Verrica Pharmaceuticals Inc. · NASDAQ:VRCA

Verrica Pharmaceuticals — Investor Presentation (April 2022)

59 slides from Verrica Pharmaceuticals's investor presentation, Apr 7, 2022

  1. Slide 1: Company Overview

    Company Overview April 7, 2022 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved. 1

  2. Slide 2: Disclaimer

    Disclaimer Certain information contained in this presentation and statements made orally identifying words. 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 The information in this presentati

  3. Slide 3: Investment Highlights

    Investment Highlights Focused on Clinician-Administered Therapies With Potential for Reimbursement as a Medical Benefit PDUFA Goal Date of May 24, 2022 for YCANTH™ (VP-102) for the Treatment of Molluscum YCANTH™ (VP-102) Dermatological Oncology  In Development to Address Two of the Largest Unmet Ne

  4. Slide 4: Verrica: Striving to Change the Game in Medical Dermatology

    Verrica: Striving to Change the Game in Medical Dermatology  Potential first and only FDA-approved product to treat Molluscum Contagiosum  Innovative distribution model to eliminate physician cost of acquiring YCANTH  Forward-deployed based inventory model to allow physicians to pay for inventory

  5. Slide 5: Our Product Portfolio

    Our Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE YCANTH PDUFA Goal Date: Molluscum Contagiosum May 24, 2022 Initiate Phase 3 in 1H External Genital Warts 2023 [b] VP-102 Evaluate potential Common Warts [a] second Phase 2 trial [c] VP-103 Plantar Warts Initiate Phase 2 trial

  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 Molluscum Common Warts US Prevalence of ~6 million(1) with US Prevalence of ~22 million(3) with ~1 million diagnosed annually(2) ~1.5 million diagnosed annually(4) 85% 22M Prevalence in U.S. Not Diagnosed 5.1 million 1.5

  7. Slide 7: Molluscum Contagiosum

    THE PROBLEM Molluscum Contagiosum 7 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  8. Slide 8: Molluscum Background

    Molluscum Background OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Caused by a pox virus Transmission • Skin to skin contact • Sharing of contaminated objects (e.g., clothing, towels, Primarily infects children, with the swimming pool toys) highest incidence occurring in children <14 years old Diagnos

  9. Slide 9: Current Treatments for Molluscum are not FDA-Approved

    Current Treatments DESCRIPTION LIMITATIONS for Molluscum are not FDA-Approved Freezing the lesions • Pain and scarring Cryotherapy with liquid nitrogen • Unsuitable for use in children and Have Many Limitations Using a curette or a surgical • Pain and scarring Curettage instrument with a scoop at •

  10. Slide 10: YCANTH (VP-102)

    THE SOLUTION YCANTH™ (VP-102) 10 Copyright © 2022 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 app

  12. 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 Trial Design double-blinded, multicenter, placebo FDA Special Protocol study period controlled trials Assessment (SPA) Primary: Secondary: End

  13. Slide 13: Molluscum History for Subjects in Phase 3 Trials

    Molluscum History for Subjects in Phase 3 Trials1 VP-102 Vehicle (n=310) (n=218) Baseline Lesion Count Mean (SD) 20.5 ± 23.1 22.5 ± 22.3 Median 12.0 15.5 Range 1-184 1-110 Time Since Clinical Diagnosis (days) Mean (SD) 122.9 ± 200.9 126.2 ± 198.7 Median 25.0 31.5 Range 1-1247 1-1302 Previous Treatme

  14. Slide 14: Phase 3 Efficacy on Primary Endpoint of Complete Clearance

    Phase 3 Studies in Molluscum Demonstrate Statistically Significant Efficacy on Primary Endpoint of Complete Clearance vs. Vehicle1 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) 14 (1) Eichenfield Amer J Clin Derm 2021 Copyright © 2022 Verrica Pharmaceuticals. All

  15. Slide 15: Phase 3 Efficacy on Percent Reduction of Lesions

    Phase 3 Studies in Molluscum Demonstrate Statistically Significant Efficacy on Percent Reduction of Lesions vs. Vehicle1 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) 15 (1) Eichenfield Amer J Clin Derm 2021 Copyright © 2022 Verrica Pharmaceuticals. All rights re

  16. Slide 16: Phase 3 Discontinuation Due to Treatment-Related Adverse Events

    Phase 3 Discontinuation of Study Medication Due to Treatment-Related Adverse Events1 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

  17. Slide 17: MC Commercial Opportunity

    MC Commercial Opportunity 17 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  18. Slide 18: Realizing the Molluscum Opportunity

    Realizing the Molluscum Opportunity US Prevalence of ~6 million in molluscum(1) with ~1 million diagnosed annually(2) 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 estimates

  19. 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 primary reason why they are not using(1) the cost of the drug was c

