Anteris Technologies Global Corp. · NASDAQ:AVR
Anteris Technologies Global — Shareholder Meeting (May 2024)
80 slides from Anteris Technologies Global's shareholder meeting presentation, May 29, 2024
Slide 1: Annual General Meeting: Chairman's Address and CEO Presentation
ASX ANNOUNCEMENT 29 May 2024 Annual General Meeting Chairman’s Address and Chief Executive Officer Presentation SYDNEY, 29 May 2024: Anteris Technologies Ltd (ASX: AVR) is pleased to provide the attached Chairman’s Address and Chief Executive Officer Presentation to the Annual General Meeting being
Slide 2: Authorisation and Additional information
Authorisation and Additional information This announcement was authorised by Mr Stephen Denaro, Company Secretary. For more information: Investor Relations Investor Relations (US) investors@anteristech.com Malini Chatterjee, Ph.D. Anteris Technologies Ltd Managing Director +61 1300 550 310 | +61 7 3
Slide 3: Address by the Chairman Mr John Seaberg
Address by the Chairman Mr John Seaberg As usual at our AGM meetings I make you suffer through a few minutes of Chairman ramblings before turning the mic over to the guy you really want to hear from, your CEO, Wayne Paterson. Thank you for indulging me and I promise to be brief. First off, please kn
Slide 4: Annual General Meeting
For personal use only Annual General Meeting Anteris Technologies Ltd 29 MAY 2024 anteristech.com Follow us @anteristech
Slide 5: 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 For personal use only the Company’s activities current at the date of this presentation. The information does n
Slide 6: Disclaimer cont.
DISCLAIMER CONT. 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”, “estimate”
Slide 7: Disclaimer cont.
DISCLAIMER CONT. 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 Regulation G under
Slide 8: Anteris 2023/24 AGM
For personal use only Anteris 2023/24 AGM
Slide 9: 2023 Financials
For personal use only [] 2023 Financials
Slide 10: FY2023 Key Numbers
FY2023 Key Numbers For personal use only CASH $30.8M * SALES REVENUE + OTHER INCOME $7.0M COMPARED TO $13.8M AT 31 DEC 2022 96.4 * R&D COSTS CAPITAL RAISED IN 2023 $45.8M FTE & CONTRACTORS $78.9M COMPARED TO $25.1M IN 2022 supporting Anteris’ business strategy * 31 December 15
Slide 11: Financial Highlights 2023
[] For personal use only Financial Highlights 2023 FY2022 FY2023 Key Financial Metrics Actual Actual $m $m • Strengthened balance sheet at Market capitalization (31 Dec) 308.6 341.3 year-end following a successful capital raise Cash position (31 Dec) 13.8 30.8 Capital raised (gross) 34.9 78.9 • Reve
Slide 12: Focused R&D Expenditures Driving the Path to Approval
[ ] Focused R&D Expenditures Driving the Path to Approval Research and development For personal use only • DurAVRTM valve development program R&D • EFS • Valve-in-valve procedures • Valve science program • Upscaling manufacturing capabilities • Medical affairs R&D • Regulatory affairs 45.8 25.1 2022
Slide 13: Negative FX Impact as AUD has Declined to USD
[ ]Negative FX Impact Over the Past Years as AUD has Declined to USD 0.80 For personal use only 0.75 2023 average: 1 AUD = 0.66 USD 0.70 0.65 Post-share consolidation average (Feb 2020 to Dec 2022): 1 AUD = 0.71 USD 0.60 0.55 Feb-2020 Aug-2020 Feb-2021 Aug-2021 Feb-2022 Aug-2022 Feb-2023 Aug-2023 De
Slide 14: USD Expenditures Translates to 50% Increase in AUD Costs
