TiGenix : Full Year 2011 Financial Results
(Thomson Reuters ONE) -
REGULATED INFORMATION
March 15, 2012
TiGenix Reports Full Year 2011 Financial Results
Merger completed successfully - ChondroCelect(®) commercial roll-out progressing
- clinical programs on track - substantial non-dilutive funding - EUR 20 million
cash at 31 Dec. 2011
Leuven (BELGIUM) - March 15, 2012 -TiGenix NV (NYSE Euronext: TIG) today gave a
business update and announced financial results for the full year 2011.
Business highlights
* Successful integration of Cellerix reinforces leadership position in cell
therapy
* ChondroCelect(® )commercial roll-out progressing with first national
reimbursement
* Phase III in perianal fistula (Cx601) on track for recruitment in mid-2012
* Phase IIa in rheumatoid arthritis (Cx611) opened 3(rd) and last cohort
* Phase I initiated for Cx621 to assess intra-lymphatic administration for
autoimmune disorders
Financial highlights
* Net sales up 85%
* Net loss significantly impacted by extraordinary charges
* EUR 33.4 million funding secured, including EUR 15.2 million through a
rights issue
* Substantial non-dilutive financing through grants and soft loans
* EUR 20 million cash at year-end
"TiGenix has created a new and strong basis in 2011 on which we can build going
forward and we have strengthened our position as the European leader in cell
therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our
promises: we have obtained national reimbursement for ChondroCelect in Belgium
and made progress in other European markets. We advanced all clinical stem cell
programs on plan, and raised substantial funds from specialized healthcare
investors and through non-dilutive financing. Today, TiGenix is well-positioned
to reach the next value-enhancing inflection points."
Business Update
Successful integration of Cellerix reinforces leadership position in cell
therapy
In May 2011, TiGenix closed the business combination with the stem cell therapy
company Cellerix, creating the European leader in cell therapy. During 2011 the
Company succeeded in rapidly integrating both entities. The Company now combines
top line revenues with an advanced pipeline of clinical stage regenerative and
immuno-modulatory products. TiGenix's operations are supported by a strong
commercial and manufacturing infrastructure for advanced cell therapies, an
experienced international management team and a solid cash position.
As a result of the merger, the Company's development focus has shifted from
early stage preclinical programs towards a number of highly promising clinical
stage products for inflammatory and autoimmune disorders of high unmet medical
need, each addressing markets in excess of EUR 1 billion. TiGenix product
pipeline is based on a proprietary stem cell platform that exploits expanded
allogeneic (donor-derived) adult stem cells derived from human adipose (fat)
tissue ('eASCs'). The platform has been extensively characterized in line with
requirements of the European Medicines Agency (EMA) and is supported by
exhaustive preclinical and CMC packages.
Given its focus on cell therapy, TiGenix is in the process of divesting its
ChondroMimetic franchise, which is based on a biomaterial platform. To be able
to concentrate on its core business and move forward with a clean slate, TiGenix
has decided to write-off the intellectual property related to the OrthoMimetics
acquisition.
ChondroCelect(®) commercial roll-out progressing with first national
reimbursement
ChondroCelect obtained reimbursement in Belgium in May 2011, and is today
available in 22 specialized treatment centers.
TiGenix is selling ChondroCelect in the UK, the Netherlands, Germany, and Spain
under managed access and private insurance schemes, while pursuing national
reimbursement in these countries and France.
In October 2011, TiGenix closed a distribution agreement for Finland with the
Finnish Red Cross Blood Service, as a first important step in its strategic
initiative to broaden access to ChondroCelect outside TiGenix's core commercial
countries.
In 2011, a total of 111 biopsies were taken and 85 implantations have been
performed.
In September, the publication entitled "Five-year outcome of characterized
chondrocyte implantation versus microfracture for symptomatic cartilage defects
of the knee," by J. Vanlauwe, D. Saris et al. was published in the American
Journal of Sports Medicine, the official journal of the American Orthopaedic
Society for Sports Medicine. The publication further underpins the long-term
benefit of the ChondroCelect procedure over microfracture. ChondroCelect remains
to date the only cartilage repair therapy that has been validated in a
randomized controlled clinical trial, which was the basis of the product's
approval by the European Commission in October 2009. The efficacy and safety of
the product has been further supported with the publication of the ChondroCelect
Compassionate Use Program study with 370 patients published in December 2011, in
Cartilage, the journal of the International Cartilage Repair Society.
The construction of the Company's centralized European cell expansion facility
in Sittard-Geleen has been completed. The site will be operational for
commercial production in late 2012. The facility will provide the extra cell
expansion capacity required to support the expected growing demand for
ChondroCelect from 2013 onward, and the commercial production of TiGenix's stem
cell products.
