Femasys - 10-Q quarterly report FY2023 Q2

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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 June 30, 2023

☐	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		(770) 500-3910
(Address of principal executive offices, including zip code)		(Registrant’s telephone number, including area code)

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 ☑

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

The Registrant had 15,073,153 shares of common stock, $0.001 par value, outstanding as of August 9, 2023.

	TABLE OF CONENTS
		Page

Part I. Financial Information
Item 1	Financial Statements	5
	Balance Sheets as of June 30, 2023 and December 31, 2022 (unaudited)	5
	Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022 (unaudited)	7
	Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022 (unaudited)	8
	Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022 (unaudited)	10
	Notes to Financial Statements (unaudited)	11
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3	Quantitative and Qualitative Disclosures About Market Risk	22
Item 4	Controls and Procedures	22

Part II. Other Information
Item 1	Legal Proceedings	23
Item 1A	Risk Factors	23
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	23
Item 3	Defaults Upon Senior Securities	24
Item 4	Mine Safety Disclosures	24
Item 5	Other Information	24
Item 6	Exhibits	24
SIGNATURES		25

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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 gain FDA grant of a de novo classification request for our intrauterine artificial insemination product, expand sales of our women-specific medical products and develop and commercialize additional products;

•

our ability to commercialize or obtain regulatory approvals, grants of de novo classification requests or 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.

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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.

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PART I. FINANCIAL INFORMATION

ITEM I.

Financial Statements

FEMASYS INC.

Balance Sheets

(unaudited)

Assets	June 30, 2023			December 31, 2022
Current assets:
Cash and cash equivalents	$	10,705,017			12,961,936
Accounts receivable, net		155,746			77,470
Inventory, net		581,474			436,723
Other current assets		587,828			655,362
Total current assets		12,030,065			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		2,628,509			2,572,243
Construction in progress		384,888			413,843
		4,727,681			4,700,370
Less accumulated depreciation		(3,472,349	)		(3,217,319	)
Net property and equipment		1,255,332			1,483,051
Long-term assets:
Lease right-of-use assets, net		162,006			319,557
Intangible assets, net of accumulated amortization		970			3,294
Other long-term assets		865,588			958,177
Total long-term assets		1,028,564			1,281,028

Total assets	$	14,313,961			16,895,570

(continued)

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FEMASYS INC.

Balance Sheets

(unaudited)

Liabilities and Stockholders’ Equity	June 30, 2023			December 31, 2022
Current liabilities:
Accounts payable	$	546,877			510,758
Accrued expenses		536,830			456,714
Note payable		—			141,298
Clinical holdback - current portion		88,738			45,206
Lease liabilities – current portion		209,098			373,833
Total current liabilities		1,381,543			1,527,809
Long-term liabilities:
Clinical holdback - long-term portion		56,245			96,658
Lease liabilities – long-term portion		—			28,584
Total long-term liabilities		56,245			125,242
Total liabilities		1,437,788			1,653,051
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par, 200,000,000 authorized, 15,190,376 shares issued and 15,073,153 outstanding as of June 30,2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022		15,190			11,987
Treasury stock, 117,223 shares		(60,000	)		(60,000	)
Warrants		1,918,103			567,972
Additional paid-in-capital		110,977,150			108,857,065
Accumulated deficit		(99,974,270	)		(94,134,505	)
Total stockholders’ equity		12,876,173			15,242,519

Total liabilities and stockholders’ equity	$	14,313,961			16,895,570

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

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FEMASYS INC.

Statements of Comprehensive Loss

(unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Sales	$	320,514			303,113			614,498			624,518
Cost of sales		110,469			102,353			215,589			225,028
Gross margin		210,045			200,760			398,909			399,490
Operating expenses:
Research and development		1,527,172			1,472,924			3,064,611			2,893,987
Sales and marketing		128,899			63,177			373,795			132,040
General and administrative		1,356,637			1,181,938			2,671,774			2,629,293
Depreciation and amortization		133,299			142,684			266,365			286,883
Total operating expenses		3,146,007			2,860,723			6,376,545			5,942,203
Loss from operations		(2,935,962	)		(2,659,963	)		(5,977,636	)		(5,542,713	)
Other income (expense):
Interest income		42,652			26,745			139,741			29,199
Interest expense		(198	)		(883	)		(1,870	)		(3,617	)
Other income (expense), net		42,454			25,862			137,871			25,582

