Orthocell Ltd · ASX:OCC
Orthocell — Shareholder Meeting (November 2024)
38 slides from Orthocell's shareholder meeting presentation, Nov 29, 2024
Slide 1: Annual General Meeting Addresses by Chair and Managing Director
Annual General Meeting Addresses by Chair and Managing Director Perth, Australia; 29 November 2024: Regenerative medicine company Orthocell Limited (ASX: OCC, “Orthocell” or the “Company”) is pleased to attach copies of the addresses to be given by the Chair and Managing Director and Chief Executive
Slide 2: Chair's Address
CHAIR’S ADDRESS Fellow shareholders, thank you for joining me today, at the close of my first full financial year as the Chair of Orthocell. The 2024 financial year has been a very successful period of revenue growth and operational execution. Our revenue grew by 30.8% over the previous financial ye
Slide 3: Chair's Address: US entry and financial performance
provides the most compelling opportunity in the history of the Company. We remain on schedule to submit the Remplir US 510(k) application in Q4 CY24, with progression into US FDA approval expected US FDA approval in the first quarter of 2025 and sales soon thereafter. Many years of research and deve
Slide 4: Cash position and revenue to expense ratio
With $32.8 million in cash and our R&D tax incentive rebate expected prior to the end of the financial year, the Company is now very well positioned to earn interest revenue whilst preparing for a moderate increase to expenses with the USA launch. The intent is to maximise returns on expense outlay
Slide 5: Managing Director's AGM Presentation
Managing Director’s AGM Presentation 29th November 2024
Slide 6: 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 7: 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 8: Corporate snapshot
Corporate snapshot Current analyst risk-adjusted valuations per share of $1.00 and $1.28/sh ASX: OCC TRADING INFORMATION 12 Month Share Price and Volume Volume (m) Price ($) 6.0 $0.90 Share Price (as @ 28th November) $0.81 $0.80 5.0 $0.70 12 month low/high $0.33/$0.83 4.0 $0.60 $0.50 Shares outstand
Slide 9: Growing Revenue
Growing Revenue FY24 revenue of $6.76 million, up 30.76% from the previous year (FY23) of $5.17 million. Total Revenue Key Highlights $8,000,000 CAGR 93% • US Striate+ and AUS Remplir product sales $7,000,000 commenced in November 2022 and now ahead of $6,000,000 expectations $5,000,000 • Quarterly
Slide 10: Highly Credentialed Board
Highly Credentialed 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 11: SMRT Manufacturing
SMRT Manufacturing DEVELOPING AND MANUFACTURING BIOLOGICAL MEDICAL DEVICES
Slide 12: 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 13: 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 14: 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 15: Remplir: Redefining Nerve Repair
Remplir REDEFINING NERVE REPAIR
Slide 16: 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 17: 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 n
Slide 18: 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 bought
Slide 19: 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, revision
Slide 20: 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 suc
Slide 21: Meet Jasmine McGough
Meet Jasmine McGough In a single moment, on 5 July 2022, time stopped for Jasmine McGough. The vibrant 14-year-old from Perth was doing what she loved most, riding her mountain bike on a trail with her family in Margaret River, when she hit a log and fell in a particularly harsh position on her back
Slide 22: Click to play video
This video is being presented to existing and prospective investors, and potential commercial partners, to provide information about certain therapeutic areas that Orthocell Ltd is focused on. The video and the matters it describes are not intended for distribution or disclosure beyond Othocell Ltd,
Slide 23: 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 24: US FDA approval expected Q1 CY25 to US$1.6 billion market
US FDA APPROVAL EXPECTED Q1 CY25 TO US$1.6 BILLION MARKET 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 25: US Sales and Medical Affairs Executives
US Sales and Medical Affairs Executives Orthocell has appointed two experienced US-based executives, John Walker and Phillip Edmondson, to drive the market launch and sales of Remplir following the expected US FDA approval in the first quarter of 2025 John Walker Phillip Edmondson Vice President – S
Slide 26: 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 27: Remplir: Market Expansion
Remplir: Market Expansion Regulatory approval for Remplir in Singapore achieved in 2H CY24 with a further four applications planned in Canada, Thailand, EU & UK in the next 6-12 months Approved in Australia, New Zealand and Singapore Regulatory Applications 2024 2025 2026 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Slide 28: 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) $8
Slide 29: Growing Better Bone in Dental Applications
GROWING BETTER BONE IN DENTAL APPLICATIONS
Slide 30: 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 31: 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 $21.5 million in upfront cash received net of fees in consideration of the global license granted • Major
Slide 32: Successful Striate+ launch, revenue growing
Successful Striate+ launch, revenue growing US commercial launch1 of Striate+ dental barrier membrane in November 2022, sales unit volumes now exceeding expectations Striate+ product sales + license revenue since US market launch • Gaining excellent traction and growing revenue in US, Europe, UK and
Slide 33: Striate+ Market Expansion
Striate+ Market Expansion Orthocell is working with BioHorizons to accelerate access into the large markets of Brazil and Singapore and to achieve further regulatory approvals into multiple other markets where they have established accounts and/or distribution networks Approved in Australia, USA, EU
Slide 34: Striate+ revenue growing in US, EU/UK & AUS – and beyond
Total Addressable Retail Striate+ revenue growing in US, Market (US$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 35: Upcoming catalysts
Upcoming catalysts1 Remplir – redefining nerve repair Data for US FDA approval 4Q CY24 US FDA submission lodged 4Q CY24 Canada submission lodged 4Q CY24 US FDA market approval 1Q CY25 First sales Singapore 1Q CY25 EU+UK, Thailand & Brazil submissions lodged 2H CY25 Striate+ – growing better bone Col
Slide 36: 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 37: Key Investment Highlights
Key Investment Highlights Commercial-stage Best in class Strengthened $32.8M 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 38: Authorised for release by Paul Anderson
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 34