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Femasys Announces Financial Results for Year Ended December 31, 2023 and Provides Corporate Update

ATLANTA, March 28, 2024 (GLOBE NEWSWIRE) -- 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 year ended December 31, 2023 and provides a corporate update.

Corporate Highlights from 4Q 2023 to date

  • Company announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility
  • Following FDA clearance of FemaSeed, the Company’s revolutionary approach to artificial insemination, Femasys announced completion of enrollment in pivotal trial in support of commercial launch
  • Activated enrollment for remaining clinical sites of initial phase of pivotal trial for FemBloc®, the Company’s proprietary solution for permanent non-surgical birth control
  • Appointed Richard Spector as Chief Commercial Officer and James Liu, M.D. as Chief Medical Officer

“The end of 2023 marked a significant milestone for the Company as we achieved the FDA clearance of FemaSeed, enabling it to become a first-line accessible and cost-effective therapeutic option for couples and women experiencing infertility. We also announced positive topline data for the product’s pivotal trial earlier this month, revealing that 24% of women in the severe male factor cohort became pregnant after receiving FemaSeed. Notably, the majority of women who became pregnant did so after the first FemaSeed procedure,” said Femasys’ CEO Kathy Lee-Sepsick. “Our focus is now on executing on commercialization of FemaSeed and our other available products, as well as advancing the clinical pivotal trial for FemBloc. We believe we have sufficient cash to fund operations into the second half of 2025, allowing us to continue our track record of achieving our stated milestones. Women’s healthcare is severely underserved, and we are proud to be a pioneer in developing innovative solutions that are purposely engineered to be safe, effective and affordable.”

Financial Results for Year Ended December 31, 2023

  • Research and Development expenses increased by $1,394,946 to $7,208,701 in 2023 from $5,813,755 in 2022
  • Sales decreased by $134,248 to $1,071,970 in 2023 from $1,206,218 in 2022
  • Net loss was $14,247,124 or $0.93 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023, compared to net loss of $11,394,170, or $0.96 per basic and diluted share attributable to common stockholders, for the year ended December 31, 2022
  • Cash and cash equivalents as of December 31, 2023 was $21,716,077 and the Company had an accumulated deficit of $108,381,629. 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 the second half of 2025

For more information, please refer to the Company’s Form 10-K filed March 28, 2024, which can be accessed on the SEC website.

Balance Sheets 
Assets December 31, 2023 December 31, 2022 
Current assets:     
 Cash and cash equivalents$21,716,077  12,961,936  
 Accounts receivable, net 98,906  77,470  
 Inventory, net 667,118  436,723  
 Prepaid and other current assets 695,879  655,362  
     Total current assets 23,177,980  14,131,491  
Property and equipment, at cost:     
 Leasehold improvements 1,212,417  1,195,637  
 Office equipment 47,308  99,344  
 Furniture and fixtures 414,303  419,303  
 Machinery and equipment 2,559,356  2,572,243  
 Construction in progress 423,077  413,843  
        4,656,461  4,700,370  
Less accumulated depreciation (3,545,422) (3,217,319) 
     Net property and equipment 1,111,039  1,483,051  
Long-term assets:     
 Lease right-of-use assets, net 2,380,225  319,557  
 Intangible assets, net of accumulated amortization   3,294  
 Other long-term assets 1,086,581  958,177  
     Total long-term assets 3,466,806  1,281,028  
     Total assets$27,755,825  16,895,570  

Balance Sheets 
Liabilities and Stockholders’ Equity  December 31, 2023 December 31, 2022 
Current liabilities:     
 Accounts payable$1,137,823  510,758  
 Accrued expenses 1,444,296  456,714  
 Note payable   141,298  
 Clinical holdback – current portion 65,300  45,206  
 Lease liabilities – current portion 406,636  373,833  
     Total current liabilities 3,054,055  1,527,809  
Long-term liabilities:     
 Clinical holdback – long-term portion 54,935  96,658  
 Convertible notes payable, net (including related parties) 4,258,179    
 Lease liabilities – long-term portion 2,036,067  28,584  
     Total long-term liabilities 6,349,181  125,242  
     Total liabilities 9,403,236  1,653,051  
Commitments and contingencies     
Stockholders’ equity:     
 Common stock, $.001 par, 200,000,000 authorized,     
  21,774,604 shares issued and 21,657,381 outstanding as of    
  December 31, 2023; and 11,986,927 shares issued     
  and 11,869,704 outstanding as of December 31, 2022 21,775  11,987  
 Treasury stock, 117,223 common shares (60,000) (60,000) 
 Warrants   2,787,137  567,972  
 Additional paid-in-capital 123,985,306  108,857,065  
 Accumulated deficit (108,381,629) (94,134,505) 
     Total stockholders’ equity 18,352,589  15,242,519  
     Total liabilities and stockholders' equity$27,755,825  16,895,570  

Statements of Comprehensive Loss
        December 31, 2023 December 31, 2022 
Sales$1,071,970  1,206,218  
Cost of sales (excluding depreciation expense) 380,069  441,938  
Operating expenses:     
 Research and development 7,208,701  5,813,755  
 Sales and marketing 650,126  558,852  
 General and administrative 6,858,008  5,430,704  
 Depreciation and amortization 483,481  561,233  
     Total operating expenses 15,200,316  12,364,544  
     Loss from operations (14,508,415) (11,600,264) 
Other income (expense):     
 Interest income 431,019  228,164  
 Interest expense (165,390) (13,464) 
 Other expense   (2,306) 
     Total other income 265,629  212,394  
     Loss before income taxes (14,242,786) (11,387,870) 
Income tax expense 4,338  6,300  
     Net loss$(14,247,124) (11,394,170) 
Net loss attributable to common stockholders, basic and diluted$(14,247,124) (11,394,170) 
Net loss per share attributable to common stockholders, basic and diluted$(0.93) (0.96) 
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 15,384,376  11,815,019  


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. Femasys’ 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. Femasys’ 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. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. The Company’s 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 endocervical tissue sampler for cervical cancer diagnosis. Learn more at, or follow us on XFacebook 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,” “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, when filed, 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. 


Gene Mannheimer 

Media Contact: 
Kati Waldenburg 


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