EX-99.1 2 brhc10037410_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1

Femasys Inc. Announces Financial Results for the First Quarter Ended
March 31, 2022

Furthers advancement of much-needed minimally invasive technologies for underserved areas of women’s health with pending commercialization of products, FemCerv® and FemCath™  expected by year-end
 
Continued progress with FemaSeed and FemBloc biomedical product candidates in development
 
ATLANTA, May 11, 2022 -- 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 first quarter ended March 31, 2022.
 
“We are adding two approved products to our commercial portfolio as we broaden solutions to improve the continuum of healthcare options for women,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “FemCath, our selective delivery catheter, and FemCerv, our endocervical tissue sampler, are pending commercialization later this year, while supporting commercial efforts for our complementary FemVue® diagnostic product, the first device enabling an in-office ultrasound diagnosis, an alternative approach to assess the fallopian tubes for infertility. Our goal is to further grow this synergistic product portfolio by exploring partnering opportunities and with our product candidates, FemBloc for permanent birth control and FemaSeed for infertility treatment once approved, designed to address substantial, multi-billion-dollar global market segments.”
 
Ms. Lee-Sepsick added, “Women deserve safe options and the right to control their reproductive health and journey. In terms of the recent discussions regarding Roe v Wade, a ruling which occurred over 48 years ago, safety for women should be upheld as paramount. Safety and choice are core drivers in our mission to develop non-surgical reproductive health solutions for women around the world.”
 
First Quarter 2022 Highlights:  Augmented Leadership

In February, Dov Elefant was appointed to chief financial officer (CFO). Mr. Elefant has 25 years of financial management experience at both public and private biopharmaceutical companies. He brings a proven record as a senior level global financial expert with financial reporting, fundraising, and mergers and acquisitions expertise.


In January, Wendy Perrow joined as a new board member. Ms. Perrow brings decades of experience in the life sciences industry related to fundraising, global product launches and corporate strategy.

First Quarter 2022 and Recent Developments Related to Clinical Programs

Femasys expects to complete enrollment for its Stage 2 study of FemBloc in the third quarter of this year and file an IDE for a pivotal trial to support a PMA in the first quarter of next year.

An interim analysis for the FemaSeed LOCAL de novo pivotal trial is planned for the fourth quarter of this year. 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 effectiveness (clinical pregnancy rate) and safety over a period of up to seven weeks. The Company expects to complete enrollment in the second quarter of next year.

Ms. Lee-Sepsick continued, “We are on target to meet our milestones later this year in terms of obtaining an interim read-out from our up to 792-patient LOCAL de novo trial for FemaSeed. Recently, we added a number of new sites to our LOCAL trial, and we are encouraged that the impact of the pandemic may be waning, which has broadly affected enrollment for many clinical trials in the industry. In addition, we are approaching enrollment completion for our FemBloc study, and are on track for submitting our Investigational Device Exemption (IDE) filing early next year for a pivotal trial, which will be used in support of a Pre-Market Authorization (PMA) application for this product candidate.”

First Quarter 2022 Financial Results

General and administrative expenses increased by $555,368, or 62.3%, to $1,447,355 for the three months ended March 31, 2022 from $891,987 for the three months ended March 31, 2021. The increase was largely due to various additional costs associated with being a public company, including salaries and related personnel costs due to an increase in headcount, facility, and other allocated overhead costs mainly for additional directors and officers (D&O) insurance, and increased professional costs for legal and accounting.
 
Research and development expenses increased by $426,041 or 42.8%, to $1,421,063 for the three months ended March 31, 2022 from $995,022 for the three months ended March 31, 2021. The net increase of $426,041 largely consists of the $88,245 increase in compensation and related personnel costs primarily due to an increase in headcount, an increase of $270,497 in clinical-related costs associated with our clinical trials, and an increase of $50,707 in professional and outside consultant costs which are largely attributable to additional consulting costs to support the Company’s clinical trials.
 
Sales of the Company’s FemVue® product decreased by $8,370, or 2.5%, to $321,405 for the three months ended March 31, 2022 from $329,775 for the same period last year. The $8,370 decrease was largely attributable to the 4.1% decrease in U.S. units sold for the three months ended March 31, 2022 as compared to the same period last year. International sales were $58,045 for both the three months ended March 31, 2022 and 2021.


Sales and marketing expenses increased by $46,044 or 201.8%, to $68,863 for the three months ended March 31, 2022 from $22,819 for the three months ended March 31, 2021 largely due to an increase in compensation and related personnel costs due to an increase in headcount and additional marketing costs associated with our FemVue social media campaign to increase our commercial presence.
 
Cost of sales and gross margin percentage
 
Cost of sales increased by $29,633, or 31.8%, to $122,675 for the three months ended March 31, 2022 from $93,042 for the three months ended March 31, 2021. The increase in cost of sales was largely due to increased labor and overhead costs applied to our cost of sales for the three months ended March 31, 2022 as compared to the same period last year mostly due to production personnel turnover as compared to the same period last year. As a result, gross margin percentage was 61.8% for the three months ended March 31, 2022 as compared to 71.8% for the three months ended March 31, 2021. The Company stated that it expects to see improvement in its gross margin in the future after investing in equipment and tooling that will replace and reduce labor in certain manufacturing processes as well as the costs of materials.
 
