Aquestive Therapeutics Inc. (AQST) reported financial results for the fourth quarter and full year ended December 31, 2025, and provided its full-year 2026 financial outlook along with key objectives for the year.
The company is a global leader in oral film drug delivery and serves as the development and commercial manufacturing partner for oral thin-film products worldwide, including Ondif, Sympazan, Emylif, and Suboxone, using its proprietary PharmFilm technology. Its pipeline includes Anaphylm sublingual film for the treatment of anaphylaxis and AQST-108 topical gel for alopecia areata. Additionally, the company's Libervant buccal film remains tentatively approved by the FDA for acute repetitive seizures through January 2027.
For the fourth quarter of 2025, excluding one-time legal expenses, Aquestive incurred a net loss of $18.7 million, or $0.15 per share, compared to a net loss of $17.1 million, or $0.19 per share, in the year-ago quarter.
Including one-time legal expenses, Aquestive's net loss for the fourth quarter of 2025 widened to $31.9 million, or $0.26 per share, from $17.1 million, or $0.19 per share, in Q4, 2024, driven mainly by higher selling, general and administrative expenses and manufacture and supply expenses.
Total revenues for the fourth quarter of 2025 increased to $13.0 million from $11.9 million in the year-ago period, helped by increases in manufacture and supply revenue, primarily reflecting growth in Suboxone and Ondif sales.
For the full year 2025, excluding one-time legal expenses, Aquestive's net loss expanded to $70.6 million, or $0.66 per share, from $44.1 million, or $0.51 per share, in the prior year.
Including one-time legal expenses, net loss widened to $83.78 million, or $0.78 per share in 2025, from $44.14 million, or $0.51 per share in 2024.
Total revenues for 2025 decreased by 3% to $44.55 million from $57.56 million in the prior year.
As of December 31, 2025, cash and cash equivalents were $121.2 million.
Looking ahead to 2026, the firm expects total revenue to be in the range of $46 million to $50 million, up from $44.55 million in 2025.
Upcoming Milestones
-- AQST-108 topical gel, being developed for alopecia areata, is currently in a phase 1 trial. The study aims to evaluate its safety, tolerability, and pharmacologic profile and to guide potential future development opportunities, including indication selection. Data readout from this study is expected in the second quarter of 2026.
-- Anaphylm, a non-device-based epinephrine product candidate being developed for the treatment of Type I allergic reactions, including anaphylaxis, was issued a Complete Response Letter by the FDA earlier this year. The agency cited concerns about pouch opening and film placement, and requested a single pharmacokinetics (PK) study to evaluate the impact of packaging and labelling changes, as reasons for not approving the product.
The company is planning to conduct a new human factors validation study and a PK study. If all goes well as planned, the company expects to resubmit the Anaphylm NDA in the third quarter of 2026.
AQST has traded between $2.12 and $7.55 in the last year. The stock closed Wednesday's trade at $4.37, up 6.07%.
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