Verrica Pharmaceuticals Inc. · NASDAQ:VRCA

Verrica Pharmaceuticals — Investor Presentation (September 2022)

68 slides from Verrica Pharmaceuticals's investor presentation, Sep 14, 2022

  1. Slide 1: Company Overview

    Company Overview September 14, 2022 Copyright © 2022 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: Reinventing dermatology therapeutics with a focus on development and commercialization

    Reinventing dermatology therapeutics with a focus on development and commercialization Focused on Clinician-Administered Therapies and High Unmet Needs Focus on products with potential for reimbursement as a Medical Benefit Providing meaningful benefit for people living with skin diseases Copyright

  4. Slide 4: Investment Highlights

    Investment Highlights NEAR TERM CATALYSTS Expect to resubmit NDA for VP-102 for Molluscum Contagiosum in Q1 2023 with potential approval/launch in H2 2023 (U.S. Prevalence of Molluscum Contagiosum ~6M1) Conclusion of Part 1 of 3 Part PH2 study on LTX-315 for Basal Cell Carcinoma expected in Q1 2023

  5. Slide 5: 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 May 2022 as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceuticals Services, LLC (Sterling) a contract manufacturing organization (CMO) that manu

  6. Slide 6: Commitment and Focus within Medical Dermatology

    Commitment and Focus within Medical Dermatology OFFICE ADMINISTERED THERAPIES Expertise of a trained Health Care Professional Guaranteed Patient Adherence MEDICAL BENEFIT VS PHARMACY BENEFIT PRODUCTS Beneficial reimbursement landscape Favorable access at launch PARTNERSHIP WITH DERMATOLOGY Unique di

  7. Slide 7: VP-102 in Development to Address Two of the Largest Unmet Needs in Dermatology

    VP-102 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 2

  8. Slide 8: LTX-315 has the potential to impact the care of 5.4MM patients annually

    LTX-315 has the potential to impact the care of 5.4MM patients annually Nonmelanoma skin cancer includes basal cell (BCC) and squamous cell carcinoma (SCC) BCC is the most common malignancy in US populations1 LTX-315 will focus on BCC as its primary indication with opportunities to expand to SCC and

  9. Slide 9: Our Product Portfolio

    Our Product Portfolio Pre-IND Phase 2 Phase 3 NDA Next Expected Milestone VP-102 Molluscum Contagiosum NDA resubmission: Q1 2023 VP-102 External Genital Warts Initiate Phase 3 in 1H 2024 Common Warts Evaluate potential second Phase 2 trial LTX-315 Dermatological Oncology Phase 2 first patient dosed:

  10. Slide 10: The Problem: Molluscum Contagiosum

    THE PROBLEM Molluscum Contagiosum

  11. Slide 11: Molluscum Background

    Molluscum Background 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 Often leads to anxiety and social

  12. Slide 12: 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

  13. Slide 13: The Potential Solution VP-102

    THE POTENTIAL SOLUTION VP-102

  14. Slide 14: VP-102 (cantharidin) topical solution 0.7%

    VP-102 (cantharidin) topical solution 0.7% Topical solution in a single-use applicator Therapeutic class: Vesicant Active ingredient cantharidin (0.7%) in a unique topical formulation Single-use applicator to reduce cross-contamination and facilitate application of the topical solution Small opening

  15. Slide 15: Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) Completed

    We Have Successfully Completed Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) In Molluscum Population Trial Design Endpoints Application Two identically designed, randomized, double-blinded, multicenter, placebo controlled trials Primary: Percent of subjects with complete clearance of molluscum at Day

  16. Slide 16: Phase 3 Studies Demonstrated Favorable Tolerability and Activity

    Phase 3 Studies Demonstrated Favorable Tolerability and Activity in Complete Clearance 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

  17. Slide 17: MC Commercial Opportunity

    MC Commercial Opportunity

  18. Slide 18: 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

  19. Slide 19: Dermatologists are Familiar with API Used in VP-102

    Dermatologists are Familiar with API Used in 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 were US ba

  20. Slide 20: Physicians are Highly Favorable to VP-102 Profile

    Physicians are Highly Favorable to 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 of admini

  21. Slide 21: VP-102 to be covered under Medical Benefit

    VP-102 to be covered under Medical Benefit and Payer Research Suggests a Favorable Reimbursement Landscape1,2 ArtSci Health Solution, Qualitative research conducted for Verrica Pharmaceuticals Inc., 2020 Real Endpoints, Qualitative research conducted for Verrica Pharmaceuticals Inc., 2019 COHORT SIZ

  22. Slide 22: Multiple Payer Research Studies Suggest Favorable Reimbursement Landscape

    Multiple Payer Research Studies Suggest Favorable Reimbursement Landscape for VP-102 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 risk of inf

  23. Slide 23: Integrated Commercial Approach with Multiple Strategic Levers

    Dedicated Institutional Team Specialists to promote to dermatologists in academic settings and group practices Integrated Commercial Approach with Multiple Strategic Levers Brand Awareness Drive VP-102 awareness through cost-efficient HCP and consumer advertising Specialized Sales Team Targeting off

