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].

Financial Performance - Sales for the three months ended March 31, 2025, were $341,264, an increase of 26% compared to $271,140 for the same period in 2024[18] - Net loss for the three months ended March 31, 2025, was $5.90 million, compared to a net loss of $3.60 million in the same period last year, reflecting a 63.9% increase in losses[18] - For the three months ended March 31, 2025, the company reported a net loss of $5,896,839, compared to a net loss of $3,599,510 for the same period in 2024, indicating an increase in losses[34] - The net loss attributable to common stockholders for the three months ended March 31, 2025, was $5,896,839, compared to a net loss of $3,599,510 for the same period in 2024, representing an increase of 63.8%[76] Assets and Liabilities - Total assets increased to $13.28 million as of March 31, 2025, up from $12.45 million at the end of 2024, representing a growth of 6.7%[14] - Cash and cash equivalents increased to $3.82 million as of March 31, 2025, from $3.45 million at the end of 2024, marking a 10.7% increase[14] - Total current liabilities rose to $9.84 million as of March 31, 2025, compared to $8.58 million at the end of 2024, an increase of 14.7%[16] - The accumulated deficit increased to $133.10 million as of March 31, 2025, from $127.20 million at the end of 2024, indicating a rise of 4.6%[16] Operating Expenses - Operating expenses totaled $5.68 million for Q1 2025, up 55.9% from $3.65 million in Q1 2024[18] - The total operating expenses for the three months ended March 31, 2025, were $5,684,605, up from $3,645,250 in the same period of 2024[80] - Research and development expenses rose to $2.97 million in Q1 2025, up 67.5% from $1.77 million in Q1 2024[18] - The company recognized total research and development expenses of $2,968,472 for the three months ended March 31, 2025, compared to $1,770,731 for the same period in 2024, reflecting a significant increase of 67.5%[80] Cash Flow - The company generated net cash used in operating activities of $4,765,214 for the three months ended March 31, 2025, compared to $4,568,124 for the same period in 2024[34] - The company raised $5,392,027 from at-the-market sales of common stock during the three months ended March 31, 2025, significantly higher than $802,242 in the same period of 2024[34] Stock and Financing - The company issued 3,731,960 shares of common stock in connection with an at-the-market offering, raising approximately $5.22 million[21] - The Company issued senior unsecured convertible notes totaling $6,850,000, convertible at a price of $1.18 per share, along with Series A and B Warrants to purchase up to 5,805,083 shares at exercise prices of $1.18 and $1.475 respectively[53] - The Series A Warrants allow for the purchase of up to 5,805,083 shares of common stock at an exercise price of $1.18 per share, expiring five years from the date of issuance[56] - The Company sold approximately 3.7 million shares of common stock for aggregate proceeds of approximately $5.4 million during the quarter ended March 31, 2025[61] Inventory and Assets - Inventory increased to $3,862,188 as of March 31, 2025, from $3,046,323 as of December 31, 2024, reflecting a growth in materials and finished goods[45] - As of March 31, 2025, the Company had 27,087,886 shares of common stock outstanding, with no dividends declared or paid[62] Future Outlook - The company anticipates continued growth in sales and market acceptance of its products, including FemBloc® and FemaSeed®[10] - The pivotal clinical trial for FemBloc is currently enrolling participants for U.S. approval, highlighting ongoing product development efforts[28] - The company plans to finance its operations through existing cash, equity, debt financing, and anticipated revenue from domestic and international sales of its products[33] - The company has an accumulated deficit of $133,095,096 as of March 31, 2025, and expects to incur additional losses and negative operating cash flows for at least the next twelve months[35] Regulatory and Market Developments - The company announced CE mark certification for the FemBloc delivery system in March 2025, marking a significant regulatory milestone for its non-surgical permanent birth control product[28] - Strategic distribution partnerships for FemBloc were announced in Spain in March 2025, indicating market expansion efforts[28] Interest and Tax - For the three months ended March 31, 2025, the Company recognized total interest expense of $459,449, an increase from $361,522 for the same period in 2024[59] - The effective tax rate for the three months ended March 31, 2025, was 0%, consistent with the previous year, due to the company remaining in a full valuation allowance position[77] Share-Based Compensation - The total share-based compensation expense for the three months ended March 31, 2025, was $367,237, significantly higher than $77,585 for the same period in 2024[71] - The company has a remaining share-based compensation expense of $2,034,357 expected to be recognized in future periods[71]

[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]

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]