Net loss	$	(2,893,508	)		(2,634,101	)		(5,839,765	)		(5,517,131	)

Net loss attributable to common stockholders, basic and diluted	$	(2,893,508	)		(2,634,101	)		(5,839,765	)		(5,517,131	)

Net loss per share attributable to common stockholders, basic and diluted	$	(0.22	)		(0.22	)		(0.47	)		(0.47	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted		13,107,590			11,812,988			12,493,334			11,808,601

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

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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 JUNE 30, 2023
Balance at March 31, 2023		11,989,796	$	11,990		117,223	$	(60,000	)	$	567,972		$	108,917,384	$	(97,080,762	)	$	12,356,584

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		—		—		—		—			—			—		—			—
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
Share-based compensation expense		—		—		—		—			—			65,216		—			65,216
Net loss		—		—		—		—			—			—		(2,893,508	)		(2,893,508	)

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

SIX MONTHS ENDED JUNE 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
Share-based compensation expense		—		—		—		—			—			122,170		—			122,170
Net loss		—		—		—		—			—			—		(5,839,765	)		(5,839,765	)

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

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

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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 JUNE 30, 2022
Balance at March 31, 2022		11,921,388	$	11,921		117,223	$	(60,000	)	$	702,492		$	108,462,663	$	(85,623,365	)	$	23,493,711

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		—		—		—		—			—			62,167		—			62,167
Net loss		—		—		—		—			—			—		(2,634,101	)		(2,634,101	)

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

SIX MONTHS ENDED JUNE 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		—		—		—		—			—			106,526		—			106,526
Net loss		—		—		—		—			—			—		(5,517,131	)		(5,517,131	)

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

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

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FEMASYS INC.

Statements ofCash Flows

(unaudited)

	Six Months Ended June 30,
	2023			2022
Cash flows from operating activities:
Net loss	$	(5,839,765	)		(5,517,131	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		264,040			272,391
Amortization		2,325			14,492
Amortization of right-of-use assets		148,541			169,680
Inventory reserve		1,770			2,900
Loss on disposal of assets		44,538			—
Share-based compensation expense		122,170			106,526
Changes in operating assets and liabilities:
Accounts receivable		(78,276	)		(29,702	)
Inventory		(146,521	)		(38,811	)
Other assets		154,065			255,271
Accounts payable		36,119			(74,957	)
Accrued expenses		80,116			(76,959	)
Lease liabilites		(181,065	)		(194,235	)
Other liabilities		3,119			(23,361	)

Net cash used in operating activities		(5,388,824	)		(5,133,896	)
Cash flows from investing activities:
Purchases of property and equipment		(71,849	)		(295,058	)

Net cash used in investing activities		(71,849	)		(295,058	)
Cash flows from financing activities:
Proceeds from the issuance of common stock, accompanying warrants and pre-funded warrants in April 2023 Financing		3,899,813			—
Equity issuance costs		(547,764	)		—
Proceeds from exercise of pre-funded warrants		188			—
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 sales agreement		3,373			—
Payments of deferred offering costs		—			(13,905	)
Repayment of note payable		(141,298	)		(228,662	)
Payments under lease obligations		(12,255	)		(11,240	)

Net cash provided by (used in) financing activities		3,203,754			(237,656	)

Net change in cash and cash equivalents		(2,256,919	)		(5,666,610	)
Cash and cash equivalents:
Beginning of period		12,961,936			24,783,029

End of period	$	10,705,017			19,116,419

Supplemental cash flow information
Cash paid for:
Interest	$	1,870			3,617
Income taxes	$	—			800
Non-cash investing and financing activities:
Deferred offering costs included in accounts payable and accrued expenses	$	—			82,760
Commissions and deferred offering costs relating to proceeds from issuance of common stock	$	6,163			—
Prepaid insurance financed with promissory notes	$	—			417,841

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

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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 women’s unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health. 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. FemaSeed® (FemaSeed), a solution which enables directed intrauterine insemination to improve on traditional intrauterine insemination (IUI) and provides 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. FemaSeed is approved for sale in Canada. 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 a solution for complete tissue sampling with minimal contamination of the endocervical canal as an alternative to the curettage method, and is approved for sale in the U.S and 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 June 30, 2023, the Company had cash and cash equivalents of $10,705,017. 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 from the sale of FemVue to support the Company’s research and development activities, largely in connection with FemBloc and FemaSeed. 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 six months ended June 30, 2023, the Company generated a net loss of $5,839,765. The Company expects such losses to increase over the next few years as the Company advances FemBloc and FemaSeed through clinical development until FDA approval is received and the products are available to be marketed.

