FEMY Femasys Inc

Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the quarter ended September 30, 2024 and provides a corporate update.

Corporate Highlights from 3Q 2024 to date

• Announced partnership with Boston IVF, prominent network of fertility centers, to offer FemaSeed®
• Announced the onboarding of the first infertility medical clinic customers to offer FemaSeed infertility treatment to patients in California and Florida
• Announced strategic distribution partnerships for CE-marked products, including FemaSeed and FemVue® in Spain, which are anticipated to generate over $1.3 million over the next year
• Received second order from Spain strategic distribution partners after successfully completing commercial FemaSeed infertility treatments
• Received 510(k) clearance from FDA for FemChec®, an innovative diagnostic solution for fallopian tube check
• Received CE Mark certification and product approval from Health Canada, the Public Health Agency of Canada, for our compact, eco-friendly FemVue MINI for fallopian tube assessment
• Announced issuance of U.S. patent covering FemBloc® device for female permanent birth control

“We continue to achieve significant commercial milestones with regard to our FemaSeed first-line infertility treatment and its supporting FemVue product. Notably, in 3Q we began commercialization of FemaSeed in the U.S., including a high-profile conglomerate, as well as in Europe with two partners in Spain. We look forward to collaborating with our expanding group of partners as we bring our next generation advancements to women,” said Femasys’ CEO Kathy Lee-Sepsick.

Financial Results for Quarter Ended September 30, 2024

• Sales increased by $310,547, or 127.1%, to $554,908 in Q3 of 2024 from $244,361 in Q3 of 2023, due to increased sales of FemaSeed and FemVue. The Company recorded its first FemaSeed U.S. and international sales for the three months ended September 30, 2024, and additional sales are expected in the 4th quarter of 2024.
• Research and development expenses increased by $230,411, or 11.1%, to $2,303,241 in Q3 of 2024 from $2,072,830 in Q3 of 2023.
• Net loss was $5,408,860, or ($0.24) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2024, compared to net loss of $3,996,905, or ($0.26) per basic and diluted share attributable to common stockholders, for the quarter ended September 30, 2023.
• Cash and cash equivalents as of September 30, 2024, was $7.6 million and the Company had an accumulated deficit of $122.1 million. The Company expects, based on its current operating plan, that its existing cash and cash equivalents will be sufficient to fund its ongoing operations into July 2025.

Financial Results for Nine Months Ended September 30, 2024

• Sales increased by $188,673, or 22.0%, to $1,047,532 for the nine months of 2024, from $858,859 for the nine months of 2023 due to increased sales of FemaSeed and FemVue.
• R&D expenses increased by $912,406 or 17.8%, to $6,049,847 for the nine months of 2024, from $5,137,441 for the nine months of 2023.
• Net loss was $13,692,944, or ($0.62) per basic and diluted share attributable to common stockholders, for the nine-month period ended September 30, 2024, compared to net loss of $9,836,670, or ($0.74) per basic and diluted share attributable to common stockholders, for the same period ended September 30, 2023.

For more information, please refer to the Company’s Form 10-Q filed November 12, 2024, which can be accessed on the SEC website.

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Assets								September 30,2024			December 31,2023
Current assets:
	Cash and cash equivalents						$	7,611,210			21,716,077
	Accounts receivable, net							378,290			98,906
	Inventory, net							1,937,670			667,118
	Prepaid and other current assets							1,370,523			695,879
					Total current assets			11,297,693			23,177,980
Property and equipment, at cost:
	Leasehold improvements							1,238,886			1,212,417
	Office equipment							67,231			47,308
	Furniture and fixtures							433,584			414,303
	Machinery and equipment							2,848,833			2,559,356
	Construction in progress							548,149			423,077
								5,136,683			4,656,461
Less accumulated depreciation								(3,748,393	)		(3,545,422	)
					Net property and equipment			1,388,290			1,111,039
Long-term assets:
	Lease right-of-use assets, net							1,941,624			2,380,225
	Intangible assets, net of accumulated amortization							70,064			—
	Other long-term assets							887,410			1,086,581
					Total long-term assets			2,899,098			3,466,806
					Total assets		$	15,585,081			27,755,825
(continued)

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders’ Equity								September 30,2024			December 31,2023
Current liabilities:
	Accounts payable						$	1,121,873			1,137,823
	Accrued expenses							1,127,645			1,444,296
	Clinical holdback – current portion							92,170			65,300
	Lease liabilities – current portion							525,752			406,636
					Total current liabilities			2,867,440			3,054,055
Long-term liabilities:
	Clinical holdback – long-term portion							36,081			54,935
	Convertible notes payable, net (including related parties)							5,068,556			4,258,179
	Lease liabilities – long-term portion							1,643,217			2,036,067
					Total long-term liabilities			6,747,854			6,349,181
					Total liabilities			9,615,294			9,403,236
Commitments and contingencies
Stockholders’ equity:
	Common stock, $.001 par, 200,000,000 authorized,
		22,350,022 shares issued and 22,232,799 outstanding as of
		September 30, 2024; and 21,774,604 shares issued
		and 21,657,381 outstanding as of December 31, 2023						22,350			21,775
	Treasury stock, 117,223 common shares							(60,000	)		(60,000	)
	Warrants							2,608,642			2,787,137
	Additional paid-in-capital							125,473,368			123,985,306
	Accumulated deficit							(122,074,573	)		(108,381,629	)
					Total stockholders’ equity			5,969,787			18,352,589
					Total liabilities and stockholders' equity		$	15,585,081			27,755,825

FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
							Three Months Ended September 30,						Nine Months Ended September 30,
							2024			2023			2024			2023
Sales						$	554,908			244,361			1,047,532			858,859
Cost of sales (excluding depreciation expense)							190,839			86,186			352,496			301,775
Operating expenses:
	Research and development						2,303,241			2,072,830			6,049,847			5,137,441
	Sales and marketing						1,572,189			70,883			2,847,866			444,678
	General and administrative						1,530,791			1,970,408			4,645,412			4,642,182
	Depreciation and amortization						76,288			125,318			215,144			391,683
					Total operating expenses		5,482,509			4,239,439			13,758,269			10,615,984
					Loss from operations		(5,118,440	)		(4,081,264	)		(13,063,233	)		(10,058,900	)
Other income (expense):
	Interest income						124,028			92,392			532,850			232,133
	Interest expense						(413,290	)		(8,033	)		(1,163,153	)		(9,903	)
					Total other income (expense), net		(289,262	)		84,359			(630,303	)		222,230
					Loss before income taxes		(5,407,702	)		(3,996,905	)		(13,693,536	)		(9,836,670	)
	Income tax expense (benefit)						1,158			—			(592	)		—
					Net loss	$	(5,408,860	)		(3,996,905	)		(13,692,944	)		(9,836,670	)
Net loss attributable to common stockholders, basic and diluted						$	(5,408,860	)		(3,996,905	)		(13,692,944	)		(9,836,670	)
Net loss per share attributable to common stockholders, basic and diluted						$	(0.24	)		(0.26	)		(0.62	)		(0.74	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted							22,232,799			15,093,147			22,075,135			13,369,462

About Femasys

Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® and FemVue® Mini for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2023, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.

Contacts:

Investors:Matt BlazeiIR@femasys.com

Media:Kati WaldenburgMedia@femasys.com