Orthocell Ltd · ASX:OCC
Orthocell — Investor Presentation (April 2018)
33 slides from Orthocell's investor presentation, Apr 16, 2018
Slide 1: Orthocell Investor update
Orthocell Advancing tissue repair and regeneration Investor update April 2018 Paul Anderson Managing Director
Slide 2: Corporate overview
Corporate overview Orthocell is a regenerative medicine company delivering breakthrough products that restore mobility and function Share price performance Trading information Share price (11-Apr-18) A$0.305 Share Price (A$) Volume (k) Shares on issue1 110.0m 0.60 3,000 Market capitalisation A$33.5m
Slide 3: Founders story
Founders story Orthocell’s founders have extensive commercial and scientific experience in regenerative medicine, having previously demonstrated success in developing, commercialising and monetising cell therapy products Paul Anderson Professor Ming Hao Zheng1 Managing Director Chief Scientific Offi
Slide 4: Board of directors
Board of directors Dr Stewart James Washer Paul Anderson Matthew Callahan Professor Lars Lidgren Mr Qi Xiao Zhou Chairman Managing Director Non-Executive Director Board Member Board Member • 20+ years’ CEO and board • 20+ years’ regenerative • Developed 3 FDA • World leading innovator in • 15+ years
Slide 5: Regenerative medicine
Regenerative medicine What is regenerative Why is regenerative medicine a What is Orthocell’s position in medicine? promising field? this space? Relatively new field of medicine Ageing population and rising that seeks to repair injured or musculoskeletal disorders diseased tissue by harnessing the D
Slide 6: Innovative products
Innovative products Orthocell is a regenerative medicine company delivering breakthrough products that restore mobility and function CelGro® Ortho-ATI® Soft tissue reconstruction platform Regeneration of tendons Medical device Cell therapy • CE Mark - approved in Europe for bone and tissue • First i
Slide 7: Significant market opportunity
Significant market opportunity At the forefront of a large and growing market opportunity in regenerative medicine in the musculoskeletal space Addressable markets1,2 CelGro® Ortho-ATI® >US$2.6bn >US$7.7bn Total addressable market is estimated to be in excess of US$10 billion p.a. 1. Addressable mar
Slide 8: CelGro® - initial focus in bone regeneration
CelGro® - initial focus in bone regeneration CelGro® is approved in the EU (CE Mark) for dental bone and soft tissue repair CelGro® - a true regenerative medicine scaffold Dental bone procedure - approved for use in the EU Superior tissue repair – unique regenerative medicine qualities 1. Defect S
Slide 9: CelGro® - bone regeneration market opportunity
CelGro® - bone regeneration market opportunity Ideally positioned to gain market traction in the rapidly growing and significant market of oral medicine Very favourable market dynamics… • No product innovation to the dental market globally • Existing products have inferior functionality and handling
Slide 10: CelGro® - bone regeneration commercial pathway
CelGro® - bone regeneration commercial pathway Key development and marketing approval milestones for CelGro® achieved, the focus is now on EU market entry in bone and soft tissue repair Achieved significant development milestones Market entry – next steps Optimised Regulatory Key opinion EU Ma
Slide 11: CelGro® - strategic focus
CelGro® - strategic focus Orthocell is driving market entry for bone repair, leveraging EU approval to accelerate introduction of the tendon and soft tissue indications Near to medium term Medium term Medium to long term Other indications Bone regeneration Tendon and soft tissue Nerve, ligament, gen
Slide 12: Chronic tendon injury – significant unmet clinical need
Chronic tendon injury – significant unmet clinical need Chronic tendon injury is a common and painful disorder affecting millions of people every year with no effective, non- surgical treatments currently available Significant unmet clinical need… Multiple tendon injury sites… • Millions of people s
Slide 13: Ortho-ATI® - preferred therapy for tendon repair
Ortho-ATI® - preferred therapy for tendon repair Orthocell is currently focused on completing current clinical studies and preparing for US market entry Ortho-ATI® overview Two stage, minimally invasive procedure • Breakthrough in regenerative medicine Healthy tendon cells 1. Biopsy removed via mini
Slide 14: Ortho-ATI® - multiple, large addressable markets
Ortho-ATI® - multiple, large addressable markets Ortho-ATI® is at the forefront of a large and growing market opportunity where the addressable market is estimated to be >US$7.7bn p.a. Estimated addressable market in excess of US$7.7bn incorporates: Tennis elbow1 Rotator cuff1 Other indications >US$
Slide 15: Ortho-ATI® - clinically validated product
Ortho-ATI® - clinically validated product Patients achieved a 207% improvement in grip strength following their treatment with Ortho-ATI® Ortho-ATI® tennis elbow study details Tennis elbow study results • Patients that had failed all other treatments Pain (VAS) Grip Strength (kg) • The patients had
Slide 16: Ortho-ATI® - patient testimonies
Ortho-ATI® - patient testimonies “I’m 100% happy with the Ortho-ATI® treatment, the only thing that enabled me to get back to doing normal daily activities without pain and return to swimming at an international level.” Christian Sprenger Swimming Olympic medallist “I couldn’t write, drive, play my
