REFERENCE DOCUMENT Annual Financial Report

REFERENCE DOCUMENT Annual Financial Report

REFERENCE DOCUMENT Annual Financial Report Translation for informational purposes only This Reference Document was filed with the Autorité des Marchés Financiers on April 17, 2014, pursuant to Article 212-13 of the General Regulations of the Autorité des Marchés Financiers . This Reference Document can be used in connection with an offering of securities if accompanied by a Note d’opération approved by the Autorité des Marchés Financiers. This document was prepared by the issuer and its signees are responsible for its content. CONTENTS 1. RESPONSIBLE PERSONS .......................................................................................................................................... 5 1.1. Persons responsible for information ................................................................................................................... 5 1.2. Declaration by the responsible person ................................................................................................................ 5 2. STATUTORY AUDITORS ............................................................................................................................................ 6 3. SELECTED FINANCIAL DATA................................................................................................................................. 7 4. RISK FACTORS ............................................................................................................................................................ 8 4.1. Risks specific to the Company ............................................................................................................................. 8 4.1.1. Risks related to the therapeutic approaches selected by the Company ...................................................... 8 4.1.2. Risks related to clinical trials ........................................................................................................................ 8 4.1.3. Risks related to commercial-scale production ........................................................................................... 10 4.1.4. Risks related to product adverse side effects ............................................................................................. 10 4.1.5. Risks related to the funding of the Company’s development and activities ............................................. 10 4.1.6. Risks related to previous and future losses ................................................................................................ 11 4.1.7. Specific risks related to development, manufacturing and marketing partnerships ............................... 11 4.1.8. Dependence on qualified personnel ............................................................................................................ 12 4.2. Risks related to the Company’s business segment ........................................................................................... 12 4.2.1. Risks related to competition and technological progress .......................................................................... 12 4.2.2. Specific risks related to patents and third-party intellectual property rights .......................................... 12 4.3. Financial risks .................................................................................................................................................... 13 4.3.1. Exchange rate risk ....................................................................................................................................... 13 4.3.2. Interest rate risks ........................................................................................................................................ 14 4.3.3. Liquidity risks ............................................................................................................................................. 14 4.3.4. Share risks ................................................................................................................................................... 15 4.4. Legal risks .......................................................................................................................................................... 15 4.4.1. Specific risks related to patents .................................................................................................................. 15 4.4.2. Specific risks related to patent litigation .................................................................................................... 16 4.4.3. Product liability ........................................................................................................................................... 16 4.4.4. Specific risks related to the use of hazardous products and those that are harmful to the environment ................................................................................................................................................. 17 4.5. Insurance and Risk Coverage ........................................................................................................................... 17 4.6. Regulatory risks ................................................................................................................................................. 17 4.6.1. Risks related to the Company’s regulatory environment ......................................................................... 18 4.6.2. Risks related to obtaining marketing authorizations ................................................................................ 18 4.6.3. Risks related to changes or announcements about drug reimbursement policies ................................... 19 5. INFORMATION ABOUT THE ISSUER .................................................................................................................. 20 5.1. History and development of the Company ....................................................................................................... 20 5.1.1. Legal Name and Commercial Name .......................................................................................................... 20 5.1.2. Place of Registration and Registration Number ........................................................................................ 20 5.1.3. Date of Incorporation and Duration .......................................................................................................... 20 5.1.4. Registered Office, Legal Form and Applicable Law ................................................................................. 20 5.1.5. Significant Events in the Development of the Company’s Business ......................................................... 20 5.2. Investments ........................................................................................................................................................ 22 6. BUSINESS OVERVIEW............................................................................................................................................. 23 6.1. Principal activities .............................................................................................................................................. 23 6.1.1. Nature of Business ...................................................................................................................................... 23 6.1.2. Research and Development ......................................................................................................................... 23 6.1.3. Production ................................................................................................................................................... 25 6.1.5. Other products ............................................................................................................................................ 33 6.2. Principal Markets .............................................................................................................................................. 34 6.2.1. Cancer .......................................................................................................................................................... 34 6.2.1.1. Non-small cell lung cancer .............................................................................................................. 35 6.2.1.2. Hepatic cancers ............................................................................................................................... 35 6.2.1.3. Cancers caused by the Human Papilloma Virus (HPV) ............................................................... 35 6.2.2. Chronic infectious diseases ......................................................................................................................... 36 2 6.2.2.1. Hepatitis C Virus Infection ............................................................................................................. 36 6.2.2.2. Hepatitis B Virus Infection ............................................................................................................. 37 6.2.3. Competition ................................................................................................................................................. 37 6.3. Exceptional events .............................................................................................................................................. 38 6.4. Dependence of the Company on patents, licenses and trade agreements ......................................................

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