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style="background-color:#000000;height:1pt;position:relative;top:0.6em;width:25.0%;border:none;margin:0 auto;"></div></div><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 6pt 0pt;"><b style="font-size:9pt;font-weight:bold;">FORM </b><ix:nonNumeric contextRef="Duration_9_10_2021_To_9_10_2021_M4dQOaALYEy77ObQEo6upA" name="dei:DocumentType" id="Narr_ofnfPVt9s0OCNk5RUIv53Q"><b style="font-size:9pt;font-weight:bold;">8-K</b></ix:nonNumeric></p><div style="font-family:'Times New Roman','Times','serif';font-size:9.0pt;margin-bottom:12pt;min-height:1.19em;position:relative;width:100%;"><div style="background-color:#000000;height:1pt;position:relative;top:0.6em;width:25.0%;border:none;margin:0 auto;"></div></div><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-align:center;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">CURRENT REPORT</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Pursuant to Section 13 or 15(D)</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">of the Securities Exchange Act of 1934</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 6pt 0pt;"><span style="font-size:9pt;text-decoration:underline;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_9_10_2021_To_9_10_2021_M4dQOaALYEy77ObQEo6upA" format="ixt:datemonthdayyearen" name="dei:DocumentPeriodEndDate" id="Narr_vlJA9Vu0aE6MOMLxNHT6ow"><b style="font-size:9pt;font-weight:bold;">September 10, 2021</b></ix:nonNumeric></p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-align:center;margin:0pt 0pt 12pt 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240.13e-4(c))</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;padding-bottom:7pt;padding-top:0pt;border-bottom:1px solid #000000;margin:0pt;">Securities registered pursuant to Section 12(b) of the Act:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:5pt;visibility:hidden;">&#8203;</span></p><a id="_88f3fa38_2b31_49a8_8368_083c4bf6e3e2"></a><a id="Tc_6sBVqSSPgk2uTjJ3JjEfIw_0_0"></a><a id="Tc_E30-3fTR50G1JkDuxSOrDQ_0_1"></a><a id="Tc_hDzw3uU3e0yauv4Ph2i3QA_0_2"></a><a id="Tc_6GjTjBe7xEWhnCIVuIOrtQ_1_0"></a><a id="Tc_-P0nIVv2WUSuMdISe8cPeQ_1_2"></a><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:100%;"><tr><td style="vertical-align:bottom;width:41.93%;border-bottom:1.0pt solid #000000;border-left:1.0pt solid #000000;border-right:1.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-align:center;margin:0pt 0pt 0pt 5pt;"><b style="font-weight:bold;">Title of Each Class</b></p></td><td style="vertical-align:bottom;width:17.96%;border-bottom:1.0pt solid #000000;border-left:1.0pt solid #000000;border-right:1.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Trading Symbol(s)</b></p></td><td style="vertical-align:bottom;width:40.09%;border-bottom:1.0pt solid #000000;border-left:1.0pt solid #000000;border-right:1.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;text-align:center;margin:0pt;"><b style="font-weight:bold;">Name of each exchange on which registered</b></p></td></tr><tr><td style="vertical-align:bottom;width:41.93%;border-bottom:1.0pt solid #000000;border-left:1.0pt solid #000000;border-right:1.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 0pt 5pt;"><ix:nonNumeric contextRef="Duration_9_10_2021_To_9_10_2021_M4dQOaALYEy77ObQEo6upA" name="dei:Security12bTitle" id="Narr_BQmn_Uttv0mI8Oro6Lc4nw"><span style="font-size:9pt;">Common stock</span></ix:nonNumeric><span style="font-size:9pt;">, par value $0.0001 per share</span></p></td><td style="vertical-align:bottom;width:17.96%;border-bottom:1.0pt solid #000000;border-left:1.0pt solid #000000;border-right:1.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;"><ix:nonNumeric contextRef="Duration_9_10_2021_To_9_10_2021_M4dQOaALYEy77ObQEo6upA" name="dei:TradingSymbol" id="Tc_TFCsQhTWy024w5ykW3IMmw_1_1"><span style="font-size:9pt;">AGRX</span></ix:nonNumeric></p></td><td style="vertical-align:bottom;width:40.09%;border-bottom:1.0pt solid #000000;border-left:1.0pt solid #000000;border-right:1.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt;">The <ix:nonNumeric contextRef="Duration_9_10_2021_To_9_10_2021_M4dQOaALYEy77ObQEo6upA" format="ixt-sec:exchnameen" name="dei:SecurityExchangeName" id="Narr_TQBFyJ1iV0uo-e35U3iaRg">Nasdaq</ix:nonNumeric> Capital Market</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;margin:0pt 0pt 6pt 0pt;">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (&#167;230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (&#167;240.12b-2 of this chapter)</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:right;margin:0pt 0pt 6pt 0pt;"><span style="font-size:9pt;">Emerging growth company </span><ix:nonNumeric contextRef="Duration_9_10_2021_To_9_10_2021_M4dQOaALYEy77ObQEo6upA" format="ixt-sec:boolballotbox" name="dei:EntityEmergingGrowthCompany" id="Narr_-gnnuDNc_0q0jvzFpeolWA"><span style="font-family:'Segoe UI Symbol';font-size:9pt;">&#9744;</span></ix:nonNumeric></p><p style="font-family:'Times New Roman','Times','serif';font-size:9pt;margin:0pt 0pt 6pt 0pt;">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. <span style="font-family:'Segoe UI Symbol';">&#9744;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:5pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-bottom:1pt;padding-top:1pt;border-bottom:3.0pt solid #000000;border-top:1.0pt solid #000000;margin:0pt;"><span style="font-family:'Segoe UI Symbol';font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="display:none;font-family:'Times New Roman','Times','serif';line-height:0pt;margin:0pt;"><span style="font-family:'Wingdings';font-size:0pt;visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:11.76%;padding-right:11.76%;position:relative;"><div style="margin-top:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;max-width:100%;position:relative;"><a id="_0fd8a12c_188f_4c58_a5ee_4c8810d88ea0"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Item 7.01. Regulation FD Disclosure. