Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Investor Presentation (February 2023)
52 slides from Verrica Pharmaceuticals's investor presentation, Feb 2, 2023
Slide 1: Company Overview February 2023
Company Overview February 2023 Copyright © 2023 Verrica Pharmaceuticals. All rights reserved. Exhibit 99.1
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
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
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. Our New Approach to a Challenging Skin Cancer Statistic. The Skin Cancer Foundation. https://www.skincancer.org
Slide 5: Our Product Candidate Portfolio: VP-102, VP-315, and VP-103
Our Product Candidate Portfolio: VP-102, VP-315, and VP-103 Pre-IND Phase 2 Phase 3 NDA NeAR-TERM CATALYSTS/ Expected Milestones VP-102 Molluscum Contagiosum Expected PDUFA Goal Date: 2H 2023 VP-102 External Genital Warts Initiate Phase 3 in 2H 2024 Common Warts Evaluate potential second Phase 2 tri
Slide 6: VP-102 Targeting Two of the Largest Unmet Needs in Dermatology
VP-102 Targeting 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
Slide 7: VP-315 In Development to Address Two Most Common Types of Skin Cancer
VP-315 In Development to Address Two Most Common Types of Skin Cancer (1)www.skincancer.org/skin-cancer-information/skin-cancer-facts/ VP-315 has the potential to impact the care of 5.4MM nonmetastatic skin cancer cases annually1 VP-315 1.8M1 Squamous cell carcinoma (SCC) 3.6M1 Basal cell carcinoma
Slide 8: Innovative Commercial Plan: Buy-and-Bill Distribution and Payment Model
Innovative Commercial Plan: Commitment and Focus within Medical Dermatology via “Buy-and-Bill” Distribution and Payment Model OFFICE ADMINISTERED THERAPIES Expertise of a trained Health Care Professional Guaranteed Patient Adherence MEDICAL BENEFIT VS PHARMACY BENEFIT PRODUCTS Beneficial reimburseme
Slide 9: Comprehensive Regulatory, IP and Manufacturing Strategy to Maintain VP-102 Exclusivity
Comprehensive Regulatory, IP and Manufacturing Strategy to Maintain VP-102 Exclusivity; VP-315 COM-Issued Protection Regulatory Exclusivity; Patent Portfolio 5 years of exclusivity for cantharidin as API potentially available upon approval (potential for additional 6 months for pediatric exclusivity
Slide 10: 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 Copyright © 2023 Verrica Pharmaceut
Slide 11: The Potential Solution: VP-102 Molluscum Contagiosum
THE POTENTIAL SOLUTION VP-102 Molluscum Contagiosum
Slide 12: Molluscum Background Overview
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
Slide 13: 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 May be unsuitable for use in children Curettage Using a curette or a surgical instrument with a scoop at the tip to scrape t
Slide 14: 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
Slide 15: 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
Slide 16: Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) Successfully Completed
We Have Successfully Completed Two Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) For 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 Da
Slide 17: Phase 3 Studies Demonstrated Favorable Tolerability and Activity in Complete Clearance
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
Slide 18: MC Commercial Opportunity
MC Commercial Opportunity
Slide 19: 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
Slide 20: Dermatologists are Familiar with Cantharidin & Would Use if Available
Dermatologists are Familiar with Cantharidin & 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 based der
Slide 21: 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
Slide 22: Payer Research Suggests a Favorable Reimbursement Landscape
after 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 The Payer Organizations and Plans represented in re
Slide 23: 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
Slide 24: 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
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
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
Slide 27: U.S. Regulatory Status of VP-102
U.S. Regulatory Status of VP-102 Verrica announced the successful tech transfer of bulk solution manufacturing from Sterling Pharmaceuticals (Dupo, IL) to Piramal Pharma Solutions1 (Sellersville, PA) in January 2023, including the completion of registration batch material and the manufacture of thre
Slide 28: Basal Cell Carcinoma: The Potential Solution VP-315
Basel Cell Carcinoma THE POTENTIAL SOLUTION VP-315
Slide 29: VP-315 Overview
VP-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 clinic May
Slide 30: Host-defense peptides with a Dual Mechanism of Action
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) Hancock RE. Cationic peptides: effectors in innate immunity and novel antimicrobials. Lancet Infect Dis. 2001;1(3):156-164. (2) Eike e
Slide 31: Phase 2 Open-Label Proof of Concept Study of VP-315 in BCC
Phase 2 Open-Label Proof of Concept Study of VP-315 in Basal Call Carcinoma (BCC)1 3 Part Study to evaluate Safety and Efficacy Part 1: DOSE EXPLORATION (Active) Designed to explore the initial VP-315 safety profile when administered in escalating doses to individual subjects Intended to quickly ass
Slide 32: VP-315 Part 1 Update
VP-315 Part 1 Update Part 1 of VP-315 Phase 2 trial enrolled 10 patients and demonstrated a favorable safety and tolerability profile with no reported serious adverse events. Patients receiving the higher range of dosing experienced a consistent response of clinical tumor necrosis. Part 2 of the Pha
Slide 33: BCC Market Opportunity
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+, of those 61% are 65+ Approxi
Slide 34: VP-315 could play a significant role as part of an alternative therapeutic regimen to surgery
VP-315 could play a significant role as part of an alternative therapeutic regimen 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 Poten
Slide 35: VP-102 in External Genital Warts
VP-102 in External Genital Warts
Slide 36: 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
Slide 37: 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
Slide 38: 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 Lesions
Slide 39: 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
Slide 40: VP-102 in Common Warts
VP-102 in Common Warts
Slide 41: 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
Slide 42: 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
Slide 43: 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
Slide 44: Adverse Events in COVE-1 Study
Adverse Events in COVE-1 Study (Incidence≥5%)1,* (1) Guenthner 2019 Fall Clinical Dermatology Symposium
Slide 45: Corporate Summary and Highlights
Corporate Summary and Highlights Analyst Coverage(4) Ken Cacciatore, Cowen Greg Renza, RBC Capital Markets Oren Livnat, H.C. Wainwright Serge Belanger, Needham Kemp Dolliver, Brookline Capital Markets As of September 30, 2022 Cash, cash equivalents and marketable securities of $39.5M Debt: None Outs
Slide 46: Appendix
Appendix
Slide 47: Molluscum Clinical Evidence
Molluscum Clinical Evidence
Slide 48: 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
Slide 49: 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
Slide 50: 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
Slide 51: 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
Slide 52: 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
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