Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Corporate Update (May 2024)
46 slides from Botanix Pharmaceuticals's corporate update, May 8, 2024
Slide 1: Botanix Webinar – Presentation Copy
8 May 2024 Botanix Webinar – Presentation Copy Philadelphia PA and Perth Australia, 8 May 2024: Clinical dermatology company, Botanix Pharmaceuticals Limited (ASX: BOT, “Botanix” or “the Company”), announces that it will be hosting a webinar this morning - Wednesday, 8 May commencing at 10:30am AEST
Slide 2: Cautionary Note on Forward-Looking Statements
The Company also has a pipeline of other products in late-stage clinical development for range of other dermatology conditions. To learn more please visit: http://www.botanixpharma.com/ For more information, please contact: General enquiries Investor enquiries Media enquiries Corporate Communication
Slide 3: Commercial Plan Sofdra
MAY 2024 W W W . B O T A N I X P H A R M A . C O M Commercial Plan Sofdra For personal use only
Slide 4: Notice and Disclaimer
Notice and 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 indicate
Slide 5: Botanix - accelerating towards commercialization of Sofdra
Botanix - accelerating towards commercialization of Sofdra™ For personal use only DERMATOLOGY FOCUS New treatments for underserved common skin diseases, with a first focus on excessive sweating (“primary axillary hyperhidrosis”) W W W . B O T A N I X P H A R M A . C O M Targeting key indications wit
Slide 6: Corporate Overview
Corporate Overview ASX: BOT TRADING INFORMATION For personal use only Share price A$0.275 6-month low / high A$0.12/0.275 W W W . B O T A N I X P H A R M A . C O M Shares outstanding 1,563,437,373 Market Capitalization A$430m Cash A$ 17.3m Debt Nil SUBSTANTIAL SHAREHOLDERS Shareholder % Antares Capi
Slide 7: Highly experienced board and management team
Highly experienced board and management team Developed, For personal use only secured approval for, and commercialized VINCE IPPOLITO HOWIE MCKIBBON DR PATRICIA WALKER MATT CALLAHAN W W W . B O T A N I X P H A R M A . C O M over 30 successful Executive Chairman • COO of Anacor and Medicis; Chief Exe
Slide 8: Experience across multiple therapeutic areas
6 For personal use only Experience across multiple therapeutic areas W W W . B O T A N I X P H A R M A . C O M
Slide 9: Patient Burden
For personal use only COMMERCIAL Patient DAY 2024 Burden
Slide 10: International Hyperhidrosis Society
International Hyperhidrosis Society For personal use only W W W . B O T A N I X P H A R M A . C O M LISA J PIERETTI, MBA Executive Director & Founding Member • Previously Director of Account Management at Medical Broadcasting Company, where she designed, developed, and executed integrated multi-chan
Slide 11: Hyperhidrosis: Significant unmet medical need
Hyperhidrosis: Significant unmet medical need Clinicians ranked hyperhidrosis last in their ability to successfully manage with available treatments For personal use only RANKING OF ABILITY TO SUCCESSFULLY MANAGE WITH AVAILABLE TREATMENT OPTIONS BY 25 SURVEYED DERMATOLOGISTS1 Atopic W W W . B O T A
Slide 12: Sofdra Overview
For personal use only COMMERCIAL Sofdra™ DAY 2024 Overview
Slide 13: Sofdra has a targeted mechanism of action
Sofdra™ has a targeted mechanism of action Binds selectively to M3 AC receptors, thereby blocking acetylcholine to inhibit sweat production, and then rapidly degrades for excretion For personal use only UNTREATED SWEAT GLAND TREATED SWEAT GLAND 11
Slide 14: Phase 3 pivotal program co-primary measures
Phase 3 pivotal program co-primary measures For personal use only Hyperhidrosis Disease Severity Measure-Axillary patient- Gravimetric Sweat Production (GSP) measure reported outcome measure (HDSM-Ax) § GSP was used for a co-primary endpoint and in composite § HDSM-Ax patient-reported outcome measur
Slide 15: In both Phase 3 studies, co-primary endpoints highly statistically significant
In both Phase 3 studies, co-primary endpoints were observed to be highly statistically significant ≥2-point improvement in HDSM-Ax GSP change from baseline from baseline to EOT to EOT1 For personal use only Pooled Data (Studies 1 & 2) Pooled Data (Studies 1 & 2) 80% Vehicle Sofdra p<0.0001 (n=348) (
Slide 16: Regulatory and manufacturing
For personal use only DAY 2024 COMMERCIAL manufacturing Regulatory and W W W . B O T A N I X P H A R M A . C O M
Slide 17: Instructions for Use revision - review being finalised with FDA
Instructions for Use revision - review being finalised with FDA For personal use only v Revised the Instruc/ons For Use to further simplify the ✔ guidance for applica/on v Updated bottle label and carton to prominently display W W W . B O T A N I X P H A R M A . C O M ✔ “wash hands with soap and wat
