Aroa Biosurgery Ltd · ASX:ARX
Aroa Biosurgery — Investor Day (July 2021)
71 slides from Aroa Biosurgery's investor day presentation, Jul 5, 2021
Slide 1: Aroa Biosurgery Investor Day
Aroa Biosurgery INVESTOR DAY Unlocking regenerative healing for everybody
Slide 2: Important Notice and Disclaimer
|2 Important Notice and Disclaimer This presentation (Presentation) is dated 5 July 2021 and has been prepared by Aroa Biosurgery Ltd, New Zealand company number 1980577, ARBN 638 867 473 (AROA or the Company). Information in this Presentation The information in this Presentation is of a general bac
Slide 3: AROA at a Glance
|3 AROA at a Glance Well established high-growth soft tissue regeneration company NZ$23.1m 68% Gross Margin 4 million+ product sales FY21 on FY21, impacted by lower sales Procedures with constant currency basis and FX AROA’s products 5 patented Regulatory AROA ECM™ products Approvals platform Provid
Slide 4: Catalysts
|4 Catalysts Post-COVID AROA Direct Sales TELA Bio® Product Momentum Synergies Vaccinations expected to Fully dedicated improve throughout CY2021 field sales team. Myriad™ Clinical outcomes & cost Complementary products for expected to drive growth. savings driving increasing every phase of healing
Slide 5: Unlocking Regenerative Healing for Everybody
|5 Unlocking Regenerative Healing for Everybody AROA ECM technology offers leading regenerative performance at a significantly lower cost than other biologics enabling more patients to have access to the benefits of regenerative healing Price Biologics ‘Regenerative but weak’ AROA Synthetics Product
Slide 6: Q&A
? Q&A Unlocking regenerative healing for everybody
Slide 7: AROA ECM Manufacturing Overview and Product Portfolio
AROA ECM Manufacturing Overview Product Portfolio Unlocking regenerative healing for everybody
Slide 8: Frazer Murray, Director of Global Marketing & Strategy
Frazer Murray Director of Global Marketing & Strategy Frazer joined Aroa in September 2020. He has over 8 years in marketing and sales in healthcare across various global markets. Prior to joining Aroa Biosurgery Frazer was Head of the Project Management Office and Strategic Assistant to the General
Slide 9: Soft Tissue Reconstruction Technologies
|9 Soft Tissue Reconstruction Technologies Biologics and Synthetics have different properties and use cases
Slide 10: Substantial Growth Opportunities
| 10 Substantial Growth Opportunities ~$2.5B1 TAM 1. SmartTRAK BiomedGPS data 2020. Aroa management estimates; 2. DRG Millennium Research data; Hernia Repair Devices, 2020. DRG Millennium Research, Breast Implants & Reconstructive devices, 2018.
Slide 11: AROA ECM - An Ideal Foundation for Regenerative Healing
| 11 AROA ECM - An Ideal Foundation for Regenerative Healing AROA’s products utilise the proprietary AROA ECM, which is a unique Extracellular Matrix (ECM) platform technology derived from sheep forestomach Laminin Collagen IV Elastin Vascular channels Collagen I & III GAG’s, hyaluronic acid, hepari
Slide 12: AROA ECM – Unique Regenerative Properties
| 12 AROA ECM – Unique Regenerative Properties Graft Origin Clinical Performance Considerations Structure Biology Tissue compatibility Cost AROA ECM +++ +++ +++ $ - $$ Human Dermis ++ + +++ $$ Human Placenta - +++ +++ $$$ Intact Mammalian Tissue +/- +/- +/- $$ Mammalian Reconstituted Collagen + + +
Slide 13: Endoform Natural and Antimicrobial
| 13 Endoform Natural and Antimicrobial A unique “Tissue Matrix” used to “short-cut” healing in complex wounds such as diabetic foot ulcers and venous ulcers
Slide 14: Ovitex & Ovitex PRS
| 14 Ovitex & Ovitex PRS “Reinforced Bioscaffold” which combines layers of the AROA ECM reinforced with polymers for abdominal wall repair (hernia) & soft tissue reinforcement Licensed to Tela Bio for Licensed to Tela Bio for Hernia Breast Surgery
Slide 15: Myriad Matrix
| 15 Myriad Matrix Engineered ECM containing layers of AROA ECM suitable for soft tissue reconstruction, both dermal repair and surgical implantation
Slide 16: Myriad Morcells
| 16 Myriad Morcells A ‘Morcellized Bioscaffold’ suitable for a wide range of dermal reconstruction and complex wound repair procedures • Deliver a bolus of the AROA ECM biology to help kick start & sustain healing • Conforms to optimise contact with irregular wound beds
