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Anteris Technologies Ltd

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Ticker: AVR

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Anteris Technologies Ltd - Company showcase

Year Founded & Workforce

1999

174 Employees

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Anteris Technologies Ltd Overview

Anteris is a clinical-stage structural heart company. It is attempting to build the first "biomimetic" transcatheter aortic valve: DurAVR, a balloon-expandable valve molded from a single piece of ADAPT anti-calcification bovine pericardium. The design aims to restore near-physiological, laminar aortic flow rather than merely relieve obstruction. The company emerged from two decades of tissue-engineering work at Admedus. That lineage includes the CardioCel patch, which was sold to LeMaitre Vascular in 2019, and the ADAPT tissue platform, which has been used in more than 55,000 patients. Anteris re-domiciled to Delaware and listed on Nasdaq in December 2024. In January 2026 it raised USD 320M, including a USD 90M strategic investment from Medtronic, the world's second-largest TAVR vendor, which now holds 16.1%. Its value now rests almost entirely on the approximately 1,000-patient, head-to-head PARADIGM randomized pivotal trial against commercial TAVR valves. A positive readout could support FDA PMA and CE Mark approval and position Anteris as a disruptive third force in a two-player TAVR market worth about USD 10B. A negative readout would leave it with minimal revenue and no approved product.


Company's own description (10-K FY2025, paraphrased). Anteris describes itself as a structural heart company focused on restoring heart valve patients to healthy function through science-driven, measurable advances. Its lead product is the DurAVR Transcatheter Heart Valve (THV) System, which it developed with leading interventional cardiologists and cardiac surgeons to treat aortic stenosis. The company characterizes DurAVR as the first biomimetic valve: a balloon-expandable device shaped to mimic a healthy native aortic valve and to replicate normal aortic blood flow. The system has three components:

  • the DurAVR valve, a single piece of molded ADAPT-treated bovine pericardium sutured inside a cobalt-chromium frame;

  • the ADAPT anti-calcification tissue technology;

  • the ComASUR balloon-expandable delivery system, which offers rotational control for commissural alignment.

The company explicitly describes itself as a development-stage company with recurring losses, generating only small revenue.

Business model. Anteris is a single-asset, pre-commercial medical device developer. It follows the classic "clinical evidence → PMA/CE Mark → commercial launch" model and intends to sell a premium-priced Class III implant (valve plus delivery system) directly or through a commercial partner to hospital heart teams. Before approval, the economic engine is equity financing.

Revenue model and mix (FY2025). All current revenue is product revenue from sales of regenerative ADAPT tissue products. There is no service, subscription or licensing revenue of significance.

Value chain position. Anteris is vertically integrated in tissue processing: it buys bovine pericardium from Harvey Industries Group (Australia) and performs ADAPT processing in Western Australia. It designs the valve and delivery system and outsources specific engineering, component manufacturing and testing to U.S. contract partners (Switchback Medical, NPX Medical, Taurus Engineering; knitted materials from Aran Biomedical/Integer). It sponsors its own clinical trials, using CRF for core lab and data services, Bright Research Partners for clinical services, and QMED for EU regulatory support.

Customer types and end-markets. The prospective customers are hospital-based structural heart teams (interventional cardiologists and cardiac surgeons) in TAVR-capable centers in North America and Europe, the company's initial targets, with reimbursement from Medicare (U.S.) and national health systems. Current customers are the device OEMs that buy tissue (4C Medical, and LeMaitre until January 2025).

Independent characterization. Anteris is best understood as a binary, venture-stage asset wrapped in a public listing. Commercially, it is a call option on one randomized trial. Its genuine differentiators are a single-piece, molded leaflet design; ADAPT tissue with 10-year calcium-free clinical data in pediatric patch use; and delivery-system commissural alignment. Early hemodynamics are excellent: single-digit mean gradients, an average effective orifice area (EOA) of about 2.2 cm², and only 3% moderate-or-greater patient-prosthesis mismatch (PPM) in small annuli. However, these come from a pooled, non-randomized cohort of about 130–140 patients. The January 2026 Medtronic investment provides strategic validation and a credible exit or partnership pathway, but it also concentrates strategic optionality in one counterparty.

Strategy

Stated strategic themes (10-K FY2025 and company releases, paraphrased).