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">Agile Therapeutics, Inc. (the &#8220;Company&#8221;) has updated the corporate presentation that it intends to use at the H.C. Wainwright 23<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">rd</sup><span style="white-space:pre-wrap;"> Annual Global Investment Conference beginning on September 13, 2021 and subsequent investor conferences.  The Company may use the presentation in meetings with investors from time to time as well.  The updates primarily involve financial projections for the third quarter of 2021 on net revenue and retail units sold based on total prescription demand for Twirla&#174; (levonorgestrel and ethinyl estradiol) transdermal system.  The Company estimates that net sales in the third quarter of 2021 will be in the range of $1.4 million to $1.6 million, and retail units sold based on total prescription demand will be 9,500 to 10,000.  The update also reiterates the Company&#8217;s financial projection of operating expenses for the second half of 2021, which the Company expects to be at levels similar to its second quarter of 2021 spending within a range of $1 million to $2 million.  Because the Company&#8217;s financial statements for the quarter ended September 30, 2021 have not yet been finalized or reviewed, this financial projection regarding the Company&#8217;s expected net revenue, units sold and operating expense is subject to change, and the Company&#8217;s results as of the end of this period may differ materially from this preliminary estimate. Accordingly, you should not place undue reliance on this preliminary estimate.</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">A copy of the Company&#8217;s updated corporate presentation is attached hereto as Exhibit 99.1.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">In accordance with General Instructions B.2 and B.6 of Form 8-K, the information included in this Report shall not be deemed &#8220;filed&#8221; for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the &#8220;Exchange Act&#8221;), 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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Forward-Looking Statements </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;"><span style="white-space:pre-wrap;">Certain information contained in this Report may include &#8220;forward-looking statements.&#8221;  Our use of terms such as &#8220;predicts,&#8221; &#8220;believes,&#8221; &#8220;potential,&#8221; &#8220;continue,&#8221; &#8220;estimates,&#8221; &#8220;anticipates,&#8221; &#8220;expects,&#8221; &#8220;plans,&#8221; &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;could,&#8221; &#8220;might,&#8221; &#8220;will,&#8221; &#8220;should&#8221; or other words that convey uncertainty of future events or outcomes may identify these forward-looking statements.  </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">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 the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and focus, the effects of the COVID-19 pandemic on our operations and the operations of third parties we rely on as well as on our potential customer base, unforeseen market factors or events in our clinical, regulatory and manufacturing development plans, and other factors, including general economic conditions and regulatory developments, not within the Company&#8217;s control.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">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 &#8220;Risk Factors&#8221; in the Company&#8217;s periodic reports filed with the SEC.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:76.47%;border:0;margin:30pt 11.76% 30pt 11.76%;"></div><div style="max-width:100%;padding-left:11.76%;padding-right:11.76%;position:relative;"><div style="margin-top:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;max-width:100%;position:relative;"><a id="_5893ccd3_1c39_4d3e_abc5_b6da79ca8253"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><span style="display:inline-block;text-indent:0pt;width:54pt;"><b style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:bold;text-align:left;">Item 9.01.</b></span><b style="font-weight:bold;">Financial Statements and Exhibits.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><span style="display:inline-block;text-indent:0pt;width:36pt;"><b style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:bold;text-align:left;">(d)</b></span><b style="font-weight:bold;">Exhibits.</b></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:3.6pt;padding-right:3.6pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:16.51%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;width:83.48%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:16.51%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;border-bottom:1px solid #000000;margin:0pt 0pt 1pt 0pt;"><b style="font-weight:bold;">Exhibit<br />Number</b></p></td><td style="vertical-align:bottom;width:83.48%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;border-bottom:1px solid #000000;margin:0pt 0pt 1pt 0pt;"><b style="font-weight:bold;">Description</b></p></td></tr><tr><td style="vertical-align:top;width:16.51%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-left:10pt;text-align:center;text-indent:-10pt;margin:0pt;"><a style="-sec-extract:exhibit;" href="agrx-20210910xex99d1.htm"><span style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:normal;text-align:center;">99.1</span></a></p></td><td style="vertical-align:top;width:83.48%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Agile Therapeutics, Inc. Presentation dated September 2021. </p></td></tr><tr><td style="vertical-align:top;width:16.51%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;padding-left:10pt;text-align:center;text-indent:-10pt;margin:0pt;">104</p></td><td style="vertical-align:top;width:83.48%;margin:0pt;padding:0pt 3.59pt 0pt 3.59pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Cover Page Interactive Data File (embedded with the Inline XBRL document).