Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Investor Presentation (January 2021)
58 slides from Verrica Pharmaceuticals's investor presentation, Jan 6, 2021
Slide 1: Company Overview January 2021
Exhibit 99.1 Company Overview January 2021 1Exhibit 99.1 Company Overview January 2021 1
Slide 2: Disclaimer
Disclaimer Certain information contained in this presentation and statements made orally The information in this presentation, including without limitation the forward- during this presentation relates to or is based on studies, publications, surveys looking statements contained herein, represent ou
Slide 3: Investment Highlights
Investment Highlights Dermatology Oncology YCANTH™ in Development to Address Two of the Largest Unmet Needs in Dermatology • Worldwide rights to LTX-315: first-in-class oncolytic peptide injected directly into tumor (1) • Prevalence of ~6 million in molluscum contagiosum (2) • Positive tumor-specifi
Slide 4: Our Product Portfolio
Our Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA acceptance of NDA that was resubmitted in Molluscum Contagiosum December 2020 Evaluate potential * Common Warts second Phase 2 trial* Request End-of-Phase 2 External Genital Warts meeting in Q1 2021 Initiate Phase 2 trial*
Slide 5: YCANTH in Development to Address Two of the Largest Unmet Needs in Dermatology
YCANTH™ in Development to Address Two of the Largest Unmet Needs in Dermatology Common Warts Molluscum (3) (1) US Prevalence of ~22 million with US Prevalence of ~6 million with (2) (4) ~1 million diagnosed annually ~1.5 million diagnosed annually 22M 85% Prevalence in U.S. Not Diagnosed 5.1 million
Slide 6: The Problem: Molluscum Contagiosum
THE PROBLEM Molluscum Contagiosum 6THE PROBLEM Molluscum Contagiosum 6
Slide 7: Molluscum Background
Molluscum Background ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW • Skin to skin contact Caused by a pox virus Transmission • Sharing of contaminated objects (e.g., clothing, towels, swimming pool toys) Primarily infects children, with the highest incidence occurring in children <14 years old Diagnos
Slide 8: Current Treatments for Molluscum
Current Treatments DESCRIPTION LIMITATIONS for Molluscum are • Pain and scarring Freezing the lesions not FDA-Approved Cryotherapy with liquid nitrogen • Unsuitable for use in children and Have Many Using a curette or a surgical • Pain and scarring Limitations instrument with a scoop at Curettage •
Slide 9: The Solution: YCANTH (VP-102)
THE SOLUTION YCANTH™ (VP-102) 9THE SOLUTION YCANTH™ (VP-102) 9
Slide 10: YCANTH (VP-102) Is a Proprietary Drug-Device Combination of Cantharidin
YCANTH™ (VP-102) Is a Proprietary Drug-Device Combination of Cantharidin Administered Through our Single-use Precision Applicator GMP-controlled new formulation of 0.7% w/v cantharidin Ampule Tube Filter Cap Tip • Consistent and shelf-stable Single-use applicator to reduce cross- contamination and a
Slide 11: U.S. Regulatory Status
U.S. Regulatory Status • NDA for VP-102 for molluscum contagiosum submitted in September 2019 • CRL received July 2020 • No clinical safety or efficacy issues identified • Requests for additional information regarding certain aspects of CMC and Human Factors validation • Resubmitted NDA in December
Slide 12: Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) in Molluscum
We Have Successfully Completed Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) In Molluscum Two identically designed, randomized, CAMP-1 conducted under 12-week double-blinded, multicenter, placebo Trial Design FDA Special Protocol study period controlled trials Assessment (SPA) Secondary: Primary: Per
Slide 13: Molluscum History for Subjects in Phase 3 Trials
Molluscum History for Subjects in Phase 3 Trials VP-102 Vehicle (N=311) (N=216) 13 * Active atopic dermatitis was determined by concomitant medication usage of the following medications during the study: topical corticosteroids, topical calcineurin inhibitors, and/or PDE-4 inhibitors. Note: Slide re
Slide 14: Phase 3 Studies Demonstrate Efficacy on Complete Clearance
Phase 3 Studies in Molluscum Demonstrate Statistically Significant Efficacy on Primary Endpoint of Complete Clearance 14 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)Phase 3 Studies in Molluscum Demonstrate Statistically Significant Efficacy on Primary Endpoint o
