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Anteris Technologies Global Corp. (AVR)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 results reflected steady operational execution toward the PARADIGM pivotal trial: 21 patients treated in the quarter (49 YTD; 130 total to date), 79 global sites qualified, continued FDA engagement, and manufacturing scale-up .
  • Versus S&P Global consensus, revenue beat ($0.62M vs $0.38M) while EPS missed (-$0.58 vs -$0.57); EBITDA was slightly better than expected (-$20.47M vs -$20.64M). Bolded: revenue beat; EPS miss [Values retrieved from S&P Global].
  • Operating spend focused on R&D ($16.3M) and SG&A ($5.0M); cash was $28.4M at quarter-end, with H1 net operating cash outflow of $41.0M aligned to trial preparation .
  • Near-term stock reaction catalysts: IDE progress and site activation, physician enthusiasm, and expanding clinical dataset; no dividend and no formal financial guidance were provided .

What Went Well and What Went Wrong

What Went Well

  • Built clinical evidence and momentum: 130 patients successfully treated with DurAVR THV since inception; 21 in Q2 and 49 in H1, including complex anatomies and a world-first double valve-in-valve in both mitral and aortic positions .
  • Trial readiness advanced: 79 global sites qualified; hosted global and European investigator meetings; continued FDA engagement to progress IDE; manufacturing capabilities scaled to anticipated trial demand .
  • Management tone positive: “I’m extremely pleased with the progress achieved during the second quarter… We are excited by physician enthusiasm across the globe to recruit into the PARADIGM study” — Wayne Paterson, CEO .

What Went Wrong

  • EPS missed consensus by ~$0.01; continued sizeable operating losses typical of pre-commercial medtech development [Values retrieved from S&P Global].
  • Cash burn elevated due to trial prep: H1 2025 net operating cash outflows of $41.0M; R&D spend of $16.3M in Q2 reflects IDE and enrolment readiness .
  • No formal financial guidance; dividend not declared, maintaining investor uncertainty on commercial timing and cash runway endpoints .

Financial Results

Key P&L vs Prior Periods (USD)

MetricQ4 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.54*$0.56*$0.62*
Diluted EPS ($USD)-$0.82*-$0.61*-$0.58*
Net Income ($USD Millions)-$19.38*-$21.86*-$20.83*

Note: Values marked with * retrieved from S&P Global.

Operating Expenses and Liquidity (USD)

MetricQ1 2025Q2 2025
R&D Expense ($USD Millions)$16.5 $16.3
SG&A Expense ($USD Millions)$5.7 $5.0
Cash and Equivalents ($USD Millions)$49.0 $28.4
Net Operating Cash Outflows (period context)—H1 2025: $41.0

H1 Year-over-Year

MetricH1 2024H1 2025Change $Change %
Revenues from ordinary activities ($USD ‘000)1,398 1,174 (224) (16%)
Loss from ordinary activities after tax ($USD ‘000)(34,972) (42,993) (8,021) 23%
Loss attributable to members ($USD ‘000)(35,057) (42,698) (7,641) 22%

Estimates vs Actuals (S&P Global)

MetricQ2 2025 ActualQ2 2025 ConsensusBeat/Miss
Revenue ($USD Millions)$0.62$0.38Bold: Beat
EPS ($USD)-$0.58-$0.57Bold: Miss
EBITDA ($USD Millions)-$20.47-$20.64Beat

Note: Values retrieved from S&P Global.

KPIs and Execution Progress

KPIQ1 2025Q2 2025Notes
Patients treated with DurAVR THV (cumulative)100 milestone reached; >110 treated by IDE submission context 130 total (49 H1; 21 in Q2) Includes complex anatomies and ViV
PARADIGM Trial sites qualified—79 U.S., Europe, Canada
Investigator meetingsEurope (May), Global (June) Completed Co-Chairs confirmed (Reardon, Windecker)
H1 net operating cash outflow ($USD Millions)—$41.0 Trial prep driven
Board appointments—David Roberts, Gregory Moss (June 10) Governance strength

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
RevenueFY/Q3-Q4 2025NoneNoneMaintained: no formal guidance
MarginsFY/Q3-Q4 2025NoneNoneMaintained: no formal guidance
OpEx (R&D, SG&A)Q3-Q4 2025Not guidedFocused on trial prep; continued elevated R&D and SG&A to support IDE and enrolment Directional only (no numeric guidance)
OI&E, Tax rateFY 2025NoneNoneMaintained: no formal guidance
DividendsFY 2025NoneNo dividend proposed/declared Maintained: none

Earnings Call Themes & Trends

Note: A Q2 2025 earnings call transcript was not available in our document search.

