Anteris Technologies Global Corp. · NASDAQ:AVR
Anteris Technologies Global — Shareholder Meeting (May 2023)
86 slides from Anteris Technologies Global's shareholder meeting presentation, May 29, 2023
Slide 1: Anteris Technologies Ltd Annual General Meeting
29 MAY 2023 ANTERIS TECHNOLOGIES LTD ANNUAL GENERAL MEETING
Slide 2: Anteris 2022 AGM CEO Presentation
Anteris 2022 AGM CEO PRESENTATION May 29th 2023 anteristech.com | Follow us @AnterisTech Copyright Anteris Technologies Ltd 2023
Slide 3: Agenda
Agenda • The year in review • Financials • Business potential • One year patient update • New patients • What are the experts saying • Valve in Valve • What else are we up to? • Taking the clinical discussion forward • Collaborations that add value • Where to from here? • Questions
Slide 4: Disclaimer
DISCLAIMER Summary information This presentation has been prepared by Anteris Technologies Ltd (the “Company”). It is a presentation of general background information in summary form about the Company’s activities current at the date of this presentation. The information does not purport to be compl
Slide 5: Disclaimer cont.
D I S C L A I M E R C O N T. Forward-looking statements This presentation contains forward looking statements Forward-looking statements can generally be identified by use of words such as “may”, “should”, “could”, “foresee”, “plan”, “aim”, “will”, “expect”, “intend”, “project”, “estimate”, “anticip
Slide 6: Disclaimer cont.
D I S C L A I M E R C O N T. Investors should be aware that financial data in this presentation include "non-IFRS financial information" under ASIC Regulatory Guide 230 "Disclosing non-IFRS financial information" published by ASIC and also "non-GAAP financial measures" within the meaning of Regulati
Slide 7: A Year of Achievements
A Year of Achievements
Slide 8: Financials
—__ Balance sheet Assets Cumant 1,734,826 Non-cumant assets Aron Liabilities 166.6 Cornet ates ‘ese Ure Eats pepe Equity 74,393 Part Capea r29e Retaned earriege ware Income statement 516 Revenues 12.079,838 Nat sabes 104028 535 expenses 072538 Equity statement Current year 1,774,576 7 Comprenonaive
Slide 9: Major milestones were achieved in 2022
Major milestones were achieved in 2022 AUGUST APRIL FEBRUARY Anteris participates Final tranche of convertible L1 Capital exercised along with Yale notes are converted and options generating $5M repaid by Mercer Street OCTOBER University & Yale JUNE Global Opportunity Fund Cardiovascular Research An
Slide 10: Financial highlights 2022
Financial highlights 2022 * 31 December 24
Slide 11: Financial highlights 2022
Financial highlights 2022 FY2021 FY2022 Key Financial Metrics Actual Actual • 115% increase in market Market capitalisation (31 Dec) ($m) 143.8 308.6 capitalisation Market capitalisation increase on prior year (%) 516% 115% • 71% increase in share price Share price (31 Dec) ($/share) 12.96 22.20 (24
Slide 12: Focused investment in R&D has accelerated progress
Focused investment in R&D has accelerated progress Projects $40.1M Corporate $8.8M • DurAVRTM valve development • Capital raising costs program • Company compliance costs • EFS approval • Insurance • Tbilisi first-in-human trials • Net financing costs • Valve science program • Nasdaq preparations •
