Annual Results Presentation 23 rd May 2016 Ian Jefferson - CFO

Transcription

1 Annual Results Presentation 23 rd May 2016 Ian Jefferson - CFO 1

2 Financial Overview Selected Highlights Income statement Jan Jan 2015 Revenue Cost of sales (154) (32) Gross Margin Overheads (10,904) (8,437) Operating Profit (10,242) (8,369) Finance income Loss before taxation (10,029) (8,201) Taxation Loss after tax (9,502) (7,581) Attributable to: Equity holders of parent (9,410) (7,581) Non-controlling interests (92) - Balance sheet Jan Jan 2015 Property, plant & equipment Inventory 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 from DermaPure in first full year of sales since launch High margins at 81% (2015: 68%) Overheads increase driven by cost of US sales & marketing organisation and clinical trial costs for orthopaedic products The Group continues to benefit from R&D tax credits Loss after tax of 9.5m in line with expectations Healthy cash balance of 19.9m. TISSUE REGENIX GROUP P L C 2

3 Financial Overview Segmental Overview SEGMENTAL 000 WOUND CARE ORTHOPAEDICS CARDIAC CENTRAL TOTAL Total segment Inter-segment (76) (76) - - (152) - Revenue Cost of sales (154) (32) (154) (32) Gross Margin 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) TISSUE REGENIX GROUP P L C 3

4 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 Wound Care SEGMENTAL 000 WOUND CARE ORTHOPAEDICS CARDIAC CENTRAL TOTAL Total segment Inter-segment (76) (76) - - (152) - Revenue Cost of sales (154) (32) (154) (32) Gross Margin 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) Revenue derived from DermaPure sales ($1.2m) in the US. Gross margins 81% c.f. 56% (underlying 86% c.f. 82%). 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%) of revenue TISSUE REGENIX GROUP P L C 4

5 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 Orthopaedics SEGMENTAL 000 WOUND CARE ORTHOPAEDICS CARDIAC CENTRAL TOTAL Total segment Inter-segment (76) (76) - - (152) - Revenue Cost of sales (154) (32) (154) (32) Gross Margin 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) Clinical trial started on both OrthoPure XM and OrthoPure XT Expenditure expected to increase again in current period as patient numbers grow TISSUE REGENIX GROUP P L C 5

6 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 Cardiac SEGMENTAL 000 WOUND CARE ORTHOPAEDICS CARDIAC CENTRAL TOTAL Total segment Inter-segment (76) (76) - - (152) - Revenue Cost of sales (154) (32) (154) (32) Gross Margin 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) Joint Venture set up with tissue bank in Germany First licence for heart valve technology TISSUE REGENIX GROUP P L C 6

7 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 Central SEGMENTAL 000 WOUND CARE ORTHOPAEDICS CARDIAC CENTRAL TOTAL Total segment Inter-segment (76) (76) - - (152) - Revenue Cost of sales (154) (32) (154) (32) Gross Margin 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) Costs held flat and expected to remain so for current period Costs include Group costs and standard operation overheads TISSUE REGENIX GROUP P L C 7

8 Financial Overview HIGHLIGHTS Results in line with expectations and significant progress across all operating division Transition from development stage to revenue generation in wound care successfully executed Both orthopaedic products in clinical trials Joint Venture and licencing deal with tissue bank in Germany for cardiac technology GUIDANCE (next 12 months) DermaPure will be the key revenue generator, $2.5m - $4.5m Cost base increases, as the business continues to progress as planned, for: - Wound care sales & marketing to support DermaPure revenue growth -Orthopaedic development as porcine products move through clinical trials to CE marking Note next reporting period only 11 months to Dec16 TISSUE REGENIX GROUP P L C

9 Corporate Highlights Antony Odell - CEO 9

10 Corporate Highlights Commercial Progress $1m revenue mark achieved with DermaPure FDA approval for SurgiPure GBM-V ggmbh joint venture Development Progress 20 patients recruited into OrthoPure XM (porcine meniscus) EU regulatory clinical trial OrthoPure XT (porcine tendon) EU regulatory clinical trial started Operational Progress Relocation to Leeds facility TISSUE REGENIX GROUP P L C 10

11 $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 TISSUE REGENIX GROUP P L C 11

12 Product positioning highlights differentiated mechanism of action TISSUE REGENIX GROUP P L C 12

13 510K FDA Market Approval Important as first time FDA has reviewed full dcell process Launch H Seeking to appoint a national distributor Focus on complex hernias Key competitor: Acelity [Straticce ] TISSUE REGENIX GROUP P L C 13