Slide 18: Manufacturing supplies and process settled
Manufacturing supplies and process settled Applicator Cap For personal use only (Japan) Pump & Applicator (France) W W W . B O T A N I X P H A R M A . C O M Translucent Bottle Drug Product CMO (Kitano, Japan) (Canada) Excipients (Various) Proposed packaging subject to FDA approval API CMO (Japan) 16
Slide 19: Eversana – our 3rd Party Logistics provider (3PL)
Eversana – our 3rd Party Logistics provider (3PL) For personal use only W W W . B O T A N I X P H A R M A . C O M Our 3PL partner can fulfill efficiently and cost-effectively: v managing inventory (including DSCSA1) v order-to-cash process (receiving POs from our customers, picking, packing and ship
Slide 20: Commercial Plan
For personal use only DAY 2024 COMMERCIAL Plan Commercial W W W . B O T A N I X P H A R M A . C O M
Slide 21: ~3.7M patients accessible by targeting derms, 6.3M via digital
~3.7M patients are accessible by targeting derms and an additional 6.3M are accessible via digital For personal use only ~336M US POPULATION W W W . B O T A N I X P H A R M A . C O M ~16.1M HYPERHIDROSIS PATIENTS Priority Targets PotenDal to diagnose and treat ~10M AXILLARY HYPERHIDROSIS PATIENTS fr
Slide 22: 85% of patients and dermatologists would use and prescribe Sofdra gel
85% of patients and dermatologists would use and prescribe Sofdra gel1 Significant opportunity exists for a new topical product to address unmet needs For personal use only “We are always looking for “I can count on one hand my more efficacious therapies The treatments that we have total armory for
Slide 23: Significant opportunity for a new topical agent with class leading efficacy and safety
Significant opportunity for a new topical agent with class leading efficacy and safety No new chemical entities were ever approved for hyperhidrosis For personal use only OLDER PRESCRIPTION ANTIPERSPIRANTS NEW CHEMICAL ENTITIES PRODUCTS INVASIVE PROCEDURES SURGERY W W W . B O T A N I X P H A R M A .
Slide 24: Dermatologists would start new patients on Sofdra gel
Research indicates dermatologists would start new patients on Sofdra gel in addition to moving existing patients CURRENT PRESCRIPTION PREFERENCES PROSPECTIVE PRESCRIPTION PREFERENCES For personal use only Share of Patients Receiving Treatments (1L) Share of Patients Receiving Treatments (1L) 100% 10
Slide 25: Sofdra gel launch strategy
Sofdra gel launch strategy For personal use only Rapidly Engage and Maximize Provide Drive Derm Hire and W W W . B O T A N I X P H A R M A . C O M establish Sofdra motivate reimbursement patient access adoption via train a highly gel as a safe patients to take and coverage and eliminate comprehensiv
Slide 26: Engage and Motivate Patients
For personal use only DAY 2024 COMMERCIAL Patients Motivate Engage and W W W . B O T A N I X P H A R M A . C O M
Slide 27: Drive impact across the patient experience and validate across channels
Drive impact across the patient experience and validate across channels For personal use only Turning Data Into Insights Lagging Business Leading Media and Lagging Business Impact KPIs: Impact KPIs: W W W . B O T A N I X P H A R M A . C O M Creative KPIs Audience Quality/ROI Brand Health NBRx Media
Slide 28: A data-centric approach activates our most valuable patient audiences
A data-centric approach allows us to activate our most valuable patient audiences cross-channel Google and DATA-DRIVEN For personal use only Microsoft HEALTHCARE Network TARGETING W W W . B O T A N I X P H A R M A . C O M HCP TARGET PATIENT LIST CONDITION Data-Driven, MODELS Addressable Health Effic
Slide 29: AI content targeting tells us more about audiences who care
AI content targeting tells us more about audiences who care and finds more like them I didn’t even realize a Dermatologist could treat this. WHERE THEY ARE For personal use only Social media as I guess it makes sense because of Gen Z 37k highly active sweat comes from the skin. a cornerstone members
Slide 30: Hone in on actual patients with AI social sentiment targeting
Hone in on actual patients during moments of sharing sweat stories with AI social sentiment targeting Engage 396,464+ highly qualified hyperhidrosis patients per month while they For personal use only are talking about their symptoms and personal journeys 1 SOCIAL POSTS/HASHTAGS 2 IMAGES/VIDEOS 3 AU
Slide 31: Reimbursement and coverage
For personal use only DAY 2024 COMMERCIAL and coverage Reimbursement W W W . B O T A N I X P H A R M A . C O M
Slide 32: What is reimbursement?