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FEMASYS INC.

Notes to Financial Statements

(unaudited)

The financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of June 30, 2023 of $99,974,270 and expects to incur additional losses and negative operating cash flows for at least the next twelve months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations and future financing transactions. Although management expects the Company will continue as a going concern, there is no assurance that management’s plans will be successful since the availability and amount of such funding is not certain. Accordingly, substantial doubt exists about the Company’s ability to continue as a going concern for at least one year from the issuance of these financial statements. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability of assets or the amounts and classifications of liabilities that may result from the possible inability of the Company to continue as a going concern.

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 June 30, 2023 and December 31, 2022, money market funds included in cash and cash equivalents on the balance sheets were $10,038,944 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:

	June 30,		December 31,
	2023		2022
Materials	$	356,274		244,498
Work in progress		71,081		100,453
Finished goods		154,119		91,772
Inventory, net	$	581,474		436,723

The FemVue reserve for slow moving, obsolete, or unusable inventories was $3,091 and $2,103 as of June 30, 2023 and December 31, 2022, respectively.

(4)	Accrued Expenses

Accrued expenses consisted of the following:

	June 30,		December 31,
	2023		2022
Clinical trial costs	$	295,582		333,440
Compensation costs		129,323		85,191
Franchise taxes		—		26,886
Director fees		90,424		—
Other		21,501		11,197
Accrued expenses	$	536,830		456,714

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FEMASYS INC.

Notes to Financial Statements

(unaudited)

(5)	Clinical Holdback

The following table shows the activity within the clinical holdback liability accounts for the six months ended June 30, 2023:

Balance at December 31, 2022	$	141,864
Clinical holdback retained		3,447
Clinical holdback paid		(328	)
Balance at June 30, 2023	$	144,983
Less: clinical holdback - current portion		(88,738	)
Clinical holdback - long-term portion	$	56,245

(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 six months ended June 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 June 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 June 30,				Six Months Ended June 30,
Primary geographical markets	2023		2022		2023		2022
U.S.	$	262,469		303,113		556,453		566,473
International		58,045		—		58,045		58,045
Total	$	320,514		303,113		614,498		624,518

(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 June 30, 2023 and December 31, 2022.

(8)	Notes Payable

AFCO Credit Corporation (AFCO)

As of June 30, 2023 and December 31, 2022, the principal balance on the remaining AFCO promissory notes was $0 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 $1,319 and $86 for the three months ended June 30, 2023 and 2022, respectively. Interest expense was $1,319 and $1,882 for the six months ended June 30, 2023 and 2022, respectively.

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FEMASYS INC.

Notes to Financial Statements

(unaudited)

(9)	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 six months ended June 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. The Company will not make any sales of its Common Stock pursuant to the Equity Distribution Agreement unless and until a new prospectus supplement is filed with the Securities and Exchange Commission; however, the Equity Distribution Agreement remains in full force and effect.

In April 2023, the Company sold an aggregate of (i) 1,318,000shares 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 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 June 30, 2023, the Company had 15,073,153 shares of common stock outstanding, and nodividends have been declared or paid.

(10)	Equity Incentive Plans and Warrants

Stock-Based Awards

(a)

Stock Option Plans

Activity under the Company’s stock option plans for the six months ended June 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

Vested and exercisable at June 30, 2023		511,472		$	3.09

Options granted under our 2021 Stock Option Plan for the six months ended June 30, 2023 to employees and nonemployees were 85,200 and 73,000, respectively and the weighted average exercise prices were $0.87 and $0.64, respectively. The weighted-average fair values of the options granted to employees and nonemployees were $0.74 and $0.51, respectively and were estimated using the following weighted-average Black-Scholes assumptions:

	Employee			Nonemployee
Expected term (in years)		6.25			5.49
Risk‑free interest rate		3.55	%		3.96	%
Dividend yield		—	%		—	%
Expected volatility		110.43	%		106.58	%

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

As of June 30, 2023, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was 1,711,914.

(b)

Inducement Grants

For the six months ended June 30, 2023, no inducement awards were granted. As of June 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.

