Ethinylestradiol/Levonorgestrel

Agile Therapeutics will combine with Insud Pharma’s US Subsidiary, Exeltis, expanding an already significant Women’s Health/contraceptive portfolio Agile Therapeutics Common Shareholders expected to receive $1.52 per share of common stock – approximately a 356% premium to the closing share price on June 25, 2024 Definitive Merger Agreement is subject to Agile Shareholder Approval. Agile Board is recommending shareholder approval of the Definitive Merger Agreement PRINCETON, N.J., June 26, 2024 (GLOBE NEWSWIRE) --Agile Therapeutics, Inc. (“Agile”) (OTCQB: AGRX), a women's healthcare company, today announced that it has entered into a definitive merger agreement (“Merger Agreement”) with Insud Pharma, S.L. (“Insud”) a global pharmaceutical group based in Spain with a 45 year track record and a presence in over 50 countries, pursuant to which Insud, through its US subsidiary, Exeltis Project, Inc. (“Exeltis”), will acquire Agile for $1.52 per share in cash net of assumed liabilities and estimated transaction costs for an approximate total enterprise value of $45 million. “We started Agile with the goal of improving women’s health through innovative, clinically differentiated products for women,” said Agile Chairperson and Chief Executive Officer Al Altomari. “We are proud of what we have been able to accomplish with our small, dedicated team: gaining approval of Twirla, the only low dose combined hormonal contraceptive patch, and developing a targeted commercial platform that allowed us to accelerate the growth of Twirla while reducing and managing our operating expenses. Now, we are excited about the future of Twirla in the hands of Exeltis, Insud’s US subsidiary, which we believe has the organization and resources to build on the growth momentum we have created. We believe this is the right path for Agile, provides a substantial premium to our current stock price, and a good development for women’s health.” On June 25, 2024, Agile also entered into a cash-out acknowledgment and cancellation agreement (the “Warrant Cash-Out Agreement”) with the holders of not less than ninety-five percent (95%) of the Company’s outstanding common stock warrants, also conditioned on closing of the merger. As a condition to entering into the Merger Agreement, Agile has also entered into a third amendment of its Manufacturing and Commercialization Agreement with Corium Innovations, Inc. (“Corium”) (“Amendment No. 3”) on commercial terms reasonably acceptable to Insud and conditioned on the closing of the merger. As part of the merger consideration for Agile, Insud has agreed to make available a line of credit of up to $8,000,000, (the “Bridge Loan”) secured by the Company’s intellectual property. The initial amount to be advanced under the Bridge Loan will be used primarily to pay for the purchase of inventory. The Board of Directors of Agile has unanimously approved the transaction. The transaction is expected to close in the third quarter of 2024, subject to completion of Agile’s obligations to Corium under Amendment No. 3 and other customary closing conditions, including approval by Agile’s stockholders. Upon completion of the transaction, Agile will no longer be listed on any public market. Advisors H.C. Wainwright & Co. acted as exclusive financial advisor to Agile Therapeutics, Inc., in this transaction and Morgan, Lewis & Bockius LLP acted as its legal advisor. Loeb & Loeb LLP and RC Law LLP acted as legal advisors to Insud Pharma, S.L. and Exeltis USA, Inc. AboutAgileTherapeutics,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 . The Company may occasionally disseminate material, nonpublic information on the Company’s website and LinkedIn account. AboutTwirla® Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated for use as a method of contraception by women of reproductive potential with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Healthcare providers (HCPs) are encouraged to consider Twirla’s reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is also contraindicated in women over 35 years old who smoke. Cigarette smoking increases the risk of serious cardiovascular events from CHC use. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. About Insud Pharma Insud Pharma is a pharmaceutical group with more than 45 years of history, presence in around 50 countries, 9,000 employees worldwide and 20 manufacturing plants. Insud Pharma operates throughout the value chain of the pharmaceutical industry, offering specialized knowledge in scientific research, development, manufacturing, sale and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and pharmaceutical products of brand for the care of humans and animals and biopharmaceuticals. Insud Pharma seeks to improve health throughout the world by providing accessible, effective, safe and quality pharmacological treatments through its different business units, with continuous investment in R&D and the latest technology. No Offer or Solicitation This communication does not constitute an offer to sell or the solicitation of an offer to buy the securities of the Company or the solicitation of any vote or approval, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made in the United States absent registration under the Securities Act of 1933, as amended, or pursuant to an exemption from, or in a transaction not subject to, such registration requirements. Additional Information and Where to Find it In connection with the proposed transaction between Agile and Insud, Agile will the Securities and Exchange Commission (SEC) a proxy statement on Schedule 14A relating to a special meeting of its stockholders. Additionally, Agile