ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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Fig. 6.5: ChondroMimetic process steps1. Defect site prepared. 2. Scaffold placed in defect. 3. Scaffold conforms to fit defect4. Cells infiltrate scaffold. 5. Scaffold replaced with new tissue. 6. Repair mimics natural tissue.Animal data have confirmed the efficacy of ChondroMimeticon both the trochlea and condyles. These data havedemonstrated positive stainings for proteoglycans and typeII collagen, indicating good tissue repair and osseo- and softtissueintegration resulting in a seamless interface betweenthe implant and the defect site. Moreover, a recent head-toheadstudy compared the performance of ChondroMimeticto a marketed synthetic osteochondral scaffold in a 6mmx6mmchondral defect in a caprine model 38 . ChondroMimeticwas found to result in better histological results withfewer subchondral cysts than the marketed syntheticosteochondral implant.To provide convenience, the all-in-one, single use procedurepack (available in three diameters; 8mm, 10mm and 12mm)comprises site-preparation instruments (drill and cuttingtube) and a pre-loaded delivery device. The unique materialproperties of ChondroMimetic allow the implant to becompressed and delivered to the defect site in an accurate,reproducible technique, providing a strong interference fitand accurate restoration of the articular surface.ChondroMimetic is delivered with a disposable ArthroscopicProcedure Pack (Figure 6.6). This unique delivery system (patentpending) has been designed to ensure accurate and efficientplacement of ChondroMimetic in the defect site.38 A Getgood et al., “Evaluation of Early-Stage Osteochondral Defect RepairUsing a Biphasic Scaffold based on a Collagen-GlycosaminoglycanBiopolymer in a Caprine Model”. The Knee, Accepted, In Press121 •
Fig. 6.6: ChondroMimetic procedure packChondroMimetic is supplied with a disposable arthroscopic procedure pack.ChondroMimetic is compatible with both open and minimallyinvasive procedures already familiar to orthopaedic surgeons,and promotes the regenerative repair of articular cartilageand the underlying subchondral bone. By helping surgeonsto treat small cartilage damages shortly after it first occurs,ChondroMimetic aims at reducing the downstream risk ofosteoarthritis, giving patients a greater chance of delaying totaljoint replacement until later in life, or avoiding it altogether.Target indication and marketChondroMimetic is indicated for the repair of small (
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TiGenix NV(Public limited liability
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Table of ContentsSummary ..........
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3.7.1 Categories of potential inves
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5.7.1 Shares and warrants held by i
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7.5.2 Taxation.....................
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SummaryThe words written in capital
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Activities and strategy of the Comp
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• Two allogeneic adult stem cell
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• TiGenix’ success depends on i
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Unaudited pro forma income statemen
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Recent developmentsAcquisition of C
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In this context, we would like to s
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Announcement of the results of theO
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After the Contribution andafter the
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ContributionContribution AgreementC
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Risk factorsAny investment in the P
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commercialisation of ChondroCelect,
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in delays in bringing products to t
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The Company cannot predict what eff
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y each of its patents and patent ap
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to exercise preferential subscripti
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this prospectus which is capable of
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• investment professionals fallin
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1. General information and informat
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1.4.2 Company documents and otherin
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• the granting of discharge of li
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• in case of registered Shares, t
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cast at the meeting. If the amount
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No one may cast a greater number of
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If a Belgian resident individual ne
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Belgium has concluded tax treaties
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3. Information on the Contributiona
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In this context, we would like to s
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TiGenix has a limited financial deb
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Thousands of Euro (€) TiGenix Cel
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3.5.2 Issuance Price and RatioThe i
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(c)Rules for subscriptionSubject to
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The Scrips Private Placement will o
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Page 83 and 84: 3.11.2 Scenario 1: Existing Shareho
Page 85 and 86: • a pledge of Locked Shares to a
Page 87 and 88: 4. General information about THECOM
Page 89 and 90: DateINCORPORATIONFebruary 21,2000Tr
Page 91 and 92: Upon completion of the IPO of TiGen
Page 93 and 94: Issue dateMay 14,2004April 20,2005T
Page 95 and 96: 4.7.2 Voting rightsAs further descr
Page 97 and 98: can be obtained free of charge at t
Page 99 and 100: 5.2.4 Composition of the Board of D