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FEMASYS INC.

Notes to Financial Statements

(unaudited)

(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 June 30,				Six Months Ended June 30,
	2023		2022		2023			2022
Research and development	$	27,192		33,436		52,251			62,575
Sales and marketing		602		1,216		(1,942	)		2,342
General and administrative		37,422		27,515		71,861			41,609
Total share-based compensation expense	$	65,216		62,167		122,170			106,526

As June 30, 2023, the remaining share-based compensation expense that is expected to be recognized in future periods for employees and nonemployees is $956,653, which includes $463,101of compensation expense to be recognized upon achieving certain performance conditions. For service-based awards, the $493,552 of unrecognized expense is expected to be recognized over a weighted average period of 2.7 years.

(d)

Employee Stock Purchase Plan (ESPP)

For the six months ended June 30, 2023, 3,858 shares of common stock were issued under the Company’s ESPP Plan. As of June 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 9, 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 191,803shares 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 $0.0001per 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:

	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. As of June 30, 2023, the common warrants and placement agent warrants have not been exercised and were still outstanding.

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FEMASYS INC.

Notes to Financial Statements

(unaudited)

(11)	Net Loss per Share Attributable to Common Stockholders

The following table sets forth the computation of the basic and diluted net loss per share:

	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022

Net loss attributable to common stockholders, basic & diluted	$	(2,893,508	)		(2,634,101	)		(5,839,765	)		(5,517,131	)

Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted		13,107,590			11,812,988			12,493,334			11,808,601
Net loss per share attributable to common stockholders, basic and diluted	$	(0.22	)		(0.22	)		(0.47	)		(0.47	)

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 June 30,				Six Months Ended June 30,
	2023		2022		2023		2022
Options to purchase common stock		1,169,671		1,050,606		1,169,671		1,050,606
Warrants to purchase common stock, in connection with April 2023 financing		3,388,525		—		3,388,525		—
Warrants to purchase common stock		233,460		233,460		233,460		233,460
Total potential shares		4,791,656		1,284,066		4,791,656		1,284,066

(12)	Subsequent Events

Effective July 11, 2023, the Company executed a promissory note with AFCO to finance certain insurance premiums for $420,618, requiring the Company to pay a down payment and monthly installment payments through March 2024.

Effective July 17, 2023, the Company executed an extension of its operating lease agreement for facilities in Suwanee, GA, obligating the company to $3,321,025in payments for an additional 63 month term. The original lease expired in January 2024, and has been extended through April 2029.

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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 women’s unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health. 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 two lead product candidates offer solutions for two ends of the spectrum: FemBloc for permanent birth control and FemaSeed as an artificial insemination infertility treatment.

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’ localized 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. FemCerv captures a tissue sample in a relatively pain-free manner and has the potential to be an improvement over 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 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.

Clinical Update

FemaSeed – Our 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 now expected in the fourth quarter of 2023 followed by a planned submission of the results from the trial to FDA in support of a future de novo classification request for FemaSeed. Extenuating circumstances at clinical trial sites have resulted in a slowdown in enrollment due to consolidation activities, staffing shortages and the aftermath of the overturn of Roe v Wade. It has been reported that there have been over 25 transactions since the start of 2021 (including 25% of our clinical trial sites) in the infertility market, which is rapidly evolving into large commercial entities. These rapidly changing market dynamics may be disruptive to the practice and affect the conduct of clinical studies as integration occurs. The American Society of Reproductive Medicine (ASRM) issued a statement March 17, 2023 on the abortion policy proposals affecting reproductive medicine. ASRM stated, “At the crux of the issue many of the proposals to ban or otherwise limit access to abortion care fail to protect the use of assisted reproductive technologies, including IVF, and so-called “personhood” measures (defining life as beginning at conception or fertilization) are multiplying across the nation, causing alarm bells to sound for medical practitioners and infertility patients alike. Such proposals could, intentionally or not, limit and even ban the use of IVF and routine, safe, and medically proven procedures, such as the removal of an embryo that fails to implant in a uterus, or the disposal of unused embryos.” This uncertainty and limitations of staff availability may affect subject enrollment in clinical studies being conducted at facilities providing infertility services.

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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. In July 2023, we announced a notice of allowance for new U.S. patent application covering use of FemBloc for female permanent birth control and we expect the resulting patent, when issued, will have an anticipated expiration in 2039 at the earliest.

