IPSOGEN SA Listed on Alternext by NYSE Euronext

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1 Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque IPSOGEN SA Listed on Alternext by NYSE Euronext SGAM meeting June 2008 Page 1

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3 Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque Ipsogen listed on Alternext by NYSE Euronext Ipsogen Executive Summary Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Organisation and strategy Page 3

4 What is molecular diagnostic? Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque «60 to 70% of medical decisions are based on information Predisposition Diagnostic Prognostic Answer Follow-up provided by in vitro diagnostic Which disease? Benin or aggressive? Which drug? Is the drug efficient? tests even though they represent only 5% of the costs of hospitals and they benefit the entire chain of care» (source : Clinical Chemistry ) 4

5 Ipsogen, pioneer and major player of molecular diagnostic in oncology Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque A molecular diagnostic expert in oncology focused on two indications: Blood cancers: Ipsogen Leukemia (tests distributed since 2003) Breast cancer: Ipsogen Breast Cancer (1 er test launched on the 30 th of may 2008) A unique positioning: the personalized medicine market Two business sites: Europe & US 250 repeated customers Top academic center as partners 2007 Sales: 2.5m (+61%) 40 employees 5

6 An Expert & International team Cliquez pour modifier le style du titre Vincent Fert President & CEO Co-Founder Former Beckman-Coulter & Immunotech Stéphane Debono COO Co-Founder Former Beckman-Coulter & Immunotech Stanislas Piot CFO Former Oddo & Natixis Susan Hertzberg VP Commercial Operations North America Former Abbott & Quest Diagnostics Fabienne Hermitte Research & Regulatory Affairs Director PhD, Co-Founder Former Rhône Poulenc Denis Meshaka IP & Licensing Director Former Novartis Marc Essodaigui Marketing & Sales Director Europe & Asia PhD Former Elsevier Béatrice Roger QA System Director PhD Former Institut Pasteur & INSERM Kevin Rakin Advisor, Member of the Board Former Advanced BioHealing & Genaissance Pharma. 6

7 Leading to a rapid & successful Development Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque Blood cancers /Leukemias Partnership with Institut Paoli Calmettes Launch of BCR-ABL tests CE mark for BCR-ABL test License of JAK2 V617F mutation (IGR) 2.5 WHO s guidelines on JAK2 V617F mutation for screening Breast Cancer Starting R&D projects in breast cancers License of Genomic Grade (ULB) Partnership with Affymetrix (GeneChip) Laaunch of MapQuant Dx TM Genomic Grade Corporate Sales ( m) First financing round 0.3 Launch of Ipsogen Inc. In the US Gross margin > 70% 250 clients US/EU Acceleration ot the activity from the 1 er round of financing 7

8 Diagnostic: a Limited Risk Profile vs. Pharma Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque Risk profile Pharma / Diagnostic Pharma Diagnostic Time to market Shorter From patent filing to market: 8-10 years From biomarkers identification to first revenues 1-2 years Development costs Limited Ratio R&D/Sales ratio: 15-20% R&D/Sales ratio: 5-7% Clinical & regulatory risks Lower Criteria of clinical validation: relative efficiency & toxicity Criteria of clinical validation: performance of the test Barriers to entry Comparable and strong Intellectual property, regulatory status, clinical data, relationship with KOLs, sales force, notoriety Value creation Incremental On/Off model: before the AMM and after the expiration date of patent with generic risk. Sales & profitability based on: medical value, RUO status, filling, reimbursement 8

9 Molecular Diagnostics for Cancers: the most attractive segment in the Cliquez pour modifier le style du titre diagnostic indudstry An emerging market currently estimated at 400m A growth estimated at 35% per year for the next 4 years CAGR e Technologies Bacterio -logy Molecular biology Clinical chemistry Hemato -logy Immunoassays Hemostasis Size of segments ( m) % Annual growth Source : BioMérieux 3 4% 10 12% 3 4% 4 5% 3 4% 3 4% 17% 14% 10% Oncology infectious Genetics Blood Diseases screning Source : Scientia Advisors The two sub-segments of emerging markets addressed by Ipsogen represent a potential market of over 800 million. 9

