Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Non-Deal Roadshow (May 2022)
29 slides from Botanix Pharmaceuticals's roadshow presentation, May 16, 2022
Slide 1: Investor Presentation - Key highlights
16 May 2022 Investor Presentation Key highlights For personal use only • Release of updated corporate presentation for Botanix’s non-deal investor roadshow this week • The presentation includes recap of the recent acquisition of Sofpironium Bromide, which has positive Phase 3 data and is being prepa
Slide 2: Cautionary Note on Forward-Looking Statements
explored with a view to being utilized in a number of other product opportunities. To learn more please visit: http://www.botanixpharma.com/ For personal use only For more information, please contact: General enquiries Investor enquiries Media enquiries Corporate Communications Hannah Howlett Haley
Slide 3: Investor Update May 2022
Investor For personal use only Update May 2022 Transforming into a commercial stage dermatology company 1
Slide 4: Botanix: a leader in topical dermatology drug development
Pharmaceutical focus New treatments for common skin diseases - such as hyperhidrosis, rosacea and acne – as well as life-threatening bacterial infections For personal use only Topically driven Targeting key indications with topical treatments that are safe, well tolerated and validated by clinical e
Slide 5: World class board and management team
Developed, secured approval World class board and for and commercialised over 30 management team dermatology products For personal use only VINCE IPPOLITO HOWIE MCKIBBON DR PATRICIA WALKER MATT CALLAHAN DR BILL BOSCH President and Executive Chairman Chief Commercial Officer Chief Medical Adviser Boa
Slide 6: Corporate Overview
Corporate Well funded and positioned Overview to transition to commercial For personal use only dermatology company SHARE PRICE PERFORMANCE ASX: BOT TRADING INFORMATION Share price A$0.077 6-month low / high A$0.061/0.115 Shares outstanding 973,142,074 Market Capitalisation A$74.9m Cash (31 Mar 2022
Slide 7: New acquisition complements existing pipeline
New acquisition Accelerates revenue generation, (Sofpironium Bromide) M&A opportunities and adds complements existing pipeline dermatology indication For personal use only INDICATION PRODUCT PHASE 1 PHASE 1B PHASE 2 PHASE 3 APPROVED STATUS Axillary Hyperhidrosis Sofprionium FDA approval filing (exce
Slide 8: Target markets with significant annual revenues and high unmet needs
Target markets with significant annual revenues and high unmet needs For personal use only Rosacea Antimicrobial 100k patients 16M patients SPECIALISED/ $1.9bn $0.5bn DERMATOLOGISTS Sales2 Sales 1 Atopic Dermatitis Hyperhidrosis 20M patients 15M people US Prescriber Base $20bn $1.6bn Sales3 1 Sales
Slide 9: Sofpironium Bromide
For personal use only Bromide Sofpironium
Slide 10: Sofpironium Bromide: Accelerating Botanix towards revenue generation
Sofpironium Bromide Accelerating First and only new chemical entity for “primary axillary hyperhidrosis” (a medical condition which results in Botanix towards excessive underarm sweating) For personal use only revenue generation Positive Phase 3 Data All co-primary and secondary endpoints statistica
Slide 11: Hyperhidrosis
Hyperhidrosis A medical condition where excessive For personal use only sweating occurs beyond what is needed to maintain normal body temperature Hyperhidrosis affects ~15M people in the US1: • Results from overstimulation of the nervous system (a physiological not psychological condition)1 • 80% of
Slide 12: Sofpironium Bromide mechanism of action
Sofpironium Bromide mechanism of action Blocks sweat gland receptors and rapidly degrades for excretion For personal use only 10
Slide 13: Phase 3 co-primary endpoints highly statistically significant
Phase 3 co-primary Measured reduction in Gravimetric endpoints - highly Sweat Production (GSP) and statistically significant HDSM-Ax-7 scale responses For personal use only Pooled Data (Cardigan I and II) Pooled Data (Cardigan I and II) ≥2-point improvement in HDSM-Ax-7 GSP change from baseline to f
Slide 14: Secondary efficacy endpoint
Pooled Data (Cardigan I and II) HDSM-Ax-7 reduction (≥1-point improvement) from baseline to end of treatment1 For personal use only 100% p=0.0002 80% 84.6% 72.3% 60% Responders Secondary 40% Efficacy % Endpoint: 20% Almost 85% of patients 0% Vehicle SB15% experienced a statistically (n=325) (n=319)
Slide 15: Hyperhidrosis treatment continuum
