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ARTIVION, INC. (AORT)·Q3 2025 Earnings Summary

Executive Summary

  • Artivion delivered a strong Q3 2025: revenue $113.4M (+18% y/y GAAP; +16% cc) and adjusted EBITDA $24.6M (+39% y/y), with gross margin up ~200 bps to 65.6% on mix (AMDS HDE and strong U.S. On‑X) .
  • Broad-based growth: stent grafts +38% GAAP (+31% cc), On‑X +25% GAAP (+23% cc), preservation services +5% cc, BioGlue +2% GAAP (+1% cc) y/y; guidance raised again for FY25 revenue to $439–$445M and adjusted EBITDA to $88–$91M .
  • Q3 beat vs S&P Global consensus: revenue $113.4M vs $110.6M*, adjusted EPS $0.16 vs $0.152*, GAAP EPS $0.13 vs $0.02*; magnitude driven by AMDS stocking and On‑X momentum; FY25 guide up suggests estimate revisions higher near term (see Estimates Context) *.
  • Catalysts: DRG‑209 reimbursement for complex arch procedures (supports AMDS adoption), first patient enrolled in Arcevo (ARTIZEN) IDE, positive late‑breaking AMDS data at EACTS, and amended credit facility (2031 maturity, lower rate, $150M delayed draw) positioning for potential Endospan acquisition .

What Went Well and What Went Wrong

What Went Well

  • High-quality growth and mix uplift: Q3 gross margin 65.6% (vs. 63.7% LY) on AMDS HDE ramp and strong U.S. On‑X; adjusted EBITDA margin 21.7% (+~320 bps y/y) .
  • Product engines executing: “Stent graft revenues grew 31% cc…AMDS early adoption and stocking orders” and “On‑X revenue grew 23% cc” .
  • Reimbursement/clinical momentum: CEO on DRG‑209, “meaningful increase to reimbursement…tailwind” and EACTS LBS data “further validated” AMDS clinical benefits .

What Went Wrong

  • Free cash flow headwind near term: despite Q3 FCF $17.7M, management expects slightly negative FCF for FY25 due to $12M Q4 facility purchase (and $8M in Q1’26) to expand On‑X capacity .
  • Tissue growth softer FY25: normalized volumes but now guided “closer to flat” for 2025 (was mid‑single digit), returning to MSD in 2026+; cybersecurity costs ~$0.7M in Q3 excluded from adj. EBITDA .
  • AMDS revenue still heavily weighted to initial stocking (sell‑in) vs implant sell‑through; sustainability/visibility of conversion curve remains a watch item .

Financial Results

Headline P&L and Cash Metrics

MetricQ3 2024Q2 2025Q3 2025
Revenue ($M)$95.8 $113.0 $113.4
GAAP Diluted EPS ($)-$0.05 $0.03 $0.13
Adjusted Diluted EPS ($)$0.12 $0.24 $0.16
Gross Margin (%)63.7% 64.7% 65.6%
Adjusted EBITDA ($M)$17.7 $24.8 $24.6
Adjusted EBITDA Margin (%)18.5% (calc: 17.7/95.8) 21.9% 21.7%
Free Cash Flow ($M, non‑GAAP)—$11.7 $17.7

Notes: Q3 y/y revenue +18% GAAP (+16% cc) ; adjusted EBITDA +39% y/y .

Actuals vs S&P Global Consensus (Q3 2025)

MetricConsensus*ActualSurprise
Revenue ($M)$110.6*$113.4 +$2.8M
GAAP EPS (Primary EPS)$0.02*$0.13 +$0.11
Adjusted EPS (Normalized)$0.152*$0.16 +$0.01

Values with asterisks (*) retrieved from S&P Global.

