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Aquestive Therapeutics (AQST) investor relations material
Aquestive Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary6 Nov, 2025
Executive summary
Anaphylm is positioned for a Q1 2026 U.S. launch, pending FDA approval with a PDUFA date of January 31, 2026; FDA confirmed no Advisory Committee review required.
Expanded commercial, medical, and manufacturing infrastructure, with increased pre-launch activities and leadership changes to support Anaphylm and pipeline programs.
Broadened Anaphylm patent estate with two new patents, extending protection to 2037.
Advanced international regulatory progress, including Health Canada and EMA engagement; Canadian filing expected in H1 2026.
AQST-108 (alopecia areata) program advancing, with IND submission planned for Q4 2025 and clinical study in H1 2026.
Financial highlights
Q3 2025 total revenue: $12.8M, up 4% YoY excluding prior year deferred revenue; nine-month 2025 revenue: $31.5M, down 31% YoY due to lower license and royalty revenue and Libervant's U.S. market loss.
Manufacturer and supply revenue rose to $11.5M in Q3 2025 from $10.7M in Q3 2024.
Net loss for Q3 2025: $15.4M ($0.14/share); nine-month net loss: $51.9M ($0.51/share), both higher than prior year periods.
Cash and cash equivalents: $129.1M as of September 30, 2025, up from $71.5M at year-end 2024.
Gross margin declined due to lower high-margin license and royalty revenue and Libervant's U.S. withdrawal.
Outlook and guidance
2025 revenue guidance: $44M–$50M; non-GAAP adjusted EBITDA loss: $47M–$51M; guidance unchanged despite increased pre-approval launch spending.
Projected cash runway extends into 2027.
Continued operating losses and negative cash flows expected until Anaphylm commercial launch.
IND submission for AQST-108 topical gel planned for Q4 2025, with clinical study in H1 2026.
Anaphylm commercial strategy effectiveness
AQST-108 market share capture strategy
Libervant delay's impact on Anaphylm launch?
How will Anaphylm leverage market growth vs devices?
Adrenaverse: What new delivery systems are explored?
What is key in selecting a new debt partner?
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Next Aquestive Therapeutics earnings date
Piper Sandler 37th Annual Healthcare Conference4 Dec, 2025
Next Aquestive Therapeutics earnings date
Piper Sandler 37th Annual Healthcare Conference4 Dec, 2025
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Frequently asked questions
Aquestive Therapeutics Inc. is a pharmaceutical company focused on developing and commercializing innovative therapies using its proprietary drug delivery technology. The company specializes in orally administered films designed to improve the efficacy, safety, and convenience of treatments for patients with central nervous system disorders and other medical conditions. Aquestive also partners with other pharmaceutical companies to develop unique drug formulations. The company is headquartered in Warren, New Jersey, and its shares are listed on the NASDAQ.
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