LEUVEN MINDGATE

TiGenix Reports Full Year 2013 Financial Results


Leuven (BELGIUM) - March 11, 2014 -TiGenix NV (Euronext Brussels: TIG), the European leader in cell therapy, gives an update of its business activities and announces financial results for the full year 2013.

"We have made very good progress on all fronts during this year," said Eduardo Bravo, CEO of TiGenix. "In Grifols, we have added a first-class strategic investor which not only validates our technology platform but strengthens our financial position. ChondroCelect growth remains strong. For Cx601, the regulatory path in the United States has been confirmed and patient recruitment for the phase III trial  is progressing well. We will maintain the pace of continuous delivery during 2014, with concrete advances to be announced in the short term".

Business update

ChondroCelect sales grew 25%, on track to become a cash flow positive asset in 2014

ChondroCelect sales for the year have grown 25% to EUR 4.3 million, compared to EUR 3.4 million in 2012 on a like-for-like basis. ChondroCelect sales for the fourth quarter of 2013 amounted to EUR 1.2 million, up 38% over the same quarter last year, with revenues still mainly fueled by sales in Belgium and the Netherlands.

Growth is expected to accelerate in 2014 with the increasing contribution of sales in the UK and Spain. We reiterate our objective for ChondroCelect to become a cash flow positive asset in the course of 2014.

Patient enrolment in ADMIRE-CD Phase III trial (Cx601) in complex perianal fistulas progressing

Patient enrolment in the ADMIRE-CD trial, the Company's pivotal European Phase III clinical trial for Cx601, is progressing. Recruitment is ongoing at more than 50 centers in 8 countries and should be completed in 2014. Final results are expected in the third quarter of 2015 and, if positive, will allow TiGenix to file for European marketing approval  in 2016.

US regulatory and development path validated in end-of-phase 2 meeting with FDA

In December 2013, TiGenix held an end-of-phase 2 meeting with the Food and Drug Administration (FDA) concerning the development of Cx601 in the United States. The objectives of the meeting were to discuss the adequacy of the existing non-clinical package to support an IND for a US-based phase III trial, to obtain guidance on the design of such a trial, and to confirm the acceptability of using the data from the ongoing ADMIRE-CD phase III study in Europe to support a BLA filing. Based on the affirmative feedback received on these three points, TiGenix is starting the technology transfer to a US Contract Manufacturing Organization (CMO) and the preparation of the application for a Special Protocol Assessment (SPA) that will allow the filing of an IND for phase III in 2015.

The Company is also re-opening discussions concerning the partnering of Cx601 in different regions.

Cx611 clinical development plan based on encouraging phase IIa results in RA almost finalised

In October, TiGenix presented the results of its Phase IIa study of Cx611 in refractory rheumatoid arthritis (RA) in a plenary session of the American College of Rheumatology Annual Meeting. Working closely together with an advisory board of international key opinion leaders on the appropriate design of follow-up studies for Cx611 in inflammatory and autoimmune disorders, TiGenix expects to finalise and announce the next steps of the development plan in the coming weeks.

Renewal of GMP licence for Dutch manufacturing facility allows completion of  sale

In October, Dutch authorities renewed TiGenix's Good Manufacturing Practice (GMP) licence for its state-of-the-art cell therapy manufacturing facility in Sittard-Geleen, the Netherlands. This renewal allowed the Company to complete negotiations which culminated in the agreement signed in January 2014 to sell the Company's Dutch subsidiary which owns the facility to PharmaCell. On top of the EUR 4.25 million cash to be received (of which EUR 3.5 million will come in 2014), the sale will reduce organisational complexity and eliminate an important part of the Company's fixed costs while maintaining ChondroCelect supply.

Board composition

Following the EUR 12 million investment by global healthcare company Grifols through its fully-owned subsidiary Gri-Cel, the Company appointed Dirk Buscher and José Terencio to the Board of Directors, replacing Joel Jean-Mairet (Ysios Capital Partners SGECR SA) and Nico Vandervelpen (LRM Beheer NV).

In March 2014, co-founder Gil Beyen (Gil Beyen BVBA) resigned from the Board of Directors to assume other responsibilities outside of TiGenix.

Financial results for the full year 2013

The 2013 financial statements can be found in the investor section of the website www.tigenix.com

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect ®, and a strong pipeline of clinical stage allogeneic adult stem cell programmes for the treatment of autoimmune and inflammatory diseases. TiGenix is based in Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.

Subscribe to our newsletter

Stay tuned and get our news in your inbox: subscribe here.

Keep me informed
Follow us