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WARREN, N.J. - Aquestive Therapeutics , Inc. (NASDAQ:AQST) reported fourth-quarter earnings that fell short of analyst expectations, sending shares down 12.5% in after-hours trading.
The pharmaceutical company posted a loss of $0.19 per share, wider than the $0.13 loss per share analysts had forecast. Revenue came in at $11.87 million, below the consensus estimate of $13.08 million and down 10% from $13.2 million in the same quarter last year.
Aquestive attributed the revenue decline primarily to a $1.0 million milestone royalty for Azstarys recognized in the prior year period that did not recur. Manufacture and supply revenue decreased slightly to $10.7 million from $11.0 million a year ago.
"We are thrilled to announce today the start of our Anaphylm application process with the FDA," said Daniel Barber, President and CEO of Aquestive. "We anticipate completion of this process in the first quarter of 2025 and achievement of the FDA acceptance milestone before the end of the second quarter of 2025."
The company is developing Anaphylm as a non-device, non-invasive treatment option for severe allergic reactions. Aquestive expects to launch Anaphylm in Q1 2026, if approved by the FDA.
Research and development expenses rose to $4.9 million from $2.9 million last year as the company advanced its Anaphylm development program. Selling, general and administrative costs increased to $16.0 million from $9.6 million.
For full-year 2025, Aquestive forecasts revenue of $47 million to $56 million, in line with analyst expectations of $53 million, and adjusted EBITDA loss of $46 million to $53 million.
The company ended 2024 with $71.5 million in cash and cash equivalents. On a proforma basis including recent financing, cash stood at approximately $93.0 million.
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