FEMASYS INC

Femasys Inc. is a biomedical innovator focused on women's health, offering a portfolio of patent-protected therapeutic and diagnostic products. The company operates as a U.S. manufacturer with global regulatory approvals and commercialization efforts underway in the U.S. and key international markets ¹. The core business model revolves around developing and commercializing in-office medical device solutions that address significant unmet needs in reproductive health, aiming to provide alternatives to pharmaceutical solutions, implants, and surgery ². The company generates revenue primarily through the sale of its FemaSeed, FemBloc, and FemVue products to medical centers, including healthcare practitioner offices, through a direct commercial team in the U.S. and distribution partners internationally ³. Revenue recognition occurs upon shipment or delivery to the customer, based on contractual shipping terms ⁴.

The company's product and service lines include FemaSeed Intratubal Insemination, FemSperm, FemVue, FemVue Controlled, FemCerv, FemBloc permanent birth control, FemChec, and FemCath. FemaSeed is an FDA-cleared first-step infertility treatment designed to enhance fertilization by delivering sperm directly to the fallopian tube, and it is also approved in Europe, UK, Canada, Israel, Australia, and New Zealand ⁵. FemSperm comprises setup, preparation, and analysis kits that enable gynecologists to perform in-office sperm preparation and analysis for use with FemaSeed ⁶. FemVue is an FDA-cleared companion diagnostic for fallopian tube assessment via ultrasound, approved in Europe, UK, Canada, Japan, Israel, Australia, and New Zealand ⁷. FemVue Controlled is a next-generation diagnostic device integrating features of FemVue and FemChec for multiple clinical uses, including confirmation of tubal patency prior to FemaSeed use ⁸. FemCerv is an FDA-cleared endocervical tissue sampler for cervical cancer diagnosis, approved in Europe, UK, Canada, Israel, and New Zealand ⁹. FemBloc permanent birth control is a revolutionary first-in-class non-surgical solution involving the minimally-invasive placement of a patented delivery system for a proprietary synthetic tissue adhesive into both fallopian tubes simultaneously, leading to permanent blockage through scar tissue ¹⁰. FemBloc received CE mark certification in the EU in March 2025 for its delivery system and in June 2025 for its blended polymer component, achieving approval for the entire system in the EU ¹¹. It also received UK and New Zealand regulatory approvals in August and September 2025, respectively ¹². FemChec is an FDA-cleared companion diagnostic product for FemBloc's ultrasound-based confirmation test, approved in Europe, UK, Canada, Israel, Australia, and New Zealand ¹³. FemCath is an FDA-cleared device for selective fallopian tube evaluation, approved in Europe, Canada, and Israel ¹⁴.

For the fiscal year ended December 31, 2025, Femasys reported total sales of $2,293,313 ¹⁵, an increase from $1,629,108 in 2024 ¹⁶. Cost of sales (excluding depreciation expense) was $872,400 ¹⁷. The company incurred a net loss of $18,627,887 ¹⁸ for 2025, compared to a net loss of $18,816,628 ¹⁹ in 2024. Basic and diluted net loss per share attributable to common stockholders was $(0.47) ²⁰ for 2025, an improvement from $(0.85) ²¹ in 2024. As of December 31, 2025, cash and cash equivalents totaled $9,266,353 ²², and the accumulated deficit was $145,826,144 ²³. Total liabilities were $14,854,875 ²⁴, and total stockholders' equity was $5,869,302 ²⁵. Net cash used in operating activities was $(18,690,565) ²⁶.

