Document De Référence 2012
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NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN UNAPPROUVED ENGLISH TRANSLATION DOCUMENT DE RÉFÉRENCE 2012 NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN This page is intentionally blank. NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN IMPORTANT NOTICE IF YOU DO NOT AGREE TO THE TERMS AND CONDITIONS CONTAINED IN THIS NOTICE, YOU SHOULD NOT READ THE FOLLOWING ENGLISH LANGUAGE DOCUMENT AND SHOULD DELETE IT UNDER ANY FORMAT. You must read the following before continuing. The following applies to the English language convenience translation of the original French-language version of the “Document de Référence”, dated 27 April 2011, published by CARMAT ("the Company") and registered with the Autorité des Marchés Financiers (“AMF”), the French Financial Markets Authority, under number R.13-027 on 30 May 2013 (the “Unapproved English Translation of the Document de Référence”) following this notice. In accessing the Unapproved English Translation of the Document de Référence, you agree to be bound by the following terms and conditions. The original French-language version of the “Document de Référence” has been translated into English for the benefit and convenience of the recipients of this Unapproved English Translation of the Document de Référence. The following Unapproved English Translation of the Document de Référence may not be forwarded or distributed to any other person and may not be reproduced in any manner whatsoever. Failure to comply with this requirement may result in a violation of applicable laws. This Unapproved English Translation of the Document de Référence has not been reviewed or approved by any French, foreign or national regulatory authority. To the fullest extent permitted by applicable laws, CARMAT disclaims all liability arising from the translation and any inconsistencies between the French-language registered “Document de Référence” and this Unapproved English Translation of the Document de Référence. In the event of a discrepancy between this Unapproved English Translation of the Document de Référence and the French-language registered “Document de Référence”, the French-language registered document shall prevail. The publication of this Unapproved English Translation of the Document de Référence in certain countries may violate applicable regulations. The information contained therein does not constitute an offer of securities in the United States, Canada, Australia or Japan or in any other jurisdiction. This Unapproved English Translation of the Document de Référence should not be published, transmitted or distributed, directly or indirectly, into the United States, Canada, Australia or Japan or in any other jurisdiction. Nothing in the Unapproved English Translation of the Document de Référence constitutes an offer of securities for sale in any jurisdiction. No public offering of securities will be conducted in France prior to the delivery by the AMF of a visa on a prospectus that complies with the provisions of Directive 2003/71/EC and no public offering of securities will be conducted abroad. This Unapproved English Translation of the Document de Référence is not an offer for sale or a solicitation of offers to purchase CARMAT securities in the United States. The securities of CARMAT may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. CARMAT does not intend to register any portion of the offering in the United States or to conduct a public offering of securities in the United States. This Unapproved English Translation of the Document de Référence is for distribution only to persons who (A) are outside the United Kingdom, or (B) are qualified investors as described in section 86(7) of the Financial Services and Markets Act 2000 and (i) have professional experience in matters relating to investments falling within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"), or (ii) are persons falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc") of the Order (all such persons together being referred to as "relevant persons"). This Unapproved English Translation of the Document de Référence is directed only at relevant persons and must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this document relates is available only to relevant persons. This Unapproved English Translation of the Document de Référence must not be used as the basis of an investment decision. This Unapproved English Translation of the Document de Référence contains forward- looking statements. No guarantee can be given as to any of the events anticipated by the forward-looking statements, which are subject to inherent risks, including, but not limited to, those described in the original French-language documents registered with the AMF, changes in economic conditions, the financial markets or the markets in which CARMAT operates. NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN This page is intentionally blank NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN A Société Anonyme with share capital of €166,427.80 Registered address: 36, avenue de l’Europe Immeuble l’Étendard Energy III 78140 Velizy-Villacoublay Versailles Trade and Companies’ Register 504 937 905 DOCUMENT DE RÉFÉRENCE 2012 In accordance with its General Regulations, in particular Article 212-13, the Financial Markets Authority has registered this Document de Référence on May 30, 2013 under number R.13.027. Pursuant to the provisions of Article L. 621-8-1-I of the Financial and Monetary Code, registration took place after the AMF had established that the document was complete and understandable, and that the information it contains was coherent. Registration does not imply that the AMF has authenticated the accounting and financial information presented. This document may be used in connection with a financing operation if it is supplemented by an operation note signed by the Financial Markets Authority. This Document de Référence has been drawn up by the issuer and liability is borne by its signatories. This document incorporates by reference: - The 2010 Document de Référence registered by the Financial Markets Authority on April 27, 2011 under number R.11-017 (the "2010 Document de Référence "). - The 2011 Document de Référence registered by the Financial Markets Authority on Wednesday, September 12, 2012 under number R.12-044 (the "2011 Document de Référence"). Copies of this Document de Référence are available free of charge from the head office of CARMAT, 36 avenue de l’Europe – Immeuble l’Etendard Energy III – 78140 Vélizy Villacoublay. This Document de Référence can also be consulted on the CARMAT website (www.carmatsas.com) and on the website of the Financial Markets Authority (www.amf-france.org). NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION IN WHOLE OR IN PART IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN CONTENTS 1 AUTHOR _________________________________________________ 9 1.1 AUTHOR OF THE DOCUMENT DE RÉFÉRENCE ........................................................................... 9 1.1.1 DECLARATION OF THE AUTHOR OF THE DOCUMENT DE RÉFÉRENCE ......................................................... 9 2 AUDITORS ______________________________________________ 10 2.1 STATUTORY AUDITORS ........................................................................................................... 10 2.2 ALTERNATE AUDITORS ........................................................................................................... 10 2.3 STATUTORY AUDITORS WHO RESIGNED, WERE DISMISSED OR WERE NOT REINSTATED ........................................................................................................................... 10 2.4 AUDITORS’ FEES ..................................................................................................................... 10 3 SELECTED FINANCIAL INFORMATION ____________________ 11 4 RISK FACTORS __________________________________________ 12 4.1 RISKS RELATING TO THE COMPANY’S ACTIVITY ...................................................................... 12 4.1.1 Risks of failure or delays in the development of the total artificial heart ..................................... 12 4.1.2 Risks involved with dependence on the total artificial heart ..................................................................... 13 4.1.3 Risks relating to competition ...................................................................................................................... 13 4.1.4 Risks of a commercial failure...................................................................................................................... 14 4.1.5 Dependence risks relating to current and future strategic partnerships and collaborations .................... 14 4.1.6 Risks connected with a slowdown in the Company’s efforts to train cardiac surgeons ............................ 15 4.1.7 Risks connected with outsourcing the manufacture of the components