Core Insights - Femasys, Inc. has achieved regulatory approvals in Australia and New Zealand for its infertility solutions, FemaSeed and FemVue, enhancing global access to innovative treatments for women facing infertility [1][2] Group 1: Product Overview - FemaSeed is a next-generation artificial insemination solution that significantly improves fertilization by delivering sperm directly to the fallopian tube, achieving over double the pregnancy rates compared to intrauterine insemination (IUI) in cases of low male sperm count [3][5] - FemVue is an ultrasound-based diagnostic tool that evaluates fallopian tube patency, providing a safe and reliable assessment within a gynecologist's office, and serves as a companion diagnostic for FemaSeed [4][5] Group 2: Market Expansion - The regulatory approvals in Australia and New Zealand represent a strategic milestone for Femasys, validating the clinical value of its products and creating commercial opportunities to grow revenue and expand its global footprint [2][5] - Femasys is actively commercializing its products in the U.S. and key international markets, with a focus on addressing critical unmet needs in women's health [5] Group 3: Additional Innovations - Femasys has also received regulatory approval for FemBloc, a non-surgical, in-office permanent birth control solution, which will begin commercialization in Spain and subsequently in other European countries [6] - FemChec, a diagnostic product that confirms the success of the FemBloc procedure, has shown compelling effectiveness and high satisfaction rates in initial clinical trials [6]

Core Points - Femasys Inc. has received CE mark certification for its FemBloc blended polymer component, marking the first global regulatory approval for a non-surgical permanent birth control solution [1][2] - The FemBloc System is now approved for marketing in the European Economic Area, which includes 27 EU member states and 3 EFTA countries [1] - Femasys plans to commercialize FemBloc in select European countries, starting with Spain, and is also pursuing U.S. FDA approval through ongoing clinical trials [2][4] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of in-office therapeutic and diagnostic products [4] - The FemBloc System is a non-surgical solution that places a proprietary blended polymer into the fallopian tubes, creating natural scar tissue to block them permanently [3] - Femasys also has a fertility portfolio that includes FemaSeed for infertility treatment and FemVue for fallopian tube assessment, with FemaSeed showing over twice the effectiveness of traditional IUI [4]

Core Insights - Femasys, Inc. has appointed Kelley Nicholas as Chief Commercial Officer to enhance its commercial strategy and revenue growth, particularly in the U.S. infertility market and through global partnerships [1][2] Company Overview - Femasys is a biomedical innovator focused on women's health, offering a range of therapeutic and diagnostic products, including FemaSeed® and FemVue® [5] - The company is actively commercializing its products in the U.S. and international markets, with a strong emphasis on addressing unmet needs in women's health [5] Leadership Appointment - Kelley Nicholas brings over 25 years of industry experience, including significant roles in commercial strategy and revenue growth in the medical device and biotechnology sectors [2] - Her previous positions include Head of Sales at NeuroPace and Global Vice President of Marketing at Hologic, where she successfully led revenue and market expansion initiatives [2] Stock Option Grant - Femasys has granted Kelley Nicholas an option to purchase 100,000 shares of common stock, effective on her first day of employment, as an inducement for her joining the company [3][4] Product Portfolio - FemaSeed® is highlighted as a groundbreaking infertility treatment, showing over twice the effectiveness of traditional IUI for low male sperm count, with high satisfaction rates [5] - FemBloc®, a non-surgical permanent birth control method, is expected to receive full regulatory approval in Europe by mid-2025, with commercialization planned to begin in Spain [6]