</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:76.47%;border:0;margin:30pt 11.76% 30pt 11.76%;"></div><div style="max-width:100%;padding-left:11.76%;padding-right:11.76%;position:relative;"><div style="margin-top:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;max-width:100%;position:relative;"><a id="_f1bf74ae_c3c8_4e28_839c_ae8f2f6d9789"></a><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-align:center;margin:0pt 0pt 12pt 0pt;">SIGNATURES</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">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.</p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:top;width:6%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div></td><td style="vertical-align:top;width:43.99%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="position:absolute;top:0pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td><td colspan="2" style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><b style="font-weight:bold;">Agile Therapeutics, Inc.</b></p></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:top;width:6%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:top;width:43.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:top;width:6%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:top;width:43.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Dated: September 10, 2021</p></td><td style="vertical-align:top;width:6%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">By:</p></td><td style="vertical-align:top;width:43.99%;border-bottom:1.0pt solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">/s/ Alfred Altomari</p></td></tr><tr><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:top;width:6%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Name:</p></td><td style="vertical-align:top;width:43.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Alfred Altomari</p></td></tr><tr style="height:3pt;"><td style="vertical-align:top;width:50%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"> <span style="visibility:hidden;">&#8203;</span></p></td><td style="vertical-align:top;width:6%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Title:</p></td><td style="vertical-align:top;width:43.99%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Chairman and Chief Executive Officer</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div><div style="clear:both;margin-bottom:30pt;width:100%;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
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​
​
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 10, 2021
Date of report (Date of earliest event reported)
Agile Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
​
​
​
Delaware
001-36464
23-2936302
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
​
​
​
​
​
​
​
​
101 Poor Farm Road
Princeton
,
New Jersey
(Address of principal executive offices)
​
08540
(Zip Code)
​
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
Trading Symbol(s)
Name of each exchange on which registered
Common stock
, par value $0.0001 per share
AGRX
The
Nasdaq
Capital Market
​
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.
Agile Therapeutics, Inc. (the "Company") has updated the corporate presentation that it intends to use at the H.C. Wainwright 23
rd
Annual Global Investment Conference beginning on September 13, 2021 and subsequent investor conferences.  The Company may use the presentation in meetings with investors from time to time as well.  The updates primarily involve financial projections for the third quarter of 2021 on net revenue and retail units sold based on total prescription demand for Twirla® (levonorgestrel and ethinyl estradiol) transdermal system.  The Company estimates that net sales in the third quarter of 2021 will be in the range of $1.4 million to $1.6 million, and retail units sold based on total prescription demand will be 9,500 to 10,000.  The update also reiterates the Company's financial projection of operating expenses for the second half of 2021, which the Company expects to be at levels similar to its second quarter of 2021 spending within a range of $1 million to $2 million.  Because the Company's financial statements for the quarter ended September 30, 2021 have not yet been finalized or reviewed, this financial projection regarding the Company's expected net revenue, units sold and operating expense is subject to change, and the Company's results as of the end of this period may differ materially from this preliminary estimate. Accordingly, you should not place undue reliance on this preliminary estimate.
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 the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and focus, the effects of the COVID-19 pandemic on our operations and the operations of third parties we rely on as well as on our potential customer base, unforeseen market factors or events in our clinical, 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 SEC.
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Item 9.01.
Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
Number
Description
99.1
Agile Therapeutics, Inc. Presentation dated September 2021.
104
Cover Page Interactive Data File (embedded with the Inline XBRL document).
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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 10, 2021
By:
/s/ Alfred Altomari
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Name:
Alfred Altomari
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Title:
Chairman and Chief Executive Officer
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