Interim Results 19 September 2005

Transcription

1 Interim Results 19 September Presentation by Dr Richard Palmer, Chief Executive Officer Tim McCarthy, Finance Director

2 Important This presentation has been organised by Alizyme plc (the Company ) in order to provide general information on the Company. This material has been prepared solely by the Company and is (i) for your private information, and the Company is not soliciting any action based upon it; (ii) not to be construed as an offer to sell or a solicitation of an offer to buy any security and (iii) based upon information that the Company considers reliable. The Company does not represent that the information contained in this material is accurate or complete, and it should not be relied upon as such. No representation, warranty or undertaking, express or implied, is or will be made with respect to the fairness, accuracy or completeness of any of the information or statement of opinion or expectation contained herein or stated in the presentation or any other such information nor shall you be entitled to rely upon it. In furnishing you with this information no obligation is undertaken to provide you with any further information, to update this information nor any other information nor to correct any information contained herein or any omission therefrom. This document is a summary of certain information contained in the Company's announcement of its interim results for the six months ended 30 June 2005 and should be read in conjunction with the full text of that announcement. The Company s securities have not been registered under the U.S. Securities Act of 1933 (as amended), and may not be offered or sold in the United States or to U.S. persons unless they have been registered under such Act, or except in compliance with an exemption from the registration requirements of such Act. No part of this material may be (i) copied, photocopied, or duplicated in any form, by any means, or (ii) redistributed, published, or disclosed by recipients to any other person, in each case without the Company s prior written consent. This material is only being provided to persons who are authorised persons or exempted persons within the meaning of the Financial Services and Markets Act 2000 or any order made thereunder or to other persons of a kind described in Articles 19 and 49 of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 or who are otherwise permitted by law to receive it. In relation to information about the price at which securities in the Company have been bought or sold in the past, note that past performance cannot be relied upon as a guide to future performance. In addition, the occurrence of some of the events described in this document and the presentation that will be made, and the achievement of the intended results, are subject to the future occurrence of many events, some or all of which are not predictable or within the Company's control; therefore, actual results may differ materially from those anticipated in any forward looking statements. The Company disclaims any obligation to update these forward looking statements. The financial information does not constitute statutory financial statements within the meaning of section 240 of the Companies Act The interim financial information has been prepared in accordance with the IFRS accounting policies that are expected to apply in The results for the six-months ended 30 June 2004 and the year ended 31 December 2004, and the balance sheets at those dates, have been restated in accordance with the accounting principles applied by the Company as set out in the interim financial statement. 2

3 2005 Interim Highlights Renzapride Agreement with FDA through SPA for Phase III clinical development in US Successful Thorough Cardiovascular Safety clinical trial Cetilistat Completed recruitment in Phase IIb clinical trial of 612 obese diabetics Completed recruitment in US clinical trial of 80 obese subjects COLAL-PRED Approval for Phase III clinical trial in active ulcerative colitis in EU Assignment of patent and intellectual property rights from BTG ATL-104 Completion of Stage 1 of Phase IIa clinical trial in up to 60 cancer patients Loss after tax 10.1 million (2004: 1.1 million) (IFRS Adoption) Cash and short term investments at 30 June 2005 of 40m (2004: 20.6m) 3

4 Overview Therapeutic product development company (LSE:AZM) Late stage clinical portfolio - 4 products in Phase II/III All Alizyme proprietary products Therapeutic area focus - gastrointestinal, obesity, diabetes Outsourcing business model (17 permanent staff) Equity financed 104 million (invested 64 million to 30 June 2005) Both cetilistat and renzapride have the opportunity to be significant products with global potential 4

5 Strategy Market focused innovative products Robust development plans & data packages for global markets Commercialise through partnering Our value is based on creating products with global commercial potential through robust, industry-standard standard clinical studies 5

6 Late Stage Development Portfolio Development stages renzapride - c-ibs renzapride m-ibs cetilistat Obesity cetilistat Obese Diabetics COLAL-PRED - Active UC COLAL-PRED - Remission UC ATL-104- Mucositis PHASE IIa PHASE IIb PHASE III FILE/LAUNCH * Completed 2005 activity Next stage 6

7 Renzapride Developing an effective treatment for both constipation predominant IBS (c-ibs) and mixed-symptom IBS (m-ibs) RENZAPRIDE Irritable Bowel Syndrome Agreement with FDA for Phase III c-ibs registration trial in USA Successful completion of Thorough Cardiovascular Safety clinical trial 7

