Femasys Announces Financial Results for Quarter Ended June 30, 2024 and Provides Corporate Update

Rhea-AI Summary

Femasys Inc. (NASDAQ: FEMY) announced financial results for Q2 2024 and provided a corporate update. Key highlights include:

1. Received EU MDR certification and CE Mark for four women's health products.

2. Completed build-out of U.S. commercial team.

3. FemaSeed® demonstrated pregnancy rates more than double historic IUI rates for male factor infertility.

Financial results:

• Q2 2024 sales: $221,484 (down from $320,514 in Q2 2023)
• Q2 2024 net loss: $4,684,574 or ($0.21) per share
• Cash and equivalents as of June 30, 2024: $13.5 million
• Sufficient funds to operate into July 2025

Positive

• Received EU MDR certification and CE Mark for four women's health products
• Completed build-out of U.S. commercial team for marketing efforts
• FemaSeed® demonstrated pregnancy rates more than double historic IUI rates for male factor infertility
• Cash and equivalents of $13.5 million as of June 30, 2024
• Sufficient funds to operate into July 2025

Negative

• Q2 2024 sales decreased to $221,484 from $320,514 in Q2 2023
• Q2 2024 net loss increased to $4,684,574 from $2,893,508 in Q2 2023
• Research and development expenses increased by $448,703 in Q2 2024 compared to Q2 2023
• Accumulated deficit of $116.7 million as of June 30, 2024

Insights

Financial Analyst

Femasys' Q2 2024 results show a mixed financial picture. While R&D expenses increased by $448,703 to $1,975,875, indicating continued investment in product development, sales decreased by $99,030 to $221,484. The net loss widened to $4,684,574 ($0.21 per share) from $2,893,508 ($0.22 per share) in Q2 2023. The company's cash position of $13.5 million is projected to fund operations only until July 2025, which may raise concerns about long-term financial sustainability. The increased R&D spending and completed commercial team build-out suggest a strategic focus on product development and market penetration, but the company needs to address declining sales to improve its financial health.

Medical Research Analyst

Femasys' FemaSeed® product shows promise, with reported pregnancy rates more than double the historic IUI rates for male factor infertility. This could position FemaSeed® as a viable alternative to IVF, potentially disrupting the fertility treatment market. The CE Mark approval for four women's health products is a significant regulatory milestone, validating the company's quality standards and opening up the European market. However, the lack of published data from the FemaSeed pivotal trial is a notable gap. The upcoming announcement of this data will be important in determining the product's scientific credibility and market potential. The company's involvement in discussions with the White House and Congress suggests a proactive approach to shaping women's healthcare policy, which could benefit Femasys in the long term.

Market Research Analyst

Femasys' market strategy appears to be at a critical juncture. The completion of its U.S. commercial team build-out and CE Mark approvals set the stage for a dual-market approach in the U.S. and EU. However, the 30.9% decrease in Q2 sales year-over-year is concerning and may indicate challenges in market penetration or product adoption. The focus on FemaSeed® as an alternative to IVF targets a significant market opportunity, given the emotional and financial burdens of IVF. The company's engagement with policymakers could potentially lead to favorable regulatory environments and increased awareness of women's health issues. The search for strategic distribution partners in Europe suggests a cautious approach to international expansion, which could be prudent given the company's current financial constraints. Overall, Femasys' market position seems promising but precarious, hinging on the success of its commercialization efforts and the reception of its innovative products.

Company gained CE Mark approval for four of its women’s health products and completed buildout of commercial team for its infertility portfolio

ATLANTA, Aug. 08, 2024 (GLOBE NEWSWIRE) --  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 June 30, 2024 and provides a corporate update.

Corporate Highlights from 2Q 2024 to date

• Company received European Union Medical Device Regulation (EU MDR) certification and CE Mark for four of its women’s health products, providing regulatory approval to begin marketing in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for its customers and their patients.
• Femasys completed the build-out of its initial commercial team in the U.S., which will be leading the Company’s marketing efforts. This milestone, together with the CE Mark approval for its product portfolio, enables Femasys to concurrently identify strategic distribution partners to begin commercialization of its products in the European Union.
• CEO and Founder Kathy Lee-Sepsick met with the White House’s Gender Policy Council to discuss the Company’s reproductive health products and the future of women’s health in the United States and the White House’s Office of Science and Technology Policy to discuss the Cancer Moonshot Initiative, as well as separately with Members of Congress to raise awareness of the Company and our women’s healthcare initiatives.
  

“The recruitment and subsequent onboarding of our commercial team, consisting of highly qualified professionals with specific expertise in women’s health is complete and our team has recently begun actively marketing our products in the U.S.. We believe that our novel fertility solution FemaSeed^®, which demonstrated pregnancy rates more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility (i.e., low sperm count), is an improved alternative and a viable option prior to in vitro fertilization (IVF) that is considerably more financially and emotionally burdensome. As we await announcement of published data for the FemaSeed prospective multi-center pivotal trial, we are actively prioritizing our U.S. efforts and concurrently identifying strategic distribution partners in Europe,” said Femasys’ CEO Kathy Lee-Sepsick.

