Agile Therapeutics Reports First Quarter 2018 Financial Results
08 5월 2018 - 5:10AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's healthcare
company, today reported financial results for the three months
ended March 31, 2018 and provided a corporate update.
First quarter 2018 and other recent
corporate developments include:
- Twirla® Update – As previously announced, on
December 22, 2017, the U.S. Food and Drug Administration (FDA)
issued a complete response letter (CRL) in connection with its
review of the New Drug Application (NDA) for the Company’s
investigational non-daily, low dose combination hormonal
contraceptive patch, Twirla (AG200-15). The CRL informed the
Company that the FDA could not approve the NDA in its present form
due to deficiencies related to the manufacturing process for
Twirla, and questions on the in vivo adhesion properties of Twirla
and their potential relationship to the Phase 3 clinical trial
results. At the Company’s request, the FDA had a Type A
meeting with the Company to discuss the deficiencies in the Twirla
NDA and the potential regulatory path for approval of Twirla. The
Company plans to provide an update on the outcome of the Type A
meeting after it receives the official meeting minutes from the FDA
and it will then be better able to determine when it will resubmit
its Twirla NDA.
“We remain focused on working with the FDA to
determine a potential path forward for the approval of Twirla,”
said Al Altomari, Chairman and Chief Executive Officer of Agile.
“We believe that women continue to seek alternative
contraceptive options that are convenient and that Twirla, if
approved, will provide women with an important option they do not
currently have, a contraceptive patch designed to deliver a low
dose of estrogen.”
First Quarter Financial
Results
- Cash and cash equivalents: As of March
31, 2018, Agile had $28.3 million of cash and cash equivalents
compared to $35.9 million of cash and cash equivalents as of
December 31, 2017. In January 2018, in response to the 2017
CRL, the Company significantly scaled back equipment qualification
and validation of its commercial manufacturing process and its
other commercial pre-launch activities. Based on these
actions and the Company’s current business plan, the Company
believes its cash and cash equivalents as of March 31, 2018, will
be sufficient to meet its operating requirements through the end of
2018. The Company’s current business plan assumes the
resubmission of the Company’s NDA for Twirla in the second quarter
of 2018, a six-month FDA review of the NDA resubmission and
resumption of both pre-launch commercial activities and
pre-validation and validation of the commercial manufacturing
process after Twirla approval, if the FDA approves Twirla.
The Company will be better able to determine when it will submit
its Twirla NDA once it receives the official minutes from the FDA
from its Type A meeting. The Company will require additional
capital to fund operating needs beyond 2018, 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 $4.0 million for the
quarter ended March 31, 2018, compared to $4.7 million for the
comparable period in 2017. 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 completed the
close-out phase during 2017. The decrease in clinical
development expenses was offset, in part, by increased expenses
associated with commercial manufacturing scale-up activities.
- General and administrative (G&A)
expenses: G&A expenses were $3.1 million for the
quarter ended March 31, 2018, compared to $2.4 million for the
comparable period in 2017. The increase in G&A expenses
was primarily due to increased pre-commercialization activities,
including personnel additions during the second half of 2017 to
help prepare for launch of Twirla, if approved.
- Net loss: Net loss was $6.8 million, or
$0.20 per share for the quarter ended March 31, 2018, compared to a
net loss of $7.5 million, or $0.26 per share for the quarter ended
March 31, 2017. Net loss for the quarter ended March 31, 2018
includes a benefit from income taxes of approximately $0.5 million,
or $0.01 per basic share related to the sale of the Company’s New
Jersey net operation losses through the State of New Jersey’s
Technology Business Tax Certificate Transfer Program (the
“Program”). The Company has now reached the maximum lifetime
benefit under the Program and will no longer be eligible to
participate in the Program.
