femasys(FEMY) - 2025 Q1 - Quarterly Results

Corporate Highlights Femasys achieved significant regulatory and commercial milestones in Q1 2025, including European approval for FemBloc® and a 78% sales increase for FemaSeed® - Achieved a 78% quarter-over-quarter sales increase for FemaSeed in the U.S. during Q1 2025, indicating strong market momentum[3] - The FemBloc® permanent birth control delivery system received regulatory approval in Europe, with the blended polymer component recommended for CE mark approval, pending final EMA review[3][4] - Secured regulatory approvals for FemaSeed® and two diagnostic devices in the United Kingdom and Israel[4] - Formed a partnership with CNY Fertility, a national group of eleven fertility centers, to offer FemaSeed®[4] - Strengthened intellectual property with notices of intention to grant two new European patents for FemBloc® and a notice of allowance for a new U.S. patent for FemaSeed®[4] Financial Results for Quarter Ended March 31, 2025 Femasys reported a 25.9% sales increase to $341,264 in Q1 2025, but net loss widened to $5.9 million due to increased R&D expenses Q1 2025 vs Q1 2024 Financial Highlights | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Sales | $341,264 | $271,140 | +25.9% | | R&D Expenses | $2,968,472 | $1,770,731 | +67.6% | | Net Loss | $5,896,839 | $3,599,510 | +63.8% | | Net Loss Per Share | ($0.23) | ($0.17) | - | - The increase in sales was attributed to the commercialization of FemaSeed®[7] - The rise in R&D expenses was primarily due to increased regulatory costs, material and development costs, and compensation costs[7] - As of March 31, 2025, cash and cash equivalents were approximately $3.8 million, which is expected to fund operations into the early third quarter of 2025[7] Financial Statements The financial statements present the company's balance sheet, showing asset and liability changes, and the comprehensive loss statement, detailing revenue and expense trends Condensed Balance Sheets Total assets increased to $13.3 million, liabilities rose to $11.3 million, and stockholders' equity decreased to $2.0 million as of March 31, 2025 Balance Sheet Summary (as of March 31, 2025 vs Dec 31, 2024) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $3,820,208 | $3,451,761 | | Total current assets | $9,132,252 | $8,022,450 | | Total assets | $13,277,803 | $12,445,002 | | Liabilities & Equity | | | | Total current liabilities | $9,841,126 | $8,582,869 | | Total liabilities | $11,281,086 | $10,140,580 | | Total stockholders' equity | $1,996,717 | $2,304,422 | Condensed Statements of Comprehensive Loss Sales increased to $341,264, but loss from operations expanded to $5.5 million, resulting in a net loss of $5.9 million for Q1 2025 Statement of Comprehensive Loss (Three Months Ended March 31) | Item | 2025 | 2024 | | :--- | :--- | :--- | | Sales | $341,264 | $271,140 | | Research and development | $2,968,472 | $1,770,731 | | Sales and marketing | $908,567 | $300,487 | | Loss from operations | ($5,460,607) | ($3,462,642) | | Net loss | ($5,896,839) | ($3,599,510) | | Net loss per share | ($0.23) | ($0.17) | Company Overview Femasys is a biomedical company focused on in-office women's health solutions, commercializing FemaSeed®, FemVue®, and developing FemBloc® - Femasys' core business is developing and commercializing a portfolio of in-office therapeutic and diagnostic products for women's health[14] - Key products include FemaSeed® (infertility), FemVue® (diagnostic), and FemBloc® (permanent birth control)[14] - FemBloc® is positioned as the first non-surgical, in-office alternative to surgical sterilization and is awaiting full regulatory approval in Europe by mid-year 2025[14] - Clinical data indicates FemaSeed® is over twice as effective as traditional intrauterine insemination (IUI)[14]