Femasys Announces Financial Results for Year Ended December 31, 2024, and Provides Corporate Update

-- Company expands commercial product offering with FemBloc$(R)$ permanent birth control (delivery system) approval in Europe and signed partnerships for distribution in Spain --

ATLANTA, March 27, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. $(FEMY)$, 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 year ended December 31, 2024 and provides a corporate update.

Corporate Highlights from 4Q 2024 to date

   -- Announced FemBloc(R) permanent birth control (delivery system) approval 
      in Europe; FemBloc blended polymer component successfully completed an 
      expedited G12 Special MDR Audit for Class III devices, and the Notified 
      Body has recommended for CE mark approval pending the final stages of 
      European Medical Agency (EMA) review 
 
   -- Announced partnership with CNY Fertility, national conglomerate of 11 
      fertility centers, to offer FemaSeed(R) 
 
   -- Announced strategic distribution partnerships for FemBloc in Spain 
 
   -- Announced peer-reviewed publication of positive safety and efficacy 
      results from FemBloc clinical trials 
 
   -- Announced UK and Israeli regulatory approvals for FemaSeed and two 
      diagnostic devices 
 
   -- Announced notices of intention to grant two new European patent 
      applications for FemBloc 
 
   -- Announced notice of allowance for new U.S. patent application for 
      FemaSeed 
 
   -- Announced partnership with HRC Fertility, conglomerate provider of 
      fertility services in Western U.S., to offer FemaSeed 
 
   -- Announced partnership with Boston IVF, prominent network of 30 centers 
      nationwide, to offer FemaSeed 
 
   -- Announced peer-reviewed publication of positive safety and efficacy 
      results from FemaSeed pivotal trial 

"During the fourth quarter of 2024 and first quarter of 2025 we achieved significant regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination products," said Femasys' CEO Kathy Lee-Sepsick. "We are focused on executing on commercialization of FemaSeed and expect U.S. revenue to increase by approximately 50% in first quarter of 2025 versus fourth quarter of 2024. We are continuing to advance our FemBloc to commercialization in Europe while executing on the clinical pivotal trial for U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2025. We remain committed to addressing major gaps in women's reproductive health by advancing safe and effective, technologically advanced product solutions."

Financial Results for Year Ended December 31, 2024

   -- Sales increased by $557,138, or 52.0%, to $1,629,108 in 2024 from 
      $1,071,970 in 2023 
 
   -- Research and development expenses increased by $1,007,842, or 14.0%, to 
      $8,216,543 in 2024 from $7,208,701 in 2023 
 
   -- Net loss was $18,816,628, or ($0.85) per basic and diluted share 
      attributable to common stockholders, for the year ended December 31, 
      2024, compared to net loss of $14,247,124, or ($0.93) per basic and 
      diluted share attributable to common stockholders, for the year ended 
      December 31, 2023 
 
   -- Cash and cash equivalents as of December 31, 2024, was $3.5 million and 
      the Company had an accumulated deficit of $127.2 million. The Company 
      expects, based on its current operating plan, our current cash and cash 
      equivalents, which includes approximately $5.4 million we raised 
      subsequent to year end, will be sufficient to fund its ongoing operations 
      into third quarter of 2025. 

For more information, please refer to the Company's Form 10-K filed March 27, 2025, which can be accessed on the SEC website.

 
 
 
                        FEMASYS INC. 
                       Balance Sheets 
                        (unaudited) 
 
                                December 31,   December 31, 
           Assets                   2024           2023 
                                ------------  -------------- 
Current assets: 
   Cash and cash equivalents   $  3,451,761    21,716,077 
   Accounts receivable, net         488,373        98,906 
   Inventory                      3,046,323       667,118 
   Prepaid and other current 
    assets                        1,035,993       695,879 
      Total current assets        8,022,450    23,177,980 
                                -----------   ----------- 
Property and equipment, at 
cost: 
   Leasehold improvements         1,238,886     1,212,417 
   Office equipment                  60,921        47,308 
   Furniture and fixtures           417,876       414,303 
   Machinery and equipment        2,856,740     2,559,356 
   Construction in progress         762,445       423,077 
                                  5,336,868     4,656,461 
Less accumulated depreciation    (3,740,769)   (3,545,422) 
      Net property and 
       equipment                  1,596,099     1,111,039 
                                -----------   ----------- 
Long-term assets: 
   Lease right-of-use assets, 
    net                           1,805,543     2,380,225 
   Intangible assets, net of 
   accumulated amortization          65,918            -- 
   Other long-term assets           954,992     1,086,581 
      Total long-term assets      2,826,453     3,466,806 
 
      Total assets             $ 12,445,002    27,755,825 
                                ===========   =========== 
(continued) 
 
 
 
                        FEMASYS INC. 
                       Balance Sheets 
                         (unaudited) 
 
