TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
To OMX Nordic Exchange Copenhagen
Announcement no. 26-08 / Copenhagen August 19, 2008
Interim report - six months ended 30 June 2008
Highlights and key ratios from the first half of 2008
• Solid sales increase for Savene®/Totect®, with total sales of 245 kits,
including 143 in Q2. Second-quarter sales climbed to DKK 9.6 million from DKK
4.6 million in Q2 2007, representing an increase of 108% on Q2 2007. Total
sales in the first six months of 2008 were DKK 16.6 million, compared with DKK
8.3 million in H1 2007. This is an improvement of 99% on 2007. TopoTarget
expects to be able to double its sales of Savene®/Totect® in 2008. In 2007,
sales were DKK 21.6 million for 305 kits sold
• Additional positive clinical results in belinostat monotherapy and in
combination with chemotherapy in ovarian cancer, leukaemia and malignant
lymphoma
• As earlier announced TopoTarget has commenced a process in order to form a
partnership with a global pharmaceutical company with sufficient development
and commercialisation resources to fully capitalise on belinostat's blockbuster
potential. Such a deal is expected to be concluded in 2008
• Loss before tax of DKK 113.7 million for six months ended 30 June 2008, as
compared to a loss of DKK 82.7 million in the same period 2007
• Following the acquisition of the global rights to belinostat, TopoTarget has
been able to revise its strategy. Increased focus on belinostat and reduced
costs for other projects etc. lead to a cost reduction of DKK 35-40 million in
the previously expected pre-tax loss for 2008 with the forecast loss now being
in the range of DKK 195-220 million. These numbers do not include future
licensing revenues.
Conference call
TopoTarget will host a conference call this afternoon, 19 August at 14.00
(CET), at which management will present and discuss the results for the first
six months of 2008. The conference call will be held 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 August 26, 2008 at 5.00 pm (CET) at the following
number: +353 1 436 4267 pin code 1307444#.
Interim report for the six months ended 30 June 2008
Copenhagen, Denmark - August 19, 2008 - The Board of Directors of TopoTarget
A/S (OMX: TOPO) today adopted the company's interim report for the six months
ended 30 June 2008.
Solid sales increase for Savene®/Totect®, with total sales of 245 kits,
including 143 in Q2. Second-quarter sales climbed to DKK 9.6 million from DKK
4.6 million in Q2 2007, representing an increase of 108% on Q2 2007. Total
sales in the first six months of 2008 were DKK 16.6 million, compared with DKK
8.3 million in H1 2007. This is an improvement of 99% on 2007.
Operating expenses for the period 1 January - 30 June 2008 were DKK 127.2
million, compared with DKK 110.9 million in the same period of last year. The
difference being primarily due to the acquisition of TopoTarget Switzerland
S.A. in June 2007. The operating loss for the period was DKK 107.3 million,
compared with DKK 85.1 million in the same period of last year. The company
posted a loss before tax for the first six months of 2008 of DKK 113.7 million
against a pre-tax loss of DKK 82.7 million in the same period of 2007.
Cash, cash equivalents and marketable securities amounted to DKK 173.6 million
at 30 June 2008.
