ANNUAL RePORT 2007 - Alle jaarverslagen
ANNUAL RePORT 2007 - Alle jaarverslagen ANNUAL RePORT 2007 - Alle jaarverslagen
ANNUAL RePORT 2007 DESTINATION NEXT DECADE
- Page 2: DESTINATION NEXT DECADE Cover photo
- Page 5 and 6: Lundbeck worldwide Parent company D
- Page 7 and 8: Financial highlights 2003-2007 Reve
- Page 9 and 10: 2007: DKK 10,985 million Revenue 20
- Page 11 and 12: Being a research-based company, Lun
- Page 13 and 14: Alzheimer’s disease A lzheimer’
- Page 15 and 16: oth depression and anxiety in compa
- Page 17 and 18: Lundbeck’s pharmaceuticals Mechan
- Page 19 and 20: Europe, revenue, DKKm Growth in Gro
- Page 21 and 22: ered by Lundbeck for the treatment
- Page 23 and 24: Foreign currency exposure Foreign c
- Page 25 and 26: Depression and mood disorders D epr
- Page 27 and 28: Partnering Developing new pharmaceu
- Page 29 and 30: Growth through innovation Lundbeck
- Page 31 and 32: At Lundbeck, research into new phar
- Page 33 and 34: Alcohol dependence I t is estimated
- Page 35 and 36: Lundbeck.com/about us Position on c
- Page 37 and 38: Parkinson’s disease P arkinson’
- Page 39 and 40: Prior to obtaining regulatory appro
- Page 41 and 42: Primary insomnia P rimary insomnia
- Page 43 and 44: Annual General Meeting Lundbeck’s
- Page 45 and 46: Analyst coverage Company Name Websi
- Page 47 and 48: Schizophrenia and psychotic disorde
- Page 49 and 50: Lundbeck sets high standards not on
- Page 51 and 52: Environmental impact under full con
<strong>ANNUAL</strong> <strong>RePORT</strong><br />
<strong>2007</strong><br />
DESTINATION<br />
NEXT DECADE
DESTINATION<br />
NEXT DECADE<br />
Cover photo:<br />
Eric Wainwright is a psychiatrist and works as Medical<br />
Advisor for Lundbeck Argentina where he is responsible<br />
for education about depression in Argentina and Chile.<br />
Read about Eric Wainwright and his work in the<br />
Lundbeck Magazine 2008.
Lundbeck<br />
at a glance<br />
H. Lundbeck A/S is an international pharmaceutical company with more than 50<br />
years of experience in research, development, production, marketing and sale of<br />
pharmaceuticals for the treatment of diseases of the central nervous system (CNS).<br />
The Group employs more than 5,300 employees in 54 countries.<br />
F<br />
ocus on research and<br />
development<br />
One of Lundbeck’s most important<br />
tasks is to develop new and innovative pharmaceuticals<br />
to help people who suffer from<br />
CNS diseases. Accordingly, Lundbeck ploughs<br />
about 20% of its revenue back into research<br />
and development each year.<br />
Latest pharmaceuticals<br />
Azilect® (rasagiline)<br />
Azilect® for the treatment of Parkinson’s disease<br />
was developed in collaboration with Teva<br />
Pharmaceutical Industries Ltd. and launched in<br />
the first market in Europe in 2005. Lundbeck<br />
currently markets Azilect® in 24 countries and<br />
plans to launch it in additional markets. According<br />
to WHO, there are five million cases of<br />
Parkinson’s disease worldwide at any given<br />
time.<br />
Cipralex®/Lexapro® (escitalopram)<br />
Cipralex®/Lexapro® for the treatment of depression<br />
and anxiety was launched in 2002<br />
and is currently the most frequently prescribed<br />
branded antidepressant in Europe and the<br />
USA. Lexapro® is marketed in the USA by<br />
Forest Laboratories, Inc. In <strong>2007</strong>, Cipralex® was<br />
approved in the EU for the treatment of obsessive-compulsive<br />
disorder (OCD). According to<br />
WHO, there are 150 million cases of depression<br />
worldwide at any given time.<br />
Circadin® (melatonin)<br />
In <strong>2007</strong>, Lundbeck in-licensed Circadin® for<br />
the treatment of primary insomnia from<br />
Neurim Pharmaceuticals Ltd. with rights to<br />
about 80% of the European market. Lundbeck<br />
expects to launch Circadin® in the first markets<br />
in Europe in 2008. Insomnia is very common<br />
and is estimated to affect about 27% of<br />
any population.<br />
Ebixa® (memantine)<br />
Ebixa® for the treatment of moderate to<br />
severe Alzheimer’s disease was launched in<br />
2002 and is marketed in cooperation with<br />
Merz Pharmaceuticals GmbH. Memantine is<br />
currently the second-most prescribed pharmaceutical<br />
in the world for the treatment of<br />
Alzheimer’s disease. According to WHO, there<br />
are 38 million cases of Alzheimer’s disease and<br />
other dementia disorders worldwide at any<br />
given time.<br />
Serdolect® (sertindole)<br />
Serdolect® for the treatment of schizophrenia<br />
has been on the market since the beginning of<br />
2006. Serdolect® was launched in 28 countries<br />
within the first two years. According to WHO,<br />
there are 25 million cases of schizophrenia<br />
worldwide at any given time.<br />
Lundbeck’s clinical development projects as of 4 March 2008<br />
Development stage Registration Expected<br />
Indication | Compound Mechanism of action Phase I Phase II Phase III application launch<br />
Schizophrenia | Serdolect® USA Dopamine/serotonin 2008 2009<br />
Schizophrenia | Bifeprunox Dopamine/serotonin 2010+<br />
Stroke | Desmoteplase Plasminogen activator 2010+<br />
Alcohol dependence | Nalmefene Specific opioid receptor antagonist 2010+<br />
Depression | Lu AA21004 Serotonin modulator & stimulator 2010 2010+<br />
Psychosis | Lu 31-130 Monoaminergic 2010+<br />
Depression | Lu AA24530 Multiple target 2010+<br />
Depression | Lu AA34893 Multiple target 2010+<br />
Psychosis/bipolar disorder | Lu AA39959 Ion channel modulator 2010+<br />
Stroke/neuronal damage | Lu AA24493 Tissue protecting cytokine 2010+<br />
Neurological diseases | Lu AA47070 Adenosine receptor antagonist 2010+<br />
Mood and anxiety disorders | Lu AA37096 Multiple target 2010+<br />
2
Lundbeck worldwide<br />
Parent company<br />
Denmark<br />
Production<br />
Denmark<br />
Italy<br />
United Kingdom<br />
Research<br />
Denmark<br />
USA<br />
Sales<br />
Europe<br />
Austria<br />
Belgium<br />
Bulgaria<br />
Croatia<br />
Czech Republic<br />
Denmark<br />
Estonia<br />
Finland<br />
France<br />
Germany<br />
Greece<br />
Hungary<br />
Netherlands<br />
Iceland<br />
Ireland<br />
Italy<br />
Latvia<br />
Lithuania<br />
Norway<br />
Poland<br />
Portugal<br />
Romania<br />
Serbia & Montenegro<br />
Slovakia<br />
Slovenia<br />
Spain<br />
Sweden<br />
Switzerland<br />
United Kingdom<br />
International Markets<br />
Argentina<br />
Australia<br />
Belarus<br />
Brazil<br />
Canada<br />
Chile<br />
China<br />
Egypt<br />
Hong Kong<br />
India<br />
Israel<br />
Japan<br />
Malaysia<br />
Mexico<br />
Pakistan<br />
Philippines<br />
Russia<br />
Saudi Arabia<br />
Singapore<br />
South Africa<br />
South Korea<br />
Turkey<br />
Ukraine<br />
United Arab Emirates<br />
Venezuela<br />
USA<br />
Foundations & institutes<br />
Lundbeck International Neuroscience Foundation<br />
Lundbeck Institute<br />
Countries are listed under Europe, International<br />
Markets and USA in accordance with Lundbeck’s<br />
market regions.<br />
3
Contents<br />
5<br />
6<br />
12<br />
16<br />
24<br />
26<br />
27<br />
32<br />
36<br />
40<br />
46<br />
51<br />
54<br />
59<br />
Financial highlights 2003-<strong>2007</strong><br />
Business review<br />
Marketed pharmaceuticals<br />
Progress in the regions<br />
Strategic focus<br />
Strategic initiatives<br />
Growth through innovation<br />
Corporate governance<br />
Risk management<br />
The Lundbeck share<br />
Focused efforts: Environment, health and safety<br />
The right skills for the new decade<br />
Research and knowledge sharing<br />
Financial statements <strong>2007</strong><br />
Information about disease areas<br />
10<br />
22<br />
30<br />
34<br />
38<br />
44<br />
56<br />
Alzheimer’s disease<br />
Depression and mood disorders<br />
Alcohol dependence<br />
Parkinson’s disease<br />
Primary insomnia<br />
Schizophrenia and psychotic disorders<br />
Acute ischaemic stroke<br />
4
Financial highlights<br />
2003-<strong>2007</strong><br />
Revenue DKK 10,985 million<br />
Research and development DKK 2,187 million<br />
Profit from operations DKK 2,695 million<br />
Net profit for the year DKK 1,770 million<br />
Group financial highlights 2003-<strong>2007</strong><br />
2003 2004 2005 2006 <strong>2007</strong> <strong>2007</strong><br />
DKKm DKKm DKKm DKKm DKKm EURm 1<br />
Revenue 9,941 9,733 9,070 9,221 10,985 1,474<br />
Research and development costs 1,931 1,776 1,782 1,958 2,187 294<br />
Profit from operations 2,147 2,554 2,170 1,784 2,695 362<br />
Net financials (76) 16 108 (64) (50) (7)<br />
Net profit for the year 1,384 1,689 1,574 1,107 1,770 238<br />
Total assets 11,070 11,509 11,628 11,631 12,326 1,653<br />
Equity 6,901 7,839 7,492 6,765 7,185 964<br />
Cash flows from operating and investing activities 2 84 884 1,587 1,633 1,610 216<br />
Property, plant and equipment investments, gross 962 305 447 567 474 64<br />
% % % % % %<br />
EBIT margin 21.6 26.2 23.9 19.3 24.5 24.5<br />
Return on capital employed 37.3 37.0 32.0 25.2 34.9 34.9<br />
Return on equity 21.9 23.2 20.7 15.6 25.3 25.3<br />
Research and development costs as a percentage of revenue 19.4 18.2 19.6 21.2 19.9 19.9<br />
Solvency ratio 62.3 68.1 64.4 58.2 58.3 58.3<br />
Capital turnover 89.8 84.6 78.0 79.3 89.1 89.1<br />
DKK DKK DKK DKK DKK EUR 1<br />
Earnings per share (EPS) 3, 4 5.98 7.42 7.04 5.24 8.63 1.16<br />
Diluted earnings per share (DEPS) 3, 4 5.98 7.42 7.02 5.23 8.63 1.16<br />
Proposed dividend per share 3 1.77 2.21 2.10 1.57 2.56 0.34<br />
Cash flow per share 3 8.19 11.62 9.20 6.59 13.18 1.77<br />
Net asset value per share 3 29.71 34.21 33.99 32.40 35.81 4.80<br />
Market capitalisation (million) 23,098 28,517 29,630 33,060 28,605 3,836<br />
2003 2004 2005 2006 <strong>2007</strong><br />
Average number of employees 5,223 5,155 5,022 5,111 5,134<br />
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<br />
31 December <strong>2007</strong> (745.66).<br />
2) Comparative figures have been restated so that securities are included in cash flows from investing activities.<br />
3) The calculation is based on a share denomination of DKK 5.<br />
4) Calculated according to IAS 33 Earnings per share.<br />
Comparative figures involving number of shares have been adjusted by an adjustment factor of 0.9988 for the effect of employees exercising warrants.<br />
5
Business<br />
review<br />
Lundbeck achieved its best ever results and also achieved its target of an EBIT margin<br />
of 25% in <strong>2007</strong>. The Group recorded considerable growth for its new pharmaceuticals<br />
and the current development pipeline is the largest and broadest in the history of the<br />
Lundbeck Group.<br />
I<br />
n <strong>2007</strong>, the Group continued to record<br />
sales growth for its new pharmaceuticals,<br />
leading to the highest revenue ever<br />
recorded; just under DKK 11 billion.<br />
The Group’s financial performance in <strong>2007</strong> was<br />
affected by three non-recurring items. In <strong>2007</strong>,<br />
Lundbeck received two non-recurring payments<br />
from Takeda Pharmaceutical Company<br />
Limited totalling DKK 420 million, which had a<br />
favourable impact on consolidated revenue.<br />
The development of an optimised production<br />
process for one of Lundbeck’s pharmaceuticals<br />
has enabled the Group to consolidate its inhouse<br />
production of active pharmaceutical ingredients<br />
at two factories instead of the three<br />
facilities used today. As a result, Lundbeck is considering<br />
whether the Seal Sands manufacturing<br />
unit in the UK can continue to be a part of the<br />
Group’s production of pharmaceuticals in the<br />
long run. Lundbeck is investigating the opportunities<br />
for divesting the facility in an attempt to<br />
maintain production at the Seal Sands site. If<br />
these attempts are not successful, a closedown<br />
of the facility may become a reality during 2008.<br />
The reduced need for production capacity for<br />
the total Group has led to a DKK 381 million<br />
write-down of the value of the Seal Sands facility<br />
in <strong>2007</strong>, adversely impacting the Group’s<br />
production costs. In the coming years, Lundbeck<br />
expects annual production cost savings of<br />
approximately DKK 70 million by the production<br />
consolidation, but for 2008 production<br />
costs will not be impacted.<br />
Overall, non-recurring items had a DKK 39<br />
million favourable impact on profit from operations<br />
for <strong>2007</strong>.<br />
6<br />
Revenue<br />
Revenue amounted to DKK 10,985 million<br />
in <strong>2007</strong>, equivalent to an increase of 19%.<br />
Measured at constant exchange rates, revenue<br />
was up 21%. Exclusive of two non-recurring<br />
payments from Takeda totalling DKK 420<br />
million, the Group generated revenue of DKK<br />
10,565 million, an increase of 17% on 2006.<br />
Sales of the Group’s new pharmaceuticals –<br />
Cipralex®/Lexapro®, Ebixa®, Azilect® and Serdolect®<br />
– were DKK 8,544 million in <strong>2007</strong>, up<br />
DKK 1,671 million, or 24%, on 2006. Revenue<br />
derived from the Group’s new pharmaceuticals<br />
accounted for 78% of total consolidated revenue<br />
in <strong>2007</strong> compared to 75% in 2006. Revenue<br />
from the Group’s mature pharmaceuticals<br />
only decreased by DKK 223 million in <strong>2007</strong>.<br />
Profit from operations<br />
Profit from operations amounted to DKK 2,695<br />
million. Exclusive of non-recurring items, profit<br />
from operations amounted to DKK 2,657 million,<br />
63% higher than in 2006. With this financial<br />
performance, the Group met the financial<br />
forecasts for profit from operations set out in<br />
connection with the presentation of the annual<br />
report for 2006, and which were later revised<br />
in connection with the presentation of<br />
the Group’s interim report for the third quarter<br />
of <strong>2007</strong>. The consolidated EBIT margin in <strong>2007</strong><br />
was 25.1% exclusive of non-recurring items, in<br />
line with the Group’s guidance which was initially<br />
announced in connection with the presentation<br />
of the annual report for 2004.<br />
The Group’s investments totalled DKK 739<br />
million in <strong>2007</strong> inclusive of the payment for<br />
in-licensing of Circadin® for the treatment of<br />
primary insomnia.<br />
<strong>2007</strong> Forecasts, DKK Realised*, DKK<br />
Profit from operations* More than 2.6bn 2,657m<br />
EBIT margin* 25% 25.1%<br />
Investments Approx. 650m 739m<br />
* Exclusive of non-recurring items.<br />
Expenses<br />
Lundbeck’s total expenses, exclusive of net financials<br />
and tax, were DKK 8,290 million in<br />
<strong>2007</strong>, or 11% more than in 2006. Excluding<br />
the write-down on the Group’s production assets,<br />
costs totalled DKK 7,909 million, corresponding<br />
to an increase of 6% on 2006.<br />
Lundbeck maintains a high level of research<br />
and development activities, and expenses<br />
amounted to DKK 2,187 million in <strong>2007</strong>, an increase<br />
of 12% on the previous year and representing<br />
21% of revenue (exclusive of non-recurring<br />
items). Production costs amounted to<br />
DKK 2,198 million in <strong>2007</strong>. Exclusive of nonrecurring<br />
items, production costs totalled DKK<br />
1,817 million, corresponding to 17% of revenue<br />
and an increase of 10% compared to 2006.<br />
Costs incurred for sales and distribution decreased<br />
by 0.4% to DKK 2,409 million, whilst<br />
administrative expenses were up by 7% to DKK<br />
1,514 million.<br />
Net profit for the year<br />
The tax charge for <strong>2007</strong> was DKK 792 million,<br />
compared with DKK 526 million in 2006. The<br />
effective tax rate was 30.9% in <strong>2007</strong> as compared<br />
with 32.2% in 2006.<br />
Lundbeck’s future basic tax rate is expected to<br />
be reduced to 30% as a consequence of the<br />
new tax reform passed by the Danish parliament<br />
in July <strong>2007</strong>. A result of the reform is<br />
that the Danish corporate tax rate has been<br />
reduced from 28% to 25%.