Slide 13: Increased project costs linked to development activities
Increased project costs linked to development activities $60.0 M $50.0 M $48.9 M • Increased Projects costs to accelerate development activities and upscale $40.1 M $40.0 M manufacturing capabilities $30.7 M • Spend linked to preparations for EFS $30.0 M approval and enrolment of further $25.2 M pat
Slide 14: Highly productive, highly diverse workforce
Highly productive, Highly diverse workforce FTE* by Function Multicultural Workforce DurAVR and product development Corporate and administrative support Zambia 2021 36.9 15.4 TOTAL 52.3 2022 51.4 16.4 TOTAL 67.8 Italy China Romania USA * FTE includes contractors Growing team focused on the developme
Slide 15: Market capitalisation post share consolidation
[ ]Market capitalisation post share consolidation Current A$M Market Cap 450 $371.6M 400 350 300 250 22 Nov 2021 DurAVR™ THV 200 28 Feb 2020 FIH #1 25 May 2022 Share DurAVR™ THV 150 consolidation FIH #2 100 50 0 28-Feb-20 28-May-20 28-Aug-20 28-Nov-20 28-Feb-21 31-May-21 31-Aug-21 30-Nov-21 28-Feb-2
Slide 16: AVR has returned 220% since the CardioCel divestiture
AVR has returned 220% since the CardioCel™ divestiture • The S&P/ASX Emerging Companies Index (XEC) is a benchmark consisting of 200 Australian microcap companies ranked anywhere between 350 to 600 by market capitalisation AVR return XEC return • The below graph compares the performance of the AVR s
Slide 17: Strong share price and Company valuation
[ ]Strong share price and Company valuation 20 March 2023 AVR added to the All Ordinaries $450M $28.80 Share Index $30.00 $400M $23.00 $25.00 $22.20 $350M $397.9M $354.7M $300M $20.00 $308.6M $250M $15.00 $12.96 $200M $10.00 $150M $10.00 $6.80 $143.8M $6.20 $6.00 $100M $4.90 $3.75 $5.00 $50M $59.1M
Slide 18: AVR continues to outperform all major health care indices
AVR continues to outperform all major health care indices Rolling 12 months 100% 30 April 2023 75% AVR S&P/ASX Emerging Companies 50% Stoxx Europe 600 Health Care 25% S&P Composite 1500 Health Care 0% Dow Jones US Medical Equipment Index NASDAQ Health Care Index -25% -50%
Slide 19: AVR outperformed major competitors
AVR outperformed major competitors 100% Rolling 12 months 30 April 2023 75% AVR 50% Edwards Lifesciences 25% Medtronic 0% Boston Scientific -25% -50%
Slide 20: Capital raising at ever increasing price points
Capital raising at ever increasing price points 200% 60% • Each capital raise has been $24/share accompanied by the achievement of significant milestones 87.5% • The value associated with those raises $15/share increased by 200% reflecting the $35.0M change from $8/share to $24/share $8/share $27.6M
Slide 21: Top 40 investors hold 64% of the Company
Top 40 investors hold 64% of the Company OWNERSHIP COUNTRY SHAREHOLDER MIX AUSTRALIA 65.0% L1 CAPITAL SIO CAPITAL 11% 6% OTHER 8.0% UNITED STATES PERCEPTIVE NEW ZEALAND 24.0% LIFE SCIENCES 3.0% 14% OTHER TOP 40 33% INVESTOR TYPE HISTORY 70% 60% March 2021 50% May 2022 40% April 2023 30% OTHER 20% SH
Slide 22: Top 20 investors hold 57% of the Company
Top 20 investors hold 57% of the Company 30 April 2023 % Change from prior Rank Investors – beneficial interest No. of shares % Share of total Investor Type Country AGM 1 Perceptive Advisors LLC 2,140,000 13.9% 16% Institution United States 2 L1 Capital Pty Ltd. 1,702,994 11.0% 53% Institution Austr
