Verrica Pharmaceuticals Inc. · NASDAQ:VRCA

Verrica Pharmaceuticals — Investor Presentation (September 2020)

54 slides from Verrica Pharmaceuticals's investor presentation, Sep 8, 2020

  1. Slide 1: Company Overview September 2020

    Exhibit 99.1 Company Overview September 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Exhibit 99.1 Company Overview September 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  2. Slide 2: Disclaimer

    DISCLAIMER Certain information contained in this presentation and statements made orally during The information in this presentation, including without limitation the forward-looking this presentation relates to or is based on studies, publications, surveys and other data statements contained herein

  3. Slide 3: Late-stage dermatology therapeutics company

    Providing meaningful benefit for people living with skin diseases Reinventing Developing dermatology dermatology therapeutics by products focusing on development and commercialization Late-stage dermatology therapeutics company Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. 3 Copyrig

  4. Slide 4: 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

  5. Slide 5: Our Product Portfolio

    OUR PRODUCT PORTFOLIO NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA Type A Meeting in September/October Molluscum Contagiosum 2020* Initiate pivotal Phase 3 Common Warts trials** Topline Phase 2 results External Genital Warts in 2H 2020 Initiate Phase 2 trial** Plantar Warts Non-Melanoma S

  6. Slide 6: 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 (4) (2) ~1.5 million diagnosed annually ~1 million diagnosed annually 22M 85% Prevalence in U.S. Not Diagnosed 5.1 million

  7. Slide 7: The Problem: Molluscum Contagiosum

    THE PROBLEM Molluscum Contagiosum Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE PROBLEM Molluscum Contagiosum Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  8. Slide 8: 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

  9. Slide 9: Current Treatments for Molluscum Are Not FDA Approved and Have Many Limitations

    CURRENT DESCRIPTION LIMITATIONS TREATMENTS • Pain and scarring Freezing the lesions FOR MOLLUSCUM Cryotherapy with liquid nitrogen • Unsuitable for use in children ARE NOT FDA Using a curette or a surgical APPROVED AND • Pain and scarring instrument with a scoop at Curettage • Unsuitable for use in

  10. Slide 10: The Solution: YCANTH (VP-102)

    THE SOLUTION YCANTH™ (VP-102) Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE SOLUTION YCANTH™ (VP-102) Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  11. Slide 11: 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 • Consistent and shelf-stable Single-use applicator to reduce cross-contamination and allow for more effective appl

  12. Slide 12: Regulatory Status

    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 • Next steps • Request Type A meeti

  13. Slide 13: Molluscum Clinical Evidence

    Molluscum Clinical Evidence Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Molluscum Clinical Evidence Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  14. Slide 14: Cantharidin Elicits a Dual Response in the Skin

    CANTHARIDIN ELICITS A DUAL RESPONSE IN THE SKIN 1 Superficial blistering of lesional skin 2 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,

  15. Slide 15: Significant Clinical Progress of YCANTH for the Treatment of 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

  16. Slide 16: 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 FDA Special Protocol Trial Design study period controlled trials Assessment (SPA) Secondary: Primary: Per

  17. Slide 17: Demographics in Phase 3 Molluscum Trials

    DEMOGRAPHICS IN PHASE 3 MOLLUSCUM TRIALS Vehicle VP-102 (N=216) (N=311) 17 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)DEMOGRAPHICS IN PHASE 3 MOLLUSCUM TRIALS Vehicle VP-102 (N=216) (N=311) 17 Copyr

  18. Slide 18: Molluscum History for Subjects in Phase 3 Trials

    MOLLUSCUM HISTORY FOR SUBJECTS IN PHASE 3 TRIALS VP-102 Vehicle (N=311) (N=216) * 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. 18 Copyright © 20

  19. Slide 19: Phase 3 Efficacy on Primary Endpoint of Complete Clearance

    PHASE 3 STUDIES IN MOLLUSCUM DEMONSTRATE STATISTICALLY SIGNIFICANT EFFICACY ON PRIMARY ENDPOINT OF COMPLETE CLEARANCE 19 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)PHASE 3 STUDIES IN MOLLUSCUM DEMON

  20. Slide 20: Phase 3 Efficacy on Percent Reduction of Lesions

    PHASE 3 STUDIES IN MOLLUSCUM DEMONSTRATE STATISTICALLY SIGNIFICANT EFFICACY ON PERCENT REDUCTION OF LESIONS 20 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)PHASE 3 STUDIES IN MOLLUSCUM DEMONSTRATE STA

  21. Slide 21: Safety Summary for Molluscum Phase 3 Trials

    SAFETY SUMMARY FOR MOLLUSCUM PHASE 3 TRIALS 21 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)SAFETY SUMMARY FOR MOLLUSCUM PHASE 3 TRIALS 21 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved

  22. Slide 22: 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) 22

  23. Slide 23: MC Commercial Opportunity

    MC Commercial Opportunity Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.MC Commercial Opportunity Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  24. Slide 24: Realizing the Molluscum Opportunity

    REALIZING THE MOLLUSCUM OPPORTUNITY (1) (2) US Prevalence of ~6 million in molluscum with ~1 million 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

  25. Slide 25: Dermatologists Are Familiar with API Used in YCANTH and Would Use If Available

    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

  26. Slide 26: 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) KEY REASONS TO USE IF APPROVED Pediatricians Efficacy Fits into their current office model

  27. Slide 27: Initial Payer Research Suggests Favorable Reimbursement Landscape

    INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR YCANTH™ (VP-102) COHORT SIZE AVERAGE LIVES COVERED The 15 Payer Organizations and Plans Represented in the Interviews Medical 7 9.8M Cover a Total of 105 Million Directors Commercial & Medicaid Lives Pharmacy 6 4.2M Directors IDN