What is reimbursement? v In 2022 in the US1: 92.1% of people, or 304 million individuals had health insurance (65.6% private + 36.1% government2) For personal use only v Health insurance comes with a “medical benefit” that largely covers medical treatments3 and a W W W . B O T A N I X P H A R M A .
Slide 33: Sofdra reimbursement as a part of the overall process
Sofdra reimbursement as a part of the overall process For personal use only MCO reimbursement plus patient’s co-pay, W W W . B O T A N I X P H A R M A . C O M minus pharmacy fee 1 For commercial patients only 31
Slide 34: Key payer account prioritization and engagement timing
Key payer account prioritization and engagement timing Execute contracts with contracting PBMs and downstream clients in 2 phases Phase 1 Accounts Phase 2 Accounts For personal use only -- Zinc Health 35.1M CVS Federal Employees Health Benefit 5.5M Ascent Premera 1.1M Zinc Wellmark 950k Ascent Medic
Slide 35: Frictionless Access with Telemedicine and Fulfillment
For personal use only Frictionless W W W . B O T A N I X P H A R M A . C O M COMMERCIAL Access with DAY 2024 Telemedicine and Fulfillment
Slide 36: Telemedicine platforms are now a mainstream tool
Telemedicine platforms are now a mainstream tool for many companies in a wide range of indications Examples of Companies Partnering with Telemedicine Solutions For personal use only Migraine W W W . B O T A N I X P H A R M A . C O M Psychiatry Birth Control Diabetes Respiratory Pfizer: Nurtec ODT br
Slide 37: Telehealth is essential for new product commercialization
Telehealth is essential for new product commercialization and significantly speeds time to therapy, especially with clinical diagnoses like HH1 For personal use only WITHIN MINUTES SAME DAY 48 HOURS W W W . B O T A N I X P H A R M A . C O M AWARENESS INTEREST QUALIFY PAYMENT SCHEDULING CONSULT E-Rx
Slide 38: GetSofdra.com telehealth site powered by UpScript Health
GetSofdra.com telehealth site powered by For personal use only UpScript Health W W W . B O T A N I X P H A R M A . C O M Patients can reach GetSofdra.com via link from Sofdra.com or by organic search Patients are prompted to register and provide contact information up front to allow email follow-up
Slide 39: Drive Dermatology Adoption
For personal use only DAY 2024 COMMERCIAL Drive Adoption Dermatology W W W . B O T A N I X P H A R M A . C O M
Slide 40: Derm tactics are grounded in a compelling clinical story
Derm tactics are grounded in a compelling clinical story For personal use only W W W . B O T A N I X P H A R M A . C O M Field Force will be armed with Data Comprehensive tools will enable sales force to effectively convey the Sofdra gel story and provide opportunity for demonstration Quick & Clear
Slide 41: Bringing our data to life
For personal use only to life our data Bringing W W W . B O T A N I X P H A R M A . C O M
Slide 42: Sales force and market opportunity
For personal use only DAY 2024 COMMERCIAL market opportunity Sales force and W W W . B O T A N I X P H A R M A . C O M
Slide 43: Target most productive prescribers and expand reach via digital channels
Target most productive prescribers and expand reach via digital channels For personal use only v Identify doctors with greatest W W W . B O T A N I X P H A R M A . C O M potential for prescribing and reimbursement v Expand doctor reach using search, media, PR, social, influencers, key opinion leader
Slide 44: Sofpironium Bromide performance in Japan supports Sofdra commercial success
Sofpironium Bromide performance in Japan supports Sofdra commercial success For personal use only Mitigation of Commercial & Clinical Risk v ~ 350,000 units of Ecclock sold by Kaken in the last W W W . B O T A N I X P H A R M A . C O M 12 months v The incidence and prevalence of hyperhidrosis in Jap
Slide 45: In Summary
For personal use only DAY 2024 COMMERCIAL In Summary W W W . B O T A N I X P H A R M A . C O M
Slide 46: Botanix is rapidly preparing to launch Sofdra gel
Botanix is rapidly preparing to launch Sofdra gel Scale & Prepare the Product Availability Product Access Medical & Regulatory Sales & Marketing For personal use only Organization ✓ Executive team ☐ ✓ Contract manufacturer ☐ ✓ Payer strategy ☐ ✓ MIS/AE vendor ☐ ✓ Ad Agency ☐ ✓ Infrastructure ☐ ✓ Ser
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