Agile Therapeutics Reports Second Quarter 2017 Financial Results
28 7월 2017 - 8:30PM
Cash Expected to Fund Operations into Q2
2018
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's healthcare
company today reported financial results for the three and six
months ended June 30, 2017, and provided a corporate update for the
second quarter 2017.
Second quarter 2017 and other recent
corporate developments include:
- Twirla® Update – On June 27,
2017, the Company announced that it had resubmitted to the U.S.
Food and Drug Administration (FDA) the New Drug Application (NDA)
for Twirla, its investigational low-dose combined hormonal
contraceptive patch (AG200-15). The Company resubmitted the
NDA in response to a February 2013 Complete Response Letter (CRL)
from the FDA. On July 27, 2017, the Company announced that
the FDA had acknowledged the resubmitted NDA for Twirla as a
complete response to the CRL, and provided a target Prescription
Drug User Fee Act (PDUFA) goal date of December 26,
2017.
- Securities Litigation – On July 13, 2017, the
previously-disclosed complaints that were filed in January 2017 in
the United States District Court for the District of New Jersey on
behalf of a putative class of investors who purchased Company stock
from March 9, 2016 through January 3, 2017 was dismissed with
prejudice as to all defendants. The complaints alleged
violations of the federal securities laws based on public
statements made regarding the Company’s Phase 3 SECURE clinical
trial and sought as damages an unspecified amount to be determined
at trial. The Company has denied all allegations in the
complaints. Following consolidation of the lawsuits and
appointment of a lead plaintiff for the putative class, in June
2017, the lead plaintiff agreed to dismiss the consolidated case
with prejudice voluntarily, without payment of any consideration
and with each side bearing its own attorney fees and costs.
“We made excellent progress during the second
quarter of 2017, most notably, with the successful submission and
acceptance of the NDA resubmission for Twirla to the FDA. We
are pleased with the assigned target PDUFA goal date
of December 26, 2017. These accomplishments have set the stage
for what we expect will be an important year for the company as we
move closer to potentially commercializing our novel low-dose
contraceptive patch and providing an important new contraceptive
option for women,” said Al Altomari, Chairman and CEO of
Agile. “We look forward to working with the FDA in moving
Twirla through the regulatory review process and will continue to
prudently manage our capital resources as we execute our business
plan, which we expect will allow us to fund operations into the
second quarter of 2018."
Second Quarter Financial
Results
- Cash and cash equivalents: As of June
30, 2017, Agile had $33.9 million of cash and cash equivalents
compared to $48.8 million of cash and cash equivalents as of
December 31, 2016. Based on the Company’s current business
plan, the Company believes its cash and cash equivalents as of June
30, 2017, will be sufficient to meet its operating requirements
into the second quarter of 2018. The Company’s current
business plan assumes the FDA review of the Company’s resubmission
of the Twirla NDA will be completed on the target PDUFA action
date, and that pre-commercial activities and initiation of
validation of its commercial manufacturing process will be
coordinated with the timing of commercialization of Twirla, if
approved. The Company will require additional capital for the
commercial launch of Twirla, if approved, and for the development
of its other product candidates. In the event of unforeseen changes
to its planned timelines and business plan assumptions, as stated
above, the Company still believes it has the ability to continue
funding its operations into the second quarter of 2018 by
postponing certain planned commercial and validation
spending.
- Research and development (R&D)
expenses: R&D expenses were $3.8 million for the
quarter ended June 30, 2017, compared to $5.6 million for the
comparable period in 2016. The decrease in R&D expense
was primarily due to decreased clinical development expenses as the
Company’s Phase 3 SECURE clinical trial for Twirla continued the
close-out phase. The decrease in clinical development
expenses was offset, in part, by increased expenses associated with
commercial manufacturing scale-up activities, which we expect to
continue to increase in 2017.
- General and administrative (G&A)
expenses: G&A expenses were $3.2 million for the
quarter ended June 30, 2017, compared to $2.3 million for the
comparable period in 2016. The increase in G&A expenses
was primarily due to increased pre-commercialization activities,
which we expect to continue to increase in 2017.
- Net loss: Net loss was $7.4 million, or
$0.26 per share for the quarter ended June 30, 2017, compared to a
net loss of $8.4 million, or $0.29 per share for the quarter ended
June 30, 2016.
- Shares Outstanding: At June 30, 2017,
Agile had 28,806,398 shares of common stock outstanding.
About Agile Therapeutics,
Inc.Agile Therapeutics is a forward-thinking women's
healthcare company dedicated to fulfilling the unmet health needs
of today’s women. Our product candidates are designed to
provide women with contraceptive options that offer freedom from
taking a daily pill, without committing to a longer-acting method.
Our lead product candidate, Twirla®, (ethinyl estradiol and
levonorgestrel transdermal system), also known as AG200-15, is a
once-weekly prescription contraceptive patch that recently
completed Phase 3 trials. Twirla is based on our proprietary
transdermal patch technology, called Skinfusion®, which is designed
to provide advantages over currently available patches and is
intended to optimize patch adhesion and patient wearability. For
more information, please visit the company website at
www.agiletherapeutics.com. The company may occasionally disseminate
material, nonpublic information on the company website.
Forward-Looking
StatementCertain information contained in this press
release includes "forward-looking statements" related to the
Company's clinical trials, regulatory submissions, projected cash
position and potential market opportunity for its product
candidates. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "continue," "anticipates," "estimates,"
"expects," "plans," "intends," "may," "could," “might," "will,"
"should" or other words that convey uncertainty of the future
events or outcomes to identify these forward-looking statements.
