Botanix Pharmaceuticals Limited · ASX:BOT
Botanix Pharmaceuticals — Investor Day (May 2024)
44 slides from Botanix Pharmaceuticals's investor day presentation, May 2024
Slide 1: 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
Slide 2: 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 3: Botanix - accelerating towards commercialization of Sofdra
Botanix - accelerating towards commercialization of Sofdra™ 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 with topical (gel) treatm
Slide 4: Corporate Overview
Corporate Overview ASX: BOT TRADING INFORMATION 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 Capital 9.0% Board and Man
Slide 5: Highly experienced board and management team
Highly experienced board and management team Developed, 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 Executive Officer Chief M
Slide 6: Experience across multiple therapeutic areas
Experience across multiple therapeutic areas W W W . B O T A N I X P H A R M A . C O M 6
Slide 7: Patient Burden
COMMERCIAL Patient DAY 2024 Burden
Slide 8: International Hyperhidrosis Society
International Hyperhidrosis Society 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-channel strategic marketin
Slide 9: Hyperhidrosis: Significant unmet medical need
Hyperhidrosis: Significant unmet medical need Clinicians ranked hyperhidrosis last in their ability to successfully manage with available treatments RANKING OF ABILITY TO SUCCESSFULLY MANAGE WITH AVAILABLE TREATMENT OPTIONS BY 25 SURVEYED DERMATOLOGISTS1 Atopic W W W . B O T A N I X P H A R M A . C
Slide 10: Sofdra Overview
COMMERCIAL Sofdra™ DAY 2024 Overview
Slide 11: 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 UNTREATED SWEAT GLAND TREATED SWEAT GLAND 11
Slide 12: Phase 3 pivotal program co-primary measures
Phase 3 pivotal program co-primary measures 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 measure was used for seconda
Slide 13: Co-primary endpoints highly statistically significant in both Phase 3 studies
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 Pooled Data (Studies 1 & 2) Pooled Data (Studies 1 & 2) 80% Vehicle Sofdra p<0.0001 (n=348) (n=353) 70% 0 W W W . B
Slide 14: Regulatory and manufacturing
W W W . B O T A N I X P H A R M A . C O M COMMERCIAL DAY Regulatory and 2024 manufacturing
Slide 15: Instructions for Use revision - review being finalised with FDA
Instructions for Use revision - review being finalised with FDA 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 water immediately after u
Slide 16: Manufacturing supplies and process settled
Manufacturing supplies and process settled Applicator Cap (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 17: Eversana – our 3rd Party Logistics provider (3PL)
Eversana – our 3rd Party Logistics provider (3PL) 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 shipping product, invoicin
Slide 18: Commercial Plan
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 19: ~3.7M patients accessible via dermatologists, 6.3M more via digital
~3.7M patients are accessible by targeting derms and an additional 6.3M are accessible via digital ~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 from home with telemedic
Slide 20: 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 “We are always looking for “I can count on one hand my more efficacious therapies The treatments that we have total armory for treating that are easi
Slide 21: 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 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 . C O M OTC ALUMINUM CH
Slide 22: 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 Share of Patients Receiving Treatments (1L) Share of Patients Receiving Treatments (1L) 100% 100% 80% 80% 59% FIRST L
Slide 23: Sofdra gel launch strategy
Sofdra gel launch strategy 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 comprehensive effective Sales and
Slide 24: Engage and Motivate Patients
W W W . B O T A N I X P H A R M A . C O M COMMERCIAL Engage and DAY 2024 Motivate Patients
Slide 25: Drive impact across the patient experience and validate across channels
Drive impact across the patient experience and validate across channels 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 and Website Attitudina
Slide 26: Data-centric approach to activate valuable patient audiences cross-channel
A data-centric approach allows us to activate our most valuable patient audiences cross-channel Google and DATA-DRIVEN 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 Efficient Scale Environment
Slide 27: 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 Social media as I guess it makes sense because of Gen Z 37k highly active sweat comes from the skin. a cornerstone members on Reddit 92% - Chloe
Slide 28: 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 are talking about their symptoms and personal journeys 1 SOCIAL POSTS/HASHTAGS 2 IMAGES/VIDEOS 3 AUDIO RECOGNITION W W W
Slide 29: Reimbursement and coverage
W W W . B O T A N I X P H A R M A . C O M COMMERCIAL DAY Reimbursement 2024 and coverage
Slide 30: 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) 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 . C O M “pharmacy benefi
Slide 31: Sofdra reimbursement as a part of the overall process
Sofdra reimbursement as a part of the overall process 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 32: 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 -- Zinc Health 35.1M CVS Federal Employees Health Benefit 5.5M Ascent Premera 1.1M Zinc Wellmark 950k Ascent Medical Mutual OH 560k -- C
Slide 33: Frictionless Access with Telemedicine and Fulfillment
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 34: 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 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 brand.com page, with lin
Slide 35: 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 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 FILL REFILL Patient Cl
Slide 36: GetSofdra.com telehealth site powered by UpScript Health
GetSofdra.com telehealth site powered by 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 with the patient The m
Slide 37: Drive Dermatology Adoption
W W W . B O T A N I X P H A R M A . C O M Drive COMMERCIAL DAY 2024 Dermatology Adoption
Slide 38: Derm tactics are grounded in a compelling clinical story
Derm tactics are grounded in a compelling clinical story 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 Visuals Optimistic Ton
Slide 39: Bringing our data to life
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 40: Sales force and market opportunity
COMMERCIAL Sales force and DAY 2024 W W W . B O T A N I X P H A R M A . C O M market opportunity
Slide 41: Target most productive prescribers and expand reach via digital channels
Target most productive prescribers and expand reach via digital channels 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 leaders v Rapid scale-up of
Slide 42: Sofpironium Bromide performance in Japan supports Sofdra commercial success
Sofpironium Bromide performance in Japan supports Sofdra commercial success 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 Japan and the USA is simi
Slide 43: In Summary
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 44: 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 Organization ✓ Executive team ☐ ✓ Contract manufacturer ☐ ✓ Payer strategy ☐ ✓ MIS/AE vendor ☐ ✓ Ad Agency ☐ ✓ Infrastructure ☐ ✓ Serialization vendor ☐ ✓