Read the Registration Document - Guerbet

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SOCIAL, ENVIRONMENTAL AND SOCIETAL RESPONSIBILITY 601) SOCIAL INFORMATION 602) ENVIRONMENTAL INFORMATION 663) SOCIETAL INFORMATION 69FINANCIAL STATEMENTS AND NOTES 701) CONSOLIDATED FINANCIAL STATEMENTS AND NOTES 702) AUDITORS’ REPORT ON THE CONSOLIDATED FINANCIAL STATEMENTS 1113) PARENT COMPANY FINANCIAL STATEMENTS AND NOTES 1134) AUDITORS' REPORT ON THE SEPARATE ANNUAL FINANCIAL STATEMENTS 1355) AUDITORS' SPECIAL REPORT ON RELATED PARTY AGREEMENTS AND COMMITMENTS 137ORDINARY AND EXTRAORDINARY GENERAL MEETING OF 24 MAY 2013 1391) AGENDA 1392) RESOLUTIONS SUBMITTED TO SHAREHOLDERS 1403) REPORT OF THE BOARD OF DIRECTORS ON THE PROPOSED RESOLUTIONS 145ADDITIONAL INFORMATION 1501) RESPONSIBILITY STATEMENT 1502) THE STATUTORY AUDITORS 1513) SHARE CAPITAL 1514) DOCUMENTS ON DISPLAY 152A) GENERAL INFORMATION ABOUT THE COMPANY 1526) ARTICLES OF ASSOCIATION (SELECTED PROVISIONS) 1537) 2013 SHAREHOLDERS CALENDAR 1558) CONCORDANCE TABLES 1563
CHIEF EXECUTIVE OFFICERS’ MESSAGEYves L'Epine, Guerbet Chief Executive Officer"A strategy combining optimal growth and profitability"What was the profile of results in 2012?Last year, our revenue reached €403.5 million. This represented growth of 6.8%, exceeding ourexpectations, and driven in part by an exceptional performance for sales in Europe at year-end.In terms of the geographic breakdown, these gains were driven mainly by Europe (up 9%) and Asia (up22.3%). With this trend, Asia will become, along with the United States, our primary source of growth overthe next five years. In contrast, this year sales in the Americas declined 8% due to under-performance inBrazil from increased competition on prices. It is now important to focus in priority on those customers ableto absorb the rise in raw material prices (mainly iodine) to stop the erosion in prices in Latin America. Exportsales that now account for 70% of total revenue are continuing to build momentum.In terms of market segment, MRI increased to 40% of revenue contributing to a more balanced businessmix for the Group alongside the X-ray segment (50% of revenue in 2012), with interventional radiology,medical equipment and miscellaneous products accounting for the remaining 10%.Our financial results in turn benefited from sales growth and the success of projects in 2012. EBITDA rosenearly 30% to €54.9 million or 13.6% of sales while operating profit and net income each surged by morethan 40%. Finally, Guerbet is supported by a solid balance sheet with debt remaining under control atslightly more than €100 million which allows us to respect a ratio of Net debt/EBITDA of 1.80What were the major projects in 2012?I would mention in particular the registration of Dotarem® in the US market, the certification of productionsites by the FDA, investments made to double our production capacity, the reduction in operating andmanufacturing expenses, the streamlining of our system of corporate governance as well setting prioritiesfor our portfolio of existing products and R&D projects.Dotarem® was approved in the United States on 21 March 2013. Should this be considered a majorsuccess for Guerbet?The US Food and Drug Administration (FDA) approved Dotarem® last March, after the end of fiscal 2012.This gadolinium-based contrast agent (GBCA) is indicated for intravenous use with magnetic resonanceimaging (MRI) in brain, spine and associated tissues in adult and paediatric patients (2 years of age andolder). This approval indeed represents a major milestone for Guerbet which has a proud history ofproviding safe and effective contrast agents to patients worldwide.Dotarem® - already a leader in Europe – is a compelling new CNS imaging option for US healthcareproviders and enriches our product portfolio for improved patient management through diagnostic imagingin the US.The US represents a promising growth market. It is estimated that there were more than 10 million contrastenhancedMRI examinations performed in the US in 2011, with approximately 60% of these examinationsperformed to image the CNS. Our objective is to acquire a 15%-20% market share in 5 years.Has your model for research and development been readjusted?We have refocused priorities within our research and development programmes with an emphasis onachieving a balance between projects, i) new chemical entities (NCEs), ii) product lifecycle management forexisting products and iii) solutions or services for medical equipment. This choice reflects a desire tooptimise the allocation of risks. NCEs in effect have a high risk of failure (new requirements by authoritiesfor market approval) and are subject to new economic constraints imposed by the healthcare payers.Among these NCEs, we consequently decided to focus in priority on P3277, a new generation ofgadolinium-based products expected to enter phase 1 trials in the 2013 second half. Our total research anddevelopment budget has remained sustained (10% of revenue), reflecting our strategy focused oncompetitiveness by developing innovative solutions.4
Page 3: CONTENTSCHIEF EXECUTIVE OFFICERS’
Page 7 and 8: THE GUERBET GROUP1) History of the
Page 9 and 10: 3) Business overview3.1 Guerbet is
Page 11 and 12: 3.4 The pathologiesIn Oncology, the
Page 13: Guerbet's offering of products is c