Core Insights - Femasys, Inc. has partnered with Carolinas Fertility Institute to offer its FemaSeed intratubal insemination product as a treatment option for infertility in North Carolina [1][2] - The partnership aims to provide a less invasive and cost-effective fertility solution before IVF, enhancing treatment options for patients [2] - FemaSeed is a next-generation artificial insemination solution that significantly improves fertilization rates, achieving over double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count [3][4] 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 is actively commercializing its products in the U.S. and international markets, including FemaSeed and FemVue, a diagnostic for fallopian tube assessment [4] - Femasys' FemBloc product, a non-surgical permanent birth control method, is expected to receive full regulatory approval in Europe by mid-2025 [5] Product Details - FemaSeed enhances fertilization by delivering sperm directly to the fallopian tube, offering a safe and cost-effective first-line treatment option [3] - The product is authorized for use in multiple regions, including the U.S., Europe, UK, Canada, and Israel [3] - FemBloc is positioned as a highly cost-effective and safer alternative to traditional surgical sterilization, with commercialization plans in Spain and other European countries [5] Partner Overview - Carolinas Fertility Institute is a leading fertility center in North Carolina, providing a range of reproductive care services [6] - The institute focuses on making fertility care more accessible and effective, aligning with Femasys' mission to offer innovative treatment options [2][6]

Core Viewpoint - Femasys Inc. has announced a public offering of 3,600,000 shares at $0.85 per share and a concurrent private placement of 1,686,275 shares at the same price for institutional stockholders, with a higher price of $1.02 for certain directors and officers, aiming to raise approximately $4.5 million for various corporate purposes [1][2]. Group 1: Offering Details - The public offering consists of 3,600,000 shares priced at $0.85 each, while the private placement includes 1,686,275 shares sold at $0.85 to institutional stockholders and $1.02 to directors and officers [1]. - The gross proceeds from both offerings are expected to be around $4.5 million before expenses [1]. - Femasys has granted the underwriter a 30-day option to purchase an additional 540,000 shares from the public offering [1]. Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized for expanding commercial efforts, product development, general corporate purposes, capital expenditures, working capital, and administrative expenses [1]. Group 3: Company Overview - Femasys Inc. is focused on women's health, developing minimally invasive, in-office technologies for reproductive health, including products like FemBloc® and FemaSeed® [5]. - The company markets products such as FemVue® for fallopian tube assessment and FemCerv®, an endocervical tissue sampler [5].

Core Viewpoint - Femasys Inc. plans to conduct an underwritten public offering of its common stock, with an additional 30-day option for underwriters to purchase up to 15% more shares, alongside a concurrent private placement involving existing institutional stockholders and certain directors and officers [1][2]. Group 1: Offering Details - The public offering and private placement are subject to market conditions, with no assurance on completion timing or terms [2]. - Jones is the sole book-running manager for the public offering and placement agent for the private placement [3]. - The net proceeds from the offerings will be used for commercial expansion, product development, general corporate purposes, capital expenditures, and working capital [3]. Group 2: Regulatory Information - The securities are being offered under a Registration Statement on Form S-3, previously filed and declared effective by the SEC [4]. - The private placement will rely on an exemption from registration under the Securities Act, meaning the securities may not be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - Femasys Inc. focuses on women's health, developing minimally invasive, in-office technologies for reproductive health, including products like FemBloc for permanent birth control and FemaSeed for infertility [6]. - Current marketed products include FemVue for fallopian tube assessment and FemCath, an intrauterine catheter for selective evaluation [6].

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]

Company Performance - Femasys Inc. reported a quarterly loss of $0.23 per share, which was better than the Zacks Consensus Estimate of a loss of $0.25, but worse than the loss of $0.19 per share from the previous year, indicating an earnings surprise of 8% [1] - The company posted revenues of $0.58 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 41.80%, compared to revenues of $0.21 million a year ago [2] - Over the last four quarters, Femasys has surpassed consensus EPS estimates two times and topped consensus revenue estimates just once [2] Stock Outlook - Femasys shares have increased by approximately 38.2% since the beginning of the year, contrasting with the S&P 500's decline of -2.9% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.23 on revenues of $1.9 million, and for the current fiscal year, it is -$0.59 on revenues of $11 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Femasys belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Femasys's stock performance [5]