Aquestive Therapeutics (AQST) H.C. Wainwright 28th Annual Global Investment Conference summary

Commercial strategy and market opportunity

• Focused on launching Anaphylm, an oral epinephrine film, targeting a $1.5 billion peak annual sales potential across multiple indications.

• Anaphylm addresses key unmet needs in anaphylaxis treatment: portability, ease of use, and rapid action, with clinical data showing best-in-class speed and efficacy.

• Launch strategy centers on allergists and pediatricians, with a disciplined sales force of 75 targeting 8,000 high-value healthcare providers.

• Extensive market research and early engagement with prescribers and payers have built strong awareness and access readiness.

• Patient and caregiver surveys show a strong preference for Anaphylm over traditional devices, reinforcing its differentiated value proposition.

Regulatory and product development updates

• Anaphylm resubmission to the FDA is planned for this month, with subsequent filings in Canada, Europe, and the UK in the following quarters.

• FDA's previous concerns focused on packaging and instructions; improvements have reduced pouch opening time and misadministration rates.

• Clinical data demonstrate rapid and sustained pharmacodynamic effects, even with suboptimal administration.

• Libervant, another rescue product for epilepsy, is expected to be available in the US in 2027.

• AQST-108, a topical gel for dermatological indications, is in development with plans to show proof of concept in patients by 2027.

Financial position and launch readiness

• Secured $75 million in launch financing from RTW, with additional debt capacity from Oaktree, ensuring capital runway through 2028.

• Current cash guidance is $70 million by year-end, with further potential from out-licensing Anaphylm in Europe and Libervant in the US.

• Commercial infrastructure and payer engagement are in place to support rapid uptake post-approval.

• Early investments in medical affairs and scientific communication have established a strong foundation for launch.

• The company is positioned to maximize Anaphylm's opportunity upon FDA approval.