Executive Summary

Q4 2024 revenue was $5.47M, down 7% year-over-year; BioEnvelope sales rose 18% to $2.70M on the pilot launch of EluPro, while SimpliDerm fell 23% to $2.27M and Cardiovascular declined 20% to $0.50M . GAAP gross margin improved to 42.5% (from 36.2% YoY); adjusted gross margin rose to 58.1% (from 50.6% YoY) .
Net loss from continuing operations narrowed to $(9.06)M (vs. $(15.22)M YoY) and adjusted EBITDA loss improved to $(3.75)M (vs. $(4.45)M YoY), reflecting mix and non-GAAP adjustments .
EluPro pilot generated strong traction: ~100 actively ordering accounts, 67 VAC approvals, EluPro accounting for ~30% of BioEnvelope sales, and same-center sales +65% after EluPro adoption; GPOs include Premier and S3P .
Liquidity bolstered post-quarter by ~$15M gross proceeds via a registered direct offering (Feb 4, 2025), a catalyst alongside anticipated Boston Scientific distribution rollout and continued VAC/GPO additions .

What Went Well and What Went Wrong

What Went Well

Strong EluPro uptake and commercial readiness: ~100 actively ordering accounts, 67 VAC approvals; EluPro already ~30% of BioEnvelope sales in Q4, with same-center sales +65% post-switch . “We are having a lot of success... obtaining hospital and GPO approvals” .
Margin progress: GAAP gross margin up to 42.5% (from 36.2% YoY) and adjusted gross margin to 58.1% (from 50.6% YoY) on mix and amortization-excluded non-GAAP metrics . CFO emphasized improved device protection margins (60%) and SimpliDerm at 55% in Q4 .
Distribution leverage: planned initiation of Boston Scientific’s ~900 rep network (“Shortly”), expected to accelerate access beyond Elutia’s direct/1099 coverage .

What Went Wrong

SimpliDerm softness: Q4 net sales fell 23% to $2.27M amid distributor transition (Sientra bankruptcy and integration at Tiger Aesthetics), with management working through “growing pains” and building proprietary distribution .
Cardiovascular decline: Q4 Cardiovascular sales decreased 20% to $0.50M as LeMaitre’s transition continues; annual Cardiovascular down 42% to $2.92M .
Cash usage elevated by litigation settlements; management highlighted resolving trial-risk 2025 cases and reducing outstanding case count, though forecasting remains difficult .

Financial Results

Consolidated and Profitability

Metric	Q2 2024	Q3 2024	Q4 2024
Net Sales ($USD Millions)	$6.29	$5.92	$5.47
GAAP Gross Margin (%)	44.5%	46.3%	42.5%
Adjusted Gross Margin (%)	58.0%	60.6%	58.1%
Total Operating Expenses ($USD Millions)	$11.31	$12.97	$10.76
Loss from Operations ($USD Millions)	$(8.51)	$(10.23)	$(8.43)
Net Income (Loss) from Continuing Ops ($USD Millions)	$(28.36)	$1.29	$(9.06)
Adjusted EBITDA ($USD Millions)	$(2.91)	$(2.91)	$(3.75)
EPS (Basic) ($)	$(1.14)	$0.03	$(0.26)
EPS (Diluted) ($)	$(1.14)	$(0.33)	$(0.26)

Segment Net Sales

Segment ($USD Millions)	Q2 2024	Q3 2024	Q4 2024
BioEnvelope (CanGaroo + EluPro)	$2.60	$2.30	$2.70
SimpliDerm (Women’s Health)	$2.60	$3.10	$2.27
Cardiovascular	$1.10	$0.60	$0.50
Total Net Sales	$6.29	$5.92	$5.47

KPIs and Operating Metrics

KPI	Q2 2024	Q3 2024	Q4 2024
Active BioEnvelope accounts (CanGaroo baseline)	~398 accounts	400+ referenced in call	400 baseline; EluPro 67 VAC approvals
EluPro Active Ordering Accounts	N/A	36	~100
EluPro share of BioEnvelope sales (%)	N/A	~25%	~30%
Same-center sales lift after EluPro (%)	N/A	N/A	+65%
Independent rep share of EluPro sales (%)	N/A	N/A	45% (press release) ; ~50% (call)
Cash Balance ($USD Millions)	$18.19	$25.74	$13.24

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY 2025	Not provided	Not provided	Maintained (no formal guidance)
Gross Margin	FY 2025	Not provided	Targeting >70% for EluPro over time (strategic aim)	Qualitative target (no formal guidance)
Operating Expenses	FY 2025	Not provided	Not provided	Maintained (no formal guidance)
Distribution	2025	N/A	Initiate Boston Scientific rollout “shortly”	New operational milestone

Note: Management reiterated they are not providing formal financial guidance; operational milestones emphasized instead .

