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Anteris Technologies Global Corp. — AGM Information 2018
May 23, 2018
33869_rns_2018-05-23_67dd5a9f-0524-438a-b7a3-f473350f7683.pdf
AGM Information
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Annual General Meeting 2017 (Jul-Dec) Chair’s address
www.admedus.com Follow us @Admedus
Key Strategic milestones
July to December 2017
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Clinical superiority of ADAPT technology
-
9+ years without calcification or toxicity
-
Delivering real health benefits in 135+centres around the world
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Strong ADAPT revenues
-
Increased sales in Europe
-
Launches into emerging markets
-
Expansion of product range
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Infusion sales growing >$1m/month
-
new Royal Adelaide Hospital opened in Sep 2017 with >2,500 Infusion pumps
-
Consumables sales growing
TAVR prototype unveiled
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CardioCel 3D - the Gamechanger
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Business partnerships
-
IP applications submitted
-
Signals entry into a market worth US$3.5B growing to US$5B by 2020
-
Concluded comprehensive user-evaluation program
-
Ready for launch in the US in January 2018
-
Exclusive supply agreement with 4C Medical Technologies Inc. for their TMVR technology
-
Lends credibility to our unique biomaterial
Annual General Meeting 2017 (Jul-Dec)
CEO Presentation 24th May 2018
www.admedus.com Follow us @Admedus
Financial Review
4
www.admedus.com
The transition : July to December 2017
| $ millions | 6 months to Dec 2017 |
|---|---|
| Group revenue Gross profit |
11.3 6.7 |
| GM% | 59.0% |
| Selling, general and administration costs | (14.8) |
| Other Income | 0.4 |
| EBITDA | (7.7) |
| Net interest expense | (0.2) |
| Depreciation and amortisation | (0.9) |
| Operating income / (loss) after income tax | (8.8) |
-
Admedus changed its financial year-end from 30 June to 31 December.
-
This change more closely aligned Admedus’ reporting period with its global business sales cycles, assisting with forecasting, cash flow management and investment decisions.
-
Admedus’s recently published statutory financial statements reported on a six-month accounting period from 1 July 2017 to 31 December 2017.
Financial results 2016/2017 - with Code Red impact pre-transition
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$ millions FY17 FY16 Change
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| Group revenue | 22.3 | 14.2 ↑ | 58% |
|---|---|---|---|
| Gross profit | 10.7 | 5.1 ↑ | 110% |
| GM% | 48.1% | 36.2% ↑ | 12%pts |
| Selling, general and administration costs | (25.0) | (33.4) ↓ | 25% |
| Other income | 3.4 | 4.7 ↓ | (28)% |
| EBITDA loss | (10.8) | (23.6) ↓ | 54% |
| Depreciation and amortisation | (1.9) | (1.5) ↑ | (20)% |
| Operating income / (loss) after income tax | (12.7) | (25.1) ↓ | 50% |
| Net working capital | 6.0 | 4.1 ↑ | (46)% |
| Net working capital % sales | 27.0% | 29.2% ↓ | (2)%pts |
| Net operating cash outflows | (12.5) | (21.9) ↓ | 43% |
6
www.admedus.com
CY16 vs CY17 with Code Red impact now appearing in second half CY 2016
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$ millions CY2016 CY2017 Change
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| Group revenue | 19.8 | 21.4 | ↑ | 8% |
|---|---|---|---|---|
| Gross profit | 8.6 | 11.6 | ↑ | 34% |
| GM% | 43.5% | 54.3% | ↑ | 11% |
| Selling, general and administration costs | (27.8) | (27.7) | ↓ | 0% |
| Other Income | 2.4 | 3.5 | ↑ | 44% |
| EBITDA | (16.7) | (12.7) | ↓ | 24% |
| Net interest expense | 0.1 | (0.1) | ↑ | 267% |
| Depreciation and amortisation | (1.7) | (1.8) | ↑ | (4)% |
| Operating income / (loss) after income tax | (18.4) | (14.7) | ↓ | 20% |
2018 - Growth in GP is significantly > than growth in costs
| $ millions | CY2017 | CY2018 | Change | |
|---|---|---|---|---|
| Group revenue | 21.4 | 34.0 | ↑ | 59% |
| Gross profit | 11.6 | 21.3 | ↑ | 83% |
| GM% | 54.3% | 62.7% | ↑ | 8% |
| Selling, general and administration costs | (27.7) | (31.3) | ↑ | (13)% |
| Other Income | 3.5 | 0.0 | ↓ | (100)% |
| EBITDA | (12.7) | (10.0) | ↓ | 21% |
| Net interest expense | (0.1) | (0.8) | ↑ | (455)% |
