Item 2.02 Results of Operations and Financial Condition.
As discussed below, in connection with its participation in the 39th Annual
Because the Company's financial statements for the year ended
Item 7.01. Regulation FD Disclosure.
The information set forth in Item 2.02 of this Current Report on Form 8-K (this "Report") is incorporated into this Item 7.01 by reference.
The Company will participate in the 39th Annual
A copy of the Company's updated corporate presentation is attached hereto as Exhibit 99.1 and is hereby incorporated by reference herein.
In accordance with General Instructions B.2 and B.6 of Form 8-K, the information included in Item 2.02 and Item 7.01 of 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 cash position and gross
revenue 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
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regulatory and manufacturing development plans, and other factors, including general economic conditions and regulatory developments, not within the Company's control.
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 datedJanuary 14, 2021 .
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