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Femasys Announces Financial Results for Quarter Ended March 31, 2026 and Provides Corporate Update

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(Positive)
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Femasys (NASDAQ: FEMY) reported results for the quarter ended March 31, 2026, highlighting early commercial adoption of FemaSeed Complete, initiation of the FINALE pivotal trial for FemBloc, new international distribution partnerships, and leadership additions.

Financials: Q1 sales $424,889 (+24.5% YoY), R&D -55.9% to $1.31M, net income of $846,100, cash ~$5.4M expected to fund operations into Q3 2026, accumulated deficit ~$145.0M.

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Positive

  • Sales +24.5% YoY to $424,889 driven by FemBloc sales
  • R&D reduced 55.9% to $1.31M, reflecting product transition to inventory
  • FINALE trial initiated for FemBloc, progressing toward U.S. regulatory pathway
  • MDSAP certification achieved for FemBloc, supporting international regulatory readiness
  • New CPT Category III code approved for FemaSeed ITI, supporting future reimbursement

Negative

  • Cash runway limited; cash ~$5.4M expected to fund operations only into Q3 2026
  • Accumulated deficit ~$145.0M, indicating extended prior losses and funding need
  • Total liabilities decreased but long-term liabilities remain substantial at $6.05M (long-term)

News Market Reaction – FEMY

-5.98%
3 alerts
-5.98% Session close to close
+5.1% Peak Tracked
-3.5% Trough Tracked
$27.12M Market Cap
0.9x Rel. Volume

In the May 11 session, FEMY declined 5.98%, reflecting a notable negative market reaction. Argus tracked a peak move of +5.1% during that session. Argus tracked a trough of -3.5% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -6.0% in the session following this news. A negative reaction despite the shift to n...
Analysis

The stock moved -6.0% in the session following this news. A negative reaction despite the shift to net income of $846,100 would fit the pattern of prior earnings updates, which averaged -9.04% moves amid recurring cash runway concerns. Investors may focus on the modest $5.4 million cash balance, accumulated deficit of $145.0 million, and the prospect of further capital raises under the existing shelf registration as key overhangs.

Key Figures

Q1 2026 sales: $424,889 Sales growth: 24.5% R&D expense: $1,309,401 +5 more
8 metrics
Q1 2026 sales $424,889 Quarter ended March 31, 2026; vs. $341,264 in Q1 2025
Sales growth 24.5% Increase in Q1 2026 sales vs. Q1 2025
R&D expense $1,309,401 Q1 2026; down from $2,968,472 in Q1 2025 (−55.9%)
Net income $846,100 Quarter ended March 31, 2026; vs. $5,896,839 net loss in Q1 2025
EPS basic $0.00 Q1 2026 basic earnings per share; vs. ($0.23) in Q1 2025
Cash & equivalents $5.4 million Cash and cash equivalents as of March 31, 2026
Accumulated deficit $145.0 million Accumulated deficit as of March 31, 2026
Runway guidance Into Q3 2026 Management expectation for funding operations with current cash

Previous Earnings Reports

5 past events · Latest: Mar 31 (Negative)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 31 2025 annual results Negative -0.8% Full-year 2025 results with higher sales but large net loss and cash constraints.
Nov 14 Q3 2025 earnings Negative -11.3% Q3 2025 results plus new financings and regulatory milestones, shares fell post-print.
Aug 08 Q2 2025 earnings Negative -13.2% Q2 2025 revenue growth but $4.6M net loss and limited cash runway.
May 08 Q1 2025 earnings Negative -7.8% Q1 2025 growth in sales and R&D but widening net loss and short runway.
Mar 27 2024 annual results Negative -12.2% 2024 results with 52% sales growth yet $18.82M net loss and added financing.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Earnings and financial updates have typically been followed by negative price reactions, with an average move of -9.04% across the last five earnings-related releases.