Phase III in perianal fistula (Cx601) on track to start recruitment in mid-2012
Cx601 is TiGenix's most advanced clinical stage product and has completed a
phase II study for the treatment of complex perianal fistulas in patients
suffering from Crohn's Disease. Based on the phase II clinical trial report,
scientific advice was sought from the EMA. In a final clarification letter, the
Committee for Medicinal Products for Human Use (CHMP) stated that the presented
preclinical data package can be considered sufficient for an MAA (Marketing
Authorisation Application) submission so no further preclinical work will be
required. The CHMP also indicated that the proposed single phase III study
should suffice to demonstrate the efficacy required to support the MAA.
The protocol of the phase III program has been submitted to the ethics
committees and regulatory agencies of several participating countries, and
recruitment is expected to start mid-2012. Cx601 has been granted orphan
designation by the EMA.
Partnership discussions are on-going for (co-)development and worldwide
commercialization of Cx601.
Phase IIa in rheumatoid arthritis (Cx611) patient enrolment progressing on plan
Cx611 is an allogeneic eASC product candidate for the treatment of rheumatoid
arthritis. The phase IIa study has recently opened the third and last cohort,
and is on track. The objective of the trial is to determine safety, feasibility,
tolerance, and optimal dosing. This multicenter, placebo-controlled study will
enrol 53 patients, divided in 3 cohorts with different dosing regimens. There
are more than 20 centers open and the Company expects to report the final
results in the first half of 2013.
Phase I initiated for Cx621 to assess intra-lymphatic administration for
autoimmune disorders
Cx621 is an allogeneic eASC product candidate for the treatment of autoimmune
diseases via a proprietary technique of intra-lymphatic administration. Based on
positive preclinical data on toxicology, biodistribution and efficacy, the
ethical committee of Clínica Universitaria de Navarra (Spain) approved a phase I
protocol to assess safety, tolerability and pharmacodynamics of intranodal
injected allogeneic eASCs in healthy volunteers. TiGenix has started recruitment
for this study in the fourth quarter of 2011 and final results are expected mid-
2012.
Preclinical development in osteoarthritis progressing
In addition to the three clinical stage programs described above, TiGenix is
investigating the potential of allogeneic stem cells for the treatment of
osteoarthritis. A first preclinical study yielded promising results. If the
follow-up studies currently underway confirm these results, TiGenix will seek
partners to take the program forward.
Financial results for the full year 2011
Key figures (Thousands of Euro, except number of employees)
+------------------------------------------------------------------------------+
| Years ended December 31 |
| |
| Thousands of Euro (?) 2011(()(*)()) 2010(()(*)())|
| |
| |
| |
|CONTINUING OPERATIONS |
| |
|Sales 1,146 621|
| |
|Gross sales 1,804 982|
| |
|Deferred sales and discounts -657 -361|
| |
|Cost of sales -455 -310|
| |
|Gross profit 691 311|
| |
|Research and development expenses -10,837 -10,595|
| |
|Sales and marketing expenses -2,726 -2,707|
| |
|General and administrative expenses -6,593 -5,473|
| |
|Other operating expenses -2,974 0|
| |
|Other operating income 393 1,802|
| |
|Operating Result -22,046 -16,662|
| |
|Interest income 708 141|
| |
|Interest expenses -408 -62|
| |
|Foreign exchange differences 434 500|
| |
|Profit/(Loss) before taxes -21,313 -16,083|
| |
|Income taxes 0 368|
| |
|Profit/(Loss) for the period from continuing |
|operations -21,313 -15,716|
| |
| |
| |
|DISCONTINUED OPERATIONS |
| |
|Profit/(Loss) for the period from discontinued |
|operations -16,234 0|
| |
|Profit/(Loss) for the period -37,547 -15,716|
| |
| |
| |
|Cash and cash equivalents 19,771 5,555|
| |
| |
| |
|Number of employees combined group (pro-forma) 75 109|
+------------------------------------------------------------------------------+
*2011 figures include TiGenix SA since May 1, 2011; TiGenix Ltd is presented in
a separate line as discontinued operations
*2010 figures do not include TiGenix SA, and present TiGenix Ltd as continued
operations
Group net sales of EUR 1.1 million
Group net sales in 2011 amounted to EUR 1.1 million, which over 2010 represents
an increase of 85%. Sales comprised EUR 1.8 million of gross sales and include
EUR 0.7 million in sales discount related to the sales of ChondroCelect in the
Netherlands during 2010 and 2011 under a risk-sharing scheme (sales discount was
previously booked as deferred product sales).
