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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 |
“With our commercial launch of Twirla expected by the end of the year, we remain on track to deliver on our plan. The final validation of our commercial manufacturing process continues to progress as all three of our batches are expected to be released for commercial use in December 2020. By taking steps to build out an experienced sales force, secure major wholesaler agreements and increase market access for Twirla, we believe we are well-prepared to hit the ground running. Having our first FDA-approved product nearing launch marks an exciting time for Agile and we look forward to bringing to the market another choice for women to help fulfill their contraceptive needs,” said Al Altomari, Chairman and Chief Executive Officer of Agile.
Third Quarter 2020 and Other Recent Corporate Developments:
Twirla Commercialization Update
Strengthened Executive Leadership Team
Launched I’m So Done – A National Unbranded Campaign
Financial Guidance
Third Quarter Financial Results
Conference Call and WebcastAgile Therapeutics will host a conference call and webcast to discuss financial results for the third quarter ended September 30, 2020 today at 4:30pm ET. Investors interested in listening to the conference call may do so by dialing (877) 407-2991 for domestic callers or (201) 389-0925 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 to prevent pregnancy. 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 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 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 the status and timing of the validation of our commercial manufacturing process, market availability of Twirla, our projected cash position, our projected fiscal year 2020 operating expenses and gross and net revenue and the expected timing and structure of our commercialization plan 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 our ability to maintain regulatory approval of Twirla, our ability along with our third-party manufacturer, Corium, to complete successfully the scale-up of the commercial manufacturing process for Twirla, the performance and financial condition of Corium or any of its suppliers, 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 successful development of our sales and marketing capabilities, the accuracy of our estimates of the potential market 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, 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)
September 30, | December 31, | ||||||
2020 | 2019 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 24,163 | $ | 34,479 | |||
Marketable securities | 47,742 | — | |||||
Prepaid expenses | 1,414 | 840 | |||||
Total current assets | 73,319 | 35,319 | |||||
Property and equipment, net | 14,271 | 14,044 | |||||
Right of use asset | 31 | 158 | |||||
Other non-current assets | 1,791 | 19 | |||||
Total assets | $ | 89,412 | $ | 49,540 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 5,016 | $ | 1,819 | |||
Accrued expenses | 2,154 | 1,804 | |||||
Lease liability, current portion | 34 | 172 | |||||
Total current liabilities | 7,204 | 3,795 | |||||
Long-term debt | 16,078 | — | |||||
Total liabilities | 23,282 | 3,795 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity | |||||||
Common stock, $.0001 par value, 150,000,000 shares authorized, 87,434,604 and 69,810,305 issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 9 | 7 | |||||
Additional paid-in capital | 360,713 | 306,108 | |||||
Accumulated other comprehensive income | 11 | — | |||||
Accumulated deficit | (294,603 | ) | (260,370 | ) | |||
Total stockholders’ equity | 66,130 | 45,745 | |||||
Total liabilities and stockholders’ equity | $ | 89,412 | $ | 49,540 |
Agile Therapeutics, Inc.Statements of Operations(Unaudited)(in thousands, except per share and share data)
Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 3,663 | $ | 2,361 | $ | 10,488 | $ | 7,021 | |||||||
General and administrative | 10,993 | 2,138 | 21,824 | 5,732 | |||||||||||
Total operating expenses | 14,656 | 4,499 | 32,312 | 12,753 | |||||||||||
Loss from operations | (14,656 | ) | (4,499 | ) | (32,312 | ) | (12,753 | ) | |||||||
Other income (expense) | |||||||||||||||
Interest income | 37 | 67 | 284 | 168 | |||||||||||
Interest expense | (905 | ) | — | (2,205 | ) | — | |||||||||
Total other income (expense), net | (868 | ) | 67 | (1,921 | ) | 168 | |||||||||
Loss before benefit from income taxes | (15,524 | ) | (4,432 | ) | (34,233 | ) | (12,585 | ) | |||||||
Benefit from income taxes | — | — | — | — | |||||||||||
Net loss | $ | (15,524 | ) | $ | (4,432 | ) | $ | (34,233 | ) | $ | (12,585 | ) | |||
Net loss per share (basic and diluted) | $ | (0.18 | ) | $ | (0.08 | ) | $ | (0.41 | ) | $ | (0.28 | ) | |||
Weighted-average common shares (basic and diluted) | 87,350,505 | 53,609,511 | 83,754,550 | 44,957,809 | |||||||||||
Comprehensive loss: | |||||||||||||||
Net loss | $ | (15,524 | ) | $ | (4,432 | ) | $ | (34,233 | ) | $ | (12,585 | ) | |||
Other comprehensive income: | |||||||||||||||
Unrealized gain on marketable securities | 1 | — | 11 | — | |||||||||||
Comprehensive loss | $ | (15,523 | ) | $ | (4,432 | ) | $ | (34,222 | ) | $ | (12,585 | ) |
1 Year Agile Therapeutics Chart |
1 Month Agile Therapeutics Chart |
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