Recent Company History

Over the past year, Femasys’ earnings releases have highlighted growing sales but persistent losses and financing needs. Events from Mar 27, 2025 through Mar 31, 2026 consistently paired double‑digit revenue growth with sizeable net losses and modest cash balances, often alongside regulatory and commercial milestones for FemBloc and FemaSeed. Despite operational progress and capital raises, shares tended to trade lower after these updates, framing today’s quarterly report against a backdrop of cautious investor reactions.

Key Terms

pivotal clinical trial, medical device single audit program (mdsap), cpt code, category iii cpt code, +3 more
7 terms
pivotal clinical trial medical
"Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®"
A pivotal clinical trial is a late-stage medical study designed to provide the main evidence regulators use to decide whether a drug or medical device can be approved and sold; think of it as the product’s final exam. For investors, the trial’s outcome is critical because a clear pass can unlock regulatory approval, market access and future revenue, while failure can halt commercialization and materially affect a company’s valuation.
medical device single audit program (mdsap) regulatory
"FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification"
A Medical Device Single Audit Program (MDSAP) is a coordinated inspection process where one comprehensive audit of a medical device maker’s quality and regulatory practices is accepted by multiple national regulators. Think of it like a single safety inspection whose report acts like a passport accepted by several countries, reducing duplicate checks. For investors, MDSAP participation signals lower regulatory and supply‑disruption risk, potentially faster market access and predictable compliance costs.
cpt code regulatory
"Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed"
A CPT code is a standardized numeric label used by healthcare providers and insurers to identify medical procedures, tests, and services for billing and reimbursement. Think of it as a SKU or price tag for each clinical service: which code is used and how it’s reimbursed directly affects a provider’s revenue and a medical product’s market adoption, so investors watch codes and payment rules to estimate financial impact.
category iii cpt code regulatory
"approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI)"
A Category III CPT code is a temporary billing code used by medical providers to report new, experimental or emerging procedures, technologies, or services that do not yet have a permanent billing code. It matters to investors because assignment of such a code signals early clinical or market adoption, provides a way to capture usage and potential reimbursement data, and can hint at future revenue growth or regulatory and payment uncertainty—much like a temporary SKU that lets a retailer track early demand for a new product.
intratubal insemination medical
"Category III CPT code for FemaSeed intratubal insemination (ITI)"
Intratubal insemination is a fertility procedure in which sperm are placed directly into a woman's fallopian tube to increase the chance of fertilization, often using a thin catheter passed through the cervix or during laparoscopy. For investors, it signals demand for specialized medical services, devices and clinic capacity—like delivering seed directly into a garden bed to boost crop odds—and can affect revenue, reimbursement and regulatory risk in the fertility-care market.
conversion option liability financial
"Change in fair value of conversion option liability | | 1,513,413"
An accounting entry recording the value of a company’s obligation tied to a financial instrument that can be converted into shares, such as convertible bonds or preferred stock. Think of it like a coupon that could be redeemed for company ownership: it sits on the balance sheet as a potential claim and matters to investors because conversion can dilute existing stock, change debt-versus-equity ratios, and alter earnings-per-share and credit metrics.
warrants liabilities financial
"Change in fair value of warrants liabilities | | 3,683,000"
Warrants liabilities are obligations a company records when it has issued warrants—contracts that give holders the right to buy stock or receive cash—but the terms make the company responsible for future payments or share changes. For investors, these items matter because they sit on the balance sheet like a potential bill or promise: they can dilute existing owners, create future cash needs, and cause earnings to swing as the warrants’ value changes, similar to a coupon that might force a store to pay out later.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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-- With fertility rates at historic lows, Femasys advances access to early infertility care through FemaSeed® Complete, enabling OB/GYNs to treat patients within their own practices --

ATLANTA, May 08, 2026 (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, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update.

