FEMY 10-Q Quarterly Report Sept. 30, 2023 | Alphaminr
ALPHAMINR

FEMY 10-Q Quarter ended Sept. 30, 2023

Balance Sheet
Cash Flow
Income Statement
Debt
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

(Mark One)
☑
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

OR

☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________to____________

Commission file number: 001-40492


Femasys Inc.


(Exact Name of Registrant as Specified in its Charter)

Delaware

11-3713499
(State or other jurisdiction of incorporation or organization)

(IRS Employer Identification No.)

3950 Johns Creek Court , Suite 100

Suwanee , GA

30024
(Address of principal executive offices)

(Zip Code)
( 770 ) 500-3910
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol

Name of each exchange on which
registered
Common stock, $0.001 par value

FEMY

The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑  No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☑ Smaller reporting company ☑
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. ☑

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes ☐ No ☑

The Registrant had 21,649,623 shares of common stock, $0.001 par value, outstanding as of November 13, 2023.
TABLE OF CONENTS
Page
Part I. Financial Information
Item 1
5
5
7
8
10
11
Item 2
17
Item 3
22
Item 4
22
Part II. Other Information
Item 1
23
Item 1A
23
Item 2
23
Item 3
23
Item 4
23
Item 5
23
Item 6
24
25

2
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “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 include, but are not limited to, statements concerning:


•
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;

•
our ability to enroll subjects in the clinical trials for our product candidates in order to advance the development thereof on a timely basis;

•
our ability to obtain additional financing to fund the clinical development of our products and fund operations;

•
estimates regarding the total addressable market for our product candidates;

•
competitive companies and technologies in our industry;

•
our ability to obtain U.S. Food and Drug Administration (FDA) approval for our permanent birth control system, ability to establish and expand sales of our women-specific medical products and develop and commercialize additional products;

•
our ability to commercialize or obtain regulatory approvals, 510(k) clearance for our product candidates, or the effect of delays in commercializing or obtaining regulatory authorizations;

•
our business model and strategic plans for our products, technologies and business, including our implementation thereof;

•
commercial success and market acceptance of our product candidates;

•
our ability to achieve and maintain adequate levels of coverage or reimbursement for our FemBloc system or any future products we may seek to commercialize;

•
our ability to manufacture our products and product candidates in compliance with applicable laws, regulations and requirements and to oversee third-party suppliers, service providers and vendors in the performance of any contracted activities in accordance with applicable laws, regulations and requirements;

•
adverse developments affecting the financial services industry;

•
the impact of the COVID-19 pandemic on our business, financial condition, results of operations, and prospects;

•
our ability to accurately forecast customer demand for our product candidates, and manage our inventory;

•
our ability to build, manage and maintain our direct sales and marketing organization, and to market and sell our permanent birth control system, artificial insemination product and women-specific medical product solutions in markets in and outside of the United States;

•
our ability to hire and retain our senior management and other highly qualified personnel;

•
FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets;

•
the timing or likelihood of regulatory filings and approvals or clearances;

•
our ability to establish and maintain intellectual property protection for our product candidates and our ability to avoid claims of infringement;

•
the volatility of the trading price of our common stock;

•
our ability to maintain compliance with Nasdaq’s continued listing requirements; and

•
our expectations about market trends.

3
The forward-looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report on 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed with the Securities and Exchange Commission as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. The forward-looking statements contained in this Quarterly Report on 10-Q are excluded from the safe harbor protection provided by the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended.
4
PART I. FINANCIAL INFORMATION

ITEM I.
Financial Statements

FEMASYS INC.
Balance Sheets
(unaudited)

Assets
September 30,
2023
December 31,
2022
Current assets:
Cash and cash equivalents
$
8,692,435
12,961,936
Accounts receivable, net
103,556
77,470
Inventory, net
602,668
436,723
Other current assets
826,373
655,362
Total current assets
10,225,032
14,131,491
Property and equipment, at cost:
Leasehold improvements
1,195,637
1,195,637
Office equipment
99,344
99,344
Furniture and fixtures
419,303
419,303
Machinery and equipment
2,645,609
2,572,243
Construction in progress
394,957
413,843
4,754,850
4,700,370
Less accumulated depreciation
( 3,594,300
)
( 3,217,319
)
Net property and equipment
1,160,550
1,483,051
Long-term assets:
Lease right-of-use assets, net
2,530,571
319,557
Intangible assets, net of accumulated amortization
388
3,294
Other long-term assets
936,996
958,177
Total long-term assets
3,467,955
1,281,028

Total assets
$
14,853,537
16,895,570

(continued)

5
FEMASYS INC.
Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
September 30,
2023
December 31,
2022
Current liabilities:
Accounts payable
$
851,877
510,758
Accrued expenses
569,442
456,714
Note payable
283,334 141,298
Clinical holdback – current portion
72,075
45,206
Lease liabilities – current portion
410,219
373,833
Total current liabilities
2,186,947
1,527,809
Long-term liabilities:
Clinical holdback – long-term portion
54,019
96,658
Lease liabilities – long-term portion
2,168,969
28,584
Total long-term liabilities
2,222,988
125,242
Total liabilities
4,409,935
1,653,051
Commitments and contingencies
Stockholders’ equity:
Common stock, $ 0.001 par, 200,000,000 authorized, 16,110,092 shares issued and
15,992,869 outstanding as of September 30,2023; and 11,986,927 shares issued and
11,869,704 outstanding as of December 31, 2022
16,110
11,987
Treasury stock, 117,223 shares
( 60,000
)
( 60,000
)
Warrants
1,581,608
567,972
Additional paid-in-capital
112,877,059
108,857,065
Accumulated deficit
( 103,971,175
)
( 94,134,505
)
Total stockholders’ equity
10,443,602
15,242,519
Total liabilities and stockholders’ equity
$
14,853,537
16,895,570
The accompanying notes are an integral part of these unaudited financial statements.

