ANNUAL REPORT 2012 - TiGenix

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Treatment with ChondroCelect comprises a two-step surgical procedure. In the first step, a cartilage biopsy is obtained arthroscopically from healthy articular cartilage from a lesser-weight bearing area of the patient’s knee. Chondrocytes are isolated from the biopsy, expanded in vitro, characterized and delivered as a suspension for implantation in the same patient. ChondroCelect can be delivered as from 9 weeks from the day of biopsy. The manufacturing process is performed under strict cGMP conditions. TiGenix has designed a state-of-the-art treatment process with ChondroCelect that includes an extensive training program for health care professionals, instructions for the best conditions for obtaining the patient’s biopsy, the implantation procedure, and the patient’s rehabilitation following the reimplantation of the cells. 6.4.2. Indication and target market Cartilage repair in the knee Musculoskeletal diseases are the second greatest cause of disability globally, according to a study on the Global Burden of Disease published in The Lancet 1 . Articular cartilage is a tough, elastic tissue that covers the ends of bones in joints and enables the bones to move smoothly over one another. Because it is poorly vascularized, damaged articular cartilage does not heal as rapidly or effectively as other tissues in the body. Instead, the damage tends to spread, resulting in pain and severely reduced mobility. When left untreated, cartilage injuries may lead to osteoarthritis, which is a major cause of disability and represents a significant socio-economic burden. It is commonly believed that repairing cartilage defects at an early stage can slow down or even prevent progression to osteoarthritis 2 . Various surgical procedures are currently used for the local treatment of cartilage defects in the knee, including debridement and lavage, microfracture and osteochondral grafting (also called mosaicoplasty). However, unlike ChondroCelect none of these surgical treatments have been proven to create functional and durable repair of cartilage in prospective, randomized clinical trials. While microfracture appears to be the currently accepted standard of care for small-sized cartilage defects, it is recognized that microfracture often leads to scar-like repair tissue, and unlike stable hyaline-like cartilage as regenerated by ChondroCelect, is not associated with long-term durable outcomes. Various investigators have communicated a reducing clinical benefit from microfracture after 2 to 3 years 3 . An alternative to such surgical procedures is Autologous Chondrocyte Implantation (ACI), a technique designed to repair articular cartilage by implanting the patient’s own expanded cartilage cells, and was developed in order to address the limitations of the surgical procedures described above. When a patient is diagnosed with a symptomatic cartilage defect eligible for ACI treatment, a small cartilage biopsy is taken arthroscopically from a healthy, 1 The Lancet, Volume 380, Issue 9859, Pages 2163 - 2196, 15. 52 TiGenix I annual report 2012 2 Cooper C, Epidemiology of osteoarthritis. Klippel JH, Dieppe PA, editors. Rheumatology, 2 nd ed. London : Mosby 1998. P 1-20. 3 Mithoefer et al., Am J Sports Med 2009.
non-weight bearing area of the joint. The cells are subsequently transported to a cell expansion laboratory and, after 9 weeks, the expanded cells are sent back to the surgeon for re-implantation in the patient. In conventional ACI, the cells are implanted underneath a periosteal flap, which has been harvested from the patient’s tibia and sewn onto the cartilage defect, or by using a biodegradable membrane or matrix in which the cells are seeded. ChondroCelect ChondroCelect is a characterized cellbased medicinal product, used in an ACI procedure, in which the cell culture methods have been specifically developed to maintain the phenotypical stability of the cells to promote the formation of stable hyaline-like articular cartilage. The procedure whereby characterized cells are implanted is called ‘Characterized Chondrocyte Implantation’ (CCI). ChondroCelect has been validated in a prospective, controlled randomized clinical trial and can be used in combination with an easy-to-use collagen membrane. Moreover, 370 patients, presenting a wide variety of lesions, have been treated in a compassionate use program 4 . Fig. 1 : ChondroCelect : regeneration of cartilage in the knee 4 Vanlauwe J, Huylebroek J, Van Der Bauwhede J, et al., Clinical Outcomes of Characterized Chondrocyte Implantation. Cartilage. 2011 : 3(2) : 173-180. 53
Page 1 and 2: ANNUAL REPORT 2012
Page 3 and 4: 9. MAJOR SHAREHOLDERS 103 9.1. OVER
Page 5 and 6: There can be no assurance that TiGe
Page 7 and 8: educing their ultimate value to the
Page 9 and 10: eimbursement in certain instances s
Page 11 and 12: or the relevant manufacturing proce
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Page 15 and 16: making this change may be costly an
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Page 21 and 22: 1. Introduction Annual report 2012
Page 23 and 24: 2. Persons Responsible for the Cont
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Page 27 and 28: 5.3. ORGANISATIONAL STRUCTURE TiGen
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Page 45 and 46: 6. Business Overview Most of the in
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Page 55 and 56: 6.4.5. Commercial launch ChondroCel
Page 57 and 58: und Behandlungsmethode”) in sever
Page 59 and 60: Therapeutics (product Hyalograft C)
Page 61 and 62: Different routes of administration
Page 63 and 64: Clinical development In January 201
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Page 67 and 68: that the average cost of treatment
Page 69 and 70: TiGenix has obtained cGMP status fo
Page 71 and 72: Biologics for treatment of Rheumato
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Page 77 and 78: manufacturing process and therapeut
Page 79 and 80: Invalidation of US patent US6777231
Page 81 and 82: 7. Corporate Governance 7.1. GENERA
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9. Major Shareholders 9.1. OVERVIEW
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10. Financial Statements : General
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11. Consolidated Financial Statemen
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11.3. CONSOLIDATED STATEMENT OF CAS
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The consolidated financial statemen
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11.5.2.2. Basis of consolidation Th
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are provided and costs are incurred
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of interest on the remaining balanc
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Deferred tax assets and liabilities
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- Partnering of Cx601 (i.e. finding
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The Group is mainly exposed to the
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fiscal year 2010, reference is made
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Sales and marketing expenses Years
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The number of employees in the R&D
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Analysis of profit/(loss) for the p
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(8) Disposal group held for sale Th
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(10) Property, plant and equipment
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The decrease of stock in 2012 compa
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dividends will be based upon the Co
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alance. As a consequence, the Compa
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(23) Other current liabilities The
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TiGenix SAU - Stock options Prior t
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(25) Business combination Descripti
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(26) Related party transactions Tra
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(28) Commitments and contingencies
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(30) Consolidation scope Name Subsi
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We believe that the audit evidence
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assets and liabilities, its financi
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the results of its operations and c
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12.2. STATUTORY BALANCE SHEET 2010-
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The value of receivables is reduced
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13. Annual Report of the Board of D
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2013. The facility will provide the
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year ended December 31, 2011, and T
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Operating result (EBIT) and net res
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Statement of financial position The
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- The total personnel costs of EUR
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- TiGenix may fail in successfully
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continue as a going concern and to
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Functioning of the Board of Directo
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The nomination and remuneration com
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Apart from the above remuneration f
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Shares and warrants held by indepen
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- Long-term incentive plan : warran
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Shares and warrants held by executi
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- identifying and implementing busi
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actual bonus equal to 78 % of her p
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was reduced to a half-time role com
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14. Business and Financial Update a
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Financial results for the full year
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15. Available Documents The Company
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Title Country Application number Ce
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Title Country Application number Is
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Country Trademark Classes USA CELLE
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ANNUAL REPORT 2012 - TiGenix

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