Anteris Technologies Global Corp. · NASDAQ:AVR
Anteris Technologies Global — IPO Roadshow (December 2024)
34 slides from Anteris Technologies Global's IPO roadshow presentation, Dec 16, 2024
Slide 1: Anteris Technologies Global Corp.
For personal use only Anteris Technologies Global Corp. December 2024 1 A NTE RIS TEC H.CO M
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Anteris Technologies Global Corp. (“Anteris,” the “Company,” “we” or “us”). This presentation, and its contents and the accompanying discussion with management are confidential and may not be further copied, distributed or passed on, directly or indi
Slide 3: Offering Summary
Offering Summary Issuer (Ticker / Exchange): Anteris Technologies Global Corp. (AVR / NASDAQ) For personal use only Base offering size: 14,800,000 shares (~$100 million gross proceeds; based on $6.781 reference price; 100% primary) Overallotment option: 2,220,000 shares (15% of base offering size; 1
Slide 4: Investment Summary
Investment Summary FAVORABLE CLINICAL FAVORABLE SAFETY MARKET OPPORTUNITY PATENTS IN PLACE COMPANY THESIS For personal use only RESULTS TO DATE PROFILE › Global aortic stenosis › Hemodynamic results › No valve related deaths › Robust IP portfolio › Strong and experienced TAVR market forecast to comp
Slide 5: Corporate Summary
CO RPOR ATE S UMMA RY Anteris has taken a targeted approach to solving a critical unmet need For personal use only We have created the first new class of transcatheter aortic Market Capitalization: USD$149m valve replacement1 (TAVR) in over a decade: DurAVR® THV (as of 31 October 2024) Shares on iss
Slide 6: Board of Directors
B OA RD OF DIR ECTORS • Anteris Chair since 2017 and director since October 2014 • Joined Anteris in October 2014 as a Non-Executive Director, served • Chair of Preceptis Medical Inc since 2016 and Phraxis Medical Inc as Chair from February 2016 to March 2017, Interim CEO from May since 2009 2016, a
Slide 7: Executive Leadership Team
EXECUTI VE LEADERSH IP TEA M • Joined Anteris in October 2014 as a Non-Executive Director, • Chief Operating Officer since July 2017 served as Chair from February 2016 to March 2017, Interim CEO • Chief Executive Officer of v2vmedtech, inc. since 2023 from May 2016, and CEO and Director of Anteris T
Slide 8: Medical Advisory Board
MEDICAL A DVI SORY B OAR D Anteris is guided by a global team of well regarded cardiovascular Physician advisors For personal use only North America Europe Australia 8
Slide 9: Company Overview
For personal use only Company Overview
Slide 10: TAVR Market Opportunity Expected to Reach US$9.9bn in 2028
THE OPPORTUNITY TAVR Market Opportunity Expected to Reach US$9.9bn in 2028 For personal use only Underpenetrated patient population with only 15-20%1 of severe aortic stenosis cases treated today US$bn TAVR Aortic Stenosis & Valve-in-Valve Market2 Potential for further significant growth 14.0 Curren
Slide 11: Aortic Stenosis (AS)
AOR TI C STENO SIS ( AS) A life-threatening heart condition which occurs when there is a narrowing of the aortic valve Treatment Options For personal use only SAVR Surgical Aortic Valve Replacement TAVR Transcatheter Aortic Valve Replacement This narrowing restricts blood flow from the heart to the
Slide 12: Unmet Clinical Need
UNMET CLI NICAL NEED Yesterday’s TAVRs were not developed for today’s patients For personal use only Patients need a valve that restores an active lifestyle Patients need a safer alternative to open heart surgery for the rest of their life First & second Third generation TAVRs generation TAVRs ~85 y
Slide 13: Design Target
DESIG N TAR GET Anteris set out to address the needs in TAVR by asking different questions For personal use only How does a healthy aortic How can we mimic a How can we put that How do we deliver the valve perform? native valve? valve in a frame? valve? Our expert panel of physicians determined what
Slide 14: The first new class of TAVR in over a decade
The first new class of TAVR in over a decade For personal use only Balloon expandable Promising hemodynamic delivery system performance1 • Simple & precise deployment The first in class biomimetic valve • The only valve to restore flow dynamics • Commissure alignment Uniquely shaped to mimic the perfor
Slide 15: Proprietary innovation that leads to a more human like valve
Proprietary innovation that leads to a more human like valve For personal use only Large open cells in stent frame to improve coronary access “A balloon expandable valve with self-expanding Designed to be anatomically correct, hemodynamics is like the intended to restore normal laminar Holy Grail1.”
