Agile Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results
13 3월 2018 - 5:15AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's healthcare
company, today reported financial results for the three months and
year ended December 31, 2017 and provided a corporate update.
Fourth quarter 2017 and other recent
corporate developments include:
- Twirla® Update –
On December 22, 2017, the Company announced that the U.S. Food and
Drug Administration (FDA) issued a complete response letter (CRL)
in response to the New Drug Application (NDA) resubmission for the
Company’s investigational non-daily, low dose combination hormonal
contraceptive patch, Twirla (AG200-15). The CRL stated that
the FDA has determined that it could not approve the NDA in its
present form due to deficiencies related to the manufacturing
process for Twirla, and questions on the in vivo adhesion
properties of Twirla and their potential relationship to the phase
3 clinical trial results. Under the FDA’s regulations, the
Company is entitled to request a Type A meeting with the FDA within
90 days of receiving a CRL, and the FDA has a goal to grant the
meeting date within 30 days of the meeting request. The Company has
submitted a request for a Type A meeting to the FDA to discuss the
deficiencies in the Twirla NDA and the regulatory path for approval
of Twirla. The Company plans to provide an update on the outcome of
the Type A meeting after it receives the official meeting minutes
from the FDA and it will then be better able to determine when it
will resubmit its Twirla NDA.
“We are focused on preparing for our upcoming
meeting with the FDA to discuss the points identified in the CRL
and a potential path forward for the approval of Twirla,” stated Al
Altomari, Chairman and Chief Executive Officer of Agile. “We
believe that Twirla, if approved, will provide women with a new
contraceptive option in the form of a patch that is designed to
deliver a low dose of estrogen and offer greater convenience for
women.”
Fourth Quarter Financial Results
- Cash and cash
equivalents: As of December 31, 2017, Agile had
$35.9 million of cash and cash equivalents compared to $48.8
million of cash and cash equivalents as of December 31, 2016.
In January 2018, in response to the 2017 CRL, the Company
significantly scaled back equipment qualification and validation of
its commercial manufacturing process and its other commercial
pre-launch activities. Based on these actions and the
Company’s current business plan, the Company believes its cash and
cash equivalents as of December 31, 2017, will be sufficient to
meet its operating requirements through the end of 2018. The
Company’s current business plan assumes the resubmission of the
Company’s NDA for Twirla in the second quarter of 2018, a six-month
FDA review of the NDA resubmission and resumption of both
pre-launch commercial activities and pre-validation and validation
of the commercial manufacturing process after Twirla approval, if
the FDA approves Twirla. The Company will require additional
capital to fund operating needs beyond 2018, including among other
items, the completion of its commercial plan for Twirla, which
primarily includes validation of the commercial manufacturing
process and the commercial launch of Twirla, if approved, and
advancing the development of its other potential product
candidates.
- Research and development
(R&D) expenses: R&D expenses were $2.7
million for the quarter ended December 31, 2017 and $14.4 million
for the year ended December 31, 2017, compared to $5.5 million and
$20.9 million for the comparable periods 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 completed the close-out phase. The decrease in
clinical development expenses was offset, in part, by increased
expenses associated with commercial manufacturing scale-up
activities.
- General and administrative (G&A)
expenses: G&A expenses were $3.3 million for the
quarter ended December 31, 2017 and $12.4 million for the year
ended December 31, 2017, compared to $2.3 million and $8.8 million
for the comparable periods in 2016. The increase in G&A
expenses was primarily due to increased pre-commercialization
activities.
- Net loss: Net loss was $6.2 million, or
$0.18 per share for the quarter ended December 31, 2017, compared
to a net loss of $5.2 million, or $0.18 per share for the quarter
ended December 31, 2016. Net loss for the quarter ended December
31, 2016 includes a benefit from income taxes of approximately $3.0
million, or $0.11 per basic share related to the sale of the
Company’s New Jersey net operation losses through the State of New
Jersey’s Technology Business Tax Certificate Transfer
Program. Net loss for the year ended December 31, 2017 was
$28.3 million, or $0.91 per share, compared to a net loss of $28.7
million or $1.02 per share for the year ended December 31,
2016.
