TopoTarget A/S
Symbion
Fruebjergvej 3
2100 Copenhagen Ø
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-no: 25695771
www.topotarget.com
To Nasdaq OMX Copenhagen A/S
Announcement no. 32 - 08 / Copenhagen, 12 November 2008
Interim report for the period 1 January to 30 September 2008
Highlights and key ratios from Q3 2008:
• TopoTarget has streamlined its organisation with a view to reducing its burn
rate, and has sufficient financial resources, to take it into 2010. This does
not include future licensing revenues
• Sales increase for Savene®/Totect®, with total sales of 388 kits, including
143 in Q3, which is an increase of 104% on Q3 2007. Third-quarter sales climbed
to DKK 8.4 million from DKK 4.6 million in Q3 2007, representing an increase of
84% on Q3 2007. Total sales for Q1-Q3 2008 were DKK 25.0 million, compared with
DKK 12.9 million in Q1-Q3 2007, representing a 94% increase and in line with
TopoTarget's expectations. 2007 sales amounted to DKK 21.6 million
• Positive Special Protocol Assessment (SPA) response from the FDA concerning
TopoTarget's pivotal trial with belinostat for the treatment of Pheripheral
T-Cell Lymphoma (PTCL)
• Additional positive clinical results in belinostat monotherapy and in
combination with chemotherapy in cutaneous lymphomas and ovarian cancer
• NCI (US) approves the transfer of its Clinical Trials Agreement (CTA) from
CuraGen to TopoTarget for belinostat
• As previously announced, TopoTarget has initiated a process in order to form
a partnership for belinostat with a pharmaceutical company with sufficient
development and commercialisation resources to fully capitalise on belinostat's
substantial commercial potential. TopoTarget maintains a positive dialogue with
a number of interested potential partners, which include global as well as
strong regional companies dedicated to cancer therapeutics. The Company remains
confident of achieving a belinostat licensing deal, however recent turbulence
in financial markets has increased the uncertainty of achieving it in 2008. As
a consequence TopoTarget has undertaken a restructuring and refocusing of its
resources to ensure that the next key steps in belinostat's development will be
supported financially, providing the company with a stronger negotiation
position
• As a result of the focus on belinostat TopoTarget will seek to out-license a
number of projects in its pipeline or to postpone development of such projects.
This leads to a reduction in expenditure. The cost savings will have a limited
effect on financial performance in 2008 and will materialise in the forecasts
for 2009 and 2010. The forecast for 2008 is unchanged in the range of DKK
195-220 mio. These numbers do not include future licensing revenues. The cost
reductions are intended to ensure the highest possible added value by directing
TopoTarget's resources towards the achievement of two important belinostat
milestones: approval of belinostat for the treatment of PTCL in the US and
obtaining randomised Phase II proof of belinostat's efficacy in the so-called
BelCaP combination in patients with solid tumours
• In undertaking the restructuring the Company has ensured that the key
competencies necessary for achieving its goals have been retained. The number
of employees has been reduced to 58 of which 18 are in the sales organisation.
In connection with the restructuring of the Company it has been agreed that CFO
Leif Hamø will retire from the company as at 31 December 2008 and Tim Corcoran,
Executive Vice President Corporate Affairs, will take over the position as from
today
• Third-quarter loss before tax of DKK 160,3 million, as compared to a loss of
DKK 139,6 million in the same period of 2007.
After the end of the reporting period, at the AACR/NCI/EORTC conference from
21-24 October in Geneva, Switzerland, TopoTarget reported new Phase I and II
results for belinostat monotherapy and as combination therapy for relapsed
bladder cancer after platinum chemotherapy (BelCaP) and soft tissue sarcoma
(BelDox) respectively. The BelDox study suggests that a full dose of
doxorubicin can be administered with a full dose of belinostat. We have shown
that BelCaP with carboplatin, paclitaxel and belinostat administered as
long-term (3-6 hour) infusions is also safe, and we have presented results for
oral belinostat in solid tumours.
The four belinostat studies have re-confirmed the company's conviction that
belinostat is a unique and best in class compound; it is tolerable in full
doses together with maximum dosage of the most effective and modern
chemotherapeutics, it has shown efficacy also in bladder cancer and the patient
may be treated intravenously, through long-term infusion in a vein and through
oral therapy (capsules).
