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EI

ELUTIA INC. (ELUT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $6.0M, down 10% YoY due to SimpliDerm (-$1.0M YoY) and Cardiovascular (-$0.5M YoY), partially offset by BioEnvelope growth (+31% YoY to $3.1M), and up ~10% sequentially vs Q4 2024 .
  • Versus S&P Global consensus, revenue missed ($6.03M actual vs $6.65M estimate, ~9% below) and diluted EPS was roughly in line to slightly worse (-$0.21 actual vs -$0.205 estimate); BioEnvelope strength was outweighed by softness in SimpliDerm and Cardiovascular* .
  • EluPro adoption accelerated: 84% sequential increase; ~52% of BioEnvelope sales; >125 VAC approvals; seven GPOs; Boston Scientific partnership now contributing sales at 50+ hospitals—key catalyst for Q2/Q3 adoption ramp .
  • Liquidity actions reduce near-term cash needs: $15M registered direct offering, SWK amendment allowing full PIK of May interest and potential $5M term loan, and Ligand royalties paid in stock (~$2.2M cash preserved H1 2025)—supporting growth investments and manufacturing scale-up .

What Went Well and What Went Wrong

What Went Well

  • EluPro momentum: “EluPro jumped 84% from the fourth quarter to the first quarter and now constitutes 52% of our BioEnvelope revenue” .
  • Commercial leverage through Boston Scientific: “Combined commercial footprint now exceeds 900 sales professionals… BSC is already generating sales in over 50 hospitals” .
  • Cash conservation and balance sheet flexibility: SWK amendment permits full PIK of May interest and potential $5M term loan; Ligand to accept equity for ~$2.2M royalties in H1, preserving cash .

What Went Wrong

  • Overall net sales decreased 10% YoY to $6.0M; SimpliDerm fell to $2.6M from $3.6M and Cardiovascular to $0.3M from $0.8M, offsetting BioEnvelope growth .
  • Gross margin compressed: GAAP gross margin 40.7% vs 42.5% YoY; adjusted gross margin 54.8% vs 55.2% YoY, reflecting mix and cost dynamics .
  • Continued litigation costs: Q1 litigation costs net were $2.6M; management still expects activity in 2025 despite progress reducing outstanding cases .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$5.922 $5.468 $6.030
Diluted EPS ($)$(0.33) $(0.26) $(0.21)
Gross Margin (GAAP, %)46.3% 42.5% 40.7%
Adjusted Gross Margin (%)60.6% 58.1% 54.8%
Total Operating Expenses ($USD Millions)$13.0 $10.8 $10.4
Loss from Operations ($USD Millions)$(10.230) $(8.432) $(7.922)
Adjusted EBITDA ($USD Millions)$(2.910) $(3.751) $(3.271)
Cash And Equivalents ($USD Millions)$25.741 $13.239 $17.358

Segment revenue

SegmentQ3 2024Q4 2024Q1 2025
BioEnvelope (EluPro + CanGaroo) ($USD Millions)$2.3 $2.7 $3.1
SimpliDerm ($USD Millions)$3.1 $2.3 $2.6
Cardiovascular ($USD Millions)$0.6 $0.5 $0.3

KPIs

KPIQ3 2024Q4 2024Q1 2025
EluPro share of BioEnvelope25% >30% ~52%
VAC approvals (actively ordering)36 accounts ~100 accounts >125 approvals; hospitals actively ordering
GPO contractsIn discussions; VA expected early 2025 4 (incl. Premier, S3P) 7 total after Q1

Estimates vs Actuals (S&P Global consensus)

MetricQ1 2025 ConsensusQ1 2025 Actual
Revenue ($USD Millions)$6.65*$6.03
Primary EPS ($)$(0.205)*$(0.21)
Revenue - # of Estimates2*—
Primary EPS - # of Estimates2*—

Values with asterisk (*) retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY 2025None providedNo formal guidance; focus on EluPro top-line growth via VAC/GPO expansion and BSC partnership Maintained no formal guidance
Gross Margin (Adjusted)FY 2025None providedManagement expects improvement driven by EluPro manufacturing efficiencies and capturing full top-line Cardiovascular revenue Qualitative improvement
Cash InterestQ2 2025N/ASWK amendment allows full PIK of May interest; potential access to $5M term loan Improved cash preservation
RoyaltiesH1 2025Cash payments dueLigand royalties (~$2.2M) satisfied in stock for H1, reducing cash outflows Improved cash preservation

