Never invest in a business you can t understand.

Transcription

1 Presentation for Pre Diagnostics AS: EARLY BIOTECH Never invest in a business you can t understand. Warren Buffett 2 1

2 INDUSTRIAL APPROACH: GIM Innovation Product Supply side Future oriented requires industrial understanding Growth Market need Demand side Qualitative analysis Quantitive analysis People Management Historical analysis generic financial analysis Finance Success 3 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy and Business model IP Validation Technology Biology Achievements Use of proceeds and Milestone plan 4 2

3 INDUSTRIAL APPROACH: GIM Innovation Growth Demand side Management Finance 5 TESMAN. With the future! But, good heavens, we know nothing of the future! LOVBORG. No; but there is a thing or two to be said about it all the same. [Opens the packet.] Look here Ibsen, Henrik (1890) Hedda Gabler 6 3

4 INDUSTRIAL APPROACH: GIM Innovation Future oriented requires industrial understanding Growth Demand side Management Finance 7 THE AGE WAVE Source:. 4

5 PREVALENCE WORLDWIDE Source: Alzheimer s Disease International PREVALENCE USA Source: Hebert et al.: Alzheimer disease in the United States ( ) estimated using the 2010 census 5

6 PREVALENCE USA Source: Hebert et al.: Alzheimer disease in the United States ( ) estimated using the 2010 census INCIDENCE USA Source: Claire Mount & Christian Downton: Alzheimer disease: progress or profit? Nature Medicine

7 THE TOLL Source: Patrizia Berto et al.: Depression: Cost of illness Studies in the International Literature, a Review, The Journal of Mental Health Policy and Economics INDUSTRIAL APPROACH: GIM Innovation Supply side Future oriented requires industrial understanding Growth Demand side Management Finance 14 7

8 THE MARKET FOR ALZHEIMER S DRUGS Alzheimer s Therapeutics 16 8

9 PIPELINE AD is more expensive to the U.S. economy than cardiovascular disease or cancer. Most drugs entering the AD drug development pipeline have failed; only one agent has been approved since 2004 (memantine). The failure rate since 2002 (excluding agents currently in Phase 3) is 99.6%. Currently, 108 trials of AD therapies represent 94 unique agents. The current AD pipeline is relatively modest, given the enormous challenge posed by this disease.. 17 You have been weighed on the scales and found wanting. 18 9

10 ( ) the clinical trials were carried out too late in the progression of disease. If we could start treatment earlier in the pre clinical phase, they might be effective. Professor Simon Lovestone, University of Oxford 20 10

11 THE SOLUTION The greatest source of hope is the current shift in industry to pre symptomatic diagnosis using biomarkers and diagnostic imaging techniques combined with earlier clinical intervention. Source: Zelicia Gerald & Waldemar Ockert: Alzheimer's disease market: hope deferred. Nature Reviews Drug Discovery 2013 THE SOLUTION The potential for earlier diagnosis and earlier clinical intervention to slow or prevent neurotoxicity, inflammation and synaptic dysfunction may actually be the beginning of meaningful hope for AD sufferers. Source: Zelicia Gerald & Waldemar Ockert: Alzheimer's disease market: hope deferred. Nature Reviews Drug Discovery

12 THE MARKET FOR ALZHEIMER S DRUGS Alzheimer s Diagnostics COMPETITIVE EDGE Price Accuracy Convenience 24 12

13 COMPETITIVE EDGE Price Accuracy specificity sensitivity Convenience speed invasive / non invasive 25 COMPETITORS 26 13

14 27 PROTEOME SCIENCES Alzheimer s begins to affect the brain many years before patients are diagnosed with the disease. Many of our drug trials fail because by the time patients are given the drugs, the brain has already been too severely affected. A simple blood test could help us identify patients at a much earlier stage to take part in new trials and hopefully develop treatments which could prevent the progression of the disease. The next step will be to validate our findings in further sample sets, to see if we can improve accuracy and reduce the risk of misdiagnosis, and to develop a reliable test suitable to be used by doctors. Professor Simon Lovestone, University of Oxford 28 14

