Item 2.02 Results of Operations and Financial Condition.
On April 28, 2023, Agile Therapeutics, Inc. (the “Company”) issued a press release announcing preliminary expectations for the first quarter of 2023 Twirla demand, net revenue, and operating expenses (“OPEX”). In the press release, the Company disclosed that it expects total demand to surpass 45,000 total cycles with retail demand expected to exceed 30,500 total cycles, and non-retail demand expected to exceed 14,000 total cycles, all of which represent at least 20% growth from the fourth quarter of 2022. The Company also disclosed that it expects factory sales to exceed 43,000, remaining approximately flat compared to the fourth quarter of 2022. In addition, the Company disclosed that it expects first quarter 2023 net revenue to be in the range of $3.8 to $4.0 million and that it expects first quarter OPEX to be in the range of $8.3 to $8.8 million. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1
Because the Company’s financial statements for the quarter ended March 31, 2023 have not yet been finalized, these preliminary statements regarding the Company’s Twirla demand, net revenue, and OPEX are subject to change, and the Company’s actual Twirla demand, net revenue, and OPEX may differ materially from these preliminary estimates. Accordingly, you should not place undue reliance on these preliminary estimates.
In accordance with General Instruction B.2 of Form 8-K, the information included in this Item 2.02, including Exhibit 99.1 hereto, 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Forward-Looking Statements
Certain information contained in this Current Report on Form 8-K includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding expected Twirla demand metrics, net revenue and operating expenses for the first quarter of 2023, our projected net revenue and expected operating expenses for 2023, our ongoing and planned manufacturing and commercialization of Twirla®, the potential market acceptance and uptake of Twirla, including the increasing demand for Twirla in 2023, our partnership with Afaxys and its ability to promote growth, our product supply agreement with Nurx and its ability to drive additional retail channel growth in the second half of 2023, our prospects for future financing arrangements, and our financial condition, growth and strategies. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to the fact that our estimated Twirla demand metrics, net revenue and operating expenses for the first quarter of 2023 are not final and may be subject to change, our ability to maintain regulatory approval of Twirla and the labeling under any approval we obtain, the ability of Corium to produce commercial supply in quantities and quality sufficient to satisfy market demand for Twirla, our ability to successfully enhance the commercialization of and increase the uptake for Twirla, the size and growth of the markets for Twirla and our ability to serve those markets, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla and our product candidates, the lingering effects of the COVID-19 pandemic on our commercialization efforts, clinical trials, supply chain, operations and the operations of third parties we rely on for services such as manufacturing, marketing support and sales support, as well as on our potential customer base, our ability to regain compliance with