Corporate Highlights from 1Q 2026 to date

  • Advanced initial commercial adoption of FemaSeed Complete, positioning Femasys to expand access to first-line fertility treatment through integrated, in-office care by OB/GYNs, supporting earlier intervention prior to referral to higher-cost specialty care.
  • Launched FemaSeed Complete at ACOG 2026, advancing commercialization and expanding provider awareness to support adoption of first-line fertility treatment in the OB/GYN office.
  • Established strategic partnership with AMI Technologies to introduce and commercialize its fertility portfolio in Israel, expanding international market opportunities.
  • Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth.
  • Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, enhancing leadership and strategic oversight.
  • Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®, advancing toward U.S. approval of a first-of-its kind, non-surgical permanent birth control.
  • FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification, supporting global regulatory readiness and future market access.
  • Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI), supporting future reimbursement and broader adoption in the U.S.
  • Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed, and other portfolio products in Switzerland, expanding European market access.
  • Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment and expanding access through community-based care.

“During the first quarter of 2026 and into the second quarter of 2026, we delivered meaningful clinical, regulatory and commercial progress across our FemBloc and FemaSeed platforms,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are accelerating commercialization of FemaSeed with the introduction of the FemSperm® product family, enabling OB/GYNs to deliver integrated, in-office fertility care. Concurrently, we advanced FemBloc with initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe our current cash resources are sufficient to fund operations into the third quarter of 2026. We remain focused on scaling a broad portfolio of innovative women’s health solutions globally, addressing critical unmet needs with safe, technologically advanced products.”

Financial Results for Quarter Ended March 31, 2026

  • Sales increased by $83,625, or 24.5%, to $424,889 in 2026 from $341,264 in 2025, primarily due to sales of FemBloc.
  • Research and development expenses decreased by $1,659,071, or 55.9%, to $1,309,401 in 2026 compared to $2,968,472 in 2025, primarily reflecting the transition of development products into inventory to support commercialization, along with lower development, clinical, compensation, and professional service costs.
  • Net income, including gains from changes in fair value of financial instruments, was $846,100, or $0.00 per basic and diluted share attributable to common stockholders for the quarter ended March 31, 2026, compared to a net loss of $5,896,839, or ($0.23) per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2025.
  • Cash and cash equivalents as of March 31, 2026, was approximately $5.4 million and the Company had an accumulated deficit of approximately $145.0 million. The Company expects, based on its current operating plan, its current cash and cash equivalents will be sufficient to fund its ongoing operations into the third quarter of 2026.

For more information, please refer to the Company’s Form 10-Q filed May 8, 2026, which can be accessed on the SEC website.

FEMASYS INC.
Condensed Balance Sheets
(unaudited)
          
Assets March 31,
2026
 December 31,
2025
Current assets:    
 Cash and cash equivalents$5,386,041  9,266,353 
 Accounts receivable, net 172,264  616,600 
 Inventory
 6,105,267  5,740,249 
 Prepaid and other current assets 679,917  833,133 
     Total current assets 12,343,489  16,456,335 
Property and equipment, at cost:    
 Leasehold improvements 1,238,886  1,238,886 
 Office equipment 80,941  78,155 
 Furniture and fixtures 421,798  417,876 
 Machinery and equipment 3,095,633  3,065,713 
 Construction in progress 955,271  897,885 
       5,792,529  5,698,515 
Less accumulated depreciation (3,868,518) (3,802,940)
     Net property and equipment 1,924,011  1,895,575 
Long-term assets:    
 Lease right-of-use assets, net 1,178,941  1,297,121 
 Intangible assets, net of accumulated amortization 124,252  134,914 
 Other long-term assets 924,552  940,232 
     Total long-term assets 2,227,745  2,372,267 
     Total assets$16,495,245  20,724,177 
(continued)
    
          



