UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): November 10, 2022
 
Femasys Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-40492
11-3713499
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

3950 Johns Creek Court, Suite 100
    
Suwanee, Georgia
  
30024
(Address of principal executive offices)
  
(Zip Code)
 
(770) 500-3910
(Registrant’s telephone number, including area code)
 
n/a
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each class
  
Trading
Symbol(s)
  
Name of each exchange
on which registered
Common Stock, par value $0.001 per share
  
FEMY
  
The Nasdaq Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
 
Emerging growth company ☒
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 2.02
Results of Operations and Financial Condition.
 
On November 10, 2022, Femasys Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2022 and provided a corporate update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
 
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
 
Item 9.01
Financial Statements and Exhibits.
 
(d) Exhibits.
Exhibit
    
No.

Description
     
 
Press Release of Femasys Inc. dated November 10, 2022
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL Document)

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
Femasys Inc.
   
 
By:
/s/ Kathy Lee-Sepsick
 
Names: Kathy Lee-Sepsick
 
Title: Chief Executive Officer
   
Date: November 10, 2022
   


Exhibit 99.1

Femasys Inc. Announces Financial Results for the Third Quarter Ended
September 30, 2022 and Provides Corporate Update

--FemaSeed® de novo trial enrollment accelerates with strategic trial design update to focus on male factor infertility--
 
--Company remains on track to file an Investigational Device Exemption (IDE) for a pivotal trial to support a Pre-Market Authorization (PMA) for FemBloc® in Q1 2023--
 
--FemCerv® now commercially available with FemCath™ launch expected by year-end--
 
ATLANTA, November 10, 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 third quarter and nine months ended September 30, 2022 and provided a corporate update.
 
“We’ve hit multiple company milestones this past quarter, as well as further strengthened our management team in key functional areas,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “Most notably, we completed enrollment in our Stage 2 trial of FemBloc® permanent birth control and strategically updated the FemaSeed® de novo trial design, accelerating enrollment for this important program. Approximately 50% of infertility is attributed to male factor and FemaSeed is being studied to offer a cost-effective, efficacious option to existing invasive and expensive treatment alternatives. We also made FemCerv®, designed for comprehensive cervical sampling and minimal contamination for the diagnosis of cervical cancer, available to gynecologists. To support all of these high-value programs, we have sales and marketing as well as regulatory and clinical affairs teams well-positioned to lead us towards the next catalysts for the company at this pivotal time.”
 
Third Quarter and Recent Developments Related to Clinical Programs and Commercial Products

FemBloc

•
In July, Femasys hosted a Key Opinion Leader (KOL) event in the wake of the overturn of Roe v. Wade, to discuss FemBloc. The webinar featured a presentation from key opinion leader, Paul D. Blumenthal, M.D., MPH, Professor of Obstetrics and Gynecology of The Stanford University Medical Center and discussion of the unmet need for women seeking permanent birth control options. Following the event, several media outlets reported on the topic, including CNN Business and other industry-focused publications.

•
In October, the Company announced enrollment completion for its Stage 2 study of FemBloc®, a first-of-its-kind, nonsurgical, in-office solution in development for permanent birth control. The Stage 2 study is a prospective, multi-center, feasibility study (NCT04273594) validating the confirmation test required after FemBloc to determine procedure success by comparing an ultrasound approach to the traditional radiology approach. Femasys intends to continue follow-up to monitor the safety of the subjects for a total duration of approximately 68 months after the FemBloc procedure. Femasys remains on track to file an Investigational Device Exemption (IDE) for a pivotal trial to support a Pre-Market Authorization (PMA) in the first quarter of next year.

FemaSeed

•
In October, the Company announced an updated study design for its FemaSeed® pivotal trial, which will now focus on couples experiencing male factor infertility. This update reflects a strategic decision to address this underserved infertility population with a goal of facilitating accelerated enrollment. The FemaSeed LOCAL de novo clinical trial is a prospective multi-center, unblinded study (NCT04968847) being conducted across centers in the United States requiring evaluation of up to 214 women undergoing 214 FemaSeed cycles due to male factor infertility. The primary endpoints of the study are to determine the effectiveness (pregnancy rate) and safety over a period of seven weeks post-FemaSeed procedure. The Company expects study enrollment to be completed in 2023.

