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Agile Therapeutics Announces the Availability of Twirla® through FPA Women’s Health

By: Agile Therapeutics, Inc. via GlobeNewswire

June 15, 2023 at 16:05 PM EDT

FPA Women’s Health is the largest independent family planning service network in the United States, and the Twirla (levonorgestrel and ethinyl estradiol) transdermal system is now the exclusive patch dispensed within FPA clinics in California

Impact of availability through FPA Women’s Health is expected to augment future non-retail channel growth and contribute to achieving 2023 net revenue of $25-$30 million

PRINCETON, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that Twirla will become available through FPA Women’s Health. The Company expects this increased availability to positively impact growth of demand and factory sales in the non-retail channel, which grew 20% and 15% respectively from the fourth quarter 2022 to first quarter 2023.

As California’s leading provider of in-clinic and telehealth women’s healthcare, FPA Women’s Health has 24 locations throughout Los Angeles County and other regions across California.

“We are thrilled to be the exclusive patch dispensed within FPA’s California clinics, and we expect to tap into a significant proportion of Twirla’s target population through the FPA network,” says Chief Commercial Officer Amy Welsh, “a connection that was made with the help of our partners at Afaxys.”

Agile continues to prioritize strategic partnerships that have the potential to efficiently and effectively grow Twirla while simultaneously allowing the Company to responsibly manage its operating expenses.

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) 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, Twitter account (@agilether), 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.

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 expected Twirla demand and growth metrics, 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, the availability of Twirla through FPA Women’s Health, and the associated increase in demand for Twirla. 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 projected Twirla demand and growth, net revenue, and operating expenses for 2023 may be incorrect, our ability to maintain regulatory approval of Twirla and the labeling under any such approval, 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 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 circumstance.

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