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. 06-08 / Copenhagen, March 12, 2008
TopoTarget Announces Financial Results for the Year ended December 31, 2007
Copenhagen, Denmark - March 12, 2008 - TopoTarget A/S (OMX: TOPO) announced
today financial results for the year ended December 31, 2007. The results are
better than expected.
• Belinostat: Research and development expenses increased in 2007 compared to
2006 partly due to costs related to increased investment in the development of
belinostat and in projects following the acquisition of Apoxis (now TopoTarget
Switzerland). During 2008 belinostat is due to enter pivotal trials in
peripheral T-cell Lymphoma and the product is currently in an additional 16
trials aimed at increasing belinostat's market reach.
• Sales of Savene®/Totect™ were DKK 21.6 million (approx. EUR 2.9 million) and
revenue of DKK 23.3 million (approx. EUR 3.1 million) was earned primarily
related to the company's collaboration with CuraGen.
• A Pre-tax Loss for 2007 of DKK 214.0 million (approx. EUR 28.7 million),
which is lower than expected. In Q3 2007 guidance was given for a pre-tax loss
of DKK 229-249 million (approx. EUR 30.7-33.4 million) (correlated to DKK
255-275 million (approx. EUR 34.2-36.9 million) due to changes in recognition
and measuring of immaterial activities)*.
• The company ended the year with a total cash position of DKK 403.6 million
(approx. EUR 54.1 million).
*(Income Statement table p53 of the Annual Report 2007)
Guidance for 2008
TopoTarget gives the following guidance for 2008.
A pre-tax loss of approximately DKK 175 - 195 million (approx. EUR 23-26
million) is forecasted for 2008. The lower loss relative to 2007 is due to
expectations of an increase in sales, and continued cost benefits from further
improved efficiencies from collaboration between the organisation's various
country activities. The company expects higher research and development costs
during 2008 compared to 2007.
Highlights
The investments made during 2007 by TopoTarget led to the following
achievements:
Belinostat
• Around 200 cancer patients were treated with TopoTarget's lead product in
clinical development, belinostat, during 2007
• Proof of concept achieved in Cutaneous T Cell Lymphoma (CTCL) and Peripheral
T Cell Lymphoma (PTCL)
• Positive Phase II data announced from trial in PTCL & CTCL
• Positive Phase II data announced from trials in chemo-resistant ovarian
cancer using the BelCaP combination (belinostat combined with carboplatin and
paclitaxel). 15 out of 16 patients experienced tumour shrinkage, and 8 out of
16 patients achieved objective response. Belinostat's market potential is
substantially increased by this positive data in solid tumours
• Positive Phase II confirmatory data in Multiple Myeloma in combination with
dexamethazone
• 4 new belinostat trials initiated
Marketed product; Savene®/Totect™
• Gained FDA approval and launched Totect™ in the US
• Built sales organisation in US with 10 sales specialists
• Built sales organisation and sales in Europe with 8 sales specialists
• Signed partnerships in Greece (VIPharma), Spain and Portugal (Gruppo Ferro)
• Appointed John Parsons Jr, President of TopoTarget Inc. US, Chief Commercial
Officer
Advancing additional pipeline programs & fuelling the pipeline
• Positive results from Phase II trials using Baceca to treat Basal Cell
Carcinoma
• Update and safety data from a Phase II trial using Savicol to treat FAP
• Two first in class products added to the pipeline following acquisition of
Apoxis
o APO866 in Phase II to treat B-CLL, MM and CTCL
o APO010 in Phase I for the treatment of advanced cancers
• Siramesine in-licensed from Lundbeck as potential cancer treatment Now being
tested in TopoTarget's pre clinical cancer models
Conference call
TopoTarget hosts a conference call this afternoon, 12 March at 14.00 (CET),
where management will present and discuss the 2007 results.
The conference call will be held in English and slides to accompany the call
can be found on www.topotarget.com , before the start of the conference call.
The dial in details are follows 70 26 50 40 (outside Denmark +45 70 26 50 40).
A replay of the conference call will be available one hour after the conference
call and until 19 March 2008 at 17.00 (CET) at the following number:
+353 1 436 4267, security code 1194024#.
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 (OMX: TOPO) is a biotech company, headquartered in Denmark and with
subsidiaries in the US, Switzerland, Germany and the UK, 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 targets
(including HDACi, NAD+, mTOR, FasLigand and topoisomerase II inhibitors) and a
strong development foundation has been built. TopoTarget has a broad portfolio
of small molecule pre-clinical drug candidates and nine drugs (both small
molecules and protein based) are in clinical development, including both novel
anti-cancer therapeutics and new cancer indications for existing drugs.
Savene®/Totect™ were approved by EMEA in 2006 and the FDA in 2007 and is
TopoTarget's first product on the market. 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.
