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Building a Leading Regenerative
Medicines Business
May 17 2018
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Disclaimer
The information in this Presentation is not intended to form the basis of any contract. By attending the meeting where this Presentation is made or reading the Presentation, you agree to the conditions set out below. The information contained in this document and made verbally to you (together the "Presentation") is confidential.
Accordingly, information contained in the Presentation is being supplied to you solely for your information and may not be copied, reproduced or further distributed to any person or published in whole or in part, for any purpose.
This Presentation includes certain statements, estimates and projections with respect to the anticipated future performance of Tissue Regenix Group plc (the "Company" and, together with its subsidiary undertakings, the "Group"), its products and the markets in which it operates. Such statements, estimates and projections reflect the various assumptions made by the Group, which
assumptions may or may not prove to be correct.
The Presentation is provided for general information only and does not purport to contain all the information that may be required to evaluate the Company. No representation or warranty, express or implied, is given as to the accuracy, completeness or fairness of the information or opinions contained in the Presentation and no liability is accepted for any such information or opinions by the Group
or any of its respective directors, members, officers, employees, agents or advisers. Save in the case of fraud, no responsibility or liability is accepted by any person for any errors, omissions or inaccuracies in such information or opinions or for any loss, cost or damage suffered or incurred, however arising, directly or indirectly, from any use of, as a result of the reliance on, or otherwise, in
connection with, the Presentation. In addition, no duty of care or otherwise is owed by any such person to recipients of the Presentation or any other person in relation to the Presentation.
This document (and the information contained herein) does not contain or constitute an offer of securities for sale, or solicitation of an offer to purchase securities, in the United States, Australia, Canada or Japan or any other jurisdiction where such an offer or solicitation would be unlawful. The securities of the Company have not been and will not be registered under the U.S. Securities Act of
1933, as amended ("Securities Act"), and may not be offered or sold in the United States unless the securities are registered under the Securities Act, or an exemption from the registration requirements of the Securities Act is available. No public offering of the securities of the Company will be made in the United States. This document is not for distribution in the United States and is only being supplied to qualified institutional buyers as defined in Rule 144A under the Securities Act ("QIBs"). This Presentation does not constitute a recommendation regarding the securities of the Company, nor shall it (or any part of it), or the fact of its distribution, form the basis of, or be relied on in connection with or act as any inducement to enter into, any contract whatsoever relating to
any securities.
Neither this presentation nor any copy of it may be, taken or transmitted into or distributed in Canada, Australia, the Republic of Ireland, Japan or the Republic of South Africa or to any resident thereof. Any failure to comply with these restrictions may constitute a violation of the securities laws or the laws of any such jurisdiction. The distribution of this document in other jurisdictions may be
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By accepting receipt of, attending any delivery of, or electronically accessing, the Presentation, you agree to be bound by the above limitations and conditions and, in particular, you represent, warrant and undertake to the Group that (i) you are a QIB (as defined above); (ii) you will not forward the Presentation to any other person, or reproduce or publish this document, in whole or in part, for any
purpose and (iii) you have read and agree to comply with the contents of this notice.
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Our Vision
“To establish Tissue Regenix as a leader in the science and innovation of regenerative medicine and become our clinicians’ partner of choice to meet growing clinical needs, transform patient care and deliver favourable health economic outcomes.”
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Transforming patient care and delivering favourable health economic outcomes
Regenerative technology platforms to process both soft tissue and bone
Multiple development and commercialisation opportunities – innovative portfolio and pipeline
Tissue processing scientific, R&D expertise
Expanded distribution opportunities &International manufacturing capabilities
AIM:TRX Market CAPR C.£150M2017 Group revenue £5.2m
Tissue Regenix Group A pioneering, international commercial medical technology company focused on the development of regenerative products
Portfolio of clinically proven products
Growing international commercial
footprint
Focus on high growth under-served markets
Deliver sustainable
growth
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Corporate Structure
BioSurgery
Orthopaedics
Dental
Cardiac
2 Innovative Technology Platforms
4 Key Clinical Areas
Dual Tissue Strategy
Human derived soft tissue and Bone
Porcine soft tissue (Xenograft Tendon, Xenograft Dermis, Xenograft Meniscus)
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Global Operations Infrastructure Platform for international expansion
Porcine TissueManufactured in-house in Leeds,UK
Human Tissue EUManufactured atGBM-V in Rostock,Germany
Human Tissue USTransition dCELL®production toCellRight, Texas
SurgiPure™ XD
OrthoPure™ XT
OrthoPure™ XM
DermaPure®
CardioPure™ HAV
CardioPure™ HPV
BioRinse portfolio
DermaPure®
OrthoPure™ HT
Detergent cycles* and
Wash
IrradiateWash and Package
Final bioburdenreduction*
Nuclease and Wash
* Dependent on the tissue used
Regeneration dCELL® Process
No special transportation or
storage needs
Patent protected
‘Know how’
Attract patient’s stem cells into matrix
ANIMAL OR HUMAN TISSUE OrthoPure™
XT
IMPLANTED USING THE SAME
TECHNIQUES
LONG TERM REGENERATIVE
REPAIR
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Tissue preparation
Pre-Treatment*
Bioburden Reduction*
21 patents granted covering US, EU
and Asia-Pacific
dCELL® processAllograft and Xenograft soft tissue products
BioRinse Technology Natural bone filler solutions guaranteed to be osteoinductive to stimulate and regenerate native bone growth
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• Maintaining the five key natural bone growth factors and Bone Morphogenic Proteins promotes active regeneration
• Contains 100% allograft bone, clinically proven to produce better patient outcomes
• Verified to be osteoinductive
• Ability to deliver malleable bone collagen scaffolds in various physical forms to meet clinical needs
Differentiated Characteristics
“For alveolar bone grafts in my
pediatric cleft lip cohort, CellRight acellular bone grafts have
dramatically reduced my operative time, eliminated donor site
morbidity, and thus far appear to offer the same osteogenic and
osteoinductive properties as with autologous cancellous bone grafts.”
