Full Year Results 2008

Transcription

1 Cliquez pour modifier le style du titre Full Year Results 2008 Vincent FERT CEO March 2009 Stanislas PIOT CFO Page 1

2 Forward Looking Statement Cliquez pour modifier le style du titre This presentation and the information contained herein is not an offer to sell or a solicitation of any offer to buy Ipsogen shares in any jurisdiction. The Ipsogen shares have not been, and will not be, registered under the US Securities Act of 1933, as amended (the 'Securities Act'), and may not be offered or sold in the United States unless they are registered with the US Securities and Exchange Commission or exempt from such registration. Ipsogen does not intend to register the shares under the Securities Act or make a public offer of the shares in the United States. The information contained in this presentation has not been independently verified by Ipsogen's advisers and no representation or warranty, express or implied, is made or given as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions expressed herein. 2

3 Cliquez pour modifier le style du titre Ipsogen Executive Summury Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Strong development since the IPO Financial elements Strategy General informations Page 3

4 Ipsogen, pioneer and major player of molecular diagnostic in Cliquez pour modifier le style du titre oncology 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 2008 Sales: 4,12m (+62.4%) OSEO-ANVAR label 48 employees A pur player of molecular diagnostic in oncology 4

5 An Expert & International team Cliquez pour modifier le style du titre Vincent Fert President & CEO Co-Founder Former Beckman-Coulter & Immunotech Fabienne Hermitte Research & Regulatory Affairs Director PhD, Co-Founder Former Rhône Poulenc Stéphane Debono COO Co-Founder Former Beckman-Coulter & Immunotech Denis Meshaka IP & Licensing Director Former Novartis Stanislas Piot CFO Former Oddo & Natixis Marc Essodaigui VP Marketing & Sales Europe & Asia PhD Former Elsevier Susan Hertzberg VP Commercial Operations North America President Ipsogen Inc. Former Abbott & Quest Diagnostics Hélène Peyro-Saint-Paul Chief Medical Officer MD/PhD Former BMS & Actelion 5

6 What is molecular diagnostic? Cliquez pour modifier le style du titre «60 to 70% of medical decisions are based on Predisposition Diagnostic Which disease? Prognostic Answer Follow-up Benin or Which drug? Is the drug efficient? aggressive? information provided by in vitro diagnostic tests even though they represent only 5% of the costs of hospitals and they benefit the entire chain of care» (source : Clinical Chemistry ) 6

7 Market Cliquez focus: pour personalized modifier le medicine: style du titre - multiple beneficiaries Molecular diagnostic companies Therapies (costly) better targeted Fewer side effects More efficient prevention Reimbursement agencies Individualized treatment Fewer side effects Improved quality of life Patients Personalized medicine Better prevention Better therapeutic control Public health Early diagnosis Guided therapeutic decisions Better therapeutic monitoring Doctors Pharmas Optimized clinical development Diagnostic companion Retargeting of average-sized molecules 7

8 A success story in personalized medicine: BCR-ABL Cliquez and pour Chronic modifier Myelogenous le style du Leukemia titre (CML) Initially used to improve the diagnosis of this form of leukemia (supplementing standard cytological techniques) Currently used to monitor the therapeutic response to Glivec and new generation molecules Confirmation of the cytological response (total or partial) Determination of a molecular response, at a lower threshold, with the development of more sensitive tests Benefits for therapeutic decisions Earlier and finer-tuned adjustment of doses Possible change of molecule after mutation is confirmed 8

9 Leading to a rapid & successful Development Cliquez pour modifier le style du titre Blood cancers Partnership with Institut Paoli Calmettes Launch of BCR-ABL kits European IVD status for several products License for JAK2 V617F mutation (IGR) Launch of several new tests 4.1 Breast Cancer Initiation of Breast Cancer R&D License of Genomic Grade (ULB) Partnership with Affymetrix (GeneChip) Launch of MapQuant Dx TM Genomic Grade 2.5 Corporate First financing round 0.3 Opening of Ipsogen Inc. (Connectcut, USA) Growth of 62.4% entre vs S et 2007 Revenue ( m) Acceleration ot the activity from the 1 er round of financing 9

10 Molecular Diagnostics for Cancers: the most attractive segment in Cliquez pour modifier le style du titre the diagnostic indudstry An emerging market currently estimated at 400m A growth estimated at 35% per year for the next 4 years Breakdown of the in-vitro diagnostic market by applications Molecular diagnostic market: CAGR e Technologies Bactério -logy Molecular biology Clinical chemistry Hémato -logy Immunoassays Hémostasis Size of segments ( m) % Annual growth Source : BioMérieux 3 4% 10 12% 3 4% 4 5% 3 4% 3 4% 17% 14% 10% Oncologiy 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. 10

