Aquestive Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Viewpoint - Aquestive Therapeutics, Inc. has reported its financial results for Q4 and the full year 2024, highlighting significant advancements in its product pipeline, particularly the Anaphylm application process with the FDA and the development of AQST-108 for alopecia areata. Financial Performance - Total revenues for Q4 2024 decreased to $11.9 million from$13.2 million in Q4 2023, a 10% decline primarily due to reduced license and royalty revenue [17] - For the full year 2024, total revenues increased to $57.6 million from$50.6 million in 2023, marking a 14% increase driven by higher license and royalty revenue [25] - The net loss for Q4 2024 was $17.1 million, or ($0.19) per share, compared to a net loss of $8.1 million, or ($0.12) per share in Q4 2023 [23] - The full year net loss for 2024 was $44.1 million, or ($0.51) per share, compared to a net loss of $7.9 million, or ($0.13) per share in 2023 [29] Product Development Updates - The company has initiated the Anaphylm application process with the FDA, expecting to complete it in Q1 2025 and achieve FDA acceptance by the end of Q2 2025 [2][4] - Anaphylm, a non-device based epinephrine product, has shown clinical results comparable to autoinjectors and completed all adult clinical trials with positive feedback from the FDA [3][4] - AQST-108 (epinephrine) Topical Gel is set to enter Phase 2a clinical trials in Q2 2025, targeting alopecia areata, which affects approximately 6.7 million people in the U.S. [7][8] Market Strategy and Outlook - The company is preparing for the launch of Anaphylm, focusing on market access and increasing awareness through medical affairs strategies [6] - The estimated market opportunity for JAK inhibitors for alopecia areata exceeds $1 billion, indicating significant potential for AQST-108 if approved [10] - The company expects total revenue for 2025 to be between$47 million and $56 million, with a non-GAAP adjusted EBITDA loss projected between$46 million and $53 million [33][34] Cash Position - As of December 31, 2024, cash and cash equivalents were approximately$71.5 million, with proforma cash and cash equivalents around $93.0 million following a capital raise [31]