UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 18, 2019
Verrica Pharmaceuticals Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 001-38529 | 46-3137900 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
10 North High Street, Suite 200 West Chester, PA |
19380 | |||
(Address of Principal Executive Offices) | (Zip Code) |
Registrants telephone number, including area code: (484) 453-3300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
Title of each class |
Trading symbol |
Name of each exchange on which registered | ||
Common Stock | VRCA | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01 | Regulation FD Disclosure |
On October 18, 2019, Verrica Pharmaceuticals Inc. (the Company) issued a press release announcing the presentation of positive data from clinical trials of VP-102 at the 2019 39th Annual Fall Clinical Dermatology Conference. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. A copy of the Companys updated presentation is also furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K.
The information included in this Item 7.01 of this Current Report on Form 8-K, including the attached Exhibit 99.1 and Exhibit 99.2, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit Number |
Exhibit Description | |
99.1 | Press Release, dated October 18, 2019 | |
99.2 | Verrica Pharmaceuticals Inc. Presentation |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Verrica Pharmaceuticals Inc. | ||||||
Date: October 18, 2019 | /s/ Ted White | |||||
Ted White | ||||||
President and Chief Executive Officer |
Exhibit 99.1
Verrica Pharmaceuticals Announces Presentation of Positive Data
from Clinical Trials of VP-102 at the 2019 39th Annual Fall Clinical Dermatology Conference
| Pooled analyses of the Phase 3 CAMP studies in molluscum contagiosum showed VP-102 achieved statistically significantly higher rate of complete lesion clearance and percentage of subjects with > 75% and > 90% lesion clearance rates over the course of therapy compared to vehicle |
| VP-102 achieved positive results in the COVE-1 study on the endpoint of complete clearance of all common warts at Day 84 (primary endpoint) as well as Day 147 (exploratory endpoint) |
WEST CHESTER, Pa., Oct. 18, 2019 (GLOBE NEWSWIRE) Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a medical dermatology company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases, today announced the presentation of positive data from three abstracts evaluating the efficacy and safety of VP-102 (cantharidin 0.7% Topical Solution), the Companys lead product candidate for the treatment of molluscum contagiosum and common warts. These data are being presented in poster form at the 2019 39th Annual Fall Clinical Dermatology Conference in Las Vegas, NV.
Data from a pooled analysis of the Phase 3 CAMP-1 and CAMP-2 clinical studies showed that treatment with VP-102 brought about a statistically significantly higher rate of complete lesion clearance at Day 84 (primary endpoint) compared to vehicle. Complete clearance of all molluscum lesions at the end of study (EOS) visit occurred in 50% of subjects treated with VP-102, as compared to 15.6% for vehicle (p<0.0001). In addition, mean lesion counts decreased by 76% for subjects in the VP-102 group, compared to a 0.3% decrease in the vehicle arm by the EOS visit (p<0.0001). VP-102 was well-tolerated, and adverse events were primarily mild to moderate in intensity, with the most common adverse events related to the pharmacodynamic action of cantharidin, including application site vesicles, pruritus, pain, erythema, and scab. Rates of discontinuation of study medication due to an adverse event were low (1.9% for VP-102; 0.5% for vehicle).
This pooled analysis of the pivotal CAMP studies reinforces the body of evidence demonstrating that VP-102 may be an important treatment option for molluscum, a highly contagious viral skin infection for which there are no FDA-approved therapies, said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology, Rady Childrens Hospital, San Diego, CA, and principal investigator of the VP-102 Phase 3 molluscum program. These data show that VP-102 has the potential to address a demonstrated unmet medical needsafely and effectively clearing the contagious molluscum lesions that can spread rapidly, may cause pain and discomfort, and can have a substantial negative impact on patient quality-of-life.
A second pooled analysis of the CAMP studies evaluated the time course and percentage of subjects with > 75% and > 90% reduction in lesions at the EOS visit in the intent-to-treat population. Data demonstrated that as early as Day 21, > 75% and > 90% lesion clearance rates were statistically significantly higher with VP-102 treatment as compared to vehicle (p<0.0001). At EOS, 77.7% of VP-102 subjects achieved > 75% reduction in lesions compared to 34.9% for vehicle, and 65.8% of VP-102 subjects achieved > 90% reduction of lesions compared to 27.1% for vehicle (p<0.0001 respectively).