  1. Generate randomized, head-to-head evidence (PARADIGM) to support FDA PMA and CE Mark, rather than relying on historical or device-generation comparisons.

  2. Reframe TAVR from "rescue therapy" to disease modification and lifetime valve management, emphasizing durability, laminar flow, ventricular remodeling and future reintervention options for younger, lower-risk patients. The company describes this as a "category reset" run on a pharmaceutical playbook (July 2026 release).

  3. Expand the treated population: only 15–20% of severe aortic stenosis patients are treated today.

  4. Build manufacturing, quality and supply readiness for commercialization.

  5. Focus initially on North American and European markets.

Strategic initiatives in the last 24 months.

ESG and cost programs: none disclosed.

Medium-term financial targets: none. Management guides only that operating losses and expenses will continue to rise, that cash is sufficient for at least 12 months, and that additional capital may be required.

Products & Services

Registered trademarks include ADAPT, ADAPT FOR LIFE, ANTERIS, ComASUR, DurAVR and GYNECEL (10-K FY2025). No GYNECEL product is commercially described in the sources reviewed.

Product Portfolio

ProductDescription and key capabilitiesTarget customerStatus / yearPricingSource

DurAVR THV (flagship)

Balloon-expandable transcatheter aortic valve. Single piece of molded ADAPT-treated bovine pericardium sutured inside a cobalt-chromium frame. Three-dimensional native-shaped leaflets, long coaptation, fewer sutures/seams, large open frame cells for coronary access. Pooled data in 100 small-annulus patients (annulus area 404 ± 37 mm²): 93% technical success, 0% mortality and 2% stroke at 30 days, mean gradient 8.2 mmHg, EOA 2.2 cm², 3% moderate-or-greater PPM, no moderate/severe paravalvular leak

Heart teams treating severe symptomatic aortic stenosis (native and valve-in-valve)

Investigational (Class III). More than 130 implants by Dec 2025 (about 140 cited Mar 2026). In PARADIGM pivotal trial

Not publicly disclosed (pre-commercial)

10-K FY2025; PCR London Valves 2025; TD Cowen, Mar 2026

ComASUR Delivery System

Physician-developed balloon-expandable delivery system with a reinforced, steerable catheter; rotational control for commissural alignment with native anatomy; even balloon expansion. Patent pending

Same as DurAVR (reviewed as part of the DurAVR PMA)

Investigational

—

10-K FY2025

ADAPT anti-calcification tissue

Decellularized, crosslinked, detoxified bovine pericardium bioscaffold stored in non-glutaraldehyde solution. Calcium-free for up to 10 years in pediatric CardioCel data (Neethling et al.). Used in more than 55,000 patients

Internal (DurAVR); OEM supply (4C Medical)

FDA 510(k)-cleared 3 Apr 2020 (Class II)

Per-unit price by annual volume (4C); no minimums

10-K FY2025

CardioCel / CardioCel 3D / CardioCel Neo (divested)

ADAPT pericardial patches for congenital and cardiovascular repair

Cardiac surgeons

FDA-cleared 2014/2017; sold to LeMaitre Oct 2019; contract manufacture ended Jan 2025

—

LeMaitre 8-K 2019

VascuCel / VascuCel 3D (divested)

Vascular repair patch

Vascular surgeons

FDA-cleared 2016; sold to LeMaitre 2019

—

LeMaitre 8-K 2019

v2vmedtech TEER device (pipeline, VIE)

Transcatheter edge-to-edge repair clip/coupler for mitral and tricuspid regurgitation; Columbia University license

Interventional cardiologists (mitral/tricuspid)

Stage 2 of 5 (concept lock on clips and coupler); first-in-human timing undetermined

—

10-K FY2025

“—” = not publicly disclosed.

Financial Narrative

Income statement

Revenue CAGR FY2021–FY2025: -23.8% (calculated). Company-reported FY2025: revenue USD 1.913M; loss after tax USD 94.225M; loss attributable USD 94.144M (FY2024: USD 2.703M, USD 75.967M and USD 76.291M respectively). FY2025 R&D of USD 69.1M and SG&A of USD 26.1M match the company release. Pre-2024 share counts and EPS reflect S&P adjustments and may not match historical ASX-reported per-share figures.

