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NeuroSearch A/S - Q3 report 2011

17-11-11 kl. 17/11 2011 07:09 | NeuroSearch 3,50 (-0,28%)

Announcement
17.11.2011

Below please find the first part of the NeuroSearch Q3 report 2011. The full
report is available in the enclosed pdf file.

-----------------------------

NeuroSearch (NEUR) is committed to creating a profitable, specialty
pharmaceutical company building on the platform that the company would achieve
from marketing of Huntexil®(pridopidine).

On 27 September, NeuroSearch provided an update on the Huntexil® development
programme for the treatment of motor symptoms associated with Huntington's
disease. At the same time, the company announced a comprehensive restructuring
and controlled discontinuation of the company's other activities in order to
optimise financial and managerial resources to complete the development and
marketing of Huntexil®.

In the future, the company's financial guidance and reporting will make
distinction between loss from continuing operations and loss from discontinuing
activities.

The Board of Directors today considered and adopted the company's interim
report for the nine months ended on 30 September 2011. An operating loss of DKK
337 million was reported for the first three quarters (a loss of DKK 126
million in the same period 2010). One-off costs with no cash effect of
approximately DKK 240 million incurred in Q3 are related to the restructuring
and relate to impairment of goodwill, intangible assets and property, plant and
equipment.

Net financials for the period amounted to DKK 36 million (net financials of DKK
20 million in the same period 2010).

Discontinuing activities amounted to a loss of DKK 345 million for the period
(a loss of DKK 111 million in the same period 2010) concerning costs from
loss-making collaborations, salaries to employees under notice, leasing
obligations, etc.

On 30 September 2011, the company's cash and cash equivalents including
securities totalled DKK 305 million (DKK 569 million at 30 September 2010).
Securities primarily consist of highly liquid short-term bonds. In addition,
NeuroSearch will receive a total of DKK 46 million in payments for staff
working on projects under the alliance with Janssen. Moreover, the company has
unused credits of DKK 29 million.

Financial expectations for 2011
NeuroSearch maintains its financial expectations for the full year 2011 as
announced by the end of September in connection with the restructuring of the
company. For the full year 2011, NeuroSearch forecasts an operating loss of
approximately DKK 370 million of which approximately 240 million represent
one-off costs with no cash effect. In addition, NeuroSearch forecasts a loss
relating to discontinuing activities of approximately DKK 345 million in 2011.

Value of cash and cash equivalents including securities are expected to be in
the range of DKK 230 million by the end of 2011.

Financial expectations for 2012
For 2012, the company foresees an operating loss relating to the continuing
activities in the range of DKK 150-175 million. No other costs are expected in
connection with discontinuing activities in 2012.

Important events in Q3

-- On 27 September, NeuroSearch announced a comprehensive restructuring, which
- when fully implemented in 2013 - will result in an organisation of
approximately 35 employees. The aim of the restructuring is primarily to
focus the company's financial and managerial resources on the final
development and marketing of Huntexil®.

-- On 27 September, NeuroSearch also announced the company's plans for the
next development step for in the form the Phase III Prime-HD study. This
study is planned to enrol approximately 630 Huntington patients who will be
dosed with placebo, 45 mg Huntexil® or 67.5 mg Huntexil® - all twice daily.
The primary study endpoint will be the Total Motor Score (the TMS).
Prime-HD is planned for initiation during the first half of 2012, provided
that funding for the completion of the study is secured by then.

-- The Multiple Ascending Dose (MAD) study, whose aim is to test the effect of
high doses of Huntexil® in healthy volunteers, was initiated at the end of
September, and NeuroSearch expects to be able to report results from this
study in Q1 2012.

-- The Open HART study, the safety extension study which was planned and
initiated following the end of the North American HART study, has continued
its enrolment of patients, and as of 14 November, 109 former HART-study
patients continued their treatment with Huntexil®. NeuroSearch plans to
continue the enrolment until mid-December 2011.

-- The compassionate use programme, which followed the MermaiHD extension
study, has now enrolled 130 patients who receive treatment with Huntexil®.

-- Earlier this year, NeuroSearch and all other shareholders sold Sophion
Bioscience A/S to Biolin Scientific AB. The company's profit from the sale
amounts to DKK 41 million of which DKK 32 million were received in
September 2011, and the remaining DKK 9 million are expected to be received
before the end of 2012.

Events after the balance sheet date

-- The announced restructuring will result in a reduction of the employee
headcount to a size necessary to primarily continue the development and
marketing of Huntexil®. All affected employees were given notice of
termination at the end of October 2011. An important part of those
employees has been given extended notice in order for NeuroSearch to be
able to observe the company's obligations relating to the alliances with
Lilly and Janssen.
-- On 8 November, the MermaiHD study was published in the distinguished
medical journal The Lancet Neurology, and the journal found the article
worthy of a separate press release.


Patrik Dahlen, CEO of NeuroSearch, states as follows in connection with the
release of the Q3 report:
"The restructuring of the company progresses as planned. All affected employees
have been given notice and have dealt with the situation in a very professional
way. The work of bringing Huntexil® to the market runs according to plan and
the next important step will be our interaction with the FDA which will
determine the last details in our Prime-HD study protocol".

Patrik Dahlen
CEO

Teleconference
NeuroSearch will host a conference call today at 9.30 am CET (8.30 pm UK time,
3.30 am New York time) during which the Q3 report will be presented.
Participating in the call will be CEO Patrik Dahlen and EVP & CFO René
Schneider.

The conference call will be conducted in English and the dial-in numbers are:

UK and international: +44 207 509 5139
US: +1 718 354 1226
Denmark +45 3271 4767

Listening to the teleconference is also possible via the company's website.

The corresponding presentation will be available at the company's website at
the time of the teleconference.

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

About NeuroSearch
NeuroSearch is a European-based biopharmaceutical company listed on NASDAQ OMX
Copenhagen A/S (NEUR) and specialising in central nervous system (CNS)
disorders. The vision is to develop NeuroSearch into a profitable specialty
pharmaceutical company. The strategy is primarily to complete the development
and subsequently to market Huntexil®, a unique drug in clinical Phase III for
the treatment of the motor symptoms of Huntington's disease.
Among discontinuing activities, NeuroSearch also has a portfolio of assets for
outlicensing or divestment. This includes tesofensine which has shown
outstanding efficacy in the treatment of obesity, the Integrative Screening
Process (ISP), which is a proprietary systems biology approach, as well as a
broad range of ion channel technologies and patented compounds identified as
ion channel modulators.




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