- Shares Outstanding: At March 31, 2018,
Agile had 34,248,268 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 has 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. We 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 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," "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 our
ability to adequately and timely respond to the deficiencies in the
CRL issued by the FDA in December 2017 may be affected by whether
any such response will be accepted by the FDA, our ability to
resubmit and the timing of our resubmission of the NDA for Twirla,
FDA acceptance and approval of the resubmitted NDA, the possibility
that the FDA may require additional studies to address the concerns
raised in the CRL (for example, if it is determined that the
product adhesion concerns raised in the CRL are due to the design
or formulation of the drug product, the FDA may recommend that we
design a new transdermal system and conduct another clinical trial
with the new transdermal system in a U.S. population, or even if
the FDA agrees with our position regarding the relationship between
the in vivo adhesion properties of Twirla and the efficacy and
safety results from our SECURE clinical trial, the FDA may still
determine that the need for a convenient, contraceptive patch and
the demonstrated efficacy of Twirla, including the pearl index from
our SECURE clinical trial, do not outweigh the potential risks
associated with the product, and therefore are not sufficient to
support the approval of Twirla), or whether other issues will arise
that will negatively impact acceptance, review, and approval of
Twirla by the FDA; our statements about the results of our clinical
trial could be affected by the potential that there are changes in
the interpretation of the data by the FDA (for example, the FDA
continues to question the number of pregnancies included in our
results and it may adjudicate additional pregnancies); our
statements about our projected cash position could be affected by
market factors, the inherent risks in our business, our ability to
execute our operational and budget plans, if the FDA requires us to
perform additional work or conduct additional studies prior to our
resubmission of the NDA for Twirla, the fact that our existing cash
and cash equivalents will not be sufficient to fund our current and
planned operations beyond 2018, 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; our statements about the potential commercial opportunity
could be affected by potential labeling restrictions, 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 our 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: Investor Relations --
609-683-1880
|
|
Agile Therapeutics, Inc. |
Condensed Balance Sheets |
|
(in thousands) |
(Unaudited) |
|
March 31, 2018 |
|
December 31, 2017 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and
cash equivalents |
$ |
28,344 |
|
|
$ |
35,952 |
|
Prepaid
expenses |
|
633 |
|
|
|
762 |
|
Total current
assets |
|
28,977 |
|
|
|
36,714 |
|
Property and equipment,
net |
|
13,927 |
|
|
|
13,863 |
|
Other assets |
|
18 |
|
|
|
18 |
|
Total assets |
$ |
42,922 |
|
|
$ |
50,595 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
$ |
3,201 |
|
|
$ |
3,636 |
|
Loan
payable, current portion |
|
9,090 |
|
|
|
10,607 |
|
Warrant
liability |
|
22 |
|
|
|
29 |
|
Total current
liabilities |
|
12,313 |
|
|
|
14,272 |
|
Loan payable,
long‑term |
|
-- |
|
|
|
-- |
|
Total liabilities |
|
12,313 |
|
|
|
14,272 |
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
Common
stock |
|
3 |
|
|
|
3 |
|
Additional paid‑in capital |
|
259,211 |
|
|
|
258,092 |
|
Accumulated deficit |
|
(228,605 |
) |
|
|
(221,772 |
) |
Total stockholders’
equity |
|
30,609 |
|
|
|
36,323 |
|
Total liabilities and
stockholders’ equity |
$ |
42,922 |
|
|
$ |
50,595 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agile Therapeutics, Inc. |
Condensed Statements of
Operations |
|
(in thousands, except share and per share
amounts) |
(Unaudited) |
|
|
Three Months Ended March
31, |
|
|
2018 |
|
|
|
2017 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
$ |
3,960 |
|
|
$ |
4,721 |
|
General
and administrative |
|
3,086 |
|
|
|
2,405 |
|
Total operating
expenses |
|
7,046 |
|
|
|
7,126 |
|
Loss from
operations |
|
(7,046 |
) |
|
|
(7,126 |
) |
Other income
(expense) |
|
|
|
|
|
|
|
Interest
expense, net |
|
(271 |
) |
|
|
(499 |
) |
Change in
fair value of warrants |
|
7 |
|
|
|
109 |
|
Loss before benefit
from income taxes |
|
(7,310 |
) |
|
|
(7,516 |
) |
Benefit from income
taxes |
|
477 |
|
|
|
— |
|
Net loss |
$ |
(6,833 |
) |
|
$ |
(7,516 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
$ |
(0.20 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
Weighted‑average shares
outstanding –basic and diluted |
|
34,229,162 |
|
|
|
28,769,361 |
|
|
|
|
|
|
|
|
|
Agile Therapeutics (NASDAQ:AGRX)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Agile Therapeutics (NASDAQ:AGRX)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024