<strong>2007</strong>: DKK 10,985 million<br />
Revenue 2006: DKK 9,221 million<br />
Net profit for the year amounted to DKK<br />
1,770 million, corresponding to an increase of<br />
60% relative to 2006.<br />
In <strong>2007</strong>, the Lundbeck Group bought back own<br />
shares amounting to DKK 1.2 billion.<br />
It is proposed to the Annual General Meeting<br />
that a dividend of 30% of net profit for the<br />
year be paid, corresponding to DKK 2.56 per<br />
share.<br />
Growth in all regions<br />
During <strong>2007</strong>, Lundbeck’s new pharmaceuticals<br />
continued to record positive growth rates in<br />
the Group’s three market regions: Europe, USA<br />
and International Markets. The Group generated<br />
the highest revenue in Europe, DKK 5,501<br />
million, which was 7% more than in 2006. International<br />
Markets achieved growth of 22%<br />
on the year before, generating revenue of DKK<br />
2,194 million. After shipments to Forest<br />
Laboratories, Inc. had been normalised in <strong>2007</strong>,<br />
income from sales in the US market amounted<br />
to DKK 2,599 million, which was an increase of<br />
35% relative to 2006.<br />
Cipralex®/Lexapro® is the Group’s best-selling<br />
pharmaceutical in terms of revenue and is the<br />
most frequently prescribed branded pharmaceutical<br />
for the treatment of depression in Europe<br />
and the USA. At the end of <strong>2007</strong>, Cipralex®<br />
had a share of 15.2% of the European<br />
market for antidepressants. Cipralex® revenue<br />
in Europe amounted to DKK 2,827 million in<br />
<strong>2007</strong>, an increase of 10% on last year. Lundbeck’s<br />
income from Lexapro® sales in the USA<br />
amounted to DKK 2,594 million, corresponding<br />
to an increase of 35% relative to 2006. At the<br />
end of <strong>2007</strong>, Lexapro® held 22.7% of the US<br />
market for antidepressants.<br />
In the third quarter of <strong>2007</strong>, Cipralex®/Lexapro®<br />
had a market share of 9.4% in International<br />
Markets. Revenue from Cipralex®/Lexapro®<br />
in International Markets amounted to<br />
DKK 1,267 million, corresponding to an increase<br />
of 34%.<br />
In January <strong>2007</strong>, Cipralex® consolidated its<br />
market position in Europe when the product<br />
was approved for the treatment of obsessivecompulsive<br />
disorder (OCD). In the EU,<br />
Cipralex® is approved for the treatment of<br />
depression, generalised anxiety disorder, panic<br />
disorder, social anxiety disorder and OCD.<br />
Furthermore, in June <strong>2007</strong> Lundbeck once<br />
again announced the results of clinical studies<br />
which demonstrate that Cipralex® is superior<br />
to Cymbalta® (duloxetine) in the treatment of<br />
major depressive disorder. Also, in November<br />
<strong>2007</strong> Lundbeck and its business partner Forest<br />
in the USA announced positive results of a<br />
phase III trial with Lexapro® in adolescents<br />
with major depressive disorder.<br />
Ebixa®, Lundbeck’s second-largest pharmaceutical,<br />
held 16,0% of the European market for<br />
pharmaceuticals to treat Alzheimer’s disease<br />
at the end of <strong>2007</strong>. Sales of Ebixa® in Europe<br />
were up 20% in <strong>2007</strong> to DKK 1,359 million. In<br />
the International Markets region, Ebixa® had a<br />
market share of 10.9% in the third quarter of<br />
<strong>2007</strong> and revenue of DKK 295 million in <strong>2007</strong>,<br />
an increase of 29% on the year before.<br />
Memantine, the active ingredient in Ebixa®, is<br />
currently the second-most prescribed pharmaceutical<br />
in Europe and International Markets<br />
for treating Alzheimer’s disease.<br />
Azilect® has now been launched in 23 countries<br />
across Europe. Marketing of the pharmaceutical<br />
is progressing well, exceeding management’s<br />
expectations for the product prior<br />
to the launch. At the end of <strong>2007</strong>, Azilect®<br />
held 4.6% of the European market for pharmaceuticals<br />
to treat Parkinson’s disease. Azilect®<br />
revenue in Europe amounted to DKK 156 million<br />
in <strong>2007</strong>, an increase of 122% on 2006.<br />
Azilect® has been launched in only one market<br />
in the International Markets region, and revenue<br />
is therefore at a relatively low level.<br />
The launch of Serdolect® for the treatment of<br />
schizophrenia fell short of management’s expectations<br />
for the pharmaceutical. Sales<br />
amounted to DKK 34 million in <strong>2007</strong>, or DKK<br />
25 million higher than in 2006. At the end of<br />
<strong>2007</strong>, Serdolect® had been launched in 28<br />
markets.<br />
Partnerships<br />
A large part of Lundbeck’s business operations<br />
are rooted in the establishment of partnership<br />
agreements, and <strong>2007</strong> was no exception.<br />
In September <strong>2007</strong>, Lundbeck entered into a<br />
strategic alliance with Japan-based Takeda for<br />
the exclusive co-development and co-commercialisation<br />
in the USA and Japan of several<br />
compounds in Lundbeck’s pipeline for the<br />
treatment of mood and anxiety disorders. The<br />
partnership will initially focus on co-development<br />
and co-commercialisation of the two<br />
most advanced compounds in Lundbeck’s<br />
pipeline for the treatment of mood and anxiety<br />
disorders, Lu AA21004 in clinical phase III and<br />
Lu AA24530 in clinical phase II, with the possibility<br />
of, under certain conditions, including<br />
two other compounds of the same class which<br />
are in clinical phase II and clinical phase I, respectively.<br />
Assuming approvals, the companies<br />
plan to co-promote the compounds in the<br />
USA and Japan. The collaboration is important<br />
for Lundbeck in connection with resource allocation<br />
for the development of other pharmaceutical<br />
candidates, and at the same time it<br />
solves the Group’s strategic challenge related<br />
to setting up its own commercial presence in<br />
the USA and Japan. Management currently expects<br />
that the Group will have set up its own<br />
commercial presence in the USA around the<br />
turn of the next decade.<br />
In September <strong>2007</strong>, Lundbeck in-licensed the<br />
approved drug Circadin® for the treatment of<br />
primary insomnia from the Israeli company<br />
Neurim Pharmaceuticals Ltd. with exclusive<br />
rights for the majority of markets in Europe,<br />
including the five major markets (France, Germany,<br />
Italy, Spain, United Kingdom). Lundbeck<br />
expects to launch Circadin® in the first markets<br />
in 2008.<br />
A broader development portfolio<br />
The year <strong>2007</strong> involved many changes to<br />
Lundbeck’s development portfolio. At the beginning<br />
of <strong>2007</strong>, Lundbeck and partner Merck<br />
& Co., Inc. decided to discontinue the further<br />
development of gaboxadol for the treatment<br />
of sleep disorders. Data from the pivotal clinical<br />
trial suggested that the overall clinical profile<br />
for gaboxadol in insomnia did not support<br />
further development.<br />
However, Lundbeck’s development portfolio<br />
has subsequently progressed successfully, and<br />
in <strong>2007</strong> the Group’s research and development<br />
efforts enabled Lundbeck to advance three<br />
pharmaceutical candidates into clinical phase<br />
7
Revenue growth:<br />
+17% +22% +136% +250%<br />
I, two pharmaceutical candidates into clinical<br />
phase II and one candidate (Lu AA21004) into<br />
clinical phase III.<br />
In October <strong>2007</strong>, Lundbeck announced that Lu<br />
AA21004 showed highly significant results in a<br />
phase II clinical trial on the primary efficacy<br />
endpoints with both 5 and 10 mg compared to<br />
placebo and that the compound also had an<br />
attractive safety profile.<br />
In December <strong>2007</strong>, the Group further consolidated<br />
its development portfolio by expanding<br />
its agreement with partner PAION AG concerning<br />
desmoteplase for the treatment of<br />
acute ischaemic stroke. The agreement came<br />
into effect in January 2008 after a satisfactory<br />
due diligence. Under the terms of the new<br />
agreement Lundbeck has obtained global exclusive<br />
rights to desmoteplase with full control<br />
of development and commercialisation of the<br />
pharmaceutical. The new agreement is based<br />
on a new analysis of the non-significant results<br />
announced by PAION and Forest in the spring<br />
of <strong>2007</strong>. The analysis has shown that a large<br />
proportion of the patients enrolled in the trial<br />
contrary to expectations did not to a sufficient<br />
degree have a blood clot, and this may explain<br />
why desmoteplase, which is a clot-dissolving<br />
agent, failed to demonstrate positive results<br />
compared to placebo.<br />
Lundbeck has thus consolidated its clinical<br />
foundation, and by the end of <strong>2007</strong>, Lundbeck<br />
had the largest and broadest pipeline of pharmaceutical<br />
candidates in the history of the<br />
Group.<br />
Protection of patents and other<br />
intellectual property rights<br />
USA<br />
On 5 September <strong>2007</strong>, Lundbeck and Forest<br />
announced that the U.S. Court of Appeals for<br />
the Federal Circuit had affirmed a 13 July 2006<br />
decision by the U.S. District Court for the District<br />
of Delaware, which determined that the<br />
U.S. patent covering escitalopram is valid. The<br />
decision upholds the injunction preventing<br />
IVAX Corporation/Teva Pharmaceutical Industries<br />
Ltd.’s proposed launch of generic escitalopram<br />
in the USA. This confirms Lundbeck’s and<br />
Forest’s US patent rights concerning Lexapro®,<br />
which expire in March 2012.<br />
Lundbeck believes that IVAX/Teva does not<br />
have any further appeal options and finds that<br />
the ruling in this case is final, thereby closing<br />
the case against IVAX/Teva.<br />
United Kingdom<br />
At the beginning of May <strong>2007</strong>, a UK court<br />
ruled that escitalopram is innovative and new,<br />
and that it was not obvious that separating<br />
r-citalopram and s-citalopram, which citalopram<br />
consists of, would lead to the benefits<br />
offered by escitalopram. However, the court<br />
found in favour of the generic plaintiffs that<br />
the patent underlying escitalopram should not<br />
be valid with reference to specific English case<br />
law. Lundbeck has appealed the ruling.<br />
Germany<br />
On 24 August <strong>2007</strong>, a German court returned<br />
a first-instance decision, which ruled against<br />
Lundbeck in respect of escitalopram. The case<br />
has been appealed, and Lundbeck does not expect<br />
a decision by the appeals court within the<br />
next couple of years.<br />
Efforts in Europe to protect intellectual property<br />
rights and patents have gradually been<br />
improved in recent years. As a result of these<br />
efforts, there are now more uniform guidelines<br />
for the issuance of exclusivity periods in the<br />
European countries, and the rules for issuing<br />
patents have also been harmonised. When<br />
Lundbeck took out a patent for Cipralex®, the<br />
rules were not harmonised to the same extent,<br />
and for this reason the patent situation for the<br />
primary patent for Cipralex® is different than it<br />
would have been under the present rules. In<br />
most countries, Cipralex® is protected by a primary<br />
patent until 2014, while in other countries<br />
protection is based on patents for the<br />
Cipralex® manufacturing process. At the end of<br />
<strong>2007</strong>, this applies to a number of European<br />
countries, where Cipralex® either has no protection<br />
or where Cipralex® is protected exclusively<br />
by process patents.<br />
Towards the end of October <strong>2007</strong>, the German<br />
health authorities approved a generic version<br />
of escitalopram. Lundbeck finds that this goes<br />
against the applicable rules and practices, and<br />
at Lundbeck’s request, the approval has been<br />
suspended in Germany while the case is being<br />
assessed. A number of countries have followed<br />
the approval in Germany, which acts as reference<br />
country in this context. In most of the<br />
countries, however, the marketing approvals<br />
have no practical implications as Cipralex® is<br />
protected by a composition-of-matter patent.<br />
A prerequisite for Lundbeck’s continued substantial<br />
investments in innovative pharmaceuticals<br />
is that intellectual property rights are respected.<br />
Lundbeck believes that the Group’s intellectual<br />
property rights are valid and enforceable, and<br />
it is Lundbeck’s policy to defend its intellectual<br />
property rights energetically, wherever they<br />
may be violated.<br />
Lundbeck is involved in pending patent trials in<br />
the USA, the UK, Australia, Canada, France and<br />
Germany.<br />
Events reported after the end<br />
of the financial year<br />
On 3 January 2008, Lundbeck announced that<br />
the Group had decided to initiate phase I clinical<br />
trials with Lu AA37096 to investigate<br />
safety, tolerability and the pharmacokinetic<br />
profile of the compound in humans. At the<br />
same time, Lundbeck decided to discontinue<br />
the phase I clinical development of Lu<br />
AA44608 for the potential treatment of mood<br />
disorders.<br />
On 18 February 2008, Lundbeck announced<br />
that clinical phase II trials had been initiated to<br />
investigate Lu AA34893 for the treatment of<br />
bipolar disorder.<br />
Outlook for 2008<br />
During the past six years, Lundbeck has marketed<br />
four pharmaceuticals which have contributed<br />
strong growth rates to the Group’s<br />
consolidated revenue since they were<br />
launched. The Group expects that all of its new<br />
pharmaceuticals will continue to grow and<br />
contribute positively to consolidated revenue<br />
in 2008 despite the fact that Lundbeck anticipates<br />
continuing price pressure from the European<br />
health authorities and pressure from generic<br />
competition for Cipralex® in specific<br />
markets in Europe.<br />
Lundbeck expects to launch Circadin® for the<br />
treatment of primary insomnia in the first<br />
markets in 2008 and that this pharmaceutical<br />
will have a minor favourable impact on consolidated<br />
revenue.<br />
8
Being a research-based company, Lundbeck<br />
believes that it is important to be able to expand<br />
and strengthen its pipeline of pharmaceutical<br />
development candidates to complement<br />
its existing business. During 2008,<br />
Lundbeck expects to advance more pharmaceutical<br />
candidates into clinical trials or to the<br />
next clinical development stage. Moreover,<br />
Lundbeck expects to initiate pivotal clinical trials<br />
for a number of the Group’s late-stage<br />
projects. These projects include desmoteplase<br />
for the treatment of acute ischaemic stroke<br />
and nalmefene for the treatment of alcohol<br />
dependence.<br />
Financial forecasts for 2008<br />
Lundbeck management looks forward to continuing<br />
growth in consolidated revenue and<br />
earnings in 2008. Lundbeck expects revenue<br />
for 2008 to amount to DKK 11-11.5 billion<br />
and that profit from operations (EBIT) will be<br />
DKK 2.8-2.9 billion in 2008, which will sustain<br />
the Group’s EBIT margin at approximately<br />
25%, while Lundbeck expects to spend more<br />
than 20% of revenue on research and development.<br />
Investments in 2008 are expected to<br />
amount to approximately DKK 500 million<br />
(exclusive of financial investments).<br />
Lundbeck’s financial forecast for 2008 is based<br />
on the exchange rates that Lundbeck regularly<br />
hedges pursuant to its hedging policy. The<br />
most important currency in respect of Lundbeck’s<br />
financial results is the US dollar (USD),<br />
which is hedged at an average exchange rate<br />
of 5.31 DKK/USD for 2008.<br />
2008 forecast<br />
Revenue<br />
Profit from operations (EBIT)<br />
Investments<br />
DKK 11-11.5bn<br />
DKK 2.8-2.9bn<br />
Approx. DKK 500 million<br />
Share buyback programme<br />
Lundbeck has continued the ongoing share<br />
buyback programme, under which Lundbeck<br />
intends to buy back shares of up to DKK 6 billion.<br />
At the end of <strong>2007</strong>, Lundbeck had bought<br />
back shares worth DKK 3.5 billion, corresponding<br />
to 59% of the complete programme. The<br />
share buyback programme is expected to be<br />
completed by the end of 2008.<br />
As previously announced, Lundbeck maintains<br />
that the share buyback programme may be<br />
terminated at any time as a consequence of<br />
changes to the company’s financial position or<br />
changes in the market, including acquisitions<br />
or in-licensing opportunities.<br />
Dividend policy<br />
Since 2003, Lundbeck has paid dividends of<br />
about 30% of the net profit for the year, and it<br />
is still the intention to pay out dividends of<br />
between 25% and 35% in the future.<br />
Reservations<br />
Forward-looking statements are subject to<br />
risks, uncertainties and inaccurate assumptions.<br />
This may cause actual results to differ<br />
materially from expectations. Factors that may<br />
affect future results include interest rate and<br />
exchange rate fluctuations, delay or failure of<br />
development projects, production problems,<br />
unexpected contract breaches or terminations,<br />
government-mandated or market-driven price<br />
decreases for Lundbeck’s products, introduction<br />
of competing products, Lundbeck’s ability<br />
to successfully market both new and existing<br />
products, exposure to product liability and<br />
other lawsuits, changes in reimbursement rules<br />
and governmental laws and related interpretation<br />
thereof and unexpected growth in costs<br />
and expenses.<br />
In accordance with section 107a of the Danish<br />
Financial Statements Act, listed companies<br />
must consider whether or not they will disclose<br />
any consequences for substantial agreements<br />
if the control of the company changes.<br />
Lundbeck does not wish to disclose this information<br />
for competitive reasons.<br />
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9
Neurobiology scientist Lone Helboe is looking at the image of<br />
brain structures in an X-ray film, which can help her to locate<br />
and analyse the areas of the brain in which compounds such<br />
as memantine (the active ingredient in Ebixa®) are bound and<br />
may affect brain function.
Alzheimer’s<br />
disease<br />
A<br />
lzheimer’s disease is the most common<br />
form of dementia. Alzheimer’s<br />
disease involves a progressive deterioration<br />
of human mental faculties. The disease<br />
affects a person’s memory, language and logical<br />
thinking, and it also has an impact on the<br />
ability to perform everyday activities and<br />
changes patient behaviour.<br />
The disease usually sets in after the age of 60.<br />
Certain nerve cells die, causing a gradual reduction<br />
of the function in the affected areas of<br />
the brain.<br />
Alzheimer’s disease is divided into three stages:<br />
mild, moderate and severe. In the late stages<br />
of the disease, sufferers will no longer be able<br />
to live an independent life and will require<br />
nursing care, either at home, in a sheltered<br />
home or a nursing home.<br />
As the disease progresses, various symptoms<br />
appear. In the mild stages, the symptoms related<br />
to memory are most noticeable. In the<br />
late stages, the patient will also have functional<br />
and behavioural symptoms.<br />
According to WHO, there are 38 million cases<br />
of Alzheimer’s disease and other dementia disorders<br />
worldwide at any given time.<br />
Lundbeck markets Ebixa® (memantine) for the<br />
treatment of moderate to severe Alzheimer’s<br />
disease in cooperation with Merz Pharmaceuticals<br />
GmbH.<br />
11
Marketed<br />
pharmaceuticals<br />
Lundbeck markets 14 pharmaceuticals worldwide for the treatment of diseases of<br />
the central nervous system (CNS). Most of Lundbeck’s pharmaceuticals are for the<br />
treatment of psychiatric disorders, but during the past few years the Group has also<br />
marketed pharmaceuticals for the treatment of neurological disorders.<br />
S<br />
ince 2002, Lundbeck has marketed<br />
four new pharmaceuticals – Cipralex®/<br />
Lexapro® for the treatment of depression<br />
and anxiety, Ebixa® for the treatment of<br />
Alzheimer’s disease, Azilect® for the treatment<br />
of Parkinson’s disease and Serdolect® for the<br />
treatment of schizophrenia. Most of the revenue<br />
derived from these pharmaceuticals is as a<br />
minimum protected by intellectual property<br />
rights some years into the next decade.<br />
In terms of revenue, Cipralex®/Lexapro® is<br />
Lundbeck’s largest pharmaceutical, followed by<br />
Ebixa®. Both pharmaceuticals were launched<br />
in the first markets in 2002. Since being<br />
launched in 2005, Azilect® has exceeded management’s<br />
sales expectations, while Serdolect®,<br />
launched in 2006, has fallen short of<br />
expectations. Lundbeck expects to launch its<br />
new pharmaceutical Circadin® for the treatment<br />
of primary insomnia in the first markets<br />
in 2008.<br />
Lundbeck’s mature pharmaceuticals represent<br />
a stable foundation for consolidated revenue,<br />
with the exception of citalopram, the revenue<br />
of which continued to decline in <strong>2007</strong> due to<br />
generic competition. Lundbeck expects that<br />
citalopram revenue will continue to decline in<br />
2008, albeit at a slower pace than previously.<br />
Cipralex®/Lexapro® (escitalopram)<br />
– depression and anxiety<br />
Cipralex®/Lexapro® is the most frequently<br />
prescribed branded pharmaceutical for the<br />
treatment of depression, both in the USA and<br />
in Europe, and the second most prescribed in<br />
International Markets. This position was retained<br />
in <strong>2007</strong>.<br />
Escitalopram, the active ingredient in Cipralex®/<br />
Lexapro®, is a so-called allosteric serotonin<br />
reuptake inhibitor (ASRI). This means that escitalopram<br />
increases the level of serotonin and<br />
allows the nerve cells to communicate with<br />
each other again, thereby alleviating depression<br />
and anxiety symptoms. This mechanism<br />
of action makes escitalopram a very effective<br />
compound, which also offers an attractive<br />
safety profile.<br />
In addition to depression, Cipralex®/Lexapro®<br />
is approved for the treatment of panic disorder,<br />
generalised anxiety disorder, social anxiety<br />
disorder and obsessive-compulsive disorder<br />
(OCD) in the European Union and for the<br />
treatment of generalised anxiety disorder in<br />
the USA. During the past few years, the<br />
Cipralex® profile has gradually been strengthened<br />
as additional clinical data have been published.<br />
A large number of clinical trials have<br />
demonstrated that Cipralex® is efficacious<br />
both in short-term and long-term treatment of<br />
depression, whilst also offering an attractive<br />
safety profile. Furthermore, a large number of<br />
clinical trials have demonstrated therapeutic<br />
benefits of using Cipralex® in the treatment of<br />
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<br />
<strong>2007</strong> 2006<br />
DKKm DKKm Growth<br />
Total revenue 10,985 9,221 19%<br />
Cipralex® 4,094 3,508 17%<br />
Income from Lexapro® 2,594 1,923 35%<br />
Ebixa® 1,655 1,361 22%<br />
Azilect® 168 71 136%<br />
Serdolect® 34 10 250%<br />
Other pharmaceuticals 1,750 1,973 -11%<br />
Other revenue 690 375 84%<br />
Profit from operations 2,695 1,784 51%<br />
Net profit for the year 1,770 1,107 60%<br />
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12
oth depression and anxiety in comparison<br />
with a number of other antidepressants. For<br />
example, a study released in June <strong>2007</strong><br />
showed that Cipralex® was superior to Cymbalta®<br />
(duloxetine) in the acute treatment of<br />
patients with major depressive disorder and<br />
was at least as efficacious in long-term treatment.<br />
Also, results of a head-to-head study<br />
announced in November <strong>2007</strong> once again<br />
showed that Cipralex® is significantly more<br />
efficacious than Cipramil® (citalopram).<br />
Other important news in <strong>2007</strong> included a<br />
phase III trial announced in November <strong>2007</strong><br />
by Lundbeck and its business partner Forest<br />
Laboratories, Inc., showing positive results for<br />
Lexapro® in adolescents with major depressive<br />
disorder in the USA.<br />
Ebixa® (memantine)<br />
– Alzheimer’s disease<br />
In-licensed from Merz Pharmaceuticals GmbH<br />
in Germany, Ebixa® is marketed in 58 countries<br />
worldwide. Lundbeck markets Ebixa® in<br />
Europe – in certain countries together with its<br />
inventor Merz – and in the rest of the world,<br />
excluding the USA and Japan.<br />
In a number of clinical trials, Ebixa® has shown<br />
to be efficacious and demonstrated an attractive<br />
safety profile in patients with moderate to<br />
severe Alzheimer’s disease. Compared with placebo,<br />
treatment with Ebixa® offers improvements,<br />
stabilisation or less marked worsening<br />
of three important domains: cognition, daily<br />
functioning and behaviour.<br />
Results of head-to-head clinical studies of Cipralex® (escitalopram) and competing<br />
pharmaceuticals in the treatment of depression<br />
Comparator Presented Main outcome<br />
Venlafaxine XR (Effexor®) SCNP, April 2003 Escitalopram was at least as efficacious and was<br />
better tolerated than venlafaxine XR. Patients<br />
treated with escitalopram reached sustained<br />
response and remission significantly faster.<br />
Venlafaxine XR (Effexor®) ECNP, September 2003 Escitalopram was at least as effective and was<br />
better tolerated than venlafaxine XR. Escitalopram<br />
was significantly more efficacious than venlafaxine<br />
XR in treating patients with severe MDD.<br />
Sertraline (Zoloft®) ACNP, December 2003 The starting dose of escitalopram was comparably<br />
efficacious to optimally dosed sertraline.<br />
Citalopram (Celexa®/Cipramil®)<br />
International Clinical Psycho- Escitalopram was significantly more efficacious<br />
pharmacology, April 2005 than citalopram.<br />
Paroxetine (Paxil®) IADC, February 2006 Escitalopram was significantly more efficacious<br />
than paroxetine in 24-week treatment of patients<br />
with severe MDD.<br />
Duloxetine (Cymbalta®) ACNP, December 2006 Escitalopram was better tolerated and at least as<br />
efficacious as duloxetine in the treatment of MDD.<br />
Duloxetine (Cymbalta®)<br />
Company release, June <strong>2007</strong> Cipralex® (escitalopram) was superior to Cymbalta®<br />
(duloxetine) in the acute treatment of patients with<br />
MDD and was at least as efficacious in long-term<br />
treatment.<br />
Citalopram (Celexa®/Cipramil®) Clinical Therapeutics, Escitalopram was significantly more efficacious<br />
Volume 29, Number 11, than citalopram. The prevalence of adverse effects<br />
<strong>2007</strong> was significantly lower in the escitalopram group.<br />
Results of head-to-head clinical studies of Cipralex® (escitalopram) and competing<br />
pharmaceuticals in the treatment of anxiety<br />
<br />
<br />
<br />
<br />
Comparator Presented Main outcome<br />
Paroxetine (Paxil®) SCNP, April 2003 Escitalopram was significantly superior to paroxetine<br />
after 24 weeks of treatment of SAD and showed<br />
fewer discontinuation effects.<br />
Paroxetine (Paxil®) ACNP, December 2003 Escitalopram was as efficacious as paroxetine in the<br />
long-term treatment of GAD and was better<br />
tolerated.<br />
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<br />
Paroxetine (Paxil®) ECNP, October 2004 Escitalopram was superior to paroxetine in the<br />
change from baseline to week 12 in the treatment<br />
of GAD and showed fewer discontinuation<br />
effects.<br />
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MDD = Major depressive disorder<br />
SAD = Social anxiety disorder<br />
GAD = Generalised anxiety disorder<br />
13
Concurrently with its in-house development activities, Lundbeck dedicates an increasing amount<br />
of resources to in-licensing pharmaceuticals developed by other pharmaceutical companies. In<br />
<strong>2007</strong>, Lundbeck in-licensed Circadin® for the treatment of primary insomnia. Insomnia is very<br />
common, and it is estimated that about 27% of a population suffers from insomnia.<br />
Read the article The sleep command centre<br />
in the Lundbeck Magazine 2008<br />
Azilect® (rasagiline)<br />
– Parkinson’s disease<br />
Azilect® has been in-licensed from Teva Pharmaceutical<br />