Slide 23: 800 million people are over 65
800 million people are over 65
Slide 24: 2%-5% of people over 65 have aortic stenosis
2% - 5% of people over 65 have aortic stenosis
Slide 25: Aortic stenosis is under treated
• The population above 65 globally is 10% or 800 million people (according to world bank) • The world population continues to age rapidly and the incidence of aortic Aortic stenosis is stenosis and severe aortic stenosis is growing with the population under treated • The available global patient poo
Slide 26: TAVR Global Market out to 2028
TAVR Global Market out to 2028 (15 billion AUD) Significant Organic Growth, with A LOT of Upside with Expanded Indications 450,000 Global TAVR Valves Implanted* 420,000 TAVR Market has the Potential to grow even more 400,000 Severe Symptomatic Patients 3 Trials Currently in Progress 350,000 300,000
Slide 27: Today we are only scratching the surface
Today we are only scratching the surface
Slide 28: 21 patients now implanted with DurAVR
21 patients now implanted with DurAVR™
Slide 29: Clinical study update: 1-Year Interim Analysis
Clinical study update 1-Year Interim Analysis
Slide 30: Cohort 1 & 2 are difficult to treat small annulus patients
[] Cohort 1 & 2 are difficult to treat small annulus patients Cohort 1 and 2 Baseline characteristics n = 13 Age (years) 73.92 ± 6.4 Gender (female) 77% STS Prom (%) 2.34 ± 1.07 Area-derived annulus diameter (mm) 22.95 ± 1.09 NYHA Class II 85% III 15% Implant timeframe Nov-2021 and May-2022
Slide 31: Excellent results maintained over 1 year
[Excellent ] results maintained over 1 year Cohort 1 & 2 Mean annulus size: 22.95 mm (N=13) EOA EOAi 2.5 1.4 1.14 1.10 1.11 2.00 1.93 1.96 1.2 2.0 1.0 cm2/m2 1.5 cm2 0.8 0.6 1.0 0.65 0.37 0.4 0.5 0.2 0.0 0.0 Baseline 30 Days 6 Months 1 Year Baseline 30 Days 6 Months 1 Year N=13 N=13 N=13 N=5 N=13 N=
Slide 32: Outstanding 1-Year Haemodynamics
Outstanding 1-Year Haemodynamics Cohort 1 & 2 Mean annulus size: 22.95 mm (N=13) DVI MPG 0.7 70 0.55 0.53 0.54 0.6 60 51.44 0.5 50 mmHg 0.4 40 0.3 30 0.20 0.2 20 9.02 8.58 8.82 0.1 10 0.0 0 Baseline 30 Days 6 Months 1 Year Baseline 30 Days 6 Months 1 Year N=13 N=13 N=13 N=5 N=13 N=13 N=13 N=5 1-year
Slide 33: Huge improvements in exercise capacity
Huge improvements in exercise capacity 40% Average Walked Distance increase 400 from 323.50 350 278.23 306.00 baseline 300 230.92 250 200 mt 150 100 50 0 Baseline 30 Days 6 Months 1 Year N=13 N=13 N=12§ N=4 §* § One subject performed the baseline and 30-day 6MWT with the support of an assistive devi
Slide 34: Significant improvements in QOL score over 12 months
Significant improvements in QOL score over 12 months Cohort 1 & 2 KCCQ Overall Summary Score 100 90 80 67.8 70 52.8 58.2 60 50 37.8 40 30 20 10 0 Baseline 30 Days 6 Months 1 Year N=13 N=13 N=13 N=5 1-year KCCQ available only for the first 5 subjects at the time of this analysis
Slide 35: Cohort 3
Cohort 3 7 new patients + 1 compassionate use patient
Slide 36: Cohort 3 Objectives
Cohort 3 Objectives Great clinical results while defining device limitations in prep for EFS • Verify improvements in balloon function • Clinical experience for EFS • Push the upper and lower bounds of the valve sizing range • Depth of implant optimization • Volume based sizing • Test Crimper
