UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission file number: 001-40492. Femasys Inc. (Exact Name of Registrant as Specified in its Charter) 3950 Johns Creek Court, Suite 100 ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to_______ ...

[Corporate Highlights](index=1&type=section&id=Corporate%20Highlights) 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](index=3&type=chunk) - 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](index=3&type=chunk)[4](index=4&type=chunk) - Secured **regulatory approvals** for FemaSeed® and two diagnostic devices in the United Kingdom and Israel[4](index=4&type=chunk) - Formed a **partnership with CNY Fertility**, a national group of eleven fertility centers, to offer FemaSeed®[4](index=4&type=chunk) - 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](index=4&type=chunk) [Financial Results for Quarter Ended March 31, 2025](index=2&type=section&id=Financial%20Results%20for%20Quarter%20Ended%20March%2031%2C%202025) 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](index=7&type=chunk) - The rise in R&D expenses was primarily due to increased regulatory costs, material and development costs, and compensation costs[7](index=7&type=chunk) - 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](index=7&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) 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](index=3&type=section&id=Condensed%20Balance%20Sheets) 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](index=5&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) 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](index=5&type=section&id=About%20Femasys) 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](index=14&type=chunk) - Key products include FemaSeed® (infertility), FemVue® (diagnostic), and FemBloc® (permanent birth control)[14](index=14&type=chunk) - 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](index=14&type=chunk) - Clinical data indicates FemaSeed® is **over twice as effective** as traditional intrauterine insemination (IUI)[14](index=14&type=chunk)

Core Insights - Femasys Inc. is focused on transforming women's health with innovative solutions, including FemaSeed for infertility treatment and FemBloc for non-surgical permanent birth control, with full system approval pending in Europe [1][3] Corporate Highlights - The company secured the first global regulatory approval for the FemBloc delivery system, marking a significant milestone for introducing a non-surgical permanent birth control option in Europe [3][7] - In Q1 2025, Femasys executed its commercialization strategy for FemaSeed, achieving a 78% quarter-over-quarter sales increase in the U.S., indicating strong market momentum [3] - Femasys announced partnerships with CNY Fertility and distribution partnerships for FemBloc in Spain, enhancing its market presence [7] Financial Results - For the quarter ended March 31, 2025, sales increased by $70,124, or 25.9%, to $341,264 compared to $271,140 in the same period of 2024, primarily driven by FemaSeed sales [8][12] - Research and development expenses rose by $1,197,741, or 67.6%, to $2,968,472 due to increased regulatory, material, and development costs [8][12] - The net loss for the quarter was $5,896,839, or ($0.23) per share, compared to a net loss of $3,599,510, or ($0.17) per share in Q1 2024 [8][12] Balance Sheet Overview - As of March 31, 2025, total assets were approximately $13.3 million, up from $12.4 million at the end of 2024 [10][11] - Current liabilities increased to $9,841,126 from $8,582,869, reflecting higher accounts payable and convertible notes payable [10] - The company had cash and cash equivalents of approximately $3.8 million and an accumulated deficit of about $133.1 million [8][10]

Femasys Inc. (FEMY) came out with a quarterly loss of $0.23 per share versus the Zacks Consensus Estimate of a loss of $0.25. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8%. A quarter ago, it was expected that this company would post a loss of $0.20 per share when it actually produced a loss of $0.24, delivering a surprise of -20%.Over the last four quarters, the company has surpassed consens ...