may relevant materials with the SEC in connection with the proposed transaction. Investors and securityholders of Agile are urged to read the proxy statement and any other relevant materials filed or that will be filed with the SEC, as well as any amendments or supplements to these materials and documents incorporated by reference therein, carefully and in their entirety when they become available because they contain or will contain important information about the proposed transaction and related matters. The definitive version of the proxy statement will be mailed or otherwise made available to Agile’s securityholders. Investors and securityholders will be able to obtain a copy of the proxy statement (when it is available) as well as other filings containing information about the proposed transaction that are filed by Agile with the SEC, free of charge on EDGAR at on the investor relations page of Agile’s website at by contacting Agile’s investor relations department at . Participants in the Solicitation Insud, Agile and certain of their directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Agile in respect of the proposed transaction and any other matters to be voted on at the special meeting. Information about Insud’s directors and executive officers, including a description of their direct interests, by security holdings or otherwise, will be included in the proxy statement (when available). Information about Agile and its directors and executive officers can be found in Agile’s Amendment No. 1 to its Annual Report on Form 10-K for the year ended December 31, 2023, filed on April 29, 2024 and Agile’s other filings with the SEC available at the SEC’s Internet site ( ), including any statements of beneficial ownership on Form 3 or Form 4 filed with the SEC after such amendment to the Annual Report. Forward-Looking Statements This communication contains “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 concerning the Company’s plans, objectives, strategy and strategic objectives, future events, business conditions, results of operations, business outlook and other information may be forward looking statements. 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 (i) the risk that the proposed merger may not be completed in a timely manner or at all, which may adversely affect the Company’s business and the price of its common stock, (ii) the failure to satisfy the conditions to the consummation of the proposed merger, including the adoption of the Merger Agreement by the stockholders of the Company and the impact on the Cash-Out Warrant Agreement and Amendment No. 3, (iii) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement, (iv) the effect of the announcement or pendency of the proposed merger on the Company’s business relationships, operating results and business generally, (v) the risk that the proposed merger disrupts the Company’s current plans and operations and potential difficulties in the Company’s employee retention as a result of the proposed merger, (vi) the outcome of any legal proceedings that may be instituted against the Company related to the Merger Agreement or the proposed merger, and (vii) the risk that the proposed merger and its announcement could have an adverse effect on the ability of the Company to retain and hire key personnel and to maintain relationships with customers, vendors, employees, stockholders and other business partners and on its operating results and business generally. The foregoing list of risk factors is not exhaustive. 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 circumstances. The Company does not give any assurances that it will achieve its expectations. Contact: For Agile: Agile Therapeutics Investor Relations ir@agiletherapeutics.com For Insud: Communication Department Edificio Ebrosa - Manuel Pombo Angulo, 28 3rd floor 28050 Madrid, Spain. Tel: +34 91 771 15 00 E-mail: comunicacion@insudpharma.com

First Quarter Net Revenue Increased 58% and Factory Sales Increased 3% from Fourth Quarter 2023 Twirla First Quarter 2024 Demand Rebounded 18% from Fourth Quarter 2023 PRINCETON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Pink: AGRX), a women's healthcare company, today reported financial results for the three months ended March 31, 2024 and provided a corporate update. “We are excited about the start of 2024, which saw a rebound in demand, factory sales and net sales in the first quarter from our fourth quarter 2023 results. We plan to continue to focus on executing our business plan, which we believe can continue to grow Twirla and enable us to manage our operating expenses,” said Agile Therapeutics Chairperson and Chief Executive Officer Al Altomari. “We think there are still areas of growth in our five-state focus, expanding our reach in telemedicine and expanding our relationships with Planned Parenthoods. Our goal is to find new ways to advance our growth plan for Twirla and increase shareholder value and we plan to explore all strategic opportunities, both internally and externally, that can help us reach our goal.” First Quarter 2024 Performance Updates Net Revenue: Twirla delivered $5.7 million in net revenue for the first quarter of 2024. This was an increase of 50% from the $3.8 million reported for the first quarter of 2023. The first quarter 2024 increase in net revenue was primarily due to increased demand. First quarter 2024 net revenue reflects performance in the following key areas: Continued Twirla Demand Growth Twirla demand for the first quarter 2024 was 81,088 total cycles, a 18% increase from the fourth quarter 2023 and a 80% increase from the first quarter 2023. Retail demand was 43,748 total cycles