These data are of significant clinical value, continued Dr. Eichenfield. Even a reduction of molluscum lesions may reduce viral burden, decrease auto-inoculation, and limit virus transmission to others.
Investigating VP-102 for the Treatment of Common Warts
The Phase 2 COVE-1 open label study evaluated the efficacy and safety of VP-102 in subjects with up to six common warts in two cohorts. Cohort 2 subjects receiving VP-102 showed a change of -50.9% of common warts and 51.4% of subjects showed complete clearance of warts at the primary endpoint of Day 84. Clinical response was maintained through the follow-up period, with a 45.5% mean reduction of warts compared to baseline, and 40% of subjects showing complete clearance at Day 147. Due to the higher complete clearance rates observed in Cohort 2 (51% of subjects showing complete clearance at Day 84), Verrica intends to use the treatment regimen of Cohort 2 (up to four treatments of VP-102 every 21 days with paring of thick scale and occlusion) in future Phase 3 studies. In the COVE-1 study, VP-102 showed a favorable tolerability and acceptable safety profile. The most common adverse events were mild to moderate in severity, and included application site blistering, pain, pruritus, erythema, and scab, and were considered related to the pharmacodynamic action of cantharidin.
The results from the CAMP and COVE studies clearly demonstrate that VP-102 has the potential to address the substantial burden of molluscum, as well as provide an important therapeutic option to treat common warts, said Ted White, President and Chief Executive Officer of Verrica. The presentation of these data is a critical step forward towards achieving our mission of providing a safe, effective therapy to address these two important unmet needs.
About Verrica Pharmaceuticals Inc.
Verrica is a medical dermatology company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases. The Companys late-stage product candidate, VP-102, is a potential first-in-class topical therapy for the treatment of molluscum contagiosum and common warts. Molluscum is a highly contagious viral skin infection affecting approximately six million people, primarily children, in the United States, and common warts are contagious skin growths affecting 22
million people. There are currently no FDA-approved treatments for molluscum or common warts. Following positive topline results from two pivotal Phase 3 trials, the Company submitted an NDA in September 2019 for VP-102 for the treatment of molluscum. Verrica is planning to meet with the FDA to determine next steps on the development of VP-102 for common warts following positive Phase 2 results. VP-102 is also currently in a Phase 2 trial for the treatment of external genital warts. A second product candidate, VP-103, is in pre-clinical development for plantar warts. For more information, visit www.verrica.com.
Forward-Looking Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as believe, expect, may, plan, potential, will, and similar expressions, and are based on Verricas current beliefs and expectations. These forward-looking statements include expectations regarding the potential benefits of VP-102 for the treatment of molluscum and the clinical development of VP-102 for additional indications, including the design of future Phase 3 studies for the treatment of common warts. These statements 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, Verricas reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Verricas Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission on March 7, 2019, and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
A. Brian Davis
Chief Financial Officer
484.453.3300 ext. 103
info@verrica.com
Chiara Russo
Solebury Trout
617.221.9197
crusso@soleburytrout.com
Media:
Joshua R. Mansbach
Solebury Trout
646-378-2964
jmansbach@troutgroup.com
# # #
October 2019 Company Overview Copyright © 2019 Verrica Pharmaceuticals. All rights reserved. Exhibit 99.2
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, 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, and future results of anticipated product candidates, 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, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on March 7, 2019, 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. DISCLAIMER
Developing novel dermatology products Providing meaningful benefit for people living with skin diseases Reinventing Skin Science by focusing on development and commercialization Late-stage medical dermatology company
