Aquestive(AQST) - 2024 Q4 - Annual Results

Revenue and Market Potential - In 2023, Aquestive Therapeutics generated over $50 million in revenue and has over$1.5 billion in potential peak annual net sales from pipeline assets[5]. - The Anaphylm (epinephrine) Sublingual Film is the first non-device based, orally delivered epinephrine product, targeting a U.S. market projected to grow to approximately $2 billion[27]. - The annual scripts written for epinephrine have increased at a 15$1 billion[110]. Product Development and Launch Timeline - The company expects to launch two new products in the U.S. by 2027, including Libervant for patients aged 2-5, which has already been FDA approved[9]. - Libervant is expected to be launched for patients aged 12 and up in 2027, with additional launches planned for ages 6-11[10]. - The expected clinical and regulatory timeline for Anaphylm includes key milestones through Q4 2024, indicating a proactive approach to market entry[43]. - The planned Phase 2a clinical study for AQST-108 in alopecia areata is set to commence in Q2 2025, with interim data expected in 12 weeks[114]. Intellectual Property and Manufacturing - The company has over 150 patents worldwide, showcasing its intellectual property strength in drug delivery technologies[13]. - The company has two manufacturing and packaging facilities located in Indiana, supporting its production capabilities[13]. - The company has commercialized its proprietary PharmFilm® technology across six FDA-approved products, establishing itself as a world leader in oral thin film delivery[36]. Clinical Studies and Efficacy - Anaphylm demonstrated a time to maximum concentration (Tmax) of 12-15 minutes, with pharmacodynamic effects onset within 2-5 minutes, comparable to standard of care[40]. - The pivotal study for Anaphylm showed a Cmax of 403.5 pg/mL when administered with allergen, significantly higher than the Manual IM administration[92]. - Anaphylm's pharmacokinetics were consistent across various temperature and pH conditions, with no significant differences observed[66]. - The OASIS study indicated that complete symptom resolution occurred within a median time of 20 minutes after Anaphylm administration[78]. - Anaphylm's self-administration study results showed no significant difference in systolic blood pressure increase whether self-administered or administered by healthcare professionals[74]. - Anaphylm's repeat dose administration achieved a Cmax of 1194.0 pg/mL, demonstrating robust pharmacokinetic performance[95]. - The pediatric study for Anaphylm™ is underway, focusing on pharmacokinetics and treatment-emergent adverse events[99]. Leadership and Team Experience - The leadership team includes experienced professionals with a track record of FDA approvals and clinical trial execution[14]. Market Access and Commercialization - Libervant's market access is established, and prescriptions are being filled[103]. - The company is pursuing the development of Adrenaverse™ to address limitations in the treatment of medical conditions related to epinephrine[107]. Pipeline and Growth Drivers - The company has a diversified pipeline with multiple growth drivers, including the Anaphylm and AQST-108 products[9]. - AQST-108 is a topical gel targeting moderate to severe alopecia areata, with a planned administration of once in the morning[109]. - The Phase 2a study will assess safety and efficacy based on a change from baseline ≥10% in Severity of Alopecia Tool (SALT) score at week 12[115]. - Combined prescriptions for Olumiant and Litfulo in Q2 2024 totaled approximately 30,000, representing a small fraction of the severe alopecia areata patient population[113].