Verrica Pharmaceuticals Reports Second Quarter 2022 Financial Results
11 Agosto 2022 - 6:30AM
Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a
dermatology therapeutics company developing medications for skin
diseases requiring medical interventions, today announced financial
results for the second quarter ended June 30, 2022.
“This quarter, we held a Type A meeting with the FDA regarding
the path forward for the resubmission and potential approval of the
New Drug Application (NDA) for VP-102 for the treatment of
molluscum,” said Ted White, Verrica’s President and Chief Executive
Officer. “We also began working with an alternative supplier for
the bulk solution of VP-102, Piramal Pharma Solutions, at their
Sellersville, Pennsylvania site. Piramal’s experience in the
commercial manufacturing of liquids combined with the facility’s
close proximity to Verrica’s headquarters will allow our teams to
work closely and collaboratively in the technology transfer
process. Based on the feedback from the FDA and the timing of the
technology transfer to Piramal, we expect to be able to resubmit
the NDA for VP-102 for the treatment of molluscum contagiosum
(molluscum) in the first quarter of 2023.”
Business Highlights and Recent Developments
Corporate Highlights
- Verrica executed an underwritten public offering of 13,575,000
shares of its common stock at a price to the public of $2.10 per
share, which includes shares sold pursuant to the underwriter’s
option to purchase additional shares. The gross proceeds from the
offering to Verrica were approximately $28.5 million, before
deducting underwriting discounts and commissions and offering
expenses.
- Verrica voluntarily repaid in full the debt outstanding under
the mezzanine loan and security agreement using restricted cash of
$40.0 million, which was set aside as cash collateral in a March
2022 amendment to the loan agreement, as well as cash on hand.
VP-102
- Verrica announced that the U.S. Food and Drug Administration
(FDA) issued a Complete Response Letter (CRL) regarding its NDA for
VP-102 for the treatment of molluscum. According to the CRL, the
only deficiency listed was related to the deficiencies identified
at a general reinspection of the contract manufacturing
organization (CMO) that manufactures Verrica’s bulk solution drug
product. None of the issues identified by FDA during the
reinspection were specific to the manufacturing of VP-102.
- Verrica has begun working with Piramal Pharma Solutions to
manufacture bulk solution for VP-102 at their Sellersville,
Pennsylvania site. Verrica will continue to work closely with
Piramal and the FDA to facilitate a timely technology transfer and
production quality at the facility.
- Verrica announced that it held a Type A Meeting with the FDA
regarding the path forward for the resubmission and potential
approval of the NDA for VP-102 for the treatment of molluscum. The
FDA indicated a willingness to work collaboratively on the amount
of stability data required from an alternative CMO for the bulk
solution of VP-102 at the time of resubmission as well as options
for post-approval use of bulk solution previously
manufactured.
Financial Results
Second Quarter 2022 Financial Results
- Verrica recognized license revenues of $0.2 million for the
three months ended June 30, 2022 and no revenue for the same period
in 2021 related to the Collaboration and License Agreement (the
“Torii Agreement”) with Torii Pharmaceutical Co., Ltd. (“Torii”)
for supplies and development activity with Torii.
- Research and development expenses were $4.2 million in the
second quarter of 2022, compared to $3.4 million for the same
period in 2021. The increase was primarily attributable to a
one-time $1.0 million milestone payment to Lytix Biopharma AS
(“Lytix”) upon the achievement of a regulatory milestone for
LTX-315.
- General and administrative expenses were $5.2 million in
the second quarter of 2022, compared to $7.3 million for the same
period in 2021. The decrease was primarily a result of higher
expenses in the prior year related
to pre-commercial activities for VP-102.
- For the second quarter of 2022, net loss on a GAAP basis was
$10.2 million, or $0.37 per share, compared to a net loss of
$11.8 million, or $0.43 per share, for the same period in
2021.
- For the second quarter of 2022, non-GAAP net loss was
$8.8 million, or $0.32 per share, compared to a non-GAAP net
loss of $9.6 million, or $0.35 per share, for the same period in
2021.