Earnings Call Themes & Trends

Topic	Q-2 (Q2 2024)	Q-1 (Q3 2024)	Current Period (Q4 2024)	Trend
EluPro launch & adoption	FDA clearance; manufacturing start; VAC submissions initiated	First commercial use; ~25% of BioEnvelope; >100 VAC submissions; 36 accounts ordering	~30% of BioEnvelope; 67 VAC approvals; ~100 actively ordering; same-center +65%	Accelerating adoption
Distribution leverage	Elutia building hybrid sales team (26 reps)	Expanded sales presence (12 direct, 34 independent, 9 consultants)	Boston Scientific rollout to begin “shortly”	Step-change capacity pending
Margins	Adj. GM 58%	Adj. GM 61%	Adj. GM 58.1%; EluPro long-term GM “north of 70%” targeted	Improving structurally
SimpliDerm	Growth +7% YoY in Q2; distributor disruption	+19% YoY; recovery	Q4 –23% YoY; working through Tiger Aesthetics transition; building direct distribution	Volatile; rebuilding
Legal/litigation	FiberCel costs ongoing	Warrants revaluation impact; cases outstanding	Settlements reduced case count; liability reduction vs Q3; cash usage impact	De-risking over 2025
Manufacturing capacity	FDA inspection with no deficiencies; capacity base	Ramping production	Facility can support ~$140M EluPro; adding in-house disc manufacturing, test lab capacity	Scaling ahead of demand
GPO/VA	VAC packages compiled	>100 VAC; GPO discussions incl. VA	GPOs incl. Premier, S3P; ongoing additions	Broadening access

Management Commentary

“EluPro… accounted for about 30% of BioEnvelope sales [in Q4]… same center sales increased 65% when we flip into a new center.” – CEO Randy Mills .
“We are initiating the EluPro rollout with our distribution partner, Boston Scientific… their 900 reps could easily bury us in demand if we’re not careful.” – CEO Randy Mills .
“Our GAAP gross margin was 43%… adjusted gross margin 58%… 60% for Device Protection, 55% for SimpliDerm, 64% for Cardiovascular.” – CFO Matt Ferguson (Q4 call) .
“Completed our FDA site inspection… no deficiencies noted… manufacturing EluPro in the same facility… capacity to do about $140 million of EluPro sales.” – CEO Randy Mills .
“Independent reps accounted for 50% of EluPro sales in the quarter… economically very efficient way of generating these sales.” – CEO Randy Mills .

Q&A Highlights

Boston Scientific distribution: Agreement allows leveraging ~900 reps; rollout to commence “shortly”; structure pays nominal per-use commissions; designed to keep TYRX out of cases .
Account cadence: From ~400 CanGaroo accounts, ~100 now ordering EluPro; management expects VAC additions to moderate from ~15/month but Boston should pull forward access .
SimpliDerm plan: Disruption from Sientra bankruptcy; Tiger Aesthetics now holds agreement; Elutia building proprietary distribution; Q4 weakness seen as anomaly; expect changes to improve trajectory .
Litigation: Reduced case count (from 79 at Q3 to 43 unsettled at year-end); focus on settling to avoid costly trials; cash burn elevated in Q4 due to settlements .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 revenue, EPS, and EBITDA was unavailable at time of analysis due to data access limits; as a result, an estimates beat/miss comparison could not be provided. Management did not issue formal guidance .

Key Takeaways for Investors

EluPro ramp is the core driver: Expect further acceleration as VAC/GPO approvals expand and Boston Scientific distribution activates; watch for growth in EluPro share within BioEnvelope and repeat order velocity .
Margin trajectory improving: Adjusted gross margin held ~58–61% with a long-term EluPro target above 70%; scale and in-house disc manufacturing should aid COGS absorption .
SimpliDerm is a swing factor: Q4 softness tied to distributor transition; proprietary channel build could restore growth; monitor quarterly variability and distributor execution .
Liquidity improved: ~$15M capital raise post-quarter extends runway for commercial rollout and capacity investments; reduces financing overhang near term .
Legal de-risking underway: Settlements reducing case count and prospective trial exposure; continue to track contingent liabilities and insurance recoveries for FiberCel matters .
Near-term trading catalysts: Boston rollout updates, additional GPO wins, VAC adds, and EluPro usage data; Investor sentiment likely to track commercialization milestones .
Medium-term thesis: Penetration of pacemaker/defibrillator device protection and optionality in neurostim markets with high complication rates; strategic partnerships may broaden reach .

Citations: Q4 2024 8-K press release and financial tables ; Q4 2024 call transcript ; Q3 2024 8-K press release and call ; Q2 2024 8-K press release and call ; Financing 8-K (Feb 4, 2025) .

ELUTIA INC. (ELUT)·Q4 2024 Earnings Summary