TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-no: 25695771
www.topotarget.com
-Commencing 2010 with a strong cash position-
Copenhagen, Denmark - March 25, 2010 - TopoTarget A/S (NASDAQ OMX: TOPO)
announced today financial results for the year ended December 31, 2009. In view
of the activities carried out during the year, the financial performance is
considered satisfactory.
• TopoTarget's cash and cash equivalents as at 31 December 2009 totalled DKK
130.2 million. On 31 December 2008 cash and cash equivalents totalled DKK 108.0
million.
- Taking into account the Spectrum deal sign-on fee of USD 30 million and
Spectrum taking on 70% of the development costs, the sales proceeds from the
Savene® sale and existing cash, TopoTarget has sufficient cash resources for at
least two to three years, without taking into account revenue from future
potential milestones.
- TopoTarget completed a capital raise in July wherein the share capital of the
Company was increased by 66,304,510 new shares raising gross proceeds of DKK
132.6 million.
• The financial performance is considered satisfactory
- For the year 2009 the Group recorded a loss before tax and before write-downs
of certain research and development projects of DKK 121.5 million compared to a
loss before tax and before write-downs of DKK 212.6 million in 2008.
- The sales income for Savene® and Totect® increased to DKK 39.7 million from
DKK 39.1 million in 2008. The supply disruptions that we experienced in the US
in 2009 have now been resolved.
- A write-down of DKK 21.2 million (2008: DKK 93.5 million) has been made
related to certain research and development projects acquired from third
parties and recognised in the balance sheet at the time of acquisition. Such
write-down does not affect the group cash flow for the year 2009.
After the reporting period:
• New CEO
- Francois Martelet, MD has taken up the position of CEO of TopoTarget in order
to add the necessary late-stage clinical development and marketing expertise to
ensure a successful development and commercialisation of belinostat. Dr.
Francois Martelet has a solid late-stage development and 18+ years of
commercialisation experience from the international pharmaceutical industry.
• Deals
- US partner for belinostat
TopoTarget entered into a Development and Commercialisation Agreement with
Spectrum under which the parties agreed to co-develop and Spectrum to
commercialise belinostat in North America and India with a right of first offer
for China. Under the terms of the agreement TopoTarget received an upfront
payment of USD 30 million (non conditional and non refundable) and the right to
receive further payments of up to USD 320 million on the achievement of certain
defined development and sales milestones. In addition TopoTarget will receive a
double digit royalty on sales of belinostat as well as one million Spectrum
shares. Spectrum commits to fund 100% of the costs of the ongoing pivotal PTCL
study and TopoTarget will fund 100% of the ongoing phase 2 CUP study. Spectrum
will pay 70% of future development costs of belinostat.
- Divesture of Savene® for Europe
TopoTarget entered into an agreement with SpePharm Holding, BV who acquired the
rights to Savene® for EUR 6 million(EUR 5 million plus the value of stock
payable on settlement plus a double digit royalty on net sales capped at EUR 1
million). Totect®, the US trademark for the same product, will remain with
TopoTarget and continue to be promoted by the TopoTarget US sales team.
• New major investor
- TopoTarget announced that a notification was received from
Försäkringsaktiebolaget Avanza Pension, that Avanza Pension's holdings of
shares and voting rights have now exceeded 5% of TopoTarget's total share
capital and total number of voting rights.
Highlights of promising clinical results with belinostat in 2009
- Significant achievements have been obtained during the ongoing clinical
development.
- More than 700 patients have been treated and the product has shown an
excellent activity, safety and tolerability profile.
- Belinostat has three important competitive advantages: The ability to be
combined in full doses with a variety of anti-cancer therapeutic agents;
Flexibility in administration as belinostat is available in oral as well as in
parenteral administration forms and an excellent safety profile.
- The product, as an intravenous (IV) administration has shown clinical
activity as monotherapy with results presented in a phase 2 study in PTCL
patients at the 2009 annual conference in American Society of Haematology
(ASH).
The BelCap regimen is currently being tested in a randomised phase 2 global,
multi-center trial in cancer of unknown primary (CUP) patients. This trial is
being conducted in collaboration with key CUP opinion leaders both in the US
and in Europe.
Conference call
A teleconference will be held on 25 March 2010 at 2 pm local time. CEO Francois
Martelet and CFO Tim Corcoran will present the 2009 Annual Report and answer
questions. The teleconference will be conducted 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
A replay of the conference call will be available approximately two hours after
the conference call and until 1 April, 2010 at: +353 1 436 4267, pin code:
2564357#. From 26 March to 19 May 2010 a replay will be available on the
TopoTarget homepage www.topotarget.com
TopoTarget A/S
For further information, please contact:
Ulla Hald Buhl Telephone +45 39 17 83 92
Director IR & Communications Mobile +45 21 70 10 49
Background information
About TopoTarget
TopoTarget (NASDAQ OMX: TOPO) is an international biotech company headquartered
in Denmark, dedicated to finding ''Answers for Cancer'' and developing improved
cancer therapies. TopoTarget currently focuses, in collaboration with Spectrum
Pharmaceuticals, Inc., on the development in pivotal studies of its lead drug
candidate, Belinostat, which has shown proof of concept as monotherapy in
treating haematological malignancies and positive results in solid tumours.
Belinostat can be used in combination with full doses of chemotherapy, and is
in a pivotal trial within PTCL (peripheral T-cell lymphoma). TopoTarget's
expertise in translational research is based on utilising its highly predictive
in vivo and in vitro cancer models. TopoTarget is directing its efforts on key
cancer targets, including HDACi, NAD+, mTOR, FASLigand and topoisomerase II
inhibitors. 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 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.