Results of Operations

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

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

	Three Months Ended June 30,						Change			% Change
	2023			2022			Change			% Change
Sales	$	320,514			303,113			17,401			5.7	%
Cost of sales		110,469			102,353			8,116			7.9	%
Gross margin		210,045			200,760			9,285			4.6	%
Operating expenses:
Research and development		1,527,172			1,472,924			54,248			3.7	%
Sales and marketing		128,899			63,177			65,722			104.0	%
General and administrative		1,356,637			1,181,938			174,699			14.8	%
Depreciation and amortization		133,299			142,684			(9,385	)		-6.6	%
Total operating expenses		3,146,007			2,860,723			285,284			10.0	%
Loss from operations		(2,935,962	)		(2,659,963	)		(275,999	)		10.4	%
Other income (expense):
Interest income		42,652			26,745			15,907			59.5	%
Interest expense		(198	)		(883	)		685			-77.6	%
Other income (expense), net		42,454			25,862			16,592			64.2	%
Net loss	$	(2,893,508	)		(2,634,101	)		(259,407	)		9.8	%

Sales

Sales increased by $17,401, or 5.7%, to $320,514 for the three months ended June 30, 2023 from $303,113 for the three months ended June 30, 2022. The $17,401 increase was largely attributable to international sales of $58,045 for the three months ended June 30, 2023, with no international sales occurring in the same period last year. U.S. sales decreased by $40,644, or 13.4%, for the three months ended June 30, 2023 as compared to the same period last year. U.S. units sold decreased by 13% for the three months ended June 30, 2023 as compared to the same period last year.

Cost of sales and gross margin percentage

Cost of sales increased by $8,116 or 7.9%, to $110,469 for the three months ended June 30, 2023 from $102,353 for the three months ended June 30, 2022 mainly due to increased international sales which have lower gross margin. Gross margin percentage was 65.5% for the three months ended June 30, 2023 as compared to 66.2% for the three months ended June 30, 2022.

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

	Three Months Ended June 30,
	2023			2022
Compensation and related personnel costs	$	840,506			790,292
Clinical-related costs		361,578			377,058
Material and development costs		205,095			175,527
Professional and outside consultant costs		120,527			116,692
Other costs		(534	)		13,355
Total research and development expenses	$	1,527,172			1,472,924

R&D expenses increased by $52,248 or 3.7%, to $1,527,172 for the three months ended June 30, 2023 from $1,472,924 for the three months ended June 30, 2022. The increase relates primarily to increased compensation and related personnel, professional and outside consultant costs, mostly offset by reduced clinical-related costs.

Sales and marketing

Sales and marketing expenses increased by $65,722 or 104%, to $128,899 for the three months ended June 30, 2023 from $63,177 for the three months ended June 30, 2022. The increase is largely due to increased marketing costs to promote our commercial efforts.

General and administrative

General and administrative expenses increased by $174,699, or 14.8%, to $1,356,637 for the three months ended June 30, 2023 from $1,181,938 for the three months ended June 30, 2022. The increase was largely due to increased professional costs, compensation and related personnel costs, partially offset by decreased facility and overhead costs.

Depreciation and amortization

Depreciation and amortization expenses decreased by $9,385, or 6.6%, to $133,299 for the three months ended June 30, 2023 from $142,684 for the three months ended June 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 $16,592, or 64.2%, to $42,454 for the three months ended June 30, 2023 from $25,862 for the three months ended June 30, 2022 mainly due to an increase in interest income.

Results of Operations

Comparison of the Six Months Ended June 30, 2023 and 2022

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

	Six Months Ended June 30,						Change			% Change
	2023			2022			Change			% Change
Sales	$	614,498			624,518			(10,020	)		-1.6	%
Cost of sales		215,589			225,028			(9,439	)		-4.2	%
Gross margin		398,909			399,490			(581	)		-0.1	%
Operating expenses:
Research and development		3,064,611			2,893,987			170,624			5.9	%
Sales and marketing		373,795			132,040			241,755			183.1	%
General and administrative		2,671,774			2,629,293			42,481			1.6	%
Depreciation and amortization		266,365			286,883			(20,518	)		-7.2	%
Total operating expenses		6,376,545			5,942,203			434,342			7.3	%
Loss from operations		(5,977,636	)		(5,542,713	)		(434,923	)		7.8	%
Other income (expense):
Interest income		139,741			29,199			110,542			378.6	%
Interest expense		(1,870	)		(3,617	)		1,747			-48.3	%
Other income (expense), net		137,871			25,582			112,289			438.9	%
Net loss	$	(5,839,765	)		(5,517,131	)		(322,634	)		5.8	%

