Aquestive 2025 Q3 Earnings Widened Net Loss of 34.2% Despite Regulatory Progress

Aquestive reported Q3 2025 earnings with a 5.4% revenue decline to $12.81M, missing estimates by 4.13%. Net losses widened to $15.45M (-34.2% YoY), with an EPS of -$0.14 (-7.7% wider loss). The company maintained full-year guidance of $44–50M revenue and -$47–51M adjusted EBITDA. Despite the shortfall, regulatory advancements for Anaphylm and a potential Q1 2026 U.S. launch highlight strategic progress.

Revenue

Revenue from manufacturing and supply rose to $11.47M, up 7.5% year-over-year, driven by Sympazan and Suboxone. However, co-development and research fees fell to $0.3M, a 38.6% decline, and license and royalty revenue dropped to $1.04M, down 52% compared to the prior year.

Earnings/Net Income

The EPS of -$0.14 reflects a 7.7% deeper loss compared to the prior year, underscoring ongoing financial pressures despite operational advancements.

Post-Earnings Price Action Review

Following the earnings release, Aquestive’s stock dipped 1.32% in the latest trading day, with a 7.41% decline over the past week. However, the stock edged up 0.50% month-to-date. The mixed price action reflects investor uncertainty about the company’s near-term prospects, despite regulatory progress for Anaphylm. The stock has gained 70.8% year-to-date, outperforming the S&P 500’s 15.1% gain, but recent volatility suggests market skepticism about the sustainability of its current trajectory.

CEO Commentary

Daniel Barber emphasized Anaphylm’s regulatory milestones, including the FDA’s decision to forgo an Advisory Committee meeting and maintain the January 31, 2026 PDUFA date. The CEO highlighted U.S. launch preparations, global expansion plans, and recent equity financing to strengthen the balance sheet.

Guidance

Aquestive reaffirmed full-year 2025 revenue guidance of $44–50M and non-GAAP adjusted EBITDA loss of $47–51M. The company plans to submit an IND for AQST-108 in Q4 2025 and anticipates clinical trials in H1 2026.

Additional News

Aquestive announced leadership changes to bolster its Anaphylm launch readiness, including hiring Matthew Davis as Chief Development Officer and promoting Peter Boyd to Chief People Officer. The company also secured new equity financing to strengthen its balance sheet and expanded Anaphylm’s patent protection through 2037. These moves aim to enhance commercial readiness and intellectual property security ahead of the anticipated Q1 2026 U.S. launch, pending FDA approval.