  20. Slide 20: Physicians are Highly Favorable to YCANTH Profile

    Physicians are Highly Favorable to YCANTH™ (VP-102) Profile Derms and Ped Derms (1) KEY REASONS TO USE IF APPROVED 5.6 Efficacy Precise and pain free application FDA approval Convenience of administration Pediatricians (1) KEY REASONS TO USE IF APPROVED 6.3 Efficacy Fits into their current office mo

  21. Slide 21: Multiple Payer Research Studies Suggest Favorable Reimbursement Landscape

    Multiple Payer Research Studies Suggest Favorable Reimbursement Landscape for YCANTH™ (VP-102) COHORT SIZE AVERAGE LIVES COVERED Medical Directors 7 9.8M Pharmacy Directors 6 4.2M The 15 Payer Organizations and Plans Represented in the IDN 2 6.5M Interviews Cover a Total of Stakeholders 105 Million

  22. Slide 22: Payer Research Key Takeaways

    Multiple Payer Research Studies Suggest Favorable Reimbursement Landscape for YCANTH™ (VP-102) Key Takeaways 1 Payers interviewed recognize a significant unmet need for molluscum contagiosum and lack of an effective treatment 2 Some of the key concerns mentioned about the undertreatment of the condi

  23. Slide 23: Medical Benefit Advantages Over Pharmacy Benefit

    Medical Benefit Advantages Over Pharmacy Benefit Medical Benefit Pharmacy Benefit Reimbursement for products More common Less common administered in office by HCP Reimbursable upon launch prior to clinical More common Less common review Subject to rebates and discounts in order Less common More comm

  24. Slide 24: 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 Increase Strong Targeting office-based Team Pharmacy treatment seekers established and institutional Specialists

  25. Slide 25: Physician Choice of Distribution Model

    Physician Choice of Distribution Model Buy-and-Bill Specialty Pharmacy HCP Reimbursement Yes (within 1-2 quarters post-launch); Permanent J-code Reimbursed under miscellaneous J-code No until permanent J-code assigned Office visit fee Yes Yes Lesion destruction Yes Yes (CPT 17110, 17111) Margin on s

  26. Slide 26: Pre-Commercialization Activities Ongoing

    Pre-Commercialization Activities Ongoing Engagement at Premier Venues & Industry Channels DISEASE AWARENESS Caregiver Molluscum HCP Molluscum education Poster Presentation education through through congresses, digital and social speaker programs, and tools professional journal space OTHER National N

  27. Slide 27: VP-102 in External Genital Warts

    VP-102 in External Genital Warts 27 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  28. Slide 28: Condyloma Acuminatum (Genital Warts)

    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

  29. Slide 29: Phase 2 Study (CARE-1) in External Genital Warts

    Phase 2 Study (CARE-1) in External Genital Warts (EGW) Multi-center, double- Dose regimen, Study comprised of two parts (A and B) Study Design blind, vehicle- efficacy, safety & Primary objective of Part A is to identify the two controlled tolerability best dosing regimens for evaluation in Part B P

  30. Slide 30: Demographics (CARE-1, ITT Population)

    Demographics (CARE-1, ITT Population)1* 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.

  31. Slide 31: Baseline EGW Characteristics (CARE-1)

    Baseline EGW Characteristics (CARE-1, ITT Population)1* 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) 14 (51.9) 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 (

  32. Slide 32: Efficacy (CARE-1, ITT Population)

    Efficacy (CARE-1, ITT Population) Percentage of Subjects with Mean Percentage Change in EGW Complete Clearance of all Baseline Lesions from Baseline1 and New Treatable EGW Lesions⸸ VP-102 Vehicle VP-102 Vehicle 100 6-hour 6-hour 24-hour 24-hour 80 ** 10 (n=30) (n=24) 1.24 (n=27) (n= 18) 0 60 -10 -20

  33. Slide 33: Safety: Treatment Emergent Adverse Events (CARE-1)

    Safety: Treatment Emergent Adverse Events (CARE-1, Safety Population)1,*,⸸ 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) 15 (68.2) 28 (100.0) 9 (45.0) TEAE Application site vesicles 25 (86.2) 0 (0.0) 26

  34. Slide 34: VP-102 in Common Warts

    VP-102 in Common Warts 34 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  35. Slide 35: 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

  36. Slide 36: 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 Endpoints Percent of subjects with com

  37. Slide 37: 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 Study1 37 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved. (1) Guenthner 2019 Fall Clinical Dermatology Symposium

  38. Slide 38: Adverse Events in COVE-1 Study

    Adverse Events in COVE-1 Study (Incidence≥5%)1,* 38 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved. (1) Guenthner 2019 Fall Clinical Dermatology Symposium

  39. Slide 39: LTX-315

    LTX-315 39 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  40. Slide 40: LTX-315 Overview

    LTX-315 Overview Induces Immunogenic Cell Death and a Tumor-specific Immune Response1 OVERVIEW 1 Kills the Tumor Cells LTX-315 enters the cells and disturbs cell membranes, causing cell death First-in-class oncolytic peptide that is and release of a patient’s tumor specific antigens injected directl

