Aquestive's Q2 2025 Earnings Call: Navigating Contradictions in FDA Approval, Launch Readiness, and Market Strategy

FDA Ad Comm Meeting and Confidence in Clinical Data Package, commercial launch readiness and payer contracting timelines, launch timing and market dynamics, FDA advisory committee meeting expectations, pricing and market access strategy are the key contradictions discussed in Aquestive Therapeutics' latest 2025Q2 earnings call.



FDA Review and Approval Process:
- Aquestive Therapeutics is on track for the FDA action date for Anaphylm epinephrine sublingual film on January 31, 2026.
- The FDA is expected to complete its mid-cycle review soon, and the company anticipates whether an advisory committee meeting will be needed.
- The company has prepared for potential FDA questions and is confident in its clinical data package.

Market Potential and Strategic Positioning:
- Anaphylm is positioned to capture a significant portion of the epinephrine market, with a market size projection of up to 10 million prescriptions annually.
- The company aims to improve patient access through a cash pay program to address pricing and access barriers.
- Aquestive's pre-commercial activities focus on physician awareness and patient choice, with a primary target of allergists.

Financial Performance and Guidance:
- Total revenues increased by 3% year-over-year in Q2 2025, and the company expects total revenue of $44 million to $50 million and non-GAAP adjusted EBITDA loss of $47 million to $51 million for the full year.
- The financial guidance includes significant pre-approval launch spending for Anaphylm.
- Manufacturing and supply revenue grew due to increases in Ondif, while decreases in Suboxone offset some of this growth.

International Expansion and Product Pipeline:
- Aquestive is pursuing international expansion plans for Anaphylm, with meetings scheduled in Canada and the EU.
- The company continues to progress with AQST-108, an epinephrine topical gel for alopecia areata, with an IND opening expected by year-end.
- The international and pipeline efforts are part of a strategy to offset the decline of Suboxone and diversify revenue streams.