-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio --
ATLANTA, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the second quarter of 2025.
Corporate Highlights from 2Q 2025 to date
-- Announced European Union Medical Device Regulation approval of FemBloc$(R)$, the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution -- Secured first European order for FemBloc from Spain distribution partners for approximately $400,000 -- Announced Australian and New Zealand regulatory approvals for FemaSeed(R) and FemVue(R), a cost-effective first step in fertility -- Announced new Chief Commercial Officer to help drive execution and global growth -- Announced partnership with Carolinas Fertility Institute, one of America's best fertility clinics, to offer FemaSeed in its eight locations -- Announced pricing of underwritten public offering and concurrent private placement with gross proceeds of $4.5 million
"Our second quarter marked several significant milestones for Femasys as we continue to secure key regulatory approvals, add partners, and strengthen our team to accelerate the commercialization of our innovative fertility portfolio across the globe," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. "European approval of the entire FemBloc System announced in June marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution. FemBloc is commercially available through strategic distribution partnerships in select countries in Europe beginning in Spain, who placed their initial order, and we will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval.
"Regulatory approvals for FemaSeed in Australia and New Zealand announced in July also provide us with the opportunity to pursue meaningful commercial opportunities as we continue to grow revenue and broaden our global footprint. Our new partnership with Carolinas Fertility Institute will help us reach and support more patients earlier in their fertility journey. We look forward to building upon this momentum as we work towards transforming the fertility sector not only for patients, but also providers."
Financial Results for Quarter Ended June 30, 2025
-- Sales increased by $187,784, or 84.8%, to $409,268 for the three months
of 2025, compared to $221,484 for the three months of 2024 due to sales
of FemaSeed and FemVue.
-- Research and development expenses decreased by $561,446, or 28.4%, to
$1,414,429 for the three months of 2025 compared to $1,975,875 for the
three months of 2024 primarily due to commercialization of development
products into inventory and reduced clinical costs, partially offset by
increased compensation costs.
-- Net loss was $4,585,922, or ($0.16) per basic and diluted share
attributable to common stockholders, for the three-month period ended
June 30, 2025, compared to a net loss of $4,684,574, or ($0.21) per basic
and diluted share attributable to common stockholders, for the
three-month period ended June 30, 2024.
-- Cash and cash equivalents as of June 30, 2025, was approximately $3.2
million and the Company had an accumulated deficit of approximately
$137.7 million. The Company expects, based on its current operating plan,
our current cash and cash equivalents will be sufficient to fund its
ongoing operations into early fourth quarter of 2025.
Financial Results for Six Months Ended June 30, 2025
-- Sales increased by $257,908, or 52.4%, to $750,532 for the six months of
2025, compared to $492,624 for the six months of 2024 due to sales of
FemaSeed and FemVue.
-- Research and development expenses increased by $636,295, or 17.0%, to
$4,382,901 for the six months of 2025 compared to $3,746,606 for the six
months of 2024 primarily due to increased compensation and regulatory
costs, partially offset by reduced material and development costs and
clinical costs.
-- Net loss was $10,482,761, or ($0.39) per basic and diluted share
attributable to common stockholders, for the six-month period ended June
30, 2025, compared to a net loss of $8,284,084, or ($0.38) per basic and
diluted share attributable to common stockholders, for the same period
ended June 30, 2024.
For more information, please refer to the Company's Form 10-Q filed August 8, 2025, which can be accessed on the SEC website.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
June 30, December 31,
Assets 2025 2024
----------- --------------
Current assets:
Cash and cash equivalents $ 3,218,067 3,451,761
Accounts receivable, net 254,584 488,373
Inventory 5,232,738 3,046,323
Prepaid and other current assets 1,045,591 1,035,993
Total current assets 9,750,980 8,022,450
---------- -----------
Property and equipment, at cost:
Leasehold improvements 1,238,886 1,238,886
Office equipment 68,530 60,921
Furniture and fixtures 417,876 417,876
Machinery and equipment 3,211,109 2,856,740
Construction in progress 548,426 762,445
5,484,827 5,336,868
Less accumulated depreciation (3,884,964) (3,740,769)
Net property and equipment 1,599,863 1,596,099
---------- -----------
Long-term assets:
Lease right-of-use assets, net 1,544,724 1,805,543
Intangible assets, net of accumulated
amortization 55,638 65,918
Other long-term assets 829,204 954,992
Total long-term assets 2,429,566 2,826,453
Total assets $13,780,409 12,445,002
========== ===========
(continued)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders' June 30, December 31,
Equity 2025 2024
------------- ---------------
Current liabilities:
Accounts payable $ 3,263,584 1,419,044
Accrued expenses 1,052,752 1,151,049
Convertible notes payable, net
(including related parties) 6,080,813 5,406,228
Clinical holdback -- current
portion 63,990 88,581
Lease liabilities -- current
portion 502,468 517,967
Total current liabilities 10,963,607 8,582,869
------------ ------------
Long-term liabilities:
Clinical holdback -- long-term
portion 40,348 39,611
Lease liabilities -- long-term
portion 1,269,019 1,518,100
Total long-term liabilities 1,309,367 1,557,711
Total liabilities 12,272,974 10,140,580
------------ ------------
Commitments and contingencies
Stockholders' equity:
Common stock, $.001 par,
200,000,000 authorized,
32,692,630 shares issued and
32,575,407 outstanding as of
June 30, 2025; and 23,473,149
shares issued
and 23,355,926 outstanding as
of December 31, 2024 32,693 23,473
Treasury stock, 117,223 common
shares (60,000) (60,000)
Warrants 1,821,744 1,860,008
Additional paid-in-capital 137,394,016 127,679,198
Accumulated deficit (137,681,018) (127,198,257)
Total stockholders' equity 1,507,435 2,304,422
------------ ------------
Total liabilities and
stockholders' equity $ 13,780,409 12,445,002
============ ============
FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
Three Months Ended June
30, Six Months Ended June 30,
------------------------ ---------------------------
2025 2024 2025 2024
---------- ---------- ----------- ----------
Sales $ 409,268 221,484 750,532 492,624
Cost of sales (excluding
depreciation expense) 158,171 73,125 275,437 161,657
Operating expenses:
Research and development 1,414,429 1,975,875 4,382,901 3,746,606
Sales and marketing 984,977 975,190 1,893,544 1,275,677
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