Page 101 and 102: Amonis. Mr. Duron has been CEO of K
Page 103 and 104: 5.3.4 Nomination and remunerationco
Page 105 and 106: • investor relations: nurturing c
Page 107 and 108: The remuneration of the members of
Page 109 and 110: 5.7.2 Shares and warrants held by e
Page 111 and 112: Cellerix EBIP 2010An EBIP for senio
Page 113 and 114: The minutes must also contain a jus
Page 115 and 116: 6. Activities of Tigenix andits sub
Page 117 and 118: • Clinical stage pipeline. TiGeni
Page 119 and 120: 6.3.3 Acquisition of CellerixAs a r
Page 121 and 122: Full thickness articular cartilage
Page 123 and 124: Fig. 6.2: Autologous Chondrocyte Im
Page 125 and 126: Preclinical work in a meniscus repa
Page 127 and 128: The Company is also ensuring high q
Page 129 and 130: Recognising the importance of pre-l
Page 131: In Spain, since the passage of Orde
Page 135 and 136: 6.5.3 Commercial strategyBuilding o
Page 137 and 138: 6.7 Manufacturing & logisticsEffici
Page 139 and 140: The international application WO06/
Page 141 and 142: ChondroMimetic competitionThe main
Page 143 and 144: in Cellerix’ GMP facility in Madr
Page 145 and 146: 6.14.3 History and development of C
Page 147 and 148: The table below gives an overview o
Page 149 and 150: Prevalence No. of cases (2010) Esti
Page 151 and 152: Fig. 6.9: Platform development stra
Page 153 and 154: In developing Cx601, Cellerix has b
Page 155 and 156: 6.14.6 Manufacturing & logisticsCel
Page 157 and 158: population, methods for the isolati
Page 159 and 160: • Cimzia (certolizumab) - UCB: Al
Page 161 and 162: Spanish Ministry of Education and S
Page 163 and 164: 7.2 Consolidated income statementTw
Page 165 and 166: 7.3.1.2 Research and development ex
Page 167 and 168: 7.3.2.3 Selling, general and admini
Page 169 and 170: 7.4.1 Cash flows from operating act
Page 171 and 172: Cash & cash equivalents and intangi
Page 173 and 174: As of December 31, 2010, the Group
Page 175 and 176: 8. Consolidated Financial informati
Page 177 and 178: 8.1.3 Consolidated cash flow statem
Page 179 and 180: 8.1.5 Notes to consolidated financi
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The Group does not account for work
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8.1.5.4 Operating result (EBIT)Resu
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8.1.5.7 TaxesThere is no current ta
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8.1.5.10 Tangible assetsThousands o
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8.1.5.14 Deferred charges & accrued
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8.1.5.18 Finance lease obligations
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Business combination Cellerix SADes
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Weighted averageexercise priceTOTAL
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the respective issue date of the wa
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Transactions with non-executive dir
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8.1.5.28 Subsequent eventsAcquisiti
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8.1.5.31 Disclosure under Article 1
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Additional statementsThe preparatio
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9.1.2 Stand-alone balance sheetYear
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9.1.4 Stand-alone statement of chan
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) Standards and interpretations iss
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The clinical development of new dru
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future against which they may be ap
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Cellerix’ research and developmen
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YearThousandsof Euro2010 2009 2008E
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Thousands of Euro (€)Laboratoryeq
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Current financial assetsShown below
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At December 31, Cellerix’ share c
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9.1.5.17 Deferred revenueThe balanc
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9.1.5.21 Share-based paymentsThe EB
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GrantsCellerix received several gra
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10. Report regarding unaudited prof
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EMAFDAFibrous tissueGCPGMPGrowth fa
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Appendix 1: Press releases 2006-201
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Appendix 2: REGULATORY APPROVALPROC
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like ChondroCelect or the future ce
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TitleCountry/regionPatent/applicati
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TitleCountry/regionPatent/applicati
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Title“Cell populations having imu
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D. Trademarks of CellerixThe table
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Decision resources.Dell’Accio, F.
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Noyes, F. R., Barber-Westin, S. D.,
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Appendix 5: 2008, 2009 and2010 mana
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Contents1. The year in brief ......
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2. Financial informationa. The Inco
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The Directors shall call a Sharehol
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• Exercise price changed to 5.291
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10 • TiGenix • Rights Offering
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Exceptionally, for the following re
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(d)(e)Duration: The Options Plan wi
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eceipt sent to the number or addres
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THE COMPANYTiGenix NVRomeinse straa
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ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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