Margins (%)

EBITDA margins for FY2022–FY2025 are calculated from the table above.

Balance sheet

Interim balance sheet as of 30 Jun 2026: total assets USD 272.51M; cash & short-term investments USD 256.87M; total debt USD 3.32M; equity USD 251.67M; working capital USD 242.29M (S&P). Company figures conflict slightly: the condensed balance sheet shows cash, cash equivalents and restricted cash of USD 257.385M, while the Q2 2026 results summary cites USD 260.9M. Both are noted; the gap is likely definitional (treatment of restricted or other cash). At 31 Mar 2026 the figure was USD 283.21M.

Cash flow

FY2025 net operating cash outflow of USD 77.8M matches the company release. Quarterly operating cash outflows in 2026 were USD 28.7M in Q1 and USD 20.8M in Q2. Trailing-twelve-month free cash flow to 30 Jun 2026 was USD -88.21M.

Ratios (calculated on year-end balances)

FY2025 ROE and debt/equity are not meaningful because year-end equity was negative (USD -0.25M). ROIC, net debt/EBITDA and interest coverage are not meaningful for a company with negative EBIT and a net cash position. The cash conversion cycle is not meaningful given immaterial inventory and receivables.

Commentary

Revenue. Revenue has declined every year since FY2021 as the company deliberately wound down legacy tissue businesses. The LeMaitre contract-manufacturing relationship ended in January 2025, and the 4C Medical supply agreement will not be renewed. Revenue is therefore not a value driver. The gross margin rebound to 70% in FY2025 reflects mix (higher-margin 4C tissue) rather than scale.

Losses. The operating loss widened roughly 5.6x between FY2021 and FY2025, driven by R&D, which grew about 12x. That growth funded the DurAVR program, manufacturing scale-up, quality management buildout (including ISO 13485 certification for DurAVR production) and PARADIGM start-up. SG&A rose in FY2024 with IPO and U.S.-listing costs and was broadly flat in FY2025.

Liquidity inflection. The balance sheet swung sharply. Year-end FY2025 cash was only USD 12.1M with negative equity, and the Q3 2025 10-Q carried a going-concern flag. In January 2026 the company raised USD 320M. By June 2026 cash was about USD 257–261M against quarterly operating burn of USD 21–29M. Management states that existing cash funds operations for at least 12 months, which on a simple run-rate basis implies roughly 2–3 years of runway before trial expansion costs. Share count dilution is the primary financing cost: shares rose from 11.1M (FY2021) to about 97.5M (Oct 2026).

Interim 2026 results

For Q2 2026 alone: net sales USD 1.0M (+63% YoY); operating loss USD 31.0M (+48% YoY); R&D USD 23.4M (+43% YoY); net loss attributable USD 29.1M. Source: Q2 2026 10-Q / ASX release; Quartr summary.

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Financial Detail

Group Entities

EntityRoleOwnershipSource

Anteris Technologies Global Corp. (Delaware)

Listed parent (Nasdaq/ASX)

—

10-K FY2025

Anteris Technologies Pty Ltd (formerly Anteris Technologies Ltd)

Former ASX parent; Australian operating company (Brisbane HQ, WA manufacturing)

100%

10-K FY2025

U.S. operating subsidiary(ies), Minnesota

Engineering, clinical, regulatory, U.S. operations

—

10-K FY2025

Swiss operations (Geneva)

European presence

—

10-K FY2025

v2vmedtech, inc.

TEER device developer (Columbia University license)

30% equity, consolidated as VIE; rises to 58–60% after Stage 5 or USD 10.0M of contributions

10-K FY2025

Admedus Biomanufacturing Pty Ltd; Admedus (Australia) Pty Ltd

Legacy entities

Deregistered by ASIC on 16 Jul 2025

FY2025 Appendix 4E-equivalent

Results by Segment and Segment Margins & Growth (%)

MetricFY2023FY2024FY2025

Consolidated revenue — regenerative tissue products (USD Mn)

2.742.701.91

YoY growth (%)

-12.33-1.17-29.23

Gross profit (USD Mn)

0.881.271.34

Gross margin (%)

32.0746.8470.26

Operating income (USD Mn)

-47.37-78.37-93.89

Contribution to total revenue (%)

