ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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Contents1. The year in brief ..................................................................... 32. Products ............................................................................ 33. Financial information ................................................................ 44. Business development. .............................................................. 55. Employees .......................................................................... 56. Risk factors.......................................................................... 57. Shareholders ........................................................................ 58. Management bodies, the Board ...................................................... 59. Significant resolutions ............................................................... 7Translation of a report originally issued in Spanish. In the event of a discrepancy, the Spanish-language version prevails.2 • <strong>TiGenix</strong> • Rights Offering
1. The year in brief2008 has been a very important year for Cellerix as it hasreached its financial targets and continued to develop andconsolidate its most important projects.The Company’s Capital and Reserves have been strengthenedfollowing receipt of the second tranche from the capitalincrease carried out in 2007.R&D spending in the year increased by around 53%. Other costsincreased in line with expectations, mainly relating to staff costsas the number of employees grew sharply in the year.EBITDA in 2008 was negative, as in previous financial years, asthe Company is currently in the development phase. For thesereasons we do not consider that the figures are comparablewith those of previous financial years.December saw a milestone in terms of clinical trials, with therecruitment of the first patient for clinical trials of Ontaril totreat Crohn’s disease, while Phase III clinical trials of Ontaril fornon-Crohn’s patients and of Cx501 for Epidermolysis Bullosa areon schedule.To sum up, these achievements show that the Company hascontinued to strengthen its domestic and international strategyin 2008, reaching its targets on schedule.2. ProductsCx501 is an innovative chimeric skin graft that combinesexpanded cutaneous cells taken from the patient (autologous)and from a donor (allogeneic) to create a dermic matrix thatis less likely to be rejected by the patient, making it suitableas a long-term cutaneous repair treatment for sufferers ofEpidermolysis Bullosa Dystrophica Recessiva (EBDR). EBDR is anextremely debilitating hereditary skin disease that producessevere damage and blistering to the skin, and, in extremecases, causes the fingers to join together, a condition known assyndactylia.Given the relative rarity and serious nature of the conditionsfor which Cellerix is developing its products, and the scarcityof available treatments for them, both Ontaril and Cx501 havebeen designated as Orphan Drugs by the European MedicinesAgency (EMEA). This designation brings a number of benefitsfrom a product development standpoint, including researchgrants and subsidies, assistance and technical collaborationfrom the EMEA in the pursuit of clinical trials, a less costlyprocedure for obtaining regulatory approval to market theproducts in Europe, and exclusive marketing rights in Europefor ten years from the product launch date.Cellerix is also developing a new generation of products basedon the use of allogeneic expanded stem cells, i.e. obtainedfrom donors (Cx601 and Cx611). These programmes arecurrently in the pre-clinical development phase and are aimedat developing treatments for fistulas and certain autoimmunedisorders, respectively.Cellerix’s products are based on innovative cell therapytechnologies.Ontaril uses expanded stem cells obtained from humanadipose tissue taken from the patient being treated, making itan efficient mechanism for treating complex perianal fistulasbased on the cells’ own anti-inflammatory properties. Complexperianal fistulas are a rare, painful and debilitating disorder thatfrequently affect patients diagnosed with Crohn’s disease orother inflammatory intestinal conditions. In clinical trials, Ontarilhas proven to be over 70% effective in completely closingcomplex perianal fistulas after 8 weeks of treatment. There areestimated to be around 69,179 cases a year in Europe (the 27 EUcountries plus Switzerland, Monaco, Norway and Liechtenstein).Ontaril’s effective action represents a new approach to celltherapies using adult stem cells, which could potentially beapplied to the treatment of other inflammatory disorders.3 •
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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
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Fig. 6.2: Autologous Chondrocyte Im
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Preclinical work in a meniscus repa
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The Company is also ensuring high q
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Recognising the importance of pre-l
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In Spain, since the passage of Orde
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Fig. 6.6: ChondroMimetic procedure
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6.5.3 Commercial strategyBuilding o
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6.7 Manufacturing & logisticsEffici
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The international application WO06/
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ChondroMimetic competitionThe main
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in Cellerix’ GMP facility in Madr
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6.14.3 History and development of C
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The table below gives an overview o
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Prevalence No. of cases (2010) Esti
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Fig. 6.9: Platform development stra
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In developing Cx601, Cellerix has b
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6.14.6 Manufacturing & logisticsCel
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population, methods for the isolati
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• Cimzia (certolizumab) - UCB: Al
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Spanish Ministry of Education and S
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7.2 Consolidated income statementTw
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7.3.1.2 Research and development ex
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7.3.2.3 Selling, general and admini
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7.4.1 Cash flows from operating act
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Cash & cash equivalents and intangi
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As of December 31, 2010, the Group
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8. Consolidated Financial informati
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8.1.3 Consolidated cash flow statem
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8.1.5 Notes to consolidated financi
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operating results and operating pla
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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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Page 234 and 235: GrantsCellerix received several gra
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Page 242 and 243: Appendix 2: REGULATORY APPROVALPROC
Page 244 and 245: like ChondroCelect or the future ce
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Page 250 and 251: Title“Cell populations having imu
Page 252 and 253: D. Trademarks of CellerixThe table
Page 254 and 255: Decision resources.Dell’Accio, F.
Page 256 and 257: Noyes, F. R., Barber-Westin, S. D.,
Page 258 and 259: Appendix 5: 2008, 2009 and2010 mana
Page 260 and 261: Contents1. The year in brief ......
Page 262 and 263: 2. Financial informationa. The Inco
Page 264 and 265: The Directors shall call a Sharehol
Page 266 and 267: • Exercise price changed to 5.291
Page 268 and 269: 10 • TiGenix • Rights Offering
Page 270 and 271: Contents1. The year in brief ......
Page 274 and 275: Exceptionally, for the following re
Page 276 and 277: (d)(e)Duration: The Options Plan wi
Page 282 and 283: eceipt sent to the number or addres
Page 284 and 285: THE COMPANYTiGenix NVRomeinse straa
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ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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