ANNUAL REPORT 2012 - TiGenix

More documents

Recommendations

Info

11.7. AUDITOR’S REPORT ON THE CONSOLIDATED FINANCIAL STATEMENTS PER DECEMBER 31, 2011 In accordance with the legal requirements, we report to you on the performance of the engagement of statutory auditor, which has been entrusted to us. This report contains our opinion on the true and fair view of the consolidated financial statements as well as the required additional statements. Unqualified audit opinion, with an explanatory paragraph on the consolidated financial statements We have audited the consolidated financial statements of TiGenix NV for the year ended 31 December 2011, prepared in accordance with International Financial Reporting Standards as agreed by the European Union, which show a balance sheet total of 74.669 kEUR and a consolidated loss of 37.547 kEUR. Management is responsible for the preparation and the fair presentation of these consolidated financial statements. This responsibility includes : designing, implementing and maintaining internal control relevant to the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting principles and making accounting estimates that are reasonable in the circumstances. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We conducted our audit in accordance with the legal requirements and the Auditing Standards applicable in Belgium, as issued by the Institut des Réviseurs d’Entreprises / Instituut van de Bedrijfsrevisoren. Those standards require that we plan and perform the audit to obtain reasonable assurance whether the consolidated financial statements are free from material misstatement, whether due to fraud or error. In accordance with the above-mentioned auditing standards, we have carried out procedures to obtain audit evidence about the amounts and disclosures in the consolidated financial statements. The selection of these procedures is a matter for our judgment, as is the assessment of the risk that the consolidated financial statements contain material misstatements, whether due to fraud or error. In making those risk assessments, we have considered the company’s internal control relating to the preparation and fair presentation of the consolidated financial statements, in order to design audit procedures that were appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control. We have also assessed the appropriateness of the accounting principles and consolidation principles, the reasonableness of accounting estimates made by management, as well as the overall presentation of the consolidated 64 TiGenix I annual report 2011 financial statement. Finally, we have obtained from management and the company’s officials the explanations and information necessary for our audit. We believe that the audit evidence we have obtained provides a reasonable basis for our opinion. In our opinion the consolidated financial statements for the year ended 31 December 2011 give a true and fair view of the group’s 156 TiGenix I annual report 2012
assets and liabilities, its financial position, the results of its operations and cashflow, in accordance with International Financial Reporting Standards as agreed by the European Union. Additional statements The preparation of the consolidated Directors’ report and its content are the responsibility of management. Notwithstanding the negative effect on the financial position due to the significant losses the company and its subsidiaries have suffered, the consolidated annual accounts have been drawn up in the assumption of going concern, and do therefore not include adjustments or changes to classifications, that should have been made in case of inability of the company to continue as a going concern. Without modifying our opinion as expressed above, we want to draw your attention to the consolidated Director’s report, in which the Board of Directors justifies the application of the valuation rules in going concern. This assumption about going concern is only justified if the budget for the coming twelve months, as drawn up and approved by the Board of Directors, and described in the consolidated Director’s report, will be realized, or if, alternatively, new financial sources can be found. Our responsibility is to supplement our report with the following additional statements, which do not modify our audit opinion on the consolidated financial statements : - The consolidated Directors’ report includes the information required by law and is consistent with the consolidated financial statements. We are, however, unable to comment on the description of the principal risks and uncertainties which the consolidated group is facing, and of its financial situation, its foreseeable evolution or the significant influence of certain facts on its future development. We can nevertheless confirm that the matters disclosed do not present any obvious inconsistencies with the information that we became aware of during the performance of our engagement. Zaventem, March 20, 2012 BDO Réviseurs d’Entreprises Soc. Civ. SCRL Statutory auditor Represented by Gert Claes 157
Page 1 and 2:
