Agile Therapeutics, Inc. (“Agile”) (OTCQB: AGRX), a women's
healthcare company, today announced that it has entered into a
definitive merger agreement (“Merger Agreement”) with Insud Pharma,
S.L. (“Insud”) a global pharmaceutical group based in Spain with a
45 year track record and a presence in over 50 countries, pursuant
to which Insud, through its US subsidiary, Exeltis Project, Inc.
(“Exeltis”), will acquire Agile for $1.52 per share in cash net of
assumed liabilities and estimated transaction costs for an
approximate total enterprise value of $45 million.
“We started Agile with the goal of improving women’s health
through innovative, clinically differentiated products for women,”
said Agile Chairperson and Chief Executive Officer Al Altomari. “We
are proud of what we have been able to accomplish with our small,
dedicated team: gaining approval of Twirla, the only low dose
combined hormonal contraceptive patch, and developing a targeted
commercial platform that allowed us to accelerate the growth of
Twirla while reducing and managing our operating expenses. Now, we
are excited about the future of Twirla in the hands of Exeltis,
Insud’s US subsidiary, which we believe has the organization and
resources to build on the growth momentum we have created. We
believe this is the right path for Agile, provides a substantial
premium to our current stock price, and a good development for
women’s health.”
On June 25, 2024, Agile also entered into a cash-out
acknowledgment and cancellation agreement (the “Warrant Cash-Out
Agreement”) with the holders of not less than ninety-five percent
(95%) of the Company’s outstanding common stock warrants, also
conditioned on closing of the merger. As a condition to entering
into the Merger Agreement, Agile has also entered into a third
amendment of its Manufacturing and Commercialization Agreement with
Corium Innovations, Inc. (“Corium”) (“Amendment No. 3”) on
commercial terms reasonably acceptable to Insud and conditioned on
the closing of the merger.
As part of the merger consideration for Agile, Insud has agreed
to make available a line of credit of up to $8,000,000, (the
“Bridge Loan”) secured by the Company’s intellectual property. The
initial amount to be advanced under the Bridge Loan will be used
primarily to pay for the purchase of inventory.
The Board of Directors of Agile has unanimously approved the
transaction. The transaction is expected to close in the third
quarter of 2024, subject to completion of Agile’s obligations to
Corium under Amendment No. 3 and other customary closing
conditions, including approval by Agile’s stockholders. Upon
completion of the transaction, Agile will no longer be listed on
any public market.
Advisors H.C. Wainwright & Co. acted as
exclusive financial advisor to Agile Therapeutics, Inc., in this
transaction and Morgan, Lewis & Bockius LLP acted as its legal
advisor. Loeb & Loeb LLP and RC Law LLP acted as legal advisors
to Insud Pharma, S.L. and Exeltis USA, Inc.
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 and
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), a transdermal system, is 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 and LinkedIn account.
About Twirla®Twirla
(levonorgestrel and ethinyl estradiol) transdermal system is a
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.
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 also contraindicated in women over 35 years old
who smoke.Cigarette smoking increases the risk of serious
cardiovascular events from CHC use. Twirla is designed to be
applied once weekly for three weeks, followed by a week without a
patch.
About Insud PharmaInsud Pharma is a
pharmaceutical group with more than 45 years of history, presence
in around 50 countries, 9,000 employees worldwide and 20
manufacturing plants.
Insud Pharma operates throughout the value chain of the
pharmaceutical industry, offering specialized knowledge in
scientific research, development, manufacturing, sale and marketing
of a wide range of active pharmaceutical ingredients (APIs),
finished dosage forms (FDFs) and pharmaceutical products of brand
for the care of humans and animals and biopharmaceuticals.
Insud Pharma seeks to improve health throughout the world by
providing accessible, effective, safe and quality pharmacological
treatments through its different business units, with continuous
investment in R&D and the latest technology.
