ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

More documents

Recommendations

Info

7.2.3 Selling, general and administrativeexpensesSelling, general and administrative expenses consist primarilyof sales and marketing expenses, professional services (suchas pricing & reimbursement, market access, financial, legal,accounting, audit, HR, IT and administration expenses andinsurances), salaries and other personnel-related expenses,general expenses and office rental payments.Although significant efforts in building the commercialteam were done in the past years, it is expected that sellingexpenses will increase further with the commercialisation ofChondroCelect, ChondroMimetic and potential third-partyproducts. Market access, pricing and reimbursement, marketingand sales efforts will continue in the years to come.General and administrative costs are expected to remainrelatively flat over the coming years.7.3 Analysis of results of operations7.3.1 Year Ended December 31, 2010 comparedto Year Ended December 31, 20097.3.1.1 RevenuesTotal revenues were €2,423k in 2010 compared to €1,032k in 2009 representing an increase of 135%.Years ended December 31Thousands of Euro (€) 2010 2009Sales billed 982Deferred sales (361)Sales 621 46Other revenues 1,802 986Total 2,423 1,032For ChondroCelect, 2010 was the first full year of nonreimbursedcommercial sales in a limited number of Europeanreference centres. Only part of the ChondroCelect sales couldbe recognized as revenues as the Company had an agreementwith a limited number of Dutch reference centres in placewhereby only part of the price had to be paid upfront withthe remainder to be paid at the moment ChondroCelectwould be admitted to the “Lijst Dure Geneesmiddelen”. TheChondroCelect sales are limited and will continue to be limitedand irregular until ChondroCelect will be reimbursed. In 6.5,an update can be found with respect to reimbursement in thedifferent European countries. Billed sales of ChondroCelectamounted to approximately €830,000 in 2010.For ChondroMimetic, the commercial sales started onlyin October of last year after the launch at the 9th WorldCongress of the International Cartilage Repair Society (ICRS) inBarcelona, Spain. Billed sales of ChondroMimetic amounted toapproximately €150,000 in 2010.For the development work done in stem cells and biomaterialsmainly in the indications of meniscus and osteoarthritis, theCompany received grant revenues of €1.8 million.153 •
7.3.1.2 Research and development expensesResearch and development expenses amounted to €9,873kin 2010 compared to €8,114k in 2009, an increase of 22%.Years ended December 31Thousands of Euro (€) 2010 2009Personnel costs 3,144 4,264Operating costs 4,064 2,035Production costs 0 433General costs 686 737Depreciation 1,979 644Total 9,873 8,114The costs of TiGenix B.V. and TiGenix Ltd. and the7.3.1.3 Selling, general and administrativeamortisation of intangible assets related to the acquisition of expensesOrthomimetics Ltd. (today TiGenix Ltd.) are in 2010 accountedSelling, general and administrative expenses were €8,353k infor a full year. Besides that, there were in 2010 the costs related2010 compared to €7,316k in 2009, an increase of 14%. The mainto the preparation of the post-approval commitments forcomponents of these expenses were as follows for 2009 andChondroCelect and the delivery device for ChondroMimetic. In2010:2010, a total of €1.6 million costs were capitalised compared to€0.8 million in 2009.Years ended December 31Thousands of Euro (€) 2010 2009Personnel costs 4,816 4,268Operating costs 2,501 2,011General costs 8042,501 773Depreciation 232 265Total 8,353 7,316The increase by 14% compared to 2009 is a result of the expansion of the commercial sales team , increased pricing andreimbursement costs and the additional G & A costs associated with the acquisition of Othomimetics Ltd (today TiGenix Ltd).7.3.1.4 Financial results7.3.2 Year Ended December 31,2009 comparedIn 2010, the