8 Renzapride : 5-HT 4 full agonist / 5-HT 3 antagonist for IBS m-ibs ca. 40% (No product) Renzapride: Efficacy in both c-ibs & m-ibs c-ibs ca. 35% (Zelnorm ) d-ibs ca. 25% (Lotronex ) Zelnorm annual sales $299m (2004) 8

9 Potentially superior efficacy to Zelnorm Superior efficacy in c-ibs 30 Renzapride Zelnorm Relief of c-ibs symptoms over placebo (%) % Placebo response 6.5% Relief of Overall IBS Symptoms Relief of Abdominal Pain 9

10 Cetilistat Developing an effective treatment for obesity and associated conditions, with a competitive side-effect profile CETILISTAT Obesity/Type II Diabetes Completed recruitment in Phase IIb clinical trial of 612 obese diabetics Completed recruitment in US clinical trial of 80 obese subjects 10

11 Cetilistat : Lipase Inhibitor for Obesity/Type II Diabetes Efficacy similar for all agents 7 After 12 weeks Weight loss (kg) Cetilistat Placebo Active Xenical Placebo Active Acomplia Placebo Active 11

12 Cetilistat vs Xenical : Frequency of GI Adverse Events Superior side effect profile shown in Phase I and Phase II trials Frequency (%) Xenical Cetilistat 0 Flatus with discharge Oily spotting Faecal incontinence Frequency over 12 weeks treatment 12

13 COLAL-PRED Developing an effective anti-inflammatory steroid treatment for moderate ulcerative colitis (UC) without the typical side effects COLAL-PRED Ulcerative Colitis ( UC ) Approval for Phase III trial in active ulcerative colitis in EU Assignment of patent and intellectual property rights from BTG 13

14 Clinical Profile of COLAL-PRED and Prednisolone 80% COLAL-PRED Unique superior product profile 60% NC Prednisolone No change 40% 20% NC NC NC 0% Clinical responders Adrenal Suppression Body wt WBC Elimination of steroid side effects and weaning 14

15 ATL-104 An orally administered treatment for mucositis of the mouth and gastrointestinal tract, caused by cancer chemotherapy and radiotherapy ATL-104 Mucositis Phase IIa clinical trial in up to 60 cancer patients Stage 1 complete ; Stage 2 ongoing 15

16 ATL-104 : GI Epithelial Cell Growth Factor for Mucositis Unique product profile to treat mucositis locally Effective treatment of mucositis Safety profile suitable for cancer patients through oral administration (swallowable mouthwash) and local action 16

17 IFRS Adoption IFRS 1: Transition to IFRS First time adoption of IFRS in 2005 Transition process completed with Ernst & Young Process reviewed by Deloitte IAS 18: Revenue recognition No change to treatment under UK GAAP IAS 38: Research and development No capitalisation until commercial viability of product demonstrable IFRS 2: Accounting for share-based payment Using an appropriate option pricing model Charge of 210k for 2005 ( 117k for 2004) 17

18 Financial Results H H FY 2004 '000 '000 '000 (restated) (restated) Turnover - 1,647 1,647 Operating expenses: Research and development (9,081) (2,854) (6,271) Acquisition and expense of IPR (1,300) - - Management and administration (517) (498) (1,172) Share-based payment (210) (117) (313) Operating loss (11,108) (1,822) (6,109) Interest receivable Taxation (net) Loss for the period (10,146) (1,091) (4,615) Cash & Liquid Resources 40,036 20,623 16,586 Placing and Open Offer (May 2005) raised 32.8 million (gross) 18

19 Anticipated News Flow 2005/6 renzapride - commence Phase III clinical programme in US COLAL-PRED - commence Phase III treatment registration trial in EU cetilistat - results from PK/PD trial in obese subjects in US cetilistat - results from Phase IIb clinical trial in obese diabetics ATL results from Phase IIa clinical trial in cancer patients cetilistat - update from Takeda on clinical development in Japan cetilistat - commence Phase III clinical programme Alizyme.. creating valuable assets 19

20 Summary Late-stage pipeline of 4 products in Phase II/III Competitive product profiles Strong cash position funding through into 2008 Clinical data to finish cetilistat Phase II development Clinical data for decision on ATL-104 development 20