Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
www.admedus.com
Follow us @Admedus
AHZ AGM 2019
Chairman and CEO 2018 company review
For
per
sona
l use
onl
y
2018 Financial Overview
For
per
sona
l use
onl
y
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)
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
www.admedus.com
Profit growing faster than costs 2015 to 2018
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
www.admedus.com
ADAPT® GP and revenue growth 2016 to 2018
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
ADAPT® Commercial Update
For
per
sona
l use
onl
y
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…
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
Medical & Reg Affairs
For
per
sona
l use
onl
y
www.admedus.com
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)
For
per
sona
l use
onl
y
www.admedus.com
VascuCel® Approval Status
Legend
Approved
Approval In Process
Not Yet Pursued
Source: Admedus Regulatory Tracking (REG UPDATE STATUS LIST_24FEB 2019.xlsx)
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
2019 Strategy Update
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
www.admedus.com
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
per
sona
l use
onl
y
www.admedus.com
New technology enables new markets
Patch Valves Catheter Conduit
ADAPT® - 3 Dimensional Shaping - PTT
For
per
sona
l use
onl
y
TAVR UPDATEFor
per
sona
l use
onl
y
www.admedus.com
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)
For
per
sona
l use
onl
y
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
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.
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y
www.admedus.com
Successful Valve Leaflet Motion Over 100 Million Cycles
4 Million 40 Million 100 Million
LN
For
per
sona
l use
onl
y
www.admedus.com
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)
LN
For
per
sona
l use
onl
y
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
For
per
sona
l use
onl
y
www.admedus.com
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
For
per
sona
l use
onl
y