  28. Slide 28: 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 1 molluscum contagiosum and lack of an effective treatment Some of the key concerns mentioned about the undertreatment of the 2 condition inc

  29. Slide 29: Integrated Commercial Approach with Multiple Strategic Levers

    INTEGRATED COMMERCIAL APPROACH WITH MULTIPLE STRATEGIC LEVERS Commercial Strategy KOL Buy and Bill Specialized Dedicated Disease Engagement or Specialty Sales Team Institutional Awareness Pharmacy Team Strong Targeting Increase established office based treatment seekers Distribution Specialists to r

  30. Slide 30: YCANTH Clinician Administered, Distributed Through 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

  31. Slide 31: Pre-Commercialization Activities Ongoing

    PRE-COMMERCIALIZATION ACTIVITIES ONGOING Engagement at Premier Venues & DISEASE AWARENESS Industry Channels Caregiver MC HCP MC education education through congresses, through digital speaker programs, and and social tools professional journal space Poster Presentation OTHER Trade distribution chann

  32. Slide 32: Our Opportunity in Common Warts

    Our Opportunity in Common Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Our Opportunity in Common Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  33. Slide 33: Verruca Vulgaris (Common Warts) Overview

    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

  34. Slide 34: 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 Efficacy, safety & tolerability Study Design 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,

  35. Slide 35: VP-102 Efficacy on Primary Endpoint in COVE-1 Study

    VP-102 DEMONSTRATED CLINICALLY MEANINGFUL EFFICACY ON PRIMARY ENDPOINT OF COMPLETE CLEARANCE IN COVE-1 STUDY 35 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.VP-102 DEMONSTRATED CLINICALLY MEANINGFUL EFFICACY ON PRIMARY ENDPOINT OF COMPLETE CLEARANCE IN COVE-1 STUDY 35 Copyright © 20

  36. Slide 36: Adverse Events in COVE-1 Study

    ADVERSE EVENTS IN COVE-1 STUDY (INCIDENCE≥5%)* 36 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.ADVERSE EVENTS IN COVE-1 STUDY (INCIDENCE≥5%)* 36 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  37. Slide 37: Our Opportunity in External Genital Warts

    Our Opportunity in External Genital Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Our Opportunity in External Genital Warts Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  38. Slide 38: Condyloma Acuminatum (Genital Warts) Overview

    CONDYLOMA ACUMINATUM (GENITAL WARTS) OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Caused by human papilloma virus Transmission • Skin to skin contact (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

  39. Slide 39: Phase 2 Study (CARE) in External Genital Warts

    PHASE 2 STUDY (CARE) IN EXTERNAL GENITAL WARTS (EGW) Study comprised of two parts (A and B) Multi-center, double-blind, Dose regimen, efficacy, Study Design Primary objective of Part A is to identify the two placebo-controlled safety & tolerability best dosing regimens for evaluation in Part B Prima

  40. Slide 40: The Problem: Non-Melanoma Skin Cancer

    THE PROBLEM Non-Melanoma Skin Cancer Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE PROBLEM Non-Melanoma Skin Cancer Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  41. Slide 41: Non-Melanoma Skin Cancer Overview

    NON-MELANOMA SKIN CANCER OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Non-melanoma skin cancer includes 1 basal cell and squamous cell • Estimated 5.4 million diagnoses of basal cell (BCC) and squamous Patient population cell (SCC) carcinomas annually carcinoma • Increasing age and sun exposure are r

  42. Slide 42: Current Treatments for Non-Melanoma Skin Cancer

    DESCRIPTION LIMITATIONS • Invasive Using a scalpel to remove Surgical Excision • Can cause scarring/disfigurement, diseased tissue and healthy skin infection, pain CURRENT • Invasive, may take several rounds Used in high risk NMSC or in TREATMENTS Mohs Surgery • Can cause scarring, disfigurement spe

  43. Slide 43: The Solution: LTX-315

    THE SOLUTION LTX-315 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.THE SOLUTION LTX-315 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  44. Slide 44: 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

  45. Slide 45: Regulatory Exclusivity and Intellectual Property

    Regulatory Exclusivity and Intellectual Property Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Regulatory Exclusivity and Intellectual Property Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  46. Slide 46: 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

  47. Slide 47: 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 May prevent generics from copying our ether-free formulation or from additions and novel cantharidin formulations making similar formulati

  48. Slide 48: 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 48 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.OVERVIEW OF LTX-315 INTELLECTUAL PROPERTY PORT

  49. Slide 49: Our Product Portfolio

    OUR PRODUCT PORTFOLIO NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE FDA Type A Meeting in September/October Molluscum Contagiosum 2020* Initiate pivotal Phase 3 Common Warts trials** Topline Phase 2 results External Genital Warts in 2H 2020 Initiate Phase 2 trial** Plantar Warts Non-Melanoma S

  50. Slide 50: 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

  51. Slide 51: Appendix

    Appendix Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.Appendix Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.

  52. Slide 52: 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

  53. Slide 53: 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 Copyright © 2020 Verrica Pharmace

  54. Slide 54: Board of Directors

    BOARD OF DIRECTORS Lawrence Mark Paul Ted Craig Sean Eichenfield, MD Prygocki Ballaron Manning Stalfort White Director Director Director Chairman Director President & Chief Executive Officer 54 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved.BOARD OF DIRECTORS Lawrence Mark Paul Ted Cr

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