Aquestive Therapeutics reported its third‑quarter 2025 results, posting revenue of $12.8 million—$0.56 million below the consensus estimate of $13.36 million—and a net loss of $15.4 million, or $0.14 per share, versus the $-0.13 estimate. The miss reflects a 5.2 % decline in top line compared with Q3 2024, driven largely by a $0.7 million drop in license and royalty revenue and higher selling, general and administrative expenses that rose to $15.3 million from $12.1 million year‑over‑year.
The company’s gross margin of 61.09 % remained largely unchanged, but the net margin contracted to a negative 147.38 %. The widening loss is attributable to increased legal and regulatory costs linked to the Anaphylm program and a one‑time deferred revenue recognition in Q3 2024 that, when excluded, shows a 4 % year‑over‑year revenue growth to $12.8 million. Manufacturing and supply revenue rose to $11.5 million from $10.7 million, supported by steady sales of Sympazan and Suboxone.
Management emphasized that the quarter’s performance is a transitional period as the company prepares for the anticipated U.S. launch of Anaphylm in Q1 2026. CEO Daniel Barber noted, “The third quarter was another period of strong execution for Aquestive as we move closer to the launch of Anaphylm, if approved by the FDA.” The guidance for 2025 remains unchanged: total revenue of $44–$50 million and a non‑GAAP adjusted EBITDA loss of $47–$51 million, underscoring confidence in the long‑term commercial potential of Anaphylm despite short‑term earnings pressure.
Analysts and investors reacted to the earnings miss with a muted market response. The stock fell 1.32 % on the day of the release and 7.41 % over the week, reflecting concerns over the revenue shortfall and widening loss. However, the company’s strong cash position of $129.1 million and the regulatory progress—FDA’s decision to forgo an advisory committee meeting and maintain the January 31, 2026 PDUFA date—helped temper the reaction, as investors weigh the long‑term upside of the first‑of‑its‑kind orally delivered epinephrine product.
Looking ahead, the company plans to submit an IND for AQST‑108, an epinephrine topical gel, in Q4 2025, targeting alopecia areata. The continued expansion of the Anaphylm patent portfolio to 2037 and the company’s focus on cost discipline amid rising SG&A expenses suggest a strategy aimed at balancing short‑term financial headwinds with long‑term pipeline development.
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