Agile Therapeutics(US:AGRX)2024-03-28 20:31Financial Performance - As of December 31, 2023, the company reported an accumulated deficit of $423.2 million and a net loss of $14.5 million for the year[305]. - Net sales for the year ended December 31, 2023, totaled $19.6 million, an increase from $10.9 million in 2022, driven by the sale of 248,220 units compared to 114,546 units in the previous year[315]. - The net loss for 2023 was $14.465 million, a decrease from a net loss of $25.412 million in 2022, representing a 43.2% improvement[393]. - Agile Therapeutics reported net revenues of $19.593 million for the year ended December 31, 2023, a 80.1% increase from $10.884 million in 2022[393]. - The company's gross profit for 2023 was $10.615 million, compared to a gross profit of $4.048 million in 2022, reflecting a significant improvement in profitability[393]. - Total operating expenses decreased to $30.499 million in 2023 from $56.604 million in 2022, indicating a reduction of 46.5%[393]. Expenses - The cost of product revenues for 2023 was $9.0 million, up from $6.8 million in 2022[317]. - Research and development expenses decreased significantly to approximately $2.2 million in 2023 from $3.3 million in 2022 and $6.2 million in 2021[321]. - Selling and marketing expenses totaled approximately $17.8 million in 2023, down from $30.4 million in 2022 and $43.4 million in 2021[325]. - General and administrative expenses were approximately $10.5 million in 2023, compared to $11.9 million in 2022 and $14.7 million in 2021[327]. - Interest expense decreased by $1.7 million, from $3.1 million in 2022 to $1.4 million in 2023, due to principal payments made throughout 2023[346]. Cash Flow and Liquidity - The company had cash and cash equivalents of $2.5 million as of December 31, 2023, which is expected to support operations through April 2024[309]. - Net cash used in operating activities was $9.6 million for the year ended December 31, 2023, compared to $35.9 million in 2022[353]. - Cash and cash equivalents decreased to $2.557 million as of December 31, 2023, down from $5.246 million in 2022[391]. - The company has a working capital deficiency and substantial doubt exists about its ability to continue as a going concern[383]. - The company has a working capital deficit of $11.2 million as of December 31, 2023, raising concerns about its liquidity and operational sustainability[404]. Capital Raising and Financing - The company raised net proceeds of approximately $12.2 million by issuing and selling 173,750 shares of common stock under the April 2022 ATM Agreement[358]. - The company raised net proceeds of $6.5 million from the May 2023 Offering by selling 1,896,286 shares of common stock[364]. - In 2022, the company completed a public offering raising net proceeds of $22.0 million through the sale of 382,966 shares of common stock and 150,366 pre-funded warrants[363]. - The Company has a common stock sales agreement allowing for the sale of up to $50.0 million in gross proceeds through "at-the-market" equity offerings[501]. - The Perceptive Credit Agreement allows for a senior secured term loan of up to $35 million, with an interest rate of 15.60% as of December 31, 2023[480]. Strategic Plans and Future Outlook - The company plans to continue focusing on the commercialization of Twirla while exploring opportunities for a second product to reduce operating losses[308]. - Future research and development costs will depend on various factors, including the uncertainties of clinical trials and access to additional capital[323]. - The company anticipates continuing to incur significant operating expenses as it seeks to commercialize Twirla and explore additional product candidates[404]. - The company is exploring strategic alternatives, including potential asset sales and mergers or acquisitions[371]. Inventory and Sales - The company recorded a product return reserve liability of $1.9 million as of December 31, 2023, reflecting the estimation of returns based on sales data[388]. - In 2023, the company had sales to five major customers that accounted for 94% of total revenue, with individual sales of $4.7 million, $3.8 million, $3.7 million, $3.5 million, and $2.8 million[427]. - Total allowances for sales as of December 31, 2023, amounted to $11.206 million, which includes customer credits, rebates, and product returns[442]. Stock and Warrants - The Company issued warrants representing the right to purchase up to 3,892,572 shares of common stock at an exercise price of $3.69 per share, later reduced to $1.25 per share[365]. - As of December 31, 2023, the Company has 5,589,637 common stock warrants outstanding, compared to 1,130,025 in 2022[460]. - The fair value of the Company's warrant liability decreased from $5,934,000 in 2022 to $5,696,000 in 2023[469]. - The significant assumptions for the option pricing model for valuing the Company's warrants as of December 31, 2023 include a volatility of 101.5% - 126.0% and a fair value of common stock at $1.95[468]. Accounting and Compliance - The Company has adopted ASC 718 for stock-based compensation, recognizing compensation cost over the requisite service period[456]. - The Company is evaluating the impact of new accounting standards issued by the FASB, including ASU 2023-07 and ASU 2023-09[462][463]. - The Company has no uncertain tax positions as of December 31, 2023[455].