TiGenix : Business Update & Financial Highlights for the First Half of 2012
(Thomson Reuters ONE) -
Regulated information
August 23, 2012
TiGenix Business Update & Financial Highlights for the First Half of 2012
* Commercial roll-out of ChondroCelect Continues to Gain Momentum
* All Clinical Stem Cell Programs on Track
* Sufficient Cash to Bring the Company to the Next Value Inflection Point
Leuven (BELGIUM) - August 23, 2012 -TiGenix NV (NYSE Euronext: TIG), the
European leader in cell therapy, gives an update of its business activities and
provides the financial highlights for the half year ending June 30, 2012.
Business highlights
* ChondroCelect:
* ChondroCelect sales EUR 2.1 million, including EUR 0.7 million of 2011
deferred sales
* ChondroCelect obtains national reimbursement in the Netherlands
* Large follow-up study in leading journal confirms efficacy and safety of
ChondroCelect
* Progress development pipeline
* ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula enrolls
first patient
* Cx611 Phase IIa in rheumatoid arthritis (RA) completes enrollment
* Cx621 Phase I clinical trial successfully concluded, confirming safety
of proprietary intra-lymphatic route of administration of stem cells
* Corporate:
* European production facility obtains manufacturing license
Financial highlights
* Group revenues of EUR 2.9 million
* Net loss reduced by 23%
* EUR 11.7 million cash on hand
"The significant progress in all our clinical programs and the commercial ramp
up of ChondroCelect in the first half year of 2012 reinforce our position as the
European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We
continue to consistently deliver on the objectives we set more than a year ago,
keeping all key programs on plan, meeting our aggressive targets, and keeping
costs under control. In addition, we are in discussions with a number of
companies in connection with the US rights to Cx601."
Business update
Commercial roll-out of ChondroCelect continues to gain momentum
ChondroCelect sales for the first half of 2012 amounted to EUR 2.1 million,
comprising EUR 1.5 million from 2012 sales, up 115% compared to the same period
of last year, and EUR 0.7 million of deferred sales from 2011 as a result of the
retroactive reimbursement in the Netherland per January 1, 2011.
Discussions to obtain full national reimbursement keep advancing in Spain,
France, and Germany. In addition to the recent important reimbursement success,
the Company has obtained a positive decision in the Netherlands by one of the
leading private healthcare insurance companies to make treatment with
ChondroCelect compulsory for its insured, no longer reimbursing non-ATMP
cartilage products. Similarly, two of the large private insurers in the UK
expressed their intention to routinely reimburse ChondroCelect going forward.
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 the June,
2012 issue of 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. The study provides TiGenix with a large and unique data set to support
the long-term safety and efficacy of ChondroCelect.
ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula enrolls first
patient
TiGenix has enrolled the first patient in the ADMIRE-CD trial, its pivotal Phase
III clinical trial with Cx601, an adipose derived allogeneic stem cell
suspension for the treatment of complex perianal fistulas in Crohn's disease
patients. This multicenter, randomized, double-blind, placebo-controlled Phase
III trial will enroll approximately 278 patients at 46 centers across 7 European
countries and Israel. The main objectives of the study are to demonstrate safety
and superior efficacy over placebo in perianal fistulas in Crohn's disease
patients who failed to respond to previous treatment(s), in most cases
biologicals, and to confirm the strong safety and efficacy results from the
Phase II trial completed in 2011. Final results of the trial are expected in H2
2014, and, if positive, will allow the Company to file for marketing
authorization with the European Medicines Agency.
TiGenix is in discussions with a number of companies in connection with the US
rights to Cx601.
Cx611 Phase IIa in rheumatoid arthritis completes enrollment
On August 8 the Company completed the enrollment in this trial. This is the most
advanced clinical trial in the world with stem cells in RA and the final results
are expected no later than April 2013. Although the primary objective is to
demonstrate safety, feasibility, tolerance and optimal dosing, this 53-subject,
randomized, placebo controlled, multicenter study will follow the patients for
6 months after three injections of Cx611. It will therefore provide a strong
first indication of the duration of the efficacy of Cx611 in this very difficult
patient population - the enrolled patients have previously failed to respond to
at least two biologicals - and will set the stage not only for the further
development of Cx611 in RA, but also in a wide range of other autoimmune
disorders.
Cx621 Phase I clinical trial successfully completed
TiGenix has successfully completed the company's Phase I clinical trial to
assess the safety of intra-lymphatic administration of its expanded adipose stem
cell product Cx621. Cx621 aims to capitalize on the benefits of TiGenix's
proprietary approach of intra-lymphatic administration to treat autoimmune
disorders. The confirmation of the safety of intra-lymphatic administration of
our expanded adipose stem cells (eASCs) has potentially important clinical and
commercial implications. It opens up the possibility of achieving efficacy at
lower dosage, which would further increase the safety profile of TiGenix's
eASCs, while it would simultaneously reduce the cost of goods and improve
margins. An additional benefit is that the subcutaneous lymph nodes are
superficial and readily visible by ultrasound, and thus allow for a rapid and
easy injection.
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 the Company's advanced stem cell therapy products.
