ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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In Germany, thirty-six German hospitals filed for NUB approvalat the end of 2010. These hospitals were recently informed byInEK that the product obtained this year NUB Status 4 meaningthat ChondroCelect is eligible for reimbursement on a case bycase basis.In Spain, a decision on the national level is expected in thesecond quarter of 2011. Discussions at the regional level willfollow and are currently being prepared.7.12 Outlook7.12.1 Outlook 2011 and beyondTiGenix will focus on the commercial activities of its leadproducts ChondroCelect and ChondroMimetic in Europe andwill try to broaden the geographic scope towards EasternEurope, North America and Asia.• the Company obtaining timely regulatory marketingapprovals for ChondroCelect and ChondroMimetic in othergeographic markets; and• the prevailing and future competitive and regulatoryenvironment.The Company will continue to expand its research anddevelopment capabilities and facilities to cope withthe development of its product pipeline, to be able tomanage the products that reach the validation phase. TheCompany will also continue to expand its commercial andmanufacturing capabilities to cope with the commercial rolloutof ChondroCelect and ChondroMimetic in the differentgeographic markets. As a result, it is not certain that TiGenix willreach profitability in the years to come.The sales of ChondroCelect should increase further andwill be complemented by the sales of ChondroMimetic. It isanticipated that sales should increase significantly once positivereimbursement decisions are obtained for ChondroCelect anddistribution agreements are signed for ChondroMimetic.Further efforts in maintaining the regulatory approvals and inexpanding the manufacturing capacity for its lead products areenvisaged.Finally, the Company will continue to progress its stem cellspipeline, in particular the Phase I/II in Rheumatoid Arthritis andthe initialisation of the clinical study for Cx621 (intra-lymphaticadministration of eASCs) and anticipates to obtain some CEmarkextensions for ChondroMimetic.Despite the anticipated growth in revenues, it is expected thatTiGenix will be in a net loss situation in 2011.7.12.2 Outlook beyond 2011In the coming years, an increasing part of TiGenix’ revenuesshould be generated from the sales of ChondroCelect andChondroMimetic. However, the timing and growth of theserevenues will depend, among others, on:• the (in)ability of TiGenix to successfully commercialise itslead products in Europe;• the pricing and the (in)ability to obtain reimbursement of itslead products in the market;163 •
8. Consolidated Financial informationon TiGenix8.1 Audited Consolidated financial statements 2010 - 2009 - 2008The consolidated financial statements of TiGenix have been drawn up in accordance with the IFRS accounting principles as adoptedby the EU, which are set out in the coming pages. The consolidation scope can be found in section 8.1.5.30.8.1.1 Consolidated income statement & statement of comprehensive incomeYears ended December 31Thousands of Euro (€) Notes 2010 2009 2008CONSOLIDATED INCOME STATEMENTSales billed 982Deferred sales (361)Sales 8.1.5.3 621 46 0Other revenues 8.1.5.3 1,802 986 321Revenues 2,423 1,032 321Cost of sales (860) 0 0Gross Profit 1,563 1,032 321Research and development expenses 8.1.5.4.a 9,873 8,114 9,975Selling, general and administrative expenses 8.1.5.4.b 8,353 7,316 6,851Other operating income 0 0 0Other operating expenses 0 0 0Total operating charges 18,226 15,430 16,825Operating Result (EBIT*) (16,663) (14,398) (16,505)Financial result 8.1.5.6 579 300 1,340Profit/(Loss) before taxes (16,084) (14,098) (15,165)Income taxes 8.1.5.22 368 0 0Net Profit/(Loss) (15,716) (14,098) (15,165)Attributable to equity holders of TiGenix NV (15,716) (14,098) (15,165)Basic loss per share (0.51) (0.55) (0.62)CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOMENet Profit/(Loss) (15,716) (14,098) (15,165)Currency translation differences (376) 107 (124)Other comprehensive income/(loss) (376) 107 (124)Total comprehensive income/(loss) (16,092) (13,991) (15,289)Attributable to equity holders of TiGenix NV (16,092) (13,991) (15,289*EBIT: Earnings before interest and taxesw164 • TiGenix • Rights Offering
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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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to comply with any of its obligatio
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3.11.2 Scenario 1: Existing Shareho
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• a pledge of Locked Shares to a
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4. General information about THECOM
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DateINCORPORATIONFebruary 21,2000Tr
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Upon completion of the IPO of TiGen
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Issue dateMay 14,2004April 20,2005T
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4.7.2 Voting rightsAs further descr
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can be obtained free of charge at t
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5.2.4 Composition of the Board of D
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Amonis. Mr. Duron has been CEO of K
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5.3.4 Nomination and remunerationco
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• investor relations: nurturing c
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The remuneration of the members of
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5.7.2 Shares and warrants held by e
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Cellerix EBIP 2010An EBIP for senio
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The minutes must also contain a jus
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6. Activities of Tigenix andits sub
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• Clinical stage pipeline. TiGeni
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6.3.3 Acquisition of CellerixAs a r
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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 and 132: In Spain, since the passage of Orde
Page 133 and 134: Fig. 6.6: ChondroMimetic procedure
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: As of December 31, 2010, the Group
Page 177 and 178: 8.1.3 Consolidated cash flow statem
Page 179 and 180: 8.1.5 Notes to consolidated financi
Page 181 and 182: operating results and operating pla
Page 183 and 184: The Group does not account for work
Page 186 and 187: 8.1.5.4 Operating result (EBIT)Resu
Page 188 and 189: 8.1.5.7 TaxesThere is no current ta
Page 190 and 191: 8.1.5.10 Tangible assetsThousands o
Page 192 and 193: 8.1.5.14 Deferred charges & accrued
Page 194 and 195: 8.1.5.18 Finance lease obligations
Page 196 and 197: Business combination Cellerix SADes
Page 198 and 199: Weighted averageexercise priceTOTAL
Page 200 and 201: the respective issue date of the wa
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Page 204 and 205: 8.1.5.28 Subsequent eventsAcquisiti
Page 206 and 207: 8.1.5.31 Disclosure under Article 1
Page 208 and 209: Additional statementsThe preparatio
Page 210 and 211: 9.1.2 Stand-alone balance sheetYear
Page 212 and 213: 9.1.4 Stand-alone statement of chan
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Page 216 and 217: The clinical development of new dru
Page 218 and 219: future against which they may be ap
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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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