Release Date: February 26, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What drove the success of the hospital channel this quarter? A: Rhonda Farnum, Senior Vice President - Commercial and Medical Affairs, Chief Business Officer, explained that the success was due to the team's clear execution of strategy, focusing on larger systems and therapeutic interchange, which brings additional volume. The team ensured that the product was adopted in protocols and converted short-acting use to long-acting, achieving significant results with a small team.
Q: Can you provide an update on the regulatory process for Upellary in China? A: Rhonda Farnum stated that they are waiting for regulatory feedback from the Chinese authorities. The planning assumption is a two-year window from submission to approval, which was submitted in June 2024. This timeline aligns with expectations for a potential $7.5 million milestone and high royalties on sales.
Q: What feedback did you receive from the FDA regarding Amproloxetine? A: Rick Winningham, CEO, mentioned that the interaction with the FDA was a Type C meeting to ensure understanding of the filing content and FDA expectations. This was part of good regulatory practice to prepare for an expedited filing once the Cyprus study results are available.
Q: What is the bar for success for the Cyprus readout, and what are the plans for the commercial organization if positive? A: Rick Winningham stated that a one-point change in the OHSA composite score is considered clinically meaningful. If Cyprus is positive, they plan to hold off on increasing the organization size until after the data is available. Rhonda Farnum added that they aim to be efficient with a focused sales effort, targeting around 3,000 prescribers across 250 centers.
Q: Was there any channel stocking or anomalies that benefited the fourth-quarter net revenue? A: Rick Winningham confirmed that inventory levels were consistent with previous years, indicating no unusual stocking. Rhonda Farnum clarified that the hospital business accounts for about 10% of total brand volume, with the majority in the community setting, which is growing.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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