Agile Therapeutics Reports Third Quarter 2019 Financial Results
October 28 2019 - 8:00AM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare
company, today reported financial results for the three and nine
months ended September 30, 2019 and provided a corporate update.
Third quarter 2019 and other recent
corporate developments:
Twirla® Update
- Regulatory update: The FDA
completed its pre-approval inspection (PAI) at Corium
International, Inc. (Corium), our third-party manufacturer, and the
Company continues its preparations for the October 30, 2019 meeting
of the Bone, Reproductive and Urologic Drugs Advisory Committee of
the U.S. Food and Drug Administration (FDA) to review the Company’s
new drug application (NDA) for Twirla. The FDA has assigned
the Twirla NDA a Prescription Drug User Fee Act (PDUFA) goal date
of November 16, 2019. In advance of the Advisory Committee meeting,
the FDA issued its briefing document in which it expresses a number
of concerns regarding Twirla’s approvability, including, but not
limited to, concerns related to Twirla’s efficacy when balanced
against its safety. The FDA also did not appear to agree with
the Company’s proposal to include a limitation of use based on
patient weight and BMI in the product label.
Public Offering
- $12.7 Million in Net Proceeds From Sale of Common Stock: The
Company completed a public offering of 14,526,315 shares of common
stock in August. Net proceeds from the public offering, after
deducting underwriting discounts and commissions and offering
expenses, were approximately $12.7 million.
Commercial
Plans
- If the Company receives approval of
the Twirla NDA, it plans to acclerate its commercial activities. In
September 2019, the Company re-started manufacturing development at
Corium. The Company is currently working with Corium to complete
manufacturing development and process improvements and plans to
commence pre-validation work when that work is complete. The
Company’s goal is to manufacture three validation batches of Twirla
and complete the validation of the commercial manufacturing process
in the second half of 2020.
- In parallel, the Company plans to initiate work with managed
care and patient payers to gain market access for Twirla in the
first quarter of 2020. In the second quarter of 2020, the
Company plans to hire and train an initial sales team, which it
estimates will be in the range of 50 to 90 persons. The Company
expects to ship product to wholesalers and commence its commercial
launch in fourth quarter of 2020. The Company’s marketing
efforts will initially focus on Obstetrician-gynecologists in the
United States, and it plans to use a significant number of samples
in the early stage of commercial launch to gain patient trial and
acceptance.
“The third quarter of 2019 was another
productive quarter for the Company” said Al Altomari, Chairman and
Chief Executive Officer of Agile. “We raised much needed cash
to fund our business and allow us to reactivate Corium to prepare
for commercialization in the event that Twirla® is approved and to
accomplish other precommercial activities. In addition, the
FDA completed Corium’s facility pre-inspection and our team has
been preparing to present the case for NDA approval of Twirla® at
the Advisory Committee meeting. We continue to believe that Twirla,
if approved, will provide women with a new, important contraception
option they do not currently have.”
Third Quarter Financial
Results
- Cash and cash
equivalents: As of September 30, 2019, Agile had
$18.4 million of cash and cash equivalents compared to $7.8 million
of cash and cash equivalents as of December 31, 2018. During
the quarter ended September 30, 2019, the Company raised net
proceeds of approximately $12.7 million from a sale of 14,526,315
shares of common stock through a public offering in August and $0.2
million from the sale of 143,482 shares of common stock from
its “at-the-market” equity offerings. The Company believes
its cash and cash equivalents as of September 30, 2019 will be
sufficient to meet its projected operating requirements through the
end of the first quarter 2020. The Company will require
additional capital to fund operating needs for the rest of 2020 and
beyond, which will primarily be used for the completion of its
commercial plan for Twirla, if approved, including the completion
of the validation of the commercial manufacturing process, the
commercial launch, 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 September 30, 2019, compared to $1.5
million for the comparable period in 2018. The increase in R&D
expenses was primarily related to consulting fees incurred in the
preparation of the upcoming FDA Advisory Committee meeting.
Partially offsetting this increase were decreases in manufacturing
expense, commercialization expenses and stock compensation
expense. The reduction in manufacturing and commercialization
expenses reflects reduced activity associated with the scale-up of
the commercial manufacturing process which was implemented as a
result of the receipt of the 2017 CRL. The decrease in stock
compensation expense was primarily the result of a lower stock
price associated with the January 2019 stock option grants as
compared to the January 2018 stock option grants.
- General and administrative
(G&A) expenses: G&A expenses were $2.1
million for the quarter ended September 30, 2019, compared to $1.8
million for the comparable period in 2018. The increase in
G&A expenses was primarily due to legal and finance costs,
including investment banking advisory fees. Partially
offsetting the increase was a decrease in stock compensation
expense primarily the result of a lower stock price associated with
the January 2019 stock option grants as compared to the January
2018 stock option grants and the suspension of
pre-commercialization activities as a result of the receipt of the
2017 CRL.
- Net loss: Net loss was $4.4 million, or
$0.08 per share, for the quarter ended September 30, 2019, compared
to a net loss of $3.8 million, or $0.11 per share, for the quarter
ended September 30, 2018.