Conference call
TopoTarget will host a conference call this afternoon, 12 November at 2.00 pm
(CET), at which management will present and discuss the results for Q3 2008 in
English.
A presentation will be available on TopoTarget's website, www.topotarget.com,
before the start of the conference call.
To participate in the conference call please dial:
From Denmark: 70 26 50 40
Outside Denmark: +45 70 26 50 40 or +44 208 817 9301.
A replay of the conference call will be available approximately two hours after
the conference call and until 19 November , 2008 at 5.00 pm (CET) at the
following number: +353 1 436 4267 pin code 1469588#.
Interim report for the period
1 January to 30 September 2008
Copenhagen, Denmark - 12 November 2008 - The Board of Directors of TopoTarget
A/S (OMX: TOPO) today adopted the company's interim report for the period 1
January to 30 September 2008.
Sales increase for Savene®/Totect®, with total sales of 388 kits, including 143
in Q3, which is an increase of 104% on Q3 2007. Third-quarter sales climbed to
DKK 8.4 million from DKK 4.6 million in Q3 2007, representing an increase of
84% on Q3 2007. Total sales for Q1-Q3 2008 were DKK 25.0 million, compared with
DKK 12.9 million in Q1-Q3 2007, representing a 94% increase and in line with
TopoTarget's expectations. 2007 sales amounted to DKK 21.6 million.
Operating expenses for the period Q1-3 2008 were DKK 182,0 million, compared
with DKK 178,4 million in the same period of last year, primarily because,
after the buyback of the global rights to belinostat, TopoTarget is now
conducting all clinical studies of belinostat at its own expense except from
the 10 NCI sponsored trials and because TopoTarget Switzerland S.A., which was
acquired in June 2007, is included in the full nine-month period of 2008.
The operating loss for the period was DKK 152,9 million, compared with DKK
143,9 million in the same period of last year. The company posted a loss before
tax for the first nine months of 2008 of DKK 160,3 million against a pre-tax
loss of DKK 139,6 million in the same period of 2007. Cash, cash equivalents
and marketable securities amounted to DKK 133,4 million at 30 September 2008.
Selected milestones met during Q3 2008
Q3
• Positive SPA response from the FDA concerning TopoTarget's pivotal trial with
belinostat for the treatment of the cancer indication PTCL in September
• Additional positive belinostat data in cutaneous T-cell lymphomas (CTCL)
presented at the EORTC lymphoma meeting in Copenhagen in September
• BelCaP update on positive results for ovarian cancer presented at Biennial
Ovarian Cancer Research Symposium in Seattle in September
• NCI (US) approves the transfer of its Clinical Trials Agreement (CTA) from
CuraGen to TopoTarget for belinostat.
Highlights for the period after 30 September 2008
• Encouraging belinostat results presented at AACR/NCI/EORTC (European
Organisation for Research and Treatment of Cancer) 21-24 October in Geneva,
Switzerland:
- Phase II data from BelCaP i.v. (intravenous) in bladder cancer
- Phase II data from BelDox (belinostat + doxorubicin) i.v. in solid tumours,
including soft tissue sarcoma
- Phase I data from oral belinostat in solid tumours
- Phase I data from trial with belinostat as 3 and 6-hour continuous infusion
for the treatment of solid tumours.
Expected key milestones for the remainder of 2008
Belinostat milestones:
• The Company remains confident of achieving a belinostat licensing deal,
however recent turbulence in financial markets has increased the uncertainty of
achieving it in 2008
• Initiation of pivotal trial with belinostat in the cancer type PTCL
• Results will be presented at ASH (American Society of Hematology) 6-9
December in San Francisco
- Phase Ib data from BelIda (belinostat + idarubicin) i.v. and 24-48 hour
continuous infusion (CIV) in patients with Acute Myeloid Leukaemia (AML)
• Initiation of a randomised Phase II study of BelCaP in solid tumours (Cancer
of Unknown Primary, CUP) around the turn of the year.
In addition, the NCI is expected to initiate the following studies:
• Phase II in incremental dose belinostat for the treatment of patients with
inoperable hepatocellular carcinoma (liver cancer)
• Randomised Phase II part with belinostat + 5-AZC in patients suffering from
AML and Myeloid Dysplastic Syndrome (MDS).
