Release Date: May 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Neurocrine Biosciences Inc (NBIX, Financial) reported robust year-over-year sales growth of 23% with Q1 sales of $506 million.
- The company successfully submitted two New Drug Applications (NDAs) for crinecerfont and received FDA approval for a new INGREZZA formulation.
- Positive Phase II top line results were announced for NBI-845 in adults with major depressive disorder, showing compelling efficacy and tolerability.
- Neurocrine Biosciences Inc (NBIX) has a strong cash position with over $1.9 billion, allowing for strategic capital allocation and shareholder value enhancement.
- The company has a deep and diverse clinical pipeline, including promising developments in treatments for psychiatric and neurological disorders.
Negative Points
- Seasonal payer dynamics and reauthorization requirements impacted refill rates and posed challenges in Q1.
- The company recorded a significant charge of $89 million related to the settlement of convertible notes, impacting financials.
- While INGREZZA continues to grow, the market for Huntington's chorea treatments remains small compared to tardive dyskinesia.
- The company faces intense competition in the neuroscience and psychiatric treatment markets, requiring continuous innovation and investment.
- Regulatory risks and uncertainties remain as new drug applications and clinical trials progress, which could affect future outcomes and market positions.
Q & A Highlights
Q: Can you discuss the dosing and dose response for 845, especially in light of the lack of a dose response?
A: Eiry Wyn Roberts, Chief Medical Officer, explained that while specific doses were not disclosed, improvements were observed at both doses tested. The robustness of the data in terms of impact on primary and key secondary endpoints, as well as tolerability, was very encouraging. There were no serious adverse events, seizures, or psychotomimetic events, and the most common adverse event was headache, which was generally mild and transient.
Q: What percentage of patients have difficulty swallowing, and what impact do you expect the new SPRINKLE formulation of INGREZZA to have on sales?
A: Eric S. Benevich, Chief Commercial Officer, noted that 5-10% of patients with tardive dyskinesia or Huntington's chorea have difficulty swallowing. The SPRINKLE formulation is expected to provide a valuable treatment option for these patients, and its approval and impact are already integrated into the company's guidance.
Q: With the upcoming data for 568, what efficacy and safety results are needed to advance this program, especially considering the competitive landscape?
A: Eiry Wyn Roberts stated that the primary outcome is the reduction in the PANSS score relative to placebo. The therapeutic index, including tolerability and safety profile, will be crucial for determining the potential to move forward. The selective M4 agonist approach may offer a chance to differentiate from other treatments.
Q: Can you provide any insights into the placebo response observed in the 845 study and discuss the safety profile concerning seizure risks?
A: Eiry Wyn Roberts highlighted the encouraging tolerability profile observed, with both doses appearing similar to placebo in terms of safety. There were no seizures reported, which is significant given the historical concerns with this class of medications.
Q: What are the expectations for the likelihood of a priority review for crinecerfont, and what are the timelines for approval and launch?
A: Eiry Wyn Roberts expressed hope that the FDA would grant a priority review considering the significant unmet need in congenital adrenal hyperplasia and the robustness of the Phase III data. The decision ultimately rests with the FDA, and the company will update as more information becomes available.
Q: How does the company view the capacity to run multiple Phase III studies concurrently, especially given the potential upcoming trials for various programs?
A: Kevin C. Gorman, CEO, emphasized the importance of prioritizing programs and managing spend. While the company has the financial resources to undertake multiple studies, it is crucial to strategically allocate resources and ensure that investments are made in the most promising areas.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