100100100

Income Statement and Per-Share Data

MetricFY2021FY2022FY2023FY2024FY2025

Revenue (USD Mn)

5.663.122.742.701.91

Cost of revenue (USD Mn)

1.191.351.861.440.57

Gross profit (USD Mn)

4.471.770.881.271.34

SG&A (USD Mn)

13.9723.3417.3628.1926.12

R&D (USD Mn)

5.838.9830.8951.4569.12

Operating income (USD Mn)

-16.73-32.21-47.37-78.37-93.89

D&A (USD Mn)

0.570.701.161.511.66

EBITDA (USD Mn)

-16.16-31.51-46.22-76.87-92.23

Pre-tax income (USD Mn)

-16.66-30.14-46.76-75.97-94.23

Net income attributable (USD Mn)

-16.66-30.14-46.02-76.29-94.14

EPS basic (USD)

-2.25-2.26-2.95-3.77-2.55

EPS diluted (USD)

-2.25-2.26-2.95-3.77-2.55

Dividends per share (USD)

00000

Weighted average shares (M)

713162037

Margin Analysis (%)

MetricFY2021FY2022FY2023FY2024FY2025

Gross margin (%)

78.9556.8332.0746.8470.26

Operating margin (%)

-295.31-1,032.36-1,732.14-2,899.45-4,908.21

EBITDA margin (%)

-285.32-1,009.94-1,686.86-2,847.04-4,828.80

Net margin (%)

-294.02-966.01-1,682.71-2,822.46-4,921.27

Balance Sheet and Share Count (M)

MetricFY2021FY2022FY2023FY2024FY2025

Total assets (USD Mn)

21.4415.9630.5380.7023.00

Cash & equivalents (USD Mn)

15.499.3821.0970.4612.08

Short-term debt incl. current leases (USD Mn)

3.850.510.670.750.59

Long-term debt incl. leases (USD Mn)

0.310.440.920.651.70

Total debt (USD Mn)

4.170.961.601.402.28

Net debt (USD Mn; negative = net cash)

-11.32-8.43-19.49-69.06-9.79

Shareholders' equity (USD Mn)

10.438.9818.9062.68-0.25

Goodwill & intangibles (USD Mn)

0.830.610.410.190.07

Working capital (USD Mn)

9.387.1514.7758.09-5.70

Shares outstanding, year-end (M)

11.0913.9017.8235.9441.58

Cash Flow

MetricFY2021FY2022FY2023FY2024FY2025

Operating cash flow (USD Mn)

-13.68-26.50-34.63-61.24-77.80

Capex (USD Mn)

-0.55-1.55-2.39-2.27-1.95

Free cash flow (USD Mn)

-14.23-28.05-37.02-63.51-79.76

Dividends paid (USD Mn)

00000

Buybacks (USD Mn)

00000

Returns & Leverage Ratios (%) and Financial Ratios (x)

MetricFY2021FY2022FY2023FY2024FY2025

ROE (%)

-159.7-335.6-243.5-121.7—

ROA (%)

-77.7-188.8-150.7-94.5-409.3

Current ratio (x)

2.002.392.564.510.73

Debt/equity (x)

0.400.110.080.02—

Asset turnover (x)

0.260.200.090.030.08

Income Statement

MetricH1 2025H1 2026

Revenue from ordinary activities (USD Mn)

1.1741.503

Loss from ordinary activities after tax (USD Mn)

-42.993-51.675

Loss attributable to members (USD Mn)

-42.698-52.118

Revenue by Region

RegionFY2021FY2022FY2023FY2024FY2025

United States (USD Mn)

3.572.382.261.781.61

Australia (USD Mn)

0.130.020.010.020.03

Germany (USD Mn)

000.470.900.27

Total (USD Mn)

3.702.402.742.701.91

Growth (%)

Growth (%)FY2024FY2025

United States YoY (%)

-21.2-9.6

Germany YoY (%)

91.5-70.0

Valuation Snapshot

MetricValueDateSource

Price (Nasdaq)

USD 7.05

6 Oct 2026

StockAnalysis

52-week range

USD 3.30–11.06

Oct 2026

StockAnalysis

ASX CDI reference price

about AUD 12.07

Aug 2026

InvestSMART

Market capitalization

USD 687.3M

6 Oct 2026

StockAnalysis

Enterprise value

about USD 433.8M (market cap less USD 253.55M net cash at 30 Jun 2026)

