Femasys Announces Second Quarter Financial Results for 2025

Rhea-AI Summary

Femasys Inc. (NASDAQ: FEMY) reported Q2 2025 financial results with notable regulatory achievements and commercial expansion. Sales increased 84.8% to $409,268 in Q2 2025, driven by FemaSeed and FemVue products. The company secured significant milestones including EU approval for FemBloc, their non-surgical permanent birth control solution, with a $400,000 initial order from Spain.

The quarter saw regulatory approvals in Australia and New Zealand for FemaSeed and FemVue, alongside a new partnership with Carolinas Fertility Institute. However, Femasys reported a net loss of $4.6 million ($0.16 per share) and had $3.2 million in cash as of June 30, 2025, expected to fund operations only into early Q4 2025.

Positive

• Sales grew 84.8% year-over-year to $409,268 in Q2 2025
• Secured first European FemBloc order from Spain worth $400,000
• Obtained EU Medical Device Regulation approval for FemBloc system
• Secured regulatory approvals in Australia and New Zealand for FemaSeed and FemVue
• Research and development expenses decreased 28.4% to $1.4 million in Q2 2025

Negative

• Net loss of $4.6 million in Q2 2025
• Cash position of only $3.2 million expected to fund operations only until early Q4 2025
• Accumulated deficit reached $137.7 million
• Interest expenses increased to $491,500 in Q2 2025 from $388,311 in Q2 2024

Insights

Biotech Financial Analyst

Femasys shows 85% quarterly revenue growth but faces cash runway concerns with only funding into early Q4 2025.

Femasys delivered 84.8% year-over-year revenue growth in Q2 2025, with sales reaching $409,268 compared to $221,484 in Q2 2024, driven by increased adoption of their FemaSeed and FemVue fertility products. This acceleration represents meaningful commercial traction for their product portfolio.

The company achieved several critical regulatory milestones, most notably securing EU Medical Device Regulation approval for FemBloc, their non-surgical permanent birth control solution. This first global regulatory endorsement validates their technology platform and has already translated into commercial results with a $400,000 initial order from Spanish distribution partners. Additional approvals in Australia and New Zealand for FemaSeed and FemVue further expand their global footprint.

Operationally, R&D expenses decreased 28.4% to $1.41 million as products transitioned from development to commercialization. However, the quarterly net loss remained substantial at $4.59 million ($0.16 per share), only slightly improved from $4.68 million ($0.21 per share) in Q2 2024.

The most concerning aspect is Femasys' precarious cash position. With only $3.2 million in cash and equivalents as of June 30, 2025, management expects funding to last only into early Q4 2025. Despite completing a $4.5 million offering during the quarter, their accumulated deficit has grown to $137.7 million. This limited runway creates significant financing risk and potential dilution for shareholders in the very near term.

The pivot toward commercialization is showing early promise with the appointment of a Chief Commercial Officer and partnership with Carolinas Fertility Institute to offer FemaSeed across eight locations. However, the company must rapidly accelerate revenue growth or secure additional capital to extend operations beyond the next few months.

08/08/2025 - 04:05 PM

-- Continued Progress on Regulatory Approvals and Global Commercialization of Fertility Portfolio --

ATLANTA, Aug. 08, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the second quarter of 2025.

Corporate Highlights from 2Q 2025 to date

• Announced European Union Medical Device Regulation approval of FemBloc^®, the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution
• Secured first European order for FemBloc from Spain distribution partners for approximately $400,000
• Announced Australian and New Zealand regulatory approvals for FemaSeed^® and FemVue^®, a cost-effective first step in fertility
• Announced new Chief Commercial Officer to help drive execution and global growth
• Announced partnership with Carolinas Fertility Institute, one of America’s best fertility clinics, to offer FemaSeed in its eight locations
• Announced pricing of underwritten public offering and concurrent private placement with gross proceeds of $4.5 million
  
  

“Our second quarter marked several significant milestones for Femasys as we continue to secure key regulatory approvals, add partners, and strengthen our team to accelerate the commercialization of our innovative fertility portfolio across the globe,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys. “European approval of the entire FemBloc System announced in June marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution. FemBloc is commercially available through strategic distribution partnerships in select countries in Europe beginning in Spain, who placed their initial order, and we will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval.

