Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Bioshares Biotech Summit 2023
14 slides from Botanix Pharmaceuticals's conference presentation, Jul 24, 2023
Slide 1: Botanix Bioshares Biotech Summit Presentation
24 July 2023 Botanix Bioshares Biotech Summit Presentation Key highlights • Botanix is presenting at the Bioshares Biotech Summit being held this week in Hobart, Tasmania • The Conference attracts attendees from around Australia and the region, and features presentations by and business development
Slide 2: About Botanix Pharmaceuticals
About Botanix Pharmaceuticals Botanix Pharmaceuticals Limited (ASX:BOT) is a dermatology company based in Philadelphia and Phoenix (US) which is progressing its lead product Sofpironium Bromide for the treatment of primary axillary hyperhidrosis, through FDA approval. A mid-cycle review for the prod
Slide 3: Bioshares Conference 2023
For personal use only Bioshares Conference 2023 www.botanixpharma.com
Slide 4: Important Notice & Disclaimer
Important Notice & Disclaimer 1. Summary information This presentation has been prepared by Botanix Pharmaceuticals Ltd (“Botanix”) and contains summary information about Botanix and the business conducted by it which is current as at the date of this presentation (“Presentation”) (unless otherwise
Slide 5: Botanix: A leader in topical drug development
Botanix: A leader in topical drug development DERMATOLOGY FOCUS New treatments for common skin diseases—such as excessive sweating (hyperhidrosis), For personal use only rosacea and acne TOPICALLY DRIVEN Targeting key indications with topical (gel) treatments that are safe, well tolerated and valida
Slide 6: Hyperhidrosis
Hyperhidrosis A medical condition where excessive sweating For personal use only occurs beyond what is needed to maintain normal body temperature ❖ Hyperhidrosis affects ~16M people in the US1 ❖ Results from overstimulation of the nervous system (a physiological not psychological condition)1 ❖ 90% o
Slide 7: Sofpironium Bromide mechanism of action
Sofpironium Bromide mechanism of action Blocks sweat gland receptors and rapidly degrades for excretion For personal use only UNTREATED SWEAT GLAND TREATED SWEAT GLAND 5
Slide 8: Label negotiations
Label negotiations Towards the end of the NDA review process, FDA and Botanix negotiate the drug’s final package label For personal use only ❖ The label will reflect the efficacy and safety data that FDA and EFFICACY AND SAFETY DATA the Sponsor (Botanix) agrees needs to be included ❖ The label provi
Slide 9: Significant opportunity for a new topical agent with class leading efficacy and safety
Significant opportunity for a new topical agent with class leading efficacy and safety For personal use only OLDER PRESCRIPTION ANTIPERSPIRANTS NEW CHEMICAL ENTITIES PRODUCTS INVASIVE PROCEDURES SURGERY OTC ALUMINUM CHLORIDE BOTOX INJECTION CUTTING NERVES REFORMULATED ORAL DRUG INTO A SOLUTION CLINI
Slide 10: Digital strategy—expands the addressable patient population
Digital strategy—expands the addressable patient population For personal use only US Hyperhidrosis Population ~336M Hyperhidrosis Patients ~16.1M Potential to diagnose and treat Axillary Hyperhidrosis from home with telemedicine ~10M Patients Patients already in dermatologist’s Patients Seeking ~3.7
Slide 11: Proposed program design: provide access via telemedicine and pharmacy network
PROVIDE ACCESS Create a pharmacy network that is directly connected to a telemedicine provider, that will facilitate prescribing of SB Gel PROPOSED PROGRAM DESIGN For personal use only Remove barriers to use by providing doctors with the ability to prescribe SB Gel at launch CONSIGNED PRODUCT TELEME
Slide 12: Royalty and Milestone buyout transaction benefits
Royalty and Milestone buyout transaction benefits Opportunity to remove milestones payments and double-digit royalties payable to Fresh Tracks (the company Botanix acquired the SB asset from) For personal use only Current Commitment to After Royalty Buyout Financial Obligations to Fresh Tracks Fresh
Slide 13: Why buy out the royalties and milestones now?
Why buy out the royalties and milestones now? Compelling and unique opportunity to add significant value to Botanix, as we approach planned FDA approval ❖ Avoids September $4M “FDA approval and potential “EU/UK approval” For personal use only VALUE OF REGULATORY MILESTONES ~ $12M and “other indicati
Slide 14: Executing on planned commercial and regulatory milestones
Executing on planned commercial and regulatory milestones For personal use only CALENDAR YEAR NDA LABEL DAY 74 MID-CYCLE FDA SUBMISSION NEGOTIATION LETTER REVIEW APPROVAL COMPLETE STARTS ✔︎ ✔︎ ✔︎ 3Q 2022 DECEMBER 2022 1Q 2023 2Q 2023 3Q 2023 12 www.botanixpharma.com
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