TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials •...

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TISSUE REGENIX GROUP PLC Antony Odell CEO

Transcript of TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials •...

Page 1: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

TISSUE REGENIX GROUP PLC

Antony Odell CEO

Page 2: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

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: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

Background to Company

• Main offices in York, UK, US office San Antonio, TX

• Over 70 employees

• Listed on AIM, Ticker: TRX.l → Market cap: £150m

• Experienced board: John Samuel (ex-Apax) Chairman

Tissue Regenix Group plc

• Removes 99% of cells/DNA creates matrix (animal or human)

• Multiple tissue types can be decellularised

• Stem cells attracted into matrix (Dardik, Yale)

• Regenerates as living tissue → ‘…a living repair’

dCELL® Platform technology

• Regenerative medical devices to address need for long term repairs

• Human dCELL™ tissues provide fast route to market launch → early revenue

• Animal dCELL™ tissue products follow

• Substantial market opportunity (Wound Care, Orthopaedics, Cardiac & more)

Strategy

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dCELL® Process

dCELL® Process

Patent protected Matrix stored at room

temperature

surge

ry

Surgeons usual technique

regeneration

Capacity to attract stem cells into matrix

Long term regenerative

repair

Animal or human

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Intellectual Property – Underpinning the Development and Commercialisation Strategy

Kn

ow

ho

w

Decellularisation of matrices

Aus, Can, EU, US

Meniscal Repair

[India]

US, China, EU, Japan, Aus

Bladder

[EU, Aus]

UK, US

Ultrasonic modification

of soft tissues

EU, US

Acellular Arteries

[Aus, Br, Can, China, EU, HK, India, Japan,

US]

Trademarks: Tissue Regenix, dCELL, TRx, DermaPureGranted patents in bold, all others

pending

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Human Tissue

•US: ‘Hybrid’ marketing model

•Partner

•ROW: ‘indirect’ marketing model

dCELL® evidence base

•Health economics

•Clinical/mechanism of action

Core focus areas

•Wound Care

•Orthopaedics

• [Cardiac]

Animal Tissue

•EU: CE Mark 3rd party distribution

•US: ‘hybrid’ model (510k products)

•Partner (PMA products)

•ROW: Regulatory pathway led

dCELL®

Strategy

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Market Size ($bn)

Wound Care (US) Meniscus (global) Tendon/ligament (global)

Other Sports Med (global) Hernia/Breast recon (US)

Market Potential = $9.8bn

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Highlights

• Launched first product DermaPure™ for chronic wounds in US (June ‘14)

• Raised £19.2m in January

– Fund US expansion

• Orthopaedics (Sports Medicine)

– Clinical trial for OrthoPure™ XM (meniscus) underway in EU

• First patients have received implant

– Clinical trial for OrthoPure™ XT (tendon) clinical trial underway

• Recruitment to start H2 ‘15

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BUSINESS REVIEW - WOUND CARETRX Wound Care Inc.

Page 10: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

Average wound duration (weeks)

Ave

rage

wo

un

d s

ize

(cm

2)

Note: Wound type & percentage of wounds closed for clinical study in parenthesis beside each product (study end points vary)

Average wound size = 13.1 cm2

Average wound duration = 4.76 years

DFU’s & VLU’s

SINGLE APPLICATION (most cases)

BIGGER

OLDER

Remarkable Clinical ResultsDermaPure™ – the visible dermal difference

Page 11: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

DermaPure™ - the visible dermal difference

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DermaPure™ Poster – May ‘15

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DermaPure® successes

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Medicare

Over 23m traditional Medicare lives now covered (63%)

Licence to sell does not guarantee business

Achieved in 7 months

Ongoing discussions with remaining 3 MAC’s

Regional Distributors

Stocking commitments now total $735k p.a.

Only a limited number of smaller states covered to date

Further agreements in pipeline

US sales strategy

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BUSINESS REVIEW -ORTHOPAEDIC

TRX Orthopaedic Ltd

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Sports Medicine and Tissue Regenix

Porcine DevelopmentsFocus on CE Marks and EMEA CommercialisationMeniscus and ACL Scaffold (OrthoPure™ XM and XT)

Clinical and ‘Economic’ Proof KOL’s, Clinical Studies, Agencies, Consultancies

Human Tissue DevelopmentsFocus on USA market model and CommercialisationMeniscus and ACL Scaffold (OrthoPure™ HM and HT)

Innovation that is commercially viable

and aligned to market requirements

addressing clinical need

Page 17: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

How is an ACL or Menisci Injured

• Usually through a ‘direct contact or no contact’ mechanism

• ‘Planting and twisting’ action

• Direct blow to the outside of the knee

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Meniscal Repair and ACL Reconstruction Market Large Global and underserved Market

• Partial Meniscectomy most common Orthopaedic Procedure at 61 per 100,000 population.

• 2014 – USA & Europe 1.5 Million Meniscal Procedures

• ACL rupture is the second most common injury of the knee requiring surgical reconstruction

• Approximately 80% of ACL injuries are surgically treated

• 2014 – USA and Europe 0.9 Million ACL procedures

Total Global Market Opportunity

$6+ billion

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Late Complications after meniscectomyand or non repaired ACL Tear…….

