Verrica Pharmaceuticals Reports Third Quarter 2019 Financial Results
November 06 2019 - 4:05PM
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
financial results for the third quarter ended September 30, 2019.
“Verrica made several important strides this quarter to advance
our lead product candidate, VP-102, for the treatment of molluscum
contagiosum and common warts,” said Ted White, President and Chief
Executive Officer of Verrica. “The highlight was the submission of
the New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for VP-102 for the treatment of molluscum, a
highly contagious viral skin infection. If approved, VP-102 could
potentially become the standard of care for this disease. We look
forward to a possible acceptance of the NDA this quarter, and
taking another step towards our goal of providing a safe and
effective therapy to address a demonstrated unmet medical
need.”
Business Highlights and Recent Developments
- Submitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration for VP-102 (cantharidin 0.7% Topical
Solution), a proprietary topical therapy for the treatment of
molluscum contagiosum, which affects an estimated six million
people – primarily children – in the United States, and has no
FDA-approved treatments available.
- Advanced the research and development of VP-102 for the
treatment of molluscum and common warts, with the presentation of
positive results from three abstracts at the Fall Clinical
Dermatology Conference, including pooled data from the Phase 3 CAMP
studies in molluscum, and results of the Phase 2 COVE-1 study in
common warts. VP-102 achieved statistically significant reductions
in molluscum lesions and complete clearance of lesions in the CAMP
studies, achieved complete clearance of common warts in 51.4% of
subjects at the primary endpoint of Day 84 and 40% of subjects at
Day 147 in Cohort 2 of the COVE-1 study, and was well-tolerated
with a low rate of adverse events across all studies.
- Continued to advance Company leadership and commercialization
capabilities with three key appointments: A. Brian Davis was named
Chief Financial Officer; Eugene Scavola joined the Company as
Executive Vice President, Technical Operations; and Christopher
Rofidal was appointed Vice President, Market Access.
Financial Results
- Verrica reported a net loss of $6.1 million for the third
quarter of 2019, compared to a net loss of $5.9 million for the
same period in 2018.
- Research and development expenses were $3.0 million in the
third quarter of 2019, compared to $3.5 million for the same period
in 2018. The decrease was primarily attributable to a decrease in
costs associated with the clinical development of VP-102 for the
treatment of molluscum, partially offset by an increase in costs
associated with the clinical development of VP-102 for the
treatment of external genital warts and costs associated with
manufacturing scale-up activities.
- General and administrative expenses were $3.5 million in the
third quarter of 2019, compared to $2.9 million for the same period
in 2018. The increase was primarily a result of 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 September 30, 2019, Verrica had aggregate cash, cash
equivalents, and marketable securities of $71.1 million.
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
Company’s 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 Verrica’s 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 common warts, external genital warts and
plantar 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, Verrica’s reliance on third parties over which it
may not always have full control, and other risks and uncertainties
that are described in Verrica’s 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.
|
VERRICA
PHARMACEUTICALS INC. |
Statements
of Operations |
(unaudited,
in thousands except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,049 |
|
|
$ |
3,467 |
|
|
$ |
11,464 |
|
|
$ |
7,909 |
|
General and administrative |
|
3,494 |
|
|
|
2,865 |
|
|
|
10,626 |
|
|
|
5,781 |
|
Total
operating expenses |
|
6,543 |
|
|
|
6,332 |
|
|
|
22,090 |
|
|
|
13,690 |
|
Loss from
operations |
|
(6,543 |
) |
|
|
(6,332 |
) |
|
|
(22,090 |
) |
|
|
(13,690 |
) |
Other
income |
|
453 |
|
|
|
426 |
|
|
|
1,520 |
|
|
|
620 |
|
Net
loss |
$ |
(6,090 |
) |
|
$ |
(5,906 |
) |
|
$ |
(20,570 |
) |
|
$ |
(13,070 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.83 |
) |
|
$ |
(1.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted |
|
24,893,036 |
|
|
|
24,847,512 |
|
|
|
24,875,589 |
|
|
|
11,230,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VERRICA
PHARMACEUTICALS INC. |
Selected
Balance Sheet Data |
(unaudited,
in thousands) |
|
|
|
|
|
|
|
|
|
September 30, 2019 |
|
December 31, 2018 |
|
|
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities |
$ |
71,078 |
|
|
$ |
89,809 |
|
Total
assets |
|
76,074 |
|
|
|
91,906 |
|
Total
liabilities |
|
4,421 |
|
|
|
2,477 |
|
Total
stockholders' equity |
|
71,653 |
|
|
|
89,429 |
|
|
|
|
|
|
|
|
|
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
A. Brian DavisChief Financial
Officer484.453.3300 ext. 103info@verrica.com
Chiara RussoSolebury
Trout617.221.9197crusso@soleburytrout.com
Media:
Joshua R. MansbachSolebury
Trout646-378-2964jmansbach@troutgroup.com
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