[ ]USD Expenditures Translates to 50% Increase in AUD Costs 60.0 AUD AUD 54.2M For personal use only 50.0 AUD 50.3M 46.7M • USD $36.0M of expenses 40.0 USD incurred in 2023 converted 36.0M into A$54.2M Millions 30.0 • The same USD $36.0M using the prior 10-year 20.0 average FX rate converts into A$4
Slide 15: AVR has Returned 210% Since the Share Consolidation
[ ] AVR has Returned 210% Since the Share Consolidation • The S&P/ASX Emerging Companies Index (XEC) is a For personal use only benchmark consisting of 200 Australian microcap companies ranked anywhere between 350 to 600 by market capitalization AVR return XEC return • The below graph compares the p
Slide 16: Market Capitalization Increase of >1800% since Consolidation
[ ]Market Capitalization Increase of > 1800% since Consolidation Current market October 2023 cap $370m 500 For personal use only EFS enrollment completion 450 400 350 300 250 July 2023 February 2020 DurAVR™ THV 200 share first valve-in-valve consolidation implantation 150 100 50 0 28-Feb-20 28-Aug-2
Slide 17: AVR has Outperformed Major TAVR Competitors
[ ]AVR has Outperformed Major TAVR Competitors since First Patient Data 400% For personal use only 350% 300% 250% 200% AVR 150% Edwards Lifesciences Medtronic 100% Boston Scientific 50% 0% -50% -100% Feb-20 Aug-20 Feb-21 Aug-21 Feb-22 Aug-22 Feb-23 Aug-23 Feb-24
Slide 18: Top Investors Hold 68% of the Company
[ ]Top 40 Investors Hold 68% of the Company SHAREHOLDER MIX OWNERSHIP COUNTRY For personal use only PERCEPTIVE LIFE SCIENCES SIO CAPITAL AUSTRALIA 11% 5% 63.0% L1 CAPITAL OTHER 17% 9.0% UNITED EUROPE STATES 5.0% NEW 21.0% ZEALAND OTHER TOP 40 2.0% 34% INVESTOR TYPE HISTORY 70% 60% May 2022 April 202
Slide 19: Anteris Has a Talented and Diverse Work Force
[ ]Anteris Has a Talented and Diverse Work Force FTE by Function Multicultural Workforce For personal use only Austr Mo roc Exec & Board co a Zambia l 4% i a HR, IT, Finance 17% Neth d erlan Turkey n ds New Zeala g la nd i c a I n dia Manufacturing n E A f r Sweden Pakistan Th Ir 48% h Italy China t
Slide 20: Let's talk about Aortic Stenosis
For personal use only Let’s talk about Aortic Stenosis
Slide 21: Aortic Stenosis is a Life Threatening Disease
[] For personal use only Aortic Stenosis is a Life Threatening Disease AS is a serious life threatening disease affecting 1 in 8 elderly Australians
Slide 22: For personal use only
For personal use only Anteris has significantly expanded its patient numbers to 64 in the past 12 months
Slide 23: The TAVR Market
For personal use only The TAVR Market
Slide 24: TAVR is a US$10 bn+ Market Opportunity
[ ]TAVR is a US$10 bn+ Market Opportunity TAVR Aortic Stenosis + Valve-in-Valve market value(1) For personal use only (US$bn) Current range Valve-in-Valve of estimates: 10% - 35% of Native Aortic Stenosis the TAVR The aortic stenosis patient market population is under penetrated, with only ~15- 20%
Slide 25: TAVR will Continue to Grow at a Significant Rate
[ ] TAVR will Continue to Grow at a Significant Rate CAGR (‘12-’19) 80,000 TAVRs For personal use only 72,991 48.12% 70,000 62,655 57,626 All SAVRs 60,000 -1.19% 50,000 40,000 28,883 30,000 20,971 Isolated SAVRs 20,000 -4.47% 10,000 4,666 0 2012 2013 2014 2015 2016 2017 2018 2019 Isolated SAVRs All
Slide 26: Balloon Expandable Technologies have the Majority of Market Share
