Agile Therapeutics Announces Definitive Merger Agreement With Insud Pharma

Agile Therapeutics, Inc. recently announced it has entered into a definitive merger agreement with Insud Pharma, S.L. pursuant to which Insud, through its US subsidiary, Exeltis Project, Inc. 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 with the holders of not less than 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. (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.

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.

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, visit www.agiletherapeutics.com.

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.

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.