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Sales

Sales decreased by $10,020, or 1.6%, to $614,498 for the six months ended June 30, 2023 from $624,518 for the six months ended June 30, 2022. The $10,020 decrease is entirely attributable to U.S. sales for the six month periods ended June 30, 2023 as compared to the same period last year; international sales remained consistent with $58,045 for both the six month periods ended June 30, 2023 and 2022. U.S. units sold decreased by 3.6% for the six months ended June 30, 2023 as compared to the same period last year.

Cost of sales and gross margin percentage

Cost of sales decreased by $9,439, or 4.2%, to $215,589 for the six months ended June 30, 2023 from $225,028 for the six months ended June 30, 2022. The decrease is largely due to prior investment in equipment and tooling, resulting in reduced labor in certain manufacturing processes, and reduced material costs. Gross margin percentage was 64.9% for the six months ended June 30, 2023 as compared to 64.0% for the six months ended June 30, 2022. Gross margins improved mainly due to manufacturing efficiencies.

Research and development

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

	Six Months Ended June 30,
	2023		2022
Compensation and related personnel costs	$	1,740,794		1,555,084
Clinical-related costs		727,938		821,028
Material and development costs		372,256		306,977
Professional and outside consultant costs		212,462		185,356
Other costs		11,161		25,542
Total research and development expenses	$	3,064,611		2,893,987

R&D expenses increased by $170,624 or 5.9%, to $3,064,611 for the six months ended June 30, 2023 from $2,893,987 for the six months ended June 30, 2022. The increase of $170,624 relates primarily to increased compensation and related personnel, professional and outside consultant costs, partially offset by reduced clinical-related costs.

Sales and marketing

Sales and marketing expenses increased by $241,755 or 183.1%, to $373,795 for the six months ended June 30, 2023 from $132,040 for the six months ended June 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 $42,481, or 1.6%, to $2,671,774 for the six months ended June 30, 2023 from $2,629,293 for the six months ended June 30, 2022. The increase was largely due to increased professional costs, partially offset by a decrease in facility and other overhead and insurance costs.

Depreciation and amortization

Depreciation and amortization expenses decreased by $20,518, or 7.2%, to $266,365 for the six months ended June 30, 2023 from $286,883 for the six months ended June 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 $112,289, or 438.9%, to $137,871 for the six months ended June 30, 2023 from $25,582 for the six months ended June 30, 2022 mainly due to an increase in interest income.

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Liquidity and Capital Resources

Sources of liquidity

Since our inception through June 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 June 30, 2023, we had $10,705,017 of cash and cash equivalents and an accumulated deficit of $99,974,270.

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 June 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.

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. 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. The offering closed on April 20, 2023.

Funding requirements

Based on our current operating plan, our current cash and cash equivalents, along with the net proceeds from our recent financing are expected to be sufficient to fund our ongoing operations into the second quarter of 2024. 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. We do not expect liquidity to be sufficient for twelve months from the date of these financial statements. As a result of our current limited financial liquidity, we have concluded that substantial doubt exists about our ability to continue as a going concern.

Our cash and cash equivalents as of June 30, 2023 will not be sufficient to fund all of our product candidates through regulatory approval, and we anticipate needing to raise additional capital to complete the development and commercialization of our product candidates. However, 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 product candidates, 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 Six Months Ended June 30, 2023 and 2022

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

	Six Months Ended June 30,
	2023			2022
Net cash used in operating activities	$	(5,388,824	)		(5,133,896	)
Net cash used in investing activities		(71,849	)		(295,058	)
Net cash provided by (used in) financing activities		3,203,754			(237,656	)
Net change in cash and cash equivalents	$	(2,256,919	)		(5,666,610	)

Operating activities

For the six months ended June 30, 2023, cash used in operating activities was $5,388,824, attributable to a net loss of $5,839,765 and a net change in our net operating assets and liabilities of $132,443, partially offset by non-cash charges of $583,384. Non-cash charges largely consisted of $266,365 in depreciation and amortization, $148,541 in right-of-use amortization, $122,170 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 changes of $78,276 in accounts receivable, $146,521 in inventory and $181,065 in lease liabilities, which were offset by changes in accounts payable and accrued expenses of $116,235 and $154,065 in other assets.

