Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Shareholder Meeting (November 2022)
17 slides from Botanix Pharmaceuticals's shareholder meeting presentation, Nov 23, 2022
Slide 1: Investor Update AGM November 2022
Investor For personal use only Update AGM November 2022 Preparing for FDA approval of first product in 3Q 2022 1
Slide 2: Botanix: a leader in topical drug 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 World class team US based team that have been responsible for more than 30 dermatology drug developments
Slide 3: Corporate Overview
Corporate Modest market cap for a Overview company with a Phase 3 asset pending FDA approval For personal use only ASX: BOT TRADING INFORMATION Share price A$0.063 6-month low / high A$0.056/0.077 SHARE PRICE PERFORMANCE Shares outstanding 1,156,011,477 BOT Market Capitalisation A$72.8m Cash (30 Sep
Slide 4: Sofpironium Bromide leads late-stage pipeline
Sofpironium Bromide leads late-stage pipeline Filed for FDA approval 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 5: Sofpironium Bromide
For personal use only Bromide Sofpironium
Slide 6: Recap – NDA filed for Sofpironium Bromide in 3Q 2022
Addressing unmet needs Recap – NDA filed First and only new chemical entity for “primary axillary for Sofpironium hyperhidrosis” For personal use only Bromide in 3Q 2022 Positive Phase 3 Data All co-primary and secondary endpoints were statistically significant with no treatment-related serious adve
Slide 7: Significant unmet need for new hyperhidrosis treatments
Significant unmet need for new hyperhidrosis Few options that are effective and treatments affordable for patients 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 acce
Slide 8: Confirmation of first and second line treatment usage
Confirmation of first and second line treatment usage For personal use only Hyperhidrosis Current Treatment First-Line Second Line Initial Presentation (1L) Failure of 1L Third-Line & (2L) to Dermatologist Therapy Beyond Physician- OTC Topical Rx Topical Patients Failing Qbrexza Miradry Reported2 An
Slide 9: SB is positioned to largely displace other topical products
SB is positioned to largely displace other Both first line and second line topical products prescription preferences favor SB For personal use only Dermatologist Treatment Preferences and Anticipated Future SBG Prescribing 9 *Share of patients by treatment type shows a weighted average across severi
Slide 10: 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 11: Pipeline dermatology programs
For personal use only Pipeline dermatology programs
Slide 12: BTX 1702 Rosacea Clinical Study
Positive Phase 1b/2 study BTX 1702 Randomised, double blind, controlled Phase 1b/2 clinical study in 133 subjects, with moderate to severe papulopustular rosacea Rosacea For personal use only Clinical Study Safe and well tolerated No serious adverse events in any arm of the study, with the 10% BTX 1
Slide 13: Limitations of current therapeutic options
Limitations of current therapeutic options For personal use only Oracea Rhofade Finacea MetroCream Soolantra (oral Antibiotic) (α-1A adrenergic agonist) (azelaic acid) (Metronidazole) (Ivermectin) Application site Resistance reactions Application site Rebound erythema Application site Limi
Slide 14: Example patient images from BTX 1702 10% arm
Example patient images from Clear visual improvements and key BTX 1702 10% arm tool for future studies For personal use only Baseline Day 57 BTX 1702 - 10% Baseline Day 57 Reduction in inflammatory lesions and improvements in redness, shown for moderate and severe patient examples 14 14
Slide 15: Example patient images from vehicle arm
Example patient images from vehicle arm For personal use only Baseline Day 57 Vehicle Baseline Day 57 No noticeable reduction in lesions or improvements in redness 15 15
Slide 16: 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 March 2023 3Q 2023 16
Slide 17: 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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