Annual Results Presentation 23rd May 2016 Ian Jefferson - CFO€¦ · Annual Results Presentation 23rd May 2016 Ian Jefferson - CFO 1. 2 Income statement £’000 31 Jan 2016 31 Jan

Annual Results Presentation

23rd May 2016

Ian Jefferson - CFO

1

2

Income statement £’000 31 Jan 2016

31 Jan 2015

Revenue 816 100

Cost of sales (154) (32)

Gross Margin 662 68

Overheads (10,904) (8,437)

Operating Profit (10,242) (8,369)

Finance income 213 168

Loss before taxation (10,029) (8,201)

Taxation 527 620

Loss after tax (9,502) (7,581)

Attributable to:

Equity holders of parent (9,410) (7,581)

Non-controlling interests (92) -

Balance sheet £’000 31 Jan 2016

31 Jan 2015

Property, plant & equipment 901 435

Inventory 64 34

Trade & other receivables 2,325 1,947

Cash & cash equivalent 19,907 10,257

Total net assets 23,197 12,673

Trade & other payables (1,958) (1,095)

Net Assets 21,239 11,578

Highlights

■Strong revenue growth fromDermaPure® in first full year of salessince launch

■High margins at 81% (2015: 68%)

■Overheads increase driven by cost ofUS sales & marketing organisationand clinical trial costs for orthopaedicproducts

■The Group continues to benefit fromR&D tax credits

■Loss after tax of £9.5m in line withexpectations

■Healthy cash balance of £19.9m.

Financial Overview – Selected Highlights

TISSUE REGENIX GROUP P L C

RESULTS PRESENTATION 2016

3

SEGMENTAL £’000 WOUND CARE ORTHOPAEDICS CARDIAC CENTRAL TOTAL

2016 2015 2016 2015 2016 2015 2016 2015 2016 2015

Total segment 884 72 - - 76 - 8 28 968 100

Inter-segment (76) - - - (76) - - (152) -

Revenue 808 72 - - - - 8 28 816 100

Cost of sales (154) (32) - - - - - - (154) (32)

Gross Margin 654 40 - - - - 8 28 662 68

Development (1,108) (1,029) (2,279) (2,032) (289) (235) - - (3,676) (3,296)

Sales & marketing (3,672) (1,766) - - - - - - (3,672) (1,766)

Operations (158) (48) (103) (22) (63) (15) (3,232) (3,290) (3,556) (3,375)

Operating Profit (4,284) (2,803) (2,382) (2,054) (352) (250) (3,224) (3,262) (10,242) (8,369)

Financial Overview – Segmental Overview

TISSU E REGENIX GROU P P L C


4


2016 2015 2016 2015 2016 2015 2016 2015 2016 2015

Total segment 884 72 - - 76 - 8 28 968 100

Inter-segment (76) - - - (76) - - (152) -

Revenue 808 72 - - - - 8 28 816 100

Cost of sales (154) (32) - - - - - - (154) (32)

Gross Margin 654 40 - - - - 8 28 662 68

Development (1,108) (1,029) (2,279) (2,032) (289) (235) - - (3,676) (3,296)

Sales & marketing (3,672) (1,766) - - - - - - (3,672) (1,766)

Operations (158) (48) (103) (22) (63) (15) (3,232) (3,290) (3,556) (3,375)


F i n a n c i a l O v e r v i e w – S e g m e n t a l O v e r v i e w



■Revenue derived from DermaPure® sales($1.2m) in the US.

■Gross margins 81% c.f. 56% (underlying86% c.f. 82%).

Wound Care

■Development expenditure relates to DermaPure®clinical trial and 510k process for SurgiPure™XD

■Sales & marketing costs include commission of£303k (2015: £21k), 37.5% (2015: 29.2%) ofrevenue

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2016 2015 2016 2015 2016 2015 2016 2015 2016 2015

Total segment 884 72 - - 76 - 8 28 968 100

Inter-segment (76) - - - (76) - - (152) -

Revenue 808 72 - - - - 8 28 816 100

Cost of sales (154) (32) - - - - - - (154) (32)

Gross Margin 654 40 - - - - 8 28 662 68

Development (1,108) (1,029) (2,279) (2,032) (289) (235) - - (3,676) (3,296)

Sales & marketing (3,672) (1,766) - - - - - - (3,672) (1,766)

Operations (158) (48) (103) (22) (63) (15) (3,232) (3,290) (3,556) (3,375)





■Clinical trial started on both OrthoPure™XM and OrthoPure™XT

■Expenditure expected to increase again in current period as patient numbersgrow

Orthopaedics

6


2016 2015 2016 2015 2016 2015 2016 2015 2016 2015

Total segment 884 72 - - 76 - 8 28 968 100

Inter-segment (76) - - - (76) - - (152) -

Revenue 808 72 - - - - 8 28 816 100

Cost of sales (154) (32) - - - - - - (154) (32)

