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Anteris Technologies Global Corp. AGM Information 2020

May 14, 2020

33869_rns_2020-05-14_a9b1fedb-9966-4176-8c19-fac9c3e45a5f.pdf

AGM Information

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15 May 2020

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ASX ANNOUNCEMENT

ANNUAL GENERAL MEETING ADDRESS

BRISBANE, 15 May 2020: Admedus Limited (ASX: AHZ) is pleased to provide the attached Chief Executive Officer’s Address and presentation to the Annual General Meeting being held today.

Yours sincerely

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Stephen Denaro Company Secretary

Admedus Limited

T: 1300 550 310 F: 1300 880 398 International: T: +61 (0)7 3152 3200 F: +61 (0)7 3152 3299 E: [email protected] W: admedus.com

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Registered Office: Suite 302, Level 3 Toowong Tower, 9 Sherwood Road, Toowong QLD 4066 Customer Service:

Brisbane • Minneapolis • Geneva • Singapore

ABN 35 088 221 078

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About Admedus Limited (ASX: AHZ)

Admedus Ltd is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. Its focus is on developing next generation technologies with world class partners.

Authorisation and Additional information

This announcement was authorised by Mr Steve Denaro, Company Secretary.

For more information:

Ms Kyahn Williamson WE Communications E: [email protected] P: +61 401 018 828

www.admedus.com Twitter: @Admedus Facebook: https://www.facebook.com/admedus/

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Presentation by Wayne Paterson, Chief Executive Officer & Managing Director

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Reproduction of this material in any form without the permission of Admedus is prohibited

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Reproduction of this material in any form without the permission of Admedus is prohibited

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Reproduction of this material in any form without the permission of Admedus is prohibited

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Reproduction of this material in any form without the permission of Admedus is prohibited

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Admedus Ltd AGM May 2020

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Developing the world’s most durable heart valve
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  • Group continues to expect the coronavirus impact to be minimal

  • Alternate suppliers identified to source at-risk supplies and manufacturing inputs

  • Restricted manufacturing site access to required personnel only. Production team split and staggered to reduce unnecessary interaction (Mid-Mar)

  • Office staff in all sites working remotely

  • Directors and Senior executives taken a 25% pay reduction effective May 2020.

  • No significant impact on operations

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Reproduction of this material in any form without the permission of Admedus is prohibited

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2019 – A year of transactions

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2019 – Restructuring for the future
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Divestments enabled company to focus on high potential opportunity for DurAVR™

Infusion division

  • Low margin business sold for AUD $6.3 million

  • Company headcount reduced by 18

Immunotherapies

  • Admedus ceased funding in 2017 due to low probability of success and high funding requirements

  • Division was put into administration in 2019

CardioCel division

  • Highly competitive market requiring scale and high cost base

  • Sold for AUD $20.3 million up front

  • Company headcount reduced by 23

Reproduction of this material in any form without the permission of Admedus is prohibited

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  • 2019 saw multiple transactions and divestitures which enabled the company to exit lower margin lower potential businesses

  • Transactions raised non – dilutive capital for investment into significantly higher potential opportunities.

  • Transformed the company from a low revenue company to a full scale Med Tech development company

  • Company can leverage the considerable benefits of its ADAPT® technology and DurAVR™ 3D single-piece valve.

  • Company now has access to a potential *USD $4.7 billion dollar market.

