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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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1. Overview 2. Technology3. Strategy4. Product Portfolio 5. Financial
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•Main offices in Leeds, UK, US office San Antonio, TX
•Over 70 employees
•Listed on AIM, Ticker: TRX.l → Market cap: £130m
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
4
Antony Odell CEO
Tony Hewitt
UK Operations Director
Greg BilaPresident, Tissue
Regenix Wound Care, Inc
Tim Buechner, VP Operations Tissue Regenix Wound Care,
Inc.
Ian Jefferson CFOPeter Hamer
Commercial Director, TRX Orthopaedics Ltd
Drew Distin, VP Tissue Regenix Orthopaedics, Inc
Andrea Rausch Commercial Director,
TRX Cardiac Ltd
Tissue Regenix has a corporate board with a wealth of experience in the commercialization of medical devices, business development and finance.
Tissue Regenix has an executive management team experienced in commercialising products around the world.
John Samuel
Chairman
Antony Odell CEO
Steve CouldwellNED
Alan Miller NEDRandeep Grewal
NEDJon Glenn NED
Ian Jefferson CFO
ShervantiHomer-
Vannianskim
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®
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Human Tissue
• US: Direct ‘hybrid’ marketing model
• ROW: Partner/JV/Licensing
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®
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Tissue Regenix entered a Joint Venture in January 2016
Enables deployment of dCELL® human tissue technology in EU
Initial licences for CardioPure™ HAV & HPV (H umanA ortic/P ulmonary V alves) & DermaPure®
Annual technology access fee per application €100k
• Processing fee per tissue (valve/cm2 etc.)
Initial revenues to be derived from cryopreserved-tissues (cornea, heart valves)
• Regulatory approvals H216
Regulatory submissions for dCELL® in progress
• Regulatory approvals expected mid 2017
Donor base expanding to plan
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Trauma426,294
5%
Burn462,352
6%Diabetic
Foot Ulcers1,451,747
18%
Venus Leg Ulcers
959,292 12%
ArterialUlcer
238,3233%
Pressure Ulcer 4,468,052
56%
Wound Prevalence in the US¹
0
10
20
Diabetic LimbComplications
Breast Cancer ColorectalCancer
Lung Cancer ProstateCancer
Leukemia
Annual Direct Healthcare Costs 3
(In Billions of US Dollars)• The CDC estimates that 86M people in the US have pre-diabetes¹
• 29.1 million children and adults have diabetes • 8.9 million are undiagnosed • 4 – 10% have a diabetic foot ulcer
• Highest prevalence of diabetic foot ulcers are found in: • Diabetic population over 65 years of age = 8%²
• Diabetic patients within the VHA = 5.5%¹
• The incidence of diabetic limb amputation is estimated at 15%²
Trauma426,294
18%
Burn41,098
1%
Pressure Ulcer 1,,098,237
34%
Diabetic Foot Ulcer
943,63529%
Venus Leg Ulcer
476,646 15%
ArterialUlcer
238,3233%
Sources: 1. US Wound Biologics Market BioMedGPS, LLC. https://www.smarttrak.net2. “Preventing Foot Ulcers in Patients with Diabetes. JAMA. 2005;293(2):217-228. doi:10.1001/jama.293.2.217; http://jama.jamanetwork.com/article.aspx?articleid=2001193. Diabetic Foot & Ankle 2013. © 2013 Neal R. Barshes et al. Published: 10 October 2013; The system of care for the diabetic foot: objectives, outcomes, and opportunities;
http://diabeticfootandankle.net/index.php/dfa/article/view/21847/html#CIT0005_21847
Surface area reduction less than 50%
in 4 weeks
“Hard to Heal” Wound Prevalence in the US¹
DFU’shighest wound
expenditure
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2014 US Skin Substitutes by Segment¹
Allograft $180.8M
37%
Xenograft $159.3M
29%
Cell-based Bioengineered
$185.9M34%
US Skin Substitutes 5 Forecast by Segment¹
Market size ( millions US Dollars )
Topical Delivery
/Drug $288M
33%Skin Substitutes
$562M66%
Sources: 1. US Wound Biologics Market BioMedGPS, LLC. https://www.smarttrak.net
Allograft18.1%CAGR
Xenograft 13%
CAGR
Cell-based-13.1%CAGR
• The Wound Biologic Market is projected to be $1.4B by 2019 • The CAGR = 9.8%
• The Skin Substitutes are comprised of three types:¹
• Allografts – Human derived tissue products • Xenograft – animal derived tissue products • Cell-based Bioengineered Tissue – “grown” tissue products
• Cell-based bioengineered tissues continue to decline (-34% in 2014)
• Many new companies have entered the skin substitute market with allograft and xenograft tissue products
$0
$200
$400
$600
$800
$1,000
2014 2015E 2016E 2017E 2018E 2019E
Collagen / Active
Dressings $51.2M
6%
2014 Wound Biologic Market
