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Full Year Results 2008
Page 1 Vincent FERT CEO Stanislas PIOT CFO March 2009
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Forward Looking Statement
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
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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.
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Ipsogen Executive Summury
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Ipsogen in the Blood Cancers
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Ipsogen in the Breast Cancer
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Strong development since the IPO
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Financial elements
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Strategy
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• A molecular diagnostic expert in oncology focused on two indications: • Blood cancers:Ipsogen Leukemia(tests distributed since 2003)
• Breast cancer: Ipsogen Breast Cancer(1er test launched on the 30th of may 2008)
• A unique positioning: the personalized medicine market
• Two business sites: Europe & US – 250 repeated customers
Ipsogen, pioneer and major player of molecular diagnostic in
oncology
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• Top academic center as partners
• 2008 Sales: €4,12m (+62.4%)
• OSEO-ANVAR label
• 48 employees
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An Expert & International team …
Stéphane Debono
COO
Co-Founder
Former Beckman-Coulter & Immunotech
Denis Meshaka
IP & Licensing Director
Former Novartis Fabienne Hermitte
Research & Regulatory Affairs Director PhD, Co-Founder
Former Rhône Poulenc Vincent Fert
President & CEO Co-Founder
Former Beckman-Coulter & Immunotech
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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
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What is molecular diagnostic?
« 60 to 70% of medical decisions are based on information provided by in vitro diagnostic tests even though
they represent
Is the drug efficient?
Prognostic Answer Follow-up
Benin or aggressive? Which drug? Diagnostic Predisposition Which disease? 6 they represent only 5% of the costs of hospitals
and they benefit the entire chain of
care » (source : Clinical Chemistry - 1996)
aggressive? disease?
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Molecular diagnostic companies Individualized treatment
Fewer side effects Improved quality of life
Therapies (costly) better targeted Fewer side effects
More efficient prevention
Better prevention
Better therapeutic control
Market focus: personalized medicine:
- multiple beneficiaries
Reimbursement agencies
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Early diagnosis
Guided therapeutic decisions Better therapeutic monitoring
Better therapeutic control
Optimized clinical development Diagnostic companion
Retargeting of “average-sized” molecules Pharmas Doctors Patients Public health Personalized medicine
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A success story in personalized medicine:
BCR-ABL and Chronic Myelogenous Leukemia (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
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– 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
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Leading to a rapid & successful Development
Breast Cancer Partnership with Institut Paoli Calmettes European IVD status for several products License for JAK2 V617F mutation (IGR) Launch of several new tests Launch of BCR-ABL kits License of Genomic Grade (ULB) Initiation of Breast Cancer R&D Launch of MapQuant DxTM Genomic Grade 2.5 4.1 Blood cancers 9 Revenue (€m) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Corporate Growth of 62.4% entre
vs S1 2008 et 2007 Breast Cancer Partnership with Affymetrix (GeneChip) First financing round Opening of Ipsogen Inc. (Connectcut, USA) 0.3 0.7 1.1 1.6 2.5
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Molecular Diagnostics for Cancers: the most attractive segment in
the diagnostic indudstry
Breakdown of the in-vitro diagnostic market by applications
Molecular diagnostic market: CAGR 2006-2012e • An emerging market currently estimated at €400m
• A growth estimated at 35% per year for the next 4 years
Technologies Bactério -logy Molecular biology Immuno-assays Clinical chemistry Hémato -logy Hémo-stasis 10 Source : BioMérieux
The two sub-segments of emerging markets addressed by Ipsogen represent a potential market of over 800 million €.
