Agile Therapeutics(AGRX) - 2024 Q1 - Quarterly Results

Q1 2024 Performance Highlights Agile Therapeutics reported strong Q1 2024 growth, with net revenue up 50% to $5.7 million, driven by Twirla demand and reduced operating costs Q1 2024 Key Performance Metrics | Metric | Q1 2024 | vs. Q4 2023 | vs. Q1 2023 | | :--- | :--- | :--- | :--- | | Net Revenue ($ million) | $5.7 | +58% | +50% | | Twirla Demand (Total Cycles) | 81,088 | +18% | +80% | | Twirla Factory Sales (Total Cycles) | 70,662 | +3% | +63% | | Operating Expenses ($ million) | $6.8 | +24% | -20% | - The increase in Q1 2024 net revenue was primarily attributed to higher demand for Twirla[3] - The company's growth strategy focuses on its five-state concentration, expanding its telemedicine reach, and strengthening relationships with planned parenthood organizations[2] Q1 2024 Financial Results Agile Therapeutics achieved a Q1 2024 GAAP net income of $1.3 million, a significant turnaround from the prior year's loss, supported by revenue growth Q1 2024 Key Financial Data | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net Revenue ($ million) | $5.7 | $3.8 | | Cost of Goods Sold (COGS) ($ million) | $1.7 | $2.0 | | Total Operating Expenses ($ million) | $6.8 | $8.5 | | GAAP Net Income (Loss) ($ million) | $1.3 | ($5.4) | | GAAP EPS (basic and diluted) | $0.28 | ($5.91) | | Non-GAAP Net Loss ($ million) | ($2.9) | ($7.1) | | Non-GAAP Net Loss Per Share | ($0.63) | ($7.76) | - Cash and cash equivalents were $2.6 million as of March 31, 2024, slightly up from $2.5 million at the end of 2023[7] - As of March 31, 2024, the company had 6,856,229 shares of common stock outstanding[7] Corporate Updates and Business Outlook Agile Therapeutics' stock moved to OTC in March 2024, with optimism for growth from new guidance expanding no-cost contraceptive access for women - As of March 26, 2024, the company's common stock is trading on the OTC market under its existing AGRX symbol[7] - The company is optimistic about new guidance from the Biden-Harris Administration announced in January 2024, which aims to expand access to FDA-approved contraceptives like Twirla at no cost for an estimated 49 million women[7] - Management plans to explore all strategic opportunities, both internal and external, to advance Twirla's growth and increase shareholder value[2] Financial Statements The financial statements detail Q1 2024 performance, showing reduced stockholders' deficit and GAAP profitability, with non-GAAP reconciliation provided Balance Sheets Balance Sheet Summary (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents ($ thousands) | $2,615 | $2,557 | | Total current assets ($ thousands) | $11,987 | $9,530 | | Total assets ($ thousands) | $12,610 | $10,255 | | Total current liabilities ($ thousands) | $21,441 | $20,777 | | Total liabilities ($ thousands) | $22,934 | $26,573 | | Total stockholders' deficit ($ thousands) | ($10,324) | ($16,318) | Statement of Operations Statement of Operations Summary (in thousands) | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenues, net ($ thousands) | $5,716 | $3,813 | | Gross profit ($ thousands) | $4,036 | $1,810 | | Total operating expenses ($ thousands) | $6,793 | $8,518 | | Loss from operations ($ thousands) | ($2,757) | ($6,708) | | Unrealized gain on warrant liability ($ thousands) | $4,203 | $1,687 | | Net income (loss) ($ thousands) | $1,284 | ($5,390) | | Net income (loss) per share | $0.28 | ($5.91) | Reconciliation of GAAP to Non-GAAP Net Loss GAAP to Non-GAAP Reconciliation (in thousands) | Metric | Q1 2024 | Q4 2023 | Q1 2023 | | :--- | :--- | :--- | :--- | | GAAP net income (loss) ($ thousands) | $1,284 | ($4,467) | ($5,390) | | Unrealized gain (loss) on warrant liability ($ thousands) | $4,203 | ($130) | $1,687 | | Non-GAAP net loss ($ thousands) | ($2,919) | ($4,337) | ($7,077) | About the Company and Product Agile Therapeutics is a women's healthcare company focused on non-daily contraceptive options, featuring its flagship Twirla® once-weekly patch About Agile Therapeutics, Inc. - Agile Therapeutics is a women's healthcare company focused on providing contraceptive options that offer freedom from a daily pill without the commitment of a longer-acting method[8] About Twirla® - Twirla® is a once-weekly combined hormonal contraceptive patch indicated for women with a BMI < 30 kg/m². It is contraindicated in women with a BMI ≥ 30 kg/m² and in women over 35 who smoke[9] Supplemental Information This section provides context for the report, defining prescription data, explaining non-GAAP financial measures, and including forward-looking statements About Prescription Data - The company sources its prescription data from Symphony Health Solutions. It believes factory sales more closely represent total demand for Twirla as not all non-retail channel data is captured by third-party services[10][11] Use of Non-GAAP Financial Measures - The company uses non-GAAP net loss, which excludes recurring unrealized gains or losses from its warrant liability, to provide what it believes is a more useful measure for period-to-period comparisons of its business operations[12] Forward-Looking Statements - The press release contains forward-looking statements regarding the commercialization of Twirla®, market acceptance, future financing, and other strategic plans, which are subject to various risks and uncertainties[14][16]