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 Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 Based on a survey of 115 dermatologists the results of which have been extrapolated to pediatric dermatologists. Two of the Largest Unmet Needs in Dermatology Prevalence of ~6 million in molluscum contagiosum(1) and ~22 million in common warts in the U.S.(2) No FDA approved drugs to treat molluscum or warts New Drug Application (NDA) Submitted for VP-102 for the Treatment of Molluscum Contagiosum Positive Phase 3 Results in Molluscum Contagiosum Achieved statistical significance for primary endpoints in our Phase 3 CAMP-1 and CAMP-2 pivotal trials for VP-102 P-value <0.0001 for primary endpoint in both pivotal trials Positive Phase 2 Results in Common Warts VP-102 achieved positive results on both the primary endpoint of complete clearance of all treatable warts at Week 12 (Day 84) and the secondary endpoint of the percentage reduction of warts Innovative Product Candidate Drug-device combination of a topical formulation in a proprietary single-use applicator Physician Acceptance 95% of pediatric dermatologists have used API(3) Barriers to Competition New chemical entity regulatory exclusivity upon approval IP pending on product candidate, including on novel formulation, applicator and methods of use Drug-device combination makes a ‘true generic’ unlikely Proven Team Industry-leading, experienced management team with extensive clinical development and product launch experience
OUR PRODUCT PORTFOLIO Phase 2 ready assuming leverage of data from VP-102. We retain exclusive, royalty-free rights to our product candidates across all indications globally Preclinical Phase 1 Phase 2 Phase 3 NDA submission Next Expected Milestone VP-102 Molluscum Contagiosum FDA acceptance of NDA Common Warts Initiate pivotal trials in 1Q 2020 External Genital Warts Topline Phase 2 results in 2H 2020 VP-103 Plantar Warts(1) IND submission in 4Q 2019
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
The problem Molluscum Contagiosum
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 Often leads to anxiety and social challenges for the patients and parents and negatively impacts quality of life 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 Copyright © 2019 Verrica Pharmaceuticals. All rights reserved.
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 solution VP-102
VP-102 IS A PROPRIETARY DRUG-DEVICE COMBINATION OF CANTHARIDIN ADMINISTERED THROUGH OUR SINGLE-USE PRECISION APPLICATOR GMP-controlled formulation of cantharidin with: API that is greater than 99% pure Defined pharmaceutical batch process Long-term, room temperature stability Visualization agent to see which lesions have been treated Bittering agent to mitigate oral ingestion by children Copyright © 2019 Verrica Pharmaceuticals. All rights reserved.
Molluscum Clinical Evidence
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 intraepidermal blistering.(1) 1 Elicits Inflammation & Immune Response Cantharidin stimulates leukocyte infiltration (e.g., neutrophils, macrophages, B and T cells and eosinophils) and the release of chemokines and cytokines including TNF-a, IL-8 and CXCL-5.(2) 2 J Invest Dermatol. 1962 Jul;39:39-45. J Immunol Methods. 2001 Nov 1;257(1-2):213-20.2 Desmosome Cleavage and Blister Formation Lymphocyte Neutrophil Eosinophil Macrophage
SIGNIFICANT CLINICAL PROGRESS OF 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 evaluate the efficacy of dermal application of VP-102 relative to placebo for complete clearance at day 84 To assess the safety and tolerability of VP-102 Pivotal Trial CAMP-2 Complete VP-102 N=262 Randomized, double blind, multi-center, placebo controlled To evaluate the efficacy of dermal application of VP-102 relative to placebo for complete clearance at day 84 To assess the safety and tolerability of VP-102 PHASE 2 Innovate Trial Complete VP-102 Open-label, single-center N=33 To determine possible systemic exposure from a single 24-hour application of VP-102 To confirm safety and efficacy with applicator Pilot Trial Complete Our proprietary formula of cantharidin used in VP-102, applied with the wooden stick part of a cotton-tipped swab Open-label, single-center N=30 To evaluate safety and efficacy and determine optimal treatment duration
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 subjects with complete clearance of molluscum at Day 84 Secondary: Percent of subjects with complete clearance at week 3, 6, and 9 Safety & tolerability 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 Application Study drug (VP-102 or placebo) is administered topically to all treatable lesions every 21 days until clearance or a maximum of 4 applications VP-102 or placebo will be left on for 24 hours before removal with soap and warm water 12-week study period
Demographics in phase 3 molluscum trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
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 inhibitors, and/or PDE-4 inhibitors.