  • *2020 Market size incudes SAVR and TAVR

Reproduction of this material in any form without the permission of Admedus is prohibited

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$17.1M $24.9M 75%
Sales Revenue Profit on Sale Improvement in Result
of divestments compared to prior year
$16.1M 42.1
Total Full Time
Cash
(including term deposits) Equivalent Staff
compared to decreased from 82.5 in the prior period
$12.0M in prior year driven by two divestments
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Reproduction of this material in any form without the permission of Admedus is prohibited

CY19 Financials

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$ millions
CY2019
CY2018
$ millions
CY2019
CY2018
$ millions
CY2019
CY2018

Group revenue of $17.1M
– ADAPT® revenue: $10.2M
– Infusion revenue: $6.9M

Gross profit margin 49% (2018: 49%)

Other income includes transaction
gains

Impairments linked to Vaccines and
residual PPE
Group revenue 17.1 25.6
Cost of sales (8.8) (13.2)
Gross profit 8.3 12.4
Other income 25.5 0.1
Selling, general and administrative costs (32.4)
(4.5)
(3.1)
(34.3)
-
(2.9)
Impairment
Other
NLAT (6.2) (24.7)
  • All values are in Australian dollars (AUD)

Reproduction of this material in any form without the permission of Admedus is prohibited

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Investments drive results
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  • Group continues to invest in Research & Development to accelerate its product development pipeline

  • • Benefits of divestments flowing through

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Exchange rate driving AUD reported costs

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AUD 17.6M
AUD 16.3M
AUD 15.9M

USD $12.3M of
expenses incurred in
USD 12.3M
2019 converting into
$A17.6M

The same USD $12.3M
in 2017 converted into
$A15.9M
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Reproduction of this material in any form without the permission of Admedus is prohibited

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Developing the world’s most durable heart valve
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Capitalizing on the multi-billion dollar TAVR opportunity
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Market Potential of AVR as
Treatment of SAS
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$10 $8 $6 $4 $2 $- SAVR TAVR

By 2025, Global Aortic Valve Replacement to reach $8B USD*

TAVR is expected to be 62% of procedure volume and 87% of market revenue.

CAGRTAVR 15.6%

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$6.9B
$2.5B
$1.1B $1.1B
2018 2025
TAVR SAVR
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  • Includes Tier 1 markets (US,EU) and China; data on file

Reproduction of this material in any form without the permission of Admedus is prohibited

Reproduction of this material in any form without the permission of Admedus is prohibited

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Why a durable heart valve matters
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  • The FDA approved the use of TAVR in “low risk” (younger) patients in 2019.

  • As a result replacement valves need to be durable and long lasting.

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Currently marketed TAVR valve showing significant calcification

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Major studies of TAVR “vs” SAVR in low risk* (younger patients) are underway

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  • trials to be conducted over 10 years to assess differences between surgical replacement valves (SAVR) and transcatheter valves (TAVR) in low risk patients

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FDA has approved TAVR in low risk (younger patients)
30 24 K Valves may need to last 15 years or more
Women in younger patients treated with TAVR
Men
25 20 K
Structural Valve Deterioration (SVD) is
Valve Durability
the driving factor behind the need for
20 20 Years 16 K increased durability
15 15 Years 12 K
Thrombosis
SVD
Endocarditis
10 10 Years 8 K
5 5 Years 4 K Pacemaker
Average age
Non-SVD PVL
of patients in
low risk trials 73 Prosthesis Mismatch
0 0 K
45 50 55 60 65 70 75 80 85 90 95 100

Age at Valve Implantation (years) Data shows valve failure as early as 5 years
TAVR today TAVR tomorrow
Life Expectancy (years)
TAVR Volume (by age at implant)
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Lancalotti et al;

Courtesy of Windecker S. TCT 2019 Barbanti et al; J AM HeartAssoc 2018

*Popma FF, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019;380(18):1706-1715.

*Mack, MJ, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380(18):1695-1705

Reproduction of this material in any form without the permission of Admedus is prohibited

Replacement valve deterioration is a key area of research

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Reproduction of this material in any form without the permission of Admedus is prohibited

DurAVR™ addresses the key areas that lead to valve deterioration

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Only DurAVR™ is made from ADAPT® treated Ca [+2] DurAVR™ is made from one
tissue with superior anti calcification properties
piece of tissue resulting in 35%
less stress on the leaflets
Other valves are constructed from
tissue that has residual DNA
which promotes inflammation and
immune response that
sub-optimal coaptation
leads to calcification
lower manufacturing costs
DurAVR™ has no residual
glutaraldehyde
Other valves require 100’s of
sutures per valve during
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Other valves are constructed of three separate pieces of tissue resulting in greater stress and sub-optimal coaptation DurAVR™ has 20-30 sutures = lower manufacturing costs

