Agile closes 2019 with $34.5 million in cash as it preps for Twirla commercialization

Agile Therapeutics Inc (NASDAQ) said Thursday it closed 2019 with $34.5 million in cash and cash equivalents. The announcement comes just days after the US Food and Drug Administration approved Agile’s lead product Twirla, a low-dose prescription contraceptive delivered through the skin through the company’s proprietary patch technology. In a statement, Agile said the cash, as of December 31 when it ended its fourth quarter, will be sufficient to meet the company’s projected operating requirements. The company closed 2018 with only $7.9 million in cash and cash equivalents.  READ: FDA approves Agile Therapeutics Inc’s Twirla contraceptive patch However, the company said it “will require additional capital to fund operating needs beyond 2020, which it expects primarily will consist of commercializing Twirla, and exploring the advancement of our existing pipeline and its possible expansion through business development activities.” In fact, Agile also announced Thursday that it intends to offer and sell shares of its common stock in an underwritten public offering in which it will grant the underwriters a 30-day option to purchase an additional 15 percent of the shares in the public offering.  Agile also announced earlier this month that an investment management firm may provide it with up to $35 million in financing. So far, $5 million has been funded. As for the company’s Twirla commercialization plans, Agile said it plans to begin the pre-validation and validation of the commercial manufacturing process in the first half of 2020, manufacture three validation batches of Twirla and complete the validation process in the second half of 2020.   At the same time, the company will prepare for the availability of commercial product supply. In the first quarter of 2020, Agile intends to initiate work with managed care and patient payors to gain market access for Twirla. In the second quarter, the company plans to begin hiring and training an initial sales team, which it estimates to be in the range of 70 to 100 persons.  Agile said it intends to ship the product to wholesalers in the fourth quarter of 2020. Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham