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2014-05-13

TiGenix: TiGenix Business and Financial Update for the first quarter of 2014

Regulated information
13 May, 2014

TiGenix Business and Financial Update
for the first quarter of 2014

ChondroCelect®agreements enable short and long term value creation

Leuven, Belgium - 13 May, 2014 -
TiGenix NV (Euronext Brussels: TIG), the European leader in cell therapy,
issued today a business and financial update for the first three months of
2014.

Business highlights

* Agreement to license the marketing and distribution rights of ChondroCelect
to Sobi, a leading European specialty pharmaceutical company dedicated to
niche disease indications, signed in April
* Agreement to sell the Dutch manufacturing facility to PharmaCell for a
total consideration of Euro 5.75 million
* Patient recruitment in the European Phase III trial of Cx601 on track
* Selection of a US Contract Manufacturing Organisation (CMO) for Cx601
technology transfer ongoing * Post-Phase IIa development plan for Cx611
being finalised following consultation with experts in several inflammatory
and autoimmune disorders

Financial highlights

* ChondroCelect® sales up 26% compared with first quarter 2013
* Total funds of Euro 25.7 million available

"The agreements to license the marketing and distribution rights of
ChondroCelect to Sobi, and to sell our Dutch manufacturing facility to
PharmaCell, were the highlights in the first quarter of this year," said
Eduardo Bravo, CEO of TiGenix. "Together, these two deals mark a
transformational milestone for TiGenix enabling us to realise both immediate
and long-term value from the ChondroCelect business for our shareholders, and
to bring ChondroCelect to many more patients in many more countries. Looking
ahead, TiGenix can focus exclusively on progressing its promising late-stage
clinical assets to patients suffering from diseases with high unmet medical
needs."

Business Update

Agreements to license the marketing and distribution rights of ChondroCelect
to Sobi, and to sell the Dutch manufacturing facility to PharmaCell, signed

To expand the commercial reach for ChondroCelect, and to realise the immediate
and long- term value potential of this asset, a licensing agreement was
signed in April with Sobi, Swedish Orphan Biovitrum AB, a leading European
specialty pharmaceutical company focused on niche disease indications.

The success of ChondroCelect requires a substantial upfront investment to
obtain reimbursement, to prepare the market, to open and train medical
centres, and to provide the medical education necessary to establish
ChondroCelect as the gold standard for the right patients. Sobi has the
infrastructure, capabilities, experience, financial resources, and a much
broader geographic coverage with which to bring ChondroCelect to many more
patients in many more countries.

Under the terms of the agreement, which is effective 1 June 2014, Sobi gains
the marketing and distribution rights to ChondroCelect for the European
markets where the product is currently available, and for the registration,
reimbursement, marketing and distribution of ChondroCelect in other markets
in Europe, Turkey and Russia, and for markets in the Middle East and North
Africa. In exchange, Sobi will pay TiGenix a royalty of 20% (22% for the
first year) of the net sales of ChondroCelect, and the vast majority of all
expenses associated with the product. This will give TiGenix a cash
flow-positive asset and a significantly higher operating margin for the
product going forward.

The agreement to sell the Dutch production facility, expected to close during
the second quarter, completes the strategic repositioning of the business.
For a total consideration of Euro 5.75 million, including an upfront payment
of Euro 3.5 million, the facility will be sold to PharmaCell, a leading
European contract manufacturing organisation active in the areas of cell
therapy and regenerative medicine. ChondroCelect will continue to be
manufactured at the facility under a long-term manufacturing agreement.

The combination of the two deals will bring an immediate cash inflow of Euro
3.5 million to TiGenix, and a reduction in annual operating costs for
manufacturing, sales and marketing of at least Euro 5 million. In time, the
broader geographical reach for ChondroCelect offered by Sobi, will give
TiGenix the potential for greater value generation in the long-term.

Patient recruitment on track with Cx601

Patient recruitment for the European Phase III ADMIRE-CD study of Cx601 in
complex perianal fistulas in Crohn's disease is on track to complete by the
end of 2014. This should enable study results to be obtained in the third
quarter of 2015, which would allow for filing for marketing authorisation
with the European Medicines Agency (EMA) in early 2016.

Post-Phase IIa development plan for Cx611 to be completed shortly

With the encouraging results of the Phase IIa study of Cx611 in rheumatoid
arthritis, TiGenix is working closely with 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 during the second quarter of this year.

Financial update

ChondroCelect sales continue to grow steadily

During the first three months ending 31 March 2014, ChondroCelect sales grew
26% to Euro 1.3 million, compared to Euro 1.0 million in the same period last
year.

Funds available will enable TiGenix to secure Cx601 study results

With cash in hand at 31 March 2014 of Euro 17.2 milllion, outstanding funds of
Euro 5 million available from the Kreos loan facility, and Euro 3.5 million
to be paid to TiGenix by PharmaCell on the sale of the Dutch manufacturing
facility, total funds of Euro 25.7 million are available to TiGenix. This
will enable the company to secure the study results from the European Phase
III trial of Cx601.

Operational expectations for the next 12 months

* To complete patient recruitment for the European Phase III study of Cx601
by the end of 2014
* To hire a Contract Manufacturing Organisation (CMO) in the United States
and to begin technology transfer for Cx601
* To file for a Special Protocol Assessment (SPA) for Cx601 with the Food and
Drug Administration (FDA)
* To complete, and communicate, the post-Phase IIa development plan for Cx611
in Europe

For more information

Richard Simpson
Senior Consultant, Comfi sprl
T: +32 494 578 278
richard@comfi.be

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy company
with a marketed product for cartilage repair, ChondroCelect®, and a pipeline
of clinical stage allogeneic adult stem cell programmes for the treatment of
autoimmune and inflammatory diseases. TiGenix is headquartered in Leuven
(Belgium) with operations in Madrid (Spain). 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 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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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TiGenix via Globenewswire

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