Aquestive Therapeutics (AQST) Investor Day 2024 summary

Strategic vision and future plans

• The Adrenoverse platform is being expanded with over 20 epinephrine prodrugs, targeting anaphylaxis, immunomodulatory, and dermatologic indications, with multiple product launches planned through 2028 and beyond.

• Anaphylm, a sublingual epinephrine film, is expected to launch in 2026 pending FDA approval, followed by Libervant in 2027 and AQST-108 after 2028.

• AQST-108 is positioned as a novel topical immunomodulator for alopecia areata, with potential expansion into vitiligo, atopic dermatitis, acne, and other autoimmune diseases.

• Commercial infrastructure is being built in phases to support sequential product launches, leveraging existing manufacturing capabilities for scalability and market expansion.

• Patent portfolio protection for AQST-108 and the prodrug platform could extend through 2046, supporting long-term growth.

Financial guidance and market opportunity

• Combined peak annual sales potential for Anaphylm, Libervant, and AQST-108 is estimated at over $1.5 billion, with AQST-108 alone projected at $250M–$750M+ depending on market positioning.

• Libervant (ages 12+) is projected to generate over $100M in annual revenue after 2027; Anaphylm and AQST-108 have estimated annual revenues of over $1B and $500M, respectively.

• JAK inhibitors for severe alopecia areata represent a $1B+ market, with AQST-108 positioned as a safer, potentially more affordable alternative.

• Dermatologists are identified as a key prescriber group for AQST-108, aligning with a targeted sales force and efficient commercial deployment.

• Manufacturing infrastructure is already in place, minimizing capital expenditure for new product launches.

Scientific and clinical developments

• Adrenoverse platform enables controlled local delivery of epinephrine, achieving immunomodulation without systemic exposure, as demonstrated in animal and human skin models.

• AQST-108 shows sustained local skin exposure, effective immunosuppression, and no systemic absorption in preclinical and first-in-human studies.

• Non-clinical data confirm reduction of pro-inflammatory cytokines and modulation of NK cell activity, supporting the mechanism of action for autoimmune skin diseases.

• Initial clinical studies confirm safety, tolerability, and lack of systemic exposure at selected doses.

• Planned Phase 2 study for AQST-108 in alopecia areata will assess safety and efficacy over 12–24 weeks, with endpoints including hair regrowth and digital imagery.