Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Investor Presentation (July 2023)
54 slides from Verrica Pharmaceuticals's investor presentation, July 2023
Slide 1: Company Overview
Company Overview July 2023 Copyright © 2023 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: Now Approved: YCANTH - First and Only FDA-Approved Treatment for Molluscum
Not For Promotional Use Now Approved: YCANTH™ - The First and Only FDA-Approved Treatment for Molluscum Contagiosum Please see Important Safety Information and full Prescribing Information Copyright © 2023 Verrica Pharmaceuticals. All rights reserved. 3
Slide 4: Verrica is a dermatology therapeutics company
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 5: YCANTH: Striving to Change the Game in Medical Dermatology
Not For Promotional Use YCANTH™: Striving to Change the Game in Medical Dermatology The only FDA-approved product to treat Molluscum Contagiosum Innovative distribution model to eliminate physician cost of acquiring YCANTH Cloud technology allows physicians to pay for inventory only after the
Slide 6: Our Product Candidate Portfolio: YCANTH
Not For Promotional Use Our Product Candidate Portfolio: NEAR-TERM CATALYSTS/ PRE-IND PHASE 2 PHASE 3 NDA EXPECTED MILESTONES YCANTH™ Molluscum Contagiosum **NOW APPROVED** Evaluating timing of Phase Common Warts 3 trial VP-102 Evaluating timing of Phase External Genital Warts 3 trial Initiated Part
Slide 7: Focused on Largest Unmet Needs in Dermatology
Not For Promotional Use Focused on Largest Unmet Needs in Dermatology YCANTH™ VP-102 VP-315 *NOW APPROVED* PH3 READY PH2 IN-PROGRESS Molluscum C o m m o n Wa r t s Nonmetastatic Skin Cancer US Prevalence of ~6 million(1) with US Prevalence of ~22 million(3) US Prevalence of ~5.4M cases annually(5) ~
Slide 8: Comprehensive Regulatory, IP and Manufacturing Strategy to Maintain Exclusivity
Not For Promotional Use Comprehensive Regulatory, IP and Manufacturing Strategy to Maintain YCANTH™ Exclusivity; VP-315 COM-Issued Protection 5 years of exclusivity for cantharidin as API Patent applications on: Regulatory potentially available upon approval • Specific formulation Extensive Issued a
Slide 9: 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 10: YCANTH (cantharidin) topical solution 0.7%
Not For Promotional Use YCANTH™ (cantharidin) topical solution 0.7% The First and Only FDA Approved Treatment for Molluscum Contagiosum Copyright © 2023 Verrica Pharmaceuticals. All rights reserved.
Slide 11: 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
Slide 12: Current Treatments for Molluscum are Not FDA-Approved and Have Many Limitations
Not For Promotional Use Current Treatments for Molluscum are Not DESCRIP TIO N LIMITATIO NS FDA-Approved and Cryotherapy Freezing the lesions with liquid nitrogen • Pain and scarring • May be unsuitable for use in Have Many Limitations children Using a curette or a surgical • Pain and scarring Curet
Slide 13: YCANTH Drug-device Combination Product Delivered Via 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 TARGE TED ADMINISTRATIO N Topical solution in a single-use applicator • Active ingredient cantharidin (0.7%) in a proprietary topical formulation • Sin
Slide 14: 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 15: 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 16: 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 17: Commercialization and Product Launch
YCANTH™ (cantharidin) topical solution 0.7% Commercialization and Product Launch
Slide 18: 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. 2
Slide 19: 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) Pomp
Slide 20: Physicians are Highly Favorable to YCANTH Profile
Not For Promotional Use Physicians are Highly Favorable to YCANTH™ Profile Derms and Ped Derms (1) KEY REASONS TO USE 5.6 Efficacy Precise and pain free application FDA approval Convenience of administration Pediatricians (1) 6.3 Efficacy Fits into their current office model Frustrated with not trea
Slide 21: Payer Research Suggests a Favorable Reimbursement Landscape
Not For Promotional Use Payer Research Suggests a Favorable Reimbursement Landscape1,2 Medical Directors, Pharmacy Directors, and IDN Stakeholders Research findings • Payers recognize the unmet need for treatment of molluscum due to the lack of FDA approved therapies • Based on market research and l
Slide 22: Medical Benefit Advantages Over Pharmacy Benefit
Not For Promotional Use Medical Benefit Advantages Over Pharmacy Benefit Medical Benefit Pharmacy Benefit Reimbursement for products More common Less common administered in office by HCP Reimbursed upon launch, More common Less common prior to clinical review Subject to rebates and discounts in orde
Slide 23: Integrated Commercial Approach with Multiple Strategic Levers
