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3.5 Guerbet productsGuerbet growth is based in large part on three major product ranges: Dotarem® (MRI), Xenetix® (X-ray)and Lipiodol®.Dotarem®, a non-specific gadolinium-based MRI contrast agent, has been Guerbet’s largest contributor torevenue since 2010 and the market leader in volume in Europe. Its physio-chemical properties (it is also theonly ionic macrocyclic contrast agent available which gives it a particularly high thermodynamic stability)and its optimal security profile makes it the industry standard for MRI. Dotarem® is used for the explorationof many pathologies and in particular for central nervous system, digestive tract, osteoarticular and vasculardiseases.First launched on the market in1989, Dotarem® acquired a leadership position in 2008 when theappearance of serious undesirable side effects were noted with the injection of MRI contrast products.Nephrogenic Systemic Fibrosis (NSF) is a potentially fatal disease that may arise in conjunction with theuse of gadolinium-based contrast agents for certain patients suffering from severe renal failure. EuropeanHealth Authorities have divided Dotarem® and its competing products into three categories for the risk ofincidence of this illness (high, intermediary and low risk). These classifications were issued on the basis ofdifferent recommendations on precautions of use and contraindications for products involving high risks forcertain population groups.Dotarem® has been identified as a low-risk product. This decision has contributed to strong growth byDotarem®. Today it is the leader in Europe with a 47% 1 market share and registering strong sustainedgrowth in other international markets.Xenetix®, for x-ray imaging (XR) is a second-generation low osmolar contrast media or non-ionic LOCM(low osmolar contrast media). It has had a track record of regular growth both for volume sales and revenuesince it was first launched in 1995.Xenetix® initially distributed in bottle format, has also been available in polypropylene flexi-bag packaging(Xenetix® in Scanbag®) since 2006 with successive launches in key European markets thereafter. Thisoriginal and innovative packaging makes it possible to preserve the qualities of Xenetix® while simplifyingprocedures of use by improving safety for patients and medical personnel, as well as by introducing notableadvances in waste management. This packaging solution also represents Guerbet's response to theincreasingly important problem of sustainable development.Xenetix® is available with two concentrations of iodine, 300 and 350 mg per millilitre. It is generallyaccepted that 350 mg per millilitre is the preferred concentration for cardiovascular pathologies, while 300mg per millilitre is used for the exploration of parenchymatous pathologies (for example, liver, kidney). Ingeneral, LOCM products offer a better tolerance than the first-generation HOCM (High Osmolar ContrastMedium) products combined with improved comfort for the patient when injected.Lipiodol® is today the only iodised oil contrast agent for x-ray imaging (XR). The company's origin wasbased on Marcel Guerbet’s discovery of Lipiodol® in 1901. Initially used as a therapeutic application, itbecame the first iodinated contrast agent injected into humans in 1921. In endocrinology, Lipiodol® in softcapsule form is used worldwide in the prevention of iodine deficiency for adults and children. For imaging,after having been indicated for lymphography, Lipiodol® is today mainly used in interventional radiology(IRT: Interventional Radiology and Theranostics) in the embolization of malignant tumours (primary cancersof the liver or liver metastasis) or benign tumours (arteriovenous malformations).For this purpose, Lipiodol®was granted a temporary authorisation for import by the US Food and Drug Administration (FDA) forinterventional radiologists and patients. Lipiodol® is also registered for chemo-embolization in Italy andMexico. In addition, for the exploration of female infertility, Lipiodol® has been shown to have therapeuticproperties after imaging exams.1 ECMIG database - European Contrast Medial Industry Group - produced by the US company W&W services in 200811
