Orthocell Ltd · ASX:OCC
Orthocell — Investor Presentation (February 2017)
31 slides from Orthocell's investor presentation, Feb 27, 2017
Slide 1: Hong Kong, February 2017
(2) oo (sh) Cal Hong Kong February 2017 5s ae aa = - Paul Anderson ortho-Cell Managing Director
Slide 2: Disclaimer
Disclaimer For personal use only This presentation prepared by Orthocell Limited ("Company") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall ther
Slide 3: Company Overview
Company Overview For personal use only Delivering breakthrough products in Regenera7ng Mobility regenera6ve medicine Cell therapies: ‣ Ortho-ATI®. World’s leading stem cell therapy to regenerate tendons ‣ Ortho-ACI®. 3rd genera6on arthroscopic car6lage repair ‣ Ac6vely engaging strategic partners in
Slide 4: Corporate Overview
Corporate Overview For personal use only Experienced team to execute CEO Paul Anderson • Verigen Key Facts • Genzyme • Biomet ASX OCC CSO Prof. Ming Hao • Verigen Share Price AU$0.47 (@22nd Feb 2017) Zheng • Genzyme • UWA Ordinary Shares on 101.4 million Execu6ve Dr Stewart • Cynata Issue Chairman W
Slide 5: Global Need & Opportunity
Global Need & Opportunity For personal use only Orthocell is deal ready and posi6oned for growth Ageing popula6on and rising musculoskeletal disorders ‣ Demand for safe, efficient, cost effec6ve treatments ‣ Global soD 6ssue repair market - US$7B in 2013 expected US$10B by 2020 Superior products with c
Slide 6: Product Pipeline
Product Pipeline For personal use only Near term regulatory approvals 6
Slide 7: Ortho-ATI: Autologous Tenocyte Implantation
For personal use only Ortho-ATI ® Autologous Tenocyte Implanta6on ‣ Breakthrough regenera-ve medicine therapy ‣ Mul-ple tendon applica-ons ‣ TGA Licence ‣ Published long term clinical data 7
Slide 8: Ortho-ATI Collaboration with Johnson & Johnson Innovation
Ortho-ATI ® For personal use only Collaboration with Johnson & Johnson Innovation ‣ Collabora6on agreement signed January 2017 ‣ Coopera6ve study designed to support US pivotal study ‣ Planned to commence in Q1 2017 and will be enrolling 20 pa6ents, randomized to receive either Ortho-ATI® or cor6cos
Slide 9: Ortho-ATI process
Ortho-ATI ® For personal use only Two stage, minimally invasive, walk-in & walk-out process. 1. Biopsy procedure 2. Tenocyte cultivation 3. Ultrasound guided tenocyte implantation 4-5 week end-to-end process 9
Slide 10: Ortho-ATI and tendon repair movie
Ortho-ATI ® For personal use only MOVIE 1.1 Ortho-ATI® and tendon repair 10
Slide 11: Ortho-ATI: Only therapy addressing underlying pathology
Ortho-ATI ® For personal use only Only therapy addressing underlying pathology Long term efficacy Total cost of surgery is up to four (4) -mes more than Ortho-ATI 11
Slide 12: Clinical data supports efficacy and durability
Ortho-ATI ® For personal use only Clinical data supports efficacy and durability Over 300 pa7ents treated with Ortho-ATI 55 Tennis Elbow Study 45 Grip Strength Clinical trials confirm Ortho-ATI is safe, durable and cost effec;ve 35 25 Pa7ents failed all previous treatments, with average over 30mth sympt
Slide 13: Orthocell is tech transfer ready
Ortho-ATI ® For personal use only Orthocell is tech transfer ready AUS and US addressable markets “How stem cells gave violinist her life back” ‣ Tennis elbow market >$850M ‣ Rotator cuff market >$900M Regulatory targets ‣ US applica?on (IND ) in prepara?on ‣ AUS applica?on (ARTG) in progress ‣ JP ap
Slide 14: CelGro: A true regenerative medicine scaffold
For personal use only CelGro® A true regenera?ve medicine scaffold ‣Highest quality available ‣Mul?ple applica?ons 14
Slide 15: CelGro is a true regenerative medicine scaffold
CelGro ® For personal use only CelGro® is a true regenera6ve medicine scaffold manufactured by Orthocell to augment soD 6ssue A paradigm shiD in soD 6ssue reconstruc6on ‣Regenera-ve medicine focus in design and development ‣Highest quality scaffold available that directly meets the requirements of soD
Slide 16: Key Benefits and Features