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Autograft 74%
Allograft 26%
Synthetics 0%
Autograft 96%
Allograft 3%
Synthetic 1%
USA 2015 CAGR 7%
EU 2015 CAGR 5%
Autograft 94%
Allograft 4%
Synthetics 2%
ROW 2015 CAGR 6%
Procedure Volume
ACL* 350,000
Knee Multi-ligament 70,000
Other 90,000
Total 510,000
Procedure Volume
ACL* 210,000
Knee Multi-ligament 42,000
Other 62,000
Total 314,000
Procedure Volume
ACL* 150,000
Knee Multi-ligament 25,000
Other 35,000
Total 210,000
Procedure Volumes of ACL Reconstruction @36 per 100,000. Scandinavian ACL Registry 2004 - 2016
• Total Sales $46.6 Billions at 1.2 % over prior year (CAGR $50 Billions 2020)
• Sports Med/Orthobiologics - Estimated combined revenue of 20% at $9.12 billions (CAGR 6.6% through 2019)
• Demographics continues to serve the segment well age, arthritis, obesity, sports
• Significant need for soft tissue grafts/replacements within ‘Sports Medicine’ arena (Meniscus, Cartilage, Ligaments)
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13
DermaPure® Redirects Vascular Behavior to Trigger Healing
DermaPure® provides an acellular, intact tissue matrix that signals the body to heal by moving through the normal phases of wound healing (inflammation, proliferation, maturation).
The result is fully revascularized tissue
Commercial traction $1.2m revenue FY16 93% Medicare Coverage Strong clinical support for
product
Treatment of Acute and Chronic Wounds
Chronic wound – A wound that develops over time and does not heal by 50% within 4 weeks of treatment. e.g Diabetic Foot Ulcers
Acute wound – A wound that happens suddenly and is not progressive. Moves through the normal phases of healing. e.g surgical wounds
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Day of Applicationof DermaPure®
Week 1 Week 4 One month post closure
US spends $11bn treating pressure ulcers annually.”National Pressure Ulcer Advisory PanelSept 18th 2015
Pressure Ulcer4 years OldHealed in 4 weeks
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Group Purchasing Organisation
Direct reps
Integrated Delivery Network
Medicare is a federal insurance programme for the
over 65s, which subsidises costs for healthcare treatments through a reimbursement programme.
In order to qualify for this subsidy, the treatment must initially be approved under the relevant Medicare jurisdiction often determined by geographic area.
DermaPure® now has coverage in 7 of the 8 Medicare jurisdictions
National Accounts/
Distributors
- Medicare 'Q' code for reimbursement, came into effect January 1st 2015 - First GPO contract signed in July 2016 which spans across 43 states and is affiliated with 48 IDNs, with a membership comprised of more than 800 acute care hospitals, 186 different Health Systems and more than 1000 long-term care facilities
Jusrisdiction Covered Non-Covered % of Total
Novitas 8,919 24
Noridian 6,460 17
NGS 7,099 19
WPS 4,134 11
First Coast 2,559 7
Palmetto 3,397 9
Cahaba 2,563 7
CGS 1,921 5
Total 34,488 2,563 100%
Tissue Regenix
Coverage
93% 7%
Medicare Coverage 93%
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•First time FDA has reviewed full dCELL® process
•Focus on complex hernias (grade 3-5)
•$300m market opportunity
•Launch H2 2017
•Seeking to appoint a national distributor
•Clarifying reimbursement pathway
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Large addressable market and potential market opportunities
Exceptional product performance
DermaPure® $1.2m in revenue achieved in first full fiscal year
$831K six months to 31 July 2016
Larger and thicker sizes to become available H2 2016
Product extensions into dental, burns and breast augmentation
SurgiPure XD to become available H2 2017
Milestones
Final Medicare jurisdiction
GPO/ IDN Agreements
SurgiPure XD distributor
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Partial Meniscectomy is most common Orthopaedic Procedure at 61 per 100,000 population
Removal of meniscal tissue creates mechanical imbalance – currently limited surgical options available
OrthoPure™ XM first EU Clinical trial enrolment completed
Second clinical trial application to commence H2 2016
Target: Regulatory approval and launch EU 2018
Without Meniscus high peak stress on cartilage
Potential Complications after meniscectomy
The meniscus is a crescent-shaped structure that sits between the femur and tibia (thigh and shin) bones and acts a shock absorber whilst also providing structural integrity to the knee joint.
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The ACL is a fibrous band of tissue that runs diagonally across the centre of the knee. Primary function is stability.