Selected milestones met during H1 2008
Q2:
• Global rights acquired for belinostat- TopoTarget's lead anti-cancer project
• Fast Track designation granted by FDA for belinostat in PTCL (peripheral
T-cell lymphoma)
• Positive clinical data from a Phase II study of belinostat monotherapy in
patients with recurrent or refractory peripheral or cutaneous T-cell lymphoma
(PTCL and CTCL) presented at the “10th International Conference on Malignant
Lymphoma” in Lugano in June 2008
• Positive clinical data presented at ASCO (American Society of Clinical
Oncology) 2008, demonstrating substantial anti-tumour activity from a Phase II
trial using belinostat, carboplatin and paclitaxel (BelCaP) to treat ovarian
cancer
• New positive clinical data presented by the NCI (National Cancer Institute,
USA) at the ASCO 2008 Annual Meeting from two belinostat studies, partly for
the treatment of advanced myeloid neoplasms in combination with azacitidine
(AZC), partly for the treatment of ovarian tumours
• Sales improvement for Savene® and Totect® with a doubling of sales for H1
2008 vs H1 2007
• The United Kingdom Oncology Nursing Society, UKONS, adopted the EONS
(European Oncology Nurses Society) guidelines for using Savene® in the
treatment of anthracycline extravasation
• Allowance of Valproic Acid patent in Europe covering Avugane™ for acne
• Allowance of Valproic Acid patent in Europe covering Savicol™ for colon polyps
Q1:
• In March, TopoTarget announced that a new international ICD-9-CM diagnosis
code had been established. The diagnosis code will facilitate coding of the
disease and, by extension, the process of obtaining reimbursement for
Savene®/Totect® therapy
• European Oncology Nursing Society (EONS) recommended Savene®/Totect® for the
treatment of anthracycline extravasation in their guidelines
• APO010 patent allowed in the US
Highlights for the period after 30 June 2008
• FDA acceptance of results for phase IV post marketing study for Totect®
• Assignment of Clinical Trials Agreement (CTA) from CuraGen to TopoTarget for
belinostat approved by the NCI
Expected key milestones for the remainder of 2008
Belinostat milestones:
• Belinostat partnership agreement to be concluded in 2008
• Completion of SPA (Special Clinical Protocol Assessment) filing process with
the FDA and initiation of Phase III registration trial for belinostat in PTCL
• Results presented at EORTC (European Organisation for Research and Treatment
of Cancer) 21-24 October in Geneva, Switzerland
- Phase II data from BelCaP i.v. (intra veneous) in bladder cancer
- Phase Ib data from BelDox (belinostat + doxorubicin) i.v. in solid tumours
- 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
• Results presented at ASH (American Society of Hematology) 6-9 December in San
Francisco, USA
- Phase Ib data from BelIda (belinostat + idarubicin) i.v. in AML (Acute
Myeloid Leukaemia)
• Results presented at ESMO (European Society for Medical Oncology) 12-16
September in Stockholm, Sweden
- Final data from Phase I BelCaP i.v. study in solid tumours and final results
with the combination in ovarian cancer.
TopoTarget expects to initiate a randomised Phase II study of BelCaP in 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 MDS (Myeloid Dysplastic Syndrome).
Additional milestones:
• Final data for APO866 for the treatment of melanoma, chronic lymphocytic
leukaemia and update on the study in cutaneous T-cell lymphoma (CTCL)
• APO010 update and approval of study extension for additional dose escalation
• Siramesine preclinical data to decide whether we can proceed with our
investigation of the agent as an anti-cancer therapeutic for human use
• Potential partnership agreement for Avugane™ and Baceca® .
Furthermore, TopoTarget expects to double its Savene®/Totect® sales for the
full year 2008 vs. full year 2007.
Strategy revised and organisation adjusted
In the first half of 2008, TopoTarget revised its strategy and adjusted its
organisation to a more dedicated focus on belinostat. The adjustments were made
on the back of very promising data from a broad range of studies with
belinostat and a unique opportunity to buy the global rights to the compound.
TopoTarget now pursues two primary goals with belinostat;
• Bringing belinostat to market as quickly as possible
• Forming a partnership with a global pharmaceutical company with sufficient
development and commercialisation resources to fully capitalise on belinostat's
blockbuster potential
In terms of organisation, TopoTarget has strengthened its medical department,
and restructured and consolidated its business development.
Selecting from a number of good opportunities to bring belinostat quickly to
market, TopoTarget has given top priority to the haematological malignancy
peripheral T-cell lymphoma (PTCL). PTCL is an attractive target in terms of
strategy and business potential as it, among other things, is a cancer for
which no standard therapy has yet been approved due to weak treatment results.
TopoTarget has been granted a Fast Track designation for belinostat in this
indication and is working closely with the authorities and investigators. The
registration study in PTCL is expected to be initiated during H2 2008 for a
potential market approval by 2010.
We believe that belinostat is a best-in-class product. Discussions with several
prospective partners have confirmed that belinostat is considered a highly
promising pharmaceutical candidate in tomorrow's cancer therapy.