“Regulatory approvals for FemaSeed in Australia and New Zealand announced in July also provide us with the opportunity to pursue meaningful commercial opportunities as we continue to grow revenue and broaden our global footprint. Our new partnership with Carolinas Fertility Institute will help us reach and support more patients earlier in their fertility journey. We look forward to building upon this momentum as we work towards transforming the fertility sector not only for patients, but also providers.”

Financial Results for Quarter Ended June 30, 2025

• Sales increased by $187,784, or 84.8%, to $409,268 for the three months of 2025, compared to $221,484 for the three months of 2024 due to sales of FemaSeed and FemVue.
• Research and development expenses decreased by $561,446, or 28.4%, to $1,414,429 for the three months of 2025 compared to $1,975,875 for the three months of 2024 primarily due to commercialization of development products into inventory and reduced clinical costs, partially offset by increased compensation costs.
• Net loss was $4,585,922, or ($0.16) per basic and diluted share attributable to common stockholders, for the three-month period ended June 30, 2025, compared to a net loss of $4,684,574, or ($0.21) per basic and diluted share attributable to common stockholders, for the three-month period ended June 30, 2024.
• Cash and cash equivalents as of June 30, 2025, was approximately $3.2 million and the Company had an accumulated deficit of approximately $137.7 million. The Company expects, based on its current operating plan, our current cash and cash equivalents will be sufficient to fund its ongoing operations into early fourth quarter of 2025.
  
  

Financial Results for Six Months Ended June 30, 2025

• Sales increased by $257,908, or 52.4%, to $750,532 for the six months of 2025, compared to $492,624 for the six months of 2024 due to sales of FemaSeed and FemVue.
• Research and development expenses increased by $636,295, or 17.0%, to $4,382,901 for the six months of 2025 compared to $3,746,606 for the six months of 2024 primarily due to increased compensation and regulatory costs, partially offset by reduced material and development costs and clinical costs.
• Net loss was $10,482,761, or ($0.39) per basic and diluted share attributable to common stockholders, for the six-month period ended June 30, 2025, compared to a net loss of $8,284,084, or ($0.38) per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2024.
  
  

For more information, please refer to the Company’s Form 10-Q filed August 8, 2025, which can be accessed on the SEC website.

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Assets				June 30, 2025			December 31, 2024
Current assets:
	Cash and cash equivalents		$	3,218,067			3,451,761
	Accounts receivable, net			254,584			488,373
	Inventory			5,232,738			3,046,323
	Prepaid and other current assets			1,045,591			1,035,993
		Total current assets		9,750,980			8,022,450
Property and equipment, at cost:
	Leasehold improvements			1,238,886			1,238,886
	Office equipment			68,530			60,921
	Furniture and fixtures			417,876			417,876
	Machinery and equipment			3,211,109			2,856,740
	Construction in progress			548,426			762,445
				5,484,827			5,336,868
Less accumulated depreciation				(3,884,964	)		(3,740,769	)
		Net property and equipment		1,599,863			1,596,099
Long-term assets:
	Lease right-of-use assets, net			1,544,724			1,805,543
	Intangible assets, net of accumulated amortization			55,638			65,918
	Other long-term assets			829,204			954,992
		Total long-term assets		2,429,566			2,826,453
		Total assets	$	13,780,409			12,445,002
(continued)