Gross Margin 654 40 - - - - 8 28 662 68

Development (1,108) (1,029) (2,279) (2,032) (289) (235) - - (3,676) (3,296)

Sales & marketing (3,672) (1,766) - - - - - - (3,672) (1,766)

Operations (158) (48) (103) (22) (63) (15) (3,232) (3,290) (3,556) (3,375)





■ Joint Venture set up with tissue bank in Germany

■ First licence for heart valve technology

Cardiac

7


2016 2015 2016 2015 2016 2015 2016 2015 2016 2015

Total segment 884 72 - - 76 - 8 28 968 100

Inter-segment (76) - - - (76) - - (152) -

Revenue 808 72 - - - - 8 28 816 100

Cost of sales (154) (32) - - - - - - (154) (32)

Gross Margin 654 40 - - - - 8 28 662 68

Development (1,108) (1,029) (2,279) (2,032) (289) (235) - - (3,676) (3,296)

Sales & marketing (3,672) (1,766) - - - - - - (3,672) (1,766)

Operations (158) (48) (103) (22) (63) (15) (3,232) (3,290) (3,556) (3,375)





■Costs held flat and expected to remain so for current period

■Costs include Group costs and standard operation overheads

Central

Financial Overview

HIGHLIGHTS■Results in line with expectations and

significant progress across all operatingdivision

■Transition from development stage torevenue generation in wound caresuccessfully executed

■Both orthopaedic products in clinicaltrials

■Joint Venture and licencing deal withtissue bank in Germany for cardiactechnology

GUIDANCE (next 12 months)■DermaPure® will be the key revenue

generator, $2.5m - $4.5m

■Cost base increases, as the businesscontinues to progress as planned, for:

- Wound care sales & marketing tosupport DermaPure revenue growth

-Orthopaedic development as porcineproducts move through clinical trialsto CE marking

■Note next reporting period only 11months to Dec16



Corporate Highlights

Antony Odell - CEO

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Commercial Progress

•$1m revenue mark achieved with DermaPure®

•FDA approval for SurgiPure™

•GBM-V gGmbH joint venture

•20 patients recruited into OrthoPure™ XM (porcine meniscus) EU regulatory clinical trial

•OrthoPure™ XT (porcine tendon) EU regulatory clinical trial started

•Relocation to Leeds facility

Corporate Highlights

10

Development Progress

Operational Progress



•$1.2m revenue FY’16

•74% coverage of Medicare beneficiaries

•Progress on private/managed Medicare

•Acute (hospital) sales

•Ortho, Trauma, Maxillo-facial

•Chronic (wound center) sales

•DFU, VLU, Pressure ulcers

•Strong clinical support for product

•12 KOL’s → 14 clinical abstracts

11TISSU E REGENIX GROU P P L C




Product positioning highlights differentiated mechanism of action

•Important as first time FDA has reviewed full dCELL® process

•Launch H2 2016

•Seeking to appoint a national distributor

•Focus on complex hernias

•Key competitor: Acelity [Straticce™]



510K FDA Market Approval

GBM-V gGmbH Joint Venture

•Enables deployment of dCELL®human tissue technology in EU

• Initial licences for CardioPure™ HAV & HPV (HumanAortic/Pulmonary Valves) & DermaPure®

•Annual technology access fee per application €100k

•Processing fee per tissue (valve/cm2 etc.)

• Initial revenues from cryo-tissues (cornea, heart valves)

•Regulatory approvals H216

•Regulatory submissions for dCELL® in progress

•Regulatory approvals mid 2017

•Donor base expanding to plan

14TISSUE REGENIX GROUP P L C


•20 patients recruited into (XenograftMeniscus) EU regulatory clinical trial

•Data collection & review in progress

• (Xenograft Tendon) EU regulatory clinical trial started

•60% recruited

Development Progress -Regulatory Pathways



•Previously FDA approved facility

•Annual costs lower than York Biocentre

•Manufacturing lines in development for SurgiPure™XD & OrthoPure™ porcine products

•Human tissue processed by partners (US, Germany)

•Manufacturing efficiency focus on COG/streamlining processes

Operational Progress



Relocation to Leeds facil ity

•DermaPure® commercial traction on remaining MACS (2) & commercial payors

•DermaPure® (thicker Dermis) launch for tissue replacement, dental & other applications

•Regulatory updates on OrthoPure™ products (XM & XT)

•Launch of SurgiPure™ XD for complex hernias in US

•GBM-V regulatory approvals for cryo-tissues

•Progress update on dCELL® submissions to PEI

•US orthopaedic updates (human & xeno)

