Verrica Pharmaceuticals Inc. · NASDAQ:VRCA
Verrica Pharmaceuticals — Investor Presentation (November 2020)
56 slides from Verrica Pharmaceuticals's investor presentation, Nov 10, 2020
Slide 1: Company Overview
November 2020 Company Overview Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. Exhibit 99.2
Slide 2: Certain information contained in this presentation and statements made orally during this presentation relates
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 third-party
Slide 3: Developing dermatology products
Developing dermatology products Providing meaningful benefit for people living with skin diseases Reinventing dermatology therapeutics by focusing on development and commercialization Late-stage dermatology therapeutics company
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. IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatme
Slide 5: Our Product Portfolio
Pre-IND Phase 2 Phase 3 NDA Next Expected Milestone YCANTH Molluscum Contagiosum Resubmission of NDA in Q1 2021 VP-102 Common Warts Initiate pivotal Phase 3 trials* External Genital Warts Request End-of-Phase 2 meeting in Q1 2021 VP-103 Plantar Warts Initiate Phase 2 trial* LTX-315 Non-Melanoma Skin
Slide 6: YCANTH in development to address two of the largest unmet needs in dermatology
YCANTH™ 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
Slide 7: The problem: Molluscum Contagiosum
The problem Molluscum Contagiosum
Slide 8: Molluscum Background
MOLLUSCUM BACKGROUND ETIOLOGY AND CLINICAL PRESENTATION 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
Slide 9: Current treatments for molluscum are not FDA approved and have 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
Slide 10: The solution: YCANTH (VP-102)
The solution YCANTH™ (VP-102)
Slide 11: YCANTH (VP-102) is a proprietary drug-device combination of cantharidin
Ycanth™ (VP-102) IS A PROPRIETARY DRUG-DEVICE COMBINATION OF CANTHARIDIN ADMINISTERED THROUGH OUR SINGLE-USE PRECISION APPLICATOR Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. GMP-controlled new formulation of 0.7% w/v cantharidin Consistent and shelf-stable Single-use applicator to
Slide 12: U.S. Regulatory Status
U.S. Regulatory Status NDA for VP-102 for molluscum contagiosum submitted in September 2019 CRL received July 2020 No clinical safety or efficacy issues identified Requests for additional information regarding certain aspects of CMC and Human Factors validation Completed Type A Meeting in October 20
Slide 13: Molluscum Clinical Evidence
Molluscum Clinical Evidence
Slide 14: 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 15: Significant clinical progress of YCANTH 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 16: Two pivotal Phase 3 trials (CAMP-1 & CAMP-2) completed
Population WE HAVE successfully COMPLETED TWO PIVOTAL PHASE 3 TRIALS (CAMP-1 & CAMP-2) IN MOLLUSCUM Trial Design Two identically designed, randomized, double-blinded, multicenter, placebo controlled trials CAMP-1 conducted under FDA Special Protocol Assessment (SPA) Endpoints Primary: Percent of sub
Slide 17: Demographics in Phase 3 molluscum trials
Demographics in phase 3 molluscum trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) VP-102 (N=311) Vehicle (N=216)
Slide 18: Molluscum history for subjects in Phase 3 trials
Molluscum history for subjects in phase 3 trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) * Active atopic dermatitis was determined by concomitant medication usage of the following medications during the study: topical corticosteroids, topical calcineurin in
Slide 19: Phase 3 efficacy on complete clearance
PHASE 3 Studies in molluscum DEMONSTRATE statistically significant efficacy on Primary endpoint of complete CLEARANCE Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 20: Phase 3 efficacy on percent reduction of lesions
PHASE 3 Studies in molluscum DEMONSTRATE statistically significant efficacy on Percent Reduction of Lesions Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 21: Safety summary for molluscum Phase 3 trials
Safety summary for molluscum Phase 3 trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
Slide 22: Discontinuation rates due to treatment-related adverse events
Phase 3 Discontinuation rates due to Treatment-Related Adverse events 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 6 (1.9) 0 (0) Not
Slide 23: MC Commercial Opportunity
WERRICA PHARMACEUTICALS. MC Commercial Opportunity
Slide 24: 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 25: Dermatologists are familiar with API used in YCANTH
DERMATOLOGISTS ARE FAMILIAR WITH API Used in Ycanth™ (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
Slide 26: Physicians are highly favorable to YCANTH profile
Physicians are highly favorable to Ycanth™ (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
Slide 27: Initial payer research suggests favorable reimbursement landscape
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR Ycanth™ (VP-102) Source: Third party study commissioned by the Company. COHORT SIZE AVERAGE LIVES COVERED Medical Directors 7 9.8M Pharmacy Directors 6 4.2M IDN Stakeholders 2 6.5M The 15 Payer Organizations and Plans Represented
Slide 28: Payer research key takeaways
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR Ycanth™ (VP-102) 1 2 3 4 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 r
Slide 29: Integrated commercial approach with multiple strategic levers