  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 Reimbursed upon launch, prior to clinical review More common Less common Subject to rebates and discounts in order to obtain formulary ac

  25. Slide 25: Physicians will have a choice of Distribution Model

    Physicians will have a 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 Ye

  26. Slide 26: Pre-Commercialization Activities Ongoing

    Pre-Commercialization Activities Ongoing Poster Presentation National and Regional Meetings National and Regional Meetings Caregiver Molluscum education through digital and social tools HCP Molluscum education through congresses, speaker programs, and professional journal space Trade distribution ch

  27. Slide 27: Non-Melanoma Skin Cancer: The Problem

    Non-Melanoma Skin Cancer THE PROBLEM

  28. Slide 28: Non-Melanoma Skin Cancer

    Non-Melanoma Skin Cancer ETIOLOGY AND CLINICAL PRESENTATION Non-melanoma skin cancer includes basal cell and squamous cell carcinoma Basal cell carcinoma is the most common malignancy in humans and has a high tumor mutational burden, which is reported to be more likely to respond to certain types of

  29. Slide 29: Current Treatments For Non-Melanoma Skin Cancer

    Current Treatments For Non-Melanoma Skin Cancer1-3 Invasive procedures may lead to permanent scarring, pain, damage to healthy tissue, and recurrence NOTE Camilio Oncoimmunology 2014 Combalia Derm Practic & Concept 2020 Bailey Int J of Wom Derm 2019 Per Prescribing Information: a hedgehog pathway in

  30. Slide 30: LTX-315 Potential Solution

    LTX-315 POTENTIAL SOLUTION

  31. Slide 31: LTX-315 Overview

    LTX-315 Overview Induces Immunogenic Cell Death and a Tumor-specific Immune Response1,2 First-in-class oncolytic peptide injected directly into a tumor to induce immunogenic cell death Host Defense Peptide designed to be administered locally to tumors easily accessible for injection in the clinic3 M

  32. Slide 32: Host-defense peptides with a Dual Mechanism of Action

    Host-defense peptides are a first-line of defense with a Dual Mechanism of Action1 LTX-315 can have both a direct killing activity and immunomodulatory properties (1) Hancock RE. Cationic peptides: effectors in innate immunity and novel antimicrobials. Lancet Infect Dis. 2001;1(3):156-164. (2) Eike

  33. Slide 33: Phase 2 Open-Label Proof of Concept Study of LTX-315 in BCC

    Phase 2 Open-Label Proof of Concept Study of LTX-315 in Basal Call Carcinoma (BCC) 3 Part Study to evaluate Safety and Efficacy (1) Hancock RE. Cationic peptides: effectors in innate immunity and novel antimicrobials. Lancet Infect Dis. 2001;1(3):156-164. (2) Eike et al. 2015. (3) Mader JS, Hoskin D

  34. Slide 34: Basal Cell Carcinoma Opportunity

    Basal Cell Carcinoma Opportunity

  35. Slide 35: BCC Treatment and Demographic Landscape

    BCC Treatment and Demographic Landscape, Affecting ~3.6MM Annually 98% of BCC patients are treated with surgery (annually), ~10% of patients are treated with drug therapies1 90% of BCC patients are age 50+, of those 61% are 65 or older1 People aged 65 and older represented 16% of the US population i

  36. Slide 36: 55% of all Procedures occur in patients 65+

    55% of all Procedures occur in patients 65+ Source: IQVIA PharMetrics+. Custom research for Verrica Pharmaceuticals. Patient counts are projected estimates of the US commercially insured patient population, 2018 and 2019. APPROXIMATELY 2.4M BCC PROCEDURES ARE PREFORMED ANNUALLY BCC Procedures 2018 &

  37. Slide 37: Distribution of BCC Patients by Number of Treatments

    Majority of patients have greater than 1, but fewer than 10 treatments over 2 years AVERAGE NUMBER OF BCC RELATED TREATMENTS IS 5.6 OVER 2 YEARS (N = 188,675 PATIENTS) Source: IQVIA PharMetrics+. Custom research for Verrica Pharmaceuticals. Patient counts are projected estimates of the US commercial

  38. Slide 38: BCC creates a significant burden for the patient and the healthcare system

    BCC creates a significant burden for the patient and the healthcare system In the US, skin cancer accounts for $8.1 billion in total healthcare costs, nonmelanoma skin cancer represents 59% of the overall category2 Leading treatments for BCC are often surgical and destructive3 and may leave a lastin

  39. Slide 39: Average BCC Costs for Patients with and without Comorbidities

    Average BCC Costs for Patients with and without Relevant Comorbidities Cost of care is higher for patients with comorbid conditions 61% Increase 32% Increase 73% Increase OPPORTUNITY Source: IQVIA PharMetrics+. Custom research for Verrica Pharmaceuticals. Patient counts are projected estimates of th

