For the full Financial Statements 2008, please see the attathed pdf document.
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The Board of Directors of NeuroSearch A/S today considered and adopted the
audited financial statements for the year ended 31 December 2008.
In 2008, the NeuroSearch Group posted a consolidated operating loss of DKK
366.0 million (2007: DKK 253.5 million), which was a slightly lower loss than
the previously announced financial guidance for 2008 of a loss before
financials in the region of DKK 400 million. NeuroSearch posted a loss after
tax of DKK 382.0 million (2007: DKK 268.4 million).
Through 2008, NeuroSearch took important steps towards attaining its primary
goal of bringing new and better drugs to the market. Most important was the
initiation of a pivotal clinical Phase III programme with ACR16, which is being
developed as a novel treatment of Huntington's disease. NeuroSearch holds all
rights to ACR16 and believe the product to be of high value and to have a very
attractive commercial potential. NeuroSearch also added to the extensive
clinical data package behind tesofensine for the treatment of obesity, further
strengthening and advancing the drug towards initiation of Phase III
development.
Another late-stage product, ABT-894, in development under a collaboration with
Abbott, saw mid-2008 positive results from a Phase II study in adult patients
with ADHD.
NeuroSearch is pursuing a strategy of continuous pipeline expansion and risk
sharing, while striving also to secure sufficient financing of its drug
discovery and development activities until the first product is on the market.
This has led to the signing of two important agreements with GlaxoSmithKline
and Eli Lilly and Company (Lilly) in the beginning of 2009.
The current capital resources including research funding from partners are
expected to finance the company's ongoing discovery and pipeline activities
until the second half of 2010. It is NeuroSearch's goal to secure sufficient
funding through partnerships until ACR16 is ready for market launch in 2011.
Key pipeline milestones in 2008:
ACR16 - Huntington's disease
• Treatment of the first Huntington patients in MermaiHD, a European Phase III
clinical study and, thus, start-up of a comprehensive pivotal Phase III
programme with ACR16.
• FDA approval and the start-up of HART, a clinical Phase IIb study in North
America and part of the ongoing pivotal Phase III development programme with
ACR16.
Tesofensine - Obesity
• Positive results from TIPO-2, a clinical metabolic study in overweight
subjects showing significant weight loss.
• A complete analysis of data from TIPO-1 (a Phase II clinical Proof of Concept
study).
• Positive mid-term results from TIPO-4 (a 48-week Phase II extension study of
TIPO-1) - and later, in 2009, confirmatory results from the full TIPO-4.
• Positive results from an abuse liability study with tesofensine.
• Publication of TIPO-1 results in the peer reviewed scientific journal, The
Lancet.
• Positive results from a cardiovascular evaluation study supporting
tesofensine's good safety profile.
Other products in development
• Initiation of a Phase I clinical study of NSD-788 with a view to developing
this drug candidate as a new treatment for anxiety.
• Positive Proof of Concept results from a Phase II study of ABT-894 for the
treatment of adults suffering from ADHD was reported in June 2008. ABT-894 is
licensed to Abbott.
• Successful completion of Phase I studies with ACR325 and the decision to
advance clinical development of the drug in Parkinson's dyskinesias.
• Successful completion of Phase I studies with ACR343. Phase II development is
expected initiated in 2009.
• Selection of two new product candidates from NeuroSearch's drug discovery
activities; NSD-847, a dopaminergic stabiliser for the treatment of psychoses
and NSD-867, a cortical enhancer for the treatment of ADHD.
Business events in 2008:
• In January 2008, NeuroSearch issued 185,755 new shares at DKK 319.21 per
share to the sellers of Carlsson Research AB as a milestone payment in
connection with the start-up of Phase I clinical studies of ACR343.
• Two new members were elected to NeuroSearch's Board of Directors, both with
broad experience from the international pharmaceutical industry: Dr. Anders
Ullman, Executive Vice President, Nycomed Altana GmbH and Dr. Gerard van Odijk,
President & CEO of Teva Pharmaceuticals Europe B.V. Further, Thomas
Hofman-Bang, CEO of NKT Holding A/S was elected new chairman of the Board.