Other milestones:
Additional milestones, unchanged from previous announcements.
Strategy revised and organisation adjusted
During 2008, TopoTarget has revised its strategy and adjusted its organisation
to a dedicated focus on belinostat based on the continuing development with
highly promising data reported from clinical studies, which has shown
beneficial effect in the treatment of patients in solid tumours and
haematological tumours in a broad range of studies giving rise to a substantial
commercial potential. TopoTarget sees belinostat as the best in class Histone
deacetylase inhibitor (HDACi) currently under development with significant
advantages relative to the only currently marketed HDAC inhibitor. TopoTarget
therefore successfully took advantage of a unique opportunity to buy back the
global rights to the compound earlier this year and now focuses its resources
on advancing belinostat to registration in PTCL and delivering data in solid
tumours.
TopoTarget has reduced its headcount to 58, of which 18 are in the sales
organisation. The company seeks to out-license a number of projects in its
pipeline or to postpone development of such projects until warranted by
circumstances. TopoTarget has streamlined its business procedures and
capitalised on the synergies of an organisation now-centralised at its
Copenhagen headquarters. The restructuring was made to ensure belinostat's
market access, while maximising the value of the programme and increasing the
likelihood of signing a partnership agreement. In the process of refocusing the
organisation, the company has kept its core functions intact to the effect that
projects which the company may subsequently wish to continue have been retained
and may be scaled up once warranted by circumstances.
TopoTarget pursues three primary goals with belinostat:
• bringing belinostat to market as quickly as possible
• documenting its broad applicability in cancer therapy
• forming a partnership with (a) global or regional pharmaceutical company(ies)
with sufficient development and commercialisation resources to successfully
capitalise on belinostat's substantial commercial potential.
Peripheral T-Cell Lymphoma (PTCL), a haematological disease is the first
priority indication for registering belinostat for commercialisation.
TopoTarget has received a positive SPA response from the FDA. TopoTarget has
reached an agreement with the FDA on the design (including endpoints and
statistics) of this pivotal trial in order to receive FDA approval. The ongoing
study in T-cell lymphomas (CTCL and PTCL) has therefore been discontinued so
that it will not compete with the pivotal trial, in which an accelerated
recruitment plan has been initiated. An up date will be announced for the
patients ongoing in the “old” protocol/trial.
PTCL is an attractive target in terms of strategy and business potential as,
among other things, it is a cancer for which no standard therapy has yet been
approved. TopoTarget has been granted a Fast Track designation for belinostat
in this indication and is working closely with recognised investigators
(doctors in charge of the trials at the hospitals) as part of an accelerated
recruitment strategy.
The registration study in PTCL is expected to be initiated in Q4 2008 for a
market approval by 2010.
The company believes that belinostat is a best-in-class product. Discussions
with several prospective partners and the encouraging data regularly reported
from doctors using belinostat in trials for their patients have confirmed that
belinostat is considered a highly promising pharmaceutical candidate in
tomorrow's cancer therapy.
TopoTarget is in the process of identifying partners to develop and finance
other trials with other drug candidates in its clinical and preclinical
pipeline.
Belinostat status
Belinostat is an intravenous (i.v.), continuous intravenous (CIV) and oral
(capsule) class I and II HDAC inhibitor for the treatment of solid tumours and
haematological malignancies. Belinostat is TopoTarget's lead clinical drug
candidate, for which it has the global rights, and the company focuses its
resources on developing belinostat to exploit the product's potential.
TopoTarget aims to provide market access for belinostat as quickly as possible,
and the strategy for achieving this involves initiating a pivotal trial
scheduled to commence in Q4 2008 in PTCL (haematological malignancy) and to
commence a randomized phase II trial of BelCaP in solid tumours (CUP) around
the turn of the year. Intravenous and orally administered belinostat is
currently evaluated in 18 clinical studies run by TopoTarget and the NCI (US).
Running 18 clinical trials belinostat has a broad potential including multiple
possibilities treating different cancers - belinostat represents “a pipeline
drug”. More than 500 patients have been treated with belinostat, which has
shown effect in solid tumours and haematological cancers as well as a positive
toxicity profile.
