Full Press Release Details
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 for first-line
infertility treatment and FemBloc non-surgical permanent birth control (full system approval pending in Europe) --
ATLANTA, May 8, 2025 -- Femasys Inc. (NASDAQ: 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
"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
For more information, please refer to the Company's Form 10-Q filed May 8, 2025, which can be accessed on the SEC
Condensed Balance Sheets
| Assets | March 31, 2025 | December 31, 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 |
Condensed Balance Sheets
| Liabilities and Stockholders' Equity | March 31, 2025 | December 31, 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 |
Condensed Statements of Comprehensive Loss
| 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 |
Femasys is a leading biomedical innovator focused on addressing critical unmet needs in women's health with a broad, patent-protected portfolio of disruptive, accessible,
in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys' fertility portfolio includes
FemaSeed Intratubal Insemination, a groundbreaking first-line infertility treatment and FemVue , a companion diagnostic for fallopian tube assessment. Published clinical trial data show FemaSeed is over twice as effective as
traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1
FemBloc permanent birth control, the first and only non-surgical, in-office alternative to centuries-old surgical sterilization, expects full regulatory
approval in Europe mid-year 2025. Commercialization of this highly cost effective, convenient and significantly safer approach, will begin in Spain through engaged partnerships followed by select European countries. Alongside FemBloc, the FemChec ,
diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For
Facebook and LinkedIn.
1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal
Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi:
10.33140/JGRM.08.02.08.
2Liu, J. H., Blumenthal, P. D., Casta o, P. M., Chudnoff, S.
C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1),
01-12. doi: 10.33140/JGRM.09.01.05.
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 obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to
demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, 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, 2024, 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.