Calculated

—

EV/Sales (trailing twelve months)

about 194x

Calculated

—

P/S (trailing twelve months)

about 307x

Calculated

—

P/B

about 2.73x (equity USD 251.67M)

Calculated

—

P/E, EV/EBITDA

Not meaningful (losses)

——

Beta

0.73

StockAnalysis

—

Share Price History

DatePrice

12 Dec 2024 (IPO price)

6.00

31 May 2025

4.24

30 Nov 2025

4.10

28 Feb 2026

6.51

27 Jun 2026

9.69

14 Aug 2026

9.40

6 Oct 2026

7.05

Analyst Ratings & Targets

BrokerRatingPrice target (USD)Date

Consensus (3 analysts)

Strong Buy

15.33 average

Oct 2026

Barclays

Overweight → reported Equal Weight

22 → 17 → 18 → 10

Feb, May, Oct 2026

Wells Fargo

Overweight

16

~Mar 2026

Cantor Fitzgerald

Overweight

15

~Apr 2026

Lake Street

Buy

20 → 15

Jan/Feb 2026

Analyst Conclusions

Management guidance: continued and rising operating losses; cash sufficient for at least 12 months; acceleration of U.S. site activation under the CMS framework; further PARADIGM expansion; eventual PMA and CE Mark submissions. No revenue or enrollment-completion guidance has been given. Consensus revenue is minimal (Q2 2026 expectation about USD 1.5M; actual about USD 1.0M); consensus EPS for Q2 2026 was USD -0.21.

Bull case

  1. DurAVR's hemodynamics (single-digit gradients, EOA about 2.2 cm², 3% PPM in small annuli) are best-in-class signals in a roughly USD 10B market dominated by two players.

  2. Medtronic's USD 90M stake, together with CEO commentary that Medtronic initially sought a full acquisition, sets a strategic floor and a plausible M&A exit.

  3. Pro-forma cash of about USD 260M funds PARADIGM through key enrollment milestones without near-term financing risk.

Bear case

  1. A non-inferiority trial of about 1,000 patients on hard 1-year endpoints is long and expensive, and the FDA has approved only 200 patients so far.

  2. Revenue of USD 1.9M against EV of about USD 434M implies the market already prices in substantial success; dilution capacity (ATM, shelf, warrants) is large.

  3. Incumbents can respond on price, on evidence and in litigation; Medtronic's stake may deter other acquirers.

12-month catalysts and monitorables: PARADIGM enrollment pace and site count; an FDA IDE supplement to expand beyond 200 patients; Australian site activation; Q3 2026 results (around 11 Nov 2026); TCT and PCR 2026 data presentations; ATM usage; any Medtronic commercial agreement; resolution of the Harvey supply agreement; analyst re-ratings following the Barclays move; v2vmedtech's Stage 2/3 decision ahead of the March 2027 milestone trigger.

Analyst verdict. Anteris has executed one of the more unusual transformations in Australian medtech. It began as a diversified distributor and tissue-patch vendor, became a focused TAVR innovator, re-domiciled to Delaware and now carries a roughly USD 690M Nasdaq market value, a strategic shareholder in Medtronic and enough capital to run a genuine pivotal trial. The scientific thesis is coherent. Leaflet stress, flow quality and durability will matter more as TAVR moves into younger patients, and a single-piece molded tissue valve is a credible engineering answer to that problem. The early data are consistently strong, especially in small annuli, the segment where incumbent balloon-expandable valves are weakest.

The investment case is nonetheless binary and back-end loaded. There is no meaningful revenue, legacy tissue sales are winding down by design, and every dollar of value depends on PARADIGM succeeding. That trial randomizes against excellent commercial comparators on hard clinical endpoints, and the FDA has so far approved enrollment of only 200 U.S. patients. A plausible timeline from completed enrollment through 1-year follow-up, PMA review and launch extends several years, during which further equity issuance is likely. The current valuation, at about 2.7x book and close to the average analyst target before Barclays' reported downgrade, already embeds meaningful probability of success.

