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SeaStar Medical Holding Corp (ICU)·Q3 2024 Earnings Summary

Executive Summary

  • SeaStar Medical reported its first commercial revenue with $67,500 from direct QUELIMMUNE shipments; net loss narrowed year over year to $4.5M as the company shifted to a direct sales model expected to lift recognized revenue per unit 3–4x .
  • Clinical execution accelerated: NEUTRALIZE-AKI adult pivotal trial enrollment reached 59 subjects with a record October, and sites expanded to 12; interim analysis planned at 100 subjects .
  • Balance sheet improved: management eliminated more than $9M in long-term debt since the beginning of 2024 and ended Q3 with $2.1M cash; company currently has no long-term debt .
  • Additional catalyst: FDA granted Breakthrough Device Designation for SCD in chronic dialysis (fourth BDD across indications) and presented cost-effectiveness data (~$30,000 per hospitalization savings) supporting payer and provider adoption for pediatrics .
  • Wall Street consensus estimates were unavailable via S&P Global for Q3 2024 at time of analysis due to API limits; therefore, estimate comparisons could not be completed (see Estimates Context).

What Went Well and What Went Wrong

What Went Well

  • Commercial inflection: “we recognized $67,500 of revenue from shipping QUELIMMUNE directly to one end-user customer… Beginning in the fourth quarter, we are able to recognize 100% of the sales value to direct end-user customers as revenue,” and management targets “adding two to three or more hospital customers by 2024 yearend” .
  • Trial momentum: Enrollment reached 59 patients with 3 new centers in Q4 bringing sites to 12; record enrollment month in October and interim review at 100 subjects expected, pointing to accelerating execution in a 50x larger adult AKI market than pediatrics .
  • Deleveraging and unit economics: “elimination of more than $9 million in long-term debt since the beginning of 2024,” and “new direct sales model… increasing sales recognized per unit by three to four times,” supportive of margin and runway as revenue scales .

What Went Wrong

  • Revenue still de minimis and mixed channel dynamics: Q3 revenue was only $67.5k; shipments under the prior distributor agreement were not recognized and the agreement’s termination constrained recognized revenue during the quarter .
  • Liquidity tight with ongoing cash burn: Cash ended at $2.1M despite July financing; YTD operating cash outflow was $11.3M, underscoring continued external capital needs until revenue scales .
  • Operating expense pressure: R&D rose to $2.3M (vs. $1.1M YoY) on clinical costs; G&A rose to $2.2M (vs. $1.9M YoY) tied to a contract termination settlement, weighing on operating loss .

Financial Results

Quarterly trends (oldest → newest)

MetricQ1 2024Q2 2024Q3 2024
Revenue ($USD)$0 (implied by 9M=Q3 only) $0 (implied by 9M=Q3 only) $67,500
Net Loss ($USD Millions)$(12.697) $(3.236) $(4.478)
Diluted EPS ($)$(0.19) $(1.03) $(1.10)
R&D Expense ($USD Millions)$1.697 $2.334 $2.336
G&A Expense ($USD Millions)$2.253 $2.335 $2.188
Cash And Equivalents ($USD Millions)$5.019 $1.179 $2.082

Year-over-year comparison

MetricQ3 2023Q3 2024
Revenue ($USD)$0 $67,500
Net Loss ($USD Millions)$(7.232) $(4.478)
Diluted EPS ($)$(9.02) $(1.10)
R&D Expense ($USD Millions)$1.087 $2.336
G&A Expense ($USD Millions)$1.855 $2.188

Estimate comparison (Q3 2024)

MetricActualConsensusSurprise
Revenue ($USD)$67,500 N/AN/A
Diluted EPS ($)$(1.10) N/AN/A

Segment breakdown: Not applicable; SeaStar reports as a single operating focus with early commercial sales of QUELIMMUNE .