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)
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)
Safety summary for molluscum Phase 3 trials Note: Slide reflects pooled data from Phase 3 molluscum trials (CAMP-1 and CAMP-2)
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 ~6 million in molluscum(1) with ~1 million diagnosed annually(2) 85% 15% Diagnosed 0.9 million
DERMATOLOGISTS ARE FAMILIAR WITH VP-102’s API & 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) ~70% 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 KEY REASONS TO USE IF APPROVED
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR 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 in the Interviews Cover a Total of 105 Million Commercial & Medicaid Lives
INITIAL PAYER RESEARCH SUGGESTS FAVORABLE REIMBURSEMENT LANDSCAPE FOR 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 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 Source: Third party study commissioned by the Company. Key Takeaways
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 dermatologists in academic settings and group practices Targeting office based dermatologists and select pediatricians Distribution with supportive HUB services Dedicated field reimbursement Team Strong established relationships and support Commercial Strategy
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 supported by a patient and HCP services platform (HUB) Benefits investigation/verification to determine coverage Full reimbursement support for miscellaneous J-code under medical benefit (1) Prior authorization support Co-pay/co-insurance assistance Dedicated field reimbursement team to support physician offices Specialty Distributor Specialty Pharmacy Physician Office “White Bag” “Buy and Bill” Potential Physician Reimbursement Opportunities “Buy and Bill” “White Bag” Office visit Office visit Procedure for lesion destruction Procedure for lesion destruction VP-102 (ASP + X%) Verrica intends to file for a product-specific J-code for VP-102
PRE-COMMERCIALIZATION ACTIVITIES ONGOING ENGAGEMENT AT KEY CONFERENCES 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, and professional journal space Trade distribution channel development Customer segment insights Brand strategy, customer segmentation, and targeting Commercial systems infrastructure OTHER
VERRICA HAS SEVERAL POTENTIAL WAYS TO MAINTAIN EXCLUSIVITY Regulatory Exclusivity 5.5 years of exclusivity for cantharidin as API potentially available upon approval (inclusive of potential for 6 months for pediatric indication) Compounding Pharmacies If VP-102 is approved, traditional compounding pharmacies will NOT be able to continue compounding cantharidin regularly or in inordinate amounts, except under patient specific circumstances as prescribed by a physician. The FDA has the authority to regulate compounders. Improper compounding can result in monetary fines plus felony convictions in case of repeat offenses and intent to fraud/mislead. Manufacturing VP-102 has the potential to address stability issues with standard packaging and container/ closure systems True Generic Unlikely Unlikely to receive approval under an ANDA due to uniqueness from patent pending protection and significant differences likely between VP-102 and potential competitors Cannot do traditional PK/bioequivalence study (no blood level profile for VP-102) May require new clinical studies with new formulation and new delivery approach that shows equivalence without violating any of Verrica's IP Limited commercial CMOs with facilities for handling highly potent and highly flammable liquid products Entered into a supply agreement for naturally-sourced cantharidin; subject to specified minimum annual purchase orders and forecasts, supplier agreed that it will not supply cantharidin, any beetles or other raw material from which cantharidin is derived to any other customer in North America
OVERVIEW OF INTELLECTUAL PROPERTY PORTFOLIO KEY CLAIMS AND PATENT APPLICATIONS VALUE TO VERRICA Our specific formulation (VP-102), key safety additions and novel cantharidin formulations (PCT/US2014/052184) May prevent generics from copying our ether-free formulation or from making similar formulations Single use applicator containing cantharidin formulations (PCT/US2014/052184) May prevent generics from utilizing a single-use applicator for cantharidin that contains both a glass ampule to maintain product stability and a filter placed prior to dispensing tip, which helps increase administration accuracy and prevents direct contact with skin Specific design of our commercial applicator (PCT/US2018/036353) May prevent generics from utilizing a similar applicator Methods of use for cantharidin in the treatment of molluscum (PCT/US2018/037808 and PCT/US2018/036353) May prevent generics from a similar treatment regimen and label Methods for purifying cantharidin and analyzing cantharidin or cantharidin solutions (PCT/US2016/14139) May force generics to find alternative methodologies to produce GMP cantharidin or determine if their API or drug product is GMP compliant Methods for complete cantharidin synthesis (PCT/US2015/066487) Synthetic version would reduce risks of outside contaminants and environmental factors affecting the naturally-sourced API. May prevent generics competing with a synthetic version of cantharidin Any patents issued from our applications are projected to expire between 2034 and 2039, excluding any patent term adjustment and patent term extensions 1 2 3 4 5
Our Opportunity in 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 Transmission Skin to skin contact Touching of contaminated objects Diagnosis & Symptoms Dome shaped flesh-colored lesions commonly on the hands, fingers, knees or elbows Lesions may occur in groups or in a linear pattern Lesions can cause considerable pain and discomfort, may spread with skin trauma, and can be itchy Complications Scarring may occur Dyspigmentation of affected areas Bacterial superinfection of lesions Irritation, pain, and redness of surrounding skin Copyright © 2019 Verrica Pharmaceuticals. All rights reserved.
