Verrica Pharmaceuticals Inc. · NASDAQ:VRCA

Verrica Pharmaceuticals — Investor Presentation (August 2024)

59 slides from Verrica Pharmaceuticals's investor presentation, August 2024

  1. Slide 1: Company Overview

    Not For Promotional Use Company Overview August 2024 Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.

  2. Slide 2: Disclaimer

    Not For Promotional Use Disclaimer Certain information contained in this presentation and statements made orally during this expectations about third-party payors to reimburse or patients to pay for YCANTH (VP-102) for the presentation relates to or is based on studies, publications, surveys and oth

  3. Slide 3: Verrica Is A Dermatology Therapeutics Company Developing Medications For Skin Diseases

    Not NotFor ForPromotional PromotionalUse Use Verrica Is A Dermatology Therapeutics Company Developing Medications For Skin Diseases Requiring Medical Intervention Focused On Reinventing Clinician-administered Dermatology Therapies and High Unmet Therapeutics Needs With a Focus On Focus On Products W

  4. Slide 4: Our Product Candidate Portfolio

    Not For Promotional Use Our Product Candidate Portfolio: NEAR-TERM CATALYSTS/ PRE-IND PHASE 2 PHASE 3 NDA EXPECTED MILESTONES Molluscum Contagiosum YCANTH **APPROVED** Initiation of Global Pivotal Common Warts Phase 3 trial expected H1 2025 [a] VP-102 External Genital Warts Initiate Phase 3 trial [b

  5. Slide 5: Focused on Largest Unmet Needs in Dermatology

    Not For Promotional Use Focused on Largest Unmet Needs in Dermatology YCANTH for Molluscum VP-102 for Common Warts VP-315 for Nonmetastatic Skin Cancer Approved in July 2023 Fir st Patient Dosed in Global Phase End-of-Phase 2 Meeting Expected H1 3 with Data Expected H1 2025 2025 Diagnosed Diagnosed

  6. Slide 6: Comprehensive Regulatory, IP and Manufacturing Strategy to Maintain YCANTH Exclusivity

    Not For Promotional Use Comprehensive Regulatory, IP and Manufacturing Strategy to Maintain YCANTH Exclusivity; VP-315 COM-Issued Protection Patent applications on: Regulatory 5 years NCE exclusivity for cantharidin as API granted; potential for • Specific formulation Exclusivity; additional 6 month

  7. Slide 7: Extensive Issued and Pending Patents Covering VP-315 from 2029-2044

    Not For Promotional Use Extensive Issued and Pending Patents Covering VP-315 from 2029-2044 PCT/EP2009/006774; composition-of-matter (COM) patent, granted • Expires 2032 (US) • Expires 2029 (Europe(1), Japan, AU, BR, CA, CN, IN, JP, KR, NZ, RU, and SG) PCT/EP2017/052279; methods-of-use patent, pendi

  8. Slide 8: Management Team with Extensive Product Launch and Dermatology Experience

    Not For Promotional Use 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 Select Product Launches Copyright © 20

  9. Slide 9: Basal Cell Carcinoma

    Not For Promotional Use Basal Cell Carcinoma THE POTENTIAL SOLUTION: VP-315 Status: End of Phase 2 Meeting Expected H1 2025 Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 9

  10. Slide 10: Basal Cell Carcinoma (BCC) Disease Overview

    Not For Promotional Use Basal Cell Carcinoma (BCC) Disease Overview BCC is characterized by slow, locally invasive growth that can be destructive of skin and surrounding tissues Overview  BCC is the most common cancer (3.6 M(1) US cases diagnosed per year), with increasing incidence rates worldwide

  11. Slide 11: Basal Cell Carcinoma Treatment Segmentation

    Not For Promotional Use Basal Cell Carcinoma Treatment Segmentation BCC is typically segmented by disease progression, location, tumor subtype, and age, with risk of recurrence (low vs. high) typically correlated with multiple segmentation criteria Stage(1,2) Tumor Location(3) Tumor Subtype(4) Age(5