| Depreciation and amortisation | (1.8) | (1.0) | ↓ | 47% |
| Operating income / (loss) after income tax | (14.7) | (11.8) | ↓ | 20% |
Profit outgrowing costs: 2015 to 2018F
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GP $ Revenue $ SGA % of Revenue
21.3 260% ▪ Record revenue of $34m (+59%)
34.0 in CY18 forecast
▪
ADAPT forecast to record 150%
revenue growth for CY18
11.6
▪
Infusion continues to provide
21.4 140%
8.6 19.8 129% solid base of revenue and
profitability, CY18 on track for
3.3 92% record earnings
11.9
▪
Product mix driving Gross
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-
Record revenue of $34m (+59%) in CY18 forecast
-
ADAPT forecast to record 150% revenue growth for CY18
-
Product mix driving Gross Margin improvement
2015 2016 2017 2018F
CAGR in expenditures significantly lower than growth in revenues and gross profit
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90.00%
85%
80.00%
70.00%
60%
60.00% 58% 57%
50.00%
43% 41% 42%
40.00%
31%
28%
30.00%
20.00%
9%
10.00% 6%
0%
0.00%
5YR 4YR 3YR 2YR
% GP Growth % Rev Growth % SGA Growth
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Costs declined by -35% as a percentage of revenue post Code Red
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SGA 91 % of revenues
31.3
2018 34
21.3
Costs declined by
35% as a function
27.7
2017 21.4 SGA 133% of revenues
of revenue post
11.6 Code Red
27.8
SGA 140% of revenues
2016 19.8
8.6
31
SGA 258% of revenues
2015 11.9
3.3
21.9
SGA 255% of revenues
2014 8.6
3.3
11.5 SGA 140% of revenues
2013 8.2
3.5
0 5 10 15 20 25 30 35 40
SGA REV GP
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A balanced business mix across the portfolio
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Gross Profit 2017 Revenue 2017
Infusion Infusion
51% 66%
ADAPT
49%
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Infusion
66%
ADAPT
34%
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Gross Profit 2018 Revenue 2018
Infusion
Infusion
38%
47%
ADAPT
53%
ADAPT
62%
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-
ADAPT Revenue to surpass Infusion revenue during 2018 ($18M vs $16M)
-
ADAPT Product lines generate higher Gross Margins (70% vs 48%)
Investments driving growth in Revenues and Profit
GP REV SGA
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40
35
34
31 31.3
30
27.8 27.7
25
21.9
21.4 21.3
20 19.8
15
11.5 11.9 11.6
10
8.2 8.6 8.6
5
3.5 3.3 3.3
0
2013 2014 2015 2016 2017 2018
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GM 2014 to 2018F investments driving growth
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$35.0 M
$30.0 M
$31.0 M $31.3 M
$25.0 M $27.8 M $27.7 M
$20.0 M $21.9 M
$21.3 M
$15.0 M
$10.0 M
$11.6 M
$8.6 M
$5.0 M
$3.3 M $3.3 M
$0.0 M
2014 2015 2016 2017 2018F
GP $ SGA $
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Growth of GP, revenues, SGA + SP 2015-2018
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600
GP grew 545% since 2015
500
400
300
Revenues increased 183% since 2015
200
SP decreased 45% since 2015
100
SGA increased 1% since 2015
0
GP REV SGA SP
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-100
Growth of GP, revenues, SGA + SP 2016-2018
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160
GP grew 147% since 2016
140
120
100
Revenues increased 70% since 2016
80
60
40
SGA increased 10%
20
SP increased 10%
0
GP REV SGA SP
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Share price trajectory 2015 – 2018 Reversing the long term decline
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$1.6000
$1.4000
-50% Jan15/Jan 16
$1.2000 Trading halt Jul16
$1.0000 +85% Nov17/May 18
-52% Jan16/May16
-76% Jan15/May16
$0.8000
-37% May16/Nov17
$0.6000
$0.4000
$0.2000 Change of Management BOD and Code Red
Debt round announced
implementation
$0.0000
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Business Review
18
www.admedus.com
ADAPT
Key highlights for ADAPT® portfolio in 2018
-
Significant investment of resources made in training sales force and the introduction of digital sales and marketing tools
-
•$7.0m
•Revenue by Quarter
-
ADAPT® launch in India late January 2018
-
CardioCel 3D® available in US from February 2018
-
•$6.0m
-
Distributor model introduced in Europe
-
ADAPT forecast to record 150% revenue growth for FY18