Product Mix

Product ($000s)Q3 2024Q2 2025Q3 2025
Aortic stent grafts$28,643 $39,841 $39,585
On‑X$21,478 $25,572 $26,797
Surgical sealants$18,437 $19,288 $18,893
Other$2,686 $2,743 $2,390
Total Products$71,244 $87,444 $87,665
Preservation services$24,535 $25,528 $25,723
Total Revenues$95,779 $112,972 $113,388

Geographic Mix

Region ($000s)Q3 2024Q2 2025Q3 2025
North America$49,089 $57,569 $58,315
EMEA$30,423 $38,713 $36,224
Asia Pacific$10,366 $11,131 $12,237
Latin America$5,901 $5,559 $6,612
Total Revenues$95,779 $112,972 $113,388

Balance Sheet/CF KPIs

KPIQ2 2025Q3 2025
Cash & Cash Equivalents ($000s)$53,476 $73,426
Long‑Term Debt, net ($000s)$215,538 $214,869
Net Leverage Ratio2.2x 1.8x
Free Cash Flow ($000s, non‑GAAP)$11,724 $17,653

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Reported Revenue ($M)FY 2025$435–$443 (Q2 guide) $439–$445 Raised midpoint
Constant Currency Revenue Growth (%)FY 202512%–14% (Q2 guide) 13%–14% Raised midpoint
Adjusted EBITDA ($M)FY 2025$86–$91 (Q2 guide) $88–$91 Raised midpoint
Adj. EBITDA growth vs 2024FY 202521%–28% (Q2) 24%–28% Raised low end
FX ImpactFY 2025~flat vs 2024 (Q2) slight positive Improved

Management also noted 2026 dynamics: tougher AMDS comps (year two of launch) and full-year Arcevo trial costs; still expect double‑digit revenue growth with adjusted EBITDA growing at 2x constant-currency revenue growth .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
AMDS launch (U.S.), adoption & reimbursementQ1: 150 sites in IRB/VAC pipeline; AMDS to add 1–2 pts to 2025 growth; modules filed for PMA . Q2: sequential acceleration; training/cross‑sell into On‑X; AMDS key swing factor; not breaking out AMDS revenue .Majority of U.S. AMDS revenue still initial stocking; implants ramping; DRG‑209 effective Oct 1 improves hospital reimbursement; strong feedback; $150M U.S. TAM .Positive adoption; reimbursement tailwind; watch sell‑through ramp
On‑X momentum & dataQ1: +11% cc; constrained by cyber but demand strong; new JACC/STS data creates $100M market expansion in <60 yrs . Q2: +24% cc; strong U.S.; early cross‑sell from AMDS trainings .+23% cc; “mechanical renaissance” commentary; plan to market to cardiologists in 2026; Austin facilities purchase to expand capacity .Accelerating growth; structural share gains
Tissue processingQ1: backlog from cyber; catch‑up by Q3; FY25 MSD growth expected . Q2: catch‑up ongoing; normalized by Q3 .Normalized volumes; FY25 now closer to flat; return to MSD growth in 2026 .Near‑term softer vs prior expectations
Gross margin & EBITDAQ1: GM 64.2% (down slightly y/y); adj. EBITDA margin 17.7% . Q2: GM 64.7%; adj. EBITDA margin 21.9% .GM 65.6%; adj. EBITDA margin 21.7%; +~320 bps y/y margin expansion .Mix-driven improvement (AMDS, On‑X)
Regulatory pipelineQ1: AMDS PMA 3/4 modules filed; NEXUS 30‑day IDE data positive; approval H2’26; Arcevo IDE targeted by YE . Q2: Arcevo IDE approval received .First patient treated in ARTIZEN IDE for Arcevo; PMA target mid‑2026 for AMDS; NEXUS 1‑yr data at STS Jan; approval H2’26 .Execution milestones achieved
Capital structure & FCFQ1: positive FCF for FY25 expected; minimal China exposure; tariffs not material . Q2: delevered via converts; FY25 positive FCF expected .Credit facility amended: 2031 maturity, lower rate, $150M delayed draw; FY25 FCF slightly negative due to $12M facility purchase; positive in 2026 .Improved flexibility; near‑term FCF dip