FemCerv

•
In September, the Company announced the commercial availability of FemCerv®, the first endocervical tissue sampler designed to improve tissue quality and quantity with minimal discomfort that is expected to be an improvement over the existing standard of care.

Third Quarter and Recent Corporate Highlights

•
In July, the Company announced that Charles Larsen, a current member of Femasys’ Board of Directors, has been appointed to the role of non-executive Chair, replacing founder, president and chief executive officer, Kathy Lee-Sepsick. Mr. Larsen has served as a member of Femasys’ board of directors since October 2015.

•
In September, the Company also announced the hiring of Michael Meier as Vice President of Sales and Marketing. Mr. Meier brings over 20 years of commercial experience to the Femasys team. He has a strong background in bringing innovative medical devices and diagnostic solutions to market as well as a proven track record of growing revenue by building and directing world-class sales and marketing teams. Mr. Meier has held various commercial leadership roles at medical device and diagnostic startups, in addition to fortune 500 companies including Hologic and Johnson & Johnson. Mr. Meier is leading sales and marketing efforts for all of Femasys’ commercial assets.

•
In October, the Company announced the appointment of Christine Thomas, RAC, as senior vice president of regulatory and clinical affairs. Ms. Thomas has over 20 years of successful leadership in regulatory and clinical affairs, including global strategy development and operations, as well as executive responsibility for medical device companies such as GE Healthcare, Boston Scientific, Smiths Medical, and RTI Surgical. Ms. Thomas most recently served as head of regulatory solutions providing FDA focused consultant expertise at IQVIA MedTech, a large clinical research organization that provides solutions and services to support the needs of the medical device and in vitro diagnostics industry. Ms. Thomas is leading all regulatory and clinical efforts for the FemBloc and FemaSeed clinical programs at Femasys.

•
In October, the Company’s management team attended the 78th Annual American Society for Reproductive Medicine (ASRM) Scientific Congress in Anaheim, California. The Company also participated in various investor conferences this past quarter and recently. Upcoming conference participation by the Company will include the American Association of Gynecologic Laparoscopists (AAGL) from December 1st – 4th in Aurora, CO and the Piper Sandler 34th Annual Healthcare Conference from November 29th-December 1st in New York, NY.

Third Quarter 2022 Financial Results

•
General and administrative expenses increased by $307,700, or 28.3%, to $1,395,063 for the three months ended September 30, 2022 compared to $1,087,363 for the three months ended September 30, 2021. The net increase was largely due to an increase in salaries and related personnel costs, an increase in facility and other allocated overhead costs, and an increase in professional costs for legal and accounting.

•
Research and Development expenses increased by $507,583, or 44.5%, to $1,648,160 for the three months ended September 30, 2022 compared to $1,140,577 for the three months ended September 30, 2021. The net increase was largely due to compensation and related personnel costs due to an increase in headcount and an increase in clinical-related costs to primarily support our clinical trials.

•
Sales the Company’s FemVue® product increased by $77,875, or 28.9%, to $347,456 for the three months ended September 30, 2022 compared to $269,581 for the three months ended September 30, 2021 due to strong U.S. sales of FemVue. U.S. sales increased by $78,106, or 36.9%, for the three months ended September 30, 2022 compared to the same period last year, and U.S. units of FemVue sold increased by 38.9% for the three months ended September 30, 2022 compared to the same period last year. International sales largely remained the same and were $57,814 and $58,045 for the three months ended September 30, 2022 and 2021, respectively.
 
•
Sales and marketing expenses increased by $47,090, or 108.8%, to $90,374 for the three months ended September 30, 2022 compared to $43,284 for the three months ended September 30, 2021. The net increase was largely due to an increase in compensation and related personnel costs due to an increase in headcount.