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
Regulatory/IDEPre-submission engagement; PMA/CE pathway context IDE submitted; on track to start pivotal in Q3 2025 Continued FDA engagement to progress IDE Steady progress
Trial readiness/sitesPlan for 80+ sites globally Scaling clinical specialist team, CRO engagement 79 sites qualified; investigator meetings held Accelerating activation
Clinical data/patient experience86 cases; multiple podiums; strong hemodynamics 100 patients milestone; one-year outcomes shared (EOA, MPG, DVI; no PPM in small annuli) 130 patients total; complex anatomies; double valve-in-valve Expanding dataset
Manufacturing scale-upDesign optimization; scale-up AU/US facilities Process validation; capacity tripled vs 2024 Ongoing scale-up ahead of trial demand Capacity build maintained
Governance/capitalIPO proceeds; strong year-end cash FTSE Russell 2000 inclusion; cash $49.0M Added two NEDs; cash $28.4M Governance strength; cash draw for trial

Management Commentary

  • “The data generated to date from 130 patients… is highly compelling… we are excited by physician enthusiasm across the globe to recruit into the PARADIGM study” — Wayne Paterson, Vice Chairman and CEO .
  • Trial operations: “Preparatory activities… are well advanced, with 79 sites now qualified to participate” .
  • Financial posture: H1 net operating cash outflows of $41.0M; Q2-end cash of $28.4M, consistent with increased clinical, regulatory and manufacturing requirements .

Q&A Highlights

  • No Q2 2025 earnings call transcript was found in our document corpus; therefore, no Q&A themes to report from the call. Company communications emphasized IDE progress, site qualification, and manufacturing scale-up .

Estimates Context

  • Revenue beat consensus by ~$0.24M; EPS missed by ~$0.01; EBITDA slightly better than expected. These outcomes suggest top-line variation likely driven by tissue product sales timing, while bottom-line reflects disciplined but elevated trial-prep OpEx [Values retrieved from S&P Global].
  • Post-quarter estimate revisions may tighten around operating expense run-rate and timing of trial activation; lack of formal guidance keeps models sensitive to regulatory and enrolment milestones .

Key Takeaways for Investors

  • Bold: Revenue beat vs consensus; EPS miss. Near-term sentiment may hinge on IDE clearance timing and initial site activation metrics [Values retrieved from S&P Global].
  • Execution remains strong: 79 sites qualified; comprehensive investigator engagements; global manufacturing scale-up underway .
  • Clinical differentiation continues to build: 130 patients treated to date, including complex anatomies and world-first double ViV case, supporting the biomimetic thesis for DurAVR THV .
  • Cash burn is purposeful: H1 operating cash outflow of $41.0M reflects pivotal trial preparation; Q2 cash $28.4M warrants continued focus on financing runway and non-dilutive options .
  • No formal financial guidance and no dividend; investors should model OpEx intensity through trial initiation and consider regulatory gating risks .
  • Medium-term thesis: If PARADIGM achieves non-inferiority on composite endpoints vs commercial TAVRs, DurAVR’s hemodynamic profile and clinical breadth could be a category-changer; watch CE Mark and PMA pathways .
  • Trading implications: Stock likely sensitive to IDE approvals, first-patient-in milestones, and any early enrolment updates; monitor additional patient outcomes and site activation cadence .

Notes:

  • S&P Global consensus and actuals used for revenue, EPS, and EBITDA comparisons where company documents did not disclose quarterly P&L line items. Values retrieved from S&P Global.