Clinical Trial Agreement with the NCI very valuable for belinostat
The Clinical Trial Agreement (CTA) for belinostat with the NCI (National Cancer
Institute, US) is very valuable for the development of belinostat. Since 2004,
the NCI has initiated ten Phase I and II trials with belinostat for patients
suffering from different cancers (i.e. in different indications) and using
different drug combinations. The NCI remains highly interested in conducting
and, by extension, also sponsoring clinical trials of belinostat activity,
either alone or in combination with other cancer therapies and for the
treatment of solid cancers and haematological malignancies. In 2008, the NCI
has also commenced and planned studies of belinostat in cancer patients.
The NCI is part of the public health system in the US and as such is financed
hereby. As part of its mission to improve cancer therapy, the NCI cooperates
with the industry, including TopoTarget in Denmark, to develop new cancer
medicine. TopoTarget supplies the belinostat compound for patients in the
trials, while the NCI sponsors and conducts the trials. Data derived from the
trials is the property of TopoTarget and may consequently be applied to
registration of belinostat for commercialisation.
TopoTarget also has a CRADA (Cooperative Research and Development Agreement)
with the NCI for laboratory research with belinostat.
T-cell lymphoma: PTCL and CTCL treated with belinostat monotherapy
The FDA has granted Fast Track designation for the development programme of
belinostat for treatment of recurrent or refractory PTCL. TopoTarget has
received a positive response from the FDA in connection with the SPA process,
allowing for initiation of the final registration trial (study designed with a
view to obtaining regulatory approval in the US) in about 120 patients at the
end of Q4 2008.
At the EORTC Lymphoma conference in Copenhagen on 8 September, TopoTarget
presented positive belinostat data from a Phase II study in patients with
recurrent or refractory peripheral or cutaneous T-cell lymphoma (PTCL and
CTCL). Two durable and still ongoing complete responses (CR) after belinostat
monotherapy were demonstrated in 11 evaluable patients with PTCL. Furthermore,
4 objective responses, 2 CR and 2 PR (Partial Response) in 21 heavily
pre-treated evaluable CTCL patients were evident. The time to response in CTCL
was quick, a median of 15.5 days, which is a promising finding. In addition, a
substantial number of patients with stable disease was observed in both
diseases. Intravenous belinostat was shown to be safe and well tolerated.
Ovarian cancer treated with BelCaP
At the Biennial Ovarian Cancer Research Symposium in Seattle on 4-5 September
2008 and later on 17 September at the ESMO conference in Stockholm, TopoTarget
presented an update of positive data concerning the BelCaP combination
(belinostat+carboplatin+taxol) in ovarian cancer. Substantial anti-tumour
activity with BelCaP was evident. The study includes 35 patients. The overall
response rate (OR) was 43%, and 4 patients continue on therapy. 3 complete
remissions (CR) and 12 partial remissions (PR) by RECIST criteria (Response
Evaluation Criteria in Solid Tumours) were reported. Median time to response
was 2.5 months and the median duration of response was +5.3 months (range +1.2
to 12.7 months) with 6 responses still ongoing. Responses were evident in
patients with platinum-sensitive and platinum-resistant tumours, including
patients with a platinum-free interval of less than 3 months. BelCaP is
well-tolerated, presenting a safety profile consistent with that observed with
chemotherapy alone.
Finally, Phase I results were presented at ESMO. It was reported that 23
patients were treated to find the recommended dose for the subsequent Phase II
part of the study, which was belinostat 1000 mg/m2 i.v. once daily on days 1-5
in combination with standard doses of carboplatin and taxol administered on day
3 of each treatment cycle. In this group of heavily pretreated patients 2
confirmed partial remissions (PR) were documented in rectal cancer and in
pancreatic cancer, respectively, and activity was observed in patients with
unknown primary tumour (CUP), ovarian, rectal, pancreatic and bladder cancer.
11 patients experienced stable disease (SD) ranging from 2 to +28 cycles.
After the reporting period, encouraging results were presented at
AACR/NCI/EORTC (European Organisation for Research and Treatment of Cancer) on
21-24 October in Geneva, Switzerland:
Bladder cancer treated with BelCaP
Promising data with the BelCaP treatment of bladder cancer was presented,
including 1 complete response (CR), 3 partial responses (PR) and 10 patients
out of 14 experiencing stable disease (SD). BelCaP (belinostat in combination
with standard doses of carboplatin and paclitaxel) was administered to patients
with bladder cancer, who had previously relapsed from treatment with
carboplatin/cisplatin.
