Immunity for Life TM. Third Quarter CEO Lars Viksmoen CFO Finn Samuelsen. 31 October 2007

Transcription

1 Immunity for Life TM Third Quarter 2007 CEO Lars Viksmoen CFO Finn Samuelsen 31 October 2007

2 Operational Highlights for Q Clinical phase III study with SBG for treatment of diabetic ulcers; enrolment on plan Treatment of 6 patients in extended phase I/II study at MSKCC completed Strategic review of consumer health business completed; reinforcement of marketing and sales activities going forward Sales revenues and operating expenses as planned 2

3 Financial Highlights for Q Sales revenues: NOK 20.2 million in Q3 07 versus NOK 17.0 million in Q3 06 Net operating expenses in line with expectations EBITDA negative with NOK 6.0 million in Q3 07 (12.1) Non-pharmaceuticals NOK +2.1 million (NOK -0.6) R&D NOK -5.2 million (NOK -5.9) Unallocated costs NOK -2.9 million (NOK -5.6) Net loss of NOK 3.7 million (8.4) (Figures in brackets refer to Q3 2006) 3

4 Clinical Development Highlights for Q SBG Status report per Q Diabetic ulcers First phase III study; 22 of 120 patients included CRO assessment for second phase III study Oral mucositis Preparing two phase III studies CRO assessment for both phase III studies Cancer Extended phase I/II study at MSKCC completed without reported safety issues Phase I/II study in breast cancer ongoing Phase I/II study in NHL initiated 4

5 Our pharmaceutical concept SBG stimulates the immune system SBG (Soluble Beta Glucan) a unique, highly bioactive, soluble beta-1,3/1,6-glucan from cell walls of yeast alien to the human body How it works: stimulates the innate immune system enhances the adaptive immune system addresses a wide range of diseases 5

6 The immune system SBG strengthens the joint forces of defense Infectious Agents (Pathogens) Bacteria Virus Paracites Fungus 1st line of defense Physical and biological barriers Skin, coughing, sneezing, vomiting, enzymes, etc 2nd line of defense Innate immune system Recognizes unfriendly intruders in a generic manner Reacts with inflammation White blood cells are the key players 3rd line of defense Adaptive immune system Improves response after initial attack (memory) Prepares the body for future attacks (antibodies) Tailored to act only on a specific intruder SBG stimulates both components of the immune system 6

7 Business segmentation 7

8 Addressing major unmet medical needs DIABETIC ULCERS ORAL MUCOSITIS IMMUNOTHERAPY OF CANCER Market opportunity: 3.5 million diabetics develop foot ulcers annually App ,000 incidents annually in the OECD Fastest growing segment of pharma industry Serious conditions: 100,000 amputations annually in the US Severe impact on curative cancer therapy The last resort of cancer therapy Therapies: No standard drug treatment has been established No standard drug treatment has been established mab + adjuvants: a new treatment paradigm? Documented effect: SBG reactivates immune cells in the skin and enhances the body s own wound healing capabilities SBG stimulates the immune system and enhances the body s own wound healing capabilities As an adjuvant to monoclonal antibodies, SBG renders the immune system more effective in killing cancer cells 8

9 Diabetic Ulcers Patients with complete healing (%) SBG Control Duration of therapy (weeks) 9

10 Diabetic Ulcers Clinical development First phase III study ongoing in UK Inclusion on plan, 22 of a total of 120 patients enrolled 5 more centres starting inclusion, securing on-time study completion Blinded interim analysis after completion of 80 patients Results ready by year-end 2008 Contracting CRO to run the second phase III study Target filing of marketing authorisation in Europe by YE 2009 Clinical phase Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase III, Nottingham, UK Phase III, second trial 10

11 Oral Mucositis Patients developing severe Oral Mucositis (%) 70 Placebo SBG Duration of therapy (days) n=14 11

12 Oral Mucositis Clinical development Initiating phase III study in North America in 2008 Detailed planning ongoing; aiming for patients Preparing for a similar sized study in Europe Contracting CRO to run both phase III studies Target filing of marketing authorisation in Europe by YE 2009 Obtained orphan drug status Initiated Investigational New Drug (IND) process with FDA Clinical phase Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase III, North-America Phase III, Europe 12