14 GBM-V ggmbh Joint Venture Enables deployment of dcell human tissue technology in EU Initial licences for CardioPure HAV & HPV (Human Aortic/Pulmonary Valves) & DermaPure Annual technology access fee per application 100k Processing fee per tissue (valve/cm 2 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 TISSUE REGENIX GROUP P L C 14

15 Development Progress -Regulatory Pathways 20 patients recruited into (Xenograft Meniscus) EU regulatory clinical trial Data collection & review in progress (Xenograft Tendon) EU regulatory clinical trial started 60% recruited TISSUE REGENIX GROUP P L C 15

16 Operational Progress Relocation to Leeds facility 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 TISSUE REGENIX GROUP P L C 16

17 Looking Forward 12 months 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 17 Progress update on dcell submissions to PEI US orthopaedic updates (human & xeno) TISSUE REGENIX GROUP P L C

18 TISSUE REGENIX GROUP P L C 18

19 Decellularized Human Heart Valves and Pericardial Patches Outcomes at 10 Years and Future Perspectives Francisco Diniz Affonso da Costa Head Cardiovascular Surgery PUCPR - Brazil

20 Conventional Heart Valve Substitutes & frequent complications Mechanical Valves Biological Valves Human Valves Allografts

21 Why to use a Homograft 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

22 Heart Valve Allografts Main Indications 1. Correction of Complex Congenital Defects 2. RVOT Reconstruction During the Ross Operation 3. AVR for Bacterial Endocarditis 4. AVR in patients with Small Ao Roots 5. AVR in Younger Patients with contraindications for anticoagulation 6. AVR in Pregnant Women

23 Decellularized Heart Valve Allografts SDS Decellularization Technique Fresh Allografts, no cryopreservation Storage at 4º C for up to 3 months

24 Decellularized Heart Valves Brazilian Experience ( ) Number of implants = 1502 cases

25 Cryopreserved Pulmonary Valve Allografts Mechanisms of Allograft Stenosis Early (2 years) Late (> 5 years) Proximal Anastomosis Conduit Retraction Distal Anastomosis Calcification Degeneration

26 Fresh Decellularized Pulmonary Valve Allografts For RVOT Reconstruction During The Ross Operation Clinical Outcomes at 10Years Fresh dcell x Cryopreserved Allografts This study - n = 374 (includes all consecutive patients operated at the author s official institution who received either a cryopreserved or a fresh dcell allograft for RVOT reconstruction) Francisco D. Costa 1, Eduardo Balbi, Filho 2, Rafael Torres 2, Daniele Colatusso 1, Claudinei Colatusso 1, Allysson Calixto 2, Marise Costa 1. 1 Santa Casa de Curitiba PUCPR, Curitiba, Brazil, 2 Instituto de Neurologia e Cardiologia de Curitiba, Curitiba, Brazil.

27 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 dcell Aortic Allografts 10 Years Clinical Data presented by Prof. Francisco da Costa at AATS Cardiovascular Valve Symposium November, 2015 Patients: n=103 Mean Age: Mean FU: 46± 17 (min=0,1 max=81) 4.2 years (0,1 10), 92% complete High risk patients 26 Concomitant Mitral Valve Disease (Multiple Reop) 18 Ascending Aorta / Hemiarch Aneurysm 23 Bacterial Endocarditis 6 Coronary Artery Disease 28

29 Max Gradient (mmhg Decellularized Ao Valve Allografts Late Gradients Gradient stable over time, up to 10 years Time (months)

30 Explanted Aortic Allograft 8 years of Follow-up CT Scan Evaluation Calcium Scores Aortic Wall Well preserved aortic wall Elastic fibers intact in vivo repopulation Endothelization Minimal Intimal Hyperplasia Decellularized Ao Valve Allografts Absent or Minimal Calcification on cusps and conduits up to 10 years of follow-up

31 Conclusions Decellularized Allografts have shown very promising results up to 10 years of follow-up Minimal inflammation and negligible immune reaction. They do not retract in the pulmonary circulation and do not dilate in the systemic side. Occasional biopsies have demonstrated partial repopulation of these grafts and minimal or absent calcification, even in children under the age of 12 years. This data demonstrate that decellularized allografts have, at least up to 10 years, better performance than conventional cryopreserved allografts and they are currently our graft of choice for patients at any age.

32 The future Decellularized Pulmonary Allograft with Decellularized Human Pericardium Extension Applied to Xenografts Anticalcification Method Applied to Xenografts Bovine Pericardium for Hernia Repair

33 TISSUE REGENIX GROUP P L C 33