15 May 2012

TiGenix Reports Business & Financial Results for the First Quarter 2012

ChondroCelect Sales up 123% – All Clinical Programs on Track – EUR 16.7 Million Cash

Leuven (BELGIUM) – May 15, 2012 – TiGenix NV (NYSE Euronext: TIG), a leader in the field of cell therapy, today gave a business update and announced the financial results for the first quarter ending March 31, 2012.

Business highlights

  • ChondroCelect-
    • Net sales increase of 123% vs. same period last year & 62% vs. Q4, 2011
    • Publication of large follow-up study in leading journal confirms efficacy and safety of ChondroCelect
  • Allogeneic stem cell platform
    • ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula on schedule
    • Cx611 Phase IIa in rheumatoid arthritis passes last safety hurdle
    • Last patient treated in Cx621 Phase I clinical trial
  • Corporate
    • European production facility obtains manufacturing license
    • Vice president commercial operations appointed


Financial highlights

  • EUR 16.7 million cash at March 31, 2012
  • Group revenues for the first 3 months of EUR 0.7 million

“In the first quarter 2012 we continued to aggressively push our commercial efforts forward,” said Eduardo Bravo, CEO of TiGenix. “As a result sales of ChondroCelect are developing in line with the improved traction we observed in the second part of last year. At the same time we are moving ahead of schedule with most of our clinical adipose stem cell programs. We closed the quarter with almost EUR 17 million cash on hand, which is sufficient to execute on our business plan and reach key inflection points.”

Business update

ChondroCelect sales increase continues apace

The Company reports net sales growth for the quarter of 123% compared with the same period of last year, and of 62% compared to Q4, 2011, a positive trend reflecting the uptake in Belgium, where we benefit from national reimbursement.

In the Netherlands one of the leading private healthcare insurance companies has made treatment with ChondroCelect compulsory for its insured, and no longer reimburses non-ATMP treatments. Similarly, one of the large private insurers in the UK has expressed its intention to routinely reimburse ChondroCelect going forward. Discussions to obtain full national reimbursement keep advancing in the Netherlands, France, Spain and Germany

Positive outcome of ChondroCelect compassionate use program published in leading journal

Positive outcome data from the ChondroCelect® compassionate use program (CUP), involving 43 orthopedic centers in 7 European countries, treating 370 patients with ChondroCelect over the span of four years, were published in advance online in Cartilage, the official journal of the International
Cartilage Repair Society. The data show that the implantation of ChondroCelect results in a positive benefit/risk ratio when used in an unselected, heterogeneous population, irrespective of the follow-up period, lesion size and type of lesion treated. In addition, the CUP study significantly expands the data set used to obtain approval for ChondroCelect from the European Medicines Agency in 2009, increasing eight-fold, from 43 to 334, the number of patients with long-term follow up data. To date almost 700 patients have been treated with ChondroCelect.

ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula on schedule

The ADMIRE-CD (Adipose Derived Mesenchymal stem cells for Induction of REmission in perianal fistulizing Crohn’s Disease) Phase III protocol was submitted to Ethics Committees or Health Authorities in all 8 participating countries, and to date approvals have been received in four of those countries already.

Cx611 Phase IIa in RA passes last safety hurdle

On April 17, upon review of the safety data of the first three patients of the third cohort of the company’s Phase IIa clinical trial in rheumatoid arthritis (Cx611), TiGenix received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining patients of this cohort.
This fact is of major importance. In RA it ensures that the product will not be held back by any doselimiting factors and that we will be able to move forward with the optimal treatment dose. Of almost equal importance is that, if required, we can expand the dosing range in other indications that we are exploring as well. With 6 months of follow-up, the current RA trial in 53 patients is expected to report meaningful results in H1 2013.

Last patient treated in Cx621 Phase I clinical trial

All 10 healthy volunteers have been recruited and treated in the Phase I study of Cx621. Cx621 investigates the safety and feasibility of intra-lymphatic administration of stem cells. Intra-lymphatic administration of (all) stem cells is patented by TiGenix. The final report of this trial will be available at the end of June.

European production facility obtains manufacturing license

On April 24, further to the cGMP inspection by the Dutch authorities TiGenix obtained the manufacturing authorization for human medicinal products for its European manufacturing plant in Sittard-Geleen in the Netherlands. The state-of-the-art manufacturing site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products. The plant provides TiGenix with crucial manufacturing capabilities to support the anticipated growth in demand for ChondroCelect for cartilage repair, and has sufficient capacity for the production of our advanced stem cell therapy products.

Vice president commercial operations appointed

In April, TiGenix appointed Dr. Guido Schopen as vice president commercial operations. Dr. Schopen brings to TiGenix more than 20 years of bio-pharmaceutical industry experience. In addition to his global commercial responsibilities, Dr. Schopen, who is a German national, will also assume the role of country manager Germany, the most developed market today for autologous chondrocyte implantation.

Group revenues(1) for the first 3 months of EUR 0.7 million

Total group sales of ChondroCelect for the first three months of 2012 amounted to EUR 0.7 million. This represents a 123% increase compared to the same period of last year. Quarter on quarter growth was 62%, a positive trend reflecting the uptake in Belgium. These revenues do not include EUR 0.1 million of deferred product sales to be recognized once ChondroCelect is reimbursed under the policy rule of expensive medicinal products in the Netherlands.

(1) Sales of ChondroMimetic are not included as TiGenix Ltd is considered as an asset to be held for sale.

Cash position of EUR 16.7 million on March 31, 2012

On March 31, the Company had a cash position of EUR 16.7 million. Net cash used during the first quarter of 2012 was EUR 3.1 million, representing a 12% decrease compared with the same quarter of last year. The company continues its successful efforts to increase efficiency and to diligently manage the use of its cash resources.

Outlook 2012

  • ChondroCelect reimbursement updates and decisions
  • Partnering of ChondroCelect in selected countries
  • First patient dosed in Cx601 Phase III clinical study in complex perianal fistulas
  • Finalize recruitment of Cx611 Phase IIa trial in RA
  • Phase I study results for Cx621

TiGenix to present at BioEquity in Frankfurt, Germany, May 15

Today TiGenix will present at BioEquity 2012 in Frankfurt, Germany. Eduardo Bravo, CEO of TiGenix, will make a formal presentation on the company at 4 p.m. at Level 1, Room Gold 1. BioEquity takes place at the Marriott Hotel, Hamburger Allee 2, Frankfurt am Main.

About TiGenix

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

Forward-looking information

This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix’ control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix’ expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

For more information:

Eduardo Bravo
Chief Executive Officer


Claudia D’Augusta
Chief Financial Officer


Hans Herklots
Director Investor & Media Relations
T: +32 16 39 60 97