Aquestive 2025 Q3 Earnings Widens Loss as Net Income Falls 34.2%

Aquestive Therapeutics (AQST) reported third-quarter 2025 earnings on Nov 5, 2025, missing revenue estimates and guiding for a $44–$50 million full-year revenue range. The company’s net loss widened to $15.45 million, a 34.2% increase from the prior-year period, while adjusted EBITDA losses expanded to $8.56 million. CEO Daniel Barber highlighted progress toward FDA approval of Anaphylm and preparations for a potential 2026 U.S. launch.

Revenue

Aquestive’s total revenue declined 5.4% year-over-year to $12.81 million in Q3 2025. Manufacturing and supply revenue rose to $11.5 million, driven by growth in Sympazan and Suboxone. However, co-development and research fees dropped 38.6% to $0.3 million, and license and royalty revenue fell 52% to $1.04 million. The company attributed the overall revenue decline to the phasing out of legacy products and competitive pressures.

Earnings/Net Income

The net loss deepened to $0.14 per share in Q3 2025, a 7.7% widening from the $0.13 per share loss in Q3 2024. Total losses increased to $15.45 million, reflecting higher operating expenses and lower revenue. The EPS performance underscored the company’s ongoing financial strain as it invests in regulatory and commercial readiness for Anaphylm.

Post-Earnings Price Action Review

Following the earnings release, AQST’s stock price edged down 1.32% on the day, declined 7.41% in the week, and gained 0.50% month-to-date. The mixed performance reflected investor caution around the widening losses despite positive regulatory developments.

CEO Commentary

Daniel Barber emphasized Anaphylm’s progress, with the NDA on track for the January 31, 2026 PDUFA date and preparations for a Q1 2026 U.S. launch. He also highlighted expanded patent protection for Anaphylm through 2037, global regulatory advancements, and strategic equity financing. The CEO expressed confidence in the company’s ability to execute its mission despite near-term financial challenges.

Guidance

Aquestive provided full-year 2025 guidance of $44–$50 million in revenue and a non-GAAP adjusted EBITDA loss of $47–$51 million. The company reiterated its PDUFA goal date for Anaphylm and outlined plans to submit an IND for AQST-108 in Q4 2025, with clinical trials expected in H1 2026.

Additional News

Aquestive announced leadership changes to support its growth strategy, appointing Matthew Davis, M.D., RPh, as Chief Development Officer, and Gary Slatko, M.D., as interim Chief Medical Officer. The company also expanded its patent estate for Anaphylm with two new patents extending protection through 2037. These moves aim to bolster regulatory readiness and long-term commercial potential.