Current Report Filing (8-k)
September 21 2020 - 04:10PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or
15(D)
of the Securities Exchange Act of
1934
September 21, 2020
Date of report (Date of earliest event reported)
Agile Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-36464
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23-2936302
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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101 Poor Farm Road
Princeton, New Jersey
(Address of principal executive offices)
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08540
(Zip Code)
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Registrant's telephone number, including area code (609) 683-1880
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the
registrant under any of the following provisions:
◻Written communications pursuant to Rule 425
under the Securities Act (17 CFR 230.425)
◻Soliciting material pursuant to Rule 14a-12
under the Exchange Act (17 CFR 240.14a-12)
◻Pre-commencement communications pursuant to
Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
◻Pre-commencement communications pursuant to
Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Common stock, par value $0.0001 per share
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AGRX
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The Nasdaq Capital Market
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter)
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Item 7.01.
Regulation FD Disclosure.
On September 21, 2020, Agile
Therapeutics, Inc. (the “Company”) hosted an analyst day
presentation (“Analyst Day”). Members of the Company’s executive
team discussed launch and commercialization plans for
Twirla®, the Company’s once weekly low-dose
prescription contraceptive patch. Management was joined by a
leading external expert who provided clinical perspectives on
Twirla, as well as insights into today’s contraceptive
marketplace.
During the presentation, the
Company reaffirmed its previously announced operating expense
guidance for the full year 2020 to be in the range of $52 million
to $56 million and its previously announced net revenue guidance
for the fourth quarter of 2020 to be in the range of $1 million to
$2 million. The Company also reaffirmed its belief that, based on
the Company’s current business plan and ability to launch Twirla,
its cash, cash equivalents and marketable securities as of June 30,
2020 will be sufficient to meet its projected operating
requirements through the end of 2021. If the COVID-19 pandemic or
other factors impact the Company’s current business plans or its
ability to generate revenue from the launch of Twirla, the Company
believes it has the ability to revise its commercial plans,
including curtailing sales and marketing spending, to allow it to
continue to fund its operations.
A live webcast of the Analyst Day as well as the presentation
materials for the event were simultaneously made accessible through
the Investor Relations section of the Company’s website. A replay
of the webcast and the presentation materials are available at
https://ir.agiletherapeutics.com/. The replay will be accessible
for the next 30 days.
In accordance with General Instructions B.2 and B.6 of Form 8-K,
the information included in this Current Report on Form 8-K, shall
not be deemed “filed” for the purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise subject to the liabilities of that section, nor shall
it be deemed incorporated by reference into any filing made by the
Company under the Exchange Act or Securities Act of 1933, as
amended, except as shall be expressly set forth by specific
reference in such a filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, as amended, the Company has duly caused this report to be
signed on its behalf by the undersigned hereunto duly
authorized.
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Agile Therapeutics, Inc.
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Dated: September 21, 2020
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By:
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/s/ Alfred Altomari
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Name:
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Alfred Altomari
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Title:
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Chairman and Chief Executive Officer
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