ACL rupture is the second most common injury of the knee requiring surgical reconstruction
Approximately 80% of ACL injuries are surgically treated (Autograft, allograft and synthetics)
Autograft requires second surgery site, allograft supply is limited and synthetics lack long term durability
OrthoPure™ XT EU Clinical trial started December 2015.
Target: Regulatory approval EU Q4 2016
US Pilot Clinical Study submission Q4 2016
ASP (£)OrthoPure™
XT
Potential Market
(£)
USA 1,500 765M
EU 1,100 345M
ROW 1,200 252M
Total 1,362B
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Knee RepairACLMeniscus
OrthoPure™XM
Partial Meniscal
Repair
Hip Arthroscopy
Cartilage Repair
OrthoPure™XT
ACL repairPCL, MCL, LCL, MPFL
Foot, Ankle, Shoulder,
Elbow
OrthoPure™XT CE Mark approval
OrthoPure™XM EU clinical trial application
OrthoPure™ XT EU market roll out
OrthoPure™ XM EU clinical trial commence
OrthoPure™ HM Technology transfer (US)
OrthoPure™ HT Technology transfer (US)
OrthoPure™ XM EU Launch
OrthoPure™ XM US clinical study commences
OrthoPure™ XM510k data collection
OrthoPure™ XT US pivotal study commences
OrthoPure™ XT pilot study US
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The data showed:
Freedom from reoperation in this high risk
group was 89% after ten years
Partial cellular repopulation of the valve
CT scans showed absence of
calcification even in the valve root,
essential in this treatment, where, in
younger patients, it is a significant
problem.
Pulmonary: 10 year follow-up
• 155 patients received dCELL® valve
• Mean age of patients 30.8 (+/- 13.1) years
• Aortic: 10 year follow up
• 103 patients received dCELL® valve
• Mean age of patients 46 (+/- 17) years (age range 0.1 to 81 years)
• High risk patient group
• Paediatric follow-up study progressing well in Brazil
• Important data set of over 100 patients below 12 years age range
• Initial results very encouraging
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•Launch of SurgiPure™ XD
•Launch of thicker DermaPure® & additional sizes
• Completion of Medicare reimbursement & private/managed medicare programme
•Federal Supply Schedule (FSS) listing
•Additional stocking distributors signed up
•Commercialisation of alternate applications in US (dental, burns etc.)
•OUS deployment of DermaPure®
•Commence regulatory application for second OrthoPure™ XM trial
•Regulatory approval (CE Mark) in EU for tendon (porcine)
•Commercialisation strategy & partners to be announced
•Regulatory Approvals for cryo- tissues (GBM-V)
23
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For the 6 months ended 31 July 2016 Tissue
Regenix Group delivered:
Revenue of £631k (2015: £252k)
Operating loss of £5,523k (2015: £4,133k)
Cash balances at the end of the period were
£13,515k (2015: £24,887k) and the Group was
debt free.
The results were in line with our expectations.
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Wound Care Orthopaedics Cardiac Central Total
6m to 31 Jul 16
£’000
6m to 31 Jul 15
£’000
12m to 31 Jan 16
£’000
6m to 31 Jul 16
£’000
6m to 31 Jul 15
£’000
12m to 31 Jan 16
£’000
6m to 31 Jul 16
£’000
6m to 31 Jul 15
£’000
12m to 31 Jan 16
£’000
6m to 31 Jul 16
£’000
6m to 31 Jul 15
£’000
12m to 31 Jan 16
£’000
6m to 31 Jul 16
£’000
6m to 31 Jul 15
£’000
12m to 31 Jan 16
£’000
Revenue 631 244 808 - - - - - - - 8 8 631 252 816
Cost of Sales (119) (62) (154) - - - - - - - - - (119) (62) (154)
Gross Profits 512 182 654 - - - - - - - 8 8 512 190 662
SG&A (3,074) (1,749) (4,938) (1,300) (1,050) (2,382) (255) (107) (352) (1,406) (1,417) (3,232) (6,035) (4,323) (10,904)
Operating Loss (2,562) (1,567) (4,284) (1,300) (1,050) (2,382) (255) (107) (352) (1,406) (1,409) (3,224) (5,523) (4,133) (10,242)
Finance Income - - - - - - - - - 81 116 213 81 116 213
Loss before Taxation (2,562) (1,567) (4,284) (1,300) (1,050) (2,382) (255) (107) (352) (1,325) (1,293) (3,011) (5,442) (4,017) (10,029)
Taxation 50 54 169 200 256 324 30 7 16 - 18 18 280 335 527
Loss for the year (2,512) (1,513) (4,115) (1,100) (794) (2,058) (255) (100) (336) (1,325) (1,275) (2,993) (5,162) (3,682) (9,502)
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