guidance, during the February earnings call.
Neurocrine Biosciences did not provide a long-term outlook on operating margin but noted their commitment to investing in R&D to build their pipeline. The company expressed confidence in their pipeline and their position as a leader in neuroscience. They also highlighted their successful quarter, regulatory approvals, and Phase III clinical trials. The company plans to leverage updated APA guidelines to improve diagnosis and treatment rates. They expressed pride in their teams and look forward to discussing their vision for the future and their position as a leader in neuroscience during the upcoming R&D or Analyst Day.
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