Agile Therapeutics, Inc. (NASDAQ:AGRX) Files An 8-K Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition.
As discussed below, in connection with its participation in the 39th Annual J.P. Morgan Healthcare Conference on January 14th, 2021, Agile Therapeutics, Inc. (the “Company”) updated its corporate presentation to include disclosure that the Company had an estimated $54.5 million of cash and cash equivalents on hand as of December 31, 2020. In the presentation, the Company also reaffirms its projections that, based on the Company’s current business plan and the launch of Twirla, its current cash, cash equivalents and marketable securities will be sufficient to meet its projected operating requirements through the end of 2021 and that it expects its gross revenue will be approximately $1 million, reflecting expectations of initial stocking of Twirla by wholesalers.
Because the Company’s financial statements for the year ended December 31, 2020 have not yet been finalized or audited, this preliminary statement regarding the Company’s cash and cash equivalents as of December 31, 2020 is subject to change, and the Company’s actual cash and cash equivalents on hand 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.
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 J.P. Morgan Healthcare Conference in San Francisco, California, which is being held virtually, on Thursday, January 14, 2021 at 9:10 a.m. Eastern Time, and has updated the corporate presentation that it intends to use at the conference. The Company may use this updated corporate presentation in meetings with investors from time to time as well. In addition to the above-referenced disclosure regarding the Company’s cash and cash equivalents as of December 31, 2020, the updates primarily involve financial projections on cash runway and gross revenue, and the Company’s commercialization of Twirla® (levonorgestrel and ethinyl estradiol) transdermal system, its first FDA-approved product.
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 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,