TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials •...
Transcript of TISSUE REGENIX GROUP PLC - Proactiveinvestors UK€¢ CE mark clinical (regulatory) trials •...
TISSUE REGENIX GROUP PLC
Antony Odell CEO
Disclaimer
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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
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
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
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
Market Size ($bn)
Wound Care (US) Meniscus (global) Tendon/ligament (global)
Other Sports Med (global) Hernia/Breast recon (US)
Market Potential = $9.8bn
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
BUSINESS REVIEW - WOUND CARETRX Wound Care Inc.
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
DermaPure™ - the visible dermal difference
DermaPure™ Poster – May ‘15
DermaPure® successes
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
BUSINESS REVIEW -ORTHOPAEDIC
TRX Orthopaedic Ltd
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
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
Late Complications after meniscectomyand or non repaired ACL Tear…….
Without Meniscus Osteoarthritis
Higher Peak stress on cartilage
Joint narrowing, articular damage, osteoarthritis
Late Complications after meniscectomyand or non repaired ACL tear…..
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HTO PKR and TKR
Health Care Costs increase $$$
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
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
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
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
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
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