Slide 15: Phase 3 Studies Demonstrate Efficacy on Percent Reduction of Lesions
Phase 3 Studies in Molluscum Demonstrate Statistically Significant Efficacy on Percent Reduction of Lesions 15 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)Phase 3 Studies in Molluscum Demonstrate Statistically Significant Efficacy on Percent Reduction of Lesions
Slide 16: Phase 3 Discontinuation Rates Due to Treatment-Related Adverse Events
Phase 3 Discontinuation Rates Due to Treatment-Related Adverse Events N (%) VP-102 Vehicle (N=311) (N=216) Application Site Vesicles 5 (1.6) 0 (0) Application Site Pain 3 (1.0) 0 (0) Application Site Pruritus 1 (0.3) 0 (0) Contact Dermatitis 1 (0.3) 0 (0) Total Discontinuation Rate 6 (1.9) 0 (0) Not
Slide 17: MC Commercial Opportunity
MC Commercial Opportunity 17MC Commercial Opportunity 17
Slide 18: Realizing the Molluscum Opportunity
Realizing the Molluscum Opportunity (1) US Prevalence of ~6 million in molluscum with ~1 million (2) diagnosed annually 85% Not Diagnosed 5.1 million 15% Diagnosed 0.9 million (1) 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 estimate
Slide 19: Dermatologists are Familiar with API Used in YCANTH
Dermatologists are Familiar with API Used in YCANTH™ (VP-102) & Would Use if Available ~70% 87% Physicians who do not use the API of Physicians reported they YCANTH™ (VP-102) stated inaccessibility as a would use YCANTH™ (VP-102) if (1) (2) primary reason why they are not using the cost of the drug
Slide 20: Physicians are Highly Favorable to YCANTH Profile
Physicians are Highly Favorable to YCANTH™ (VP-102) Profile (1) Derms and Ped Derms KEY REASONS TO USE IF APPROVED Efficacy Precise and pain free application 5.6 FDA approval Convenience of administration (1) Pediatricians KEY REASONS TO USE IF APPROVED Efficacy Fits into their current office model
Slide 21: Initial Payer Research Suggests Favorable Reimbursement Landscape
Initial Payer Research Suggests Favorable Reimbursement Landscape for YCANTH™ (VP-102) COHORT SIZE AVERAGE LIVES COVERED Medical 79.8M Directors Pharmacy 64.2M The 15 Payer Organizations Directors and Plans Represented in the IDN Interviews Cover a Total of 26.5M Stakeholders 105 Million Commercial
Slide 22: Payer Research Key Takeaways
Initial Payer Research Suggests Favorable Reimbursement Landscape for YCANTH™ (VP-102) Key Takeaways Payers interviewed recognize a significant unmet need for molluscum contagiosum 1 and lack of an effective treatment Some of the key concerns mentioned about the undertreatment of the condition inclu
Slide 23: Integrated Commercial Approach with Multiple Strategic Levers
Integrated Commercial Approach with Multiple Strategic Levers Commercial Strategy Disease KOL Specialized Dedicated Buy and Bill Awareness Engagement Sales Team Institutional or Specialty Team Pharmacy Increase Strong Targeting office-based treatment seekers established and institutional Specialists
Slide 24: Pre-Commercialization Activities Ongoing
Pre-Commercialization Activities Ongoing Engagement at Premier Venues & Industry Channels DISEASE AWARENESS Caregiver MC HCP MC education Poster Presentation education through congresses, through digital speaker programs, and and social tools professional journal space OTHER National National Trade
Slide 25: VP-102 in Common Warts
VP-102 in Common Warts 25VP-102 in Common Warts 25
Slide 26: Verruca Vulgaris (Common Warts)
Verruca Vulgaris (Common Warts) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Transmission • Skin to skin contact Caused by human papilloma virus (HPV) • Touching of contaminated objects Infects patients of all ages Diagnosis • Dome shaped flesh-colored lesions commonly & Symptoms on the hands, finger
Slide 27: Phase 2 Study (COVE-1) in Common Warts
We Have Successfully Completed a Phase 2 Study (COVE-1) in Common Warts Cohort 1: one center Study Design Efficacy, safety & tolerability Open label study with two cohorts Cohort 2: four centers Secondary Primary Percent of subjects achieving complete clearance of all treatable warts at Visits 2, 3,
Slide 28: VP-102 Efficacy on Complete Clearance in COVE-1 Study
VP-102 Demonstrated Clinically Meaningful Efficacy on Primary Endpoint of Complete Clearance in COVE-1 Study 28VP-102 Demonstrated Clinically Meaningful Efficacy on Primary Endpoint of Complete Clearance in COVE-1 Study 28