Net loss was $2,883,030, or $0.24 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the period ended March 31, 2022, compared to $1,830,232, or $1.84 per basic and diluted share attributable to common stockholders, for the same period ended March 31, 2021.

Cash and cash equivalents as of March 31, 2022 and December 31, 2021, were $21,767,634 and $24,783,029, respectively.


FEMASYS INC.
Balance Sheets
(unaudited)

Assets
 
March 31, 2022
   
December 31, 2021
 
Current assets:
           
Cash and cash equivalents
 
$
21,767,634
     
24,783,029
 
Accounts receivable, net
   
170,302
     
84,258
 
Inventory, net
   
223,008
     
208,270
 
Other current assets
   
567,300
     
555,853
 
Total current assets
   
22,728,244
     
25,631,410
 
Property and equipment, at cost:
               
Leasehold improvements
   
1,195,637
     
1,155,332
 
Office equipment
   
99,344
     
99,344
 
Furniture and fixtures
   
424,947
     
424,947
 
Machinery and equipment
   
2,287,126
     
2,261,793
 
Construction in progress
   
434,443
     
379,713
 
     
4,441,497
     
4,321,129
 
Less accumulated depreciation
   
(2,854,315
)
   
(2,722,117
)
Net property and equipment
   
1,587,182
     
1,599,012
 
Long-term assets:
               
Lease right-of-use assets, net
   
574,943
     
665,747
 
Intangible assets, net of accumulated amortization
   
17,663
     
25,093
 
Other long-term assets
   
625,418
     
655,418
 
Total long-term assets
   
1,218,024
     
1,346,258
 
                 
Total assets
 
$
25,533,450
     
28,576,680
 


FEMASYS INC.
Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
 
March 31, 2022
   
December 31, 2021
 
Current liabilities:
           
Accounts payable
 
$
548,377
     
445,522
 
Accrued expenses
   
565,228
     
603,787
 
Clinical holdback - current portion
   
36,238
     
18,947
 
Note payable – current portion
   
45,666
     
181,123
 
Lease liabilities – current portion
   
400,620
     
406,674
 
Other – current
   
36,037
     
36,037
 
Total current liabilities
   
1,632,166
     
1,692,090
 
Long-term liabilities:
               
Clinical holdback - long-term portion
   
102,502
     
149,791
 
Lease liabilities – long-term portion
   
305,071
     
402,417
 
Total long-term liabilities
   
407,573
     
552,208
 
Total liabilities
   
2,039,739
     
2,244,298
 
Commitments and contingencies
               
Stockholders’ equity:
               
Common stock, $.001 par, 200,000,000 authorized,
11,921,388 shares issued and 11,804,165 outstanding as of
March 31, 2022 and December 31, 2021
   
11,921
     
11,921
 
Treasury stock, 117,223 shares
   
(60,000
)
   
(60,000
)
Warrants
   
702,492
     
702,492
 
Additional paid-in-capital
   
108,462,663
     
108,418,304
 
Accumulated deficit
   
(85,623,365
)
   
(82,740,335
)
Total stockholders’ equity
   
23,493,711
     
26,332,382
 
Total liabilities and stockholders' equity
 
$
25,533,450
     
28,576,680
 



FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)

   
Three Months Ended March 31,
 
   
2022
   
2021
 
Sales
 
$
321,405
     
329,775
 
Cost of sales
   
122,675
     
93,042
 
Gross margin
   
198,730
     
236,733
 
Operating expenses:
               
Research and development
   
1,421,063
     
995,022
 
Sales and marketing
   
68,863
     
22,819
 
General and administrative
   
1,447,355
     
891,987
 
Depreciation and amortization
   
144,199
     
153,453
 
Total operating expenses
   
3,081,480
     
2,063,281
 
Loss from operations
   
(2,882,750
)
   
(1,826,548
)
Other income (expense):
               
Interest income, net
   
2,454
     
164
 
Interest expense
   
(2,734
)
   
(3,848
)
Other expense, net
   
(280
)
   
(3,684
)
Net loss
 
$
(2,883,030
)
   
(1,830,232
)
                 
Net loss attributable to common stockholders, basic and diluted
 
$
(2,883,030
)
   
(1,830,232
)
Net loss per share attributable to common stockholders, basic and diluted
 
$
(0.24
)
   
(1.84
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
   
11,804,165
     
995,208
 
 
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 FemCath, an intrauterine catheter for selective evaluation of the fallopian tubes and FemCerv®, an endocervical tissue sampler that is the first product of the 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,” “pending,” “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, 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 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 Annual Report on Form 10-K for the year ended December 31, 2021 and our Form 10-Q for the quarter ended March 31, 2022, when filed with the Securities and Exchange Commission (the “SEC”), 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
Zuri McClelland
LifeSci Communications
zmcclelland@lifescicomms.com

Femasys Inc.
Investor Contact:
IR@femasys.com

Media Contact:
Media@femasys.com