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Agile Therapeutics Reports Third Quarter 2018 Financial Results
Cash Expected to
Third quarter 2018 and other recent corporate developments:
Twirla® Update – As previously announced, Agile initiated formal dispute resolution with the U.S. Food and Drug Administration’s (
Specifically, OND suggested that the Company conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane®, the generic version of the previously marketed
“We are pleased that the
Third Quarter Financial Results
- Cash and cash equivalents: As of
September 30, 2018, Agile had $16.9 millionof cash and cash equivalents compared to $35.9 millionof cash and cash equivalents as of December 31, 2017. The Company believes its cash and cash equivalents as of September 30, 2018, will be sufficient to meet its projected operating requirements into the second quarter of 2019, which include an estimate of the costs to complete a comparative wear study. The Company anticipates providing a further business update after it agrees with the FDAon the parameters of the wear study for Twirla. The Company will require additional capital to fund operating needs for the remainder of the second quarter of 2019 and beyond, including among other items, preparation for an anticipated Advisory Committee meeting, the completion of its commercial plan for Twirla, which primarily includes validation of the commercial manufacturing process and the commercial launch of Twirla, if approved, and advancing the development of its other potential product candidates.
- Research and development (R&D) expenses: R&D expenses were
$1.6 millionfor the quarter ended September 30, 2018, compared to $3.2 millionfor the comparable period in 2017. The decrease in R&D expenses was primarily due to a decrease in manufacturing and commercialization expenses reflecting reduced activity associated with the scale-up process and the on-going qualification process of the commercial manufacturing equipment primarily as a result of the receipt of the 2017 CRL.
- General and administrative (G&A) expenses: G&A expenses were
$1.8 millionfor the quarter ended September 30, 2018, compared to $3.5 millionfor the comparable period in 2017. The decrease in G&A expenses was primarily due to the suspension of pre-commercialization activities as a result of the receipt of the CRL in December 2017.
- Net loss: Net loss was
$3.8 million, or $0.11per share, for the quarter ended September 30, 2018, compared to a net loss of $7.1 million, or $0.22per share, for the quarter ended September 30, 2017.
- Shares Outstanding: At
September 30, 2018, Agile had 34,377,329 shares of common stock outstanding.
About Twirla® (AG200-15)
Twirla (ethinyl estradiol and levonorgestrel transdermal system) or AG200-15 is an investigational low-dose, once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), a type of estrogen and levonorgestrel (LNG), a type of progestin. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. The Company has completed its Phase 3 clinical trials of Twirla and is pursuing regulatory approval in the U.S. Agile received a complete response letter (CRL) from the
Xulane® is a registered trademark of
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, related to our regulatory submissions and projected cash position. 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 fact that our existing cash and cash equivalents likely will not be sufficient to fund our current and planned operations beyond the second quarter of 2019, which raises substantial doubt about our ability to continue as a going concern, and which, in turn, may create negative reactions to the price of our common stock making it more difficult to obtain financing in the future, our intention to meet with the
Contact: Investor Relations -- 609-683-1880
|Agile Therapeutics, Inc.
Condensed Balance Sheets
|Cash and cash equivalents||$||16,926||$||35,952|
|Total current assets||17,657||36,714|
|Property and equipment, net||13,921||13,863|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||2,510||$||3,636|
|Loan payable, current portion||5,905||10,607|
|Additional paid‑in capital||260,919||258,092|
|Total stockholders’ equity||23,181||36,323|
|Total liabilities and stockholders’ equity||$||31,596||$||50,595|
|Agile Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share amounts)
|Three Months Ended
|Nine Months Ended
|Research and development||$||1,549||$||3,175||$||7,921||$||11,694|
|General and administrative||1,767||3,526||7,173||9,130|
|Total operating expenses||3,615||6,701||15,809||20,824|
|Loss from operations||(3,615||)||(6,701||)||(15,809||)||(20,824||)|
|Other income (expense)|
|Change in fair value of warrants||—||(20||)||29||82|
|Loss before benefit from income taxes||(3,792||)||(7,102||)||(16,446||)||(22,064||)|
|Benefit from income taxes||—||—||477||—|
Net loss per share - basic and diluted
|Weighted‑average shares outstanding –basic and diluted||34,377,329||31,937,628||34,295,240||29,847,972|
Source: Agile Therapeutics, Inc.