Industries Ltd., and is used both as<br />
monotherapy and in combination treatments<br />
of Parkinson’s disease.<br />
Azilect® is a potent and selective monoamine<br />
oxidase type B inhibitor that blocks the breakdown<br />
of dopamine, a neurotransmitter used by<br />
the brain to regulate movement. In addition to<br />
being effective, Azilect® is well-tolerated by<br />
patients and has only few adverse effects. Unlike<br />
competing pharmaceuticals which the patient<br />
must administer in multiple doses during<br />
the course of one day, the dosage of Azilect® is<br />
simple with a single tablet once a day.<br />
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Serdolect® (sertindole)<br />
– schizophrenia<br />
Serdolect® is an effective antipsychotic for the<br />
treatment of schizophrenia without sedative<br />
effect and with placebo-level extrapyramidal<br />
symptoms (i.e. motor side effects such as slow<br />
movements and tremors).<br />
Serdolect’s clinical and pharmacological profile<br />
indicates that the pharmaceutical may increase<br />
the likelihood of patients remaining in<br />
therapy, which will increase the quality of life<br />
for patients and relatives alike.<br />
Serdolect® is a result of Lundbeck’s in-house<br />
research, and Lundbeck holds the global rights.<br />
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Circadin® (melatonin)<br />
– primary insomnia<br />
In September <strong>2007</strong>, Lundbeck in-licensed the<br />
exclusive rights to Circadin® for the treatment<br />
of primary insomnia in a number of markets in<br />
Europe, including the five major markets. Furthermore,<br />
Lundbeck holds the exclusive option<br />
to evaluate commercialisation of the drug in<br />
markets outside Europe.<br />
Circadin® was approved by the European<br />
Medicines Agency (EMEA) on 29 June <strong>2007</strong><br />
indicated as monotherapy for the short-term<br />
treatment of primary insomnia in patients<br />
aged 55 or over. The approval was based on<br />
clinical studies showing positive effects on<br />
sleep quality and daytime functioning as well<br />
as quality of life. The trials also showed that<br />
there are no signs of development of dependency.<br />
Circadin® is the first and only IP-protected,<br />
prolonged-release, melatonin-containing prescription<br />
drug approved in the EU. Melatonin is<br />
a naturally occurring hormone produced by<br />
the pineal glands; and it has a pivotal role in<br />
the regulation of circadian rhythm and sleep.<br />
Endogenous melatonin levels decrease with<br />
age and may contribute to the common complaint<br />
of poor sleep quality seen amongst<br />
those in middle age and in the elderly. Administration<br />
of Circadin®, which essentially mimics<br />
the normal nocturnal melatonin profile, improves<br />
sleep quality and morning alertness in<br />
patients aged 55 or over. Lundbeck expects to<br />
launch Circadin® in the first markets in 2008.<br />
14
Lundbeck’s pharmaceuticals<br />
Mechanism of<br />
First Approved, no.<br />
Compound action Indication Trademark registration of countries<br />
Melatonin Regulation of circadian Primary insomnia Circadin® <strong>2007</strong> 29<br />
rhythm<br />
Escitalopram ASRI Depression, generalised anxiety disorder, Cipralex®, Lexapro®, Sipralexa®, Sipralex® 2001 92<br />
panic disorder, social anxiety disorder, OCD<br />
Citalopram SSRI Depression, panic disorder, OCD Cipramil®, Seropram®, Cipram®, Celexa® 1989 81<br />
Memantine NMDA-antagonist Moderate to severe Alzheimer’s disease Ebixa®, Ebix® 2002 65<br />
Rasagiline MAO-B inhibitor Parkinson’s disease Azilect® 2005 33<br />
Sertindole Atypical antipsychotic Schizophrenia Serdolect®, Serlect® 1996 43<br />
Flupentixol Typical antipsychotic Mild depression Deanxit® 1971 28<br />
+melitracene + TCA<br />
Nortriptylin TCA Depression Noritren®, Nortrilen®, Sensaval® 1963 26<br />
Amitriptylin TCA Depression Saroten®, Sarotex®, Redomex® 1961 31<br />
Zuclopenthixol Typical antipsychotic Schizophrenia and other psychotic disorders, Cisordinol®, Clopixol® 1982 77<br />
anxiety, restlessness, insomnia<br />
Zuclopenthixol Depot antipsychotic Maintenance treatment Cisordinol Depot®, Clopixol Depot®, 1976 77<br />
decanoate of chronic psychotic disorders Ciatyl-Z Depot®<br />
Zuclopenthixol Typical antipsychotic Acute psychotic episodes, Cisordinol-Acutard®, Clopixol-Acutard®, 1986 73<br />
acetate exacerbation of psychotic disorders Clopixol-Acuphase®, Ciatyl-Z-Acuphase®<br />
Flupentixol Typical antipsychotic Schizophrenia and other psychotic disorders, Fluanxol®, Fluanxol Mite®, Depixol® 1965 69<br />
mild depression<br />
Cis(Z)- Depot antipsychotic Maintenance treatment Fluanxol Depot®, Depixol® 1970 73<br />
flupentixoldecanoate<br />
of chronic psychotic disorders<br />
Chlorprothixene Typical antipsychotic Schizophrenia and other psychotic disorders, Truxal®, Truxaletten® 1959 23<br />
anxiety, restlessness, withdrawal<br />
symptoms in drug addicts<br />
15
Progress<br />
in the regions<br />
Lundbeck divides its operations into three market regions: Europe, the USA and<br />
International Markets. All three regions recorded positive growth in <strong>2007</strong>, especially<br />
International Markets, which posted an increase of 22% on the year before.<br />
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Europe<br />
Lundbeck considers Europe its home market,<br />
and Europe is Lundbeck’s largest region. Revenue<br />
from European operations amounted to<br />
DKK 5,501 million in <strong>2007</strong>, an increase of 7%<br />
on 2006. Cipralex® and Ebixa® are still Lundbeck’s<br />
largest pharmaceuticals in Europe in<br />
terms of revenue and continue to make positive<br />
contributions to growth in Europe, posting<br />
growth rates of 10% and 20%, respectively,<br />
relative to 2006.<br />
The markets in Europe are characterised by<br />
constant price pressure from healthcare reforms<br />
in the individual countries, and a price<br />
change in one European market may affect<br />
prices in a number of other markets through a<br />
reference price system. Generic competition is<br />
expected to grow in the years ahead, with a<br />
resulting adverse impact on Cipralex® growth<br />
in Europe.<br />
These factors contribute to restricting the<br />
growth potential in Europe and call for constant<br />
changes in the way Lundbeck organises<br />
its group infrastructure to face and compensate<br />
for the changed market conditions. As a<br />
result, Lundbeck has been compelled to regularly<br />
adjust the number of employees in the<br />
Group’s subsidiaries. Lundbeck has with this<br />
adjustment succeeded in maintaining earnings.<br />
Cipralex® – extended indications<br />
and growth<br />
Cipralex® (escitalopram) represented 51% of<br />
revenue in Europe in <strong>2007</strong>, and Lundbeck recorded<br />
strong growth in Cipralex® sales in Europe<br />
of 10% to DKK 2,827 million.<br />
At the end of December <strong>2007</strong>, Cipralex® represented<br />
15.2% of total antidepressants sales in<br />
Europe, an increase of 19% compared to the<br />
end of December 2006.<br />
Launched in the first European market in 2002,<br />
Cipralex® has achieved a stable and high market<br />
share. In terms of volume, Cipralex® is the<br />
most widely used branded antidepressant in<br />
Europe.<br />
In early <strong>2007</strong>, Cipralex® was approved in the<br />
EU for the treatment of obsessive-compulsive<br />
disorder (OCD). This approval further strengthens<br />
Cipralex’s position as the best treatment<br />
option for depression and anxiety currently<br />
available in the market. In Europe, Cipralex® is<br />
approved for the treatment of depression,<br />
panic disorder, generalised anxiety disorder, social<br />
anxiety disorder and obsessive-compulsive<br />
disorder (OCD).<br />
Ebixa® – second-largest in Europe<br />
Ebixa® (memantine) accounted for 25% of<br />
Lundbeck’s revenue in Europe in <strong>2007</strong>, and revenue<br />
from Ebixa® grew by 20% to DKK 1,359<br />
million.<br />
Ebixa® is approved for the treatment of moderate<br />
to severe Alzheimer’s disease and is the<br />
first pharmaceutical in the world for treating<br />
patients with severe Alzheimer’s disease. This<br />
approval allows for Ebixa® to be used in about<br />
80% of all Alzheimer’s patients.<br />
Memantine, the active ingredient in Ebixa®, is<br />
currently the second-most prescribed pharmaceutical<br />
in Europe for treating Alzheimer’s dis-<br />
16
Europe, revenue, DKKm<br />
Growth in<br />
Growth in<br />
Q4 ’07 Q4 ’06 Growth local currency <strong>2007</strong> 2006 Growth local currency<br />
Cipralex® 720 675 7% 9% 2,827 2,561 10% 11%<br />
Ebixa® 350 311 13% 14% 1,359 1,132 20% 20%<br />
Azilect® 44 27 61% 62% 156 70 122% 122%<br />
Serdolect® 7 3 157% 152% 24 7 247% 244%<br />
Other revenue 275 313 -12% -11% 1,135 1,353 -16% -16%<br />
Total revenue 1,396 1,329 5% 7% 5,501 5,123 7% 8%<br />
ease. At the end of December <strong>2007</strong>, memantine<br />
held 23.3% of the European market for<br />
pharmaceuticals to treat Alzheimer’s disease,<br />
as compared with a share of 19.3% at the<br />
same time in 2006.<br />
Successful launch of Azilect®<br />
In <strong>2007</strong>, Lundbeck generated revenue from<br />
Azilect® (rasagiline) in Europe of DKK 156 million,<br />
which was an increase of 122% relative to<br />
2006. Since 2005, Lundbeck has launched Azilect®<br />
in 23 countries across Europe. The launch<br />
of Azilect® has progressed well and better than<br />
Lundbeck had expected. At the end of December<br />
<strong>2007</strong>, Azilect® held 4.6% in terms of value<br />
of the composite European market for pharmaceuticals<br />
to treat Parkinson’s disease.<br />
Mature pharmaceuticals<br />
Lundbeck’s revenue from mature pharmaceuticals<br />
decreased from DKK 1,353 million in 2006<br />
to DKK 1,135 million in <strong>2007</strong>. The decline was<br />
driven by falling sales of citalopram, which has<br />
been exposed to generic competition since<br />
2002. Revenue from other mature pharmaceuticals<br />
in the Group was stable in <strong>2007</strong>.<br />
Foreign currency exposure<br />
Foreign currency management is handled centrally<br />
by the parent company, and Lundbeck<br />
aims as a minimum to hedge its anticipated<br />
cash flows for any future period of approximately<br />
9-15 months. In <strong>2007</strong>, 81% of Lundbeck’s<br />
sales in Europe were exposed to the<br />
euro (EUR) as compared with 74% in 2006.<br />
The second-highest exposure in Europe in<br />
<strong>2007</strong> was vis-à-vis the British pound (GBP),<br />
at 6%.<br />
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17
Lundbeck is one of the world’s leading companies in the development of antidepressants.<br />
In addition to the development and sale of antidepressants, Lundbeck<br />
has taken a number of other initiatives to help people suffering from depression.<br />
One of these initiatives is an online community on the internet.<br />
Read the article Untreated depression is terrible<br />
in the Lundbeck Magazine 2008<br />
USA<br />
Lundbeck’s income from the Group’s pharmaceuticals<br />
in the USA amounted to DKK 2,599<br />
million in <strong>2007</strong>.<br />
Lundbeck’s pharmaceuticals are presently sold<br />
in the US market through an agreement with<br />
business partner Forest Laboratories, Inc., who<br />
handles the marketing of Lexapro® (escitalopram)<br />
and Lundbeck’s mature pharmaceutical<br />
Celexa® (citalopram) for the treatment of depression.<br />
Since entering into the agreement in<br />
the mid-1990s, Lundbeck and Forest have enjoyed<br />
a good and successful partnership, and<br />
the launches of Celexa® in 1998 and Lexapro®<br />
in 2002 were among the most successful drug<br />
launches in US history measured in terms of<br />
rapidly achieving relatively high market shares<br />
(see notes 1-2 in Financial statements <strong>2007</strong> for<br />
more information about income from Forest).<br />
Lexapro®<br />
Lundbeck’s income from sales of Lexapro® in<br />
the USA was DKK 2,594 million in <strong>2007</strong>, compared<br />
with DKK 1,923 million in 2006, an increase<br />
of 35%. The increase was partly attributable<br />
to a low income level for Lexapro® in<br />
2006 due to the inventory reductions, partly<br />
to rising Lexapro® sales in the US market. At<br />
31 December <strong>2007</strong>, inventories were at a level<br />
corresponding to about eight months of commercial<br />
supply.<br />
At the end of December <strong>2007</strong>, Lexapro® represented<br />
22.7% of total antidepressants sales in<br />
the USA, as compared with a market share of<br />
17.9% at the same time in 2006. Measured by<br />
the total number of prescriptions (TRx), Lexapro®<br />
grew by 2% in <strong>2007</strong>.<br />
Growth forecasts (in terms of value) for the US<br />
market for branded pharmaceuticals to treat<br />
depression have been toned down due to the<br />
launch of inexpensive generic pharmaceuticals.<br />
In terms of volume, Lundbeck projects limited<br />
growth, and a volume decline in the US market<br />
could prove a negative surprise for Lundbeck.<br />
Lundbeck expects to be able to raise the price<br />
of Lexapro®, not least because the product remains<br />
the least expensive branded antidepressant<br />
in the US market.<br />
Foreign currency exposure<br />
Foreign currency management is handled centrally<br />
by the parent company, and Lundbeck<br />
aims to hedge its anticipated cash flows for<br />
any future period of approximately 12 months.<br />
At the same time, Lundbeck’s accounting policies<br />
concerning recognition of income from<br />
Lexapro® stipulate that the hedged part of the<br />
income is recognised in the Group’s balance<br />
sheet together with that part of the income<br />
that corresponds to the difference between the<br />
invoiced price and the minimum price, and<br />
which is not recognised in the consolidated income<br />
statement until the volumes in question<br />
have been sold in the market. At the end of<br />
<strong>2007</strong>, the inventories were at a level corresponding<br />
to about eight months of commercial<br />
supply. In practice, this means that the Group’s<br />
present USD hedging will impact on the consolidated<br />
income statement in about 20<br />
months.<br />
The average forward rate for 2008 will be approximately<br />
5.31 DKK/USD, using the existing<br />
hedging contracts. The corresponding forward<br />
rate for <strong>2007</strong> was approximately 5.75 DKK/<br />
USD.<br />
Establishing future operations<br />
in the USA<br />
Representing 45% of the global market in<br />
2006, the USA is the world’s largest pharmaceutical<br />
market. The USA is an even larger mar-<br />
ket in terms of pharmaceuticals to treat disorders<br />
of the central nervous system (CNS). Thus,<br />
the USA accounted for 56% of the global market<br />
for pharmaceuticals to treat CNS disorders<br />
in 2006.<br />
The large part of the global market held by the<br />
USA is not explained exclusively by the size of<br />
the country’s population. The larger market is<br />
primarily attributable to the fact that prices of<br />
pharmaceuticals generally are higher in the<br />
USA than in other parts of the world, and at<br />
the same time the consumption of pharmaceuticals<br />
here is generally higher. This applies<br />
especially to the latest generation of pharmaceuticals.<br />
Lundbeck is currently established in the USA<br />
with 147 employees, the majority of whom<br />
work at Lundbeck’s research facility in New<br />
Jersey. It is Lundbeck’s strategy to establish its<br />
own commercial presence in the US market.<br />
Establishing a commercial presence in the USA<br />
must be seen in relation to the fact that Lundbeck<br />
has pharmaceutical candidates within<br />
two areas that can potentially be launched in<br />
the USA within three years. They include a<br />
number of drug candidates for the treatment<br />
of mood and anxiety disorders, which are currently<br />
under development with the most advanced<br />
project in pivotal clinical trials. The<br />
products also include Serdolect® for the treatment<br />
of schizophrenia and pharmaceutical<br />
candidates in clinical development for the<br />
treatment of psychotic disorders.<br />
Partnership with Takeda<br />
In September <strong>2007</strong>, Lundbeck and Takeda<br />
Pharmaceutical Company Limited of Japan announced<br />
that the companies had formed a<br />
strategic alliance for the development and<br />
marketing of several new compounds discov-<br />
USA, revenue, DKKm<br />
Growth in<br />
Growth in<br />
Q4 ’07 Q4 ’06 Growth local currency <strong>2007</strong> 2006 Growth local currency<br />
Lexapro® 626 525 19% 24% 2,594 1,923 35% 39%<br />
Other revenue 0 5 -107% -108% 6 7 -21% -16%<br />
Total revenue 626 530 18% 22% 2,599 1,930 35% 39%<br />
18
ered by Lundbeck for the treatment of mood<br />
and anxiety disorders. The compounds are<br />
Lu AA21004 and Lu AA24530, which are in<br />
phase III and phase II clinical development,<br />
respectively, and the agreement includes the<br />
possibility of, under certain conditions, including<br />
two other compounds. However, a maximum<br />
of three compounds can be included in<br />
the collaboration at the same time.<br />
Lundbeck believes that the agreement offers<br />
great potential for the joint development<br />
projects as well as providing Lundbeck with a<br />
unique opportunity to build a commercial specialist<br />
sales force in the USA with a view to a<br />
planned launch of Lu AA21004 in 2011.<br />
Serdolect®<br />
Lundbeck expects to file for approval of its<br />
own pharmaceutical Serdolect® with the U.S.<br />
Food and Drug Administration (FDA) in the<br />
first half of 2008. Serdolect® may thus become<br />
Lundbeck’s next pharmaceutical in the<br />
US market. Lundbeck believes that the experience<br />
learned from the rollout in Europe, where<br />
the pharmaceutical has had a difficult launch<br />
with a small market share, cannot necessarily<br />
be transferred to the US market. Serdolect®<br />
will not become a dominant antipsychotic in<br />
the US market, but due to the compound’s<br />
unique profile, it will be a good alternative to<br />
existing treatments.<br />
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19
International Markets<br />
Revenue from International Markets rose 22%<br />
relative to 2006 to DKK 2,194 million in <strong>2007</strong>.<br />
Sales in International Markets in <strong>2007</strong> accounted<br />
for 21% of Lundbeck’s consolidated<br />
revenue (exclusive of non-recurring items). In<br />
comparison, three years ago International Markets<br />
revenue in 2004 made up only 14% of<br />
Lundbeck’s revenue.<br />
The International Markets region covers a<br />
combination of more mature markets such as<br />
Canada, Australia and South Africa and developing<br />
markets such as Brazil, China and other<br />
markets in Asia.<br />
Revenue in International Markets is driven primarily<br />
by sales of Lundbeck’s two best-selling<br />
pharmaceuticals Cipralex®/Lexapro® and<br />
Ebixa®. These two pharmaceuticals made up<br />
71% of <strong>2007</strong> revenue in the region. At the<br />
same time, revenue from the company’s mature<br />
pharmaceuticals in International Markets<br />
was maintained on a level with 2006.<br />
Conditions in International Markets<br />
The markets outside Europe and the USA traditionally<br />
make up a small proportion of the<br />
combined market for pharmaceuticals to treat<br />
CNS diseases. In 2006, International Markets<br />
accounted for 17% of the global CNS market.<br />
Japan, Canada and Brazil are the largest markets<br />
of this geographic segment, accounting<br />
for more than 50% of its market value.<br />
In several markets of the region, therapies for<br />
CNS disorders are not as common as they are<br />
in the USA and in Europe. Accordingly, Lundbeck<br />
has in recent years given priority to establishing<br />
a position in the key markets of the<br />
region to exploit the growth potential and in<br />
order to contribute to disseminating knowl-<br />
edge of therapies for psychiatric and neurological<br />
disorders.<br />
Lundbeck previously opted to minimise its risk<br />
in the region by having distributors build a<br />
sales infrastructure and handle its marketing<br />
initiatives. Under these conditions, Lundbeck’s<br />
pharmaceuticals have already been available in<br />
some of the markets for many years; for example<br />
in Thailand for about 45 years.<br />
Lundbeck set up its first subsidiary in the International<br />
Markets region in South Africa in<br />
1984 and has since established subsidiaries<br />
and representative offices in a total of 24 markets<br />
in the region. By the end of <strong>2007</strong>, Lundbeck<br />
had its own sales force in the most important<br />
markets of the segment with the<br />
exception of Japan.<br />
In China, Cipramil® is currently marketed by<br />
Lundbeck’s business partner Xian-Janssen, and<br />
Lundbeck expects to launch Lexapro® in China<br />
during 2008. In 2005, Lundbeck started to<br />
build its own commercial presence in China,<br />
and at the end of <strong>2007</strong> Lundbeck’s subsidiary<br />
in China counted about 45 medical representatives<br />
who market Ebixa®.<br />
In International Markets, the protection of intellectual<br />
property rights represents a risk factor,<br />
and in a number of markets, Lundbeck expects<br />
to be unable to protect intellectual<br />
property rights for its existing pharmaceuticals.<br />
In some of these markets, Lundbeck’s pharmaceuticals<br />
are already exposed to generic competition,<br />
but as a large proportion of the population<br />
uses branded pharmaceuticals, the<br />
impact from generic competition is less dramatic<br />
than elsewhere.<br />
Cipralex®/Lexapro®<br />
Cipralex®/Lexapro® is by far Lundbeck’s bestselling<br />
product in International Markets, where<br />
it accounts for more than half of total revenue.<br />
In spite of competition from generic products<br />
in a number of these markets, Cipralex® has<br />
posted very strong growth rates.<br />
In the third quarter of <strong>2007</strong>, Cipralex®/Lexapro®<br />
held a market share of 9.4% of the aggregate<br />
market for antidepressants in terms of<br />
value in International Markets, an increase of<br />
24% compared with the third quarter of 2006.<br />
In several markets, Lundbeck is now the market-leading<br />
provider of treatments for depression<br />
and anxiety, even if there is no patent<br />
protection. Thus, in Latin America Lundbeck<br />
was the market leader at the end of <strong>2007</strong> in<br />
Brazil, Mexico and Chile, and Lundbeck continues<br />
to see growth in the small markets of the<br />
region. In the Asian markets, Cipralex® is the<br />
market leader in countries such as South<br />
Korea, which ranks among the world’s 15 largest<br />
antidepressant markets. Cipralex® has also<br />
been successfully launched in the Middle East,<br />
having gained market shares in excess of 10%<br />
in terms of value in the major markets.<br />
Ebixa®<br />
Ebixa® is Lundbeck’s second-largest pharmaceutical<br />
in International Markets. Also in these<br />
markets, the efficacy and attractive safety profile<br />
offered by the product help to generate<br />
decent growth rates. In the third quarter of<br />
<strong>2007</strong>, Ebixa® held 10.9% of the total market<br />
for pharmaceuticals to treat Alzheimer’s disease<br />
in International Markets. In Asia, Ebixa®<br />
has been launched in markets such as China as<br />
the first pharmaceutical marketed by Lundbeck<br />
itself, and the product has already conquered<br />
a double-digit market share after only<br />
one year in the market. In Egypt, Ebixa® is the<br />
International Markets, revenue, DKKm<br />
Growth in<br />
Growth in<br />
Q4 ’07 Q4 ’06 Growth local currency <strong>2007</strong> 2006 Growth local currency<br />
Cipralex®/Lexapro® 311 262 19% 11% 1,267 948 34% 36%<br />
Ebixa® 72 63 14% 4% 295 230 29% 29%<br />
Azilect® 4 1 613% 612% 11 1 1210% 1210%<br />
Serdolect® 2 1 41% 123% 11 3 257% 311%<br />
Other revenue 134 149 -10% -14% 609 613 -1% 3%<br />
Total revenue 523 476 10% 3% 2,194 1,794 22% 25%<br />
20
Foreign currency exposure<br />
Foreign currency management is handled cenmost<br />
frequently used pharmaceutical to treat<br />
Alzheimer’s disease, and Ebixa® continues to<br />
grow in the Arabic countries.<br />
Other pharmaceuticals<br />
Azilect® and Serdolect® have only been<br />
launched in a few markets in the International<br />
Markets region, but in specific markets the<br />
products have achieved great success by winning<br />
relatively high market shares. For example,<br />
Serdolect® experienced a successful<br />
launch in the Russian market, and Russia is expected<br />
to become one of the principal markets<br />
for Serdolect® in International Markets. In International<br />
Markets, Azilect® has only been<br />
launched in Turkey, where the launch progressed<br />
well.<br />
Mature pharmaceuticals<br />
Revenue from mature pharmaceuticals stabilised<br />
during <strong>2007</strong> and amounted to DKK 609<br />
million. This trend is expected to continue in<br />
2008.<br />
Strategy for Japan<br />
Japan is currently the second-largest pharmaceutical<br />
market in the world, but in the field of<br />
pharmaceuticals to treat CNS diseases, Japan<br />
is only the world’s third-largest market. Lundbeck<br />
has had its own subsidiary in Japan since<br />
2001 with the main objective of developing a<br />
number of Lundbeck’s pharmaceuticals for the<br />
Japanese market. These products include escitalopram<br />
for the treatment of depression,<br />
Lundbeck’s pharmaceutical development<br />
candidates for the treatment of mood and<br />
anxiety disorders and desmoteplase for the<br />
treatment of acute ischaemic stroke.<br />
Even though the size of the CNS market is only<br />
comparable to the largest markets in Europe,<br />
the Japanese market offers attractive growth<br />
potential, but it is also a market which foreign<br />
companies have historically found it difficult<br />
to enter. Thus, Lundbeck cannot register new<br />
pharmaceuticals in Japan if the application is<br />
based exclusively on documentation generated<br />
in other countries. However, it looks as if the<br />
health authorities are changing their position<br />
on the issue, making it easier for pharmaceutical<br />
businesses to obtain approval of pharmaceuticals<br />
based on preclinical and clinical data<br />
prepared in other countries.<br />
In Japan, Lundbeck is developing escitalopram<br />
in collaboration with Mochida Pharmaceutical<br />
Co., Ltd., and escitalopram is currently in phase<br />
III clinical trials with Japanese patients. Lundbeck<br />
has exclusive rights to desmoteplase in<br />
Japan and is currently planning the clinical development<br />
phases for the compound in Japan.<br />
Moreover, the agreement with Takeda will increase<br />
the opportunities for Lundbeck to start<br />
marketing pharmaceuticals in Japan after 2010.<br />
Alzheimer’s disease – Ebixa®<br />
market shares and market growth<br />
in International Markets<br />
Market share, value (%) Market growth, volume (%)<br />
15<br />
10<br />
5<br />
0<br />
Q3-04<br />
Depression – Cipralex®/Lexapro®<br />
market shares and market growth<br />
in International Markets<br />
Market share, value (%) Market growth, volume (%)<br />
20<br />
15<br />
10<br />
5<br />
0<br />
Q3-04<br />
20<br />
15<br />
10<br />
0<br />
Q3-05 Q3-06 Q3-07<br />
Volume market growth (three-month average)<br />
Market share: Cipralex®/Lexapro®<br />
Source: IMS sales data<br />
60<br />
40<br />
20<br />
0<br />
Q3-05 Q3-06 Q3-07<br />
Volume market growth (three-month average)<br />
Market shares:<br />
Ebixa® Other memantine Total memantine<br />
Source: IMS sales data<br />
5<br />
trally by the parent company, and Lundbeck<br />
aims as a minimum to hedge its anticipated<br />
cash flows for any future period of approximately<br />
9-15 months. In <strong>2007</strong>, 26% of Lundbeck’s<br />
sales in International Markets were exposed<br />
to the US dollar (USD) and 17% to the<br />
Canadian dollar (CAD).<br />
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21
22<br />
In recent years, Lundbeck’s scientists have invented<br />
a number of novel and innovative compounds for<br />
the treatment of mood and anxiety disorders. Medical<br />
chemist Anette Graven Sams is making preparations<br />
for the synthesis of a new compound in Lundbeck’s<br />
medical chemistry research.
