Agile Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results
21 2월 2020 - 6:01AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three months and
year ended December 31, 2019 and provided a corporate update.
Fourth Quarter 2019 and Other Recent
Corporate Developments:
Twirla® Update
- FDA Advisory Committee Meeting Completed: As previously
announced, in October 2019, The Bone, Reproductive, and Urologic
Drugs Advisory Committee (BRUDAC) of the U.S. Food and Drug
Administration (FDA) met to discuss the Company’s New Drug
Application for Twirla. The BRUDAC voted 14-1, with 1
abstention, that the benefits of Twirla in the prevention of
pregnancy outweigh the risks to support approval.
- Twirla (levonorgestrel and ethynyl estradiol) transdermal
system Approved by FDA: On February 14, 2020, the Company announced
that it had received FDA approval for its lead product candidate,
Twirla. Twirla is approved for the prevention of pregnancy in
women with a BMI <30 kg/m2 for whom a combined hormonal
contraceptive is appropriate. Healthcare providers (HCPs) are
encouraged to consider Twirla’s reduced efficacy in women with a
BMI ≥ 25 to <30 kg/m2 before prescribing. Twirla is
contraindicated in women with a BMI ≥ 30 kg/m2.
- Twirla Commercialization Plans: The Company plans to begin the
pre-validation and validation of the commercial manufacturing
process in the first half of 2020, manufacture three validation
batches of Twirla and complete the validation process in the second
half of 2020. At the same time, the Company will prepare for
the availability of commercial product supply. In the first quarter
of 2020, the Company intends to initiate work with managed care and
patient payors to gain market access for Twirla. In the
second quarter of 2020, the Company plans to begin hiring and
training an initial sales team, which it estimates to be in the
range of 70 to 100 persons. The Company intends to ship product to
wholesalers in the fourth quarter of 2020.
Financing Update
- In November 2019, the Company entered into an at-the
market (ATM) agreement, under which the Company was authorized to
issue and sell shares of common stock having aggregate sales
proceeds of up to $20.0 million from time to time. In the
year ended December 31, 2019, the Company issued and sold
10,440,908 shares of common stock under the ATM, resulting in net
proceeds of approximately $19.3 million and representing the entire
capacity of the ATM.
- In February 2020, the Company entered into a senior secured
term loan credit facility with Perceptive Advisors for a senior
secured term loan facility of up to $35 million. A first tranche of
$5 million was funded on execution of the credit agreement. A
second tranche of $15 million was funded as a result of the
approval of Twirla by the FDA. Another $15 million tranche
will be available upon the achievement of certain revenue
milestones. The Company is permitted to make interest-only payments
on the loan until February 2023. In addition, the Company
issued Perceptive warrants to purchase 1,400,000 shares of Agile
common stock.
Fourth Quarter Financial
Results
- Cash and cash equivalents: As of
December 31, 2019, Agile had $34.5 million of cash and cash
equivalents compared to $7.9 million of cash and cash equivalents
as of December 31, 2018. The Company believes its cash and
cash equivalents as of December 31, 2019, along with the proceeds
of the Perceptive credit agreement received to date, will be
sufficient to meet its projected operating requirements through the
end of 2020. The Company will require additional capital to
fund operating needs beyond 2020, which it expects primarily will
consist of commercializing Twirla, and exploring the advancement of
our existing pipeline and its possible expansion through business
development activities.
- Research and development (R&D)
expenses: R&D expenses were $2.7 million for the
quarter ended December 31, 2019 and $9.9 million for the year ended
December 31, 2019, compared to $1.9 million and $9.8 million for
the comparable periods in 2018. The increase in R&D expenses
was primarily due to consulting fees and costs associated with the
preparation for and attendance at the FDA advisory committee
meeting as well as costs associated with the on-going qualification
process of the commercial manufacturing equipment at Corium.
- General and administrative (G&A)
expenses: G&A expenses were $3.3 million for the
quarter ended December 31, 2019 and $9.0 million for the year ended
December 31, 2019, compared to $1.6 million and $8.7 million for
the comparable periods in 2018. The increase in G&A
expenses was primarily due to the use of financial consultants,
recruiting and search fees and an increase in promotional
activities as the Company prepares for the commercialization of
Twirla.
- Net loss: Net loss was $6.0 million, or
$0.10 per share, for the quarter ended December 31, 2019, compared
to a net loss of $3.8 million, or $0.11 per share, for the quarter
ended December 31, 2018. Net loss for the year ended December
31, 2019 was $18.6 million, or $0.38 per share, compared to a net
loss of $19.8 million, or $0.58 per share, for the year ended
December 31, 2018.