[Balloon ] Expandable Technologies have the Majority of Market Share US TAVR $ Market Share WW TAVR $ Market Share For personal use only 100% 100% 80% 60% 68.9% 71.3% 90% 40% 80% 20% 29.6% 23.1% 2.8% 70% 0% 2.8% 61.3% 63.9% 63.9% 65.5% 65.3% 2019 2027E 60% Abbott Boston Scientific Medtronic Edwards
Slide 27: Balloon Expandable TAVRs Favored in First Implantation
[ ]Balloon Expandable TAVRs are Favored in First Implantation, but Currently Valve- in-Valve are Seeing Greater Use of Self-Expanding 100% For personal use only 90% 80% 70% 60% 50% Self-Expanding Ballon Expandable 40% 30% 20% 10% 0% TAVR in Native Valve TAVR in TAVR/SAVR Carroll, J, Mack, M, Vemulap
Slide 28: Over 12M Patients with Aortic Stenosis, Underpenetrated
There are over 12M Patients with Aortic Stenosis, but Diagnosis and Treatment [] Remains Underpenetrated 12.3M 12,000,000 1,200,000 For personal use only 1.9M 964K 1.2M 8,000,000 800,000 3.4M At least 70% of AS Severe Symptomatic AS 560K patients are not 60.7% Severe Asymptomatic AS evaluated by car
Slide 29: For personal use only
For personal use only
Slide 30: Product Launches and Market Share are Not a Function of Luck
Product Launches and Market Share are Not a Function of Luck For personal use only • The commercial plan was written before the product existed and drove the product design • The Medical Advisory Board was chosen for their experience, center volume, podium presence and influence, to facilitate the m
Slide 31: So What Drives Adoption?
So What Drives Adoption? For personal use only üClinical data – superiority üEase of use üAdvanced science üPhysician peer advocacy üHands on experience
Slide 32: Clinical Data
For personal use only Clinical Data
Slide 33: DurAVR EFS: Excellent 30-Day Results
[ ]DurAVR™ EFS: Excellent 30-Day Results Paradigm Shifting 30-Day Hemodynamic Results* Excellent Safety Profile 30 Day Events N = 15 For personal use only EOA (Effective Orifice 2.18 Mean Annulus Size: 22.2 mm Primary Safety Endpoints All-cause mortality or disabling stroke 0 (0) Area) cm2 Secondary
Slide 34: DurAVR FIH: Consistent Hemodynamic Results through Year 1
[ ] DurAVR™ FIH: Consistent Hemodynamic Results through 1 Year Excellent Post-procedure Hemodynamic Results Sustained Hemodynamics Through 1 Year (N=41) For personal use only FIH 1 Year (to date) 2.5 60 Mean Annulus Size: 53.4 22.57 mm EOA 2.03 2.20 2.00 2.02 50 2.0 (Effective Orifice 40 Area) cm2 1
Slide 35: DurAVR has Excellent Hemodynamics
[ ]DurAVRTM has Excellent Hemodynamics Patients at 30 Days use only Mean Pressure Gradient 7.8 30 Day Follow Up 43 Patients Mean Gradient 7.8 mmHg mmHg For personal Mean Annulus 22.48 mm 1 2 3 4 5 6 7 8 9 10 11 12 13 14 68.2% 95.5% 42
Slide 36: Outstanding Effective Orifice Area at 30 days in Small Annulus
[] Outstanding Effective Orifice Area in DurAVRTM Patients at 30 days in Small Annulus For personal use only Effective Orifice Area cm2 2.15 30 Day Follow Up 43 Patients EOA 2.15 cm2 Mean Annulus 22.48 mm 1.0 1.5 2.0 2.5 3.0 68.2% 95.5% 43
Slide 37: DurAVR FIH: Improved Post-Procedure Hemodynamics over time
[ DurAVR™ ] FIH: Improved Post-Procedure Hemodynamics over time Latest Cohorts (4-5) Initial Cohorts (1-3) For personal use only (N=21) (N=20) Mean Annulus Size: Mean Annulus Size: 22.41 mm 22.73 mm EOA (Effective Orifice 2.27 EOA (Effective Orifice 2.12 Area) cm2 Area) cm2 MPG (Mean Pressure 8.4 MP