Depression<br />
and mood disorders<br />
D<br />
epression is a serious disease with<br />
symptoms that include persistent low<br />
mood, diminished energy, low selfesteem,<br />
difficulty concentrating and suicidal<br />
thoughts. The patient is no longer in control of<br />
his own mood and feelings and functions inadequately<br />
socially and in the workplace. For this<br />
reason, it is important that people suffering<br />
from depression receive treatment.<br />
Mood disorders include bipolar disorder (previously<br />
referred to as manic-depressive illness),<br />
and whereas depression is characterised by<br />
low mood, mood disorders affect the mood to<br />
varying degrees and directions, for example<br />
between depression and mania.<br />
There is a close correlation between depression<br />
and various anxiety disorders. It is estimated<br />
that more than half of the patients suffering<br />
from anxiety also suffer from another<br />
psychiatric disorder, primarily depression. Consequently,<br />
it is a huge advantage if an antidepressant<br />
also has a documented effect in the<br />
treatment of anxiety disorders.<br />
Lundbeck currently markets six different pharmaceuticals<br />
for the treatment of depression.<br />
The most recent pharmaceutical is Cipralex®,<br />
which is marketed in the USA by Lundbeck’s<br />
partner Forest Laboratories, Inc. under the<br />
Lexapro® brand.<br />
Furthermore, Lundbeck has four development<br />
compounds for the treatment of depression,<br />
anxiety and mood disorders: Lu AA21004,<br />
Lu AA24530, Lu AA34893 and Lu AA37096.<br />
According to WHO, there are 150 million cases<br />
of depression worldwide at any given time.<br />
23
Strategic<br />
focus<br />
Lundbeck is a research-based specialist company dedicated to the treatment of<br />
disorders of the central nervous system. To be successful in a global pharmaceuticals<br />
market characterised by much larger companies and intense competition, Lundbeck<br />
has developed a strategy aimed at providing sufficient innovative capacity whilst at<br />
the same time maintaining a competitive cost structure.<br />
L<br />
undbeck’s vision is to become one of<br />
the world’s leading psychiatry and neurology<br />
businesses by developing pharmaceuticals<br />
for the treatment of central nervous<br />
system (CNS) disorders. It follows from<br />
this ambitious vision that Lundbeck must continue<br />
to expand the Group’s professional and<br />
commercial position in psychiatry and neurology.<br />
At the same time, Lundbeck must exploit<br />
its flexibility as a small pharmaceutical company<br />
by responding quickly and constantly optimising<br />
all links of the value chain and expanding<br />
its global competitive strength.<br />
Through its extensive and dedicated operations<br />
as a specialist company, Lundbeck has<br />
built a strong foundation of resources that offers<br />
a number of competitive benefits:<br />
• a solid position in the CNS market with<br />
more than 50 years’ research and commercialisation<br />
experience and insight with<br />
respect to innovative pharmaceuticals<br />
• skilful and highly specialised employees with<br />
competencies across the value chain<br />
• a competitive research organisation with<br />
access to innovation based on in-depth<br />
understanding of patients and unmet CNS<br />
needs<br />
• a broad pipeline<br />
• dedicated market coverage and sales<br />
companies with a strong local presence<br />
• the ability to form and extensive experience<br />
in forming partnerships with large and small<br />
companies.<br />
Lundbeck’s business is rooted in a focused<br />
niche strategy, integration and control of the<br />
entire value chain, global market coverage and<br />
partnering.<br />
24<br />
Specialised<br />
Lundbeck’s focused niche strategy has been<br />
and continues to be instrumental in the<br />
Group’s success. A focused approach offers obvious<br />
benefits in terms of research and development,<br />
but it also means that Lundbeck’s<br />
medical representatives can communicate<br />
knowledge about diseases and pharmaceuticals<br />
at a high technical level to the authorities,<br />
specialists and general practitioners.<br />
Integrated<br />
All links of the pharmaceutical value chain are<br />
important if success is to be achieved in the<br />
pharmaceuticals market. Lundbeck is a fully integrated<br />
pharmaceutical company, and management<br />
believes that knowledge and control<br />
of research into and development of new<br />
pharmaceuticals and of production, marketing<br />
and sales provide Lundbeck with a number of<br />
competitive benefits.<br />
A fully integrated pharmaceutical value chain<br />
does not mean that Lundbeck’s interests are<br />
best served by owning or performing all the<br />
activities itself. In all parts of its operations,<br />
Lundbeck evaluates which activities Lundbeck<br />
should perform itself and which activities the<br />
company can benefit from outsourcing.<br />
Global presence<br />
The global market for pharmaceuticals to treat<br />
CNS disorders is the largest pharmaceutical<br />
therapy area, and today represents a value of<br />
more than DKK 500 billion.<br />
Lundbeck’s activities in the form of marketed<br />
pharmaceuticals and late-stage projects in<br />
clinical development target diseases that represent<br />
about half of the CNS market. Lundbeck<br />
wishes to optimise the value of its pharmaceuticals<br />
by ensuring their availability in all relevant<br />
markets.<br />
Lundbeck currently has registered pharmaceuticals<br />
in over 90 countries. For each market,<br />
Lundbeck evaluates whether the Group should<br />
be present with its own organisation or<br />
whether it should market its products through<br />
partnerships.<br />
Lundbeck currently has a presence in 54 countries<br />
through its own sales entities, but has yet<br />
to establish a direct presence in two important<br />
countries: Japan and the USA. These two countries<br />
combine to represent two-thirds of the<br />
global market for pharmaceuticals to treat<br />
psychiatric and neurological disorders. The collaboration<br />
with Takeda Pharmaceutical Company<br />
Limited on the exclusive co-development<br />
and co-commercialisation in the USA and<br />
Japan of a number of compounds in Lundbeck’s<br />
pipeline gives Lundbeck the opportunity to build<br />
its own commercial presence in the USA and<br />
Japan; an approach which will provide a higher<br />
return than conventional out-licensing without<br />
substantially increasing the risk involved.<br />
A direct presence in these two markets is instrumental<br />
if Lundbeck is to build a foundation<br />
for long-term growth and thereby accomplish<br />
its vision of being a leading specialist CNS<br />
company.<br />
Even though Lundbeck’s headquarters are<br />
located in Denmark and Lundbeck expects to<br />
continue to carry out large parts of its activities<br />
here in the future, the Group will site new<br />
activities in the locations that are most appropriate<br />
with respect to quality, price and access<br />
to commodities and labour.
Partnering<br />
Developing new pharmaceuticals today is a<br />
more difficult and resource consuming process<br />
than ever before. In addition, companies have<br />
less time in which to earn back their investment.<br />
In order to face these challenges, network<br />
agreements and partnering have become<br />
more common in the pharmaceutical industry.<br />
PAION AG) and the already approved product<br />
Circadin® (from Neurim Pharmaceuticals Ltd.),<br />
Lundbeck has been able to considerably add to<br />
its own pharmaceutical pipeline.<br />
Each year, Lundbeck investigates about 200<br />
potential in-licensing projects, and a due diligence<br />
review is performed in connection with<br />
about 10% of these projects. In recent years,<br />
Lundbeck has in-licensed a new pharmaceutical<br />
candidate every year as a result of these efforts.<br />
Lundbeck will continue to focus on partnering<br />
and in-licensing pharmaceuticals to<br />
complement the Group’s existing operations<br />
and help underpin our continuing development<br />
and growth.<br />
Lundbeck has pursued a partnering strategy for<br />
years, providing the possibility of compensating<br />
for the Group’s limited size and financial<br />
resources. Also, partnerships allow Lundbeck<br />
access to the competencies, know-how and resources<br />
important for clinical research and<br />
commercialisation of pharmaceuticals.<br />
Lundbeck currently enjoys a reputation as a<br />
solid and reliable partner in the field of CNS.<br />
In <strong>2007</strong>, Lundbeck and the Japanese company<br />
Takeda formed a strategic alliance for the<br />
exclusive co-development and co-commercialisation<br />
in the USA and Japan of several compounds<br />
in Lundbeck’s pipeline for the treatment<br />
of mood and anxiety disorders. This gives<br />
Lundbeck the opportunity to scale up the<br />
development of these compounds and allocate<br />
resources to other projects.<br />
Major partnerships<br />
Company Compound Indication<br />
BioTie Therapies Corp. Nalmefene Alcohol dependence<br />
Forest Laboratories, Inc. Escitalopram Depression<br />
Merz Pharmaceuticals GmbH Memantine Alzheimer’s disease<br />
Neurim Pharmaceuticals Ltd. Melatonin Primary insomnia<br />
PAION AG Desmoteplase Stroke<br />
Solvay Pharmaceuticals B.V. Bifeprunox Schizophrenia<br />
Takeda Pharmaceutical Company Limited Lu AA21004/ Depression, mood<br />
Lu AA24530<br />
disorders and anxiety<br />
Teva Pharmaceutical Industries Ltd. Rasagiline Parkinson’s disease<br />
In recent years, Lundbeck has also in-licensed<br />
pharmaceuticals from other companies. At the<br />
end of <strong>2007</strong>, revenue from the pharmaceuticals<br />
Ebixa® (in-licensed from Merz Pharmaceuticals<br />
GmbH) and Azilect® (in-licensed<br />
from Teva Pharmaceutical Industries Ltd.) represented<br />
17% of Lundbeck’s consolidated revenue.<br />
Also, with the late-stage projects<br />
nalmefene (in collaboration with BioTie Therapies<br />
Corp.), desmoteplase (together with<br />
25
Strategic<br />
initiatives<br />
Lundbeck aims to become a high-growth research-based CNS company. The Group’s<br />
development and growth initiatives are based on three focus areas: streamlining<br />
and simplifying its business to ensure efficiency and flexibility in the organisation,<br />
extending and protecting Lundbeck’s marketed pharmaceuticals, and creating a<br />
platform for future growth.<br />
S<br />
treamline and simplify<br />
Lundbeck ensures a competitive cost<br />
structure and optimises the Group’s<br />
flexibility and response times. In all parts of the<br />
Group, we have initiated projects to simplify<br />
and streamline the organisation to optimise<br />
consumption of resources.<br />
Streamlined infrastructure in clinical<br />
development<br />
Lundbeck expects to scale up the number of clinical<br />
trials for pharmaceutical candidates in the<br />
Group’s development pipeline. At the same time,<br />
regulatory requirements with respect to documentation<br />
from clinical trials are steadily growing.<br />
To optimise its resource consumption, Lundbeck<br />
has begun building an electronic infrastructure<br />
for its clinical development efforts. The new and<br />
streamlined infrastructure is intended to ensure<br />
a simpler and more effective process in terms of<br />
reporting and handling clinical data without<br />
compromising on quality.<br />
Lundbeck initiated the first trial based on the<br />
new electronic platform in <strong>2007</strong>. In 2008, clinical<br />
trials launched in connection with Lundbeck’s<br />
depression projects will be implemented using<br />
this platform. Management believes that the<br />
new infrastructure will very much help optimise<br />
the resources Lundbeck uses in clinical development<br />
and also ensure adherence to the regulatory<br />
guidelines on clinical trials.<br />
European distribution<br />
In recent years, Lundbeck’s manufacturing organisation<br />
has focused its efforts on establishing<br />
two centralised distribution centres in Europe<br />
instead of maintaining inventories and<br />
handling distribution locally in each country.<br />
The objective is to increase transparency in the<br />
26<br />
supply chain while reducing distribution costs.<br />
Over the course of the past few years, inventories<br />
in the Nordic countries have gradually been<br />
transferred to a central warehouse adjacent to<br />
the Lundbeck headquarters in Denmark, and in<br />
<strong>2007</strong> Lundbeck established a similar central<br />
warehouse in Germany to handle distribution to<br />
other European countries.<br />
The new distribution structure allows Lundbeck<br />
to act as a single entity across Europe. Lundbeck<br />
has already obtained substantial savings in<br />
connection with the negotiation of new distribution<br />
agreements, and management believes<br />
that Lundbeck will continue to be able to<br />
achieve additional savings when entering into<br />
agreements on the distribution of the Group’s<br />
pharmaceuticals.<br />
Targeted sales and marketing<br />
In recent years, Lundbeck has adjusted its sales<br />
and marketing initiatives so that its medical<br />
representatives visit the doctors and specialists<br />
who focus most on CNS disorders. Furthermore,<br />
by adjusting its sales organisations in the individual<br />
markets, Lundbeck has achieved lower<br />
sales and marketing costs.<br />
As a result of these efforts, Lundbeck has since<br />
2005 launched two new pharmaceuticals and<br />
increased its revenue from DKK 4,680 million to<br />
DKK 5,501 million in the Group’s European<br />
markets while also reducing the number of<br />
medical representatives.<br />
In the International Markets region, Lundbeck<br />
also managed to increase the profitability of<br />
the Group’s sales initiatives, resulting in a reduction<br />
of sales, general and administrative expenses<br />
(SG&A margin) from 46% to 42% between<br />
2006 and <strong>2007</strong>.<br />
Maintain and expand existing business<br />
In <strong>2007</strong>, Lundbeck recorded strong trends and<br />
growth in its existing business. Lundbeck derives<br />
78% of its revenue from the Group’s new and<br />
proprietary pharmaceuticals Cipralex®/Lexapro®,<br />
Ebixa®, Azilect® and Serdolect®. Also in<br />
<strong>2007</strong>, Lundbeck in-licensed Circadin®, an already<br />
approved pharmaceutical for insomnia. In the<br />
years ahead, these pharmaceuticals will represent<br />
a solid foundation for Lundbeck’s business,<br />
and the Group aims to retain and protect the<br />
market position held by these products, ensure<br />
that they are disseminated in all relevant markets,<br />
and launch life-cycle initiatives to capitalise<br />
fully on the potential of its pharmaceuticals.<br />
Platform for long-term growth<br />
Management is committed to ensuring that<br />
Lundbeck, also in the long term, remains a<br />
healthy and well-managed business that constantly<br />
evolves and demonstrates a substantial<br />
growth potential.<br />
The ability to develop and disseminate innovative<br />
pharmaceuticals has been the key driver<br />
behind Lundbeck’s successful track record. Management<br />
finds that innovation will continue to<br />
be the key prerequisite for success in the pharmaceutical<br />
industry and that this will apply in<br />
particular to Lundbeck’s long-term growth.<br />
The protection that Lundbeck enjoys for certain<br />
of the Group’s pharmaceuticals will expire in<br />
most markets in 2012-2014. In <strong>2007</strong>, these<br />
pharmaceuticals accounted for 78% of consolidated<br />
revenue. Consequently, Lundbeck aims to<br />
capitalise on the Group’s favourable financial<br />
position to create a foundation for long-term<br />
growth based on in-house research and inlicensing<br />
of innovative pharmaceuticals.