in the first quarter of 2024, an increase of 8% from the fourth quarter 2023 and a 43% increase from the first quarter 2023. Non-retail demand for the first quarter 2024 was 37,340 total cycles, an increase of 32% from the fourth quarter 2023 and a 158% increase from the first quarter 2023. Twirla Factory Sales Twirla factory sales for the first quarter 2024 were 70,662 total cycles, a 3% increase from the fourth quarter 2023 and a 63% increase from the first quarter 2023. Company Operating Expenses First quarter 2024 operating expenses were $6.8 million, a 24% increase from the fourth quarter 2023, and a decrease of 20% from the $8.5 million reported for the first quarter 2023. Continued Twirla Demand Growth Twirla demand for the first quarter 2024 was 81,088 total cycles, a 18% increase from the fourth quarter 2023 and a 80% increase from the first quarter 2023. Retail demand was 43,748 total cycles in the first quarter of 2024, an increase of 8% from the fourth quarter 2023 and a 43% increase from the first quarter 2023. Non-retail demand for the first quarter 2024 was 37,340 total cycles, an increase of 32% from the fourth quarter 2023 and a 158% increase from the first quarter 2023. Twirla Factory Sales Twirla factory sales for the first quarter 2024 were 70,662 total cycles, a 3% increase from the fourth quarter 2023 and a 63% increase from the first quarter 2023. Company Operating Expenses First quarter 2024 operating expenses were $6.8 million, a 24% increase from the fourth quarter 2023, and a decrease of 20% from the $8.5 million reported for the first quarter 2023. Twirla demand for the first quarter 2024 was 81,088 total cycles, a 18% increase from the fourth quarter 2023 and a 80% increase from the first quarter 2023. Retail demand was 43,748 total cycles in the first quarter of 2024, an increase of 8% from the fourth quarter 2023 and a 43% increase from the first quarter 2023. Non-retail demand for the first quarter 2024 was 37,340 total cycles, an increase of 32% from the fourth quarter 2023 and a 158% increase from the first quarter 2023. Twirla factory sales for the first quarter 2024 were 70,662 total cycles, a 3% increase from the fourth quarter 2023 and a 63% increase from the first quarter 2023. First quarter 2024 operating expenses were $6.8 million, a 24% increase from the fourth quarter 2023, and a decrease of 20% from the $8.5 million reported for the first quarter 2023. Additional Corporate Updates Trading on the “Over the Counter” Market As of March 26, 2024, the Company’s common stock is now trading on the “over the counter” market operated by the OTC Markets Group under its existing “AGRX” trading symbol. The Company has applied for trading on the OTC-QB market. The Company does not expect the transition to OTC to impact its business operation and it remains focused on executing its business plan while continuing to explore strategic opportunities. Potential for Enhanced Access to Twirla The Company remains optimistic about the steps being taken by the Biden-Harris Administration to enhance access to no-cost contraception products like Twirla. In January 2024, the Administration announced new guidance to enable expanded access to all FDA-approved contraceptives without cost. Implementation of the new guidance could eliminate financial barriers for contraceptive products like Twirla for an estimated 49 million women. As of March 26, 2024, the Company’s common stock is now trading on the “over the counter” market operated by the OTC Markets Group under its existing “AGRX” trading symbol. The Company has applied for trading on the OTC-QB market. The Company does not expect the transition to OTC to impact its business operation and it remains focused on executing its business plan while continuing to explore strategic opportunities. The Company remains optimistic about the steps being taken by the Biden-Harris Administration to enhance access to no-cost contraception products like Twirla. In January 2024, the Administration announced new guidance to enable expanded access to all FDA-approved contraceptives without cost. Implementation of the new guidance could eliminate financial barriers for contraceptive products like Twirla for an estimated 49 million women. First Quarter 2024 Financial Results Net Revenue: In the first quarter 2024, the Company realized net product sales revenue of $5.7 million, a 58% increase from the fourth quarter 2023 and an increase of 50% as compared to the first quarter of 2023 net revenue of $3.8 million. Cost of Goods Sold (COGS): Cost of goods sold, which consists of direct and indirect costs related to the manufacturing of Twirla, were $1.7 million for the first quarter 2024 compared to the $2.2 million for the fourth quarter 2023 and compared to the $2.0 million for the first quarter 2023. Total operating expenses: Total GAAP operating expenses were $6.8 million for the quarter ended March 31, 2024, compared to the $5.5 million for the fourth quarter 2023 and compared to $8.5 million for the comparable period in 2023 – a decrease of 20%. GAAP Net income (loss): GAAP net income was $1.3 million, or $0.28 per share, for the quarter ended March 31, 2024, compared to a GAAP net loss of $4.5 million, or $1.51 per share, for the fourth quarter 2023 and compared to a GAAP net loss of $5.4 million, or $5.91 per share, for the comparable period in 2023. Non-GAAP Net Loss: Non-GAAP net loss was $2.9 million, or $0.63 per share, for the quarter ended March 31, 2024, compared to a non-GAAP net loss of $4.3 million, or $1.46 per share, for the fourth quarter 2023 and compared to a non-GAAP net loss of $7.1 million, or $7.76 per share, for the comparable