Slide 37: Difficult to treat anatomies
Difficult to treat anatomies 51
Slide 38: Baseline Characteristics
Baseline Characteristics Baseline characteristics n=7 Age (years) 74.86 ± 4.60 Gender (female) 86% STS Prom (%) 2.07 ± 0.47 Area-derived annulus diameter (mm) 22.33 ± 1.51 NYHA Class II 71% III 29% Implant timeframe April 2023
Slide 39: Post-procedure (48h) Haemodynamics
Post-procedure (48h) Haemodynamics Cohort 3 Mean annulus size: 22.33 mm EOA EOAi 2.5 1.4 2.11 1.17 1.2 2.0 1.0 cm2/m2 1.5 0.8 cm2 0.6 1.0 0.76 0.42 0.4 0.5 0.2 0.0 0.0 Baseline Post-procedure Baseline Post-procedure EOA: Effective Orifice Area | EOAi: Effective Orifice Area indexed
Slide 40: Post-procedure (48h) Haemodynamics all patients
Post-procedure (48h) Haemodynamics all patients Mean annulus size: 22.73 mm DVI MPG 0.8 80 0.7 70 0.61 0.6 60 53.34 0.5 50 mmHg 0.4 40 0.3 0.20 30 0.2 20 8.66 0.1 10 0.0 0 Baseline Post-procedure Baseline Post-procedure DVI: Doppler Velocity Index | MPG: Mean Pressure Gradient
Slide 41: High-Level Results
High-Level Results 8/8 Successful Cases • 7 FIH, 1 Compassionate Use • Mean annulus 22.3 • Percutaneous Closure in all • Intraop TEE- 7 trace/zero, 1 mild PVL • ZERO Central leak • No pacer at d/c
Slide 42: Compassionate use case
Compassionate use case
Slide 43: Baseline Characteristics
Baseline Characteristics Compassionate case – 24 April 2023 Baseline characteristics Age (years) 66 Gender Female STS Prom 1.12 % Area-derived annulus diameter 24 mm NYHA Class 3 AV morphology Bicuspid LV Ejection Fraction 33 % Comorbidities and risk factors systemic hypertension, mild-moderate mitr
Slide 44: Excellent haemodynamics results in severe bicuspid anatomy
Excellent haemodynamics results in severe bicuspid anatomy Compassionate case – 24 April 2023 EOA (cm2) EOAi (cm2/m2) DVI 0.6 2.5 1.2 1.10 0.51 2.10 0.5 2.0 1.0 0.8 0.4 1.5 0.6 0.3 1.0 0.60 0.4 0.29 0.2 0.15 0.5 0.2 0.1 0.0 0.0 0.0 Baseline Post-procedure Baseline Post-procedure Baseline Post-proced
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Slide 46: All Subjects Post-procedure (48h) Interim Analysis
All Subjects Post-procedure (48h) Interim Analysis
Slide 47: Baseline Characteristics
Baseline Characteristics All Subjects Baseline characteristics n = 20 Age (years) 74.25 ± 5.72 Gender (female) 80% STS Prom (%) 2.25 ± 0.90 Area-derived annulus diameter (mm) 22.73 ± 1.25 NYHA Class II 80% III 20% Implant timeframe Nov-2021, May-2022, Apr-2023
Slide 48: Post-procedure (48h) Haemodynamics
Post-procedure (48h) Haemodynamics All Subjects Mean annulus size: 22.73 mm EOA EOAi 2.5 1.6 2.12 1.4 2.0 1.18 1.2 1.0 cm2/m2 1.5 cm2 0.8 1.0 0.70 0.6 0.39 0.4 0.5 0.2 0.0 0.0 Baseline Post-procedure Baseline Post-procedure EOA: Effective Orifice Area | EOAi: Effective Orifice Area indexed
Slide 49: Post-procedure (48h) Haemodynamics
Post-procedure (48h) Haemodynamics All Subjects Mean annulus size: 22.73 mm DVI MPG 0.8 80 0.7 70 0.61 0.6 60 53.24 0.5 50 mmHg 0.4 40 0.3 30 0.21 0.2 20 8.66 0.1 10 0.0 0 Baseline Post-procedure Baseline Post-procedure DVI: Doppler Velocity Index | MPG: Mean Pressure Gradient
Slide 50: What are the experts saying about DurAVR?
What are the experts saying about DurAVR™ ?