financial result was €579k compared to €300k into Year Ended December 31, 20082009. The vast majority relates to unrealized exchange ratedifferences with respect to the intercompany loans in USD7.3.2.1 Revenuesand GBP.7.3.1.5 Net lossTotal revenues came in at €1,032k in 2009 compared to €321k in2008.The net loss was €15,716k in 2010 compared to €14,098k in 2009,an increase of 11%. This increase is mainly related to the increaseof the operating charges, both in R&D and S,G&A expenses, andthe cost of sales of ChondroCelect and ChondroMimetic.Years ended DecThousands of Euro (€) 2009154 • TiGenix • Rights Offering
Page 2 and 3:
TiGenix NV(Public limited liability
Page 4 and 5:
Table of ContentsSummary ..........
Page 7 and 8:
3.7.1 Categories of potential inves
Page 9 and 10:
5.7.1 Shares and warrants held by i
Page 11 and 12:
7.5.2 Taxation.....................
Page 13 and 14:
SummaryThe words written in capital
Page 15 and 16:
Activities and strategy of the Comp
Page 17 and 18:
• Two allogeneic adult stem cell
Page 19 and 20:
• TiGenix’ success depends on i
Page 22 and 23:
Unaudited pro forma income statemen
Page 24 and 25:
Recent developmentsAcquisition of C
Page 26 and 27:
In this context, we would like to s
Page 28 and 29:
Announcement of the results of theO
Page 30 and 31:
After the Contribution andafter the
Page 32 and 33:
ContributionContribution AgreementC
Page 34 and 35:
Risk factorsAny investment in the P
Page 36 and 37:
commercialisation of ChondroCelect,
Page 38 and 39:
in delays in bringing products to t
Page 40 and 41:
The Company cannot predict what eff
Page 42 and 43:
y each of its patents and patent ap
Page 44:
to exercise preferential subscripti
Page 47 and 48:
this prospectus which is capable of
Page 49 and 50:
• investment professionals fallin
Page 51 and 52:
1. General information and informat
Page 53 and 54:
1.4.2 Company documents and otherin
Page 55 and 56:
• the granting of discharge of li
Page 57 and 58:
• in case of registered Shares, t
Page 59 and 60:
cast at the meeting. If the amount
Page 61 and 62:
No one may cast a greater number of
Page 63 and 64:
If a Belgian resident individual ne
Page 65 and 66:
Belgium has concluded tax treaties
Page 67 and 68:
3. Information on the Contributiona
Page 69 and 70:
In this context, we would like to s
Page 71 and 72:
TiGenix has a limited financial deb
Page 73 and 74:
Thousands of Euro (€) TiGenix Cel
Page 75 and 76:
3.5.2 Issuance Price and RatioThe i
Page 77 and 78:
(c)Rules for subscriptionSubject to
Page 79 and 80:
The Scrips Private Placement will o
Page 81 and 82:
to comply with any of its obligatio
Page 83 and 84:
3.11.2 Scenario 1: Existing Shareho
Page 85 and 86:
• a pledge of Locked Shares to a
Page 87 and 88:
4. General information about THECOM
Page 89 and 90:
DateINCORPORATIONFebruary 21,2000Tr
Page 91 and 92:
Upon completion of the IPO of TiGen
Page 93 and 94:
Issue dateMay 14,2004April 20,2005T
Page 95 and 96:
4.7.2 Voting rightsAs further descr
Page 97 and 98:
can be obtained free of charge at t
Page 99 and 100:
5.2.4 Composition of the Board of D
Page 101 and 102:
Amonis. Mr. Duron has been CEO of K
Page 103 and 104:
5.3.4 Nomination and remunerationco
Page 105 and 106:
• investor relations: nurturing c
Page 107 and 108:
The remuneration of the members of
Page 109 and 110:
5.7.2 Shares and warrants held by e
Page 111 and 112:
Cellerix EBIP 2010An EBIP for senio
Page 113 and 114: The minutes must also contain a jus
Page 115 and 116: 6. Activities of Tigenix andits sub
Page 117 and 118: • Clinical stage pipeline. TiGeni
Page 119 and 120: 6.3.3 Acquisition of CellerixAs a r
Page 121 and 122: Full thickness articular cartilage
Page 123 and 124: Fig. 6.2: Autologous Chondrocyte Im
Page 125 and 126: Preclinical work in a meniscus repa
Page 127 and 128: The Company is also ensuring high q
Page 129 and 130: Recognising the importance of pre-l
Page 131 and 132: In Spain, since the passage of Orde
Page 133 and 134: Fig. 6.6: ChondroMimetic procedure
