Full Press Release Details
Femasys Announces Financial Results for Quarter Ended June 30, 2024 and Provides Corporate Update
-- Company gained CE Mark approval for four of its women's health products and completed buildout of commercial team for its
infertility portfolio --
ATLANTA, August 8, 2024 -- 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 June 30, 2024 and provides a corporate update.
Corporate Highlights from 2Q 2024 to date
"The recruitment and subsequent onboarding of our commercial team, consisting of highly qualified professionals with specific expertise in women's health is complete and
our team has recently begun actively marketing our products in the U.S.. We believe that our novel fertility solution FemaSeed , which demonstrated pregnancy rates more than double the historic intrauterine
insemination (IUI) pregnancy rates for male factor infertility (i.e., low sperm count), is an improved alternative and a viable option prior to in vitro fertilization (IVF) that is considerably more financially and emotionally burdensome. As we
await announcement of published data for the FemaSeed prospective multi-center pivotal trial, we are actively prioritizing our U.S. efforts and concurrently identifying strategic distribution
partners in Europe," said Femasys' CEO Kathy Lee-Sepsick.
Financial Results for Quarter Ended June 30, 2024
Financial Results for Six Months Ended June 30, 2024
For more information, please refer to the Company's Form 10-Q filed August 8, 2024, which can be accessed on the SEC website.
PART I. FINANCIAL INFORMATION
ITEM I. Financial Statements
Condensed Balance Sheets
| Assets | June 30, 2024 | December 31, 2023 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,525,898 | 21,716,077 | |||||
| Accounts receivable, net | 92,535 | 98,906 | ||||||
| Inventory, net | 1,315,580 | 667,118 | ||||||
| Prepaid and other current assets | 997,623 | 695,879 | ||||||
| Total current assets | 15,931,636 | 23,177,980 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,212,417 | 1,212,417 | ||||||
| Office equipment | 47,308 | 47,308 | ||||||
| Furniture and fixtures | 429,933 | 414,303 | ||||||
| Machinery and equipment | 2,599,994 | 2,559,356 | ||||||
| Construction in progress | 651,157 | 423,077 | ||||||
| 4,940,809 | 4,656,461 | |||||||
| Less accumulated depreciation | (3,678,450 | ) | (3,545,422 | ) | ||||
| Net property and equipment | 1,262,359 | 1,111,039 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 2,081,054 | 2,380,225 | ||||||
| Intangible assets, net of accumulated amortization | 44,317 | - | ||||||
| Other long-term assets | 957,078 | 1,086,581 | ||||||
| Total long-term assets | 3,082,449 | 3,466,806 | ||||||
| Total assets | $ | 20,276,444 | 27,755,825 |
Condensed Balance Sheets
| Liabilities and Stockholders' Equity | June 30, 2024 | December 31, 2023 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 951,510 | 1,137,823 | |||||
| Accrued expenses | 886,352 | 1,444,296 | ||||||
| Clinical holdback - current portion | 92,397 | 65,300 | ||||||
| Lease liabilities - current portion | 533,734 | 406,636 | ||||||
| Total current liabilities | 2,463,993 | 3,054,055 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback - long-term portion | 32,706 | 54,935 | ||||||
| Convertible notes payable, net (including related parties) | 4,758,017 | 4,258,179 | ||||||
| Lease liabilities - long-term portion | 1,771,487 | 2,036,067 | ||||||
| Total long-term liabilities | 6,562,210 | 6,349,181 | ||||||
| Total liabilities | 9,026,203 | 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 June 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 | 125,344,962 | 123,985,306 | ||||||
| Accumulated deficit | (116,665,713 | ) | (108,381,629 | ) | ||||
| Total stockholders' equity | 11,250,241 | 18,352,589 | ||||||
| Total liabilities and stockholders' equity | $ | 20,276,444 | 27,755,825 |
The accompanying notes are an integral part of these condensed unaudited financial statements.
Condensed Statements of Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Sales | $ | 221,484 | 320,514 | 492,624 | 614,498 | |||||||||||
| Cost of sales (excluding depreciation expense) | 73,125 | 110,469 | 161,657 | 215,589 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,975,875 | 1,527,172 | 3,746,606 | 3,064,611 | ||||||||||||
| Sales and marketing | 975,190 | 128,899 | 1,275,677 | 373,795 | ||||||||||||
| General and administrative | 1,611,817 | 1,356,637 | 3,114,621 | 2,671,774 | ||||||||||||
| Depreciation and amortization | 67,628 | 133,299 | 138,856 | 266,365 | ||||||||||||
| Total operating expenses | 4,630,510 | 3,146,007 | 8,275,760 | 6,376,545 | ||||||||||||
| Loss from operations | (4,482,151 | ) | (2,935,962 | ) | (7,944,793 | ) | (5,977,636 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 184,138 | 42,652 | 408,822 | 139,741 | ||||||||||||
| Interest expense | (388,311 | ) | (198 | ) | (749,863 | ) | (1,870 | ) | ||||||||
| Total other income (expense), net | (204,173 | ) | 42,454 | (341,041 | ) | 137,871 | ||||||||||
| Loss before income taxes | (4,686,324 | ) | (2,893,508 | ) | (8,285,834 | ) | (5,839,765 | ) | ||||||||
| Income tax benefit | (1,750 | ) | - | (1,750 | ) | - | ||||||||||
| Net loss | $ | (4,684,574 | ) | (2,893,508 | ) | (8,284,084 | ) | (5,839,765 | ) | |||||||
| Net loss attributable to common stockholders, basic and diluted | $ | (4,684,574 | ) | (2,893,508 | ) | (8,284,084 | ) | (5,839,765 | ) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.21 | ) | (0.22 | ) | (0.38 | ) | (0.47 | ) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 22,215,516 | 13,107,590 | 21,995,436 | 12,493,334 |
The accompanying notes are an integral part of these condensed unaudited financial statements.
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
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
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, 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.