Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Investor Presentation (October 2019)
51 slides from Verrica Pharmaceuticals's investor presentation, Oct 18, 2019
Slide 1: Company Overview
October 2019 Company Overview Copyright © 2019 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 novel dermatology products
Developing novel dermatology products Providing meaningful benefit for people living with skin diseases Reinventing Skin Science by focusing on development and commercialization Late-stage medical dermatology 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: Our Product Portfolio
OUR PRODUCT PORTFOLIO Phase 2 ready assuming leverage of data from VP-102. We retain exclusive, royalty-free rights to our product candidates across all indications globally Preclinical Phase 1 Phase 2 Phase 3 NDA submission Next Expected Milestone VP-102 Molluscum Contagiosum FDA acceptance of NDA
Slide 6: Two of the largest unmet needs in dermatology
two of the largest unmet needs in dermatology 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. IQVIA projected dataset for 12 months ending October 2017 IMS National Disease and Ther
Slide 7: The Problem: Molluscum Contagiosum
The problem Molluscum Contagiosum
Slide 8: 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 9: Current Treatments for Molluscum Are Not FDA Approved and Have 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 10: The Solution: VP-102
WERRICA PHARMACEUTICALS. THE SOLUTION VP-102 Copyright © 2019 Verrica Pharmaceuticals. All rights reserved.
Slide 11: VP-102 Is a Proprietary Drug-Device Combination of Cantharidin
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 12: Molluscum Clinical Evidence
Molluscum Clinical Evidence
Slide 13: Cantharidin Elicits a Dual Response in the Skin
CANTHARIDIN elicits a dual response in the skin Superficial blistering of lesional skin Cantharidin is a vesicant, causing the pharmacodynamic response of blistering in the skin. Once applied, cantharidin activates neutral serine proteases that cause degeneration of the desmosomal plaque and intraep
Slide 14: Significant Clinical Progress of VP-102 for 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 Complete VP-102 N=266 Conducted under SPA Randomized, double blind, multi-center, placebo controlled To evaluate the eff
Slide 15: Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) in Molluscum
Population WE HAVE successfully COMPLETED 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 sub
Slide 16: Demographics in Phase 3 Molluscum Trials
Demographics in phase 3 molluscum trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 17: Molluscum History for Subjects in Phase 3 Trials
Molluscum history for subjects in phase 3 trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) * Active atopic dermatitis was determined by concomitant medication usage of the following medications during the study: topical corticosteroids, topical calcineurin in
Slide 18: Phase 3 Studies Demonstrate Efficacy on Complete Clearance
PHASE 3 Studies in molluscum DEMONSTRATE statistically significant efficacy on Primary endpoint of complete CLEARANCE Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 19: Phase 3 Studies Demonstrate Efficacy on Percent Reduction of Lesions
PHASE 3 Studies in molluscum DEMONSTRATE statistically significant efficacy on Percent Reduction of Lesions Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 20: Safety Summary for Molluscum Phase 3 Trials
Safety summary for molluscum Phase 3 trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 21: MC Commercial Opportunity
WERRICA PHARMACEUTICALS. MC Commercial Opportunity
Slide 22: Realizing the Molluscum Opportunity
Realizing the Molluscum Opportunity 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. IQVIA projected dataset for 12 months ending October 2017 Not Diagnosed 5.1 million US Prevalence
Slide 23: Dermatologists Are Familiar with VP-102's API
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 24: Physicians Are Highly Favorable to VP-102 Profile
Physicians are highly favorable to VP-102 profile Physician Qualitative research- one-hour individual interviews [n=30 Pediatricians, 13 Dermatologist, 5 Pediatric Dermatologists] Derms and Ped Derms (1) Pediatricians (1) 5.6 6.3 Efficacy Efficacy KEY REASONS TO USE IF APPROVED Convenience of admini
Slide 25: Initial Payer Research Suggests Favorable Reimbursement Landscape
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 26: Initial Payer Research: 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 27: 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 Dedicated Institutional Team Increase treatment seekers through cost- efficient consumer advertising Specialists to promote to pediatric dermatolog
Slide 28: VP-102 Clinician Administered, Specialty Distribution Channels