Slide 38: DurAVR Outperforms Competitor Benchmark Hemodynamics
[DurAVR ] TM Outperforms Competitor Benchmark Hemodynamics* Mean Annulus Size 22.2mm (Area 389.3) For personal use only DurAVR™ EOA Sapien 3 EOA Evolut EOA 2.36 1.58 1.82 cm2 49% LOWER 30% LOWER DurAVR™ DVI Sapien 3 DVI Evolut DVI 0.71 0.44 0.61 61% LOWER 16% LOWER Hahn RT, Leipsic J, Douglas PS, Ja
Slide 39: DurAVR Resolves Compromises in Today's Valve-in-Valve
[ DurAVR™ ] Resolves Compromises in Today’s Valve-in-Valve Current valves require compromises for Valve-in-Valve § Balloon expandable (BE) TAVR have poor hemodynamics in small SAVR For personal use only § Self expanding (SE) TAVR have moderate hemodynamics, but higher rates of limited future coronar
Slide 40: DurAVR Outperforms All Valves - Even When Inside Them
[DurAVR ] TM Outperforms All Valves - Even When Inside Them! • 77-year-old male, too high risk for repeat surgery with failure of his valve-in-valve. For personal use only • First surgical valve went in with mediocre hemodynamics and eventually failed. • A self expanding TAVR was placed in it (curre
Slide 41: For personal use only
For personal use only
Slide 42: Advanced Science
For personal use only Advanced Science
Slide 43: Laminar Flow: A Therapeutic Target
[ ] Laminar Flow: A Therapeutic Target 4D Flow Before and After DurAVRTM For personal use only Post Pre Garg P, Markl M, Sathananthan J, Sellers SL, Meduri C, Cavalcante J. “Restoration of flow in the aorta: a novel therapeutic target in aortic valve intervention”. Nat Rev Cardiol. 2023 Oct 25. doi:
Slide 44: Clinical Data and the Perfect Storm
[ ] Clinical Data and the Perfect Storm SMART is the first head-to-head randomized TAVR trial demonstrated statistically significant performance differences in small annuli patients For personal use only 40% of global TAVR market is Small Sapien3 demonstrated significantly Annuli patients worse BVD
Slide 45: Small Annuli Sapien3 Creates Poor Flow and Leaflet Function
[ ] Small Annuli Sapien3 Creates Poor Flow and Leaflet Function promotes high mean gradients and prosthesis patient mismatch – leading to BVD Bioprosthetic Valve For personal use only Competitor valves look like nature but have turbulent blood flow performance Sapien3 Excess tissue in small deployme
Slide 46: Three highly innovative technologies = clinical and commercial advantage
Three highly innovative technologies = clinical and commercial advantage For personal use only Anteris has addressed unmet medical needs with a new class of products for the treatment of aortic stenosis. This first-in-class biomimetic technology can be used for new patients, (USD 10 BN) and replace
Slide 47: Physician Advocacy
For personal use only Physician Advocacy 55
Slide 48: Biomimetic THV to Restore Normal Aortic Flow
ample: Biomimetic THV to Restore Normal Ao INTEGRATION Ex MPG (nmts 16:19 May, 2028
Slide 49: Expert Reviews
[] Expert Reviews Cardiologists globally are recognising the capabilities of DurAVR™, mentioning that the hemodynamics are amazing and that it has the potential to offer superior gradients for ViV patients. For personal use only Professor Martin B. Leon, MD Professor of Cardiology at the Columbia Un
Slide 50: Hands on Experience
For personal use only Hands on Experience
Slide 51: DurAVR FIH and EFS Study Design and Baseline Characteristics
