ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

In Germany, thirty-six German hospitals filed for NUB approvalat the end of 2010. 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.7.12 Outlook7.12.1 Outlook 2011 and beyondTiGenix will focus on the commercial activities of its leadproducts ChondroCelect and ChondroMimetic in Europe andwill try to broaden the geographic scope towards EasternEurope, North America and Asia.• the Company obtaining timely regulatory marketingapprovals for ChondroCelect and ChondroMimetic in othergeographic markets; and• the prevailing and future competitive and regulatoryenvironment.The Company will continue to expand its research anddevelopment capabilities and facilities to cope withthe development of its product pipeline, to be able tomanage the products that reach the validation phase. TheCompany will also continue to expand its commercial andmanufacturing capabilities to cope with the commercial rolloutof ChondroCelect and ChondroMimetic in the differentgeographic markets. As a result, it is not certain that TiGenix willreach profitability in the years to come.The sales of ChondroCelect should increase further andwill be complemented by the sales of ChondroMimetic. It isanticipated that sales should increase significantly once positivereimbursement decisions are obtained for ChondroCelect anddistribution agreements are signed for ChondroMimetic.Further efforts in maintaining the regulatory approvals and inexpanding the manufacturing capacity for its lead products areenvisaged.Finally, the Company will continue to progress its stem cellspipeline, in particular the Phase I/II in Rheumatoid Arthritis andthe initialisation of the clinical study for Cx621 (intra-lymphaticadministration of eASCs) and anticipates to obtain some CEmarkextensions for ChondroMimetic.Despite the anticipated growth in revenues, it is expected thatTiGenix will be in a net loss situation in 2011.7.12.2 Outlook beyond 2011In the coming years, an increasing part of TiGenix’ revenuesshould be generated from the sales of ChondroCelect andChondroMimetic. However, the timing and growth of theserevenues will depend, among others, on:• the (in)ability of TiGenix to successfully commercialise itslead products in Europe;• the pricing and the (in)ability to obtain reimbursement of itslead products in the market;163 •