  12. Slide 12: Current Treatment Landscape of Basal Cell Carcinoma in the U.S.

    Not For Promotional Use Current Treatment Landscape of Basal Cell Carcinoma in the U.S. Surgical and non-surgical alternatives have limitations  Mohs micrographic surgery is considered the most Non-Surgical effective technique for treating BCCs(1) with 700K+ Treatments procedures in the U.S. annual

  13. Slide 13: Projected Global BCC Market

    Not For Promotional Use Basal Cell Carcinoma Market Analysis(1) 2028 2021 Projected Estimated Global BCC 2021-2028 Global BCC CAGR Market 7.9% Market $6.7B $11.5B 1) 2022 Coherent Market Insights Pvt Ltd. All rights reserved. Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 13

  14. Slide 14: VP-315 A Potential Non-Surgical Alternative

    Not For Promotional Use VP-315 A Potential Non-Surgical Alternative Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 14

  15. Slide 15: VP-315 for Basal Cell Carcinoma

    Not For Promotional Use VP-315 for Basal Cell Carcinoma Large Estimated Market Size Favorable Safety Profile Non-invasive Treatment Option  Patient receives injections over the  3.6+ million new cases of basal  No SAEs course of 2 or 3 days cell carcinoma annually Few mild-to-moderate treatment 

  16. Slide 16: VP-315 is an oncolytic molecule designed from host defense peptide

    Not For Promotional Use VP-315 is an oncolytic molecule designed from host defense peptide VP-315 HAS A DUAL MODE OF ACTION: DIRECT KILLING AND IMMUNE MODULATION  VP-315 composed of 5 cationic residues and 4  VP-315 shows specificity for cancer cells lipophilic residues, including one synthetic ov

  17. Slide 17: VP-315 Dual Mechanism of Action

    Not For Promotional Use VP-315 Dual Mechanism of Action 1 Dendritic cell Local Killing of Cancer Cells VP-315 2. Release of immune-activating molecules Effective exposure of tumor antigens (mutated proteins) 1. 2 Activation of dendritic cells (antigen Lymph presenting cells) node Through direct and

  18. Slide 18: VP-315 Phase 2 Clinical Study Design

    Not For Promotional Use VP-315 Phase 2 Clinical Study Design Open label proof of concept study to assess safety & tolerability, dose regimen, efficacy Study comprised of two parts (Part 1 and Part 2); primary objective of Part 1 was to assess the maximal tolerated dose for Part 2 Part 1  Designed t

  19. Slide 19: VP-315 Phase 2 Design and Preliminary Results

    Not For Promotional Use VP-315 Phase 2 Design and Preliminary Results Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 19

  20. Slide 20: VP-315 Phase 2 BCC: Preliminary Efficacy Results

    Not For Promotional Use VP-315 Phase 2 BCC: Preliminary Efficacy Results 51% Complete Clearance Rate of Basal Cell Carcinomas 71% Reduction in Tumor Size of Patients with Residual Carcinomas 86% Overall Reduction of Tumor Size 1) Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 20

  21. Slide 21: VP-315 Phase 2 BCC: Preliminary Efficacy Data

    Not For Promotional Use VP-315 Phase 2 BCC: Preliminary Efficacy Data COMPLETE HISTOLOGIC HISTOLOGIC REDUCTION IN OVERALL REDUCTION OF TUMOR SIZE COHORT CLEARANCE RESIDUAL TUMOR SIZE (ALL SUBJECTS) 1 71% 93% 98% (n=7) (n=7) (n=7) 2 33% 83% 88% (n=3) (n=3) (n=3) 4 53% 72% 87% (n=38) (n=37) (1) (n=37)

  22. Slide 22: VP-315 Phase 2 BCC: Preliminary Safety and Tolerability Results

    Not For Promotional Use VP-315 Phase 2 BCC: Preliminary Safety and Tolerability Results No treatment-related serious adverse events (SAEs) were reported Most treatment-related adverse events (TRAEs) were mild to moderate and expected Expected cutaneous reactions were observed Copyright © 2024 Verric