Other valves require 100’s of sutures per valve during manufacturing

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Other valves have residual glutaraldehyde
which is toxic and requires manual
rinsing pre-implantation
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Addressing even one of these could be a significant competitive advantage… The DurAVR™ 3D single-piece heart valve addresses all of these.

Reproduction of this material in any form without the permission of Admedus is prohibited

Data on File Barbanti et al; J AM HeartAssoc 2018

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DurAVR™ Durability experiments continue to be positive
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ACCELERATED WEAR TESTING SHEEP CALCIFICATION MODEL Admedus Valve shows no wear at 400 million cycles A hostile environment for valves Well Anchored Supple Clean Margins Day 1 200 million 400 million Sutures Cusps (Annulus) Competitor Valves demonstrate wear and may Valves implanted in juvenile sheep and assessed at 6 months: breakdown at 250 million cycles • ADAPT® aortic valves show no calcification

Data on File

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DurAVR™ is addressing the key issues impacting valve durability

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  1. We have a unique tissue science (ADAPT®) which has zero DNA and proven not to calcify over 10 years in humans

  2. 3D single-piece Aortic Valve (DurAVR™) which has shown no signs of wear over 450 million cycles (approx. 10 years )

  3. DurAVR™ is now being studied in humans with excellent early results

  4. Evidence is building that indicates superior hemodynamics*

  5. DurAVR™ has addressed the key variables that lead to longer lasting valves. The tissue science and valve design.

  6. Data continues to show consistent results, however experiments and trials are ongoing

Reproduction of this material in any form without the permission of Admedus is prohibited

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Key Clinical and Preclinical Programs

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  • 2020 Milestones

  • First in Human DurAVR™ THV Conduit

  • DurAVR™ SAVR Anti-Calcification Preclinical Proof of Concept

  • Feasibility Clinical Comparison Study Animal Studies Animal Study

  • Study Ca + 2

  • • Confirm safety and clinical • Successful transcatheter access, • Confirm ADAPT® Technology’s • Proof of Concept Study of performance of 3D single-piece valve deployment and delivery of superior resistance to calcification • ADAPT® Technology processed single-piece 3D valve vs. a commercially available conduit

  • • ClinicalTrials.gov Identifier: anti-calcification technology tissue NCT0417821 • Acute and Chronic implants commonly used in surgical and • Potential Carotid and Coronary TAVR valves. Bypass Graft

  • • Ethics Committee Approval • (Feb 2020) • Assess optimal valve function and improved hemodynamics

  • • Belgium Competent Authority Approval (Mar 2020) • Data (along with FIH) could bolster

  • • First Patient Enrolled and Successfully our position with regulatory bodies Discharged (Apr 2020)

Reproduction of this material in any form without the permission of Admedus is prohibited

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ADAPT®
Portfolio Patent Filings
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YTD in 2020, the Company has filed 18 applications worldwide for its 3D valve and its novel sterilized packaging system.

If all proposed additional filings due later in 2020 are filed, total patent applications filed on the ADAPT® portfolio will be 2X their 2019 levels.