11 Value of a diagnostic test Cliquez pour modifier le style du titre 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 Ipsogen diagnostic tests guide therapies 11

12 Molecular diagnostic a major contribution to survival in cancer Cliquez pour modifier le style du titre 1900 Microscope 1970 Coloration 1980 Immunochimie 1990 Molecular Diagnostic 89% 70% Number of leukemia s type and subtypes indications / 60 products Taux de survie : 0% Number of breast cancer type Tests launched Molecular diagnostic, a break s innovation 12

13 Cliquez pour modifier le style du titre Ipsogen Executive Summury Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Strong development since the IPO Financial elements Strategy General informations Page 13

14 Blood cancer molecular diagnostic an emerging market Ipsogen offer the most comprehensive range of molecular tests to screen, diagnose or monitor leukemia s Acute Myeloid Leukemia (AML) 27% Myeloproliferative neoplasm (ET, PV, MI) 32% Main leukemia subtypes by frequency 144 M Acute Lymphoblastic Leukemia (ALL) 9% Chronic Lymphocytic Leukemia (CLL) 22% Chronic Myeloid Leukemia (CML) 10% A 144 M potential market WW M BCR -ABL JAK 2 V617F PML-RARA WT1 NPM1 BCR-ABL TEL-AML1. 24 M 14 A leader in onco-hematology MDx 14

15 JAK2, a breakthrough test in Ipsogen portfolio Exclusive and worldwide Intellectual property A potential market of 2 millions tests in developed countries for 2 majors application : screening and follow-up At 60 target price, a potential market of 140 M JAK2 sales increased 282% between 2007 and 2008 January 2008 : Recommendation of World Health Organisation (WHO) in order to use JAK2 in the screening of three blood cancers 15

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

17 A growing commercial franchise Sales in Blood cancers ( m) Strong recurrence of sales Sales by cutomers 2008 Sales 2008 by countries Rest of the world 14% North America 44% France 12% Sales in 48 countries Direct sales: 64% of revenue Gross margin EU (Excluding France) 30% 73% 74% Institutions 52% clients Reference aboratories 25% 61% 67% Distributors 22% 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 % 30.8% 41.1% 28.2% 29.4% 51.5% JAK2 BCR-ABL Autres tests Other tests Distribution 18

19 Cliquez pour modifier le style du titre Ipsogen Executive Summury Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Strong development since the IPO Financial elements Strategy General informations Page 19

20 Breast cancer A strong needs for better classification, more accurate prognosis determination and predictive information to guide treatment decisions 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 Breast Cancer A unique portfolio of diagnostic tests developed to enhance existing pathology testing Clinical examination / Mammography Breast Cancer Diagnosis Surgery MapQuant Dx TM Grade MapQuant Dx TM FEC-R Sample 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 Herceptin Chemotherapy: Yes / No? Which chemotherapy? Hormonotherapy: Yes / No? Targeted therapy: Yes / No? An estimated market over 700m 21

22 Breast cancer MapQuant Genomic Grade resolves cases with equivocal histological grade With histological grading, 50% of breast cancer cases fall under the uncertain grade 2 Histological grading is poorly reproducible specially for grade 2 uncertain cases Grade 2 tumors patients may receive an unnecessary chemotherapy or miss the benefit of a chemotherapy Histological Grade Genomic Grade classifies 80 % of grade 2 tumors in grade 1 or grade 3 Genomic Grade is predictive of proliferation Genomic Grade is accurate and reproducible Genomic Grade allows to better assess the need & the benefit of chemotherapy in equivocal cases Genomic Grade A test validated on patients many international publications From Sotiriou & al JNCI 2006 Discovered by the team of Pr. Martine Piccart and Dr. Christos Sotiriou in the Institut J. Bordet 86,000 new patients a year can benefit of MapQuant Dx Genomic Grade 22

23 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 * Company bought by BioMerieux in September 2008 for $60m ** 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 23

24 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 24

25 Cliquez pour modifier le style du titre Ipsogen Executive Summury Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Strong development since the IPO Financial elements Strategy General informations Page 25

26 Initial achievements in line with the market plan Cliquez pour modifier le style du titre May 2008: launch of the MapQuantDX diagnostic test Ipsogen officially enters the breast cancer market June 2008: success of the IPO 12 million devoted to controlled development on the molecular diagnostics market June 2008: granting of CE certification for the JAK2 kit in leukemia Test accessible to European laboratories in accordance with the European Directive on in-vitro diagnostics October 2008: JAK2 V617F acknowledged on the US market Granting of a patent following a fast-track process laying witness to the validity of this test October 2008: signing of a licensing agreement with Quest Diagnostics Utilization of the JAK2 V617F mutation by the n 1 medical diagnostic services player in the US within the framework of a non-exclusive operating license. December 2008: launch of 3 three new molecular diagnostic kits for leukemia Leukemia product portfolio increased to 21 kits, in line with the Group s development plan 26