Page 135 and 136: 6.5.3 Commercial strategyBuilding o
Page 137 and 138: 6.7 Manufacturing & logisticsEffici
Page 139 and 140: The international application WO06/
Page 141 and 142: ChondroMimetic competitionThe main
Page 143 and 144: in Cellerix’ GMP facility in Madr
Page 145 and 146: 6.14.3 History and development of C
Page 147 and 148: The table below gives an overview o
Page 149 and 150: Prevalence No. of cases (2010) Esti
Page 151 and 152: Fig. 6.9: Platform development stra
Page 153 and 154: In developing Cx601, Cellerix has b
Page 155 and 156: 6.14.6 Manufacturing & logisticsCel
Page 157 and 158: population, methods for the isolati
Page 159 and 160: • Cimzia (certolizumab) - UCB: Al
Page 161 and 162: Spanish Ministry of Education and S
Page 163: 7.2 Consolidated income statementTw
Page 167 and 168: 7.3.2.3 Selling, general and admini
Page 169 and 170: 7.4.1 Cash flows from operating act
Page 171 and 172: Cash & cash equivalents and intangi
Page 173 and 174: As of December 31, 2010, the Group
Page 175 and 176: 8. Consolidated Financial informati
Page 177 and 178: 8.1.3 Consolidated cash flow statem
Page 179 and 180: 8.1.5 Notes to consolidated financi
Page 181 and 182: operating results and operating pla
Page 183 and 184: The Group does not account for work
Page 186 and 187: 8.1.5.4 Operating result (EBIT)Resu
Page 188 and 189: 8.1.5.7 TaxesThere is no current ta
Page 190 and 191: 8.1.5.10 Tangible assetsThousands o
Page 192 and 193: 8.1.5.14 Deferred charges & accrued
Page 194 and 195: 8.1.5.18 Finance lease obligations
Page 196 and 197: Business combination Cellerix SADes
Page 198 and 199: Weighted averageexercise priceTOTAL
Page 200 and 201: the respective issue date of the wa
Page 202 and 203: Transactions with non-executive dir
Page 204 and 205: 8.1.5.28 Subsequent eventsAcquisiti
Page 206 and 207: 8.1.5.31 Disclosure under Article 1
Page 208 and 209: Additional statementsThe preparatio
Page 210 and 211: 9.1.2 Stand-alone balance sheetYear
Page 212 and 213: 9.1.4 Stand-alone statement of chan
Page 214 and 215:
) Standards and interpretations iss
Page 216 and 217:
The clinical development of new dru
Page 218 and 219:
future against which they may be ap
Page 220 and 221:
Cellerix’ research and developmen
Page 222 and 223:
YearThousandsof Euro2010 2009 2008E
Page 224 and 225:
Thousands of Euro (€)Laboratoryeq
Page 226 and 227:
Current financial assetsShown below
Page 228 and 229:
At December 31, Cellerix’ share c
Page 230 and 231:
9.1.5.17 Deferred revenueThe balanc
Page 232 and 233:
9.1.5.21 Share-based paymentsThe EB
Page 234 and 235:
GrantsCellerix received several gra
Page 236 and 237:
10. Report regarding unaudited prof
Page 238 and 239:
EMAFDAFibrous tissueGCPGMPGrowth fa
Page 240 and 241:
Appendix 1: Press releases 2006-201
Page 242 and 243:
Appendix 2: REGULATORY APPROVALPROC
Page 244 and 245:
like ChondroCelect or the future ce
Page 246 and 247:
TitleCountry/regionPatent/applicati
Page 248 and 249:
TitleCountry/regionPatent/applicati
Page 250 and 251:
Title“Cell populations having imu
Page 252 and 253:
D. Trademarks of CellerixThe table
Page 254 and 255:
Decision resources.Dell’Accio, F.
Page 256 and 257:
Noyes, F. R., Barber-Westin, S. D.,
Page 258 and 259:
Appendix 5: 2008, 2009 and2010 mana
Page 260 and 261:
Contents1. The year in brief ......
Page 262 and 263:
2. Financial informationa. The Inco
Page 264 and 265:
The Directors shall call a Sharehol
Page 266 and 267:
• Exercise price changed to 5.291
Page 268 and 269:
10 • TiGenix • Rights Offering
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Exceptionally, for the following re
Page 276 and 277:
(d)(e)Duration: The Options Plan wi
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
eceipt sent to the number or addres
Page 284 and 285:
THE COMPANYTiGenix NVRomeinse straa
show all

ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

Create successful ePaper yourself

Delete template?

Save as template?