6
FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)

Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Sales
$
244,361
347,456
858,859
971,974
Cost of sales
86,186
131,451
301,775
356,479
Gross margin
158,175
216,005
557,084
615,495
Operating expenses:
Research and development
2,072,830
1,648,160
5,137,441
4,542,147
Sales and marketing
70,883
90,374
444,678
222,414
General and administrative
1,970,408
1,395,063
4,642,182
4,024,356
Depreciation and amortization
125,318
139,597
391,683
426,480
Total operating expenses
4,239,439
3,273,194
10,615,984
9,215,397
Loss from operations
( 4,081,264
)
( 3,057,189
)
( 10,058,900
)
( 8,599,902
)
Other income (expense):
Interest income
92,392
80,373
232,133
109,572
Interest expense
( 8,033 ) ( 6,005 ) ( 9,903 ) ( 9,622 )
Other expense
— ( 22 ) — ( 22 )
Other income (expense), net
84,359 74,346 222,230 99,928
Net loss
$
( 3,996,905
)
( 2,982,843
)
( 9,836,670
)
( 8,499,974
)
Net loss attributable to common stockholders, basic and diluted
$
( 3,996,905
)
( 2,982,843
)
( 9,836,670
)
( 8,499,974
)
Net loss per share attributable to common stockholders, basic and diluted
$
( 0.26
)
( 0.25
)
( 0.74
)
( 0.72
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
15,093,147
11,813,610
13,369,462
11,810,289

The accompanying notes are an integral part of these unaudited financial statements.

7
FEMASYS INC.
Statements of Stockholders’ Equity
(unaudited)


Total
Common stock
Treasury stock
Additional Accumulated stockholders’
Shares
Amount
Shares
Amount
Warrants
paid-in capital
deficit
Equity
THREE MONTHS ENDED SEPTEMBER 30, 2023
Balance at June 30, 2023
15,190,376
$
15,190
117,223
$
( 60,000
)
$
1,918,103
$
110,977,150
$
( 99,974,270
)
$
12,876,173
Share-based compensation expense
—
—
—
—
—
504,359
—
504,359
Exercise of common warrants 919,716 920 — — ( 336,495 ) 1,395,550 — 1,059,975
Net loss
—
—
—
—
— — ( 3,996,905 ) ( 3,996,905 )
Balance at September 30, 2023
16,110,092
$
16,110
117,223
$
( 60,000
)
$
1,581,608
$
112,877,059
$
( 103,971,175
)
$
10,443,602
NINE MONTHS ENDED SEPTEMBER 30, 2023
Balance at December 31, 2022
11,986,927
$
11,987
117,223
$
( 60,000
)
$
567,972
$
108,857,065
$
( 94,134,505
)
$
15,242,519
Issuance of common stock and warrants in connection with April 2023 Financing, net of issuance costs
1,318,000
1,318
—
—
2,526,664
818,014
—
3,345,996
Issuance of common stock in connection with at-the-market offering, net of issuance costs
2,869
3
—
—
—
3,365
—
3,368
Issuance of common stock in connection with ESPP
3,858
3
—
—
—
1,694
—
1,697
Exercise of pre-funded warrants
1,878,722
1,879
—
—
( 1,176,533
)
1,174,842
—
188
Exercise of common warrants
919,716
920
—
—
( 336,495
)
1,395,550
—
1,059,975
Share-based compensation expense — — — — — 626,529 — 626,529
Net loss
—
—
—
—
—
—
( 9,836,670
)
( 9,836,670
)
Balance at September 30, 2023
16,110,092
$
16,110
117,223
$
( 60,000
)
$
1,581,608
$
112,877,059
$
( 103,971,175
)
$
10,443,602

The accompanying notes are an integral part of these unaudited financial statements.

8
FEMASYS INC.
Statements of Stockholders’ Equity
(unaudited)

Total

Common stock
Treasury stock
Additional Accumulated stockholders’
Shares
Amount
Shares
Amount
Warrants
paid-in capital
deficit
Equity
THREE MONTHS ENDED SEPTEMBER 30, 2022
Balance at June 30, 2022
11,930,833
$
11,931
117,223
$
( 60,000
)
$
567,972
$
108,675,491
$
( 88,257,466
)
$
20,937,928
Share-based compensation expense
—
—
—
—
—
51,762
—
51,762
Net loss
—
—
—
—
—
—
( 2,982,843
)
( 2,982,843
)
Balance at September 30, 2022
11,930,833
$
11,931
117,223
$
( 60,000
)
$
567,972
$
108,727,253
$
( 91,240,309
)
$
18,006,847
NINE MONTHS ENDED SEPTEMBER 30, 2022
Balance at December 31, 2021
11,921,388
$
11,921
117,223
$
( 60,000
)
$
702,492
$
108,418,304
$
( 82,740,335
)
$
26,332,382
Expiration of warrant
( 134,520
)
134,520
—
Issuance of common stock for cash upon exercise of options
9,445
10
—
—
—
16,141
—
16,151
Share-based compensation expense
—
—
—
—
—
158,288
—
158,288
Net loss
—
—
—
—
—
—
( 8,499,974
)
( 8,499,974
)
Balance at September 30, 2022
11,930,833
$
11,931
117,223
$
( 60,000
)
$
567,972
$
108,727,253
$
( 91,240,309
)
$
18,006,847

The accompanying notes are an integral part of these unaudited financial statements.

9
FEMASYS INC.
Statements of Cash Flows
(unaudited)

Nine Months Ended September 30,
2023
2022
Cash flows from operating activities:
Net loss
$
( 9,836,670
)
( 8,499,974
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
388,777
407,146
Amortization
2,906
19,334
Amortization of right-of-use assets
274,158
249,972
Inventory reserve
4,972 3,800
Loss on disposal of assets
44,538 —
Share-based compensation expense
626,529
158,288
Changes in operating assets and liabilities:
Accounts receivable
( 26,086
)
( 98,872
)
Inventory
( 170,917
)
( 138,666
)
Other assets
313,154
359,307
Accounts payable
341,119
( 49,449
)
Accrued expenses
112,728
45,828
Lease liabilites
( 304,004
)
( 290,104
)
Other liabilities
( 15,770
)
( 30,696
)
Net cash used in operating activities
( 8,244,566
)
( 7,864,086
)
Cash flows from investing activities:
Purchases of property and equipment
( 99,018
)
( 313,598
)
Net cash used in investing activities
( 99,018
)
( 313,598
)
Cash flows from financing activities:
Proceeds from the issuance of common stock and warrants in April 2023 Financing
3,899,813 —
Equity issuance costs
( 547,764 ) —
Proceeds from exercise of pre-funded warrants
188 —
Proceeds from exercise of common warrants
1,059,975 —
Proceeds from common stock issued through ESPP and exercised options
1,697 16,151
Net proceeds from issuance of common stock in connection with at-the-market offering
3,373
—
Payments of deferred offering costs
— ( 232,845 )
Repayment of note payable
( 327,006
)
( 365,926
)
Payments under lease obligations
( 16,193
)
( 17,075
)
Net cash provided by (used in) financing activities
4,074,083
( 599,695
)
Net change in cash and cash equivalents
( 4,269,501
)
( 8,777,379
)
Cash and cash equivalents:
Beginning of period
12,961,936
24,783,029
End of period
$
8,692,435
16,005,650
Supplemental cash flow information
Cash paid for:
Interest
$ 9,903 9,622
Income taxes
$ 4,550 5,050
Non-cash investing and financing activities:
Right-of-use asset obtained in exchange for a lease liability
$
2,496,968 —
Property and equipment costs included in accounts payable
$
— 23,037
Commissions and deferred offering costs relating to proceeds from issuance of common stock
$ 6,163 —
Prepaid insurance financed with promissory notes
$
283,334
280,577

The accompanying notes are an integral part of these unaudited financial statements.