Kevin S. Hopkins, MD, FACSCraniomaxillofacial
Driscoll Children’s Hospital
Significant Market Opportunities
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LONG TERM REGENERATIVE
REPAIR
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Strategic Plan BioSurgery - execution, execution, execution via ‘DermaPure Accelerator’ Program
Targeted Market Opportunity
Hospital VAC approval
GPO Approval
KOL Adoption
Medicare
Strengthen Case Study series to broaden and support new clinical
applications
Commission Health Economic
data capture to establish cost and
utility benefits
Building Real World Data observational studies to support proven technology
Direct sales force augmented by Medical Affairs personnel in each region
Strengthened Distributor coverage and performance
Additional IDN/GPO contracts increasing adoption opportunities
Development of key strategic partnerships in selected clinical settings
Improving access
Investing in Scale
Sales Process Efficiency
• Account targeting top volume and teaching institutions
• Leverage internal ‘disciple’ to reduce conversion time & drive volume: Orthopaedic Trauma
Follow ‘Narrow and Deep’ principle to drive tech penetration and ROI
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The Product & the Technology
Unique, Patented Dermal Allograft Tissue• Produced using patented dCELL® Technology
Redirects Vascular Behavior to Trigger Healing (Revascularization)• Intact vascular like channels allow an access
point for proliferation of native cells, including endothelial cells and fibroblasts
Signals the body, not the wound for healing• Replaces the damaged extracellular matrix so
living cells can flourish• Provides a strong foundation for angiogenesis
Natural Structure & Biomechanical Properties • Use of proprietary cleaning process and
proteinase inhibitors preserves Structure, Biomechanical Properties, and Performance.
Biologic Scaffold • Promotes regeneration/remodeling • Maintains functional repair/replacement
Cell Removal• 99% DNA Free Allograft • Less likely to trigger an immune response• Less susceptible to rejection/degradation
References: 1. Data on file. Tissue Regenix Wound Care Inc. 2. Moore, Mark A. Decellularization of human dermis using matrecell technology:
process, preclinical studies, and medical applications; LifeNet Health 2011. http://elibrary.lifenethealth.org/uploads/resource0084254001405003560.pdf
3. Derwin KA, Baker AR, Spragg RK, Leigh DR, Ianotti JP. Commercial extracellular matrix scaffolds for rotator cuff tendon repair. Biomechanical, biochemical, and cellular properties. J Bone Joint Surg Am. 2006; 88:2655-2672