Slide 17: AROA Product Portfolio
| 17 AROA Product Portfolio Products to match wound type, stage & site of care
Slide 18: Q&A
? Q&A Unlocking regenerative healing for everybody
Slide 19: US Sales
US Sales Unlocking regenerative healing for everybody
Slide 20: AROA Sales
AROA Sales _—
Slide 21: Brad Adams and Wes Snodgrass
Brad Adams Wes Snodgrass Vice President of Commercial Operations Director of National Accounts Brad joined Aroa Biosurgery in November 2019. He has over 20 years Wes brings to Aroa over 30 years of experience in working in the US of experience in the strategic sales and marketing of medical devices
Slide 22: US Sales Operations – Multiple Channels
| 22 US Sales Operations – Multiple Channels Unique sales channels based on call point and product indication, collaborating to grow AROA ECM product portfolio in the US Channel Products Target Specialties Call Point Sales Force (FTE) Commercial Strategy • Increase Endoform utilization in current cu
Slide 23: AROA’s US Sales Channel
| 23 AROA’s US Sales Channel Direct Sales Representative Independent Sales Representative VP Commercial Inside Sales Team
Slide 24: Tela Bio Sales
Tela Bio Sales _— inlet, SS ARROW
Slide 25: US Sales Operations – Multiple Channels
| 25 US Sales Operations – Multiple Channels Unique sales channels based on call point and product indication, collaborating to grow AROA ECM product portfolio in the US Channel Products Target Specialties Call Point Sales Force (FTE) Commercial Strategy OviTex, OviTex PRS 46 Sales territories • Dri
Slide 26: Q&A
? Q&A Unlocking regenerative healing for everybody
Slide 27: Clinical Evidence
Clinical Evidence Unlocking regenerative healing for everybody
Slide 28: Brandon Bosque and Barnaby May
Brandon Bosque, DPM, CWSP Barnaby May, PhD Medical Science Liaison Chief Scientific Officer Dr. Brandon Bosque is board-certified foot & ankle surgeon with Barnaby joined Aroa Biosurgery’s management team over 12 years extensive training and experience in surgical reconstruction, complex ago. Barnab
Slide 29: Clinical Need
| 29 Clinical Need • Increase patient/surgeon access to advanced regenerative scaffolds • Reduce time to build new tissue • Reduce time to definitive closure • Reduce surgical complications (e.g. infection, recurrence, scarring, adhesions) • Improve patient Quality of Life and outcomes
Slide 30: Endoform – Key Learnings
| 30 Endoform – Key Learnings • Overcomes wounds inflammation • Rapid tissue regeneration • Well vascularized tissue • Aids wound epithelization • Use across the spectrum of wound care providers as first-line treatment 4+ million product applications
Slide 31: Endoform Clinical Evidence
| 31 Endoform Clinical Evidence Complex Non- Reference Sample Size Wound Types Outcomes healing Wounds Liden, B. A. and B. C. May (2013) N=24 Various Yes 50% of wounds closed at 12 weeks Simcock, J. and B. C. May (2013) N=4 Tumor excision Yes Single stage STSG procedure Simcock, et al (2013) N=1 Nec
Slide 32: Endoform Clinical Evidence
| 32 Endoform Clinical Evidence Week 0 Week 4 Week 15 Correct wound inflammation and Scaffold the growth of well Accelerate wound closure by driving chronicity vascularized granulation tissue epithelialization
Slide 33: Myriad Matrix - Key Learnings
| 33 Myriad Matrix - Key Learnings • Suitable for a wide range of reconstructive procedures requiring implant or dermal regeneration • Low rates of surgical complications (e.g. infection, dehiscence, seroma) • Rapid tissue regeneration • Well vascularized tissue • No infections • Compatible with con
Slide 34: Myriad Matrix – Procedure Types
| 34 Myriad Matrix – Procedure Types Tumor resection, trauma, necrotizing fasciitis, abdominal dehiscence, complex wounds, limb salvage, hidradenitis suppurativa, pilonidal sinus disease, anal fistula… Myriad Matrix – Clinical Evidence Rates of Sample Contaminated Granulation Major Reference Reconst
Slide 35: Complex Reconstruction of Stage III Hidradenitis Suppurativa
| 35 Complex Reconstruction of Stage III Hidradenitis Suppurativa • Complex inflammatory skin condition • Contaminated surgical sites • High rates of complications • Pilot n=8 procedures, 2 minor complications • No infections, no recurrences Chaffin A, Buckley M. Extracellular matrix graft for the s
