ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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While debridement and lavage is the most frequently usedprocedure, microfracture appears to be the currently acceptedstandard of care for small-sized cartilage defects. However,it is recognised that microfracture often leads to scar-likerepair tissue, which, unlike stable hyaline-like cartilage, hasnot been associated with long-term durable outcomes.Various investigators have communicated a reducing clinicalbenefit from microfracture after 2 to 3 years 17 . Recent clinicalexperience has also identified issues in the subchondral bonerelated to a moving up of the bone front after microfracture.This could eventually compromise subsequent cartilage repairprocedures such as autologous chondrocyte implantation 18 .Autologous Chondrocyte Implantation (“ACI”) is a techniquedesigned to repair articular cartilage by implanting the patient’sown expanded cartilage cells, and was developed in order toaddress the limitations of the surgical procedures describedabove. ACI was invented in the early 1980s by researchers at theHospital for Joint Diseases in New York and was subsequentlyimproved at the University of Göteborg in Sweden 19 . Figure6.2 gives an overview of the ACI procedure. When a patient isdiagnosed with a symptomatic cartilage defect eligible for ACItreatment, a small cartilage biopsy is taken arthroscopicallyfrom a healthy, non-weight bearing area of the joint. The cellsare subsequently transported to a cell expansion laboratoryand, after approximately 4-5 weeks of cell culture, the expandedcells are sent back to the surgeon for re-implantation in thepatient. In conventional ACI, the cells are implanted underneatha periosteal flap, which has been harvested from the patient’stibia and sewn onto the cartilage defect. Newer techniques usea biodegradable membrane or a matrix in which the cells areseeded.Although over 20,000 patients have been treated using ACIsince the 1980s, only a fraction of patients suffering fromcartilage defects are currently treated in this way. The Companybelieves that the limited market share of ACI procedures isattributable to several factors, most notably the lack of proofwith regard to the reproducibility of formation of stablearticular cartilage, the lack of clinical validation and the relativelycomplex surgical procedure associated with the implantationof the cells.The ChondroCelect development programme has focusedon providing solutions for these hurdles and thus aims toexploit the potential of the ACI market. ChondroCelect is acharacterised cell-based medicinal product, used in an ACIprocedure, in which the cell culture methods have beenfocused to maintain the phenotypical stability of the cells inview of favouring the formation of stable hyaline-like articularcartilage. The product has been validated in a prospective,controlled randomised clinical trial and can be used incombination with an easy-to-use collagen membrane.17 Mithoefer et al., Am J Sports Med 2009.18 Minas et al., Am J Sports Med 2009.19 Grande et al. J Orthoped Res 1989; Brittberg et al. NEJM 1994.111 •
Fig. 6.2: Autologous Chondrocyte ImplantationThe question mark indicates an important unknown in the ACI procedure: will the cells, after expansion be able to makestable cartilage or will they form a scar-like fibrous or fibrocartilaginous tissue?Osteochondral lesionsA special part of the full thickness lesions of the cartilageconcerns the small deeper lesions, the so-called osteochondrallesions. For this indication, the Company has developedChondroMimetic, which is an off-the-shelf, bi-layer collagenbased implant for the treatment of small osteochondral(cartilage and underlying bone) defects. The concept is derivedfrom the osteochondral grafting procedure, but avoids theneed of harvesting patient own plugs and the associated comorbidity.<strong>TiGenix</strong> estimates the worldwide incidence of large (>2cm²) fullthickness cartilage defects on the femoral condyle of the knee(ICRS Grade 3 and 4) in the adult population below 50 years old,the target indication of the ChondroCelect product, to be over140,000 cases per year worldwide.The worldwide incidence of smaller (
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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
Page 71 and 72: TiGenix has a limited financial deb
Page 73 and 74: Thousands of Euro (€) TiGenix Cel
Page 75 and 76: 3.5.2 Issuance Price and RatioThe i
Page 77 and 78: (c)Rules for subscriptionSubject to
Page 79 and 80: The Scrips Private Placement will o
Page 81 and 82: to comply with any of its obligatio
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: Full thickness articular cartilage
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
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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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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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