For the six months ended June 30, 2022, cash used in operating activities was $5,133,896, attributable to a net loss of $5,517,131 and a net change in our net operating assets and liabilities of $182,754, partially offset by non-cash charges of $565,989. Non-cash charges largely consisted of $286,883 in depreciation and amortization, $169,680 in right-of-use amortization, and $106,526 in stock-based compensation. The change in our net operating assets and liabilities was primarily due to a decrease of $151,916 in accounts payable and accrued expenses, a decrease of $194,235 in lease liabilities, which were offset partially offset by a decrease in other assets of $255,271.

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Investing activities

For the six months ended June 30, 2023, cash used in investing activities for the purchase of property and equipment was $71,849.

For the six months ended June 30, 2022, cash used in investing activities for the purchase of property and equipment was $295,058.

Financing activities

For the six months ended June 30, 2023, cash provided by financing activities was $3,203,754, primarily attributable to proceeds from the issuance of common stock and warrants of $3,905,071, partially offset by financing offering costs of $547,764, repayments on notes payable of $141,298 and payments under lease obligations of $12,255.

For the six months ended June 30, 2022, cash used in financing activities was $237,656, attributable to repayments on notes payable of $228,662, payments under lease obligations of $11,240, deferred offering costs of $13,905, 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 June 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 is (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 June 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 June 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

You should carefully review and consider the information regarding certain risks and uncertainties facing us that could have a material adverse effect on our business prospects, financial condition, results of operations, liquidity and available capital resources set forth in Part I, Item 1A. Risk Factors, of the Company’s Annual Report on Form 10-K filed with the SEC on March 30, 2023.

Risks Related to Our Common Stock

We have received a deficiency letter from Nasdaq relating to our non-compliance with Nasdaq’s continued listing requirements and our common stock could become subject to delisting from Nasdaq if we fail to regain compliance.

On June 1, 2023, we received a notice from Nasdaq that we are not in compliance with Nasdaq’s Minimum Bid Price Requirement. We have until November 28, 2023, to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the minimum bid price of our common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this grace period. In the event we do not regain compliance with the Minimum Bid Price Requirement by November 28, 2023, we may be eligible for an additional 180-calendar day compliance period. If we do not regain compliance with the Minimum Bid Price Requirement by the end of the compliance period (or the second compliance period, if applicable), our common stock will become subject to delisting. In the event that we receive notice that our common stock is being delisted, the Nasdaq listing rules permit us to appeal a delisting determination by Nasdaq to a hearings panel.

We intend to continue to monitor the closing bid price of our common stock and may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement, including initiating a reverse stock split. However, there can be no assurance that we will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq Listing Rules. Failure to meet applicable Nasdaq Listing Rules could result in a delisting of our common stock, which could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the inability to advance our programs, potential loss of confidence by investors and employees, and fewer business development opportunities.

Item 2.

Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities

None.

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Item 3.

Defaults Upon Senior Securities

Not applicable.

Item 4.

Mine Safety Disclosures

Not applicable.

Item 5.

Other Information

Not applicable.

Item 6.

Exhibits

Exhibit			Incorporated by Reference
Exhibit			File
Number	Description of Document	Schedule/Form	Number	Exhibit	Filing Date

4.1	Pre-Funded Common Stock Purchase Warrant	Form 8-K	001-40492	4.1	April 20, 2023

4.2	Common Stock Purchase Warrant	Form 8-K	001-40492	4.2	April 20, 2023

4.3	Placement Agent Common Stock Purchase Warrant	Form 8-K	001-40492	4.3	April 20, 2023

10.1	Securities Purchase Agreement dated April 18, 2023, between Femasys Inc. and the Purchaser	Form 8-K	001-40492	10.1	April 20, 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

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 10^th day of August 2023.

FEMASYS INC.

Dated: August 10, 2023	By:	/s/ Kathy Lee-Sepsick
	Kathy Lee-Sepsick
	Chief Executive Officer and President

	By:	/s/ Dov Elefant
	Dov Elefant Chief Financial Officer (principal financial and accounting officer)

Femasys - 10-Q quarterly report FY2023 Q2

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