Sales increased by $664,205 ²⁷, or 40.8% ²⁸, in 2025 compared to 2024, primarily driven by FemBloc product sales of $810,000 ²⁹, which were commercialized in 2025. Cost of sales increased by $327,497 ³⁰, or 60.1% ³¹, to $872,400 ³² in 2025, mainly due to increased sales and newly commercialized products. Research and development (R&D) expenses decreased by $638,839 ³³, or 7.8% ³⁴, to $7,577,704 ³⁵ in 2025, primarily due to reduced clinical costs, commercialization of development products into inventory, reduced professional fees, and reduced compensation, partially offset by increased regulatory costs. Sales and marketing expenses increased by $413,657 ³⁶, or 10.3% ³⁷, to $4,443,807 ³⁸ in 2025, mainly due to compensation, marketing, and travel costs as the company began recruiting a commercial team in 2024. General and administrative expenses increased by $320,038 ³⁹, or 5.1% ⁴⁰, to $6,646,037 ⁴¹ in 2025, primarily due to increased compensation expense. Depreciation and amortization expenses increased by $44,716 ⁴², or 15.0% ⁴³, to $342,034 ⁴⁴ in 2025 due to additional fixed and intangible assets in service. Net cash provided by financing activities was $25,135,255 ⁴⁵ in 2025, a significant increase from $2,027,457 ⁴⁶ in 2024, driven by proceeds from the November 2025 financing of $11,281,472 ⁴⁷, August 2025 financing of $10,388,073 ⁴⁸, and at-the-market sales of $6,802,767 ⁴⁹.

During 2025, Femasys announced CE mark certification under EU MDR for the FemBloc delivery system in March 2025 and for the class III blended polymer component in June 2025, achieving full EU approval ⁵⁰. In August and September 2025, FemBloc received UK and New Zealand regulatory approvals, respectively ⁵¹. Strategic distribution partnerships for FemBloc were announced in Spain in March 2025 and in France/Benelux region in September 2025 ⁵². The company received FDA approval in November 2025 for its IDE supplement to advance to the final phase of the pivotal clinical trial for FemBloc in the U.S., with enrollment initiated in March 2026 ⁵³. In August and September 2025, the FemSperm family of product kits became available through customized products and selected partnerships ⁵⁴. The company also entered into partnerships with prominent infertility center conglomerates, Boston IVF, HRC Fertility, and CNY Fertility, in October and December 2024 and March 2025, respectively, for FemaSeed and FemVue ⁵⁵.

Femasys anticipates that its current cash and cash equivalents of $9,266,353 ⁵⁶ as of December 31, 2025, along with anticipated revenues from product sales and approximately $0.4 million ⁵⁷ raised subsequent to year-end, will be sufficient to fund ongoing operations into the third quarter of 2026 ⁵⁸. However, this funding is not expected to be sufficient to sustain operations, including funding the U.S. product candidate, FemBloc, through regulatory approval ⁵⁹. The company will need to raise additional capital to complete the U.S. development and EU commercialization of FemBloc ⁶⁰.

A major growth area for Femasys is the commercialization of its FemBloc permanent birth control system. The company received CE mark certification for the FemBloc delivery system in March 2025 and for the class III blended polymer component in June 2025, securing full approval in the EU ⁶¹. Regulatory approvals in the UK and New Zealand followed in August and September 2025, respectively ⁶². Strategic distribution partnerships for FemBloc were established in Spain in March 2025 and in the France/Benelux region in September 2025 ⁶³. The company received FDA IDE approval in November 2025 for the final phase of the FINALE pivotal trial for U.S. approval, with enrollment initiated in March 2026 ⁶⁴. Management estimates the U.S. market for the FemBloc system may be over $20 billion ⁶⁵, with an immediate addressable market of over $3 billion annually ⁶⁶ from women electing surgical sterilization. The non-surgical, non-implant, in-office nature of FemBloc is expected to offer significant cost savings, potentially half the overall cost of surgical alternatives, and a confirmation test to ensure procedure success ⁶⁷.