•
Cost of sales increased by $26,048, or 24.7%, to $131,451 for the three months ended September 30, 2022 compared to $105,403 for the three months ended September 30, 2021 which was largely due to our increase in U.S. FemVue sales. Gross margin percentage was 62.2% for the three months ended September 30, 2022 compared to 60.9% for the three months ended September 30, 2021, representing a 1.3% change in our gross margin due to certain improvements we have started implementing in order to improve our manufacturing processes.

•
Net loss was $2,982,843 or $0.25 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the three months ended September 30, 2022, compared to $2,259,701, or $0.19 per basic and diluted share attributable to common stockholders, for the three months ended September 30, 2021.

•
Cash and cash equivalents as of September 30, 2022 and December 31, 2021, were $16,005,650 and $24,783,029, respectively.

Year to Date 2022 (Nine-Months) Financial Results

•
General and administrative expenses increased by $993,607, or 32.8%, to $4,024,356 for the nine months ended September 30, 2022 compared to $3,030,749 for the nine months ended September 30, 2021. The net increase was largely due to various additional costs associated with being a public company, including, an increase in salaries and related personnel and an increase in facility and other allocated overhead costs mainly for additional directors and officers insurance.

•
Research and Development expenses increased by $1,511,680, or 49.9%, to $4,542,147 for the nine months ended September 30, 2022 compared to $3,030,467 for the nine months ended September 30, 2021. The net increase of $1,511,680 largely consists of an increase of compensation and related personnel costs primarily due to an increase in headcount and in clinical-related costs, to mainly support our clinical trials.

•
Sales of the Company’s FemVue® product increased by $46,612, or 5.0%, to $971,974 for the nine months ended September 30, 2022 compared to $925,362 for the nine months ended September 30, 2021. The $46,612 net increase was largely attributable to the increase in U.S. FemVue sales of $104,830 for the nine months ended September 30, 2022 compared to the same period last year. This amount was offset by the decrease of $58,218 in international sales for the nine months ended September 30, 2022 compared to the same period last year. U.S. units of FemVue sold increased by 13.8% for the nine months ended September 30, 2022 compared to the same period last year. International sales decreased by 33.4% and were $115,859 and $174,077 for the nine months ended September 30, 2022 and 2021, respectively.

•
Sales and marketing expenses increased by $134,483, or 152.9%, to $222,414 for the nine months ended September 30, 2022 compared to $87,931 for the nine months ended September 30, 2021. This net increase was largely due to an increase in compensation and related personnel costs due to an increase in headcount and additional marketing costs mainly associated with our FemVue social media campaign earlier this year.

•
Cost of sales increased by $50,407, or 16.5%, to $356,479 for the nine months ended September 30, 2022 compared to $306,072 for the nine months ended September 30, 2021. The net increase in cost of sales was mainly due to net increase in sales and increased production personnel labor and overhead costs applied to our cost of sales for the nine months ended September 30, 2022 compared to the same period last year. Gross margin percentage was 63.3% for the nine months ended September 30, 2022 compared to 66.9% for the nine months ended September 30, 2021. We expect to see improvement in our gross margin in the future as we are investing in equipment and tooling which will enable us to reduce labor in certain manufacturing processes and reduce material costs as well.

Net loss was $8,499,974, or $0.72 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the nine months ended September 30, 2022, compared to $5,172,992, or $1.04 per basic and diluted share attributable to common stockholders, for the nine months ended September 30, 2021.

FEMASYS INC.
Balance Sheets
(unaudited)

Assets
  
September 30,
2022
    
December 31,
2021
  
Current assets:
            
Cash and cash equivalents
  
$
16,005,650
      
24,783,029
  
Accounts receivable, net
    
183,130
      
84,258
  
Inventory, net
    
343,136
      
208,270
  
Other current assets
    
760,573
      
555,853
  
Total current assets
    
17,292,489
      
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
    
2,434,524
      
2,261,793
  
Construction in progress
    
503,312
      
379,713
  
     
4,657,764
      
4,321,129
  
Less accumulated depreciation
    
(3,115,551
)
    
(2,722,117
)
Net property and equipment
    
1,542,213
      
1,599,012
  
Long-term assets:
                
