Femasys Announces Financial Results for Year Ended December 31, 2024, and Provides Corporate Update

-- Company expands commercial product offering with FemBloc® permanent birth control (delivery system) approval in Europe and signed partnerships for distribution in Spain --

ATLANTA, March 27, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ:FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces financial results for the year ended December 31, 2024 and provides a corporate update.

Corporate Highlights from 4Q 2024 to date

Announced FemBloc® permanent birth control (delivery system) approval in Europe; FemBloc blended polymer component successfully completed an expedited G12 Special MDR Audit for Class III devices, and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review

Announced partnership with CNY Fertility, national conglomerate of 11 fertility centers, to offer FemaSeed®

Announced strategic distribution partnerships for FemBloc in Spain

Announced peer-reviewed publication of positive safety and efficacy results from FemBloc clinical trials

Announced UK and Israeli regulatory approvals for FemaSeed and two diagnostic devices

Announced notices of intention to grant two new European patent applications for FemBloc

Announced notice of allowance for new U.S. patent application for FemaSeed

Announced partnership with HRC Fertility, conglomerate provider of fertility services in Western U.S., to offer FemaSeed

Announced partnership with Boston IVF, prominent network of 30 centers nationwide, to offer FemaSeed

Announced peer-reviewed publication of positive safety and efficacy results from FemaSeed pivotal trial

"During the fourth quarter of 2024 and first quarter of 2025 we achieved significant regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination products," said Femasys' CEO Kathy Lee-Sepsick. "We are focused on executing on commercialization of FemaSeed and expect U.S. revenue to increase by approximately 50% in first quarter of 2025 versus fourth quarter of 2024. We are continuing to advance our FemBloc to commercialization in Europe while executing on the clinical pivotal trial for U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2025. We remain committed to addressing major gaps in women's reproductive health by advancing safe and effective, technologically advanced product solutions."

Financial Results for Year Ended December 31, 2024

Sales increased by $557,138, or 52.0%, to $1,629,108 in 2024 from $1,071,970 in 2023

Research and development expenses increased by $1,007,842, or 14.0%, to $8,216,543 in 2024 from $7,208,701 in 2023

Net loss was $18,816,628, or ($0.85) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2024, compared to net loss of $14,247,124, or ($0.93) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2023

Cash and cash equivalents as of December 31, 2024, was $3.5 million and the Company had an accumulated deficit of $127.2 million. The Company expects, based on its current operating plan, our current cash and cash equivalents, which includes approximately $5.4 million we raised subsequent to year end, will be sufficient to fund its ongoing operations into third quarter of 2025.

For more information, please refer to the Company's Form 10-K filed March 27, 2025, which can be accessed on the SEC website.

 

 

FEMASYS INC.

Balance Sheets

(unaudited)

       

 

 

 

 

Assets

 

December 31, 2024

 

December 31, 2023

Current assets: 

 

 

 

 

Cash and cash equivalents

$

3,451,761

 

 

21,716,077

 

Accounts receivable, net

 

488,373

 

 

98,906

 

Inventory  

 

3,046,323

 

 

667,118

 

Prepaid and other current assets

 

1,035,993

 

 

695,879

 

Total current assets

 

8,022,450

 

 

23,177,980

 

Property and equipment, at cost:

 

 

 

 

Leasehold improvements

 

1,238,886

 

 

1,212,417

 

Office equipment

 

60,921

 

 

47,308

 

Furniture and fixtures

 

417,876

 

 

414,303

 

Machinery and equipment

 

2,856,740

 

 

2,559,356

 

Construction in progress

 

762,445

 

 

423,077

 

       

 

5,336,868

 

 

4,656,461

 

Less accumulated depreciation

 

(3,740,769

)

 

(3,545,422

)

Net property and equipment

 

1,596,099

 

 

1,111,039

 

Long-term assets:

 

 

 

 

Lease right-of-use assets, net

 

1,805,543

 

 

2,380,225

 

Intangible assets, net of accumulated amortization

 

65,918

 

 



 

Other long-term assets

 

954,992

 

 

1,086,581