Our forward-looking statements are based on current beliefs and
expectations of our management team that involve risks, potential
changes in circumstances, assumptions and uncertainties. Any or all
of the forward-looking statements may turn out to be wrong, or be
affected by inaccurate assumptions we might make or by known or
unknown risks and uncertainties. Our statements about the results
and conduct of our clinical trial could be affected by the
potential that there are changes in the data or interpretation of
the data by the FDA (for example, the FDA may include additional
pregnancies in its calculation of the Pearl Index, which would
increase the Pearl Index), whether the results will be deemed
satisfactory by the FDA (for example, we describe the results of
the SECURE trial as positive, the FDA may disagree with that
characterization), and whether additional studies will be required
or other issues will arise that will negatively impact acceptance,
review, and approval of Twirla by the FDA; our statements about our
projected cash position could be affected by market factors, the
inherent risks in our business, our ability to execute the
Company’s operational and budget plans, the FDA does not approve
Twirla, the FDA’s timeline for review is not completed by the
target PDUFA goal date, our ability to timely complete the
qualification and validation of our commercial manufacturing
process, the fact that our existing cash and cash equivalents will
not be sufficient to fund our current and planned operations
through the next 12 months, which raises substantial doubt about
our ability to continue as a going concern, and which, in turn, may
create negative reactions to the price of our common stock making
it more difficult to obtain financing in the future, and unforeseen
events in our clinical and manufacturing development plans; and our
statements about the potential commercial opportunity could be
affected by the potential that our product does not receive
regulatory approval, does not receive reimbursement by third party
payors, or a commercial market for the product does not develop
because of any of the risks inherent in the commercialization of
contraceptive products. For all these reasons, actual results and
developments could be materially different from those expressed in
or implied by our forward-looking statements. All forward looking
statements are subject to risks detailed in our filings with the
U.S. Securities and Exchange Commission, including the Company's
Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q.
You are cautioned not to place undue reliance on these
forward-looking statements, which are made only as of the date of
this press release. We undertake no obligation to publicly update
such forward-looking statements to reflect subsequent events or
circumstances.
Agile Therapeutics,
Inc.Condensed Balance Sheets(in
thousands) (Unaudited) |
|
|
|
|
June 30, 2017 |
December 31, 2016 |
Assets |
|
|
Current assets: |
|
|
Cash and
cash equivalents |
$33,938 |
|
$48,750 |
|
Prepaid
expenses |
|
525 |
|
|
2,768 |
|
Total current
assets |
|
34,463 |
|
|
51,518 |
|
Property and equipment,
net |
|
12,769 |
|
|
12,330 |
|
Other assets |
|
18 |
|
|
18 |
|
Total assets |
|
$47,250 |
|
|
$63,866 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
Accounts
payable and accrued expenses |
$4,172 |
|
$5,402 |
|
Loan
payable, current portion |
|
5,981 |
|
|
5,104 |
|
Warrant
liability |
|
70 |
|
|
172 |
|
Total current
liabilities |
|
10,223 |
|
|
10,678 |
|
Loan payable,
long‑term |
|
7,886 |
|
|
10,899 |
|
|
|
|
Stockholders’
equity |
|
|
Common
stock |
|
3 |
|
|
3 |
|
Additional paid‑in capital |
|
237,567 |
|
|
235,754 |
|
Accumulated deficit |
|
(208,429) |
|
|
(193,468) |
|
Total stockholders’
equity |
|
29,141 |
|
|
42,289 |
|
Total liabilities and
stockholders’ equity |
$47,250 |
|
$63,866 |
|
Agile
Therapeutics, Inc.Condensed Statements of
Operations(in thousands, except share and per
share amounts) (Unaudited) |
|
|
|
|
Three Months Ended June
30, |
Six Months Ended June
30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
Research
and development |
$3,798 |
|
$5,577 |
|
$8,519 |
|
$10,505 |
|
General
and administrative |
|
3,198 |
|
|
2,264 |
|
|
5,603 |
|
|
4,316 |
|
Total operating
expenses |
|
6,996 |
|
|
7,841 |
|
|
14,122 |
|
|
14,821 |
|
Loss from
operations |
|
(6,996) |
|
|
(7,841) |
|
|
(14,122) |
|
|
(14,821) |
|
Other income
(expense) |
|
|
|
|
Interest
expense |
|
(504) |
|
|
(548) |
|
|
(1,050) |
|
|
(1,095) |
|
Interest
income |
|
61 |
|
|
33 |
|
|
109 |
|
|
50 |
|
Change in
fair value of warrants |
|
(7 |
) |
|
(62 |
) |
|
102 |
|
|
130 |
|
Loss before benefit
from income taxes |
|
(7,446) |
|
|
(8,418) |
|
|
(14,961) |
|
|
(15,736) |
|
Benefit from income
taxes |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Net loss |
$(7,446) |
|
|
$(8,418) |
|
|
$(14,961) |
|
|
$(15,736) |
|
Net loss per share -
basic and diluted |
$(0.26) |
|
|
$(0.29) |
|
|
$(0.52) |
|
|
$(0.57) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted‑average shares
outstanding – basic and diluted |
|
28,802,112 |
|
|
28,744,004 |
|
|
28,785,827 |
|
|
27,785,113 |
|
Contact: Mary Coleman -- 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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