10 Value of a diagnostic test Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque Average price per test ( ) Commodity Low value tests High value tests Therapy drivers NA+ Glucose Thyroïds HER/neu VIH Genotyping SeptiFast OncotypeDX Ipsogen Blood Tests Ipsogen Breast Tests 10

11 Increase of the survival rate of patients with molecular diagnostic Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque 1900 Microscope 1970 Coloration 1980 Immunochemistry 1990 Molecular diagnostic 89% 70% Number of type of leukemias identified indications / 60 references Survival rate: 0% Number of type of breast cancers identified product Molecular diagnostic, a breakthrough innovation

12 Product portfolio and development plan Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque Scientific Licensing Product Clinical studies Clinical studies evaluation development in Europe in the US Reimbursment R&D CE marking FDA clearance Blood cancers BCR-ABL Breast cancer JAK2 WT1 Genomic Grade HER2 HR FEC-ER Tests on the market Launched 30 th of may End of development Development 12

13 Cliquez pour modifier le style du titre Ipsogen listed on Alternext by NYSE Euronext Ipsogen Executive Summary Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Organisation and strategy Page 13

14 An emerging market addressed by a complete offer The most complete offer on the market: 60 diagnostic products commercialized addressing the major types of leukemia s Acute Myeloïd Leukemias (AML) 27% Myeloproliferative Diseases (ET, PV, MI) 32% Major types of Leukemias Acute Lymphoïd Leukemias (ALL) 9% Chronic Lymphoïd Leukemias (CLL) 22% Chronic Myeloïd Leukemias (CML) 10% 144m A 144m+ market opportunity m 12m OTHER TESTS BCR-ABL JAK 2 V617F PML-RARA WT1 NPM1 BCR-ABL TEL-AML1 In development 14 The position of a leader in a market with high growth potential 14

15 JAK2, a major test in the Ipsogen s blood cancer portfolio Exclusive and worldwide intellectual property rights 2 million tests opportunity in developed countries for two major applications: screening and follow-up 498 JAK2 Annual Consolidated Sales (K ) x15 25% of sales in Potential price point of 60 per test: 120m market January 2008: Worldwide Health Organisation (WHO) recommends JAK2 V617F mutation testing for screening of 3 leukemias 15

16 Favourable Competitive Landscape Small number of competitors, mostly small scale companies Unique product range Screening 16

17 Sales in Blood cancers ( m) Sales 2007 by countries + 53% + 88% 2.0 Rest of the world 17% EU (excluding France) 36% France 22% Strong recurrence of sales Reference Laboratories 8% Sales by cutomers 2007 Commercialisation in 48 countries Sales in direct: 64% of the sales Gross margin % North America 25% 73% Distributors 38% cust. Institutions 54% 61% 200 of the 450 main worldwide cancer treatment centres Important prospection potential (e.g. the «non specialists» hospitals) Gross margin in line with the major actor in molecular diagnostic 17

18 Product portfolio and development plan Scientific evaluation Licensing Product development Clinical studies in Europe Clinical studies in the US Reimbursment R&D CE marking FDA clearance Blood cancers BCR-ABL JAK2 WT1 Tests on the market 2007 Sales breakdown Distribution 18

19 Cliquez pour modifier le style du titre Ipsogen listed on Alternext by NYSE Euronext Ipsogen Executive Summary Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Organisation and strategy Page 19