13 Immunotherapy of Cancer SBG as adjuvant to established monoclonal antibodies in cancer therapy Awaiting final results from clinical phase I/II neuroblastoma study in Q Received positive safety data and positive preliminary effect data in Q2 Dose escalation extension in 6 patients without reported safety issues Investigator request; 3 additional dose levels to identify MTD Slow patient recruitment in the two Norwegian studies SBG plus Herceptin in breast cancer patients (4/12) SBG plus Rituxan for non-hodgkins lymphoma (0/12) Measures taken to accelerate patient inclusion Clinical phase Ph. I/II, Sloan-Kettering Ph. I/II, Ullevaal Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Ph. I/II, Radiumhospitalet 13

14 The non-pharmaceutical business 14

15 Non-pharmaceuticals Consumer Health, Animal Health and Marine Biochemicals Consumer Health Q Strategic review completed; reinforcement of marketing and sales activities going forward Animal Health Q Higher sales to the aquaculture industry Higher sales to livestock industry Marine Biochemicals Q In talks with leading international diagnostic and life science companies regarding supply contracts for Cod UNG 15

16 Financial Figures Third Quarter and First Nine Months 2007

17 Summary of P&L Third Quarter 2007 versus Third Quarter 2006 Q (NOK 000) Group Non-pharma R&D Non-allocated Sales Net operating expenses EBITDA Depreciation EBIT Q (NOK 000) Group Non-pharma R&D Non-allocated Sales Net operating expenses EBITDA Depreciation EBIT

18 Summary of P&L First 9M 2007 versus First 9M 2006 R&D 9M 2007 (NOK 000) Group Nonpharma Nonallocated Sales Net operating expenses EBITDA Depreciation EBIT R&D 9M 2006 (NOK 000) Group Nonpharma Nonallocated Sales Net operating expenses EBITDA Depreciation EBIT

19 Revenues (non-pharmaceutical) By Quarter By Product Group NOK ( 000) NOK ( 000) Q3 06 Q Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Consumer Health Marine Biochemicals Animal Health Other 19

20 Summary of P&L Non-Pharmaceutical (NOK 000) Q Q M M Sales Cost of goods sold Gross profit Gross margin 79.6% 76.4% 77.0% 80.4% 79.9% Other OPEX (net) EBITDA EBITDA margin 10.4% -3.5% 9.2% 11.8% 10.5% Depreciation EBIT EBIT margin 8.0% -6.7% 6.2% 8.7% 7.3% 20

21 Quarterly Cost Development R&D and unallocated costs R&D Costs (incl. depreciation) in NOK Unallocated Costs in NOK Legal expenses in line with expectations No news in the patents dispute with Biothera during the first 9M Q106 Q206 Q306 Q406 Q107 Q207 Q307 0 Q106 Q206 Q306 Q406 Q107 Q207 Q307 21

22 Consolidated Balance Sheet Condensed figures (NOK 000) 30 Sept June Dec Sept 2006 Non-current assets Cash and cash equivalents Other current assets Total current assets Total Assets Equity Liabilities Total Equity and Liabilities Cash Flow (in reporting period) Equity Ratio 94% 93% 85% 91% 22

23 Outlook Q Final results from the phase I/II MSKCC study Initiation of 3 to 4 additional centres in the Nottingham phase III diabetic ulcers study; securing on time study completion Selection of CRO for the remaining phase III programs, followed by intensified study preparations in line with previously communicated timelines Supply contracts for Cod UNG with leading international diagnostic and life science companies Reinforced marketing and sales activities in the Consumer Health area 23

24 Summary SBG works Proven and documented to stimulate/modulate the immune system Addressing major unsolved medical needs; representing major market opportunities Should attract strong commercial partners Well advanced clinical program Close to market; in phase III on diabetic ulcers and oral mucositis Strong financial position Phase III studies for diabetic ulcers and oral mucositis fully funded 24