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www.admedus.com Follow us @Admedus AHZ AGM 2019 Chairman and CEO 2018 company review For personal use only

AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Page 1: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Follow us @Admedus

AHZ AGM 2019

Chairman and CEO 2018 company review

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Page 2: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

2018 Financial Overview

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Page 3: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

CY18 Financials

• Group revenue up 20% on prior year. ADAPT® revenue $11.1m and Infusion revenue $14.5m

• Gross profit for the group was $12.4m representing a gross margin percentage of 49%.

• Selling, general and administrative (SG&A) costs includes research and development of $6.7m

• SG&A costs for ADAPT® have declined as a percentage of revenue from 144% in prior year to 122%

$ millions CY2018

Group revenue 25.6

Gross profit 12.4

Gross profit margin % 49%

Selling, general and administration costs (34.3)

Other net income 1.2

EBITDA (20.7)

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Page 4: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Revenue and profit split across the business units

ADAPT® has grown from 34% of the portfolio to almost 43% in 1 year

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Page 5: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Profit growing faster than costs 2015 to 2018

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Page 6: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Gross profit and revenues growing significantly faster than costs 2015-2018

GP up 272% since 2015

Revenues 115% since 2015

SGA up 11% since 2015

0%

50%

100%

150%

200%

250%

300%

GP REV SGA

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Page 7: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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CAGR Revenue and GP growing quicker than costs

40%

55%

20%

31%29%

14%12%

3%

11%

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

4YR 3YR 2YR

% GP Growth % Rev Growth % SGA Growth

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Page 8: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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ADAPT® GP and revenue growth 2016 to 2018

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Page 9: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Investments driving growth in Revenues and Profit

$3.5 M $3.3 M $3.3 M

$8.6 M

$11.6 M$12.4 M

$11.5 M

$21.9 M

$31.0 M

$27.8 M $27.7 M

$34.3 M

$8.2 M $8.6 M

$11.9 M

$19.8 M$21.4 M

$25.6 M

$9.2 M

$17.5 M

$22.3 M$20.9 M

$22.8 M

$27.6 M

$0.0 M

$5.0 M

$10.0 M

$15.0 M

$20.0 M

$25.0 M

$30.0 M

$35.0 M

$40.0 M

2013 2014 2015 2016 2017 2018

GP $ SGA $ Revenue $ SGA $ exc R&D

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Page 10: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Q1 US ADAPT® sales 2016 - 2019

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

2

Q1 2016 Q1 2017 Q1 2018 Q1 2019

Chart Title

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Page 11: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Q1 Global ADAPT® sales 2016 - 2019

0

0.5

1

1.5

2

2.5

3

Q1 2016 Q1 2017 Q1 2018 Q1 2019

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Page 12: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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ADAPT® Revenue by QTR

North America

69%

Europe20%

Emerging Markets

11%

Sales by region

North America Europe Emerging Markets

1Q

16

2Q

16

3Q

16

4Q

16

1Q

17

2Q

17

3Q

17

4Q

17

1Q

18

2Q

18

3Q

18

4Q

18

-

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Revenue$m

Revenue by Quarter

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Page 13: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Headcount & Employee Location

Jul-

17

▪ Global headcount remained relatively flat in FY2018

▪ As overall revenue grew in Q3 & Q4, global headcount went down leading to greater effectiveness & efficiencies

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Page 14: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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FX impact as cost base moves to the US

69%

63%61%

18%

26%

30%

14%

11%9%

0%

10%

20%

30%

40%

50%

60%

70%

80%

CY 16 CY17 CY18

FTE headcount

Australia USA Other

57.1%

24.1%18.8%

59.2%

26.8%

14.0%

43.5%47.9%

8.6%

Australia USA Other

SGA (incl. R&D) split by region

CY2016 CY2017 CY 2018

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Page 15: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

FX IMPACT 2018

0

2

4

6

8

10

12

14

16

18

CY18 USD CY18 AUD (equivalent of USD costs)

Mill

ion

s

Impact of weak AUD on US costs

Employee benefits Other SG&A

converts to

USD12.3

AUD16.4

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Page 16: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Shareholder mix as at 7 May 2019

23%

22%

11%

44%

Split of all shareholders at 7 May 2019

Star Bright

Sio

Other top 20

Other

Star Bright Group

Sio Capital Management

Other

Other top 20

40%

40%

20%

Split of top 20 shareholders at 7 May 2019

Star Bright

Sio

Other top 20

Star Bright Group

Sio Capital Management

Other top 20

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Page 17: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Infusion Division

• Binding sale agreement signed between Admedus and BTC

• AUD $ 6.3 million for Summit range of pumps.