Size of segments (€m) 2 300 1 800 8 700 9 100 1 200 1 200 Annual growth 3 – 4% 10 – 12% 3 – 4% 4 – 5% 3 – 4% 3 – 4%
Source : Scientia Advisors Source : Scientia Advisors
35% 17% 14% 10% Oncologiy Diseases
infectious Genetics Blood screning
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Value of a diagnostic test
100 - 500
Average price per test (€) ≥ 2 000
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0.5 - 2 5 - 10
20 - 50
Commodity Low value
tests High value tests VIH Genotyping SeptiFast OncotypeDX HER/neu NA+ Glucose Thyroïds Ipsogen Blood Tests Ipsogen Breast Tests Therapy drivers
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Molecular diagnostic a major contribution to survival in cancer
1900 Microscope 1970 Coloration 1980 Immunochimie 1990 Molecular Diagnostic 70% 89% 12
Molecular diagnostic, a break’s innovation
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3
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Number of leukemia’s type and subtypes Number of breast cancer type3
6
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5 indications / 60 products 2 Tests launched Taux de survie : 0%5
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Ipsogen Executive Summury
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Ipsogen in the Blood Cancers
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Ipsogen in the Breast Cancer
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Strong development since the IPO
Page 13
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Financial elements
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Strategy
Myeloproliferative neoplasm (ET, PV, MI) 32% Chronic Myeloid Leukemia (CML) 10% Chronic Lymphocytic Acute Lymphoblastic Leukemia (ALL) 9% Acute Myeloid Leukemia (AML) 27%
Blood cancer molecular diagnostic
an emerging market
Main leukemia subtypes by
frequency 144 M€
• Ipsogen offer the most comprehensive range of molecular tests to screen, diagnose or monitor leukemia’s 14 Chronic Lymphocytic Leukemia (CLL) 22% 14 A leader in onco-hematology MDx • A 144 M€ potential market WW - --2002 2004 2008 PML-RARA WT1 NPM1
BCR-ABL TEL-AML1 …. BCR -ABL JAK 2 V617F 12 M€
• Exclusive and worldwide Intellectual property
• A potential market of 2 millions tests in developed countries for 2 majors application : screening and follow-up
JAK2, a breakthrough test in Ipsogen portfolio
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• 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
Favourable Competitive Landscape
• Small number of competitors, mostly small scale companies
• Unique product range
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0.7 1.1
2.1
3.9
2005 2006 2007 2008
A growing commercial franchise
• Strong recurrence of sales
Sales 2008 by countries • Sales in 48 countries France 12% EU (Excluding France) 30% North America 44% Rest of the world 14%
Sales in Blood cancers (€m)
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Gross margin 2005-2008
• Gross margin in line with the major
actor in molecular diagnostic
• Sales in 48 countries
• Direct sales: 64% of revenue
61% 67% 73% 74% 2005 2006 2007 2008 Institutions 52% Distributors 22% Reference aboratories 25%
• 200 of the 450 main worldwide cancer treatment
centres
• Important prospection potential (e.g. the « non specialists » hospitals)
+ 250 clients
Product portfolio and development plan
JAK2 BCR-ABL Blood cancers JAK2 R&D Scientific evaluation Product development Clinical studies in EuropeLicensing Clinical studies
CE marking FDA clearance Reimbursment in the US 18
Distribution
51.5% 29.4% 19.1% 2008 JAK2 BCR-ABL Autres testsOther tests 28.2% 41.1% 30.8% 2007 Sales breakdown JAK2 WT1 Tests on the market JAK2 WT1Cliquez pour modifier le style du titre
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Ipsogen Executive Summury
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Ipsogen in the Blood Cancers
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Ipsogen in the Breast Cance
r
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Strong development since the IPO
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Financial elements
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Strategy
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
500 000 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
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patients
Chemotherapy unnecessary prescribed in 85% of cases
Toxic and expensive therapy (€12.000)
Large diagnostic unmet needs still exist
Should I prescribe chemotherapy?
Should I prescribe hormonotherapy?
Should I prescribe targeted therapy?
Breast Cancer
A unique portfolio of diagnostic tests developed to enhance existing pathology testing
Clinical examination / Mammography
Surgery
Breast Cancer Diagnosis
Sample MapQuant DxTMGrade
MapQuant DxTMFEC-R
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An estimated market over €700m
Targeted therapy: Yes / No? MapQuant Dx TMHER2 ® Immunotherapy Herceptin Chemotherapy Hormonotherapy Radiotherapy Hormone response
- IHC ER/PR Test
Herceptine response
- IHC / FISH HER2/neu Test
Hormonotherapy: Yes / No? MapQuant Dx TM HR Chemotherapy: Yes / No? Which chemotherapy ? Pronostic factors - Histological grade - Infiltration - Lymph nodes - Size of the tumor
Histological Grade Genomic 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
Breast cancer
MapQuant™ Genomic Grade resolves cases with equivocal 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
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86,000 new patients a year can benefit of MapQuant Dx
™
Genomic GradeFrom Sotiriou & al JNCI 2006 • A test validated on 2 800 + patients – many international publications
* Company bought by BioMerieux in September 2008 for $60m
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
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* 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
Portfolio and Development Plan
R&D Scientific evaluation Product development Clinical studies in EuropeLicensing Clinical studies
CE marking FDA clearance Reimbursment in the US 24 Launch just done Genomic Grade
Breast cancer tests
HER2 End of development Development HR FEC-R
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Ipsogen Executive Summury
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Ipsogen in the Blood Cancers
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Ipsogen in the Breast Cancer
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Strong development since the IPO
Page 25
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Financial elements
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Strategy
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Initial achievements in line with the market plan
• 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
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• 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
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Ipsogen Executive Summury
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Ipsogen in the Blood Cancers
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Ipsogen in the Breast Cancer
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Strong development since the IPO
Page 27
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Financial elements
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Strategy
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€m (IFRS) 2007 2008 Var.