- Shares Outstanding: At September 30,
2019, Agile had 59,302,126 shares of common stock outstanding.
About Twirla® (AG200-15)Twirla
(ethinyl estradiol and levonorgestrel transdermal system) or
AG200-15 is an investigational low-dose, once-weekly 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. The Company has completed its Phase 3 clinical trials
of Twirla and is pursuing regulatory approval in the U.S. The
Company resubmitted the Twirla NDA in the second quarter of 2019
and has been assigned a November 16, 2019 PDUFA goal date.
Xulane® is a registered trademark of Mylan N.V.,
and Ortho Evra® is a registered trademark of Johnson &
Johnson.
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”, 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,
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 approvability and subsequent availability
of Twirla, the interpretation of data that supports the approval of
Twirla, the timing of our advisory committee meeting and of the
FDA’s review of the Twirla NDA, and the fact that our existing cash
and cash equivalents likely will not be sufficient to fund our
current and planned operations after the end 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 expectations about Twirla and its NDA. 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 available cash and our ability to obtain additional funding to
fund our business plan without delay and to continue as a going
concern, our ability to adequately respond to the deficiencies in
the second Twirla CRL issued by the FDA on December 21, 2017, the
potential that the FDA determines that our data do not support
approval of Twirla NDA and requires us to conduct additional
studies or reformulate Twirla to address the concerns raised in the
2017 CRL, our ability to obtain and maintain regulatory approval of
Twirla, our ability to obtain a favorable advisory committee vote
regarding the benefit and risk profile of Twirla, the accuracy of
our estimates regarding expenses, future revenues, capital
requirements and needs for additional financing, the inability of
our third-party manufacturer, Corium International, Inc. (Corium),
to complete any work or provide any data and other information
necessary to support the approval of our Twirla NDA, our ability
along with 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 and to pass a likely FDA
pre-approval inspection, the performance and financial condition of
Corium or any of the suppliers to our third-party manufacturer, the
success and timing of our clinical trials or other studies, our
inability to timely obtain from our third-party manufacturer,
Corium, sufficient quantities or quality of our product candidates
or other materials required for a clinical trial or other tests and
studies, 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) |
|
|
September 30, 2019 |
December 31, 2018 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
18,370 |
|
$ |
7,851 |
|
Prepaid expenses |
|
1,316 |
|
|
607 |
|
Total current assets |
|
19,686 |
|
|
8,458 |
|
Property and equipment,
net |
|
13,932 |
|
|
13,916 |
|
Right of use and other
assets |
|
214 |
|
|
18 |
|
Total assets |
$ |
33,832 |
|
$ |
22,392 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
Accounts payable and accrued expenses |
$ |
1,717 |
|
$ |
2,218 |
|
Lease liability, current portion |
|
178 |
|
|
- |
|
Total current liabilities |
|
1,895 |
|
|
2,218 |
|
Lease liability, long-term |
|
34 |
|
|
- |
|
|
|
|
Stockholders’
equity |
|
|
Common stock |
|
6 |
|
|
3 |
|
Additional paid‑in capital |
|
286,246 |
|
|
261,722 |
|
Accumulated deficit |
|
(254,349 |
) |
|
(241,551 |
) |
Total stockholders’ equity |
|
31,903 |
|
|
20,174 |
|
Total liabilities and
stockholders’ equity |
$ |
33,832 |
|
$ |
22,392 |
|
|
Agile Therapeutics, Inc.Condensed
Statements of Operations(in thousands, except
share and per share
amounts) (Unaudited) |
|
|
Three Months Ended September
30, |
Nine Months EndedSeptember
30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
2,361 |
|
$ |
1,549 |
|
$ |
7,021 |
|
$ |
7,921 |
|
General and administrative |
|
2,138 |
|
|
1,767 |
|
|
5,732 |
|
|
7,173 |
|
Restructuring costs |
|
— |
|
|
299 |
|
|
— |
|
|
715 |
|
Total operating expenses |
|
4,499 |
|
|
3,615 |
|
|
12,753 |
|
|
15,809 |
|
Loss from operations |
|
(4,499 |
) |
|
(3,615 |
) |
|
(12,753 |
) |
|
(15,809 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
— |
|
|
(268 |
) |
|
— |
|
|
(955 |
) |
Interest income |
|
67 |
|
|
91 |
|
|
168 |
|
|
289 |
|
Change in fair value of warrants |
|
— |
|
|
— |
|
|
— |
|
|
29 |
|
Loss before benefit from income taxes |
|
(4,432 |
) |
|
(3,792 |
) |
|
(12,585 |
) |
|
(16,446 |
) |
Benefit from income taxes |
|
— |
|
|
— |
|
|
— |
|
|
477 |
|
Net loss |
$ |
(4,432 |
) |
$ |
(3,792 |
) |
$ |
(12,585 |
) |
$ |
(15,969 |
) |
Net loss per share - basic and diluted |
$ |
(0.08 |
) |
$ |
(0.11 |
) |
$ |
(0.28 |
) |
$ |
(0.47 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted‑average shares outstanding –basic and diluted |
|
53,609,511 |
|
|
34,377,329 |
|
|
40,957,809 |
|
|
34,295,240 |
|
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