TiGenix : Business Update & Financial Highlights for the First Half of 2013
(Thomson Reuters ONE) -
Regulated information
August 20, 2013
TiGenix Business Update & Financial Highlights for the First Half of 2013
* ChondroCelect revenues up 55%
* Enrollment lead program Cx601 on track
* Advanced discussions for partnering of Cx601 and to monetize manufacturing
facility
Leuven (BELGIUM) - August 20, 2013 - TiGenix NV (NYSE Euronext: TIG), the
European leader in cell therapy, gives an update of its business activities and
provides key financial data for the half year ending June 30, 2013.
Business highlights
* ChondroCelect:
* ChondroCelect sales EUR 2.3 million, up 55% from H1 2012
* ChondroCelect obtains national reimbursement in Spain
* Product development pipeline
* ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula enrollment
on track
* Cx611 Phase IIa in rheumatoid arthritis (RA) shows good safety data and
first evidence of therapeutic activity in RA patients
* Corporate:
* Madrid production facility renews GMP license
Financial highlights
* ChondroCelect sales of EUR 2.3 million
* Loss for the period reduced by 11%
* EUR 3.7 million cash on hand at June 30 (and, after private placement
completed on July 26, EUR 8.9 million on July 31)
"Despite challenging conditions we continue to make significant progress in
reaching our corporate objectives," says Eduardo Bravo, CEO of TiGenix. "We are
in advanced discussions to license our lead program Cx601, and we remain
confident that we can conclude our partnering discussions before year-end. This
will bring some non-dilutive funds plus external validation of our innovative
platform of adipose derived stem cells. In addition, we are making progress with
a number of players in the cell therapy space to allow us to monetize our state-
of-the-art cell therapy facility in the Netherlands. This transaction should
further decrease our fixed cost base and reduce operational complexity."
Business update
Commercial roll-out of ChondroCelect continues apace
ChondroCelect sales for the first half of 2013 amounted to EUR 2.3 million, up
55% compared to the same period of last year on a like for like basis.
Current revenues are still mainly fueled by sales in Belgium and the
Netherlands. Based on increased traction with private payers in the UK, the
Company expects that the UK market will start making a more substantial
contribution to ChondroCelect sales in the second half of the year. Similarly,
based on its pre-marketing activities in Spain, the Company expects the Spanish
market to start contributing to ChondroCelect's continued growth in the last
four months of the year. Taken together, the Company anticipates that the growth
will be maintained for the second half of this year and will further increase in
2014, turning ChondroCelect a cash flow positive asset in the course of 2014.
ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula in Crohn's Disease
- enrollment on track
The enrollment of the ADMIRE-CD trial remains on track. Recruitment of this
Phase III study is expected to be finalized in early 2014, and should allow the
Company to file for marketing authorization with the European Medicines Agency
in the first half of 2015. The product has orphan drug designation and could be
launched in Europe in 2016.
ADMIRE-CD is a multicenter, randomized, double-blind, placebo-controlled pivotal
Phase III trial that is to enroll approximately 278 patients at 46 centers
across 7 European countries and Israel.
TiGenix is in advanced discussions with a number of companies in connection with
the rights to Cx601 for different geographic regions and remains confident that
it can close an agreement before year-end.
Cx611 Phase IIa reports good safety and first indication of efficacy in
refractory rheumatoid arthritis
On April 22, the Company announced that its 6-month multicenter, randomized,
single-blind, placebo-controlled Phase IIa study of Cx611 in refractory
rheumatoid arthritis (RA) met all of its endpoints of safety and therapeutic
activity on standard outcome measures of inflammation for at least three months
after dosing. Preliminary results suggest Cx611 has the potential to positively
impact disease in refractory patients, showing a clear improvement over placebo
over three months and a sustained benefit over six months. Four patients were in
DAS28 (one of the key outcome measures of RA studies) remission after six
months, which is a remarkable result in this difficult to treat patient
population.
The Company is working closely together with an advisory board of key opinion
leaders on the appropriate design of follow-up studies for Cx611/Cx621 in RA and
other autoimmune disorders and expects to finalize the development plan before
year-end.
Exploratory partnering discussions are underway with a number of companies.
Manufacturing facilities in Spain and the Netherlands
In January, Spanish health authorities renewed TiGenix's manufacturing
authorization for stem cell products at its GMP facility in Madrid, Spain, where
the Company manufactures high-quality, clinical grade allogeneic stem cell
products to fuel its key clinical programs. This approval supports the leading
position of TiGenix in the allogeneic cell therapy production and demonstrates
the robustness of the current manufacturing process.
TiGenix is in advanced discussions with several companies that are active in
cell therapy to monetize the state-of-the-art European GMP cell therapy facility
the Company operates in Sittard-Geleen, the Netherlands, to manufacture
commercial grade ChondroCelect. Such a transaction should bring non-dilutive
funds to the Company, reduce operational complexity and improve the margins of
ChondroCelect at least in the first years.