VP-102 designed to be clinician administered and intend to distribute through specialty product channels, if approved Note: For illustrative purposes only. If approved, actual distribution channels and support services may change as strategy is finalized. Distribution model will be supported by a pa
Slide 29: Pre-Commercialization Activities Ongoing
PRE-COMMERCIALIZATION ACTIVITIES ONGOING ENGAGEMENT AT KEY CONFERENCES Poster Presentation National and Regional Meetings National and Regional Meetings DISEASE AWARENESS Caregiver MC education through digital and social tools HCP MC education through congresses, speaker programs, and professional j
Slide 30: 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 potentially available upon approval (inclusive of potential for 6 months for pediatric indication) Compounding Pharmacies If VP-102 is approved, traditional compounding p
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: Our Opportunity in Common Warts
Our Opportunity in Common Warts
Slide 33: 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 Touchi
Slide 34: Completed Phase 2 Study (COVE-1) in Common Warts
WE HAVE successfully COMPLETED A PHASE 2 STUDY (COVE-1) IN common WARTS Study Design Cohort 1: one center Cohort 2: four centers Efficacy, safety & tolerability Endpoints Primary Percent of subjects with complete clearance of all treatable warts (baseline and new) at Day 84 Secondary Percent of subj
Slide 35: Demographics in COVE-1 Study
Demographics in cove-1 STUDY Cohort 1 VP-102 (N=21) Cohort 2 VP-102 (N=35) Randomized 21 35 Age (years) Mean 38 38 Median 37 42 Min, Max 7, 83 12, 67 Gender (N (%)) Female 11 (52.4%) 22 (62.9%) Male 10 (47.6%) 13 (37.1%)
Slide 36: Wart History for Subjects in COVE-1 Study
Wart history for subjects in cove-1 STUDY Cohort 1 VP-102 (N=21) Cohort 2 VP-102 (N=35) Time Since Clinical Diagnosis (months) 70.3 15.9 Age at Diagnosis (mean, years) 32.1 36.4 Any Previous Treatments for Common Warts? (Yes) 3 (14.3%) 24 (68.6%) Wart Number at Baseline (mean) 2.19 1.65
Slide 37: VP-102 Efficacy on Complete Clearance in COVE-1
VP-102 demonstrated Clinically meaningful efficacy on Primary endpoint of complete CLEARANCE in COVE-1 STUDY
Slide 38: VP-102 Efficacy on Percent Change in Common Warts
VP-102 demonstrated Clinically meaningful efficacy on Percent Change in number of common warts from baseline in COVE-1 STUDY
Slide 39: Adverse Events in COVE-1 Study
adverse events in cove-1 study (incidence≥5%)*
Slide 40: Adverse Events for COVE-1 Study by Severity
Adverse Events for Cove-1 Study by Severity (incidence≥5%)
Slide 41: Realizing the Common Warts Opportunity
Realizing the common warts Opportunity IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 IQVIA Anonymous Longitudinal Patient Level Data (APLD) for 12 m
Slide 42: Our Opportunity in External Genital Warts
Our Opportunity in External Genital Warts
Slide 43: Condyloma Acuminatum (Genital Warts) Etiology and Clinical Presentation
CONDYLOMA ACUMINATum (genital warts) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Caused by human papilloma virus (HPV) Lesions on the surface of the skin in the genital and perianal regions Highly contagious and recurrences are common Treatment options have limitations Transmission Skin to skin cont
Slide 44: Phase 2 Study (CARE) in External Genital Warts
Frequency of administration is every 21 days PHASE 2 STUDY (care) IN external genital warts (EGW) Study Design Multi-center, double-blind, placebo-controlled Dose regimen, efficacy, safety & tolerability Endpoints Primary Percent of subjects with complete clearance of all treatable warts at Day 84 S
Slide 45: Significant Recent and Expected Milestones
DATE EVENT 1Q 2019 Positive topline results from two pivotal Phase 3 trials in molluscum 2Q 2019 Positive topline results from Phase 2 trial in common warts 2Q 2019 Initiate Phase 2 trial in external genital warts 3Q 2019 VP-102 NDA submission in molluscum 4Q 2019 FDA acceptance of VP-102 NDA submis
Slide 46: 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 47: Appendix
WERRICA PHARMACEUTICALS. Appendix Copyright © 2019 Verrica Pharmaceutical Is. All rights reserves J
Slide 48: 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 man
Slide 49: Management Team with Extensive Product Launch and Dermatology Experience
MANAGEMENT TEAM WITH EXTENSIVE PRODUCT LAUNCH AND DERMATOLOGY EXPERIENCE Selected Launched Products Copyright © 2019 Verrica Pharmaceuticals. All rights reserved. A. Brian Davis Chief Financial Officer Ted White President & Chief Executive Officer Patrick Burnett MD, PhD Chief Medical Officer Joe Bo
Slide 50: 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 Craig Ballaron Director
Slide 51: Highly Acclaimed Scientific Advisory Board
HIGHLY ACCLAIMED SCIENTIFIC ADVISORY BOARD Waldman Chair of Dermatology, Icahn School of Medicine at Mount Sinai Former President of the American Academy of Dermatology Mark Lebwohl, MD Chief of Dermatology at the Albert Einstein School of Medicine Steven Cohen, MD Professor of Dermatology and Pedia
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