Femasys Announces Financial Results for Year Ended December 31, 2024, and Provides Corporate Update
-- Company expands commercial product offering with FemBloc® permanent birth control (delivery system) approval in Europe and signed partnerships for distribution in Spain --
ATLANTA, March 27, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the year ended December 31, 2024 and provides a corporate update.
Corporate Highlights from 4Q 2024 to date
Announced FemBloc® permanent birth control (delivery system) approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review
Announced partnership with CNY Fertility, national conglomerate of 11 fertility centers, to offer FemaSeed®
Announced strategic distribution partnerships for FemBloc in Spain
Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials
Announced UK and Israeli regulatory approvals for FemaSeed and two diagnostic devices
Announced notices of intention to grant two new European patent applications for FemBloc
Announced notice of allowance for new U.S. patent application for FemaSeed
Announced partnership with HRC Fertility, conglomerate provider of fertility services in Western U.S., to offer FemaSeed
Announced partnership with Boston IVF, prominent network of 30 centers nationwide, to offer FemaSeed
Announced peer-reviewed publication of positive safety and efficacy results from FemaSeed pivotal trial
"During the fourth quarter of 2024 and first quarter of 2025 we achieved significant regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination products," said Femasys' CEO Kathy Lee-Sepsick. "We are focused on executing on commercialization of FemaSeed and expect U.S. revenue to increase by approximately 50% in first quarter of 2025 versus fourth quarter of 2024. We are continuing to advance our FemBloc to commercialization in Europe while executing on the clinical pivotal trial for U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2025. We remain committed to addressing major gaps in women's reproductive health by advancing safe and effective, technologically advanced product solutions."
Financial Results for Year Ended December 31, 2024
Sales increased by $557,138, or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023
Research and development expenses increased by $1,007,842, or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023
Net loss was $18,816,628, or ($0.85) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2024, compared to net loss of $14,247,124, or ($0.93) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023
Cash and cash equivalents as of December 31, 2024, was $3.5 million and the Company had an accumulated deficit of $127.2 million. The Company expects, based on its current operating plan, our current cash and cash equivalents, which includes approximately $5.4 million we raised subsequent to year end, will be sufficient to fund its ongoing operations into third quarter of 2025.
For more information, please refer to the Company's Form 10-K filed March 27, 2025, which can be accessed on the SEC website.
FEMASYS INC.
Balance Sheets
(unaudited)
Assets
December 31, 2024
December 31, 2023
Current assets:
Cash and cash equivalents
$
3,451,761
21,716,077
Accounts receivable, net
488,373
98,906
Inventory
3,046,323
667,118
Prepaid and other current assets
1,035,993
695,879
Total current assets
8,022,450
23,177,980
Property and equipment, at cost:
Leasehold improvements
1,238,886
1,212,417
Office equipment
60,921
47,308
Furniture and fixtures
417,876
414,303
Machinery and equipment
2,856,740
2,559,356
Construction in progress
762,445
423,077
5,336,868
4,656,461
Less accumulated depreciation
(3,740,769
)
(3,545,422
)
Net property and equipment
1,596,099
1,111,039
Long-term assets:
Lease right-of-use assets, net
1,805,543
2,380,225
Intangible assets, net of accumulated amortization
65,918
—
Other long-term assets
954,992
1,086,581