Anteris Technologies Global Corp. · NASDAQ:AVR
Anteris Technologies Global — Shareholder Meeting (May 2023)
88 slides from Anteris Technologies Global's shareholder meeting presentation, May 29, 2023
Slide 1: ASX Announcement: Annual General Meeting Chairman's Address and CEO Presentation
ASX ANNOUNCEMENT 29 May 2023 Annual General Meeting Chairman’s Address and Chief Executive Officer Presentation BRISBANE, 29 May 2023: Anteris Technologies Ltd (ASX: AVR) is pleased to provide the attached Chairman’s Address and Chief Executive Officer Presentation to the Annual General Meeting bein
Slide 2: Address by the Chairman Mr John Seaberg
Address by the Chairman Mr John Seaberg Again, welcome on behalf of my fellow Directors, Steve Denaro, Wenyi Gu and of course our CEO, Wayne Paterson. Also, a sincere thank-you for your continued support as we continue this incredible Anteris journey together. Before turning the meeting over to Wayn
Slide 3: Anteris Technologies Ltd Annual General Meeting
For personal use only 29 MAY 2023 ANTERIS TECHNOLOGIES LTD ANNUAL GENERAL MEETING
Slide 4: Anteris 2022 AGM CEO Presentation
For personal use only Anteris 2022 AGM CEO PRESENTATION May 29th 2023 anteristech.com | Follow us @AnterisTech Copyright Anteris Technologies Ltd 2023
Slide 5: Agenda
Agenda • The year in review For personal use only • 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? • Quest
Slide 6: Disclaimer
DISCLAIMER Summary information For personal use only 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 n
Slide 7: Disclaimer cont.
D I S C L A I M E R C O N T. Forward-looking statements For personal use only 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”
Slide 8: 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 9: A Year of Achievements
For personal use only A Year of Achievements
Slide 10: 2022 Financials
For personal use only 2022 Financials
Slide 11: Major milestones were achieved in 2022
Major milestones were achieved in 2022 AUGUST APRIL FEBRUARY For personal use only Anteris participates Final tranche of convertible L1 Capital exercised along with Yale notes are converted and options generating $5M repaid by Mercer Street OCTOBER University & Yale JUNE Global Opportunity Fund Card
Slide 12: Financial highlights 2022
Financial highlights 2022 For personal use only * 31 December 24
Slide 13: Financial highlights 2022
Financial highlights 2022 FY2021 FY2022 For personal use only Key Financial Metrics Actual Actual • 115% increase in market Market capitalisation (31 Dec) ($m) 143.8 308.6 capitalisation Market capitalisation increase on prior year (%) 516% 115% • 71% increase in share price Share price (31 Dec) ($/
Slide 14: Focused investment in R&D has accelerated progress
Focused investment in R&D has accelerated progress For personal use only 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 •
Slide 15: Increased project costs linked to development activities
Increased project costs linked to development activities For personal use only $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 $30.0 M approval and enrolment
Slide 16: Highly productive, highly diverse workforce
Highly productive, Highly diverse workforce FTE* by Function Multicultural Workforce For personal use only DurAVR and product development Corporate and administrative support Zambia 2021 36.9 15.4 TOTAL 52.3 2022 51.4 16.4 TOTAL 67.8 Italy China Romania USA * FTE includes contractors Growing team fo
Slide 17: Market capitalisation post share consolidation
[ ]Market capitalisation post share consolidation Current A$M Market Cap 450 $371.6M For personal use only 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
Slide 18: 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 For personal use only consisting of 200 Australian microcap companies ranked anywhere between 350 to 600 by market capitalisation AVR return XEC return • The below graph compares the pe
Slide 19: Strong share price and Company valuation
[ ]Strong share price and Company valuation 20 March 2023 AVR added to the For personal use only 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
Slide 20: AVR continues to outperform all major health care indices
AVR continues to outperform all major health care indices Rolling 12 months 100% For personal use only 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 21: AVR outperformed major competitors
AVR outperformed major competitors 100% Rolling 12 months For personal use only 30 April 2023 75% AVR 50% Edwards Lifesciences 25% Medtronic 0% Boston Scientific -25% -50%
Slide 22: Capital raising at ever increasing price points
Capital raising at ever increasing price points For personal use only 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
