TiGenix : Full Year 2013 Financial Results

TiGenix : Full Year 2013 Financial Results

  *ChondroCelect® sales increase to EUR 4.3 million, up 25%
  *Cx601 US regulatory and development path confirmed
  *EUR 18.5 million secured in private placements, of which EUR 12 million
    with strategic investor Grifols
  *EUR 15.9 million cash at December 31, 2013

LEUVEN, Belgium,  March 11,  2014  (GLOBE NEWSWIRE)  -- 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.

Business highlights

  *ChondroCelect sales grew 25%, on track to become a cash flow positive
    asset in 2014
  *US regulatory and development path for Cx601 validated in end-of-phase 2
    meeting with FDA
  *2/3 of patients enrolled in European Phase III trial of Cx601 in complex
    perianal fistulas
  *Encouraging phase IIa results of Cx611 in rheumatoid arthritis
  *Renewal of GMP licence for Dutch manufacturing facility allows completion
    of sale

Financial highlights

  *EUR 18.5 million secured in private placements, of which EUR 12 million
    with strategic investor Grifols 
  *Facility loan agreement secured for up to EUR 10 million in December
  *EUR 15.9 million in cash & cash equivalents at 31 December, 2013. Average
    monthly cash burn reduced to EUR 1.1 million
  *Net loss of EUR 18.4 million, a 10% reduction from EUR 20.4 million in

"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

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 

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 

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 

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

Key figures  (thousands  of  Euro,  except number  of  employees  and  mandate 

                                                     Years ended December 31
Thousands of Euro (€)                                 2013         2012*
CONSOLIDATED INCOME STATEMENT                                     
CONTINUING OPERATIONS                                 4.301        
Sales                                                 4.301        4.084
Gross sales                                           4.301        4.084
Cost of sales                                         -1.136       -905
Gross profit                                         3.165        3.179
Research and development expenses                     -10.905      -13.264
Sales and marketing expenses                          -3.416       -2.863
General and administrative expenses                   -5.796       -5.924
Total operating charges                               -21.252      -22.956
Other operating income                                939          1.389
Operating Result                                      -16.013      -17.482
Interest income                                       11           35
Interest expenses                                     -45          -60
Foreign exchange differences                          -354         -142
Profit/(Loss) before taxes                            -16.401      -17.649
Income taxes                                          59           -1
Profit/(Loss) for the period from continuing          -16.342      -17.650
                                                     0            0
DISCONTINUED OPERATIONS                                           
Profit/(Loss) for the period from discontinued        -2.048       -2.743
Profit/(Loss) for the period                          -18.390      -20.393
Basic (diluted) loss per share (EURO)                 -0,16        -0,22
Basic (diluted) loss per share from continuing        -0,14        -0,19
operations (EURO)
Cash and cash equivalents of continued operations     15.565       11.034
Employees and mandate contractors from continuing     56           61

* 2012 figures have been restated to present TiGenix BV as discontinued

Gross sales of EUR 4.3 million

ChondroCelect sales for the twelve months  to December 31 2013 have grown  25% 
to EUR 4.3 million,  compared to EUR  3.4 million in the  same period of  last 
year on a  like-for-like basis. Revenues  in 2013 have  been mainly driven  by 
sales in Belgium and in the Netherlands while additional growth is expected to
be fueled by sales  in the UK  and in Spain  where reimbursement was  obtained 
during 2013.

Net loss for the period significantly reduced

The net  loss for  2013 amounted  to EUR  18.4 million  compared to  EUR  20.4 
million in  2012. The  reduced net  loss in  2013 is  a direct  result of  the 
reduced operating loss of the Group's continuing operations as well as of  the 
reduced loss for  the period by  the wholly-owned subsidiary,  TiGenix BV.  In 
line with the decision taken during 2013  to sell this company, this is  shown 
as discontinued operations. 

EUR 18.5 million secured in private placements

In 2013,  TiGenix raised  a total  of  EUR 18.5  million through  two  private 
placements from domestic  and international healthcare-specialised  investors. 
The latest equity increase for EUR 12 million took place in November 2013  and 
was fully subscribed by Grifols through its wholly owned subsidiary Gri-Cel.

In addition to its ability  to attract dilutive funding, TiGenix  successfully 
secured in 2013 a total of EUR 2.7 million of non-dilutive funding from grants
and soft loans.

Secured facility loan agreement for up to EUR 10 million in December

In December 2013, TiGenix announced the signing of a structured debt financing
agreement of up  to EUR 10  million with Kreos  Capital, Europe's largest  and 
leading provider of debt to high-growth companies. The loan can be drawn  down 
in three tranches at the Company`s discretion.

EUR 15.9 million cash & cash equivalents at year-end (including cash from
discontinued operations)

At 31  December 2013,  the Company  had EUR  15.9 million  cash in  hand,  not 
including the EUR  10 million available  from the loan  agreement signed  with 
Kreos. Average monthly  cash burn for  the year  has been reduced  to EUR  1.1 

Outlook for the next 12 months

  *The continued uptake of ChondroCelect will make it a cash flow positive
    asset during 2014
  *Cx601: finalise the recruitment of the phase III trial
  *Cx601: initiate the technology transfer process with US Contract
    Manufacturing Organisation (CMO) and submit the application for a Special
    Protocol Assessment (SPA) in the United States
  *Cx611: development plan for new indications to be presented 

Complete financial statements

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

Conference call webcast

On March 11, at 14:00 CET/9 a.m.  EDT, TiGenix will conduct a conference  call 

+32 2 620 0138  Belgium

+34 91 114 6582  Spain

+31 20 716 8295  Netherlands

+44 20 3427 1907 UK

+1 646 254 3366  USA

Confirmation code 7083606

The live webcast can be followed online via the link:


Following the business activities  update and financial results  presentation, 
participants will be able  to ask questions. The  press release and the  slide 
presentation will  be made  available in  the Newsroom/Events  section of  our 
website. A replay  of the  webcast will be  available on  our website  shortly 
after the conference call.

For more information Eduardo Bravo
Chief Executive Officer

Claudia D'Augusta
Chief Financial Officer

Richard Simpson
Senior Consultant, Comfi sprl

About TiGenix

TiGenix NV  (Euronext  Brussels:  TIG)is  a  leading  European  cell  therapy 
companywith a marketed product for  cartilage repair, ChondroCelect ®, and  a 
strongpipeline of clinical  stage allogeneic  adultstem cell  programmesfor 
the treatment  ofautoimmune and  inflammatory diseases.TiGenixis  based  in 
Leuven (Belgium)  and has  operations in  Madrid (Spain),  and  Sittard-Geleen 
(theNetherlands). For more information please visitwww.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 the  Company's 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 the Company's 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.

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