Financial Results for Quarter Ended June 30, 2024

• Research and development expenses increased by $448,703 to $1,975,875 in Q2 of 2024 from $1,527,172 in Q2 of 2023.
• Sales decreased by $99,030 to $221,484 in Q2 of 2024 from $320,514 in Q2 of 2023.
• Net loss was $4,684,574 or ($0.21) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2024, compared to net loss of $2,893,508, or ($0.22) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2023.
• Cash and cash equivalents as of June 30, 2024 was $13.5 million and the Company had an accumulated deficit of $116.7 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 Six Months Ended June 30, 2024

• Research and development expenses increased by $681,995 to $3,746,606 for the first six months of 2024 from $3,064,611 for the first six months of 2023.
• Sales decreased by $121,874 to $492,624 for the first six months of 2024 from $614,498 for the first six months of 2023.
• Net loss was $8,284,084 or ($0.38) per basic and diluted share attributable to common stockholders, for the six month period ended June 30, 2024, compared to net loss of $5,839,765, or ($0.47) per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2023.
  

For more information, please refer to the Company’s Form 10-Q filed August 8, 2024, which can be accessed on the SEC website.

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Assets								June 30, 2024			December 31, 2023
Current assets:
	Cash and cash equivalents						$	13,525,898			21,716,077
	Accounts receivable, net							92,535			98,906
	Inventory, net							1,315,580			667,118
	Prepaid and other current assets							997,623			695,879
					Total current assets			15,931,636			23,177,980
Property and equipment, at cost:
	Leasehold improvements							1,212,417			1,212,417
	Office equipment							47,308			47,308
	Furniture and fixtures							429,933			414,303
	Machinery and equipment							2,599,994			2,559,356
	Construction in progress							651,157			423,077
								4,940,809			4,656,461
Less accumulated depreciation								(3,678,450	)		(3,545,422	)
					Net property and equipment			1,262,359			1,111,039
Long-term assets:
	Lease right-of-use assets, net							2,081,054			2,380,225
	Intangible assets, net of accumulated amortization							44,317			—
	Other long-term assets							957,078			1,086,581
					Total long-term assets			3,082,449			3,466,806
					Total assets		$	20,276,444			27,755,825
(continued)

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders’ Equity								June 30, 2024			December 31, 2023
Current liabilities:
	Accounts payable						$	951,510			1,137,823
	Accrued expenses							886,352			1,444,296
	Clinical holdback – current portion							92,397			65,300
	Lease liabilities – current portion							533,734			406,636
					Total current liabilities			2,463,993			3,054,055
Long-term liabilities:
	Clinical holdback – long-term portion							32,706			54,935
	Convertible notes payable, net (including related parties)							4,758,017			4,258,179
	Lease liabilities – long-term portion							1,771,487			2,036,067
					Total long-term liabilities			6,562,210			6,349,181
					Total liabilities			9,026,203			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
		June 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							125,344,962			123,985,306
	Accumulated deficit							(116,665,713	)		(108,381,629	)
					Total stockholders’ equity			11,250,241			18,352,589
					Total liabilities and stockholders' equity		$	20,276,444			27,755,825

FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
								Three Months Ended June 30,						Six Months Ended June 30,
								2024			2023			2024			2023
Sales							$	221,484			320,514			492,624			614,498
Cost of sales (excluding depreciation expense)								73,125			110,469			161,657			215,589
Operating expenses:
	Research and development							1,975,875			1,527,172			3,746,606			3,064,611
	Sales and marketing							975,190			128,899			1,275,677			373,795
	General and administrative							1,611,817			1,356,637			3,114,621			2,671,774
	Depreciation and amortization							67,628			133,299			138,856			266,365
					Total operating expenses			4,630,510			3,146,007			8,275,760			6,376,545
					Loss from operations			(4,482,151	)		(2,935,962	)		(7,944,793	)		(5,977,636	)
Other income (expense):
	Interest income							184,138			42,652			408,822			139,741
	Interest expense							(388,311	)		(198	)		(749,863	)		(1,870	)
					Total other income (expense), net			(204,173	)		42,454			(341,041	)		137,871
					Loss before income taxes			(4,686,324	)		(2,893,508	)		(8,285,834	)		(5,839,765	)
	Income tax benefit							(1,750	)		—			(1,750	)		—
					Net loss		$	(4,684,574	)		(2,893,508	)		(8,284,084	)		(5,839,765	)
Net loss attributable to common stockholders, basic and diluted							$	(4,684,574	)		(2,893,508	)		(8,284,084	)		(5,839,765	)
Net loss per share attributable to common stockholders, basic and diluted							$	(0.21	)		(0.22	)		(0.38	)		(0.47	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted								22,215,516			13,107,590			21,995,436			12,493,334

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^® 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, 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: 
Gene Mannheimer
IR@femasys.com

Media Contact: 
Kati Waldenburg
Media@femasys.com

FAQ

What were Femasys' (FEMY) Q2 2024 financial results?

Femasys reported Q2 2024 sales of $221,484, down from $320,514 in Q2 2023. Net loss was $4,684,574 or ($0.21) per share, compared to a net loss of $2,893,508 or ($0.22) per share in Q2 2023.

What regulatory approvals did Femasys (FEMY) receive in Q2 2024?

Femasys received European Union Medical Device Regulation (EU MDR) certification and CE Mark for four of its women's health products, allowing marketing in the European Union.

How much cash does Femasys (FEMY) have as of June 30, 2024?

Femasys reported cash and cash equivalents of $13.5 million as of June 30, 2024, which is expected to fund operations into July 2025.

What were the key corporate developments for Femasys (FEMY) in Q2 2024?

Femasys completed the build-out of its U.S. commercial team, received EU MDR certification and CE Mark for four products, and reported positive results for its FemaSeed® fertility solution.