Full Press Release Details
Company Overview September 14, 2022
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 third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained
from third-party sources. While Verrica believes its internal research is reliable, such research has not been verified by any independent source. This presentation contains forward-looking statements. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future
conditions. All statements other than statements of historical facts contained in this presentation, including statements regarding future results of operations and financial position, business strategy, interactions with the FDA with regard
to the resolution of the CRL, the timing of an NDA resubmission, potential approval of the NDA for VP-102, the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved, current and prospective product
candidates, planned clinical trials and preclinical activities, product approvals, degree of market acceptance of approved products, research and development costs, current and prospective collaborations, timing and likelihood of success, plans and
objectives of management for future operations, future results of anticipated product candidates, and the potential payments and benefits to Verrica of the license agreement with Torii, are forward-looking statements. The words "may,"
"will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe,"
"predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. The information in this presentation, including without limitation the forward-looking statements contained herein, represent our views as of the date of this presentation. Although we believe the expectations
reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as
required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties
(expressed or implied) are made about the accuracy of any such forward-looking statements. The forward-looking statements in this presentation involve risks and uncertainties that could cause actual results to differ materially from those
reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, our reliance on third parties over which we
may not always have full control, and other risks and uncertainties that are described in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the U.S. Securities and Exchange Commission (SEC) on March 2, 2022, and our
other filings made with the SEC. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. There can be no assurance that the opportunity will meet your
investment objectives, that you will receive a return of all or part of such investment. Investment results may vary significantly over any given time period. The appropriateness of a particular investment or strategy will depend on an investor's
individual circumstances and objectives. We recommend that investors independently evaluate specific investments and strategies.
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
Investment Highlights NEAR TERM
CATALYSTS Expect to resubmit NDA for VP-102 for Molluscum Contagiosum in Q1 2023 with potential approval/launch in H2 2023 (U.S. Prevalence of Molluscum Contagiosum ~6M1) Conclusion of Part 1 of 3 Part PH2 study on LTX-315 for Basal Cell Carcinoma
expected in Q1 2023 (safety and dose exploration) (U.S. Prevalence of Basal Cell Carcinoma 3.6M2) VP-102 In development to address two of the largest unmet needs in dermatology Proprietary drug-device combination of formulation and single-use
applicator In development to address two of the largest unmet needs in dermatology Payer research suggests favorable reimbursement landscape Exclusive license for Torii Pharmaceutical to develop and commercialize VP-102 in Japan Patents projected to
expire between 2034 and 2039 LTX-315 Potential non-surgical alternative (injectable) for treatment of basal cell and squamous cell carcinomas First-in-class oncolytic peptide injected directly into tumor to induce immunogenic cell death Positive
tumor-specific immune cell responses in multi-indication Phase 1/2 oncology trials Verrica to focus initially on development to treat basal cell and squamous cell carcinoma Worldwide rights for dermatological oncology, including basal cell and
squamous cell carcinomas and non-metastatic melanoma licensed from Lytix Biopharma. Patents projected to expire between 2032 and 2037 Proven Management Team Industry-leading, experienced management team with extensive dermatology product launch
experience Strong Balance Sheet Pro Forma cash as of June 30, 2022 of $45M3; sufficient to support operations into Q3 2023; additional capital will be required for commercial launch of VP-102 for molluscum contagiosum Debt free 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/blog/our-new-approach-to-a-challenging-skin-cancer-statistic/ Pro Forma figures include the impact of an underwritten public offering closed in July 2022, the repayment of $43.9M in debt in July 2022 and
the receipt of an $8M milestone payment from Torii Pharmaceutical Co., Ltd. in August 2022 for the initiation of the Phase 3 clinical trial for VP-102 for molluscum in Japan.
U.S. Regulatory Status of VP-102
Verrica received a Complete Response Letter (CRL) from the FDA in May 2022 as a direct result of deficiencies identified at a general reinspection of a facility of Sterling Pharmaceuticals Services, LLC (Sterling) a contract manufacturing
organization (CMO) that manufactured the bulk solution for VP-102. None of the issues identified by the FDA during the reinspection were specific to the manufacturing of VP-102; a pre-approval inspection (PAI) was also conducted on VP-102 at
Sterling with no observations. The FDA confirmed in a Type A meeting on June 27, 2022 that the NDA for VP-102 for molluscum contagiosum was fully reviewed and there were no other deficiencies in the NDA; label comments were completed by the FDA and
were ready to be communicated. Verrica has engaged Piramal Pharma Solutions, at their Sellersville, PA site, as an alternative supplier for VP-102's bulk solution. The technology transfer process is underway. Verrica expects to resubmit the
NDA for VP-102 for molluscum in Q1 2023.