-
•$5.0m
-
•$4.0m
-
•$3.0m
•Sales by region
- •$2.0m •$1.0m •$0.0m
• 10
2018-Making friends and gaining traction
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ADAPT North America
Our 4 Pillar strategy is being executed according to plan ADAPT® US
Growth Q1 stronger than previous year
Qtr 1 Revenue Growth Comparison
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2,000,000
1,800,000
77%
1,600,000
1,400,000 1,511,287
1,200,000
1,000,000 9%
800,000
853,858
781,449
600,000
400,000
200,000
-
North America 1Q16 North America 1Q17 North America 1Q18
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Increase
Price Product Demand &
Access Management Introduction Utilization
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22
www.admedus.com
Solid progress Increase Access
Funnel Progress
HealthTrust Agreement Executed per plan – contract Awarded April
Next Step: drive agreements with High Potential HealthTrust IDNs
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-
Largest and highest priority system on track for June award
-
2[nd] & 3[rd] target systems on track for July award
-
4[th] & 5[th] priority targets in process – currently projecting award in August or September
Other Activities
1 Kaiser – significant progress, targeting agreement in December 2 Ascension - in process – progress slower than planned; working to expedite
3 Premier – decision to reprioritize this partnership due to strategic fit
Potential Upside
In process with two independent IDNs
-
one targeted June
-
• the 2[nd] July/August
23
www.admedus.com
VascuCel – year on year strong growth and robust opportunity funnel Product Launch
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Quarter 1 Quarter 2
UCD
SAH
FHS
ANA
VM
UML
WM
MD
SH
RB
YTD April 2017 YTD April 2018 OHH
BSA
FHV
Growth forecasted in Plan
VAC submitted Expected Approval
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Growth forecasted in Plan
for the year:300%
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24
www.admedus.com
Product Launch
Completed At VAC Approval Lab Scheduled
C
CardioCel 3D – agressively moving cases through the funnel
Since launch in mid-Q1, we have executed a robust education and training program, and developed clinical experience
-
Model requires education in the form of “dry lab” and then participation in first case by Admedus Clinical expert
-
Approach slightly slows the sales process, but ensures successful outcome with this specialised product
-
7 cycles completed already in Q2
-
12 labs completed and awaiting hospital committee approval (expected this month)
-
5 new labs scheduled already for the remainder of Q2
-
Pace will continue to increase throughout the year
-
33 units since launch
-
3D accounts for 18% of planned revenue for 2018
25
www.admedus.com
Demand New Products VascuCel and 3D strong, but CardioCel line also growing YoY
We have executed the plan we detailed at last AGM – a tremendous amount of new capability established while increasing sales
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CardioCel & CardioCel NEO
▪ Created New Training Program - “Admedus Institute”
46%
-
World class curriculum
-
Facilitates progression from territory Rep to Clinical Specialist
▪ Refreshed Field Force with new Rep profiles
-
Field force recruited and trained by Mid-February
-
All territories filled – no current vacancies
-
Attracted high performing reps from BioPharma and Regenerative Medicine
▪ New Area Manager structure for increased performance
-
Created 2 new regions under newly created regional manager position
-
▪ Recruited experience First Line Sales Manager for East Region
-
Implemented Metrics system around account management
▪ Re-organised territories
-
Reorganized territories to focus on strategic accounts
-
Penetration first, expansion second – more efficient
Qtr1 - 2017
Qtr1 - 2018
▪ Geographic expansion & penetration via third party partnerships
-
Engaged new partner for South Carolina, Georgia
-
Engaged existing partners to expand coverage in central and mid-west territories
26
www.admedus.com
ADAPT Europe
Executing the plan... establishing permanent presence and critical scale Europe
Performance was mixed in Q1 due to regulatory delay, despite major momentum on building operations….
