Aquestive's Q1 2025: Key Contradictions on Anaphylm's Launch Readiness, Distribution, and Market Strategy

Anaphylm's commercial readiness and launch timeline, Anaphylm's distribution infrastructure, Anaphylm launch timeline and market access, Anaphylm commercial readiness and launch strategy, and Anaphylm pediatric study design and FDA interaction are the key contradictions discussed in Aquestive Therapeutics' latest 2025Q1 earnings call.



FDA Review and Launch Preparedness:
- Aquestive Therapeutics anticipates receiving its FDA acceptance letter for Anaphylm in mid-June, with an expected FDA action date in late January or early February 2026.
- The company has entered the commercial prelaunch phase, focusing on hiring experienced teams and conducting physician outreach to increase awareness of Anaphylm.

Revenue Decline and Financial Strategy:
- Total revenues for the first quarter decreased to $8.7 million, down 28% from $12.1 million in the previous year.
- The decline was primarily due to decreases in manufacturer and supply revenue, partially offset by increases in proprietary product revenue.
- Aquestive plans to de-emphasize AQST-108 studies during the Anaphylm launch, diverting capital to commercial activities.

Commercial Readiness and Payer Engagement:
- Aquestive has hired a VP of Market Access and is actively engaging with payers, aiming for 80% payer coverage within the first six months of launch.
- The company is leveraging existing distribution and payer contracts established during the marketing of Libervant, aiming to streamline the launch process.

Supply Chain Stability Amid Global Uncertainty:
- Despite global supply chain challenges and tariff uncertainties, Aquestive's U.S.-based manufacturing facility has maintained minimal risk to price or supply volatility.
- The company's intellectual property being housed in the U.S. provides additional stability in production and global distribution.