After TopoTarget's acquisition of the global rights to belinostat, the company
has streamlined its business procedures and projects, reducing the number of
employees outside the medical department and capitalised on the synergies by
centralising the organisation at the Copenhagen headquarters. Reductions in
technical and administrative personnel has also been carried out after the end
of the reporting period at headquarters while still ensuring that key functions
remain intact.
TopoTarget is in the process of identifying partners to develop and finance
trials with other drug candidates in its clinical and preclinical pipeline.
Belinostat status
Belinostat is an intravenous and oral 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 it to exploit the product's
potential. Intravenous and orally administered belinostat is currently
evaluated in 18 clinical studies run by TopoTarget and the NCI.
More than 500 patients have been treated with belinostat which has showed
effect in several cancer indications as well as a positive toxicity profile.
NCI agrees to CTA assignment
The Clinical Trials Agreement (CTA) for belinostat with the NCI (National
Cancer Institute) has been assigned from CuraGen to TopoTarget. Since 2004 nine
clinical trials in different indications and drug combinations have been
carried out under the CTA. Under the agreement the Division of Cancer Treatment
and Diagnosis at the NCI will continue to sponsor and run clinical trials to
evaluate the activity of belinostat alone or in combination with other cancer
therapies for the treatment of solid and haematological cancers. TopoTarget
also has a CRADA (Cooperative Research and Development Agreement) for
belinostat with the NCI.
T-cell lymphoma: PTCL and CTCL
The FDA has granted Fast Track designation for the development programme for
belinostat for i.v. treatment of recurrent or refractory PTCL. TopoTarget
expects to receive a positive response in connection with the SPA (Special
Protocol Assessment) process, allowing for initiation of a final registration
trial (Phase III study designed with a view to obtaining regulatory approval)
in about 100 patients in 2008.
At the “10th International Conference on Malignant Lymphoma” in Lugano,
Switzerland, in June 2008, 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, 1 CR and 3 PR (Partial
Response) in 20 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 were
observed in both diseases. Intravenous belinostat was shown to be safe and well
tolerated. The objective response rate in both arms has met the pre-defined
criteria for advancement to the second stage of the Simon two-stage design.
Enrolment is ongoing in the CTCL and PTCL arms of the study to a total of 34
patients per arm.
Ovarian cancer
At ASCO 2008, TopoTarget announced positive data from the company's BelCaP
programme (full-dose belinostat in combination with full-dose carboplatin and
paclitaxel) in patients with relapsed epithelial ovarian cancer. Substantial
anti-tumour activity with BelCaP was evident, with efficacy in 15 out of 16
patients and an overall response rate of 43%. 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.
NCI studies
NCI presented positive data at the 2008 ASCO conference on belinostat from two
clinical trials:
Belinostat and azacitidine (AZC) in patients with advanced myeloid neoplasms
The combination of belinostat (escalating doses) and azacitidine (a well known
compound for the treatment of myeloid dysplastic syndrome) was investigated in
21 patients with AML or myeloid dysplastic syndrome. The combination was well
tolerated in full doses of both drugs. The results were positive with 2
complete responses (CR), 1 partial response (PR) and haematological improvement
(including improved platelet counts) in 4 patients. The intention is now to
continue the study as a randomised study to further assess the effect of the
combination.
Belinostat in patients with platinum-resistant epithelial ovarian tumours and
micropapillary/borderline (LMP) ovarian tumours
18 patients with epithelial ovarian cancer (EOC) and 12 patients with
borderline ovarian tumours (LMP) were treated with belinostat monotherapy.
Efficacy in the form of stable disease (SD) was evident in 9 EOC patients and 9
LMP patients, and 1 LMP patient had a partial response (PR) and further patient
had a CA125 response (disease marker in the blood). Patient recruitment is
ongoing.
Savene®/Totect®
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.
