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SeaStar Medical Holding Corp (ICU)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $0.067M with net loss of $4.419M and EPS of $(0.90), reflecting an early-stage, lumpy commercial launch of QUELIMMUNE; five pediatric hospitals are activated and management emphasized tracking adoption progress over near-term sales predictability .
  • Versus S&P Global consensus, revenue missed ($0.067M vs $0.150M*) while EPS was essentially in line ($(0.90) vs $(0.89)*); coverage is thin (one estimate), limiting statistical significance (Values retrieved from S&P Global).
  • No formal revenue or margin guidance; management will provide adoption metrics and expects interim analysis after 100 adult AKI patients (likely July/Aug 2025) and maintains adult AKI PMA approval/launch timing in 2H 2026 .
  • Balance sheet strengthened in 2024 with capital raised and deleveraging; year-end cash was $1.819M (excludes $6M raised on Feb 3, 2025), and management noted ~$25M raised in 2024 to support commercialization and pivotal trial execution .

What Went Well and What Went Wrong

What Went Well

  • QUELIMMUNE launch and early adoption: five hospital customers activated; management reported strong clinical feedback and doubling of the adoption pipeline from Q3 to Q4 2024, with additional increases in early 2025 . “We are thrilled with the feedback to date from our first commercial customers…we expect customers to expand their use of QUELIMMUNE” .
  • Clinical execution: NEUTRALIZE-AKI pivotal trial enrollment reached 94/200 with new site activations; citrate shortage resolved; interim analysis targeted after 100 patients reach 90-day endpoint . “We anticipate a steady, if not accelerated pace of enrollment through the rest of the year” .
  • Strategic/financial progress: fourth FDA Breakthrough Device Designation, CMS Category B coverage supporting trial costs, NKF 2025 Corporate Innovator Award; balance sheet deleveraging and capital raises support operations .

What Went Wrong

  • Revenue below consensus and sequential softness: Q4 revenue $0.067M vs $0.068M in Q3, missing the $0.150M* consensus; management emphasized sales will be “lumpy” given IRB/registry activation timelines .
  • Limited cash at year-end: cash was $1.819M at 12/31/2024 (before the $6M Feb 2025 financing), underscoring reliance on external funding to execute commercialization and trials .
  • Operating expenses rising and losses persist: R&D and G&A increased YoY; FY 2024 net loss was $24.830M, with ~$6.9M of non-cash items, still requiring disciplined spend and financing visibility .

Financial Results

Q4 2024 Actual vs Consensus and Prior Year

MetricQ4 2023Q4 2024 ActualQ4 2024 ConsensusCoverage
Revenue ($USD Millions)$0.000 $0.067 $0.150*1 estimate*
EPS ($USD)$(6.17) $(0.90) $(0.89)*1 estimate*

Values retrieved from S&P Global.*

Quarterly Trend (oldest → newest)

MetricQ2 2024Q3 2024Q4 2024
Net Revenue ($USD Millions)N/A (no net revenue line presented) $0.068 $0.067
R&D Expense ($USD Millions)$2.334 $2.336 $2.738
G&A Expense ($USD Millions)$2.335 $2.188 $2.096
Net Loss ($USD Millions)$(3.236) $(4.478) $(4.419)
EPS ($USD)$(1.03) $(1.10) $(0.90)
Cash, End of Period ($USD Millions)$1.179 $2.082 $1.819

Footnote: Q2 2024 press release and statements reference initial commercial shipments but did not report net revenue on the face of the quarterly statement .

FY 2024 Summary

MetricFY 2024
Net Revenue ($USD Millions)$0.135
Net Loss ($USD Millions)$(24.830)
EPS ($USD)$(6.63)
Cash at 12/31/2024 ($USD Millions)$1.819
Post-period Financing (Feb 3, 2025)$6.000M raised

