Aquestive Therapeutics reports Q1 EPS (24c), consensus (16c)

Reports Q1 revenue $8.72M, consensus $12.23M. “In the first quarter of 2025, we achieved a major milestone for Aquestive with the submission of the NDA for Anaphylm,” said Daniel Barber, President and Chief Executive Officer of Aquestive. “This represents a critical step toward delivering the first oral, non-invasive epinephrine treatment for patients experiencing severe allergic reactions, including anaphylaxis. We anticipate receipt of FDA’s determination of acceptance of our NDA submission in the second quarter of 2025 and our full team is actively preparing for a potential U.S. launch in the first quarter of 2026, if approved by the FDA. We continue to gain enthusiasm from all of our expanding pre-commercial efforts for Anaphylm, as we believe that we are the potential best-in-class epinephrine therapy in a multi-billion dollar growing market. Going forward we will have complete focus on our pre-commercial preparedness and the FDA approval process for Anaphylm. From now until post-launch, we will de-emphasize other activities such as the advancement of AQST-108, and we will not appeal the court decision on Libervant. This will focus resources, both people and financial, towards the upcoming launch of Anaphylm, if approved by the FDA.”