Intercytex Group plc

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1 Intercytex Group plc 0

2 Disclaimer This information contained in this document 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. The distribution of this document may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe any, such restrictions. Any failure to comply with these restrictions may constitute a violation of laws of any such overseas jurisdiction. In the United Kingdom this document is being supplied only to persons with professional experience in matters relating to investments and/or to high net worth companies, as described in articles 19(5) and 49(2) of the Financial Services and Markets Act 2000 (Financial Promotions) Order This document should not be distributed in or into the United States, Canada, Japan, South Africa or Australia or to any residents, citizens or nationals of any such jurisdictions or to any corporation, partnership or other entity created or organised under the laws thereof, where such distribution may lead to breach of any law or regulatory requirement. This document and the information contained in it does not constitute or form any part of an offer of, or invitation to apply for, securities. No representation or warranty, express or implied, is given as to the accuracy of the information or opinions contained in this document and in the presentation made to you verbally and no liability is accepted by Intercytex Group plc ( the Company ) or any of its directors, members, officers, employees, agents or advisers for any such information or opinions. Notwithstanding this, nothing in this paragraph shall exclude liability for any representation or warranty made fraudulently. The information contained in this document includes forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of the Company and its subsidiaries (the Group ) and certain of the plans and objectives of management of the Group with respect thereto. These statements may generally, but not always, be identified by the use of words such as "should", "expects", "estimates", "believes" or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect the Group's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause the Group's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements. 1

3 Cell therapy products to restore and regenerate skin and hair ICX-PRO Healing chronic wounds VAVELTA Facial rejuvenation ICX-SKN Skin graft replacement Skin ICX-TRC Hair regeneration 2

4 Product pipeline Pre-Clinical Phase I Phase II Phase III Registration Launch ICX-PRO Venous Leg Ulcers ICX-PRO Diabetic Foot Ulcers VAVELTA Facial Rejuvenation H2 07 ICX-SKN Graft Replacement ICX-TRC Hair loss 3

5 Skin and hair represent huge commercial opportunities US MARKET ONLY Indication Potential Patient population Market Size Estimated peak product sales ICX-PRO Healing chronic wounds 1.2m $800m $ m VAVELTA Facial rejuvenation 15.3m $4,000m $ m ICX-SKN Skin graft replacement - - ~$200m ICX-TRC Hair regeneration 40m $1,500m >$1,000m 4

6 ICX-PRO Healing chronic wounds Human fibroblasts in a human fibrin matrix Young, active fibroblasts promote healing New standard in ease-of-use First indication venous leg ulcers, followed by diabetic foot ulcers $800m market in the US alone 5

7 ICX-PRO Clinical status Phase II trial (n=90) open label - complete Good safety and efficacy data at 24 weeks 80% of patients with hard-to-heal ulcers showed clinical benefit 41% of patients with wounds <20cm 2 had complete closure Phase III trial (n=396) double blind, controlled - ongoing Pivotal trial Multicentre US, Canada and the UK Three arms Control, Vehicle (Fibrin) and ICX-PRO Interim data positive Final data available mid

8 ICX-PRO - Commercial proposition Indication: Hard to heal chronic wounds (VLUs and DFUs) Advantages over competing products: Actively stimulates healing Available from inventory Easier to use than current treatments Stored in a fridge, 21 day shelf-life ICX to complete regulatory process and manufacture In discussions with potential distribution partners 7

9 VAVELTA - Facial rejuvenation Allogeneic (donor) human fibroblasts Repopulates skin with young, active cells Stimulates soft tissue augmentation generating collagen and hyaluronic acid Superficial injection into the upper dermis Notanother filler $1billion market; 25% growth in

10 VAVELTA - Clinical status Phase I trial (n=10) Trial completed in July 2006, no safety issues identified Two Phase II trials commencing in H1 07 Nasolabial folds London ongoing Acne scars Birmingham planned to start Q Data available Q Not regulated as a medicine or a device in the UK and some other EU countries 9

11 VAVELTA TM Market positioning First commercial sale in the UK planned for Q Top of the non-surgical segment Will be sold by ICX to accredited doctors only Extensive market research carried out, launch customer base identified Strong evidence that cell therapy works when delivered correctly A course of two treatments 6 weeks apart Cost to patient for a course ~ 3,000 ~$35m market opportunity in UK 10

12 ICX-SKN Skin graft replacement Fibroblasts used to manufacture human collagen in a skin-like structure Tertiary structure and cross-linking of collagen are critical Living product human collagen matrix containing living human fibroblasts 11

13 ICX-SKN Clinical status Phase I trial - complete Replacement of excision biopsy of the arm with ICX-SKN Safety and persistence at one month Preliminary results very encouraging Full results available Q Phase II trial design Skin replacement following surgical intervention Basal Cell Carcinoma (BCC) excision site likely first indication 12

14 ICX-TRC Hair regeneration Biopsy Critical proprietary step Reimplantation DP cells Cell culture Growth Dermal papilla (DP) cells at the base of the follicle have hair inductive properties ICX proprietary method multiplies a small sample, maintaining inductive properties When re-implanted cultured DP cells promote new hair growth Substantial market opportunity (>$1billion) 13

15 ICX-TRC Clinical status Phase I trial - complete No safety issues 71% had increased hair numbers after treatment, a medical first Phase II trials (n = ~10 per cohort) - ongoing Efficacy trials designed to look for new hair growth Rolling programme to optimise formulation/delivery First cohort enrolled Preliminary data available H m Grant from DTI to assist with automation/commercialisation of process 14

16 Financial summary Year ended 31 December ( 000s) Operating Loss (9,692) (7,195) Cash flow before financing (8,283) (5,668) Net Assets 11,404 5,505 Cash 10,987* 5,686 * 12m financing completed in May

17 Potential value drivers over next 18 months H H H ICX-PRO Phase II DFU patient recruitment complete Phase III VLU patient recruitment complete Data from Phase II DFU Data from Phase III VLU (mid 2008) ICX-SKN Proof of principle data from Phase I Phase II commences Phase II data Vavelta Second Phase II trial commences Preliminary Phase II data Commercial launch in the UK Additional Phase II data ICX-TRC Preliminary Phase II data Additional Phase II data 16

18 Summary Cell therapy has been shown to be safe and effective Clinical efficacy data on all four products during 2007 Tissue repair market largely untapped Aesthetic medicine and other patient pays markets are expanding rapidly Proven technology in large, rapidly expanding markets 17

19 Intercytex Group plc 18