4. Choe JM, Bell T. Genetic material is present in cadaveric dermis and cadaveric fascia lata. J Urol. 2001;166:122-4.
LONG TERM REGENERATIVE
REPAIR
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Strategic PlanOrthopaedics – leverage proven technologies to deliver sustained growth
We are focusing our Orthopaedics business via two distinct surgical disciplines:Sports Medicine and Spine
Two different successful go to market strategies:
Direct sales in Sports Medicine OEM partnership in spine
Initial dialogue with selected Multinational organisations
encouraging
dCELL®
BioRinse®
Products recognised for delivering
significant patient outcomes in soft tissue repair and
bone regeneration
Driving growth in partnership with Regional, National and International MedTech organisations leveraging the combination of our proven technologies with the scale and reach of our partners
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Strategic Plan Dental – shaping a new therapeutic treatment in $400m market
Processed using BioRinse addressing allograft bone replacement
Key indications: • Void filling following extraction • Augmentation or reconstruction • Sinus lift to create space for implant
Superior handling characteristics
Proven Osteoinductivity of
every product leading to bone growth
Anecdotal faster healing time
Patient Experience
• Reduced time of dental procedure
• Faster preparation of implant site leading to reduction in total recovery time Processed using dCELL® addressing soft
tissue augmentation
Key indications: • Periodontal tissue replacement
following gum disease• Covering of extraction sockets • Aesthetic reconstruction• Gum disease
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Strategic Plan Cardiac – at forefront of potential game changing patient care in $3.1BN heart valve market
Significant opportunity in dCELL® human allografts, changing surgical options and delivering Health Economic and Utility benefits to hospital partners
In Progress HAV/HPV
Manufacturing license H2 2018
HAV/HPV Marketing
authorisation license H2 2019
HAV/HPV Launch 2019
In PipelineEvaluating:
dCELL® Xenograft AV/PV
Evaluating: Pericardium patch HT/XT
Key Development Milestones• Focus on Human Aortic Valves and
Human Pulmonary Valves
• Leverage FD Costa 10 year published data to launch dCELL® HAV/HPV in Germany via our Joint Venture GBM-V
• FDC data augmented by 90 patient, 3 site Paediatric study currently enrolling
Financial Highlights
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Consolidated Statement of Comprehensive Income Year to
31 December
2017
11 Months
to 31
December
2016
£000 £000
REVENUE 5,233 1,443
Cost of sales (2,627) (730)
GROSS PROFIT 2,606 713
Administrative expenses before exceptional items (12,324) (11,773)
Exceptional items (1,098) -
Total administrative expenses (13,422) (11,773)
OPERATING LOSS (10,816) (11,060)
Finance income 47 114
LOSS BEFORE TAXATION (10,769) (10,946)
Taxation 1,348 1,034
LOSS FOR YEAR (9,421) (9,912)
• Revenues increased more than three-fold to £5.2m (2016: £1.4million)o Dermapure - sales increased by 46% to £1.9m (2016: £1.3m)o Controlled joint venture – sales increased more than 8-fold to
£1.1m (2016: £0.1k)o CellRight – sales momentum maintained – period post-acquisition
were £2.2m (FY including pre-acquisition was £5.1m)• Gross profit increased to £2.6m (2016: £0.7m)• Operating loss before exceptional items of £9.7m (2016: £11.1m) • Cash at 31 December 2017 of £16.4m
o Operating - cash from operations (£9.8m) (2016: (£10.8m))o Including R&D tax credit of £1.5m (2016: £0.3m)o Including exceptional costs: acquisition expenses £1.0m,
litigation costs £0.1m)o Investing - Cash of £19.9m was used for investment in CellRight
Technologies o Towards total consideration at fair value of up to £22.7mo Together with £1.0m used to pay costs
o Financing - Equity issued during the year of £40.0m o Raised cash of £37.7m net of costs
(Note: 2016 comparatives are for the 11 months ended 31 December 2016)
LOSS PER SHARE
Basic and diluted on loss attributable to equity holders of parent (1.00)p (1.29)p
LONG TERM REGENERATIVE
REPAIR
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Recent Achievements and Future Milestones Strategy in action
Recent Achievements
✓ Strategic Partnerships signed – Orthopaedics, Biosurgery
- Arthrex
- ARMS Medical
✓ Integration activities tracking to plan
✓ In house manufacturing of DermaPure
✓ DermaPure ‘Accelerator Programme’ launched
✓ Encouraging start to 2018 revenue growth
✓ Realigned senior management roles to focus on value creation
✓ Established Global R&D portfolio review
✓ Revised JV Board and Governance
Future Milestones
• Further strategic partnerships
• OrthoPure XT CE Mark
• HTA Licence
• UK BioRinse distribution
• SurgiPure XD US distribution agreement
• GPO approval
• FDA pre-clinical trial OrthoPure XT
• OrthoPure HT US launch
LONG TERM REGENERATIVE
REPAIR
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SummaryOperating in large and growing markets, potential to access c.$7BN enterprise opportunity
Strategic focus areas: BioSurgeryOrthopaedics Dental Cardiac
Innovative platform Technologies:
dCELL®BioRinse®
Leverage core competencies across
the business; science, R&D, commercial
execution
Evolution of strategy to
drive sales momentum and
market penetration
✓ Strategy to drive commercial growth
✓ Two proven regenerative medical technology platforms
✓ Differentiated product offering
✓ Multiple pipeline opportunities
✓ Growing global distribution network
✓ Poised for product launches in both the EU and US
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Q&A
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