Financial Performance - Total assets decreased from $27,755,825 in 2023 to $12,445,002 in 2024, representing a decline of approximately 55.1%[463] - Cash and cash equivalents dropped significantly from $21,716,077 in 2023 to $3,451,761 in 2024, a decrease of about 84.1%[463] - The company reported a net accumulated deficit of $127,198,257 as of December 31, 2024, up from $108,381,629 in 2023, indicating an increase in losses[465] - Sales for the year ended December 31, 2024, reached $1,629,108, an increase of 51.9% compared to $1,071,970 in 2023[467] - Net loss for 2024 was $18,816,628, compared to a net loss of $14,247,124 in 2023, representing a 32.5% increase in losses[467] - Total revenue for the year ended December 31, 2024, was $1,629,108, a significant increase from $1,071,970 in 2023, representing a growth of approximately 52%[509] - U.S. revenue for 2024 was $1,073,508, up from $1,013,925 in 2023, while international revenue surged to $555,600 from $58,045[509] Operating Expenses - Total operating expenses increased to $18,870,010 in 2024, up 24.1% from $15,200,316 in 2023[467] - Research and development expenses rose to $8,216,543 in 2024, up 14.0% from $7,208,701 in 2023[467] - Sales and marketing expenses surged to $4,030,150 in 2024, a significant increase from $650,126 in 2023[467] - Interest expense rose significantly to $(1,603,575) in 2024 from $(165,390) in 2023, indicating a substantial increase in borrowing costs[467] - The company incurred depreciation expenses of $277,178 in 2024, a decrease from $480,187 in 2023[473] - The company’s operating lease cost for the year ending December 31, 2024, was $619,796, an increase from $469,995 in 2023[533] Cash Flow and Liquidity - Net cash used in operating activities for 2024 was $19,444,009, compared to $11,280,546 in 2023, indicating a significant increase in cash outflow[473] - The company has a substantial reliance on the FDA's approval for its FemBloc system, which is currently in late-stage development[18] - The company plans to finance operations through existing cash, additional equity, and anticipated revenue from product sales, primarily focusing on FemaSeed and FemVue[478] - The company faces substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows[457] Debt and Financing - The company’s convertible notes mature in November 2025, raising concerns about future funding[457] - The Company recognized total interest expense on the convertible notes of $1,603,575 for the year ended December 31, 2024, including coupon interest expense of $411,001 and amortization of debt discount of $1,192,574[547] - The Company issued senior unsecured convertible notes totaling $6,850,000 on November 21, 2023, convertible at a price of $1.18 per share[540] - The effective interest rate for the discount amortization of the convertible notes was 32.3%[547] - As of December 31, 2024, the fair value of the convertible notes was $6,493,720, calculated using a discounted cash flow analysis[547] Regulatory and Market Position - The company has received global regulatory approvals for its product portfolio, including FemaSeed, FemVue, and FemBloc, with ongoing commercialization efforts[476] - The pivotal clinical trial for FemBloc is currently enrolling participants for U.S. approval, with CE mark certification expected in mid-2025[476] - The company has limited experience in marketing and selling its women-specific medical product solutions[24] - The company plans to rely on distribution partners outside of North America to market its women-specific medical products[22] Stock and Equity - The company sold approximately 1.3 million shares of common stock for aggregate proceeds of $2 million during the year ended December 31, 2024[559] - The company completed an April 2023 financing that resulted in gross proceeds of $3,899,813, after deducting $547,764 in transaction costs[560] - The company is authorized to sell up to $150 million in common and preferred stock, debt securities, and warrants under a shelf registration statement filed in July 2022[559] - As of December 31, 2024, the total stock-based compensation expense recognized was $444,147, a decrease from $675,700 in 2023[598] Tax and Valuation - As of December 31, 2024, the company has federal net operating loss carryforwards of $104,880,492, an increase from $90,380,015 in 2023[553] - The company recorded a valuation allowance change of $4,776,250 for the year ended December 31, 2024, compared to $3,397,568 for 2023[550] - The company has federal research and experimentation tax credits of $3,723,817 as of December 31, 2024, up from $3,231,910 in 2023[553] - The effective tax rate for the company is influenced by a valuation allowance of $(26.00)% in 2024 and $(24.00)% in 2023[550] Employee Compensation and Stock Options - The company contributed $97,876 and $75,202 in voluntary employer matching contributions to its 401(k) plan for the years ended December 31, 2024 and 2023, respectively[600] - As of December 31, 2024, 84,621 shares of common stock have been purchased under the Employee Stock Purchase Plan (ESPP), with 535,356 shares reserved for future awards[596] - The total number of shares of common stock available for awards under the 2021 Equity Incentive Plan is 1,111,111, with automatic increases based on outstanding shares[579] - As of December 31, 2024, the company had 2,974,219 stock options outstanding, with a weighted average exercise price of $1.60[582]

Financial Performance - Sales increased by $557,138, or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023[7] - Net loss was $18,816,628, or ($0.85) per basic and diluted share for the year ended December 31, 2024, compared to a net loss of $14,247,124, or ($0.93) per share for 2023[7] - Total current liabilities increased to $8,582,869 in 2024 from $3,054,055 in 2023[11] - Total assets decreased to $12,445,002 in 2024 from $27,755,825 in 2023[11] Research and Development - Research and development expenses increased by $1,007,842, or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023[7] Cash Position - Cash and cash equivalents as of December 31, 2024, was $3.5 million, with an accumulated deficit of $127.2 million[7] - The company expects current cash and equivalents to fund operations into Q3 2025[3] Revenue Expectations - U.S. revenue for FemaSeed is expected to increase by approximately 50% in Q1 2025 versus Q4 2024[3] Product Development and Partnerships - FemBloc® permanent birth control received approval in Europe, with CE mark approval pending[4] - Strategic partnerships announced for FemaSeed with CNY Fertility and HRC Fertility[4]

