Agile Therapeutics Reports Third Quarter 2017 Financial Results
November 06 2017 - 4:20PM
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 nine
months ended September 30, 2017, and provided a corporate update
for the third quarter 2017.
Third quarter 2017 and other recent
corporate developments include:
- Twirla® Update – On October 10, 2017, the
Company hosted its first analyst day to present its corporate
vision and commercial strategy for the potential launch of Twirla®
(AG200-15), its investigational low-dose combined hormonal
contraceptive patch product candidate. The Company also announced
that the U.S. Patent and Trademark Office issued the Company four
new patents with claims directed to novel transdermal contraceptive
dosing regimens. These new patents provide an expanded
proprietary platform not only for the development of Twirla and
Agile’s pipeline, but also for potential new products utilizing a
broad selection of other progestins and estrogens.
- Medical Congress Updates - In September 2017,
the Company announced that an abstract presenting data from the
Phase 3 SECURE clinical trial of Twirla was selected for an oral
presentation during the American Society of Reproductive Medicine
(ASRM) Annual Congress which was held from October 28th to November
1st. The abstract, titled “Selected Efficacy And
Bleeding/Spotting Outcomes From The SECURE Trial: A Phase 3 Study
of AG200-15, An Investigational Weekly Transdermal Contraceptive
Patch” is available in the September 2017 issue of Fertility and
Sterility and online at www.fertstert.org.- In September 2017, the
Company announced that an abstract based on the Phase 3 SECURE
clinical trial of Twirla was selected for a poster presentation
during the 2017 North American Forum on Family Planning which was
held from October 14th to October 16th. The abstract, titled
“Bleeding And Spotting Results From The SECURE Trial: A Phase 3
Study of AG200-15 Investigational Transdermal Contraceptive Patch”
is available in the October 2017 issue of Contraception and online
at www.contraceptionjournal.org.
- Financing Update – In August 2017, the Company
completed an underwritten public offering of 5,333,334 shares of
common stock at a public offering price of $3.75 per share.
Proceeds from the offering, net of underwriting discounts,
commissions and other offering costs were approximately $18.5
million and will be used to support commercialization activities
for Twirla.
“This is an exciting time for the company as we
continue preparing for the potential approval and commercialization
of Twirla, our novel once-weekly contraceptive patch. If
approved, Twirla would be the first low-dose non-daily alternative
to an oral combined hormonal contraceptive introduced in over 15
years and represents a significant market opportunity,” stated Al
Altomari, Chairman and Chief Executive Officer of Agile. “We
look forward to the potential growth opportunity ahead as we
continue to execute on our strategic plans in preparation for our
PDUFA goal date of December 26, 2017.”
Third Quarter Financial
Results
- Cash and cash equivalents: As of
September 30, 2017, Agile had $43.8 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 September 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 will complete its review of
the Company’s NDA resubmission by the target PDUFA goal date,
December 26, 2017, initiation of certain pre-commercial activities
prior to approval of Twirla and initiation and completion of
validation of our commercial manufacturing process after the target
PDUFA goal date, if the FDA approves Twirla. The Company will
require additional capital to fund operating needs thereafter,
including, among other items, continued commercial activities after
the initial commercial launch for Twirla and advancing the
development of our 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 $3.2 million for the
quarter ended September 30, 2017, compared to $4.9 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 $3.5 million for the
quarter ended September 30, 2017, compared to $2.2 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 $7.1 million, or
$0.22 per share for the quarter ended September 30, 2017, compared
to a net loss of $7.8 million, or $0.27 per share for the quarter
ended September 30, 2016.
- Shares Outstanding: At September 30,
2017, Agile had 34,158,004 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.
Source: Agile Therapeutics
Contact: Mary Coleman -- 609-356-1921
|
|
|
Agile Therapeutics,
Inc.Condensed Balance Sheets(in
thousands) (Unaudited) |
|
|
|
|
|
September 30, 2017 |
|
|
December 31, 2016 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
Cash and
cash equivalents |
$ |
43,806 |
|
$ |
48,750 |
|
Prepaid
expenses |
|
1,161 |
|
|
2,768 |
|
Total current
assets |
|
44,967 |
|
|
51,518 |
|
Property and equipment,
net |
|
13,426 |
|
|
12,330 |
|
Other assets |
|
18 |
|
|
18 |
|
Total assets |
$ |
58,411 |
|
$ |
63,866 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
Accounts
payable and accrued expenses |
$ |
4,680 |
|
$ |
5,694 |
|
Loan
payable, current portion |
|
6,190 |
|
|
5,104 |
|
Warrant
liability |
|
90 |
|
|
172 |
|
Total current
liabilities |
|
10,960 |
|
|
10,970 |
|
Loan payable,
long‑term |
|
5,887 |
|
|
10,607 |
|
|
|
|
Stockholders’
equity |
|
|
Common
stock |
|
3 |
|
|
3 |
|
Additional paid‑in capital |
|
257,093 |
|
|
235,754 |
|
Accumulated deficit |
|
(215,532 |
) |
|
(193,468 |
) |
Total stockholders’
equity |
|
41,564 |
|
|
42,289 |
|
Total liabilities and
stockholders’ equity |
$ |
58,411 |
|
$ |
63,866 |
|
|
|
|
|
|
|
|
|
|
|
Agile
Therapeutics, Inc.Condensed Statements of
Operations(in thousands, except share and per
share amounts) (Unaudited) |
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months
Ended September 30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
3,175 |
|
$ |
4,911 |
|
$ |
11,694 |
|
$ |
15,415 |
|
General
and administrative |
|
3,526 |
|
|
2,180 |
|
|
9,130 |
|
|
6,497 |
|
Total operating
expenses |
|
6,701 |
|
|
7,091 |
|
|
20,824 |
|
|
21,912 |
|
Loss from
operations |
|
(6,701 |
) |
|
(7,091 |
) |
|
(20,824 |
) |
|
(21,912 |
) |
Other income
(expense) |
|
|
|
|
Interest
expense |
|
(459 |
) |
|
(784 |
) |
|
(1,509 |
) |
|
(1,879 |
) |
Interest
income |
|
78 |
|
|
33 |
|
|
187 |
|
|
83 |
|
Change in
fair value of warrants |
|
(20 |
) |
|
38 |
|
|
82 |
|
|
168 |
|
Loss before benefit
from income taxes |
|
(7,102 |
) |
|
(7,804 |
) |
|
(22,064 |
) |
|
(23,540 |
) |
Benefit from income
taxes |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Net loss |
$ |
(7,102 |
) |
$ |
(7,804 |
) |
$ |
(22,064 |
) |
$ |
(23,540 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share – basic and diluted |
$ |
(0.22 |
) |
$ |
(0.27 |
) |
$ |
(0.74 |
) |
$ |
(0.84 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted‑average shares
outstanding – basic and diluted |
|
31,937,628 |
|
|
28,754,458 |
|
|
29,847,972 |
|
|
28,110,587 |
|
|
|
|
|
|
|
|
|
|
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