Aquestive Therapeutics Reports 23% Revenue Decline, Focuses on Anaphylm Development

Aquestive Therapeutics, Inc. reported a significant decline in its financial performance for the fiscal year ending December 31, 2025, with total revenues decreasing by 23% to $44.5 million, down from $57.6 million in 2024. The decrease was primarily attributed to a sharp drop in license and royalty revenue, which fell by 77% to $3.5 million, largely due to the one-time recognition of deferred revenues from terminated licensing agreements in the previous year. Additionally, proprietary product revenue turned negative, reflecting the withdrawal of Libervant from the U.S. market, which had previously contributed to the company's income.

In terms of expenses, Aquestive's selling, general, and administrative costs surged by 59% to $79.8 million, driven by increased legal expenses and preparations for the anticipated launch of its epinephrine prodrug candidate, Anaphylm. Research and development expenses decreased by 15% to $17.2 million, reflecting reduced clinical trial costs associated with Anaphylm, although personnel costs and product research expenses saw increases. The company reported an interest expense of $11.1 million, consistent with the previous year, while interest related to royalty obligations rose slightly.

Strategically, Aquestive is focusing on the development of its late-stage product candidates, particularly Anaphylm, which is designed for the treatment of severe allergic reactions. The company is working to address concerns raised by the FDA in a Complete Response Letter (CRL) received in January 2026, which highlighted deficiencies in the product's human factors validation study. The company plans to resubmit its New Drug Application (NDA) in the third quarter of 2026, contingent upon completing necessary studies. Additionally, Aquestive is pursuing regulatory strategies in international markets, with plans to submit applications in Europe and Canada.

Operationally, Aquestive's workforce consisted of approximately 147 employees as of December 31, 2025, with a significant portion involved in manufacturing and research and development. The company continues to rely heavily on its primary customer, Indivior, which accounted for 73% of its revenues in 2025. The company’s financial outlook remains cautious, with substantial debt obligations beginning in June 2026, necessitating ongoing capital raises to support operations and product development. The company has established an At-The-Market (ATM) facility and has engaged in public offerings to bolster its liquidity, but future financing remains uncertain.

Looking ahead, Aquestive's success hinges on the timely approval and commercialization of Anaphylm and its ability to navigate the complexities of regulatory requirements and market competition. The company acknowledges the risks associated with its reliance on a limited number of products and customers, as well as the potential impact of external market conditions and regulatory changes on its financial health and operational capabilities.