  23. Slide 23: VP-315 Phase 2 BCC: Preliminary Safety and Tolerability Data

    Not For Promotional Use VP-315 Phase 2 BCC: Preliminary Safety and Tolerability Data Top 5 Adverse Events from Part 2 of Phase 2 clinical trial of VP-315 for the treatment of basal cell carcinoma PRELIMINARY TREATMENT EMERGENT ADVERSE EVENTS (EXCLUDING CUTANEOUS INJECTION SITE REACTIONS) (N=82 SUBJE

  24. Slide 24: Preliminary Data and Market Research Support Use of VP-315 as a Potential 1L Treatment

    Not For Promotional Use Preliminary Data and Market Research Support Use of VP-315 as a Potential 1L Treatment for Basal Cell Carcinoma Based on primary market research conducted utilizing target product profiles, surveyed physicians believe VP-315 has the potential to be utilized as a first line th

  25. Slide 25: VP-315: First Line Treatment Potential

    Not For Promotional Use Preliminary Data and Market Research Support Use of VP-315 as a Potential 1L Treatment for Basal Cell Carcinoma (Continued) Based on primary market research conducted utilizing target product profiles, surveyed physicians believe VP-315 has the potential to be utilized as a f

  26. Slide 26: Anticipated Next Steps on VP-315

    Not For Promotional Use Anticipated Next Steps on VP-315 3Q 2024 Database lock 4Q 2024 Clinical Study Report 1Q 2025 Genomic and T-cell (immune response) data 1H 2025 FDA End-of-Phase 2 meeting Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 26

  27. Slide 27: YCANTH (cantharidin) topical solution 0.7%: The First FDA Approved Product for Molluscum

    Not For Promotional Use YCANTH (cantharidin) topical solution 0.7% The First FDA Approved Product for Molluscum Contagiosum Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 27

  28. Slide 28: YCANTH Drug-device Combination Product Delivered Via a Single-use Applicator

    Not For Promotional Use YCANTH (cantharidin, 0.7%) Drug-device Combination Product Delivered Via a Single-use Applicator DESIGNED FOR RELIABLE, AND TARGETED ADMINISTRATION Topical solution in a single-use applicator • Active ingredient cantharidin (0.7%) in a proprietary topical formulation • Single

  29. Slide 29: Molluscum Background

    Not For Promotional Use Molluscum Background Etiology and Clinical Presentation TRANSMISSIO N Overview • Skin to skin contact • Caused by a pox virus • Sharing of contaminated objects (e.g., clothing, towels, swimming pool toys) • Primarily infects children, with the highest incidence occurring in c

  30. Slide 30: Other Non-FDA Approved Treatments for Molluscum Have Many Limitations

    Not For Promotional Use Other Non-FDA Approved Treatments DESCRIP TIO N LIMITATIO NS for Molluscum Have Cryotherapy Freezing the lesions • Pain and scarring Many Limitations with liquid nitrogen • May be unsuitable for use in children Using a curette or a surgical • Pain and scarring • Broad use lim

  31. Slide 31: Methods in two Phase 3 Trials, CAMP-1 & CAMP-2, in Molluscum Contagiosum

    Not For Promotional Use Methods in two Phase 3 Trials, CAMP-1 & CAMP-2, in Molluscum Contagiosum1,2 • YCANTH was studied in two randomized, double-blind, placebo-controlled phase 3 trials, Trial 1 and Trial 2 (n =wo 266, and ndesigned, identically = 262, respectively) in subjects 2 years and older w

  32. Slide 32: Phase 3 Studies Demonstrated Favorable Activity in Complete Clearance and Reducing Lesions

    Not For Promotional Use Phase 3 Studies Demonstrated Favorable Activity in Complete Clearance and Reducing Lesions Phase 3 Studies for Molluscum Demonstrate Statistically Significant Phase 3 Studies for Molluscum Demonstrate Statistically Significant Activity on Primary Endpoint of Percentage of Sub

  33. Slide 33: Application Site Adverse Reactions Leading to Discontinuation of Study Drug

    Not For Promotional Use Application Site Adverse Reactions Leading to Discontinuation of Study Drug (Pooled, Safety Population)1 VP-102 Vehicle N (%) (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