Financial results for the first half of 2013
Key figures (Thousands of Euro, except number of employees)
+---------------------------------------------------------------------------+
| Period ended June|
| 30 |
| |
| Thousands of Euro (?) 2013 2012|
| |
|CONSOLIDATED INCOME STATEMENT |
| |
| |
| |
|CONTINUING OPERATIONS |
| |
|Sales 2.288 2.129|
| |
|Gross sales 2.288 1.471|
| |
|Deferred sales 0 658|
| |
|Cost of sales -611 -391|
| |
|Gross profit 1.677 1.738|
| |
|Research and development expenses -6.689 -7.396|
| |
|Sales and marketing expenses -2.105 -1.153|
| |
|General and administrative expenses -2.514 -3.143|
| |
|Total operating charges -11.919 -11.691|
| |
|Other operating income 763 787|
| |
|Operating Result -8.868 -9.166|
| |
|Interest income 5 50|
| |
|Interest expenses -30 -33|
| |
|Foreign exchange differences -38 -358|
| |
|Profit/(Loss) before taxes -8.929 -9.507|
| |
|Income taxes 42 0|
| |
|Profit/(Loss) for the period from continuing operations -8.888 -9.507|
| |
| |
| |
|DISCONTINUED OPERATIONS |
| |
|Profit/(Loss) for the period from discontinued operations 51 -461|
| |
|Profit/(Loss) for the period -8.837 -9.968|
| |
|Attributable to equity holders of TiGenix NV -8.837 -9.968|
| |
| |
| |
|Cash and cash equivalents (*) 3.738 11.727|
| |
| |
| |
|Number of employees and mandate contractors 64 69|
+---------------------------------------------------------------------------+
(*) cash position of EUR 8.9 million on July 31, 2013
Salesfor the first 6 months of EUR 2.3 million
Sales for ChondroCelect for the first six months of 2013 were EUR 2.3 million, a
55% increase compared with the same period last year on a like for like basis,
reflecting the continued uptake in Belgium and the Netherlands which still
remain the key markets for 2013.
Loss for the period reduced by 11%
Loss for the first six months of 2013 amounted to EUR 8.9 million, compared to
EUR 10.0 million in the same period of 2012. This decrease of 11% is the direct
result of strict cost control measures resulting from the reduction in G&A
expenses and the number of employees and mandate contractors, and the near
completion of the divestment of the TiGenix Ltd. Additionally, during the first
half of 2013, R&D expenses show a slight reduction due to the completion of the
Cx611 Phase IIa clinical trial.
Net cash used for the period of EUR 7.3 million
Net cash used during the first six months of 2013 was EUR 7.3 million, based on
a use of cash of EUR 1.2 million per month, which is below management's guidance
of EUR 1.5 million per month.
Material events after the reporting period - cash position of EUR 8.9 million on
July 31, 2013
On July 26, the Company completed a private placement raising EUR 6.5 million,
placing new shares with mainly international healthcare specialist investors
selected via the accelerated book-building procedure. Taking account of the
proceeds of the private placement, as well as the operational costs for the
month of July, the Company had a cash position of EUR 8.9 million on July
31, 2013.
Outlook & action plan
To cover a period of at least 12 months following the date of publication of
these interim financial statements, additional working capital of approximately
EUR 12 million is needed, in the assumption that no additional programs to
the current ones are launched. The Company intends to provide for this
additional working capital by means of the following actions:
* Growth of the projected ChondroCelect sales in line with the trend
experienced in the first 6 months of 2013 on a like-for-like basis over the
same period 2012;
* Partnering of Cx601 (i.e. finding a partner for the co-development and/or
commercialization of Cx601 in different regions);
* Monetizing of some assets, such as the Dutch manufacturing facility (which
was constructed by the Company in a building leased under a long-term lease
contract running until July 2029);
* Additional non-dilutive funding, such as grants or soft loans;
* Additional dilutive funding (i.e. capital increase).
Auditor's limited review
The statutory auditors BDO Bedrijfsrevisoren Burg.Ven.CBVA's review can be found
in the H1 2013 Condensed Consolidated Financial Statements in the investor
section on our website at www.tigenix.com
Financial Half Year Results
The H1 2013 interim financial statements can be found in the investor section on
our website www.tigenix.com
Conference call webcast
On August 20, at 14:00 Central European Time (CET), TiGenix will conduct a
conference call webcast.
To participate in the conference call, please dial:
+32 2 620 0138 (Belgium)
+ +31 20 721 9158 (NL)
+44 20 3427 1900 (UK)
+1 212 444 0896 (US)
+34 91 114 6583 (Spain)
The online live webcast can be followed via the link:
http://www.media-server.com/m/p/5ppu3wbm
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#1723775]
Unternehmensinformation / Kurzprofil:
Datum: 20.08.2013 - 07:01 Uhr
Sprache: Deutsch
News-ID 289088
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contact information:
Town:
Leuven
Kategorie:
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