Aquestive Therapeutics reported a Q4 2025 net loss of $31.9 million, or $0.26 per share, when one‑time legal expenses are included. Excluding those legal costs, the loss narrows to $18.7 million, or $0.15 per share. The prior‑year quarter ended in a $17.1 million loss, or $0.19 per share, showing a widening loss largely driven by the legal expense spike.
For the full year, the company posted a net loss of $83.8 million, a significant increase from the $44.1 million loss reported in 2024. The higher loss reflects both the one‑time legal settlement and increased SG&A spending associated with the Anaphylm development program.
Total revenue for Q4 2025 reached $13.0 million, up from $11.9 million in the same period a year earlier. Manufacturing and supply revenue grew to $12.0 million, a 12% year‑over‑year increase from $10.7 million in Q4 2024, while license and royalty revenue was not disclosed for the quarter. Full‑year revenue fell 3% to $44.5 million, down from $45.8 million in 2024.
The company secured additional financing through an amendment to its RTW agreement that extends the marketing approval deadline for Anaphylm to June 30 2027. The amendment also includes a warrant allowing RTW to purchase up to 375,000 shares at $4.00 each, and RTW has committed to buying at least $5 million of common stock over the next 90 days. Cash and cash equivalents stood at $121.2 million as of December 31 2025, providing a runway through 2027.
Anaphylm, the sublingual epinephrine film, received a Complete Response Letter from the FDA on January 30 2026 citing human‑factor deficiencies. The company plans to resubmit the NDA in Q3 2026 after addressing the FDA’s concerns. "We are well‑positioned in 2026 to advance Anaphylm, the first and only oral epinephrine rescue medication, towards approval for patients around the world," said CEO Daniel Barber.
AQST‑108, a topical gel for alopecia areata, is progressing toward a Phase 1 readout expected in Q2 2026, adding a potential new revenue stream to the company’s pipeline.
Market reaction to the earnings was negative, with the stock falling between 2.75% and 3.89% in pre‑market trading. The decline was driven by the EPS miss, the revenue shortfall, the regulatory setback for Anaphylm, and the continued cash burn associated with the company’s development and legal expenses.
Analysts had expected an EPS of –$0.13 and revenue of $13.34 million. The company missed both metrics, reporting an EPS of –$0.26 (a $0.13 miss) and revenue of $13.0 million (a $0.34 miss).
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.