Slide 23: Top investors hold 64% of the Company
Top 40 investors hold 64% of the Company OWNERSHIP COUNTRY For personal use only 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
Slide 24: Top 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 For personal use only AGM 1 Perceptive Advisors LLC 2,140,000 13.9% 16% Institution United States 2 L1 Capital Pty Ltd. 1,702,994 11.0%
Slide 25: For personal use only
For personal use only 800 million people are over 65
Slide 26: 2%-5% of people over have aortic stenosis
For personal use only 2% - 5% of people over 65 have aortic stenosis
Slide 27: Aortic stenosis is under treated
For personal use only • 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 availa
Slide 28: 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 For personal use only 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 Pro
Slide 29: Today we are only scratching the surface
Today we are only For personal use only scratching the surface
Slide 30: Patients now implanted with DurAVR
For personal use only 21 patients now implanted with DurAVR™
Slide 31: Clinical study update: 1-Year Interim Analysis
For personal use only Clinical study update 1-Year Interim Analysis
Slide 32: Cohort 1 & 2 baseline characteristics
[] Cohort 1 & 2 are difficult to treat small annulus patients Cohort 1 and 2 For personal use only 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
Slide 33: Excellent results maintained over one year
[Excellent ] results maintained over 1 year Cohort 1 & 2 Mean annulus size: 22.95 mm use only (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 For personal 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
Slide 34: Outstanding 1-Year Haemodynamics
Outstanding 1-Year Haemodynamics Cohort 1 & 2 Mean annulus size: 22.95 mm For personal use only (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=1
Slide 35: Huge improvements in exercise capacity
Huge improvements in exercise capacity 40% increase For personal use only Average Walked Distance 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 suppor
Slide 36: Significant improvements in QOL score over months
Significant improvements in QOL score over 12 months Cohort 1 & 2 For personal use only 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 37: Cohort 3 new patients + compassionate use patient
For personal use only Cohort 3 7 new patients + 1 compassionate use patient
Slide 38: Cohort 3 Objectives
Cohort 3 Objectives For personal use only 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
Slide 39: Difficult to treat anatomies
Difficult to treat anatomies For personal use only 51
Slide 40: Baseline Characteristics
Baseline Characteristics For personal use only 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 41: Post-procedure (48h) Haemodynamics Cohort 3
Post-procedure (48h) Haemodynamics Cohort 3 Mean annulus size: 22.33 mm use only EOA EOAi 2.5 1.4 2.11 1.17 1.2 2.0 1.0 For personal 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 ind
Slide 42: Post-procedure (48h) Haemodynamics all patients
Post-procedure (48h) Haemodynamics all patients Mean annulus size: 22.73 mm For personal use only 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 43: High-Level Results
High-Level Results For personal use only 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 44: Compassionate use case
For personal use only Compassionate use case
Slide 45: Baseline Characteristics
Baseline Characteristics Compassionate case – 24 April 2023 For personal use only 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 hypertensi
Slide 46: Excellent haemodynamics results in severe bicuspid anatomy
Excellent haemodynamics results in severe bicuspid anatomy Compassionate case – 24 April 2023 For personal use only 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-procedur
Slide 47: For personal use only
For personal use only []
Slide 48: All Subjects Post-procedure (48h) Interim Analysis
For personal use only All Subjects Post-procedure (48h) Interim Analysis
Slide 49: Baseline Characteristics
Baseline Characteristics All Subjects For personal use only 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 50: Post-procedure (48h) Haemodynamics All Subjects
Post-procedure (48h) Haemodynamics All Subjects Mean annulus size: 22.73 mm use only EOA EOAi 2.5 1.6 2.12 1.4 2.0 1.18 1.2 For personal 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
Slide 51: Post-procedure (48h) Haemodynamics All Subjects
Post-procedure (48h) Haemodynamics All Subjects Mean annulus size: 22.73 mm For personal use only 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 52: What are the experts saying about DurAVR?
For personal use only What are the experts saying about DurAVR™ ?
