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1 CEO s Presentation ASX Announcement 12 th November 2012 ABN Announcement At the Annual General Meeting of Biomedical company, (ASX: TIS) held on 12 November 2012, the following CEO s presentation was delivered to the audience. Please see the PDF of the powerpoint presentation on the following pages. 1

2 Tissue Therapies Ltd AGM CEO Presentation 12 November 2012 Commercialising VitroGro ECM A Revolution in Wound Healing Dr Steven Mercer, CEO

3 AGM CEO Presentation! Introduction! VitroGro ECM! Clinical Effectiveness: Wound Healing Pain Reduction! Economic Effectiveness! Market Size! Sales Estimates! Commercial Partners! CE Mark! Revised EU Launch! Rest of World (ROW) Timelines! USA Clinical Trials, Approval and Launch Timelines! Summary 2

4 Introduction Tissue Therapies:! An Australian biomedical company developing advanced technologies for more cost effective wound healing, tissue repair, cell culture and other global applications! Worldwide exclusive rights to commercialise VitroGro technology: first product VitroGro ECM for difficult to heal wounds! Patents granted in the USA, Europe, China, Hong Kong, South Korea, Japan, South Africa, Australia and New Zealand (pending applications in Canada & India)! CE Mark (EU) approval expected 2013: immediate sales launch in UK, Germany, Switzerland, Austria, the Netherlands and Nordic countries! Approved EU claim is for treatment of difficult to heal wounds: broad on-label use! Partnerships with Quintiles (hiring & support services) and Movianto (logistics) that minimise operational risk, restrain cost and optimise revenue! Attractive margin product; more convenient, consistent and cost effective than existing wound care treatments! USA FDA trials scheduled to start

5 VitroGro ECM What is VitroGro ECM VitroGro ECM is a synthe2c, extra- cellular matrix (ECM) protein crea2ng a physical structure (a scaffold) that binds to the wound bed! Restores acachment sites in skin & guides cells during wound healing! Diabe2c (DFU), Venous (VLU) & Pressure Ulcers are primary markets! Addressing a significant un- met need in providing a convenient, cost effec2ve treatment improved healing, only 1 applica2on per week x 10 weeks Correc2on of wound 2ssue pathology by delivery of biologically appropriate matrix! Scale up manufacturing complete; VitroGro ECM in warehouses ready to ship 4

6 VitroGro ECM Additional indications / market segments VitroGro ECM can also be used to address:! Burns: Paediatric & Adult! Surgical Wound Applica2ons (especially at- risk pa2ents)! Specialist Units & Retail Specialist unit, general hospital, outpa2ent, GP, pharmacy, retail Poten2al retail applica2ons include dressings, creams, lo2ons, product range for burns, chronic wounds, acute sunburn etc. 5

7 VitroGro ECM: Principle of Operation VitroGro ECM replaces the degraded matrix of the hard-to-heal wound providing a physical structure (a scaffold), for cell attachment. This process is vital for subsequent cell functions that are critical for healing. 6

8 Clinical Effectiveness: Wound Healing EU clinical trial : Venous Leg Ulcer (VLU) study In human trials, VitroGro ECM has demonstrated consistent and convenient healing of venous, diabetic and pressure ulcers that had not responded to expert care Wound area reduction in 45 patients treated with VitroGro ECM over 12 weeks* % Number of patients % 11% 16% 20% 2 0 >90% - 100% >70% - 90% >50% - 70% >20% - 50% Not improved Wound area reduction (%) * Prior to treatment, patients had no response to 4 weeks of standard care! Results: Trial patients were relatively old (average age 72 years) and had suffered venous ulcers that had not responded to expert care for an average of 36 months Strong results: 34 % completely healed & 42% more than 90% healed within 12 weeks 7

9 Clinical Effectiveness: Pain Reduction Reduction of patients pain is important! Improved pain management outcomes during healing delivers pa2ent and health economic benefits. 100 Change in pain of patients grouped by baseline pain category % of patients % reduction to no pain % no change in pain % Increased pain severe pain (6 patients) moderate pain (7 patients) mild pain (15 patients) Pain category at baseline (VAS) scale Jensen M., Chen C., Brugger A. Interpretation of visual analog scale ratings and scores: a reanalysis of two clinical trials of postoperative pain. Pain. 2003: Sep 4 (7):

10 VitroGro ECM Economic Effectiveness Preliminary UK economic modelling:! VitroGro ECM cost reduction of 22% in the clinic setting and 32% in community care setting for a treatment period of 12 weeks.! Many ulcers do not heal promptly when managed using current standard of care treatment. Up to 50% of venous ulcers may be present for 7 to 9 months and between 8% and 34% may be present for more than 5 years For this reason it is appropriate to show the cost comparison between using VitroGro ECM and managing a nonhealing ulcer with standard of care for a duration of one year.! 51% saving for the cost of treatment for a non healing ulcer with a duration of 1 year 9

