Anteris Technologies Global Corp. · NASDAQ:AVR
Anteris Technologies Global — Shareholder Meeting (May 2024)
77 slides from Anteris Technologies Global's shareholder meeting presentation, May 29, 2024
Slide 1: Annual General Meeting
Annual General Meeting Anteris Technologies Ltd 29 MAY 2024 anteristech.com Follow us @anteristech
Slide 2: 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 3: Disclaimer cont.
DISCLAIMER CONT. 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”, “anticipate”, “belie
Slide 4: 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 5: Anteris 2023/24 AGM
Anteris 2023/24 AGM
Slide 6: 2023 Financials
Assets Cuarort sen 1,734,826 Non-cumeet assets. es Liabilities 166, a eye20 abates: 00 Equity 74,393 Pain captal Rotaned ewnngs mn Income statement 78,516 Bevooues 12,9 73 516 tnvestiment tones. 2,535 Expenses oO saunas Equity statement Current year —-1,774,576 A 15807 apmabenene 890 pant pepe Owate
Slide 7: FY2023 Key Numbers
FY2023 Key Numbers 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
Slide 8: Financial Highlights 2023
[] 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 • Revenues and Other income
Slide 9: Focused R&D Expenditures Driving the Path to Approval
[ ] Focused R&D Expenditures Driving the Path to Approval Research and development • 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 2023
Slide 10: Negative FX Impact as AUD has Declined to USD
[ ]Negative FX Impact Over the Past Years as AUD has Declined to USD 0.80 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 Dec-2023 18
Slide 11: USD Expenditures Translates to 50% Increase in AUD Costs
[ ]USD Expenditures Translates to 50% Increase in AUD Costs 60.0 AUD AUD 54.2M 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$46.7M 10.0 0.0 2023 USD
Slide 12: 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 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 performance of the AVR
Slide 13: Market Capitalization Increase of >1800% since Consolidation
[ ]Market Capitalization Increase of > 1800% since Consolidation Current market October 2023 cap $370m 500 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-20 28-Feb-21 31-Aug-21
Slide 14: AVR has Outperformed Major TAVR Competitors
[ ]AVR has Outperformed Major TAVR Competitors since First Patient Data 400% 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 15: Top Investors Hold 68% of the Company
[ ]Top 40 Investors Hold 68% of the Company SHAREHOLDER MIX OWNERSHIP COUNTRY 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 2023 50% April 2024 40% O
Slide 16: Anteris Has a Talented and Diverse Work Force
[ ]Anteris Has a Talented and Diverse Work Force FTE by Function Multicultural Workforce 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 u ail elan S o an d S
Slide 17: Let's talk about Aortic Stenosis
Let’s talk about Aortic Stenosis
Slide 18: Aortic Stenosis is a Life Threatening Disease
[] Aortic Stenosis is a Life Threatening Disease AS is a serious life threatening disease affecting 1 in 8 elderly Australians
Slide 19: Anteris has significantly expanded its patient numbers
Anteris has significantly expanded its patient numbers to 64 in the past 12 months
Slide 20: The TAVR Market
The TAVR Market
Slide 21: TAVR is a US$10 bn+ Market Opportunity
[ ]TAVR is a US$10 bn+ Market Opportunity TAVR Aortic Stenosis + Valve-in-Valve market value(1) (US$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% of severe AS cases tre
Slide 22: TAVR will Continue to Grow at a Significant Rate
[ ] TAVR will Continue to Grow at a Significant Rate CAGR (‘12-’19) 80,000 72,991 TAVRs 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 SAVRs TAVRs The volume
Slide 23: 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 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 50% OUS TAVR $ Market
Slide 24: 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% 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, Vemulapalli, S. et al. STS-AC
Slide 25: 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 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 cardiac specialist3 424K
Slide 26: Go to Market Strategy
Slide 27: Product Launches and Market Share are Not a Function of Luck
Product Launches and Market Share are Not a Function of Luck • 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 market adoption at laun
Slide 28: So What Drives Adoption?
So What Drives Adoption? üClinical data – superiority üEase of use üAdvanced science üPhysician peer advocacy üHands on experience
Slide 29: Clinical Data
o Clinical Data
Slide 30: 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 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 Safety Endpoints All-
Slide 31: 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) 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 1.5 EOA (cm2) & DVI MPG
Slide 32: DurAVR has Excellent Hemodynamics: Mean Pressure Gradient
[ ]DurAVRTM has Excellent Hemodynamics Patients at 30 Days Mean Pressure Gradient 7.8 30 Day Follow Up 43 Patients Mean Gradient 7.8 mmHg mmHg 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 33: Outstanding Effective Orifice Area in Small Annulus
[] Outstanding Effective Orifice Area in DurAVRTM Patients at 30 days in Small Annulus 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 34: FIH: Improved Post-Procedure Hemodynamics over time
[ DurAVR™ ] FIH: Improved Post-Procedure Hemodynamics over time Latest Cohorts (4-5) Initial Cohorts (1-3) (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 MPG (Mean Pressure 8.7 G
Slide 35: DurAVR Outperforms Competitor Benchmark Hemodynamics
[DurAVR ] TM Outperforms Competitor Benchmark Hemodynamics* Mean Annulus Size 22.2mm (Area 389.3) 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, Jaber WA, Weissman NJ, P
Slide 36: 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 § Self expanding (SE) TAVR have moderate hemodynamics, but higher rates of limited future coronary access § Physicians
Slide 37: 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. • First surgical valve went in with mediocre hemodynamics and eventually failed. • A self expanding TAVR was placed in it (currently believed to be be