Reproduction of this material in any form without the permission of Admedus is prohibited

Key Opinion Leader Advocacy supports the science

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  • Dr. Paul Sorajja (Abbott Northwestern, Minneapolis)

  • World renowned interventional cardiologist

  • First podium presentation of our TAVR at 2019 Cardiovascular Innovations Conference (07/19)

  • Dr. Alan Zajarias (Washington University, St. Louis)

  • Advancements in tissue technology in TAVR specifically with ADAPT[®] at the Cardiovascular Innovations Conference (07/19)

  • Dr. Kiran Bhirangi (Admedus, CMO)

  • Next generation ADAPT[® ] treated BioScaffold at TCT Meeting during Innovation Session (09/19 )

  • EACTS Symposium (Prof Meuris, Belgium)

  • Over 110 cardiac surgeons in attendance, the benefits of the Next Generation ADAPT[® ] BioScaffold in Aortic Valve Repair to Replacement (10/19)

  • Dr. Vinayak Bapat (New York Presbyterian / Columbia University)

  • Presented Admedus Innovative TAVR Device at PCR London Valve innovation session (11/19)

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DurAVR [TM]
First in Human study patient #1
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Patients with other
DurAVR
surgical valves
Patient 1
(N>1400)
Peak Gradient 23 11
Mean Gradient 11 5
EOA 1.9 2.9
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  • Average of 1400 patients implanted with commercially available surgical valves at Leuven University Hospitals Reproduction of this material in any form without the permission of Admedus is prohibited

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Anteris™ – A new name for a new direction
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A new name to reflect the Company’s new positioning

Anteris is associated with wasps

  • Wasps are:

  • Industrious

  • Team focused

  • o Great engineers

  • o Undaunted by larger foes

  • o Aggressive

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Reproduction of this material in any form without the permission of Admedus is prohibited

Developing the world’s most durable heart valve

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The right science

  • ADAPT® anti-calcification treatment is proven over 10 years in humans, with zero calcification in published studies

The right design

  • The DurAVR™ 3D single-piece valve is proven to have less wear at the leaflets than conventional valves

The right time

  • The FDA approved the use of TAVR in “low risk” (younger) patients in 2019. Replacement valves need to last longer.

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Capitalizing on the assets

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Discussions are ongoing with several of the large MedTech companies

Potential partnership deals could include:

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  • Licensing of ADAPT® technology to existing in-market TAVR and SAVR products

  • Supply of ADAPT® treated material for current in-market products

  • Co development of DurAVR™

  • Co Commercialisation of DurAVR™

Reproduction of this material in any form without the permission of Admedus is prohibited

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World class TAVR specific advisory board
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Gorav Ailawadi, MD University of Virginia Health System Charlottesville, VA

Vinayak Bapat, MD New York-Presbyterian/Columbia Medical Center, New York, NY

Susheel Kodali, MD Columbia University Medical Center New York, NY

Susheel Kodali, MD Christopher Meduri, MD Columbia University Medical Center Piedmont Heart Institute New York, NY Atlanta, GA Jeffery Popma, MD Paul Sorajja, MD Harvard Medical Abbott Northwestern Hospital Boston, MA Minneapolis, MN

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Samir Kapadia, MD Cleveland Clinic Cleveland, OH

Michael Reardon, MD Houston Methodist DeBakey Heart & Surgery Vascular Center, Houston, TX

Alan Zajarias, MD Center for Advance Medicine Heart & Vascular St. Louis, MO

Reproduction of this material in any form without the permission of Admedus is prohibited

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OPPORTUNITY SUMMARY

Total Aortic valve replacement market expected to be $7B USD or more by 2025

THE RIGHT TIME

FDA has approved TAVR in younger, lower risk patients creates need for ultra-durable valve

THE RIGHT TECHNOLOGY

DurAVR™ 3D single-piece aortic valve with ADAPT® tissue technology

  • Superior resistance to calcification

  • Scientific evidence of superior durability and hemodynamics

THE RIGHT OPPORTUNITY

TAVR in younger, lower risk patients creates need for ultra-durable valve

  • ADAPT® advantages support business development opportunities

  • Path forward for partnering or independent TAVR development in select markets

More to come - parallel early-stage R&D:

  • large potential markets for other structural heart indications, as well as non-structural heart indications, with

  • potential to be best-in-class using ADAPT®

Reproduction of this material in any form without the permission of Admedus is prohibitedReproduction of this material in any form without the permission of Admedus is prohibited