There has been a solid sales increase for Savene®/Totect®, with total sales of
245 kits, including 143 in Q2. Second-quarter sales climbed to DKK 9.6 million
from DKK 4.6 million in Q2 2007, representing an increase and in line with
earlier communicated expectations of 108% on Q2 2007. Total sales in the first
six months of 2008 were DKK 16.6 million, compared with DKK 8.3 million in H1
2007. This is an improvement of 99% on 2007.
TopoTarget expects to be able to double its sales of Savene®/Totect® in 2008.
2007 sales amounted to DKK 21.6 million.
The figure below illustrates sales in Q2 and H1 2007 and Q2 and H1 2008 for
Savene® and Totect®, measured in TDKK.
For figures please see attached PDF
Savene® has been recommended as the standard treatment of anthracycline
extravasation in the new guidelines from the European Oncology Nursing Society
(EONS) and later by the United Kingdom Oncology Nursing Society, UKONS.
In March, TopoTarget announced that a new international ICD-9-CM diagnosis code
had been established. The diagnosis code will facilitate coding of the disease
and, by extension, the process of obtaining reimbursement for Savene®/Totect®
therapy.
TopoTarget has besides belinostat four very promising drug candidates with
Novel Targets
A partnership agreement for belinostat in 2008 would allow us to dedicate our
efforts to developing the promising anti-cancer drug candidates in our
pipeline. The completion of the new and improved production of Zemab will allow
us to initiate studies to follow up on the data in the pilot study. Zemab
demonstrated an effect, when injected directly into the tumour, in 6 out of 10
cancer patients. 4 out of these 6 tumours totally disappeared.
Zemab is a protein product targeting ErB2/HER2, an antigen on the surface of
the cancer cell. This antigen is the target of the drug Herceptin®
(trastuzumab), which is very successful in the treatment of breast cancer.
Herceptin® is developed by the American biotech company Genentech and sold for
4.6 billions USD in 2007. Unlike Herceptin®, Zemab has a toxin that binds to
the protein. When Zemab binds to this antigen, the toxin bound to the protein
is allowed to enter the cancer cell where it causes the death of that cell. In
its pipeline, Genentech has a similar compound named Trastuzumab-DM1 in Phase
II for the treatment of HER2-positive breast cancer patients with metastases.
TopoTarget intends to develop Zemab for the treatment of breast cancer and
head-and-neck cancer patients. New production of Zemab is ongoing and expected
to be finalised in the second half of 2008.
As it is the case with Zemab, Genentech also has a programme similar to
TopoTarget's APO010, referred to as Apo2L/TRAIL, which is in Phase II in
Non-Hodgkin's Lymphoma and in non-small cell lung cancer (NSCLC) and in Phase I
for the treatment of colon cancer. TopoTarget is conducting a Phase I
dose-escalating study, in which we have reached the level of treatment where we
expect to see anti-tumour activity. Final results are expected to be available
around the turn of the year. It is likely that we can reach even higher doses,
and we are currently awaiting approval from the Swiss health authorities for
further dose escalation. TopoTarget intends to develop APO010 for the treatment
of multiple myeloma and ovarian cancer.
APO866 is a specific inhibitor of a key enzyme involved in the synthesis of
NAD+ and is being developed in three Phase II clinical trials: advanced
melanoma, cutaneous T-cell lymphoma (CTCL), and in a phase I/II clinical trial
in B-cell chronic lymphocytic leukaemia (B-CLL).
In October 2007, APO866 was selected as was belinostat by Windhover Information
as one of the 10 most interesting oncology products globally that is available
for partnering.
Patient recruitment is completed for the CLL and melanoma studies, while
recruitment is ongoing in the CTCL study. Analysis of the two first-mentioned
studies is expected to be finalised in 2008.
TOP216, which we acquired from BioImage in December 2005, has demonstrated
highly promising preclinical effect in the treatment of cancer in our
predictive cancer model technology. TopoTarget intends to develop a TOP216
analogue to move into the clinic.
Other clinical activities
In addition to belinostat and Savene®/Totect® described above, TopoTarget's
clinical pipeline consists of seven product candidates, covering a broad range
of cancer and other indications. Having consolidated the belinostat rights,
TopoTarget is now seeking partnerships for several of the following development
programmes.
