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IC

IMMUCELL CORP /DE/ (ICCC)·Q1 2025 Earnings Summary

Executive Summary

  • Record quarter: revenue $8.07M (+11% y/y, +4% q/q), gross margin 42% (vs 37% in Q4), net income $1.45M ($0.16 diluted EPS) and Adjusted EBITDA $2.31M; cash rose to $4.60M, aided by a $0.43M insurance recovery .
  • Operational recovery continues: no new contamination events since Apr-2024; elevated output helped reduce backlog to $4.0M at 3/31 and further to $3.4M by 5/6, supporting near‑term sales visibility .
  • Mix and pricing tailwinds: Tri‑Shield share reached ~70% of Q1 sales; price increase (~6%) effective 1/1/25; management targets gross margin ≥45% as yields improve .
  • Re‑Tain: Investigational Product use to gather field feedback in 2H25; NADA review is pending resolution of the contract manufacturer’s FDA inspection observations—no near‑term revenue expected from this activity .
  • Key stock catalysts: pace of backlog conversion and margin expansion, FDA/CMO resolution for Re‑Tain, sustained contamination‑free production and evidence of normalized seasonality (Q1 is the seasonal high) .

What Went Well and What Went Wrong

  • What Went Well

    • Record sales and profitability: “Product sales… of $8.1 million set a record high… We also set a quarterly record for net income… approximately $1.4 million” .
    • Margin expansion: gross margin improved to 42% (vs 37% in Q4) as higher volumes leveraged fixed costs and yields improved .
    • Backlog reduction and cash build: backlog fell to $4.0M (3/31) and $3.4M (5/6); cash grew to $4.60M with no LOC draw .
  • What Went Wrong

    • Gross margin still below 45% target; management acknowledges “more work to do” to reach ≥45% as yields continue to normalize .
    • Re‑Tain timing remains constrained by CMO inspection issues; Investigational use won’t drive revenue and a supply pause is likely after initial lots .
    • Concentrated distribution and ongoing cost pressures: top two customers were 71% of receivables at Q1 end; inflation and supply costs continue to impact COGS .

Financial Results

MetricQ1 2024Q4 2024Q1 2025
Revenue ($M)$7.258 $7.751 $8.067
Gross Margin ($M)$2.296 $2.832 $3.354
Gross Margin (%)32% 37% 42%
Operating Income (Loss) ($M)($0.300) $0.622 $1.118
Net Income ($M)($0.438) $0.515 $1.447
Diluted EPS ($)($0.06) $0.06 $0.16
Adjusted EBITDA ($M)$0.458 $1.331 $2.305

Segment breakdown (Q1 2025):

  • Sales by segment and profitability
SegmentProduct Sales ($)Gross Margin ($)Net Operating Income (Loss) ($)
Scours (First Defense)8,028,486 3,353,943 2,473,321
Mastitis (incl. Re‑Tain)38,688 29 (698,404)
Other/Unallocated(657,293)

KPIs and operating drivers:

  • Mix: Tri‑Shield First Defense $5.669M (70% of Q1 sales) vs $4.055M (56%) in Q1’24; trailing twelve months $17.377M (64%) .
  • Backlog: $4.4M (12/31/24) → $4.0M (3/31/25) → $3.4M (5/6/25) .
  • Cash and liquidity: Cash $3.758M (12/31/24) → $4.599M (3/31/25); no LOC draws .
  • Other income: includes $426,587 insurance recovery in Q1 2025 .
  • Seasonality: Q1 is typically the seasonal high .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Gross Margin TargetOngoingNot specifiedManagement goal ≈45%+ as yields improve n/a
Product Development Expense (ex‑D&A)FY 2025~FY24 $2.53M actual (ex‑D&A) Target ≈$2.1M (Re‑Tain ≈$1.7M) Lowered
Interest Expense (ex amortization)FY 2025Not specified≈$452k; FY26 ≈$322k Initiated outlook
PricingEffective 1/1/2025Nov‑2023 action noted ~6% increase First Defense; ~7% CMT Implemented
Re‑Tain field plan2H 2025Controlled Launch pending approvals Investigational Product use; no significant revenue expected Revised approach
DividendsOngoingNoneNone mentioned Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Current Period (Q1 2025)Trend
Manufacturing recovery/contaminationNo new events since Apr‑2024; remediation in place Reinforced: >1 year without events; output increasing Improving
Gross margin trajectory36.5–37% in Q4; target >40% 42% achieved; target ~45%+ remains Improving
Backlog and capacityCapacity ≈$30M+; backlog high exiting 2024 Backlog reduced to $4.0M (3/31) and $3.4M (5/6) Improving
Product mix (Tri‑Shield)Mix benefits long‑term; margin WIP Tri‑Shield ~70% of Q1; volume leverages fixed costs Positive mix
Re‑Tain regulatory/CMONADA focused on CMC; contract manufacturer path FDA 483 at CMO in Apr; investigational use plan in 2H25 Delayed; interim field use
Capital strategy/ATMRaised ~$4.4M in 2024; cautious use Opportunistic ATM; less active recently Neutral
SeasonalityQ1 is seasonal high; backlog tempers seasonality Neutral

Management Commentary

  • “Product sales during the first quarter of 2025 of $8.1 million set a record high… We also set a quarterly record for net income… approximately $1.4 million” — Michael F. Brigham, CEO .
  • “The 42% gross margin… represented an improvement over… 37% recorded during fourth quarter of 2024” .
  • “We have not incurred another contamination event for over a year now” .
  • “We are moving ahead with Investigational Product use of Re‑Tain to collect market feedback… over the second half of 2025” .
  • “Adjusted EBITDA of $2.3M… compares very favorably to… $458k… last year” — Tim Fiori, CFO .

Q&A Highlights

  • Mix and margin: Management noted Tri‑Shield at ~70% of Q1 sales and explained margin gains mainly from higher volumes over largely fixed costs; they still price by format cost and see room to improve yields .
  • Near‑term outlook: Backlog fell to $3.4M by 5/6; management refrained from numeric guidance but expects better y/y EBITDA as comps normalize and sales shift from allocation to growth mode .
  • Re‑Tain path: Investigational use begins late Q2–Q3 to gather field data while CMO resolves FDA observations; this will not generate revenue but informs launch planning .
  • Capital/dilution: ATM now used opportunistically after heavier 2024 issuance; profitability reduces urgency though broader capital needs (debt, capex) are considered .

Estimates Context

  • No S&P Global Wall Street consensus EPS or revenue estimates were available for ICCC for Q1 2025 or forward quarters; consequently, no vs‑consensus comparisons are presented. Management also highlighted absence of third‑party analyst coverage at present .

Key Takeaways for Investors

  • Execution inflecting: contamination‑free operations, record revenue, and 42% gross margin point to sustainable recovery; watch for progression toward the ~45% margin target via yields and throughput .
  • Mix and pricing should support margins: Tri‑Shield penetration (~70%) and 2025 price increases are tailwinds; monitor if mix strength persists into seasonally softer quarters .
  • Backlog conversion is a near‑term growth lever: backlog reduced to $3.4M by May 6; robust production should translate to continued q/q sales resilience even post‑seasonality .
  • Re‑Tain remains a medium‑term optionality: FDA/CMO resolution is the gating item; investigational use provides market feedback but no revenue—plan for a pause after initial lots unless fill solution is secured .
  • Balance sheet/liquidity improving: cash up, operating cash flow positive, no LOC draws; interest expense outlook manageable though debt service remains a watch item .
  • Stock catalysts: 1) further margin expansion toward 45%; 2) additional backlog drawdown; 3) FDA/CMO inspection clearance and NADA visibility; 4) updates on bulk powder format and segment expansion .