Slide 29: Adverse Events in COVE-1 Study
Adverse Events in COVE-1 Study (Incidence≥5%)* 29Adverse Events in COVE-1 Study (Incidence≥5%)* 29
Slide 30: VP-102 in External Genital Warts
VP-102 in External Genital Warts 30VP-102 in External Genital Warts 30
Slide 31: Condyloma Acuminatum (Genital Warts)
Condyloma Acuminatum (Genital Warts) ETIOLOGY AND CLINICAL PRESENTATION OVERVIEW Transmission • Skin to skin contact Caused by human papilloma virus (HPV) • Spread through sexual contact Lesions on the surface of the skin in Diagnosis • Can be flat, dome-shaped, keratotic, the genital and perianal r
Slide 32: Phase 2 Study (CARE-1) in External Genital Warts
Phase 2 Study (CARE-1) in External Genital Warts (EGW) Study comprised of two parts (A and B) Dose regimen, Multi-center, double- efficacy, safety & Study Design blind, vehicle- Primary objective of Part A is to identify the two tolerability controlled best dosing regimens for evaluation in Part B P
Slide 33: Demographics (CARE-1, ITT Population)
Demographics (CARE-1, ITT Population)* VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour (N=30) (N=24) (N=27) (N=18) Age Mean (SD) 38.93 (9.9) 35.83 (7.8) 34.33 (7.1) 33.83 (6.3) Min, Max 26, 59 26, 58 25, 53 25, 43 Gender, n (%) Male 17 (56.7) 14 (58.3) 15 (55.6) 11 (61.1) Female 13 (43.3
Slide 34: Baseline EGW Characteristics (CARE-1)
Baseline EGW Characteristics (CARE-1, ITT Population*) VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour (N=30) (N=24) (N=27) (N=18) Duration of Warts, No. (%) <1 year 15 (50.0) 12 (50.0) 13 (48.1) 9 (50.0) 1-2 years 3 (10) 1 (4.2) 2 (7.4) 0 (0.0) >2-5 Years 4 (13.3) 5 (20.8) 8 (29.6) 3 (1
Slide 35: Efficacy (CARE-1, ITT Population)
Efficacy (CARE-1, ITT Population) Mean Percentage Change in EGW Percentage of Subjects with Lesions from Baseline Complete Clearance of all Baseline ⸸ and New Treatable EGW Lesions VP-102 Vehicle VP-102 Vehicle 6-hour 6-hour 24-hour 24-hour 100 (n=30) (n=24) (n=27) (n= 18) ** 80 10 1.24 0 60 -10 -7.
Slide 36: Safety: Treatment Emergent Adverse Events (CARE-1)
Safety: Treatment Emergent Adverse Events ≥ 5% (CARE-1, Safety Population)*,⸸ VP-102 Vehicle VP-102 Vehicle TEAEs, N 6-hour 6-hour 24-hour 24-hour (N=29) (N=22) (N=28) (N=20) (%) Subjects reporting at least one 29 (100.0) 8 (36.4) 28 (100.0) 6 (30.0) TEAE Application site vesicles 25 (86.2) 0 (0.0)
Slide 37: LTX-315
LTX-315 37LTX-315 37
Slide 38: LTX-315 Overview
LTX-315 Overview 1 Induces Immunogenic Cell Death and a Tumor-specific Immune Response Kills the Tumor Cells 1 OVERVIEW LTX-315 enters the cells and disturbs cell membranes, causing cell death and release of a patient’s tumor specific antigens First-in-class oncolytic peptide that is 2 Triggers Immu
Slide 39: Non-Melanoma Skin Cancer
Non-Melanoma Skin Cancer OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION • Estimated 5.4 million diagnoses of basal cell (BCC) and Patient squamous cell (SCC) carcinomas annually 1 population Non-melanoma skin cancer includes • Increasing age and sun exposure are risk factors basal cell and squamous cel
Slide 40: Current Treatments for Non-Melanoma Skin Cancer
DESCRIPTION LIMITATIONS • Invasive Using a scalpel to remove Current Treatments Surgical Excision • Can cause scarring/disfigurement, diseased tissue and healthy skin infection, pain For Non-Melanoma 1-3 • Invasive, may take several rounds Skin Cancer Used in high risk NMSC or in Mohs Surgery • Can
Slide 41: Regulatory Exclusivity and Intellectual Property
Regulatory Exclusivity and Intellectual Property 41Regulatory Exclusivity and Intellectual Property 41
Slide 42: Several Potential Ways to Maintain Exclusivity for VP-102
Verrica has Several Potential Ways to Maintain Exclusivity for VP-102 Regulatory 5 years of exclusivity for cantharidin as API potentially available upon approval (potential for additional 6 months for pediatric exclusivity for common warts and plantar warts indications) Exclusivity If VP-102 is app
Slide 43: Overview of VP-102/103 Intellectual Property Portfolio
Overview of VP-102/103 Intellectual Property Portfolio KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA Our specific formulation, YCANTH™ (VP-102), key safety 1 May prevent generics from copying our ether-free formulation or from additions and novel cantharidin formulations making similar formula
