Agile Therapeutics Reports First Quarter Financial Results
13 5월 2015 - 5:05AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty
pharmaceutical company focused on the development and
commercialization of new prescription contraceptive products, today
reported financial results for the quarter ended March 31, 2015.
First quarter 2015 corporate developments
include:
- In January 2015, the Company completed the private placement of
approximately 3.4 million shares of common stock resulting in net
proceeds of approximately $19.3 million.
- In February 2015, the Company entered into a loan and security
agreement with Hercules Technology Growth Capital, Inc. for a term
loan of up to $25.0 million; $16.5 million was funded upon
execution of the loan agreement, and was used to repay the
Company's prior term loan facility and to provide additional
working capital for general corporate purposes; an additional $8.5
million may be drawn at the Company's option prior to July 1, 2016,
subject to the achievement of certain clinical milestones.
- In March 2015, safety and tolerability data from previous Phase
3 studies was published in American Journal of Obstetrics &
Gynecology.
"We made significant progress during the first quarter of 2015
by improving our cash position and continuing enrollment of
patients into our Phase 3 SECURE clinical trial. We currently
have 80 sites with patients on active treatment across the United
States," stated Al Altomari, President and Chief Executive
Officer. "We will continue to diligently execute on the
management of the trial and continue to believe we will finish
enrollment in the third quarter of 2015."
First Quarter Financial Results
- Cash and cash equivalents: As of March
31, 2015, Agile had $53.9 million of cash and cash equivalents
compared to $40.2 million of cash and cash equivalents as of
December 31, 2014. Agile believes its cash and cash equivalents
will be sufficient to meet its operating requirements through the
end of 2016. In addition to its existing cash and cash
equivalents, upon the achievement of certain clinical milestones,
the Company would be eligible to draw an additional tranche of $8.5
million under the terms of the loan and security agreement with
Hercules.
- Research and development (R&D)
expenses: R&D expenses were $5.4 million for the
quarter ended March 31, 2015, compared to $1.4 million for the
comparable period in 2014. The increase in R&D expense of
$4.0 million was primarily due to CRO costs associated with the
ongoing Phase 3 clinical trial for Twirla.
- General and administrative (G&A)
expenses: G&A expenses were $1.6 million for the
quarter ended March 31, 2015, compared to $1.1 million for the
comparable period in 2014. The increase in G&A expenses of
$0.5 million was primarily due to increased stock-based
compensation expense and increased directors' and officers'
insurance expense to support public company operations.
- Net loss: Net loss was $8.5 million, or
$0.40 per basic share for the quarter ended March 31, 2015,
compared to net income of $0.8 million, or $0.10 per basic share
for the quarter ended March 31, 2014. Basic net loss per share
for the quarter ended March 31, 2015 includes a loss on
extinguishment of debt of $1.0 million, or approximately $0.05 per
basic share. Net income for the quarter ended March 31, 2014
was primarily the result of a benefit from income taxes of $3.6
million representing the proceeds we received from the sale of New
Jersey net operating losses (NOLs) as part of the Technology and
Business Tax Certificate Program sponsored by the New Jersey
Economic Development Authority.
- Shares Outstanding: At March 31, 2015,
Agile had 22,160,233 shares of common stock outstanding.
About Agile Therapeutics, Inc.
Agile Therapeutics is a women's health specialty pharmaceutical
company focused on the development and commercialization of new
prescription contraceptive products. Our product candidates are
designed to provide women with contraceptive options that offer
greater convenience and facilitate compliance. Our lead product
candidate, Twirla®, (ethinyl estradiol and levonorgestrel
transdermal system), also known as AG200-15, is a once-weekly
prescription contraceptive patch currently in Phase 3 clinical
development. 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 adherence and patient acceptability. 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 Statement
Certain information contained in this press release includes
"forward-looking statements" related to the Company's, projected
cash position, timeline for clinical trials 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 expectations 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. For example, 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, and unforeseen events in
our clinical and manufacturing development plans; our statements
about the timing and conduct of our clinical trial could be
affected by the potential that we experience difficulty in
identifying and initiating sites and enrolling subjects, we
identify serious side effects or other safety issues, we do not
have clinical supply of our product candidate that is adequate in
amount and quality and supplied in a timely fashion, and the
inherent risks of clinical development; 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) |
|
|
March 31,
2015 |
December 31,
2014 |
Assets |
|
|
Current assets: |
|
|
Cash and cash
equivalents |
$53,865 |
$40,182 |
Prepaid expenses |
495 |
804 |
Total current assets |
54,360 |
40,986 |
Property and equipment, net |
12,230 |
12,046 |
Other assets, long-term |
2,106 |
1,794 |
Total assets |
$68,696 |
$54,826 |
Liabilities and stockholders'
equity |
|
|
Current liabilities: |
|
|
Accounts payable and accrued
expenses |
$4,417 |
$3,693 |
Loan payable, current
portion |
-- |
5,003 |
Warrant liability |
397 |
296 |
Total current liabilities |
4,814 |
8,992 |
Loan payable, long‑term |
15,125 |
9,828 |
|
|
|
Stockholders' equity |
|
|
Common stock |
2 |
2 |
Additional paid‑in
capital |
191,685 |
170,396 |
Accumulated deficit |
(142,930) |
(134,392) |
Total stockholders' equity |
48,757 |
36,006 |
Total liabilities and stockholders'
equity |
$68,696 |
$54,826 |
Agile
Therapeutics, Inc. |
Condensed Statements of
Operations |
|
(in thousands, except
share and per share amounts) |
(Unaudited) |
|
|
Three Months
Ended March 31 |
|
2015 |
2014 |
Operating expenses: |
|
|
Research and development |
$5,378 |
$1,394 |
General and administrative |
1,599 |
1,053 |
Total operating expenses |
6,977 |
2,447 |
Loss from operations |
(6,977) |
(2,447) |
Other income (expense) |
|
|
Interest expense, net |
(424) |
(378) |
Change in fair value of
warrants |
(101) |
12 |
Loss on extinguishment of
debt |
(1,036) |
-- |
Loss before benefit from income taxes |
(8,538) |
(2,813) |
Benefit from income taxes |
-- |
3,652 |
Net (loss) income |
$(8,538) |
$839 |
|
|
|
Net (loss) income per share (basic) |
$(0.40) |
$0.10 |
Net (loss) income per share (diluted) |
$(0.40) |
$0.01 |
|
|
|
Weighted‑average shares outstanding
(basic) |
21,282,692 |
106,309 |
Weighted‑average shares outstanding
(diluted) |
21,282,692 |
822,178 |
CONTACT: Mary Coleman -- 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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