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Femasys Announces Financial Results for Quarter Ended June 30, 2024 and Provides Corporate Update

ATLANTA, Aug. 08, 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 quarter ended June 30, 2024 and provides a corporate update.

Corporate Highlights from 2Q 2024 to date

  • Company received European Union Medical Device Regulation (EU MDR) certification and CE Mark for four of its women’s health products, providing regulatory approval to begin marketing in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for its customers and their patients.
  • Femasys completed the build-out of its initial commercial team in the U.S., which will be leading the Company’s marketing efforts. This milestone, together with the CE Mark approval for its product portfolio, enables Femasys to concurrently identify strategic distribution partners to begin commercialization of its products in the European Union.
  • CEO and Founder Kathy Lee-Sepsick met with the White House’s Gender Policy Council to discuss the Company’s reproductive health products and the future of women’s health in the United States and the White House’s Office of Science and Technology Policy to discuss the Cancer Moonshot Initiative, as well as separately with Members of Congress to raise awareness of the Company and our women’s healthcare initiatives.

“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

  • Research and development expenses increased by $448,703 to $1,975,875 in Q2 of 2024 from $1,527,172 in Q2 of 2023.
  • Sales decreased by $99,030 to $221,484 in Q2 of 2024 from $320,514 in Q2 of 2023.
  • Net loss was $4,684,574 or ($0.21) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2024, compared to net loss of $2,893,508, or ($0.22) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2023.
  • Cash and cash equivalents as of June 30, 2024 was $13.5 million and the Company had an accumulated deficit of $116.7 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 Six Months Ended June 30, 2024

  • Research and development expenses increased by $681,995 to $3,746,606 for the first six months of 2024 from $3,064,611 for the first six months of 2023.
  • Sales decreased by $121,874 to $492,624 for the first six months of 2024 from $614,498 for the first six months of 2023.
  • Net loss was $8,284,084 or ($0.38) per basic and diluted share attributable to common stockholders, for the six month period ended June 30, 2024, compared to net loss of $5,839,765, or ($0.47) per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2023.

For more information, please refer to the Company’s Form 10-Q filed August 8, 2024, which can be accessed on the SEC website.


FEMASYS INC. 
Condensed Balance Sheets 
(unaudited) 
            
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  
(continued)       
            



FEMASYS INC. 
Condensed Balance Sheets 
(unaudited) 
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  
            



FEMASYS INC.    
Condensed Statements of Comprehensive Loss    
(unaudited)     
        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  
                


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® 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, 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: 
Gene Mannheimer
IR@femasys.com

Media Contact: 
Kati Waldenburg
Media@femasys.com


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