Slide 44: Overview of LTX-315 Intellectual Property Portfolio
Overview of LTX-315 Intellectual Property Portfolio 1 In force in: UK, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland and Turkey 44Overview of LTX-315 Intellectual Property Portfolio 1 In force in: UK, Belgium, Denmark, Finland, France, Ger
Slide 45: Investor Relations
Investor Relations—NASDAQ: VRCA (1) As of September 30, 2020 Analyst Coverage Ken Cacciatore, Cowen • Cash and marketable securities: $71.8M • Long-term debt: $35.0M Oren Livnat, H.C. Wainwright • Outstanding shares: 25.9M • Outstanding option shares and RSUs: 4.1M David Steinberg, Jefferies Serge B
Slide 46: Our Product Portfolio
Our Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA acceptance of NDA that was resubmitted in Molluscum Contagiosum December 2020 Evaluate potential * Common Warts second Phase 2 trial* Request End-of-Phase 2 External Genital Warts meeting in Q1 2021 Initiate Phase 2 trial*
Slide 47: Investment Highlights
Investment Highlights Dermatology Oncology YCANTH™ in Development to Address Two of the Largest Unmet Needs in Dermatology • Worldwide rights to LTX-315: first-in-class oncolytic peptide injected directly into tumor (1) • Prevalence of ~6 million in molluscum contagiosum (2) • Positive tumor-specifi
Slide 48: Management Team with Extensive Product Launch and Dermatology Experience
Management Team with Extensive Product Launch and Dermatology Experience Ted White A. Brian Davis Gary Goldenberg, MD Joe Bonaccorso President & Chief Chief Financial Chief Medical Chief Commercial Executive Officer Officer Officer Officer Selected Launched Products 48Management Team with Extensive
Slide 49: Appendix
Appendix 49Appendix 49
Slide 50: Reinventing dermatology therapeutics
Providing meaningful benefit for people living with skin diseases Developing Reinventing dermatology dermatology therapeutics by products focusing on development and commercialization Late-stage dermatology therapeutics company 50Providing meaningful benefit for people living with skin diseases Deve
Slide 51: Molluscum Clinical Evidence
Molluscum Clinical Evidence 51Molluscum Clinical Evidence 51
Slide 52: Cantharidin Elicits a Dual Response in the Skin
Cantharidin Elicits a Dual Response in the Skin 1 2 Superficial blistering of lesional skin Elicits Inflammation & Immune Response Cantharidin is a vesicant, causing the Cantharidin stimulates leukocyte infiltration (e.g., pharmacodynamic response of blistering in the skin. neutrophils, macrophages,
Slide 53: Significant Clinical Progress of YCANTH for Molluscum
Significant Clinical Progress of YCANTH™ (VP-102) for the Treatment of Molluscum TRIAL FORMULATION / TRIAL TRIAL AND STATUS APPLICATION METHOD DESIGN OBJECTIVES Pivotal Trial VP-102 • N=266 • To evaluate the efficacy of dermal application CAMP-1 of VP-102 relative to placebo for complete • Conducted
Slide 54: Demographics in Phase 3 Molluscum Trials
Demographics in Phase 3 Molluscum Trials 54 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)Demographics in Phase 3 Molluscum Trials 54 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 55: Safety Summary for Molluscum Phase 3 Trials
Safety Summary for Molluscum Phase 3 Trials 55 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)Safety Summary for Molluscum Phase 3 Trials 55 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 56: YCANTH Clinician-Administered, Specialty Product Channels
YCANTH™ (VP-102) Designed to be Clinician-Administered and Intend to Distribute Through Specialty Product Channels, if Approved Distribution model will be supported by a patient and HCP services platform (HUB) Specialty Specialty Distributor Pharmacy • Benefits investigation/verification to determin
Slide 57: Non-Melanoma Skin Cancer
Non-Melanoma Skin Cancer 57Non-Melanoma Skin Cancer 57
Slide 58: Historical Compounded Cantharidin Presents a Number of Limitations
Historical Compounded Cantharidin Presents a Number of Limitations 1 2 3 Varying Inconsistent Lack of concentration purity and lack reimbursement of controlled • Evaporation of volatile • Not FDA approved solvents leads to and therefore not product concentration increases eligible for drug manufactu
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