Aquestive 2025 Q3 Earnings Widened Loss of $15.45M, 34.2% Increase from 2024

Aquestive Therapeutics (AQST) reported Q3 2025 results below expectations, with revenue missing estimates and a 34.2% wider loss compared to the prior year. The company reiterated full-year guidance of $44–$50 million in revenue but acknowledged ongoing operational challenges. Analysts remain cautiously optimistic, citing potential upside from Anaphylm’s pending FDA approval and expanded patent protections.

Revenue

Aquestive’s total revenue declined by 5.4% year-over-year to $12.81 million, driven by a 38.6% drop in co-development and research fees to $302,000. Manufacturing and supply revenue rose to $11.47 million, supported by increased demand for Sympazan and Suboxone. However, license and royalty revenue contracted sharply to $1.04 million, reflecting weaker performance in intellectual property monetization.

Earnings/Net Income

The company’s losses deepened significantly, with a net loss of $15.45 million for Q3 2025, a 34.2% increase from $11.51 million in the prior-year period. Earnings per share (EPS) also worsened to -$0.14 from -$0.13, a 7.7% widening. The EPS loss and net income decline underscore deteriorating profitability despite cost management efforts.

Post-Earnings Price Action Review

Following the earnings release, Aquestive’s stock edged down 1.32% in the latest trading day, marking a 7.41% drop over the prior week. Month-to-date, shares rose 0.50%, reflecting mixed investor sentiment. Analysts note the stock’s 70.8% year-to-date gain outperformed the S&P 50.1% but caution that near-term volatility remains tied to FDA approval risks for Anaphylm and broader market conditions. The Zacks Rank #2 (Buy) rating suggests potential outperformance, though earnings revisions and regulatory outcomes will remain critical drivers.

CEO Commentary

Daniel Barber, CEO, emphasized progress toward Anaphylm’s potential U.S. launch in Q1 2026, highlighting the FDA’s decision to skip an advisory committee review and set a January 31 PDUFA date. He also cited strengthened liquidity from recent equity financing and regulatory advancements in Canada and the EU. The CEO expressed confidence in leveraging the AdrenaVerse™ platform for long-term product development, despite near-term financial pressures.

Guidance

Aquestive reaffirmed full-year 2025 revenue guidance of $44–$50 million and a non-GAAP adjusted EBITDA loss of $47–$51 million. The company plans to submit an IND for AQST-108 in Q4 2025 and initiate clinical trials in H1 2026. Cash reserves of $129.1 million as of September 30, 2025, are expected to support operations through the Anaphylm launch window, though sustained losses and regulatory delays remain key risks.

Additional News

Aquestive recently expanded Anaphylm’s patent estate with two new patents extending exclusivity to 2037, reinforcing long-term commercial potential. The FDA’s decision to forgo an advisory committee review for Anaphylm’s NDA accelerates the timeline for potential U.S. approval. Additionally, the company secured strategic funding commitments, strengthening its balance sheet ahead of the anticipated launch. Analysts highlight the Zacks Rank #2 (Buy) rating and $8.97 average 12-month price target as bullish signals, though near-term execution risks persist.