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Dec 31, 2025
Aquestive Q4 2025 Earnings Report
Aquestive Therapeutics reported its fourth quarter 2025 financial results, highlighting a 10% revenue increase and progress on its Anaphylm development program despite a recent FDA Complete Response Letter.
Key Takeaways
Aquestive saw revenue growth driven by its manufacturing business, though net losses widened significantly due to one-time legal settlement costs and increased pre-commercial spending for Anaphylm. The company is focused on resubmitting its Anaphylm NDA in Q3 2026 following a Type A meeting with the FDA.
Total revenue increased 10% year-over-year to $13.0 million, primarily driven by manufacture and supply growth.
Received an FDA Complete Response Letter for Anaphylm in January 2026; resubmission is targeted for Q3 2026.
Net loss widened to $31.9 million, impacted by a $13.6 million one-time legal expense related to a settlement with Neurelis.
Maintained a strong cash position of $121.2 million to fund operations and the planned launch of Anaphylm.
Revenue by Segment
Forward Guidance
Aquestive provided full year 2026 guidance focusing on revenue growth and controlled EBITDA losses while advancing its clinical pipeline.
Positive Outlook
- Full year 2026 revenue projected between $46 million and $50 million.
- Expected year-end 2026 cash balance of approximately $70 million.
- Planned resubmission of Anaphylm NDA in Q3 2026.
- Regulatory applications for Anaphylm in Canada and EU on track for 2026.
- Extension of RTW revenue sharing agreement to June 2027 provides stability.
Challenges Ahead
- Non-GAAP adjusted EBITDA loss expected between $30 million and $35 million.
- Guidance does not yet include sales and marketing costs for Anaphylm launch.
- Libervant remains tentatively approved with market access delayed until 2027.
- Ongoing requirement for additional human factors and PK studies for Anaphylm.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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