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 subjects achieving complete clearance of all treatable warts at Visits 2, 3, and 4 Change from baseline in number (%) of treatable warts at Day 84 Patients Cohort 1: 21 subjects 2+ years of age with common warts, who have not received any type of treatment within the past 14 days Application Study drug (VP-102) is administered topically to each treatable wart to a maximum of 4 applications Cohort 1 is treated until clear, Cohort 2 receives one additional treatment at the first visit clearance was observed up to a maximum of 4 total applications Frequency of administration is at least 14 days (Cohort 1) or 21 days (Cohort 2) Paring was allowed in Cohort 2 VP-102 will be left on for 24 hours before removal with soap and warm water Open label study with two cohorts Cohort 2: 35 subjects 12+ years of age with common warts, who have not received any type of treatment within the past 14 days
Demographics in cove-1 STUDY Cohort 1 VP-102 (N=21) Cohort 2 VP-102 (N=35) Randomized 21 35 Age (years) Mean 38 38 Median 37 42 Min, Max 7, 83 12, 67 Gender (N (%)) Female 11 (52.4%) 22 (62.9%) Male 10 (47.6%) 13 (37.1%)
Wart history for subjects in cove-1 STUDY Cohort 1 VP-102 (N=21) Cohort 2 VP-102 (N=35) Time Since Clinical Diagnosis (months) 70.3 15.9 Age at Diagnosis (mean, years) 32.1 36.4 Any Previous Treatments for Common Warts? (Yes) 3 (14.3%) 24 (68.6%) Wart Number at Baseline (mean) 2.19 1.65
VP-102 demonstrated Clinically meaningful efficacy on Primary endpoint of complete CLEARANCE in COVE-1 STUDY
VP-102 demonstrated Clinically meaningful efficacy on Percent Change in number of common warts from baseline in COVE-1 STUDY
adverse events in cove-1 study (incidence≥5%)*
Adverse Events for Cove-1 Study by Severity (incidence≥5%)
Realizing the common warts Opportunity 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. US Prevalence of ~22 million in common warts(1) with ~1.5 million diagnosed annually(2) 22M 1.5M Patients Diagnosed Annually
Our Opportunity in External 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 contact Spread through sexual contact Diagnosis & Symptoms Can be flat, dome-shaped, keratotic, pedunculated and cauliflower-shaped Lesions may occur singularly, in clusters, or as plaques Lesions can be itchy, and can cause pain and discomfort Complications Irritation, pain, and redness of surrounding skin Dyspigmentation of affected areas Scarring may occur Bacterial superinfection of lesions Copyright © 2019 Verrica Pharmaceuticals. All rights reserved.