  34. Slide 34: YCANTH Commercialization and Product Launch

    Not For Promotional Use YCANTH (cantharidin) topical solution 0.7% Commercialization and Product Launch Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 34

  35. Slide 35: Realizing the Molluscum Opportunity

    Not For Promotional Use Realizing the Molluscum Opportunity US PREVAL EN CE OF 15% Diagnosed ~6 million in 0.9 million molluscum(1) US PREVAL EN CE WITH ~1 million diagnosed annually(2) 85% Not Diagnosed 5.1 million 1) Prevalence in the US of 5.1% to 11.5% in children aged 0-16 years. (Fam Pract. 20

  36. Slide 36: Favorable Reimbursement Landscape

    Not For Promotional Use Favorable Medical Benefit Advantages Over Pharmacy Benefit Reimbursement Landscape MEDICAL BENEFIT PHARMACY BENEFIT • Over 200 Million Lives Reimbursement for products More common Less common Covered commercially, administered in office by HCP through state Medicaid programs,

  37. Slide 37: Integrated Commercial Approach with Multiple Strategic Levers

    Not For Promotional Use Integrated Commercial Approach with Multiple Strategic Levers COMMERCIAL STRATEGY Brand KOL Specialized Dedicated Buy-and-Bill / Awareness Engagement Sales Team Institutional Team Specialty Pharmacy Drive YCANTH Established relationships Targeting office-based Specialists to

  38. Slide 38: Total of 78 YCANTH sales representatives

    Not For Promotional Use Total of 78 YCANTH sales representatives 48 office-based representatives targeting dermatologists targeting Pediatric 10 dedicated institutional representatives Dermatologists and focusing on Health Systems Dermatologists, Health 20 dedicated pediatric representatives Systems

  39. Slide 39: Physicians will have a choice of Distribution Model

    Not For Promotional Use Physicians will have a choice of Distribution Model BUY-AND-BILL SPECIALTY PHARMACY HCP Reimbursement Permanent J-code Permanent J-code (J7354) effective April 1, 2024 No Office visit fee Yes Yes Lesion destruction Yes Yes (CPT 17110, 17111) Yes, typically 6%-10% of ASP Margi

  40. Slide 40: Common Warts

    Not For Promotional Use Common Warts THE POTENTIAL SOLUTION: Status: Initiation of Global Phase 3 Trial Expected H1 2025 Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 40

  41. Slide 41: Verruca Vulgaris (Common Warts)

    Not For Promotional Use Verruca Vulgaris Etiology and Clinical Presentation (Common Warts) TRANSMISSIO N Overview • Skin to skin contact • Touching of contaminated objects • Caused by human papilloma virus (HPV) DIAGNO SIS & SYMPTOMS • Infects patients of all ages • Dome shaped flesh-colored • Persi

  42. Slide 42: We Have Successfully Completed a Phase 2 Study (COVE-1) in Common Warts

    We Have Successfully Completed a Phase Not For Promotional Use 2 Study (COVE-1) in Common Warts Open label study Cohort 1: one center Study Design Efficacy, safety & tolerability with two cohorts Cohort 2: four centers Primary Secondary Percent of subjects with complete clearance of Percent of subje

  43. Slide 43: YCANTH (VP-102) Demonstrated Clinically Meaningful Activity on Primary Endpoint in COVE-1

    Not For Promotional Use YCANTH (VP-102) Demonstrated Clinically Meaningful Activity on Primary Endpoint of Complete Clearance in COVE-1 Study1 1) Guenthner 2019 Fall Clinical Dermatology Symposium Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 43

  44. Slide 44: Adverse Events in COVE-1 Study (Incidence≥5%)

    Not For Promotional Use Adverse Events in COVE-1 Study (Incidence≥5%)1,* 1) Guenthner 2019 Fall Clinical Dermatology Symposium Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 44

  45. Slide 45: External Genital Warts

    Not For Promotional Use External Genital Warts THE POTENTIAL SOLUTION: Status: Timing of Phase 3 Study to be determined Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 45

