Release Date: March 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Could you help us understand the timelines around the citizen petition and what options you have if the decision doesn't go in your favor? Also, do you expect growth in Q1 relative to Q4? A: Terry Curran, President and CEO: We submitted the citizen petition in December, and the FDA is required to respond within 180 days. We anticipate a response by June and are confident in our legal position. If the decision doesn't go our way, we may pursue litigation. Regarding Q1, we expect it to be softer due to industry dynamics, but we are still working through the quarter.
Q: For the phase 3 on-demand trial, when do you think you'll have enough real-world data to make a go/no-go decision? A: Terry Curran, President and CEO: We are evaluating real-world utilization and expect to have enough information by mid-year to make a decision on proceeding with the study.
Q: Is the significant increase in prescribing physicians driven by the DTC campaign, and how do you balance this with cash runway to profitability? A: Martin Gilligan, Chief Commercial Officer: The campaign is an evolution of our current efforts and has motivated patients to ask physicians for our product. We've seen a 55% increase in physicians receiving requests. We will evaluate the ROI mid-year to ensure it's the best use of resources. Molly Henderson, CFO: Our OpEx guidance for 2025 includes a significant investment in DTC, and we will assess its effectiveness mid-year.
Q: Can you speak to early metrics on refill trends and usage for non-erosive GERD? A: Martin Gilligan, Chief Commercial Officer: We are tracking well with refill rates and persistency, in line with PPIs. The 10 mg dosage is growing faster due to non-erosive GERD, and feedback from physicians indicates patients are doing well and continuing treatment.
Q: Regarding the ODT formulation, would you seek pediatric extension first, or the formulation patent? Also, can you clarify the gross-to-net calculation? A: Unidentified Executive: The ODT formulation has broader applicability beyond pediatrics and will run in parallel with patent efforts. Molly Henderson, CFO: Gross-to-net takes gross revenue to net revenue, considering different price points for retail and Blink RX channels. The lion's share of gross-to-net is from rebating and wholesaler discounts.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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