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NeuroSearch A/S - Financial statements and release of Annual Report 2010

10-03-11 kl. 10/3 2011 07:47 | NeuroSearch 3,50 (-0,28%)

Announcement
10 March 2011

In 2010, the NeuroSearch Group (NEUR) posted an operating loss of DKK 328
million (2009: DKK 356 million), which is in line with the company's
expectations of an operating loss in the range of DKK 350 million. The net loss
after tax was DKK 259 million (2009: DKK 287 million).

The company's capital resources totalled DKK 609 million at 31 December 2010,
consisting of DKK 481 million in cash and securities as well as fixed future
payments, excluding possible milestones, from partners of DKK 99 million and
unused credits of DKK 29 million.

Please see the enclosed Annual Report 2010 for NeuroSearch for a full
description of the financial year 2010.

Events:
Early 2010, NeuroSearch reported data from the Phase III MermaiHD study which
included 437 Huntington patients. The 26 weeks' study was the most
comprehensive of its kind and included a placebo group and two groups which
were treated with Huntexil®. The study demonstrated that treatment with
Huntexil® (45 mg twice daily) had a significant effect on the Total Motor Score
(TMS), but the primary endpoint, being effect on the modified Motor Score
(mMS), was not met. The MermaiHD study was extended in an open label phase for
another 26 weeks. This part was completed by 305 patients that all received
Huntexil® (45 mg twice daily) and demonstrated that Huntexil® is well tolerated
for 12 months.

End 2010, NeuroSearch reported results from the HART study, a North American
Phase IIb study showing a significant effect on Huntington patients' general
motor functions after 12 weeks' treatment with Huntexil® measured on the TMS,
but the primary endpoint, the mMS, was not met. The study showed a significant
dose-response relationship and in general highly supports the previous clinical
results from the Phase III MermaiHD study.

The drug candidates ordopidine and seridopidine belong to the same class of
drugs as Huntexil®. This class is designated dopidines, a designation which has
been assigned by the WHO. It is expected that these drug candidates, which are
aimed for neurology specialist indications, will be the next drugs developed in
house to follow Huntexil®. During 2010, both have progressed and we expect to
be able to initiate a Phase II study with one or both drug candidates in the
course of 2011.

Beginning of January 2011, a restructuring of the company was carried out to
strengthen strategic focus. The objective is to become a profitable specialty
pharma business after the first product launch. Huntexil® is the most advanced
drug candidate of the speciality pharma business and closest to market
registration. Ion channel discovery and existing alliances have been organised
in a new division, NsDiscovery, creating a highly specialised and CNS focused
drug discovery division. The objective is to obtain research funding as well as
milestones and royalty payments from products marketed by partners in
non-specialist indications requiring significant marketing and sales resources.
As part of the restructuring, a number of cost reductions were decided upon,
including a staff cut of 20%.

NsDiscovery has drug discovery and development alliances with Eli Lilly and
Janssen and a licensing agreement with Abbott. Besides, NsDiscovery handles a
portfolio of drug candidates for non-specialist indications, including
tesofensine for the treatment of obesity. There is a considerable and unmet
need within the treatment of obesity and a substantial market potential, but
given the difficult regulatory environment for novel products for medical
treatment of obesity and the considerable financial burden associated with
Phase III studies, NeuroSearch decided not to invest further in the development
of tesofensine and is continuously in dialogue with potential partners to
ensure adequate continuous development of the product.

In the autumn 2010, Patrik Dahlen took up his position as new CEO of
NeuroSearch and afterwards the Executive Management has been strengthened with
appointment of Karin Garre, Executive Vice President & CMO and René Schneider,
Executive Vice President & CFO.

Patrik Dahlen, CEO of NeuroSearch, comments:
“In 2010, we have obtained very promising results with Huntexil® and we look
forward to the discussion with the authorities in both Europe and the US. With
the new management team, a focused strategy of building a broad pipeline of
products for specialist indications within the CNS area and with the
NsDiscovery division building on their well-working alliances, we will be able
to maintain NeuroSearch as one of Europe's strongest biopharmaceutical
companies.”

Expectations for 2011
In the course of 2010, NeuroSearch completed a full data package with Huntexil®
with a view to discussing the first Phase II/III results with the regulatory
authorities in the US and Europe in the first half of 2011. These discussions
will be decisive for defining the best possible strategy towards market
registration of the product as a new treatment for Huntington's disease.
NeuroSearch expects to be able to publish a statement regarding the regulatory
prospects for Huntexil® in the first half of 2011.

