Aquestive(US:AQST)2024-11-05 20:57Financial Data and Key Metrics Changes - Total revenues increased to $13.5 million in Q3 2024 from $13 million in Q3 2023, a 4% increase primarily driven by an increase in license and royalty revenue [18] - Net loss for Q3 2024 was $11.5 million or $0.13 per share, compared to a net loss of $2 million or $0.03 per share in Q3 2023, driven by increased expenses [22] - Non-GAAP adjusted EBITDA loss was $6.6 million in Q3 2024 compared to a loss of $1.3 million in Q3 2023 [23] Business Line Data and Key Metrics Changes - Manufacture and supply revenue decreased to $10.7 million in Q3 2024 from $11.4 million in Q3 2023, primarily due to timing of revenues [18] - Research and development expenses increased to $5.3 million in Q3 2024 from $3.2 million in Q3 2023, driven by clinical trial costs [20] - Selling, general and administrative expenses increased to $12.1 million in Q3 2024 from $7.4 million in Q3 2023, influenced by increased commercial spending [21] Market Data and Key Metrics Changes - Medicaid coverage for Libervant is now available in all 50 states, enhancing market access [12] - Libervant prescriptions have steadily increased between September and October 2024 due to expanded retail distribution and a national sales team [13] Company Strategy and Development Direction - The company is focused on advancing Anaphylm towards NDA submission and growing Libervant prescriptions in the pediatric space [15] - Plans for a Phase 2a study for AQST-108 are set for 2025, targeting alopecia areata, with expectations for significant market opportunity [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made with Anaphylm and the supportive feedback received from the FDA [9][10] - The outlook for 2024 remains unchanged, with total revenues expected to be approximately $57 million to $60 million [25] Other Important Information - Cash and cash equivalents were $77.9 million as of September 30, 2024, supporting ongoing development and commercialization efforts [24] - The company is preparing for a pre-NDA meeting with the FDA and plans to share findings post-meeting [10] Q&A Session Summary Question: What topics will be highlighted in the Anaphylm clinical briefing book? - The company aims to demonstrate that they have met all FDA requirements and is looking for guidance on the completeness of their package [28] Question: How did negotiations with PBMs for Libervant go? - Negotiations have been positive, with coverage being secured for patients aged two to five [29] Question: Will there be an Ad Comm for Anaphylm? - The company is prepared for the possibility of an Ad Comm but does not have insight into the FDA's thinking [36] Question: What is the pricing paradigm for Libervant? - Pricing has not been an obstacle, and the payer community understands the necessity of the product [46] Question: How will the NDA for Anaphylm be prepared while the pediatric study is ongoing? - The NDA preparation is ongoing, and the company expects alignment with the FDA on the pediatric study design [66]