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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 |
“The theme of Agile’s 2021 second quarter is growth. We believe we have the building blocks in place for continued growth and we remain on track to achieve our near-term goal of establishing Twirla in the $4.1B U.S. hormonal contraceptive market,” said Chairman and Chief Executive Officer Al Altomari. “We have an approved product that is growing in all major prescription performance areas and we believe we are only scratching the surface as we unleash more direct-to-consumer advertising and further develop the channels that provide women access to Twirla.”
Recent Corporate Developments and Second Quarter 2021 Results:
Twirla Performance and Updates
Marketing Campaign Updates
Second Quarter 2021 Financial Results
Financial Update
Conference Call and Webcast
Date | Monday, July 26, 2021 |
Time | 4:30 p.m. EDT |
Webcast (live and archived) | Events & Presentations |
Dial-in numbers | (833) 979-2857 (U.S. toll-free) or (236) 714-2948 |
Conference ID | 1732729 |
Investors interested in listening to the conference call may do so by dialing (833) 979-2857 for domestic callers or (236) 714-2948 for international callers. 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 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 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 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.
Forward-Looking StatementCertain 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 results of operations, revenues, financial condition, liquidity, prospects, growth and strategies, the expected benefits of our marketing and sales distribution strategies, including the use of samples to grow prescriptions, current and future Medicare coverage for Twirla, the development of our other potential product candidates, the length of time that we will be able to continue to fund our operating expenses and capital expenditures and our expected financing needs and sources of financing, including our debt financing from Perceptive Advisors. 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, the ability of Corium to produce commercial supply in quantities and quality sufficient to satisfy market demand for Twirla, our ability to successfully commercialize Twirla, the accuracy of our estimates of the potential market and the market demand for Twirla, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and focus, the effects of the COVID-19 pandemic on our operations and the operations of third parties we rely upon as well as on our potential customer base, our ability to meet or exceed the revenue thresholds necessary to permit us to access the remaining amounts available under our existing debt financing from Perceptive Advisors 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 Communications mriley@agiletherapeutics.com
Agile Therapeutics, Inc.Balance Sheets(Unaudited)(in thousands, except par value and share data)
June 30, | December 31, | ||||||
2021 | 2020 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 26,118 | $ | 14,463 | |||
Marketable securities | 4,999 | 40,008 | |||||
Accounts receivable, net | 1,167 | 865 | |||||
Inventory | 3,462 | — | |||||
Prepaid expenses and other current assets | 1,202 | 1,449 | |||||
Total current assets | 36,948 | 56,785 | |||||
Property and equipment, net | 13,363 | 14,243 | |||||
Right of use asset | 72 | 138 | |||||
Other non-current assets | 1,896 | 1,896 | |||||
Total assets | $ | 52,279 | $ | 73,062 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,410 | $ | 3,867 | |||
Accrued expenses | 5,153 | 3,348 | |||||
Lease liability, current portion | 72 | 138 | |||||
Total current liabilities | 11,635 | 7,353 | |||||
Long-term debt | 16,035 | 16,381 | |||||
Total liabilities | 27,670 | 23,734 | |||||
Commitments and contingencies (Note 12) | |||||||
Stockholders’ equity | |||||||
Common stock, $.0001 par value, 150,000,000 shares authorized, 92,928,205 and 87,563,753 issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 9 | 9 | |||||
Additional paid-in capital | 371,588 | 361,539 | |||||
Accumulated other comprehensive income | — | 3 | |||||
Accumulated deficit | (346,988 | ) | (312,223 | ) | |||
Total stockholders’ equity | 24,609 | 49,328 | |||||
Total liabilities and stockholders’ equity | $ | 52,279 | $ | 73,062 |
Agile Therapeutics, Inc.Statements of Operations(Unaudited)(in thousands, except per share and share data)
Three Months Ended | Six Months Ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues, net | $ | 1,185 | $ | — | $ | 1,301 | $ | — | |||||||
Cost of product revenues | 1,145 | — | 2,306 | — | |||||||||||
Gross profit (loss) | 40 | — | (1,005 | ) | — | ||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 862 | $ | 3,661 | $ | 2,975 | $ | 6,825 | |||||||
Selling and marketing | 11,714 | 3,150 | 20,877 | 4,892 | |||||||||||
General and administrative | 4,115 | 3,228 | 8,016 | 5,939 | |||||||||||
Total operating expenses | 16,691 | 10,039 | 31,868 | 17,656 | |||||||||||
Loss from operations | (16,651 | ) | (10,039 | ) | (32,873 | ) | (17,656 | ) | |||||||
Other income (expense) | |||||||||||||||
Interest income | 7 | 115 | 23 | 247 | |||||||||||
Interest expense | (993 | ) | (902 | ) | (1,915 | ) | (1,300 | ) | |||||||
Total other income (expense), net | (986 | ) | (787 | ) | (1,892 | ) | (1,053 | ) | |||||||
Loss before benefit from income taxes | (17,637 | ) | (10,826 | ) | (34,765 | ) | (18,709 | ) | |||||||
Benefit from income taxes | — | — | — | — | |||||||||||
Net loss | $ | (17,637 | ) | $ | (10,826 | ) | $ | (34,765 | ) | $ | (18,709 | ) | |||
Net loss per share (basic and diluted) | $ | (0.20 | ) | $ | (0.12 | ) | $ | (0.39 | ) | $ | (0.23 | ) | |||
Weighted-average common shares (basic and diluted) | 88,693,968 | 87,221,441 | 88,162,929 | 81,936,815 | |||||||||||
1 Year Agile Therapeutics Chart |
1 Month Agile Therapeutics Chart |
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