Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Investor Presentation (September 2018)
37 slides from Verrica Pharmaceuticals's investor presentation, Sep 12, 2018
Slide 1: Company Overview
September 2018 Company Overview Copyright © 2018 Verrica Pharmaceuticals. All rights reserved. Exhibit 99.2
Slide 2: Certain information contained in this presentation and statements made orally during this presentation relates
Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Verrica’s own internal estimates and research. While Verrica believes these third-party
Slide 3: Developing innovative dermatology products
Developing innovative dermatology products Solving unmet needs Reinventing Skin Science by focusing on research and development Late-stage clinical pharmaceutical company
Slide 4: Investment Highlights
INVESTMENT HIGHLIGHTS Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6). US Census estimates ~69.4MM children aged 0 to 16 years in 2016. IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatme
Slide 5: Management team with extensive product launch and dermatology experience
MANAGEMENT TEAM WITH EXTENSIVE PRODUCT LAUNCH AND DERMATOLOGY EXPERIENCE Selected Launched Products Copyright © 2018 Verrica Pharmaceuticals. All rights reserved. Linda Palczuk Chief Operating Officer Chris Degnan Chief Financial Officer Ted White President & Chief Executive Officer Patrick Burnett
Slide 6: Our product portfolio
OUR PRODUCT PORTFOLIO Additional indications under consideration include subungual warts, flat warts, actinic keratosis, genital warts and seborrheic keratosis. Phase 2 ready assuming use of the same formulation. Phase 2 ready assuming leverage of data from VP-102. We retain exclusive, royalty-free
Slide 7: First product candidate is VP-102, a proprietary drug-device combination containing cantharidin
FIRST PRODUCT CANDIDATE IS VP-102, A PROPRIETARY DRUG-DEVICE COMBINATION CONTAINING CANTHARIDIN Based on a survey of 115 dermatologists the results of which have been extrapolated to pediatric dermatologists. Pompei D, et al. Cantharidin therapy: Practice patterns and attitudes of health care provid
Slide 8: The problem: Molluscum Contagiosum
The problem Molluscum Contagiosum
Slide 9: Molluscum background: etiology and clinical presentation
MOLLUSCUM BACKGROUND ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Caused by a pox virus Primarily infects children, with the highest incidence occurring in children <14 years old Highly contagious If untreated, lesions persist an average of 13 months, with some cases remaining unresolved for 2+ years
Slide 10: Current treatments for molluscum are not FDA approved and have many limitations
CURRENT TREATMENTS FOR MOLLUSCUM ARE NOT FDA APPROVED AND HAVE MANY LIMITATIONS DESCRIPTION LIMITATIONS Cryotherapy Freezing the lesions with liquid nitrogen Pain and scarring Unsuitable for use in children Curettage Using a curette or a surgical instrument with a scoop at the tip to scrape the lesi
Slide 11: VP-102's API has a long history of clinical evidence
VP-102’s API HAS A LONG HISTORY OF CLINICAL EVIDENCE Copyright © 2018 Verrica Pharmaceuticals. All rights reserved. Cantharidin: A Comprehensive Review of the Clinical Literature Richard Torbeck MD1, Michael Pan BA2, Ellen de Moll BA3, Jacob Levitt MD2 1The University of Toledo College of Medicine,
Slide 12: Historical compounded cantharidin presents a number of limitations
HISTORICAL COMPOUNDED CANTHARIDIN PRESENTS A NUMBER OF LIMITATIONS Varying concentration Evaporation of volatile solvents leads to concentration increases Patients can receive more drug than clinically necessary resulting in excessive blistering Inconsistent purity and lack of controlled product Per
Slide 13: The Solution: VP-102
WERRICA PHARMACEUTICALS. THE SOLUTION VP-102