Slide 51: Expert interview with CEO Wayne Paterson and Rebecca T. Hahn, MD
ANTERIS TECHNOLOGIES A Structural Heart Company EXPERT INTERVIEW WITH CEO WAYNE PATERSON AND REBECCA T. HAHN, MD
Slide 52: 2 products, 2 indications, 2 pathways
2 products , 2 indications 2 pathways • Aortic Stenosis (at the current rate will be AUD 15 billion by 2028) • Valve in Valve (up to 30% of existing patients)
Slide 53: Global Aortic Valve-in-Valve
Valve-in-Valve Global Aortic Valve-in-Valve An Evolving New Market for Repeat SAVR & TAVI Procedures 500,000 450,000 Implanted Aortic Valve Requiring Replacement Valve-in-Valve Represents a Large Growing Market 400,000 for DurAVR™ THV 350,000 • Between 5 to 7 years after implantation of a bioprosthe
Slide 54: TAV in 21mm SAV hydrodynamic results
TAV in 21mm SAV hydrodynamic results Magna Ease 21mm Mosaic AV 21mm Hancock AV 21mm +19% +26% +16% +18% +10% +13% 2.26 2.23 2.16 1.81 1.62 1.56 1.47 1.43 1.47 1.90 1.53 1.55 1.80 EOA (cm2) DurAVR Sapien 3 EvolutPro Acurate Navitor DurAVR Sapien 3 EvolutPro Acurate DurAVR Sapien 3 EvolutPro Acurate N
Slide 55: DurAVR can address current challenges
DurAVR™ can address current challenges Poor Haemodynamics Improved Haemodynamics Sapien 23 DurAVR™ EOA 1.9 EOA 2.26 (+19%) MG 11.7 MG 8.8 (-25%) Moderate pinwheeling No pinwheeling Poor Coronary Access Ease of Coronary Access Evolut 23 DurAVR™ Short frame Tall frame prevents Large open cells coronar
Slide 56: Current valves: Result in clinical compromises
Current valves: Result in clinical compromises • Poor Haemodynamics Coronary Access Issues Evolut 23: Tall frame prevents coronary access Sapien 23 ViV - in 21 mm Magna Ease SAVR 64% severe PPM Current valves do not address all these challenges ▪ Balloon expandable (BE) TAVR have poor haemodynamics
Slide 57: Yesterday's TAVRs Were Not Imagined For Today's Patients
Yesterday’s TAVR’s Were Not Imagined For Today’s Patients 1st and 2nd Generation TAVR’s designed to solve different problems for today’s patients “Patients need a valve that restores an active lifestyle “Patients need a safe alternative to open heart surgery” for the rest of their life” 1st and 2nd
Slide 58: Patients Need New Solutions that Last Longer and Work Better
Patients Need New Solutions that Last Longer and Work Better Valve Science Must Progress Beyond 3 Piece Designs PATIENT AGE KEY CONSIDERATIONS Younger patients now eligible Life ~85 years old Expectancy Guidelines What Does TAVR as class for ages 65-80 this Mean? Exercise ~65 years old Capacity Indi
Slide 59: What else are we up to?
What else are we up to ? ANTERIS
Slide 60: Example: Biomimetic THV to Restore Normal Aortic Integration
xample: Biomimetic THV to Restore Normal Ao INTEGRATION E
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76
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Slide 64: Even Frame Expansion
• Even Frame Expansion
Slide 65: New Patents issued that change the landscape
New Patents issued that change the landscape
Slide 66: Patents that change the landscape
Patents that change the landscape US Patent 11,648,107 provides Anteris with exclusivity to protect the following key features of the DurAVR™ THV: • The single-piece 3-dimensionally molded biomimetic valve for high performance and fatigue resistance US Patent 11,622,853 provides Anteris with exclusi
Slide 67: US facilities validated and online
[] US facilities validated and online
Slide 68: Taking the clinical discussion forward
[] Taking the clinical discussion forward 82
Slide 69: DurAVR: First AVR Shown to Restore Normal Aortic Flow
DurAVR™: First AVR Shown to Restore Normal Aortic Flow Normal Valve Flow vs DurAVR™ : No Significant Difference in Flow (p=0.45) Healthy Aortic Valve Post DurAVR™ HV Flow Displacement (FD) = 12% Flow Displacement (FD) = 14% Flow Reversal Ratio (FRR) = 0% Flow Reversal Ratio (FRR) = 4% Impaired Aorti
Slide 70: Flow restoration at 12 months by 4D flow MRI
Pre-intervention Post DurAVRTM Post Flow DurValve TM implantation streamlines at peak systole restoration implantation at 12 demonstrating of aortic flow restoration assessed byof cutting-edge normal flow months 4D flow MRI patterns at 12 months 400 400 Systole Diastole Systole Diastole 300 300 200
