Agile Therapeutics, Inc. Enters into up to $35 Million Loan Facility with Perceptive Advisors
February 10 2020 - 4:30PM
Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare
company, today announced that it has entered into a senior secured
term loan credit facility with Perceptive Advisors to provide
Agile with up to $35 million through term loans in three
tranches. $5 million was funded today after the satisfaction
of customary closing conditions, $15 million will be available if
Twirla® is approved by the U.S. Food and Drug Administration
(“FDA”), and $15 million will be available upon the achievement of
certain revenue milestones. Agile is permitted to make
interest only payments on the loan until February 2023.
“This strategic debt financing coupled with our current cash
increases our balance sheet strength and positions us well to
continue our commercialization strategy for Twirla®, with an
expected FDA decision less than one week away,” stated Al
Altomari, Chairman and Chief Executive Officer of Agile. Mr.
Altomari continued, "We expect that our existing estimated
cash on hand as of December 31, 2019, and the $20 million in
loan proceeds which we would be eligible to receive upon the FDA’s
approval of Twirla will allow us to fund our operations through the
end of 2020. We are pleased to have the support from Perceptive,
which is a recognized leader in growth capital financing."
“We are pleased to provide growth capital to support Agile’s
strategy and are excited about the potential prospects for Twirla
in the market,” said Sam Chawla, Portfolio Manager at Perceptive
Advisors.
In connection with the credit agreement, Agile issued Perceptive
warrants to purchase 1,400,000 shares of Agile common stock.
The per share exercise price for 700,000 shares is $3.74,
which is equal to the 5 day volume weighted average price (“5 Day
VWAP”) as of the trading day immediately prior to closing.
The per share exercise price for the remaining 700,000 shares of
Agile common stock is $4.67, which is equal to 1.25 times the 5 Day
VWAP.
Oppenheimer & Co. Inc. acted as the company’s sole financial
adviser in connection with the loan facility.
About Twirla® (AG200-15) Twirla
(levonorgestrel/ethinyl estradiol transdermal system) or AG200-15
is an investigational, 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. after resubmitting a New Drug
Application (NDA) for Twirla on May 16, 2019.
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,
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.
About Perceptive Advisors Founded in 1999 and
based in New York, NY, Perceptive Advisors is an investment
management firm with over $5 billion in assets whose activities are
focused on supporting the progress of the life sciences industry by
identifying opportunities and directing financial resources to the
most promising technologies in healthcare. For more
information about Perceptive, visit www.perceptivelife.com.
Forward-Looking Statement
Certain 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 for Twirla. 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
funding conditions under the credit facility, the timing of the
FDA’s decision on Twirla and our cash runway. 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 our ability
to obtain and maintain regulatory approval of Twirla, 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, 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, regulatory and legislative developments in the
United States and foreign countries, our ability to obtain and
maintain intellectual property protection for Twirla, 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.
Contact: Investor Relations – 609-683-1880
Source: Agile Therapeutics, Inc.
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