Femasys Announces Financial Results for Quarter Ended March 31, 2025, and Provides Corporate Update
-- Company delivers on mission to transform women's health with innovative solutions, including FemaSeed$(R)$ for first-line infertility treatment and FemBloc(R) non-surgical permanent birth control (full system approval pending in Europe) --
ATLANTA, May 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, 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 quarter ended March 31, 2025 and provides a corporate update.
Corporate Highlights from 1Q 2025 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 United Kingdom and Israeli regulatory approvals for FemaSeed
and two diagnostic devices
-- Announced partnership with CNY Fertility, a national conglomerate of
eleven fertility centers, to offer FemaSeed
-- Announced distribution partnerships for FemBloc in Spain
-- Announced peer-reviewed publication of positive safety and efficacy
results from FemBloc clinical trials
-- 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
"Securing the first regulatory approval globally for the FemBloc delivery system marks a key milestone toward full system approval and the introduction of a first-of-its-kind, non-surgical permanent birth control option for women in Europe," said Femasys' CEO Kathy Lee-Sepsick. "Additionally in the first quarter of 2025, we began executing our commercialization strategy for FemaSeed, achieving a 78% quarter-over-quarter sales increase in the U.S., an encouraging early indicator of strong market momentum and the unmet need for additional fertility treatment options. We remain dedicated to closing critical gaps in women's reproductive health through the advancement of safe, effective, accessible and innovative solutions."
Financial Results for Quarter Ended March 31, 2025
-- Sales increased by $70,124, or 25.9%, to $341,264 for the three months of
2025, from $271,140 for the three months of 2024 due to sales of FemaSeed
-- Research and development expenses increased by $1,197,741, or 67.6%, to
$2,968,472 for the three months of 2025 from $1,770,731 for the three
months of 2024 primarily due to increased regulatory costs, material and
development costs, and compensation costs
-- Net loss was $5,896,839, or ($0.23) per basic and diluted share
attributable to common stockholders, for the three-month period ended
March 31, 2025, compared to net loss of $3,599,510, or ($0.17) per basic
and diluted share attributable to common stockholders, for the same
period ended March 31, 2024
-- Cash and cash equivalents as of March 31, 2025, was approximately $3.8
million and the Company had an accumulated deficit of approximately
$133.1 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 third quarter of 2025.
For more information, please refer to the Company's Form 10-Q filed May 8, 2025, which can be accessed on the SEC website.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
March 31, December 31,
Assets 2025 2024
------------ --------------
Current assets:
Cash and cash equivalents $ 3,820,208 3,451,761
Accounts receivable, net 233,598 488,373
Inventory 3,862,188 3,046,323
Prepaid and other current
assets 1,216,258 1,035,993
Total current
assets 9,132,252 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 3,068,033 2,856,740
Construction in progress 600,551 762,445
5,393,876 5,336,868
Less accumulated depreciation (3,818,451) (3,740,769)
Net property
and
equipment 1,575,425 1,596,099
----------- -----------
Long-term assets:
Lease right-of-use assets, net 1,673,336 1,805,543
Intangible assets, net of
accumulated amortization 58,747 65,918
Other long-term assets 838,043 954,992
Total
long-term
assets 2,570,126 2,826,453
Total assets $ 13,277,803 12,445,002
=========== ===========
(continued)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders' March 31, December 31,
Equity 2025 2024
------------- ---------------
Current liabilities:
Accounts payable $ 2,331,794 1,419,044
Accrued expenses 1,170,288 1,151,049
Convertible notes payable,
net (including related
parties) 5,762,927 5,406,228
Clinical holdback -- current
portion 65,946 88,581
Lease liabilities -- current
portion 510,171 517,967
Total current
liabilities 9,841,126 8,582,869
------------ ------------
Long-term liabilities:
Clinical holdback --
long-term portion 47,140 39,611
Lease liabilities --
long-term portion 1,392,820 1,518,100
Total long-term
liabilities 1,439,960 1,557,711
Total
liabilities 11,281,086 10,140,580
------------ ------------
Commitments and contingencies
Stockholders' equity:
Common stock, $.001 par,
200,000,000 authorized,
27,205,109 shares issued and
27,087,886 outstanding as of
March 31, 2025; and
23,473,149 shares issued
and 23,355,926 outstanding
as of December 31, 2024 27,205 23,473
Treasury stock, 117,223
common shares (60,000) (60,000)
Warrants 1,860,008 1,860,008
Additional paid-in-capital 133,264,600 127,679,198
Accumulated deficit (133,095,096) (127,198,257)
Total
stockholders'
equity 1,996,717 2,304,422
------------ ------------
Total
liabilities
and
stockholders'
equity $ 13,277,803 12,445,002
------------ ------------
FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
Three Months Ended March 31,
-------------------------------
2025 2024
----------- -----------
Sales $ 341,264 271,140
Cost of sales (excluding
depreciation expense) 117,266 88,532
Operating expenses:
Research and development 2,968,472 1,770,731
Sales and marketing 908,567 300,487
General and administrative 1,722,713 1,502,804
Depreciation and amortization 84,853 71,228
Total
operating
expenses 5,684,605 3,645,250
Loss from
operations (5,460,607) (3,462,642)
----------- -----------
Other (expense) income:
Interest income 19,029 224,684
Interest expense (459,449) (361,552)
Total other
(expense)
income, net (440,420) (136,868)
----------- -----------
Loss before
income taxes (5,901,027) (3,599,510)
Income tax expense (benefit) (4,188) --
----------- -----------
Net loss $ (5,896,839) (3,599,510)
=========== ===========
Net loss attributable to common
stockholders, basic and
diluted $ (5,896,839) (3,599,510)
=========== ===========
Net loss per share attributable
to common stockholders, basic
and diluted $ (0.23) (0.17)
Weighted-average shares used in
computing net loss per share
attributable to common
stockholders, basic and
diluted 25,149,236 21,775,357
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