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Organization and Description of Business
9 Months Ended
Sep. 30, 2017
Organization and Description of Business  
Organization and Description of Business

1. Organization and Description of Business

 

Nature of Operations

 

Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women.  The Company’s activities since inception have consisted principally of raising capital and performing research and development. The Company is headquartered in Princeton, New Jersey.

 

The Company’s lead product candidate, Twirla®, also known as AG200-15, is a once-weekly prescription contraceptive patch that is at the end of Phase 3 clinical development.  Substantially all of the Company’s resources are currently dedicated to developing and seeking regulatory approval for Twirla. The Company has not generated product revenue to date and is subject to a number of risks similar to those of other early stage companies, including dependence on key individuals, the difficulties inherent in the development of commercially usable products, the potential need to obtain additional capital necessary to fund the development of its products, and competition from larger companies. The Company has incurred losses each year since inception. As of September 30, 2017, the Company had an accumulated deficit of approximately $215.5 million.

 

The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 7), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. The Company expects to continue to incur net losses into the foreseeable future.

 

As of September 30, 2017, the Company had cash and cash equivalents of $43.8 million.  The Company believes that its existing cash and cash equivalents will not be sufficient to fund its current and planned operations through the next 12 months, which raises substantial doubt about the Company’s ability to continue as a going concern.  The Company has based this belief on assumptions and estimates that may prove to be wrong, and the Company could spend its available cash and cash equivalents less or more rapidly than expected.  The Company will continue to require additional funding to support its continued development and commercialization efforts for Twirla as well as advancing the development of its other product candidates.  Management intends to seek additional capital through equity and/or debt financings or through other sources of financing in the future.  Adequate additional funding may not be available to the Company on acceptable terms, or at all.  If the Company is unable to raise additional capital when required or on acceptable terms, the Company may be required to delay or scale back the planned development and planned commercialization of Twirla and its business, operating results and financial condition would be adversely affected.

 

The unaudited condensed financial statements as of September 30, 2017 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months.  The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional equity and/or debt financing and reduce expenditures.  The unaudited condensed financial statements as of September 30, 2017 do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis of Presentation

 

The accompanying unaudited interim condensed financial statements have been prepared by the Company, without audit, in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s annual report on Form 10-K for the year ended December 31, 2016 filed with the SEC.

 

In the opinion of management, the unaudited interim condensed financial statements reflects all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods have been made.  Certain prior period amounts have been reclassified to conform to the current period presentation. The results of operations for the three and nine months ended September 30, 2017 are not necessarily indicative of the operating results for the full fiscal year or any future period.