Botanix Pharmaceuticals (BOT) Investor Update summary

Product and Market Overview

• Sofdra (sofpironium) topical gel, 12.45%, is FDA approved for primary axillary hyperhidrosis in adults and children 9+ years old.

• No new chemical entities have previously been approved for hyperhidrosis, highlighting Sofdra's novelty.

• The US market for hyperhidrosis treatments is ~$1.6B annually, projected to reach $2.8B by 2030.

• About 10 million Americans have axillary hyperhidrosis, with 3.7 million seeking prescriptions via dermatologists.

• Botanix is well-capitalized with AUD 79 million cash, no debt, and a market cap of AUD 762 million.

Clinical Efficacy and Differentiation

• Phase 3 trials showed highly significant improvements in both patient-reported and objective sweat reduction endpoints.

• Sofdra acts by selectively blocking M3-AC receptors in sweat glands, minimizing side effects through rapid metabolism.

• 60% of patients achieved a ≥2-point improvement in severity, compared to 40% for placebo.

• Sofdra offers a non-invasive alternative to older prescription products and procedures like Botox or surgery.

Commercial Readiness and Launch Strategy

• Three-phased commercialization: early patient engagement, targeted digital campaigns, and expansion based on real-time data.

• Sales force hiring underway, with launch meeting and field deployment set for January; digital engagement precedes field sales.

• Patient Experience Program (PEP) provides early access, collects feedback, and generates initial revenues ahead of full launch in Q1 2025.

• Telemedicine and digital campaigns will facilitate frictionless access and rapid prescription fulfillment.

• Direct-to-patient fulfillment aims to ensure every refill and maximize patient outcomes and profitability.