Agile Therapeutics(US:AGRX)2021-07-25 16:00Financial Performance - The net loss for the six months ended June 30, 2021, was $34.8 million, compared to a net loss of $18.7 million for the same period in 2020[144]. - For the six months ended June 30, 2021, net revenues were $1.301 million, an increase from $0 in the same period in 2020[176]. - The net loss for the six months ended June 30, 2021, was $34.765 million, compared to a net loss of $18.709 million for the same period in 2020, reflecting an increase in loss of $16.056 million[176]. - Total operating expenses for the six months ended June 30, 2021, were $31.868 million, up from $17.656 million in the same period in 2020, representing an increase of $14.212 million[176]. - Selling and marketing expenses for the six months ended June 30, 2021, totaled $20.877 million, a rise of $15.985 million, or 327%, from $4.892 million in the same period in 2020[180]. Research and Development - The company incurred research and development expenses of $13.5 million, $9.9 million, and $9.8 million for the years ended December 31, 2020, 2019, and 2018, respectively[138]. - For the three months ended June 30, 2021, research and development expenses were approximately $0.9 million, down from $3.7 million for the same period in 2020[157]. - Research and development expenses decreased by $2.799 million, or 76%, from $3.661 million in Q2 2020 to $0.862 million in Q2 2021[172]. - Research and development expenses for the six months ended June 30, 2021, were $2.975 million, a decrease of $3.850 million, or 56%, from $6.825 million in the same period in 2020[177]. - Approximately 29% of the product sold during the six months ended June 30, 2021, consisted of validation inventory previously expensed as research and development in Q4 2020[177]. Cash and Liquidity - The company had cash, cash equivalents, and marketable securities of $31.1 million as of June 30, 2021, compared to $54.5 million as of December 31, 2020[139]. - Net cash used in operating activities was $30.0 million for the six months ended June 30, 2021, primarily due to a net loss of $34.8 million[185]. - Net cash provided by investing activities for the six months ended June 30, 2021 was $34.6 million, primarily from net sales and maturities of marketable securities[189]. - Net cash provided by financing activities for the six months ended June 30, 2021 was $7.1 million, consisting of net proceeds of $7.0 million from the sale of 5,113,971 shares of common stock[190]. - The company plans to monitor its liquidity closely and may revise its commercial plans if the COVID-19 pandemic impacts its ability to generate revenue[142]. Commercialization Efforts - The company plans to continue its commercialization efforts for Twirla, focusing on expanding coverage and reimbursement in the U.S.[133]. - The company expects to continue incurring significant operating expenses to support the commercialization of Twirla and evaluate additional product candidates[192]. - As of June 30, 2021, the company committed $7.1 million for purchases under the Manufacturing and Commercialization Agreement with Corium, Inc.[193]. Capital and Financing - A public offering in February 2020 raised approximately $48.4 million from the sale of 17,250,000 shares at $3.00 per share[141]. - The company entered into a Credit Agreement for a senior secured term loan credit facility of up to $35.0 million, with additional tranches available upon achieving revenue milestones[140]. - The company plans to monitor its liquidity to ensure adequate funding for operations, with a potential to access up to $200.0 million through the 2020 Shelf Registration Statement[191]. Operational Challenges - The company recognizes substantial doubt about its ability to continue as a going concern through the next 12 months due to its reliance on raising additional capital[147]. - The company does not believe inflation had a material effect on its business during the six months ended June 30, 2021[207].