[ ]DurAVR™ FIH and EFS Study Design and Baseline Characteristics FIH EFS Study & Baseline Characteristics sign N = 41 N = 15 De Prospective, 1 7 For personal use only Number of Centers non-randomized (Tbilisi, Georgia) (United States) single-arm, studies Population Severe symptomatic AS Severe sympt
Slide 52: Path to Commercial Approval
For personal use only Path to Commercial Approval
Slide 53: DurAVR Pivotal Study is the First All Risk Head-to-Head TAVR Registration Trial
[DurAVR ] TM Pivotal Study is the First All Risk Head-to-Head TAVR Registration Trial Symptomatic Severe Native Aortic Valve in Valve Registry for Study Co-Chairs: Stenosis Bioprosthetic Surgical Valves For personal use only Dr. Martin B. Leon Dr. Michael J. Reardon All risks, assessed by Heart Team
Slide 54: First of a Kind All Comers Head-to-Head TAVR Randomized Trial
[Our ] First of a Kind all Comers Head-to-Head TAVR Randomized Clinical Trial is Expected To Enroll Quickly Biomimefc outcomes are driving enthusiasm - Anteris will request confnued access for For personal use only DurAVR™ with FDA ENROLLMENT FOLLOW UP REVIEW Patients return monthly for 12 Company a
Slide 55: Mitral Repair TEER Project
For personal use only Mitral Repair TEER Project
Slide 56: TEER Procedure
[] TEER Procedure Transcatheter Edge to Edge Repair (TEER) improves valve performance by approximating the For personal use only edges of the Mitral or Tricuspid valve leaflets together to improve valve function and reduce regurgitation. Edge to edge was proven as a surgical repair It has transition
Slide 57: The Mitral and Tricuspid Space is Large and Underpenetrated
[ ] The Mitral and Tricuspid Space is Large and Underpenetrated Large & Underpenetrated Transcatheter Mitral & Tricuspid Therapies TAM For personal use only US TMTT TAM Estimates & Market Segmentation Transcatheter Mitral & Tricuspid Therapies (TMTT) Mitral Tricuspid $19B US TAM $6B US TAM Repair Re
Slide 58: TMTT Growing at 14% CAGR
[ ]TMTT Growing at 14% CAGR Resulting in 2028 Market of ~US$2.8B For personal use only TMTT Market Revenue ($US M) Surgery $6,250 Transcatheter Tricuspid repair Transcatheter Tricuspid replace In 2022 Surgery is the Gold $5,110 Transcatheter Mitral repair $2,685 Standard Treatment for Mitral Transca
Slide 59: Small Number of Players with Older Technologies
[ ]Small Number of Players with Older Technologies Currently Available Devices with FDA and CE Mark For personal use only • Abbott’s MitraClip received CE Mark 2009 & FDA • Edwards PASCAL obtained CE Mark in 2019 approved in 2013 & since then >150,000 patients with ~ 4,500 pa1ents Treated, ~$US 100m
Slide 60: Anteris will Establish a Leadership Foundation in High-Growth High-Value Markets
[ ]Anteris will Establish a Leadership Foundation in High-Growth High-Value Markets 1 Deliver DurAVRTM in growing TAVR 2 Establish foothold in emerging high For personal use only market growth adjacent SH markets +$1B +$2B $19B $1B +$9B $3B $7B $15B $1B $6B Tricuspid repair Mitral repair TAVR 2020 M
Slide 61: V2V in Action
For personal use only [] V2V in Action
Slide 62: Anteris Patent Summary
For personal use only Anteris Patent Summary
Slide 63: IP Protection
IP Protection Anteris has been issued patents for its ground breaking biomimetic design, which has changed the landscape. For personal use only DurAVR™ THV IS NOT AVAILABLE FOR SALE, FOR CLINICAL INVESTIGATIONAL USE ONLY.