INTEGRATED COMMERCIAL APPROACH WITH MULTIPLE STRATEGIC LEVERS Buy and Bill or Specialty Pharmacy KOL Engagement Specialized Sales Team Disease Awareness Dedicated Institutional Team Increase treatment seekers through cost- efficient consumer advertising Specialists to promote to pediatric dermatolog
Slide 30: YCANTH designed to be clinician administered, specialty distribution
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
Slide 31: Pre-commercialization activities ongoing
PRE-COMMERCIALIZATION ACTIVITIES ONGOING Engagement at Premier Venues & Industry Channels Poster Presentation National and Regional Meetings National and Regional Meetings DISEASE AWARENESS Caregiver MC education through digital and social tools HCP MC education through congresses, speaker programs,
Slide 32: Our Opportunity in Common Warts
Our Opportunity in Common Warts
Slide 33: Verruca Vulgaris (Common Warts)
VERRUCA VULGARIS (COMMON WARTS) ETIOLOGY AND CLINICAL PRESENTATION 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
Slide 34: Phase 2 study (COVE-1) in common warts
WE HAVE successfully COMPLETED A PHASE 2 STUDY (COVE-1) IN common WARTS Study Design Cohort 1: one center Cohort 2: four centers Efficacy, safety & tolerability Endpoints Primary Percent of subjects with complete clearance of all treatable warts (baseline and new) at Day 84 Secondary Percent of subj
Slide 35: VP-102 efficacy on complete clearance in COVE-1
VP-102 demonstrated Clinically meaningful efficacy on Primary endpoint of complete CLEARANCE in COVE-1 STUDY
Slide 36: Adverse events in COVE-1 study
adverse events in cove-1 study (incidence≥5%)*
Slide 37: Our Opportunity in External Genital Warts
Our Opportunity in External Genital Warts
Slide 38: Condyloma Acuminatum (Genital Warts)
CONDYLOMA ACUMINATum (genital warts) ETIOLOGY AND CLINICAL PRESENTATION 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 Transmission Skin to skin cont
Slide 39: Phase 2 study (CARE-1) in external genital warts
Frequency of administration is every 21 days PHASE 2 STUDY (care-1) IN external genital warts (EGW) Study Design Multi-center, double-blind, vehicle-controlled Dose regimen, efficacy, safety & tolerability Endpoints Primary Percent of subjects with complete clearance of all treatable warts at Day 84
Slide 40: Demographics (CARE-1, safety population)
DEMOGRAPHICS (CARE-1, SAFETY POPULATION)* 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 (5
Slide 41: Baseline EGW characteristics (CARE-1)
BASELINE EGW CHARACTERISTICS (CARE-1, ITT POPULATION)* 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) 13 (48.1) 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 (1
Slide 42: Efficacy (CARE-1, ITT population)
Efficacy (care-1, ITT population) Pooled data from Part A and B *P<0.001 **P≤0.0001 ** ** *
Slide 43: Safety: Treatment emergent adverse events (CARE-1)
Safety: Treatment emergent Adverse Events ≥ 5% (CARE-1, Safety Population)*, TEAEs, N (%) VP-102 6-hour (N=30) Vehicle 6-hour (N=24) VP-102 24-hour (N=27) Vehicle 24-hour (N=18) 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 (0.0)
Slide 44: The problem: Non-Melanoma Skin Cancer
The problem Non-Melanoma Skin Cancer
Slide 45: Non-melanoma skin cancer includes basal cell and squamous cell carcinoma
Non-melanoma skin cancer includes basal cell and squamous cell carcinoma Basal cell carcinoma is the most common malignancy in humans1 Common treatments are invasive, painful, can cause scarring, and may require destruction of healthy tissue Non-melanoma skin cancer ETIOLOGY AND CLINICAL PRESENTATIO
Slide 46: Current treatments for non-melanoma skin cancer
CURRENT TREATMENTS FOR Non-Melanoma Skin Cancer1-3 DESCRIPTION LIMITATIONS Surgical Excision Using a scalpel to remove diseased tissue and healthy skin Invasive Can cause scarring/disfigurement, infection, pain Mohs Surgery Used in high risk NMSC or in special sites Invasive, may take several rounds
Slide 47: The Solution: LTX-315
THE SOLUTION LTX-315 WERRICA PHARMACEUTICALS.
Slide 48: LTX-315 Overview
LTX-315 Overview Induces Immunogenic Cell Death and a Tumor-specific Immune Response1 OVERVIEW First-in-class oncolytic peptide that is injected directly into a tumor to induce immunogenic cell death Worldwide license in dermatology oncology2 from Lytix Biopharma in August 2020 Verrica intends to fo
Slide 49: Regulatory Exclusivity and Intellectual Property
Regulatory Exclusivity and Intellectual Property
Slide 50: 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
Slide 51: 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
Slide 52: 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
Slide 53: Our Product Portfolio
Pre-IND Phase 2 Phase 3 NDA Next Expected Milestone YCANTH Molluscum Contagiosum Resubmission of NDA in Q1 2021 VP-102 Common Warts Initiate pivotal Phase 3 trials* External Genital Warts Request End-of-Phase 2 meeting in Q1 2021 VP-103 Plantar Warts Initiate Phase 2 trial* LTX-315 Non-Melanoma Skin
Slide 54: 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. IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatme
Slide 55: 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 56: Management team with extensive product launch and dermatology experience
MANAGEMENT TEAM WITH EXTENSIVE PRODUCT LAUNCH AND DERMATOLOGY EXPERIENCE Selected Launched Products Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. A. Brian Davis Chief Financial Officer Ted White President & Chief Executive Officer Chief Medical Officer Joe Bonaccorso Chief Commercia
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