ANNUAL REPORT 2012 - TiGenix

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- A EU 7 th FP granted in 2011 EUR 2,9 million, part of which was paid in the course of 2012 and part of which will be paid in the course of the following years). TiGenix has also received a grant for the set-up of its office in the U.S. To the extent the granting conditions are met, these grants must not be refunded. In general, expenses covered by the grants include personnel costs, consumables, subcontracting and other direct costs of the project funded. Since all public bodies’ requirements have been fulfilled, no refund of these grants is expected. In addition, TiGenix SAU has benefited from “soft loans” awarded by various public and semi public entities as enumerated in the table below : Public and Semi Public Body Soft Loan Year Status Amount (KEUR) Spanish Ministry of Science and Education PROFIT Loan 2005 2005 Cashed in 2005 159 Empresa Nacional de Innovación SA Participative loan, 2006 Repaid 450 (“ENISA”)(National Innovation Company) first payment ENISA Participative 2006 Repaid 450 loan, second payment Spanish Ministry of Science and Education Singular Loans 2006 Cashed in 2006 100 Spanish Ministry of Science and Innovation ACTEPARQ 2009 Cashed in 2009 109 (“MICINN”) MICINN Soft loan under 2009 Cashed in 2010 312 the "Singular" scheme MICINN Soft loan under 2010 Cashed in 2010 888 the "Singular" scheme MICINN INNPACTO 2010 Cashed in 2011 527 MICINN INNPACTO 2011 Cashed in 2011 659 Madrid Network Soft loan 2011 Cashed in 2011 3,964 MICINN INNPACTO 2012 Cashed in 2013 404 Subtotal Cellerix soft loans 8.022 These “soft” loans are all awarded with a 0 % or very low interest rate and a repayment period between 10 and 15 years. Additionally, there is a grace period for the payment of around 3 and 5 years from the moment the loan has been awarded. 6.9. LITIGATION On the date of this registration document, none of the TiGenix companies, except for TiGenix SAU as set out below, is involved in any litigation or legal proceeding. TiGenix SAU is involved in the following legal proceedings. 78 TiGenix I annual report 2012
Invalidation of US patent US6777231 On April 1, 2011, TiGenix SAU (then still Cellerix S.A.) filed a re-examination request with the United States Patent and Trademark Office (“USPTO”) regarding US6777231, owned by the University of Pittsburgh and licensed to several parties, including Artecell. TiGenix requested re-examination of all claims of this patent and asked the USPTO to consider prior art not evaluated during previous examination of the patent. TiGenix is of the opinion that this prior art is materially relevant to the patentability of the claims. The USPTO Examiner has issued a decision concluding that all claims of the patent are invalid, and subsequent to the issue of the right of appeal notice the University of Pittsburgh has appealed the Examiner’s decision. Repayment of subsidies On January 5, 2012, TiGenix SAU lodged an ordinary appeal before the Contentious- Administrative Chamber of the National Appellate Court (Audiencia Nacional) against two decisions taken by the Director General of Technology Transfer and Business Development at the Spanish Ministry of Science and Innovation (the “Administration”) on November 16, 2011, which partially revoked and claimed the repayment of two subsidies granted in 2006 and 2007, respectively (the “Contested Subsidies”). the Contested Subsidies, together with other subsidies granted to TiGenix SAU during the same time period (i.e. 2006 and 2007), exceeded the maximum limit permitted by law, requesting, therefore, the reimbursement of the excess amount granted, and that (ii) some of the expenses attributed to the project financed by the Contested Subsidies had already been financed from other subsidies. Against these arguments maintained by the Administration, TiGenix SAU holds, among other arguments, that the Administration cannot accumulate all subsidies granted to TiGenix SAU (i.e. the Contested Subsidies and other subsidies granted) for purposes of applying the maximum legal limit applicable (i.e. in the particular case of TiGenix SAU, 60 % of the eligible cost of the project) , as the various subsidies were granted for financing different projects with different purposes and scopes. The total claim of the Administration, for the full consortium, for both Contested Subsidies, including late payment interest, amounts to EUR 896,989.83. Such amount is claimed entirely from TiGenix SAU, as the representative of the consortium. However, TiGenix’s part thereof would only amount to EUR 309,353.46, with the remainder of the claim, in case the appeal does not succeed, to be repaid to TiGenix SAU by the other members of the consortium. Both Contested Subsidies were granted to a consortium of beneficiaries, one of which was TiGenix SAU. TiGenix SAU also acted as representative of the beneficiaries in the consortium. Within the contentious-administrative appeal, the Administration claims that (i) As an intermediary measure, TiGenix SAU obtained an injunctive decision that, until a final decision is taken in the matter, the amounts claimed by the Administration do not yet have to be repaid. Instead, TiGenix SAU granted a guarantee for the benefit of the Administration for the amount claimed. 79
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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
Page 27 and 28: 5.3. ORGANISATIONAL STRUCTURE TiGen
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Page 43 and 44: Issue date Term Number of warrants
Page 45 and 46: 6. Business Overview Most of the in
Page 47 and 48: 6.2. COMPETITIVE STRENGTHS The Comp
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Page 51 and 52: 6.3.5. Funding history Since its in
Page 53 and 54: non-weight bearing area of the join
Page 55 and 56: 6.4.5. Commercial launch ChondroCel
Page 57 and 58: und Behandlungsmethode”) in sever
Page 59 and 60: Therapeutics (product Hyalograft C)
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Page 63 and 64: Clinical development In January 201
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Page 67 and 68: that the average cost of treatment
Page 69 and 70: TiGenix has obtained cGMP status fo
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Page 81 and 82: 7. Corporate Governance 7.1. GENERA
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Page 97 and 98: As of the date of publication of th
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Page 101 and 102: usiness at customary market conditi
Page 103 and 104: 9. Major Shareholders 9.1. OVERVIEW
Page 105 and 106: 10. Financial Statements : General
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Page 111 and 112: The consolidated financial statemen
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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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(26) Related party transactions Tra
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(28) Commitments and contingencies
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(30) Consolidation scope Name Subsi
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We believe that the audit evidence
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assets and liabilities, its financi
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the results of its operations and c
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12.2. STATUTORY BALANCE SHEET 2010-
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The value of receivables is reduced
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13. Annual Report of the Board of D
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2013. The facility will provide the
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year ended December 31, 2011, and T
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Operating result (EBIT) and net res
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Statement of financial position The
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- The total personnel costs of EUR
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- TiGenix may fail in successfully
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continue as a going concern and to
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Functioning of the Board of Directo
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The nomination and remuneration com
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Apart from the above remuneration f
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Shares and warrants held by indepen
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- Long-term incentive plan : warran
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Shares and warrants held by executi
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- identifying and implementing busi
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actual bonus equal to 78 % of her p
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was reduced to a half-time role com
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14. Business and Financial Update a
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Financial results for the full year
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15. Available Documents The Company
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Title Country Application number Ce
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Title Country Application number Is
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Country Trademark Classes USA CELLE
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ANNUAL REPORT 2012 - TiGenix

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