Another significant growth area is the expansion of the infertility portfolio, particularly with FemaSeed and the new FemSperm product line. FemaSeed is an FDA-cleared intratubal insemination solution, approved in Europe, UK, Canada, Israel, Australia, and New Zealand ⁶⁸. The FemSperm product family, introduced in August and September 2025 through customized products and selected partnerships, includes setup, insemination preparation, and analysis kits, enabling gynecologists to perform in-office sperm preparation and analysis for use with FemaSeed ⁶⁹. This expansion aims to broaden access to fertility treatment earlier in the patient journey by activating gynecologists for sperm handling, eliminating the need for referral to an infertility specialist ⁷⁰. The immediately addressable U.S. market for FemaSeed, FemVue, and FemSperm is estimated to be over $1 billion ⁷¹. The company has also formed partnerships with prominent infertility center conglomerates, Boston IVF, HRC Fertility, and CNY Fertility, in October and December 2024 and March 2025, respectively ⁷².

Operationally, Femasys expects R&D expenses to increase in absolute dollars as it continues to develop FemBloc, expand its product candidate pipeline, enhance existing products, and pursue additional regulatory approvals ⁷³. Sales and marketing expenses are also expected to increase in absolute dollars as the company expands its sales force and marketing efforts to commercialize its products ⁷⁴. The company plans to continue manufacturing its products in-house but will consider outsourcing arrangements for certain sub-assemblies as commercial production scales ⁷⁵. The current manufacturing capacity is believed to be sufficient to meet clinical program demands and launch requirements for FemaSeed and FemBloc in the U.S. and select international countries, with the ability to scale up quickly with modest capital investment ⁷⁶.

Regarding capital allocation, Femasys intends to continue substantial investments in the ongoing pivotal trial for FemBloc and in R&D activities for future products, manufacturing, regulatory affairs, and post-market clinical trials ⁷⁷. Investments will also be made in the sales and marketing organization for FemaSeed and FemBloc ⁷⁸. The company has not declared or paid cash dividends and intends to retain all future earnings, if any, to finance business growth and development ⁷⁹. In November 2025, Femasys issued $12,000,000 ⁸⁰ in senior secured convertible notes, convertible into 16,378,563 ⁸¹ shares of common stock at a conversion price of $0.73 per share ⁸², accruing interest at 8.5% per annum ⁸³ payable in kind. Additionally, three series of warrants to purchase an aggregate of 49,135,689 ⁸⁴ shares of common stock were issued at exercise prices ranging from $0.81 to $1.10 per share ⁸⁵. The company also has an at-the-market facility to sell up to $9.8 million ⁸⁶ and an Any Market Purchase Agreement with Alumni Capital LP to sell up to $10 million ⁸⁷ in shares of common stock.

Management explicitly flagged several structural headwinds and execution risks. The company has incurred significant operating losses since inception and expects to continue incurring losses, with current cash and cash equivalents sufficient only into the third quarter of 2026 ⁸⁸. Substantial additional funding is required to complete the FINALE pivotal trial and file a PMA for FemBloc in the U.S. ⁸⁹. The company's ability to raise capital is constrained by the "baby shelf" rule, limiting sales to one-third of its public float in any 12 consecutive months while the public float remains below $75.0 million ⁹⁰. There is substantial doubt about the company's ability to continue as a going concern ⁹¹. The convertible notes and warrants issued in November 2025 pose a significant and compounding risk of dilution to existing stockholders ⁹². The company has received deficiency notices from Nasdaq for non-compliance with continued listing requirements, including the minimum $1.00 bid price, and faces potential delisting if compliance is not regained by July 13, 2026 ⁹³. Delays or failures in clinical trial enrollment and retention, as well as the lengthy and expensive regulatory approval process, could adversely affect commercial viability ⁹⁴. Market acceptance of new products is uncertain, and healthcare practitioners may be unwilling to change current practices ⁹⁵. Inadequate third-party payor coverage or reimbursement for products could severely hinder commercial success ⁹⁶. The company relies on a limited number of third-party suppliers for components and sterilization, and disruptions could have a material adverse effect ⁹⁷.

