Alzheimer's Disease
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The specialist in psychiatry and pioneer in neurology H. LUNDBECK A/S LUNDBECK H. ANNUAL REPORT 2007 annual R E PORT PORT 2007 H. Lundbeck A/S Ottiliavej 9 2500 Copenhagen - Valby Denmark Corporate Reporting Tel. +45 36 30 13 11 Fax +45 36 30 19 40 DESTINATION [email protected] www.lundbeck.com NEXT DECADE CVR nr. 56759913 DESTINATION NEXT DECADE DESTINATION NEXT DECADE Cover photo: Eric Wainwright is a psychiatrist and works as Medical Advisor for Lundbeck Argentina where he is responsible Design: Bysted A/S for education about depression in Argentina and Chile. Annual Report photos: Nicky Bonne and Lars Bech Read about Eric Wainwright and his work in the Print: Quickly Tryk A/S Lundbeck Magazine 2008. March 2008 Lundbeck at a glance H. Lundbeck A/S is an international pharmaceutical company with more than 50 years of experience in research, development, production, marketing and sale of pharmaceuticals for the treatment of diseases of the central nervous system (CNS). The Group employs more than 5,300 employees in 54 countries. ocus on research and Cipralex®/Lexapro® (escitalopram) Ebixa® (memantine) development Cipralex®/Lexapro® for the treatment of de- Ebixa® for the treatment of moderate to F One of Lundbeck’s most important pression and anxiety was launched in 2002 severe Alzheimer’s disease was launched in tasks is to develop new and innovative phar- and is currently the most frequently prescribed 2002 and is marketed in cooperation with maceuticals to help people who suffer from branded antidepressant in Europe and the Merz Pharmaceuticals GmbH. Memantine is CNS diseases. Accordingly, Lundbeck ploughs USA. Lexapro® is marketed in the USA by currently the second-most prescribed pharma- about 20% of its revenue back into research Forest Laboratories, Inc. In 2007, Cipralex® was ceutical in the world for the treatment of and development each year. approved in the EU for the treatment of obses- Alzheimer’s disease. According to WHO, there sive-compulsive disorder (OCD). According to are 38 million cases of Alzheimer’s disease and Latest pharmaceuticals WHO, there are 150 million cases of depres- other dementia disorders worldwide at any Azilect® (rasagiline) sion worldwide at any given time. given time. Azilect® for the treatment of Parkinson’s dis- ease was developed in collaboration with Teva Circadin® (melatonin) Serdolect® (sertindole) Pharmaceutical Industries Ltd. and launched in In 2007, Lundbeck in-licensed Circadin® for Serdolect® for the treatment of schizophrenia the first market in Europe in 2005. Lundbeck the treatment of primary insomnia from has been on the market since the beginning of currently markets Azilect® in 24 countries and Neurim Pharmaceuticals Ltd. with rights to 2006. Serdolect® was launched in 28 countries plans to launch it in additional markets. Ac- about 80% of the European market. Lundbeck within the first two years. According to WHO, cording to WHO, there are five million cases of expects to launch Circadin® in the first mar- there are 25 million cases of schizophrenia Parkinson’s disease worldwide at any given kets in Europe in 2008. Insomnia is very com- worldwide at any given time. time. mon and is estimated to affect about 27% of any population. Lundbeck’s clinical development projects as of 4 March 2008 Development stage Registration Expected Indication | Compound Mechanism of action Phase I Phase II Phase III application launch Schizophrenia | Serdolect® USA Dopamine/serotonin 2008 2009 Schizophrenia | Bifeprunox Dopamine/serotonin 2010+ Stroke | Desmoteplase Plasminogen activator 2010+ Alcohol dependence | Nalmefene Specific opioid receptor antagonist 2010+ Depression | Lu AA21004 Serotonin modulator & stimulator 2010 2010+ Psychosis | Lu 31-130 Monoaminergic 2010+ Depression | Lu AA24530 Multiple target 2010+ Depression | Lu AA34893 Multiple target 2010+ Psychosis/bipolar disorder | Lu AA39959 Ion channel modulator 2010+ Stroke/neuronal damage | Lu AA24493 Tissue protecting cytokine 2010+ Neurological diseases | Lu AA47070 Adenosine receptor antagonist 2010+ Mood and anxiety disorders | Lu AA37096 Multiple target 2010+ 2 Lundbeck worldwide Parent company Iceland India Denmark Ireland Israel Italy Japan Production Latvia Malaysia Denmark Lithuania Mexico Italy Norway Pakistan United Kingdom Poland Philippines Portugal Russia Research Romania Saudi Arabia Denmark Serbia & Montenegro Singapore USA Slovakia South Africa Slovenia South Korea Sales Spain Turkey Europe Sweden Ukraine Austria Switzerland United Arab Emirates Belgium United Kingdom Venezuela Bulgaria Croatia International Markets USA Czech Republic Argentina Denmark Australia Foundations & institutes Estonia Belarus