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders’ Equity					June 30, 2025			December 31, 2024
Current liabilities:
	Accounts payable			$	3,263,584			1,419,044
	Accrued expenses				1,052,752			1,151,049
	Convertible notes payable, net (including related parties)				6,080,813			5,406,228
	Clinical holdback – current portion				63,990			88,581
	Lease liabilities – current portion				502,468			517,967
			Total current liabilities		10,963,607			8,582,869
Long-term liabilities:
	Clinical holdback – long-term portion				40,348			39,611
	Lease liabilities – long-term portion				1,269,019			1,518,100
			Total long-term liabilities		1,309,367			1,557,711
			Total liabilities		12,272,974			10,140,580
Commitments and contingencies
Stockholders’ equity:
	Common stock, $.001 par, 200,000,000 authorized,
		32,692,630 shares issued and 32,575,407 outstanding as of
		June 30, 2025; and 23,473,149 shares issued
		and 23,355,926 outstanding as of December 31, 2024			32,693			23,473
	Treasury stock, 117,223 common shares				(60,000	)		(60,000	)
	Warrants				1,821,744			1,860,008
	Additional paid-in-capital				137,394,016			127,679,198
	Accumulated deficit				(137,681,018	)		(127,198,257	)
			Total stockholders’ equity		1,507,435			2,304,422
			Total liabilities and stockholders' equity	$	13,780,409			12,445,002

FEMASYS INC.
Condensed Statements of Comprehensive Loss
(unaudited)
				Three Months Ended June 30,						Six Months Ended June 30,
				2025			2024			2025			2024
Sales			$	409,268			221,484			750,532			492,624
Cost of sales (excluding depreciation expense)				158,171			73,125			275,437			161,657
Operating expenses:
	Research and development			1,414,429			1,975,875			4,382,901			3,746,606
	Sales and marketing			984,977			975,190			1,893,544			1,275,677
	General and administrative			1,616,972			1,611,817			3,339,685			3,114,621
	Depreciation and amortization			86,285			67,628			171,138			138,856
		Total operating expenses		4,102,663			4,630,510			9,787,268			8,275,760
		Loss from operations		(3,851,566	)		(4,482,151	)		(9,312,173	)		(7,944,793	)
Other (expense) income:
	Interest income			17,144			184,138			36,173			408,822
	Interest expense			(491,500	)		(388,311	)		(950,949	)		(749,863	)
	Other expense			(260,000	)		—			(260,000	)		—
		Total other expense, net		(734,356	)		(204,173	)		(1,174,776	)		(341,041	)
		Loss before income taxes		(4,585,922	)		(4,686,324	)		(10,486,949	)		(8,285,834	)
	Income tax benefit			—			(1,750	)		(4,188	)		(1,750	)
		Net loss	$	(4,585,922	)		(4,684,574	)		(10,482,761	)		(8,284,084	)
Net loss attributable to common stockholders, basic and diluted			$	(4,585,922	)		(4,684,574	)		(10,482,761	)		(8,284,084	)
Net loss per share attributable to common stockholders, basic and diluted			$	(0.16	)		(0.21	)		(0.39	)		(0.38	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted				28,880,704			22,215,516			27,025,277			21,995,436

About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed^® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue^®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.¹

FemBloc^® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec^®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.² For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.

Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

References
¹Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.

²Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.

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 obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, 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, 2024, 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: 
IR@femasys.com

Media:
Media@femasys.com

FAQ

What were Femasys (FEMY) Q2 2025 earnings results?

Femasys reported Q2 2025 sales of $409,268, up 84.8% year-over-year, with a net loss of $4.6 million ($0.16 per share) compared to a net loss of $4.7 million ($0.21 per share) in Q2 2024.

What regulatory approvals did Femasys receive in 2025?

Femasys received EU Medical Device Regulation approval for FemBloc and regulatory approvals in Australia and New Zealand for FemaSeed and FemVue products.

How much cash does Femasys have and how long will it last?

Femasys had $3.2 million in cash as of June 30, 2025, which is expected to fund operations only into early fourth quarter of 2025.

What was the size of Femasys's first European order for FemBloc?

Femasys secured their first European order for FemBloc from Spain distribution partners for approximately $400,000.

What is Femasys's accumulated deficit as of Q2 2025?

Femasys reported an accumulated deficit of approximately $137.7 million as of June 30, 2025.