Verrica Pharmaceuticals Inc. · NASDAQ:VRCA

Verrica Pharmaceuticals — Investor Presentation (April 2020)

54 slides from Verrica Pharmaceuticals's investor presentation, Apr 17, 2020

  1. Slide 1: Company Overview April 2020

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

  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

  3. 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 dermatology therapeutics company

  4. 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

  5. Slide 5: Our Product Portfolio

    OUR PRODUCT PORTFOLIO We retain exclusive, royalty-free rights to our product candidates across all indications globally Preclinical Phase 1 Phase 2 Phase 3 NDA Acceptance Next Expected Milestone VP-102 Molluscum Contagiosum PDUFA Goal Date: July 13, 2020 Common Warts Initiate pivotal Phase 3 trials

  6. 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

  7. Slide 7: The problem: Molluscum Contagiosum

    The problem Molluscum Contagiosum

  8. 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

  9. 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

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

    The solution YCANTH™ (VP-102)

  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 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

  12. Slide 12: Molluscum Clinical Evidence

    Molluscum Clinical Evidence

  13. 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

  14. Slide 14: Significant clinical progress of Ycanth (VP-102) for 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

  15. Slide 15: Two pivotal Phase 3 trials (CAMP-1 & CAMP-2) completed 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

  16. 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) VP-102 (N=311) Vehicle (N=216)

  17. 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

  18. Slide 18: Phase 3 efficacy on complete clearance primary endpoint

    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)

  19. Slide 19: Phase 3 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)

  20. 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)

  21. Slide 21: Discontinuation rates due to treatment-related adverse events

    Phase 3 Discontinuation rates due to Treatment-Related Adverse events 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 (1.9) 0 (0) Not

  22. Slide 22: MC Commercial Opportunity

    WERRICA PHARMACEUTICALS. MC Commercial Opportunity

  23. Slide 23: 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

  24. Slide 24: 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

  25. Slide 25: 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

  26. Slide 26: Initial payer research suggests favorable reimbursement landscape

    INITIAL PAYER RESEARCH SUGGESTS 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 Represented

  27. Slide 27: Payer research key takeaways

    INITIAL PAYER RESEARCH SUGGESTS 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 include the r

  28. Slide 28: 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

  29. Slide 29: Ycanth clinician administered; specialty product channel distribution

    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

  30. Slide 30: 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

  31. Slide 31: Our Opportunity in Common Warts

    Our Opportunity in Common Warts

  32. Slide 32: 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

  33. Slide 33: 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

  34. Slide 34: 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%)

  35. Slide 35: 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

  36. Slide 36: 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

  37. Slide 37: VP-102 percent change in number of common warts

    VP-102 demonstrated Clinically meaningful efficacy on Percent Change in number of common warts from baseline in COVE-1 STUDY

  38. Slide 38: Adverse events in COVE-1 study (incidence ≥5%)

    adverse events in cove-1 study (incidence≥5%)*

  39. Slide 39: Adverse events for COVE-1 by severity

    Adverse Events for Cove-1 Study by Severity (incidence≥5%)

  40. Slide 40: Discontinuation rates for COVE-1

    Discontinuation rates for Cove-1 Cohort 1 VP-102 (N=21) Cohort 2 VP-102 (N=35) Discontinued (total, N(%)) 4 (19.0%) 2 (5.7%) Lost to follow-up 2 (9.5%) 1 (2.9%) Withdrawal by subject 2 (9.5%) 0 Protocol violation 0 1 (2.9%)

  41. 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

  42. Slide 42: Our Opportunity in External Genital Warts

    Our Opportunity in External Genital Warts

  43. 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

  44. 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

  45. Slide 45: Regulatory Exclusivity and Intellectual Property

    Regulatory Exclusivity and Intellectual Property

  46. Slide 46: Several potential ways to maintain exclusivity

    VERRICA HAS SEVERAL POTENTIAL WAYS TO MAINTAIN EXCLUSIVITY Regulatory Exclusivity 5 years of exclusivity for cantharidin as API potentially available upon approval (potential for additional 6 months for pediatric exclusivity where applicable) Compounding Pharmacies If VP-102 is approved, traditional

  47. Slide 47: Overview of Intellectual Property Portfolio

    OVERVIEW OF 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) May prevent generics from copying our ether-free formulation or from making similar

  48. Slide 48: Significant recent and expected milestones

    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 Ycanth™ (VP-102) NDA submission in

  49. Slide 49: 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

  50. Slide 50: Appendix

    WERRICA PHARMACEUTICALS. Appendix Copyright © 2020 Verrica Pharmaceutical Is. All rights reserves J

  51. Slide 51: 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

  52. Slide 52: Management team with extensive product launch and dermatology experience

    MANAGEMENT TEAM WITH EXTENSIVE PRODUCT LAUNCH AND DERMATOLOGY EXPERIENCE Selected Launched Products Copyright © 2020 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

  53. Slide 53: Board of Directors

    BOARD OF DIRECTORS Sean Stalfort Director Mark Prygocki Director Gary Goldenberg, MD Director Ted White President & Chief Executive Officer Paul Manning Chairman Craig Ballaron Director

  54. Slide 54: 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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