Commitment and Focus within Medical
Dermatology OFFICE ADMINISTERED THERAPIES Expertise of a trained Health Care Professional Guaranteed Patient Adherence MEDICAL BENEFIT VS PHARMACY BENEFIT PRODUCTS Beneficial reimbursement landscape Favorable access at launch PARTNERSHIP WITH
DERMATOLOGY Unique distribution strategies create financial opportunities for physicians and hospitals
VP-102 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 2017 IMS National Disease and Therapeutic Index (NDTI) Rolling 5 Years Ending June 2016. Nguyen et al, Laser Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 IQVIA Anonymous Longitudinal
Patient Level Data (APLD) for 12 months ending September 2018 Prevalence in U.S. COMMON WARTS US Prevalence of ~22 million(3) with ~1.5 million diagnosed annually(4) 22M 1.5M Patients Diagnosed Annually Not Diagnosed 5.1 million MOLLUSCUM US
Prevalence of ~6 million(1) with ~1 million diagnosed annually(2) 85% 15% Diagnosed 0.9 million
LTX-315 has the potential to impact the
care of 5.4MM patients annually Nonmelanoma skin cancer includes basal cell (BCC) and squamous cell carcinoma (SCC) BCC is the most common malignancy in US populations1 LTX-315 will focus on BCC as its primary indication with opportunities to expand
to SCC and other dermatological indications Current treatment(s) for BCC and SCC are invasive, painful, disfiguring, and may require destruction of healthy tissue https://www.aad.org/media/stats-skin-cancer
https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/ IQVIA PharMetrics+. Custom research for Verrica Pharmaceuticals (claims, non-projected) Nonmelanoma skin cancers1 5.4MM BCC2 3.6MM SCC2 1.8MM 89% Treated3 NONMELANOMA SKIN CANCER
Our Product Portfolio Pre-IND Phase 2
Phase 3 NDA Next Expected Milestone VP-102 Molluscum Contagiosum NDA resubmission: Q1 2023 VP-102 External Genital Warts Initiate Phase 3 in 1H 2024 Common Warts Evaluate potential second Phase 2 trial LTX-315 Dermatological Oncology Phase 2 first
patient dosed: April 2022 VP-103 Plantar Warts Initiate Phase 2 trial [a]Originally designed Phase 2 program completed. [b]Timing of clinical trials for External Genital Warts may be subject to change. [c]Company evaluating potential for conducting
an additional Phase 2 trial based on FDA feedback for Phase 3 trial protocol. [d]Timing for initiating clinical trials for Plantar Warts to be determined. [e]License excludes metastatic melanoma and metastatic merkel cell carcinoma. Phase 2 study
initiated in April 2022 for the treatment of Basal Cell Carcinoma. [a] [b] [c] [d] [e]
THE PROBLEM Molluscum
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 challenges for the patients and parents and negatively impacts quality of life Etiology and Clinical Presentation TRANSMISSION Skin to skin contact Sharing of contaminated objects (e.g., clothing, towels, swimming pool toys)
DIAGNOSIS & SYMPTOMS Typically 10 to 30 lesions 100+ lesions can be observed Lesions may be the only sign of infection and are often painless Can be diagnosed with skin biopsy to differentiate from other lesions COMPLICATIONS Skin irritation,
inflammation, and re-infection Follicular or papillary conjunctivitis if lesions on eyelids Cellulitis
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 lesions Pain and scarring Unsuitable for use in children Laser Surgery Applying a laser to target and destroy the lesions Pain, cost and lack of availability Unsuitable for use in children Topical Products Applying various acids (e.g.
salicylic acid), creams or blistering solutions to destroy the lesions Unproven efficacy Off-Label Drugs Retinoids, antiviral medicines, or immune modulating therapies Limited efficacy Side-effects Natural Remedies Applying natural oils (e.g. tea
tree oil) with antimicrobial properties Unproven efficacy Pain, irritation and allergic reactions Broad use limited by unproven efficacy, scarring, lack of availability, safety concerns & pain Significantly undertreated patient population
THE POTENTIAL SOLUTION
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 allows for targeting of affected skin Physician administered in-office procedure GMP-controlled, shelf-stable, consistent topical formulation Bittering agent to deter oral ingestion Visualization agent to identify treated
lesions Potential first FDA Approved therapy for molluscum contagiosum Cap Tip Filter Ampule Tube DESIGNED FOR RELIABLE, AND TARGETED ADMINISTRATION
We Have Successfully Completed Two
Pivotal Phase 3 Trials (CAMP-1 & CAMP-2) In 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 Day 84 Subjects 2+ years of age with MC lesions who have not received any type of treatment within the past 14 days; Enrollment complete with 266 subjects for CAMP-1 and 262 subjects for CAMP-2 Study drug (VP-102 or placebo) is
administered topically to all treatable lesions every 21 days until clearance or a maximum of 4 applications CAMP-1 conducted under FDA Special Protocol Assessment (SPA) 12-week study period Secondary: Percent of subjects with complete clearance at
week 3, 6, 9 Safety & tolerability VP-102 or placebo will be left on for 24 hours before removal with soap and warm water
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 6 (1.9) 0 (0) Phase 3 Studies in Molluscum Demonstrate Statistically Significant Activity on Primary Endpoint of Complete Clearance vs. Vehicle1 Phase 3 Discontinuation of Study Medication Due to Treatment-Related Adverse
Events2 Note: slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2) Eichenfield Amer J Clin Derm 2021
MC Commercial 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 OF 85% 15% Diagnosed 0.9 million US PREVALENCE WITH ~6 million in molluscum(1) ~1 million diagnosed annually(2)
Dermatologists are Familiar with API
Used in 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 were US based dermatologists. Company survey of 40 physicians. Physicians who do not use the API of VP-102 stated inaccessibility as a primary reason why they are not using(1) Physicians reported they would use VP-102 if the cost of the
drug was covered(2) 87%
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 administration Frustrated with not treating and having no viable options Scale of 1 (unlikely to use at all) to 7 (highly likely to use) Precise and pain free application FDA approval Fits into their current office model
VP-102 to be covered under Medical
Benefit and 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 COHORT SIZE AVERAGE LIVES COVERED Medical Directors 11 9.8M Pharmacy Directors 15 4.2M IDN Stakeholders 3 6.5M The Payer Organizations and Plans Represented in the Interviews Cover a Total of 205 Million Commercial & Medicaid Lives
Multiple Payer Research Studies
Suggest Favorable Reimbursement Landscape for VP-102 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 risk of infection, scarring, or spread of the disease Payers perceived VP-102 to be highly favorable based on the majority of patients experiencing clearance within 12 weeks Given the unmet need and favorable clinical outcomes in Phase 2
trials, payers anticipate the majority of patients would have access to VP-102 with minimal to no restrictions Key Takeaways