Not For Promotional Use Integrated Commercial Approach with Multiple Strategic Levers COMMERCIAL STRATEG Y Brand KOL Specialized Dedicated Buy-and-Bill / Awareness Engagement Sales Team Institutional Team Specialty Pharmacy Drive YCANTH™ Established relationships Targeting office-based Specialists t
Slide 24: Verrica has Cleared a Critical Milestone in Commercial Readiness
Not For Promotional Use Verrica has Cleared Employment offers have been extended to 90% of Sales Organization a Critical Milestone in 50 office-based representatives will join Commercial Readiness the organization August 7th 50 Office-Based Representatives calling on ~9K HCPs, covers 85% of the targ
Slide 25: Launch of Now Approved Brand Awareness Campaigns
Not For Promotional Use Launch of Now Approved Brand Awareness Campaigns YCANTH will employ a multi-channel strategy to support HCP WEBSITE INTERACTIVE VISUAL AID physicians and patients along their disease journey to treatment Full media launch will align with commercial supply (Q3 2023). Additiona
Slide 26: 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 Yes (within 1-2 quarters post-launch); Permanent J-code Reimbursed under miscellaneous J-code No until permanent J-code assigned Office visit fee Yes Yes Lesion destruction Y
Slide 27: YCANTH Pricing Strategy
Not For Promotional Use YCANTH™ Pricing Strategy Wholesale Acquisition Cost (WAC) for YCANTH™ expected to be $685 per applicator WAC for YCANTH™ was determined following comprehensive review of significant third- party research, including, but not limited to: Rounds of market research and quan
Slide 28: Basal Cell Carcinoma
Not For Promotional Use Basal Cell Carcinoma THE POTENTIAL SOLUTION VP-315 Copyright © 2023 Verrica Pharmaceuticals. All rights reserved.
Slide 29: VP-315 Overview
Not For Promotional Use VP-315 Overview Induces Immunogenic Cell Death and a Tumor-specific Immune Response1,2 OVERV IE 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 acc
Slide 30: 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 31: 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 32: 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 33: VP-315 could play a significant role as alternative 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 Potential for decreased risk of scaring, improved post-treatment recovery outlook procedures
Slide 34: VP-102 in Common Warts
Not For Promotional Use VP-102 in Common Warts Copyright © 2023 Verrica Pharmaceuticals. All rights reserved.
Slide 35: 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
Slide 36: Successfully Completed 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 37: VP-102 Demonstrated Clinically Meaningful Activity in COVE-1
Not For Promotional Use VP-102 Demonstrated Clinically Meaningful Activity on Primary Endpoint of Complete Clearance in COVE-1 Study1 (1) Guenthner 2019 Fall Clinical Dermatology Symposium Copyright © 2023 Verrica Pharmaceuticals. All rights reserved. 37
Slide 38: 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 © 2023 Verrica Pharmaceuticals. All rights reserved. 38
Slide 39: VP-102 in External Genital Warts
Not For Promotional Use VP-102 in External Genital Warts Copyright © 2023 Verrica Pharmaceuticals. All rights reserved.
Slide 40: Condyloma Acuminatum (Genital Warts)
Not For Promotional Use Condyloma Acuminatum Etiology and Clinical Presentation (Genital Warts) Overview TRANSMISSIO N • 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 DIAGNO SIS &
Slide 41: 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 42: 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 43: 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 44: Corporate Summary and Highlights
Not For Promotional Use Corporate Summary and Highlights • Cash & cash equivalents as of 3/31/23: $60M • $47.2M Added July 20233 • U.S. commercial launch of YCANTH™ for treatment of molluscum Near-term catalysts contagiosum in Q3 2023; first and only FDA approved therapy for • Pro Forma Debt: $50M3
Slide 45: Appendix
Appendix PHARMACEUTICALS
Slide 46: YCANTH US Prescribing Information
YCANTH™ (cantharidin) topical solution 0.7% US Prescribing Information
Slide 47: 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 48: 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 49: Molluscum Clinical Evidence
Molluscum Clinical Evidence
Slide 50: 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 51: Significant Clinical Progress of YCANTH (VP-102) for 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
Slide 52: 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 53: 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 © 2023 Verrica Pharmaceuticals. All rights reserved. 53
Slide 54: 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 VALUE TO VERRICA Our specific formulation, YCANTH™ (VP-102), key safety 1 additions and novel cantharidin formulations May prevent generics from copying our ether-free formulation or fro
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