Lundbeck International Neuroscience Foundation Finland Brazil Lundbeck Institute France Canada Germany Chile Countries are listed under Europe, International Greece China Markets and USA in accordance with Lundbeck’s Hungary Egypt market regions. Netherlands Hong Kong 3 w w w w Contents 5 Financial highlights 2003-2007 6 Business review 12 Marketed pharmaceuticals 16 Progress in the regions 24 Strategic focus 26 Strategic initiatives 27 Growth through innovation 32 Corporate governance 36 Risk management 40 The Lundbeck share 46 Focused efforts: Environment, health and safety 51 The right skills for the new decade 54 Research and knowledge sharing 59 Financial statements 2007 Information about disease areas 10 Alzheimer’s disease 22 Depression and mood disorders 30 Alcohol dependence 34 Parkinson’s disease 38 Primary insomnia 44 Schizophrenia and psychotic disorders 56 Acute ischaemic stroke 4 Financial highlights 2003-2007 Revenue DKK 10,985 million Research and development DKK 2,187 million Profit from operations DKK 2,695 million Net profit for the year DKK 1,770 million Group financial highlights 2003-2007 2003 2004 2005 2006 2007 2007 DKKm DKKm DKKm DKKm DKKm EURm1 Revenue 9,941 9,733 9,070 9,221 10,985 1,474 Research and development costs 1,931 1,776 1,782 1,958 2,187 294 Profit from operations 2,147 2,554 2,170 1,784 2,695 362 Net financials (76) 16 108 (64) (50) (7) Net profit for the year 1,384 1,689 1,574 1,107 1,770 238 Total assets 11,070 11,509 11,628 11,631 12,326 1,653 Equity 6,901 7,839 7,492 6,765 7,185 964 Cash flows from operating and investing activities2 84 884 1,587 1,633 1,610 216 Property, plant and equipment investments, gross 962 305 447 567 474 64 % % % % % % EBIT margin 21.6 26.2 23.9 19.3 24.5 24.5 Return on capital employed 37.3 37.0 32.0 25.2 34.9 34.9 Return on equity 21.9 23.2 20.7 15.6 25.3 25.3 Research and development costs as a percentage of revenue 19.4 18.2 19.6 21.2 19.9 19.9 Solvency ratio 62.3 68.1 64.4 58.2 58.3 58.3 Capital turnover 89.8 84.6 78.0 79.3 89.1 89.1 DKK DKK DKK DKK DKK EUR1 Earnings per share (EPS)3, 4 5.98 7.42 7.04 5.24 8.63 1.16 Diluted earnings per share (DEPS)3, 4 5.98 7.42 7.02 5.23 8.63 1.16 Proposed dividend per share3 1.77 2.21 2.10 1.57 2.56 0.34 Cash flow per share3 8.19 11.62 9.20 6.59 13.18 1.77 Net asset value per share3 29.71 34.21 33.99 32.40 35.81 4.80 Market capitalisation (million) 23,098 28,517 29,630 33,060 28,605 3,836 2003 2004 2005 2006 2007 Average number of employees 5,223 5,155 5,022 5,111 5,134 1) Income statement items are translated using the average EUR exchange rate for the year (745.11). Balance sheet items are translated at the EUR exchange rate on 31 December 2007 (745.66). 2) Comparative figures have been restated so that securities are included in cash flows from investing activities. 3) The calculation is based on a share denomination of DKK 5. 4) Calculated according to IAS 33 Earnings per share. Comparative figures involving number of shares have been adjusted by an adjustment factor of 0.9988 for the effect of employees exercising warrants. 5 Business review Lundbeck achieved its best ever results and also achieved its target of an EBIT margin of 25% in 2007. The Group recorded considerable growth for its new pharmaceuticals and the current development pipeline is the largest and broadest in the history of the Lundbeck Group. n 2007, the Group continued to record Revenue 2007 Forecasts, DKK Realised*, DKK sales growth for its new pharmaceuti- Revenue amounted to DKK 10,985 million Profit from operations* More than 2.6bn 2,657m I cals, leading to the highest revenue ever in 2007, equivalent to an increase of 19%. EBIT margin* 25% 25.1% recorded; just under DKK 11 billion. Measured at constant exchange rates, revenue Investments Approx. 650m 739m was up 21%. Exclusive of two non-recurring * Exclusive of non-recurring items. The Group’s financial performance in 2007 was payments from Takeda totalling DKK 420 affected by three non-recurring items. In 2007, million, the Group generated revenue of DKK Expenses Lundbeck received two non-recurring pay- 10,565 million, an increase of 17% on 2006. Lundbeck’s total expenses, exclusive of net fi- ments from Takeda Pharmaceutical Company nancials and tax, were DKK 8,290 million in Limited totalling DKK 420 million, which had a Sales of the Group’s new pharmaceuticals – 2007, or 11% more than in 2006. Excluding favourable impact on consolidated revenue. Cipralex®/Lexapro®, Ebixa®, Azilect® and Ser- the write-down on the Group’s production as- dolect® – were DKK 8,544 million in 2007, up sets, costs totalled DKK 7,909 million, corre- The development of an optimised production DKK 1,671 million, or 24%, on 2006. Revenue sponding to an increase of 6% on 2006.