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FEMASYS INC (FEMY)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered accelerating top-line growth with sales up 31.4% year-over-year to $0.73M, driven primarily by initial FemBloc commercialization; net loss narrowed to $4.19M and EPS improved to -$0.10 from -$0.24 YoY .
  • Revenue materially missed Wall Street consensus ($0.73M vs $1.35M; -46%), while EPS was slightly better than expected (-$0.10 vs -$0.115); the revenue miss reflects an early-stage ramp versus optimistic sell-side models, whereas disciplined OpEx and financing cushioned EPS . Values retrieved from S&P Global*.
  • Balance sheet strengthened with $8.0M underwritten offering and a $12M secured convertible notes agreement (total potential funding up to $58M if all warrants exercised), extending cash runway into September 2026—an important de-risking catalyst as the FemBloc U.S. pivotal FINALE trial advances .
  • Multiple regulatory and commercial milestones—UK and New Zealand approvals for FemBloc, initiation of EU post-market surveillance, partnerships (e.g., Kebomed) and second European partner order—support the commercialization narrative and potential re-rating catalysts tied to regulatory/regional execution .

What Went Well and What Went Wrong

What Went Well

  • Regulatory approvals for FemBloc in the UK and New Zealand and FDA IDE approval to continue enrollment in the final pivotal phase (FINALE), clarifying the pathway to potential U.S. approval .
  • Commercial traction: second partner order in Europe and partnerships with Kebomed and Medical Electronic Systems; initial orders in Spain and France helped drive YoY sales growth .
  • CEO tone underscores strategic momentum: “Regulatory approvals… significantly expand access… With initial commercial orders… we are building early momentum… we continue to advance toward U.S. approval of FemBloc…” .

What Went Wrong

  • Revenue meaningfully missed consensus for the third consecutive quarter, indicating the sell-side may be ahead of the actual commercialization ramp trajectory ($0.73M vs $1.35M; -$0.62M) . Values retrieved from S&P Global*.
  • Gross margin compressed sequentially versus Q1 as commercialization costs and mix evolved; operating losses remain significant despite improvements (Loss from operations improved to -$3.65M from -$3.85M in Q2) .
  • Inventory build and continued interest expense highlight capital intensity and working capital demands amid the scale-up (Inventory $5.78M; Interest expense Q3: $0.53M) .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD)$341,264 $409,268 $729,394
Cost of Sales ($USD)$117,266 $158,171 $293,838
Gross Profit ($USD)$223,998 $251,097 $435,556
Gross Margin %65.6% 61.4% 59.7%
Total Operating Expenses ($USD)$5,684,605 $4,102,663 $4,089,324
Operating Income (Loss) ($USD)$(5,460,607) $(3,851,566) $(3,653,768)
Net Income - (IS) ($USD)$(5,896,839) $(4,585,922) $(4,194,821)
Diluted EPS ($USD)$(0.23) $(0.16) $(0.10)
Q3 2025 Performance vs Prior Year and ConsensusQ3 2024Q3 2025 ActualConsensus Estimate*Surprise*
Revenue ($USD)$554,908 $729,394 $1,350,000*$(620,606) (-45.9%)*
EPS ($USD)$(0.24) $(0.10) $(0.115)*+$0.015 (better)*

KPIs and Operating Drivers

KPIQ1 2025Q2 2025Q3 2025
R&D Expense ($USD)$2,968,472 $1,414,429 $1,382,022
Sales & Marketing ($USD)$908,567 $984,977 $1,143,805
G&A ($USD)$1,722,713 $1,616,972 $1,477,800
Interest Expense ($USD)$459,449 $491,500 $532,073
Cash & Equivalents ($USD)$3,820,208 $3,218,067 $4,569,038
Inventory ($USD)$3,862,188 $5,232,738 $5,783,974
Accounts Receivable, net ($USD)$233,598 $254,584 $572,199
Convertible Notes Payable, net ($USD)$5,762,927 $6,080,813 $6,507,354
Weighted-Average Shares25,149,236 28,880,704 41,015,196

Segment Breakdown

  • No segment reporting provided; results presented on a consolidated basis .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany outlookSufficient into early Q4 2025 Sufficient into September 2026 Raised runway
Revenue GuidanceCompany outlookNot providedNot providedMaintained (no guidance)
Margin GuidanceCompany outlookNot providedNot providedMaintained (no guidance)
OpEx GuidanceCompany outlookNot providedNot providedMaintained (no guidance)
Tax RateCompany outlookNot providedNot providedMaintained (no guidance)
DividendsCompany outlookNone providedNone providedMaintained (no guidance)
Regulatory MilestoneQ3 2025Ongoing FINALE enrollment FDA IDE approval to initiate final pivotal phase Progressed milestone

Earnings Call Themes & Trends

  • The Q3 2025 earnings call transcript was not available; no call transcript was found in the document catalog, and external searches did not locate a Femasys Q3 transcript [ListDocuments: earnings-call-transcript=0].