Baceca® - an HDAC inhibitor for the treatment of basal cell carcinoma (BCC)
TopoTarget has completed two randomised and blinded Phase II proof-of-concept
trials to investigate Baceca® monotherapy and in combination with two different
vitamin A like compounds for the treatment of basal cell carcinoma (BCC). The
results of a Danish, double-blind, randomised and placebo-controlled study to
evaluate the efficacy and tolerability of Baceca® in combination with the
retinoid tazarotene showed a 69% clinical and pathological complete remission
obtained at three months after the end of the 16 weeks treatment period with
the combination treatment. This response rate confirmed the positive results of
an earlier Italian pilot study. In a second Phase II trial performed in Russia
using an eight week treatment course with Baceca® in combination with another
retinoid (Isotrex®), Baceca® showed clear anti-cancer efficacy.
Savicol™ - an HDAC inhibitor for the treatment of familial adenomatous
polyposis (FAP)
TopoTarget is continuing its Phase II trial, evaluating the effect of Savicol™
in the treatment of FAP. The development process has been delayed due to
slower-than-expected patient recruitment. This randomised, placebo-controlled
Phase II study takes place in a number of countries across Europe. An
evaluation of the final treatment results is expected in the first half of
2009.
Topotect - a Topoisomerase II inhibitor - a protectant to enable chemotherapy
treatment of brain metastasis
An ongoing Phase I-II trial is seeking to identify the potential of combining
Topotect and etoposide. Recruitment of patients has been slow in this rare
subset of metastasis patients. Final results are expected in 2009.
Avugane™ - an HDAC inhibitor for the treatment of acne vulgaris
Based on Phase II proof-of-concept results showing comparable efficacy and
advantageous tolerability compared with a standard, marketed retinoid therapy,
TopoTarget is now running a double-blind, randomised, placebo-controlled Phase
II clinical trial in mild to moderate acne vulgaris. Data is expected from this
trial in 2008.
TopoTarget A/S
Highlights and key figures
For figures please see attached PDF
Comments on the interim financial statements for the six months ended 30 June
2008
Sales of Savene® in Europe and Totect® in the US were higher in Q1 and Q2 2008
compared to Q1 and Q2 2007, rising to DKK 16.6 million in H1 2008 from DKK 8.3
million in H1 2007.
The company generated total revenue of DKK 19.9 million during the period 1
January to 30 June 2008 compared with DKK 25.8 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 referred to above. The lower total
revenue in H1 2008 is primarily due to lower re-invoicing of research and
development costs to CuraGen, which amounted to DKK 2.6 million in H1 2008
against DKK 13.2 million in H1 2007.
In the first six months of 2008, production costs amounted to DKK 6.3 million
as compared with DKK 13.7 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 June 2008, research and development costs
amounted to DKK 70.4 million as compared with DKK 46.1 million in the
year-earlier period. The company recorded higher research and development costs
primarily because TopoTarget is conducting clinical studies of belinostat and
because TopoTarget Switzerland S.A., which was acquired in June 2007, is
included in full in H1 2008.
Sales and distribution costs amounted to DKK 25.4 million in the first
half-year 2008, down from DKK 26.3 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 cost adjustments, which started to
materialise in Q2 2008.
In the period 1 January to 30 June 2008, administrative expenses amounted to
DKK 25.2 million as compared with DKK 24.9 million in the year-earlier period.
TopoTarget Switzerland S.A., which was acquired in June 2007, is included in
full in H1 2008.
Net financial expenses amounted to DKK 6.4 million in the first six months, as
compared with net financial income of DKK 2.5 million in the year-earlier
period. The difference was primarily due to interest expenses on the loan
provision for payment of the expected milestone to the former owners of
TopoTarget Switzerland S.A. concerning APO866 and large currency translation
differences on consolidation of group enterprises.
In the first six 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 June 2008, the company recorded a loss after tax
of DKK 111.4 million as compared with a loss after tax of DKK 82.7 million in
the same period of 2007.