Our assessment is that Anteris is a high-quality speculative asset. Monitoring should focus on enrollment velocity, any IDE expansion and the shape of the Medtronic relationship. A commercial partnership would materially de-risk the launch; a full takeover would crystallize value. The principal downside markers are slower-than-expected enrollment, a safety signal or aggressive ATM issuance at depressed prices.


Sources referenced throughout: Anteris Technologies Global Corp. Form 10-K FY2025 (filed 26 Feb 2026); Forms 10-Q (2025–2026); Form 8-Ks and ASX releases (Feb, May and Aug 2026); 424B3/424B5/FWP (Jan–Aug 2026); DEF 14A (10 Nov 2025); Schedule 13D (Medtronic) and 13G (Nantahala, Perceptive); LeMaitre Vascular 8-K (Oct 2019); Admedus, bioMD and Allied releases (2011–2019); Jones Day deal note; MassDevice; S&P Global via StockAnalysis.com; Quartr; TheFly/TipRanks; Trefis; InvestSMART; Frazis Capital interview; MarketBeat (TD Cowen conference summary).

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Executive Leadership

Executive Leadership Team

NameTitleTenureBackgroundAge / bornSource

Wayne Paterson

Vice Chairman & CEO

CEO since 2016 (start month varies by source)

Merck KGaA 2005–2013 (President Europe/Canada/Australia, Emerging Markets, Japan, Cardiovascular Medicine); Roche (Head of Pharmaceuticals South Korea; Head of Commercial Operations China)

Born 1967

Motley Fool AU; Yahoo; 8-Ks

David St Denis

President & Director; CEO of v2vmedtech

President since Mar 2025; COO from Jul 2017

Merck (Head of Commercial Operations Europe & Canada from 2013; Head of Operations Emerging Markets from 2008); Millennium Pharmaceuticals 1996–2006. BS University of Connecticut, MA Boston University, MBA Babson College

56 (Mar 2025)

DEF 14A 2025; 8-K Mar 2025

Matthew McDonnell

Chief Financial Officer

—

Not detailed in sources reviewed

Born 1974

Kalkine; S-3ASR

Dr Chris Meduri, MD, MPH

Chief Medical Officer; Medical Advisory Board member

—

Interventional cardiologist

—

Yahoo profile

“—” = not publicly disclosed.

Board of Directors

DirectorRoleAppointed / classBackgroundSource

John Seaberg

Independent Chair

—

Co-founder, Chair and CEO of NeoChord (2007–2014); Chair of Synovis (acquired by Baxter); co-founder and CEO of ACIST Medical (1991–1995); senior sales and marketing roles at a cardiac company later acquired by Boston Scientific; chair of Preceptis Medical and Phraxis Medical

Motley Fool AU; S-3ASR 2026

Wayne Paterson

Vice Chairman, CEO

Executive director

See above

—

David St Denis

Executive director, President

Class II, Mar 2025

See above

8-K Mar 2025

David Roberts

Independent director

7 Jun 2025; Class III (term to 2027); Audit & Risk and Compensation committees

President of LeMaitre Vascular (joined 1997; CFO from 2000)

8-K Jun 2025

Gregory Moss

Independent director

7 Jun 2025

Chief Business & Legal Officer, Evommune; formerly EVP and General Counsel at Kadmon (acquired by Sanofi for USD 1.9B in 2021)

8-K Jun 2025

Susan Knight

Independent director

11 May 2026; Class I (term to 2028); Audit & Risk Committee

Board Chair of Surmodics 2015–Nov 2025; former CFO of MTS Systems; 24 years at Honeywell

8-K May 2026

Stephen Denaro

Director (rejoined)

11 May 2026; Class II (term to 2026)

Company secretary of Anteris Australian subsidiaries; previously a director

8-K May 2026

Directors' Remuneration

ItemDetailSource

CEO options (2024)

300,000 options at USD 14.64 exercise price (translated from AUD), vesting in three equal annual tranches from 19 Jun 2024

10-K FY2025

IPO RSUs

Paterson 1,000,000 (granted 3 Dec 2025 after stockholder approval); St Denis 500,000; McDonnell 83,333. Three-year annual vesting; double-trigger acceleration on change of control

10-K FY2025; AGM results Dec 2025

Director RSUs

52,742 RSUs each to Moss and Roberts on appointment; annual non-employee director RSU award with USD 125,000 grant-date fair value

Proxy 2025; 8-K May 2026

CEO total compensation

USD 3.04M (aggregator; 22.9% salary).

