Aquestive Therapeutics (AQST) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Company overview and technology

• Focuses on oral thin film drug delivery technology, with nearly 20 years of experience and six FDA-approved products delivered globally across six continents.

• Notable products include Suboxone for opioid addiction, Emylif for ALS in Europe, Sympazan in the U.S., and Ondif in Brazil, all demonstrating the platform's versatility.

• The Adrenoverse platform enables tailored absorption and release profiles for drugs like epinephrine, supporting expansion into allergy and dermatology markets.

• Leadership team includes experienced executives from major pharmaceutical backgrounds, enhancing execution capabilities.

Pipeline and product development

• Lead asset Anaphylm is a sublingual epinephrine film for severe allergic reactions, aiming to replace auto-injectors with a needle-free, easy-to-carry alternative.

• Libervant, a diazepam buccal film for acute repetitive seizures, is tentatively FDA-approved and expected to launch in the U.S. after orphan drug exclusivity expires in January next year.

• AQST108, a topical epinephrine gel for alopecia areata, is in phase I trials, targeting a treatment gap between steroids and JAK inhibitors.

• Surveys indicate strong patient preference for the film format over nasal sprays and auto-injectors, supporting anticipated market adoption.

Regulatory and launch milestones

• Received a complete response letter from the FDA for Anaphylm, requiring additional human factors and PK studies, with resubmission planned for Q3 and potential approval in Q1 2027.

• Human factors and PK studies are considered straightforward and within the company's expertise, with a standard six-month FDA review expected.

• Commercial team is maintained and ready for rapid scale-up upon approval, with launch readiness activities ongoing.