Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Non-Deal Roadshow (July 2022)
27 slides from Botanix Pharmaceuticals's roadshow presentation, Jul 12, 2022
Slide 1: Updated Investor Presentation: Key highlights
12 July 2022 Updated Investor Presentation Key highlights For personal use only • Release of updated corporate presentation to be used in a number of non-deal investor meetings scheduled this week • The presentation includes: o an update on the accelerated FDA submission timetable of the New Drug Ap
Slide 2: Contacts and Cautionary Note on Forward-Looking Statements
Botanix leverages its proprietary drug delivery system (PermetrexTM) for direct skin delivery of active pharmaceuticals in all skin diseases, which is utilised in its existing development programs and is being explored with a view to being utilized in a number of other product opportunities. To lear
Slide 3: Investor Update July 2022
Investor For personal use only Update July 2022 Preparing to file first dermatology product for FDA approval in Q3 2022 1
Slide 4: Botanix: a leader in topical dermatology development
Pharmaceutical focus New treatments for common skin diseases - such as excessive sweating (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 v
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 Positioned to transition to Overview commercial dermatology For personal use only company SHARE PRICE PERFORMANCE ASX: BOT TRADING INFORMATION Share price A$0.07 6-month low / high A$0.052/0.095 Shares outstanding 979,233,384 Market Capitalisation A$68.5m Cash (31 Mar 2022) A$ 16.4m Debt (
Slide 7: Sofpironium Bromide leads late-stage pipeline
Sofpironium Bromide leads late-stage pipeline Planned for FDA filing in 3Q 2022 with 12-month review period For personal use only INDICATION PRODUCT PHASE 1 PHASE 1B PHASE 2 PHASE 3 APPROVED STATUS (CY) Axillary Hyperhidrosis Sofprionium (excessive underarm FDA approval filing Bromide sweating) plan
Slide 8: Target markets with significant US patient numbers and high unmet needs
Target markets with significant US patient numbers and high unmet needs For personal use only Rosacea Antimicrobial 100k patients 16M patients SPECIALISED/ $1.9bn $0.5bn DERMATOLOGISTS Sales 1 Sales2 Hyperhidrosis 16M people Atopic Dermatitis $1.6bn 20M patients Sales3 US Prescriber Base $20bn Sales
Slide 9: Sofpironium Bromide
For personal use only Bromide Sofpironium
Slide 10: Accelerating Botanix towards revenue generation
Addressing unmet needs Accelerating First and only new chemical entity for “primary axillary Botanix towards hyperhidrosis” For personal use only revenue generation Positive Phase 3 Data All co-primary and secondary endpoints were statistically significant and side effects were mild to moderate with
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 ~16M people in the US1: • Results from overstimulation of the nervous system (a physiological not psychological condition)1 • 90% 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% experienced a statistically Vehicle (n=325) SB 15% (n=319)
Slide 15: Hyperhidrosis treatment continuum
Hyperhidrosis No new chemical entities have been 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 Strength oral drug into
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: Market opportunity for hyperhidrosis
Market opportunity for Even a modest market share provides a hyperhidrosis1 significant financial opportunity For personal use only 336,107m USA population Share of patients already Patients Potential gross seeking treatment sales* 16.1m Hyperhidrosis patients 0.5% 18,500 $144,300,000 11.2m 1.0% 36,
Slide 18: Focused prescriber base enables a cost-effective launch
Focused prescriber base and active patients enables a cost-effective launch For personal use only Geographic Spread of Patient Claims Data for Hyperhidrosis Efficiently target and extend reach • The majority of dermatologists can be covered with a very small sales force • A regionally targeted digit
Slide 19: Kaken partnership – Japan and Asia
Kaken partnership – Sofpironium Bromide is already Japan and Asia approved in Japan and has For personal use only recently been launched Kaken is a leading specialty Kaken has rights to sofpironium pharmaceutical company ~US$1.26B bromide in Japan, Korea, China & Market Cap Net Sales of $660M (FY202
Slide 20: Key Upcoming Milestones
Key Upcoming Milestones For personal use only Rapid pathway to approval and revenue • NDA submission • Commercial manufacturing for approval for launch • Targeted FDA approval 1H 2022 3Q 2022 1H 2023 3Q 2023 Expected Timing (calendar Pre Submission meeting • Sale force and market prep year) with FDA
Slide 21: Pipeline dermatology programs
For personal use only Pipeline dermatology programs
Slide 22: BTX 1702: Rosacea Phase 1b/2 study fully recruited
BTX 1702: Rosacea Phase Study completion targeted for 3Q 2022 1b/2 study fully recruited For personal use only Study Three dose groups, ~120 patients: • Papulopustular rosacea Details - BTX 1702 high dose - twice daily: 40 patients is a highly visible chronic - BTX 1702 low dose - twice daily: 40 pa
Slide 23: BTX 1801: Phase 2 study preparing to launch in 2H 2022
BTX 1801: Phase 2 study preparing to Targeting nasal decolonisation of Staph aureus in launch in 2H 2022 patients undergoing haemodialysis to reduce For personal use only incidence of life threatening blood stream infections PROOF OF CONCEPT PhaseCANINE 2 study 9-week FDA incentives provide accelera
Slide 24: Executing on key commercial and clinical milestones
Executing on key commercial and clinical milestones For personal use only Calendar year Sofpironium Rosacea Dermatitis Antimicrobial Acne Bromide BTX 1702 BTX 1204A BTX 1801 BTX 1503 FDA filing for Enrolment Enrolment Phase 2 study Study start pending approval in complete, complete, preparing to com
Slide 25: 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 26: Sofpironium Bromide IP and regulatory summary
Sofpironium Bromide IP Protected by strong IP in the US and regulatory summary and other major global markets and For personal use only expecting strong regulatory exclusivity COMPOSITION OF MATTER METHOD OF DOSING • US patent issued with claims covering compounds, compositions, • US patent issued w
Slide 27: Opportunities for expansion with Sofpironium Bromide
Opportunities for Can be approved for other distinct expansion with body areas, using Permetrex™ Sofpironium Bromide For personal use only and new delivery devices US HH SUFFERERS BY BODY AREA 1 OTHER OPPORTUNITIES (% OCCURRENCE) HEAD - 42% Indication expansion • New indications for treatment of pal
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