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-
RVP recruited and on-boarded
-
Operational assessment completed
-
Vacant position in UK filled
-
New Rep in France recruited
-
Spain distribution contract signed
-
New agents for Poland, CH, and Benelux
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- Impending changes to regulations are impacting ongoing indication expansion
- While not yet in force, new Regs causing slowness in decisions
- Dossier harmonization originally planned Q2 is now projected to Q3
- Impacts CardioCel and 3D in forecast
-
7 New accounts opened in Germany
-
Permanent Geneva Office opened
-
EU Operations Manager hired – starts June 1st
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-
Delayed dossier harmonization offers opportunity to include VascuCel
-
Represents significant upside in 2[nd] half of year; will offset much of 1[st] half softness
28
www.admedus.com
ADAPT Emerging Markets
Emerging Markets
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Strong performance and clinical advocacy
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Performance in the region is further underscored by upcoming publication of unprecedented clinical results
▪ Q1 results above plan
-
India launched successfully
-
Turkey approval and first order received
-
Mexico regulatory submission ongoing
▪ New Australian business manager on-boarded – driving upsides in SAS and building launch readiness ahead of TGA approval (Q3)
Potential Upside
-
Mexico approval (not in plan)
-
3D submission to MENA, approval pending
-
Access path Japan
-
China regulatory environment shifting
30
www.admedus.com
Infusion
Infusion
Ahead of plan – remodelling for the future
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Leveraging solid performance, our restructured Infusion team and new Business Unit Head, are developing a strategic vision and revised operating model.
-
Flinders tender submitted per plan
-
New Royal Adelaide account moving into stable operating mode
-
Conducted review of territory alignments to ensure commercial footprint is aligned with opportunity
-
Recruited key new positions
-
Product Manager
-
National Sales Manager
-
Portfolio Review – all product lines growing
-
Identify opportunities to add portfolio breadth
-
April sales ahead of plan
32
www.admedus.com
Immunotherapies
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Immunotherapies
Changing direction
Partnering with world-leading researchers, including Professor Ian Frazer, Admedus Immunotherapies has been researching potential herpes vaccines.
-
The global cancer immunotherapy market was estimated at $63 billion in 2016 and is expected to reach $160 billion by 2023 growing at a CAGR of 14.3%*.
-
Cancer is the second leading cause of death globally, and was responsible for 8.8 million deaths in 2015. Globally, nearly 1 in 6 deaths are due to cancer according to WHO.
-
Pre-clinical data established using combination HPV vaccine and checkpoint inhibitor anti-PD-L1.
-
Secured access to AstraZeneca’s checkpoint inhibitor Imfinzi[TM] for Phase 1b clinical trial.
Admedus took the strategic decision in 2017 to de-fund this division and seek alternative funding options
-
Protocol currently being finalised with AstraZeneca.
-
Further pre-clinical research combining HPV vaccine with other checkpoint inhibitors.
-
The team has successfully completed Phase I and IIa trials, testing our therapeutic HSV-2 vaccine, demonstrating proof-of-concept.
-
The team has won approval to test our therapeutic HPV vaccine in head and neck cancer patients, who have received curative treatment.
We are currently finalizing a contract with a consortium who will fund the division through to IPO
**Statistics Market Research Consulting Cancer Immunotherapy Market Report, Size, Share, Analysis 2017 and Forecast to 2023
-
Alternative funding opportunity identified
-
Letter of Intent signed with Hong Kong-based investor , Star Bright .
-
Holding Ltd
-
Initial investment of $18M for 60% interest with existing shareholders .
-
retaining 40%
-
Terms and conditions of the deal to be negotiated over the next 5 months .
-
Deal to continue the important and life-saving work of developing vaccines and treatments for a .
-
variety of diseases and cancers
Immunotherapies – Changing Direction
-
Approval to test the therapeutic HPV vaccine in head and neck cancer patients , who have received curative treatment .
-
.
-
First patient dosed at Princess Alexandra Hospital in Brisbane
-
Pre-clinical data established using combination HPV vaccine and .
