Executive Summary

Q1 2024 showed modest sales of $0.27M and a wider net loss versus prior year, reflecting continued investment ahead of commercialization; EPS was $(0.17) vs $(0.25) in Q1 2023 and $(0.26) in Q3 2023 .
Management advanced key catalysts: positive topline data for FDA‑cleared FemaSeed, first commercial in‑office FemaSeed procedure, and FemBloc pivotal trial enrollment expanded to six active academic sites (max allowed in stage one) .
Liquidity remains solid with $17.84M cash; runway guided “into the second half of 2025,” supporting commercial build‑out and clinical execution .
Street consensus (S&P Global) for Q1 2024 EPS and revenue was unavailable at time of review; beat/miss assessment cannot be determined. Values would have been sourced from S&P Global if available.

What Went Well and What Went Wrong

What Went Well

FemaSeed clinical and commercial progress: “promising top line data… more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility” and first commercial in‑office procedure completed .
Pipeline execution: FemBloc pivotal (“FINALE”) trial enrollment initiated at two additional academic sites, totaling six active sites permitted in stage one .
Organizational scaling: Appointment of a seasoned Chief Commercial Officer to drive infertility portfolio commercialization .

What Went Wrong

Sales dipped year over year: Q1 2024 sales were $0.271M, down $0.023M from $0.294M in Q1 2023, reflecting early-stage commercialization dynamics .
Higher operating spend pressured losses: Total OpEx rose to $3.65M (vs $3.23M in Q1 2023) driven by R&D and G&A, widening net loss to $(3.60)M .
Lack of formal financial guidance (revenue/margins/OpEx) limits estimate anchoring and near-term model visibility; only cash runway was provided .

Financial Results

Income Statement Comparison (oldest → newest)

Metric	Q1 2023	Q3 2023	Q1 2024
Revenue ($USD Millions)	$0.294	$0.244	$0.271
Cost of Sales ($USD Millions)	$0.105	$0.086	$0.089
Gross Margin (%)	64.3% (computed from sales and cost)	64.7%	67.3% (computed from sales and cost)
Loss from Operations ($USD Millions)	$(3.04)	$(4.08)	$(3.46)
Net Loss ($USD Millions)	$(2.95)	$(3.997)	$(3.600)
EPS ($)	$(0.25)	$(0.26)	$(0.17)

Operating Expense Detail (Q1 2023 vs Q1 2024)

Metric	Q1 2023	Q1 2024
Research & Development ($USD Millions)	$1.537	$1.771
Sales & Marketing ($USD Millions)	$0.245	$0.300
General & Administrative ($USD Millions)	$1.315	$1.503
Depreciation & Amortization ($USD Millions)	$0.133	$0.071
Total Operating Expenses ($USD Millions)	$3.231	$3.645

Liquidity and Capitalization

Metric	Dec 31, 2023	Mar 31, 2024
Cash and Cash Equivalents ($USD Millions)	$21.716	$17.836
Total Assets ($USD Millions)	$27.756	$24.371
Total Liabilities ($USD Millions)	$9.403	$8.763
Stockholders’ Equity ($USD Millions)	$18.353	$15.608
Convertible Notes Payable, net ($USD Millions)	$4.258	$4.472

Estimates vs Actuals (S&P Global)

Metric	Q1 2024 Consensus	Q1 2024 Actual
Revenue ($USD Millions)	Unavailable*	$0.271
EPS ($)	Unavailable*	$(0.17)

Note: *S&P Global consensus values unavailable at time of query due to vendor limits. Values would be retrieved from S&P Global.

Segment Breakdown

Femasys does not report segments; revenue reflects portfolio sales across women’s health products .

