Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Presentation (October 2023)
26 slides from Botanix Pharmaceuticals's investor presentation, Oct 31, 2023
Slide 1: Investor Presentation and Investor Meetings
31 October 2023 Investor Presentation and Investor Meetings Philadelphia and Phoenix US, 31 October 2023: Clinical dermatology company, Botanix Pharmaceuticals Limited (ASX: BOT, “Botanix” or “the Company”), is pleased to provide a copy of its updated investor presentation as attached to this releas
Slide 2: For more information, please contact
For more information, please contact: General enquiries Investor enquiries Media enquiries Corporate Communications Hannah Howlett Haley Chartres Botanix Pharmaceuticals WE Communications H^CK P: +61 8 6555 2945 P: +61 450 648 064 P: +61 423 139 163 investors@botanixpharma.com hhowlett@we-worldwide.
Slide 3: Investor Update
Investor Update October 2023 www.botanixpharma.com
Slide 4: 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 5: Botanix – Accelerating towards commercialization of SOFDRA
Botanix – Accelerating towards commercialization of SOFDRA™️ New treatments for underserved common skin diseases, with a first focus DERMATOLOGY FOCUS on excessive sweating (“primary axillary hyperhidrosis”) Targeting key indications with topical (gel) treatments that are safe, well TOPICALLY DRIVEN
Slide 6: World class board and management team
World class board and management team Developed, secured approval for and commercialised over 30 successful dermatology products VINCE IPPOLITO HOWIE MCKIBBON DR PATRICIA WALKER MATT CALLAHAN Executive Chairman Chief Executive Officer Chief Medical Adviser Board Executive Director • COO of Anacor an
Slide 7: Corporate Overview
Corporate Overview Well-funded to FDA approval, supported by leading life science institutional investors ASX: BOT TRADING INFORMATION Share price A$0.14 6-month low / high A$0.052/0.21 Shares outstanding 1,421,196,813 Market Capitalization A$199m 14.0 Cash (30 Sep 2022) A$ 6.8m Debt (30 Sep 2022) N
Slide 8: Hyperhidrosis
Hyperhidrosis A medical condition where excessive 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 axillary (underarm)
Slide 9: Sofdra mechanism of action
Sofdra™️ mechanism of action Blocks sweat gland receptors and rapidly degrades for excretion UNTREATED SWEAT GLAND TREATED SWEAT GLAND 7
Slide 10: Both Phase 3 clinical study co-primary endpoints were highly statistically significant
Both Phase 3 clinical study co-primary endpoints were highly statistically 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 baseline to end of treatment1 end of treatment1 80% SB = Sofpironium Bromide Vehic
Slide 11: FDA Communication
FDA Communication Efficacy, safety and manufacturing all acceptable, one issue to address - patient use instructions ❖ The only area identified by FDA was related to the patient Instructions for Use ❖ No efficacy, safety, or manufacturing issues were raised, and no additional clinical studies are re
Slide 12: Instructions for Use revision – well advanced and on target
Instructions for Use revision – well advanced and on target ❖ Revised the Instructions For Use to further simplify the ✔️ guidance for application ❖ Updated bottle label and carton to prominently display ✔️ “wash hands with soap and water immediately after use” ❖ Conducted a pilot human factors stud
Slide 13: Commercial preparation for Sofdra launch
Commercial preparation for Sofdra™️ launch 11 www.botanixpharma.com
Slide 14: Sofdra launch strategy
Sofdra™️ launch strategy Rapidly establish Sofdra as a safe and effective first-line topical treatment of primary axillary hyperhidrosis, in patients 9 years of age and older Drive dermatology adoption through comprehensive engagement around a compelling clinical story Engage and motivate patients t
Slide 15: Drive Adoption: significant opportunity for a new topical agent