ANNUAL REPORT 2012
Page 3 and 4:
9. MAJOR SHAREHOLDERS 103 9.1. OVER
Page 5 and 6:
There can be no assurance that TiGe
Page 7 and 8:
educing their ultimate value to the
Page 9 and 10:
eimbursement in certain instances s
Page 11 and 12:
or the relevant manufacturing proce
Page 13 and 14:
In recent years, it expanded its op
Page 15 and 16:
making this change may be costly an
Page 17 and 18:
TiGenix’s development stage produ
Page 19 and 20:
qualified employees and consultants
Page 21 and 22:
1. Introduction Annual report 2012
Page 23 and 24:
2. Persons Responsible for the Cont
Page 25 and 26:
4. Selected Financial Information Y
Page 27 and 28:
5.3. ORGANISATIONAL STRUCTURE TiGen
Page 29 and 30:
Date Transaction Number and class o
Page 31 and 32:
Date Transaction Number and class o
Page 33 and 34:
(12) The shares were subscribed to
Page 35 and 36:
5.5. DESCRIPTION OF RIGHTS AND BENE
Page 37 and 38:
Formalities to attend the sharehold
Page 39 and 40:
amendments to the Articles of Assoc
Page 41 and 42:
the existing shareholders have a pr
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
Page 49 and 50:
6.3. IMPORTANT EVENTS IN THE DEVELO
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)
Page 61 and 62:
Different routes of administration
Page 63 and 64:
Clinical development In January 201
Page 65 and 66:
evenues from this pipeline within t
Page 67 and 68:
that the average cost of treatment
Page 69 and 70:
TiGenix has obtained cGMP status fo
Page 71 and 72:
Biologics for treatment of Rheumato
Page 73 and 74:
of the patents and patent applicati
Page 75 and 76:
- “Marker genes for use in the id
Page 77 and 78:
manufacturing process and therapeut
Page 79 and 80:
Invalidation of US patent US6777231
Page 81 and 82:
7. Corporate Governance 7.1. GENERA
Page 83 and 84:
7.2.3. Independent directors As to
Page 85 and 86:
7.2.4. Composition of the Board of
Page 87 and 88:
of Ravago NV, Vanbreda Risk & Benef
Page 89 and 90:
Litigation statement concerning the
Page 91 and 92:
As proof of the independence and an
Page 93 and 94:
for their healthcare and biotechnol
Page 95 and 96:
7.5. SCIENTIFIC ADVISORY BOARD AND
Page 97 and 98:
As of the date of publication of th
Page 99 and 100:
(rounded down to the nearest intege
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
Page 107 and 108: 11. Consolidated Financial Statemen
Page 109 and 110: 11.3. CONSOLIDATED STATEMENT OF CAS
Page 111 and 112: The consolidated financial statemen
Page 113 and 114: 11.5.2.2. Basis of consolidation Th
Page 115 and 116: are provided and costs are incurred
Page 117 and 118: of interest on the remaining balanc
Page 119 and 120: Deferred tax assets and liabilities
Page 121 and 122: - Partnering of Cx601 (i.e. finding
Page 123 and 124: The Group is mainly exposed to the
Page 125 and 126: fiscal year 2010, reference is made
Page 127 and 128: Sales and marketing expenses Years
Page 129 and 130: The number of employees in the R&D
Page 131 and 132: Analysis of profit/(loss) for the p
Page 133 and 134: (8) Disposal group held for sale Th
Page 135 and 136: (10) Property, plant and equipment
Page 137 and 138: The decrease of stock in 2012 compa
Page 139 and 140: dividends will be based upon the Co
Page 141 and 142: alance. As a consequence, the Compa
Page 143 and 144: (23) Other current liabilities The
Page 145 and 146: TiGenix SAU - Stock options Prior t
Page 147 and 148: (25) Business combination Descripti
Page 149 and 150: (26) Related party transactions Tra
Page 151 and 152: (28) Commitments and contingencies
Page 153 and 154: (30) Consolidation scope Name Subsi
Page 155: We believe that the audit evidence
Page 159 and 160: the results of its operations and c
Page 161 and 162: 12.2. STATUTORY BALANCE SHEET 2010-
Page 163 and 164: The value of receivables is reduced
Page 165 and 166: 13. Annual Report of the Board of D
Page 167 and 168: 2013. The facility will provide the
Page 169 and 170: year ended December 31, 2011, and T
Page 171 and 172: Operating result (EBIT) and net res
Page 173 and 174: Statement of financial position The
Page 175 and 176: - The total personnel costs of EUR
Page 177 and 178: - TiGenix may fail in successfully
Page 179 and 180: continue as a going concern and to
Page 181 and 182: Functioning of the Board of Directo
Page 183 and 184: The nomination and remuneration com
Page 185 and 186: Apart from the above remuneration f
Page 187 and 188: Shares and warrants held by indepen
Page 189 and 190: - Long-term incentive plan : warran
Page 191 and 192: Shares and warrants held by executi
Page 193 and 194: - identifying and implementing busi
Page 195 and 196: actual bonus equal to 78 % of her p
Page 197 and 198: was reduced to a half-time role com
Page 199 and 200: 14. Business and Financial Update a
Page 201 and 202: Financial results for the full year
Page 203 and 204: 15. Available Documents The Company
Page 205 and 206: Title Country Application number Ce
Page 207 and 208:
Title Country Application number Is
Page 209 and 210:
Country Trademark Classes USA CELLE
show all

ANNUAL REPORT 2012 - TiGenix

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?