Release Date: March 06, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Aquestive Therapeutics Inc (NASDAQ:AQST) has begun the FDA filing process for its Afilm epinephrine sublingual film, with expectations for NDA acceptance by June 2025.
• The company is on track to launch Anafilm in the first quarter of 2026, aligning with the allergy season, which could enhance market penetration.
• Pediatric studies for Anafilm have progressed as expected, with data supporting a product label similar to existing EpiPen autoinjectors.
• Aquestive Therapeutics Inc (NASDAQ:AQST) has strengthened its balance sheet by raising over $78 million from institutional healthcare investors.
• The company is preparing for potential international market expansion, targeting submissions in the EU, UK, and Canada.

Negative Points

• Total revenue decreased by 10% in Q4 2024 compared to Q4 2023, primarily due to declines in license and royalty revenue.
• Research and development expenses increased significantly, driven by clinical trial costs for NFLM and AQST 108 programs.
• Selling, general, and administrative expenses rose sharply due to increased commercial spending and regulatory fees.
• Aquestive Therapeutics Inc (NASDAQ:AQST) reported a net loss of $17.1 million for Q4 2024, a substantial increase from the $8.1 million loss in Q4 2023.
• The company faces legal challenges regarding Libervan's market exclusivity, which could impact its availability and revenue potential.

Q & A Highlights

• Warning! GuruFocus has detected 3 Warning Signs with AQST.

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.