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ArcticZymes Technologies Investor Presentation 2010

Jan 21, 2010

3538_rns_2010-01-21_23b41fbc-62c1-4f08-afbf-c1e71ae4abc5.pdf

Investor Presentation

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BIOTEC PHARMACON

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BIOTEC PHARMACON

Immunity for Life™

Ekstraordinær Generalforsamling

Tromsø 21. januar, 2010

Lars Viksmoen, CEO


BIOTEC PHARMACON

3Q09 Messages

  • Pharma:
  • Q4'09: Results from both phase III studies for diabetic foot ulcer, expected already in November
  • Q1'10: Results from first phase III study for oral mucositis
  • Q3'10: Filing for MAA in Europe for diabetic foot ulcers in July 2010
  • 2H'10: Securing commercial partner for launch of SBG for treatment of diabetic foot ulcer

  • Non-pharma:
    Continued growth of Biotec Marine Biochemicals, revenue decline to be met with cost measures in Immunocorp

  • Funding:
    Processes ongoing to secure funding through 2010


BIOTEC PHARMACON

Tracking of partnering activities

Dialogue with > 150 companies
Strong interest expressed by > 60 companies
Confidentiality agreements with approx. 30 companies

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BIOTEC PHARMACON

What happened during Q4?

  • End of November
  • Two negative phase III studies
  • Severe market capitalization drop
  • Early December
  • Significant cost management
  • Significant organizational downsizing
  • End of December
  • Capitalization on non-core business (ICH)

4


BIOTEC
PHARMACON

Phase III – diabetic foot ulcer

Two negative pivotal studies - a big surprise !

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Blue area = periods of patient inclusion, black areas = periods of study completion and reporting

Q4 2009 • Two negative phase III studies
Q12010 • Investigating reasons behind the negative studies
Q12010 • Re-direct the pharma development strategy
2010 • Identify alternatives to capitalize on DU

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BIOTEC PHARMACON

Possible explanations

  • Study design flaws
  • Technical study flaws
  • Product flaws
  • SBG
  • Placebo

6


BIOTEC PHARMACON

Re-analysis of study medication

Planned sampling of drug substance/product

Substance Storage place
Drug substance
(API) Quality laboratorium Tromsø
Drug product
(PE-ampules) Production factory Tromsø
(fra Holopack)
Drug product
(PE-ampules) Return from study centers
(UK og Europa)
  • Where available also compared with samples of drug substance/product from phase I and II
  • Basket of tests, both for SBG and placebo

BIOTEC PHARMACON

New organization after downsizing

Biotec Pharmacon ASA

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BIOTEC PHARMACON

New organization

Biotec Marine Biochemicals AS

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BIOTEC PHARMACON

Immunocorp Consumer Health Divested end of Q4

  • Divested non-core business
  • Good strategic match with buyer
  • Selling price: 31,5 MNOK
  • 5-year supply agreement

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BIOTEC PHARMACON

Biotec Marine Biochemicals ASA Enzymes for R&D and diagnostics markets

  • Strong revenue growth
  • High EBITDA-margin: ~40% on a stand-alone basis
  • Exceeded 2009 revenue target of 15 MNOK, achieving 17,5 MNOK
  • Longer-term revenue target: More than doubling over the next three years

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Molecular structure of cod Uracil-DNA N-glycosylase (Leiros, et al. 2003)


BIOTEC PHARMACON

SBG development pipeline

Immunotherapy of cancer:

  • Phase I/II studies with SBG in combinations with mAbs for;
  • Neuroblastoma
  • Non-Hodgkins’ lymphoma
  • Breast cancer
  • Further progress pending strategic decisions

Other potential indications:

  • Filed patent application with SBG for inflammatory bowel disease (IBD)
  • Filed patent application with SBG for asthma

BIOTEC PHARMACON

Summary

Moving forward

  • Identify and address reasons behind phase III diabetic foot ulcer results
  • Re-establish the pharmaceutical strategy platform
  • Ensure funding for future R&D activities

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BIOTEC PHARMACON

The End

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BIOTEC PHARMACON

Back-ups

15


BIOTEC PHARMACON

Oral Mucositis – Clinical Program

Clinical phase 2008 2009 2010
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Phase III, Europe
Phase III, Eastern Europe 2^{nd} study put on hold awaiting results from the 1^{st} study

Blue area represent periods of patient inclusion, black areas represent periods of study completion and reporting

  • Treatment follow-up completed in Q4 2009
  • Study results expected in Q1 2010
  • Possible second study and timing of filing pending these results
  • Lowered expectations...

BIOTEC PHARMACON

Re-analysis of study medication

Planned tests

SBG Placebo
Visual inspection Visual inspection
Identification Identification
Biological activity Biological activity
Endotoksin-content Endotoksin-content
SEC-MALS-RI
(molecular weigth distribution)
Contamination of glukan