- Shares Outstanding: At December 31,
2017, Agile had 34,186,342 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 has 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. We 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 our
regulatory submissions and projected cash position. 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 our ability to
adequately and timely respond to the deficiencies in the CRL issued
by the FDA in December 2017 may be affected by whether any such
response will be accepted by the FDA, our ability to resubmit and
the timing of our resubmission of the NDA for Twirla, FDA
acceptance and approval of the resubmitted NDA, the possibility
that the FDA may require additional studies to address the concerns
raised in the CRL (for example, if it is determined that the
product adhesion concerns raised in the CRL are due to the design
or formulation of the drug product, the FDA may recommend that we
design a new transdermal system and conduct another clinical trial
with the new transdermal system in a U.S. population, or even if
the FDA agrees with our position regarding the relationship between
the in vivo adhesion properties of Twirla and the efficacy and
safety results from our SECURE clinical trial, the FDA may still
determine that the need for a convenient, contraceptive patch and
the demonstrated efficacy of Twirla, including the pearl index from
our SECURE clinical trial, do not outweigh the potential risks
associated with the product, and therefore are not sufficient to
support the approval of Twirla), or whether other issues will arise
that will negatively impact acceptance, review, and approval of
Twirla by the FDA; our statements about the results of our clinical
trial could be affected by the potential that there are changes in
the interpretation of the data by the FDA (for example, the FDA
continues to question the number of pregnancies included in our
results and it may adjudicate additional pregnancies); our
statements about our projected cash position could be affected by
market factors, the inherent risks in our business, our ability to
execute our operational and budget plans, if the FDA requires us to
perform additional work or conduct additional studies prior to our
resubmission of the NDA for Twirla, the fact that our existing cash
and cash equivalents will not be sufficient to fund our current and
planned operations beyond 2018, 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; our statements about the potential commercial opportunity
could be affected by potential labeling restrictions, 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 our 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.
Source: Agile Therapeutics
Contact: Mary Coleman -- 609-356-1921
Agile Therapeutics, Inc. |
Condensed Balance Sheets |
|
(in thousands) |
(Unaudited) |
|
|
December 31, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
Cash and
cash equivalents |
$ |
35,952 |
|
|
$ |
48,750 |
|
Prepaid
expenses |
|
762 |
|
|
|
2,768 |
|
Total current
assets |
|
36,714 |
|
|
|
51,518 |
|
Property and equipment,
net |
|
13,863 |
|
|
|
12,330 |
|
Other assets |
|
18 |
|
|
|
18 |
|
Total assets |
$ |
50,595 |
|
|
$ |
63,866 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
$ |
3,636 |
|
|
$ |
5,694 |
|
Loan
payable, current portion |
|
10,607 |
|
|
|
5,104 |
|
Warrant
liability |
|
29 |
|
|
|
172 |
|
Total current
liabilities |
|
14,272 |
|
|
|
10,970 |
|
Loan payable,
long‑term |
|
-- |
|
|
|
10,607 |
|
Total liabilities |
|
14,272 |
|
|
|
21,577 |
|
|
|
|
Stockholders’
equity |
|
|
Common stock |
|
3 |
|
|
|
3 |
|
Additional paid‑in capital |
|
258,092 |
|
|
|
235,754 |
|
Accumulated deficit |
|
(221,772 |
) |
|
|
(193,468 |
) |
Total stockholders’
equity |
|
36,323 |
|
|
|
42,289 |
|
Total liabilities and
stockholders’ equity |
$ |
50,595 |
|
|
$ |
63,866 |
|
Agile Therapeutics, Inc. |
Condensed Statements of
Operations |
|
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
Three Months Ended December
31, |
|
Year Ended December
31, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
2,734 |
|
|
$ |
5,514 |
|
|
$ |
14,428 |
|
|
$ |
20,929 |
|
General
and administrative |
|
3,254 |
|
|
|
2,295 |
|
|
|
12,383 |
|
|
|
8,792 |
|
Total operating
expenses |
|
5,988 |
|
|
|
7,809 |
|
|
|
26,811 |
|
|
|
29,721 |
|
Loss from
operations |
|
(5,988 |
) |
|
|
(7,809 |
) |
|
|
(26,811 |
) |
|
|
(29,721 |
) |
Other income
(expense) |
|
|
|
|
Interest
expense, net |
|
(314 |
) |
|
|
(533 |
) |
|
|
(1,636 |
) |
|
|
(2,329 |
) |
Change in
fair value of warrants |
|
62 |
|
|
|
66 |
|
|
|
143 |
|
|
|
234 |
|
Loss before benefit
from income taxes |
|
(6,240 |
) |
|
|
(8,276 |
) |
|
|
(28,304 |
) |
|
|
(31,816 |
) |
Benefit from income
taxes |
|
— |
|
|
|
3,075 |
|
|
|
— |
|
|
|
3,075 |
|
Net loss |
$ |
(6,240 |
) |
|
$ |
(5,201 |
) |
|
$ |
(28,304 |
) |
|
$ |
(28,741 |
) |
Net loss per share -
basic and diluted |
$ |
(0.18 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.91 |
) |
|
$ |
(1.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted‑average shares
outstanding – basic and diluted |
|
34,183,772 |
|
|
|
28,758,025 |
|
|
|
30,940,831 |
|
|
|
28,273,331 |
|
Agile Therapeutics (NASDAQ:AGRX)
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Agile Therapeutics (NASDAQ:AGRX)
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