Without Meniscus Osteoarthritis

Higher Peak stress on cartilage

Joint narrowing, articular damage, osteoarthritis

Page 20: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

Late Complications after meniscectomyand or non repaired ACL tear…..

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HTO PKR and TKR

Health Care Costs increase $$$

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Early Intervention – Joint Preservation

Goals of OrthoPure™XM, XT, HM, HT

• In the short term – restore load bearing, shock absorbing functions, biomechanics and functional mobility.

• In the long term to lower the risk of OA and the need for further operations. e.g. HTO, PKR and TKR Economic Benefits to Health Care * The above indicates the opportunity

addressed by TR’s products that are currently in development, line extensions will increase this. Currently TR would need to fundraise to perform the US regulatory studies for meniscus & tendon

Page 22: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

Sports Medicine – current status

• OrthoPure™ XM & XT [PORCINE] (meniscus & tendon)

• CE mark clinical (regulatory) trials

• Actively recruiting into meniscus trial

• Tendon trial received UK regulatory approval, anticipated in Poland & Spain

• Recruitment for tendon starting H2 2015

• Pre-IDE programme: tendon (submitted) & meniscus (in process)

• Target: EU regulatory approval & launch in 2016

• Clinical recruitment rate key factor in timeline

• OrthoPure™ HM & HT [HUMAN] (meniscus & tendon)

• Processes in development

• Room-temperature tendon & partial meniscal repair devices

• Target: launch in US 2016

• DermaPure™ (thick)

• Rotator cuff, tendon and plantar augmentation

• Target: Launch H2 2015

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Income Statement12 months to

31-Jan-15£'000

12 months to 31-Jan-14

£'000Comments

Operating Income 100 6

Administrative expenses (8,469) (6,583)

Increase in line with expectations as we invest in development and in infrastructure to market our products

Operating loss (8,369) (6,577)

Finance income 168 274

Loss before tax (8,201) (6,303)

Taxation 620 710 Continued R&D tax credit refund

Loss after tax attributable to equity holders of the parent (7,581) (5,593)

Loss per share, basic and diluted (1.19p) (0.88p)

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Balance Sheet31 Jan 2015

£'00031 Jan 2014

£'000 Comments

Non-current assets

Property, plant and equipment 435 472

Total non-current assets 435 472

Current assets

Inventory 34 -

Trade and other receivables 1,947 1,127

Cash and cash equivalent 10,257 18,483 Additional £19m raised post year-end

Total current assets 12,238 19,610

Total assets 12,673 20,082

Current liabilities

Trade and other payables (1,095) (1,104)

Total liabilities (1,095) (1,104)

Net assets 11,578 18,978

Equity

Share capital 3,271 3,267

Share premium 31,972 31,971

Merger Reserve 10,884 10,884

Reverse acquisition reserve (7,148) (7,148)

Reserve for own shares (831) (831)

Share based payment reserve 810 630

Retained earning deficit (27,380) (19,795)

Total equity 11,578 18,978

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Share Register

• Invesco Perpetual 27.8%

• Woodford I.M. 15.7%

• IP Group plc 14.6%

• Baillie Gifford & Co 4.9%

• University Of Leeds 4.5%

• Jupiter A.M. 4.5%

• NFU Mutual 4.0%

January fund raise oversubscribed

0

5

10

15

20

25

30

30-Dec-14 28-Feb-15 30-Apr-15 30-Jun-15 30-Aug-15

Top 10 Shareholders

Invesco A.M. Woodford I.M.

IP Group Baillie Gifford

Leeds University Jupiter A.M.

NFU Mutual Henderson A.M.

Aberdeen A.M. BlackRock I.M.

Note: shareholder register taken at 30/8/15

Page 26: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

Product line extensions

DermaPure™ Chronic Wounds

Acute Wounds Dental BurnsRotator Cuff

Repair

OrthoPure™XM

Partial Meniscal

Repair

Hip Arthroscopy

Cartilage Repair

OrthoPure™XT

ACL repairPCL, MCL, LCL,

MPFL

Foot, Ankle, Shoulder,

Elbow

SurgiPure™ General Surgery

Breast Reconstruction

Page 27: TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials • Actively recruiting into meniscus trial • Tendon trial received UK regulatory approval,

Conclusion & Outlook• DermaPure® clinical performance

outstanding

• Medicare coverage increasing

• Multiple product launches (US & EU) planned in next 18 months

• Huge market opportunity

• Vibrant M&A space

• Strong shareholder base

FIRST PRODUCT LAUNCHED ON TIME INTO WORLDS LARGEST

HEALTHCARE MARKET

MULTIPLE CLINICAL TRIALS IN PROGRESS US, EU & BRAZIL

EARLY REIMBURSEMENT FOR DERMAPURE™

SOLID WOUND CARE COMMERCIALISATION

PLATFORM BUILT FOR FUTURE GROWTH

VALIDATION OF TECHNOLOGY IN MULTIPLE APPLICATION AREAS &

COMMERCIAL DELIVERY