Looking Forward 12 months

17





Decellularized Human Heart Valves and Pericardial Patches

Outcomes at 10 Years and Future Perspectives

Francisco Diniz Affonso da CostaHead Cardiovascular Surgery –PUCPR - Brazil

Conventional Heart Valve Substitutes & frequent complications

Mechanical Valves

Biological Valves

Human Valves Allografts

• Physiologic hemodynamic performance

• Almost null incidence of thromboembolism

• Does not require anticoagulation

• Very resistant to infection

• Associated with better patient survival

• Better durability compared to conventional bioprosthesis

• Limited supply

• Implantation techniques more complex

Why to use a Homograft

1. Correction of Complex Congenital Defects2. RVOT Reconstruction During the Ross Operation3. AVR for Bacterial Endocarditis4. AVR in patients with Small Ao Roots5. AVR in Younger Patients with contraindications for anticoagulation6. AVR in Pregnant Women

Heart Valve AllograftsMain Indications

Decellularized Heart Valve Allografts

SDS Decellularization Technique

Fresh Allografts, no cryopreservation

Storage at 4º C for up to 3 months

Decellularized Heart ValvesBrazilian Experience (2005 – 2015)

Number of implants = 1502 cases

40

60

60

19

41631

22

871

37

Cryopreserved Pulmonary Valve AllograftsMechanisms of Allograft Stenosis

Early (2 years) Late (> 5 years)

CalcificationDegeneration

Proximal AnastomosisConduit RetractionDistal Anastomosis

Fresh dCELL® x Cryopreserved Allografts

This study - n = 374 (includes all consecutivepatients operated at the author’s officialinstitution who received either acryopreserved or a fresh dCell allograft forRVOT reconstruction)

• Francisco D. Costa1, Eduardo Balbi, Filho2, Rafael Torres2, Daniele Colatusso1, Claudinei Colatusso1, Allysson Calixto2, Marise Costa1.1Santa Casa de Curitiba PUCPR, Curitiba, Brazil, 2Instituto de Neurologia e Cardiologia de Curitiba, Curitiba, Brazil.

Fresh Decellularized Pulmonary Valve Allografts For RVOT Reconstruction During The Ross Operation – Clinical Outcomes at

10Years

Decellularized Allografts for Pediatric Patients under 12 Years of Age with Complex Congenital Heart Disease

• On going study (n.100 patients)

• Multi-Institutional (Curitiba, São Paulo and Recife)

• Preliminary Results have shown excellent

hemodynamics, no calcification and no

reoperations up to 9 years in the Curitiba

group

28

Patients: n=103Mean Age: 46± 17 (min=0,1 – max=81)Mean FU: 4.2 years (0,1 – 10), 92% complete

High risk patients 26 Concomitant Mitral Valve Disease (Multiple Reop)18 Ascending Aorta / Hemiarch Aneurysm23 Bacterial Endocarditis6 Coronary Artery Disease

dCELL® Aortic Allografts

10 Years Clinical Data 2005-2015presented by Prof. Francisco da Costa at AATS Cardiovascular Valve Symposium November, 2015

Decellularized Ao Valve AllograftsLate Gradients

0

10

20

30

40

50

60

70

80

90

100

0 12 24 36 48 60 72 84 96

Max

Gra

die

nt

(mm

Hg

Time (months)

Gradient stable over time, up to 10 years.

Explanted Aortic Allograft8 years of Follow-up

Aortic Wall

• Well preserved aortic wall• Elastic fibers intact• “ in vivo”repopulation• Endothelization• Minimal Intimal Hyperplasia

CT Scan Evaluation – Calcium Scores

Absent or Minimal Calcification on cusps and conduits up to 10 years of follow-up

Decellularized Ao Valve Allografts

Conclusions

• Minimal inflammation and negligible immune reaction.

• They do not retract in the pulmonary circulation and do not dilate in the systemicside.

• Occasional biopsies have demonstrated partial repopulation of these grafts andminimal or absent calcification, even in children under the age of 12 years.

Decellularized Allografts have shown very promising results up to 10 years of follow-up

This data demonstrate that decellularized allograftshave, at least up to 10 years, better performance thanconventional cryopreserved allografts and they arecurrently our graft of choice for patients at any age.

The future

Decellularized Pulmonary Allograft with Decellularized

Human Pericardium Extension

Applied to XenograftsAnticalcification Method

Applied to XenograftsBovine Pericardium for Hernia

Repair



Documents

Annual Results Presentation 23rd May 2016 Ian Jefferson - CFO€¦ · Annual Results Presentation 23rd May 2016 Ian Jefferson - CFO 1. 2 Income statement £’000 31 Jan 2016 31 Jan