EX-99.1 2 ef20025488_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1
 
Femasys Announces Financial Results for Year Ended December 31, 2023 and Provides Corporate Update
 
-- Following FDA Clearance of FemaSeed®, Company Secures Capital to Support Commercial Initiatives; Cash Expected to Fund Operations Into 2H 2025 --
 
ATLANTA, March 28, 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 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.
 
FEMASYS INC.
Balance Sheets
(unaudited)

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
 
                 
(continued)
               
 

FEMASYS INC.
Balance Sheets
(unaudited)

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
 
 

FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)

   
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 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,” “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.

Contacts:
 
Investors:
Gene Mannheimer
IR@femasys.com

Media Contact:
Kati Waldenburg
Media@femasys.com