Executive Summary

Q4 2024 marked a strong inflection: revenue rose to $7.75M, gross margin improved to 37%, and the company returned to profitability with $0.06 diluted EPS and ~$1.33M EBITDA, driven by higher output and better yields after resolving contamination issues since April 2024 .
Full-year 2024 product sales grew 52% to ~$26.5M, while Q4 sales annualized indicate ~$30M+ production capacity now achievable; order backlog was worked down materially entering 2025 .
Management reiterated focus on margin recovery (targeting 40%+ gross margin over time), yield improvement, and a 2025 price increase tailwind; contamination remediation and throughput gains are the core levers .
Regulatory: Re-Tain moved forward with the Non-Administrative NADA submission in early January 2025 and pending FDA clearance of contract manufacturer observations; management is seeking expedited review and evaluating strategic options to support launch .
Estimates: S&P Global/Capital IQ consensus for Q4 2024 was unavailable in our data pull; no beat/miss vs. Street provided. We show detailed sequential and YoY comparisons vs. prior periods and company commentary instead.

What Went Well and What Went Wrong

What Went Well

Material re-acceleration and operating turn: Q4 revenue up to $7.75M (+52% YoY) with gross margin up to 37% (vs. 25% LY), flipping to net income of $0.515M ($0.06) and ~$1.33M EBITDA; full-year EBITDA also positive at ~$1.11M .
Manufacturing remediation progress: No contamination events since April 2024; management believes processes now keep bioburden within spec, supporting sustainable throughput and yield improvements .
Capacity and demand: Q4 sales suggest ~$30M+ annual production capacity; backlog reduced to ~$4.4M by 1/1/25 as distributors replenish inventories ahead of peak season .

What Went Wrong

Gross margin remains below target: Despite progress to ~36.5–37% in Q4, management’s long-term goal is >40%; mix (Tri‑Shield is costlier), inflation and yield variability remain headwinds .
Prior-period disruptions still echo: 2023–early 2024 contamination and remediation created scrap and constrained output, contributing to depressed margins and elevated WIP inventories that are still being managed down and repurposed .
Regulatory timing uncertainty: Re-Tain approval timing depends on FDA disposition of contract manufacturer observations and review of the January 2025 NADA; management seeks expedited handling but cannot guide timing .

Financial Results

Quarterly P&L and EBITDA progression

Metric	Q2 2024	Q3 2024	Q4 2024
Revenue ($USD Millions)	$5.473	$6.012	$7.751
Gross Margin %	22%	26%	37%
Net Income (Loss) ($USD Millions)	($1.532)	($0.702)	$0.515
Diluted EPS ($USD)	($0.20)	($0.09)	$0.06
EBITDA ($USD Millions)	($0.717)	$0.119	$1.331

Notes:

YoY Q4: revenue +52% to $7.8M; gross margin 37% vs. 25%; EPS $0.06 vs. ($0.15) .
Sequential Q4 vs Q3: revenue increased from $6.012M to $7.751M as output normalized and backlog conversion improved .

Q4 2024 YoY comparison (headline)

Metric	Q4 2023	Q4 2024
Revenue ($USD Millions)	$5.096	$7.751
Gross Margin %	25%	37%
Net Income (Loss) ($USD Millions)	($1.140)	$0.515
Diluted EPS ($USD)	($0.15)	$0.06
EBITDA ($USD Millions)	($0.311)	$1.331

Segment breakdown: ImmuCell does not report revenue by segment in these releases; product mix commentary indicates Tri‑Shield adoption is driving growth but at higher unit cost than the bolus format .

KPIs and Balance Sheet Trends

KPI	Q2 2024	Q3 2024	Q4 2024
Cash & Equivalents ($M)	$1.324 (6/30)	$3.809 (9/30)	$3.758 (12/31)
Net Working Capital ($M)	$6.237 (6/30)	$9.422 (9/30)	$10.631 (12/31)
Stockholders’ Equity ($M)	$23.455 (6/30)	$26.412 (9/30)	$27.518 (12/31)
Backlog ($M, approx date)	$7.9 (Aug 6)	$6.8 (Oct 30)	$4.4 (Jan 1, 2025)
Capacity Utilization	~85% annualized in 1H24	—	~103% of $30M capacity annualized in Q4

Non-GAAP: EBITDA reconciliations provided by the company; includes interest, depreciation, amortization addbacks (see exhibits) .

Guidance Changes

Metric/Item	Period	Previous Guidance/Commentary	Current Guidance/Commentary	Change
Gross Margin Target	Multi‑quarter	Target 35–40% over time	Target “over 40%” over time; Q4 at ~36.5–37% with 2025 price increase and yield/throughput improvement expected to help	Reframed upward emphasis
Production Capacity	Ongoing	Full capacity ~$30M p.a.; objective ≥$12M finished goods per six months (~80%+)	Q4 sales suggest ~$30M+ annual production capacity achieved	Achieved/maintained
Re‑Tain Regulatory	2024–2025	Await contract manufacturer observation resolution; plan NADA resubmission; seeking expedited review	Non‑Administrative NADA submitted early Jan 2025; Controlled Launch pending FDA clearance and review; seeking expedited review	Advanced filing status
Product Development Spend	Near‑term	Reducing R&D as Re‑Tain awaits approval; maintain “aggressive idle” readiness	Continuing to reduce product development expenses while awaiting approval; exploring strategic options to enhance launch	Maintained direction
Revenue/Margins/OpEx Numeric Guidance	—	None provided	None provided	No formal guidance

