Aquestive Therapeutics (AQST) H.C. Wainwright 27th Annual Global Investment Conference summary

Company background and technology

• Over 20 years in operation, with six FDA approvals and products available on six continents.

• Employs 150+ staff, $50M annual base revenue, with R&D in New Jersey and manufacturing in Indiana.

• Focuses on drug delivery via PharmFilm, an oral polymeric matrix for buccal or sublingual absorption.

• Introduced Adrenaverse, an epinephrine prodrug technology enabling extended absorption and new indications.

• Lead pipeline product is Anaphylm, a sublingual film for anaphylaxis, currently under FDA review.

Product pipeline and market opportunity

• Anaphylm has a PDUFA date of January 31 and is positioned as a potential billion-dollar global product.

• AQST-108, a topical gel for alopecia areata, leverages extended release for immune suppression.

• Global expansion underway, with recent EMA meeting and upcoming Health Canada and UK filings.

• U.S. epinephrine market estimated at $800M–$1B, dominated by autoinjectors, with potential to reach $2B.

• Recent capital raise of $85M and $75M revenue-sharing agreement provide over $200M for Anaphylm launch.

Anaphylm value proposition and commercial readiness

• Anaphylm is designed for ease of use, portability, and rapid action, addressing needle phobia and device bulkiness.

• Peak absorption in 12 minutes, with therapeutic levels in as little as 5 minutes.

• Market research shows strong interest from patients and HCPs for a non-injection film option.

• Commercial readiness includes medical education, payer engagement, and advocacy outreach.

• Launch strategy targets allergists and pediatricians, aligning with seasonal prescription peaks.