Release Date: March 11, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you clarify what still needs to be done before the NDA submission for smoking cessation, and are there any specific FDA requirements from a manufacturing standpoint? A: Richard Stewart, CEO, emphasized the focus on executing a high-quality NDA submission. Cindy Jacobs, President and CMO, mentioned that they are finalizing summary documents for efficacy and safety, with CMC sections nearly complete. They have engaged external experts to ensure accuracy and quality.
Q: Regarding commercial access for cytisinicline, do you expect any prior authorization or step edits for generics, and will you use a specialty pharmacy to ensure patients get their full treatment? A: Jaime Xinos, Chief Commercial Officer, stated they are considering a "specialty light" pharmacy to track prescriptions and mitigate access barriers. The strategy will depend on contracting and payer formulary placement, with plans to address potential barriers through medical exceptions and patient refusal to use other medications.
Q: Are you getting closer to a potential partner for a comorbid indication with cytisinicline, and could this help accelerate the start of the vaping Phase 3 trial? A: Richard Stewart, CEO, noted that while there is interest in cytisinicline's impact on COPD patients, the current focus is on the NDA submission. They are open to partnerships that align with shareholder interests but are primarily focused on launching cytisinicline themselves.
Q: Are there future DSMC reviews planned, and how are the mock reviews with Sopharma going? A: Cindy Jacobs, President and CMO, mentioned one more DSMC review is likely for the long-term safety data. Richard Stewart, CEO, assured that they are using external consultants to ensure the NDA's quality, including manufacturing aspects with Sopharma.
Q: Can you provide more details on the sales ramp and segmentation strategy for the launch in Q3 2026? A: Jaime Xinos, Chief Commercial Officer, indicated a slow initial ramp due to access and awareness building. They are targeting high-volume prescribers and highly motivated quitters, focusing on those most likely to adopt the product.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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