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Building a Leading Regenerative Medicines Business May 17 2018

Building a Leading Regenerative Medicines Business...This Presentation includes certain statements, estimates and projections with respect to the anticipated future performance of

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Page 1: Building a Leading Regenerative Medicines Business...This Presentation includes certain statements, estimates and projections with respect to the anticipated future performance of

Building a Leading Regenerative

Medicines Business

May 17 2018

Page 2: Building a Leading Regenerative Medicines Business...This Presentation includes certain statements, estimates and projections with respect to the anticipated future performance of

2

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

restricted by law and the persons into whose possession this document comes should inform themselves about, and observe, any such restrictions.

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.

Page 3: Building a Leading Regenerative Medicines Business...This Presentation includes certain statements, estimates and projections with respect to the anticipated future performance of

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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

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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

7

Tissue preparation

Pre-Treatment*

Bioburden Reduction*

21 patents granted covering US, EU

and Asia-Pacific

dCELL® processAllograft and Xenograft soft tissue products

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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

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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.

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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

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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

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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

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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