Aquestive(US:AQST)2023-11-07 18:39Financial Data and Key Metrics Changes - Total revenues increased from $9.2 million in Q3 2022 to $13 million in Q3 2023, representing a 42% increase [17] - Net loss for Q3 2023 was $2 million or $0.03 loss per share, compared to a net loss of $12.5 million or $0.23 loss per share in Q3 2022 [20] - Non-GAAP adjusted EBITDA loss was $1.3 million in Q3 2023, an improvement from a loss of $7.7 million in Q3 2022 [21] - Cash and cash equivalents were $24.9 million as of September 30, 2023 [22] - Revenue guidance for 2023 was increased to approximately $47 million to $50 million from $44 million to $48 million [23] Business Line Data and Key Metrics Changes - License and royalty revenue increased by 193%, primarily due to Sympazan and Azstarys [18] - Manufacturing and supply revenue rose by 36% from Suboxone and Sympazan [18] - Co-development and research fees increased by 24% [18] Market Data and Key Metrics Changes - There was a 31% increase in prescriptions in the two-to-five-year-old space during Q3 2023 compared to Q3 2022 [11] Company Strategy and Development Direction - The company is focused on the clinical development of Anaphylm, with plans to start a pivotal Phase 3 study in Q4 2023 and provide top-line data in Q1 2024 [8] - The company is also advancing its Libervant application for patients aged two to five, with an FDA target action date in April 2024 [11] - The ADRENAVERSE platform is being developed for a topical product, with initial formulations completed and human testing planned [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refinancing of debt, which provides flexibility for upcoming clinical and regulatory milestones [6] - The company believes that the demand for oral epinephrine products remains high, especially with delays in nasal spray alternatives [9] - Management remains optimistic about the potential for Anaphylm to transform the company in 2024 [8] Other Important Information - The company has no revenue, EBITDA, or cash covenants in its new debt agreement, which allows for operational flexibility [6] - The company anticipates continued growth in its base business and is focused on capital conservation to extend its cash runway [23] Q&A Session Summary Question: Differences in design between the two PK pivotal trials - Management indicated that the design is based on FDA feedback and marketplace learnings, with the adult pivotal study starting in Q4 2023 and data readout expected in Q1 2024 [27][29] Question: Clarity on pivotal studies against IM injection - Management clarified that the pivotal study is a bracketing approach against established reference products, including autoinjectors [36][37] Question: Gating factors for pivotal PK study - Management stated there are no gating factors for starting the pivotal PK study in Q4, focusing on operational readiness [44] Question: Insights on Libervant exclusivity block - Management noted that while they cannot share specific details, they believe there are avenues to bring Libervant to market ahead of orphan drug exclusivity exploration for competing products [47] Question: Cost of remaining trials and NDA filing readiness - Management indicated that the remaining pharmacokinetic studies are cost-efficient and they expect to file for NDA by the end of 2024 [66] Question: Competitive intelligence on ARS Pharma and Neffy - Management stated they only have public domain information regarding competitors and are prepared for an Adcom if requested by the FDA [68]