Slide 53: Becky Hanh interview
For personal use only Becky Hanh interview
Slide 54: Products, indications, pathways
For personal use only 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 55: Valve-in-Valve
Valve-in-Valve Global Aortic Valve-in-Valve An Evolving New Market for Repeat SAVR & TAVI Procedures 500,000 For personal use only 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 implan
Slide 56: TAV in 21mm SAV hydrodynamic results
TAV in 21mm SAV hydrodynamic results Magna Ease 21mm Mosaic AV 21mm Hancock AV 21mm For personal use only +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
Slide 57: DurAVR can address current challenges
DurAVR™ can address current challenges Poor Haemodynamics Improved Haemodynamics For personal use only 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 La
Slide 58: Current valves: Result in clinical compromises
Current valves: Result in clinical compromises • Poor Haemodynamics Coronary Access Issues For personal use only 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 ha
Slide 59: 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 For personal use only “Patients need a valve that restores an active lifestyle “Patients need a safe alternative to open heart surgery” for the rest of th
Slide 60: 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 For personal use only 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 y
Slide 61: What else are we up to?
[] For personal use only What else are we up to ?
Slide 62: Biomimetic THV to Restore Normal Aortic Integration
xample: Biomimetic THV to Restore Normal Ao INTEGRATION E
Slide 63: For personal use only
For personal use only
Slide 64: For personal use only
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Slide 65: For personal use only
For personal use only
Slide 66: Even Frame Expansion
• Even Frame Expansion For personal use only
Slide 67: New Patents issued that change the landscape
For personal use only New Patents issued that change the landscape
Slide 68: Patents that change the landscape
Patents that change the landscape For personal use only 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 provide
Slide 69: US facilities validated and online
[] For personal use only US facilities validated and online
Slide 70: Taking the clinical discussion forward
[] For personal use only Taking the clinical discussion forward 82
Slide 71: 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 For personal use only Flow Displacement (FD) = 12% Flow Displacement (FD) = 14% Flow Reversal Ratio (FRR) = 0% Flow Reversal Ratio (FR
Slide 72: Post DurAVR implantation flow restoration at 12 months
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 For personal use only 400 400 Systole Diastole Systole
Slide 73: DurAVR Shaped to Perform like Native Aortic Valve
DurAVR™ Shaped to Perform like Native Aortic Valve For personal use only 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
Slide 74: Collaborations that drive value
[] For personal use only Collaborations that drive value 86
Slide 75: Research Collaboration: Anteris – Ear Science Institute
For personal use only Research Collaboration Anteris – Ear Science Institute anteristech.com Follow us @anteristech Copyright Anteris Technologies Ltd 2023
Slide 76: Next Gen DurAVR that can be injection molded
Next Gen DurAVR™ that can be injection molded ESIA For personal use only Anteris • Novel Protein + Polyurethane/Glycerol Scaffold • Scaffold testing • Scaffold development • Valve Design & Engineering Concepts • Prototype manufacturing & optimization • Prototype - performance testing First Single Pi
Slide 77: V2V Medtech
For personal use only V2V Medtech The next big thing in mitral valve repair anteristech.com Follow us @anteristech Copyright Anteris Technologies Ltd 2023
Slide 78: 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 For personal use only regurgitation • Anteris will partner with leading physicians including Dr. Vinayak Bapat (v2v CMO and primary developer) • Market is exp
Slide 79: 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 For personal use only V-Clip is a versatile TEER device that can address anatomical configurations – uniquely expanding TEER therapy to more patients that otherwise would be s
Slide 80: 13.9% CAGR resulting in 2028 Market of ~US$2.8B
For personal use only 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 replac
Slide 81: Anteris Institutional Partnerships
Anteris Institutional Partnerships Partnering to Define a New Paradigm in Aortic Valve Science For personal use only 93
Slide 82: The sky really is the limit
For personal use only The sky really is the limit
Slide 83: Anteris Has Addressed Unmet Medical Needs With A New Class Of Product
Anteris Has Addressed Unmet Medical Needs With A New Class Of Product For personal use only 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 pr
Slide 84: Milestones
Milestones ADAPT ® Commercial Use - Global For personal use only 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)
Slide 85: Path to Commercialisation
Path to Commercialisation For personal use only
Slide 86: Go alone
For personal use only Go alone
Slide 87: 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 For personal use only market ⚫ Anteris is supported by Global Tier 1 Physicians, Scientists and Institutions Anteri
Slide 88: 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 For personal use only first 12 months post launch based on currently proven clinical results (best in class) • TAVR procedures continue to be concentrated in high
Anteris Technologies Global — Shareholder Meeting (May 2023) on 6ix