Slide 1: Company Presentation
Company Presentation 30 August 2024
Slide 2: Disclaimer
Disclaimer This presentation prepared by Orthocell Ltd (“Company”) does not constitute, or contained in this presentation, and they do not accept any liability whatsoever form part of, an offer to sell or the solicitation of an offer to subscribe for or buy (including in negligence) for any informat
Slide 3: Orthocell at a glance
Orthocell at a glance Well-funded Australian medical device company with growing international revenue and US approval of breakthrough nerve repair device pending BEST IN CLASS PRODUCTS APPROVED MANUFACTURED IN AUSTRALIA IN EIGHT JURISDICTIONS Scaled facility certified to manufacture in major jurisd
Slide 4: Corporate snapshot
Corporate snapshot Current analyst risk-adjusted valuations per share of $1.00 and $1.28/sh ASX: OCC TRADING INFORMATION SUBSTANTIAL SHAREHOLDERS Share Price (30 day VWAP) $0.38 Shareholder % 12 month low/high $0.33/$0.43 Founders & Management ~13% Shares outstanding 209M Institutions & HNW’s (Mr Ch
Slide 5: Growing Revenue
Growing Revenue FY24 revenue of $6.76 million, up 30.76% from the previous year (FY23) of $5.17 million. Striate+ and Remplir ahead of expectations Total Revenue FY2024 Total Revenue $6.76 Million $8,000,000 CAGR 93% $7,000,000 $1.4 M $6,000,000 $5,000,000 $3.4 M $4,000,000 $0.8 M $3,000,000 $2,000,
Slide 6: High-profile Board
High-profile Board Recent appointments of John Van Der Wielen and Professor Fiona Wood AM places Orthocell in a strong position to drive its products into global markets and accelerate revenue growth 6
Slide 7: SMRT Manufacturing
SMRT Manufacturing DEVELOPING AND MANUFACTURING BIOLOGICAL MEDICAL DEVICES
Slide 8: Collagen medical device platform
Collagen medical device platform Our collagen medical device platform is comprised of a range of acellular, type 1 collagen devices for the surgical repair of bone, nerve, tendon and cartilage BONE NERVE TENDON Striate+ membrane Remplir nerve wrap SmrtGraft scaffold Dental bone and tissue repair Per
Slide 9: SMRT manufacturing
SMRT manufacturing Orthocell develops and manufactures innovative collagen medical devices that deliver the highest quality surgical repair of bone, nerve, tendon and cartilage Barrier function prevents infiltration of cells not SMRT manufacturing process involved in tissue repair but enables the pa
Slide 10: Australian manufacturer
Australian manufacturer Scaled facility certified to manufacture medical devices to major jurisdictions under strict international quality standards (i.e. MDSAP and MDR) 10
Slide 11: Remplir
Remplir REDEFINING NERVE REPAIR
Slide 12: Remplir: Nerve repair breakthrough
Remplir : Nerve repair breakthrough Current repair methods can place delicate nerve tissue under tension, causing scarring, fibrosis and neuroma formation 1860s 2000s 2020s Suturing Conduits Next generation infl sep Success 50-70% 55% 85% Rates 12
Slide 13: Remplir: Redefining nerve repair
Remplir : Redefining nerve repair Collagen nerve wrap approved and reimbursed in Australia. Intended for use in peripheral nerve repair GUIDING PREDICTABLE OUTCOMES IN PERIPHERAL NERVE REPAIR ✓ Exceptional handling characteristics ✓ Mimics epineurium (nerve outer layer) ✓ Reducing sutures ✓ Returns
Slide 14: Remplir: surgical technique
Remplir : surgical technique A breakthrough product guiding predictable outcomes in peripheral nerve repair and return of muscle function 1 2 3 Damaged peripheral nerve after Damaged section of nerve is removed, and Remplir is wrapped around nerve, reducing suture traumatic injury to limb ends bough
Slide 15: Remplir: indications
Remplir : indications Remplir is the only device that can be used for either connecting severed nerves, protecting CONNECT damaged nerves or capping amputated nerves Trauma: motor vehicle, power tool, surgical injuries, sports and military related accidents PROTECT Compression: blunt trauma, revisio
Slide 16: Remplir: compelling clinical results
Remplir : compelling clinical results Patients regained voluntary muscle movement within 12 months, increasing strength and range of motion at 24 months 100% We are now seeing a consistent return of arm and hand function following nerve transfer surgery with Remplir . 80% Remplir is increasing the s
Slide 17: Click to play video
Meet Adrian Walsh, a 43-year-old father of three who was diagnosed with quadriplegia after he broke his neck in a mountain bike accident in June 2017. Click to play video
Slide 18: Australian Remplir case study opens up global nerve repair opportunity
Australian Remplir case study opens up global nerve repair opportunity Injury • Mountain bike accident • C5 quadriplegia Impact Remplir patient: Adrian Walsh • No arm strength and no movement in fingers and thumbs • Life in a wheelchair was difficult Surgery This treatment has made a world of differ