Key Benefits and Features For personal use only CelGro® is a plaForm technology with significant compe66ve advantages Superior soD 6ssue and bone repair quali6es CelGro® regenerative medicine scaffold ✓Guided ?ssue repair / op?mal ?ssue integra?on and remodelling Bone Tendon Nerve Cartilage ✓Versa?le
Slide 17: How CelGro Works
How CelGro Works ® For personal use only 1.Smooth layer 2.Rough layer 3. Tissue remodelling Densely packed collagen Loosely arranged collagen Integration of cells Passage of fluids Applied to tissue defect Guiding quality tissue regeneration 17
Slide 18: Tendon Opportunity
Tendon Opportunity For personal use only Applica6ons - rotator cuff Opportunity ✙ 1.6 650,000 billion 1. 2. # annual rotator Value of cuff procedures addressable market suitable for Celgro 1. in rotator cuff surgeries 1. 3. 4. 1. US, JP, EU & AUS 18
Slide 19: Dental Opportunity
Dental Opportunity For personal use only Applica6ons - Dental Opportunity ✙ 800 1. 2. 2 million million # annual dental membranes used in Value of addressable conjunction with market in dental 1. bone graft substitutes 1. 3. 4. 1. US, JP, EU & AUS - 2015 19
Slide 20: Nerve Opportunity
Nerve Opportunity For personal use only •Twenty million Americans suffer from peripheral nerve injury caused by trauma and medical disorders •$150 billion spent in annual health-care dollars in the US •Devasta-ng impact on a pa-ent’s quality of life •Clear unmet market need for a fit for purpose pure
Slide 21: Competitors Limitations
Compe6tors Limita6ons Compe6tors limita6ons include: not fit for purpose, poor For personal use only integra6on and limited applica6on Dental Tendon Nerve BioMend Biogide® GraftJacket® Tissuemend® AxoGuard® Neuroflex® CelGro ® (porcine mesentery) Extend® (human dermis) (bovine dermis) (porcine s.i.s)
Slide 22: The CelGro Advantage
The CelGro Advantage ® For personal use only 22
Slide 23: CelGro - CE Mark
CelGro - CE Mark® For personal use only EU approval for “guided bone regenera3on and so5 3ssue reconstruc3on” in final stages EU approval provides a founda3on for regulatory applica/ons in US (FDA), JP (PMDA) and AUS (ARTG): ! Tendon ! Nerve ! Car3lage Strategic Partnering & Distribu3on • EU discussi
Slide 24: Next Generation Pipeline
Next Generation Pipeline For personal use only Strong product pipeline: CelGro® • ACL ligament replacement • collagen powder for bone void fillers Lab Grown Tendons • laboratory manufactured human tendon Lab grown tendon • replacement tendons for hands and other applica;ons Growth Factors • ;ssue spe
Slide 25: Tendon Therapy Continuum
Tendon Therapy Continuum For personal use only Non-Surgical GF’s ATI ATI Physical therapies Rehab. - post surgery ACUTE DEGENERATE Surgery - rupture Surgery - chronic injury CelGro CelGro CelGro + ATI Pipeline product Current product Surgical [ MATT ] CelGro - Regenerative Medicine Scaffold G.F - Gr
Slide 26: Ortho-ACI: Autologous Chondrocyte Implantation
For personal use only Ortho-ACI ® Autologous Chondrocyte Implanta?on ✓Gold standard car-lage repair ✓Mul-ple applica-ons 26
Slide 27: Ortho-ACI: Arthroscopic 3rd generation ACI
Ortho-ACI ® For personal use only Arthroscopic 3rd genera<on autologous chondrocyte implanta<on FDA approves first autologous cellularized scaffold for the repair of car,lage defects of the knee (December 13, 2016) Ortho-ACI is the gold standard interven<on for symptoma,c defects of the ar,cula,ng car
Slide 28: Ortho-ACI procedure
Ortho-ACI ® For personal use only 1. Biopsy procedure 2. Seeding scaffold in theatre 3. Arthroscopic implant 4. Implant completed 28
Slide 29: Upcoming Milestones
Upcoming Milestones For personal use only Regulatory applica6ons and approvals •CelGro® - EU approval for “Guided Bone Regenera-on and SoD Tissue Reconstruc-on” •CelGro® - Regulatory applica-ons/approvals for Dental, Tendon and Nerve in EU, US, AUS and JP •Ortho-ATI® – Advance US tendon and ligament
Slide 30: Investment Highlights
Investment Highlights For personal use only ➢ Superior products ➢ Significant de-risked opportunity ➢ Clear pathway to large markets ➢ Strong partner interest ➢ Exper6se to partner and execute 30
Slide 31: Advancing tissue repair and regeneration
For personal use only Advancing tissue repair and regeneration Paul Anderson Managing Director 31