Femasys Announces Financial Results for Quarter Ended September 30, 2024, and Provides Corporate Update
Company accelerated commercialization with significant new partnerships both in the U.S. and Europe
ATLANTA, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the quarter ended September 30, 2024 and provides a corporate update.
Corporate Highlights from 3Q 2024 to date
-- Announced partnership with Boston IVF, prominent network of fertility
centers, to offer FemaSeed$(R)$
-- Announced the onboarding of the first infertility medical clinic
customers to offer FemaSeed infertility treatment to patients in
California and Florida
-- Announced strategic distribution partnerships for CE-marked products,
including FemaSeed and FemVue(R) in Spain, which are anticipated to
generate over $1.3 million over the next year
-- Received second order from Spain strategic distribution partners after
successfully completing commercial FemaSeed infertility treatments
-- Received 510(k) clearance from FDA for FemChec(R), an innovative
diagnostic solution for fallopian tube check
-- Received CE Mark certification and product approval from Health Canada,
the Public Health Agency of Canada, for our compact, eco-friendly FemVue
MINI for fallopian tube assessment
-- Announced issuance of U.S. patent covering FemBloc(R) device for female
permanent birth control
"We continue to achieve significant commercial milestones with regard to our FemaSeed first-line infertility treatment and its supporting FemVue product. Notably, in 3Q we began commercialization of FemaSeed in the U.S., including a high-profile conglomerate, as well as in Europe with two partners in Spain. We look forward to collaborating with our expanding group of partners as we bring our next generation advancements to women," said Femasys' CEO Kathy Lee-Sepsick.
Financial Results for Quarter Ended September 30, 2024
-- Sales increased by $310,547, or 127.1%, to $554,908 in Q3 of 2024 from
$244,361 in Q3 of 2023, due to increased sales of FemaSeed and FemVue.
The Company recorded its first FemaSeed U.S. and international sales for
the three months ended September 30, 2024, and additional sales are
expected in the 4th quarter of 2024.
-- Research and development expenses increased by $230,411, or 11.1%, to
$2,303,241 in Q3 of 2024 from $2,072,830 in Q3 of 2023.
-- Net loss was $5,408,860, or ($0.24) per basic and diluted share
attributable to common stockholders, for the quarter ended September 30,
2024, compared to net loss of $3,996,905, or ($0.26) per basic and
diluted share attributable to common stockholders, for the quarter ended
September 30, 2023.
-- Cash and cash equivalents as of September 30, 2024, was $7.6 million and
the Company had an accumulated deficit of $122.1 million. The Company
expects, based on its current operating plan, that its existing cash and
cash equivalents will be sufficient to fund its ongoing operations into
July 2025.
Financial Results for Nine Months Ended September 30, 2024
-- Sales increased by $188,673, or 22.0%, to $1,047,532 for the nine months
of 2024, from $858,859 for the nine months of 2023 due to increased sales
of FemaSeed and FemVue.
-- R&D expenses increased by $912,406 or 17.8%, to $6,049,847 for the nine
months of 2024, from $5,137,441 for the nine months of 2023.
-- Net loss was $13,692,944, or ($0.62) per basic and diluted share
attributable to common stockholders, for the nine-month period ended
September 30, 2024, compared to net loss of $9,836,670, or ($0.74) per
basic and diluted share attributable to common stockholders, for the same
period ended September 30, 2023.
For more information, please refer to the Company's Form 10-Q filed November 12, 2024, which can be accessed on the SEC website.
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
September 30, December 31,
Assets 2024 2023
------------- ------------
Current assets:
Cash and cash equivalents $ 7,611,210 21,716,077
Accounts receivable, net 378,290 98,906
Inventory, net 1,937,670 667,118
Prepaid and other current
assets 1,370,523 695,879
Total current assets 11,297,693 23,177,980
------------ -----------
Property and equipment, at
cost:
Leasehold improvements 1,238,886 1,212,417
Office equipment 67,231 47,308
Furniture and fixtures 433,584 414,303
Machinery and equipment 2,848,833 2,559,356
Construction in progress 548,149 423,077
5,136,683 4,656,461
Less accumulated
depreciation (3,748,393) (3,545,422)
Net property and
equipment 1,388,290 1,111,039
------------ -----------
Long-term assets:
Lease right-of-use
assets, net 1,941,624 2,380,225
Intangible assets, net of
accumulated amortization 70,064 --
Other long-term assets 887,410 1,086,581
Total long-term
assets 2,899,098 3,466,806
Total assets $ 15,585,081 27,755,825
============ ===========
(continued)
FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders' September 30, December 31,
Equity 2024 2023
------------- -------------
Current liabilities:
Accounts payable $ 1,121,873 1,137,823
Accrued expenses 1,127,645 1,444,296
Clinical holdback -- current
portion 92,170 65,300
Lease liabilities -- current
portion 525,752 406,636
Total current
liabilities 2,867,440 3,054,055
------------ ------------
Long-term liabilities:
Clinical holdback --
long-term portion 36,081 54,935
Convertible notes payable,
net (including related
parties) 5,068,556 4,258,179
Lease liabilities --
long-term portion 1,643,217 2,036,067
Total long-term
liabilities 6,747,854 6,349,181
Total
liabilities 9,615,294 9,403,236
------------ ------------
Commitments and contingencies
Stockholders' equity:
Common stock, $.001 par,
200,000,000 authorized,
22,350,022 shares issued and
22,232,799 outstanding as of
September 30, 2024; and
21,774,604 shares issued
and 21,657,381 outstanding
as of December 31, 2023 22,350 21,775
Treasury stock, 117,223
common shares (60,000) (60,000)
Warrants 2,608,642 2,787,137
Additional paid-in-capital 125,473,368 123,985,306
Accumulated deficit (122,074,573) (108,381,629)
Total
stockholders'
equity 5,969,787 18,352,589
------------ ------------
Total
liabilities
and
stockholders'
equity $ 15,585,081 27,755,825
============ ============
FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------ --------------------------
2024 2023 2024 2023
---------- ---------- ----------- -----------
Sales $ 554,908 244,361 1,047,532 858,859
Cost of sales (excluding
depreciation expense) 190,839 86,186 352,496 301,775
Operating expenses:
Research and development 2,303,241 2,072,830 6,049,847 5,137,441
Sales and marketing 1,572,189 70,883 2,847,866 444,678
General and administrative 1,530,791 1,970,408 4,645,412 4,642,182
Depreciation and amortization 76,288 125,318 215,144 391,683
Total operating expenses 5,482,509 4,239,439 13,758,269 10,615,984
Loss from operations (5,118,440) (4,081,264) (13,063,233) (10,058,900)
---------- ---------- ----------- -----------
Other income (expense):
Interest income 124,028 92,392 532,850 232,133
Interest expense (413,290) (8,033) (1,163,153) (9,903)
Total other income
(expense), net (289,262) 84,359 (630,303) 222,230
---------- ---------- ----------- -----------
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