Slide 36: Example Case – Dermal Reconstruction
| 36 Example Case – Dermal Reconstruction 1 29-Year old male with 2-year history of Stage III 2 Wide excision of the diseased 3 ECM graft (*) placed into the base of the tissue. defect. axillary HS. * 4 5 6 4 days 1.5 weeks 6 weeks New tissue New healthy Wound is nearly begins to ‘grow’ tissue has g
Slide 37: Reconstruction over Exposed Vital Structures
| 37 Reconstruction over Exposed Vital Structures • Complex surgical reconstructions (n=6) • Rapid Myriad infiltration (1-4 weeks) • 100% Myriad graft take • No complications • No infections Bohn, G. A. and A. E. Chaffin (2020). “Extracellular matrix graft for reconstruction over exposed structures:
Slide 38: Example Case – Complex Forearm Reconstruction
| 38 Example Case – Complex Forearm Reconstruction Post debridement Graft placed Week 1 Week 4 Week 6 STSG
Slide 39: Reconstruction of Complex Non-Healing Wounds
| 39 Reconstruction of Complex Non-Healing Wounds • Chronic non-healing wounds (e.g. pressure injuries) • Contaminated surgical sites • Surgical reconstructions (n=9) • All wounds healed • Two minor complications • No infections Desvigne, M. N., K. Bauer, K. Holifield, K. Day, D. Gilmore and A. L. W
Slide 40: Example Case – Pressure Injury
| 40 Example Case – Pressure Injury Initial tissue defect Graft placement Flap advancement Negative pressure • No complications • Remained closed at 6 months.
Slide 41: Reinforced Biologic – OviTex/Myriad Ultra
| 41 Reinforced Biologic – OviTex/Myriad Ultra™ • Thoughtfully engineered reinforced biologic for abdominal wall repair • Low hernia recurrence • Low rate of complications, infections • Moderate-to-complex ventral hernia patients • Compatible with minimal invasive procedures • Tolerates a contaminat
Slide 42: OviTex/Myriad Ultra Clinical Evidence
| 42 OviTex/Myriad Ultra Clinical Evidence Reference Type Sample Size Contaminated Fields Recurrence Ferozoca et al (2018) Inguinal N=31 No N=0 (0%) Sawyer et al (2018) Hiatal N=25 No N=0 (0%) Parker, et al (2020) Ventral N=100 Yes N=3 (6%) BRAVO – 12 month Ventral N=76 Yes N=2 (3%) BRAVO – 24 month
Slide 43: AROA ECM - FY22 Clinical Evidence Pipeline
| 43 AROA ECM - FY22 Clinical Evidence Pipeline Product Type Forecast Real World Data Study – large retrospective comparative Endoform Q2, FY22 analysis in the treatment of DFU (n>2000 wounds) Endoform Facial burns case series Q3, FY22 Endoform Chronic wounds case series Q3, FY22 Symphony Pilot (n=1
Slide 44: Q&A
? Q&A Unlocking regenerative healing for everybody
Slide 45: 10 Minute Session Break
10 Minute Session Break Our next presentation will start at 11:50am Unlocking regenerative healing for everybody
Slide 46: Dead Space Management Platform
Dead Space Management Platform Unlocking regenerative healing for everybody
Slide 47: Shane Dowling and Isaac Mason
Shane Dowling, MSPAS, PA-C, CWS Isaac Mason Medical Science Liaison Director of Product Development Shane Dowling is a Medical Science Liaison at Aroa, based in Denver, Isaac joined Aroa Biosurgery over 6 years ago and has over 14 years’ CO. He trained as a Physician Assistant in New York City. His
Slide 48: Clinical Need
Clinical Need Epidermis —<ag Dermis —33) Subcutaneous Tissues Muscle Tissue Dead Space 48
Slide 49: Clinical Need
| 49 Clinical Need Mastectomy Laparotomy Breast Reconstruction Hernia Abdominoplasty Flap Surgery Caesarean Compound Fractures Panniculectomy Joint Replacement
Slide 50: Surgical Complications
Uremia Radiation Therapy Malignancy Hypertension Obesity Steroid Use Diabetes Anemia 50 Smoker Vascular Disease AROA
Slide 51: Surgical Complications
| 51 Surgical Complications Clinical Speciality Surgical Sites Complications 9.6% increase in mortality associated with surgical wound dehiscence (SWD)1 Various (Hernia, General SSIs require 7 – 11 days2 extra hospital care (~US $38,656)3 Laparotomy etc) Patients with SWD have 61% higher odds of rea
Slide 52: New System
New System Treatment i Site yi \ “Implant Se Lee eowe Meee Exudate Bags Vacuum Device viele. setote: “ey AROA
Slide 53: How Does It Work?