• Transaction will close 31st May. Full transition of the business will be complete by June 1st.

• Headcount reduction of 19%

• Admedus will retain the Arcomed range of pumps and associated business

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Page 18: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

ADAPT® Commercial Update

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Page 19: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

Taking Market Share From Larger Competitors

North America MAT 2018

MAT

Despite being outnumbered 6 to 1 by our major competitors, our highly specialized

field force drove awareness and adoption of the ADAPT® platform…

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Page 20: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

2018 North America – becoming the company to beat

Our Science

Meta-Analysis demonstrating superiority over alternatives

GROWING

+67%

USA, Canada, 4C

Becoming the Standard

POSITIONING

Competition on the Defensive: “we’re just as good”

Admedus is well positioned for

Market LeadershipDurability, Consistency, and Regeneration are key attributes sought in Tissue Technology

SHAPE MATTERS

In Congenital Heart Disease

CardioCel 3D® expanded Portfolio (60&30)

Health Systems

4 IDNs and 1 Major GPO Signed

Our Value

ADAPT® DATA

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Page 21: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

2018 Europe – revitalized team and return to revenue growth… hampered by

regulatory change driven delays

Our Science

Repositioning to Emphasize clinical superiority

Recovery

Halted Decline

Returned to Growth

Revitalization

TEAM

New RVP, Reps, Distributors

Anticipation of MDR

Regulatory DelayNew Indications and Line Extensions requiring more data, Notified Bodies unprepared for changes

SHAPE MATTERS

Launch Preparation 3D-60°

Built market anticipation, positioning, and pilot centers

Health EconPublication in Health Economics Journal demonstrating benefit of ADAPT

Our Value

ADAPT® DATA

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Page 22: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

2018 Emerging Markets – continued growth despite some challenges

GROWING

+127%

MENA largest contributor and continued growth YoY

New Approvals

MARKET ACCESS

Vietnam, Kuwait 3D, etc.

Lessons Learned

INDIA

Key Success Factors and Market Specificities

TGAGrew Business by 100% via Special Access which demonstrates strong demand pre-approval

Regulatory DelayEMERGING MARKETS MAT 2018

MAT

ADAPT® becoming recognized as

innovative platform – strongly

differentiated from alternatives

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Page 23: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

Medical & Reg Affairs

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Page 24: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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CardioCel® Approval StatusLegend

CC & CC3D Approved

CC ApprovedCC3D In Process

CC Approved

CC In Process (SAP)

CC In Process

Future Registrations

Source: Admedus Regulatory Tracking (REG UPDATE STATUS LIST_24FEB 2019.xlsx)

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Page 25: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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VascuCel® Approval Status

Legend

Approved

Approval In Process

Not Yet Pursued

Source: Admedus Regulatory Tracking (REG UPDATE STATUS LIST_24FEB 2019.xlsx)

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Page 26: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Preclinical updateEarly Animal data suggests

• Normal valve function after aortic valve replacement with Admedus 3D aortic prosthesis

• Easily implanted• No surgical failure• Low gradients and no

regurgitation were observed.• Good overall clinical status of the

animals

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Page 27: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

2019 Strategy Update

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Page 28: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Creating ADAPT® brand equity since 2016

First and only

✓Bio scaffold with true anti-calcification treatment

✓Bio scaffold with 10 years of data in man

✓Bio scaffold with ZERO DNA

✓Bio scaffold to be moulded into a 3D valve

✓Product now far more widely known by Dr’s , competitors and major strategics

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Page 29: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

2019 ADAPT® set for further growth

Our Science

“First and only data “ Being Published & Presented at major congresses

ropeGROWTH

Portfolio expansion and new launches

USA, Europe

Precision Tissue Technology

Q4 LAUNCH READY

Starting USA (followed by Europe)

Admedus is well positioned

ADMEDUS TAVR

Durability is becoming a key driver for Cardiologists treating low risk (younger patients)

