Aquestive(US:AQST)2022-05-04 15:16Financial Data and Key Metrics Changes - The company reported a 41% year-over-year increase in revenue from Suboxone, which remains a significant part of the near-term revenue outlook [19] - Total revenue for 2022 is projected to be approximately $42 million to $47 million, with a non-GAAP adjusted gross margin of approximately 70% to 75% [22][23] - The non-GAAP adjusted EBITDA loss is expected to be approximately $51 million to $58 million, excluding any revenues from Libervant until market access is secured [22][23] Business Line Data and Key Metrics Changes - The Suboxone business performed well, exceeding expectations with a 41% year-over-year revenue increase [19] - SYMPAZAN has shown consistent growth, generating revenue growth for 13 consecutive quarters [19][17] - The core business continues to contribute new opportunities and cash, with expectations for continued growth in SYMPAZAN throughout 2022 [17] Market Data and Key Metrics Changes - The company entered into a purchase agreement with Lincoln Park Capital Fund, allowing for the sale of up to $40 million of common stock over 36 months [20] - Royalty streams from license agreements are expected to contribute to future revenue, including AZSTARYS, Suboxone in international markets, and EXSERVAN [21] Company Strategy and Development Direction - The company remains focused on advancing its proprietary products, particularly Libervant and AQST-109, with ongoing communication with the FDA regarding regulatory approvals [17][18] - The company is preparing for the end of Phase II meeting and pivotal trials for AQST-109, with plans to complete Part 3 of the EPIPHAST study by the end of Q2 2022 [16][18] - The company is also exploring potential partnerships for commercialization outside the U.S. for AQST-109 and Libervant [55] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the approvability of Libervant based on safety and efficacy data, and is prepared to launch immediately upon receiving market access [11][12] - The ongoing COVID-19 pandemic presents uncertainties, but the company is focused on advancing its clinical development and maintaining strong business performance [6][7] - Management is committed to capital efficiency and prudent cost management while investing in R&D for AQST-109 [23] Other Important Information - The FDA granted fast track designation for AQST-109, facilitating its development and review process [14] - The company is actively engaging with various FDA departments to clarify the status of Libervant's orphan drug exclusivity [26][27] Q&A Session Summary Question: Are there any recent discussions with the FDA regarding Libervant? - Management confirmed ongoing communication with the FDA, including discussions with various departments, and emphasized the agency's focus on the orphan drug exclusivity issues [26][27] Question: What are the goals for Part 3 of the EPIPHAST study for AQST-109? - The study aims to further characterize the product under various conditions and prepare for the end of Phase II meeting [30][31] Question: What is the expected timeline for pivotal studies and FDA submission for AQST-109? - If the end of Phase II meeting goes well, pivotal studies are expected to occur in the first half of 2023, leading to a potential filing by the end of 2023 [41] Question: Are there any updates on AQST-108? - Management indicated that while AQST-108 has potential, the focus remains on Libervant and AQST-109 for the time being [45] Question: How does the company plan to optimize the value of Libervant outside the U.S.? - The company is in discussions with potential partners for Libervant in international markets, emphasizing its competitive potential [55]