Products Revenue 2.06 3.88 +88.6%
Services Revenue 0.48 0.24 -49.9%
Total Revenue 2.54 4.12 +62.4%
Operating revenue 2.65 4.34 +63.9%
Products gross margin 73.3% 74.3% na
Group gross margin 66.9% 71.6% na
Simplified consolidated P&L statement
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R&D costs 1.20 1.36 +12.9%
Marketing & Sales costs 0.67 1.74 +161.7%
Administrative costs 1.14 1.33 +16.5%
Operating Profit -1.21 -1.27 na
Net Profit -1.31 -1.10 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.
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€m (IFRS) Dec. 07 Dec. 08
Assets
Intangible fixed assets 0.55 1.59
Tangible fixed assets 0.30 0.48
Other non-current assets 0.26 0.09
Total Non-current assets 1.11 2.16
€m (IFRS) Dec. 07 Dec. 08
Liabilities
Shareholders’ equity 0.56 15.14
Advances over a year 0.51 0.36
Other non-current liabilities 0.23 0.57
Total Non-current liabilities 0.74 0.93
Simplified consolidated balance sheet
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Total Non-current assets 1.11 2.16
Inventories 0.24 0.39
Accounts receivable 0.46 0.97
Other current assets 0.73 1.26
Cash and cash equivalents 3.02 13.33
Total Current assets 4.45 15.95
Total Assets 5.56 18.11
Total Non-current liabilities 0.74 0.93
Trade accounts payable 0.57 1.02
Tax and social security liabilities 0.36 0.67 Financial debt
Under a year 3.29 0.00
Other current liabilities 0.04 0.34
Total of current liabilities 4.26 2.04
Total Liabilities 5.56 18.11
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€m (IFRS) 2007 2008
Net profit - 1.31 -1.10
Cash flow from operating activities - 0.36 0.46
Cash flow from investing activities - 0.61 -1.53
Cash flow from financial activities 3.47 11.36
Net cash increase 2.50 10.29
Cash flow table
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Net cash increase 2.50 10.29
Closing cash position 3.02 13.33
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Ipsogen Executive Summury
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Ipsogen in the Blood Cancers
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Ipsogen in the Breast Cancer
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Strong development since the IPO
Page 31
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Financial elements
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Strategy
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IPSOGEN: an efficient and secure economic model…
• 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
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• 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
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A strategy based on clear objectives
• 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
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• 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
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A WW commercial coverage
Direct presence in Germany, Austria, Netherlands
Direct presence in the USA : Ipsogen Inc with representatives on the West and East Coast
Direct presence in France Direct presence in UK and Scandinavia Distributor in Russia Distributors in
Austria, Belarus, Bulgari a, CZ, Slovakia, Italy, La tvia, Lithuania, Greece, Poland, Serbia, Sloveni
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2007 2008 Q1 2009
Marketing and Sales employees 6 11 16
Direct presence in Spain and Portugal
Distributor in Brazil Distributors in Egypt and South Africa
Distributors in China, Hong Kong, South
Korea, Japan, Malaysia, Australia, New Zealand Distributors in
India, Iran, Israel, Jorda n, Syria, UAE, Lebanon,
Pakistan, Saudi Arabia Poland, Serbia, Sloveni a, Turkey
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Ipsogen Executive Summury
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Ipsogen in the Blood Cancers
•
Ipsogen in the Breast Cancer
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Strong development since the IPO
Page 35
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Financial elements
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Strategy
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Why invest in Ipsogen?
• 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
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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
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General information
Capital 4,427,384 shares Managers 15.7 % Public 35.0 % Others 2.6 % Historical financial investors 46.7 % 37 Listing infosListed on Alternext by Euronext Paris Main index : Alternext All-Share Sector : biotechnology
Id: FR0010626028 - ALIPS
Contacts
Chairman and CEO : Vincent Fert –[email protected]
CFO: Stanislas Piot –[email protected]
NewCap – Financial communication: Axelle Vuillermet –[email protected]