Femasys (FEMY) Q3 2024 earnings summary

Executive summary

• Focused on minimally invasive, non-surgical reproductive health solutions, with a portfolio including FDA-cleared and CE-marked products for infertility and permanent birth control.

• Accelerated commercialization with new partnerships in the U.S. and Europe, including Boston IVF and Spanish distributors.

• Achieved significant regulatory milestones: EU MDR and CE Mark for four products, Health Canada approval, and FDA 510(k) clearance for new devices.

• Initiated commercial launch of FemaSeed in the U.S. and Europe, with first sales and strategic distribution partnerships in Spain and partnerships with major fertility clinics.

• Ongoing pivotal clinical trial for FemBloc, a permanent birth control solution, with all permitted sites actively enrolling.

Financial highlights

• Q3 2024 sales rose 127.1% year-over-year to $554,908, driven by FemaSeed and FemVue sales.

• Net loss for Q3 2024 was $5.41 million, or ($0.24) per share, compared to $4.00 million, or ($0.26) per share, in Q3 2023.

• Nine-month net loss was $13.69 million, or ($0.62) per share, up from $9.84 million, or ($0.74) per share, year-over-year.

• Cash and cash equivalents at September 30, 2024 were $7.61 million, down from $21.72 million at year-end 2023.

• Nine-month 2024 sales increased 22.0% year-over-year to $1.05 million.

Outlook and guidance

• Current cash is expected to fund operations into July 2025, but not for a full twelve months from the report date; additional financing will be required.

• Substantial doubt exists about the ability to continue as a going concern without new capital.

• Ongoing focus on commercial expansion of FemaSeed and advancing FemBloc clinical development.

• Additional FemaSeed sales anticipated in Q4 2024.