Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 •...
Transcript of Tissue Regenix Group plc - Jefferies Group Regenix.pdf · • recruitment to start H2 ‘15 •...
REGENERATIVE MEDICAL DEVICES
4TH JUNE 2015
TISSUE REGENIX GROUP PLC
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.
2
Background To Company
• Main offices in York, UK, US office San Antonio, TX • Over 70 employees • Listed on AIM (London Stock Exchange) Ticker: TRX.l • Market cap: $220m
Tissue Regenix Group plc
• University of Leeds, UK (inventors of dCELL® process) • Community Tissue Services Dayton OH • NHSBT, UK • PUCPR, Curitiba, Brazil (heart valves)
Technology partners
• Decellularisation of tissues (animal or human) • Multiple tissue types can be decellularised • Stem cells attracted into matrix (Dardik, Yale)
dCELL® Platform technology
3
dCELL® Process
dCELL® Process
Patent protected
Matrix stored at room
temperature
surgery
Surgeons usual technique
regeneration
Capacity to attract stem cells into matrix
Long term regenerative
repair
Animal or human
4
Multiple Applications
Animal or human • Soft tissues
– Wound care – Orthopaedics – Cardiac – Vascular – Urinary
• Future: liver etc.
5
dCELL® - why is it different? • Derived from the natural structural tissue to be replaced
– Biomechanical structure and function – short and long term – Appropriate tissue repair environment - attract and support tissue
regeneration, tissue specific micro-scale physical and biochemical architecture.
• Use of low concentration SDS & proteinase inhibitors preserves tissue structure – Others have used high concentrations of reagents that destroy tissue
structure • No use of chemical fixatives
– Others treat acellular biological scaffolds with fixatives which prevents cells migration
• Provides low cost regenerative solution by recruiting and stimulating patients own cells to repair
6
Intellectual Property – Underpinning the Development and Commercialisation Strategy
Know
how
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]
Granted patents in bold, all others
pending
Trademarks: Tissue Regenix, dCELL, TRx, DermaPure
7
Strategy – focussed on core dCELL® technology
US • Human ‘minimally manipulated’
products • Porcine dermis (general surgery) • Pre-IDE preparation
dCELL® evidence base • Health economics • Clinical/mechanism of action
Core focus areas • Wound Care • Orthopaedics • [Cardiac]
EU • CE Mark (porcine products) • Tissue Bank licensing (human tissue)
dCELL®
8
Highlights • Launched first product DermaPure™ for chronic wounds (June ‘14)
– Initial revenues – Secured ‘Q’ code – First Medicare coverage secured (Novitas JH/JL & CGS) early ‘15
• Raised £19.2m ($28m) in January – Fund US expansion
• Orthopaedics (Sports Medicine) – Clinical trial for OrthoPure™ XM (meniscus) underway in EU – Clinical trial for OrthoPure™ XT (tendon) clinical trial approved in UK
• recruitment to start H2 ‘15 • Developments
– Human sports medicine process development • Meniscus & tendon
– SurgiPure™ Porcine Dermis – Line extensions
• DermaPure™ - dental/sports medicine • Relocation to new site – expansion of manufacturing
9
BUSINESS REVIEW - WOUND CARE TRX Wound Care Inc.
Remarkable Clinical Results
11
Average wound duration (weeks)
Aver
age
wou
nd si
ze (c
m2 )
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
DermaPure™ – the visible dermal difference
US Clinical Validation
• DFU (Diabetic Foot Ulcer) Randomised Control Trial (RCT) • 60 patients
– 3 month follow up – Standard of care crossover @ 12 weeks
• 6 centres recruiting
Presentation at SAWC
12
• 10 US case series − 12.9cm2 (big) wounds − 100% healing − 6.5 weeks avg time to heal − 1.1 applications (only one
case required two)
US Rollout Strategy
Phase 1: ACUTE CARE Phase 2: POST-ACUTE CARE
20-30% of chronic wound patients
70-80% of chronic wound patients
Reimbursement not needed Value Analysis Ctte’s [VAC’s]
6-18 months to approve
Reimbursement required under Medicare
First coverage secured in less than 3 months
Chronic wounds associated with other conditions
DFU’s (Diabetic Foot Ulcers) VLU’s (Venous Leg Ulcers)
Hospitals, VA, LTAC’s Wound Care Centers, Outpatient Surgery Centers, Physician Offices
13
Reimbursement first steps: Novitas & CGS notices & initial distributor contract
14
ABMAC & Private P Tissue Regenix Wound Care Inc. received reimbursement for DermaPure
within the Novitas region effective April 9, 2015 , CGS followed in May ‘15
This allowed Tissue Regenix to execute phase II strategy
Reimbursement scene continues to change potentially favourable to TR as will limit number of applications
Regional distributor contract Signed after Novitas notice became effective
Experienced surgical & wound care distributor
Covers only 2 of 12 states in Novitas jurisdiction
11% of total Novitas potential population
Minimum $600k commitment over next 12 months
Scope to extend coverage area
Further agreements in pipeline
52m covered lives
Novitas largest of eight national ABMAC’s
Reimbursement → Patient Access & Commercial Opportunity
Patients, Clinicians & Payors • Continue to build awareness of clinical
success • Continue with active engagement with
other ABMAC’s • Leverage Medicare approvals to secure
uptake by: – Commercial payers – Managed Medicare beneficiaries – Paying patients
Hybrid distribution model • Indirect
– Extend in Novitas & CGS states – As other ABMAC’s come on-
stream add to existing or add new partners
• Direct – Focus sales reps in key Novitas &
CGS states – Pipeline visibility – Phased deployment as remaining
ABMAC’s come onstream
15
Hybrid Model Gaining Traction
16
October 2014
May 2015 NOVITAS
CGS
US Wound Care
• Commercial traction building – Distribution channels are building
in depth & quality – Novitas decision key as product
now can be used in largest group of chronic wound patients (post-acute)
• Clinical results more than compelling they’re “..visibly different” – Other application areas (burns
etc.)
