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Anteris Technologies Global Corp. (AVR)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 remained execution-heavy: net sales were $0.43M with operating loss of $22.27M as R&D scaled for PARADIGM; cash ended at $9.12M, later supplemented by ~$25.2M gross private placement proceeds closed in late Oct/early Nov .
  • Regulatory momentum accelerated: first PARADIGM patients treated in Denmark (Oct) and FDA IDE approval to commence U.S. recruitment (Nov), setting up pivotal enrollment across U.S./EU/Canada .
  • Versus S&P Global consensus for Q3: revenue missed ($0.43M vs $0.49M*) and EPS missed (-$0.63 vs -$0.48*); coverage remains thin (1 EPS estimate, 4 revenue estimates). Bolded below. Values retrieved from S&P Global.
  • Near-term catalysts: U.S./EU site activations and patient enrollment ramp, plus ISO 13485 certification and manufacturing scale-up supporting trial execution .

What Went Well and What Went Wrong

What Went Well

  • Regulatory milestones: “FDA approval to commence U.S. recruitment… announced in November 2025” and first patients treated in Denmark in October, marking formal initiation of PARADIGM .
  • Operational readiness and quality: advanced QMS buildout and manufacturing scale-up (clean room expansion, cross-training, process development) to support pivotal trial demand .
  • Management tone: “significant progress on the regulatory front with approvals to start the PARADIGM pivotal study being achieved in both Europe and the U.S. in Q4 as a result,” said CEO Wayne Paterson .

What Went Wrong

  • Top-line remains very small and declined due to end of LeMaitre agreement; Q3 net sales fell to $0.43M (vs $0.77M prior-year Q3) as legacy tissue revenues tapered .
  • Elevated cash burn driven by R&D scaling for PARADIGM; nine-month operating cash outflows reached $59.28M, raising going-concern flag absent additional financing (partly addressed by late-Q4 private placement) .
  • Q3 missed consensus: revenue miss and EPS miss reflect ongoing investment over revenue generation; EPS of -$0.62 vs -$0.48* consensus, revenue $0.43M vs $0.49M* consensus. Values retrieved from S&P Global.

Financial Results

Income Statement Overview (quarterly)

Metric ($USD)Q1 2025Q2 2025Q3 2025
Net Sales$0.56M $0.62M $0.43M
Operating Loss$(21.78)M $(20.88)M $(22.27)M
Net Loss Attributable to Stockholders$(21.86)M $(20.83)M $(22.24)M
Diluted EPS$(0.61) $(0.58) $(0.62)

Operating Expenses

Metric ($USD)Q1 2025Q2 2025Q3 2025
R&D Expense$16.46M $16.34M $16.81M
SG&A Expense$5.67M $5.01M $5.76M

Cash and Operating Cash Flow (YTD at each quarter-end)

Metric ($USD)Q1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Restricted Cash$48.96M $28.44M $9.12M
Net Cash Used in Operating Activities (YTD)$(21.49)M $(41.02)M $(59.28)M

Geography Revenue Breakdown

Geography ($USD)Q1 2025Q2 2025Q3 2025
United States$0.28M $0.61M $0.42M
Australia$0.01M $0.01M $0.01M
Germany$0.27M $0.00M $0.00M
Total$0.56M $0.62M $0.43M

Estimate vs Actual (Q3 2025)

MetricConsensusActual
Revenue ($USD)$0.49M*$0.43M
Primary EPS-$0.48*-$0.62
EPS # of Estimates1*—
Revenue # of Estimates4*—
Target Price Consensus Mean$6.46*$6.46*

Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious Guidance/ExpectationCurrent UpdateChange
PARADIGM Trial Start2H 2025Anticipated Q3 2025 enrollment Shifted to Q4 2025; FDA requested additional bench testing; response submitted Deferred
U.S. PARADIGM IDEQ4 2025Pending IDE approval FDA IDE approval received in Nov 2025 Achieved
EU PARADIGM InitiationQ4 2025Ongoing EU submissions First approval in Denmark; first patients treated Oct 2025 Achieved
Financial GuidanceFY/Q3None providedNone providedMaintained (no guidance)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2025)Trend
Regulatory progress (IDE/EU)IDE submitted (Q1); ongoing FDA dialogue; 79 sites qualified (Q2) FDA IDE approval (Nov); Denmark approval; first PARADIGM patients treated (Oct) Improving
Manufacturing scale-upISO clean rooms; 3x capacity vs 2024 (Q1/Q2) Continued scale-up; clean room expansion; inspection cross-training Steady execution
Cash runway/financingCash $49.0M (Q1); $28.4M (Q2); going-concern risk Cash $9.12M (Q3); ~$25.2M gross private placement closed post-Q3 Addressed post-Q3
Clinical program>100 patients (Q1); 130 patients (Q2) Initiated PARADIGM in EU; U.S. launch approved by FDA Transition to pivotal
Revenue mixLeMaitre TSA expired Jan’25; tissue sales taper (Q1/Q2) Low sales persist ($0.43M) Structural low until commercialization

Note: No Q3 earnings call transcript was available.

Management Commentary

  • “Third Quarter activities were critical to set the company on its path for the rest of the year and into 2026. The company made significant progress on the regulatory front with approvals to start the PARADIGM pivotal study being achieved in both Europe and the U.S. in Q4 as a result.” — Wayne Paterson, Vice Chairman & CEO .
  • “FDA approval to commence patient recruitment in the United States was subsequently announced in November 2025… first PARADIGM patients were enrolled and treated in Denmark in October 2025.” .
  • “Strengthening… operational infrastructure… advancing QMS buildout… and manufacturing scale-up… for projected DurAVR THV demand.” .

Q&A Highlights

  • No earnings call transcript located for Q3 2025; no Q&A available from primary sources.

Estimates Context

  • Q3 2025 vs S&P Global consensus: revenue $0.43M vs $0.49M* (miss); EPS -$0.62 vs -$0.48* (miss). Coverage remains thin (1 EPS estimate, 4 revenue estimates). Values retrieved from S&P Global.
  • Implications: As PARADIGM ramps, near-term estimate revisions likely focus on cash burn trajectory and timing of pivotal enrollment/ISO certification rather than revenue/EPS beats. Weak top-line reflects strategic focus pre-commercialization .

Key Takeaways for Investors

  • Regulatory momentum is the key driver: EU first-in-country treatment and FDA IDE approval materially de-risk trial initiation; watch U.S./EU site activations and enrollment cadence .
  • Cash runway improved post-quarter via ~$25.2M gross private placement; monitor additional financing needs as burn persists through pivotal execution .
  • Top-line to remain modest until commercial approvals; revenue misses are unsurprising given LeMaitre TSA expiration and tissue sales decline .
  • Operating expense discipline within plan: R&D elevation aligns with manufacturing/quality scale-up and field clinical team expansion; SG&A trending down YoY .
  • Manufacturing/QMS investments (ISO 13485) are critical leading indicators of readiness; progress supports trial execution and future regulatory filings .
  • Near-term trading: stock likely reacts to trial milestones (IDE approvals, first patient in U.S., site count growth, early safety signals); financing announcements can be double-edged catalysts .
  • Medium-term thesis: DurAVR’s biomimetic profile and prior hemodynamic data underpin potential differentiation; pivotal design (head-to-head vs current THVs) sets pathway to PMA/CE Mark if non-inferiority achieved .