15 INDUSTRIAL APPROACH: GIM Innovation Unique products come with a high margin Supply side Future oriented requires industrial understanding Market / Product Fit Growth Strong growth Demand side will eventually boost the valuation Management Finance 29 15

16 INDUSTRIAL APPROACH: GIM Innovation Supply side Future oriented requires industrial understanding Market / Product Fit Growth Demand side Qualitative analysis Management Finance 32 16

17 THE PEOPLE Competent Experienced Candid Commercially driven Håkon Sæterøy CEO & Co-Founder Sæterøy is Managing Director of INVESTOR Corporate AS. He is Board member of Nansen Neuroscience Network (NNN) and previous chairman of DiaGenic ASA He has a Master of Science in Business from NHH. Erik Christensen, MD PhD CMO/COO & Co-Founder Chairman of NNN. Previous DiaGenic ASA & Abbott Diagnostics. His medical background is in clinical chemistry and has a PhD in medical biochemistry from University of Oslo. Frank Swenson, O.D. PhD CSO/BD (Americas) Former Director Diagnostics Neuroscience in Pfizer ( ), managed several Alzheimer diagnostic projects and external Dx-collaborations. VP BD/COO/CSO in several biotech companies in the US. He has a PhD in Medical Sciences, MS in immunology and O.D (optometry) Birgitte Booij, PhD IVD/ELISA consultant Former Clavis Pharma, DiaGenic and Axis-Shield Nine Haflan QA/Regulatory consultant Former Axis-Shield, Dynal Biotech Esben Nilssen PhD European patent attorney CEO Epitarget. Former Zacco, Gjensidige NOR Equities Sigrid Marie Blom PhD Project leader Nansen Neuroscience Network. Former Lundbeck 33 INDUSTRIAL APPROACH: GIM Innovation Product Supply side Future oriented requires industrial understanding Market / Product Fit Growth Market need Demand side Qualitative analysis People Management Finance Success 34 17

18 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy and Business model IP Validation Technology Biology Achievements Use of proceeds and Milestone plan 35 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH 36 18

19 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH 37 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH 38 19

20 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy A well defined and configured strategy: Focused? Based on analysis? Technological feasibility? Commerical feasibility? With high probability for success 39 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy and Business model What added value to clinical trials can be documented? Will the pharma industry use the test? What is thesizeofthis market? How will market access be achieved? Who pays for the product? Will the clinicians support the product? Will it be reimbursed? 40 20

21 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy and Business model IP Validation Industrial and academic partners Scientific papers and researchers Analysts Investors 41 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy and Business model IP Validation Technology Biology Erik Christensen, MD PhD CMO/COO & Co-Founder Chairman of NNN. Previous DiaGenic ASA & Abbott Diagnostics. His medical background is in clinical chemistry and has a PhD in medical biochemistry from University of Oslo. Birgitte Booij, PhD IVD/ELISA consultant Former Clavis Pharma, DiaGenic and Axis-Shield Nine Haflan QA/Regulatory consultant Former Axis-Shield, Dynal Biotech 42 21

22 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy and Business model IP Validation Technology Biology Achievements There are people in place. There are partners in place. There is money in place There is a plan in place. There is support in place. 43 CHECK LIST INVESTMENTS IN EARLY STAGE BIOTECH Strategy and Business model IP Validation Technology Biology Achievements Use of Proceeds and Milestone plan 44 22

23 INDUSTRIAL APPROACH: GIM Innovation Product Supply side Future oriented requires industrial understanding Market / Product Fit Growth Market need Demand side Qualitative analysis Quantitive analysis People Management Historical analysis generic financial analysis Finance Success 45 Pre The Caterpillar 46 23