TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen
Denmark
Phone: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-No.: 25695771
www.topotarget.com
To the Copenhagen Stock Exchange
Announcement no. 04-07 / 14 March 2007
TopoTarget announces its results for 2006
Copenhagen, Denmark - 14 March 2007 - TopoTarget A/S (Copenhagen Stock
Exchange: TOPO) today published its financial statements for 2006 as approved
by the Board of Directors. The Group recorded a loss after tax of DKK 174.7
million compared with a loss of DKK 45.5 million in 2005. The higher loss was
due to reduced income in 2006 relative to 2005, significantly higher costs of
research and development activities, especially in connection with belinostat
(PXD101), and selling and distribution costs associated with the sales and
marketing of Savene™ in Europe and in the USA concerning Totect™. TopoTarget
will hold a conference call today at 14.00 (CET), at which management will
present and discuss the results. TopoTarget's Annual Report for 2006 is
available on the company's website, www.topotarget.com.
• The Group recorded a loss of DKK 174.7 million in 2006 compared with a loss
of DKK 45.5 million in 2005. The financial performance for the year is
considered satisfactory considering the significant progress made by the
company in 2006.
• Revenue amounted to DKK 45.7 million in 2006 compared with DKK 79.0 million
in 2005.
• Research and development costs amounted to DKK 129.2 million in 2006 against
DKK 85.7 million in 2005, an increase of 51%, while selling and distribution
expenses were DKK 29.7 million in 2006 as compared with DKK 0 million in 2005.
• Consolidated equity amounted to DKK 384.4 million at 31 December 2006,
against DKK 413.9 million at 31 December 2005
• At 31 December 2006, the Group's securities and cash deposits totalled DKK
271.6 million, as compared with DKK 298.3 million at 31 December 2005
• For 2007 TopoTarget forecasts a loss before tax of approximately DKK 200-220
million
Expected milestones for the remainder of 2007
• The roll out of Savene™ in additional countries across Europe will continue
• FDA approval of Totect™ for sales in the US market by the end of May 2007,
after which Totect™ will be launched
• Results from studies of belinostat, forming the basis of the regulatory
strategy, are expected to be available by mid 2007:
- Phase II results of intravenous belinostat in combination with carboplatin
and paclitaxel for advanced ovarian cancer
- Phase II results of intravenous belinostat in combination with 5-fluorouracil
for advanced colorectal cancer
- Phase II results of intravenous belinostat for T-cell lymphoma
- Phase Ib results of intravenous belinostat in combination with Velcade®
(bortezomib) for injection for advanced multiple myeloma
-Phase I results of oral belinostat in advanced solid tumours anticipated
• Results from two Phase II studies of Baceca® in a total of 100 patients in
combination with two different vitamin A like products are expected to be
announced in the first half of 2007
• A placebo-controlled Phase II clinical study will be initiated to further
investigate the use of Avugane™ in acne
• Results from a pivotal Phase II study of Savicol™ for the treatment of
colorectal polyps in approximately 60 patients with FAP (Familial Adenomatous
Polyposis - genetic predisposition to develop colorectal cancer) expected to
be announced in Q4 2007
• Results from ongoing Phase I studies of Topotect aimed to help define the
optimum dose level and the risk involved in a combination of Topotect and
Etoposid are expected to be announced in the first half of 2007
• Following a currently ongoing production of Zemab®, the next clinical studies
of the compound will be prepared in Q4 2007
Key development and business milestones in 2006
Favourable results with belinostat (PXD101)
• Belinostat monotherapy has shown efficacy in patients with cutaneous T-cell
lymphoma (CTCL), and the trial will be extended to include 34 patients
• Belinostat in combination with dexamethasone (steroid hormone) has shown
efficacy in treating patients with multiple myeloma. Belinostat was
well-tolerated following intravenous administration, with patients achieving
clinical benefit
• Belinostat has shown that there are no serious side effects involved in using
the drug in combination with full-dose chemotherapy for patients with advanced
solid tumours. Clinical activity was observed in 12 out of 23 patients
• Used in combination with the compound 5-FU, belinostat showed promising
results. Studies involving 17 patients with solid tumours show that belinostat