In order to meet request from patients and treating physicians, who
participated in the HART study, of continued access to treatment with
Huntexil®, NeuroSearch has decided to initiate an open label study for patients
who have completed treatment in the HART study. The first patients are expected
to be enrolled in the open label study during the first half of 2011.

NeuroSearch has initiated and sponsored the first health economics study
related to Huntington's disease. The outcome of the study, which is being
performed in several European countries, will be published in scientific and
health economic fora and form the basis for the commercial evaluation of the
market potential for Huntexil® in 2011.

For 2011, NeuroSearch expects an operating loss in the range of DKK 325 million.

Patrik Dahlen
CEO

Contact persons:
Patrik Dahlen, CEO, telephone: +45 4460 8214 or +45 2629 7296
René Schneider, Executive Vice President & CFO, telephone: +45 4460 8700 or +45
2911 2097

Conference call
NeuroSearch will host a conference call today at 10.30 am local time (09.30 am
UK time/04.30 New York time) to present the Annual Report 2010. Participating
in the call will be CEO Patrik Dahlen and Executive Vice President & CFO René
Schneider. The conference call will be conducted in English and the dial-in
numbers are: UK: +44 207 509 5139, US: +1 718 354 1226 and DK +45 3271 4767.
The conference call can also be accessed on the company's website
www.neurosearch.com. The corresponding Power Point presentation will be
available at the company's website just prior to the teleconference.

About NeuroSearch A/S
NeuroSearch A/S is a European based biopharmaceutical company, specialising in
CNS diseases, and listed on NASDAQ OMX Copenhagen A/S (NEUR). The company has a
pipeline of speciality CNS drugs, including Huntexil® (pridopidine), a unique
orphan drug in Phase III for the treatment of Huntington's disease. NeuroSearch
is building commercial competences with a view to commercialising Huntexil®
through an in-house marketing and sales organisation.

NeuroSearch has a well-established drug discovery division, NsDiscovery, with
unique capabilities in the field of ion channels and CNS diseases. The company
has strategic drug discovery and development alliances with Janssen
Pharmaceutica and Eli Lilly as well as a licence collaboration with Abbott.
NeuroSearch also has equity interests in a number of unlisted companies in the
Life Science industry.



APPENDIX

Financial highlights for the NeuroSearch Group



(DKK million) 2006 2007 2008 2009 2010
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Income statement and comprehensive 66.3 115.2 66.8 84.6 69.3
income 172.3 200.4 216.8 217.0 202.4
Revenue 54.8 131.7 176.9 184.6 153.5
Research costs (186.7) (253.5 (366.0) (355.8 (328.0)
Development costs (25.5) ) (49.9) ) 21.8
Operating profit/(loss) (212.2) (41.3) (415.9) 24.6 (306.2)
Financials (212.2) (294.7 (382.0) (331.2 (259.0)
Profit/(loss) before taxes (196.0) ) (444.5) ) (216.7)
Net profit/(loss) (268.4 (287.1
Comprehensive income ) )
(311.6 (276.9
) )
--------------------------------------------------------------------------------

-------------------------------------------------------
Balance sheet 1,267.5 1,780. 1,245.8 1,630. 1,391.5
Total assets 387.0 6 453.4 0 480.6*
Cash and cash equiva- 657.7 845.3 844.1 808.5 994.1
lents and securities 12.9 1,121. 50.3 1,173. 10.8
Equity 4 8
Investments in property, 15.7 19.8
plant and equipment
--------------------------------------------------------------------------------

-------------------------------------------------------
Per share ratios (DKK) (24.17) (21.17 (24.47) (16.39 (10.56)
Earnings per share (24.17) ) (24.47) ) (10.56)
Diluted earnings per share 53.38 (21.17 53.61 (16.39 40.49
Net asset value 321.5 ) 136.0 ) 95.0
Market price at year-end 6.02 73.57 2.54 48.15 2.35
Market price/net asset value 199 326.0 242 77.0 235
Average number of employees 4.43 1.60
230 235
--------------------------------------------------------------------------------

* Capital resources, including future contingent payments from the
collaborative partners Lilly and Janssen of DKK 99.0 million (2009: DKK 130.8
million) and undrawn credits of DKK 29.0 million (2009: DKK 28.3 million),
total DKK 608.6 million.

The ratios are stated in accordance with the guidelines in “Recommendations and
Ratios” issued by the Danish Society of Financial Analysts.




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