Femasys Inc. — Q3 2026 Earnings Summary

Financial Performance:

• Total sales for the quarter ended September 30, 2026, were $404,597, a 44.5% decrease from $729,394 in the same period in 2025; U.S. sales increased slightly to $347,039 from $336,594.
• Total sales for the nine months ended September 30, 2026, were $1,161,313, a 21.5% decrease from $1,479,926 in 2025; U.S. sales increased slightly to $1,038,997 from $1,015,168.
• Net loss for the quarter ended September 30, 2026, was $4,564,815 ($0.53 per share), compared to a net loss of $4,194,821 ($2.05 per share) in 2025.
• Net loss for the nine months ended September 30, 2026, was $8,187,810 ($1.59 per share), compared to a net loss of $14,677,582 ($9.25 per share) in 2025.
• Research and development expenses for the quarter increased 40.6% to $1,942,927 from $1,382,022 in 2025; for the nine months, they decreased 9.8% to $5,199,206 from $5,764,923 in 2025.
• Sales and marketing expenses for the quarter were $943,002 compared to $1,143,805 in 2025; for the nine months, they were $3,552,755 compared to $3,037,349 in 2025.
• Cash and cash equivalents as of September 30, 2026, were $23,913,946, up from $9,266,353 as of December 31, 2025.
• Accumulated deficit as of September 30, 2026, was approximately $154.0 million.
• Total liabilities decreased to $8,059,496 from $14,854,875 as of December 31, 2025, driven by the elimination of conversion option and warrant liabilities.
• Total stockholders' equity increased to $27,028,162 from $5,869,302 as of December 31, 2025.

Guidance and Future Outlook:

• Management anticipates reorders for FemBloc from distributors after post-market studies are completed, as distributors are currently utilizing existing inventory.
• The company expects to broaden adoption and drive revenue growth by deploying its commercial team in target U.S. territories following the completion of recruitment efforts.
• The company is advancing FemBloc toward U.S. FDA approval through the ongoing FINALE pivotal trial.

Business Segments and Product Lines:

• FemaSeed Fertility Portfolio (including FemVue, SpermVue, FemaSeed, and FemSperm) secured partnerships with UNC Health and Minnesota Women's Care to introduce the portfolio across OB/GYN practice locations.
• Partnerships were announced with CapexMD for patient financing solutions and SandsRx Pharmacy to support treatment timing.
• FemBloc Permanent Birth Control received FDA approval of the modular premarket approval (PMA) submission approach.
• The number of actively enrolling sites in the FINALE trial for FemBloc doubled to twelve.
• Patents were issued in the U.S. and key international markets expanding intellectual property protection for the FemBloc blended polymer component.

Market and Competitive Landscape:

• The company cites U.S. fertility rates at historic lows as a driver for the need to bring treatment to the OB/GYN office.
• FemBloc has received regulatory approvals in Europe, the UK, and New Zealand in 2025, supporting commercialization through strategic partnerships in select international markets.
• The company notes that the overall sales decline reflects distributors' customary bulk-ordering practices and the timing of international FemBloc orders.

Risks and Challenges:

• The company faced significant funding constraints prior to mid-August financing, which limited commercial team build-out and sales growth during the quarter.
• Forward-looking statements highlight risks regarding the ability to obtain regulatory approvals for FemBloc, successfully enroll and complete the FINALE pivotal trial, and demonstrate safety and effectiveness.
• Risks include the ability to commercialize products, establish or grow sales and revenues, and the potential for delays in commercializing FemaSeed.

Management Commentary and Tone:

• CEO Kathy Lee-Sepsick described the closing of the $30 million financing in mid-August 2026 as an "important turning point" for the company.
• Management expressed strong confidence that deploying the commercial team in target U.S. territories will drive revenue growth, citing successful commercial recruitment and initial sales achieved with limited resources.
• The company maintained a lean team and tightly managed resources while prioritizing financing from long-term institutional investors.

Other Key Points:

• Completed a $30 million private placement with potential total proceeds of up to $85 million upon full cash exercise of warrants.
• Proceeds from the private placement are designated to build out the U.S. commercial team and fund the FemBloc pivotal trial.
• Weighted-average common shares and pre-funded warrants outstanding for the quarter ended September 30, 2026, were 8,660,381, compared to 2,050,761 in 2025.
• The company filed its Form 10-Q for the quarter ended September 30, 2026, on November 13, 2026.