Financial results for the first half of 2012
Key figures (Thousands of Euro, except number of employees)
+---------------------------------------------------------------------------+
| Period ended June|
| 30 |
| |
| Thousands of Euro (?) 2012 2011|
| |
|CONSOLIDATED INCOME STATEMENT |
| |
|CONTINUING OPERATIONS |
| |
|Sales 2.129 370|
| |
|Gross sales 1.471 781|
| |
|Deferred sales 658 -411|
| |
|Cost of sales -391 -182|
| |
|Gross profit 1.738 188|
| |
|Research and development expenses -7.396 -5.296|
| |
|Sales and marketing expenses -1.153 -1.248|
| |
|General and administrative expenses -3.143 -3.676|
| |
|Other operating expenses 0 -2.779|
+---------------------------------------------------------------------------+
|Total operating charges -11.691 -12.999|
+---------------------------------------------------------------------------+
|Other operating income 787 103|
| |
|Operating Result -9.166 -12.707|
| |
|Interest income 50 82|
| |
|Interest expenses -33 -93|
| |
|Foreign exchange differences -358 -664|
| |
|Profit/(Loss) before taxes -9.507 -13.383|
| |
|Income taxes 0 380|
| |
|Profit/(Loss) for the period from continuing operations -9.507 -13.003|
| |
|DISCONTINUED OPERATIONS |
| |
|Profit/(Loss) for the period from discontinued operations -461 0|
| |
|Profit/(Loss) for the period -9.968 -13.003|
| |
|Attributable to equity holders of TiGenix NV -9.968 -13.003|
| |
| |
| |
|Cash and cash equivalents 11.727 24.881|
| |
| |
| |
|Number of employees and mandate contractors 69 80|
+---------------------------------------------------------------------------+
Group sales((1)) for the first 6 months of EUR 2.1 million
Group sales for the first six months of 2012 amounted to EUR 2.1 million, a
substantial increase from EUR 0.4 million in the same period of last year. Gross
sales for ChondroCelect for the first six months of 2012 were EUR 1.5 million, a
115% increase compared with the same period last year, reflecting the continued
uptake in Belgium and the Netherlands. As a result of the retroactive
reimbursement in the Netherlands per January 1, 2011, an additional EUR 0.7
million in deferred 2011 sales bring the total sales of ChondroCelect for H1
2012 to EUR 2.1 million.
(1) Sales of ChondroMimetic are not included in 2012 figures as TiGenix Ltd is
considered as an asset to be held for sale.
Net loss reduced by 23%
Net loss for the first six months of 2012 decreased by 23% compared with the
same period last year as a direct result of sales growth during the period, and
strict cost controls, which offset continued investments in the
commercialization effort to support ChondroCelect and increased R&D expenses to
keep advancing our clinical programs. At the end of June 2012, the total number
of employees and mandate contractors was equal to 69 people, compared with 80 at
the end of June 2011.
Cash position of EUR 11.7 million on June 30, 2012
On June 30, the Company had a cash position of EUR 11.7 million. Net cash used
during the first six months of 2012 was EUR 8.1 million in line with
management's guidance. Based on its current cash position, anticipated
commercial revenues from ChondroCelect sales, partnering of Cx601, and the sale
of TiGenix Ltd, the company believes it is sufficiently financed to keep
executing on its business plan.
Outlook next 12 months
* National reimbursement decisions in major European countries for
ChondroCelect
* ChondroCelect distribution agreements in selected countries
* First commercial batches of ChondroCelect produced at Sittard-Geleen
manufacturing facility
* US partnering agreement for Cx601
* Final results of Cx611 in Rheumatoid Arthritis
* Additional non dilutive funding through R&D grants and soft loan programs
Auditor's limited review
The statutory auditors BDO Bedrijfsrevisoren BCV's limited review can be found
in the H1 2012 Condensed Consolidated Financial Statements in the investor
section on our website at www.tigenix.com
Financial Half Year Results
The H1 2012 financial interim statements can be found in the investor section on
our website www.tigenix.com
Conference call webcast
On August 23, at 14:00 Central European Time (CET), TiGenix will conduct a
conference call webcast.
To participate in the conference call, please dial:
+32 2 400 6864 (Belgium)
+44 207 136 2056 (UK)
+1 718 354 1359 (US)
+34 91 791 1292 (Spain)
The online live webcast can be followed via the link:
http://www.media-server.com/m/p/99jia5i5
Following an update of the business activities and presentation of the financial
results, the participants will be able to ask questions.
The press release and the presentation will be made available in the Investor
and Newsroom sections on our website.
A replay of the webcast will be available shortly after the conference call.
For more information:
Eduardo Bravo
Chief Executive Officer
eduardo.bravo(at)tigenix.com
Claudia D'Augusta
Chief Financial Officer
claudia.daugusta(at)tigenix.com
Hans Herklots
Director Investor & Media Relations
hans.herklots(at)tigenix.com
+32 16 39 60 97
About TiGenix
TiGenix NV (NYSE Euronext: TIG) is a leading European cell therapy company with
a marketed cell therapy 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.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: TiGenix via Thomson Reuters ONE
[HUG#1635603]
Unternehmensinformation / Kurzprofil:
Datum: 23.08.2012 - 07:01 Uhr
Sprache: Deutsch
News-ID 176981
Anzahl Zeichen: 21133
contact information:
Town:
Leuven
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 190 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"TiGenix : Business Update & Financial Highlights for the First Half of 2012"
steht unter der journalistisch-redaktionellen Verantwortung von
TiGenix (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