  41. Slide 41: Non-Melanoma Skin Cancer

    Non-Melanoma Skin Cancer OVERVIEW ETIOLOGY AND CLINICAL PRESENTATION Non-melanoma skin cancer includes Patient • Estimated 5.4 million diagnoses of basal cell (BCC) and basal cell and squamous cell population1 squamous cell (SCC) carcinomas annually carcinoma • Increasing age and sun exposure are ri

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

    DESCRIPTION LIMITATIONS • Invasive Current Treatments Surgical Excision Using a scalpel to remove diseased tissue and healthy skin • Can cause scarring/disfigurement, For Non-Melanoma infection, pain Skin Cancer1-3 Used in high risk NMSC or in • Invasive, may take several rounds Mohs Surgery special

  43. Slide 43: Regulatory Exclusivity and Intellectual Property

    Regulatory Exclusivity and Intellectual Property 43 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  44. Slide 44: 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 Exclusivity for pediatric exclusivity for common warts and plantar warts indications) If VP-102 is app

  45. Slide 45: Overview of VP-102/103 Intellectual Property Portfolio

    Overview of VP-102/103 Intellectual Property Portfolio KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA 1 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 formula

  46. Slide 46: 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 46 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  47. Slide 47: Investor Relations—NASDAQ: VRCA

    Investor Relations—NASDAQ: VRCA Analyst Coverage(1) As of December 31, 2021 Ken Cacciatore, Cowen • Cash and marketable securities: $70.4M • Debt: $40M Oren Livnat, H.C. Wainwright • Outstanding shares: 27.5M Caleb Ezell, Jefferies • Outstanding option shares and RSUs: 3.9M Serge Belanger, Needham T

  48. Slide 48: Investment Highlights

    Investment Highlights Focused on Clinician-Administered Therapies With Potential for Reimbursement as a Medical Benefit PDUFA Goal Date of May 24, 2022 for YCANTH™ (VP-102) for the Treatment of Molluscum YCANTH™ (VP-102) Dermatological Oncology  In Development to Address Two of the Largest Unmet Ne

  49. Slide 49: Our Product Portfolio

    Our Product Portfolio NEXT EXPECTED PRE-IND PHASE 2 PHASE 3 NDA MILESTONE YCANTH PDUFA Goal Date: Molluscum Contagiosum May 24, 2022 Initiate Phase 3 in 1H External Genital Warts 2023 [b] VP-102 Evaluate potential Common Warts [a] second Phase 2 trial [c] VP-103 Plantar Warts Initiate Phase 2 trial

  50. Slide 50: Management Team with Extensive Product Launch and Dermatology Experience

    Management Team with Extensive Product Launch and Dermatology Experience Ted White Terry Kohler Gary Goldenberg, MD Joe Bonaccorso President & Chief Chief Financial Chief Medical Chief Commercial Executive Officer Officer Officer Officer Selected Launched Products 50 Copyright © 2022 Verrica Pharmac

  51. Slide 51: Appendix

    Appendix 51 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  52. Slide 52: Developing dermatology products

    Providing meaningful benefit for people living with skin diseases Developing Reinventing dermatology dermatology products therapeutics by focusing on development and commercialization Late-stage dermatology therapeutics company 52 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  53. Slide 53: Molluscum Clinical Evidence

    Molluscum Clinical Evidence 53 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  54. Slide 54: 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,

  55. Slide 55: 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

  56. Slide 56: Demographics in Phase 3 Trials

    Demographics in Phase 3 Trials1 VP-102 Vehicle (n=310) (n=218) Age (years) Mean (SD) 7.5 ± 6.7 6.8 ± 5.8 Median 6.0 6.0 Range 2-60 2-54 Age Group - no.(%) ≥ 2 to 5 yr 137 (44.2) 106 (48.6) ≥6 to 11 yr 140 (45.2) 89 (40.8) ≥12-18 yr 22 (7.1) 18 (8.3) ≥ 19 yr 11 (3.5) 5 (2.3) Gender – no. (%) Female 1

  57. Slide 57: Safety Summary for Molluscum Phase 3 Trials

    Safety Summary for Molluscum Phase 3 Trials1 Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) 57 (1) Eichenfield JAMA Derm 2020 Copyright © 2022 Verrica Pharmaceuticals. All rights reserved.

  58. Slide 58: YCANTH Designed to be 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 Specialty Specialty (HUB) Distributor Pharmacy • Benefits investigation/verification to determin

  59. Slide 59: Historical Compounded Cantharidin Presents a Number of Limitations

    Historical Compounded Cantharidin Presents a Number of Limitations 1 Varying 2 Inconsistent 3 Lack of concentration purity and lack reimbursement • Evaporation of volatile of controlled • Not FDA approved solvents leads to product and therefore not concentration increases manufacturing eligible for

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