Slide 64: Our Patent Portfolio has Grown Significantly Over the Past 18 Months
[ ]Our Patent Portfolio has Grown Significantly Over the Past 18 Months 13 Patents Issues in 2023 and 6 Patents Issued Year-to-Date Granted Patents For personal use only 14 13 12 10 8 6 6 4 2 0 2008 2009 2010 2011 2012 2013 2014 2015 2016* 2017 2018 2019 2020 2021 2022 2023 2024 (YTD) US Patents OUS
Slide 65: DurAVR TAVR
[] DurAVR™ TAVR Examples: For personal use only • US 9,205,172 o Covers the current ADAPT manufacturing process o Active patents in: US, AU, BR, CA, CH, CN, DE, FR, GB, IE, JP, MX, NL • US 11,648,107 o Covers the current TAVR valve design (focused on the molded valve) o Active patents in: US, AU, JP
Slide 66: Delivery System
[] Delivery System Examples: For personal use only • US 11,883,286 o Covers the current delivery system (focused on predictable commissural alignment) o Pending applications in: US, AU, CA, EP, JP • US 63/469,121 o Covers the current delivery system overall o Pending applications in: US, OUS (TBD) •
Slide 67: Sterilization, Packaging, and Valve Preparation
[] For personal use only Steriliza\on, Packaging, and Valve Prepara\on Examples: • US 10,758,642 o Covers the current sterilization and storage of the tissue valve o Active patents in: US, AU, BR, JP, KR, MX, MY o Pending applications in: US, CN, IN • US 63/504,383 o Covers the current packaging and
Slide 68: For personal use only
For personal use only []
Slide 69: The TAVR Space is High Value and DurAVR is Competitive
[ ]The TAVR Space is High Value and DurAVRTM is Competitive Anteris Estimated Edwards Lifesciences: Clinical results For personal use only - 65% US TAVR market share >30% better market size post - Majority of revenue from TAVR commercial: - Current market cap A$79bn Edwards Lifesciences A$15bn+ (202
Slide 70: What Happens When a Medtech Lists on the Nasdaq?
[ ] What Happens When a Medtech Lists on the Nasdaq? 1000% increase since listing For personal use only
Slide 71: Working towards Nasdaq dual listing with ASX
[ Working ] towards Nasdaq dual listing with ASX • As previously reported, Anteris continues to evaluate a potential dual listing of its securities on For personal use only Nasdaq and ASX and has undertaken preparatory work related to this. • A Nasdaq listing would facilitate greater exposure to the
Slide 72: For personal use only
For personal use only [] 86
Slide 73: What to Expect from AVR over the Coming Period
[ ]What to Expect from AVR over the Coming Period • Company confirms DurAVRTM is clinically relevant and competitive, data For personal use only continues to support the commercial thesis. Expect ongoing follow up data as cohorts reach significant milestones. • FDA Approval for Pivotal study • Comme
Slide 74: For personal use only
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Slide 75: Board of Directors and Management Team
[ ] Board of Directors and Management Team For personal use only JOHN DR WENYI STEPHEN SEABERG GU DENARO CHAIRMAN NON-EXECUTIVE NON-EXECUTIVE DIRECTOR & DIRECTOR COMPANY SECRETARY DAVID ST MATTHEW DR CHRIS DENIS MCDONNELL MEDURI CHIEF OPERATING CHIEF FINANCIAL CHIEF MEDICAL OFFICER OFFICER OFFICER
Slide 76: For personal use only
For personal use only
Slide 77: Our Amazing Physician Advisors
[ ]Our Amazing Physician Advisors For personal use only Martin Leon, MD Columbia Medical Center Michael Reardon, MD Samir Kapadia, MD Gorav Ailawadi, MD Allen Zajarias, MD Nicolas Van Mieghem, MD Thomas Modine, MD Karl Poon, MBBS Jayme Bennetts, MBBS Cardiovascular Research Houston Methodist Clevela
Slide 78: Our Incredible and Visionary Shareholders
For personal use only Our Incredible and Visionary Shareholders
Slide 79: And of Course our Patients
For personal use only And of Course our Patients
Slide 80: Thank You
For personal use only Thank You anteristech.com Follow us @anteristech
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