11 Global Market Global venous, diabetic and pressure ulcer market in % 22% 42% USA / Canada UK / Europe Rest of World Global market is growing rapidly:! In 2008, the market size was estimated at US$14 Bn & growing at ~15% per annum! Multiple publications now suggest true market size is US$30 40 Bn (refer publications, Appendix)! Growth driven by an aging population, increasing incidence of venous disease & diabetes as well as expanding affordability of health care, primarily in developing countries! Further potential in consumer, retail and acute wound care products 10

12 VitroGro ECM: Sales Estimates VitroGro ECM sophisticated sales modelling: diabetic, venous & pressure ulcers! Ini2al focus on UK, German speaking Europe, the Netherlands, Nordic, then ROW and FDA! Cost compe22ve, convenient, consistent healing versus exis2ng treatments Revenue projection (USD) per market size phased with start of sales million million Calendar Year million 209 million 358 million USA Europe Rest of World million million Revenue in USD (millions) 11

13 Commercialisation: Partnership Structure Tissue Therapies has in place partnerships that minimise operational risk, restrain cost and optimise revenue while maintaining flexibility and control! Quin&les Outsourced HR for dedicated VitroGro ECM Sales team; shared risk/reward: KPI based fee structure! Movianto Integrated Logis2cs, Mul2- lingual Customer Support, Order Entry, Supply, Accounts Receivable! Eurogentec Manufacture of VitroGro ECM Protein! Catalent Fill, finish & release! Queensland University of Technology (QUT) Research & Development; only royalty payable to QUT 12

14 VitroGro ECM: CE Mark! Notification of CE Mark approval received July 2012: now expected 2013! New MHRA requirement for European Medicines Agency (EMA) review of manufacturing and quality data: statutory maximum 210 calendar days! Delay in EU sales, but compensating factors from EMA review: EMA review completes all possible regulatory requirements Result will be definitive regulatory approval for sale signed off by all EU member countries Stronger, more comprehensive VitroGro ECM regulatory package for approval for sale in Turkey, Middle East, Latin America, Russia, Taiwan, Canada and Australia! EMA review period will be used to: Prepare for earlier sales launches in: Nordic countries, Middle East, Turkey, Latin America & Russia: bring revenue forward Finalise and lodge FDA applications for venous and diabetic ulcer trials! EMA submission is Common Technical Document; well understood format and submission substantially complete! EU sales will start within 1 business day of CE Mark being granted 13

15 VitroGro ECM: Revised EU Launch 2013 United Kingdom, Benelux, Austria Germany, Switzerland, Northern Italy, Sweden* Denmark* Finland*, Norway* * Brought Forward 2014 Hungary*, Czech Republic*, Poland*, (plus Russia*, Turkey*, UAE*, Saudi Arabia*, Bahrain*) * Brought Forward 2015 France (clinical data from FDA trial for reimbursement) 14

16 VitroGro ECM: Germany, Austria, Switzerland German % Share of Global VLU and DFU market Sales strategy! launch immediately amer CE Mark ! Immediate sales to 10 most influen2al clinics: pyramid rollout USA UK France Germany Nordic Japan China India Brazil Canada Rest of World Market preparation! 12 months work with most influen2al KOL s! Health economics project with German data! Publica2ons planned based on clinical results and health economics! German, Austrian, Swiss wound care expenditure x 2.5 UK: 3 Bn in 2009! 800 specialist wound care private clinic network! Private Insurance: 10% popula2on: KOL led assessment of 50 pa2ents. Guideline doc for private insurance applica2on: approval target 2014! Public reimbursement: 90% popula2on: Accelerated 137e Review, target approval 2014: VitroGro ECM purchased for approx. 550 pa2ents. Earlier approvals of smaller 40 pubic reimbursement agencies during 137e Review 15

17 VitroGro ECM: United Kingdom UK % Share of Global VLU and DFU Market Sales strategy USA UK France Germany Nordic Japan China India Brazil Canada! UK launch immediately amer CE Mark Rest of World! Sampling program to key 72 specialist wound clinics! Applica2on for Drug Tariff inclusion (pharmacy access)! Immediate sales to PCT wound clinics: formulary discre2on Market preparation! NHS expenditure on wound care > 1 Bn in 2009*! 12 months work with most influen2al key opinion leaders (KOL s)! Health economics analysis: data ready now! Prepara2on for journal adver2sing! Publica2ons wricen with UK experts! 72 PCT Wound Care Clinics generate > 80% of wound care expenditure * Madden, M. Alienating evidence based medicine vs. innovative medical device marketing: A report on the evidence debate at a Wounds conference. In press Social Science & Medicine xxx (2012) 1e7 16

18 VitroGro ECM: Rest of World ROW* Sales Timeline 2013! Finalise & lodge planned applications for sale in ROW countries! Finalise sales & distribution channels 2014! Sales: CE Mark Recognition: Russia, Turkey, Middle East, Latin America, Australia, South Africa! Sales: Independent Approval Process: China, Hong Kong, South Korea, Taiwan, Japan, SE Asia, India (* ROW = all countries outside EU & North America) 17

