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Press release content from Globe Newswire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Globe Newswire
Press release content from Globe Newswire. The AP news staff was not involved in its creation.

Femasys Inc. Announces Financial Results for the Third Quarter of 2021

November 10, 2021 GMT

-- Up to 792-patient, pivotal LOCAL trial progressing for FemaSeed®after receipt of investigational device exemption (IDE) submission approval --

-- Femasys added to the Russell Microcap® Index in Q3 --

ATLANTA, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the third quarter and nine months ended September 30, 2021 and provided a corporate update on the Company’s business and clinical programs.

“Since becoming public approximately five months ago, we’ve gained substantial traction for our product candidates that have the opportunity to provide women access to superior technologies and revolutionize their options related to reproductive care,” stated Kathy Lee-Sepsick, president, chief executive officer and founder of Femasys. “Our pipeline progress has been driven by the advancement of FemaSeed, our novel product candidate that delivers sperm directly to a selected fallopian tube where conception occurs, with enrollment progressing for our LOCAL trial that commenced in July, enrolling qualified women seeking conception at centers across the U.S. with additional centers being added.”

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Ms. Lee-Sepsick, further commented, “We are now gearing up for the pivotal trial planned for next year associated with our planned IDE submission for FemBloc®, our permanent birth control product candidate. We are eager to address the existing limitations of infertility and birth control options– both vast and underserved markets within women’s reproductive health worldwide – with non-surgical solutions that are driven by safety and affordability.”

Recent Corporate Developments

  • On September 20, 2021, Femasys announced that the Company was added to the Russell Microcap® Index. The Russell Microcap Index is widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.
  • On September 1, 2021, Femasys announced the appointment of Edward G. Evantash, M.D., as chief medical officer. Dr. Evantash brings over two decades of industry experience in medical and clinical affairs to Femasys, having previously served as chief medical officer of Alydia Health and vice president of medical affairs at Hologic, Inc., both medical technology companies focused on women’s healthcare. He will be responsible for providing leadership and direction for Femasys’ pipeline of clinical development programs.

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Q3 Developments Related to Clinical Programs

  • On July 20, 2021, Femasys announced the initiation of and first patient treated with FemaSeed in the LOCAL trial. The trial is being conducted across centers in the United States and is expected to enroll up to 792 patients who are diagnosed as infertile. The primary endpoints of the study are to determine the effectiveness (clinical pregnancy rate) and safety over a period of 7 weeks. Enrollment in this trial is ongoing.

Third Quarter (Three-Months) 2021 Financial Results:

  • Research and Development expenses increased by $144,957, or 14.6%, to $1,140,577 for the third quarter of 2021 compared the third quarter of 2020. The increase was primarily due to an increase in research and development project spending and consulting costs to support the company’s clinical trials.
  • General and Administrative expenses increased by $490,585, or 82.2%, to $1,087,363 for the third quarter of 2021 compared to the third quarter of 2020. The increase was largely due to an increase of $309,749 in professional costs associated with being a public company.
  • Sales of the Company’s FemVue® product, decreased by $43,627, or 13.9%, to $269,581 from $313,208 for the third quarter of 2021. The sales decrease was attributable to a 19.9% decline in units sold, largely due to a rebound of sales in the third quarter of 2020 from the heavily impacted second quarter of 2020 due to the COVID-19 pandemic. International sales were $58,045 for the three months ended September 30, 2021 and 2020.
  • Primarily reflecting the factors noted above, net loss was $(2,259,701), or $(0.19) per basic and diluted share attributable to common stockholders, for the third quarter of 2021, compared to $(1,568,295), or $(1.64) per basic and diluted share attributable to common stockholders, for the third quarter of 2020.
  • The cash and cash equivalents balance as of September 30, 2021 was $27,280,309. The Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its operations at least through 2022.

Year to Date 2021 (Nine-Months) Financial Results:

  • Research and Development expenses decreased by $204,555, or 6.3%, to $3,030,467 for the nine months ended September 30, 2021, compared to the nine months ended September 30, 2020. The decrease was primarily due to the decrease of $161,555 in compensation and related personnel costs due to the reduction in staff in March 2020 and a decrease in clinical-related trial costs and material and development costs due to deferring certain R&D projects in the first half of 2021 to preserve cash, which was partially offset by an increase in other costs related to support of our clinical trials.
  • General and Administrative expenses increased by $1,240,154, or 69.3%, to $3,030,749 for the nine months ended September 30, 2021, compared to the nine months ended September 30, 2020. The increase was largely due to an increase of $1,050,483 in professional costs largely associated with our financing transactions and additional costs associated with being a public company.
  • Sales of the Company’s FemVue® product increased by $168,408, or 22.2%, to $925,362 from $756,954 for the nine months ended September 30, 2020. The increase was attributable to a $112,613 increase in U.S. sales and a $55,795 increase in international sales. The increase in sales was largely attributable to the decrease in sales for the nine months ended September 30, 2020, primarily due to the impacts of the COVID-19 pandemic.
  • Primarily reflecting the factors noted above, net loss decreased to $(5,172,992), or $(1.04) per basic and diluted share attributable to common stockholders, for the nine months ended September 30, 2021, as compared to a net loss of $(5,255,473), or $(5.50) per basic and diluted share attributable to common stockholders, for the nine months ended September 30, 2020.

About Femasys

Femasys Inc. is a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates are FemBloc® permanent birth control and FemaSeed® localized directional insemination for infertility. The Company’s product for fallopian tube assessment by ultrasound, FemVue®, is currently marketed in the United States. Femasys is also advancing FemCerv®, a technology platform for tissue sampling intended to be marketed alongside its other women-specific medical products in the physician’s office setting.

