Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Investor Presentation (May 2024)
48 slides from Verrica Pharmaceuticals's investor presentation, May 2024
Slide 1: Company Overview
Company Overview May 2024 Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.
Slide 2: Disclaimer
Not For Promotional Use Disclaimer Certain information contained in this presentation and statements made orally during Although we believe the expectations reflected in such forward-looking statements are this presentation relates to or is based on studies, publications, surveys and other data reas
Slide 3: Verrica is a dermatology therapeutics company developing medications for skin diseases
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 with Needs a focus on Focus on products with development and potential for commerciali
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 **NOW APPROVED** Initiation of Global Pivotal Common Warts Phase 3 trial expected H1 2025 [a] VP-102 External Genital Warts Initiate Phase 3 tria
Slide 5: Focused on Largest Unmet Needs in Dermatology
Not For Promotional Use Focused on Largest Unmet Needs in Dermatology YCANTH VP-102 First Patient Dosed Global PH3 expected VP-315 *NOW APPROVED* PH2 Preliminary Top-Line Results Q2 ‘24 H1 2025 Molluscum C o m m o n Wa r t s Nonmetastatic Skin Cancer US Prevalence of ~6 million(1) with US Prevalence
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 5 years NCE exclusivity for cantharidin as Patent applications on: Regulatory API granted; potential for additional 6 • Specific formulation Extensive Issued a
Slide 7: 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 Selected Launched Products Copyright ©
Slide 8: YCANTH (cantharidin) topical solution 0.7%
Not For Promotional Use YCANTH (cantharidin) topical solution 0.7% The First FDA Approved Treatment for Molluscum Contagiosum Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.
Slide 9: 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
Slide 10: Molluscum Background
Not For Promotional Use Molluscum Background Etiology and Clinical Presentation TRANSMISSION 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 ch
Slide 11: Other Non-FDA Approved Treatments for Molluscum Have Many Limitations
Not For Promotional Use Other Non-FDA Approved Treatments DESCRIPTION LIMITATIONS for Molluscum Have Cryotherapy Freezing the lesions with liquid nitrogen • Pain and scarring • May be unsuitable for use in Many Limitations children Using a curette or a surgical • Pain and scarring Curettage instrume
Slide 12: Methods in Two Phase 3 Trials, CAMP-1 & CAMP-2
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 = 266, and n = 262, respectively) in subjects 2 years and older with molluscum contagios
Slide 13: 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
Slide 14: 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 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
Slide 15: Commercialization and Product Launch
YCANTH (cantharidin) topical solution 0.7% Commercialization and Product Launch
Slide 16: Realizing the Molluscum Opportunity
Not For Promotional Use Realizing the Molluscum Opportunity US PREVALENCE OF 15% Diagnosed ~6 million in 0.9 million molluscum(1) US PREVALENCE 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. 2014
Slide 17: Dermatologists are Familiar with Cantharidin & Would Use if Available
Not For Promotional Use Dermatologists are Familiar with Cantharidin & Would Use if Available ~70% 87% Physicians who do not use Cantharidin stated Physicians reported they inaccessibility as a primary reason why they would use YCANTH if the cost of are not using(1) the drug was covered(2) (1) Pompe
Slide 18: Reimbursement Landscape
Favorable Not For Promotional Use Reimbursement Medical Benefit Advantages Over Pharmacy Benefit Landscape Medical Benefit Pharmacy Benefit • Over 228 Million Lives Covered Reimbursement for products More common Less common commercially, through state administered in office by HCP Medicaid programs,
Slide 19: 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
Slide 20: Total of 80 YCANTH sales representatives targeting Pediatric Dermatologists
Not For Promotional Use Total of 80 YCANTH 53 office-based representatives targeting ~9K sales representatives HCPs targeting Pediatric 7 dedicated institutional representatives focusing on the most important ~90 Health Systems Dermatologists and Dermatologists, Health 20 dedicated pediatric represe
Slide 21: 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
Slide 22: Basal Cell Carcinoma
Not For Promotional Use Basal Cell Carcinoma THE POTENTIAL SOLUTION: VP-315 Status: Preliminary Phase 2 Top-Line Data Expected Q2 2024 Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.