19 VitroGro ECM: USA 1 USA % Share of Global VLU and DFU Market Sales strategy 10 Market preparation! Largest single global market: US$15.3Bn in 2010*! 18 months work with KOL s, Chief Clinical Inves2gator & Clinical Research Org.! Venous & diabe2c ulcer trial protocols complete! All clinical trial sites iden2fied including reserve sites! Almost en2re market is reimbursement based 100% popula2on coverage! FDA Biologics classifica2on; prac2cal benefits in clinical trials & reimbursement! Complete VLU trial 2014 & DFU 2015: 15 months for approval & reimbursement: Sales 2016! Single reimbursement nego2a2on with Centers for Medicare & Medicaid Services (CMS): avoids device reimbursement nego2a2ons with all private insurance payers! Extended health economics based on US data: agreement with hospital network! Decision on North American fill / finish / release, logis2cs, sales, customer service! Sampling program USA UK France Germany Nordic Japan China India Brazil Canada Rest of World * Sen KS, Gordillo GM, Sashwa2 R, Kirsner R, Lambert L, Hunt TK, GoCrup F, Gurtner GC, Longaker MT. Human Skin Wounds: A Major and Snowballing Threat. Wound Repair Regen ; 17(6):

20 Tissue Therapies Summary! Global exclusive rights to commercialise VitroGro ECM: multiple large and fast growing markets unmet need! European CE Mark approval expected 2013 allowing transition into commercialisation phase; sales in EU and ROW countries brought forward from original launch plan! USA FDA trials commencing in 2013 with North American sales to follow Revenue projection (USD) per market size phased with start of sales million million Calendar Year million 209 million 358 million USA Europe Rest of World million million Revenue in USD (millions) 19

21 Disclaimer! This document has been prepared by Tissue Therapies Ltd (the Company) to provide existing and prospective investors in Tissue Therapies Ltd with an update on the Company and its operations! The information contained in the presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares in any jurisdiction.! No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the course of this presentation. The information contained in this presentation is subject to change without notification.! This presentation contains forward-looking statements which can be identified by the use of words such as may, should, will, expect, anticipate, believe, estimate, intend, scheduled or continue or similar expressions. Any forward-looking statements contained in this presentation are subject to significant risks, uncertainties, assumptions, contingencies and other factors (many of which are outside the control of, and unknown to, Tissue Therapies Ltd ( TIS ) and its officers, employees, agents or associates), which may cause the actual results or performance to be materially different from any future result so performed, expressed or implied by such forward-looking statements.! There can be no assurance or guarantee that actual outcomes will not differ materially from these statements.! The photographs of clinical subjects used in this presentation are illustrative of medical conditions associated with potential applications of VitroGro. Actual clinical results may vary from those shown. 20

22 VitroGro ECM: Product Ready 21

23 CEO s Presentation ASX Announcement 12 th November 2012 ABN What is VitroGro ECM VitroGro ECM is a topically applied, biomimetic scaffold, comprising a synthetic extracellular matrix (ECM) protein. How it works: VitroGro ECM replaces the degraded matrix of a hard to heal wound. VitroGro ECM binds to a prepared wound bed and provides a physical structure (a scaffold) for cell attachment, which is a primary requirement for subsequent cell functions critical for healing, such as cell proliferation and migration [1]. An optimal scaffold: One of the characteristics of hard to heal wounds is prolonged inflammation, which damages the native ECM that would normally guide the wound healing process [1,2,3,4]. Replacement of this damaged ECM is a beneficial strategy for treating hard to heal wounds [1]. VitroGro ECM is ideal as an ECM replacement since its structural and functional elements mimic those present in the ECM at the early stages of normal wound healing. Expert health economics modelling indicates that VitroGro ECM offers the opportunity for substantially more cost effective treatment of wounds compared to the current standard of care. [1] Widgerow AD. Deconstructing the stalled wound. Wounds 2012 [2] Schultz GS. Extracellular Matrix: review of its roles in acute and chronic wounds. World Wide Wounds [3] Moor AN. et al. Proteolytic activity in wound fluids and tissues derived from chronic venous leg ulcers. Wound Rep Reg [4] International consensus, Acellular matrices for treatment of wounds. Wounds Int About is a biomedical technology company that is developing significantly more effective treatments for acute and chronic wound healing applications, including chronic skin ulcers and burns. is commercialising VitroGro ECM, a technology created by cell biology, tissue engineering and protein engineering experts at the Institute of Health and Biomedical Innovation at the Queensland University of Technology. The company is also developing treatments for psoriasis, scar prevention and various cancers including those of the breast, colon and prostate. Tissue Therapies Limited s shares are traded on the Australian, Berlin and Frankfurt stock exchanges. More information: 2 ABN Level 19, 179 Turbot Street, Brisbane, QLD 4000 Australia