Verrica Pharmaceuticals Reports Fourth Quarter and Full-Year 2020 Financial Results
March 04 2021 - 7:30AM
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 ended December 31, 2020.
“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 June 23, 2021,” said Ted White, Verrica’s
President and Chief Executive Officer. “We are excited to announce
today that Torii Pharmaceutical Co., Ltd. has exercised the option
we granted to them in August to develop and commercialize VP-102 in
Japan for the treatment of molluscum contagiosum and common warts.
The prevalence of molluscum contagiosum alone in Japan was
approximately 1.6 million cases in 2017. The option exercise
triggers a 60-day period for Torii and us to finalize and execute a
license agreement. Further, new analyses of Verrica’s pivotal Phase
3 molluscum trials and Verrica’s Phase 2 study in external genital
warts continue to generate positive results, which have been
published in medical journals and presented at top dermatology
conferences.”
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 is June 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 in Japan, 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 in Japan.
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 2021 Winter 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 the
Journal 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 the
American 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 in December 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 in December 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
ended December 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 ended December 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 ended December 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 in December 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 U.S. Food and Drug
Administration (FDA) review, with a PDUFA goal date of June 23,
2021, 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 genital
warts.
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.
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
September 30, 2020 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.Condensed Statements of
Operations(unaudited, in thousands except share
and per share data)
|
|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
|
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 |
|
VERRICA PHARMACEUTICALS
INC.Selected Balance Sheet
Data(unaudited, in thousands)
|
|
December 31, 2020 |
|
|
December 31, 2019 |
|
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:
A. Brian DavisChief Financial
Officer484.453.3300 ext. 103info@verrica.com
William WindhamSolebury
Trout646.378.2946wwindham@troutgroup.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@troutgroup.com
Verrica Parmaceuticals (NASDAQ:VRCA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Verrica Parmaceuticals (NASDAQ:VRCA)
Historical Stock Chart
From Apr 2023 to Apr 2024