Item 7.01. Regulation FD Disclosure.
A copy of the Company's updated corporate presentation is attached hereto as Exhibit 99.1.
In accordance with General Instructions B.2 and B.6 of Form 8-K, the information included in this Report 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 the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Forward-Looking Statements
Certain information contained in this Report may include "forward-looking statements." Our use of terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes may identify these forward-looking statements.
In particular, statements regarding our projected third quarter 2021 net
revenue, retail units sold based on total prescription demand for Twirla, and
operating expenses for the second half of 2021 are examples of such
forward-looking statements. Such forward-looking statements are subject to
important risks and uncertainties, including, but not limited to, risks related
to our ability to maintain regulatory approval of Twirla, the ability of our
third party manufacturer, Corium, to produce commercial supply in quantities and
quality sufficient to satisfy market demand for Twirla, our ability to
successfully commercialize and obtain market access for Twirla, the successful
development of our sales and marketing capabilities, the accuracy of our
estimates of the potential market for Twirla, our ability to achieve our target
formulary access goals, regulatory and legislative developments in
These factors could cause actual results and developments to be materially
different from those expressed in or implied by such statements. These
forward-looking statements are made only as of the date of this Report and the
Company undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances. For additional
information about the risks and uncertainties that may affect our business
please see the factors discussed in "Risk Factors" in the Company's periodic
reports filed with the
Item 9.01.Financial Statements and Exhibits.
(d)Exhibits. Exhibit Number Description 99.1Agile Therapeutics, Inc. Presentation datedSeptember 2021 . 104 Cover Page Interactive Data File (embedded with the Inline XBRL document).
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