Verrica Pharmaceuticals Inc. · NASDAQ:VRCA

Verrica Pharmaceuticals — Investor Presentation (September 2021)

60 slides from Verrica Pharmaceuticals's investor presentation, Sep 29, 2021

  1. Slide 1: Company Overview

    Company Overview September 28, 2021 Copyright © 2021 Verrica Pharmaceuticals. All rights reserved. Exhibit 99.1

  2. Slide 2: Disclaimer

    Disclaimer 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

  3. Slide 3: 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

  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 only

  5. Slide 5: Our Product Portfolio

    Our Product Portfolio Pre-IND Phase 2 Phase 3 NDA Next Expected Milestone YCANTH Molluscum Contagiosum Type A meeting to be requested with FDA Q4 2021 VP-102 Common Warts Evaluate potential second Phase 2 trial** External Genital Warts Initiate Phase 3 in 2H 2022 VP-103 Plantar Warts Initiate Phase

  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 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

  7. Slide 7: U.S. Regulatory Status of VP-102

    U.S. Regulatory Status of VP-102 Verrica received a Complete Response Letter (CRL) from the FDA in September 2021 due to open general inspection items at a contract manufacturer (CMO) that were not specific to VP-102. The Company will request a Type A meeting with the FDA in Q4 ‘21 to demonstrate th

  8. Slide 8: The Problem: Molluscum Contagiosum

    THE PROBLEM Molluscum Contagiosum Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  9. Slide 9: Molluscum Background

    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

  10. 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

  11. Slide 11: The Solution: YCANTH (VP-102)

    THE SOLUTION YCANTH™ (VP-102) Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  12. Slide 12: 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 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. GMP-controlled new formulation of 0.7% w/v cantharidin Consistent and shelf-stable Single-use applicator to

  13. Slide 13: 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 Population 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

  14. Slide 14: Molluscum History for Subjects in Phase 3 Trials

    Molluscum History for Subjects in Phase 3 Trials1 (1) Eichenfield Amer J Clin Derm 2021 VP-102 (n=310) Vehicle (n=218) Baseline Lesion Count Mean (SD) Median Range 20.5 ± 23.1 12.0 1-184 22.5 ± 22.3 15.5 1-110 Time Since Clinical Diagnosis (days) Mean (SD) Median Range 122.9 ± 200.9 25.0 1-1247 126.

  15. Slide 15: Phase 3 Efficacy on Complete Clearance vs. Vehicle

    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) (1) Eichenfield Amer J Clin Derm 2021 Copyright © 2021 Verrica Pharmaceuticals. All ri

  16. Slide 16: Phase 3 Efficacy on Percent Reduction of Lesions vs. Vehicle

    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) (1) Eichenfield Amer J Clin Derm 2021 Copyright © 2021 Verrica Pharmaceuticals. All rights reser

  17. Slide 17: Phase 3 Discontinuation Due to Treatment-Related Adverse Events

    Phase 3 Discontinuation of Study Medication Due to Treatment-Related Adverse Events1 N (%) VP-102 (N=311) Vehicle (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

  18. Slide 18: MC Commercial Opportunity

    MC Commercial Opportunity Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  19. Slide 19: 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

  20. Slide 20: Dermatologists are Familiar with API Used in YCANTH

    Dermatologists are Familiar with API Used in YCANTH™ (VP-102) & 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

  21. Slide 21: Physicians are Highly Favorable to YCANTH Profile

    Physicians are Highly Favorable to YCANTH™ (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

  22. Slide 22: Payer Research Suggests Favorable Reimbursement Landscape

    Multiple Payer Research Studies Suggest Favorable Reimbursement Landscape for YCANTH™ (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 Repr

  23. Slide 23: Payer Research Key Takeaways

    Multiple Payer Research Studies Suggest Favorable Reimbursement Landscape for YCANTH™ (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 inclu

  24. Slide 24: Medical Benefit Advantages Over Pharmacy Benefit

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

  25. Slide 25: Integrated Commercial Approach with Multiple Strategic Levers

    Integrated Commercial Approach with Multiple Strategic Levers Disease Awareness Increase treatment seekers through cost- efficient consumer advertising Dedicated Institutional Team Specialists to promote to dermatologists in academic settings and group practices Specialized Sales Team Targeting offi

  26. Slide 26: Physician Choice of Distribution Model

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

  27. Slide 27: Pre-Commercialization Activities Ongoing

    Pre-Commercialization Activities Ongoing Engagement at Premier Venues & Industry Channels Poster Presentation National and Regional Meetings National and Regional Meetings DISEASE AWARENESS Caregiver Molluscum education through digital and social tools HCP Molluscum education through congresses, spe

  28. Slide 28: VP-102 in Common Warts

    VP-102 in Common Warts Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  29. Slide 29: Verruca Vulgaris (Common Warts)

    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 U.S prevalence of 22 million1, with 1.5

  30. Slide 30: 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

  31. Slide 31: VP-102 Clinically Meaningful Efficacy in COVE-1

    VP-102 Demonstrated Clinically Meaningful Efficacy on Primary Endpoint of Complete Clearance in COVE-1 Study1 (1) Guenthner 2019 Fall Clinical Dermatology Symposium Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  32. Slide 32: Adverse Events in COVE-1 Study

    Adverse Events in COVE-1 Study (Incidence≥5%)1,* (1) Guenthner 2019 Fall Clinical Dermatology Symposium Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  33. Slide 33: VP-102 in External Genital Warts

    VP-102 in External Genital Warts Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  34. Slide 34: Condyloma Acuminatum (Genital Warts)

    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 Approximately 500,000 to 1 mil

