Company Overview
May 2024
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.
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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, the commercial launch of YCANTH | , and the potential benefits of |
YCANTH | and Verrica's product candidates to patients, 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, 2023 filed with the U.S. Securities and Exchange Commission (SEC) on February 29, 2024, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed with SEC on May 13, 2024 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.
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. | 2 |
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical intervention
Reinventing dermatology therapeutics with a focus on development and commercialization
Focused on
Clinician-Administered
Therapies and High Unmet
Needs
Providing meaningful benefit for people living with skin diseases
Focus on products with potential for reimbursement as a
Medical Benefit
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. | 3 |
Not For Promotional Use
Our Product Candidate Portfolio:
YCANTH
VP-102
VP-103VP-315
PRE-IND | PHASE 2 | PHASE 3 | NDA | NEAR-TERM CATALYSTS/ |
EXPECTED MILESTONES | ||||
Molluscum Contagiosum | **NOW APPROVED** |
Common Warts | Initiation of Global Pivotal |
Phase 3 trial expected H1 | |
2025 [a] | |
External Genital Warts | Initiate Phase 3 trial [b] |
Basal Cell Carcinoma [c] | Phase 2 Last Patient Dosed |
December '23; Phase 2 | |
results expected Q2 2024 | |
Plantar Warts | Initiate Phase 2 trial [b] |
- Verrica and its partner in Japan, Torii Pharmaceutical Co., Ltd. expect to start a global Phase 3 clinical trial to study YCANTH® for the treatment of common warts in 2025.
- Timing for initiating clinical trials for External Genital Warts and Plantar Warts to be determined.
[c] | License excludes metastatic melanoma and metastatic Merkel cell carcinoma. Phase 2 study initiated in April 2022 for the treatment of | Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. | 4 |
Basal Cell Carcinoma. |
Not For Promotional Use
Focused on Largest Unmet Needs in Dermatology
YCANTH
*NOW APPROVED*
VP-102
First Patient Dosed Global PH3 expected
H1 2025
VP-315
PH2 Preliminary Top-Line Results Q2 '24
M o l l u s c u m | Common War ts | |
US Prevalence of ~6 million(1) | with | US Prevalence of ~22 million(3) |
~1 million diagnosed annually(2) | with ~1.5 million diagnosed annually(4) |
1.5M | |||
15% | Patients | ||
85% | Diagnosed | 22M | Diagnosed |
Annually | |||
Not Diagnosed | 0.9 million | Prevalence | |
5.1 million | in U.S. |
- 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
- www.skincancer.org/skin-cancer-information/skin-cancer-facts/
Nonmetastatic Skin Cancer US Prevalence of ~5.4M cases annually(5)
Squamous cell carcinoma
1.8M1
3.6M1
Basal cell carcinoma
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. | 5 |
Comprehensive Regulatory, IP and Manufacturing Strategy to Maintain YCANTH Exclusivity; VP-315COM-Issued Protection
YCANTH
Regulatory | 5 years NCE exclusivity for cantharidin as | Patent applications on: | |
API granted; potential for additional 6 | • | Specific formulation | |
Exclusivity; | months for pediatric exclusivity for | • | Applicator |
Patent Portfolio | common warts and plantar warts | • | Method of Use |
indications | • | Design | |
Verrica has and will enforce its rights to remove any compounded | |||
Compounding | cantharidin that is essentially a copy of YCANTH from the market unless | ||
it meets the FDA statutory exemptions. In addition, with the approval of | |||
Pharmacies | from 503B Category 1 and has sought an Import Alert from the FDA to | ||
YCANTH , Verrica has petitioned the FDA to have Cantharidin removed |
detain any compounded cantharidin before importation into the USA. *
-315
Extensive Issued and Pending
Patents Covering VP-315
from 2029-2037
PCT/EP2009/006774; composition-of-matter (COM) patent
- Expires 2029 (EU) ***
- Expires 2032 (US)
- Expires 2029 (Japan)
YCANTH addresses stability
Manufacturing ** issues with standard packaging and container/ closure systems
Limited commercial CMOs with facilities for handling highly potent and highly flammable liquid products
VP
PCT/EP2017/052279; methods-of-use patent, pending
- Expires 2037 (EU)
- Expires 2037 (US)
- Expires 2037 (Japan)
True Generic | Unlikely to receive approval under an ANDA due to uniqueness |
Unlikely | from patent pending protection and significant differences likely |
between YCANTH and potential competitors |
- 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.
-
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 - In force in: UK, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland and Turkey
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. | 6 |
Not For Promotional Use
Management Team with Extensive Product
Launch and Dermatology Experience
Ted White
President & Chief
Executive Officer
Selected
Launched
Products
Terry Kohler
Chief Financial
Officer
Gary Goldenberg, MD
Chief Medical
Officer
Joe Bonaccorso
Chief Commercial
Officer
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.
Not For Promotional Use
YCANTH (cantharidin)
topical solution 0.7%
The First FDA Approved Treatment for Molluscum
Contagiosum
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved.
Not For Promotional Use
YCANTH (cantharidin, 0.7%) Drug-device Combination Product Delivered Via a Single-use Applicator
DESIGNED FOR RELIABLE,
AND TARGETED ADMINISTRATION
Topical solution in a single-use applicator
- Active ingredient cantharidin (0.7%) in a proprietary topical formulation
- Single-useapplicator to reduce cross-contamination and facilitate application of the topical solution
- Small opening allows for targeting of affected skin
GMP-controlled,shelf-stable, consistent topical formulation
- Allows for reliable dosing/administration
- Oral deterrent to help mitigate the risk of accidental ingestion
- Visualization agent to identify treated lesions
Cap | Tip | Filter Ampule | Tube |
Copyright © 2024 Verrica Pharmaceuticals. All rights reserved. | 9 |
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, although in some people it can take up to five years - Often leads to anxiety and social challenges for the patients and parents and negatively impacts quality of life
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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
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Verrica Pharmaceuticals Inc. published this content on 15 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 15 May 2024 12:32:37 UTC.