Agile Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results
March 08 2017 - 4:15PM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty
pharmaceutical company today reported financial results for the
three months and year ended December 31, 2016 and provided a
corporate update for the fourth quarter 2016.
Fourth quarter 2016 and other recent
corporate developments include:
- In December 2016, the Company announced that it had received
net proceeds of approximately $3.0 million in non-dilutive
financing through the State of New Jersey’s Technology Business Tax
Certificate Transfer Program.
- In January 2017, the Company announced positive top-line
results from its Phase 3 SECURE clinical trial of Twirla®, its
investigational low-dose combined hormonal contraceptive
patch. SECURE was a multicenter, single-arm, open-label, 13
cycle trial that evaluated safety, efficacy and tolerability of
Twirla in 2,032 healthy women, aged 18 and over, at 102 experienced
investigative sites across the United States. The Company plans to
resubmit its new drug application (“NDA”) for Twirla in the first
half of 2017 on the basis of the SECURE results and other
information relating to the manufacture of Twirla.
“We made significant progress during 2016 with
the successful completion of our SECURE Phase 3 clinical trial,
which we believe achieved positive top-line results. We continue to
advance our plans to file our NDA resubmission for Twirla in the
first half of this year. Once filed, we expect the FDA to complete
its review within six months, with a potential approval by the end
of 2017.” said Al Altomari, Chairman and Chief Executive Officer of
Agile. “Our priority moving forward is clear, give precedence to
our Twirla development activities and prepare for a potential U.S.
launch of Twirla. If approved, we look forward to providing women
with a new contraceptive option that is designed to offer greater
convenience and flexibility for women’s busy lives.”
Fourth Quarter Financial
Results
- Cash and cash equivalents: As of December
31, 2016, Agile had $48.8 million of cash and cash equivalents
compared to $34.4 million of cash and cash equivalents as of
December 31, 2015. Based on the Company’s current business plan,
the Company believes its cash and cash equivalents as of December
31, 2016 will be sufficient to meet its operating requirements into
the second quarter of 2018. The Company’s current business plan
assumes resubmission of the NDA for Twirla in the first half of
2017, a six month FDA review of the Company’s resubmission,
initiation of pre-commercial activities and initiation of
validation of its commercial manufacturing process in coordination
with the commercialization of Twirla. In the event of unforeseen
changes to its planned timelines, the Company has the ability to
postpone certain commercial and validation spending in order to
continue the funding of its operations into the second quarter of
2018. The Company will require additional capital for the
commercial launch of Twirla, if approved, as well as advancing the
development of its other product candidates.
- Research and development (R&D)
expenses: R&D expenses were $5.5 million for the
quarter ended December 31, 2016 and $20.9 million for the year
ended December 31, 2016, compared to $6.9 million and $25.6 million
for the comparable periods in 2015. The decrease in R&D expense
was primarily due to decreased clinical development expenses as our
Phase 3 clinical trial for Twirla moved closer to completion. In
July 2016, the Company began preparations for an initial Phase 2
clinical trial examining the use of AG200-SP along with a smaller
lower-dose combination ethinyl estradiol/levongestrel patch (SmP)
in the fourth week of the woman’s cycle. The Company has decided to
postpone the trial and will continue to evaluate the timing for
initiating dosing of the subjects for this Phase 2 clinical trial,
which is dependent on available capital resources.
- General and administrative (G&A)
expenses: G&A expenses were $2.3 million for the
quarter ended December 31, 2016 and $8.8 million for the year ended
December 31, 2016, compared to $2.3 million and $7.5 million for
the comparable periods 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
professional fee expense to support public company
operations.
- Net loss: Net loss was $5.2 million, or
$0.18 per basic share for the quarter ended December 31, 2016,
compared to a net loss of $3.9 million, or $0.17 per basic share
for the quarter ended December 31, 2015. Net loss per share 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 our New Jersey net operating losses through
the State of New Jersey’s Technology Business Tax Certificate
Transfer Program. Net loss per share for the quarter ended December
31, 2015 includes a benefit from income taxes of approximately $6.0
million, or $0.27 per share related to the sale of our New Jersey
net operating losses. Net loss for the year ended December 31, 2016
was $28.7 million, or $1.02 per basic share, compared to a net loss
of $30.3 million, or $1.38 per basic share for the year ended
December 31, 2015.