BelDox in solid tumours and soft tissue sarcoma
At the conference, positive data was reported from a study of full-dose
belinostat in combination with a full dose of doxorubicin for the treatment of
patients with solid tumours in a dose-escalation setting, which proved safe and
well-tolerated. Among 13 evaluable patients, one partial response (PR) and 8
stable disease (SD) were observed.
Orally administered belinostat
Furthermore, data was presented from the Phase I study of belinostat
administered orally (as a capsule) in different schedules/regimens. Prolonged
stable disease was observed in a number of patients. The optimum dose was
established in two out of three regimens and the study continues.
Belinostat administered as continuous treatment
Finally, data was presented from a Phase I study with belinostat being
administered as a continuous intravenous treatment over 3 or 6 hours in
combination with carboplatin and paclitaxel (BelCaP) to, so far, 7 patients
with solid tumours. The regimens are well-tolerated, increasing the time of
high belinostat plasma concentrations in the blood. Preclinical studies show
that this will lead to improved tumour cell destruction.
Savene®/Totect® status
TopoTarget's first marketed product Savene®/Totect® is used for the prevention
of serious tissue damage caused by anthracycline extravasation. Savene® was
launched in October 2006 in selected European countries and Totect® was
launched on the US market in October 2007.
Sales increase for Savene®/Totect®, with total sales of 388 kits, including 143
in Q3, which is an increase of 104% on Q3 2007. Third-quarter sales climbed to
DKK 8.4 million from DKK 4.6 million in Q3 2007, representing an increase of
84% on Q3 2007. Total sales for Q1-Q3 2008 were DKK 25.0 million, compared with
DKK 12.9 million in Q1-Q3 2007, representing a 94% increase and in line with
TopoTarget's expectations. 2007 sales amounted to DKK 21.6 million
Figure 1 in the attached PDF file illustrates sales for the first nine month of
2008 compared with 2007 for Savene® and Totect®, measured in TDKK.
Savene® has been recommended as the standard treatment of anthracycline
extravasation in the guidelines from the ONS (Oncology Nurses Society, US),
EONS (European Oncology Nursing Society) and UKONS (United Kingdom Oncology
Nursing Society).
Moreover, an international ICD-9-CM diagnosis code has been established to
register anthracycline extravasations. The diagnosis code will facilitate
coding of the disease and, by extension, the process of obtaining reimbursement
for Savene®/Totect® therapy.
New product strategy for Totect® in the US
Sales in the US are still in the build-up phase. The US oncology market differs
from the European one in many ways for example in that there are many small
treatment units offering cancer therapy, whereas the European market is more
centralised. The strategy for Totect® has been a price of USD 14,750 combined
with a replacement policy, under which Totect® will be replaced at the end of
the shelf life if the hospital has not used it. Many of the small cancer units
were unable to buy Totect® as the reimbursement does not fully cover the USD
14,750 price and would consequently involve a net expense when patients are
treated with TopoTarget's product. Following financial analysis and
considerations, TopoTarget has launched a product variant which means that
Totect® is now also available without a replacement guarantee at a lower price.
We expect that this strategy will lead to an increase in sales on numbers of
kits and to a revenue in accordance with the announced expectations.
TopoTarget's refocusing of its portfolio
As a result of the focus on belinostat, TopoTarget will seek to out-license a
number of projects in its pipeline or to postpone development of such projects
until warranted by circumstances. Also the development pace for certain
products in the remaining pipeline will be reduced:
• APO010 is still in the dose-escalating Phase I stage. There is no competition
with compounds with the same mechanism of action. Manufacture of the product
has been secured and a pause will not involve any technical risk but will of
course slow down the development
• The development of APO866 continues without any changes with final reporting
in the Chronic lymphocytic leukemia (CLL) and melanoma protocols and will
continue with the accrual of the 5 remaining evaluable patients in the Phase II
Cutaneous T-Cell Lymphoma (CTCL) study. In addition the project was
strengthened in 2008 through the synthesis of a number of novel pre-clinical
and highly efficacious APO866 analogues for oral use and the filing of a patent
application
• A number of efficacious mTOR analogues have also been synthesised and patent
applications filed. The mTOR analogues and the APO866 analogues are both first
in class without any direct competition. Until further notice, no animal
toxicity trials will be initiated with either mTOR or APO866 analogues. This
causes a delay in the clinical development. However, this delay may produce a
more thorough evaluation of the most promising candidates, providing
development benefits
• Zemab was recently enhanced and a patent application has been filed for the
enhanced and more potent product. Manufacture of the product has been secured
and a pause will not involve any technical risk but will of course slow down
the development
• Baceca® and Avugane™ have completed the scheduled trials. Publication of
results for Avugane are still pending. TopoTarget is not planning to conduct
further studies until a partnership agreement has been concluded. Accordingly,
the company does not believe that the belinostat prioritisation will lead to a
loss of value.