Year-to-Date June 2022 Financial Results
- Verrica recognized license revenues related to the Torii
Agreement of $0.6 million for the six months ended June 30, 2022
compared to $12.0 million for the same period in 2021. The license
revenue for the six months ended June 30, 2022 related to Torii’s
purchase of supplies and reimbursement for development activities
while the 2021 license revenue was driven by the Torii upfront
license milestone payment of $12.0 million.
- Research and development expenses were $6.9 million for
the six months ended June 30, 2022, compared to $8.8 million for
the same period in 2021. The decrease was primarily attributable to
one-time payments of $1.0 and $2.3 million to Lytix upon the
achievement of regulatory milestones for LTX-315, during the six
months ended June 30, 2022 and 2021, respectively, as well as
decreased Chemistry, Manufacturing and Controls (CMC) and clinical
costs related to Verrica’s development of VP-102 for molluscum
contagiosum, external genital warts, and common warts in 2022.
- General and administrative expenses were $10.3 million for
the six months ended June 30, 2022, compared to $13.9 million for
the same period in 2021. The decrease of $3.6 million was primarily
a result of a decrease in expenses related
to pre-commercial activities for VP-102.
- For six months ended June 30, 2022, net loss on a GAAP basis
was $18.6 million, or $0.68 per share, compared to a net loss
of $12.7 million, or $0.46 per share, for the same period in
2021.
- For the six months ended June 30, 2022, non-GAAP net loss was
$15.6 million, or $0.57 per share, compared to a non-GAAP net
loss of $8.8 million, or $0.32 per share, for the same period in
2021.
- As of June 30, 2022, Verrica had aggregate cash, cash
equivalents, marketable securities and restricted cash of
$54.4 million. The Company believes that its existing cash,
cash equivalents, and marketable securities as of June 30, 2022,
together with the proceeds from the July 2022 underwritten public
offering, will be sufficient to support planned operations into the
third quarter of 2023.
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.
About VP-102
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. If
approved, VP-102 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. Verrica expects to
resubmit the NDA for VP-102 for the treatment of molluscum in the
first quarter of 2023 and in its resubmission will seek conditional
approval to market VP-102 in the United States under the 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
satisfaction of the CRL for VP-102, the technology transfer to
Piramal, the timing of the resubmission of the NDA for VP-102, the
clinical development of VP-102 for additional indications and
Verrica’s cash, cash equivalents, marketable securities and
restricted cash being sufficient to support planned operations into
the third quarter of 2023. 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 June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
License revenues: |
|
$ |
214 |
|
|
$ |
- |
|
|
$ |
645 |
|
|
$ |
12,000 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,162 |
|
|
|
3 447 |
|
|
|
6,885 |
|
|
|
8,809 |
|
General and administrative |
|
|
5,173 |
|
|
|
7,284 |
|
|
|
10,291 |
|
|
|
13,861 |
|
Total operating expenses |
|
|
9,335 |
|
|
|
10,731 |
|
|
|
17,176 |
|
|
|
22,670 |
|
Loss from operations |
|
|
(9,121 |
) |
|
|
(10,731 |
) |
|
|
(16,531 |
) |
|
|
(10,670 |
) |
Interest income |
|
|
20 |
|
|
|
33 |
|
|
|
42 |
|
|
|
65 |
|
Interest expense |
|
|
(1,067 |
) |
|
|
(1,077 |
) |
|
|
(2,149 |
) |
|
|
(2,106 |
) |
Net loss |
|
$ |
(10,168 |
) |
|
$ |
(11,775 |
) |
|
$ |
(18,638 |
) |
|
$ |
(12,711 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.46 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
27,519,053 |
|
|
|
27,513,665 |
|
|
|
