Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Shareholder Meeting (November 2023)
19 slides from Botanix Pharmaceuticals's shareholder meeting presentation, Nov 8, 2023
Slide 1: AGM Presentation November 2023
For personal use only AGM Presenta,on November 2023 www.botanixpharma.com
Slide 2: Important Notice & Disclaimer
Important No2ce & Disclaimer 1. Summary informa2on This presenta-on has been prepared by Botanix Pharmaceu-cals Ltd (“Botanix”) and contains summary informa-on about Botanix and the business conducted by it which is current as at the date of this presenta-on (“Presenta-on”) (unless otherwise indicat
Slide 3: Botanix – Accelerating towards commercialization of SOFDRA
Botanix – Accelera,ng towards commercializa,on of SOFDRA™ For personal use only DERMATOLOGY FOCUS New treatments for underserved common skin diseases, with a first focus on excessive sweating (“primary axillary hyperhidrosis”) Targeting key indications with topical (gel) treatments that are safe, we
Slide 4: Hyperhidrosis
Hyperhidrosis A medical condition where excessive sweating For personal use only occurs beyond what is needed to maintain normal body temperature v Hyperhidrosis affects ~16M people in the US1 v Results from overs=mula=on of the nervous system (a physiological not psychological condi=on)1 v 90% of ax
Slide 5: Sofdra mechanism of action
Sofdra™ mechanism of ac,on Blocks sweat gland receptors and rapidly degrades for excretion For personal use only UNTREATED SWEAT GLAND TREATED SWEAT GLAND 5
Slide 6: Both Phase 3 clinical study co-primary endpoints were highly statistically significant
Both Phase 3 clinical study co-primary endpoints were highly sta,s,cally significant POOLED DATA (CARDIGAN I AND II) POOLED DATA (CARDIGAN I AND II) ≥2-point improvement in HDSM-Ax-7 from GSP change from baseline to For personal use only baseline to end of treatment1 end of treatment1 80% SB = Sofpir
Slide 7: FDA Communication
FDA Communication Efficacy, safety and manufacturing all acceptable, one issue to address - paCent use instrucCons For personal use only v The only area iden-fied by FDA was related to the pa-ent Instruc(ons for Use v No efficacy, safety, or manufacturing issues were raised, and no addi-onal clinical stu
Slide 8: Instructions for Use revision – well advanced and on target
Instruc,ons for Use revision – well advanced and on target For personal use only v Revised the Instruc/ons For Use to further simplify the ✔ guidance for applica/on v Updated bottle label and carton to prominently display ✔ “wash hands with soap and water immediately after use” v Conducted a pilot h
Slide 9: Commercial preparation for Sofdra launch
For personal use only Commercial prepara,on for Sofdra™ launch 9 www.botanixpharma.com
Slide 10: Sofdra launch strategy
Sofdra™ launch strategy Rapidly establish Sofdra as a safe and effective first-line topical treatment of For personal use only primary axillary hyperhidrosis, in patients 9 years of age and older Drive dermatology adopCon through comprehensive engagement around a compelling clinical story Engage and
Slide 11: 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 INVASIVE PROCEDURES SURGERY PRODUCTS OTC ALUMINUM CHLORIDE BOTOX INJECTION CUTTING NERVES REFORMULATED ORAL DRUG INTO A SOLUTION CLINICAL
Slide 12: Drive adoption
DRIVE ADOPTION Engagement with dermatologists supported by nonpersonal tac,cs CLINICAL RE-PRINT WEBSITE JOURNAL AD BANNER ADS For personal use only Arm field force with data Support field force interac=ons through print/digital channels Ar=cle reprint with Provide full information on Print and digital
Slide 13: Engage & motivate
ENGAGE & MOTIVATE Engage consumers where they are already ac,ve Launch integrated DTC campaign to drive targeted awareness and moCvate paCents to take acCon; drive rapid uptake of prescripCons DIGITAL TRADITIONAL PR For personal use only Branded banner ads and updated website Customized branded bann
Slide 14: Maximize coverage
MAXIMIZE COVERAGE Ensuring favorable Payer coverage leading up to and post launch For personal use only Maximize coverage through strategic contracting Pre-Approval Period PDUFA–Launch Period Post-Launch Period Confirm anUcipated Payer Execute contracts Contract for Favorable Coverage management v Pr
Slide 15: Digital strategy—expands the addressable patient population
TELEHEALTH Digital strategy—expands the addressable pa,ent popula,on For personal use only US Hyperhidrosis Population ~336M Hyperhidrosis PaCents ~16.1M Potential to diagnose and treat Axillary Hyperhidrosis from home with telemedicine ~10M Patients Pa9ents already in dermatologist’s PaCents Seekin
Slide 16: Telehealth experience significantly speeds time to therapy
TELEHEALTH Telehealth experience significantly speeds ,me to therapy Within Minutes Same Day 48 Hours For personal use only AWARENESS INTEREST QUALIFY PAYMENT SCHEDULING CONSULT E-Rx FILL REFILL Pa.ent has Clicking Pa.ent Pa.ent Pa.ent Patient If appropriate Electronic Rx Pa.ent medical through from
Slide 17: Sales force
SALES FORCE Target most produc,ve prescribers & expand reach via digital For personal use only v Rapid scale-up of a new 20 - 30 rep field force to reach 4,500 high prescribing dermatologists v Top sales professionals identified v Recruiting ongoing for post approval start 17 www.botanixpharma.com
Slide 18: Focused pre-launch period ahead
Focused pre-launch period ahead v FDA submission on track for 1Q CY2024, with approval targeted for mid-CY2024 For personal use only v Only remaining issue to be addressed for FDA approval relates to pa-ent Instruc-ons for Use – no efficacy, safety or manufacturing issues v Commercial prepara-on accel
Slide 19: For personal use only
For personal use only www.botanixpharma.com
Botanix Pharmaceuticals — Shareholder Meeting (November 2023) on 6ix