LEUVEN MINDGATE

TiGenix reports its full year 2014 results


TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platform of allogeneic, expanded adipose-derived stem cells, or eASC's, in inflammatory and autoimmune diseases, reported its results for 2014.

"We are very pleased with our progress in the last year," said Eduardo Bravo, CEO of TiGenix. "We have transformed the operational focus of the Company to exploit the potential of our proprietary technology platform of allogeneic eASCs. From this, we have an advanced pipeline of products in areas of high unmet medical need in inflammatory and autoimmune diseases, including Cx601 which will deliver Phase III results in the third quarter of this year, and Cx611 which will enter Phase IIb in early rheumatoid arthritis in the fourth quarter of this year, and which is already in Phase I in severe sepsis. Finally, through a convertible bond issue in February 2015, we have refinanced the Company. TiGenix is re-positioned with an enhanced clinical pipeline and a bright future".

Updates

Business update

  • Strategic refocusing of the Company successfully completed

  • Patient recruitment of Cx601 European Phase III study completed

  • Cx601 development for the United States progressed according to plan

  • Development plan for Cx611 completed and implementation begun

Financial update

  • In 2014, the operating loss was reduced by 15%, from Euro 14.8 million in 2013 to Euro 12.6 million, resulting from a significant increase in total revenues together with a lower increase in operating expenses.

  • Total revenues for the period amounted to Euro 6.3 million. Grants income, Euro 5.6 million, significantly increased during 2014. Growth has been mainly driven by grants related to soft loans received in previous years (Euro 4.5 million). In addition to grants, total revenues include Euro 0.3 million of royalties from the net sales of ChondroCelect, and Euro 0.4 million of other operating income.

  • Total operating charges for the period amounted to Euro 18.8 million. The increase over 2013 is mainly due to progress made with the clinical development of Cx601 in Phase III as well as the launch of the Phase I sepsis challenge trial for Cx611.

  • The financial result (the balance of financial income, financial expenses and foreign exchange differences) improved from a negative result of Euro -0.4 million in 2013 to a positive result of Euro 0.3 million in 2014. This was due to the combined effect of an increase in financial expenses related to the Kreos loan (which was signed in 2013 but only came into effect in 2014), positive exchange differences coming from loans receivable in foreign currency (the US dollar strengthened significantly against the Euro in 2014), and improved financial income from bank deposits.

  • Loss for the period from continuing operations has been reduced by 25% compared to 2013, from Euro 15.1 million to Euro 11.4 million, as a consequence of the significant increase in total revenues and the lower increase in operating expenses.

  • Income taxes increased to Euro 0.9 million due to fiscal benefits obtained from research and development activities performed in 2013.

  • Loss for the period from discontinued operations decreased 51%, from Euro 3.3 million to Euro 1.6 million. During the first half of 2014, the Group discontinued ChondroCelect operations through the combination of the sale of the Dutch manufacturing facility and a licensing agreement for the marketing and distribution rights of the product from which TiGenix will receive royalties.

  • As a result of the above, the loss for the period decreased significantly by 29%, from Euro 18.4 million to Euro 13.0 million, in 2014.

More info can be found on www.tigenix.com

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