  40. Slide 40: LTX-315 could play a significant role as an alternative to surgery

    LTX-315 could play a significant role as part of an alternative therapeutic regime to surgery Potential alternative to current surgical procedures like destruction, excision, or MOHS surgery Reduced out-patient and recovery costs, potentially leading to an improved total cost for many patients Decre

  41. Slide 41: VP-102 in External Genital Warts

    VP-102 in External Genital Warts

  42. Slide 42: Condyloma Acuminatum (Genital Warts) Overview

    Condyloma Acuminatum (Genital Warts) 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 million cases of EGW are newly diagnos

  43. Slide 43: Phase 2 Study (CARE-1) in External Genital Warts Patients

    Phase 2 Study (CARE-1) in External Genital Warts (EGW) Patients Study Design Endpoints Application Primary: Percent of subjects with complete clearance of all treatable warts at Day 84 Secondary: Percent of subjects achieving complete clearance of all treatable warts at days 21, 42, and 63 Multi-cen

  44. Slide 44: 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.

  45. Slide 45: Baseline EGW Characteristics (CARE-1)

    Baseline EGW Characteristics (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) 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 (

  46. Slide 46: Efficacy Results (CARE-1, ITT Population)

    Efficacy Results (CARE-1, ITT Population) Pooled data from Part A and B *P<0.001 **P≤0.0001 ** ** (1) Guenthner 2020 Winter Clinical Dermatology Symposium Mean Percentage Change in EGW Lesions from Baseline1 * Percentage of Subjects with Complete Clearance of all Baseline and New Treatable EGW Lesio

  47. Slide 47: Safety Results: Treatment Emergent Adverse Events (CARE-1)

    Safety Results: 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

  48. Slide 48: VP-102 in Common Warts

    VP-102 in Common Warts MERRICA i 0am

  49. Slide 49: Verruca Vulgaris (Common Warts) Overview

    Verruca Vulgaris (Common Warts) 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 million2 diagnosed annually Etiolog

  50. Slide 50: Phase 2 Study (COVE-1) in Common Warts Patients

    We Have Successfully Completed a Phase 2 Study (COVE-1) in Common Warts Patients Study Design Endpoints Application Cohort 1: one center Cohort 2: four centers Efficacy, safety & tolerability Open label study with two cohorts Primary Percent of subjects with complete clearance of all treatable warts

  51. Slide 51: VP-102 Demonstrated Clinically Meaningful Activity in COVE-1 Study

    VP-102 Demonstrated Clinically Meaningful Activity on Primary Endpoint of Complete Clearance in COVE-1 Study1 (1) Guenthner 2019 Fall Clinical Dermatology Symposium

  52. Slide 52: Adverse Events in COVE-1 Study

    Adverse Events in COVE-1 Study (Incidence≥5%)1,* (1) Guenthner 2019 Fall Clinical Dermatology Symposium

  53. Slide 53: Regulatory Exclusivity and Intellectual Property

    Regulatory Exclusivity and Intellectual Property

  54. Slide 54: 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

  55. Slide 55: 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

  56. Slide 56: 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

  57. Slide 57: Investor Relations— Analyst Coverage

    Investor Relations—NASDAQ: VRCA Analyst Coverage(1) Ken Cacciatore, Cowen Greg Renza, RBC Capital Markets Oren Livnat, H.C. Wainwright Serge Belanger, Needham Kemp Dolliver, Brookline Capital Markets As of June 30, 2022 Pro Forma Cash and marketable securities of $45.3M(2) Pro Forma Debt: None(2) Pr

  58. Slide 58: Investment Highlights

    Investment Highlights NEAR TERM CATALYSTS Expect to resubmit NDA for VP-102 for Molluscum Contagiosum in Q1 2023 with potential approval/launch in H2 2023 (U.S. Prevalence of Molluscum Contagiosum ~6M1) Conclusion of Part 1 of 3 Part PH2 study on LTX-315 for Basal Cell Carcinoma expected in Q1 2023

  59. Slide 59: Our Product Portfolio

    Our Product Portfolio Pre-IND Phase 2 Phase 3 NDA Next Expected Milestone VP-102 Molluscum Contagiosum NDA resubmission: Q1 2023 VP-102 External Genital Warts Initiate Phase 3 in 1H 2024 Common Warts Evaluate potential second Phase 2 trial LTX-315 Dermatological Oncology Phase 2 first patient dosed:

  60. Slide 60: 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

  61. Slide 61: Appendix

    Appendix

  62. Slide 62: Molluscum Clinical Evidence

    Molluscum Clinical Evidence

  63. Slide 63: 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

  64. Slide 64: 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

  65. Slide 65: 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

  66. Slide 66: Safety Results Summary for Molluscum Phase 3 Trials

    Safety Results 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

  67. Slide 67: YCANTH (VP-102) 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 Note: For illustrative purposes only. If approved, actual distribution channels and support services may change as strategy is finalized. Distribution model will be support

  68. Slide 68: 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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