27,519,053 |
|
|
|
27,697,985 |
|
VERRICA PHARMACEUTICALS INC.Selected
Balance Sheet Data(unaudited, in
thousands) |
|
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
Cash, cash equivalents, marketable securities and restricted
cash |
|
$ |
54,398 |
|
|
$ |
70,354 |
|
Total assets |
|
|
63,436 |
|
|
|
80,125 |
|
Debt, net |
|
|
42,293 |
|
|
|
41,693 |
|
Total liabilities |
|
|
47,103 |
|
|
|
47,520 |
|
Total stockholders’
equity |
|
|
16,333 |
|
|
|
32,605 |
|
VERRICA PHARMACEUTICALS INC.Reconciliation
of Non-GAAP Financial Measures (unaudited)(in
thousands except share and per share data) |
|
|
Three Months Ended June 30, 2022 |
|
|
Loss fromOperations |
|
|
Net loss |
|
|
Net loss pershare |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
$ |
(9,121 |
) |
|
$ |
(10,168 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation –
General & Admin (a) |
|
745 |
|
|
|
745 |
|
|
|
|
Stock-based compensation –
Research & Development (a) |
|
340 |
|
|
|
340 |
|
|
|
|
Non-cash interest expense
(b) |
|
- |
|
|
|
302 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
$ |
(8,036 |
) |
|
$ |
(8,781 |
) |
$ |
(0.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2021 |
|
|
|
Loss fromOperations |
|
|
|
Net loss |
|
|
Net loss pershare |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
$ |
(10,731 |
) |
|
$ |
(11,775 |
) |
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation –
General & Admin (a) |
|
1,423 |
|
|
|
1,423 |
|
|
|
|
Stock-based compensation –
Research & Development (a) |
|
425 |
|
|
|
425 |
|
|
|
|
Non-cash interest expense
(b) |
|
- |
|
|
|
344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
$ |
(8,883 |
) |
|
$ |
(9,583 |
) |
$ |
(0.35 |
) |
|
|
Six Months Ended June 30, 2022 |
|
|
|
Loss fromOperations |
|
|
Net loss |
|
|
Net loss pershare |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
$ |
|
(16,531 |
) |
|
$ |
(18,638 |
) |
|
$ |
(0.68 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation –
General & Admin (a) |
|
|
1,644 |
|
|
|
1,644 |
|
|
|
|
|
Stock-based compensation –
Research & Development (a) |
|
|
757 |
|
|
|
757 |
|
|
|
|
|
Non-cash interest expense
(b) |
|
|
- |
|
|
|
634 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
$ |
|
(14,130 |
) |
|
$ |
(15,603 |
) |
|
$ |
(0.57 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2021 |
|
|
|
Loss fromOperations |
|
|
Net loss |
|
|
Net loss pershare |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP |
$ |
|
(10,670 |
) |
|
$ |
(12,711 |
) |
|
$ |
(0.46 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation –
General & Admin (a) |
|
|
2,528 |
|
|
|
2,528 |
|
|
|
|
|
Stock-based compensation –
Research & Development (a) |
|
|
723 |
|
|
|
723 |
|
|
|
|
|
Non-cash interest expense
(b) |
|
|
- |
|
|
|
707 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted |
$ |
|
( 7,419 |
) |
|
$ |
( 8,753 |
) |
|
$ |
(0.32 |
) |
|
(a) The effects of non-cash stock-based compensation are excluded
because of varying available valuation methodologies and subjective
assumptions. We believe this is a useful measure for investors
because such exclusion facilitates comparison to peer companies who
also provide similar non-GAAP disclosures and is reflective of how
management internally manages the business.(b) The effects of
non-cash interest charges are excluded. We believe such exclusion
facilitates an understanding of the effects of the debt service
obligations on the Company’s liquidity and comparisons to peer
group companies and is reflective of how management internally
manages the business. |
|
FOR MORE INFORMATION, PLEASE
CONTACT:Investors:
Terry KohlerChief Financial
Officer484.453.3296info@verrica.com
William WindhamSolebury
Trout646.378.2946wwindham@troutgroup.com
Media:
Zara LockshinSolebury
Trout646.378.2960zlockshin@troutgroup.com
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