Growth through<br />
innovation<br />
Lundbeck expects to continue to invest heavily in research and development in the<br />
years to come, allowing the Group’s pipeline of pharmaceutical candidates to be its<br />
development and growth driver, also in the years ahead.<br />
O<br />
ver the past decade, Lundbeck has<br />
invested heavily in research and<br />
development. In the past couple of<br />
years, these efforts have yielded a steady flow<br />
of new and innovative pharmaceutical candidates<br />
in clinical development. Whereas Lundbeck<br />
previously had its key strengths in the<br />
field of psychiatry, intensified research in neurology<br />
has produced new research and development<br />
projects in Parkinson’s disease, Alzheimer’s<br />
disease, epilepsy and stroke.<br />
In the past few years, Lundbeck has ploughed<br />
about 20% of its revenue back into research<br />
and development, a figure above the industry<br />
average of approximately 17%. In addition,<br />
Lundbeck’s partners contribute substantially to<br />
Lundbeck’s research and development, resulting<br />
in a total investment in research and development<br />
that is actually much higher than 20% of<br />
Lundbeck’s revenue.<br />
Lundbeck expects to continue to invest heavily<br />
in research and development in the years to<br />
come, allowing the Group’s pipeline of pharmaceutical<br />
candidates to be its development and<br />
growth driver, also in the years ahead.<br />
A strong pipeline<br />
In the course of <strong>2007</strong>, Lundbeck was able to<br />
ensure progress and expand the Group’s development<br />
pipeline by a number of new pharmaceutical<br />
candidates, but also had to discontinue<br />
the advanced development project with gaboxadol<br />
for the treatment of sleep disorders.<br />
Management believes that Lundbeck’s pipeline<br />
will provide the foundation for the Group’s<br />
long-term progress and growth. Also, the portfolio<br />
of late-stage projects coupled with the<br />
in-licensing of one or two pharmaceutical candidates<br />
in the years ahead will provide medium-term<br />
growth, thus compensating for the<br />
slowing sales of Lundbeck’s current range of<br />
pharmaceuticals from 2012 onwards.<br />
Phase III projects<br />
In <strong>2007</strong>, Lundbeck initiated phase III clinical trials<br />
with Lu AA21004, the most advanced pharmaceutical<br />
candidate in Lundbeck’s pipeline of<br />
new and innovative compounds for the treatment<br />
of mood and anxiety disorders. Lu<br />
AA21004, discovered by Lundbeck and being<br />
jointly developed by Lundbeck and Takeda<br />
Pharmaceutical Company Limited, belongs to a<br />
new chemical class of compounds with a mode<br />
of action that is different from currently marketed<br />
antidepressants. In a phase II clinical trial<br />
Lu AA21004 showed highly significant improvements<br />
on the primary efficacy endpoints<br />
for both 5 and 10 mg doses compared to placebo.<br />
Lu AA21004 also showed an attractive<br />
safety profile.<br />
In <strong>2007</strong>, Lundbeck in-licensed the European<br />
rights for the pharmaceutical candidate<br />
nalmefene for the treatment of alcohol dependence<br />
from Finnish biotech company Bio-<br />
Tie Therapies Corp. Nalmefene is a specific opioid<br />
receptor antagonist and the first oral drug<br />
showing efficacy in reducing heavy drinking in<br />
multicentre, controlled studies. BioTie has studied<br />
the safety and efficacy of nalmefene in a<br />
total of 1,200 patients suffering from alcoholism<br />
and alcohol dependence, including two<br />
phase III trials in the UK and Finland. Lundbeck<br />
and BioTie expect to seek marketing authorisation<br />
simultaneously in all 27 EU member states<br />
via the centralised procedure. To this end, Lundbeck<br />
plans to further strengthen the existing<br />
nalmefene registration dossier in its alcohol dependence<br />
indication by initiating additional<br />
phase III clinical trials during 2008.<br />
Lundbeck has in-licensed the global rights to<br />
desmoteplase for the treatment of acute ischaemic<br />
stroke from German biotech company<br />
PAION AG and expects to commence new<br />
phase III clinical trials of desmoteplase in acute<br />
ischaemic stroke in the second half of 2008.<br />
Desmoteplase has the potential to become the<br />
first pharmaceutical that extends the time window<br />
within which patients can reach the hospital,<br />
be diagnosed and receive treatment.<br />
Desmoteplase may thus provide treatment for<br />
many of those patients who currently have no<br />
treatment options. Desmoteplase has shown<br />
positive results in phase II clinical trials. In<br />
<strong>2007</strong>, PAION announced results from the first<br />
phase III trial in which desmoteplase was not<br />
statistically significantly different from placebo<br />
on the primary efficacy endpoints. Subsequent<br />
analyses of data from the trial have shown that<br />
patients with a sufficient degree of blood clot<br />
benefited from desmoteplase.<br />
In collaboration with Solvay Pharmaceuticals<br />
B.V., Lundbeck is developing bifeprunox for the<br />
treatment of schizophrenia and possibly mood<br />
disorders such as bipolar disorder in Europe and<br />
the rest of the world apart from North America,<br />
Argentina, Brazil, Japan and Mexico. Bifeprunox<br />
is currently in phase III.<br />
Results of phase II and phase III clinical trials in<br />
patients with schizophrenia show that bifeprunox<br />
demonstrated a clinical effect and a favourable<br />
weight and metabolic profile. Weight gain<br />
and metabolic disturbances are common and<br />
serious side effects of many antipsychotic pharmaceuticals<br />
which can cause some patients with<br />
schizophrenia to stop taking their medication.<br />
27
Clinical trials are a key component in the<br />
development and approval of new pharmaceuticals.<br />
The requirements for safety and<br />
efficacy documentation are international and<br />
comprise clinical trials that involve thousands<br />
of patients.<br />
Read the article Safe<br />
and efficacious in the<br />
Lundbeck Magazine 2008<br />
Phase II projects<br />
In <strong>2007</strong>, Lundbeck initiated phase II clinical trials<br />
with Lu 31-130 in 210 patients suffering<br />
from schizophrenia. Based on preclinical and<br />
clinical data, Lu 31-130 is expected to show a<br />
beneficial effect on both the positive and the<br />
negative symptoms and to demonstrate a good<br />
balance between efficacy and safety. Lu 31-130<br />
has a multi receptor profile, and data from a<br />
PET study of healthy individuals in combination<br />
with preclinical studies have shown that Lu<br />
31-130 has a unique dopamine and serotonin<br />
receptor binding profile.<br />
In <strong>2007</strong>, Lundbeck and Takeda jointly initiated<br />
phase II clinical trials with Lu AA24530, which<br />
is the second most advanced compound in the<br />
collaboration on a new class of compounds to<br />
treat mood and anxiety disorders. Lundbeck expects<br />
to see the initial results from the phase II<br />
trials in early 2009.<br />
Furthermore, at the beginning of 2008, Lundbeck<br />
embarked on phase II clinical trials to<br />
investigate Lu AA34893 for the treatment of<br />
bipolar disorder.<br />
Phase I projects<br />
In <strong>2007</strong>, Lundbeck initiated phase I clinical trials<br />
with the pharmaceutical candidate Lu<br />
AA39959 for the treatment of bipolar disorder<br />
and psychoses. Lu AA39959, invented by Lundbeck’s<br />
own scientists, modulates ion channels<br />
in the brain via a new mechanism of action. In<br />
preclinical models of schizophrenia, the compound<br />
has demonstrated a highly convincing<br />
potential as an antipsychotic. Schizophrenia<br />
and bipolar disorder are long-term illnesses<br />
with significant problems despite the existing<br />
treatments.<br />
In <strong>2007</strong>, Lundbeck initiated phase I clinical trials<br />
with the pharmaceutical candidate Lu<br />
AA24493 in patients suffering from acute ischaemic<br />
stroke. Lu AA24493 is a novel carbamoylated<br />
form of human erythropoietin<br />
(EPO) – a modification of EPO that results in<br />
loss of haematopoietic effects but maintains<br />
the tissue protective effect. This tissue protective<br />
effect translates into very positive effects<br />
in a number of animal models for neuronal<br />
damage including models for cerebral stroke. Lu<br />
AA24493 is developed in collaboration between<br />
Lundbeck and Warren Pharmaceuticals,<br />
Inc. and is in-licensed from Warren as part of<br />
the license agreement that the companies announced<br />
in 2002. Lundbeck holds worldwide<br />
rights for indications related to the central<br />
nervous system.<br />
In <strong>2007</strong>, Lundbeck initiated phase I clinical trials<br />
with Lu AA47070 for the treatment of Parkinson’s<br />
disease. Lu AA47070 is discovered by<br />
Lundbeck and is the first compound within the<br />
neurology area from Lundbeck’s internal research.<br />
Lu AA47070 is a novel adenosine receptor<br />
antagonist that has shown efficacy in a<br />
number of animal models for neurological diseases,<br />
including models of Parkinson’s disease.<br />
It is therefore expected that Lu AA47070 may<br />
have a potential in certain neurological indications<br />
and could be an alternative to e.g.<br />
dopamine agonists in the treatment of<br />
Parkinson’s disease.<br />
In 2008, Lundbeck has initiated phase I clinical<br />
trials with Lu AA37096. Lu AA37096 has been<br />
discovered based on findings involving the<br />
unique mechanism of action of escitalopram<br />
(Cipralex®) but incorporates effects on a<br />
number of additional targets in the brain.<br />
Lu AA37096 has shown very convincing effects<br />
in animal models of mood disorders as well as<br />
in pain models.<br />
Lundbeck has a number of preclinical development<br />
projects and expects to initiate additional<br />
clinical studies of pharmaceutical candidates<br />
from its in-house research activities during 2008.<br />
28
At Lundbeck, research into new pharmaceuticals<br />
is the cornerstone of the company’s<br />
operations. The goal is to develop pharmaceuticals<br />
which, by the end of the next<br />
decade, will represent a novel and innovative<br />
approach in the treatment of psychiatric and<br />
neurological disorders.<br />
Read the article Strategy in<br />
place for new drugs in the<br />
Lundbeck Magazine 2008<br />
Pharmaceuticals in clinical development as of 4 March 2008<br />
Development stage Registration Expected<br />
Indication | Compound Mechanism of action Phase I Phase II Phase III application launch<br />
Schizophrenia | Serdolect® USA Dopamine/serotonin 2008 2009<br />
Schizophrenia | Bifeprunox Dopamine/serotonin 2010+<br />
Stroke | Desmoteplase Plasminogen activator 2010+<br />
Alcohol dependence | Nalmefene Specific opioid receptor antagonist 2010+<br />
Depression | Lu AA21004 Serotonin modulator & stimulator 2010 2010+<br />
Psychosis | Lu 31-130 Monoaminergic 2010+<br />
Depression | Lu AA24530 Multiple target 2010+<br />
Depression | Lu AA34893 Multiple target 2010+<br />
Psychosis/bipolar disorder | Lu AA39959 Ion channel modulator 2010+<br />
Stroke/neuronal damage | Lu AA24493 Tissue protecting cytokine 2010+<br />
Neurological diseases | Lu AA47070 Adenosine receptor antagonist 2010+<br />
Mood and anxiety disorders | Lu AA37096 Multiple target 2010+<br />
29
30<br />
Using methods such as microscopy, senior specialist<br />
Heidi Lopez de Diego analyses the crystals in the<br />
compound nalmefene for the treatment of alcohol<br />
dependence. The shape and the size of the crystals<br />
are important to ensure the right composition in<br />
the subsequent tablet manufacturing process.
Alcohol<br />
dependence<br />
I<br />
t is estimated that more than 30 million<br />
people in the USA, Europe and Japan<br />
suffer from alcohol dependence and<br />
alcohol abuse.<br />
Alcohol abuse involves major social consequences<br />
and in the longer term leads to<br />
damage of many body organs. For example,<br />
in the UK alone, there are 150,000 hospital admissions<br />
and 20,000 premature deaths directly<br />
due to alcohol and 1.2 million alcohol-related<br />
violent incidents. The UK National Health<br />
Service (NHS) estimates the annual costs of<br />
alcohol abuse to GBP 1.4-1.7 billion.<br />
Lundbeck collaborates with BioTie Therapies<br />
Corp. on the development of nalmefene for the<br />
treatment of alcohol dependence. Nalmefene<br />
is an opioid receptor antagonist which acts by<br />
blocking a few specific opioid receptors in the<br />
brain. When you drink alcohol, the body releases<br />
endorphins. They work by binding to the<br />
opioid receptors, which trigger a process in the<br />
brain that gives a good feeling in the body; a<br />
reward. Nalmefene is intended to block the<br />
opioid receptors, preventing the endorphins<br />
from binding to the receptors. This eliminates<br />
the reward and reduces the incentive for consuming<br />
alcohol.<br />
31
Corporate<br />
governance<br />
Owing to recent years’ focus on corporate governance, many listed companies<br />
have adopted a clear and uniform position on the topic, ensuring the necessary<br />
transparency and control while at the same time giving Executive Management<br />
as well as employees the trust and manoeuvring space required to implement<br />
innovative strategies and exploit market opportunities.<br />
L<br />
undbeck’s Supervisory Board and Executive<br />
Management consistently seek to<br />
ensure that Lundbeck pursues adequate<br />
policies and procedures to ensure good<br />
corporate governance and strong business ethics.<br />
Corporate governance recommendations<br />
Already in 2005, Lundbeck management implemented<br />
the revised corporate governance recommendations<br />
set out by the OMX Nordic Exchange<br />
Copenhagen. The Supervisory Board<br />
believes that the Group meets these corporate<br />
governance recommendations, except for the<br />
combined specified remuneration of the individual<br />
members of Executive Management and<br />
the Supervisory Board. Furthermore, Lundbeck<br />
does not disclose the number of shares held by<br />
each individual member of the Supervisory<br />
Board nor any changes to the number of shares<br />
held. Lundbeck does not believe that this would<br />
provide relevant further information.<br />
Lundbeck has opted not to disclose the remuneration<br />
paid to each individual member of Executive<br />
Management but only the remuneration<br />
paid to the President & CEO and the combined<br />
remuneration paid to Executive Management.<br />
The individual members of Executive Management<br />
basically receive the same remuneration,<br />
and the Supervisory Board believes that disclosing<br />
differences in the overall remuneration that<br />
result from individual bonus schemes, etc. would<br />
not provide additional value.<br />
A detailed description of the Supervisory<br />
Board’s considerations in respect of the OMX<br />
Nordic Exchange Copenhagen recommendations<br />
is available on lundbeck.com/about us.<br />
32<br />
Policies and procedures for business<br />
ethics<br />
Lundbeck aims to run its operations on the basis<br />
of integrity and responsibility.<br />
Lundbeck’s corporate values and rules of conduct<br />
represent the overall management tool<br />
for ensuring that Lundbeck achieves its business<br />
goals in an ethically responsible manner.<br />
The pharmaceutical market is subject to strict<br />
regulation. Lundbeck’s management believes<br />
that it is pivotal for the Group’s operations that<br />
it complies with all relevant national and international<br />
legislation, rules and guidelines issued<br />
by public institutions such as the U.S. Food and<br />
Drug Administration (FDA) and the European<br />
Medicines Agency (EMEA).<br />
In a number of specific areas, Lundbeck has established<br />
additional policies and procedures to<br />
ensure responsible business ethics. This applies<br />
to areas in which Lundbeck intends to ensure<br />
higher ethical standards than those required by<br />
local legislation. For example, Lundbeck has defined<br />
special rules on marketing of pharmaceuticals,<br />
business intelligence, corruption and areas<br />
such as animal ethics and health, safety<br />
and environmental aspects.<br />
At Lundbeck’s headquarters, a person has been<br />
appointed to be in charge of ensuring compliance<br />
with good marketing practice in the Group’s<br />
international marketing activities. Similarly, each<br />
sales entity employs a person responsible for ensuring<br />
that Lundbeck complies with local rules<br />
and industrial codes on good marketing practice.<br />
As a member of the European Federation of<br />
Pharmaceutical Industries and Associations (EF-<br />
PIA), Lundbeck also complies with the EFPIA<br />
code on the promotion of pharmaceuticals.<br />
Lundbeck’s policy on business ethics explicitly<br />
states that Lundbeck does not accept corruption,<br />
including bribery, kickbacks or similar illegal<br />
methods of any kind. Lundbeck has established<br />
an in-house audit function that reports<br />
to the Audit Committee under the Supervisory<br />
Board. As part of its duties, Internal Audit must<br />
ensure compliance with Lundbeck’s business<br />
ethics policies. Furthermore, Lundbeck has established<br />
a whistleblower system that all employees<br />
may use via the Group’s intranet if<br />
they experience non-compliance with Lundbeck’s<br />
business ethics policies. Reporting of<br />
non-compliance may be made anonymously.<br />
European Commission inspection<br />
In 2005, representatives from the European<br />
Commission conducted an inspection of Lundbeck’s<br />
premises. The purpose was to identify<br />
whether Lundbeck had misused a dominant<br />
position or had been involved in anticompetitive<br />
agreements in the markets for antidepressants.<br />
Lundbeck is cooperating fully with the<br />
European Commission. Lundbeck is confident<br />
that the Group has complied with all relevant<br />
national and international competition legislation,<br />
and expects the European Commission to<br />
reach the same conclusion.<br />
Board practice<br />
Lundbeck’s Supervisory Board held 11 board<br />
meetings in <strong>2007</strong>. In connection with the Annual<br />
General Meeting and in connection with<br />
Flemming Lindeløv’s retirement as chairman of<br />
the Board, the Supervisory Board held constitutive<br />
meetings. Furthermore, the Supervisory<br />
Board and the Executive Management held a<br />
joint two-day strategy seminar. During <strong>2007</strong>,<br />
the chairman and deputy chairman held eight<br />
meetings.
Lundbeck.com/about us<br />
Position on corporate governance<br />
Lundbeck’s Supervisory Board has considered the revised corporate governance recommendations issued by the OMX Nordic Exchange Copenhagen.<br />
A detailed description hereof is available on Lundbeck’s website.<br />
Articles of Association of H. Lundbeck A/S<br />
The Articles of Association of H. Lundbeck A/S are available on the Lundbeck website.<br />
The Articles of Association include rules concerning the election of members to the company’s Supervisory Board<br />
and rules for changing the Articles of Association.<br />
Competencies<br />
The Supervisory Board must define Lundbeck’s<br />
overall strategy and set clear goals for the<br />
Group’s Executive Management. In order to<br />
carry out these assignments effectively and<br />
successfully, it is appropriate that the Supervisory<br />
Board possesses the required competencies.<br />
The chairman and deputy chairman find<br />
that the existing board members possess the<br />
financial, pharmaceutical, information technology<br />
and production competencies required to<br />
serve on the board of an international group<br />
such as Lundbeck.<br />
Lundbeck’s Supervisory Board has started the<br />
process of recruiting a new board member following<br />
Flemming Lindeløv’s decision to step<br />
down from the Supervisory Board. The Supervisory<br />
Board wishes to recruit a new member<br />
whose competencies complement those of the<br />
existing board members, and expects to be able<br />
to present the new board member in connection<br />
with Lundbeck’s Annual General Meeting,<br />
which is scheduled for 22 April 2008.<br />
Independence<br />
The OMX Nordic Exchange Copenhagen recommends<br />
that half of a company’s board members<br />
(except those elected by the employees) be independent<br />
persons. The issue of board member<br />
independence is particularly relevant for companies<br />
that, like Lundbeck, have a single principal<br />
shareholder, the Lundbeck Foundation, holding<br />
more than half of the Group’s shares. Based on<br />
the OMX Nordic Exchange Copenhagen’s definition<br />
of independence, the Supervisory Board believes<br />
that at least half of the board members<br />
elected at the Annual General Meeting are independent.<br />
Two of the five members, Thorleif<br />
Krarup, the deputy chairman, and Jes Østergaard,<br />
are not independent due to their close ties with<br />
the Group’s principal shareholder. The same applies<br />
to the three board members elected by<br />
Lundbeck’s Danish employees.<br />
Committees<br />
The Supervisory Board has set up a remuneration<br />
committee and an audit committee.<br />
Audit Committee<br />
In December <strong>2007</strong>, the Danish Commerce and<br />
Companies Agency published a bill on implementation<br />
of the EU’s eighth company law directive’s<br />
proposal on implementation of audit<br />
committees in listed companies. The provision<br />
is to be implemented in Danish legislation by<br />
July 2008. Lundbeck’s Supervisory Board has<br />
already set up an audit committee that consists<br />
of Peter Kürstein (chairman), Per Wold-<br />
Olsen and Thorleif Krarup. The Audit Committee<br />
held three meetings in <strong>2007</strong>.<br />
The duties of the Audit Committee are advisory<br />
to the Supervisory Board and comprise:<br />
• review of the Group’s financial reporting<br />
procedures, including the procedures for reviewing<br />
interim and annual reports<br />
• evaluation of the Group’s financial reporting<br />
and other financial information published by<br />
the Group, including information about related<br />
parties<br />
• internal controls in relation to financial reporting<br />
to ensure consistency and transparency<br />
• review of the reports submitted by the auditors<br />
and communicating with the auditors<br />
• submitting recommendations to the Supervisory<br />
Board for use by the board in its recommendation<br />
at the Annual General Meeting<br />
concerning the appointment of external<br />
auditors.<br />
Lundbeck’s Supervisory Board concluded in<br />
<strong>2007</strong> that the new regulations in connection<br />
with the EU’s eighth company law directive<br />
will not give grounds for significant alterations<br />
in the operations of the Supervisory Board, including<br />
the Audit Committee.<br />
Remuneration Committee<br />
The Remuneration Committee set up by the<br />
Supervisory Board consists of Per Wold-Olsen<br />
(chairman), Mats Pettersson and Jes Østergaard.<br />
In <strong>2007</strong>, the committee held three meetings.<br />
The purpose of the Remuneration Committee<br />
is to provide the members of the Supervisory<br />
Board with the best possible decision-making<br />
basis concerning the total remuneration provided<br />
to the members of Executive Management.<br />
The committee prepares its recommendation<br />
to the Supervisory Board on the basis of<br />
general trends among industry peers in Denmark<br />
and other regions.<br />
Remuneration of the Supervisory Board<br />
Members of Lundbeck’s Supervisory Board receive<br />
a fixed remuneration and are not included<br />
in the Group’s other bonus and incentive<br />
programmes. In addition, the members of<br />
the board’s audit and remuneration committees<br />
receive a fee for their committee work.<br />
Summary of the remuneration<br />
guidelines for Executive Management<br />
The 2008 remuneration for Executive Management<br />
members will be based on the remuneration<br />
guidelines to be presented for approval at<br />
the Annual General Meeting on 22 April 2008.<br />
The comprehensive guidelines will subsequently<br />
be available on Lundbeck’s website.<br />
The composition of the remuneration reflects<br />
Lundbeck’s objective of being a high-growth<br />
research-based CNS company. The Executive<br />
Management members are rewarded for<br />
achieving stretched targets for short and longterm<br />
performance, including outperforming a<br />
peer group.<br />
Remuneration of the Executive Management<br />
members comprises base salary, pension, cash<br />
bonus, share-based payments and benefits. The<br />
Executive Management members are offered a<br />
base salary slightly below the average of the<br />
remuneration peer group as well as a variable<br />
bonus and a long-term incentive opportunity<br />
that depend on the achieved value creation for<br />
the company.<br />
The pension scheme for Executive Management<br />
is a defined contribution scheme, which<br />
corresponds to the market level in the country<br />
of residence of the executive.<br />
The short-term incentive programme provides<br />
a cash bonus for the achievement of pre-determined<br />
group goals and individual goals. The<br />
CEO and the Non-CEO members of Executive<br />
Management have the possibility of receiving a<br />
maximum of nine months’ and six months’<br />
base salary respectively as a bonus on condition<br />
of achievement of exceptional results.<br />
The members of Executive Management participate<br />
in a three-year revolving long-term incentive<br />
programme that includes shares as well<br />
as warrants. The performance criteria for the<br />
long-term incentive programme are based on<br />
relative stock price development against a<br />
group of selected pharmaceutical companies.<br />
In the programme, the CEO and the Non-CEO<br />
members of Executive Management can<br />
achieve a maximum of twelve months’ and<br />
eight months’ base salary respectively. However,<br />
this can only be obtained if the company<br />
experiences an extraordinarily favourable stock<br />
price development<br />
33
Lundbeck is developing a novel potential pharmaceutical<br />
compound which has demonstrated promising properties<br />
in models of Parkinson’s disease. In the picture, head of<br />
department Mads Kreilgård is analysing a PET scan on his<br />
computer. The PET scan shows the areas of the brain in<br />
which a compound such as Lu AA47070 works.