On 21 April 2008, TopoTarget bought back all rights to belinostat from CuraGen,
our former business partner. The consideration was agreed to comprise a cash
payment of USD 26 million (approximately DKK 122.8 million), 5 million new
TopoTarget shares issued in a private placement and a commercial milestone
payment totalling USD 6 million (approximately DKK 28.3 million), which is
defined as 10% of the first USD 60 million of belinostat sales or partnership
revenues. The milestone payment is recognised as current liability in the
balance sheet at the fair value at the contract date.
At 30 June 2008, total assets amounted to DKK 798.0 million. Of this amount,
cash bank deposits and short-term securities amounted to DKK 173.6 million.
At 30 June 2008, equity amounted to DKK 613.9 million compared with DKK 791.3
million at the same time in 2007. The change consists of a loss of DKK 240.4
million during the period from 1 July 2007 to 30 June 2008, the capital
increase in May 2008 totalling DKK 55.5 million, additions during the period of
share-based payment totalling DKK 8.8 million and fair value adjustment of the
bond portfolio totalling minus DKK 1.3 million.
Outlook and other forward-looking statements
Following the acquisition of the global rights to belinostat, TopoTarget has
been able to revise its strategy. Increased focus on belinostat and reduced
costs for other projects etc. lead to a cost reduction of DKK 35-40 million in
the previously expected pre-tax loss for 2008 with the forecast loss now being
in the range of DKK 195-220 million. These numbers do not include future
licensing revenues.
Statement by the Board of Directors and Senior Management
The Board of Directors and the Senior Management today discussed and
adopted the interim report for the six months ended 30 June 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 June 2008 and of the results of the Group's operations
and cash flows for the six months ended 30 June 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, 19 August 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 further information, please contact:
Dr. Peter Buhl Jensen Telephone +45 39 17 83 41
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 with 9
products in development, including 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.
Condensed income statements etc.
For figures please see attached PDF
Notes to the consolidated interim financial statements
1. ACCOUNTING POLICIES
The interim financial statements have been prepared in accordance with IAS 34,
Interim financial reporting, and additional requirements for interim financial
statements of listed companies. No interim financial statements have been
prepared for the parent company.
The accounting policies applied in the interim report are unchanged relative to
the accounting policies applied in the company's annual report for 2007, and are
in accordance with the International Financial Reporting Standards (IFRS) as
adopted by the EU and additional Danish disclosure requirements for annual
reports of listed companies.
The annual report for 2007 contains a more detailed description of the
company's accounting policies, including a definition of the ratios used, which
are calculated in accordance with the definitions in “Recommendations &
Financial Ratios 2005” issued by the Danish Society of Financial Analysts.
Due to reorganisation in Germany and Switzerland the allocation of costs have
been changed. Some of the costs, in previous years classified as administration
costs, is from 1 January 2008 recognised as research and development costs.
The interim report is presented in Danish kroner (DKK), which is the parent
company's functional currency.
The following new and revised standards and interpretations are effective from
the financial year 2008:
• IFRIC 11, IFRS 2 - Group and treasury share transactions.
• IFRIC 12, Service concession arrangements
• IFRIC 14, IAS 19 - The limit on a defined benefit asset, minimum funding
requirements and their interaction.
The application of these new and revised standards and interpretations has not
resulted in changes in the accounting policies with respect to recognition and
measurement.
2. REVENUE
For figures please see attached PDF
3. SEGMENT INFORMATION
For figures please see attached PDF
4. STAFF COSTS
For figures please see attached PDF
5. INTANGIBLE ASSETS
For figures please see attached PDF
6. SECURITIES
For figures please see attached PDF
7. LONG TERM COMMITMENTS
For figures please see attached PDF
In June 2007 TopoTarget acquired the development project APO866 together with
the acquisition of Apoxis S.A. The purchase price included a conditional
payment (APO866 milestone) payable when certain clinical endpoints were met.
At acquisition the discounted value of the APO866 milestone was included in the
calculation of the purchase price. The assumption for the calculation is now
changed compared to initial recognition, leading to a reduction of the
liability end June 2008 amounting to DKK 9,2 million and a similar adjustment
in acquired research and development projects in progress c.f. note 5. As at
31.12.2007 the APO866 milestone was included in current liabilities.