• NeuroSearch's associated company NsGene A/S (25% interest) reached an
important milestone with its successful Phase Ib dosing of NsG0202 in Alzheimer
patients.
• In May 2008, NeuroSearch issued 300,000 new shares in a directed offering
subscribed for by institutional investors at a price of DKK 280 per share to
finance an ACR16 Phase III related milestone payment of SEK 100 million
(approximately DKK 80 million/approximately EUR 10.7 million) to the sellers of
Carlsson Research AB.
Important events after 2008:
• In January 2009, NeuroSearch announced an expansion of the alliance agreement
with GSK, adding a number of novel compounds to the existing portfolio of drug
candidates in development under the collaboration. The expansion included a
conditional share put option for NeuroSearch to sell shares to GSK totalling up
to DKK 149 million (EUR 20 million) until the end of November 2010. Under the
collaboration, NeuroSearch may receive milestone payments from GSK of more than
DKK 6 billion plus double-digit royalties on global sales of products from the
alliance.
• In February 2009, NeuroSearch reported the results from Phase II studies with
ABT-894 in diabetic neuropathic pain, conducted and financed by Abbott under an
existing license collaboration. In the studies, ABT-894 was well tolerated and
demonstrated a good safety profile, but the drug's effect on pain reduction did
not support continued development in neuropathic pain.
• Further in February 2009, NeuroSearch announced a new three-year drug
discovery and development alliance with Lilly focusing on new CNS therapeutics
based upon defined ion channel targets. Under the alliance, NeuroSearch is
eligible to receive upfront payment and research funding of up to USD 30
million (DKK 175.1 million) over three years plus substantial milestone
payments and sales royalties on any product from the alliance.
• On 23 February 2009, NeuroSearch announced the results from two Phase II
Proof of Concept studies with NS2359 in Major Depressive Disorder, which were
conducted by GSK under the existing collaboration. The results showed no
statistically significant effect from treatment with NS2359 compared to placebo
and no further development of the drug will be pursued in this indication.
• On 2 March 2009, NeuroSearch regained global rights to ACR16, in Phase III
development for the treatment of Huntington's disease, following former license
partner Astellas' decision to discontinue development of ACR16 in schizophrenia
after a strategic assessment of the potential for the compound in this
indication.
Outlook for 2009
NeuroSearch expects a loss before financials and other shares of results in the
region of DKK 350 million.
Flemming Pedersen
CEO
Contact persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor Relations & Corporate
Communications, telephone: +45 4460 8212 or +45 4017 5103
Teleconference
A teleconference will be held today at 3 pm Copenhagen time (2 pm London time,
9 am New York time). Flemming Pedersen, CEO, Anita Milland, Vice President, CFO
and Hanne Leth Hillman, Vice President, Director of IR & Corporate
Communications, will present the 2008 announcement and answer questions. The
telephone conference will be conducted in English and the telephone number is
+44 (0)20 7162 0077. The corresponding PowerPoint presentation will be
available via www.neurosearch.com.
NeuroSearch - Company profile
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on Nasdaq
OMX Copenhagen. The company's core business covers the development of novel
drugs, based on a broad and well-established drug discovery platform focusing
on ion channels and CNS disorders. A substantial share of NeuroSearch's
activities is partner financed through an alliance with Eli Lilly and Company
and collaborations with GlaxoSmithKline (GSK) and Abbott. The drug pipeline
comprises 8 clinical (Phase I-III) development programmes: ACR16 for
Huntington's disease (Phase III), tesofensine for obesity (Phase III ready),
ABT-894 for ADHD (Phase II) in partnership with Abbott, ACR325 for Parkinson's
disease (Phase II ready), ABT-107 and ABT-560 for the treatment of various CNS
disorders - both (Phase I) in collaboration with Abbott, ACR343 for Parkinson's
disease (Phase I) and NSD-788 for anxiety/depression (Phase I). In addition,
NeuroSearch has a broad portfolio of preclinical drug candidates and holds
equity interests in several biotech companies.
