Agile Therapeutics Reports Second Quarter 2018 Financial Results
August 03 2018 - 8:00AM
Cash Expected to Enable Company to Fund
Operations into Second Quarter 2019
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three and six
months ended June 30, 2018 and provided a corporate update.
Second quarter 2018 and other recent
corporate developments:
- Twirla® Update – As previously announced,
Agile initiated formal dispute resolution with the U.S. Food and
Drug Administration’s (FDA) Office of Drug Evaluation III (ODE III)
on June 6, 2018 to appeal the complete response letter (CRL) the
FDA issued in December 2017 relating to the New Drug Application
(NDA) for Twirla (AG200-15), the Company’s investigational
non-daily, low-dose combination hormonal contraceptive patch.
The Company initiated the formal dispute resolution process
following an end-of-review meeting in April 2018 in which the FDA
provided the Company with a more complete understanding of its
assessment of the in vivo adhesion data for Twirla in the
CRL. On July 24, 2018, the Company announced that FDA’s ODE
III had affirmed the position of the Division of Bone, Reproductive
and Urologic Products (DBRUP) and denied the Company’s
appeal. The Company had appealed the decision communicated in
the CRL that DBRUP’s concerns surrounding the in vivo adhesion
properties of Twirla prevent its approval and cannot be addressed
through the Company’s proposed patient compliance programs.
The Company will escalate its appeal to the Office of New Drugs
(OND) and, potentially, additional levels of FDA management if
necessary.
“We are focused on presenting and discussing our
appeal with the Office of New Drugs and carefully managing our
financial resources,” said Al Altomari, Chairman and Chief
Executive Officer of Agile. “We continue to believe that the
in vivo adhesion data from our Phase 3 SECURE clinical trial is
adequate for approval and that Twirla, if approved, will provide
women with an important contraception option they do not currently
have – a contraceptive patch designed to deliver a low dose of
estrogen.”
Second Quarter Financial
Results
- Cash and cash
equivalents: As of June 30, 2018, Agile had $22.5
million of cash and cash equivalents compared to $35.9 million of
cash and cash equivalents as of December 31, 2017. In June
2018, the Company announced a reduction in its workforce and
reductions on other planned operating expenses as the Company
pursues formal dispute resolution. As a result of these
planned cost reductions, the Company believes its cash and cash
equivalents as of June 30, 2018, will be sufficient to meet its
operating requirements into the second quarter of 2019. The
Company will require additional capital to fund operating needs for
the remainder of the second quarter of 2019 and beyond, 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 $2.4
million for the quarter ended June 30, 2018, compared to $3.8
million for the comparable period in 2017. The decrease in
R&D expenses was primarily due to decreased clinical
development expenses as the Company’s Phase 3 SECURE clinical trial
for Twirla completed the close-out phase during 2017 as well as
decreased regulatory expenses related to the preparation of the
Company’s NDA resubmission and response to the FDA’s February 2013
CRL in June 2017.
- General and administrative
(G&A) expenses: G&A expenses were $2.3
million for the quarter ended June 30, 2018, compared to $3.2
million for the comparable period in 2017. The decrease in
G&A expenses was primarily due to the suspension of
pre-commercialization activities as a result of the receipt of the
CRL in December 2017.
- Net loss:
Net loss was $5.3 million, or $0.16 per share for the quarter ended
June 30, 2018, compared to a net loss of $7.4 million, or $0.26 per
share for the quarter ended June 30, 2017.
- Shares
Outstanding: At June 30, 2018, Agile had 34,377,329
shares of common stock outstanding.
About Twirla® (AG200-15)Twirla
(levonorgestrel/ethinyl estradiol transdermal system) or AG200-15
is an investigational low-dose, once-weekly contraceptive patch.
AG200-15 is a combined hormonal contraceptive (CHC) patch that
contains the active ingredients ethinyl estradiol (EE), a type of
estrogen and levonorgestrel (LNG), a type of progestin. Twirla is
designed to be applied once weekly for three weeks, followed by a
week without a patch. Agile received a complete response
letter (CRL) from the FDA on December 21, 2017 relating to the New
Drug Application (NDA) for Twirla. In the CRL, the FDA
informed the Company that the product could not be approved in its
present form due to deficiencies related to quality adhesion test
methods, observations identified during the pre-approval inspection
of the manufacturing facility for Twirla, and because of questions
the FDA had on the in vivo adhesion properties of Twirla and their
potential relationship to the Company’s Phase 3 clinical trial
results. As announced on May 18, 2018, Agile met with the FDA
during a Type A meeting on April 16, 2018 to discuss the CRL and
received the official end of review (EOR) minutes on May 15,
2018. The Company initiated formal dispute resolution with
the FDA on June 6, 2018 in response to the FDA’s position on
Twirla’s in vivo adhesion properties communicated in the EOR
minutes. The Company believes the FDA provided guidance on a
path forward for addressing the manufacturing issues related to
Twirla.
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 an
investigational low-dose, non-daily prescription contraceptive.
