Aquestive Therapeutics Reports 14% Revenue Growth to $57.6 Million for Fiscal Year 2024

Aquestive Therapeutics, Inc. reported a 14% increase in total revenues for the fiscal year ending December 31, 2024, amounting to $57.6 million, compared to $50.6 million in 2023. This growth was primarily driven by a significant rise in license and royalty revenue, which surged by 185% to $15.3 million, largely due to the one-time recognition of deferred revenues from terminated licensing agreements. However, the company experienced a 9% decline in manufacture and supply revenue, which fell to $40 million, attributed to decreased sales volumes of its flagship product, Suboxone, and a reduction in Sympazan revenue. The overall financial performance reflects a complex interplay of product demand and strategic licensing activities.

In terms of expenses, Aquestive's research and development costs rose sharply by 55% to $20.3 million, driven by increased clinical trial expenditures for its product candidates, particularly Anaphylm and AQST-108. Selling, general, and administrative expenses also saw a significant increase of 58%, totaling $50.2 million, due to higher commercial spending and personnel costs. Interest expenses related to the company's debt obligations increased by 76% to $11.1 million, reflecting the costs associated with its 13.5% Notes issued in November 2023. The net loss for the year was $36.3 million, highlighting the ongoing financial challenges faced by the company as it invests heavily in product development and commercialization efforts.

Strategically, Aquestive launched Libervant, a diazepam buccal film for pediatric epilepsy patients, in April 2024, marking a significant milestone in its product portfolio. The company is also advancing its Anaphylm product, an epinephrine sublingual film aimed at treating severe allergic reactions, with plans for a New Drug Application (NDA) submission in early 2025. The FDA has granted Fast Track designation to Anaphylm, which could expedite its review process. However, the company faces potential legal challenges regarding the market access of Libervant due to a competing product's orphan drug exclusivity, which could impact its revenue projections.

As of December 31, 2024, Aquestive had approximately $71.5 million in cash and cash equivalents, bolstered by a successful public offering that generated nearly $72.9 million in net proceeds. The company is actively managing its liquidity needs while navigating a complex regulatory landscape and competitive market. Looking ahead, Aquestive anticipates continued investment in its product pipeline, particularly in the development of Anaphylm and the expansion of Libervant's market access. However, the company acknowledges the risks associated with regulatory approvals, market competition, and the need for additional capital to sustain its operations and growth initiatives.