plus 5-FU is well tolerated. The study will continue with a view to evaluating
whether the combination may be administered in full doses
Approval and launch of Savene™
• In August 2006, TopoTarget was granted a marketing authorisation by the
European health authorities to sell Savene™ and Savene™ was subsequently
launched at ESMO (European Society of Medical Oncology) in Istanbul in October
2006. At the end of February 2007, TopoTarget had sold a total of 55 kits in 12
European countries
Approvable letter for Totect™ (brand used for Savene™ in the USA)
• In August 2006, TopoTarget received an approvable letter for Totect™ from the
FDA
Initiation of study of Savicol™
• TopoTarget has initiated a pivotal Phase II study in the treatment of
colorectal polyps in patients with FAP (Familial Adenomatous Polyposis)
Promising results with Avugane™
• TopoTarget reported promising results from a Phase II clinical trial in acne
Preclinical pipeline
• In 2006, TopoTarget acquired an mTOR drug programme from BioImage, giving
TopoTarget full ownership of the TOP216 drug candidate and its family
• The company outlicensed a PXD family compound to LEO Pharma for the purpose
of developing a treatment for psoriasis
Significant events since the balance sheet date include the announcement on 21
February 2007 of the launch status for Savene™ and the forecast loss and cash
burn for 2006, and the announcement on 12 March 2007 that TopoTarget had
exercised its option from Novartis to inlicense the drug candidate Zemab®.
Outlook for 2007
As a result of the fact that TopoTarget is in the early stage of launching
Savene™ in Europe and that Totect™ is expected to be launched in the second
half of 2007, it is anticipated that expenses related to sales activities will
exceed sales income for 2007.
The company intends to expand its development activities in 2007, with an
increase in clinical and preclinical development of in-house and new,
inlicensed projects. TopoTarget's clinical development activities will centre
on the company's projects belinostat, Baceca®, Savicol™ and Avugane™.
TopoTarget forecasts a loss before tax of approximately DKK 200 - 220 million
for 2007 due to the higher development costs and expected sales and marketing
costs associated with the launch of Totect™ in the USA.
TopoTarget's cash burn may be higher than the expected pre-tax loss due to an
increase in sales activities and the resulting change in working capital.
If the company takes advantage of acquisition opportunities or enters into
major licensing agreements to strengthen its product pipeline, the above
forecasts may be revised.
Conference call
TopoTarget hosts a conference call this afternoon,
14 March at 14.00 (CET),
where management will present and discuss the 2006 results.
A PowerPoint presentation will be available at TopoTarget's website,
www.topotarget.com (under “Investor and Media” > Presentations and Events), one
hour from the start of the conference call.
To participate in the conference call please dial:
70 26 50 40 (outside Denmark +45 70 26 50 40).
The conference call will be held in English.
A replay of the conference call will be available one hour after the conference
call and until 21 March 2007 at 17.00 (CET) at the following number:
+353 1 436 4267, security code 859093#.
TopoTarget A/S
For further information, please contact:
Peter Buhl Jensen Phone +45 39 17 83 41
Chief Executive Officer Mobile +45 21 60 89 22
Tim Corcoran Phone +44 1235 443 713
Chief Operating Officer Mobile +44 787 656 1027
Background information
About TopoTarget
TopoTarget (OMX - The Nordic Exchange: TOPO) is a biopharmaceutical company,
headquartered in Denmark and with subsidiaries in the UK, Germany and the USA,
dedicated to finding ''Answers for Cancer'' and developing improved cancer
therapies. TopoTarget 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 enzyme regulators (mainly HDAC, mTOR, and topoisomerase
II inhibitors) and a strong development foundation has been built. TopoTarget
has a broad portfolio of small molecule preclinical drug candidates and seven
drugs are in clinical development, including both novel anti-cancer
therapeutics and new cancer indications for existing drugs. Savene™ is
TopoTarget's first product on the market. In addition to organic growth,
TopoTarget consistently looks for opportunities to strengthen and expand its
activities through acquisitions and in-licensing. For more information, please
refer to Hwww.topotarget.com.H
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 nonclinical 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 exposure; 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.