Slide 23: VP-315 Overview: Induces Immunogenic Cell Death
VP-315 Overview Not For Promotional Use Induces Immunogenic Cell Death and a Tumor-specific Immune Response1,2 OVERVIE W • 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 acce
Slide 24: Host-defense peptides with a Dual Mechanism of Action
Not For Promotional Use Host-defense peptides are a first-line of defense with a Dual Mechanism of Action1 VP-315 can have both a direct killing activity and immunomodulatory properties 1. Kills the Tumor Cells VP-315 enters the cells by disturbing cell membranes and targets mitochondria, and other
Slide 25: Phase 2 Open-Label Proof of Concept Study of VP-315 in BCC
Not For Promotional Use Phase 2 Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma (BCC) 2 Part Study to evaluate Safety and Efficacy Part 1: Dose Exploration (Completed Q1 2023) • Designed to explore the initial VP-315 safety profile when administered in escalating doses to individ
Slide 26: BCC Market Opportunity
Not For Promotional Use BCC Market Opportunity BCC creates significant burden for the patient and healthcare system • In the US, skin cancer accounts for $8.1 billion in total healthcare costs, nonmelanoma skin cancer represents 59% of the overall category3 • Majority of patients, 90%, are age 50+,
Slide 27: VP-315 could play a significant role as part of an alternative regimen to surgery
Not For Promotional Use OPPORTUNITY VP-315 could play a significant role as part of an alternative therapeutic regimen to surgery Key Commercialization Opportunities Potential alternative to current surgical Reduced out-patient and recovery costs, potentially leading to an improved total cost proced
Slide 28: 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.
Slide 29: Verruca Vulgaris (Common Warts)
Not For Promotional Use Verruca Vulgaris Etiology and Clinical Presentation (Common Warts) TRANSMISSION Overview • Skin to skin contact • Touching of contaminated objects • Caused by human papilloma virus (HPV) DIAGNOSIS & SYMPTOMS • Infects patients of all ages • Dome shaped flesh-colored • Persist
Slide 30: Successfully Completed a Phase 2 Study (COVE-1) in Common Warts
Not For Promotional Use 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 of all treatab
Slide 31: YCANTH (VP-102) Demonstrated Clinically Meaningful Activity on Primary Endpoint
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. 31
Slide 32: Adverse Events in COVE-1 Study
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. 32
Slide 33: 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.
Slide 34: 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
Slide 35: Phase 2 Study (CARE-1) in External Genital Warts
Not For Promotional Use Phase 2 Study (CARE-1) in External Genital Warts (EGW) Dose regimen, Study comprised of two parts (A and B) Study Design Multi-center, double-blind, efficacy, safety & Primary objective of Part A is to identify the two vehicle-controlled tolerability best dosing regimens for
Slide 36: Efficacy Results (CARE-1, ITT Population)
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) (n= 18) 20 80 1.24 70 *
Slide 37: 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
Slide 38: Corporate Summary and Highlights
Not For Promotional Use Corporate Summary and Highlights As of March 31, 2024 • Execution of YCANTH for treatment of molluscum contagiosum launch; • Cash and cash equivalents of $48.9M Near-term catalysts first FDA approved therapy for molluscum, which impacts ~6 million1 • Debt: $50M3 annually in t
Slide 39: Appendix
Appendix PHARMACEUTICALS
Slide 40: YCANTH US Prescribing Information
YCANTH (cantharidin) topical solution 0.7% US Prescribing Information
Slide 41: Highlights of YCANTH Prescribing Information
U.S. Prescribing Information Not For Promotional Use 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
Slide 42: 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
Slide 43: Molluscum Clinical Evidence
Molluscum Clinical Evidence
Slide 44: 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 Response Cantharidin is a vesicant, causing the Cantharidin stimulates leukocyte infiltration (e.g., pharmacodynamic response of blistering in the skin. n
Slide 45: Significant Clinical Progress of YCANTH 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 of VP-102 relative to placebo f
Slide 46: 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)
Slide 47: 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. 47
Slide 48: Overview of VP-102/103 Intellectual Property Portfolio
Not For Promotional Use Overview of 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 May prevent generics from copying our ether-free 1 of YCANTH (VP-102) US 11
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