Agile Therapeutics Provides Updates on 2022 Twirla Performance and 2023 Commercial Plan

Agile Therapeutics, Inc.

Agile Therapeutics, Inc.

Fourth Quarter 2022 Twirla Factory Income Expected to Enhance Close to 30{194d821e0dc8d10be69d2d4a52551aeafc2dee4011c6c9faa8f16ae7103581f6} from Third Quarter 2022

Entire Calendar year 2022 Factory Income Predicted to Enhance Around 232{194d821e0dc8d10be69d2d4a52551aeafc2dee4011c6c9faa8f16ae7103581f6} from Whole Calendar year 2021

Total Calendar year 2023 Web Revenue Expected to be in Assortment of $25-$30 Million

PRINCETON, N.J., Jan. 09, 2023 (Globe NEWSWIRE) — Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s health care company, now provided an update on Twirla for 2022 and its industrial program for 2023.

2022 Twirla Manufacturing facility Revenue

  • Twirla manufacturing facility gross sales for the fourth quarter 2022 are anticipated to be around 42,200 whole cycles, a 30{194d821e0dc8d10be69d2d4a52551aeafc2dee4011c6c9faa8f16ae7103581f6} increase from the 33,282 total cycles noted for the third quarter 2022. The around 42,600 whole cycles would represent an all-time superior for one-quarter manufacturing unit gross sales.

  • Twirla factory profits for the comprehensive calendar year 2022 are envisioned to be around 113,600 total cycles, a 232{194d821e0dc8d10be69d2d4a52551aeafc2dee4011c6c9faa8f16ae7103581f6} enhance from the 34,227 full cycles documented for the comprehensive year 2021.

“Our 1st business solution, Twirla, shown accelerated development in the 2nd half of 2022 and now we are fired up to enter 2023 with robust development momentum,” reported Agile Therapeutics’ Chairman and Chief Govt Officer Al Altomari. “We anticipate to see that trend continue during 2023, even as we prepare to keep our functioning bills at stages equivalent to the 2nd half of 2022.”

2023 Industrial Strategy

The Company’s commercial approach for 2023 is created to continue escalating desire for Twirla in both equally the retail and non-retail channels in critical states that have massive marketplaces for contraceptives and possibly robust reimbursement coverage for Twirla (“Key States”). To accomplish this expansion on the retail side, the Company intends to emphasis on rising its footprint in telemedicine by way of its collaboration with Nurx, which has a affected individual community of extra than 1 million patients, and targeted marketing and advertising in Important States to raise depth of prescribing. In the non-retail channel, the Firm programs to proceed to emphasis on growth as a result of the get to of the Afaxys consumer community, which features Planned Parenthood and university student wellness facilities. The Organization also thinks it will start off to see elevated advancement in the retail channel as doctors who obtain scientific expertise with Twirla in the Planned Parenthood setting and then prescribe Twirla in their other procedures. The Enterprise is also actively pursuing organization development chances targeted on including commercial products to the Company’s women’s wellness franchise.

  • 2023 Net Profits

    • Primarily based on its commercial strategy for 2023, the Firm expects improved earnings contributions from the Twirla organization in 2023 and entire 12 months net revenue to be in the selection of $25-$30 million. The Firm plans to retain operating bills at identical stages to the next fifty percent of 2022.

Mr. Altomari stated, “the complete firm continues to be concentrated on accomplishing our vital goals of growing Twirla, producing beneficial dollars move, and pursuing options to establish our organization. We consider we have designed a capable professional infrastructure, tested the capability to continuously develop our to start with industrial solution more than the earlier hard 12 months, managed our operating expenditures in a targeted way, and laid the basis for setting up a broader women’s wellbeing small business. We consider that these traits make us an interesting business lover. Based on our present organization program, we hope that adding an extra business product or service to our portfolio would lessen the time required to generate optimistic hard cash flow and speed up our advancement as a business. We are actively pursuing these styles of prospects.”

About Agile Therapeutics, Inc.
Agile Therapeutics is a women’s health care company committed to satisfying the unmet wellbeing needs of today’s women. Our merchandise and item candidates are made to deliver women of all ages with contraceptive possibilities that supply freedom from having a day-to-day pill, without committing to a for a longer time-performing method. Our original item, Twirla®, (levonorgestrel and ethinyl estradiol) transdermal method, is a non-day by day prescription contraceptive. Twirla is based mostly on our proprietary transdermal patch technological know-how, named Skinfusion®, which is developed to let drug delivery via the pores and skin. For far more facts, be sure to check out the business site at The Organization may once in a while disseminate product, nonpublic details on the Company’s web site, Twitter account (@agilether), and LinkedIn account.

About Twirla®
Twirla (levonorgestrel and ethinyl estradiol) transdermal method is a the moment-weekly combined hormonal contraceptive (CHC) patch that is made up of the lively components levonorgestrel (LNG), a sort of progestin, and ethinyl estradiol (EE), a form of estrogen. Twirla is indicated for use as a strategy of contraception by females of reproductive opportunity with a physique 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 Data

The 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. 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.

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 our projections regarding our net revenue and operating expenses for 2023, 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 the fourth quarter of 2022 and 2023, 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 future plans with respect to additional commercial products, our ability to become cash flow positive, 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 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, that factory sales for the fourth quarter of 2022 are not final and may be subject to change, 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, the effects of the ongoing COVID-19 pandemic on our commercialization efforts, 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, our ability to maintain compliance with the listing requirements of the Nasdaq Capital Market 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.

Matt Riley

Head of Investor Relations & Corporate Communications

[email protected]