Parkinson’s<br />
disease<br />
P<br />
arkinson’s disease is a progressive,<br />
degenerative disorder caused by the<br />
degeneration of dopamine-producing<br />
cells in the brain. Symptoms associated with<br />
the disease are rigidity, tremors, slower and<br />
involuntary movements and impaired balance.<br />
It is estimated that the disease affects about<br />
1% of the population over the age of 65. The<br />
disease is both chronic and progressive. The<br />
precise cause of Parkinson’s disease is unknown<br />
and is believed to be multifactorial,<br />
including genes, environmental factors and<br />
age.<br />
As the disease progresses, the characteristic<br />
motor and facial expressions manifest themselves,<br />
and inhibited and rigid movements<br />
may leave the patient unable to take care of<br />
himself. In the late stage of the disease, the<br />
patient’s condition has deteriorated strongly,<br />
often confining him to a chair or bed.<br />
Lundbeck markets Azilect® for the treatment<br />
of Parkinson’s disease in collaboration with<br />
Teva Pharmaceutical Industries Ltd. and has<br />
also initiated phase I trials with Lu AA47070,<br />
which is expected to have a potential in<br />
certain neurological indications, including<br />
Parkinson’s disease.<br />
According to WHO, there are five million cases<br />
of Parkinson’s disease worldwide at any given<br />
time.<br />
35
Risk<br />
management<br />
To a company conducting research and international operations such as Lundbeck,<br />
avoiding risk is neither possible, nor is it a defined goal. Rather, one of Lundbeck’s<br />
goals is to handle such risk by maintaining a reasonable balance between the Group’s<br />
overall risk exposure and the anticipated value-generation and that the Group<br />
maintains the systems necessary to swiftly respond to any risk changes.<br />
L<br />
undbeck’s risk management systems<br />
are consistently updated and adapted<br />
to external and intra-Group requirements<br />
and needs. Such revisions help provide<br />
the Group management with a solid foundation<br />
from which to decide on Lundbeck’s overall<br />
risk exposure and an overview of the activities<br />
and resources available to handle specific<br />
risks.<br />
The pharmaceutical industry is characterised<br />
by a high number of risks which a group such<br />
as Lundbeck must handle. The general risks<br />
found in a pharmaceutical business are illustrated<br />
in the figure below.<br />
Lundbeck pursues decentralised management<br />
of specific risks in those parts of the organisation<br />
that have the most extensive knowledge<br />
of such risks and the best possibility of minimising<br />
such exposure. The individual business<br />
units take a systematic approach to monitoring,<br />
identifying, quantifying and responding to<br />
risks relative to their activities. Furthermore,<br />
Lundbeck has defined reporting, decision-making<br />
and follow-up procedures and routines.<br />
Particularly critical risks<br />
Based on reports received from its business<br />
entities, every six months Lundbeck management<br />
identifies the risks that are particularly<br />
critical for Lundbeck’s ability to achieve the<br />
Group’s business targets. These risks are monitored<br />
and evaluated in an ongoing process and,<br />
where possible, risk-reducing initiatives are<br />
made.<br />
The risks identified by management as particularly<br />
critical relative to the Group’s present risk<br />
exposure are described below. The risk factors<br />
are not listed in any order of priority.<br />
Risks associated with the Group’s research<br />
and development portfolio<br />
Lundbeck’s future success depends on its ability<br />
to develop new innovative pharmaceuticals.<br />
Risks in the pharmaceutical value chain<br />
Risks associated with corporate governance, business ethics and public reputation<br />
Y<br />
Risks associated with mergers, acquisitions and partnerships<br />
Financial risks<br />
Risks associated with employees and organisation<br />
Research Development Y<br />
Production<br />
Y<br />
Sales & marketing<br />
• Portfolio risk<br />
• In-licensing risk<br />
• Out-licensing risk<br />
• Technology risk<br />
• Protection of intellectual<br />
property rights<br />
• Partnership risk<br />
• Portfolio risk<br />
• Trial and product approval risk<br />
• Supply of materials for clinical<br />
trials<br />
• In-licensing risk<br />
• Out-licensing risk<br />
• Partnership risk<br />
• Regulatory risk<br />
• Risk related to reliability of supply<br />
• Supplier risk<br />
• Distribution risk<br />
• Protection of intellectual property<br />
rights<br />
• Generic competition<br />
• Adherence to sales and marketing<br />
guidelines<br />
• Product liability risk<br />
• Product recall<br />
• Risk in connection with price decrease<br />
and market access restrictions<br />
• Partnership risk<br />
36
Prior to obtaining regulatory approval for the<br />
sale of a product, Lundbeck must demonstrate<br />
for each specific indication the safety and efficacy<br />
of the drug candidate for the treatment<br />
of humans by conducting preclinical studies<br />
and clinical trials. Throughout the development<br />
stage, there is a risk of a development project<br />
suffering delays or being discontinued altogether.<br />
For example, in <strong>2007</strong> Lundbeck was<br />
compelled to discontinue the development of<br />
gaboxadol for the treatment of sleep disorders,<br />
although the pharmaceutical candidate had<br />
reached the late development stage.<br />
To minimise the business risks associated with<br />
the development of pharmaceuticals, Lundbeck<br />
consistently seeks, through in-house research<br />
and in-licensing of pharmaceuticals, to<br />
ensure a sufficiently broad portfolio of pharmaceutical<br />
candidates. In <strong>2007</strong>, Lundbeck initiated<br />
phase I trials with three new pharmaceutical<br />
candidates and in-licensed Circadin® for<br />
the treatment of primary insomnia.<br />
Risks associated with intellectual property<br />
rights and generic competition<br />
Lundbeck’s continued success hinges on its<br />
ability to protect intellectual rights for new<br />
pharmaceuticals and to operate its business<br />
without infringing on other’s rights. However,<br />
patents and the patent application process in<br />
pharmaceutical companies such as Lundbeck<br />
are legally and scientifically complicated processes<br />
and may be subject to uncertainty.<br />
To minimise the business risks associated with<br />
intellectual property rights and generic competition,<br />
Lundbeck thoroughly monitors and<br />
analyses the generic market and actively protects<br />
the company’s portfolio of intellectual<br />
property rights. In <strong>2007</strong>, Lundbeck was involved<br />
in pending patent trials in the USA, the<br />
UK, Australia, Canada, France and Germany. It<br />
is Lundbeck’s policy to defend the company’s<br />
intellectual property rights energetically, wherever<br />
they may be violated.<br />
Financial risks<br />
The bulk of the Group’s commercial transactions<br />
are settled in foreign currency. The foreign<br />
currency exposure is reduced by hedging<br />
positions in the most important foreign currencies<br />
through forward and option contracts<br />
and, to a minor extent, by raising foreign currency<br />
loans. The interest rate risk related to the<br />
Group’s bond portfolio, debt portfolio and cash<br />
holdings is reduced by seeking short duration<br />
on both the asset side and the liabilities side.<br />
The credit risk that arises in connection with<br />
the sale of goods, the Group’s bond portfolio<br />
and cash holdings is reduced by avoiding credit<br />
risk concentration and by diversifying receivables<br />
on a large number of creditworthy trading<br />
partners. In addition, the Group exclusively<br />
deals with banks that have a high credit rating.<br />
At the present time, the currency risk associated<br />
with the depreciating US dollar (USD) is<br />
the most critical financial risk to Lundbeck’s<br />
operations. At the end of <strong>2007</strong>, Lundbeck has<br />
hedged income in US dollars for the entire<br />
2008. Accordingly, if the US dollar depreciates<br />
further in 2008, this will not have any impact<br />
on Lundbeck’s financial results for 2008, but it<br />
may affect the company’s financial performance<br />
from 2009 onwards.<br />
Risks associated with price pressure and<br />
restricted market access<br />
The pharmaceutical market is characterised by<br />
the aim of the authorities to reduce prices and<br />
regulate access to the market in order to minimise<br />
increases in government healthcare<br />
budgets. Unexpected market changes such as<br />
price reductions may have a material impact<br />
on the earnings potential of each individual<br />
pharmaceutical.<br />
Lundbeck expects that new healthcare reforms<br />
will be initiated in 2008 in several of Lundbeck’s<br />
markets, reducing prices and restricting<br />
access for Lundbeck’s pharmaceuticals. Lundbeck<br />
has established functions to ensure systematic<br />
and coordinated monitoring and<br />
response with a view to maintaining pharmaceutical<br />
prices as well as market access. Also,<br />
Lundbeck continuously seeks to adjust its<br />
organisation to accommodate the effect of<br />
changes in market conditions for the Group’s<br />
pharmaceuticals.<br />
Risks associated with reliability of supply<br />
Managing reliability of supply is pivotal for<br />
Lundbeck, enabling the Group to secure patients’<br />
access to Lundbeck’s pharmaceuticals<br />
at all times.<br />
To handle the risk associated with reliability of<br />
supply, Lundbeck carefully monitors the supply<br />
situation, and in principle the aim is to maintain<br />
an inventory level that will help overcome<br />
a production breakdown. In addition, Lundbeck<br />
has prepared plans for accessing alternative<br />
production facilities. Conversely, having too<br />
high an inventory level may entail e.g. a financial<br />
risk, which the Group takes into account<br />
when evaluating the size of inventories held by<br />
Lundbeck or its collaboration partners.<br />
It sometimes happens that pharmaceutical<br />
companies have to recall a product from the<br />
market due to the safety or quality of the<br />
pharmaceutical. Fortunately, pharmaceuticals<br />
are seldom recalled because the health of the<br />
patients is in jeopardy. However, due to the serious<br />
consequences that such situations may<br />
have, it is paramount that pharmaceutical<br />
companies thoroughly monitor the safety and<br />
quality of their pharmaceuticals. At Lundbeck,<br />
quality and safety is a key concern, and the<br />
company has procedures and systems to ensure<br />
the quality and safety of its pharmaceuticals.<br />
If, despite high levels of quality and safety,<br />
Lundbeck should be faced with a situation in<br />
which the company has to recall a product,<br />
procedures to ensure a swift and efficient response<br />
have been set up and risk-reducing<br />
measures to minimise the impact of a product<br />
recall have been launched.<br />
The sale of counterfeit medicine in the pharmaceuticals<br />
market has become a growing<br />
problem in recent years. In particular, this has<br />
been a problem with respect to pharmaceuticals<br />
to treat impotence and regulate weight,<br />
which is not the type of pharmaceuticals that<br />
Lundbeck markets. So far, Lundbeck has only<br />
experienced very few cases where attempts<br />
have been made to sell counterfeit medicine in<br />
the Group’s markets in Asia and the Middle<br />
East.<br />
However, counterfeit pharmaceuticals represent<br />
a very serious problem as they jeopardise<br />
patient health and generally contribute to undermining<br />
confidence in the healthcare system.<br />
Lundbeck therefore continuously seeks to<br />
limit and counter any attempt to adulterate<br />
the Group’s pharmaceuticals.<br />
37
Nils Ole Dalby works as a scientist in Lundbeck’s department for<br />
electrophysiology. He measures neuronal activity in the parts of<br />
the brain that affect human sleep. Through the thin plastic tube<br />
he makes a pore in the cell membrane in order to penetrate the<br />
cell and measure the level of activity.
Primary<br />
insomnia<br />
P<br />
rimary insomnia is characterised by a<br />
person experiencing inadequate or<br />
poor-quality sleep. This may include<br />
difficulty falling asleep, waking up frequently<br />
during the night with difficulty returning to<br />
sleep, and/or experiencing unrefreshing sleep.<br />
Primary insomnia is not associated with other<br />
medical illnesses such as depression and is not<br />
caused by the intake of substances such as<br />
caffeine, nor that a person is kept awake by<br />
factors such as pain in connection with an injury<br />
or disease. Insomnia is very common, and<br />
it is estimated that about 27% of a population<br />
suffers from insomnia and that it affects about<br />
15% of people aged 20-54 and 30% of those<br />
aged 55 or over. Insomnia is more common<br />
among women than among men.<br />
Insomnia affects a person’s ability to function<br />
during the daytime and may in the long term<br />
affect quality of life and have adverse economic<br />
implications.<br />
Lundbeck has in-licensed Circadin® for the<br />
treatment of primary insomnia for patients<br />
aged 55 or over from Neurim Pharmaceuticals<br />
Ltd. and expects to launch the pharmaceutical<br />
in the first markets in Europe during 2008.<br />
39
The Lundbeck<br />
share<br />
In connection with the ongoing share buyback programme, Lundbeck bought<br />
back shares at a value of DKK 1.2 billion in <strong>2007</strong>. This corresponds to 3.6% of the<br />
market capitalisation at the beginning of the year. Lundbeck’s Supervisory Board<br />
recommends that dividends of DKK 2.56 per share be paid for the year.<br />
T<br />
he Lundbeck share ranks among the 20<br />
most traded shares on OMX Nordic<br />
Exchange Copenhagen*. The price of<br />
the Lundbeck share fluctuated heavily in <strong>2007</strong>.<br />
The share price closed at a year-high of DKK<br />
170.25 on 7 February <strong>2007</strong> and was quoted at<br />
the lowest closing price on 17 August <strong>2007</strong> at<br />
DKK 125.50. On 31 December <strong>2007</strong>, the share<br />
closed at a price of DKK 138.00.<br />
Trading of shares<br />
Total trading in Lundbeck shares in <strong>2007</strong><br />
amounted to DKK 23.5 billion on OMX Nordic<br />
Exchange Copenhagen, an increase of 3% relative<br />
to 2006. The number of shares traded fell<br />
by 2% from 168 million traded shares in 2006<br />
to 164 million traded shares in <strong>2007</strong>.<br />
Dividend<br />
Lundbeck’s Supervisory Board proposes the<br />
payment of dividend of 30% of the net profit<br />
for the year after tax, corresponding to DKK<br />
2.56 per share.<br />
The dividend for the year will be paid automatically<br />
via the Danish Securities Centre no<br />
later than five days after Lundbeck has held its<br />
Annual General Meeting on 22 April 2008.<br />
Share capital<br />
The denomination of each share is DKK 5<br />
nominal value. The number of shares at 31<br />
December <strong>2007</strong> was 207,279,631, corresponding<br />
to a nominal share capital of DKK<br />
1,036,398,155. The company has only one<br />
class of shares, and all shares rank equally. The<br />
shares are negotiable instruments with no restrictions<br />
on their transferability.<br />
The company changed its share capital on six<br />
occasions during <strong>2007</strong> as a result of employees<br />
exercising warrants. A total of 992,121<br />
new shares were issued in <strong>2007</strong>. The authorisation<br />
to issue new shares and increase the share<br />
capital appears from article 4 of Lundbeck’s<br />
Articles of Association.<br />
As a result of the resolution passed at the Annual<br />
General Meeting to cancel treasury shares<br />
acquired, on 3 August <strong>2007</strong> the company’s<br />
share capital was reduced by 5,867,644 shares,<br />
corresponding to DKK 29,338,220.<br />
Facts about the Lundbeck share on OMX<br />
Nordic Exchange Copenhagen:<br />
ISIN-number DK0010287234<br />
Ticker symbol Reuters (LUN.CO)<br />
Bloomberg (LUN DC)<br />
Facts about unsponsored ADR programmes:<br />
CUSIP-number 40422M107<br />
ADR ticker symbol HLUKY<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
* Formerly called the Copenhagen Stock Exchange<br />
<br />
<br />
40
Annual General Meeting<br />
Lundbeck’s Annual General Meeting will be held on 22 April 2008<br />
at 10am at H. Lundbeck A/S, Ottiliavej 9, DK-2500 Valby.<br />
The Annual General Meeting will be transmitted live in Danish and<br />
English and may be downloaded later from lundbeck.com/investor.<br />
At the end of <strong>2007</strong>, Lundbeck held treasury<br />
shares equivalent to 3.21% of the total<br />
number of shares issued.<br />
Share buyback programme<br />
Lundbeck continues the ongoing share buyback<br />
programme, under which Lundbeck intends<br />
to buy back shares of up to DKK 6 billion<br />
until the end of 2008. The programme was initiated<br />
in 2005.<br />
As Lundbeck has appointed an external bank<br />
(Danske Markets from 1 January 2008) as lead<br />
manager of its share buyback programme, the<br />
bank will buy back shares on behalf of Lundbeck<br />
and make trading decisions in respect of<br />
Lundbeck shares independently of and without<br />
influence from Lundbeck as to the timing of<br />
the purchases. The bank will also carry out the<br />
buyback within the schedule set out.<br />
Lundbeck is entitled to terminate the programme<br />
at any time as a consequence of<br />
changes to the company’s financial position or<br />
changes in the market, for example acquisition<br />
or in-licensing opportunities.<br />
In <strong>2007</strong>, Lundbeck bought back shares for DKK<br />
1.2 billion, corresponding to approximately<br />
20% of the combined programme of DKK 6<br />
billion. Thus, Lundbeck has completed 59% of<br />
the combined programme.<br />
Share capital<br />
Share Cancellation<br />
2006, Share capital of shares <strong>2007</strong>,<br />
year-end buyback increase bought back year-end<br />
Shares issued 212,155,154 992,121 (5,867,644) 207,279,631<br />
Treasury shares 3,963,353 8,557,204 (5,867,644) 6,652,913<br />
Share capital 1.87% 3.21%<br />
Share buyback, 2005-<strong>2007</strong><br />
Number of shares Value, DKK Average price, DKK<br />
Q3 93,458 14,929,608 159.75<br />
Q4 5,147,176 712,030,953 138.33<br />
Total 2005 5,240,634 726,960,561 138.72<br />
Q1 8,048,509 1,064,656,508 132.28<br />
Q2 1,688,736 219,924,665 130.23<br />
Q3 1,843,524 245,739,480 133.30<br />
Q4 431,093 60,733,434 140.88<br />
Total 2006 12,011,862 1,591,054,086 132.46<br />
Q1 1,904,291 280,961,907 147.54<br />
Q2 1,993,588 258,267,537 129.55<br />
Q3 1,878,152 245,205,051 130.56<br />
Q4 2,781,173 406,866,308 146.29<br />
Total <strong>2007</strong> 8,557,204 1,191,300,802 139.22<br />
Accumulated 25,809,700 3,509,315,449 135.97<br />
The Lundbeck Foundation will through its<br />
wholly owned subsidiary LFI a/s participate in<br />
the buyback on a pro rata basis in order to<br />
maintain the free float at approximately 30%.<br />
See release no. 166 to the OMX Nordic Exchange<br />
Copenhagen at www.lundbeck.com/investor.<br />
41
Website<br />
Lundbeck aims to provide a good overview of the company’s development to its shareholders and stakeholders.<br />
Lundbeck.com/investor provides releases to OMX Nordic Exchange Copenhagen, financial presentations, background<br />
material about products and annual and interim reports since the company’s IPO in 1999. Moreover, the<br />
website allows for the viewing of transmissions from general meetings and access to quarterly conference calls,<br />
at which the Lundbeck management comments on business developments.<br />
Composition of shareholders<br />
The company’s shares are registered by name<br />
and entered in the register of shareholders. At<br />
the end of <strong>2007</strong>, approximately 25,200 registered<br />
shareholders held about 97% of the<br />
share capital.<br />
Through its wholly owned company LFI a/s,<br />
the Lundbeck Foundation, which is the company’s<br />
largest shareholder, held 141,443,241<br />
shares at the end of <strong>2007</strong>, corresponding to<br />
approximately 70% of the shares and votes in<br />
H. Lundbeck A/S. LFI a/s is the only shareholder<br />
who has notified the company that it holds<br />
more than 5% of the share capital.<br />
Institutional investors in North America increased<br />
their holdings of Lundbeck shares<br />
throughout <strong>2007</strong> to hold approximately 28%<br />
of the free float at 31 December <strong>2007</strong>. This is<br />
an increase of 231% or more than 40 million<br />
shares compared with 2006. International institutional<br />
investors now hold more than 50%<br />
of the free float.<br />
During <strong>2007</strong>, Danish institutional investors reduced<br />
their holdings of Lundbeck shares in free<br />
float from 33% to 24%. European institutional<br />
investors kept their ownership at a fairly constant<br />
level, but their stake was reduced as a result<br />
of the company issuing treasury shares.<br />
The share of the free float held by private investors<br />
has declined to approximately 15%.<br />
Share ratios<br />
Ratios per share, DKK <strong>2007</strong> 2006<br />
Earnings per share (EPS)* 8.63 5.24<br />
Diluted earnings per share (DEPS)** 8.63 5.23<br />
Cash flow 13.18 6.59<br />
Net asset value 35.81 32.40<br />
Dividend 2.56 1.57<br />
Dividend pay-out ratio 30% 30%<br />
Price-related data, DKK <strong>2007</strong> 2006<br />
Market price, year-end 138.00 155.75<br />
High market price 170.25 155.75<br />
Low market price 125.50 122.25<br />
Average price 144.33 136.12<br />
H. Lundbeck A/S, growth -11.4% 19.5%<br />
OMXC20, growth 5.1% 12.2%<br />
CX35PI, growth 9.0% 34.4%<br />
Price/earnings 16.0 29.80<br />
Price/cash flow 10.47 23.66<br />
Price/net asset value 3.85 4.81<br />
Market capitalisation, year-end, DKKbn 28.6 33.1<br />
Annual trading, million of shares 164.3 167.9<br />
* Number of shares used for EPS calculation: 204,990,396<br />
** Number of shares used for DEPS calculation: 205,153,080<br />
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At the end of <strong>2007</strong>, members of Lundbeck’s<br />
Supervisory Board and Executive Management<br />
held a total of 81,630 Lundbeck shares.<br />
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42
Analyst coverage<br />
Company Name Website<br />
ABG Sundal Collier Peter Hugreffe Ankersen www.abgsc.com<br />
Blue Oak Capital John Reeve www.blueoakcapital.com<br />
Carnegie Bank Carsten Lønborg Madsen www.carnegie.dk<br />
Credit Suisse Ravi Mehrotra www.credit-suisse.com<br />
Dansk Aktie Analyse Peter Falk-Sørensen www.danskaktieanalyse.dk<br />
Danske Equities Martin Parkhøi www.danskeequities.com<br />
Deutsche Bank Brian White www.db.com<br />
Dresdner Kleinwort Wasserstein Tero Weckroth www.drkwresearch.com<br />
Exane BNP Paribas Jonathan Kwok www.exane.com<br />
Goldman Sachs Dani Saurymper www.gs.com<br />
Handelsbanken Michael Novod www.handelsbanken.com<br />
ING Tim Race www.ing.com<br />
JP Morgan Annie J. Cheng www.jpmorgan.com<br />
Jyske Bank Peter B. Andersen www.jyskebank.com<br />
Kaupthing Poul La Cour www.kaupthing.com<br />
Merrill Lynch Erica Whittaker www.ml.com<br />
Brigitte de Lima<br />
Morgan Stanley Caius Christoe www.morganstanley.com<br />
Oppenheim Peter A. Düllmann www.oppenheim.com<br />
Redburn Partners Paul Major www.redburn.com<br />
SEB Enskilda Henrik D. Simonsen www.enskilda.com<br />
Societe Generale Ian Wainwright www.sgcib.com<br />
Standard & Poors Torben Vest www.standardandpoors.com<br />
Sydbank Rune Majlund Dahl www.sydbank.dk<br />
Investor Relations contacts<br />
Jacob Tolstrup<br />
Director<br />
Tel. +45 36 43 30 79<br />
Fax + 45 36 43 82 62<br />
jtl@lundbeck.com<br />
Palle Holm Olesen<br />
Head of Investor Relations<br />
Tel. + +45 36 43 24 26<br />
Fax + 45 36 43 82 62<br />
palo@lundbeck.com<br />
Thomas Bay-Wedel<br />
Investor Relations Officer<br />
Tel. + 45 36 43 39 80<br />
Fax + 45 36 43 82 62<br />
tbw@lundbeck.com<br />
Financial calendar 2008<br />
Date<br />
Event<br />
4 March Announcement of the financial results for the period<br />
1 January-31 December <strong>2007</strong><br />
22 April Annual General Meeting 2008<br />
7 May Interim report for the first quarter of 2008 (January-March)<br />
13 August Interim report for the second quarter of 2008 (April-June)<br />
12 November Interim report for the third quarter of 2008 (July-September)<br />
43
In Lundbeck’s department for analytical chemistry, senior laboratory<br />
technician Rikke García Andreasen is examining how the release of<br />
the active ingredient Lu 31-130 for the treatment of schizophrenia<br />
is progressing. The tablets are put into so-called dissolution vessels,<br />
and samples are taken for subsequent analysis. The results are used<br />
to sketch a dissolution profile that can indicate how quickly the<br />
compound is released from the tablet after administration.
