Agile Therapeutics Reports Second Quarter 2016 Financial Results
09 August 2016 - 6:05AM
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 three and six months ended June
30, 2016 and provided a corporate update for the second quarter
2016.
Second quarter 2016 and other recent
corporate developments include:
- In June 2016, the Company received notice that the U.S. Patent
and Trademark Office issued a patent with claims covering the
formulation of a progestin-only transdermal patch containing
levonorgestrel.
- In July 2016, the Company announced the appointment of Renee
Selman as its new Chief Commercial Officer. Ms. Selman is a
former senior executive at Johnson & Johnson who led the
commercial launch of ORTHO EVRA®, one of the most successful
contraceptive launches in the U.S. and the first ever contraceptive
patch.
- In July 2016, the Company announced that it planned to begin
clinical development of AG200-SP, an intended line extension of
Twirla®, a once weekly contraceptive patch currently in Phase 3
development. The Company is preparing to conduct an initial Phase 2
clinical trial that will examine the use of AG200-SP in a novel
regimen designed to allow women to experience shorter, lighter
periods. The planned AG200-SP regimen will include the use of
Twirla for three weeks followed by the use of a small patch in the
fourth week of the woman’s cycle. The initial Phase 2
clinical trial is designed to optimize the bleeding profile by
delivering hormones beyond the typical 21-day regimen using a
smaller lower-dose combination ethinyl/levonorgestrel patch in the
fourth week of the woman’s cycle.
- In July 2016, the Company announced the appointment of Seth H.
Z. Fischer to the Company’s Board of Directors. Mr. Fischer,
who brings significant management and commercial experience, has
more than three decades of healthcare experience in the
pharmaceutical and medical device industry and currently serves as
Chief Executive Officer and Director of Vivus, Inc., a publicly
traded biopharmaceutical company.
“During the first half of this year, we believe we made
significant progress on the execution of our business strategy to
build a commercially competitive women’s health franchise,” stated
Al Altomari, President and Chief Executive Officer of Agile.
“Our primary focus continues to be on the SECURE trial, which we
expect to complete in the fourth quarter of 2016. In
addition, with the planned clinical development of our first line
extension for Twirla, we believe we will be positioned to expand
our market potential.”
Second Quarter 2016 Financial
Results
- Cash and cash equivalents: As of June
30, 2016, Agile had $59.2 million of cash and cash equivalents
compared to $34.4 million of cash and cash equivalents as of
December 31, 2015. Based on its current business plan,
Agile believes its cash and cash equivalents will be sufficient to
meet its operating requirements through the end of 2017.
- Research and development (R&D)
expenses: R&D expenses were $5.6 million for the
quarter ended June 30, 2016, compared to $6.2 million for the
comparable period in 2015. The decrease in R&D expense
was primarily due to decreased clinical site costs associated with
the ongoing Phase 3 clinical trial for Twirla.
- General and administrative (G&A)
expenses: G&A expenses were $2.3 million for the
quarter ended June 30, 2016, compared to $1.8 million for the
comparable period in 2015. The increase in G&A expenses
was primarily due to increased stock-based compensation expense
associated with 2016 stock option grants as well as increased legal
costs, search fees and consulting expense.
- Net loss: Net loss was $8.4 million, or
$0.29 per basic share for the quarter ended June 30, 2016, compared
to a net loss of $8.5 million, or $0.38 per basic share for the
quarter ended June 30, 2015.
- Shares Outstanding: At June 30, 2016,
Agile had 28,752,719 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
StatementCertain 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 of completion of our
clinical trials and our ability to potentially commercialize our
product candidates, 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) |
|
|
June 30, 2016 |
|
December 31,2015 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
|
59,224 |
|
$ |
34,395 |
|
Prepaid expenses |
|
|
2,073 |
|
|
3,690 |
|
Total current assets |
|
|
61,297 |
|
|
38,085 |
|
Property and equipment,
net |
|
|
12,329 |
|
|
12,318 |
|
Other assets,
long-term |
|
|
18 |
|
|
18 |
|
Total assets |
$ |
|
73,644 |
|
$ |
50,421 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
Accounts payable and accrued
expenses |
$ |
|
4,270 |
|
$ |
5,040 |
|
Loan payable, current portion |
|
|
5,568 |
|
|
2,336 |
|
Warrant liability |
|
|
276 |
|
|
406 |
|
Total current
liabilities |
|
|
10,114 |
|
|
7,782 |
|
Loan payable,
long‑term |
|
|
10,008 |
|
|
12,896 |
|
|
|
|
Stockholders’
equity |
|
|
Common stock |
|
|
3 |
|
|
2 |
|
Additional paid‑in capital |
|
|
233,982 |
|
|
194,468 |
|
Accumulated deficit |
|
|
(180,463 |
) |
|
(164,727 |
) |
Total stockholders’
equity |
|
|
53,522 |
|
|
29,743 |
|
Total liabilities and
stockholders’ equity |
$ |
|
73,644 |
|
$ |
50,421 |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
$ |
5,577 |
|
|
$ |
6,168 |
|
|
$ |
10,505 |
|
|
$ |
11,546 |
|
General and administrative |
|
2,264 |
|
|
|
1,813 |
|
|
|
4,316 |
|
|
3,413 |
|
Total operating
expenses |
|
7,841 |
|
|
|
7,981 |
|
|
|
14,821 |
|
|
14,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(7,841 |
) |
|
|
(7,981 |
) |
|
|
(14,821 |
) |
|
(14,959 |
) |
|
|
|
|
|
|
|
Interest expense, net |
|
(515 |
) |
|
|
(546 |
) |
|
|
(1,045 |
) |
|
(971 |
) |
Change in fair value of
warrants |
|
(62 |
) |
|
|
41 |
|
|
|
130 |
|
|
(59 |
) |
Loss on extinguishment of debt |
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
(1,036 |
) |
Loss before benefit from
income taxes |
|
(8,418 |
) |
|
|
(8,486 |
) |
|
|
(15,736 |
) |
|
(17,025 |
) |
Benefit from income
taxes |
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Net
loss |
$ |
(8,418 |
) |
|
$ |
(8,486 |
) |
|
$ |
(15,736 |
) |
|
$ |
(17,025 |
) |
Net loss
per common share:Basic and Diluted |
$ |
(0.29 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.78 |
) |
Weighted-average shares outstanding:Basic and
Diluted |
|
28,744,004 |
|
|
|
22,202,680 |
|
|
|
27,785,113 |
|
|
21,745,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact: Mary Coleman -- 609-356-1921
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