10
FEMASYS INC.
Notes to Financial Statements
(unaudited)

(1)
Organization , Nature of Business, and Liquidity
Organization and Nature of Business
Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19, 2004 and is headquartered in Suwanee, Georgia. The Company is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative therapeutic and diagnostic products. The Company currently operates as one segment with an initial focus on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility issues.


Femasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemBloc® (FemBloc), the Company’s solution for permanent birth control, is based on the Company’s non-surgical platform technology. In June 2023 the Company received approval of its Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for the pivotal clinical trial of FemBloc. In July 2023 the Company announced the notice of allowance for a new U.S. patent application covering use of FemBloc for female permanent birth control. In August 2023 the Company announced the initiation of enrollment for the pivotal clinical trial of FemBloc. FemaSeed® (FemaSeed), a solution which enables intratubal artificial insemination to provide a lower cost option to in vitro fertilization methods, received approval in April 2021 from the FDA on its IDE and the clinical trial was initiated in July 2021. An updated trial design received approval in October 2022 from the FDA and the trial enrollment is ongoing. In April 2023 the Company received approval to sell FemaSeed in Canada. In September 2023 the Company announced 510(k) clearance from the FDA for FemaSeed for intratubal insemination. FemVue® (FemVue), a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S., Japan, and Canada. FemChec® (FemChec) allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success) and is being studied as part of the FemBloc pivotal trial. FemCath® (FemCath), allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter that is undirected, is approved for sale in the U.S and Canada. FemCerv® (FemCerv) is an alternative for the diagnosis of cervical cancer by obtaining a comprehensive tissue sample with minimal contamination of the endocervical canal, and is approved for sale in the U.S and Canada. In August 2023 the Company announced it had obtained a Medical Device Establishment License from Health Canada allowing the Company to directly sell its four products, FemaSeed®, FemVue®, FemCath® and FemCerv®, in Canada.

Basis of Presentation

The Company has prepared the accompanying financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to these rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2022 included in our Annual Report on Form 10K filed with the SEC on March 30, 2023 (the Annual Report). There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in the Annual Report.


In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the Company’s financial position and the results of its operations and cash flows at the dates for periods presented. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expense during the reporting periods. The most significant estimates used in these financial statements include the valuation of stock options, warrants, useful lives of property and equipment and intangible assets. Estimates for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates.

Liquidity
As of September 30, 2023, the Company had cash and cash equivalents of $ 8,692,435 . The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and revenue primarily anticipated from the sale of FemVue and FemaSeed to support the Company’s research and development activities, largely in connection with FemBloc. There can be no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could be materially adversely impacted.

For the nine months ended September 30, 2023, the Company generated a net loss of $ 9,836,670 . The Company expects such losses to increase over the next few years as the Company advances FemBloc through clinical development until FDA approval is received and is available to be marketed in the United States.

11
FEMASYS INC.
Notes to Financial Statements
(unaudited)
The Company believes that its cash and cash equivalents as of September 30, 2023 and cash received subsequent to quarter end (see Note 13, Subsequent Events ) will be sufficient to fund our ongoing operations at least 12 months from the date of filing these financial statements.

Recently Issued Accounting Pronouncements – Recently Adopted

On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the Financial Accounting Standards Board (FASB) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets, which are not measured at fair value through net income. Under legacy standards, we recognize an impairment of receivables when it was probable that a loss had been incurred. Under the new standard, we are required to recognize estimated credit losses expected to occur over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions. The guidance is effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this new guidance did not have a material impact on the Company’s financial statements and footnote disclosures (unaudited).
Recently Issued Accounting Pronouncements – Not Yet Adopted
No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s financial statements.
(2)
Cash and Cash Equivalents
As of September 30, 2023 and December 31, 2022, money market funds included in cash and cash equivalents on the balance sheets were $ 7,330,371 and $ 12,553,557 , respectively, which represent level 1 within the fair value hierarchy where there are quoted prices in active markets for identical assets.

(3)
Inventories
Inventory stated at cost, net of reserve, consisted of the following:

September 30, December 31,
2023
2022
Materials
$
361,569
244,498
Work in progress
51,358
100,453
Finished goods
189,741
91,772
Inventory, net
$
602,668
436,723

The FemVue reserve for slow moving, obsolete, or unusable inventories was $ 3,560 and $ 2,103 as of September 30, 2023 and December 31, 2022, respectively.

(4)
Accrued Expenses
Accrued expenses consisted of the following:

September 30, December 31,
2023
2022
Clinical trial costs
$
313,029
333,440
Compensation costs
155,192
85,191
Franchise taxes
— 26,886
Director fees
90,000 —
Other
11,221
11,197
Accrued expenses
$
569,442
456,714

12
FEMASYS INC.
Notes to Financial Statements
(unaudited)
(5)
Clinical Holdback
The following table shows the activity within the clinical holdback liability accounts for the nine months ended September 30, 2023:
Balance at December 31, 2022
$
141,864
Clinical holdback retained
4,529
Clinical holdback paid
( 20,299
)
Balance at September 30 , 2023
$
126,094
Less: clinical holdback - current portion
( 72,075
)
Clinical holdback - long-term portion
$
54,019

(6)
Revenue Recognition
Revenue is recognized upon shipment of our goods based upon contractually stated pricing at standard payment terms ranging from 30 to 60 days. All revenue is recognized point in time and no revenue is recognized over time. For the three and nine months ended September 30, 2023 and 2022, there was no revenue recognized from performance obligations satisfied or partially satisfied in prior periods, nor were there any unsatisfied performance obligations as of September 30, 2023 or 2022.
The majority of products sold directly to U.S customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to our international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in original unopened cartons and are subject to a 30 % restocking fee. Throughout the periods presented, the Company has not had a history of significant returns.
The following table summarizes our sales, primarily from FemVue, by geographic region as follows:

Three Months Ended September 30,
Nine Months Ended September 30,
Primary geographical markets
2023
2022
2023
2022
U.S.
$
244,361
289,642
800,814
856,115
International
—
57,814
58,045
115,859
Total
$
244,361
347,456
858,859
971,974

(7)
Commitments and Contingencies

Legal Claims
Occasionally, the Company may be a party to legal claims or proceedings of which the outcomes are subject to significant uncertainty. In accordance with Accounting Standards Codification (ASC) 450, Contingencies , the Company will assess the likelihood of an adverse judgment for any outstanding claim as well as ranges of probable losses. When it has been determined that a loss is probable and the amount can be reasonably estimated, the Company will record a liability. For both periods presented, there were no material legal contingencies requiring accrual or disclosure.

