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Verrica Pharmaceuticals Reports Fourth Quarter and Full-Year 2021 Financial Results NDA for VP-102 for the treatment of molluscum assigned a PDUFA date of

Key Takeaway: Verrica Pharmaceuticals Reports Fourth Quarter and Full-Year 2021 Financial Results NDA for VP-102 for the treatment of molluscum assigned a PDUFA date of May 24, 2022 Company expects to dose first patient in Phase 2 trial of LTX-315 in basal cell carcinoma in the first quarte

Full Press Release Details

Verrica Pharmaceuticals Reports Fourth Quarter and Full-Year 2021 Financial Results
NDA for VP-102 for the treatment of molluscum assigned a PDUFA date of May 24, 2022
Company expects to dose first patient in Phase 2 trial of LTX-315 in basal cell carcinoma in the
first quarter of 2022
WEST CHESTER, PA March 2, 2022 (GLOBE NEWSWIRE) Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the fourth quarter and year ended December 31, 2021.
2022 is poised to be an exciting year for Verrica as we prepare to potentially launch VP-102 this summer for the
treatment of molluscum, a disease affecting an estimated six million patients with no approved treatments, representing a significant market opportunity, said Ted White, Verrica s President and Chief Executive Officer. In addition,
in keeping with our mission to develop treatments for the most significant unmet needs in medical dermatology, we are rapidly advancing LTX-315, a novel immunotherapy for the treatment of non-melanoma skin cancers. The first patient is expected to be dosed in the Phase 2 trial evaluating LTX-315 in basal cell carcinoma in the first quarter of 2022.
Business Highlights and Recent Developments
Corporate Highlights
Fourth Quarter 2021 Financial
Full Year 2021 Financial Results
Non-GAAP Financial Measures
In evaluating the operating performance of its business, Verrica s management considers non-GAAP loss
from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial
measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary
course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP loss from
operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but
should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net
loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.
Verrica s lead product candidate, VP-102, is a
proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via
a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug
Administration (FDA) review and could potentially be the first product approved by the FDA to treat molluscum contagiosum a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily
children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH . In addition, Verrica
has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external
About Molluscum Contagiosum (Molluscum)
There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that
affects approximately six million people primarily children in the United States. Molluscum is caused by a pox virus that produces distinctive
raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to
other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.
About Verrica Pharmaceuticals Inc.
dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica s late-stage product candidate, VP-102, is in development to treat molluscum,
common warts and external genital warts, three of the largest unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment
of plantar warts. The Company has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology conditions. For more information,
Forward-Looking Statements
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 Verrica s current beliefs and expectations. These forward-looking statements include expectations regarding Verrica s expectations with regard to the potential approval of the NDA
for VP-102 and the potential benefits and potential commercialization of VP-102 for the treatment of molluscum, if approved, including the timing of
launch, the clinical development of Verrica s VP-102 for additional indications and Verrica s other product candidates, expectations with regard to the when dosing will begin for
Verrica s Phase 2 clinical trial for LTX-315 and Verrica s cash, cash equivalents and marketable securities being sufficient to support planned operations into the third quarter of 2022. 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, Verrica s reliance on third parties over which it may not always have full control, uncertainties related to the COVID-19 pandemic
and other risks and uncertainties that are described in Verrica s Annual Report on Form 10-K for the year ended December 31, 2021 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.
VERRICA PHARMACEUTICALS INC.
Statements of Operations
(unaudited, in thousands except share and per share data)
Three Months Ended December 31, Twelve Months Ended December 31,
2021 2020 2021 2020
Licensing Revenue $ $ $ 12,000 $
Operating expenses:
Research and development 3,357 2,272 15,929 15,673
General and administrative 5,113 9,760 26,979 24,508
Total operating expenses 8,470 12,032 42,908 40,181
Loss from operations (8,470 ) (12,032 ) (30,908 ) (40,181 )
Interest income 27 46 123 521
Interest and other expense (1,097 ) (991 ) (4,295 ) (3,034 )
Net loss $ (9,540 ) $ (12,977 ) $ (35,080 ) $ (42,694 )
Net loss per share, basic and diluted $ (0.35 ) $ (0.52 ) $ (1.30 ) $ (1.71 )
Weighted average common shares outstanding, basic and diluted 27,519,053 25,062,817 27,044,462 24,995,556
VERRICA PHARMACEUTICALS INC.
Selected Balance Sheet Data
(unaudited, in thousands)
December 31, 2021 December 31, 2020
Cash, cash equivalents and marketable securities $ 70,354 $ 65,470
Prepaid assets and other expenses 3,974 2,180
Total current assets 74,328 67,650
PP&E, lease right of use asset, other 5,797 6,504
Total assets $ 80,125 $ 74,154
Total liabilities 47,520 41,168
Total stockholders equity (deficit) 32,605 32,986
Total $ 80,125 $ 74,154
VERRICA PHARMACEUTICALS INC.
Reconciliation of Non-GAAP Financial Measures (unaudited)
(in thousands except per share data)
Twelve Months Ended December 31, 2021
Loss from Operations Net loss Net loss per share
GAAP $ (30,908 ) $ (35,080 ) $ (1.30 )
Non-GAAP Adjustments:
Stock-based compensation - Selling, General & Admin (a) 4,540 4,540
Stock-based compensation - Research & Development (a) 1,513 1,513
Non-cash interest expense (b) 1,412
Adjusted $ (24,855 ) $ (27,615 ) $ (1.02 )
Twelve Months Ended December 31, 2020
Loss from Operations Net loss Net loss per share
GAAP $ (40,181 ) $ (42,694 ) $ (1.71 )
Non-GAAP Adjustments:
Stock-based compensation - Selling, General & Admin (a) 9,008 9,008
Stock-based compensation - Research & Development (a) 813 813
Non-cash interest expense (b) 940
Adjusted $ (30,360 ) $ (31,933 ) $ (1.28 )
FOR MORE INFORMATION, PLEASE CONTACT:
Chief Financial Officer
Last updated: Mar 2, 2022