Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Presentation (January 2023)
18 slides from Botanix Pharmaceuticals's investor presentation, Jan 31, 2023
Slide 1: Investor Presentation and Video
31 January 2023 Investor Presentation and Video 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 a focus on the mid-cycle review meeting scheduled for this quarter
Slide 2: Contacts and Cautionary Note on Forward-Looking Statements
respectively. Botanix is also developing a topical antimicrobial product for the eradication of bacteria on the skin surface, initially in patients who are undergoing hemodialysis. To learn more please visit: http://www.botanixpharma.com/ For personal use only For more information, please contact: G
Slide 3: Investor Update January 2023
Investor For personal use only Update January 2023 Preparing for FDA mid-cycle review of Sofpironium Bromide in Q1 2023 1
Slide 4: Botanix: a leader in topical dermatology development
Dermatology 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 (gel) treatments that are safe, well tolerated an
Slide 5: World class board and management team
Developed, secured approval World class board and for and commercialised over 30 management team successful dermatology products For personal use only VINCE IPPOLITO HOWIE MCKIBBON DR PATRICIA WALKER MATT CALLAHAN Executive Chairman Chief Operating Officer Chief Medical Adviser Board Executive Direc
Slide 6: Corporate Overview
Corporate Modest market cap for a Overview company with a Phase 3 asset under FDA review For personal use only ASX: BOT TRADING INFORMATION Share price A$0.057 6-month low / high A$0.052/0.095 SHARE PRICE PERFORMANCE Shares outstanding 1,187,481,068 Market Capitalisation A$67.7m Cash (31 Dec 2022) A
Slide 7: Value inflection points accrue as FDA review progresses
Positive efficacy data for both co-primary ✔ Phase 3 Clinical Studies endpoints and positive extended safety For personal use only ✔ Completion of NDA submission NDA submission to FDA assembling all pre-clinical, clinical and manufacturing information for review Confirmation that the file is substan
Slide 8: 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 US:1 • Results from overstimulation of the nervous system (a physiological not psychological condition)1 • 90% of
Slide 9: Sofpironium Bromide mechanism of action
Sofpironium Bromide Blocks sweat gland receptors and mechanism of action rapidly degrades for excretion For personal use only 7
Slide 10: Both Phase 3 co-primary endpoints highly statistically significant
Both Phase 3 clinical study co-primary endpoints were highly statistically significant 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 from baseline to end of treatment1 end of treatment1 80% Vehicle
Slide 11: Secondary efficacy endpoint: HDSM-Ax-7 reduction
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% Secondary 60% Efficacy Responders Endpoint: 40% % 20% Almost 85% of patients experienced a statistically 0% Vehicle SB 15% significant and
Slide 12: 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 Reformulated oral drug into Heat
Slide 13: US market opportunity for hyperhidrosis
US 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%
Slide 14: Independent market research shows 85% would use and prescribe
Independent market research shows 85% of patients and dermatologists would use and prescribe Sofpironium Bromide For personal use only Stakeholders indicated the top two unmet needs are as follows: 1) New treatment options (i.e., limited options) and 2) and More efficacious treatments without access
Slide 15: Dermatologists would start new patients on Sofpironium Bromide
Research indicates dermatologists would start new patients on Sofpironium Bromide in addition to moving existing patients For personal use only Current Prescription Preferences Prospective Prescription Preferences Share of Patients Receiving Treatments (1L) Share of Patients Receiving Treatments (1L
Slide 16: Japan approval de-risks FDA approval and supports commercial success
Sofpironium Bromide approval in Japan de-risks FDA approval and supports commercial success For personal use only Mitigation of Commercial & Clinical Risk Clinical & Regulatory • Japanese approval paired with strong Phase 3 clinical trial results in the U.S. help to support safety and efficacy and d
Slide 17: Executing on planned commercial and regulatory milestones
Executing on planned commercial and regulatory milestones For personal use only Calendar year NDA submission Day 74 Mid-cycle FDA complete letter review approval 3Q 2022 ✔ December 2022 ✔ 1Q 2023 3Q 2023 15
Slide 18: 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
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