Note: Company does not provide formal numerical revenue/EPS guidance .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
EluPro adoptionFirst implant; 25% of BioEnvelope; registry started; strong VAC pipeline -Pilot launch success; ~30% of BioEnvelope; same-center sales +65%; ~100 active ordering accounts 84% sequential growth; ~52% of BioEnvelope; >125 VAC approvals; national marketing push (HRS) Accelerating
Boston Scientific partnershipIn discussions; planned for full launch Jan’25 Agreement “shortly”; rollout planned; 900 reps Active: training complete; >50 hospitals selling via BSC; combined footprint >900 reps Ramping
Manufacturing capacity/costsSite cleared; scaling; 70%+ gross margin target -Roswell capacity ~$140M; scaling testing labs Antibiotic disc bottleneck; Gaithersburg GMP facility to remove constraint and lower COGS; capacity target unchanged Improving capacity; cost down
SimpliDerm distribution+19% YoY; growing Disruption from Sientra bankruptcy; transition to Tiger; plan to expand own distribution Q1 up ~13% vs Q4; exploring strategic alternatives for SimpliDerm Stabilizing; strategic review
Cardiovascular portfolioDistributor-led, declining Distributed via LeMaitre; lower sales Regained full commercial rights; expect ~80% GM and immediate positive cash flow contribution Positive shift
Litigation (FiberCel/VBM)Liability high; ongoing Settled many cases; liability reduced; more work ahead Q1 litigation costs $2.6M; activity to decline after Q2 for committed items Progressing downward

Management Commentary

  • “EluPro jumped 84% from the fourth quarter to the first quarter and now constitutes 52% of our BioEnvelope revenue” – CEO Randy Mills .
  • “Boston Scientific reps… are already generating sales at over 52 hospitals” – CEO Randy Mills .
  • “Our Roswell, Georgia facility… has capacity to do about $140 million in revenue of EluPro at about a 70%-plus gross margin… [new Gaithersburg facility] removes the bottleneck and significantly reduce[s] the cost of goods” – CEO Randy Mills .
  • “Adjusted gross margin… 54.8%… we believe… will [improve]… as we make efficiencies… and [capture] direct revenue on the Cardiovascular side” – CFO Matthew Ferguson .
  • “SWK… includes… potential term loan… $5 million… and a deferral of… cash interest… [Ligand] payments for the first half… in stock… eliminates… $2.2 million [cash]” – CFO Matthew Ferguson .

Q&A Highlights

  • Boston Scientific adoption cadence: physicians often begin with trial cases then spread usage across their broader practice (including non-BSC pacemaker brands); BSC reps help both VAC approvals and in-procedure adoption .
  • Capacity constraints and remedy: Roswell can support ~$140M EluPro revenue, but antibiotic disc supply constrained capacity to ~$25–$30M annually until Gaithersburg comes online .
  • Cash burn trajectory: Q1 operating cash flow reflects ~$8M outflow, including ~$4M litigation settlements; management expects decline after Q2 toward historical $4–$5M per quarter .
  • Clinical/regulatory: real-world registry will support commercial conversion and EU/ OUS regulatory pathways, with impactful publications targeted in H2 next year .
  • Mix shift: EluPro expected to increasingly dominate BioEnvelope revenue while CanGaroo remains for specific indications; EluPro share rose from ~32% in Q4 to >50% in Q1 .

Estimates Context

  • Revenue missed consensus by ~9% ($6.03M actual vs $6.65M estimate*), driven by SimpliDerm (-$1.0M YoY) and Cardiovascular (-$0.5M YoY) declines despite BioEnvelope strength .
  • EPS roughly in line to slightly worse (diluted -$0.21 actual vs -$0.205 estimate*), with margin compression (GAAP GM 40.7%) and product mix as headwinds; operating expenses declined YoY by ~$0.9M .
  • Forward estimates point to continued revenue growth in Q2–Q3 2025 (consensus ~$6.55–$6.65M*), contingent on BSC ramp and VAC additions; estimate counts remain thin (two contributors), increasing forecast uncertainty*.

Values with asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

  • EluPro is the core growth engine; BSC’s 900-rep footprint and >50 active hospital sales should drive accelerated adoption in Q2/Q3—key stock catalyst tied to VAC and training throughput .
  • Near-term revenue volatility persists given SimpliDerm and Cardiovascular transitions, but Cardiovascular insourcing (80% GM) and manufacturing cost reductions should support margin improvement .
  • Liquidity profile improved: equity raise, SWK PIK, and Ligand equity settlement collectively reduce cash outflows and add optionality for scaling inventory and capacity .
  • Watch adjusted gross margin trajectory; management targets mid-70% gross margins for EluPro with internal antibiotic disc production—an inflection lever for profitability .
  • Estimate dispersion is low (two contributors), increasing sensitivity to execution updates on BSC rollout, VAC approvals (~10–12 per month), and OUS pathways (registry data) .
  • Litigation overhang is diminishing; expect lower cash burn post-Q2 as settlements roll off—reducing a key risk to funding growth .
  • Strategic options for SimpliDerm under review; updates could unlock value or reduce operational complexity—monitor for announcements .