News Release Details
Verrica Pharmaceuticals Reports Fourth Quarter and Full-Year 2020 Financial Results
– FDA accepts resubmitted NDA for VP-102 for the treatment of molluscum contagiosum with PDUFA goal date of
– Verrica Announces Torii Pharmaceutical Has Exercised Option to Acquire Exclusive License Agreement to Develop and Commercialize VP-102 in
“Over the past year, we worked rapidly to resubmit the NDA for our lead product candidate, VP-102, in molluscum contagiosum, which we recently announced has been accepted for filing and assigned a PDUFA goal date of
Business Highlights and Recent Developments
- The Company recently announced that its resubmitted New Drug Application (NDA) for VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy for the treatment of molluscum, has been accepted for filing by the
U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA isJune 23, 2021 . - On
March 2 , Torii Pharmaceutical Co., Ltd. (Torii) exercised its option to acquire an exclusive license to develop and commercialize Verrica’s product candidates for the treatment of molluscum contagiosum and common warts inJapan , including VP-102. The parties have 60 days from the option exercise date to finalize and execute a license agreement. Under the terms of the Option Agreement, the license agreement would provide for Torii to make an up-front payment of$11.5 million , up to an additional$58 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, and tiered transfer price payments for supply of product in the percentage range of the mid-30s to the mid-40s of net sales. Torii would be responsible for all development activities and costs in support of obtaining regulatory approval inJapan .
Clinical Program Results
- Verrica announced positive topline results from its Phase 2
CARE -1 clinical study of VP-102 in external genital warts (EGW). VP-102 achieved positive results on both the primary endpoint of complete clearance of all treatable EGW at Day 84 and the secondary endpoint of the percentage reduction of EGW at Day 84. - Positive data from new post-hoc pooled analyses of the pivotal Phase 3 CAMP trials, segmenting molluscum lesions by body region and study visit, were presented in poster format online for the 2021
Winter Clinical Dermatology Conference . The results demonstrated that the percentage of participants with complete clearance of all baseline and new molluscum lesions was statistically significantly higher in the VP-102 group compared to vehicle across all body regions, beginning at earlier timepoints and continuing through the end of study visit (Day 84). - Positive data from Verrica’s Phase 2
CARE -1 clinical study of VP-102 in EGW were also presented at the 2021Winter Clinical Dermatology Conference . Results demonstrated that treatment with VP-102 resulted in a statistically significantly higher complete clearance rate of all EGW compared to vehicle at Visit 4 (Day 63) and at the End of Treatment Visit (Day 84) regardless of drug exposure duration (6 or 24 hours). - Positive results from the Phase 2, open-label study evaluated the safety, efficacy, systemic exposure, and impact on quality of life (QoL) with treatment using VP-102 for the treatment of molluscum were published online in the
January 2021 issue of theJournal of Drugs in Dermatology. - Positive pooled results from the Company’s two pivotal Phase 3 CAMP studies evaluating VP-102 in children and adults with molluscum were published in the online
February 2021 issue of theAmerican Journal of Clinical Dermatology .
Financial Results
Fourth Quarter 2020 Financial Results
- Verrica reported a net loss of
$13 .0 million for the fourth quarter of 2020, compared to a$7.6 million net loss for the same period in 2019. - Research and development expenses were
$2 .3 million in the fourth quarter of 2020, compared to$4.0 million for the same period in 2019. The decrease was primarily attributable to decreased costs related to Verrica’s development of VP-102 for common warts and external genital warts and VP-103 for plantar warts, partially offset by increased costs related to the resubmission of the NDA for VP-102 inDecember 2020 . - General and administrative expenses were
$9 .8 million in the fourth quarter of 2020, compared to$4.0 million for the same period in 2019. The increase was primarily a result of higher stock-based compensation costs, which includes$4.8 million of stock-based compensation expense recorded inDecember 2020 related to the modification of a stock award to a former executive. The increase was also driven by expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
Full Year 2020 Financial Results
- Verrica reported a net loss of
$42 .7 million for the year endedDecember 31, 2020 , compared to a$28.2 million net loss for the same period in 2019. - Research and development expenses were
$15 .7 million for the year endedDecember 31, 2020 , compared to$15 .4 million for the same period in 2019. The increase was primarily attributable to increased Chemistry, Manufacturing and Controls (CMC) costs related to Verrica’s development of VP-102 for molluscum contagiosum and increased compensation costs, partially offset by decreased clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum. - General and administrative expenses were
$24 .5 million for the year endedDecember 31, 2020 , compared to$14.6 million for the same period in 2019. The increase was primarily a result of higher stock-based compensation costs, which includes$4.8 million of stock-based compensation expense recorded inDecember 2020 related to the modification of a stock award to a former executive. The increase was also driven by expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102. - As of
December 31, 2020 , Verrica had aggregate cash, cash equivalents, and marketable securities of$65 .5 million, which the Company believes will be sufficient to support planned operations at least into the first quarter of 2022.
About VP-102
Verricaʼs 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
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
About
Verrica is a 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, visit www.verrica.com.
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 the Company’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, the clinical development of Verrica’s VP-102 for additional indications and Verrica’s other product candidates, the potential entry into a license agreement with Torii and the terms of such license agreement, and Verrica’s cash, cash equivalents and marketable securities being sufficient to support planned operations at least into the first 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, 2019, Verrica’s Quarterly Report on Form 10-Q for the quarter ended
Condensed Statements of Operations
(unaudited, in thousands except share and per share data)
Three Months Ended |
Twelve Months Ended |
|||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 2,272 | $ | 3,972 | $ | 15,673 | $ | 15,436 | ||||||||
General and administrative | 9,761 | 4,018 | 24,508 | 14,644 | ||||||||||||
Total operating expenses | 12,033 | 7,990 | 40,181 | 30,080 | ||||||||||||
Loss from operations | (12,033 | ) | (7,990 | ) | (40,181 | ) | (30,080 | ) | ||||||||
Interest income | 48 | 354 | 521 | 1,877 | ||||||||||||
Interest expense | (991 | ) | - | (3,033 | ) | - | ||||||||||
Other expense | (1 | ) | (1 | ) | (1 | ) | (4 | ) | ||||||||
Net loss | $ | (12,977 | ) | $ | (7,637 | ) | $ | (42,694 | ) | $ | (28,207 | ) | ||||
Net loss per share, basic and diluted | $ | (0.52 | ) | $ | (0.31 | ) | $ | (1.71 | ) | $ | (1.13 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 25,062,817 | 24,922,080 | 24,995,556 | 24,897,889 |
Selected Balance Sheet Data
(unaudited, in thousands)
Cash, cash equivalents and marketable securities | $ | 65,470 | $ | 62,017 | ||||
Total assets | 74,154 | 68,424 | ||||||
Debt, net | 35,315 | — | ||||||
Total liabilities | 41,168 | 3,409 | ||||||
Total stockholders’ equity | 32,986 | 65,015 |
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
Chief Financial Officer
484.453.3300 ext. 103
info@verrica.com
Solebury Trout
646.378.2946
wwindham@troutgroup.com
Media:
Solebury Trout
646.378.2960
zlockshin@troutgroup.com
Source: Verrica Pharmaceuticals Inc.