Femasys Announces Financial Results for Quarter Ended September 30, 2024, and Provides Corporate Update
November 12 2024 - 8:30AM
Femasys Inc. (NASDAQ: 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®
- 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® 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®, 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® 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) |
|
|
Assets |
|
September 30,2024 |
|
December 31,2023 |
|
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’ Equity |
|
September 30,2024 |
|
December 31,2023 |
|
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 September 30, |
|
Nine Months Ended 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 |
|
|
|
|
|
|
|
Loss before income taxes |
|
(5,407,702 |
) |
|
(3,996,905 |
) |
|
(13,693,536 |
) |
|
(9,836,670 |
) |
|
|
Income tax expense (benefit) |
|
1,158 |
|
|
— |
|
|
(592 |
) |
|
— |
|
|
|
|
|
|
|
Net loss |
$ |
(5,408,860 |
) |
|
(3,996,905 |
) |
|
(13,692,944 |
) |
|
(9,836,670 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders, basic and
diluted |
$ |
(5,408,860 |
) |
|
(3,996,905 |
) |
|
(13,692,944 |
) |
|
(9,836,670 |
) |
|
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.24 |
) |
|
(0.26 |
) |
|
(0.62 |
) |
|
(0.74 |
) |
|
Weighted-average shares used in computing net loss per share
attributable to common stockholders, basic and diluted |
|
22,232,799 |
|
|
15,093,147 |
|
|
22,075,135 |
|
|
13,369,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
About Femasys
Femasys is 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
solutions, including a lead revolutionary product candidate and
FDA-cleared products. FemaSeed® Intratubal Insemination, an
innovative infertility treatment designed to deliver sperm directly
where conception occurs, is FDA-cleared and has received regulatory
approval in Canada and Europe. FemBloc® permanent birth
control in late-stage clinical development is the first and only
non-surgical, in-office, permanent birth control method intended to
be a safer option for women at substantially less cost than the
long-standing surgical alternative. The Company has developed
diagnostic products that are complementary for which it has
achieved regulatory approvals to market in the U.S., Canada,
Europe, and other ex-U.S. territories, and which are
commercial-ready due to its in-house manufacturing capabilities.
Its diagnostic products include FemVue® and FemVue® Mini for
fallopian tube assessment by ultrasound, which can be used in
conjunction with FemCath®, an intrauterine catheter for selective
fallopian tube evaluation, and FemCerv®, an endocervical tissue
sampler for cervical cancer diagnosis. Learn more at
www.femasys.com, or follow us on X, Facebook and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that are
subject to substantial risks and uncertainties. Forward-looking
statements can be identified by terms such as “may,” “will,”
“should,” “expect,” “plan,” “anticipate,” “could,” “pending,”
“intend,” “believe,” “suggests,” “potential,” “hope,” or “continue”
or the negative of these terms or other similar expressions,
although not all forward-looking statements contain these words.
Forward-looking statements are based on our current expectations
and are subject to inherent uncertainties, risks and assumptions,
many of which are beyond our control, difficult to predict and
could cause actual results to differ materially from what we
expect. Further, certain forward-looking statements are based on
assumptions as to future events that may not prove to be
accurate. Factors that could cause actual results to differ
include, among others: our ability to develop and advance our
current product candidates and programs into, and successfully
initiate, enroll and complete, clinical trials; the ability of our
clinical trials to demonstrate safety and effectiveness of our
product candidates and other positive results; estimates regarding
the total addressable market for our products and product
candidates; our ability to commercialize our products and product
candidates, our ability to establish, maintain, grow or increase
sales and revenues, or the effect of delays in commercializing our
products, including FemaSeed; our business model and strategic
plans for our products, technologies and business, including our
implementation thereof; and those other risks and uncertainties
described in the section titled "Risk Factors" in our Annual Report
on Form 10-K for the year ended December 31, 2023, and other
reports as filed with the SEC. Forward-looking statements contained
in this press release are made as of this date, and Femasys
undertakes no duty to update such information except as required
under applicable law.
Contacts:
Investors:Matt BlazeiIR@femasys.com
Media:Kati WaldenburgMedia@femasys.com
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