Core Insights - Femasys Inc. has achieved significant regulatory and commercial milestones for its FemBloc and FemaSeed products, with expectations of a 50% increase in U.S. revenue for FemaSeed in Q1 2025 compared to Q4 2024 [3] - The company has received approval for FemBloc in Europe and is advancing its clinical trial for U.S. FDA approval, indicating a strong commitment to addressing women's reproductive health needs [3][6] - Financial results for 2024 show a sales increase of 52% to $1.63 million, while net loss increased to $18.82 million, reflecting ongoing investment in research and development [7][11] Company Developments - Femasys announced partnerships for the distribution of FemBloc in Spain and with CNY Fertility for FemaSeed, expanding its market reach [6] - The company has received regulatory approvals for FemaSeed in the UK and Israel, and has published positive clinical trial results for both FemBloc and FemaSeed [6][12] - The FemBloc delivery system is noted as the first non-surgical, in-office permanent birth control method, with expected CE mark approval pending [13] Financial Performance - Sales increased by $557,138, or 52%, from $1.07 million in 2023 to $1.63 million in 2024 [7] - Research and development expenses rose by $1.01 million, or 14%, to $8.22 million in 2024 [7] - As of December 31, 2024, cash and cash equivalents were $3.5 million, with an accumulated deficit of $127.2 million, but the company expects sufficient funds to operate into Q3 2025 [7][9]

Core Insights - Femasys, Inc. has announced a partnership with CNY Fertility to provide its FemaSeed intratubal insemination product as a treatment option for infertility across CNY Fertility's 11 locations [1][2] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of therapeutic and diagnostic products that are disruptive and accessible [4] - The company has received regulatory approvals for its product portfolio worldwide, including FDA clearance for FemaSeed in the U.S. and approvals in Europe, UK, Canada, and Israel [4] Product Details - FemaSeed is designed to enhance fertilization by delivering sperm directly into the fallopian tube, providing a safe and cost-effective first-line option for couples facing infertility [3] - The product serves as an alternative to intrauterine insemination (IUI) and is positioned as a less burdensome step before in vitro fertilization (IVF) [3] Partnership Significance - The partnership with CNY Fertility aims to expand access to FemaSeed, aligning with CNY's mission to provide comprehensive and affordable fertility solutions [2][6] - CNY Fertility has a strong track record, having helped create over 30,000 lives since its inception in 1997, emphasizing its commitment to accessible fertility treatments [6]

Core Insights - Femasys Inc. has secured distribution partnerships in Spain for its FemBloc product, marking a significant step in its global expansion strategy [1][2] - FemBloc is a non-surgical permanent birth control solution that utilizes a patented delivery system to block fallopian tubes, offering a safer alternative to traditional surgical methods [3][5] Company Overview - Femasys is a biomedical innovator focused on women's health, with a portfolio of patent-protected therapeutic and diagnostic products [4] - The company has received regulatory approvals for its products in various international markets, including the U.S., Europe, UK, Canada, and Israel [4] Product Details - FemBloc is the first non-surgical approach for permanent birth control, involving the placement of a synthetic tissue adhesive into the fallopian tubes [3][5] - The product aims to reduce risks associated with surgical sterilization, such as infection and bleeding, and is designed to be a more accessible and cost-effective option [3][5] Market Positioning - The distribution partners, Comercial Medico Quirurigca, SA and Durgalab, have extensive experience in women's healthcare, having previously marketed the Conceptus Essure product [2] - The approval of FemBloc in Europe and the ongoing clinical trials for U.S. FDA approval indicate a strong market entry strategy [5]

Core Insights - Femasys Inc. has received the first regulatory approval in the world for the FemBloc delivery system, a non-surgical option for permanent birth control, with CE mark certification expected mid-2025 [1][2][6] - The FemBloc system represents a significant advancement in women's reproductive health, providing a safer and more accessible alternative to traditional surgical sterilization methods [2][4] Company Overview - Femasys is a biomedical innovator focused on addressing unmet needs in women's health, with a portfolio of therapeutic and diagnostic products [5] - The company has received regulatory approvals for its products globally, including FemaSeed for infertility treatment and FemVue for fallopian tube assessment [5][6] Product Details - The FemBloc delivery system allows for the minimally-invasive placement of a synthetic tissue adhesive into the fallopian tubes, leading to permanent blockage over time [4][6] - This non-surgical approach is designed to reduce risks associated with traditional surgical methods, such as infection and anesthesia-related complications [3][4] Market Context - The approval of FemBloc addresses a long-standing gap in permanent contraception options, as surgical sterilization has been the predominant method for over a century [3] - The rise in unintended pregnancies highlights the need for innovative contraceptive solutions, making FemBloc a timely development in the market [3]