Aquestive Therapeutics Reports Q3 2025 Revenue Decline and Increased Net Loss

Aquestive Therapeutics, Inc. reported its financial results for the third quarter of 2025, revealing a decline in total revenues to $12.8 million, down 5% from $13.5 million in the same period last year. For the nine months ending September 30, 2025, revenues decreased by 31% to $31.5 million compared to $45.7 million in 2024. The decrease was primarily attributed to a significant drop in license and royalty revenue, which fell 52% in the third quarter and 82% year-to-date, largely due to the one-time recognition of deferred revenue from terminated agreements in the previous year. In contrast, manufacture and supply revenue increased by 7% in the third quarter, driven by higher sales of Sympazan and Suboxone.

The company's net loss for the third quarter was $15.4 million, compared to a loss of $11.5 million in the same quarter of 2024. For the nine-month period, the net loss totaled $51.9 million, significantly higher than the $27.1 million loss reported in the prior year. The increase in losses was attributed to higher selling, general, and administrative expenses, which rose by 26% in the third quarter and 38% year-to-date, reflecting increased commercial spending in preparation for the anticipated launch of Anaphylm, as well as higher legal and regulatory costs.

In terms of operational developments, Aquestive continues to advance its product pipeline, particularly focusing on Anaphylm, an epinephrine sublingual film. The company has received positive feedback from the FDA regarding its New Drug Application (NDA) submission, with a target action date set for January 31, 2026. The company is also pursuing international regulatory strategies for Anaphylm and has expanded its territory for Libervant through a recent amendment to its agreement with Pharmanovia. However, the company has faced challenges, including the withdrawal of Libervant from the U.S. market due to a court ruling that vacated its FDA approval for certain pediatric patients.

As of September 30, 2025, Aquestive reported cash and cash equivalents of $129.1 million, a significant increase from $71.5 million at the end of 2024. This increase was bolstered by proceeds from recent public offerings, including $79.9 million from an underwritten public offering completed in August 2025. The company has also engaged in a purchase and sale agreement with RTW Investments LP, which could provide additional funding contingent on the approval of Anaphylm. Despite these financial resources, the company anticipates continued operating losses and negative cash flows as it invests in product development and commercialization efforts.

Looking ahead, Aquestive's management remains focused on executing its business strategy while managing expenses and seeking additional funding sources. The company acknowledges the uncertainty surrounding its ability to achieve profitability and the potential need for further capital to support its operations and product development initiatives. The successful launch of Anaphylm, if approved, is seen as a critical factor in the company's future financial performance.