period in 2023. These results reflect the exclusion of the $4.2 million in other income for the first quarter of 2024, $0.1 million in other loss for the fourth quarter 2023, and $1.7 million in other income for the first quarter of 2023, all resulting from the change in value of the Company’s warrant liability. A reconciliation of non-GAAP to GAAP net loss is provided in the tables accompanying this press release. Cash: As of March 31, 2024, the Company had $2.6 million of cash and cash equivalents, compared to $2.5 million of cash and cash equivalents as of December 31, 2023. The Company will continue to evaluate all available options to finance the Company and continue to explore all opportunities that can potentially accelerate the timeline to generating positive cash flow. Shares Outstanding: As of March 31, 2024, Agile had 6,856,229 shares outstanding and 4,631,902 weighted average shares of common stock outstanding for the three months ended March 31, 2024. Conference Call and WebcastAgile Therapeutics will not host a conference call and webcast relating to its First Quarter 2024 financial results and does not plan to do so moving forward. 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. About Twirla®Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated for use as a method of contraception by women of reproductive potential with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Healthcare providers (HCPs) are encouraged to consider Twirla’s reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is also contraindicated in women over 35 years old who smoke.Cigarette smoking increases the risk of serious cardiovascular events from CHC use. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. About Prescription DataThe Company receives prescription data for Twirla from Symphony Health Solutions, and the data are not created or owned by the Company. Prescription data are available through other subscription services as well, such as IQVIA. Unless otherwise noted, the prescription data results reported in this press release are reported as of December 31, 2023, by Symphony Health Solutions. The prescription data terms are defined as follows: Twirla cycles dispensed are the number of 3-patch packages dispensed. Each 3-patch package represents one 28-day cycle of therapy. Total Cycles Dispensed represents every cycle dispensed from both retail and non-retail channels. Retail channels include retail pharmacies, mail order, and long-term care while non-retail channels include clinics and hospitals and other entities where prescriptions are dispensed directly to the patient. Total prescriptions (TRx) are the total number of prescriptions dispensed through the retail channels. This represents both new and refill prescriptions. New prescriptions (NRx) are new prescriptions dispensed through retail channels. Refill prescriptions (RRx) are refill prescriptions filled through retail channels. Total prescribers are the cumulative number of prescribers whose prescriptions were filled through retail channels since launch. Not all prescription demand in the non-retail channel is reported into third parties like Symphony Health Solutions and IQVIA. The factory sales reported from Twirla wholesalers do include sales to the non-retail channel and, therefore, the Company believes factory sales more closely represent the total demand for Twirla across all channels. Use of Non-GAAP Financial MeasuresTo supplement our consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles (GAAP), we use non-GAAP net loss to measure our financial performance. We define the term non-GAAP net loss as GAAP net loss excluding recurring unrealized gains or losses pertaining to liability classified warrants. We believe that the presentation of these non-GAAP financial metrics provides useful information about our operating results, enhances the overall understanding of past financial performance and future prospects, allows for greater transparency with respect to metrics used by our management in its financial and operational decision-making and produces a useful measure for period-to-period comparisons of our business. The presentation of these non-GAAP financial measures are not intended to be a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP and may be different from non-GAAP financial measures used by other companies, and therefore, may not be comparable among companies. We believe the presentation of these non-GAAP financial measures provides meaningful supplemental information regarding our performance; however, we urge investors to review the reconciliation of this financial measures to the comparable GAAP financial measures included in the accompanying tables, and not to rely on any single financial measure to evaluate our business. 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 ongoing and planned manufacturing and commercialization of Twirla®, the potential market acceptance and uptake of Twirla, including the increasing demand for Twirla in 2024, our partnership with Afaxys and its ability to promote growth, our product supply agreement with Nurx and its ability to educate patients about Twirla, our connected TV (CTV) campaign and its ability to promote growth, 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 our ability to raise additional capital, ability to pay our obligations as they become due, 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, 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, and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. 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 circumstances. Contact:Agile Therapeutics Investor Relationsir@agiletherapeutics.com