Analyst Summary:
Pharmaceutical company Aquestive Therapeutics reported its financial results for Q4 and FY 2022, and discussed their achievements for the year. CEO Daniel Barber noted that the Company is focused on initiatives such as advancing AQST-109 into a pivotal PK study, exploring new capabilities for their manufacturing business, and strengthening their balance sheet. Additionally, the Company continues to work with FDA to potentially accelerate the U.S. market access for Libervant. The Company has revised its pivotal study protocol and expects to start the crucial study in Q3 2023. Data from AQST-109 posters presented at the American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting highlighted that the rapid absorption of epinephrine could be a critical factor in the utilization of epinephrine for treating severe allergic reactions, such as anaphylaxis.
The Company has also concluded a Patent Litigation Settlement with BDSI, resolving all patent claims pending between BDSI and Aquestive. The Company reported total revenue for FY 2022 of $50.4 million, including $37.5 million in manufacturing and supply revenue and royalty fees. The revenue guidance for 2023 no longer includes proprietary net sales for Sympazan due to the license of Sympazan to Assertio, but it does include the Company's manufacturing and supply revenue and royalty fees. The Company continues to focus on expanding its collaborations activities and potentially generating additional non-dilutive capital in 2023.