FEMASYS INC (FEMY)·Q2 2024 Earnings Summary

Executive Summary

• Q2 revenue was $0.22M, down 30.9% year over year and down sequentially from $0.27M, as international sales paused and the team ramped commercial capabilities ahead of FemaSeed U.S./EU commercialization .
• Net loss widened to $4.68M, with EPS of ($0.21) vs ($0.22) a year ago; operating expenses rose 47.2% YoY driven by sales & marketing investment (+656.6%) to build a commercial team and launch readiness .
• Balance sheet: cash and cash equivalents were $13.53M with management stating runway into July 2025; however the 10-Q explicitly raises substantial doubt about going concern absent additional financing .
• Strategic/regulatory: EU MDR certification and CE Mark for FemaSeed, FemVue, FemCerv, and FemCath; U.S. commercial team completed; prioritizing U.S. efforts while identifying EU distribution partners—a near-term commercialization catalyst .
• Consensus estimates from S&P Global were unavailable; third-party coverage flagged an EPS miss vs -$0.17 and revenue miss vs $0.78M, but these are not SPGI figures (S&P Global consensus unavailable).

What Went Well and What Went Wrong

What Went Well

• EU MDR certification and CE Marks for four products, providing regulatory approval to begin EU marketing and validating quality and safety standards .
• Commercial team build-out completed; CEO: “our team has recently begun actively marketing our products in the U.S.” and “prioritizing our U.S. efforts” while “identifying strategic distribution partners in Europe” .
• FemaSeed pivotal topline: pregnancy rates “more than double” historic IUI rates for male factor infertility; management positioning FemaSeed as an improved alternative before IVF .

What Went Wrong

• Sales fell 30.9% YoY to $0.22M; units sold decreased 41.7% YoY given timing of international orders, compressing scale ahead of commercialization .
• Net loss widened to $4.68M; sales & marketing expense spiked 656.6% YoY to $0.98M as commercialization costs hit the P&L, driving total operating expenses up 47.2% YoY .
• Interest expense surged to $0.39M in Q2 due to convertible notes (6% coupon plus non-cash discount amortization), flipping other income to net expense; accrued interest rose to $0.25M .

Financial Results

Notes:

• Gross profit and margin derived from Sales and Cost of Sales figures cited above .

Estimates vs Actuals (SPGI unavailable)

Third-party context (non-SPGI): InvestorPlace (via TradeSmith) cited consensus EPS -$0.17 and revenue $0.78M and reported misses; use with caution .

Segment breakdown (company reports one segment)

KPIs (Geography)

Balance Sheet Snapshot

Guidance Changes

No formal revenue/margin/OpEx/tax rate guidance ranges were provided in Q2 materials .

Earnings Call Themes & Trends

No Q2 2024 earnings call transcript was available in our document catalog; themes below reflect prepared remarks and MD&A.

Management Commentary

• “We believe that our novel fertility solution FemaSeed®, which demonstrated pregnancy rates more than double the historic intrauterine insemination (IUI) pregnancy rates for male factor infertility… is an improved alternative and a viable option prior to in vitro fertilization (IVF)… As we await announcement of published data for the FemaSeed prospective multi-center pivotal trial, we are actively prioritizing our U.S. efforts and concurrently identifying strategic distribution partners in Europe.” — Kathy Lee‑Sepsick, CEO .
• “The end of 2023 marked a significant milestone… FDA clearance of FemaSeed… topline data… 24% of women in the severe male factor cohort became pregnant… majority… after the first FemaSeed procedure.” — Kathy Lee‑Sepsick, CEO .

Q&A Highlights

• No Q2 2024 earnings call transcript available; no Q&A themes to report from a call. We relied on the press release and 10‑Q MD&A for qualitative insights .

Estimates Context

• S&P Global/Capital IQ consensus estimates were unavailable for Q2 2024 via our data connection; therefore, beats/misses versus SPGI consensus cannot be presented (S&P Global consensus unavailable).
• Third-party coverage (not SPGI) reported EPS of ($0.21) vs consensus -$0.17 and revenue $0.22M vs consensus $0.78M, indicating misses; treat as directional only and not a definitive SPGI benchmark .

Key Takeaways for Investors

• Commercial inflection approaching: U.S. commercial team is in place, and FemaSeed sales are expected to commence in 2H 2024—watch for sequential sales lift and initial reorder patterns .
• EU beachhead secured: MDR certification and CE Marks for four products enable EU marketing; near-term EU distribution agreements could broaden revenue channels .
• Operating leverage timing: S&M investment surged for launch readiness; monitor opex normalization versus ramping gross profit as sales scale (gross margin ~67% in Q2) .
• Liquidity is the swing factor: Cash $13.53M with runway into July 2025 but substantial doubt clause underscores the need for financing or faster commercial traction to mitigate dilution risk .
• Clinical/commercial catalysts: Publication of FemaSeed pivotal data, FemBloc trial enrollment and interim milestones, and EU/U.S. partner wins are key narrative drivers .
• Geographic mix recovery: International sales paused in Q2; resumption with EU distribution partners would diversify and support growth into FY24/FY25 .
• Balance sheet watch: Convertible notes increase interest burden; observe accrued interest and potential warrant/ATM usage as part of funding strategy .

Appendix: Prior Two Quarters (Trend Reference)

• Q1 2024: Revenue $0.27M; Net loss $(3.60)M; EPS ($0.17); cash $17.84M; commercialization recruitment underway; first commercial FemaSeed procedure announced in March .
• Q4 2023/Full Year: Revenue $1.07M; Net loss $(14.25)M; EPS ($0.93); cash $21.72M; FDA clearance of FemaSeed; pivotal topline announced; CCO & CMO appointments .