Page 16 and 17: c) Research & development• R&D ob
Page 18 and 19: • A proactive partnering strategy
Page 20 and 21: 5) Group organisation at 31 Decembe
Page 22 and 23: e) DistributionGuerbet distribute i
Page 24 and 25: DirectorsOther offices and director
Page 26 and 27: There exist no arrangements or unde
Page 28 and 29: Summary of compensation for Marie-C
Page 30 and 31: • Stock options granted to non-of
Page 32 and 33: I - 1Organisation of the work of th
Page 34 and 35: "Research and Innovation" Committee
Page 36 and 37: II - Internal control and risk mana
Page 38 and 39: 4) Statutory Auditors’ report pre
Page 40 and 41: SHAREHOLDER INFORMATION1) The Guerb
Page 42 and 43: As at 31 December 2010SHARESVOTING
Page 44 and 45: considered to have automatically re
Page 46 and 47: 10) Provisions of the Articles of A
Page 48 and 49: c) Earnings highlightsIFRS(in thous
Page 50 and 51: g) OutlookStrongly focused on the n
Page 52 and 53: 3) Risk factorsThe company conducte
Page 54 and 55:
• Sourcing risksGuerbet has an ex
Page 56 and 57:
• Information technology risksAn
Page 58 and 59:
• Five-year summary of consolidat
Page 60 and 61:
• Other information included in t
Page 62 and 63:
• Recruitment and dismissalsGuerb
Page 64 and 65:
and employee savings. The goal is s
Page 66 and 67:
• Measures adopted to promote emp
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) Pollution and waste managementThe
Page 70 and 71:
3) Societal informationa) Territori
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• Consolidated income statementIn
Page 74 and 75:
In thousands of euros• Statement
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Changes in standards and interpreta
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g) Research and development expendi
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Held to maturity investmentsHeld-to
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creation are recorded under "Other
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III) Notes to the financial stateme
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Aged trial balance information for
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2.2 - Borrowings by currencyCurrenc
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3.3 - Analysis of the sensitivity o
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Revenue2012European companiesfor th
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In 2005, the Group acquired for ¥5
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6.2 - Analysis of property, plant a
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The change in the net value of inve
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12.2 - Accrued employee benefitsa)
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Change in net liabilities of the pe
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14.4 - Personnel by region at year-
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Note 22 - Research and development
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Note 25 - Related parties25.1 - Rel
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Note 27 - Basic earnings per share
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2) Auditors’ report on the consol
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3) Parent company financial stateme
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• Income statementIn thousands of
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• Statement of cash flowsIn milli
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c) Property, plant and equipmentPro
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Note 1 - Intangible assets1 - 1 - C
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Note 6 - Receivables by maturityCos
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Note 9 - Regulated provisionsInvest
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Note 13 - Sales by region2012 2011F
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Tax income or expense recorded in t
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Debt waiver agreements granted to a
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Capital lease commitments relative
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4) Auditors' report on the separate
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5) Auditors' special report on rela
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ORDINARY AND EXTRAORDINARY GENERAL
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RESOLUTION THREE (Special report of
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Extraordinary resolutionsRESOLUTION
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3) Report of the Board of Directors
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Application of legal provisions gov
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• Tenth draft resolution: stock s
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2) The Statutory Auditorsa) Statuto
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6) Articles of association (selecte
Page 156 and 157:
7) 2013 shareholders calendarEventD
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) Annual financial reportInformatio
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