ANNUAL REPORT 2012 - TiGenix
ANNUAL REPORT 2012 - TiGenix
ANNUAL REPORT 2012 - TiGenix
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11.5.2.23. Critical accounting judgements<br />
and key sources of estimation<br />
uncertainty<br />
In the application of the Group’s accounting<br />
policies, the directors are required to use<br />
certain critical accounting estimates,<br />
assumptions and judgment about the<br />
carrying amounts of certain assets and<br />
liabilities. The areas involving a high degree<br />
of judgement or complexity or areas where<br />
assumptions and estimates are significant to<br />
the consolidated financial statements, are<br />
the following :<br />
Recognition and measurement<br />
of intangible assets<br />
has been carried out and the directors are<br />
confident that the carrying amount of the<br />
internally generated intangible assets will be<br />
recovered.<br />
Additionally, in <strong>2012</strong>, the directors also<br />
reconsidered the recoverability of the<br />
Group´s externally acquired assets, which<br />
are included in the consolidated statement<br />
of financial position at December 31, <strong>2012</strong><br />
at KEUR 37,287 (2011 : KEUR 39,861; 2010 :<br />
KEUR 18,386). A detailed sensitivity analysis<br />
has been carried out and the directors are<br />
confident that the carrying amount of the<br />
externally acquired assets will be recovered.<br />
Going concern<br />
The Company considers that the regulatory<br />
and clinical risks inherent to the development<br />
of its products preclude it in general<br />
from capitalising development costs<br />
until the moment of regulatory approval.<br />
Nevertheless after the positive CHMP opinion<br />
of ChondroCelect end of June 2009, the<br />
Company has decided to capitalise the<br />
development costs. In the consolidated<br />
IFRS financial statements of the Group,<br />
development costs of ChondroCelect have<br />
been capitalized as intangible assets if all<br />
conditions for capitalisation have been<br />
satisfied as specified in IAS 38.<br />
On December 31, <strong>2012</strong>, the Company had a<br />
cash position of EUR 11.1 million. Based on the<br />
monthly net cash burn during <strong>2012</strong> in operating<br />
activities (EUR 1,5 million), this cash position is<br />
not sufficient to continue the operations for<br />
the next twelve months (until the next ordinary<br />
shareholders’ meeting of April 2014).<br />
In order to generate sufficient additional<br />
cash to continue the operations for the<br />
next twelve months, the Board of Directors<br />
developed an action plan, which is reflected<br />
in the budget, based on the following key<br />
assumptions :<br />
In <strong>2012</strong>, the directors reconsidered the<br />
recoverability of the Group’s internally<br />
generated intangible assets, which are<br />
included in the consolidated statement<br />
of financial position at December 31, <strong>2012</strong><br />
at KEUR 1,918 (2011 : KEUR 2,166; 2010 : KEUR<br />
2,297). The project continues to progress in a<br />
very satisfactory manner, and management<br />
has reconfirmed the directors’ previous<br />
estimates of anticipated revenues from<br />
the project. A detailed sensitivity analysis<br />
- An increase of the projected commercial<br />
revenues of ChondroCelect, expected to<br />
continue the same trend in units sold as in<br />
<strong>2012</strong>, based on the expected progressing<br />
reimbursement activities in additional<br />
countries;<br />
- Additonal non-dilutive funding, such as<br />
grants (EU 7 th FP) and soft loans already<br />
granted (Innpacto, Madrid Network), and<br />
others not yet granted;<br />
120 <strong>TiGenix</strong> I annual report <strong>2012</strong>