ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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Contents1. The year in brief ..................................................................... 32. Financial information ................................................................ 43. Business development ............................................................... 54. Employees .......................................................................... 55. Risk factors .......................................................................... 56. Shareholders ........................................................................ 57. Management bodies, the Board ...................................................... 58. Significant resolutions ............................................................... 79. Post-balance sheet events ........................................................... 910. Evolution of the business ........................................................... 9Translation of a report originally issued in Spanish. In the event of a discrepancy, the Spanish-language version prevails.2 • TiGenix • Rights Offering
1. The year in briefThe Company has reached its financial targets and most of itsstrategic milestones for 2010 on schedule, both in Spain andinternationally.The Company’s Capital and Reserves have been strengthenedwith the disbursement of a new tranche of 4 million euroswithin the latest “Series C” financing round (established inlate 2009 for a total of 27 million euros to be disbursed inseveral tranches, the first of which, worth 5 million euros, wasdisbursed during the last financial year).Progress with respect to clinical trials can be broken downacross two platforms, the autologous platform and theallogeneic platform:Autologous platformOntaril (*): The results of the phase III clinical trials for theproduct Ontaril did not meet expectations in terms of efficacycompared with the treatment used in the control arm of thetrial. At the end of 2009, therefore, the Company’s Board ofDirectors decided not to go ahead with clinical development ofthis product for the time being.Note (*): Ontaril is the name of the product conceived as analternative for treatment of complex perianal fistulas in patientswith and without Crohn’s disease. This product was the firstcellular therapy product to be designated an Orphan Drug bythe European Medicines Agency (EMA) in July 2005.Cx501(**): Once the results of the clinical trials were known,the need to evaluate its use on ulcers (of various types:burns, diabetic, etc.) became clear, requiring a structuredDevelopment Plan. Cellerix has decided not to carry out thismeasure itself but to seek a dermatology specialist to do thework.Note (**): Cx501 is an innovative chimeric skin graft that combines expandedcutaneous cells taken from the patient (autologous) and from a donor(allogeneic) to create a dermic matrix that is less likely to be rejected by thepatient, making it suitable as a long-term cutaneous repair treatment forsufferers of Epidermolysis Bullosa Dystrophica Recessiva (EBDR). EBDR is anextremely debilitating hereditary skin disease that produces severe damage andblistering to the skin, and, in extreme cases, causes the fingers to join together, acondition known as syndactylia.Allogeneic platformCx601: (Gastroenterology -- Complex perianal fistula). This isthe allogeneic version of Ontaril (from stem cells taken froma donor other than the recipient). It is being developed asan alternative to Ontaril (FATT 1 autologous platform). Themolecule, presently known as Cx601, has been designated anOrphan Drug by the European Medicines Agency. Phase II ofthe clinical development (obtaining preliminary informationon the effectiveness of the drug) was completed at the end of2010.Cx611: Programme aimed at developing an intravenoustreatment for rheumatoid arthritis. Phase II clinical trialswere about to begin at the end of 2010 (which will provideinformation on the efficacy of the drug).Cx-621. Allogeneic product aimed at providing an intralymphatictreatment for certain autoimmune and inflammatorydisorders as rheumatoid arthritis. Phase I trials on healthypatients are expected to take place in 2011.Cx-602. Allogeneic product for the treatment of autoimmuneand inflammatory disorders, as ulcerative colitis, in pre-clinicaldevelopment phase.Cx911 T-regs: Product aimed at the treatment of autoimmunedisorders based on the use of regulatory T cells. In pre-clinicalphase at the close of 2010.Having decided to abandon the autologous platform, Cellerixhas had to reformulate its business plan, involving a number ofdecisions which have had a major impact on the Company:Staffing cuts: A workforce adjustment plan (ERE) wasimplemented in the first quarter of 2010, affecting 31employees.Two clinical trials which were in progress were abandoned:Ontaril FATT2 (same indications as Ontaril but aimed at Crohn’sdisease sufferers) and an additional clinical trial on this productto analyse the data from the first trial over the long term.This change of strategy to focus on the allogeneic platform hasresulted in lower operating costs in 2010 than in 2009.EBITDA in 2010 was negative, as in previous financial years,as the Company is currently in the development phase. As insimilar companies, the figures for previous financial years arenot comparable.The Company has decided to develop a number of productsbased on the allogeneic platform: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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Page 218 and 219: future against which they may be ap
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Page 224 and 225: Thousands of Euro (€)Laboratoryeq
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Page 234 and 235: GrantsCellerix received several gra
Page 236 and 237: 10. Report regarding unaudited prof
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Page 242 and 243: Appendix 2: REGULATORY APPROVALPROC
Page 244 and 245: like ChondroCelect or the future ce
Page 246 and 247: TitleCountry/regionPatent/applicati
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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 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 278 and 279: Contents1. The year in brief ......
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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