20 Strong Need for Diagnostics Currently Poorly Met Breast Cancer: an heterogeneous disease better addressed thanks to molecular diagnostic estimated new cases each year in the USA and in Europe Therapy decisions already based on diagnostic tests Chemotherapy is still the one size fits all therapeutic regimen for most of the patients Chemotherapy unnecessary prescribed in 85% of cases Toxic and expensive therapy ( ) Large diagnostic unmet needs still exist Should I prescribe chemotherapy? Should I prescribe hormonotherapy? Should I prescribe targeted therapy? Which type of therapy? 20

21 Unique portfolio of Diagnostic Tests Developed by Ipsogen Breast injury Clinical examination / Mammography Breast Cancer Diagnostic Surgery MapQuant Dx TM Grade Sample MapQuant Dx TM FEC-R Radiotherapy Pronostic factors - Histological grade - Infiltration - Lymph nodes - Size of the tumor MapQuant Dx TM HR Hormone response - IHC ER/PR Test MapQuant Dx TM HER2 Herceptine response - IHC / FISH HER2/neu Test Chemotherapy Hormonotherapy Immunotherapy Chemotherapy: Yes / No? Which chemotherapy? Hormonotherapy: Yes / No? Targeted therapy: Yes / No? An estimated market over 700m 21

22 MapQuant Dx Genomic Grade: the 1 st test of a promising portfolio Today, 50% of breast cancer cases fall under the uncertain grade 2, which generally implies an over-chemotherapy prescription From Sotiriou & al JNCI new patients each year can benefit from MapQuant Dx Genomic Grade

23 A unique test to guide therapeutic options Discovered by a leading scientific and clinical team - Pr. Martine Piccart and Christos Sotiriou, Institute Jules Bordet (Bruxelles) Analyses of 97 genes involved in tumor cell proliferation (grade) Improve grading Validated on patients Exclusive and worldwide license granted to Ipsogen 23

24 Competition environnement: unique strategic advantages Company Test Status Technology Partnership Nb. of tests Business model Territory Agendia MammaPrint Commercialised DNA chips Agilent 1 Central Lab EU + USA AviaraDx MGI Commercialised RQPCR na 3 Central Lab USA Genomic Health * OncotypeDx Commercialised RQPCR na 1 Central Lab USA + Israël Ipsogen MapQuant Launch done DNA chips Affymetrix 4 Decentralised EU + USA * 2007 Sales : $60m Technological expertise Extended range of tests Decentralised model targetting the pathologists, internationally expandable US and European sale forces Less capital intensive A fast follower positioning on an open maket 24

25 Portfolio and Development Plan Scientific evaluation Licensing Product development Clinical studies in Europe Clinical studies in the US Reimbursment R&D CE marking FDA clearance Breast cancer tests Genomic Grade HER2 HR FEC-R Launch just done End of development Development 25

26 Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque Ipsogen listed on Alternext by NYSE Euronext Ipsogen Executive Summary Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Organisation and strategy Page 26

27 A secured Cliquez and pour focused modifier business le style model du titre Cliquez pour modifier les styles du texte du masque Optimize R&D efforts Exploitation of patented tests Focus on development Commercialization of «RUO» products as soon as possible Commercialize our products to end users Integration of development, manufacturing and commercialization to end customers A specialized sale force in EU and in the US Develop high value products Which optimizes drug prescription Which allows health savings scaled for growth 27

28 A strategy Cliquez based pour on modifier key assets le style and clear du titre objectives Cliquez pour modifier les styles du texte du masque Take advantage of the blood cancer franchise Strengthen the company strong image in expert cancer centers to leverage it toward commercial expansion Increase the revenue per tests Expand regulatory status for major products (CE and FDA) Negotiate breast cancer test reimbursement (health insurance systems) Expand the market Target the hospitals in Europe and US potential prescribers of Ipsogen tests Triple our sale force within the end of 2010 Further develop our product portfolios Complete blood cancers and breast cancer test menu Intensify biomarkers «sourcing» 28

29 Cliquez pour modifier le style du titre Cliquez pour modifier les styles du texte du masque Thank you for your attention Contact: FR ALIPS Page 29