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ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

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8.1.5.28 Subsequent eventsAcquisition wof Cellerix and expected pro froma cashpositionOn February 25, 2011 <strong>TiGenix</strong> NV and Cellerix announcedthat the two cell therapy-focused biotechnology companies,Cellerix’ shareholders and certain other investors of Cellerixentered into a Contribution Agreement to combine theoperations of both companies by means of a share for shareexchange.Shareholders and investors of Cellerix committed to make acash contribution of €18,155, 669.74 in Cellerix before the closingof the proposed Contribution.The Company also announced its intention to raise additionalfunds through a public rights offering, of which €10 million hasalready been secured via commitments from certain existingshareholders and new investors.The capital increase at Cellerix was subject to approval by theshareholders’ meeting of Cellerix. Besides this, the transactionis also subject to the approval of the contribution by <strong>TiGenix</strong>shareholders at an extraordinary shareholders’ meeting(“ESM”) to be convened by the Board of <strong>TiGenix</strong> and certainother conditions, including the approval by the FSMA of theprospectus relating to the subsequent public rights offeringand the admission to trading of the new <strong>TiGenix</strong> shares.As a result, the combined group is expected to have a proforma cash position of at least €33.5 million at closing.ReimbursementIn Belgium <strong>TiGenix</strong> NV has received on February 24, 2011 thenotification by the Minister of Social Affairs of the approval of aconvention agreement between the RIZIV/INAMI and <strong>TiGenix</strong>for the reimbursement of ChondroCelect for well-indicatedpatients in specialised treatment centres. This conventioncovers a period of three years and defines the specifictreatment criteria and follow-up measures the company has toconduct.In France a positive advice has now been issued by the “HautCollège” of the “Haut Autorité de Santé” recommending theconditional reimbursement of the combination of culturedautologous chondrocytes, membrane and surgical procedureunder a special reimbursement scheme (“Remboursementdérogatoire” Art. 165-1-1). Since ChondroCelect is the onlyapproved medicinal product for autologous chondrocytetransplantation in France, this decision opens the perspective toobtain controlled access to the French market.In the Netherlands, the procedure for reimbursemet ofChondroCelect under a special reimbursement schemefor innovative new medicines (“Beleidsregel DureGeneesmiddelen”) is still ongoing. A decision is now expectedin the second quarter of 2011.In Germany, thirty-six German hospitals filed for NUB approvalat the end of <strong>2010</strong>. These hospitals were recently informed byInEK that the product obtained this year NUB Status 4 meaningthat ChondroCelect is eligible for reimbursement on a case bycase basis.In Spain, a decision on the national level is expected in thesecond quarter of 2011. Discussions at the regional level willfollow and are currently being prepared.8.1.5.29 Reconciliation between the consolidatedfinancial statements under local GAAP and IFRSThe Group’s consolidated financial statements have beenprepared in accordance with IFRS as endorsed by the EU.The statutory annual accounts are prepared on a nonconsolidatedbasis and under local (Belgian) GAAP.In the table below the equity reconciliation and profit & lossreconciliation between local (Belgian) GAAP and IFRS can befound:193 •

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