-
checkpoint inhibitor anti-PD-L1
-
Secured access to anti-PD-L1 checkpoint inhibitor for Phase 1b clinical trial in combination with HPV vaccine .
-
Trial to involve patients with recurrent and/or metastatic HPVrelated head and neck cancer .
-
Plans to carry-out cervical cancer study in China following safety studies of HPV vaccine in Brisbane .
-
Further development of the HSV-2 vaccine also planned for clinical studies in China .
35
24 May 2018
o BUSINESS
-
Secure $18M funding in 2H 2018 .
-
Appoint new CEO to oversee global Immunotherapies business .
-
Public listing of business on overseas stock exchange in 2020/21 .
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Immunotherapies – Milestones
-
CLINICAL
-
Phase I safety study of therapeutic HPV vaccine to be completed end 2018 .
-
Phase Ib combination HPV vaccine and anti-PD-L1 checkpoint .
-
inhibitor study to commence 1H 2019
-
China Phase Ib study of HPV vaccine in cervical cancer .
-
anticipated to commence in 2020
-
.
-
Phase II study of HSV-2 vaccine to commence in 2020 in China
-
.
-
Pubic listing of business on overseas stock exchange in 2020/21
36
24 May 2018
Famous quotes
-
“The abdomen, the chest and the brain, will forever be shut from the intrusion of the wise and humane surgeon.” Sir Eric Ericksen, Surgeon Extraordinary to Queen Victoria 1873
-
“
-
• ”
-
Louis Pastueur’s theory of germs is ridiculous fiction. Pierre Pachet, Professor of
-
Physiology Toulouse 1872
-
“
-
• Man will never reach the moon regardless of all future scientific advances. ” Dr Lee De
-
Forest , inventor of the vacuum tube and father of television
-
“
-
• .”
-
I cannot tell a lie. I cut down the cherry tree George Washington.
-
“
-
• .”
-
I will not raise dilutive capital Wayne Paterson, 2016.
Profit versus Growth or Profitable Growth
-
Vision 2020 requires an extended portfolio (as outlined in 2016).
-
The current revenues will support us to breakeven and profit but will not allow us to meet the Vision 2020 objective in terms of number of products in the market.
-
Share price is a function of shares on issue, total revenues, market traction, pipeline and expenditure management.
-
Total revenue and revenue growth are key drivers of SP.
-
Profitable growth requires resources to build revenue streams.
-
In early stage companies profit versus growth is a trade off.
38
www.admedus.com
Share price disconnect…or is it ?
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$1.80
CardioCel License
$1.60 granted in Canada
CardioCel initial sales in
Italy/France and entry to
$1.40
Half year report
Genpharm appointed as
$1.20 CardioCel distributor in CardioCel approved for valve Admedus contracts with
MENA and annular repair in Europe US Group Purchasing
CardioCel approval in CODE RED
$1.00
CardioCel portfolio expansion
Canada regulatory approval
for 2cmx2cm product for CardioCel 3D & Vascucel
US$5M Placement Vascular product
(VascuCel) launch
$0.80 First CardioCel
Commence CardioCel regulatory
FDA clearance granted for
CardioCel
VascuCel
shipments to US Admedus awarded
$0.60 Infusion supply FDA clearance for
CardioCel 3D
PFG funding
CardioCel calcification
Placement &
results after 7 yrs
$0.40 Rights Issue
New CardioCel product
2cmx8cm launched
First CardioCel sales in
$0.20 Malaysia
Placement & Rights CardioCel approval TAVR patent applications in US
Issue in UAE
Placement & SPP
$0.00
Share Price A$/share
1-Jul-14 1-Aug-14 1-Sep-14 1-Oct-14 1-Nov-14 1-Dec-14 1-Jan-15 1-Feb-15 1-Mar-15 1-Apr-15 1-May-15 1-Jun-15 1-Jul-15 1-Aug-15 1-Sep-15 1-Oct-15 1-Nov-15 1-Dec-15 1-Jan-16 1-Feb-16 1-Mar-16 1-Apr-16 1-May-16 1-Jun-16 1-Jul-16 1-Aug-16 1-Sep-16 1-Oct-16 1-Nov-16 1-Dec-16 1-Jan-17 1-Feb-17 1-Mar-17 1-Apr-17 1-May-17 1-Jun-17 1-Jul-17 1-Aug-17 1-Sep-17 1-Oct-17 1-Nov-17 1-Dec-17 1-Jan-18 1-Feb-18 1-Mar-18 1-Apr-18 1-May-18
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Share price trajectory 2015 – 2018 Reversing the long term decline
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$1.6000
$1.4000
-50% Jan15/Jan 16
$1.2000 Trading halt Jul16