KPIs and operating metrics

KPIQ1 2024Q2 2024Q3 2024
QUELIMMUNE commercial statusPreparing initial sales; qualifying 5 children’s hospitals First commercial sales to distributor; first commercial patient treated in July Direct shipment to one end-user; distributor shipment not recognized; direct model from Q4
Hospitals targeted/addedTarget: 5 qualifying hospitals Robust rollout planned Q4’24 Target: add 2–3+ hospital customers by YE’24
Adult AKI enrollment (NEUTRALIZE-AKI)31 subjects; 8 sites 42 subjects; 9 sites 59 subjects; 12 sites; record Oct month
Regulatory milestonesHDE approval for pediatrics (Feb’24) CMS Category B coverage for adult trial BDD for chronic dialysis (4th designation)
Expected adult AKI PMA/launchPMA 2H’25; launch 1H’26 PMA 1H’26; launch 2H’26 PMA and launch in 2026
Cost-effectiveness (pediatrics)——~$30k savings per hospitalization presented at ASN
Debt and capitalSenior secured debt eliminated; cash $5.0M July raise $10M gross; debt reduction >$9M long-term debt eliminated YTD; no LT debt; cash $2.1M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Adult AKI PMA approval2025–2026PMA in 2H 2025; launch 1H 2026 PMA in 2026 Timing pushed out vs initial 2H’25 target
Adult AKI launch2026Launch 2H 2026 Launch in 2026 Window broadened (still 2026)
Pediatric commercial model2024Through distributor initially Direct sales to hospitals from Q4; recognize 100% of sales value Shifted to direct model (higher recognized revenue/unit)
Hospital additions (pediatrics)YE 2024Qualify 5 hospitals as first sites Add 2–3+ hospital customers by YE’24 Clarified numeric near-term adoption target
Trial economics2024—CMS Category B coverage for adult trial expenses Improves trial site adoption/cost profile

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was available; themes are drawn from company 8-K press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2024)Trend
Commercialization strategyQ1: Qualify 5 children’s hospitals; initial sales expected “in coming weeks” . Q2: First sales to distributor; first commercial patient; robust Q4 rollout .Direct sales model from Q4; recognized $67.5k revenue; target 2–3+ hospital customers by YE .Improving execution; pivot to direct revenue recognition
Reimbursement & economicsQ2: CMS Category B coverage for adult trial .Presented ~$30k hospitalization savings for pediatrics at ASN Kidney Week .Strengthening payor/provider case
Clinical enrollment (adult AKI)Q1: 31 subjects; 8 sites . Q2: 42 subjects; 9 sites .59 subjects; 12 sites; record October; interim at 100 .Accelerating
RegulatoryQ1: HDE (pediatrics) ; 2025 PMA target (adult) . Q2: PMA 1H’26; launch 2H’26 .BDD awarded for chronic dialysis (4th BDD) ; adult PMA/launch “2026” .Mixed (new BDD, broader PMA timeline)
Balance sheetQ1: Debt eliminated (senior secured); cash $5.0M .Q2: $10M gross raise; debt reduced .Q3: >$9M LT debt eliminated YTD; no LT debt; cash $2.1M .

Management Commentary

  • “We are delighted to report market demand and our first commercial sales of QUELIMMUNE… we recognized $67,500 of revenue from shipping QUELIMMUNE directly to one end-user customer… Beginning in the fourth quarter, we are able to recognize 100% of the sales value to direct end-user customers as revenue… goal of adding two to three or more hospital customers by 2024 yearend.” — CEO, Eric Schlorff .
  • “The adult AKI patient population is 50 times larger than the pediatric population… NEUTRALIZE-AKI pivotal trial is gaining momentum with 59 subjects now enrolled… three new medical centers… increasing clinical sites to 12… moving us closer to the interim data review we anticipate at 100 subjects.” — CEO, Eric Schlorff .
  • “I’m pleased to report the elimination of more than $9 million in long-term debt since the beginning of 2024… our new direct sales model for QUELIMMUNE will have a dramatic impact on revenue by increasing sales recognized per unit by three to four times.” — CFO, David Green .

Q&A Highlights

  • No Q3 2024 earnings call transcript was available in the document set; management commentary is based on the 8-K press release .

Estimates Context

  • S&P Global consensus for Q3 2024 revenue and EPS was unavailable at time of analysis due to request limits, so we cannot provide a versus-consensus comparison for this quarter. We will update when S&P Global data is accessible.

Key Takeaways for Investors

  • Early commercial traction has started; the shift to direct sales should materially improve recognized revenue per unit (3–4x), providing operating leverage as hospital adoption scales .
  • Clinical catalysts are building: accelerated adult AKI enrollment and site activation set up an interim read at 100 patients; positive signals could be a stock-moving event .
  • The payer/provider case is strengthening with new economic data (~$30k per hospitalization savings) that can support hospital P&T approvals and budget impact analyses for pediatrics .
  • Regulatory momentum continues with a fourth Breakthrough Device Designation (chronic dialysis), expanding the long-term optionality beyond AKI .
  • Liquidity is tight and cash burn remains significant; despite deleveraging, near-term financing risk persists until revenue scales materially .
  • Near-term execution focus: converting targeted 2–3+ hospital additions by YE, demonstrating repeat utilization per patient (5–7 units on average), and broadening pediatric center adoption .
  • Timeline watch: adult AKI PMA and launch guidance consolidated to 2026; progress to interim analysis and any regulatory interactions will be key de-risking events .

Citations:

  • Q3 2024 8-K press release and financials .
  • Q2 2024 8-K press release and financials .
  • Q1 2024 8-K press release and financials .