Earnings Call Themes & Trends

Topic	Q2 2024 (Aug)	Q3 2024 (Nov)	Q4 2024 (Feb)	Trend
Manufacturing remediation	Disclosed contamination root causes (bioburden, process heat/yield trade-offs); no events since April; yield programs underway	Continued no contamination since April; optimizing parameters within USDA outline	Still no events since April; focus on yield/throughput to lift margins	Improving stability
Gross margin trajectory	28% in 1H24; below 40% target; identified 17% and 5% yield improvement levers in process steps	26% in Q3; reiterated 35–40% target with mix/yield inflation headwinds	~36.5–37% in Q4; target >40% with 2025 price increase and yield gains	Up and to the right
Backlog and demand	Backlog $7.9M (Aug 6); capacity ~85% annualized in 1H	Backlog $6.8M (Oct 30)	Backlog ~$4.4M (Jan 1, 2025); Q4 annualized ~103% of $30M capacity	Working down
Re‑Tain path	Awaiting DP CMO observation resolution; expedited review sought	Still pending; expectation for December submission by CMO; expedited review sought	Non‑Administrative NADA submitted Jan; Controlled Launch pending FDA actions	Milestone reached
Capital & liquidity	Frozen nonessential capex; no LOC draw	ATM used to bolster cash (~$3.8M by 9/30)	Cash ~$3.8M at 12/31; ATM raised ~$4.4M during 2024	Stabilized cash

Management Commentary

“The $7.8 million in sales recorded during the fourth quarter of 2024 suggests that we have achieved our goal of increasing annual production capacity to $30 million or more per year.”
“We have not incurred another contamination event since April of 2024… It suggests that we have effectively remediated the problem and are keeping the bioburden within specification.”
“The 36.5% gross margin… is a step in the right direction, but we still have some work to do to return to our target of over 40%.”
“The initiation of our Controlled Launch [of Re‑Tain] is pending FDA clearance of inspectional observations… and the FDA’s review of our Non‑Administrative NADA, which we submitted during early January of 2025… We have been in discussions with the FDA to seek an expedited review.”

Q&A Highlights

Gross margin path to >40%: Key levers are product mix management (Tri‑Shield is costlier but drives growth), 2025 pricing, throughput, and—critically—yield resumption to historical levels; contamination-driven scrap and remediation burden depressed prior margins .
Yield variability and operations: Biological variability persists; focus is “same work, more doses” through process optimization and equipment improvements across a six‑month cycle .
Inventory/WIP utilization: Elevated WIP partly from contracted colostrum amid disruptions; exploring a spray‑dried bulk powder format to monetize inventory via feed applications (no USDA claim), targeted for 2025 pilots to inform 2026+ .
Backlog trajectory: Management expects backlog reduction over “months,” complicated by peak seasonality, but higher output is accelerating progress .
Capital: ATM proceeds strengthened liquidity; future use depends on capital needs and share price; cash position “workable” at current levels .

Estimates Context

Wall Street consensus (S&P Global/Capital IQ): EPS, revenue, and EBITDA estimates for Q4 2024 and FY 2024 were unavailable in our data pull; as a result, beat/miss versus Street cannot be assessed in this report. We relied on company-reported actuals and sequential/YoY comparisons from filings and the call instead.
Where estimates become available, focus areas for potential revisions: gross margin trajectory (Q4 step-up to 37%), EBITDA inflection to positive, and production capacity normalization should drive upward adjustments to near-term profitability assumptions; Re‑Tain timing remains an uncertainty skew .

Key Takeaways for Investors

Operational recovery is taking hold: Q4 delivered positive EPS/EBITDA on accelerating revenue and margin, validating remediation and throughput improvements; sustaining yields is the linchpin to hitting >40% gross margin .
Backlog normalization underway into peak season; annualized Q4 output implies ~$30M+ capacity, supporting 2025 top‑line momentum if execution holds .
Product mix is a double‑edged sword: Tri‑Shield drives growth but compresses margin vs. bolus; pricing and yield improvements must offset mix headwinds to reach long‑term margin targets .
Liquidity improved via ATM; balance sheet metrics strengthened in 2H24, reducing near‑term financing risk while preserving optionality .
Re‑Tain is a major optionality catalyst: January NADA submission and pending FDA actions could unlock Controlled Launch; any clarity on expedited review is a stock‑moving event .
Watch for sustained contamination‑free operations, yield KPIs, and inventory monetization (spray‑dried bulk format) to support incremental margin and cash generation .
Without consensus benchmarks, trading setup leans on narrative momentum: continued margin expansion and regulatory updates are likely the primary near‑term catalysts.

Appendices

Other Relevant Press Releases

Preliminary Q4 and FY2024 sales: $7.8M (+52% YoY) and $26.5M (+52% YoY); Q4 output annualized at ~103% of $30M capacity; backlog ~$4.4M (Jan 1, 2025) .
Insurance claim settlement: $426,587 additional proceeds related to contamination events (on top of $250,000 recognized in Q3 2023) .

Source Documents

Q4 2024 8‑K with press release and full financials .
Q4 2024 earnings call transcript (Feb 26, 2025) .
Q3 2024 8‑K and call (Nov 2024) .
Q2 2024 8‑K and call (Aug 2024) .

IMMUCELL CORP /DE/ (ICCC)·Q4 2024 Earnings Summary