Management Commentary

  • “Our third quarter performance was exceptionally strong… delivering 16% constant currency revenue growth… stent grafts of 38%, On‑X of 25%… preservation services of 5%, BioGlue of 2%” .
  • “Adjusted EBITDA margin was 21.7%… ~320 bps improvement over the prior year, driven by improvements in gross margin and leverage in SG&A” .
  • On reimbursement: “CMS… established… DRG‑209… reflects… meaningful increase… expected to… act as an incremental tailwind” .
  • On AMDS: “Revenue is still heavily weighted towards initial stocking, with positive, exciting ramp to the implantations” .
  • On On‑X: “We maintain our strong conviction that On‑X is the best aortic valve… under the age of 65 and will continue to take market share worldwide” .
  • On Arcevo: “Enrolled the first patient in our ARTIZEN trial… we estimate a PMA for Arcevo would open an incremental $80 million U.S. market opportunity” .

Q&A Highlights

  • 2026 setup: tougher AMDS comps and full-year Arcevo trial costs, yet still targeting double‑digit revenue growth and adjusted EBITDA growing at 2x cc growth .
  • AMDS dynamics: majority of current U.S. revenue from initial stocking; implants rising; DRG‑209 supportive; not breaking out AMDS revenue; trending toward high end of year‑1 expectations .
  • On‑X “mechanical comeback”: mgmt cites large database studies showing superiority in <60–65 years; plan to expand marketing to cardiologists in 2026; strong new account adds .
  • BioGlue China: consider incremental to reaching MSD global growth; don’t model as discrete step‑up .
  • Capital/FCF: amended facility reduces annual interest by ~$1.5M; FY25 FCF slightly negative due to $12M Austin purchase; expect positive FCF in 2026 despite $8M Q1 payment .

Estimates Context

  • Q3 2025 vs S&P Global consensus: revenue $113.4M vs $110.6M*; adjusted EPS $0.16 vs $0.152*; GAAP EPS $0.13 vs $0.02* — broad beat, with outperformance driven by mix (AMDS, On‑X) and margin expansion *.
  • FY25 guidance raised (revenue and adjusted EBITDA midpoints); analysts likely to lift FY25 revenue/EBITDA and modestly adjust EPS higher, while incorporating CFO’s 2026 caution (AMDS comps, Arcevo trial costs) .

Values with asterisks (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Mix-driven upside continuing: AMDS HDE stocking and On‑X share gains are expanding gross margin and EBITDA; watch progression from stocking to sustained implant utilization in 2026 .
  • Guidance credibility strengthening: second consecutive raise this year; full-year revenue now $439–$445M and adj. EBITDA $88–$91M .
  • Reimbursement and data tailwinds: DRG‑209 improves U.S. hospital economics for complex arch procedures; positive EACTS late‑breaking AMDS data supports adoption .
  • Pipeline milestones de‑risking medium‑term: AMDS PMA targeted mid‑2026; NEXUS U.S. 1‑yr data in Jan; Arcevo pivotal enrolling with $80M U.S. opportunity .
  • Near‑term FCF dip is strategic: facility purchases expand On‑X capacity and lower occupancy costs over time; leverage down to 1.8x; amended facility adds $150M optionality for Endospan .
  • Monitoring points: AMDS sell‑through cadence, tissue revenue normalization path (FY25 closer to flat), and 2026 cost envelope for Arcevo trial .

Supporting Documents Reviewed

  • Q3 2025 Earnings Press Release and Financials (full): revenue, margins, segment/geo mix, guidance, non‑GAAP reconciliations .
  • Q3 2025 Earnings Call Transcript (full): product dynamics, DRG‑209, margins, 2026 commentary, cash/leverage .
  • Other Q3‑period press releases: first patient in Arcevo ARTIZEN IDE ; EACTS late‑breaking AMDS data .
  • Prior quarters for trend: Q2 2025 press release and call ; Q1 2025 press release and call .