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Adagio Medical Holdings, Inc. (ADGM)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered no revenue and a net loss of $7.7M (−$0.50 basic EPS), with disciplined OpEx: R&D $3.7M (+6% YoY) and SG&A $3.5M (−27% YoY) as management prioritized clinical and product optimization initiatives .
  • Cash and equivalents declined to $13.0M from $20.6M in Q4 and $28.3M in Q3, reflecting operating burn and a pivot away from the limited EU launch to focus on the U.S. pivotal program .
  • Strategic catalysts: FDA Breakthrough Device Designation for vCLAS, and FULCRUM‑VT pivotal study enrollment surpassed 50%; enrollment completion remains targeted for 2H 2025 .
  • Prior quarter volatility stemmed from Q4 impairment ($49.2M) driving unusually high OpEx and net loss; Q1 reflects normalized spend and tightened SG&A, which should improve cash efficiency near term .
  • No earnings call transcript or S&P Global consensus estimates were available for EPS/revenue; investor focus should remain on clinical milestones, regulatory pathway, and cash management [GetEstimates]*.

What Went Well and What Went Wrong

What Went Well

  • FDA Breakthrough Device Designation for vCLAS, potentially enabling priority review and interactive FDA communication during the review phase .
  • FULCRUM‑VT pivotal study surpassed 50% enrollment; enrollment completion still targeted for 2H 2025, underscoring operational execution in trial recruitment .
  • SG&A reduced to $3.5M from $4.8M YoY as the company implemented corporate prioritization to focus resources on pivotal trial and product design optimization: “This has been a defining quarter… the continued momentum in enrolling patients in our FULCRUM‑VT trial all underscore the clinical promise and growing validation of our proprietary ULTC platform technology” — Todd Usen, CEO .

What Went Wrong

  • No Q1 revenue; cost of revenue persisted at $0.3M due to ongoing activity despite pause in EU launch, highlighting near‑term commercialization constraints .
  • Cash declined to $13.0M from $20.6M in Q4 and $28.3M in Q3, emphasizing the need for careful liquidity management while advancing pivotal study and product optimization .
  • Management turnover: CFO resigned effective March 21, 2025, with a transitional CFO stepping in, adding execution risk during a critical clinical phase .

Financial Results

Quarterly Trends (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Thousands)$185 $137 $0
Net Loss ($USD Millions)$4.6 $57.4 $7.7
Cash & Equivalents ($USD Millions)$28.3 $20.6 $13.0
Gross Margin (%)−209% −1012% n/a

Q1 2025 vs Prior Year (YoY)

MetricQ1 2024Q1 2025
Revenue ($USD Thousands)$26 $0
Cost of Revenue ($USD Thousands)$542 $253
R&D ($USD Millions)$3.5 $3.7
SG&A ($USD Millions)$4.8 $3.5
Net Loss ($USD Millions)$8.0 $7.7
Basic EPS ($)$(10.28) $(0.50)

Notes:

  • Q4 2024 OpEx and net loss were distorted by a $49.2M impairment charge, explaining the sequential volatility into Q1 .

Segment Breakdown

  • No segment reporting disclosed in the Q1 2025 press materials .

KPIs and Operational Metrics

KPIQ3 2024Q4 2024Q1 2025
FULCRUM‑VT Enrollment ProgressInitiated; early procedures reported >40% enrolled >50% enrolled; on‑track for 2H 2025 completion
vCLAS EU CommercializationExpanding cases across centers Introduction in Europe cited Limited EU launch paused to prioritize U.S. pivotal and design optimization
Regulatory MilestonesCMS Category B coverage for U.S. pivotal (Sept 2024) —FDA Breakthrough Device Designation

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FULCRUM‑VT Enrollment Completion2025On track for completion 2H 2025 On track for completion 2H 2025 Maintained
vCLAS EU Launch Status2025Limited EU introduction cited Limited EU launch paused pending product design optimization Lowered/Paused
Regulatory Pathway (U.S.)2025Pivotal IDE supports PMA filing Breakthrough Device Designation may enable priority review and interactive communication Enhanced pathway

No numeric revenue/margin/tax/OpEx guidance provided in Q1 materials .

Earnings Call Themes & Trends

No earnings call transcript was available for Q1 2025.

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
VT Pivotal Trial ExecutionCMS Category B coverage and first procedures; >40% enrolled by Q4 >50% enrolled; H2 2025 completion targeted Improving cadence
RegulatoryU.S. PMA path via pivotal trial FDA Breakthrough Device Designation Strengthening
Commercialization (EU)Growing EU cases, introduction of vCLAS EU limited launch paused to focus on optimization Paused/Refocused
Product Design Optimization—Formal prioritization to accelerate iteration New emphasis
Management/OrgPublic listing and PIPE close (Q3); normal course CFO resignation; transitional CFO in place Transition risk

Management Commentary

  • “This has been a defining quarter for Adagio Medical… the FDA’s Breakthrough Device Designation… and the continued momentum in enrolling patients in our FULCRUM‑VT trial all underscore the clinical promise and growing validation of our proprietary ULTC platform technology.” — Todd Usen, CEO .
  • “After a comprehensive strategic review, we are doubling down on the priorities that will drive the most meaningful impact… With over 35% enrollment complete, we… are very encouraged by the system’s performance and early outcomes… [and] product design optimization program.” — Todd Usen, CEO (restructuring) .
  • “I’m extremely pleased with the FULCRUM‑VT enrollment progress and the expanded use of the vCLAS™ catheter by European thought leaders… We are confident we have the financial resources and the corporate structure to achieve our goals…” — Todd Usen, CEO (business updates) .

Q&A Highlights

  • No Q1 2025 earnings call transcript filed; Q&A details are unavailable.

Estimates Context

Consensus from S&P Global was not available for ADGM’s Q1 2025 EPS or revenue; coverage appears limited for this micro‑cap medical device issuer [GetEstimates]*.

MetricQ3 2024Q4 2024Q1 2025
EPS Consensus Mean ($)n/a*n/a*n/a*
Revenue Consensus Mean ($)n/a*n/a*n/a*
Primary EPS – # of Estimatesn/a*n/a*n/a*
Revenue – # of Estimatesn/a*n/a*n/a*

*Values retrieved from S&P Global. No consensus values were available.

Key Takeaways for Investors

  • Regulatory momentum is a key upside catalyst: Breakthrough Device Designation can accelerate PMA review dynamics and lowers regulatory risk on the path to U.S. approval .
  • Clinical execution remains strong: >50% FULCRUM‑VT enrollment and H2 2025 completion target underpin the thesis; watch for site activations and enrollment cadence updates .
  • Commercial strategy has refocused: Pause of EU limited launch reallocates resources to product iteration and U.S. pivotal milestones; near‑term revenue will likely stay minimal .
  • Cost discipline is visible: SG&A materially down YoY and normalized OpEx post Q4 impairment; monitor quarterly burn vs. cash to assess runway adequacy .
  • Management transitions introduce execution risk: CFO departure mid‑pivot elevates need for tight financial controls and investor communications .
  • Trading implications near term: Stock likely driven by clinical/regulatory headlines (enrollment milestones, FDA interactions) rather than fundamentals, given no Q1 revenue and limited sell‑side coverage [GetEstimates]*.
  • Medium‑term thesis: If pivotal outcomes and PMA progress align, vCLAS could address a large, underserved VT market; product optimization could enhance adoption post‑approval, supporting a durable commercialization curve .