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Adagio Medical Holdings, Inc. (ADGM)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025: Zero revenue, net loss improved to $3.9M (basic EPS $(0.26), diluted $(0.35)) on materially lower R&D and SG&A, reflecting execution of a corporate prioritization initiative that reduced cash burn quarter-over-quarter .
  • Clinical execution remains the core catalyst: FULCRUM‑VT pivotal IDE crossed 85% enrollment, on track to complete in 2H 2025, sustaining the medium‑term PMA approval narrative and U.S. commercialization path .
  • Technology momentum: first‑in‑human PFCA results published, plus investor presentation highlighted a ~$5.8B VT ablation TAM and a two‑year competitive head start in purpose‑built VT systems (Europe commercial; U.S. investigational) .
  • No Wall Street consensus estimates available via S&P Global for Q2 2025; comparisons to “Street” are not possible at this time (coverage unavailable) .
  • Liquidity tightened: cash fell to $8.2M at quarter‑end vs $13.0M in Q1 and $20.6M at YE 2024; balance sheet includes $22.49M convertible notes payable, warrant overhang, and 15.38M shares outstanding—funding and dilution risk remain watchpoints .

What Went Well and What Went Wrong

What Went Well

  • FULCRUM‑VT enrollment surpassed 85%; management reaffirmed completion in 2H 2025, strengthening the path to potential FDA PMA submission for vCLAS in VT .
  • Operating discipline: R&D fell to $2.0M (from $3.7M in Q1 and $2.9M YoY), SG&A fell to $2.4M (from $3.5M in Q1 and $3.4M YoY), supporting improved net loss and reduced cash burn QoQ .
  • Strategic validation: first‑in‑human PFCA results published; investor materials outline a large VT TAM and favorable CE‑Mark clinical profile, reinforcing technology differentiation and commercial potential .
    • CEO: “continued strong momentum in the enrollment of our FULCRUM‑VT study… brings us one step closer to offering our proprietary ULTC solutions to patients in the United States” .

What Went Wrong

  • No recognized revenue in Q2, down from $0.254M in Q2 2024; ADGM remains pre‑commercial in the U.S., relying on clinical progress rather than sales to drive the story .
  • Cash decreased to $8.2M from $13.0M in Q1 and $20.6M at YE 2024, increasing near‑term financing risk amid ongoing clinical and product development spend .
  • Results benefited from non‑operating items (e.g., convertible notes fair value adjustment $1.427M), obscuring pure operating trajectory; total other income, net was $0.77M in Q2 .

Financial Results

Quarterly trend (oldest → newest)

MetricQ4 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.137 $0.000 $0.000
Cost of Revenue ($USD Millions)N/A$0.253 $0.342
Research & Development ($USD Millions)N/A$3.659 $1.971
SG&A ($USD Millions)N/A$3.485 $2.404
Total OpEx incl. CoR ($USD Millions)$56.7 $7.397 $4.717
Loss from Operations ($USD Millions)N/A$(7.397) $(4.717)
Total Other Income (Expense), net ($USD Millions)N/A$(0.316) $0.770
Net Loss ($USD Millions)$(57.4) $(7.713) $(3.947)
Basic EPS ($)N/A$(0.50) $(0.26)
Diluted EPS ($)N/A$(0.51) $(0.35)
Cash & Cash Equivalents ($USD Millions)$20.586 $12.963 $8.200
Gross Margin %(1,012)% N/AN/A

Year-over-year (Q2)

MetricQ2 2024Q2 2025
Revenue ($USD Millions)$0.254 $0.000
Cost of Revenue ($USD Millions)$0.682 $0.342
Research & Development ($USD Millions)$2.865 $1.971
SG&A ($USD Millions)$3.366 $2.404
Net Loss ($USD Millions)$(5.734) $(3.947)
Basic EPS ($)$(7.35) $(0.26)
Diluted EPS ($)$(7.35) $(0.35)

KPIs and Capitalization

KPIQ2 2025Notes
FULCRUM‑VT enrollment>85% Enrollment completion expected 2H 2025
Patients treated (cumulative)300+ CE‑Mark markets; U.S. investigational
Shares Outstanding (M)15.38As of 6/30/25
Convertible Notes Payable ($M)22.49Incl. accrued interest
Warrants (Base, $10 strike) (M)7.53Overhang
Warrants (Convert, $25 strike) (M)1.50Overhang
Cash & Cash Equivalents ($M)8.20 Liquidity watchpoint