Femasys Inc. faces several material risks, including significant operating losses since inception and the expectation of continued losses, with an accumulated deficit of $145,826,144 ⁹⁸ as of December 31, 2025. There is substantial doubt about the company's ability to continue as a going concern, as current cash and cash equivalents, plus anticipated revenues, are only expected to fund operations into the third quarter of 2026 ⁹⁹. The company needs substantial additional funding to complete the U.S. clinical development of FemBloc and commercialization, but its ability to raise equity capital is constrained by the "baby shelf" rule, limiting sales to one-third of its public float in any 12 consecutive months while the public float is below $75.0 million ¹⁰⁰. The issuance of $12,000,000 ¹⁰¹ in senior secured convertible notes and warrants to purchase 49,135,689 ¹⁰² shares of common stock in November 2025 presents a significant and compounding risk of dilution to existing stockholders. The company has received Nasdaq deficiency notices for failing to maintain a minimum $35.0 million ¹⁰³ Market Value of Listed Securities and a $1.00 ¹⁰⁴ minimum bid price, with a final compliance period until July 13, 2026 ¹⁰⁵ to regain the bid price compliance, or face delisting. Clinical trials are expensive and time-consuming, with uncertain outcomes, and delays in enrollment or failure to demonstrate safety and effectiveness could prevent regulatory approval. Market acceptance of new products like FemBloc and FemaSeed is not guaranteed, as healthcare practitioners may be reluctant to change existing practices or due to inadequate third-party payor coverage. The company relies on a limited number of third-party suppliers for critical components and sterilization, and any disruptions could materially affect manufacturing and product delivery. The biomedical industry is highly competitive, with many competitors possessing greater resources and more established products. The company is also subject to extensive government regulations, including FDA and foreign regulatory approvals, and failure to comply or changes in regulations could harm the business. Product liability claims, particularly given the nature of medical devices affecting bodily functions, pose a significant risk, as exemplified by the Essure recall, and current insurance may not be adequate. Cybersecurity threats, including data breaches, could disrupt operations and lead to significant liabilities, despite current cybersecurity programs and insurance. Unfavorable global economic conditions, including inflation and rising interest rates, could adversely affect demand for products and the ability to raise capital.

Management's message to shareholders emphasizes Femasys Inc.'s position as a leading biomedical innovator addressing significant unmet needs in women's health globally, with a broad portfolio of patent-protected, disruptive, accessible, in-office therapeutic and diagnostic products. The company is a U.S. manufacturer with global regulatory approvals and active commercialization in the U.S. and key international markets. Management highlights the potential of its products, such as FemaSeed and FemBloc, to disrupt multi-billion dollar global market segments that have seen little advancement, by offering alternatives to expensive and potentially harmful pharmaceutical solutions, implants, and surgery. A key strategic priority is to execute on the clinical program to achieve FDA approval for the FemBloc system, which has already received CE mark certification in the EU in March 2025 for its delivery system and in June 2025 for its class III blended polymer component, as well as UK and New Zealand regulatory approvals in August and September 2025, respectively ¹⁰⁶. The company received FDA IDE approval in November 2025 for the final phase of the FINALE pivotal trial for U.S. approval, with enrollment initiated in March 2026 ¹⁰⁷. Another strategic priority is to execute on the commercial strategy for the FemaSeed product, along with its companion diagnostic FemVue and the new FemSperm sperm handling solution, as a first-line option for infertility treatment, building a specialized direct sales and marketing team ¹⁰⁸. Management also stresses the importance of continuously innovating to introduce additional product offerings for women and penetrating addressable markets by promoting patient and practice awareness. Despite these ambitions, management explicitly acknowledges the company's limited financial liquidity, stating that current cash and cash equivalents, along with anticipated revenues, are expected to fund operations only into the third quarter of 2026 ¹⁰⁹, and that substantial additional funding will be required to complete the U.S. development and EU commercialization of FemBloc ¹¹⁰.