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Sep 30
Aquestive Q3 2025 Earnings Report
Aquestive Therapeutics reported its financial results for the third quarter ended September 30, 2025, highlighting progress towards the Anaphylm launch and a strengthened balance sheet.
Key Takeaways
Aquestive Therapeutics had a strong third quarter in 2025, with total revenues of $12.8 million and a net loss of $15.4 million. The company is actively preparing for the potential U.S. launch of Anaphylm in Q1 2026, while also advancing regulatory activities in Canada and the EU. The balance sheet was strengthened to support future commercialization efforts.
Total revenues for Q3 2025 were $12.8 million, a decrease from $13.5 million in Q3 2024, but an increase of $0.5 million year-over-year excluding a one-time deferred revenue recognition in the prior year.
The net loss for Q3 2025 was $15.4 million, or $0.14 per basic and diluted share, compared to a net loss of $11.5 million in Q3 2024.
Non-GAAP adjusted EBITDA loss was $8.6 million in Q3 2025, an increase from $6.6 million in Q3 2024.
Cash and cash equivalents stood at $129.1 million as of September 30, 2025, indicating a strengthened financial position to support future commercial launches.
Aquestive
Aquestive
Aquestive Revenue by Segment
Revenue by Segment
Manufacture and Supply Revenue
CapyFin.com Forward Guidance
Aquestive Therapeutics provided full-year 2025 financial guidance, expecting total revenue between $44 million and $50 million and a non-GAAP adjusted EBITDA loss between $47 million and $51 million. The company is focused on the potential U.S. launch of Anaphylm in Q1 2026 and advancing its pipeline.
Positive Outlook
- Planned U.S. launch of Anaphylm in the first quarter of 2026, if approved by the FDA.
- Advancing Anaphylm regulatory activities in Canada and the EU, expanding global opportunities.
- Strengthened balance sheet to support planned commercial launch execution of Anaphylm.
- NDA for Anaphylm remains on track for the scheduled January 31, 2026 PDUFA goal date.
- On track to submit an Investigational New Drug (IND) application for AQST-108 in Q4 2025, with a clinical study expected in H1 2026.
Challenges Ahead
- Full-year 2025 non-GAAP adjusted EBITDA loss is projected to be between $47 million and $51 million.
- Potential for further FDA inspections to be necessary for Anaphylm approval.
- Libervant remains tentatively approved until January 11, 2027, due to existing orphan drug exclusivity.
- Risk of delays in advancement of the regulatory approval process or failure to receive FDA approval for product candidates.
- Risk of eroding market share for Suboxone®, which accounts for a substantial part of current operating revenue.