Finally, the preclinical studies of Siramesine have been completed. The studies
were conducted to determine whether TopoTarget should examine the compound as
an anti-cancer therapeutic for use in humans. As Siramesine did not demonstrate
any anti-cancer effect in our models, TopoTarget has ended the project,
returning all data and rights to Lundbeck.
TopoTarget A/S
Statement by the Board of Directors and Senior Management
The Board of Directors and Senior Management today discussed and adopted the
interim report for the nine months ended 30 September 2008.
The interim report is presented in accordance with IAS 34 and additional Danish
disclosure requirements on the presentation of interim reports by listed
companies. The interim report is not audited or reviewed.
We consider the accounting policies to be appropriate. Accordingly, the interim
report gives a true and fair view of the Group's assets, liabilities, and
financial position at 30 September 2008 and of the results of the Group's
operations and cash flows for the nine months ended 30 September 2008.
In our opinion, the management's report gives a true and fair view of
developments in the activities and financial position of the Group, the results
for the period and of the Group's financial position in general and gives a
fair description of significant risk and uncertainty factors that may affect
the Group.
Copenhagen, 12 November 2008
Senior Management
Peter Buhl Jensen
CEO
Board of Directors
Håkan Åström Jesper Zeuthen Jeffrey Buchalter
Chairman
Anders Gersel Pedersen Ingelise Saunders Torbjørn Bjerke
Peter Buhl Jensen
For highlights and key figures please see the attached PDF file.
Comments on the interim financial statements for the nine months ended 30
September 2008
The company generated revenue of DKK 29.2 million during the period 1 January
to 30 September 2008 compared with DKK 34.5 million in the same period of last
year. Included in revenues are invoicing to CuraGen and the Savene® sales in
Europe and Totect® sales in the US The lower revenue in 2008 is due to lower
re-invoicing of research and development costs to CuraGen. In line with
expectations, sales of Savene® in Europe and Totect® in the US were higher in
Q1, Q2 and Q3 2008 relative to the same quarters of 2007.
In the first nine months of 2008, production costs amounted to DKK 7.6 million
as compared with DKK 20.9 million in the same period of 2007. The lower costs
relative to revenue were mainly due to the fact that research and development
costs are no longer re-invoiced to CuraGen after TopoTarget bought back the
rights to belinostat on 21 April 2008.
In the period 1 January to 30 September 2008, research and development costs
amounted to DKK 108.4 million as compared with DKK 80.3 million in the
year-earlier period. The company recorded higher research and development costs
primarily because, after the buyback of the global rights to belinostat,
TopoTarget is now conducting all clinical studies of belinostat at its own
expense except from the 10 NCI sponsored trials and because TopoTarget
Switzerland S.A., which was acquired in June 2007, is included in the full
nine-month period of 2008.
Sales and distribution costs amounted to DKK 35.4 million in the first nine
months, down from DKK 39.7 million in the same period of 2007. TopoTarget has
retained its focus on allocating sales and distribution costs to the most
profitable markets and has made adjustments which also in Q3 2008 resulted in
lower costs relative to the same period of 2007.
In the period 1 January to 30 September 2008, administrative expenses amounted
to DKK 30.7 million as compared with DKK 37.6 million in the year-earlier
period. In 2008, the amount includes higher costs due to the operation of our
Swiss subsidiary following the acquisition of that company at the end of June
2007. Administrative expenses in Q3 2008 amounted to DKK 5.5 million as
compared with DKK 12.7 million in the year-earlier period. In addition to
reduced liabilities in respect of holiday allowance due to the lower number of
staff, the reduction is attributable to a reclassification of subsidiary
activities, which now exclusively comprise research and development operations
after a reduction of administrative functions in the subsidiaries.