Guerbet's offering of products is completed by other ranges to better meet the needs of healthcareprofessionals:Hexabrix® is currently the only ionic LOCM x-ray agent available on the market. This product has particularphysio-chemical properties conferring it with a good renal tolerance and can be used to visualise the risk ofarterial thrombosis. As such it is a molecule of choice for radiologists and interventional cardiologists as wellas vascular surgeons for cardiovascular exploration.Telebrix®, an x-ray product belonging to the HOCM category of contrast products (developed prior toLOCM and gradually being replaced by the latter notably for scanner examinations). Because of itsexcellent acceptability, Telebrix® continues to be used in a number of countries. It also retains preferredindications in its drinkable form of Telebrix® Gastro®, particularly useful for digestive tract examinationsand in particular for the performance of virtual colonoscopies for colorectal cancer. This examination ishenceforth officially recognised as useful for a certain number of patients (recommendation of the FrenchNational Authority for Health (Haute Autorité de Santé or HAS) of February 2010).Optiray®/Optiject®, a non-ionic LOCM x-ray product, is marketed by Guerbet under license by Covidienin France, Belgium and Switzerland. Optiject® is an alternative presentation of Optiray® packaged in prefilledsyringes. In addition, Guerbet distributes a range of injectors and medical devices of the CovidienGroup for the same geographical markets.Oxilan®, a non-ionic LOCM x-ray product, was added to the Group's line of x-ray contrast products inFebruary 2002 within the framework of an agreement concluded with the North American company, Cook.Since this date, Oxilan® has been sold directly in the U.S. and in Japan under the Imagenil® brand nameby Terumo, the exclusive distributor for Guerbet products in Japan following the agreement concluded sinceOctober 2005.Artirem®, an arthrography-specific MRI contrast agent was successfully launched in the main Europeancountries. This is the first product proposed for these pathologies for exploration through local injection(intra-articular). Artirem® enables Guerbet to propose an expanded and differentiated MRI offering.Injectors and medical devicesMedex, acquired by Guerbet Group in late 2004 sells a range of medical equipment that includes injectorsfor x-ray scanners as well as the associated medical devices.An injector was specifically developed for x-ray scanners (SBI 5002-CT®) allowing for the exclusive use offlexi-bags ScanBag® for Xenetix®. This development makes it possible to propose a service offeringadapted to radiology clinics ranging from contrast media, injection systems and medical devices (Secufill®,Manyfill®, Linkfill®). Its gradual commercial introduction in Europe will enable Guerbet and Medex toreconcile the goals of clinical utility, ease-of-use and sustainable development, notably in terms of reducedwaste.12
Page 3 and 4: CONTENTSCHIEF EXECUTIVE OFFICERS’
Page 5 and 6: CHIEF EXECUTIVE OFFICERS’ MESSAGE
Page 7 and 8: THE GUERBET GROUP1) History of the
Page 9 and 10: 3) Business overview3.1 Guerbet is
Page 11: 3.4 The pathologiesIn Oncology, the
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
Page 68 and 69:
) Pollution and waste managementThe
Page 70 and 71:
3) Societal informationa) Territori
Page 72 and 73:
• Consolidated income statementIn
Page 74 and 75:
In thousands of euros• Statement
Page 76 and 77:
Changes in standards and interpreta
Page 78 and 79:
g) Research and development expendi
Page 80 and 81:
Held to maturity investmentsHeld-to
Page 82 and 83:
creation are recorded under "Other
Page 84 and 85:
III) Notes to the financial stateme
Page 86 and 87:
Aged trial balance information for
Page 88 and 89:
2.2 - Borrowings by currencyCurrenc
Page 90 and 91:
3.3 - Analysis of the sensitivity o
Page 92 and 93:
Revenue2012European companiesfor th
Page 94 and 95:
In 2005, the Group acquired for ¥5
Page 96 and 97:
6.2 - Analysis of property, plant a
Page 98 and 99:
The change in the net value of inve
Page 100 and 101:
12.2 - Accrued employee benefitsa)
Page 102 and 103:
Change in net liabilities of the pe
Page 104 and 105:
14.4 - Personnel by region at year-
Page 106 and 107:
Note 22 - Research and development
Page 108 and 109:
Note 25 - Related parties25.1 - Rel
Page 110 and 111:
Note 27 - Basic earnings per share
Page 112 and 113:
2) Auditors’ report on the consol
Page 114 and 115:
3) Parent company financial stateme
Page 116 and 117:
• Income statementIn thousands of
Page 118 and 119:
• Statement of cash flowsIn milli
Page 120 and 121:
c) Property, plant and equipmentPro
Page 122 and 123:
Note 1 - Intangible assets1 - 1 - C
Page 124 and 125:
Note 6 - Receivables by maturityCos
Page 126 and 127:
Note 9 - Regulated provisionsInvest
Page 128 and 129:
Note 13 - Sales by region2012 2011F
Page 130 and 131:
Tax income or expense recorded in t
Page 132 and 133:
Debt waiver agreements granted to a
Page 134 and 135:
Capital lease commitments relative
Page 136 and 137:
4) Auditors' report on the separate
Page 138 and 139:
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
Page 150 and 151:
• Tenth draft resolution: stock s
Page 152 and 153:
2) The Statutory Auditorsa) Statuto
Page 154 and 155:
6) Articles of association (selecte
Page 156 and 157:
7) 2013 shareholders calendarEventD
Page 158 and 159:
) Annual financial reportInformatio
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