Simply Wall St

Related-party payments

USD 460k in Q4 2025 and USD 583k in Q2 2026 (director fees plus CEO, President and CFO salaries)

ASX supplementary disclosures

Major Shareholders

HolderShares% of outstanding (as reported)DateSource

Medtronic plc (via Covidien Group S.à r.l.)

15,652,17316.1

25 Feb 2026

10-K FY2025; Schedule 13D

Nantahala Capital Management

3,143,154

about 7.6 at the time; about 3.2 on the current share count (calculated)

31 Dec 2025

Schedule 13G/A

Perceptive Advisors

1,705,130

4.7 at the time; about 1.8 on the current share count (calculated)

30 Jun 2025

Schedule 13G/A

Competitive Landscape

Key Competitors

CompetitorKey TAVR platformPositioning vs DurAVR

Edwards Lifesciences

SAPIEN 3 family (balloon-expandable)

Market leader. Its balloon-expandable delivery is the ease-of-use benchmark DurAVR aims to match; three-piece leaflet design

Medtronic (also a 16.1% Anteris shareholder)

Evolut (self-expanding, supra-annular)

Strong hemodynamics in small annuli; the CEO noted recent Evolut disclosures could ease DurAVR's commercial path in small annuli and valve-in-valve

Abbott

Navitor (self-expanding)

Third global player

Boston Scientific

—

Exit would reduce the field

JenaValve

Trilogy (aortic regurgitation focus)

Edwards' acquisition attempt failed over FTC antitrust concerns

Meril Life Sciences

Myval (balloon-expandable)

Price-competitive challenger outside the U.S.

MicroPort CardioFlow

VitaFlow

China

Venus Medtech

VenusA

China

Peijia Medical

TaurusOne

China

Polymeric valve developers (e.g. Foldax)

Polymer leaflets

Alternative durability thesis

Competitor Detail

MetricAnteris (FY2025)

Revenue (USD Mn)

1.91

Revenue growth (%)

-29.2

Operating margin (%)

-4,908

R&D intensity (% of revenue)

3,619

Recent Developments

--

Company Snapshot

$1.9M

Revenue

174

Employees

$687.3M

Market Cap

1999

Founded

Toowong, Australia

Headquarters

SWOT Analysis

Strengths

  • A first-in-class single-piece molded tissue valve; no competitor has a disclosed equivalent (10-K FY2025).
  • Pooled data in 100 patients: mean gradient 8.2 mmHg, EOA 2.2 cm², 3% PPM, 0% mortality at 30 days (EuroIntervention / 10-K).
  • ADAPT tissue used in more than 55,000 patients, with up to 10 years calcium-free (Neethling et al.).
  • Cash of about USD 257–261M at 30 Jun 2026, against Q2 burn of USD 20.8M.
  • Medtronic holds 16.1%, a strategic endorsement (13D, Jan 2026).
  • IP estate of 47 active patents to 2045 plus 75 pending applications.

Weaknesses

  • FY2025 revenue of only USD 1.91M, declining 29%.
  • FY2025 net loss of USD 94.1M; accumulated deficit of USD 422.7M (Jun 2026).
  • Negative equity at FY2025 year-end and a going-concern flag in Q3 2025.
  • Single-asset concentration on DurAVR.
  • Single-source suppliers for pericardium (Harvey, contract expiring May 2026) and knitted materials (Aran).
  • FDA's request for additional bench testing delayed PARADIGM by one quarter in 2025.

Opportunities

  • A TAVR market of about USD 10–12B with only 15–20% of patients treated.
  • Small annuli (about 40% of the market) and valve-in-valve segments where DurAVR's hemodynamics are strongest.
  • Potential Medtronic co-commercialization or acquisition (CEO commentary, Jan 2026).
  • Younger, low-risk patients for whom durability matters most.
  • CMS coverage already in place for trial procedures (Apr 2026).
  • TEER optionality through v2vmedtech.