Schizophrenia and<br />
psychotic disorders<br />
S<br />
chizophrenia is a mental disorder that<br />
occurs in varying degrees but is most<br />
often chronic. Up to 1% of the population<br />
is directly affected by schizophrenia.<br />
Schizophrenia is the most common psychotic<br />
disorder. The disease most often occurs in late<br />
adolescence or early adulthood and is characterised<br />
by distinct changes in the patient’s way<br />
of thinking and perception of the outside<br />
world. Furthermore, schizophrenia is characterised<br />
by short or long periods during which the<br />
patient is in an acute psychotic condition, suffering<br />
from definite hallucinations and delusions.<br />
But there are also stable periods during<br />
which the patient experiences a significant reduction<br />
in symptoms or is symptom-free.<br />
Even in stable periods, many patients have difficulty<br />
in establishing social contact, complete<br />
an education programme or hold a normal job.<br />
Schizophrenia patients have difficulty in performing<br />
even everyday activities such as cooking,<br />
personal hygiene and cleaning.<br />
The disease is often disabling and can be very<br />
painful, first and foremost to the patient, but<br />
also to the patient’s relatives.<br />
According to WHO, there are 25 million cases<br />
of schizophrenia worldwide at any given time.<br />
Lundbeck markets Serdolect® for the treatment<br />
of schizophrenia. In addition, Lundbeck is<br />
developing bifeprunox for the treatment of<br />
schizophrenia, Lu 31-130 for the treatment of<br />
psychoses and Lu AA39959 for the treatment<br />
of psychoses and bipolar disorder.<br />
45
Focused efforts:<br />
Environment, health<br />
and safety<br />
Lundbeck aims to conduct its activities in a way that harms neither its employees nor its<br />
local communities in the countries in which it operates. In <strong>2007</strong>, Lundbeck increased its<br />
production without recording a corresponding increase in its consumption of raw materials,<br />
energy and water and also recorded the lowest number of accidents in four years.<br />
In addition, Lundbeck has defined a new goal to reduce Lundbeck’s CO 2<br />
emissions by 2016.<br />
L<br />
undbeck’s development of pharmaceuticals<br />
and manufacturing processes is<br />
based on chemical synthesis. This<br />
means that Lundbeck’s most significant effects<br />
on humans and the environment derive from<br />
consumption of raw materials – primarily organic<br />
solvents, energy and water – along with<br />
waste production and the emission of solvents<br />
into the air.<br />
The active ingredients in Lundbeck’s pharmaceuticals<br />
are manufactured at Seal Sands in<br />
the UK, Lumsås in Denmark and Padova in<br />
Italy. These factories have been certified to<br />
the ISO 14001 environmental standard for a<br />
number of years. In <strong>2007</strong>, this certification was<br />
extended to Lundbeck’s production of finished<br />
pharmaceuticals. All Lundbeck’s production<br />
sites now follow the same system in their environment,<br />
health and safety initiatives: Lundbeck’s<br />
HS&E 1 system, which complies with<br />
ISO 14001 and OHSAS 18001.<br />
Certification of the HS&E system will be completed<br />
in 2008 with the inclusion of the remaining<br />
areas of Lundbeck’s Valby headquarters<br />
and its research unit in New Jersey, USA.<br />
This will conclude a four-year strategic initiative<br />
aimed at ensuring that Lundbeck will, also<br />
in the years ahead, show a continuing commitment<br />
to constantly improve its environmental<br />
protection measures and the health and safety<br />
conditions offered to its employees.<br />
Read more about the specific improvements<br />
made to Lundbeck’s production facilities in<br />
<strong>2007</strong> at lundbeck.com/sustainability.<br />
1) Health, Safety and Environment<br />
HS&E strategy 2010 updated<br />
Lundbeck aims to ensure a safe and healthy<br />
working environment for its employees and<br />
take responsibility for its environmental impact.<br />
The ambition is to be one of the leading<br />
businesses in the field of health, safety and the<br />
environment. To put action behind its words,<br />
Lundbeck management adopted a focused<br />
strategy in 2004 involving ten focus areas as<br />
outlined in the figure on the next page. Management<br />
is very satisfied to note that the<br />
strategy is progressing according to plan. By<br />
the end of <strong>2007</strong>, halfway through the<br />
2005-2010 strategy period, more than half of<br />
the strategy’s activities had been implemented<br />
in the company’s day-to-day operations.<br />
With the support of management and employees<br />
alike, the strategy has helped to ensure<br />
significant progress in accordance with the<br />
company’s health, safety and environment<br />
(HS&E) policy. The specific improvements involve<br />
a reduced resource consumption, lower<br />
solvent emissions, the introduction of routines<br />
for environmental assessment of new pharmaceuticals<br />
and an evaluation of suppliers with<br />
respect to environmental and employee conditions.<br />
Also, data compilation and communication<br />
about Lundbeck HS&E matters and initiatives<br />
have been expanded and improved.<br />
One of Lundbeck’s goals for <strong>2007</strong> was to update<br />
Lundbeck’s HS&E strategy 2010, which<br />
will enable the company to continue the positive<br />
trends in the years ahead.<br />
The updated strategy builds on experience<br />
gained and on improved systems for analysis<br />
and follow-up. This provides for a more precise<br />
analysis of problems, allowing the company to<br />
customise more effective solutions. In the<br />
years ahead, Lundbeck will use this platform to<br />
increase its focus on matters such as HS&E<br />
considerations when developing new pharmaceuticals,<br />
minimising resource consumption<br />
and waste in the business, and implementing<br />
Lundbeck’s CO 2<br />
strategy.<br />
For all strategy focus areas, Lundbeck has defined<br />
clear success criteria to determine when<br />
an initiative has been accomplished. Lundbeck<br />
has also defined a number of indicators for its<br />
impact on people and the environment for inhouse<br />
and external benchmarking purposes.<br />
Lundbeck intends to use these success criteria<br />
and indicators to regularly monitor whether<br />
Lundbeck ranks among the leading companies<br />
in the HS&E field.<br />
Lundbeck defines targets for<br />
CO 2<br />
emissions<br />
Energy, carbon dioxide and the climate are<br />
topics that dominate in the media and affect<br />
the political debate. Companies and others are<br />
expected to take responsibility for their actions<br />
and reduce greenhouse gas emissions as<br />
much as possible.<br />
Lundbeck intends to act responsibly in terms<br />
of energy consumption and CO 2<br />
emissions.<br />
Thus, in <strong>2007</strong>, Lundbeck’s Executive Management<br />
adopted a long-term CO 2<br />
strategy defining<br />
targets for reductions in the company’s<br />
CO 2<br />
emissions. As part of this strategy, Lundbeck<br />
intends to sever the connection between<br />
business growth, energy consumption and resultant<br />
CO 2<br />
emissions. The specific target is for<br />
CO 2<br />
emissions in 2016 not to exceed the level<br />
recorded in 2006.<br />
46
Lundbeck sets high standards not only for the<br />
Group’s in-house health, safety and environment<br />
initiatives, but also expects that its<br />
suppliers maintain high standards with respect<br />
to the environment and employee conditions.<br />
Read the article Inge’s forest in<br />
the Lundbeck Magazine 2008<br />
In 2006, Lundbeck emitted 45,000 tonnes of<br />
CO 2<br />
, 27% deriving from the burning of fossil<br />
fuels in its own boiler plants and 73% from<br />
external supplies of power and heating. These<br />
calculated CO 2<br />
emissions include those from<br />
Lundbeck’s facilities for research, development<br />
and production.<br />
Lundbeck is not under any legal obligation to<br />
reduce its CO 2<br />
emissions, but adopting this<br />
goal is a natural next step in the company’s<br />
long-standing efforts to optimise its energy<br />
consumption.<br />
Until 2016, this CO 2<br />
strategy will lay the foundation<br />
for energy conservation efforts<br />
throughout the Group. The efforts involve the<br />
systematic mapping and implementation of<br />
projects aimed at energy savings and reducing<br />
CO 2<br />
emissions from Lundbeck’s research, development<br />
and manufacturing locations.<br />
The initiatives will be coordinated from Lundbeck’s<br />
headquarters, and this will centralise the<br />
prioritisation of projects so that Lundbeck can<br />
achieve optimum energy savings and reductions<br />
in CO 2<br />
emissions.<br />
The CO 2<br />
strategy matches well with Lundbeck’s<br />
traditions for research, development and<br />
process optimisation. It also fits well with Lundbeck’s<br />
Lean programme, which aims to eliminate<br />
waste and boost quality in the production<br />
department. A number of improvements have<br />
already been made that benefit productivity<br />
and reduce energy consumption, which will<br />
help achieve the CO 2<br />
target for 2016.<br />
Lundbeck is off to a good start with these initiatives.<br />
Total emissions in <strong>2007</strong> amounted to<br />
Lundbeck’s HS&E strategy 2005-2010 05 06 07 08 09 10<br />
HS&E system<br />
HS&E system certified to ISO 14001 and OHSAS 18001 in<br />
research and development, production and headquarters.<br />
Targets and data<br />
Determine and follow up on HS&E targets.<br />
Compile and report HS&E data.<br />
HS&E considerations in pharmaceutical development<br />
Environmental toxicology studies of new pharmaceuticals.<br />
System for including HS&E considerations in development projects.<br />
Consumption and waste<br />
System for including HS&E considerations in productivity<br />
improvements.<br />
Action plan to minimise consumption and waste and recycle more.<br />
Energy optimisation and CO 2<br />
strategy<br />
Action plan for energy optimisation.<br />
Lundbeck CO 2<br />
strategy with the main emphasis on energy optimisation.<br />
Evaluation of suppliers<br />
System for evaluation of suppliers based on environmental<br />
and employee conditions.<br />
Prevent physical and psychological health and safety issues<br />
Create a safe and healthy working environment through<br />
prevention and training.<br />
Health-promoting policy.<br />
Communication<br />
Strategy for in-house and external HS&E communication<br />
about Lundbeck’s HS&E initiatives.<br />
Legislation and requirements<br />
System for monitoring and implementing statutory<br />
and non-mandatory requirements.<br />
Strategy and organisation<br />
HS&E strategy for decisions and organisation of HS&E work.<br />
= Establish = Maintain and develop<br />
47
44,100 tonnes, which was slightly less than in<br />
2006. This single figure actually covers two different<br />
elements: lower energy consumption<br />
levels at Lundbeck’s research, development and<br />
production facilities in Denmark, Italy and the<br />
UK and new data added for energy consumption<br />
from Lundbeck’s research unit in New Jersey<br />
in the USA.<br />
Lundbeck’s long-term growth targets and the<br />
expansion of its facilities in Denmark and the<br />
USA do not make its CO 2<br />
targets for 2016 any<br />
less ambitious.<br />
Health and safety<br />
Lundbeck aims to ensure that its employees<br />
enjoy a safe and healthy working environment.<br />
As in previous years, Lundbeck improved both<br />
its physical and psychological working environment<br />
in <strong>2007</strong>.<br />
The number of industrial accidents occurring at<br />
Lundbeck has been very low for many years<br />
and below the industry average. Hence it is particularly<br />
pleasing to see that the positive trend<br />
in registering near-misses between 2003 and<br />
2006 continued in <strong>2007</strong>. This means that more<br />
problems are being resolved before they develop;<br />
a trend which is reflected in the number<br />
of lost-time accidents and the frequency of accidents,<br />
as both figures dropped in <strong>2007</strong> to<br />
their lowest level in four years. The accidents<br />
that did occur in <strong>2007</strong> were less serious ones,<br />
and the number of lost workdays per accident<br />
remained unchanged compared with 2006.<br />
In <strong>2007</strong>, Lundbeck contributed to the development<br />
of a Danish information campaign on<br />
safety in the workplace. The campaign was conducted<br />
by Industriens Branchearbejdsmiljøråd<br />
(a board that advises industry on matters related<br />
to health and safety) and involved a spot<br />
on national television and a website. The aim<br />
was to promote dialogue on safety in the workplace,<br />
as there has been an increase in the<br />
number of accidents in Danish industrial workplaces<br />
in recent years.<br />
The work to ensure a good psychological working<br />
environment at Lundbeck continued in<br />
<strong>2007</strong> with the cross-organisational project entitled<br />
No Stress. The project group consists of<br />
employees and managers from Human Resources,<br />
the HS&E department, the works<br />
council and the safety organisation.<br />
The project involved planning courses on the<br />
topic for Lundbeck’s managers, shop stewards<br />
and safety representatives. Other specific results<br />
from the projects are presented on the<br />
Lundbeck intranet together with good advice<br />
and tools that can be used by departments and<br />
individual employees to prevent and handle<br />
stress. The intranet provides a number of case<br />
stories on the prevention and handling of stress<br />
told by Lundbeck managers and staff. These<br />
cases show that an increasing number of departments<br />
are taking preventive measures in<br />
this often difficult and tabooed topic.<br />
Lundbeck has added a stress indicator in the<br />
company’s employee satisfaction survey to the<br />
range of tools it uses to monitor the psychological<br />
working environment. The aim is to<br />
maintain a focus on the topic and to monitor<br />
changes in the factors that affect employee<br />
stress levels. With these initiatives, Lundbeck<br />
aims to maintain a healthy psychological working<br />
environment, also in the long term.<br />
Health and safety statistics, 2003-<strong>2007</strong><br />
2003 2004 2005 2006 <strong>2007</strong><br />
Lost-time accidents 19 32 25 27 22<br />
Recorded near-misses 41 78 160 258 250<br />
Indicators for prevention of accidents: near-misses per registered<br />
lost-time accident 2.2 2.4 6.4 9.6 11.4<br />
Number of lost workdays per accident 8.1 9.7 9.0 10.9 11.0<br />
Accident frequency: number of lost-time accidents per million hours of work 4.5 8.8 7.2 7.8 5.9<br />
48
Environmental impact under full control<br />
The positive trends in the key environmental impact figures from Lundbeck’s pharmaceutical research, development<br />
and production continued in <strong>2007</strong>. Although Lundbeck recorded an increase in the consumption of raw materials,<br />
energy and water in <strong>2007</strong>, the rise was lower than the increase in production, which is what has the greatest impact<br />
on these indicators. Starting in <strong>2007</strong>, the calculation includes Lundbeck’s research unit in New Jersey, USA, which<br />
also raises consumption and emission levels. The complete set of data is available at lundbeck.com/sustainability.<br />
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<br />
Production up and raw materials consumption down<br />
In <strong>2007</strong>, Lundbeck used 4,440 tonnes of solvents in its chemical production, 32 of which were used<br />
in research, development and pharmaceutical production at Group headquarters. Lundbeck’s research<br />
unit in the USA used three tonnes of solvents in <strong>2007</strong>.<br />
Production of active ingredients and intermediates rose 10% and production of finished goods 14%<br />
relative to 2006. Lundbeck’s research laboratories optimised their work routines, increased their focus<br />
on small-scale synthesis chemistry and outsourced a number of medium-scale synthesis<br />
<br />
projects to contract laboratories.<br />
Overall consumption of raw materials was up by a mere 4%. This figure reflects a 1% decline in the<br />
<br />
consumption of solvents and a 13% increase in the use of other raw materials, including the active<br />
ingredients used in Lundbeck’s pharmaceuticals.<br />
Total energy consumption in <strong>2007</strong> was 127,200 MWh, with a resultant total of 44,100 tonnes of<br />
CO 2<br />
emissions from Lundbeck’s boiler plant and external supplies of power and district heating.<br />
Lundbeck’s combined energy consumption was 7,100 MWh higher than in 2006, but this increase<br />
was exclusively due to the addition of data from the research unit in the USA. Without this addition,<br />
total energy consumption would have been 7,400 MWh lower than in 2006. The total consumption<br />
of water rose 2% relative to 2006, again due to the addition of consumption figures from<br />
the research unit in the USA.<br />
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<br />
<br />
Low solvent emissions despite increase in <strong>2007</strong><br />
When you work with organic solvents, there is no way to avoid a low level of emissions into the<br />
atmosphere through ventilation air. Lundbeck has been successfully reducing emissions over a<br />
number of years, partly by planning its work so processing takes place in a closed system and partly<br />
by purifying the ventilation air before releasing it outdoors. The total loss of solvents in Lundbeck’s<br />
ventilation air in <strong>2007</strong> was thus less than 1% of total solvent consumption.<br />
<br />
For the first time in five years, <strong>2007</strong> saw an increase in total emissions of organic solvents to a level<br />
of 35 tonnes, which is 57% more than in 2006. This undesirable trend is now under control. The increase<br />
was solely due to higher emissions from the Lumsås<br />
<br />
<br />
manufacturing<br />
<br />
facility. The increase was<br />
the result not only of a higher production output and consumption of solvents, but also of a<br />
number of independent changes made to production and operation conditions for the machinery<br />
that purifies the air before it is emitted. It is important to emphasise that <strong>2007</strong> emissions remained<br />
<br />
at a low level and were hazardous to neither people nor the environment.<br />
<br />
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<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
Construction activity adds to total waste volumes<br />
Lundbeck’s waste consists primarily of chemical waste, which accounts for 75% of the total waste<br />
volume. This percentage has remained stable over the past five years, but the total volume of waste<br />
has dropped. During this same five-year period, the waste volume remained proportional to the<br />
production of active ingredients and intermediates.<br />
<br />
Relative to 2006, the total waste volume rose by 2,800 tonnes in <strong>2007</strong>. The increase was primarily<br />
<br />
due to the expansion of Lundbeck’s Danish headquarters with new buildings. Most of the construction<br />
waste was recycled. Chemical waste accounts for only one-fifth of the increase in terms of to-<br />
<br />
tal waste volume. This increase was lower than the corresponding increase in the production of active<br />
ingredients and intermediates.<br />
<br />
Less than 1% of Lundbeck’s total waste volume was disposed of in landfills in <strong>2007</strong>.<br />
<br />
49
Lundbeck’s HS&E strategy 2010, target status in <strong>2007</strong> and new targets for 2008<br />
Lundbeck HS&E strategy 2010<br />
HS&E system<br />
• HS&E system certified to ISO 14001 and OH-<br />
SAS 18001 in research and development, production<br />
and headquarters.<br />
HS&E considerations in drug development<br />
• Environmental toxicology studies of new<br />
pharmaceuticals.<br />
• System for including HS&E considerations in<br />
development projects.<br />
Consumption and waste<br />
• System for including HS&E considerations in<br />
productivity improvements.<br />
• Action plan to minimise consumption and<br />
waste and to recycle more.<br />
Energy optimisation and CO 2<br />
strategy<br />
• Action plan for energy optimisation.<br />
• Lundbeck CO 2<br />
strategy with the main<br />
emphasis on energy optimisation.<br />
Evaluation of suppliers<br />
• System for evaluation of suppliers based on<br />
environmental and employee conditions.<br />
Preventing physical and psychological<br />
health and safety issues<br />
• Create a safe and healthy working environment<br />
through prevention and training.<br />
• Health-promoting policy.<br />
Communication<br />
• Strategy for in-house and external HS&E<br />
communication about Lundbeck’s HS&E<br />
initiatives.<br />
Strategy and organisation<br />
• HS&E strategy for decisions and organisation<br />
of HS&E work.<br />
Target status in <strong>2007</strong><br />
+<br />
+<br />
–<br />
+<br />
+<br />
–<br />
+<br />
+<br />
+<br />
+<br />
–<br />
+<br />
+<br />
+<br />
+<br />
Implement the HS&E system in Lundbeck,<br />
Denmark.<br />
Achieve ISO 14001 and OHSAS 18001 certification<br />
of Lundbeck’s production sites.<br />
Conduct environmental toxicology studies of<br />
the development candidate bifeprunox.<br />
Replace substances or materials that have an<br />
adverse impact on the environment or working<br />
environment.<br />
Reduce emissions of volatiles through the use<br />
of solvent savers, solvent supermarkets,<br />
process optimisation or substitution in all<br />
relevant areas.<br />
Prepare a minimum of four business cases<br />
that illustrate the financial impact of Lundbeck’s<br />
HS&E initiatives.<br />
Define a CO 2<br />
strategy and adopt long-term<br />
targets for CO 2<br />
emissions.<br />
Conduct at least 20 energy and resourcesaving<br />
activities, including identification and<br />
energy investigations.<br />
Perform audits of two suppliers with respect<br />
to environmental and employee conditions.<br />
Identify unwanted noise in the APV (workplace<br />
assessment) and attenuate all noise<br />
above 80 dB(A) at stationary work stations<br />
when technically and financially feasible.<br />
Launch an HS&E module in Lundbeck’s management<br />
training programme.<br />
Reduce the number of lost-time accidents in<br />
<strong>2007</strong> relative to 2006.<br />
Reduce the frequency of lost-time accidents<br />
in <strong>2007</strong> relative to 2006.<br />
Register at least seven near-misses per registered<br />
lost-time accident.<br />
No specific targets had been defined for this<br />
area for <strong>2007</strong>.<br />
Update Lundbeck’s HS&E strategy in collaboration<br />
with relevant stakeholders.<br />
Targets for 2008<br />
• Complete ISO 14001 and OHSAS 18001<br />
certification of Lundbeck’s HS&E system.<br />
• Define method for systematic HS&E<br />
assessment of development projects.<br />