  35. Slide 35: Phase 2 Study (CARE-1) in External Genital Warts

    Phase 2 Study (CARE-1) in External Genital Warts (EGW) Frequency of administration is every 21 days Study Design Multi-center, double-blind, vehicle-controlled Dose regimen, efficacy, safety & tolerability Endpoints Primary Percent of subjects with complete clearance of all treatable warts at Day 84

  36. Slide 36: Demographics (CARE-1, ITT Population)

    Demographics (CARE-1, ITT Population)1* VP-102 6-hour (N=30) Vehicle 6-hour (N=24) VP-102 24-hour (N=27) Vehicle 24-hour (N=18) Age Mean (SD) Min, Max 38.93 (9.9) 26, 59 35.83 (7.8) 26, 58 34.33 (7.1) 25, 53 33.83 (6.3) 25, 43 Gender, n (%) Male Female 17 (56.7) 13 (43.3) 14 (58.3) 10 (41.7) 15 (55.

  37. Slide 37: Baseline EGW Characteristics (CARE-1)

    Baseline EGW Characteristics (CARE-1, ITT Population)1* *Pooled data from Part A and B VP-102 6-hour (N=30) Vehicle 6-hour (N=24) VP-102 24-hour (N=27) Vehicle 24-hour (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

  38. Slide 38: Efficacy (CARE-1, ITT Population)

    Efficacy (CARE-1, ITT Population) Pooled data from Part A and B *P<0.001 **P≤0.0001 ** ** * (1) Guenthner 2020 Winter Clinical Dermatology Symposium Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  39. Slide 39: Safety: Treatment Emergent Adverse Events (CARE-1)

    Safety: Treatment Emergent Adverse Events (CARE-1, Safety Population)1,*, TEAEs, N (%) VP-102 6-hour (N=29) Vehicle 6-hour (N=22) VP-102 24-hour (N=28) Vehicle 24-hour (N=20) Subjects reporting at least one TEAE 29 (100.0) 15 (68.2) 28 (100.0) 9 (45.0) Application site vesicles 25 (86.2) 0 (0.0) 26

  40. Slide 40: LTX-315

    LTX-315 Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  41. Slide 41: LTX-315 Overview

    LTX-315 Overview Induces Immunogenic Cell Death and a Tumor-specific Immune Response1 OVERVIEW First-in-class oncolytic peptide that is injected directly into a tumor to induce immunogenic cell death Worldwide license in dermatological oncology2 from Lytix Biopharma in August 2020 Verrica intends to

  42. Slide 42: Non-Melanoma Skin Cancer

    Non-Melanoma Skin Cancer Non-melanoma skin cancer includes basal cell and squamous cell carcinoma Basal cell carcinoma is the most common malignancy in humans1 Common treatments are invasive, painful, can cause scarring, and may require destruction of healthy tissue ETIOLOGY AND CLINICAL PRESENTATIO

  43. Slide 43: Current Non-Melanoma Skin Cancer Treatments and Limitations

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

  44. Slide 44: Regulatory Exclusivity and Intellectual Property

    Regulatory Exclusivity and Intellectual Property Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  45. Slide 45: Several Potential Ways to Maintain Exclusivity for VP-102

    Verrica has Several Potential Ways to Maintain Exclusivity for VP-102 Regulatory Exclusivity 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) Compounding Phar

  46. Slide 46: 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 additions and novel cantharidin formulations (PCT/US2014/052184) (PCT/US2018/036353) May prevent generics from copying our ether-free form

  47. Slide 47: 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 Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  48. Slide 48: Investor Relations — Analyst Coverage

    Investor Relations—NASDAQ: VRCA Analyst Coverage(1) Ken Cacciatore, Cowen Oren Livnat, H.C. Wainwright David Steinberg, Jefferies Serge Belanger, Needham Tim Chiang, Northland Capital Markets Greg Renza, RBC Capital Markets As of June 30, 2021 Cash and marketable securities: $90M Debt: $40M Outstand

  49. Slide 49: Our Product Portfolio

    Our Product Portfolio Pre-IND Phase 2 Phase 3 NDA Next Expected Milestone YCANTH Molluscum Contagiosum Type A meeting to be requested with FDA Q4 2021 VP-102 Common Warts Evaluate potential second Phase 2 trial** External Genital Warts Initiate Phase 3 in 2H 2022 VP-103 Plantar Warts Initiate Phase

  50. Slide 50: 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

  51. Slide 51: Management Team with Extensive Product Launch and Dermatology Experience

    Management Team with Extensive Product Launch and Dermatology Experience Selected Launched Products Terry Kohler Chief Financial Officer Ted White President & Chief Executive Officer Chief Medical Officer Joe Bonaccorso Chief Commercial Officer Gary Goldenberg, MD Copyright © 2021 Verrica Pharmaceut

  52. Slide 52: Appendix

    Appendix Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  53. Slide 53: Developing dermatology products

    Developing dermatology products Providing meaningful benefit for people living with skin diseases Reinventing dermatology therapeutics by focusing on development and commercialization Late-stage dermatology therapeutics company Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  54. Slide 54: Molluscum Clinical Evidence

    Molluscum Clinical Evidence Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  55. Slide 55: 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

  56. Slide 56: Significant Clinical Progress of YCANTH for the Treatment of Molluscum

    Significant Clinical Progress of YCANTH™ (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 evalua

  57. Slide 57: Demographics in Phase 3 Trials

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

  58. Slide 58: 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) (1) Eichenfield JAMA Derm 2020 Copyright © 2021 Verrica Pharmaceuticals. All rights reserved.

  59. Slide 59: YCANTH Designed to be Clinician-Administered, Distributed Through Specialty Channels

    YCANTH™ (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 support

  60. Slide 60: 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

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