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FULCRUM‑VT enrollment completion2H 2025“On track for completion in 2H 2025” (Q1 press release) “On track for completion in 2H 2025” (Q2 press release) Maintained
Cash burn trajectoryQ2 2025 vs Q1 2025N/AReduced cash burn QoQ due to prioritization initiative Improving
Financial guidance (Revenue/EPS/Margins)FY/Q3 2025None provided None provided N/A

Earnings Call Themes & Trends

No Q2 2025 earnings call transcript was found; analysis based on press releases and investor presentation .

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
Regulatory pathwayCE‑Mark achieved; FULCRUM‑VT IDE approved; Breakthrough Device Designation in Q1 Reaffirmed 2H 2025 enrollment completion; continued IDE pivotal progress Stable/positive
Technology differentiation (ULTC)CE‑Mark data and CRYOCURE‑VT results showcased; next‑gen ULTC introduced PFCA first‑in‑human results published; investor deck details VT TAM and ULTC depth Strengthening
Commercial progress (EU)Early EU launch cited; Q4 2024 revenue $0.137M No Q2 revenue; focus on clinical prioritization and burn reduction Mixed (EU nascent; U.S. investigational)
Operating disciplineAnnounced resource realignment in Q4; Q1 spend levels high R&D and SG&A down materially QoQ and YoY; burn reduced Improving
Capital & liquidityPro forma cash ~$35M post‑SPAC (Aug 2024) Cash $8.2M at Q2; notes and warrants outstanding Deteriorating

Management Commentary

  • Todd Usen, CEO (Q2): “continued strong momentum in the enrollment of our FULCRUM‑VT study… brings us one step closer to offering our proprietary ULTC solutions to patients in the United States… meaningful progress in advancing our pipeline… next‑generation product… improve usability… further enhancing… ULTC platform” .
  • Todd Usen, CEO (Q1): “defining quarter… Breakthrough Device Designation… momentum in enrolling patients in our FULCRUM‑VT trial… clinical promise and growing validation of our proprietary ULTC platform technology” .

Q&A Highlights

  • No Q2 2025 earnings call transcript found; no Q&A content available to review .

Estimates Context

  • S&P Global consensus: Not available for ADGM’s Q2 2025 EPS and revenue; as a result, “vs. estimates” comparisons cannot be provided (coverage unavailable) .
  • Implication: Near‑term price reactions likely hinge on clinical milestones (FULCRUM‑VT completion timing, next‑gen ULTC progress) and funding clarity rather than consensus beats/misses .

Key Takeaways for Investors

  • Execution over income: With zero revenue and improved loss driven by lower OpEx, the stock’s near‑term drivers are clinical enrollment completion, regulatory milestones, and liquidity management rather than P&L beats .
  • Clinical catalyst path intact: >85% pivotal enrollment and maintained 2H 2025 completion timeline sustain the PMA narrative; watch for IDE updates and any U.S. reimbursement developments (e.g., NTAP prospects post‑Breakthrough designation) .
  • Technology moat: ULTC and PFCA data plus CE‑Mark experience frame a differentiated VT solution with deep lesion capability; this underpins medium‑term commercialization potential, especially in high‑burden VT segments .
  • Funding watchpoint: Cash $8.2M and $22.49M notes/warrant overhang point to probable financing needs; track dilution risk, structure (equity vs structured), and timing relative to pivotal completion .
  • Operating discipline improving: R&D and SG&A down materially QoQ/YoY; sustained prioritization could further extend runway, but non‑operating items also influenced reported loss—focus on cash burn and operating loss trend .
  • EU commercial ramp visibility low: Q4 2024 showed modest revenue; Q2 2025 was zero—monitor EU traction, site adoption, and early‑use feedback to gauge pre‑PMA monetization potential .
  • Trading implications: Near‑term moves likely tied to clinical news flow (enrollment milestones, PFCA data publications) and financing signals; absence of consensus estimates reduces “printed beat/miss” dynamics, increasing sensitivity to qualitative catalysts .