- Shares Outstanding: At December 31,
2016, Agile had 28,759,731 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 delay resubmission of our NDA
or 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, and
unforeseen events in our clinical and manufacturing development
plans; 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) |
|
|
|
|
|
|
|
|
|
December 31, 2016 |
|
December 31,2015 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
$ |
48,750 |
|
|
$ |
34,395 |
|
Prepaid
expenses |
|
2,768 |
|
|
|
3,690 |
|
Total current
assets |
|
51,518 |
|
|
|
38,085 |
|
Property and equipment,
net |
|
12,330 |
|
|
|
12,318 |
|
Other assets |
|
18 |
|
|
|
18 |
|
Total assets |
$ |
63,866 |
|
|
$ |
50,421 |
|
Liabilities and
stockholders’ equity |
|
|
Current
liabilities: |
|
|
Accounts
payable and accrued expenses |
$ |
5,402 |
|
|
$ |
5,040 |
|
Loan
payable, current portion |
|
5,104 |
|
|
|
2,336 |
|
Warrant liability |
|
172 |
|
|
|
406 |
|
Total current
liabilities |
|
10,678 |
|
|
|
7,782 |
|
Loan payable,
long‑term |
|
10,899 |
|
|
|
12,896 |
|
|
|
|
Stockholders’
equity |
|
|
Common
stock |
|
3 |
|
|
|
2 |
|
Additional paid‑in capital |
|
235,754 |
|
|
|
194,468 |
|
Accumulated deficit |
|
(193,468 |
) |
|
|
(164,727 |
) |
Total stockholders’
equity |
|
42,289 |
|
|
|
29,743 |
|
Total liabilities and
stockholders’ equity |
$ |
63,866 |
|
|
$ |
50,421 |
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
2016 |
|
|
|
|
2015 |
|
|
|
2016 |
|
|
2015 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
|
5,514 |
|
|
$ |
|
6,914 |
|
|
|
$ |
|
20,929 |
|
|
$ |
|
25,622 |
|
|
General
and administrative |
|
|
2,295 |
|
|
|
|
2,251 |
|
|
|
8,792 |
|
|
7,467 |
|
|
Total operating
expenses |
|
|
7,809 |
|
|
|
|
9,165 |
|
|
|
29,721 |
|
|
33,089 |
|
|
Loss from
operations |
|
|
(7,809 |
) |
|
|
|
(9,165 |
) |
|
|
(29,721 |
) |
|
(33,089 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense, net |
|
|
(533 |
) |
|
|
|
(551 |
) |
|
|
(2,329 |
) |
|
(2,072 |
) |
|
Change in
fair value of warrants |
|
|
66 |
|
|
|
|
(155 |
) |
|
|
234 |
|
|
(110 |
) |
|
Loss on
extinguishment of debt |
|
|
-- |
|
|
|
|
-- |
|
|
|
-- |
|
|
(1,036 |
) |
|
Loss before benefit
from income taxes |
|
|
(8,276 |
) |
|
|
|
(9,871 |
) |
|
|
(31,816 |
) |
|
(36,307 |
) |
|
Benefit from income
taxes |
|
|
3,075 |
|
|
|
|
5,972 |
|
|
|
3,075 |
|
|
5,972 |
|
|
Net
loss |
|
$ |
(5,201 |
) |
|
|
$ |
(3,899 |
) |
|
|
|
$ |
(28,741 |
) |
|
|
$ |
(30,335 |
) |
|
Net loss per
common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
(0.18 |
) |
|
|
$ |
(0.17 |
) |
|
|
|
$ |
(1.02 |
) |
|
|
$ |
(1.38 |
) |
|
Weighted-average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted |
|
|
28,758,025 |
|
|
|
|
22,296,638 |
|
|
|
|
|
28,273,331 |
|
|
|
|
22,017,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact: Mary Coleman -- 609-356-1921
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