The Company, as permitted under Delaware law and in accordance with its bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The Company entered into employment agreements with its officers, which provides for indemnification protection in the executive’s capacity as an officer for actions taken within the scope of employment. The maximum amount of potential future indemnification is unlimited; however, the Company has obtained director and officer insurance that limits its exposure. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of September 30, 2023 and December 31, 2022.

(8)
Notes Payable

AFCO Credit Corporation (AFCO)
In July 2023, the Company executed a promissory note with AFCO to finance certain insurance premiums totaling $ 469,042 , requiring the Company to pay $ 48,423 in a down payment and make monthly installment payments. The annual interest rate is 8.587 % and the monthly installment is $ 48,423 , which represents principal and interest.

As of September 30, 2023 and December 31, 2022, the principal balance on the remaining AFCO promissory notes was $ 283,334 and $ 141,298 , respectively and is included in Notes payable in the accompanying balance sheets. Interest expense in connection with the AFCO promissory notes was $ 7,998 and $ 5,352 for the three months ended September 30, 2023 and 2022, respectively. Interest expense was $ 9,317 and $ 7,235 for the nine months ended September 30, 2023 and 2022, respectively .

13
FEMASYS INC.
Notes to Financial Statements
(unaudited)
(9)
Leases

Operating Lease

In July 2023, the Company executed an extension of its operating lease agreement for facilities in Suwanee, GA, obligating the company to make $ 3,321,025 in payments for an additional 63 months, through April 2029 . The operating lease extension resulted in a corresponding right of use asset and lease liability increase of $ 2,496,968 in July 2023.

(10)
Stockholders’ Equity

In July 2022, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler” or the “Sales Agent”) and filed a related Prospectus establishing an “at-the-market” facility, pursuant to which the Company may offer and sell shares of common stock having an aggregate offering price of up to $ 8,800,000 from time to time through the Sales Agent pursuant to the Prospectus. For the nine months ended September 30, 2023, 2,869 shares of common stock were sold under the Equity Distribution Agreement. In April 2023, the Company suspended its at-the-market facility with the Sales Agent, which was subsequently reinstated in October 2023 (see Note 13, Subsequent Events ) .

In April 2023, the Company sold an aggregate of (i) 1,318,000 shares of common stock and (ii) pre-funded warrants to purchase up to 1,878,722 shares of common stock in a registered direct offering (“pre-funded warrants”) and, in a concurrent private placement, warrants to purchase up to 3,196,722 shares of common stock (“common warrants”). Additionally, common warrants were issued to the placement agent to purchase up to 191,803 shares of common stock as compensation for services (“placement agent warrants”), collectively the (“April 2023 Financing”). The purchase price per share for the common stock, pre-funded warrants was $ 1.22 and $ 1.2199 , respectively. The gross proceeds from the offering were $ 3,899,813 , less placement agent fees and offering expenses of $ 547,764 . The Company intends to use the net proceeds from the offering for general corporate purposes.

As of September 30, 2023, the Company had 15,992,869 shares of common stock outstanding, and no dividends have been declared or paid.

(11)
Equity Incentive Plans and Warrants

Stock-Based Awards


(a)
Stock Option Plans
Activity under the Company’s stock option plans for the nine months ended September 30, 2023 was as follows:

Number of
options
Weighted
average
exercise
price
Outstanding at December 31, 2022 931,550 $ 3.97
Granted 5,000 1.18
Forfeited ( 50,055 ) 1.87
Outstanding at March 31, 2023 886,495 $ 4.07
Granted
153,200 0.75
Forfeited
( 20,024 ) 3.94
Outstanding at June 30, 2023
1,019,671 $ 3.57
Granted
1,064,800 0.49
Forfeited
( 5,200 ) 1.25
Outstanding at September 30, 2023 2,079,271 $ 2.00
Vested and exercisable at September 30 , 2023 1,217,298 $ 2.62

14
FEMASYS INC.
Notes to Financial Statements
(unaudited)
Options granted under our 2021 Stock Option Plan for the nine months ended September 30, 2023 to employees and nonemployees were 1,150,000 and 73,000 , respectively and the weighted average exercise prices were $ 0.52 and $ 0.64 , respectively. The weighted-average fair values of the options granted to employees and nonemployees were $ 0.42 and $ 0.51 , respectively and were estimated using the following Black-Scholes assumptions:

Employee
Nonemployee
Expected term (in years)
5.60
5.49
Risk‑free interest rate
4.06
%
3.96 %
Dividend yield
—
%
— %
Expected volatility
105.14
%
106.58 %

No options were exercised for the nine months ended September 30, 2023 under our stock option plans.

As of September 30, 2023, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was 652,314 .


(b)
Inducement Grants

For the nine months ended September 30, 2023, no inducement awards were granted. As of September 30, 2023 , 150,000 shares were outstanding with a weighted average exercise price of $ 2.42 , and 25,000 shares were vested and exercisable with a weighted average exercise price of $ 2.97 .


(c) Share-Based Compensation Expense

The following table shows the share-based compensation expense related to vested stock option grants to employees and nonemployees by financial statement line item on the accompanying statement of comprehensive loss:

Three Months Ended September 30 , Nine Months Ended September 30 ,
2023
2022
2023 2022
Research and development
$
79,561
10,820
131,812 73,395
Sales and marketing
623
1,515
( 1,319 ) 3,857
General and administrative
424,175
39,427
496,036 81,036
Total share-based compensation expense
$
504,359
51,762
626,529 158,288

As September 30, 2023 , the remaining share-based compensation expense that is expected to be recognized in future periods for employees and nonemployees is $ 864,904 , which includes $ 155,222 of compensation expense to be recognized upon achieving certain performance conditions. For service-based awards, the $ 709,682 of unrecognized expense is expected to be recognized over a weighted average period of 3.0 years.