      Liabilities and          December 31,    December 31, 
    Stockholders' Equity            2024            2023 
                               -------------  --------------- 
Current liabilities: 
   Accounts payable           $   1,419,044      1,137,823 
   Accrued expenses               1,151,049      1,444,296 
   Convertible notes 
   payable, net (including 
   related parties)               5,406,228             -- 
   Clinical holdback -- 
    current portion                  88,581         65,300 
   Operating lease 
    liabilities -- current 
    portion                         517,967        406,636 
      Total current 
       liabilities                8,582,869      3,054,055 
                               ------------   ------------ 
Long-term liabilities: 
   Clinical holdback -- 
    long-term portion                39,611         54,935 
   Convertible notes 
    payable, net (including 
    related parties)                     --      4,258,179 
   Operating lease 
    liabilities -- long-term 
    portion                       1,518,100      2,036,067 
      Total long-term 
       liabilities                1,557,711      6,349,181 
      Total liabilities          10,140,580      9,403,236 
                               ------------   ------------ 
Commitments and 
contingencies 
Stockholders' equity: 
   Common stock, $.001 par, 
    200,000,000 authorized, 
    23,473,149 shares issued 
    and 23,355,926 
    outstanding as of 
    December 31, 2024; and 
    21,774,604 shares issued 
    and 21,657,381 
    outstanding as of 
    December 31, 2023                23,473         21,775 
   Treasury stock, 117,223 
    common shares                   (60,000)       (60,000) 
   Warrants                       1,860,008      2,787,137 
   Additional 
    paid-in-capital             127,679,198    123,985,306 
   Accumulated deficit         (127,198,257)  (108,381,629) 
 
      Total stockholders' 
       equity                     2,304,422     18,352,589 
                               ------------   ------------ 
 
      Total liabilities and 
       stockholders' equity   $  12,445,002     27,755,825 
                               ============   ============ 
 
 
 
                        FEMASYS INC. 
              Statements of Comprehensive Loss 
                         (unaudited) 
 
                                 December 31,   December 31, 
                                     2024           2023 
                                 ------------  -------------- 
Sales                           $  1,629,108     1,071,970 
Cost of sales (excluding 
 depreciation expense)               544,903       380,069 
 
Operating expenses: 
   Research and development        8,216,543     7,208,701 
   Sales and marketing             4,030,150       650,126 
   General and administrative      6,325,999     6,858,008 
   Depreciation and 
    amortization                     297,318       483,481 
      Total operating expenses    18,870,010    15,200,316 
      Loss from operations       (17,785,805)  (14,508,415) 
                                 -----------   ----------- 
Other (expense) income: 
   Interest income                   582,354       431,019 
   Interest expense               (1,603,575)     (165,390) 
      Total other (expense) 
       income                     (1,021,221)      265,629 
                                 -----------   ----------- 
      Loss before income taxes   (18,807,026)  (14,242,786) 
Income tax expense                     9,602         4,338 
 
      Net loss                  $(18,816,628)  (14,247,124) 
                                 ===========   =========== 
 
Net loss attributable to 
 common stockholders, basic 
 and diluted                    $(18,816,628)  (14,247,124) 
                                 ===========   =========== 
Net loss per share 
 attributable to common 
 stockholders, basic and 
 diluted                        $      (0.85)        (0.93) 
Weighted-average shares used 
 in computing net loss per 
 share attributable to common 
 stockholders, basic and 
 diluted                          22,267,695    15,384,376 
                                 ===========   =========== 
 
 

About Femasys

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. The Company, a U.S. manufacturer, has received regulatory approvals for its product portfolio worldwide, and they are currently being commercialized in the U.S. and key international markets. FemaSeed(R) Intratubal Insemination, a groundbreaking first-line infertility treatment, is FDA-cleared and approved in Europe, UK, Canada and Israel. Clinical trial data, published in peer-reviewed journal, demonstrate safety, effectiveness, and high satisfaction from patients and practitioners.(1) FemVue(R) , a companion diagnostic for fallopian tube assessment, is FDA-cleared and approved in Europe, UK, Canada, Japan and Israel. FemCerv(R) , a tissue sampler for cervical cancer diagnosis, is FDA-cleared and approved in Europe, UK, Canada and Israel.

FemBloc(R) permanent birth control, is the first and only non-surgical, in-office approach offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The revolutionary FemBloc delivery system is approved in Europe and the proprietary blended polymer has been recommended for approval, which is expected mid-year 2025. For U.S. FDA approval, the FINALE pivotal clinical trial (NCT05977751) is currently enrolling participants. Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.(2) FemCath(R) and FemChec(R) , diagnostic products for FemBloc's ultrasound-based confirmation test, are FDA-cleared and approved in Europe and Canada.

References

(1) Liu, 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.

(2) Liu, J. H., Blumenthal, P. D., Castaño, 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.

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, 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.

Contacts:

Investors:

IR@femasys.com

Media:

Media@femasys.com

(END) Dow Jones Newswires

March 27, 2025 09:00 ET (13:00 GMT)