Agile Therapeutics Announces Extension Granted by Nasdaq Hearings Panel to Regain Compliance with the Stockholders’ Equity Continued Listing Requirement & Provides Performance Update

Rhea-AI Summary

Agile Therapeutics, Inc. (AGRX) has been granted an extension by Nasdaq to regain compliance with the stockholders' equity requirement until March 25, 2024. The company expects a significant increase in net revenue for full year 2023, ranging from $20 to $21 million, representing an 84% to 93% growth compared to 2022. Additionally, GAAP operating expenses for full year 2023 are anticipated to decrease by 47% to 44% compared to 2022.

Positive

• Extension granted by Nasdaq to Agile Therapeutics, Inc. (AGRX) to regain compliance with stockholders' equity requirement until March 25, 2024.
• Expected net revenue for full year 2023 to be in the range of $20 to $21 million, an increase of 84% to 93% compared to full year 2022.
• Anticipated decrease in GAAP operating expenses for full year 2023 to be in the range of $30 to $31.5 million, a decrease of 47% to 44% compared to full year 2022.

Negative

• None.

Insights

Financial Analyst

The announcement from Agile Therapeutics regarding its extension to regain compliance with Nasdaq's stockholders’ equity requirement is a critical development for the company's financial stability and investor confidence. The ability to maintain listing standards is often seen as a signal of a company's overall health and prospects. The extension provides Agile Therapeutics with a temporal cushion to strengthen its balance sheet, which could involve strategic financial maneuvers such as equity financing or operational restructuring.

Furthermore, the projected increase in net revenue by 84% to 93% for the full year 2023 is a significant growth trajectory, indicative of successful product adoption and market penetration. However, the anticipated operating expenses, even though reduced by 44% to 47%, still exceed the forecasted revenue, which suggests that the company is not yet at a break-even point and may continue to burn through cash reserves or require additional financing to sustain operations.

Management's decision to forgo performance bonuses and reverse a $2.1 million accrual could be viewed as a cost-control measure, reflecting a commitment to fiscal responsibility and possibly a strategic move to improve the company's financial position in the short term. However, stakeholders should closely monitor the impact of such decisions on employee morale and retention, as well as the long-term sustainability of cost-cutting measures.

Market Research Analyst

In the context of the women's healthcare market, Agile Therapeutics' projected revenue growth signifies a robust demand for its products. The company's performance must be contextualized within the broader industry trends, where innovation and competitive pricing can drive market share. The substantial reduction in operating expenses could be indicative of improved operational efficiency or a strategic realignment of resources towards high-growth areas.

It is essential to assess the competitive landscape and how Agile Therapeutics' product offerings and pricing strategies compare with its peers. The company's ability to sustain and potentially increase its market share in the upcoming fiscal periods will be a key determinant of its long-term success and its stock's performance. Additionally, the market will likely respond to the preliminary financial results, factoring in the potential for upward or downward revisions post-external audit, which could introduce volatility in the stock price.

Legal Expert

Agile Therapeutics' compliance with Nasdaq's stockholders’ equity requirements is not only a financial issue but also a legal and regulatory matter. The extension granted by the Nasdaq Hearings Panel allows the company to avoid immediate delisting, which could have legal ramifications and trigger breach of covenants in financing agreements. Investors should be aware of the regulatory environment in which the company operates, including the implications of failing to meet Nasdaq's continued listing standards in the future.

Moreover, the accuracy of preliminary financial results is subject to the rigors of external auditing. Any significant discrepancies revealed during the audit could lead to legal scrutiny and necessitate revisions to public disclosures. These factors could influence investor sentiment and the company's legal standing, affecting its market valuation and operational freedom.

Company Granted Extension by Nasdaq Hearings Panel to Regain Compliance with the Stockholders’ Equity Continued Listing Requirement Until March 25, 2024

Net Revenue for Full Year 2023 Expected to be in the Range of $20 to $21 Million, an Increase of 84% to 93% Compared to Full Year 2022  

GAAP Operating Expenses for Full Year 2023 Expected to be in the Range of $30 to $31.5 Million, a Decrease of 47% to 44% Compared to Full Year 2022

PRINCETON, N.J., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX), a women's healthcare company, today announced it has been granted an extension by Nasdaq to regain compliance with the stockholders’ equity requirement for continued listing and provided performance update for full year 2023.

Company Granted Extension by Nasdaq Hearings Panel to Regain Compliance with the Stockholders’ Equity Continued Listing Requirement

On February 13, 2024, the Company received a letter from the Hearings Panel (“Panel”) of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that it has been granted an additional period, or until March 25, 2024, to regain compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(b)(1) requiring companies listed on the Nasdaq Capital Market to maintain stockholder’s equity of at least $2,500,000. The Company had previously presented its plan to the Panel and is continuing to proceed with initiatives to regain compliance within the extension granted.

Expected Full Year 2023 Performance Update (Unaudited)

The Company also announced its preliminary expectations for net revenue and operating expenses for the full year 2023.

• Full year 2023 net revenue is expected to be in the range of $20 to $21 million compared to $10.9 million for the full year 2022, representing an increase of 84% to 93%.
• Full year 2023 GAAP operating expenses (“OPEX”) are expected to be in the range of $30 to $31.5 million compared to $56.6 million for the full year 2022, representing a decrease of 47% to 44%. Management has recommended to the Board of Directors, that the Company not pay performance bonuses for the 2023 fiscal year. As a result, the Company plans to reverse an accrual of approximately $2.1 million.

The preliminary results and estimates in this press release are based on management’s initial review of our operations for the fiscal year ended December 31, 2023, and are subject to revision based upon our quarter-end and year-end closing procedures and the completion of the external audit of our year-end financial statements.

About Agile Therapeutics, Inc.
Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. Our product and product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. Our initial product, Twirla®, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company website at www.agiletherapeutics.com. The Company may occasionally disseminate material, nonpublic information on the Company’s website and LinkedIn account.

Forward-Looking Statements
Certain information contained in this press release 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 our financial condition, our ability to repay our debt to Perceptive, our expected net revenue and expected operating expenses for fiscal year 2023, and our ability to regain compliance with Nasdaq continued listing requirements and continue trading on the Nasdaq Capital Market. 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 our ability to raise enough capital to fund our operations in the near term and long term, including our ability to obtain funding through public or private equity offerings, debt financings or other sources, on terms acceptable to us or at all, our ability to come into and maintain compliance with the Nasdaq Capital Market listing requirements, the potential de-listing of our shares on the Nasdaq Capital Market, our ability to continue to commercialize and grow Twirla the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, please refer to our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

Contact:
Matt Riley
Head of Investor Relations & Corporate Communications
mriley@agiletherapeutics.com

FAQ

What extension has Agile Therapeutics, Inc. (AGRX) been granted by Nasdaq?

Agile Therapeutics, Inc. (AGRX) has been granted an extension by Nasdaq to regain compliance with the stockholders' equity requirement until March 25, 2024.

What is the expected net revenue range for Agile Therapeutics, Inc. (AGRX) for full year 2023?

The expected net revenue range for Agile Therapeutics, Inc. (AGRX) for full year 2023 is $20 to $21 million, representing an increase of 84% to 93% compared to full year 2022.

What is the anticipated decrease in GAAP operating expenses for Agile Therapeutics, Inc. (AGRX) for full year 2023?

The anticipated decrease in GAAP operating expenses for Agile Therapeutics, Inc. (AGRX) for full year 2023 is in the range of $30 to $31.5 million, a decrease of 47% to 44% compared to full year 2022.