Slide 17: Ortho-ATI® - research collaboration
Ortho-ATI® - research collaboration Ortho-ATI® has attracted the interest of the worlds largest health care company Key factors in attracting research collaboration interest Large unmet clinical need 1.5m+ addressable procedures per year in the shoulder and elbow alone Clinical validation Ortho-
Slide 18: Significant upside value potential
Significant upside value potential Significant value upside potential exists given Orthocell’s valuable diversified product portfolio of cell therapies and regenerative medicine products, when compared to similar global peers Vericel’s market capitalisation (US$m) Value upside 500 potential Develops
Slide 19: Significant M&A activity in regenerative medicine
Significant M&A activity in regenerative medicine Smith & Nephew’s recent US$210m acquisition of Rotation Medical, a comparable peer to Orthocell, demonstrates the strong interest by major players within the regenerative medicine sector US$210m acquisition of Rotation Medical Product comparison (Ort
Slide 20: Upcoming catalysts
Upcoming catalysts Summary of the upcoming operational milestones • Supplementary marketing clinical data release – April 2018 • Secure distribution networks - 2Q 2018 CelGro® • First sales in the EU – 2Q 2018 • US and Australian market authorisation – 1Q 2019 • Strategic partnership discussions - o
Slide 21: Key investment highlights
Key investment highlights Significant upside De-risked Validated Credentialed and highly product portfolio manufacturing process aligned leadership team Significant market interest Substantial clinical data GMP-certified and TGA- Proven track record in Addressable markets worth CE Mark (EU) achieved
Slide 22: Appendix
Appendix Executive management, key product portfolio, intellectual property, additional product information, clinical data and R&D pipeline
Slide 23: Executive Management Team
Executive Management Team Professor M.H. Zheng Alexander McHenry Nicole Telford Chief Scientific Officer Chief Operating Officer Chief Financial Officer • Inventor of the Orthocell technology with a strong track record • Over 14 years of experience in corporate advisory and • Chartered accountant wi
Slide 24: Key product portfolio
Key product portfolio Diversified product portfolio with exciting R&D development pipeline Diversified Stages of development health care Products Key focus Applications Discovery Pre-clinical Clinical CelGro® Bone EU (CE Mark) Pure Tissue and bone repair collagen Biological medical device for CelGro
Slide 25: Key products are well protected and clinically validated
Key products are well protected and clinically validated Orthocell has significant levels of clinical validation and has protected its suite of development products through various patents granted across major jurisdictions, with further applications awaiting grant IP portfolio and strategy • Focuse
Slide 26: CelGro® - key advantages
CelGro® - key advantages CelGro® boasts superior tissue repair qualities and can be customised to accommodate the specific needs of tissue repair in multiple applications, making it the best in class bioderived scaffold on the market Orthocell’s proprietary SMRTTM manufacturing process method produc
Slide 27: CelGro® - platform technology
CelGro® - platform technology CelGro® is a platform technology that supports tissue growth and enables rapid repair, it has demonstrated clinical efficacy and has a clear path to market across multiple applications Multiple applications Bone Tendon Neurological e.g. Dental surgery e.g. Orthopaedic s
Slide 28: CelGro® - clinical trials completed and in progress
CelGro® - clinical trials completed and in progress Orthocell’s clinical development strategy is designed to increase the probability of achieving regulatory approvals, with significant levels of clinical validation achieved, and optimised manufacturing capabilities in place Study ID Description No.
Slide 29: Ortho-ATI® - tendinopathy
Ortho-ATI® - tendinopathy What is tendinopathy? Where does it occur? What causes it? • Chronic degenerative tendon The severity of the injury is injury usually brought on by influenced by many factors, repetitive motion including: • Reduces healthy tenocyte • Amount of overuse population, tendon can
Slide 30: Ortho-ATI® - key advantages
Ortho-ATI® - key advantages Ortho-ATI® is the preferred therapy for degenerative tendon repair because it addresses the underlying pathology, is minimally invasive, cost effective with long term clinical data Comparative advantages to traditional therapies Tenocytes PRP1 Corticosteroids Surgery (Ort
Slide 31: Ortho-ATI® - clinical data
Ortho-ATI® - clinical data Ortho-ATI® tennis elbow study Ortho-ATI® gluteal tendon study • 17 patients that had failed all other treatments • 12 patients with gluteal tendinopathy – no remaining • The patients had been experiencing symptoms for an treatment options average of 31 month • Average dura
Slide 32: Ortho-ACI® and R&D pipeline
Ortho-ACI® and R&D pipeline Orthocell is undertaking a “capital light” approach to commercialising Ortho-ACI® and developing other pipeline products which represent exciting potential value upside within the regenerative medicine space Orthocell’s foundation product Significant market opportunity Si
Slide 33: Disclaimer
Disclaimer This presentation prepared by Orthocell Ltd ("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 there be any sale, issue or tr