Twirla is based on our proprietary transdermal patch technology,
called Skinfusion®, which is designed to allow drug delivery
through the skin. For more information, please visit the company
website at www.agiletherapeutics.com. The Company may
occasionally disseminate material, nonpublic information on the
Company’s 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," “likely,” "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 including
statements regarding the fact that our existing cash and cash
equivalents likely will not be sufficient to fund our current and
planned operations beyond the second quarter of 2019, 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, our ability to succeed in formal dispute resolution
with the FDA, which can be lengthy and expensive and the success of
which is not guaranteed and our belief that Twirla’s adhesion
profile is adequate for approval and a reformulation of Twirla is
not necessary. 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. These
forward looking statements are subject to risks and uncertainties
including risks related to our ability to manage costs and execute
on our operational and budget plans, our ability to either succeed
in our formal dispute resolution with the FDA, or, if we are
unsuccessful, our ability to develop a reformulation that will
address the FDA’s concerns, if we are required to reformulate
Twirla, our ability to successfully complete an additional adhesion
study and bioequivalence study, the potential that we may be
required to conduct an additional Phase 3 trial, the likelihood
that we will require additional correspondence with the FDA prior
to the resubmission of our NDA, our ability to resubmit and the
timing of our resubmission of the NDA for Twirla, FDA acceptance
and approval of the resubmitted NDA, or whether other issues will
arise that will negatively impact acceptance, review and approval
of Twirla by the FDA, our ability to address the deficiencies
identified by the FDA in the CRL issued in December 2017 and in the
Type A meeting minutes issued in May 2018, and unforeseen market
factors or events in our clinical and manufacturing development
plans and the other risks set forth 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 . For all
these reasons, actual results and developments could be materially
different from those expressed in or implied by our forward-looking
statements. 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: Investor Relations --
609-683-1880
|
Agile Therapeutics, Inc. |
Condensed Balance Sheets |
|
(in thousands) |
(Unaudited) |
|
|
|
|
|
June
30, 2018 |
|
December 31, 2017 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
22,465 |
|
|
$ |
35,952 |
|
Prepaid
expenses |
|
200 |
|
|
|
762 |
|
Total current
assets |
|
22,665 |
|
|
|
36,714 |
|
Property and equipment,
net |
|
13,924 |
|
|
|
13,863 |
|
Other assets |
|
18 |
|
|
|
18 |
|
Total assets |
$ |
36,607 |
|
|
$ |
50,595 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
Current
liabilities: |
|
|
Accounts
payable and accrued expenses |
$ |
2,829 |
|
|
$ |
3,636 |
|
Loan
payable, current portion |
|
7,525 |
|
|
|
10,607 |
|
Warrant
liability |
|
- |
|
|
|
29 |
|
Total liabilities |
|
10,354 |
|
|
|
14,272 |
|
|
|
|
Stockholders’
equity |
|
|
Common
stock |
|
3 |
|
|
|
3 |
|
Additional paid‑in capital |
|
260,199 |
|
|
|
258,092 |
|
Accumulated deficit |
|
(233,949 |
) |
|
|
(221,772 |
) |
Total stockholders’
equity |
|
26,253 |
|
|
|
36,323 |
|
Total liabilities and
stockholders’ equity |
$ |
36,607 |
|
|
$ |
50,595 |
|
|
|
|
|
|
|
|
|
|
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, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
2,413 |
|
|
$ |
3,798 |
|
|
$ |
6,372 |
|
|
$ |
8,519 |
|
General
and administrative |
|
2,318 |
|
|
|
3,198 |
|
|
|
5,404 |
|
|
|
5,603 |
|
Restructuring costs |
|
416 |
|
|
|
— |
|
|
|
416 |
|
|
|
— |
|
Total operating
expenses |
|
5,147 |
|
|
|
6,996 |
|
|
|
12,192 |
|
|
|
14,122 |
|
Loss from
operations |
|
(5,147 |
) |
|
|
(6,996 |
) |
|
|
(12,192 |
) |
|
|
(14,122 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
(320 |
) |
|
|
(504 |
) |
|
|
(689 |
) |
|
|
(1,050 |
) |
Interest
income |
|
101 |
|
|
|
61 |
|
|
|
198 |
|
|
|
109 |
|
Change in
fair value of warrants |
|
22 |
|
|
|
(7 |
) |
|
|
29 |
|
|
|
102 |
|
Loss before benefit
from income taxes |
|
(5,344 |
) |
|
|
(7,446 |
) |
|
|
(12,654 |
) |
|
|
(14,961 |
) |
Benefit from income
taxes |
|
— |
|
|
|
— |
|
|
|
477 |
|
|
|
— |
|
Net loss |
$ |
(5,344 |
) |
|
$ |
(7,446 |
) |
|
$ |
(12,177 |
) |
|
$ |
(14,961 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.16 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted‑average shares
outstanding –basic and diluted |
|
34,277,601 |
|
|
|
28,802,112 |
|
|
|
34,253,515 |
|
|
|
28,785,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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