DRIVE ADOPTION Significant opportunity for a new topical agent with class leading efficacy and safety OLDER PRESCRIPTION ANTIPERSPIRANTS NEW CHEMICAL ENTITIES PRODUCTS INVASIVE PROCEDURES SURGERY BOTOX OTC ALUMINUM CHLORIDE CUTTING NERVES INJECTION REFORMULATED ORAL DRUG INTO A SOLUTION CLINICAL STR
Slide 16: Drive Adoption: tactics grounded on tested product position
DRIVE ADOPTION Tactics grounded on tested product position and messages DRAFT HIGH-LEVEL STORY FLOW CORE VISUAL AID New product for HH – New MOA Approved Efficacy Approved Safety Approved Use Long Term Safety Patient Preference for Use Accessible to patients eDetail format 14 www.botanixpharma.com
Slide 17: Drive Adoption: sales force conveys story and provides trial
DRIVE ADOPTION Sales force effectively convey story & provide opportunity for trial eDETAIL WITH MOA ANIMATION PLACEBO DEMO AND VIDEO DEMO Digital platform to contain approved information to Aim to provide placebo product for every sales facilitate field force communication with physicians represent
Slide 18: Drive Adoption: engagement with dermatologists via nonpersonal tactics
DRIVE ADOPTION Engagement with dermatologists supported by nonpersonal tactics CLINICAL RE-PRINT WEBSITE JOURNAL AD BANNER ADS Arm field force with data Support field force interactions through print/digital channels Article reprint with Provide full information on Print and digital journal Strategi
Slide 19: Engage & Motivate: information across multiple platforms
ENGAGE & MOTIVATE Tactics will provide information across multiple platforms Drive awareness of approval and provide resources to patients seeking further information PR “Now Approved” website SEO, SEM Opt-Ins NAME Yes, tell me when NAME gel is available Let me know when I can use telemedicine Send
Slide 20: Engage & Motivate: engage consumers where they are active
ENGAGE & MOTIVATE Engage consumers where they are already active Launch integrated DTC campaign to drive targeted awareness and motivate patients to take action; drive rapid uptake of prescriptions DIGITAL TRADITIONAL PR Branded banner ads and updated website Customized branded banner ads that drive
Slide 21: Maximize Coverage: favorable payer coverage
MAXIMIZE COVERAGE Ensuring favorable Payer coverage leading up to and post launch Maximize coverage through strategic contracting Pre-Approval Period PDUFA–Launch Period Post-Launch Period Confirm anticipated Payer Execute contracts Contract for Favorable Coverage management ❖ Pricing and Product Fa
Slide 22: Telehealth: digital strategy expands addressable patient population
TELEHEALTH Digital strategy—expands the addressable patient population US Hyperhidrosis Population ~336M Hyperhidrosis Patients ~16.1M Potential to diagnose and treat Axillary Hyperhidrosis from home with telemedicine ~10M Patients Patients already in dermatologist’s Patients Seeking ~3.7M office th
Slide 23: Telehealth experience significantly speeds time to therapy
TELEHEALTH Telehealth experience significantly speeds time to therapy Within Minutes Same Day 48 Hours AWARENESS INTEREST QUALIFY PAYMENT SCHEDULING CONSULT E-Rx FILL REFILL Patient has Clicking Patient Patient Patient Patient If appropriate Electronic Rx Patient medical through from completes a pro
Slide 24: Sales Force
SALES FORCE Target most productive prescribers & expand reach via digital ❖ Rapid scale-up of a new 20 - 30 rep field force to reach 4,500 high prescribing dermatologists ❖ Top sales professionals identified ❖ Recruiting ongoing for post approval start 22 www.botanixpharma.com
Slide 25: Focused pre-launch period ahead
Focused pre-launch period ahead ❖ FDA submission on track for 1Q CY2024, with approval targeted for mid-CY2024 ❖ Only remaining issue to be addressed for FDA approval relates to patient Instructions for Use – no efficacy, safety or manufacturing issues ❖ Commercial preparation accelerating, given de
Slide 26: Investor Update
Investor Update October 2023 www.botanixpharma.com
Botanix Pharmaceuticals — Investor Presentation (October 2023) on 6ix