(d)
Employee Stock Purchase Plan (ESPP)
For the nine months ended September 30, 2023 , 3,858 shares of common stock were issued under the Company’s ESPP Plan. As of September 30, 2023 , the total number of shares of common stock reserved for future awards under the ESPP Plan was 394,704 .


(e)
April 2023 Financing

On  April 20, 2023, the Company entered into a securities purchase agreement pursuant to which the Company sold (i) 1,318,000 shares of common stock (see Note 10, Stockholders’ Equity ), (ii) pre-funded warrants to purchase 1,878,722 shares of common stock, (iii) common warrants to purchase 3,196,722 shares of common stock. Additionally, common warrants to purchase 191,803 shares of common stock were issued to the placement agent compensation for services performed.

The pre-funded warrants, common warrants and placement agent warrants were exercisable immediately following the closing date of the offering. The pre-funded warrants have an unlimited term and an exercise price of $ 0.0001 per share. The common warrants have a 5.5 year term and an exercise price of $ 1.095 per share. The placement agent warrants have a 5 year term and exercise price of $ 1.525 per share. The offering resulted in aggregate gross proceeds of $ 3,899,813 , before $ 547,764 of transaction costs.

The pre-funded warrants and common warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise.

The common stock was valued at $ 1,133,480 , based on the Company’s stock price. The pre-funded warrants and common warrants were valued at $ 1,615,701 and $ 1,854,099 , respectively, using the following Black-Scholes assumptions:

15
FEMASYS INC.
Notes to Financial Statements
(unaudited)
Pre-funded
warrants
Common
warrants
Expected term (in years)
4
4
Risk‑free interest rate
3.83
%
3.83
%
Dividend yield
—
%
—
%
Expected volatility
100.25
%
100.25
%
Exercise price
$
0.0001
$
1.095
Stock price
$
0.86
$
0.86
Black-Scholes value
$ 0.86 $ 0.58

The net proceeds of $ 3,352,049 were allocated to the common stock, pre-funded warrants and common warrants using the relative fair value method. The valuations were recorded to stockholders’ equity.
In June 2023, all pre-funded warrants were exercised for shares of common stock. In September 2023, 796,722 common warrants and 122,994 placement agent warrants were exercised for cash proceeds of $ 1,059,975 . As of September 30, 2023 2,400,000 common warrants and 68,809 placement agent warrants remain outstanding.

(12)
Net Loss per Share Attributable to Common Stockholders
The following ta ble sets forth the computation of t he basic and diluted net loss per share:

Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022

Net loss attributable to common stockholders, basic & diluted
$
( 3,996,905
)
( 2,982,843
)
( 9,836,670
)
( 8,499,974
)
Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted
15,093,147
11,813,610
13,369,462
11,810,289
Net loss per share attributable to common stockholders, basic and diluted
$
( 0.26
)
( 0.25
)
( 0.74
)
( 0.72
)

The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive:
Three Months Ended September 30,
Nine Months Ended September 30,

2023
2022
2023
2022
Options to purchase common stock
2,229,271
1,071,573
2,229,271
1,071,573
Warrants to purchase common stock, in connection with April 2023 financing
2,468,809 — 2,468,809 —
Warrants to purchase common stock
233,460
233,460
233,460
233,460
Total potential shares
4,931,540
1,305,033
4,931,540
1,305,033


(13)
Subsequent Events



In October 2023, 2,400,000 common warrants were exercised for cash proceeds of $ 2,628,000 .



In October 2023, the Company reinstated the at-the-market agreement and authorized the Sales Agent to sell up to $ 16.7 million shares at current market prices until all shares are sold. In October 2023, the Company sold 3,256,754 shares under this facility, resulting in gross cash proceeds of $ 7,661,587 .
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes included elsewhere in this in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, or the SEC, on March 30, 2023. This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “goal,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements and reflect our beliefs and opinions on the relevant subject. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report on Form 10-Q. The forward-looking statements included in this Quarterly Report on Form 10-Q are made only as of the date hereof. These statements are based upon information available to us as of the filing date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

Overview

We are a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead late-clinical stage product candidate and innovative therapeutic and diagnostic products. We are a woman-founded and led company with an expansive, internally created intellectual property portfolio with over 150 patents globally, in- house chemistry, manufacturing, and controls (CMC) and device manufacturing capabilities and proven ability to develop and commercialize products. Our suite of products and product candidates address what we believe are multi-billion dollar global market segments in which there has been little advancement for many years, helping women avoid pharmaceutical solutions, implants and surgery that can be expensive and expose women to harm. With an initial focus in the area of reproductive health, our lead product candidate offers a solution for permanent birth control (FemBloc) and infertility treatment with our FemaSeed product for intratubal artificial insemination, which received FDA 510(k) clearance in September 2023.

Corporate Update

On April 18, 2023, we announced that Health Canada, the Public Health Agency of Canada, has granted product approval of FemaSeed, the first-ever infertility solution designed to deliver sperm directly to where contraception occurs. FemaSeed is Femasys’ intratubal artificial insemination option that is designed to be less invasive and more affordable than assisted reproduction, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

On May 3, 2023, we announced that Health Canada, the Public Health Agency of Canada, has granted product approval of FemCerv, the first endocervical tissue sampler (curette) designed to collect and contain a comprehensive sample to maximize quality and quantity in a relatively pain-free manner.  FemCerv is designed to improve the existing standard of care to diagnose the presence of cancerous cells in a woman’s cervix.

On June 8, 2023, we announced that Health Canada, the Public Health Agency of Canada, has granted product approval of FemCath, the first intrauterine catheter which involves placement of balloon technology close to the opening of a selected fallopian tube for directed delivery of contrast.

On June 26, 2023, we announced FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial.

On July 27, 2023, we announced a notice of allowance for a new U.S. patent application covering use of FemBloc for female permanent birth control.

On August 3, 2023, we announced initiation of enrollment in pivotal trial of our permanent birth control candidate FemBloc and we expect that the resulting patent, when issued, will have an anticipated expiration in 2039 at the earliest.

On August 31, 2023, we announced that we obtained a Medical Device Establishment License from Health Canada that allows us to directly sell our four products, FemaSeed ® , FemVue ® , FemCath ® and FemCerv ® , in Canada.

On September 25, 2023, we announced FDA 510(k) clearance of our intratubal artificial insemination product FemaSeed.