SHAPE MATTERS

In Congenital Heart Disease

& CardioCel 3D® now approved both US & EU

PRICING STABLE

In US & EU

ADAPT® DATA

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Page 30: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Patches landscape (global sales)

Dural Repair($320 M)

Cardiac($1,900M)

CCD

Adult

Soft Tissue($1,700 M)

Vascular($800 M)

Peripheral vascular reconstruction

Hernia (70%)

Wall defects (26%)

Source: Grand View Research report – Global 2020

opportunity

approved Indications For

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Page 31: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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New technology enables new markets

Patch Valves Catheter Conduit

ADAPT® - 3 Dimensional Shaping - PTT

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Page 32: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

TAVR UPDATEFor

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Page 33: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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What's driving the growth in TAVR

• CAGR reported to be 22% and approximately USD 12 bn by 2025

• Less invasive , quicker recovery period

• Quicker procedure times

• Recent data released by Medtronic and Edwards support the use of TAVR in “low risk” patients (i.e. younger)

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Page 34: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

www.admedus.com

Data released in March from two studies suggest TAVR is beneficial in “low risk” patients

Study 1 Study 2

Objective To assess the safety and efficacy of TAVR with SAVR in low-risk patients. (N,1403), 24 month follow up

To evaluate TAVR compared with SAVR among low-risk patients . (N1000), 1 year follow up

Primary Endpoint All-cause mortality or disabling stroke (24 months)

All-cause mortality, stroke, or rehospitalization (1 year)

TAVR vs SAVR 5.3% vs. 6.7% (p < 0.05 for noninferiority, p > 0.05 for superiority).

8.5% vs 15.1% (p < 0.001 for noninferiority, p = 0.001 for superiority

TAVR vs SAVR Also at 2 years, all-cause mortality was 4.5% vs. 4.5% (p > 0.05). Disabling stroke was 1.1% vs.3.5% (p < 0.05).F

or p

erso

nal u

se o

nly

Page 35: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

Structural Valve Deterioration happens in stages

*Salaun E, Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation. Heart, (August 2018).

“Calcification is the very first sign of Structural Valve Deterioration”

AATS, May 6, 2019(Philippe Pibarot, Quebec, Canada)

The latest definition of structural valve deterioration can be categorised into three stages:

Stage 1: morphological abnormalities (fibrocalcific remodeling and tear) of bio prosthesis valve leaflets without hemodynamic valve deterioration;

Stage 2: morphological abnormalities and moderate hemodynamic deterioration (increase in gradient and/or new onset of transvalvular regurgitation); and

Stage 3: morphological abnormalities and severe hemodynamic deterioration.

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Page 36: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Durability is more than anti calcification

• Anti calcification is one key element effecting durability

• Structural elements play a role including :

1. Valve design

2. Manufacturing inputs such as sutures

3. Leaflet structure

4. Tissue properties

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Page 37: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Successful Valve Leaflet Motion Over 100 Million Cycles

4 Million 40 Million 100 Million

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Page 38: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Valve Tissue Conclusive Remarks

Durability

Results

Zero suture tears up to 100 million cycles

Zero visible tissue fatigue up to 100 million cycles

Zero visible change in GOA/EOA (0 to 100 million cycles)

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Page 39: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

Value thru Durable TAVR technologies that will last longer than 10yrs

Admedus Leadership

2nd Generation TAVR(Durability & Hemodynamics)

1st Generation TAVR(Complications & Procedural Efficiency)

Admedus will win the “Durability Race” in TAVR

Data showing superiorty in low risk (younger) TAVR patients

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Page 40: AHZ AGM 2019 · Shareholder mix as at 7 May 2019 23% 22% 11% 44% Split of all shareholders at 7 May 2019 Star Bright Sio Other top 20 ... Durability, Consistency, and Regeneration

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Conclusion

• Admedus will be a single focused structural heart company post divestiture

• Commercial sales of ADAPT® continue to grow significantly in the US YOY

• Clinical data demonstrating superiority continues to be published. 10 year anti calcification data now complete

• Feasibility study concluding and first explants being examined

• Rapid progress on TAVR project. New data creates the perfect storm for valve durability.

• Planning FIH for 3D valve has commenced

• Company and brand profile now globally recognized within the industry

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