17
Validation
Commercial Delivery
BUSINESS REVIEW - ORTHOPAEDICS TRX Ortho Ltd
Meniscal Repair Market - responding to clinical needs
Large Global Market Opportunity • Partial Meniscectomy most common Orthopaedic Procedure at 61 per 100,000
population • 2013 – USA 1 Million, Europe 400,000 Meniscal Procedures
Current Therapies/Treatments • For every 100,000 Meniscal injuries approx 20% are repairable • Remaining 80% - Partial Meniscectomy is the treatment of choice and regarded
as sub-optimal • 20-25% of patients remain symptomatic and require ongoing treatments and
surgical interventions • Competitive landscape – Other scaffolds – Orteq, Ivy Sports Medicine, Azellon,
Orthox
19
OrthoPure™ XM (Meniscus) Background
Primary goals with OrthoPure™ XM • In the short term – restore load bearing and shock absorbing functions, contributing to
pain relief and restoring functional mobility • In the long term to lower the risk of Osteoarthritis and the need for further operations.
e.g. Partial Knee Replacement and Total Knee Replacement
20
• Meniscus structure is complex and poor to heal beyond the outermost 20%
• Irreparable meniscus tear
• Partial Menisectomy
• dCELL® Meniscus Replacement
ACL Reconstruction Market - responding to clinical needs
Large Global Market Opportunity
• ACL rupture is the second most common injury of the knee requiring surgical reconstruction
• Approximately 80% of ACL injuries are surgically treated • An estimated 900,000 procedures performed annually growing at 7% CAGR (2012-2020)
Current Therapies/Treatments
• Autograft – 73% • Allograft – 26% • Synthetics – 1% LARS, Neoligaments, Soft Tissue Regeneration • Xenograft Scaffolds – Aperion Biologics
21
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, further approvals pending in Poland &
Spain – Pre-IDE programme underway (tendon & meniscus) – Target: regulatory approval & launch in EU 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) – Process in development – Target: rotator cuff repair
22
Launch
Work closely with corporate partner to ensure robust launch package Secure pathway for US pivotal clinical trial (PMA)
Post Launch
Broaden Portfolio through Line Extensions
Build Strong Corporate
Partnership
Pre-Launch
Strategy – Sports Medicine
Select corporate partner with appropriate EU/US sales & marketing infrastructure Target EU markets with clear reimbursement pathways Targeted KOLs (EU/US)
23
BUSINESS REVIEW - CARDIAC TRX Cardiac Ltd
dCELL® Human Heart Valves
• Brazils first heart valve bank adopted technology early (10 years ago) and has over 1700 patients with implanted valves
• Compelling clinical data continues to emerge from Brazil – Presentations at recent Heart Valve Society meeting in Monaco – 10 year 160 patient follow up for dCELL® Human Pulmonary Heart Valves –
demonstrably more effective than standard cryopreserved – Unique 10 year follow up for dCELL® Human Aortic valves in 100 patients
• High risk group of younger patients • Partial repopulation of grafts
• Retrospective data collection from 50 paediatric patients underway – Initial findings encouraging – Unique data set in complex patient type
• Licensing discussions with selected partners now entering an advanced stage
25
FINANCIAL
26
Income Statement
12 months to 31-Jan-15
£'000
12 months to 31-Jan-14
£'000 Comments
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)
27
28
Balance Sheet
31 Jan 2015 £'000
31 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% IP Group plc 16.8% Woodford Investment Management 14.5% • Strong blue chip fund investor base • January fund raise oversubscribed
PRODUCT PORTFOLIO
30
Product line extensions
DermaPure™ Chronic Wounds Acute Wounds Dental Burns Rotator Cuff
Repair
OrthoPure™ XM
Partial Meniscal
Repair
Hip Arthroscopy
Cartilage Repair
OrthoPure™ XT ACL repair PCL, MCL, LCL,
MPFL
Foot, Ankle, Shoulder,
Elbow
SurgiPure™ General Surgery
Breast Reconstruction
Product Pipeline – Through Development To Commercially Available Products
32
2015* 2016*
DermaPure®(Dental) (US)
DermaPure®(Ortho) (US)
SurgiPure™ XD G. Surgery (US)
OrthoPure™ XM (EU)
OrthoPure™ XT (EU)
OrthoPure™ XM (US)
OrthoPure™ XT (US)
PORCINE
HUMAN
SurgiPure™ XD G. Surgery (EU)
dCELL® Heart Valve
*Calendar years – indicative timings only dependant on development timings & regulatory considerations
Conclusion & Outlook • DermaPure® clinical
performance outstanding – Medicare coverage increasing
• Clinical trials for porcine sports medicine products underway in EU
• Multiple product launches (US & EU) planned in next 18 months
• Pre-IDE programme underway for porcine sports medicine products in US
33
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
APPENDIX Tissue Regenix Group plc – Preliminary Results
DermaPure™ - the visible dermal difference
35
SAWC Poster – May ‘15
36