On October 11, 2023, we regained compliance with Nasdaq’s minimum bid price requirement, after having received a notice on June 1, 2023 from Nasdaq that we were not in compliance with such requirement. We are now in compliance with all applicable Nasdaq listing standards.

17
Clinical Update

FemaSeed – Our Intratubal Artificial Insemination Solution . In April 2021 we received an IDE approval from FDA that allowed us to initiate a pivotal trial for the FemaSeed device. The first subject was enrolled in July 2021. In October 2022, we announced an updated study design for the pivotal trial, which now focuses on couples experiencing male factor infertility. This update reflects a revised strategy to address this underserved population experiencing infertility with a goal of facilitating accelerated enrollment. Completion of enrollment is expected in the fourth quarter of 2023 followed by a planned submission of the results from the trial for publication. In September 2023 the Company announced 510(k) clearance from the FDA for FemaSeed intratubal insemination with no restrictions in patient population.

FemBloc – Our Permanent Birth Control Solution. In June 2023 we received FDA approval of our IDE to evaluate the safety and efficacy of FemBloc, our non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial. In August 2023 we announced the initiation of enrollment in the FINALE [Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control] pivotal trial designed to evaluate the safety and efficacy of FemBloc. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint, which will be analyzed once 401 women have used FemBloc for one year for permanent birth control. In addition, the study is designed as a roll-in beginning with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling the remaining subjects. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc for permanent birth control for one year. Follow-up will continue annually for five years post-market.

Results of Operations

Comparison of the Three Months Ended September 30, 2023 and 2022

The following table shows our results of operations for the three months ended September 30, 2023 and 2022:

Three Months Ended September 30,
2023
2022
Change
% Change
Sales
$
244,361
347,456
(103,095
)
-29.7
%
Cost of sales
86,186
131,451
(45,265
)
-34.4
%
Gross margin
158,175
216,005
(57,830
)
-26.8
%
Operating expenses:
Research and development
2,072,830
1,648,160
424,670
25.8
%
Sales and marketing
70,883
90,374
(19,491
)
-21.6
%
General and administrative
1,970,408
1,395,063
575,345
41.2
%
Depreciation and amortization
125,318
139,597
(14,279
)
-10.2
%
Total operating expenses
4,239,439
3,273,194
966,245
29.5
%
Loss from operations
(4,081,264
)
(3,057,189
)
(1,024,075
)
33.5
%
Other income (expense):
Interest income
92,392
80,373
12,019
15.0
%
Interest expense
(8,033
)
(6,005
)
(2,028
)
33.8
%
Other expense
—
(22
)
22
-100.0
%
Other income (expense), net
84,359
74,346
10,013
13.5
%
Net loss
$
(3,996,905
)
(2,982,843
)
(1,014,062
)
34.0
%

Sales

Sales decreased by $103,095, or 29.7%, to $244,361 for the three months ended September 30, 2023 from $347,456 for the three months ended September 30, 2022. The decrease is attributable to reduced international and U.S. sales of $45,281 and $57,814, respectively for the comparable periods. U.S. units sold decreased by 18.4% for the comparable periods.

Cost of sales and gross margin percentage

Cost of sales decreased by $45,265 or 34.4%, to $86,186 for the three months ended September 30, 2023 from $131,451 for the three months ended September 30, 2022. The decrease is primarily attributed to reduced sales and certain manufacturing efficiencies. Gross margin percentage improved to 64.7% for the three months ended September 30, 2023 as compared to 62.2% for the three months ended September 30, 2022.

18
The following table summarizes our R&D expenses incurred during the periods presented:

Three Months Ended September 30,

2023
2022
Compensation and related personnel costs
$
918,617
771,979
Clinical-related costs
534,789
628,046
Material and development costs
455,347
145,692
Professional and outside consultant costs
133,476
87,012
Other costs
30,601
15,431
Total research and development expenses
$
2,072,830
1,648,160

R&D expenses increased by $424,670 or 25.8%, to $2,072,830 for the three months ended September 30, 2023 from $1,648,160 for the three months ended September 30, 2022. The increase relates primarily to increased material and development costs, compensation costs and professional and outside consultant costs, partially offset by reduced clinical-related costs.

Sales and marketing

Sales and marketing expenses decreased by $19,491 or 21.6%, to $70,883 for the three months ended September 30, 2023 from $90,374 for the three months ended September 30, 2022. The decrease is largely due to reduced compensation costs for the comparable periods.

General and administrative

General and administrative expenses increased by $575,345, or 41.2%, to $1,970,408 for the three months ended September 30, 2023 from $1,395,063 for the three months ended September 30, 2022. The increase was largely due to increased compensation and professional costs, partially offset by decreased facility and overhead costs.

Depreciation and amortization

Depreciation and amortization expenses decreased by $14,279, or 10.2%, to $125,318 for the three months ended September 30, 2023 from $139,597 for the three months ended September 30, 2022. The decrease is due to a reduction of amortization expense associated with our intangible assets and depreciation expense associated with our fixed assets.

Other income (expense), net

Other income (expense), net increased by $10,013, or 13.5%, to $84,359 for the three months ended September 30, 2023 from $74,346 for the three months ended September 30, 2022, primarily due to an increase in interest income.

Results of Operations

Comparison of the Nine months ended September 30, 2023 and 2022

The following table shows our results of operations for the nine months ended September 30, 2023 and 2022:


Nine Months Ended September 30,

2023
2022
Change
% Change
Sales
$
858,859
971,974
(113,115
)
-11.6
%
Cost of sales
301,775
356,479
(54,704
)
-15.3
%
Gross margin
557,084
615,495
(58,411
)
-9.5
%
Operating expenses:
Research and development
5,137,441
4,542,147
595,294
13.1
%
Sales and marketing
444,678
222,414
222,264
99.9
%
General and administrative
4,642,182
4,024,356
617,826
15.4
%
Depreciation and amortization
391,683
426,480
(34,797
)
-8.2
%
Total operating expenses
10,615,984
9,215,397
1,400,587
15.2
%
Loss from operations
(10,058,900
)
(8,599,902
)
(1,458,998
)
17.0
%
Other income (expense):
Interest income
232,133
109,572
122,561
111.9
%
Interest expense
(9,903
)
(9,622
)
(281
)
2.9
%
Other expense
—
(22
)
22
-100.0
%
Other income (expense), net
222,230
99,928
122,302
122.4
%
Net loss
$
(9,836,670
)
(8,499,974
)
(1,336,696
)
15.7
%

19
Sales

Sales decreased by $113,115, or 11.6%, to $858,859 for the nine months ended September 30, 2023 from $971,974 for the nine months ended September 30, 2022. The decrease is attributable to reduced international and U.S. sales of $57,814 and $55,301, respectively for the comparable periods. U.S. units sold decreased by 8.6% for the comparable periods.

