Release Date: March 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Could you remind us what are some of the key topics that the FDA might want to clarify or dig into at a potential advisory committee meeting, and what gives you confidence in Anafilm's profile from a PKPD standpoint heading into this potential meeting? A: Dan Barber, CEO: We have grown more confident in Anafilm's profile, which we believe is the best for someone experiencing an allergic reaction. The rapid uptake of epinephrine and its effects on blood pressure and mucosal edema are comparable to auto-injectors. We believe our product will be well-received at the advisory committee meeting if it occurs.
Q: Which types of patients do you think would be the early adopters of Anafilm compared to other approved epinephrine products? A: Sherry Kurzynski, SVP Sales and Marketing: Anafilm is easy to carry and works quickly, making it appealing to a broad market. We expect early adopters to include teenagers, young adults, and men who prefer a non-device option that fits easily in their pockets.
Q: Regarding commercialization, are you open to partnership arrangements, and what are your thoughts on the launch of the nasal spray competitor? A: Dan Barber, CEO: We are prepared to launch Anafilm on our own but are open to partnerships if they can expand our reach. Sherry Kurzynski noted that awareness of alternatives to needle-based products is key, and we have a robust data package to support Anafilm's efficacy.
Q: Can you discuss the importance of the timing of Anafilm's launch and how seasonality affects the market? A: Sherry Kurzynski, SVP Sales and Marketing: The epinephrine market has significant seasonality, peaking in August and September. Launching Anafilm in early 2026 aligns well with this cycle, allowing us to capture demand as patients prepare for back-to-school and refill prescriptions.
Q: How do you feel about the safety profile of Anafilm, especially concerning the CMAX on single and repeat doses? A: Dan Barber, CEO: We have the most robust package ever for epinephrine, with over 900 dosings and a clean AE profile. We believe our rapid onset and sufficient epinephrine levels are crucial for addressing allergic reactions effectively.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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