  46. Slide 46: Condyloma Acuminatum (Genital Warts)

    Not For Promotional Use Condyloma Acuminatum Etiology and Clinical Presentation (Genital Warts) Overview TRANSMISSION • Skin to skin contact • Caused by human papilloma virus (HPV) • Spread through sexual contact • Lesions on the surface of the skin in the genital and perianal regions DIAGNOSIS & SY

  47. Slide 47: Phase 2 Study (CARE-1) in External Genital Warts (EGW)

    Not For Promotional Use Phase 2 Study (CARE-1) in External Genital Warts (EGW) Dose regimen, Study comprised of two parts (A and B) Multi-center, double-blind, Study Design vehicle-controlled efficacy, safety & Primary objective of Part A is to identify the two tolerability best dosing regimens for

  48. Slide 48: Efficacy Results (CARE-1, ITT Population)

    Not For Promotional Use Efficacy Results (CARE-1, ITT Population) Percentage of Subjects with Complete Clearance of all Mean Percentage Change in EGW Lesions from Baseline1 Baseline and New Treatable EGW Lesions⸸ VP-102 Vehicle VP-102 Vehicle 100 6-hour 6-hour 24-hour 24-hour 90 (n=30) (n=24) (n=27)

  49. Slide 49: Safety Results: Treatment Emergent Adverse Events (CARE-1)

    Not For Promotional Use Safety Results: 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 TEAE 29 (100.0) 15 (68.2) 28 (100.0) 9 (45.0) Application si

  50. Slide 50: Corporate Summary and Highlights

    Not For Promotional Use Corporate Summary and Highlights  Execution of YCANTH for treatment of molluscum contagiosum launch; first FDA As of June 30, 2024 approved therapy for molluscum, which impacts ~6 million(1) annually in the U.S.; J- Code effective April 2024; NCE status and Orange Book listi

  51. Slide 51: YCANTH US Prescribing Information

    Not For Promotional Use YCANTH (cantharidin) topical solution 0.7% US Prescribing Information Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 51

  52. Slide 52: U.S. Prescribing Information

    Not For Promotional Use U.S. Prescribing Information Highlights of YCANTH Prescribing Information and associated Important Safety Information shown in the table below HIGHLIGHTS OF PRESCRIBING INFORMATION Indications and Usage YCANTH is indicated for the topical treatment of molluscum contagiosum in

  53. Slide 53: Warnings and Precautions

    Not For Promotional Use Warnings and Precautions • Toxicities Associated with Inappropriate Administration: Life threatening or fatal toxicities can occur if administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes

  54. Slide 54: Molluscum Clinical Evidence

    Not For Promotional Use Molluscum Clinical Evidence Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 54

  55. Slide 55: Cantharidin Elicits a Dual Response in the Skin

    Not For Promotional Use Cantharidin Elicits a Dual Response in the Skin 1 Superficial blistering of lesional skin 2 Elicits Inflammation & Immune Cantharidin is a vesicant, causing the Response pharmacodynamic response of blistering in the skin. Cantharidin stimulates leukocyte infiltration (e.g., O

  56. Slide 56: Significant Clinical Progress of YCANTH (VP-102) for the Treatment of Molluscum

    Not For Promotional Use 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 • Conducted under SPA of VP-102

  57. Slide 57: Demographics in Phase 3 Trials

    Not For Promotional Use 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)

  58. Slide 58: Safety Results Summary for Molluscum Phase 3 Trials

    Not For Promotional Use 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 Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. 58

  59. Slide 59: Overview of YCANTH, VP-102/103 Intellectual Property Portfolio

    Not For Promotional Use Overview of YCANTH , VP-102/103 Intellectual Property Portfolio KEY CLAIMS AND PATENT APPLICATIONS GRANTED US PATENTS AND EXPIRATION VALUE TO VERRICA Novel cantharidin formulations and our specific formulation of YCANTH May prevent generics from copying our ether-free formula

Verrica Pharmaceuticals — Investor Presentation (August 2024) on 6ix