Aquestive Therapeutics Reports 28% Revenue Decline and Increased Net Loss in Q1 2025

Aquestive Therapeutics, Inc. reported a significant decline in financial performance for the first quarter of 2025, with total revenues of $8.72 million, down 28% from $12.05 million in the same period last year. The decrease was primarily attributed to a 32% drop in manufacture and supply revenue, which fell to $7.19 million from $10.52 million, largely due to reduced sales of Suboxone. License and royalty revenue also decreased by 30% to $790,000, reflecting lower royalties from Aztarys and the impact of a terminated licensing agreement. However, proprietary product revenue saw an increase, contributing $319,000, marking a new revenue stream for the company.

The company's expenses rose sharply, particularly in selling, general, and administrative costs, which surged by 78% to $19.07 million, driven by regulatory fees associated with the Anaphylm product and increased legal and commercial spending. Research and development expenses decreased by 10% to $5.36 million, reflecting lower clinical trial costs for Anaphylm, although personnel costs and share-based compensation increased. Overall, Aquestive reported a net loss of $22.93 million, compared to a loss of $12.83 million in the prior year, resulting in a loss per share of $0.24, up from $0.17.

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, which was completed in early 2025. The anticipated launch of Anaphylm, if approved, is planned for the first quarter of 2026. Additionally, the company is working on AQST-108, an epinephrine topical gel, with plans to initiate a Phase 2a clinical trial in 2026.

As of March 31, 2025, Aquestive had cash and cash equivalents of $68.66 million, a decrease from $71.55 million at the end of 2024. The company has utilized its At-The-Market (ATM) facility to raise funds, generating approximately $21.31 million from the sale of 7.46 million shares during the quarter. The company’s liquidity strategy includes managing expenses and exploring potential asset sales or product outlicensing to support ongoing operations and product development.

Looking ahead, Aquestive's management remains cautious about achieving profitability, given the ongoing losses and significant debt obligations, including the 13.5% Senior Secured Notes due in 2028. The company is focused on executing its business strategy while navigating the challenges posed by market conditions and regulatory requirements. The outlook for the remainder of 2025 will depend on the successful advancement of its product candidates and the ability to generate sustainable revenue streams.