Femasys (FEMY 1.19%), a women’s health medical technology firm developing permanent birth control and fertility solutions, released its second quarter 2025 results on August 8, 2025. The earnings report was marked by strong revenue growth to $0.41 million (GAAP)—an 84.8% jump in GAAP sales from the prior year period—driven by accelerating early-stage sales of FemaSeed intratubal insemination devices and FemVue diagnostic systems. This figure (GAAP revenue of $409,268) came in far above analyst estimates. Th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to____________ Commission file number: 001-40492. Femasys Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction ...

Femasys Announces Second Quarter Financial Results for 2025 -- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio -- ATLANTA, August 8, 2025 -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the second quarter of 2025. Corporate Highlights from 2Q 2025 to date "Our second quarter marked several significan ...

Core Viewpoint - Femasys Inc. has made significant progress in securing regulatory approvals and expanding its commercialization efforts for its fertility portfolio, including the FemBloc and FemaSeed products, which aim to enhance accessibility and cost-effectiveness for women globally [3][4][19]. Group 1: Regulatory Approvals and Partnerships - The European approval of the FemBloc System marks the first global regulatory endorsement for Femasys's non-surgical permanent birth control solution, with initial commercial availability in Spain [3][7]. - Regulatory approvals for FemaSeed in Australia and New Zealand have been secured, providing opportunities for revenue growth and expansion [4][7]. - A new partnership with Carolinas Fertility Institute aims to enhance patient support and access to FemaSeed across its eight locations [4][7]. Group 2: Financial Performance - Sales for the second quarter of 2025 increased by $187,784, or 84.8%, reaching $409,268 compared to $221,484 in the same period of 2024, driven by FemaSeed and FemVue sales [8][16]. - Research and development expenses decreased by $561,446, or 28.4%, to $1,414,429 for the second quarter of 2025, primarily due to commercialization efforts and reduced clinical costs [8][16]. - The net loss for the second quarter of 2025 was $4,585,922, or ($0.16) per share, compared to a net loss of $4,684,574, or ($0.21) per share, for the same period in 2024 [8][17]. Group 3: Product Innovations - Femasys's fertility portfolio includes FemaSeed, which is over twice as effective as traditional intrauterine insemination (IUI) and has a comparable safety profile [18]. - FemBloc is the first non-surgical, in-office alternative to surgical sterilization, with full regulatory approval in Europe, and aims to provide a safer and more cost-effective solution [19]. - The FemChec diagnostic product complements FemBloc by providing an ultrasound-based test to confirm procedural success [19].

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].