Themes across quarters

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Regulatory/legal (FemBloc)EU delivery system approval; CE mark pending; pivotal data publication Full EU CE mark achieved; UK MHRA approval pending; initial EU order UK and NZ approvals; FDA IDE approval for final pivotal phase; EU PMS study initiated Accelerating approvals and evidence generation
Commercialization (FemBloc)EU partnerships initiated (Spain) First EU order (~$400k) Spain; partner build-out Second partner order; Kebomed partnership for France/Benelux; initial orders in France Expansion into new EU geographies
Fertility portfolio (FemaSeed/FemVue)U.S. adoption and partnerships; QoQ sales up 78% ANZ regulatory approvals; new clinic partnerships Expanded FemSperm kits enabling gynecologist in-office procedures Enabling broader point-of-care adoption
Financing/Balance SheetSufficient cash into early Q3 2025 Cash into early Q4 2025; offering priced $12M notes agreement; $8M offering closed; runway to Sep-2026 De-risked capital runway
Clinical/Real-world evidenceFocus on pivotal trial enrollment Continued enrollment; partner-supported commercialization EU PMS real-world study initiated Building evidence base

Management Commentary

  • “Regulatory approvals of the complete FemBloc System in the U.K. and New Zealand significantly expand access… With initial commercial orders… in Spain and France, we are building early momentum… we continue to advance toward U.S. approval… following the FDA’s recent IDE approval to initiate the final pivotal trial phase…” — Kathy Lee-Sepsick, CEO .
  • On commercialization enablement: “The availability of the FemSperm Insemination Prep Kit… enables tens of thousands of gynecologists to offer our first-step fertility solution directly within their practices…” — Kathy Lee-Sepsick .
  • On financing priorities: “Ramping commercialization of our FemaSeed® and FemBloc® offerings remains our highest priority, and this financing enables us to execute on our strategy…” — Kathy Lee-Sepsick .

Q&A Highlights

  • Not available. An earnings call transcript for Q3 2025 was not found in the document catalog or via external search, preventing extraction of Q&A themes or guidance clarifications [ListDocuments: earnings-call-transcript=0].

Estimates Context

  • Q3 2025 revenue missed consensus materially ($0.73M vs $1.35M; -45.9%); EPS modestly beat (-$0.10 vs -$0.115), aided by lower R&D and steady operating discipline despite higher interest expense . Values retrieved from S&P Global*.
  • Prior quarters show a similar pattern: revenue below consensus while EPS near/above consensus (Q2: $0.41M vs $1.17M; EPS -$0.16 vs -$0.1625; Q1: $0.34M vs $1.14M; EPS -$0.23 vs -$0.20), suggesting models need to recalibrate commercialization timing and pacing . Values retrieved from S&P Global*.
  • We expect near-term estimate revisions to lower revenue trajectories and adjust cash burn/OpEx timing, while factoring extended runway and regulatory momentum as offsetting positives. Values retrieved from S&P Global*.

Key Takeaways for Investors

  • Commercial ramp is real but gradual: revenue growth is improving, yet consensus continues to overestimate near-term pace; expect continued estimate right-sizing on top line while EPS resilience persists due to cost discipline . Values retrieved from S&P Global*.
  • Balance sheet de-risked: $8M offering and $12M notes extend cash runway into September 2026, reducing near-term financing overhang and enabling sustained execution across EU/US milestones .
  • Regulatory and evidence catalysts: UK/NZ approvals, EU PMS real-world data, and FDA IDE pivotal advancement provide multiple shots-on-goal for narrative strengthening over the next 12 months .
  • EU commercialization expanding: second partner order and Kebomed partnership broaden geographic reach; watch order intake cadence and production scale to gauge traction in Spain, France, and Benelux .
  • Fertility platform enablement: FemSperm kits unlock gynecologist in-office workflow, potentially accelerating FemaSeed adoption ahead of IVF—monitor U.S. clinic onboarding and utilization rates .
  • Risk factors: inventory build and interest expense underscore working capital and capital costs during scale-up; execution in regulatory and reimbursement pathways remains critical .
  • Trading implications: regulatory/regional milestones and financing clarity are positive catalysts; top-line misses vs consensus can create volatility—focus on order flow updates and pivotal trial progression for directional moves .

Footnote: *Values retrieved from S&P Global (analyst consensus via GetEstimates).