Cost of sales and gross margin percentage

Cost of sales decreased by $54,704, or 15.3%, to $301,775 for the nine months ended September 30, 2023 from $356,479 for the nine months ended September 30, 2022. The decrease is primarily attributed to reduced sales and certain manufacturing efficiencies. Gross margin percentage improved to 64.9% for the nine months ended September 30, 2023 as compared to 63.3% for the nine months ended September 30, 2022.

Research and development

The following table summarizes our R&D expenses incurred during the periods presented:

Nine Months Ended September 30,
2023
2022
Compensation and related personnel costs
$
2,659,411
2,327,063
Clinical-related costs
1,262,727
1,449,074
Material and development costs
827,603
452,669
Professional and outside consultant costs
345,938
272,368
Other costs
41,762
40,973
Total research and development expenses
$
5,137,441
4,542,147

R&D expenses increased by $595,294 or 13.1%, to $5,137,441 for the nine months ended September 30, 2023 from $4,542,147 for the nine months ended September 30, 2022. The increase relates primarily to increased material and development costs, compensation costs and professional and outside consultant costs, partially offset by reduced clinical-related costs.

Sales and marketing

Sales and marketing expenses increased by $222,264 or 99.9%, to $444,678 for the nine months ended September 30, 2023 from $222,414 for the nine months ended September 30, 2022 largely due to increased compensation and related personnel costs and marketing costs to promote our commercial efforts.

General and administrative

General and administrative expenses increased by $617,826, or 15.4%, to $4,642,182 for the nine months ended September 30, 2023 from $4,024,356 for the nine months ended September 30, 2022. The increase was largely due to increased compensation and professional costs, partially offset by decreased facility and other overhead costs.

Depreciation and amortization

Depreciation and amortization expenses decreased by $34,797, or 8.2%, to $391,683 for the nine months ended September 30, 2023 from $426,480 for the nine months ended September 30, 2022. The decrease is due to a reduction of amortization expense associated with our intangible assets and depreciation expense associated with our fixed assets.

Other income (expense), net

Other income (expense), net increased by $122,302 or 122.4%, to $222,230 for the nine months ended September 30, 2023 from $99,928 for the nine months ended September 30, 2022 primarily due to an increase in interest income.

Liquidity and Capital Resources

Sources of liquidity

Since our inception through September 30, 2023, our operations have been financed primarily by net proceeds from the sale of our common stock and convertible preferred stock, indebtedness and, to a lesser extent, product revenue. As of September 30, 2023, we had $8,692,435 of cash and cash equivalents and an accumulated deficit of $103,971,175.

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On July 1, 2022, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (the “Sales Agent”) and filed a related Prospectus establishing an “at-the-market” facility, pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $8,800,000 from time to time through the Sales Agent pursuant to the Prospectus. As of September 30, 2023, 54,120 shares of our common stock have been sold under the Equity Distribution Agreement. In April 2023, the Company suspended its at-the-market facility with the Sales Agent. The at-the-market facility was subsequently reinstated in October 2023, and the Sales Agent was authorized to sell up to $16.7 million shares at current market prices until all shares are sold. In October 2023, we sold 3,256,754 shares under the facility, resulting in gross cash proceeds of $7,661,587.

On April 18, 2023, we entered into a definitive agreement for the issuance and sale of an aggregate of 3,196,722 of its shares of common stock (or common stock equivalents) at a purchase price of $1.22 per share (or common stock equivalent) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, we also issued and sold unregistered warrants to purchase up to an aggregate of 3,196,722 shares of common stock (“April 2023 Financing”). The gross proceeds from this offering was $3,899,813, which closed on April 20, 2023. The net proceeds to us from this offering was $3,352,049, after deducting placement agent fees expenses and offering expenses payable by us. We intend to use the net proceeds from this offering for general corporate purposes. In September 2023, 796,722 common warrants and 122,994 placement agent warrants were exercised for cash proceeds of $1,059,975. In October 2023, 2,400,000 common warrants were exercised for cash proceeds of $2,628,000.

Funding requirements

Based on our current operating plan, our current cash and cash equivalents, along with the net proceeds from our recent financings and warrant exercises are expected to be sufficient to fund our ongoing operations at least 12 months from the date of filing these financial statements. Our estimate as to how long we expect our existing cash and cash equivalents to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate.

Our cash and cash equivalents as of September 30, 2023 and cash received subsequent to quarter end will be sufficient to fund our lead product candidate through Part A of the pivotal trial, however, we anticipate needing to raise additional capital to complete the clinical development for our lead product candidate through regulatory approval, development and commercialization of our other product candidates. We can give no assurances that we will be able to secure additional sources of funds to support our operations, or if such funds will be available to us, that such additional financing will be sufficient to meet our needs or be on terms acceptable to us. This risk may increase if economic and market conditions deteriorate. If we are unable to obtain additional financing when needed, we may need to terminate, significantly modify, or delay the development of our lead product candidate, or we may need to obtain funds through collaborations or otherwise on terms that may require us to relinquish rights to our technologies or product candidates that we might otherwise seek to develop or commercialize independently. If we are unable to raise adequate additional capital as and when required in the future, we could be forced to cease development activities and terminate our operations, and you could experience a complete loss of your investment.

Cash Flows

Comparison of the Nine months ended September 30, 2023 and 2022

The following table summarizes our cash flows for the nine months ended September 30, 2023 and 2022:

Nine Months Ended September 30,
2023
2022
Net cash used in operating activities
$
(8,244,566
)
(7,864,086
)
Net cash used in investing activities
(99,018
)
(313,598
)
Net cash provided by (used in) financing activities
4,074,083
(599,695
)
Net change in cash and cash equivalents
$
(4,269,501
)
(8,777,379
)

Operating activities

For the nine months ended September 30, 2023, cash used in operating activities was $8,244,566, attributable to a net loss of $9,836,670, partially offset by non-cash charges of $1,341,880 and a net change in our net operating assets and liabilities of $250,224. Non-cash charges largely consisted of $391,683 in depreciation and amortization, $274,158 in right-of-use amortization, $626,529 in stock-based compensation and $44,538 for loss on disposal of assets. The change in our net operating assets and liabilities was primarily due to a decrease in other assets of $313,154 and an increase in accounts payable and accrued expenses of $453,847, which were offset partially by increases in accounts receivable of $26,086, inventory of $170,917 and a decrease in lease and other liabilities of $319,774.