Slide 38: Ease of Use
Slide 39: Advanced Science
Advanced Science
Slide 40: Laminar Flow: A Therapeutic Target
[ ] Laminar Flow: A Therapeutic Target 4D Flow Before and After DurAVRTM 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: 10.1038/s41569-023-00
Slide 41: 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 40% of global TAVR market is Small Sapien3 demonstrated significantly Annuli patients worse BVD at 1 year 41.6% 15% p<
Slide 42: 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 Competitor valves look like nature but have turbulent blood flow performance Sapien3 Excess tissue in small deployments Sapien3 Evolut g E
Slide 43: Three highly innovative technologies = clinical and commercial advantage
Three highly innovative technologies = clinical and commercial advantage 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 existing valves in pat
Slide 44: Physician Advocacy
. PCR Round table | Nllondon valves PCR Roundtable Fs Rliontion volves PCR Roun
Slide 45: Biomimetic THV to Restore Normal Aortic Flow
ample: Biomimetic THV to Restore Normal Ao INTEGRATION Ex MPG (nmts 16:19 May, 2028
Slide 46: 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. Professor Martin B. Leon, MD Professor of Cardiology at the Columbia University Irving Medica
Slide 47: Hands on Experience
ASX : AVeR ANTERG STECH.COM Hands on Experience
Slide 48: 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, Number of Centers 1 7 non-randomized (Tbilisi, Georgia) (United States) single-arm, studies Population Severe symptomatic AS Severe symptomatic AS (Nov 2021 –
Slide 49: Path to Commercial Approval
Path to Commercial Approval
Slide 50: DurAVR Pivotal Study is the First All Risk Head-to-Head TAVR 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 Dr. Martin B. Leon Dr. Michael J. Reardon All risks, assessed by Heart Team 60 US sites 20 OUS si
Slide 51: 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 DurAVR™ with FDA ENROLLMENT FOLLOW UP REVIEW Patients return monthly for 12 Company assembles the data Pati
Slide 52: Mitral Repair TEER Project
ASX: AVR Mitral Repair TEER Project
Slide 53: TEER Procedure
[] TEER Procedure Transcatheter Edge to Edge Repair (TEER) improves valve performance by approximating the 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 transitioned to a transcatheter
Slide 54: 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 US TMTT TAM Estimates & Market Segmentation Transcatheter Mitral & Tricuspid Therapies (TMTT) Mitral Tricuspid $19B US TAM $6B US TAM Repair Replacement Repair Repla
Slide 55: TMTT Growing at 14% CAGR
[ ]TMTT Growing at 14% CAGR Resulting in 2028 Market of ~US$2.8B TMTT Market Revenue ($US M) Surgery $6,250 Transcatheter Tricuspid repair Transcatheter Tricuspid replace In 2022 Surgery is the Gold $5,110 Transcatheter Mitral repair $2,685 Standard Treatment for Mitral Transcatheter Mirtal replace
Slide 56: Small Number of Players with Older Technologies
[ ]Small Number of Players with Older Technologies Currently Available Devices with FDA and CE Mark • Abbott’s MitraClip received CE Mark 2009 & FDA • Edwards PASCAL obtained CE Mark in 2019 approved in 2013 & since then >150,000 patients with ~ 4,500 pa1ents Treated, ~$US 100m (Edwards Investor Con
Slide 57: Anteris will Establish a Leadership Foundation in High-Growth Markets
[ ]Anteris will Establish a Leadership Foundation in High-Growth High-Value Markets 1 Deliver DurAVRTM in growing TAVR market 2 Establish foothold in emerging high growth adjacent SH markets +$1B +$2B $19B $1B +$9B $3B $7B $15B $1B $6B Tricuspid repair Mitral repair TAVR 2020 Mkts TAVR Mitral repair
Slide 58: V2V in Action
[] V2V in Action
Slide 59: Anteris Patent Summary
Anteris Patent Summary
Slide 60: IP Protection
IP Protection Anteris has been issued patents for its ground breaking biomimetic design, which has changed the landscape. DurAVR™ THV IS NOT AVAILABLE FOR SALE, FOR CLINICAL INVESTIGATIONAL USE ONLY.
Slide 61: Our Patent Portfolio has Grown Significantly
[ ]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 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 Patents * Includes an
Slide 62: DurAVR TAVR
[] DurAVR™ TAVR Examples: • 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, KR o Pending applica
Slide 63: Delivery System
[] Delivery System Examples: • 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) • US 63/469,267 o Cover
Slide 64: Sterilization, Packaging, and Valve Preparation
[] 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 preparation system o
Slide 65: []
[]
Slide 66: 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 - 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+ (2023)* What if…? TAVR rev
Slide 67: What Happens When a Medtech Lists on the Nasdaq?
[ ] What Happens When a Medtech Lists on the Nasdaq? 1000% increase since listing
Slide 68: 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 Nasdaq and ASX and has undertaken preparatory work related to this. • A Nasdaq listing would facilitate greater exposure to the US markets, with pote
Slide 69: []
[] 86
Slide 70: 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 continues to support the commercial thesis. Expect ongoing follow up data as cohorts reach significant milestones. • FDA Approval for Pivotal study • Commencement of study • “Po
Slide 71: se
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Slide 72: Board of Directors and Management Team
[ ] Board of Directors and Management Team 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 73: Anteris Technologies
ANTERIS TECHNOLOGIES sy
Slide 74: Our Amazing Physician Advisors
[ ]Our Amazing Physician Advisors 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 Cleveland Clinic Univ of Virg
Slide 75: Our Incredible and Visionary Shareholders
Our Incredible and Visionary Shareholders
Slide 76: And of Course our Patients
And of Course our Patients
Slide 77: Thank you
Thank you anteristech.com Follow us @anteristech
Anteris Technologies — Shareholder Meeting (May 2024) on 6ix