FEMASYS INC.
Condensed Balance Sheets
(unaudited)
Liabilities and Stockholders’ Equity March 31,
2026
 December 31,
2025
Current liabilities:    
 Accounts payable$1,597,591  1,830,124 
 Accrued expenses 1,024,706  1,265,773 
 Clinical holdback – current portion 52,572  52,644 
 Operating lease liabilities – current portion 480,286  487,624 
     Total current liabilities 3,155,155  3,636,165 
Long-term liabilities:    
 Clinical holdback – long-term portion 54,487  52,370 
 Convertible notes payable, net 3,335,176  3,178,864 
 Conversion option liability 488,000  2,014,000 
 Warrants liabilities 1,260,000  4,943,000 
 Operating lease liabilities – long-term portion 912,534  1,030,476 
     Total long-term liabilities 6,050,197  11,218,710 
     Total liabilities 9,205,352  14,854,875 
Commitments and contingencies    
Stockholders’ equity:    
 Common stock, $0.001 par, 200,000,000 authorized,    
  60,507,909 shares issued and 60,390,686 outstanding as of   
  March 31, 2026; and 59,720,010 shares issued    
  and 59,602,787 outstanding as of December 31, 2025 60,508  59,720 
 Treasury stock, 117,223 common shares (60,000) (60,000)
 Warrants   5,246,150  5,246,150 
 Additional paid-in capital 147,023,279  146,449,576 
 Accumulated deficit (144,980,044) (145,826,144)
     Total stockholders’ equity 7,289,893  5,869,302 
     Total liabilities and stockholders' equity$16,495,245  20,724,177 
           



FEMASYS INC.
Condensed Statements of Comprehensive Income (Loss)
(unaudited)
        Three Months Ended March 31,
        2026  2025 
Sales    $424,889  341,264 
Cost of sales (excluding depreciation expense) 158,606  117,266 
           
Operating expenses:    
 Research and development 1,309,401  2,968,472 
 Sales and marketing 1,315,755  908,567 
 General and administrative 1,782,390  1,722,713 
 Depreciation and amortization 82,270  84,853 
     Total operating expenses 4,489,816  5,684,605 
     Loss from operations (4,223,533) (5,460,607)
Other income (expense):    
 Interest income 49,827  19,029 
 Change in fair value of conversion option liability 1,513,413   
 Change in fair value of warrants liabilities 3,683,000   
 Interest expense (176,607) (459,449)
     Total other income (expense), net 5,069,633  (440,420)
     Income (loss) before income taxes 846,100  (5,901,027)
 Income tax benefit   (4,188)
     Net income (loss)$846,100  (5,896,839)
           
Net income (loss) attributable to common stockholders$328,646  (5,896,839)
           
Earnings (losses) per share:    
Basic
$0.00  (0.23)
Diluted
 0.00  (0.23)
           
Weighted-average common shares outstanding:    
Basic
 66,645,591  25,149,236 
Diluted
 78,095,633  25,149,236 
           


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 (ITI), a groundbreaking first-step infertility treatment; FemSperm®, a CLIA waived sperm preparation and analysis product line; and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of 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 2025, the UK in August 2025, and New Zealand in September 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 ongoing.

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; our ability to 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, 2025, 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: 
IR@femasys.com
Media@femasys.com


FAQ

What did Femasys (FEMY) report for Q1 2026 sales and how did it compare year-over-year?

Femasys reported Q1 2026 sales of $424,889, a 24.5% increase versus Q1 2025. According to the company, the increase was primarily driven by sales of FemBloc and early commercial adoption.

What is Femasys' cash position and how long will it fund operations (FEMY)?

Femasys had approximately $5.4 million in cash and cash equivalents as of March 31, 2026. According to the company, current resources are expected to fund operations into the third quarter of 2026.

What clinical and regulatory progress did Femasys announce for FemBloc (FEMY)?

Femasys initiated patient enrollment in the FINALE pivotal trial for FemBloc and achieved MDSAP certification. According to the company, these steps advance the product toward U.S. FDA approval and global readiness.

How did research and development spending change for Femasys in Q1 2026 (FEMY)?

R&D expenses decreased by 55.9% to $1.31 million in Q1 2026 versus Q1 2025. According to the company, the decline reflects transition of development products into inventory and lower development and clinical costs.

What commercial milestones did Femasys announce to support FemaSeed adoption (FEMY)?

Femasys launched FemaSeed Complete, secured a new CPT Category III code for FemaSeed ITI, and signed international distribution partnerships. According to the company, these moves are intended to expand OB/GYN in-office fertility care and market access.