Slide 19: Successful launch with growing revenue
Successful launch with growing revenue AUS commercial launch1 of Remplir with Device Technologies, reimbursed in the private healthcare system in November 2022, with sales unit volumes exceeding expectations Remplir product revenue since AUS market launch • 127% growth in Remplir revenue from $457K
Slide 20: The US is the largest market
The US is the largest market Approval anticipated 1Q CY25 Annual US nerve reconstructions 6,516 4,475 Over 700,0001 peripheral nerve repair 2,309 procedures in the US per year, 90% undertaken using suture only method. 56,700 • Current devices are not widely adopted due to suboptimal outcomes – Axoge
Slide 21: Remplir: Path to partnering
Remplir : Path to partnering Orthocell is underpinned by a proven business model for innovating, developing, launching and successfully partnering medical device products Scale Organisation US Approval Brand Ambassadors Data Package Sales and Marketing Executive team Pilot study Scientific narrative
Slide 22: Remplir: Market Expansion
Remplir : Market Expansion Regulatory approval for Remplir in Singapore anticipated in 2H CY24 with a further four applications planned in Canada, Thailand, EU & UK in the next 6-12 months Approved in Australia and New Zealand Regulatory Applications 2024 2025 2026 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q
Slide 23: Remplir: Large addressable market in nerve reconstruction
Remplir : Large addressable market in nerve reconstruction Remplir is a breakthrough product on track to be the global market leader in peripheral nerve repair – a retail market estimated to exceed US$3.5 billion¹ per annum Total Addressable Retail Est. procedures Market (US$m) p.a. at peak (‘000) $
Slide 24: Growing Better Bone in Dental Applications
GROWING BETTER BONE IN DENTAL APPLICATIONS
Slide 25: Striate+ premium dental membrane
Striate+ premium dental membrane Next generation dental membrane for high quality bone repair • Striate+ is a sterile, resorbable collagen membrane for use in dental bone and tissue regeneration procedures. • Striate+ is designed to protect the bone defect from ingrowth of gingival tissue, to provid
Slide 26: Striate+ global license and manufacturing agreement
Striate+ global license and manufacturing agreement Innovation backed by world-class KOL’s and an exclusive licensing deal with fifth largest global provider of dental products, BioHorizons • AU $21.5 million in upfront cash received net of fees in consideration of the global license granted • Major
Slide 27: Successful Striate+ launch, revenue growing
Successful Striate+ launch, revenue growing US commercial launch1 of Striate+ dental barrier membrane in November 2022, sales unit volumes now exceeding expectations Striate+ product sales + license revenue since US market launch • Gaining excellent traction and growing revenue in US, Europe, UK and
Slide 28: Striate+ Market Expansion
Striate+ Market Expansion Orthocell is working with BioHorizons to accelerate access into the large markets of Brazil and Singapore and to achieve further regulatory approvals into multiple other markets where they have established accounts and/or distribution networks Approved in Australia, USA, EU
Slide 29: Striate+ revenue growing in US, EU/UK & AUS – and beyond
Total Addressable Retail Striate+ revenue growing in US, Market (US$m) EU/UK & AUS – and beyond $114 $34 Significant opportunity to secure 20% share of the US$732M1 global dental barrier membrane market which would generate ~US $40 million in recurring wholesale revenue to Orthocell $65 US$732M $300
Slide 30: Upcoming catalysts
Upcoming catalysts1 Remplir international regulatory approval program US registration study results 4Q CY24 US market authorisation 1Q CY25 Singapore product registration 4Q CY24 Canada product registration 3Q CY25 Striate international regulatory approval program Brazil product registration 2Q CY25
Slide 31: Pipeline
Pipeline Advanced product portfolio with near term milestones and emerging pipeline. Orthocell is working with a US adviser to secure a partner to accelerate the commercialisation of the tendon cell therapy. Multi-Billion Product Status Next Steps US Markets Medical Devices Ligament Pre-clinical and
Slide 32: Key Investment Highlights
Key Investment Highlights Commercial-stage Best in class Strengthened $20.6M cash at Near term value medical device products for Bone, board with the bank, strengthened drivers including company at revenue Nerve and Tendon appointments of register, no royalty Remplir 510k study inflection point repa
Slide 33: Authorised for release by
Authorised for release by: Co-Founder and Managing Director, Paul Anderson Orthocell Limited P: +61 8 9360 2888 E: paul.anderson@orthocell.com.au orthocell.com 33