Femasys (FEMY) Q2 2024 earnings summary

Executive summary

• Achieved CE Mark and EU MDR certification for four women's health products, enabling European market entry and focused on minimally invasive, non-surgical reproductive health solutions.

• Completed pivotal trial enrollment for FemaSeed and initiated commercial launch; awaiting publication of pivotal trial data.

• U.S. commercial team fully onboarded and actively marketing infertility portfolio domestically.

• Engaged with U.S. government agencies and Congress to raise awareness of women's health initiatives.

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

Financial highlights

• Q2 2024 revenue was $221,484, down 30.9% year-over-year; six-month revenue was $492,624, down 19.8%.

• Net loss for Q2 2024 was $4,684,574, up 61.9% year-over-year; six-month net loss was $8,284,084, up 41.9%.

• Operating expenses rose sharply, with sales and marketing up 656.6% in Q2 and R&D expenses up 29.4% in Q2.

• Cash and cash equivalents at June 30, 2024 were $13.5 million; accumulated deficit reached $116.7 million.

• Gross margin for Q2 2024 was approximately 67%.

Outlook and guidance

• Cash is sufficient into July 2025, but not for twelve months from the report date; additional financing is required to fund ongoing operations and product development.

• FemaSeed sales expected to commence in the second half of 2024.

• Actively prioritizing U.S. commercialization and seeking European distribution partners.

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