Net financial expenses amounted to DKK 7.4 million in the first nine months, as
compared with net financial income of DKK 4.4 million in the year-earlier
period. The difference was primarily due to large currency translation
differences on consolidation of group enterprises and interest expenses on the
loan provision for payment of the expected milestone to the former owners of
TopoTarget Switzerland S.A. concerning APO866.
In the first nine months of 2008, tax amounted to an income of DKK 2.3 million
as compared with DKK 0.0 million in the same period of 2007. The tax income was
due to a reduction in the deferred tax liability concerning TopoTarget
Switzerland S.A.
In the period 1 January to 30 September 2008, the company recorded a loss after
tax of DKK 158.0 million as compared with a loss after tax of DKK 139.6 million
in the same period of 2007.
At 30 September 2008, total assets amounted to DKK 760.6 million. Of this
amount, cash, bank deposits and short-term securities amounted to DKK 133.4
million.
At 30 September 2008, equity amounted to DKK 569.7 million compared with DKK
735.8 million at the same time in 2007. The change consists of a loss of DKK
230.1 million during the period from 1 October 2007 to 30 September 2008, the
capital increase in May 2008 totalling DKK 55.5 million, additions during the
period of share-based payments totalling DKK 9.6 million and fair value
adjustment of the bond portfolio totalling minus DKK 1.1 million.
Outlook for 2008
The forecast for 2008 is unchanged in the range of DKK 195-220 mio. The cost
savings will only have a limited effect on financial performance in 2008 and
will materialise in the forecasts for 2009 and 2010. These numbers do not
include future licensing revenues.
For further information, please contact:
Dr. Peter Buhl Jensen Telephone +45 39 17 83 43
Chief Executive Officer Mobile +45 21 60 89 22
Ulla Hald Buhl Telephone +45 39 17 83 92
Director IR & Communications Mobile +45 21 70 10 49
Background information
About TopoTarget
TopoTarget (OMX: TOPO) is an international biotech company headquartered in
Denmark, dedicated to finding ''Answers for Cancer'' and developing improved
cancer therapies. The company is founded and run by clinical cancer specialists
and combines years of hands-on clinical experience with in-depth understanding
of the molecular mechanisms of cancer. Focus lies on highly predictive cancer
models and key cancer targets (including HDACi, NAD+, mTOR, FasLigand and
topoisomerase II inhibitors). TopoTarget has a broad cllinical pipeline but are
currently focusing on belinostat which has shown proof of concept as
monotherapy in treating haematological malignancies and positive results in
solid tumours where it can be used in combination with full doses of
chemotherapy. The company's first marketed product Savene®/Totect® was approved
by EMEA in 2006 and the FDA in 2007 and is marketed by TopoTarget's own sales
force in Europe and the US. For more information, please refer to
www.topotarget.com.
TopoTarget Safe Harbour Statement
This announcement may contain forward-looking statements, including statements
about our expectations of the progression of our preclinical and clinical
pipeline including the timing for commencement and completion of clinical
trials and with respect to cash burn guidance. Such statements are based on
management's current expectations and are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements. TopoTarget cautions investors
that there can be no assurance that actual results or business conditions will
not differ materially from those projected or suggested in such forward-looking
statements as a result of various factors, including, but not limited to, the
following: The risk that any one or more of the drug development programs of
TopoTarget will not proceed as planned for technical, scientific or commercial
reasons or due to patient enrolment issues or based on new information from
non-clinical or clinical studies or from other sources; the success of
competing products and technologies; technological uncertainty and product
development risks; uncertainty of additional funding; TopoTarget's history of
incurring losses and the uncertainty of achieving profitability; TopoTarget's
stage of development as a biopharmaceutical company; government regulation;
patent infringement claims against TopoTarget's products, processes and
technologies; the ability to protect TopoTarget's patents and proprietary
rights; uncertainties relating to commercialization rights; and product
liability expo-sure; We disclaim any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events, or otherwise, unless required by law.
For financial figures please see the attached PDF file.