27 Cliquez pour modifier le style du titre Ipsogen Executive Summury Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Strong development since the IPO Financial elements Strategy General informations Page 27

28 Simplified consolidated P&L statement Cliquez pour modifier le style du titre m (IFRS) Var. Products Revenue % Services Revenue % Total Revenue % Operating revenue % Products gross margin 73.3% 74.3% na Group gross margin 66.9% 71.6% na R&D costs % Marketing & Sales costs % Administrative costs % Operating Profit na Net Profit na At constant forex, annual revenue growth stands at +66.1% The fall in revenue from services corresponds to the Company s change in focus towards a Product business model. Costs under control 28

29 Simplified consolidated balance sheet Cliquez pour modifier le style du titre m (IFRS) Dec. 07 Dec. 08 Assets Intangible fixed assets Tangible fixed assets Other non-current assets Total Non-current assets m (IFRS) Dec. 07 Dec. 08 Liabilities Shareholders equity Advances over a year Other non-current liabilities Total Non-current liabilities Inventories Accounts receivable Other current assets Cash and cash equivalents Total Current assets Total Assets Trade accounts payable Tax and social security liabilities Financial debt Under a year Other current liabilities Total of current liabilities Total Liabilities A solid financial structure 29

30 Cash flow table Cliquez pour modifier le style du titre m (IFRS) Net profit Cash flow from operating activities Cash flow from investing activities Cash flow from financial activities Net cash increase Closing cash position The IPO enabled the raising of million 30

31 Cliquez pour modifier le style du titre Ipsogen Executive Summury Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Strong development since the IPO Financial elements Strategy General informations Page 31

32 IPSOGEN: an efficient and secure economic model Cliquez pour modifier le style du titre Optimize R&D efforts Commercialization of products from the Research stage Build a solid medical and scientific platform for each test A medical and scientific usage rationale, justifying high reimbursement Capture the essence of the value of tests Integration of development, manufacturing and commercialization Commercialize products In accordance with the expectations of the European and North American markets proportioned for growth 32

33 A strategy Cliquez based pour modifier on clear le objectives style du titre 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 (CE and FDA) Negotiate breast cancer test reimbursement (health insurance systems) Expand the market Target the 3,000 hospitals in Europe and the 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» 33

34 A WW commercial coverage Cliquez pour modifier le style du titre Direct presence in UK and Scandinavia Direct presence in France Direct presence in Germany, Austria, Netherlands Direct presence in the USA : Ipsogen Inc with representatives on the West and East Coast Distributor in Russia Distributors in Austria, Belarus, Bulgari a, CZ, Slovakia, Italy, La tvia, Lithuania, Greece, Poland, Serbia, Sloveni a, Turkey Direct presence in Spain and Portugal Distributors in India, Iran, Israel, Jorda n, Syria, UAE, Lebanon, Pakistan, Saudi Arabia Distributor in Brazil Distributors in Egypt and South Africa Distributors in China, Hong Kong, South Korea, Japan, Malaysia, Australia, New Zealand Q Marketing and Sales employees

35 Cliquez pour modifier le style du titre Ipsogen Executive Summury Ipsogen in the Blood Cancers Ipsogen in the Breast Cancer Strong development since the IPO Financial elements Strategy General informations Page 35

36 Why invest in Ipsogen? Cliquez pour modifier le style du titre Specialized in the molecular diagnosis of cancer, the most dynamic in vitro diagnosis market segment An experienced team with proven diagnostic know-how Proof of concept validated in blood cancers on a scientific, industrial and commercial level An established commercial presence in Europe and the United States amongst reference centers, powerful relays of sales action A portfolio of tests for breast cancer addressing a market worth 700m developed in collaboration with opinion leader centers Strong barriers to entry: a portfolio of 49 patents, 6 of them definitive Major value-creating stages based on the commercial launch of products and regulatory submissions The only pure player in molecular diagnosis listed on the Paris market 36

37 General Cliquez information pour modifier le style du titre Capital 4,427,384 shares Public 35.0 % Others 2.6 % Managers 15.7 % Historical financial investors 46.7 % Listing infos Listed on Alternext by Euronext Paris Main index : Alternext All-Share Sector : biotechnology Id: FR ALIPS Contacts Chairman and CEO : Vincent Fert fert@ipsogen.com CFO: Stanislas Piot piot@ipsogen.com NewCap Financial communication: Axelle Vuillermet ipsogen@newcap.fr Tel. : Fax: