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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

NeuroSearch announces the company's Annual Report 2011

28-02-12 kl. 28/2 2012 07:44 | NeuroSearch 3,50 (-0,28%)

Announcement
28.02.2012

In 2011, the NeuroSearch Group (NEUR) posted an operating loss from continuing
activities of DKK 383 million (2010: DKK 168 million), which is in line with
the company's expectations of an operating loss in the region of DKK 370
million. This includes DKK 170 million as one-off costs without a cash flow
effect regarding an impairment write-down of intangible assets and a provision
for changed milestone payments to the sellers of Carlsson Research and
additional DKK 99 million representing impairment charges on property and other
assets with no cash flow effect.

Additionally, the company incurred losses from discontinued operations
amounting to DKK 329 million (2010: DKK 160 million) related to a provision for
loss-making collaborations, including the contracts with Lilly and Janssen,
impairment write-downs of property, plant and equipment and intangible assets,
salaries to redundant employees during the notice period and related
infrastructure.

The consolidated loss in 2011 for the group after tax and financial income was
DKK 678 million (2010: DKK 259 million).

The company’s capital resources consisting of cash and securities totalled DKK
221 million (2010: DKK 481 million) at 31 December 2011.

Future expected payments from Janssen related to staff working under the
agreement with this partner amount to DKK 38 million, and an additional payment
from the sale of Sophion Bioscience in the form of release of an escrow of DKK
9 million is expected at year end 2012.

NeuroSearch is working on securing financing required to conduct the Prime-HD
study and the associated supportive studies in the Huntexil® development
programme. The Prime-HD study will not be initiated before financing is secured
to finalise the study. NeuroSearch continues to seek a partner to market
Huntexil® outside Europe and in parallel NeuroSearch is exploring potential
financing through a capital increase. So far, no decision on preferred route of
financing has been taken.

Please see the enclosed Annual Report 2011 for NeuroSearch for a full
description of the financial year 2011.

Events during 2011 to date:

Organisation

-- On 27 September 2011, 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 to focus the
company's financial and managerial resources on the phase III development
and subsequent marketing of Huntexil®.

Huntexil®

-- During Q2 2011, NeuroSearch received feedback from the End of Phase II
meeting with FDA and held a scientific advice meeting with EMA regarding
the clinical development programme for Huntexil®. Both the FDA and EMA
requested additional phase III data to support the previously observed
effect on the TMS and to substantiate the clinical relevance of this
finding. The FDA further requested evidence of a statistically significant
effect on an endpoint which supports clinical relevance and the FDA also
recommended investigating doses of Huntexil® higher than those used in
MermaiHD and HART.
-- After discussions with leading experts in the field, NeuroSearch has
designed the continued development programme for Huntexil®, including the
phase III Prime-HD study. This study is planned to enrol approximately 630
patients with Huntington's disease who will be dosed with 45 mg or 67.5 mg
Huntexil® or placebo, all twice daily. The primary study endpoint will be
the TMS. To further demonstrate the clinical relevance of Huntexil®, the
patients overall function will be measured using the Clinical Global
Impression (CGI) scale.
-- The Multiple Ascending Dose (MAD) study, which is aimed at evaluating the
safety, tolerability and pharmacokinetics of multiple ascending doses of
Huntexil® in healthy volunteers, was initiated at the end of September. The
study has concluded its active phase and the maximum tolerated dose in
healthy volunteers has been identified. The twice daily doses of 45 mg and
67.5 mg Huntexil® which are planned for the Prime-HD study appear to be
safe and well tolerated and will thus remain as planned. The data
management and analysis of data from the MAD study is still on-going and
final results are expected to be ready in Q2 2012.
-- NeuroSearch is providing a research grant to The University of Lyon to
conduct the Global Huntington Disease Burden Study in Europe, Australia and
the USA and some results have been received already. In France, the direct
treatment costs (hospital visits, nursing home, etc.) excluding
productivity losses associated with Huntington’s disease amount to
approximately EUR 24,000 per patient per year.
-- The compassionate use program that followed MermaiHD now enrols 130
patients, which is 43% of the 305 eligible patients who completed the
MermaiHD study. The Open-HART study was initiated in March 2011 and
concluded enrolment in December 2011 with 118 patients, which is more than
55% of the eligible 213 patients from the HART study. Both the
compassionate study and the Open-HART study contribute to the long term
safety database of 45 mg Huntexil® twice daily, and to date this dose has
been very well tolerated.
-- In Q4 2011, the MermaiHD study was published in The Lancet Neurology.


Ordopidine and Seridopidine

-- Together with Huntexil®, seridopidine and ordopidine constitute a range of
patent families which are important to NeuroSearch. Seridopidine has been
evaluated in phase I clinical studies with satisfactory results. Ordopidine
has finalised the active part of a phase Ib study and the data are
currently being analysed.
-- In order to focus on the development of Huntexil®, NeuroSearch has decided
not to initiate phase II studies with any of these projects at this time.


Alliances and NsDiscovery

-- The alliances with Eli Lilly and Janssen have continued as planned. In
accordance with its terms, the Lilly agreement expired on 17 February 2012.
During Q2 2011, the Janssen agreement was extended until August 2013 with
no change in the total payments to NeuroSearch.
-- In Q4 2011, leading employees from NsDiscovery founded the company Aniona
ApS with the aim of establishing the basis for a continuation of research
and development activities from NsDiscovery within a new company and with
new investors. NeuroSearch endorses this initiative and participates with a
non-binding agreement which allows the sale of selected intellectual rights
to Aniona provided that Aniona establishes the necessary external
financing. This agreement denotes that NeuroSearch obtains ownership in
Aniona as well as certain royalty payments depending on the transferred
rights. NeuroSearch shareholders will thus have the possibility of a future
flow of earnings relating to the transferred rights, but the company will
not invest further in NsDiscovery activities.

Group

-- During Q3 2011, NeuroSearch and all other shareholders sold Sophion
Bioscience A/S to Biolin Scientific AB. The company's proceeds from the
sale amounted to DKK 41 million of which DKK 32 million were received in
September 2011, and the remaining DKK 9 million in the form of release of
an escrow are expected to be received before the end of 2012.
-- During Q4 2011, NeuroSearch and the sellers of Carlsson Research
renegotiated and agreed on an amendment to the share purchase agreement
that was entered into in connection with the acquisition of Carlsson
Research in 2006. As a consequence, the following milestones are now
outstanding:
First registration application for Huntexil® (SEK 100 million)
First marketing approval in EU/EFTA of Huntexil® (SEK 75 million)
First marketing approval outside EU/EFTA of Huntexil® (SEK 75 million)
This amendment gives NeuroSearch full freedom to deal with seridopidine and
ordopidine in the best possible way without obligation to the sellers of
Carlsson Research.
-- On 20 February 2012, NeuroSearch conducted an extraordinary general meeting
and was granted the permission to reduce the share capital to DKK
24,553,947 in shares of DKK 0.05. The reduction of the share capital
neither dilutes any existing shareholding nor has any impact on the number
of shares owned by each shareholder. Notice has been given to the company's
creditors, requesting them to file their claims against NeuroSearch within
four weeks. Implementation of the reduction of the share capital will not
take place until after expiry of this four week time limit, which will
expire on 19 March 2012.

Financial expectations for 2012
NeuroSearch expects an operating loss on continuing operations of approximately
DKK 75 million excluding any possible costs related to the phase III programme
on Huntexil®. Costs mainly relate to the continuing organisation, fixed costs
and continuation of the Open-HART study and the compassionate use programme.
NeuroSearch is working on securing the financing required to conduct the
Prime-HD study and the associated supportive studies in the Huntexil®
development programme. The Prime-HD study will not be initiated before
financing is secured to finalise the study. So far, no decision on preferred
route of financing has been taken.

No further costs related to the discontinued operations are expected in 2012.
The cash flow effect in 2012 is expected to be in the region of DKK 70 million.

CEO of NeuroSearch, Patrik Dahlen, comments as follows in connection with the
annual reporting:
"NeuroSearch has undergone significant changes during 2011. Unfortunately, we
had to part with a large group of the employees to focus the company's
resources on the continued development of Huntexil®. I'm impressed with the
professionalism among those leaving us and also happy to see that so many have
got new jobs. At the same time, NeuroSearch is committed to putting every
effort into the development and commercialisation of Huntexil® with our current
organisation. We are convinced we have a unique opportunity to ease the
challenges of patients suffering from Huntington's disease."

Patrik Dahlen
CEO

Contact person:
René Schneider, EVP & CFO, telephone: +45 4460 8700 or +45 2911 2097

Teleconference
NeuroSearch will host a conference call today at 9.30 am Copenhagen time (8.30
am London time and 3.30 am New York time) during which the Annual Report 2011
will be presented. Participating in the call will be CEO Patrik Dahlen and EVP
& CFO René Schneider.

The telephone conference will be conducted in English and the dial-in numbers
are as follows:

UK: +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
www.neurosearch.com. The corresponding presentation will be available at the
company's website at the time of the teleconference.

About NeuroSearch
NeuroSearch A/S (NEUR) is a European-based biopharmaceutical company listed on
NASDAQ OMX Copenhagen A/S and specialising in central nervous system (CNS)
disorders. The vision is to develop NeuroSearch into a profitable specialty
pharmaceutical company. The strategy is 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.
As a consequence of the restructuring of NeuroSearch that was announced 27
September 2011, the company also has a portfolio of assets for outlicensing or
divestment.


APPENDIX
Financial highlights for the NeuroSearch Group*


(DKK millions) 2007 2008 2009 2010 2011
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Income statement and comprehensive
income

Revenue 115.2 66.8 84.6 - -

Research costs 200.4 216.8 217.0 - -

Development costs 131.7 176.9 184.6 144.4 259.1

Operating profit/(loss) (253.5) (366.0) (355.8) (167.6) (382.5)

Net financials (41.3) (49.9) 24.6 21.8 33.5

Profit/(loss) of continuing (294.7) (415.9) (331.2) (145.8) (349.1)
operations before tax


Net profit/(loss) of discontinued - - - (160.4) (329.3)
operations

Profit/(loss) for the period (268.4) (382.0) (287.1) (259.0) (678.4)
Comprehensive income (311.6) (444.5) (276.9) (216.7) (694.8)
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
--------------------------------------------
Balance sheet

Total assets 1,780.6 1,245.8 1,630.0 1,391.5 840.8

Cash and cash equivalents and 845.3 453.4 808.5 480.6 **220.6
securities

Equity 1,121.4 844.1 1,173.8 994.1 320.6

Investments in property, plant and 15.7 50.3 19.8 10.8 3.6
equipment
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Per share ratios (DKK)
Earnings per share (21.17) (24.47) (16.39) (10.56) (27.63)
Diluted earnings per share (21.17) (24.47) (16.39) (10.56) (27.63)
Net asset value 73.57 53.61 48.15 40.49 13.06
Market price at year-end 326.0 136.0 77.0 95.0 17.7
Market price/net asset value 4.43 2.54 1.60 2.35 1.36

Average number of employees 230 242 235 235 222
--------------------------------------------------------------------------------

* Only the comparative figures for 2010 have been restated to reflect the
continuing operation. It has not been possible to make the same split between
continuing and discontinued operations for years prior to 2010 as the company
has only had more than one organisational segment since 2011.

** Excluding future contingent payments from the collaboration partner Janssen
of DKK 38 million (2010: DKK 99.0 million) and contingent proceeds of DKK 9
million from the divestment of Sophion Bioscience A/S (2010: DKK 0 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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