KPIs

KPIQ4 2024 Status
QUELIMMUNE activated pediatric hospital customers5
Pediatric adoption pipelineDoubled from Q3 to Q4 2024
NEUTRALIZE-AKI pivotal trial enrollment94 of 200
New adult AKI trial sites (early 2025)+2 sites activated
Breakthrough Device Designations4 indications
NKF 2025 Corporate Innovator AwardAwarded March 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Revenue (Commercial QUELIMMUNE)FY 2025None providedNo formal guidance; will report adoption metrics and internal targets only Maintained: no formal guidance
Adult AKI PMA approval/launch2H 2026PMA approval 1H 2026, launch 2H 2026 (earlier messaging) PMA filing post-trial; availability in 2H 2026, subject to FDA review Maintained timing to 2H 2026
Adult AKI interim analysis timingMid-2025Interim after 100 patients (design feature) 100th enrollment expected April 2025; DSMB review and readout around July/Aug 2025 New specific timing color
Cost of Goods recognition2025N/AGAAP COGS to begin as new commercial inventory is produced/sold; none recognized for pre-approval inventory Clarified accounting timing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2, Q3)Current Period (Q4)Trend
Commercial modelDistribution partner used in Q2; shift to direct sales in Q3 to recognize full revenue value Direct sales model in place; five customers activated; pipeline doubled; lumpy sales expected Improving adoption, more control over sales cycle
Trial funding and operationsCMS Category B coverage obtained to offset site costs; 42 enrolled in Q2; 59 in Q3 with record October 94 enrolled; 2 new sites; citrate shortage resolved; interim DSMB review targeted mid-2025 Accelerating enrollment, operational bottlenecks easing
Regulatory statusFDA HDE approval (pediatric); Breakthrough designations in cardiorenal and hepatorenal; pursuing PMA for adult AKI Fourth Breakthrough Device Designation (chronic dialysis); feasibility study approved for cardiorenal bridge-to-LVAD Expanding indications, regulatory momentum
Financial positionCapital raise in July; debt eliminated by Q3; cash $2.082M at 9/30 ~$25M raised in 2024; $6M added in Feb 2025; cash $1.819M at 12/31 Strengthened capital base, but modest cash at year-end
Clinical/medical validationPublications/presentations (Transplantation Direct; Nature Scientific Reports; ASN Kidney Week) Continued publications; strong clinical case outcomes cited by CEO; NKF Corporate Innovator Award Building external validation and awareness

Management Commentary

  • “Our significant accomplishment in 2024 position us well for a transformational year in 2025…we received our first product approval for QUELIMMUNE and began our commercial launch…added 14 new clinical sites for our NEUTRALIZE AKI pivotal clinical trial” — Eric Schlorff, CEO .
  • “We intend to provide updates on the number of customers working through the IRB adoption process…we are not providing guidance due to uncertainties that are inherent in launching a product” — Eric Schlorff, CEO .
  • “We substantially improved the balance sheet by adding new capital and reducing debt and other liabilities…we raised approximately $25,000,000…and ended the year with $1,800,000 in cash” — David Green, CFO .
  • “I am pleased to report that our NEUTRALIZE-AKI pivotal trial continues at a steady enrollment pace with 94 of our anticipated 200 subjects enrolled” — Kevin Chung, CMO .

Q&A Highlights

  • Timing of interim analysis: Management expects reaching 100 enrolled in April 2025; 90-day endpoint would place DSMB review and interim data around July/August 2025 .
  • Sales force and activation learnings: Current staffing viewed as “right-sized”; activation hinges on complex IRB plus post-approval registry setup; unit-level training support provided by clinical nurses .
  • IRB process decoupling: FDA encouraged treatment even if registry is not yet active to save a child’s life; this may enable sales prior to full registry activation at a site .
  • Activation efficiency: Bringing ICU physicians and nephrologists into the process early is a “big time saver” .

Estimates Context

  • Q4 2024 revenue missed consensus ($0.067M actual vs $0.150M*), while EPS was almost in line (actual $(0.90) vs $(0.89)); coverage is minimal (one estimate), limiting signal quality. Values retrieved from S&P Global.
  • FY 2024 revenue ($0.135M) was below the $0.218M* consensus. Values retrieved from S&P Global.*
  • Given the early-stage launch with lumpy sales due to IRB/post-approval registry activation, near-term estimate revisions may hinge on disclosed adoption metrics and cadence of new hospital activations .

Key Takeaways for Investors

  • Commercial traction is building in pediatrics with five activated hospitals and a growing adoption pipeline, but quarterly revenue will remain lumpy until more sites complete IRB/registry processes .
  • The mid-2025 interim analysis for adult AKI is the principal near-term catalyst; positive DSMB feedback could de-risk the path to a 2H 2026 PMA approval and launch .
  • Revenue missed consensus while EPS was essentially in line; with limited analyst coverage and nascent sales, monitoring hospital activations and registry progress is more informative than quarter-to-quarter prints (Values retrieved from S&P Global).* .
  • Balance sheet improved with capital raises and debt reduction, but year-end cash was modest; continued access to capital remains important to fund commercialization and pivotal trials .
  • Regulatory momentum (four Breakthrough Device Designations, CMS trial coverage, NKF award) strengthens the platform’s credibility and potential reimbursement positioning at commercial launch .
  • Accounting note: No GAAP COGS recognized yet due to pre-approval inventory; COGS will begin appearing as new commercial inventory is produced/sold later in 2025, affecting gross margin optics .
  • Trading implications: Near-term stock moves likely tied to site activations/adoption updates and interim analysis timing; medium-term thesis rests on adult AKI efficacy readout and scaling across broader inflammatory indications .

Additional Document Notes

  • Q4 2024 8-K 2.02 and press release read in full, including financial tables .
  • Q4 2024 earnings call transcript read in full -.
  • No independent company press releases found in Q4 2024; relevant post-period press release: NKF Corporate Innovator Award (March 18, 2025) .
  • Prior quarters reviewed: Q3 2024 8-K 2.02 and press release (financials, business update) -; Q2 2024 8-K 2.02 and press release (financials, business update) -.