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Jun 30
Aquestive Q2 2025 Earnings Report
Aquestive Therapeutics reported its second quarter 2025 financial results, highlighting progress with its lead product candidate, Anaphylm, and providing a business update.
Key Takeaways
Aquestive Therapeutics reported a decrease in total revenue to $10.0 million in Q2 2025 from $20.1 million in Q2 2024, primarily due to a one-time deferred revenue recognition in the prior year. Excluding this impact, revenue increased by 3%. The company's net loss widened to $13.5 million, or $0.14 per share, compared to a net loss of $2.7 million in the same period last year. Despite the financial decline, Aquestive made significant strides in its pipeline, with the FDA accepting the NDA for Anaphylm and setting a PDUFA date for January 31, 2026, alongside accelerating global expansion plans for the product.
Total revenue for Q2 2025 was $10.0 million, a decrease from $20.1 million in Q2 2024, largely due to a one-time deferred revenue recognition in the prior year.
Net loss for Q2 2025 was $13.5 million, or $0.14 per share, compared to a net loss of $2.7 million, or $0.03 per share, in Q2 2024.
The FDA accepted the New Drug Application (NDA) submission for Anaphylm, with a PDUFA date set for January 31, 2026.
Aquestive is accelerating its global expansion strategy for Anaphylm, with initial regulatory engagements underway in Canada and the EU.
Aquestive
Aquestive
Aquestive Revenue by Segment
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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.
Positive Outlook
- FDA acceptance of NDA for Anaphylm with a PDUFA date set for January 31, 2026, indicating potential market entry in early 2026.
- Accelerated global expansion strategy for Anaphylm to Canada and the EU, broadening potential market reach.
- Continued progress on AQST-108 for alopecia areata, with anticipated IND submission in Q4 2025.
- Diversification of manufacturing operations and growth in newer collaborations offsetting the decline of Suboxone®.
- Commitment to relaunching Libervant in 2027 or sooner if full marketing approval is granted.
Challenges Ahead
- Total revenues decreased significantly year-over-year due to a one-time deferred revenue recognition in the prior year.
- Net loss for the second quarter 2025 increased to $13.5 million from $2.7 million in the prior year.
- Non-GAAP adjusted EBITDA shifted from an income of $1.8 million in Q2 2024 to a loss of $9.3 million in Q2 2025.
- Libervant's regulatory status was revised from full to tentative approval, delaying its relaunch until 2027 or sooner.
- Increased selling, general and administrative expenses, primarily due to higher commercial spending and regulatory fees.