Aquestive(US:AQST)2023-03-08 16:45Financial Data and Key Metrics Changes - Total revenues for Q4 2022 were $10.7 million, a decrease of 4% compared to $11.1 million in Q4 2021 [24] - For the full year 2022, total revenues were $47.7 million, down 6% from $50.8 million in 2021, but increased by 2% when excluding non-recurring revenue from 2021 [25] - The net loss for Q4 2022 was $12.4 million, or $0.23 loss per share, compared to a net loss of $28.9 million, or $0.72 loss per share in Q4 2021 [26] - The net loss for the full year 2022 was $54.4 million, or $1.12 loss per share, an improvement from a net loss of $70.5 million, or $1.85 loss per share in 2021 [26] - Non-GAAP adjusted EBITDA loss was $9.6 million in Q4 2022, compared to a loss of $9.2 million in Q4 2021, and $35.3 million for the full year 2022, up from $24.9 million in 2021 [27] Business Line Data and Key Metrics Changes - License and royalty revenue increased by 141% in Q4 2022 due to higher sales from licensees [24] - Co-development and research fees revenue rose by 17%, while manufacturing and supply revenue increased by 16% due to higher manufacturing volume for Ondif in Brazil [24] - Proprietary sales net revenue decreased by 79% due to the licensing of Sympazan to Assertio in October 2022 [24] Market Data and Key Metrics Changes - The company has seven significant out-licensing collaborations across six continents, with notable launches in Brazil and Europe [15] - Indivior retains a U.S. market share of approximately 34% for the Buccal Film, which remains a significant part of the near-term revenue outlook [28] Company Strategy and Development Direction - The company aims to rapidly progress AQST-109 into a pivotal study, with a target start in Q3 2023 and a goal for NDA submission by mid-2024 [11][20] - Focus on expanding commercial collaborations and strengthening the balance sheet, with a disciplined approach to out-licensing [17][19] - Continued advocacy for Libervant to ensure market access, with plans for potential collaborations in Europe and China [18][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the unmet need for better products for anaphylaxis treatment and the potential market for AQST-109 [12][13] - The company is focused on capital conservation to extend its cash runway and expects to reduce overall debt by 40% by the end of 2023 [19][23] - Management remains optimistic about the future, emphasizing the importance of AQST-109 and Libervant in addressing patient needs [65] Other Important Information - The company generated over $25 million in non-dilutive financing in 2022 through significant deals [10][22] - Cash and cash equivalents as of December 31, 2022, were $27.3 million, with additional capital raised in early 2023 [27][23] Q&A Session Summary Question: Can you discuss the March FDA interaction regarding AQST-109? - The interaction was initiated by the company to gain clarity on pivotal protocol requirements, with the selection of reference products being the company's choice [30][32][33] Question: What feedback was received from the recent allergy conference? - The meeting was successful, with positive feedback on AQST-109's rapid Tmax and the frustration of the medical community with current injection methods [34][36] Question: What is the expense trajectory for 2023? - The company plans to manage expenses closely, with reductions from the Sympazan licensing carrying into 2023 [43][44] Question: Are there potential partnerships for Libervant? - There are ongoing discussions for partnerships both in the U.S. and abroad, with a focus on finding the right fit [72][73] Question: Will additional litigation settlements impact financial guidance? - The financial guidance for 2023 does not account for any potential additional litigation settlements [66]