ANNUAL REPORT 2012 - TiGenix

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Regularisation accounts on the liabilities side 12.3.11. Currencies These accounts include : - The pro rata parts of the charges that will only be paid during a subsequent financial year but that relate to a previous financial year. - The pro rata parts of the proceeds received during the financial year or a previous financial year but that relate to one or more subsequent financial years. The amounts receivable and debts in other currencies are converted at the applicable exchange rate at the date of the closing of the financial year. Currency losses are recorded in the statement of results. Unrealised currency gains are recorded in the statement of results as revenues. 164 TiGenix I annual report 2012
13. Annual Report of the Board of Directors on the Consolidated Financial Statements and the Statutory Financial Statements per December 31, 2012 Dear shareholders, We are pleased to present to you the consolidated financial statements and the statutory financial statements for the fiscal year ended December 31, 2012. 1. MAIN EVENTS IN 2012 In June 2012, TiGenix obtained national reimbursement in the Netherlands for ChondroCelect. The reimbursement was granted retroactively as per January 1, 2011. This event together with the ramp up in the Belgium sales had a huge impact in the 2012 sales (increase of 101 % compared to 2011). In July 2012, TiGenix reported positive results of the Cx621 Phase I to assess the safety of intra-lymphatic administration of its expanded adipose stem cells. Cx621 aims to capitalise on the benefits of TiGenix´s proprietary approach of intra-lymphatic administration to treat autoimmune disorders. patients suffering from complex perianal fistulas. The main objectives of the study are to demonstrate safety and superior efficacy over placebo in perianal fistulas in Crohn’s disease patients after failure with their previous treatment, in most cases biologicals, and to confirm the strong safety and efficacy results from the Phase II trial completed in 2011. To date, the Company received approvals from Ethical Committees or Regulatory Agencies in all 8 participating countries, which should allow the Company to accelerate patient enrolment in the study. In September 2012, the Dutch manufacturing facility obtained EMA approval for commercial production of ChondroCelect. After the successful cGMP inspection by the Dutch authorities earlier in 2012, it now obtained the crucial approval from EMA for the production of ChondroCelect, the Company’s commercial cell therapy product for cartilage repair in the knee, in its new state-of-the-art manufacturing facility in Geleen (the Netherlands). In August 2012, the first patient enrolled in pivotal Phase III trial with lead product Cx601 in perianal fistulas (ADMIRE-CD). The trial is a multicenter, randomized, doubleblind, placebo-controlled Phase III trial of Cx601 in approximately 200 Crohn’s disease In November 2012, TiGenix signed a commercialization agreement for ChondroCelect in the Middle East with pharmaceutical marketing and distribution company Genpharm in Dubai, United Arab Emirates. 165
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ANNUAL REPORT 2012
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9. MAJOR SHAREHOLDERS 103 9.1. OVER
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There can be no assurance that TiGe
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educing their ultimate value to the
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eimbursement in certain instances s
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or the relevant manufacturing proce
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In recent years, it expanded its op
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making this change may be costly an
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TiGenix’s development stage produ
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qualified employees and consultants
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1. Introduction Annual report 2012
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2. Persons Responsible for the Cont
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4. Selected Financial Information Y
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5.3. ORGANISATIONAL STRUCTURE TiGen
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Date Transaction Number and class o
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Date Transaction Number and class o
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(12) The shares were subscribed to
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5.5. DESCRIPTION OF RIGHTS AND BENE
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Formalities to attend the sharehold
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amendments to the Articles of Assoc
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the existing shareholders have a pr
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Issue date Term Number of warrants
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6. Business Overview Most of the in
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6.2. COMPETITIVE STRENGTHS The Comp
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6.3. IMPORTANT EVENTS IN THE DEVELO
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6.3.5. Funding history Since its in
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non-weight bearing area of the join
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6.4.5. Commercial launch ChondroCel
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und Behandlungsmethode”) in sever
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Therapeutics (product Hyalograft C)
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Different routes of administration
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Clinical development In January 201
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evenues from this pipeline within t
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that the average cost of treatment
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TiGenix has obtained cGMP status fo
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Biologics for treatment of Rheumato
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of the patents and patent applicati
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- “Marker genes for use in the id
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manufacturing process and therapeut
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Invalidation of US patent US6777231
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7. Corporate Governance 7.1. GENERA
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7.2.3. Independent directors As to
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7.2.4. Composition of the Board of
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of Ravago NV, Vanbreda Risk & Benef
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Litigation statement concerning the
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As proof of the independence and an
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for their healthcare and biotechnol
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7.5. SCIENTIFIC ADVISORY BOARD AND
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As of the date of publication of th
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(rounded down to the nearest intege
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usiness at customary market conditi
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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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Page 203 and 204: 15. Available Documents The Company
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Page 209 and 210: Country Trademark Classes USA CELLE
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ANNUAL REPORT 2012 - TiGenix

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