Slide 71: DurAVR Shaped to Perform like Native Aortic Valve
DurAVR™ Shaped to Perform like Native Aortic Valve Optimizes flow dynamics, restoring haemodynamic performance Single Piece Three Piece Graphical representation of the 3D single-piece geometry of DurAVR™ THV (left), and standard balloon-expandable TAVI devices (right). VD 2004 (PMID: 15473482) DurAV
Slide 72: Collaborations that drive value
[] Collaborations that drive value 86
Slide 73: Research Collaboration: Anteris – Ear Science Institute
Research Collaboration Anteris – Ear Science Institute anteristech.com Follow us @anteristech Copyright Anteris Technologies Ltd 2023
Slide 74: Next Gen DurAVR that can be injection molded
Next Gen DurAVR™ that can be injection molded ESIA Anteris • Novel Protein + Polyurethane/Glycerol Scaffold • Scaffold testing • Scaffold development • Valve Design & Engineering Concepts • Prototype manufacturing & optimization • Prototype - performance testing First Single Piece Heart Valve Protot
Slide 75: V2V Medtech: The next big thing in mitral valve repair
V2V Medtech The next big thing in mitral valve repair anteristech.com Follow us @anteristech Copyright Anteris Technologies Ltd 2023
Slide 76: V2Vmedtech – Innovative mitral valve TEER device
V2Vmedtech – Innovative mitral valve TEER device • Development of a minimally invasive device for the treatment of mitral and tricuspid valve regurgitation • Anteris will partner with leading physicians including Dr. Vinayak Bapat (v2v CMO and primary developer) • Market is expected to be A$4.1B by
Slide 77: Capitalizing on a culture of Dr driven innovation
Capitalizing on a culture of Dr driven innovation “Fixed” TEER devices lack the ability to treat a range of mitral anatomies V-Clip is a versatile TEER device that can address anatomical configurations – uniquely expanding TEER therapy to more patients that otherwise would be sent to surgery Fixed C
Slide 78: 13.9% CAGR resulting in 2028 Market of ~US$2.8B
13.9% CAGR resulting in 2028 Market of ~US$2.8B TMTT Market Revenue ($M) $6,250 Surgery Transcatheter Tricuspid repair Transcatheter Tricuspid replace $5,110 In 2022 Surgery is the Gold Transcatheter Mitral repair $2,685 Standard Treatment for Mitral Transcatheter Mirtal replace valve disease. $3,81
Slide 79: Anteris Institutional Partnerships
Anteris Institutional Partnerships Partnering to Define a New Paradigm in Aortic Valve Science 93
Slide 80: Where do we go from here! The sky really is the limit
WHERE DO WE GO FROM HERE! The sky really is the limit =
Slide 81: Anteris Has Addressed Unmet Medical Needs With A New Class Of Product
Anteris Has Addressed Unmet Medical Needs With A New Class Of Product By combining…. • Tissue science (ADAPT®) • Valve design (DurAVR™) • Physician developed delivery system (ComASUR™) Anteris has created a more “human like” aortic valve replacement with results that reflect pre-disease states DurAV
Slide 82: Milestones
Milestones ADAPT ® Commercial Use - Global ADAPT ® vs. AOA Anti-Calcification Study DurAVR™ THV Design Validation We are past the POC stage ! ComASUR™ Design Validation Bench and Pre-clinical Studies DurAVR™ THV FIH Valve Study - Ethics Submission Early Feasibility Study (USA) Patent Grant (ComASUR™
Slide 83: Path to Commercialisation
Path to Commercialisation FDASUBMISSION | FDA APPROVAL Pivotal TRIAL DESIGN AND Trial FDA ENGAGEMENT ANTERIS
Slide 84: Go alone
Go alone
Slide 85: Anteris investment thesis
Anteris investment thesis ⚫ Anteris has demonstrated significant clinical benefits for patients and therefore commercial viability and potential market leadership (>51%) in a USD $10bn market ⚫ Anteris is supported by Global Tier 1 Physicians, Scientists and Institutions Anteris has ⚫ Anteris’ key i
Slide 86: Key account focus enables self funding commercial rollout upon launch
Key account focus enables self funding commercial rollout upon launch • Anteris anticipates >5% (USD 250-300 million) market share in the first 12 months post launch based on currently proven clinical results (best in class) • TAVR procedures continue to be concentrated in high volume centers. • 65%
Anteris Technologies — Shareholder Meeting (May 2023) on 6ix