For the nine months ended September 30, 2022, cash used in operating activities was $7,864,086, attributable to a net loss of $8,499,974 and a net change in our net operating assets and liabilities of $202,652, partially offset by non-cash charges of $838,540. Non-cash charges largely consisted of $426,480 in depreciation and amortization, $249,972 in right-of-use amortization and $158,288 in stock-based compensation.  The change in our net operating assets and liabilities was primarily due to an increase in accounts receivable and inventory of $98,872 and $138,666, respectively and a decrease of $324,421 in lease liabilities, accounts payable and accrued expenses and other liabilities, which were offset partially by a decrease in other assets of $359,307.

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Investing activities

For the nine months ended September 30, 2023, cash used in investing activities for the purchase of property and equipment was $99,018.

For the nine months ended September 30, 2022, cash used in investing activities for the purchase of property and equipment was $313,598.

Financing activities

For the nine months ended September 30, 2023, cash provided by financing activities was $4,074,083, primarily attributable to proceeds from the issuance of common stock and warrants of $4,965,046, partially offset by financing offering costs of $547,764, repayments on notes payable of $327,006 and payments under lease obligations of $16,193.

For the nine months ended September 30, 2022, cash used in financing activities was $599,695, attributable to repayments on notes payable of $365,926, payments under lease obligations of $17,075 and deferred offering costs payments of $232,845, partially offset by proceeds from the exercise of a stock option of $16,151.

Critical Accounting Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.

While our significant accounting policies are more fully described in Note 2 to our financial statements appearing the Annual Report on Form 10-K for the year ended December 31, 2022 as filed on March 30, 2023, we believe the following discussion addresses our most critical accounting policies, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.

Revenue recognition

Our policy is to recognize revenue when a customer obtains control of the promised goods under Accounting Standards Update (ASU) 2020-05, Revenue from Contracts with Customers (Topic 606), which we adopted effective January 1, 2018. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods, and we have elected to exclude amounts collected from customers for all sales (and other similar) taxes from the transaction price. We do not have multiple performance obligations in our customer orders, so revenue is recognized upon shipment of our goods based upon contractually stated pricing at standard payment terms ranging from 30 to 60 days. All revenue is recognized point in time and no revenue is recognized over time.

The majority of products sold directly to U.S. customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to our international distributors are in accordance with their respective agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in original unopened cartons and are subject to a 30% restocking fee. As of September 30, 2023, we have not had a history of significant returns.

Accrued expenses

We accrue expenses for estimated costs of R&D activities conducted by our third-party service providers, which include the conduct of preclinical studies and clinical trials. We record the estimated costs of R&D activities based upon the estimated amount of services provided but not yet invoiced. These costs, at times, may be a significant component of the research and development expenses and the Company makes estimates in determining the accrued expense each period. As actual costs become known, the Company adjusts its accrual. These accrued R&D costs are included in accrued expenses on the balance sheet and within R&D expense on the statement of comprehensive loss.

Item 3.
Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4.
Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act are (1) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (2) accumulated and communicated to our management, including to our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial and accounting officer), has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on such evaluation, our management has concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2023.

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Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Our management, including our Chief Executive Officer and Chief Financial Officer (principal financial and accounting officer), does not expect that our disclosure controls and procedures or internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well designed and implemented, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues within a company are detected. The inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple errors or mistakes. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and may not be detected.

PART II OTHER INFORMATION

Item 1.
Legal Proceedings

From time to time we may be involved in legal proceedings arising in connection with our business. Based on information currently available, we believe that the amount, or range, of reasonably possible losses in connection with any pending actions against us in excess of established reserves, in the aggregate, is not material to our consolidated financial condition or cash flows. However, losses may be material to our operating results for any particular future period, depending on the level of income for such period.

Item 1A.
Risk Factors

As of the date of this report, there are no material changes to our risk factors as previously disclosed in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022.

Item 2.
Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities

None.

Item 3.
Defaults Upon Senior Securities

None.

Item 4.
Mine Safety Disclosures

Not applicable.

Item 5.
Other Information

During the period covered by this Quarterly Report, none of the Company’s directors or executive officers have adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).

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Item 6.
Exhibits


Incorporated by Reference
Exhibit
Number
Description of Document
Schedule/Form
File
Number
Exhibit
Filing Date
Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc.
Form 8-K
001-40492
3.1
June 22, 2021
Amended and Restated Bylaws of Femasys Inc.
Form 8-K
001-40492
3.2
June 22, 2021
3.3
First Amendment to the Amended and Restated Bylaws of Femasys Inc.
Form 8-K
001-40492
3.1
March 30, 2023





Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002








Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002








Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002




Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002



101.INS* Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)





101.SCH*
Inline XBRL Taxonomy Extension Schema Document



101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document



101.DEF*
Inline XBRL Taxonomy Definition Linkbase Document



101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document



104*
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)




*
Filed herewith

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SIGNATURES

Pursuant to the requirements of the Securities Act, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Suwanee, State of Georgia, on this 14 th day of November 2023.

FEMASYS INC.


Dated: November 14, 2023
By: /s/ Kathy Lee-Sepsick


Kathy Lee-Sepsick


Chief Executive Officer and President




Dated: November 14, 2023
By: /s/ Dov Elefant


Dov Elefant


Chief Financial Officer



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TABLE OF CONTENTS
Part I. Financial InformationItem I. Financial StatementsItem 2. Management S Discussion and Analysis Of Financial Condition and Results Of OperationsItem 3. Quantitative and Qualitative Disclosures About Market RiskItem 4. Controls and ProceduresPart II Other InformationItem 1. Legal ProceedingsItem 1A. Risk FactorsItem 2. Unregistered Sales Of Equity Securities, Use Of Proceeds, and Issuer Purchases Of Equity SecuritiesItem 3. Defaults Upon Senior SecuritiesItem 4. Mine Safety DisclosuresItem 5. Other InformationItem 6. Exhibits

Exhibits

3.1 Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc. Form 8-K 001-40492 3.1 June 22, 2021 3.2 Amended and Restated Bylaws of Femasys Inc. Form 8-K 001-40492 3.2 June 22, 2021 3.3 First Amendment to the Amended and Restated Bylaws of Femasys Inc. Form 8-K 001-40492 3.1 March 30, 2023 31.1* Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2* Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 32.1* Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 32.2* Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002