No Offer or SolicitationThis communication does
not constitute an offer to sell or the solicitation of an offer to
buy the securities of the Company or the solicitation of any vote
or approval, nor shall there be any offer, solicitation or sale of
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of any such jurisdiction. No offer of
securities shall be made in the United States absent registration
under the Securities Act of 1933, as amended, or pursuant to an
exemption from, or in a transaction not subject to, such
registration requirements.
Additional Information and Where to Find itIn
connection with the proposed transaction between Agile and Insud,
Agile will file with the Securities and Exchange Commission (SEC) a
proxy statement on Schedule 14A relating to a special meeting of
its stockholders. Additionally, Agile may file other relevant
materials with the SEC in connection with the proposed transaction.
Investors and securityholders of Agile are urged to read the proxy
statement and any other relevant materials filed or that will be
filed with the SEC, as well as any amendments or supplements to
these materials and documents incorporated by reference therein,
carefully and in their entirety when they become available because
they contain or will contain important information about the
proposed transaction and related matters. The definitive version of
the proxy statement will be mailed or otherwise made available to
Agile’s securityholders. Investors and securityholders will be able
to obtain a copy of the proxy statement (when it is available) as
well as other filings containing information about the proposed
transaction that are filed by Agile with the SEC, free of charge on
EDGAR at www.sec.gov, on the investor relations page of Agile’s
website at
https://ir.agiletherapeutics.com/financial-information/sec-filings,
by contacting Agile’s investor relations department at
https://ir.agiletherapeutics.com/contact-ir.
Participants in the SolicitationInsud, Agile
and certain of their directors and executive officers may be deemed
to be participants in the solicitation of proxies from the
stockholders of Agile in respect of the proposed transaction and
any other matters to be voted on at the special meeting.
Information about Insud’s directors and executive officers,
including a description of their direct interests, by security
holdings or otherwise, will be included in the proxy statement
(when available). Information about Agile and its directors and
executive officers can be found in Agile’s Amendment No. 1 to its
Annual Report on Form 10-K for the year ended December 31, 2023,
filed on April 29, 2024 and Agile’s other filings with the SEC
available at the SEC’s Internet site (www.sec.gov), including any
statements of beneficial ownership on Form 3 or Form 4 filed with
the SEC after such amendment to the Annual Report.
Forward-Looking StatementsThis communication
contains “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 concerning the Company’s plans, objectives, strategy and
strategic objectives, future events, business conditions, results
of operations, business outlook and other information may be
forward looking statements. 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 (i) the risk that the proposed
merger may not be completed in a timely manner or at all, which may
adversely affect the Company’s business and the price of its common
stock, (ii) the failure to satisfy the conditions to the
consummation of the proposed merger, including the adoption of the
Merger Agreement by the stockholders of the Company and the impact
on the Cash-Out Warrant Agreement and Amendment No. 3, (iii) the
occurrence of any event, change or other circumstance that could
give rise to the termination of the Merger Agreement, (iv) the
effect of the announcement or pendency of the proposed merger on
the Company’s business relationships, operating results and
business generally, (v) the risk that the proposed merger disrupts
the Company’s current plans and operations and potential
difficulties in the Company’s employee retention as a result of the
proposed merger, (vi) the outcome of any legal proceedings that may
be instituted against the Company related to the Merger Agreement
or the proposed merger, and (vii) the risk that the proposed merger
and its announcement could have an adverse effect on the ability of
the Company to retain and hire key personnel and to maintain
relationships with customers, vendors, employees, stockholders and
other business partners and on its operating results and business
generally. The foregoing list of risk factors is not exhaustive.
For a more detailed description of the risks and uncertainties that
could cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to our
business in general, please refer to 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. The Company does not
give any assurances that it will achieve its expectations.
Contact:
For Agile:Agile Therapeutics Investor
Relationsir@agiletherapeutics.com
For Insud:
Communication DepartmentEdificio Ebrosa - Manuel Pombo Angulo,
28 3rd floor28050 Madrid, Spain.Tel: +34 91 771 15 00E-mail:
comunicacion@insudpharma.com
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