Slide 14: VP-102 is a proprietary drug-device combination administered through single-use precision applicator
VP-102 IS A PROPRIETARY DRUG-DEVICE COMBINATION OF CANTHARIDIN ADMINISTERED THROUGH OUR SINGLE-USE PRECISION APPLICATOR GMP-controlled formulation of cantharidin with: API that is greater than 99% pure Defined pharmaceutical batch process Long-term, room temperature stability Visualization agent to
Slide 15: Mechanism of Action and Clinical Evidence
Mechanism of Action and Clinical Evidence
Slide 16: Cantharidin has a proven dual mechanism of action
CANTHARIDIN HAS A PROVEN DUAL MECHANISM OF ACTION Targeted Destruction of Infected Skin Leads to Lesion Clearance Once applied, cantharidin activates neutral serine proteases that cause degeneration of the desmosomal plaque, leading to detachment of tonofilaments from desmosomes.(1) This leads to in
Slide 17: Significant clinical progress of VP-102 for the treatment of molluscum
SIGNIFICANT CLINICAL PROGRESS OF VP-102 FOR THE TREATMENT OF MOLLUSCUM TRIAL AND STATUS FORMULATION / APPLICATION METHOD TRIAL DESIGN TRIAL OBJECTIVES PHASE 3 Pivotal Trial CAMP-1 Enrollment Complete VP-102 N=266 Conducted under SPA Randomized, double blind, multi-center, placebo controlled To evalu
Slide 18: Phase 2 trial data demonstrates a favorable profile for VP-102 in molluscum clearance
PHASE 2 TRIAL DATA DEMONSTRATES A FAVORABLE PROFILE FOR VP-102 IN MOLLUSCUM CLEARANCE Historical placebo data from third-party trials with cantharidin; No head-to-head trials have been run against VP-102. Burke BE, Baillie J, Olson RD. Essential oil of Australian lemon myrtle (Backhousia citriodora)
Slide 19: Phase 2 trial data: lesion clearance after VP-102
PHASE 2 TRIAL DATA DEMONSTRATES A FAVORABLE PROFILE FOR VP-102 IN MOLLUSCUM CLEARANCE Lesion Clearance After VP-102 (No Applicator) Number of Lesions 140 120 100 80 60 40 20 0 0 3 6 9 12 n=25 n=25 n=25 n=25 n=25 Lesion Clearance After VP-102 (w/Applicator) Number of Lesions 140 120 100 80 60 40 20 0
Slide 20: We have completed enrollment in two pivotal Phase 3 trials (CAMP-1 & CAMP-2)
Population WE HAVE COMPLETED ENROLLMENT IN TWO PIVOTAL PHASE 3 TRIALS (CAMP-1 & CAMP-2) IN MOLLUSCUM Trial Design Two identically designed, randomized, double-blinded, multicenter, placebo controlled trials CAMP-1 conducted under FDA Special Protocol Assessment (SPA) Endpoints Primary: Percent of su
Slide 21: Our Opportunity in Common Warts
Our Opportunity in Common Warts
Slide 22: Verruca vulgaris (common warts): etiology and clinical presentation
VERRUCA VULGARIS (COMMON WARTS) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Caused by Human Papilloma virus (HPV) Infects patients of all ages Persistent infection, highly refractory Typically 2-5 lesions No FDA approved drug for the treatment of common warts Transmission Skin to skin contact Sharin
Slide 23: We have initiated a Phase 2 trial (COVE-1) in warts
WE HAVE INITIATED A PHASE 2 TRIAL (COVE-1) IN WARTS Trial Design Open label, single center Safety & tolerability Endpoints Primary Percent of subjects with complete clearance of all treatable warts (baseline and new) at Day 84 Secondary Percent of subjects achieving complete clearance of all treatab
Slide 24: Commercial Opportunity
WERRICA PHARMACEUTICALS. Commercial Opportunity Copyright © 2018 Verica Pharmaceuticals. All rights reserved,
Slide 25: Dermatologists are familiar with VP-102's API and would use if available
DERMATOLOGISTS ARE FAMILIAR WITH VP-102’s API & WOULD USE IF AVAILABLE Pompei DT et al. Cantharidin Therapy: Practice patterns and attitudes of health care providers. Journal of the American Academy of Dermatology. 2013; 68(6). Survey of 400 healthcare providers, 87.7% of responders were US based de
Slide 26: Initial payer research suggests favorable reimbursement landscape for VP-102
