femasys(FEMY) - 2025 Q2 - Quarterly Results

Executive Summary Femasys Inc. is a biomedical innovator in fertility and non-surgical birth control, achieving significant Q2 2025 milestones including regulatory approvals and commercial orders Company Overview Femasys Inc. is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control solutions more accessible and cost-effective for women globally - Femasys Inc. is a leading biomedical innovator in fertility and non-surgical permanent birth control solutions[1] Key Corporate Highlights (2Q 2025) Femasys achieved significant milestones in Q2 2025, including key regulatory approvals for FemBloc in Europe and FemaSeed/FemVue in Australia and New Zealand, securing initial commercial orders, and expanding partnerships to drive global commercialization - European Union Medical Device Regulation approval for FemBloc®, the first global regulatory endorsement for their non-surgical permanent birth control solution[3][5] - Secured first European order for FemBloc from Spain distribution partners for approximately $400,000[5] - Announced Australian and New Zealand regulatory approvals for FemaSeed® and FemVue®, a cost-effective first step in fertility[4][5] - Announced partnership with Carolinas Fertility Institute to offer FemaSeed in its eight locations and appointed a new Chief Commercial Officer to drive global growth[4][5] - Completed a public offering and concurrent private placement with gross proceeds of $4.5 million[5] Financial Performance Summary Femasys reported significant sales growth in Q2 2025, driven by FemaSeed and FemVue, alongside changes in R&D expenses and net loss for both quarterly and half-yearly periods Financial Results (Q2 2025) For the second quarter of 2025, Femasys reported significant sales growth driven by FemaSeed and FemVue, a decrease in R&D expenses, and a reduced net loss compared to the prior year period Key Financials (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Sales | $409,268 | $221,484 | 84.8% | | Research and development expenses | $1,414,429 | $1,975,875 | -28.4% | | Net loss | ($4,585,922) | ($4,684,574) | -2.1% | | Net loss per share (basic & diluted) | ($0.16) | ($0.21) | -23.8% | - Sales increase was primarily due to sales of FemaSeed and FemVue[9] - R&D expense decrease was primarily due to commercialization of development products into inventory and reduced clinical costs, partially offset by increased compensation costs[9] - Cash and cash equivalents as of June 30, 2025, was approximately $3.2 million, with an accumulated deficit of approximately $137.7 million; current cash is expected to fund operations into early Q4 2025[9] Financial Results (Six Months Ended June 30) For the first half of 2025, Femasys experienced substantial sales growth, an increase in R&D expenses, and a higher net loss compared to the same period in the prior year Key Financials (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change (%) | | :-------------------------------- | :----------- | :----------- | :--------- | | Sales | $750,532 | $492,624 | 52.4% | | Research and development expenses | $4,382,901 | $3,746,606 | 17.0% | | Net loss | ($10,482,761) | ($8,284,084) | 26.5% | | Net loss per share (basic & diluted) | ($0.39) | ($0.38) | 2.6% | - Sales increase was primarily due to sales of FemaSeed and FemVue[9] - R&D expense increase was primarily due to increased compensation and regulatory costs, partially offset by reduced material and development costs and clinical costs[9] Condensed Financial Statements Femasys's condensed financial statements for Q2 2025 show increased total assets and liabilities, driven by inventory and convertible notes, alongside detailed comprehensive loss figures Condensed Balance Sheets As of June 30, 2025, Femasys reported an increase in total assets, primarily driven by inventory, and a significant increase in total liabilities, mainly due to accounts payable and convertible notes payable, while stockholders' equity decreased Condensed Balance Sheet Highlights (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 ($) | December 31, 2024 ($) | Change ($) | | :-------------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $3,218,067 | $3,451,761 | ($233,694) | | Inventory | $5,232,738 | $3,046,323 | $2,186,415 | | Total current assets | $9,750,980 | $8,022,450 | $1,728,530 | | Total assets | $13,780,409 | $12,445,002 | $1,335,407 | | Accounts payable | $3,263,584 | $1,419,044 | $1,844,540 | | Convertible notes payable, net | $6,080,813 | $5,406,228 | $674,585 | | Total current liabilities | $10,963,607 | $8,582,869 | $2,380,738 | | Total liabilities | $12,272,974 | $10,140,580 | $2,132,394 | | Total stockholders' equity | $1,507,435 | $2,304,422 | ($796,987) | Condensed Statements of Comprehensive Loss The condensed statements of comprehensive loss show increased sales and cost of sales for both the three and six-month periods ended June 30, 2025; operating expenses also increased for the six-month period, leading to higher net losses Condensed Statements of Comprehensive Loss (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | | :-------------------------------- | :----------- | :----------- | | Sales | $409,268 | $221,484 | | Cost of sales | $158,171 | $73,125 | | Research and development | $1,414,429 | $1,975,875 | | Sales and marketing | $984,977 | $975,190 | | General and administrative | $1,616,972 | $1,611,817 | | Loss from operations | ($3,851,566) | ($4,482,151) | | Net loss | ($4,585,922) | ($4,684,574) | Condensed Statements of Comprehensive Loss (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | | :-------------------------------- | :----------- | :----------- | | Sales | $750,532 | $492,624 | | Cost of sales | $275,437 | $161,657 | | Research and development | $4,382,901 | $3,746,606 | | Sales and marketing | $1,893,544 | $1,275,677 | | General and administrative | $3,339,685 | $3,114,621 | | Loss from operations | ($9,312,173) | ($7,944,793) | | Net loss | ($10,482,761) | ($8,284,084) | Company Information Femasys is a biomedical innovator offering patent-protected fertility and non-surgical birth control solutions, with ongoing commercialization and clinical trials, while also outlining forward-looking statement risks About Femasys Femasys is a biomedical innovator providing patent-protected, in-office therapeutic and diagnostic products for fertility and non-surgical permanent birth control, actively commercializing its innovations globally and in the U.S. - Femasys offers a broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products for fertility and non-surgical permanent birth control[16] - Key fertility products include FemaSeed® Intratubal Insemination (over twice as effective as traditional IUI) and FemVue® for fallopian tube assessment[16] - FemBloc® is the first and only non-surgical, in-office alternative to surgical sterilization, with full European regulatory approval in June 2025, complemented by FemChec® diagnostic product[16] - Enrollment in the FINALE pivotal trial (NCT05977751) is ongoing for U.S. FDA approval of FemBloc[16] Forward-Looking Statements This section contains forward-looking statements subject to substantial risks and uncertainties, cautioning that actual results may differ materially from expectations due to various factors, including regulatory approvals, clinical trial success, market estimates, and commercialization efforts - Forward-looking statements are subject to inherent uncertainties, risks, and assumptions, many beyond control, which could cause actual results to differ materially from expectations[20] - Key risk factors include the ability to obtain regulatory approvals for FemBloc, successfully complete clinical trials, demonstrate product safety and effectiveness, commercialize products, and grow sales and revenues[20]