Lease right-of-use assets, net
    
402,063
      
665,747
  
Intangible assets, net of accumulated amortization
    
5,759
      
25,093
  
Other long-term assets
    
789,616
      
655,418
  
Total long-term assets
    
1,197,438
      
1,346,258
  
                 
Total assets
  
$
20,032,140
      
28,576,680
  

(continued)

FEMASYS INC.
Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
  
September 30,
2022
    
December 31,
2021
  
Current liabilities:
            
Accounts payable
  
$
419,110
      
445,522
  
Accrued expenses
    
649,615
      
603,787
  
Clinical holdback - current portion
    
36,238
      
18,947
  
Note payable
    
280,577
      
181,123
  
Lease liabilities – current portion
    
386,139
      
406,674
  
Other
    
36,037
      
36,037
  
Total current liabilities
    
1,807,716
      
1,692,090
  
Long-term liabilities:
                
Clinical holdback - long-term portion
    
101,804
      
149,791
  
Lease liabilities – long-term portion
    
115,773
      
402,417
  
Total long-term liabilities
    
217,577
      
552,208
  
Total liabilities
    
2,025,293
      
2,244,298
  
Commitments and contingencies
                
Stockholders’ equity:
                
Common stock, $0.001 par, 200,000,000 authorized, 11,930,833 shares issued and 11,813,610 outstanding as of September 30, 2022; and 11,921,388 shares issued 11,804,165 outstanding as of December 31, 2021
    
11,931
      
11,921
  
Treasury stock, 117,223 shares
    
(60,000
)
    
(60,000
)
Warrants
    
567,972
      
702,492
  
Additional paid-in-capital
    
108,727,253
      
108,418,304
  
Accumulated deficit
    
(91,240,309
)
    
(82,740,335
)
Total stockholders’ equity
    
18,006,847
      
26,332,382
  
Total liabilities and stockholders' equity
  
$
20,032,140
      
28,576,680
  

FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)

   
Three Months Ended September 30,
    
Nine Months Ended September 30,
  
   
2022
    
2021
    
2022
    
2021
  
Sales
  
$
347,456
      
269,581
      
971,974
      
925,362
  
Cost of sales
    
131,451
      
105,403
      
356,479
      
306,072
  
Gross margin
    
216,005
      
164,178
      
615,495
      
619,290
  
Operating expenses:
                                
Research and development
    
1,648,160
      
1,140,577
      
4,542,147
      
3,030,467
  
Sales and marketing
    
90,374
      
43,284
      
222,414
      
87,931
  
General and administrative
    
1,395,063
      
1,087,363
      
4,024,356
      
3,030,749
  
Depreciation and amortization
    
139,597
      
144,399
      
426,480
      
449,211
  
Total operating expenses
    
3,273,194
      
2,415,623
      
9,215,397
      
6,598,358
  
Loss from operations
    
(3,057,189
)
    
(2,251,445
)
    
(8,599,902
)
    
(5,979,068
)
Other income (expense):
                                
Interest income, net
    
80,373
      
1,649
      
109,572
      
1,957
  
Other income
    
—
      
—
      
—
      
821,515
  
Interest expense
    
(6,005
)
    
(7,055
)
    
(9,622
)
    
(14,546
)
Other expense
    
(22
)
    
(2,850
)
    
(22
)
    
(2,850
)
Other income (expense), net
    
74,346
      
(8,256
)
    
99,928
      
806,076
  
Net loss
  
$
(2,982,843
)
    
(2,259,701
)
    
(8,499,974
)
    
(5,172,992
)
                                 
Net loss attributable to common stockholders, basic and diluted
  
$
(2,982,843
)
    
(2,259,701
)
    
(8,499,974
)
    
(5,172,992
)
Net loss per share attributable to common stockholders, basic and diluted
  
$
(0.25
)
    
(0.19
)
    
(0.72
)
    
(1.04
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
    
11,813,610
      
11,799,720
      
11,810,289
      
4,996,680
  

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. To learn more, visit www.femasys.com or follow us on Twitter 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 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 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
[email protected]

Media
Karissa Cross, Ph.D.
LifeSci Communications
[email protected]

Femasys Inc.
Investor Contact:
[email protected]

Media Contact:
[email protected]