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,” “intend,” “believe,” “potential” 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 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 product candidates; 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 11, 2021, 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
Chuck Padala
LifeSci Advisors, LLC
+1-917-741-7792
chuck@lifesciadvisors.com

Media
Sky Striar
LifeSci Communications
sstriar@lifescicomms.com

Femasys Inc.
Investor Contact:
IR@femasys.com

Media Contact:
Media@femasys.com

FEMASYS INC.
Balance Sheets
(unaudited)
Assets   September 30,
2021
   December 31,
2020
Current assets:     
 Cash and cash equivalents$27,280,309  3,322,226 
 Accounts receivable, net 143,459  125,790 
 Inventory, net  150,336  131,378 
 Other current assets 759,453  284,115 
     Total current assets 28,333,557  3,863,509 
Property and equipment, at cost:    
 Leasehold improvements 1,155,332  1,155,332 
 Office equipment 99,344  64,145 
 Furniture and fixtures 424,947  424,947 
 Machinery and equipment 2,262,908  2,242,088 
 Construction in progress 268,226  139,150 
        4,210,757  4,025,662 
Less accumulated depreciation (2,600,787) (2,197,868)
     Net property and equipment 1,609,970  1,827,794 
Long-term assets:    
 Lease right-of-use assets, net 759,018  1,057,506 
 Intangible assets, net of accumulated amortization 33,046  65,069 
 Other long-term assets 428,933  792,440 
     Total long-term assets 1,220,997  1,915,015 
     Total assets$31,164,524  7,606,318 
(continued)      
           
FEMASYS INC.
Balance Sheets
(unaudited)
Liabilities, Redeemable Preferred Stock and Stockholders' Equity (Deficit)  September 30,
2021
  December 31,
2020
Current liabilities:    
 Accounts payable$436,890  674,333 
 Accrued expenses 597,856  1,117,601 
 Clinical holdback – current portion 18,947   
 Notes payable – current portion 320,866  630,010 
 Lease liabilities – current portion 412,911  434,072 
 Other – current 32,895  32,895 
     Total current liabilities 1,820,365  2,888,911 
Long-term liabilities:    
 Clinical holdback – long-term portion 155,960  164,972 
 Note payable – long-term portion   182,490 
 Lease liabilities – long-term portion 501,912  809,092 
 Other – long-term 32,895  32,895 
     Total long-term liabilities 690,767  1,189,449 
     Total liabilities 2,511,132  4,078,360 
Commitments and contingencies    
Redeemable convertible preferred stock:    
 Preferred stock, Series B, $.001 par, none authorized, issued    
  and outstanding as of September 30, 2021; 13,344,349 shares    
  authorized, issued and outstanding as of December 31, 2020   10,748,873 
 Preferred stock, Series C, $.001 par, none authorized, issued    
  and outstanding as of September 30, 2021; 42,491,484 shares    
  authorized, issued and outstanding as of December 31, 2020   44,594,813 
Stockholders' equity (deficit):    
 Common stock, $.001 par, 200,000,000 authorized,    
  11,916,943 shares issued and 11,799,720 outstanding as of    
  September 30, 2021; and 95,583,558 authorized, 1,110,347 shares   
  issued and 993,124 outstanding as of December 31, 2020 11,916  1,110 
 Treasury stock, 117,223 shares (60,000) (60,000)
 Preferred stock, Series A, $.001 par, none authorized, issued    
  and outstanding as of September 30, 2021; 17,310,609 shares    
  authorized, and 17,210,609 shares issued and outstanding    
  as of December 31, 2020   17,211 
 Warrants 702,492  702,492 
 Additional paid-in-capital 108,374,466  22,725,949 
 Accumulated deficit (80,375,482) (75,202,490)
     Total stockholders' equity (deficit) 28,653,392  (51,815,728)
     Total liabilities, redeemable convertible preferred stock    
      and stockholders' equity (deficit)$31,164,524  7,606,318 
           
FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)
        Three Months Ended September 30, Nine Months Ended September 30,
        2021  2020  2021  2020 
Sales    $269,581  313,208  925,362  756,954 
Cost of sales  105,403  90,435  306,072  218,898 
     Gross margin 164,178  222,773  619,290  538,056 
Operating expenses:        
 Research and development 1,140,577  995,620  3,030,467  3,235,022 
 Sales and marketing 43,284  31,010  87,931  281,583 
 General and administrative 1,087,363  596,778  3,030,749  1,790,595 
 Depreciation and amortization 144,399  164,242  449,211  499,534 
     Total operating expenses 2,415,623  1,787,650  6,598,358  5,806,734 
     Loss from operations (2,251,445) (1,564,877) (5,979,068) (5,268,678)
Other income (expense):        
 Interest income, net 1,649  342  1,957  22,298 
 Other income      821,515   
 Interest expense (7,055) (3,760) (14,546) (9,093)
 Other expense (2,850)   (2,850)  
     Total other income (expense) (8,256) (3,418) 806,076  13,205 
     Loss before income taxes (2,259,701) (1,568,295) (5,172,992) (5,255,473)
Income tax expense        
     Net loss$(2,259,701) (1,568,295) (5,172,992) (5,255,473)
Comprehensive loss:        
     Net loss$(2,259,701) (1,568,295) (5,172,992) (5,255,473)
     Change in fair value of available for sale investments       (20)
     Total comprehensive loss$(2,259,701) (1,568,295) (5,172,992) (5,255,493)
               
Net loss attributable to common stockholders, basic and diluted$(2,259,701) (1,568,295) (5,172,992) (5,255,473)
Net loss per share attributable to common stockholders, basic and diluted$(0.19) (1.64) (1.04) (5.50)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted  11,799,720  955,649  4,996,680  955,402