KPIs (selected)

KPI	Q1 2023	Q1 2024
Weighted-Average Shares (Millions)	11.872	21.775
Interest Income ($USD Millions)	$0.097	$0.225
Interest Expense ($USD Millions)	$0.002	$0.362

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY2024	Not provided	Not provided	Maintained: Not provided
Gross Margin	FY2024	Not provided	Not provided	Maintained: Not provided
Operating Expenses	FY2024	Not provided	Not provided	Maintained: Not provided
Tax Rate	FY2024	Not provided	Not provided	Maintained: Not provided
Cash Runway	Through FY2025	“Sufficient… into the second half of 2025”	“Sufficient… into the second half of 2025”	Maintained

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was found in our document catalog; themes below synthesize press releases.

Topic	Previous Mentions (Q4 2023 press release)	Previous Mentions (Q3 2023 press release)	Current Period (Q1 2024 press release)	Trend
FemaSeed clinical outcomes & launch	Positive topline data: 24% pregnancy in severe male factor cohort; commercialization focus initiated	510(k) FDA clearance, completion of pivotal trial enrollment for launch support	“More than double” historic IUI pregnancy rates; first in‑office commercial procedure	Strengthening clinical validation; progressing commercialization
FemBloc pivotal trial	Activated enrollment for remaining sites of initial phase	Initiated enrollment; first academic site activated; First‑Patient‑In	Enrollment initiated at two additional academic sites; six active sites in stage one	Steady trial ramp within FDA‑cleared design
Regulatory readiness	Capital secured; CE Mark pathway advanced via MDR audits (Stage 2 success) referenced earlier	MDR Stage 2 EU audit completed; MDSAP surveillance audit no findings; Canada MDEL license	No new Q1 regulatory news in release; commercial readiness reiterated	Strong quality/regulatory foundation maintained
Commercial team build-out	CCO and CMO appointments	N/A	CCO appointment emphasized; commercial team recruitment ongoing	Scaling go‑to‑market leadership
Liquidity/runway	Cash $21.7M; runway into 2H 2025	Cash $8.7M pre capital raises; noted extensions	Cash $17.8M; runway reiterated into 2H 2025	Adequate funding to execute near-term milestones

Management Commentary

“Femasys is well positioned to commercialize our infertility portfolio, led by FemaSeed in 2024 with promising top line data… more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility… We believe we have sufficient cash to fund operations into the second half of 2025…” — Kathy Lee‑Sepsick, CEO .
“Our focus is now on executing on commercialization of FemaSeed and our other available products, as well as advancing the clinical pivotal trial for FemBloc.” — Kathy Lee‑Sepsick, CEO (Year‑end press release) .

Q&A Highlights

No Q1 2024 earnings call transcript available in our dataset; no Q&A to summarize [Search returned none].

Estimates Context

Consensus EPS and revenue for Q1 2024 were unavailable via S&P Global at time of query due to vendor request limits; as a result, we cannot assess beat/miss versus Street. S&P Global would be the default source if available.
Implication: Without Street anchors, investor focus should shift to operational milestones and cash runway until formal guidance or estimate visibility improves.

Key Takeaways for Investors

Clinical/Commercial momentum: FemaSeed’s favorable topline data and first commercial procedure are meaningful validation and potential adoption catalysts in infertility care .
Execution on FemBloc: Pivotal trial continues ramp (six active sites in stage one), keeping optionality on a large permanent birth control market opportunity .
Operating spend rising ahead of launch: OpEx stepped up to $3.65M; expect continued investment in commercial build‑out and trial activities near term .
Gross margin resilient despite small scale: Q1 GM ~67% (computed), consistent with prior quarters’ mid‑60s performance .
Liquidity supports runway: $17.84M cash and reiterated runway into 2H 2025 reduce near‑term financing overhang risk .
Modeling caution: Absence of formal revenue/margin guidance and unavailable Street estimates limit near‑term visibility; watch for commercial traction updates and additional clinical milestones .
Trading implications: Newsflow‑driven set‑up—monitor regulatory, clinical updates, and commercial wins (site onboarding, procedure volumes) as near‑term stock catalysts .

FEMASYS INC (FEMY)·Q1 2024 Earnings Summary