Release Date: February 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Neurocrine Biosciences Inc (NBIX, Financial) reported record sales growth for INGREZZA in 2024, with an increase of approximately $475 million driven by increased volume and strong compliance.
- The company anticipates INGREZZA's sales to reach $2.5 billion to $2.6 billion in 2025, reflecting continued growth despite increased competitive pressure.
- CRENESSITY, a first-in-class treatment for congenital adrenal hyperplasia, received early FDA approval and has shown promising early launch dynamics.
- Neurocrine Biosciences Inc (NBIX) plans to expand its clinical stage pipeline from 12 to 18 programs by the end of 2025, indicating a robust and broad neuroscience pipeline.
- The company has a strong focus on research and development, with plans to initiate multiple Phase 3 programs in 2025, including Osavampator for major depressive disorder and NBI-568 for schizophrenia.
Negative Points
- Neurocrine Biosciences Inc (NBIX) faces increased competitive pressure and utilization management by payers, which has led to a slower growth trajectory for INGREZZA heading into 2025.
- The launch of CRENESSITY is expected to be measured initially due to delayed timing of reimbursement, patient flow frequency, and trialing by clinicians.
- The company anticipates a complex payer environment and competitive dynamics to impact INGREZZA's growth, with increased hurdles related to prior authorization.
- There is uncertainty regarding the long-term growth trajectory of INGREZZA, with ongoing debates about its peak sales potential in the US.
- Neurocrine Biosciences Inc (NBIX) acknowledges potential headwinds from its own sales force expansion, which may cause disruption before contributing to growth.
Q & A Highlights
Q: Can you provide insights on the expected trajectory for CRENESSITY's new start forms in 2025?
A: Eric Benevich, Chief Commercial Officer, stated that they are pleased with the early approval and broad label for CRENESSITY. They will provide quarterly updates on treatment forms, and the initial 11 forms represent just a few working days before the year's end. The launch dynamics are positive, and while they won't specify what constitutes a good ramp, the feedback from providers has been strong.
Q: Can you explain the rationale behind the conservative guidance for INGREZZA in 2025?
A: Eric Benevich explained that despite record growth in 2024, the 2025 guidance reflects continued growth of the VMAT2 category and considers external factors like a complex payer environment and competitive dynamics. They are taking proactive steps, including sales team expansion and direct-to-consumer efforts, to address these challenges and maximize access to INGREZZA.
Q: What are the expectations for INGREZZA's performance in Q1 2025, considering potential seasonal impacts?
A: Eric Benevich noted that Q1 is typically challenging due to the need for reauthorization of refills and gross-to-net impacts from commercial co-pay contributions and rebates. While specifics on intra-quarter performance can't be shared, they are focused on minimizing treatment gaps and retaining patients. Matthew Abernethy added that net revenue per script in 2025 is expected to be similar to 2024, with some sequential headwinds from Q4 to Q1.
Q: How is the payer traction for CRENESSITY, and what is the expected duration of the free drug program?
A: Eric Benevich explained that CRENESSITY is not yet on any formularies, so they have a fast start program to provide free product while reimbursement is secured. Most patients may require one to two months of free goods initially. Feedback from health plans has been positive, with some patients receiving quick reimbursement. They expect the majority of patients to pay less than $12 per month.
Q: Can you elaborate on the utilization management challenges for INGREZZA and any competitive pressures from other VMAT2 inhibitors?
A: Eric Benevich mentioned that utilization management has evolved, with some plans tightening criteria. They have a sophisticated infrastructure to maximize access and are addressing these challenges proactively. Despite competitive pressures, INGREZZA remains the leader in the VMAT2 category, and they are confident in its long-term growth potential.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
