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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Agile Therapeutics Inc | NASDAQ:AGRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.6022 | 0.27 | 0.2994 | 0 | 01:00:00 |
“Our goals as a company are to grow our Twirla brand and become cash flow positive. We believe we took important steps towards achieving these goals in the second quarter by once again increasing Twirla demand and revenue while significantly decreasing our operating expenses,” said Agile Therapeutics Chairman and Chief Executive Officer Al Altomari. “We plan to drive further growth in the second half of 2022 by executing on previously disclosed components of our business plan like the Afaxys partnership and connected TV campaign, while also exploring and implementing new initiatives like the product supply agreement we are announcing with Nurx, Thirty Madison’s Reproductive Health Brand.”
Second Quarter and Recent Corporate Updates
Second Quarter 2022 Financial Results
Conference Call and Webcast
Date | Thursday, August 11, 2022 |
Time | 4:30 p.m. ET |
Webcast (live and archived) | Events & Presentations |
Dial-in numbers | (888) 330-2454 (U.S. toll-free) or (240) 789-2714 |
Conference ID | 7871426 |
Investors interested in listening to the conference call may do so by dialing (888) 330-2454 for domestic callers or (240) 789-2714 for international callers. The Conference ID is 7871426. A live webcast will be available in the Events and Presentations section of the Investor Relations page at https://ir.agiletherapeutics.com/events-and-presentations, or by clicking here.
Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events and Presentations section of the company's website.
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, 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.
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 June 30, 2022, 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.
Forward-Looking StatementsCertain 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, 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 our existing debt financing from Perceptive Advisors, our prospects for future financing arrangements, and our operating expenses, 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, 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.
Contact:Matt RileyHead of Investor Relations & Corporate Communicationsmriley@agiletherapeutics.com
Agile Therapeutics, Inc.Balance Sheets(Unaudited)(in thousands, except par value and share data) | |||||||
June 30, | December 31, | ||||||
2022 | 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 13,027 | $ | 19,143 | |||
Accounts receivable, net | 2,087 | 1,533 | |||||
Inventory, net | 2,340 | 966 | |||||
Prepaid expenses and other current assets | 1,016 | 2,283 | |||||
Total current assets | 18,470 | 23,925 | |||||
Property and equipment, net | 11,524 | 12,447 | |||||
Right of use asset | 825 | 949 | |||||
Other non-current assets | 2,012 | 2,012 | |||||
Total assets | $ | 32,831 | $ | 39,333 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Long-term debt, current portion | $ | 12,630 | $ | 16,833 | |||
Accounts payable | 12,036 | 8,707 | |||||
Accrued expenses | 3,877 | 3,563 | |||||
Lease liability, current portion | 239 | 175 | |||||
Total current liabilities | 28,782 | 29,278 | |||||
Lease liabilities, long-term | 630 | 784 | |||||
Long-term debt | — | — | |||||
Total liabilities | 29,412 | 30,062 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity | |||||||
Preferred stock, $.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at June 30, 2022 and no shares issued and outstanding at December 31, 2021 | — | — | |||||
Common stock, $.0001 par value, 300,000,000 shares authorized, 12,360,157 and 3,034,901 issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 1 | — | |||||
Additional paid-in capital | 414,523 | 396,388 | |||||
Accumulated deficit | (411,105 | ) | (387,117 | ) | |||
Total stockholders’ equity | 3,419 | 9,271 | |||||
Total liabilities and stockholders’ equity | $ | 32,831 | $ | 39,333 | |||
Agile Therapeutics, Inc.Statements of Operations(Unaudited)(in thousands, except per share and share data) | |||||||
Three Months EndedJune 30, | |||||||
2022 | 2021 | ||||||
Revenues, net | $ | 2,126 | $ | 1,185 | |||
Cost of product revenues | 2,231 | 1,145 | |||||
Gross profit (loss) | (105 | ) | 40 | ||||
Operating expenses: | |||||||
Research and development | $ | 856 | $ | 862 | |||
Selling and marketing | 7,411 | 11,977 | |||||
General and administrative | 3,026 | 3,852 | |||||
Total operating expenses | 11,293 | 16,691 | |||||
Loss from operations | (11,398 | ) | (16,651 | ) | |||
Other income (expense) | |||||||
Interest income | 2 | 7 | |||||
Interest expense | (823 | ) | (993 | ) | |||
Total other income (expense), net | (821 | ) | (986 | ) | |||
Loss before benefit from income taxes | (12,219 | ) | (17,637 | ) | |||
Benefit from income taxes | — | — | |||||
Net loss | $ | (12,219 | ) | $ | (17,637 | ) | |
Net loss per share (basic and diluted) | $ | (2.71 | ) | $ | (8.00 | ) | |
Weighted-average common shares (basic and diluted) | 4,510,219 | 2,217,349 | |||||
Comprehensive loss: | |||||||
Net loss | $ | (12,219 | ) | $ | (17,637 | ) | |
Other comprehensive income: | |||||||
Unrealized loss on marketable securities | — | — | |||||
Comprehensive loss | $ | (12,219 | ) | $ | (17,637 | ) | |
1 Year Agile Therapeutics Chart |
1 Month Agile Therapeutics Chart |
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