Threats

  • PARADIGM must show non-inferiority against mature incumbents on hard endpoints (death, stroke, cardiovascular hospitalization).
  • Incumbent iteration and pricing pressure.
  • Equity overhang: USD 250M ATM, resale registrations of 9.1M and 5.39M shares, and warrants at USD 4.90.
  • Analyst downgrade sentiment (Barclays reported at Equal Weight, USD 10, Oct 2026).
  • Concentration risk if Medtronic's interests diverge (risk factor).
  • Patent litigation endemic to the TAVR field.

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Key Developments

DateEventSignificance
May 2025Q1 2025: net loss USD 21.9M (+36%); cash USD 49.0MRising burn
May–Jun 2025European and global PARADIGM investigator meetings; 79 sites qualifiedTrial readiness
7 Jun 2025Roberts and Moss join board; Gu resignsU.S. governance
16 Jul 2025Two Admedus legacy entities deregisteredSimplification
28 Jul 2025Switchback amended and restated MSASupply chain
11 Aug 2025Q2 2025: cash USD 28.4MFinancing pressure
Sep 2025Special meeting adjourned for lack of quorum (ASX LR 7.1 waiver), reconvened 29 SepShareholder engagement issue
Q3 2025FDA requested additional bench testing; PARADIGM start shifted from Q3 to Q4 2025Delay
Oct 2025Danish approval; first PARADIGM patients treatedTrial start
23–27 Oct 2025USD 25.2M PIPE with warrantsBridge financing
27 Oct 2025TCT 2025: 1-year small-annulus outcomesClinical support
3 Nov 2025FDA IDE approval (staged 200 patients)U.S. trial unlocked
13 Nov 2025Q3 2025: cash USD 9.1M; going-concern flagLiquidity low point
Nov 2025PCR London Valves: 30-day data in 100 patientsClinical support
26 Nov 20254C non-renewal noticeExit from tissue supply
Dec 2025AGM approves CEO IPO RSUs and director grants; resale registration for 9.1M shares; USD 500M shelf filedCapital readiness
8 Jan 2026S-3 effective—
20–22 Jan 2026USD 230M offering plus USD 90M Medtronic placementTransformational funding
Jan–Feb 2026Lake Street PT cut USD 20 → 15 (Buy); Barclays PT cut USD 22 → 17 (Overweight)Dilution reset
26 Feb 2026FY2025 10-K: net loss USD 94.1M—
5 Mar 2026TD Cowen fireside: about 140 patients, 5–10 mmHg gradients; small annuli about 40% of marketInvestor positioning
~Mar 2026Wells Fargo initiates at Overweight, PT USD 16Coverage
~Apr 2026Cantor Fitzgerald assumes at Overweight, PT USD 15Coverage
28 Apr 2026CMS reimbursement for PARADIGM (NCD 20.32)U.S. enrollment enabler
5 May 2026First U.S. patients treated (Montefiore)U.S. start
11–13 May 2026Q1 2026 results (operating cash out USD 28.7M); Knight and Denaro join board—
May 2026USD 250M ATM program; Barclays PT raised to USD 18Financing flexibility
8 Jun 2026French ANSM clearanceEU expansion
~Jun–Jul 2026Resale registration for 5.39M shares; S-3ASR filed 1 JulOverhang
13 Jul 2026Thought-leadership release reframing the TAVR marketNarrative
Jul 2026Employee incentive equity issuance; Appendix 3GRoutine
11 Aug 2026Q2 2026: R&D USD 23.4M; cash about USD 260.9M; New York Valves presentation—
31 Aug 2026Announces September investor conference schedule—
~6 Oct 2026Barclays coverage reported as initiated at Equal Weight, PT USD 10 (previously Overweight, USD 18); shares -6.6% that daySentiment shift

Financial Performance

Explore key financial metrics, segmented revenue, balance sheet health, and performance trends.

Revenue

4 charts
Income Statement: Revenue & Gross Profit: Revenue fell from USD 5.7 Mn in FY2021 to USD 1.9 Mn in FY2025.
Anteris Technologies Ltd — Income Statement: Revenue & Gross Profit
Series (USD Mn)FY2021FY2022FY2023FY2024FY2025
Revenue5.73.12.72.71.9
Cost of revenue1.21.41.91.40.6
Gross profit4.51.80.91.31.3

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