- Shares Outstanding: At February 18,
2020, Agile had 69,810,305 shares of common stock outstanding.
About Twirla® Twirla (levonorgestrel and
ethinyl estradiol) transdermal system is once-weekly combined
hormonal contraceptive (CHC) patch that contains the active
ingredients levonorgestrel (LNG), a type of progestin, and ethinyl
estradiol (EE), a type of estrogen. Twirla is indicated for use as
a method of contraception by women of reproductive potential with a
body mass index (BMI) < 30 kg/m2 for whom a combined hormonal
contraceptive is appropriate to prevent pregnancy. Healthcare
providers (HCPs) are encouraged to consider Twirla’s reduced
efficacy in women with a BMI ≥ 25 to <30 kg/m2 before
prescribing. Twirla is contraindicated in women with a BMI ≥
30 kg/m2. Twirla is designed to be applied once weekly for three
weeks, followed by a week without a patch.
About Agile Therapeutics,
Inc.Agile Therapeutics is a 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
initial product, Twirla®, (levonorgestrel and ethinyl estradiol)
transdermal system is a, a 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”, within the meaning of Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. 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
market availability of Twirla, our projected cash position and the
expected timing and structure of our commercialization plan for
Twirla. 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 maintain regulatory
approval of Twirla, our ability along with our third-party
manufacturer, Corium, to complete successfully the scale-up of the
commercial manufacturing process for Twirla, including the
qualification and validation of equipment related to the expansion
of Corium's manufacturing facility, the performance and financial
condition of Corium or any of the suppliers to our third-party
manufacturer, the ability of Corium to produce commercial supply in
quantities and quality sufficient to satisfy market demand for
Twirla, our ability to successfully commercialize Twirla, the
successful development of our sales and marketing capabilities, the
accuracy of our estimates of the potential market for Twirla,
regulatory and legislative developments in the United States and
foreign countries, our ability to obtain and maintain intellectual
property protection for Twirla, our strategy, business plans and
focus, 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)
|
December 31, 2019 |
|
December 31, 2018 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$34,479 |
|
$7,851 |
|
Prepaid expenses |
840 |
|
607 |
|
Total current assets |
35,319 |
|
8,458 |
|
Property and equipment, net |
14,044 |
|
13,916 |
|
Other assets |
177 |
|
18 |
|
Total assets |
$49,540 |
|
$22,392 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
$3,623 |
|
$2,218 |
|
Lease liability, current portion |
172 |
|
- |
|
Total liabilities |
3,795 |
|
2,218 |
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
Common stock |
7 |
|
3 |
|
Additional paid‑in capital |
306,108 |
|
261,722 |
|
Accumulated deficit |
(260,370) |
|
(241,551) |
|
Total stockholders’ equity |
45,745 |
|
20,174 |
|
Total liabilities and
stockholders’ equity |
$49,540 |
|
$22,392 |
|
|
|
|
|
|
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, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
$2,728 |
|
$1,856 |
|
$9,858 |
|
$9,777 |
|
General and administrative |
3,337 |
|
1,567 |
|
9,000 |
|
8,739 |
|
Restructuring costs |
— |
|
304 |
|
— |
|
1,019 |
|
Total operating expenses |
6,105 |
|
3,727 |
|
18,858 |
|
19,535 |
|
Loss from operations |
(6,105) |
|
(3,727) |
|
(18,858) |
|
(19,535) |
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
Interest income |
84 |
|
77 |
|
252 |
|
366 |
|
Interest expense |
— |
|
(160) |
|
— |
|
(1,116) |
|
Change in fair value of warrants |
— |
|
— |
|
— |
|
29 |
|
Loss before benefit from income taxes |
(6,021) |
|
(3,810) |
|
(18,606) |
|
(20,256) |
|
Benefit from income taxes |
— |
|
— |
|
— |
|
477 |
|
Net loss |
$(6,021) |
|
$(3,810) |
|
$(18,606) |
|
$(19,779) |
|
Net loss per share - basic and diluted |
$(0.10) |
|
$(0.11) |
|
$(0.38) |
|
$(0.58) |
|
|
|
|
|
|
|
|
|
|
|
Weighted‑average shares outstanding –basic and diluted |
62,559,514 |
|
34,377,329 |
|
49,432,487 |
|
34,315,931 |
|
|
|
|
|
|
|
|
|
|
Agile Therapeutics (NASDAQ:AGRX)
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