Business
Aquestive Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update
Reports full year 2023 revenue of $50.6 million and non-GAAP adjusted EBITDA loss of $11.6 millionReaffirms expected release of topline pivotal clinical data
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Reports full year 2023 revenue of $50.6 million and non-GAAP adjusted EBITDA loss of $11.6 millionReaffirms expected release of topline pivotal clinical data for Anaphylm™ (epinephrine) Sublingual Film in March 2024Reaffirms anticipated FDA decision on Libervant™ (diazepam) Buccal Film application in April 2024Provides full year 2024 financial guidanceHosts investment community conference call on March 6, 2024 WARREN, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a progress update on the key 2024 objectives previously outlined by the Company. “We ended 2023 on a strong note with double digit base revenue growth, an improved balance sheet, and the start of our pivotal study for Anaphylm. We are now focused on continuing our progress in 2024 and building a strong foundation for the long-term growth of the Company. This includes (1) progressing Anaphylm to a US filing, (2) expanding and growing our revenue base, (3) licensing or launching Libervant (diazepam) Buccal Film, if approved by the FDA with market access, and (4) advancing our next pipeline assets by utilizing our Adrenaverse technology,” stated Daniel Barber, President and Chief Executive Officer of Aquestive. “Anaphylm, as the only orally administered epinephrine product under development for the treatment of severe allergic reactions including anaphylaxis, continues to represent a transformational opportunity for both patients and the Company. We remain excited to see our topline pivotal data and continue to anticipate reporting topline data from our Anaphylm pivotal study this month.” Anaphylm™Aquestive is advancing the development of Anaphylm, the first and only orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of allergic reactions, including anaphylaxis. Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm. The FDA indicated that ...