ANNUAL REPORT 2012 - TiGenix

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Cx611 Phase IIa in rheumatoid arthritis (RA) reported positive interim safety results Cx611 is an allogeneic eASC product candidate for the treatment of RA. This is the most advanced trial in the world with stem cells in RA and the Company expects to report final results in April 2013. Positive interim safety results were reported in December 2012. This multicenter (20 centers), placebo-controlled study enrolled 53 patients, divided in 3 cohorts with different dosing regimens. The objective of the trial is to determine safety, feasibility, tolerance, and optimal dosing, and obtain a first indication of efficacy in this very difficult to treat patient population that has previously failed to respond to at least two biologicals. TiGenix expects that the phase IIa results will set the stage for the further development of Cx611 in RA, and potentially in a wide range of other autoimmune disorders. Phase I successfully concluded for Cx621 to assess intra-lymphatic administration of eASCs Cx621 is an allogeneic eASC product candidate for the treatment of autoimmune diseases via a proprietary technique of intra-lymphatic administration. In July 2012, TiGenix successfully concluded a phase I study to assess safety, tolerability and pharmacodynamics of intra-lymphatic administration of Cx621 in healthy volunteers. The Company filed a patent for this novel route of administration and is currently evaluating in which autoimmune indication eventually move the product forward into the next clinical stage of development. Appointments of Jean Stéphenne as chairman & Russell Greig as member of Board of Directors On September 19, TiGenix appointed Jean Stéphenne chairman and Russell Greig member of the Board of Directors. Both are former members of the Corporate Executive Team of GlaxoSmithKline, and have a sterling track record that will be of immense value as TiGenix enters into a pivotal phase of its growth with the commercial roll-out of ChondroCelect and the advanced clinical development of its cell therapy programs. Key approvals for manufacturing facilities in the Netherlands and Spain In September 2012, TiGenix obtained the approval from the EMA for the production of ChondroCelect in its new state-of-the-art manufacturing facility in Sittard-Geleen, the Netherlands. The new site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products. It provides crucial manufacturing capabilities to support the expected growth in demand for ChondroCelect for cartilage repair, and has sufficient capacity for the production of other advanced stem cell therapy products. In addition, in January 2013, TiGenix successfully renewed its manufacturing authorization for stem cell products at its manufacturing facility in Madrid, Spain. The GMP facility in Madrid performs a vital function by manufacturing high-quality, clinical grade allogeneic stem cell products to fuel TiGenix’s key clinical programs. 200 TiGenix I annual report 2012
Financial results for the full year 2012 Key figures (Thousands of Euro, except number of employees) Years ended December 31 Thousands of Euro (€) 2012 2011* CONSOLIDATED INCOME STATEMENT CONTINUING OPERATIONS Sales 4,084 1,146 Gross sales 4,084 1,804 ** Deferred sales and discounts 0 -657 Cost of sales -905 -455 Gross profit 3,179 691 Research and development expenses -13,936 -10,595 Sales and marketing expenses -2,881 -2,726 General and administrative expenses -6,026 -6,593 Other operating expenses 0 -2,974 Total operating charges -23,749 -23,344 Other operating income 1,389 393 Operating Result -18,276 -21,805 Interest income 35 708 Interest expenses -61 -408 Foreign exchange differences -142 434 Profit/(Loss) before taxes -18,443 -21,071 Income taxes -1 0 Profit/(Loss) for the period from continuing operations -18,444 -21,071 DISCONTINUED OPERATIONS Profit/(Loss) for the period from discontinued operations -1,949 -16,234 Profit/(Loss) for the period -20,393 -37,305 Cash and cash equivalents 11,072 19,771 Number of employees and mandate contractors 67 75 * The 2011 consolidated financial statements have been adjusted to reflect the capitalization of the expenses incurred that were essential to bring the Dutch manufacturing facility into operations. ** 2011 gross sales include EUR 0.1 million in ChondroMimetic sales. 201
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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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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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ANNUAL REPORT 2012 - TiGenix

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