Hyperhidrosis No new chemical entities ever treatment continuum approved for hyperhidrosis For personal use only OLDER PRESCRIPTION ANTIPERSPIRANTS INVASIVE PROCEDURES SURGERY PRODUCTS OTC Aluminum Botox Cutting Chloride injection Nerves Clinical Reformulated Heat energy oral drug into device Streng
Slide 16: Significant opportunity for a new topical agent
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 Aluminum Botox Cutting OTC Chloride injection Nerves Sofpironium Clinical Bromide Reformulated or
Slide 17: Key Upcoming Milestones
Key Upcoming Milestones For personal use only Rapid pathway to approval and revenue • Commercial manufacturing • NDA submission for approval for launch • Day 74 review letter from FDA • FDA approval 1H 2022 2H 2022 1H 2023 2H 2023 Expected Timing Pre Submission meeting • FDA feedback on proposed wit
Slide 18: Cannabinoid dermatology programs
For personal use only Cannabinoid dermatology programs
Slide 19: Synthetic cannabinoids are well suited to treat skin diseases and infections
Synthetic cannabinoids are well suited to treat skin diseases and infections For personal use only Botanix’s studies show that synthetic cannabidiol: 1 ü is safe and well tolerated ü has broad anti-inflammatory properties ü has a strong and consistent impact on skin lesions ü has antimicrobial prope
Slide 20: BTX 1702: high impact of rosacea and significant market opportunity
BTX 1702: high impact of rosacea on patients and significant market opportunity For personal use only • Papulopustular rosacea A rapidly growing market: is a highly visible chronic Rosacea market projected to grow skin disease to US$2.6bn by 20253 characterised by redness US $2.6bn (inflammation) an
Slide 21: BTX 1702: Rosacea Phase 1b/2 study is almost fully recruited
BTX 1702: Rosacea Phase 1b/2 study is almost fully Improved data capture design with dose recruited ranging over 8 week treatment period For personal use only Study Three dose groups, ~120 patients: Details - BTX 1702 high dose - twice daily: 40 patients - BTX 1702 low dose - twice daily: 40 patient
Slide 22: BTX 1204A: Atopic dermatitis canine study
BTX 1204A: Canine study, will inform licensing in animal Atopic dermatitis health and potential launch of late-stage For personal use only Phase 2b human clinical program PROOF OF CONCEPT PLANNED PATHWAY TO APPROVAL CANINE STUDY Canine Pilot Study Canine POC Study Partnering Reductions in itch Study
Slide 23: BTX 1503: Acne in preparation for Phase 3
BTX 1503: Acne in preparation for Phase 3 Successful End-of-Phase 2 FDA meeting and completion of rosacea BTX 1702 study will and future filing For personal use only inform final design for Phase 3 acne study DEVELOPMENT UPDATE SIZEABLE ACNE PRESCRIPTION MARKET End of Phase 2 meeting with FDA succes
Slide 24: Cannabinoid antimicrobial programs
For personal use only Cannabinoid antimicrobial programs
Slide 25: BTX 1801 demonstrated clinical efficacy vs Staph aureus in Phase 2a study
Staphylococcus aureus (Staph aureus or ‘staph’) is a common bacterium that lives on skin and in nasal passages. It can cause skin infection and serious or life- threatening blood stream infections, pneumonia or bone and joint infections For personal use only Efficacy of ointment and gel formulations
Slide 26: BTX 1801: Haemodialysis patients at risk of bloodstream infections
BTX 1801: Haemodialysis patients with central venous catheters at risk of bloodstream infections For personal use only Replicates the functions of the kidneys in patients with kidney Haemodialysis failure, by using a machine to filter and clean the blood Rationale for Infection is a leading cause of
Slide 27: BTX 1801: Phase 2 study preparing to launch in 2Q 2022
BTX 1801: Phase 2 study preparing to Targeting nasal decolonisation of Staph in patients launch in 2Q 2022 undergoing haemodialysis to reduce incidence of For personal use only life threatening blood stream infections PROOF OF CONCEPT PhaseCANINE 2 study 9-week FDA incentives provide accelerated STU
Slide 28: Executing on key commercial and clinical milestones
Executing on key commercial and clinical milestones For personal use only Rosacea Dermatitis Antimicrobial Acne Sofpironium BTX 1702 BTX 1204A BTX 1801 BTX 1503 Bromide Enrolment almost Enrolment Phase 2 study Study start pending FDA filing for complete, complete 2Q 2022, start end 2Q completion of
Slide 29: 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
Botanix Pharmaceuticals — Non-Deal Roadshow (May 2022) on 6ix