Slide 16: Three Highly Innovative Technologies
Three Highly Innovative Technologies Anteris aims to address unmet medical needs with a new class of products for the treatment of aortic stenosis. This new class of biomimetic technology can be used for new patients and to replace existing valves in patients (valve-in-valve (“ViV”)). For personal u
Slide 17: For personal use only
For personal use only 1. Waggoner T. “DurAVR® Biomimetic Transcatheter Heart Valve: Early Feasibility Study (EFS) Update”. Oral Presentation at: CRT Conference, March 2024; Washington, USA 2. Cavalcante J. Biomimetic Design Restores Flow and Hemodynamics and Leads to Significant LV Mass Regression:
Slide 18: DurAVR Consistent Hemodynamic Results through 1 Year
CLINICAL RESULTS DurAVR® Consistent Hemodynamic Results through 1 Year 1 Post-procedure Hemodynamic Results Sustained Hemodynamics Through 1 Year For personal use only (N=41) Mean Annulus Size: 22.57 mm Mean Annulus Size: 22.73 mm EOA (Effective Orifice 2.20 Area) cm2 No moderate or severe PVL MPG (
Slide 19: DurAVR US Early Feasibility Study
US CLI NICAL RESULTS DurAVR® US Early Feasibility Study For personal use only Promising 30-day hemodynamic (blood flow) results* Favorable safety profile, no paravalvular leak at 30-day follow up Effective Orifice Area (EOA) • The cross–sectional area of the aortic valve opening that is available fo
Slide 20: Normal Aortic Flow
NOR MAL AORTIC FLOW DurAVR® is the first aortic For personal use only valve to restore normal Healthy FD = 10% aortic flow Aortic Valve FRR = 1% (n=5) When compared to a healthy aortic valve, DurAVR® THV showed no significant difference in flow (p>0.05) Post FD = 14% DurAVR ® FRR = 4% THV (n=5) FD =
Slide 21: Laminar Flow – A Therapeutic Target
LAMINAR FLOW – A THERA PEUTIC TA RGET 4D Flow pre and post DurAVR® For personal use only Pre DurAVR® Post DurAVR® 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 Oc
Slide 22: Easy to Deliver, 100% Precise Placement and Implant Success
Easy to Deliver, 100% Precise Placement and Implant Success No PVL reported at 30-days EFS 30 Day Events1 N = 15 No PVL reported at 30-days For personal use only Primary Safety Endpoints All-cause mortality or disabling stroke 0 (0) Secondary Safety Endpoints All-cause mortality 0 (0) Disabling Stro
Slide 23: DurAVR Valve in Valve in Valve (ViViV)
DurAVR® Valve in Valve in Valve (ViViV) › 77-year-old male, too high risk for repeat surgery with failure of his valve For personal use only 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 bes
Slide 24: DurAVR Pivotal Study (Phase 3)
DurAVR ® PIVOTA L STUDY (PHA SE 3) The First All Risk Head-to-Head TAVR Registration Trial For personal use only 24
Slide 25: DurAVR Pivotal Study (Phase 3)
DurAVR ® PIVOTA L STUDY (PHA SE 3) Biomimetic outcomes are driving enthusiasm, the trial is expected to enroll quickly For personal use only Anteris will request continued access for DurAVR ® with the FDA ENROLLMENT FOLLOW UP REVIEW Patients are followed up at 1 Company assembles the data into Patie
Slide 26: Manufacturing
MA NUFACTUR ING ADAPT® tissue engineering (AU), DurAVR® assembly (US) For personal use only • ADAPT® : multi-step, anti-calcification, tissue engineering process • Transforms animal tissue into a durable bio-scaffold (intended Malaga, WA, Australia to mimic human tissue and mitigate structural valve
Slide 27: Anticipated Milestones
Anticipated Milestones For personal use only Q4 2024 Q2 2025 Q4 2025 Q2 2026 Q4 2026 • TCT presentation: Flow • DurAVR® IDE approval • TCT presentation: Cardiac Remodeling • DurAVR® CE Mark Submission • LPI Pivotal • EU ViV Study 5-10 patients • TVT presentation: FIH 1 year • PCR LV presentation: EU
Slide 28: Anticipated Next Steps
Anticipated Next Steps For personal use only › Seek FDA approval for global pivotal trial (US, EU, AU, ~80 sites) › Pivotal trial patient recruitment commences › FDA submission commences (modular approach) › Monthly discussions with FDA › Ongoing pre-market commercialization activities › Ongoing dis
Slide 29: Investment Summary
Investment Summary FAVORABLE CLINICAL FAVORABLE SAFETY MARKET OPPORTUNITY PATENTS IN PLACE COMPANY THESIS For personal use only RESULTS TO DATE PROFILE › Global aortic stenosis › Hemodynamic results › No valve related deaths › Robust IP portfolio › Strong and experienced TAVR market forecast to comp
Slide 30: Appendices
For personal use only Appendices
Slide 31: IP Protection
IP PROTECTI ON Our patent portfolio has grown significantly since 2022, with 13 patents issued in 2023 and 9 patents issued year-to-date For personal use only Granted Patents 14 13 12 10 9 8 6 4 2 0 2008 2009 2010 2011 2012 2013 2014 2015 2016* 2017 2018 2019 2020 2021 2022 2023 2024 (YTD) US Patent
Slide 32: IP Protection – DurAVR
IP PROTECTI ON – DURAVR ® Examples: › US 9,205,172 For personal use only Covers the current ADAPT manufacturing process Active country patents include: US, AU, BR, CA, CH, CN, DE, FR, GB, IE, JP, MX, NL, EP › US 11,648,107 Covers the current TAVR valve design (focused on the molded valve) Active cou
Slide 33: IP Protection – Delivery System
IP PROTECTI ON – DELIV ERY SYSTEM Examples: For personal use only › US 11,883,286 Covers the current delivery system (focused on predictable commissural alignment) Active country patents include: US Pending applications in: US, AU, CA, EP, JP › US 18/669,999 Covers the current delivery system overal
Slide 34: IP Protection – Sterilization, Packaging, and Valve Preparation
IP PROTECTI ON – STERIL IZATION, PACKAG ING, AND VALV E PREPAR ATI ON Examples: For personal use only › US 10,758,642 Covers the current sterilization and storage of the tissue valve Active country patents include: US, AU, BR, CA, IN, JP, KR, MX, MY Pending applications in: CN › US 18/669,086 Covers
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