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR VP-102 Source: Third party study commissioned by the Company. COHORT SIZE AVERAGE LIVES COVERED Medical Directors 7 9.8M Pharmacy Directors 6 4.2M IDN Stakeholders 2 6.5M The 15 Payer Organizations and Plans Represented in the Int
Slide 27: Initial payer research suggests favorable reimbursement landscape: key takeaways
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR VP-102 1 2 3 4 Payers interviewed recognize a significant unmet need for molluscum contagiosum and lack of an effective treatment Some of the key concerns mentioned about the undertreatment of the condition include the risk of inf
Slide 28: Integrated commercial approach with multiple strategic levers
INTEGRATED COMMERCIAL APPROACH WITH MULTIPLE STRATEGIC LEVERS Buy and Bill or Specialty Pharmacy KOL Engagement Specialized Sales Team Disease Awareness Small Institutional Team Increase treatment seekers through cost- efficient consumer advertising Specialists to promote to pediatric dermatologists
Slide 29: Pre-commercialization activities ongoing
PRE-COMMERCIALIZATION ACTIVITIES ONGOING ENGAGEMENT AT KEY CONFERENCES Copyright © 2018 Verrica Pharmaceuticals. All rights reserved. LAUNCH OF DISEASE AWARENESS CAMPAIGN Society for Pediatric Dermatology, July Advisory Board and Poster Presentation Digital and social research completed to understan
Slide 30: Verrica has several potential ways to maintain exclusivity
VERRICA HAS SEVERAL POTENTIAL WAYS TO MAINTAIN EXCLUSIVITY Regulatory Exclusivity 5.5 years of exclusivity for cantharidin as API possible upon approval (inclusive of potential for 6 months for pediatric indication) Compounding Pharmacies If VP-102 is approved, traditional compounding pharmacies wil
Slide 31: Overview of intellectual property portfolio
OVERVIEW OF INTELLECTUAL PROPERTY PORTFOLIO KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA Our specific formulation (VP-102), key safety additions and novel cantharidin formulations (PCT/US2014/052184) May prevent generics from copying our ether-free formulation or from making similar formulati
Slide 32: Key events and milestones
DATE EVENT September 2017 End of Phase 2 Meeting with FDA 1Q 2018 Received go ahead from FDA to initiate two Phase 3 trials, including SPA on pivotal trial 1Q 2018 Initiated Phase 3 trials for molluscum and Phase 2 trial for warts 1Q 2018 Executed purchase order for API that is expected to last thro
Slide 33: Investment Highlights
INVESTMENT HIGHLIGHTS Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 2014 Apr;31(2):130-6). US Census estimates ~69.4MM children aged 0 to 16 years in 2016. IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatme
Slide 34: Appendix
WERRICA PHARMACEUTICALS. Copyright © 2018 Verica Pharmaceuticals. All rights reserved,
Slide 35: Phase 3 statistical powering assumptions
Phase 3 Statistical Powering assumptions support positive results across a range of potential scenarios Phase 3 power assumptions: Sample size=250 subjects Randomization 3:2 (n=150 VP-102, n=100 placebo) 44% VP-102 complete clearance rate 20% Placebo complete clearance rate 10% drop out rate Assumpt
Slide 36: Board of Directors
BOARD OF DIRECTORS Sean Stalfort Director Glenn Oclassen Director Mark Prygocki Director Gary Goldenberg, MD Director Ted White President & Chief Executive Officer Paul Manning Chairman
Slide 37: Highly acclaimed Scientific Advisory Board
HIGHLY ACCLAIMED SCIENTIFIC ADVISORY BOARD (1)(*)We intend to engage Dr. Lebwohl as principal investigator for future clinical trial(s) in our common warts program. Waldman Chair of Dermatology, Icahn School of Medicine at Mount Sinai Former President of the American Academy of Dermatology Mark Lebw
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