Frequency of administration is every 21 days PHASE 2 STUDY (care) IN external genital warts (EGW) Study Design Multi-center, double-blind, placebo-controlled Dose regimen, efficacy, safety & tolerability Endpoints 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 Visits 2, 3, and 4 Patients Part A: ~18 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit Application Study drug (VP-102) is administered topically to each treatable wart to a maximum of 4 applications or until complete clearance Part A: To include 3 treatment groups with a 2-hour, 6-hour and 24-hour duration of skin exposure before removal with soap and warm water Part B: Two selected treatment dosing regimens (duration of skin exposure) based on Part A with follow up period through Day 147 Study comprised of two parts (A and B) Primary objective of Part A is to identify the two best dosing regimens for evaluation in Part B Part B: ~90 subjects 18+ years of age with 2-30 external genital and/or perianal warts for ≥ 4 weeks at baseline visit
DATE EVENT 1Q 2019 Positive topline results from two pivotal Phase 3 trials in molluscum 2Q 2019 Positive topline results from Phase 2 trial in common warts 2Q 2019 Initiate Phase 2 trial in external genital warts 3Q 2019 VP-102 NDA submission in molluscum 4Q 2019 FDA acceptance of VP-102 NDA submission in molluscum 4Q 2019 VP-103 IND submission in plantar warts 1Q 2020 Initiate pivotal Phase 3 trials in common warts 2H 2020 Topline results from Phase 2 trial in external genital warts SIGNIFICANT recent and EXPECTED MILESTONES
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 Treatment of Nongenital Verrucae A Systemic Review. JAMA Dermatology. 2016; 152(9): 1025-1033 Based on a survey of 115 dermatologists the results of which have been extrapolated to pediatric dermatologists. Two of the Largest Unmet Needs in Dermatology Prevalence of ~6 million in molluscum contagiosum(1) and ~22 million in common warts in the U.S.(2) No FDA approved drugs to treat molluscum or warts New Drug Application (NDA) Submitted for VP-102 for the Treatment of Molluscum Contagiosum Positive Phase 3 Results in Molluscum Contagiosum Achieved statistical significance for primary endpoints in our Phase 3 CAMP-1 and CAMP-2 pivotal trials for VP-102 P-value <0.0001 for primary endpoint in both pivotal trials Positive Phase 2 Results in Common Warts VP-102 achieved positive results on both the primary endpoint of complete clearance of all treatable warts at Week 12 (Day 84) and the secondary endpoint of the percentage reduction of warts Innovative Product Candidate Drug-device combination of a topical formulation in a proprietary single-use applicator Physician Acceptance 95% of pediatric dermatologists have used API(3) Barriers to Competition New chemical entity regulatory exclusivity upon approval IP pending on product candidate, including on novel formulation, applicator and methods of use Drug-device combination makes a ‘true generic’ unlikely Proven Team Industry-leading, experienced management team with extensive clinical development and product launch experience
Appendix
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 manufacturing Risk of impurities present such as residual solvents and pesticides Lack of reimbursement Not FDA approved and therefore not eligible for drug reimbursement Inconvenient and variable administration Application with the wooden stick part of a cotton-tipped swab can lead to patients receiving more drug than necessary Inability for physicians to identify where the drug has been applied Limited availability Illegal to import formulated cantharidin Generally not available in hospitals and academic settings, which require FDA approved product Only an estimated 7% of 503B compounders produce formulations containing cantharidin(1) 2 1 3 5 4 Based on 57 503B facilities and 4 compounders of cantharidin per FDA database (January – June 2019).
MANAGEMENT TEAM WITH EXTENSIVE PRODUCT LAUNCH AND DERMATOLOGY EXPERIENCE Selected Launched Products Copyright © 2019 Verrica Pharmaceuticals. All rights reserved. A. Brian Davis Chief Financial Officer Ted White President & Chief Executive Officer Patrick Burnett MD, PhD Chief Medical Officer Joe Bonaccorso Chief Commercial Officer
BOARD OF DIRECTORS Sean Stalfort Director Glenn Oclassen Director Mark Prygocki Director Gary Goldenberg, MD Director Ted White President & Chief Executive Officer Paul Manning Chairman Craig Ballaron Director
HIGHLY ACCLAIMED SCIENTIFIC ADVISORY BOARD Waldman Chair of Dermatology, Icahn School of Medicine at Mount Sinai Former President of the American Academy of Dermatology Mark Lebwohl, MD Chief of Dermatology at the Albert Einstein School of Medicine Steven Cohen, MD Professor of Dermatology and Pediatrics at the St. Louis University School of Medicine Elaine Siegfried, MD Head of the Division of Dermatology at Feinberg School of Medicine at Northwestern University Anthony Mancini, MD Professor at the University of Vermont College of Medicine Janice Pelletier, MD Director of the residency training program and professor at UNC Dean Morrell, MD Founder Former Chief Scientific Officer of Verrica Matt Davidson, PhD Chief of Pediatric and Adolescent Dermatology, Rady Children’s Hospital – San Diego Lawrence Eichenfield, MD Dermatologist at Golden State Dermatology Robert Greenberg, MD