$1.0000 +85% Nov17/May 18
-52% Jan16/May16
-76% Jan15/May16
$0.8000
-37% May16/Nov17
$0.6000
$0.4000
$0.2000 Change of Management BOD and Code Red
implementation Debt round announced
$0.0000
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Share price appreciation as a function of pipeline/revenue growth
Revenue growth Increases Shareholder Value
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SP
Second phase pipeline
$7.00
$6.00 Impact of first 3D
$5.00 pipeline products on
revenue
Share price
$4.00
projected to
$3.00 grow to 5x
Baseline
$2.00
$1.00
$0.00
2016 2017 2018 2019 2020 2021 2022 2023
Baseline Growth SP = 3X Revenue projections /# of shares on issue
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41
www.admedus.com
TAVR,SAVR and the 3D universe
-
Multiple 3D projects in the pipeline
-
Prioritized by 510k and PMA regulatory pathways
-
Development of Surgical and Transcatheter Aortic valves simultaneously
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42
www.admedus.com
We intend to invest $34.5M over next 6 years to transform into a mid-sized company R&D
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6 Year Investment Plan
$10,000,000
$9,000,000
$8,000,000
$7,000,000
$6,000,000
$5,000,000
$4,000,000
$3,000,000
$2,000,000
$1,000,000
$-
2018 2019 2020 2021 2022 2023
510k Surgical Valves TAVR
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1 $2.4M investment to drive near-term revenue ▪ $28.8M in Revenue 2018-2022
2 $17.7M investment to drive mid-term revenue
▪ $205M in Revenue 2023-2028 ▪ Investment funds projects through to full commercialization
Investment Significantly offset by partnership revenue
3
$14.3M investment to drive long-term revenue
▪ Investment funds projects through pre-clinical up to Pivotal study
43
www.admedus.com
Mid-LongTerm Revenue Out ADAPT technology offers the potential for a paradigm shift in this high value space...
Investment
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$14.3M
2018-2023
2018 2019 2020 2021 2022 2023
$-
$(1,000,000)
$(2,000,000)
$(3,000,000)
$(4,000,000)
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Allows us to play in a US$3.9B space
-
CAGR of 16% - projected to be $5.8B by 2025
-
Investment funds us up though Pivotal Trial
-
10% Market share for Admedus equals $580M
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44
$(5,000,000)
www.admedus.com
Our initial investment allows us to bridge to partnership revenue Investment
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20,000,000
15,000,000
10,000,000
5,000,000
0
(5,000,000)
(10,000,000)
2018 2019 2020 2021 2022 2023
(15,000,000)
Investment Partnership Revenue
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Pipeline funding post CR
-
Initial investment allows for bridge to partnership revenue
-
Partnership revenue funds $9M of $11M investment needed 2019-21
-
Partnership funds development fully to nearterm commercialization and pivotal trial for TAVR 2022-2023
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2018 2019 2020 2021 2022 2023
Investment (5,101,266) (2,357,595) (2,364,557) (7,097,046) (8,109,705) (9,451,477)
Partnership Revenue 475,949 1,189,873 2,379,747 5,354,430 10,506,329 14,620,253
Total (4,625,316) (1,167,722) 15,190 (1,742,616) 2,396,624 5,168,776
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*Partnership revenues from 4C and dependant on successful commercialization
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Regulatory Status
Nov 2017 - May 2018
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VascuCel CardioCel 3D CardioCel NEO Pending Approvals Pending Vietnam Canada Philippines Taiwan Taiwan Thailand Vietnam Philippines Thailand Malaysia Kuwait Singapore EU
CardioCel 3D CardioCel VascuCel Pending Approvals Approvals KSA India India Kuwait Turkey Canada UAE Lebanon Singapore Malaysia Vietnam Taiwan EU
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Innovation to support life’s journey is at the heart of our story.
ADMEDUS
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www.admedus.com