Pharma Focus Asia

Agile Therapeutics, Inc. and Insud Pharma, S.L. Sign Definitive Merger Agreement

Thursday, June 27, 2024

Agile Therapeutics, Inc. (“Agile”) (OTCQB: AGRX), a women’s healthcare company, announced a definitive merger agreement with Insud Pharma, S.L. (“Insud”), a global pharmaceutical group based in Spain. Through its US subsidiary Exeltis Project, Inc. (“Exeltis”), Insud 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.

Al Altomari, Agile's Chairperson and CEO, highlighted the company’s achievements, including the approval of Twirla, the only low-dose combined hormonal contraceptive patch, and the development of a commercial platform that spurred Twirla’s growth while managing expenses. He expressed confidence in Exeltis’ ability to continue building on this progress, viewing the merger as advantageous for both Agile and women's health.

On June 25, 2024, Agile also entered into a cash-out acknowledgment and cancellation agreement with holders of at least 95% of the company’s outstanding common stock warrants, contingent on the merger's completion. Furthermore, Agile amended its Manufacturing and Commercialization Agreement with Corium Innovations, Inc. (“Corium”) to align with the merger terms.

As part of the merger, Insud will provide a line of credit up to $8 million, secured by Agile’s intellectual property. The initial amount will primarily be used to purchase inventory. Agile's Board of Directors unanimously approved the transaction, which is expected to close in the third quarter of 2024, subject to stockholder approval and other conditions. Upon completion, Agile will no longer be publicly listed.

H.C. Wainwright & Co. acted as Agile’s exclusive financial advisor, and Morgan, Lewis & Bockius LLP served as its legal advisor. Loeb & Loeb LLP and RC Law LLP provided legal counsel to Insud Pharma, S.L. and Exeltis USA, Inc.

Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch for women with a body mass index (BMI) below 30 kg/m². Healthcare providers should note the reduced efficacy in women with a BMI of 25 to 30 kg/m². Twirla is contraindicated for women with a BMI of 30 kg/m² or higher, and for women over 35 who smoke due to increased cardiovascular risks. The patch is applied weekly for three weeks, followed by a patch-free week.



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