| 53 How Does It Work? Treated Site ‘Under Vacuum’ Treatment Area = 100% Device Area = 75% Conduit Area = 20%
Slide 54: Pre-Clinical Validation
| 54 Pre-Clinical Validation Pre-Clinical Snapshot • 48 total test subjects • +30 versions of treatment system assessed Control Device – ‘Standard of Care’ Treatment with new system
Slide 55: Market Opportunity
| 55 Market Opportunity Addressable Procedures Clinical Speciality U.S. TAM (USD)1 Primary Use Cases (PA)1 Hernia ~75,000 General $690m Other ~133,000 Mastectomy ~76,000 Plastics & Reconstructive $1.09b Abdominoplasty ~135,000 Trauma ~190,000 Orthopaedics $675m Hip Revision ~80,000 Obstetrics & Gyne
Slide 56: Competitor Landscape
| 56 Competitor Landscape New AROA Dead Space Management Tissue Platform Apposition Adhesives / Fixation Drainage Devices Fluid Removal
Slide 57: Q&A
? Q&A Unlocking regenerative healing for everybody
Slide 58: Manufacturing Overview
| 58 Manufacturing Overview Unlocking regenerative healing for everybody
Slide 59: Simone Von Fircks and Rod Stanley
Simone Von Fircks Rod Stanley Chief Operations Officer Director of Manufacturing Simone joined Aroa Biosurgery’s management team over 7 years ago. Rod Stanley joined Aroa over 8 years ago, and has over 12 years’ total She brings extensive expertise in biological product manufacture, with experience
Slide 60: Manufacturing and Production
| 60 Manufacturing and Production Well established commercial manufacturing facility Unique process produces a Scalable high-quality product • Raw materials readily available • 12 successful Quality in New Zealand inspections since 2014 • Modular manufacturing design • 83 staff in Manufacturing allo
Slide 61: Gentle and Low-Cost Process
| 61 Gentle and Low-Cost Process Subtractive processing • All products manufactured from the same base AROA ECM material that can be fabricated into different shapes, sizes and designs depending on clinical need. • Manufacturing process removes everything that ‘makes the material a sheep’ while reta
Slide 62: Minimally Processed Matrix
| 62 Minimally Processed Matrix Removal of xenogeneic components while retaining native structure • AROA ECM material has melt onset temperature similar to that of native, unprocessed tissue suggesting minimal damage during processing. • Histological assessment shows absence of cells (purple haemato
Slide 63: VIDEO – Quality Control
VIDEO — Quality Control _— inlet, SS ARROW
Slide 64: Unlocking regenerative healing for everybody
Unlocking regenerative healing for everybody
Slide 65: VIDEO – Manufacturing Tour
VIDEO - Manufacturing tour ROW
Slide 66: Unlocking regenerative healing for everybody
Unlocking regenerative healing for everybody
Slide 67: Q&A
? Q&A Unlocking regenerative healing for everybody
Slide 68: FY2022 Outlook & Executive Q&A
FY2022 Outlook & Executive Q&A Unlocking regenerative healing for everybody
Slide 69: AROA FY22 Outlook
| 69 AROA FY22 Outlook NZ$30-$33m1 GM product sales FY22 39-53% higher than FY21 improvement • AROA is well placed for FY22 following an improved second half of FY21 and sales transition • Focused on building our US commercial operations over next 24 months to drive revenue growth to take advantage
Slide 70: Q&A
? Q&A Unlocking regenerative healing for everybody
Slide 71: Contacts
CONTACTS Simon Hinsley Matt Wright Investor Relations Media m +61 401 809 653 m +61 451 896 420 shinsley@aroabio.com matt@nwrcommunications.com.au Visit our website www.aroabio.com and find us on LinkedIn at www.linkedin.com/company/aroa-biosurgery-limited/ 64 Richard Pearse Drive, PO Box 107111, Au