ANNUAL REPORT 2012 - TiGenix

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the Company as soon as he receives the corresponding reimbursement of the Spanish tax authorities. The Company now wishes to formalize the agreement. The pre-financing issue will normally occur each year as regards Eduardo Bravo. A similar issue of pre-financing occurred with respect to the Belgian salary taxes that had to be withheld on the 2011 remuneration of Claudia D’Augusta. The Company prefinanced these salary taxes subject to the condition that Claudia D’Augusta fully repays the prepaid amounts to the Company as soon as she receives the corresponding reimbursement of the Spanish tax authorities. The Company also wishes to formalise this agreement. Given that, in Spain, Claudia D’Augusta is subject to a different tax regime than the regime applicable to Eduardo Bravo, it is possible, although it cannot be excluded, that the pre-financing issue will not occur anymore for Claudia D’Augusta. 10. BRANCHES The Company does not have any branches 11. SUBSEQUENT EVENTS No material events took place, and no significant change occurred in the financial or trading position of the Group, after December 2012. The shareholders’ meeting shall be requested to approve the statutory financial statements as submitted and to release the directors and auditor from liability for the performance of their duties in the course of the financial year ended December 31, 2012. Done on March 11, 2013 On behalf of the Board of Directors Consequently, the board of directors DECIDED to approve the entering into of one or more agreements between the Company and Eduardo Bravo on the one hand (for 2011, 2012 and the future, to the extent applicable) and between the Company and Claudia D’Augusta on the other hand (for 2011 and the future, to the extent applicable) in respect of the reimbursement of the prepaid Belgian salary taxes, and DECIDED to grant a power of attorney to two directors acing jointly to sign these agreements on behalf of the board.” 198 TiGenix I annual report 2012
14. Business and Financial Update and Outlook for the next 12 Months Extract from the March 12, 2013 press release The remainder of the press release is incorporated by reference. Business Update ChondroCelect ® sales up substantially ChondroCelect gross sales for 2012 amounted to EUR 4.1 million, comprising of EUR 3.4 million in 2012 sales and EUR 0.7 million from deferred sales in 2011. Adjusting for these deferred sales, 2012 numbers represent a 101% growth over 2011 on a likefor-like basis. This excellent result in the commercial roll out of ChondroCelect reflects the continued sales growth in Belgium and in the Netherlands after the reimbursement obtained in both countries respectively in May 2011 and in June 2012. In addition, in 2012 TiGenix has put in place a broad market access strategy to further grow sales. Aside from Belgium and the Netherlands, ChondroCelect is reimbursed on a case-by-case basis in Germany (NUB4 status), and by selected primary care trusts in the UK. Additionally, two leading private insurance companies in the UK have started to reimburse ChondroCelect on a routine basis. Private insurance groups in Spain have reimbursed a limited number of patients. TiGenix is pursuing national reimbursement in Spain 10 and France and expanded reimbursement in Germany and the UK. Outside TiGenix’s core commercial countries, the Company closed a distribution agreement for the Middle-East, with Genpharm. An agreement with the Finnish Red Cross Blood Service for Finland has been in place since the end of 2011. Cx601: ADMIRE-CD Phase III trial in complex perianal fistula in Crohn´s disease patients on track & partnering discussions on-going Cx601 is TiGenix’s most advanced clinical stage product and has completed a Phase II study, published in October 2012 in the International Journal of Colorectal Disease. Cx601 is an adipose derived allogeneic stem cell suspension (eASC) for the treatment of complex perianal fistulas in Crohn’s disease patients. Cx601 has been granted orphan designation by the EMA. Ethics committees and regulatory agencies in all of the eight participating countries have approved the protocol of the phase III study, and patient recruitment is progressing on plan. The main objectives of the study are to demonstrate safety and superior efficacy over placebo in perianal fistulas in Crohn’s disease patients who failed to respond to previous treatment(s), in most cases biologicals, and to confirm the strong safety and efficacy results of the Phase II trial. Final results of the trial are expected in 2H 2014, and, if positive, should allow the Company to file for marketing authorisation with the EMA in the first half of 2015. Partnership discussions are ongoing for co-development and commercialization of Cx601 in different regions. 10 Since the date on which the annual report of the Board of Directors was approved, the Company was informed by the Spanish Health Authority that it will obtain national reimbursement in Spain. 199
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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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Page 203 and 204: 15. Available Documents The Company
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ANNUAL REPORT 2012 - TiGenix

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