Operational expenses after business combination in line with previous year
In 2011, through a combination of restructuring, focus and cost control, the
combined companies' cost basis has been kept under strict control. At the end of
2011, total staff of the combined group was 75 employees, compared to 105
employees at the end of 2010 for the pro forma combined group.
Excluding extraordinary charges, group operating expenses amounted to EUR 20.6
million compared to EUR 19.1 million in 2010. The slight increase is primarily
related to the restructuring plan implemented after the business combination.
Net loss significantly impacted by extraordinary non-cash charges
The net loss for 2011 amounted to EUR 37.5 million compared to EUR 15.7 million
in 2010 primarily as result of extraordinary non-cash charges due to the
following non-recurrent items:
* EUR 16.2 million of non-cash charges from discontinued operations (TiGenix
Ltd). The Company has concluded that to develop ChondroMimetic into a viable
commercial product, substantial funding, resources and time would still be
required. Because the Company is now exclusively focused on cell therapy,
management and board have agreed that it is in the best interest of the
Company and shareholders to divest this biomaterial business and recognize a
complete write-off of EUR 16.2 million in 2011 to be able to continue with a
clean balance sheet going forward.
* EUR 3.0 million of extraordinary charges for the acquisition of 100% of
Cellerix shares.
EUR 33.4 million secured, including EUR 15.2 million through a rights issue
In the first half of 2011, and under challenging market conditions, TiGenix
secured EUR 33.4 million in financing. EUR 18.2 million was raised through a
private placement in Cellerix, in conjunction with the combination with TiGenix.
EUR 15.2 million was raised through a public rights issue. Both the private
placement and the rights issue showed strong support from existing shareholders
from both companies and new institutional and specialised health care investors
across Europe.
Substantial non-dilutive financing through grants and soft loans
Throughout 2011, TiGenix has been very successful in obtaining substantial
grants and soft loans. In September 2011, through its wholly owned subsidiary
Cellerix SA, TiGenix announced it is to receive a EUR 4.95 million innovation
credit from the "Madrid Network" to finance the Company's phase III study for
complex perianal fistulas in Crohn's disease patients. The soft loan, which was
concluded under very favourable terms for the Company, will cover a significant
part of the Cx601 program.
In December 2011, as the coordinator of an international consortium, TiGenix
obtained a substantial grant from the European Seventh Framework Programme (FP7)
to support its Cx611 program for the treatment of rheumatoid arthritis. The
total grant amounts to EUR 5.9 million, of which EUR 2.9 million is allocated to
TiGenix. This amount will be paid out in several tranches in 2012-2014.
Including the cost of the preclinical studies conducted by some members of the
consortium, the grant will effectively lower TiGenix's cash outlay to finance
the development of Cx611 by EUR 3.3 million.
EUR 20 million cash and reduced cash burn
At the end of December 2011 the Company had EUR 19.7 million cash on its balance
sheet, compared to EUR 5.6 million at the end of 2010.
The net cash used in operating activities, excluding the cash used for
ChondroMimetic business, during the period amounted to EUR 18.0 million, of
which EUR 3.0 million was a non-recurrent expenditure for the acquisition of
Cellerix. Excluding extraordinary items, the cash used to finance day to day
operations amounted to EUR 15.0 million, representing a 11% decrease compared to
the operating cash burn in 2010, and in line with the Company's effort to
increase efficiency and to carefully manage its operational cash flow.
Outlook for the next 12 months
* Distribution agreements for ChondroCelect in additional countries
* ChondroCelect reimbursement updates and decisions
* Last patient treated in Phase IIa study for Cx611
* Phase I study results for Cx621
* Preclinical data in osteoarthritis
* Start of Phase III clinical study for complex perianal fistula's
* GMP approval of European production facility in Sittard-Geleen
Complete financial statements
The 2011 financial statements can be found in the investor section on our
website www.tigenix.com
Conference call webcast
On March 15, at 14:00 CET/8a.m. EDT, TiGenix will conduct a conference call
webcast.
International dial-in numbers are:
+32 2 620 0138 Belgium
+34 91 791 7146 Spain
+31 20 721 9158 Netherlands
+44 20 3106 4822 UK
+1 646 254 3388 USA
The online live webcast can be followed via the link:
http://www.tigenix.com/en/page/165/webcast
Following the 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 newsroom section on
our website. A replay of the webcast will be available shortly after the
conference call.
For more information
Eduardo Bravo
Chief Executive Officer
Gil Beyen
Chief Business Officer
Claudia D'Augusta
Chief Financial Officer
+32 16 39 60 97
investor(at)tigenix.com
About TiGenix
TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy
company with a 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 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.
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#1594221]
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Datum: 15.03.2012 - 07:01 Uhr
Sprache: Deutsch
News-ID 125013
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contact information:
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