• Identify Lundbeck’s consumption of goods and<br />
handling of waste and draw up a combined<br />
action plan.<br />
• Optimise consumption of raw materials and<br />
minimise the volume of waste through local<br />
activities in at least 15 departments.<br />
• Contribute to Lundbeck’s CO 2<br />
strategy by<br />
accomplishing specific energy-saving initiatives<br />
in at least 15 departments.<br />
• Define guidelines for HS&E assessment of<br />
commercial purchasing.<br />
Noise and harmful noise<br />
• Conduct activities related to noise action plan<br />
2008-2010 in Denmark.<br />
• Reduce harmful and unnecessary noise through<br />
local activities in at least 15 departments.<br />
Working positions and heavy lifts<br />
• Conduct a combined mapping of heavy lifts<br />
and inappropriate work positions.<br />
• Reduce heavy lifts and inappropriate working<br />
positions through local activities in at least 15<br />
departments.<br />
Psychological working environment<br />
• Conduct activities to focus on the psychological<br />
working environment in at least 25 departments.<br />
Accidents<br />
• Launch global Lundbeck accident database.<br />
• Reduce the number of lost-time accidents in<br />
2008 relative to <strong>2007</strong>.<br />
• Reduce the frequency of lost-time accidents<br />
in 2008 relative to <strong>2007</strong>.<br />
Health promotion<br />
• Implement Lundbeck’s strategy for health promotion<br />
with goals, targets and measurements.<br />
• Update websites at lundbeck.com/<br />
sustainability.<br />
• Update Lundbeck’s HS&E strategy in collaboration<br />
with relevant stakeholders.<br />
+<br />
–<br />
= Target met = Target not met<br />
50
The right skills<br />
for the new decade<br />
In <strong>2007</strong>, Lundbeck strengthened its efforts to recruit and retain the employees that it<br />
needs to successfully lead the company into the next decade. Accordingly, the company<br />
developed plans and programmes for management development, talent management<br />
and employer branding and invested extensively in employee health and competencybuilding<br />
initiatives.<br />
L<br />
undbeck is an international company<br />
with more than 5,300 employees.<br />
Headquartered in Denmark, the Group<br />
has employees in 54 countries. More than 62%<br />
of Lundbeck’s employees are employed outside<br />
Denmark, a figure that has increased steadily<br />
over the past six years.<br />
Lundbeck is a fully integrated pharmaceutical<br />
company, possessing competencies throughout<br />
its value chain. Of total staff, 22% are engaged<br />
in research and development, 18% in<br />
production, 44% in sales and marketing, and<br />
15% in administrative functions.<br />
In <strong>2007</strong>, Lundbeck’s HR organisation focused<br />
on three development areas: manager and employee<br />
development, recruiting and retaining<br />
talent and well-being in the workplace.<br />
A single leadership development<br />
programme<br />
In <strong>2007</strong>, Lundbeck’s HR organisation focused<br />
on setting up a single and targeted leadership<br />
development programme with the aim of preparing<br />
the Group’s managers for present and<br />
future challenges.<br />
The programme aims to enable all managers<br />
to motivate, develop and coach employees so<br />
that everyone knows his or her role and is able<br />
to make valuable contributions to Lundbeck<br />
achieving its vision, mission and goals.<br />
Over the course of <strong>2007</strong>, a number of extensive<br />
interviews were carried out in order to<br />
identify the requirements imposed by Lundbeck’s<br />
strategy and business targets with respect<br />
to leadership competencies. This survey<br />
provided the basis for a new leadership development<br />
programme, which offers tailor-made<br />
coaching for each individual manager. The individual<br />
components of the development programme<br />
also reflect a stronger focus on management<br />
tools and skills in areas such as<br />
motivation, targets and change management.<br />
Also, as a second component of Lundbeck’s efforts<br />
to recognise and develop leadership skills,<br />
a performance-rewarding bonus scheme for all<br />
managers above head of department level in<br />
the Danish part of the organisation has been<br />
introduced. As part of their salary, these managers<br />
are now eligible for a variable annual bonus<br />
if they meet certain specific targets. The<br />
scheme will be expanded to include head of<br />
department level managers in 2008.<br />
Developing employee competencies<br />
Lundbeck recognises the fact that employee<br />
training is vital in ensuring that its employees<br />
consistently possess the necessary skills in a<br />
rapidly evolving company, and it is also crucial<br />
in retaining the company’s position as an attractive<br />
workplace. Accordingly, in <strong>2007</strong> as<br />
well, Lundbeck scaled up its talent management<br />
programme, which is aimed at identifying<br />
and developing management and specialist<br />
talent. To this end, three multi-level career<br />
paths for salaried employees at Lundbeck have<br />
been established: the line manager path, the<br />
project manager path and the specialist path.<br />
For each employee who follows one of these<br />
career paths, an individualised plan is prepared<br />
that maps the development path and is<br />
adapted to the needs of that manager or specialist.<br />
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51
Lundbeck aims to be a workplace at which<br />
employees feel comfortable and would like<br />
to stay.<br />
Marie-Claude Ballandras is HR Director of<br />
Lundbeck France, where she is responsible<br />
for recruitment and retention of the right<br />
employees.<br />
Read the article Prepared for<br />
the future in the Lundbeck<br />
Magazine 2008.<br />
At the end of <strong>2007</strong>, a total of 120 employees<br />
at Lundbeck headquarters and the synthesis<br />
factory in Denmark had embarked on the specialist<br />
and project manager career path and<br />
228 employees on the line manager path.<br />
Among employees currently underway on one<br />
of these career paths, 16% were at the divisional<br />
director level, 38% at the head of department<br />
level, and 46% at the head of section<br />
level.<br />
Each year, Lundbeck devotes substantial resources<br />
to developing employee competencies.<br />
In <strong>2007</strong>, the Lundbeck HR organisation arranged<br />
in excess of 85 courses for more than<br />
1,300 managers and other employees. In addition,<br />
the individual business areas arranged local<br />
activities of particular importance to their<br />
own employees.<br />
At least once every year, the goals defined for<br />
each employee are followed up at individual<br />
manager/employee performance reviews. At<br />
these reviews, goals are revised for the upcoming<br />
year and the employee and manager agree<br />
on initiatives for competence building aimed<br />
at ensuring that the employee possesses the<br />
skills required to achieve the goals.<br />
Competing for the best employees<br />
Lundbeck’s total staff turnover in <strong>2007</strong> was<br />
16%, an increase on the 13% recorded in<br />
2006. The increase was partly due to a reduction<br />
of the sales forces in several European<br />
subsidiaries in <strong>2007</strong>. Staff turnover based on<br />
voluntary resignations was 10%, which is an<br />
increase from 2006, when the figure was 8%.<br />
This increase could to a large extent be ascribed<br />
to the current lack of available workforce,<br />
which makes it attractive for employees<br />
to seek new employment opportunities. Lundbeck<br />
is aware of the increased competition for<br />
qualified employees that will characterise the<br />
coming years. Consequently, Lundbeck must<br />
establish itself as an attractive workplace. The<br />
company began building an employer branding<br />
strategy in <strong>2007</strong>, which is expected to lead to<br />
a number of tools in 2008 that can support<br />
Lundbeck’s efforts to attract and retain employees<br />
with the professional and social skills<br />
that match Lundbeck’s mission, targets and<br />
competency requirements.<br />
Streamlined organisational processes<br />
One of the initiatives required to prepare Lundbeck<br />
for the future is a streamlining of all<br />
processes. As a result, Lundbeck has given high<br />
priority over the past couple of years to introducing<br />
a Lean culture at Lundbeck. Since the<br />
first Lean pilot project in 2006, the culture has<br />
been spread to all parts of the Danish production<br />
organisation and to IT operations. In January<br />
<strong>2007</strong>, Lean ceased to be simply a project,<br />
and the activities were scaled up by setting up<br />
an independent organisational Lean entity that<br />
reports directly to Executive Management.<br />
In <strong>2007</strong>, employees at Lundbeck’s manufacturing<br />
facilities received training in basic Lean<br />
principles at the Lundbeck Lean Academy. Also,<br />
32 Lean specialists were trained in <strong>2007</strong>, so<br />
Lundbeck now has a total of 50 employees<br />
with an in-depth knowledge of and experience<br />
in Lean tools and principles. By the end of<br />
<strong>2007</strong>, just under 100 Kaizen events (improvement<br />
workshops) have been carried out, and<br />
more than 50% of the employees in Lundbeck’s<br />
production organisation have now participated<br />
in Kaizen events.<br />
In 2008, all managers in Lundbeck’s production<br />
organisation in Denmark will complete an ambitious<br />
training programme that aims to put<br />
the principles of good leadership into a Lean<br />
perspective. A total of 120 managers will receive<br />
twelve days of intensive training. The<br />
purpose of the programme is to ensure that<br />
production managers apply Lean as an integral<br />
part of their day-to-day management work so<br />
that Lean becomes the basic culture of the organisation.<br />
In 2006, Lundbeck’s research organisation<br />
launched a large-scale innovation project<br />
whose first phase focused on communication<br />
within and across research areas and on optimising<br />
key processes and building an innovation<br />
culture in the organisation. The project<br />
was evaluated as part of an employee satisfaction<br />
survey in the autumn of <strong>2007</strong>. The survey<br />
showed that employees now have a better understanding<br />
of innovation and the importance<br />
of innovation, that the organisation has succeeded<br />
in optimising a number of key processes,<br />
and that the research organisation now<br />
has more projects with a high level of innovation.<br />
In addition, an important initiative referred<br />
to as the Lundbeck Research Way of<br />
Working (LWW) has emerged from the innovation<br />
project. The LWW programme is a fourday<br />
course involving three focus areas: Lundbeck’s<br />
culture and values, pharmaceutical<br />
innovation in Lundbeck’s research and development,<br />
and the interaction between specialists,<br />
project managers and line managers in<br />
pharmaceutical innovation. The second phase<br />
of the research organisation’s innovation<br />
project will begin towards the end of 2008 and<br />
52
will focus on projects in the drug discovery and<br />
development organisation.<br />
Well-being in the workplace<br />
As in previous years, employee health and<br />
well-being was on the Lundbeck agenda in<br />
<strong>2007</strong>. A good work environment helps attract<br />
and retain enthusiastic employees, so it is natural<br />
for Lundbeck to be aware of its employees’<br />
level of satisfaction with their working<br />
conditions and their workplace in general. Lundbeck<br />
regularly carries out online questionnaire<br />
surveys to measure employee satisfaction by<br />
certain parameters such as management, collaboration<br />
and competency building. In <strong>2007</strong>,<br />
the questionnaire framework was extended to<br />
optimise it for use as a tool for management<br />
and dialogue. A high average response rate was<br />
recorded (91%) for the satisfaction surveys<br />
conducted in <strong>2007</strong>, with an employee satisfaction<br />
score of 69 on a scale from 1 to 100. The<br />
average for companies using the same analytical<br />
method is 67.<br />
Read more about Lundbeck’s recruitment and<br />
HR development policy at lundbeck.com/careers.<br />
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53
Research and<br />
knowledge sharing<br />
Lundbeck contributes to society’s treatment of patients with disorders of the central<br />
nervous system through the development of innovative pharmaceuticals and by sharing<br />
knowledge of research and clinical practice. In addition, the Lundbeck Foundation<br />
makes substantial contributions to scientific research for the benefit of society.<br />
E<br />
ach year, Lundbeck ploughs about 20%<br />
of its revenue back into research and<br />
development, a figure above the industry<br />
average of approximately 17%. In <strong>2007</strong>,<br />
Lundbeck invested just over DKK 2,187 million<br />
in the research into and development of new<br />
pharmaceuticals.<br />
Knowledge sharing<br />
Knowledge is the cornerstone of optimum therapeutic<br />
treatments. Accordingly, an important<br />
part of Lundbeck’s operations involves offering<br />
training programmes for specialists in depression,<br />
anxiety, schizophrenia and dementia.<br />
The Lundbeck Institute was established in 1997<br />
as an international non-commercial forum with<br />
the aim of helping improve the quality of life<br />
for patients suffering from disorders of the central<br />
nervous system.<br />
All activities build on objective knowledge and<br />
involve interactive and international seminars<br />
for specialists, educational materials, professional<br />
websites and resources for specialists,<br />
and web-based forums on depression and dementia<br />
that allow experts, patients and their<br />
relatives to exchange information.<br />
The seminars held by the Lundbeck Institute are<br />
accredited by the European Accreditation Committee<br />
in CNS, and the training activities are<br />
approved by the institute’s faculty, which counts<br />
86 leading psychiatrists and neurologists from<br />
around the world.<br />
Donations for independent research<br />
The Lundbeck Foundation, the principal shareholder<br />
of the Lundbeck Group, holds approximately<br />
70% of the shares, making it the primary<br />
recipient of dividends from Lundbeck<br />
Group operations.<br />
Since Lundbeck’s IPO in 1999, the Lundbeck<br />
Foundation has in its capacity of principal<br />
shareholder received substantial distributions<br />
in the form of dividends and share buybacks.<br />
The objectives of the Lundbeck Foundation are<br />
to support and expand the activities of the<br />
Lundbeck Group and to grant financial support<br />
to high-quality scientific research.<br />
Group management is pleased with the fact<br />
that Lundbeck’s value-generating initiatives<br />
also benefit society at large through the donations<br />
made by the Lundbeck Foundation. Donations<br />
from the Lundbeck Foundation have<br />
risen considerably in recent years, with an increase<br />
in donations from DKK 22 million in<br />
1999 to DKK 281 million in <strong>2007</strong>.<br />
Towards the end of <strong>2007</strong>, the Lundbeck<br />
Foundation announced its decision to<br />
distribute DKK 1 billion for research in health<br />
and natural sciences over the next three years.<br />
The Lundbeck Institute<br />
• In <strong>2007</strong>, the Lundbeck Institute held 12<br />
seminars attended by 295 people from 28<br />
countries.<br />
• Since it was established in 1997, the Lundbeck<br />
Institute has held 134 one-week seminars<br />
for a total of 3,055 specialists from 55<br />
countries.<br />
• These specialists hold additional seminars<br />
and workshops in their home countries, so<br />
about 100,000 specialists around the world<br />
have benefited from the Lundbeck Institute’s<br />
direct and indirect training activities<br />
over the past 11 years.<br />
• The Lundbeck Institute’s web-based forum<br />
for patients and relatives, DepNet (about<br />
depression), is now available in 17 countries.<br />
• DementiaNet, which provides information<br />
about dementia for patients and relatives, is<br />
available in two countries.<br />
• Local Lundbeck institutes have been set up<br />
in 16 countries.<br />
• The Institute issues a large number of publications<br />
and an Institute Magazine.<br />
The Association of European Psychiatrists<br />
(AEP), Collegium Internationale Neuro-<br />
Psychopharmacologicum (CINP), the European<br />
Federation of Neurological Societies (EFNS),<br />
the European College of Neuropsychopharmacology<br />
(ECNP) and the World Psychiatric Association<br />
(WPA) support the work of the institute<br />
and are represented in the Lundbeck<br />
International Neuroscience Foundation, which<br />
manages the institute’s activities.<br />
Read more at cnsforum.com/lundbeck institute.<br />
54
The Lundbeck Foundation is one of the largest private financial<br />
contributors to public health care research in Denmark.<br />
Read the article The Lundbeck Foundation<br />
increases donations to research in the<br />
Lundbeck Magazine 2008<br />
Examples of donations from the Lundbeck Foundation in <strong>2007</strong><br />
• In <strong>2007</strong> and 2008, the foundation will donate<br />
funds for establishing research centres<br />
with a view to bringing the results obtained<br />
in basic research faster and more effectively<br />
into use to the benefit of the patients. Accordingly,<br />
in October <strong>2007</strong> the Lundbeck<br />
Foundation donated a total of DKK 100 million<br />
for three research centres:<br />
- DKK 20 million for a research centre to<br />
develop and test new markers that may<br />
predict whether a given cancer patient’s<br />
disease will turn aggressive or stop progressing.<br />
- DKK 60 million for a research centre to investigate<br />
any apparent differences in the<br />
exposure to early atherosclerosis caused<br />
by obesity, hypertension and Type 2<br />
diabetes. The centre is a Danish-Chinese<br />
collaboration.<br />
- DKK 20 million for a research centre to<br />
uncover the impact of genetic disposition<br />
and bacterial flora in the respiratory tract<br />
of infants on early development of<br />
asthma, allergy and eczema in children.<br />
• DKK 1.1 million for the development of new<br />
methods to record how the brain of a schizophrenic<br />
patient processes information<br />
compared with healthy persons and for a<br />
description of the disturbances seen in patients<br />
with schizophrenia. It has been demonstrated<br />
that the disturbances are more<br />
important to disease process than the actual<br />
symptoms of schizophrenia.<br />
• DKK 240,000 to examine the correlation between<br />
EPO and rehabilitation after a patient<br />
has been confined to a bed for a long time.<br />
It has been demonstrated that EPO prevents<br />
cell death in a number of cell types, and<br />
that new muscle fibres may be formed if we<br />
stimulate the EPO receptor in muscle satellite<br />
cells. This may help prevent prolonged<br />
and expensive attempts of rehabilitation,<br />
especially among older patients.<br />
• DKK 1.54 million for a basic research project<br />
aimed at constructing Denmark’s first<br />
atomic clock. Such an atomic clock would<br />
provide fundamental knowledge about the<br />
picture of our universe.<br />
• DKK 1.07 million to analyse DNA from 900<br />
patients suffering from multiple sclerosis<br />
and DNA from a comparator group of<br />
healthy individuals. The objective is to<br />
examine inherited differences in specific<br />
genes in order to obtain new knowledge<br />
about the disease mechanisms in connection<br />
with multiple sclerosis. Furthermore,<br />
the objective is to develop new prevention<br />
and treatment methods.<br />
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Section leader Lars Torup and molecular biologist Jacob Nielsen<br />
are looking at a 3D image of the CEPO molecule, a novel and<br />
innovative compound developed by Lundbeck scientists in<br />
collaboration with Warren. CEPO has a neuroprotective effect<br />
that may help to limit damage following an incident such as<br />
a blood clot in the brain, where parts of the brain are damaged<br />
by lack of oxygen due to impaired blood supply.
Acute ischaemic<br />
stroke<br />
S<br />
troke is the third leading cause of death<br />
in the industrialised world and a leading<br />
cause of serious, long-term disability.<br />
In the USA alone, 600,000 people suffer<br />
from a stroke each year, and around 20% of<br />
them die within four weeks.<br />
Ischaemic stroke is the most common type of<br />
stroke and occurs when an artery in the brain<br />
is obstructed by a blood clot.<br />
The only currently available clot-dissolving<br />
agent must be administered within three hours<br />
of symptom onset; however, approximately<br />
80% of stroke patients arrive at the hospital<br />
after the three-hour limit.<br />
Lundbeck is developing desmoteplase for the<br />
treatment of acute ischaemic stroke and<br />
– in collaboration with the American biotech<br />
company Warren Pharmaceuticals, Inc. –<br />
Lu AA24493 for the treatment of acute<br />
ischaemic stroke and other diseases with<br />
neuronal damage.<br />
57
Financial statements<br />
<strong>2007</strong><br />
Revenue DKK 10,985 million<br />
Profit from operations DKK 2,695 million<br />
Net profit for the year DKK 1,770 million<br />
60<br />
62<br />
63<br />
64<br />
66<br />
68<br />
69<br />
116<br />
117<br />
118<br />
120<br />
Summary for the Group<br />
Financial review <strong>2007</strong><br />
Income statement<br />
Balance sheet<br />
Statement of changes in equity<br />
Cash flow statement<br />
Notes to the financial statements<br />
Management statement<br />
Independent auditors’ report<br />
Supervisory Board<br />
Executive Management<br />
59
Summary for the Group<br />
2003-<strong>2007</strong><br />
Income statement (DKKm) 2003 2004 2005 2006 <strong>2007</strong><br />
Revenue 9,941 9,733 9,070 9,221 10,985<br />
Profit before research and development costs 4,093 4,342 3,943 3,738 4,865<br />
Research and development costs 1,931 1,776 1,782 1,958 2,187<br />
Profit from operations 2,147 2,554 2,170 1,784 2,695<br />
Net financials (76) 16 108 (64) (50)<br />
Profit before tax 2,068 2,521 2,242 1,633 2,562<br />
Net profit for the year 1,384 1,689 1,574 1,107 1,770<br />
Net profit for the year, shareholders in the parent company 1,387 1,709 1,584 1,107 1,770<br />
Assets (DKKm) 2003 2004 2005 2006 <strong>2007</strong><br />
Non-current assets 5,972 5,555 5,754 6,104 5,726<br />
Inventories 1,334 1,282 1,267 1,155 924<br />
Receivables 2,430 1,770 1,938 1,994 2,368<br />
Cash and securities 1,334 2,902 2,669 2,378 3,308<br />
Total assets 11,070 11,509 11,628 11,631 12,326<br />
Equity and liabilities (DKKm) 2003 2004 2005 2006 <strong>2007</strong><br />
Equity 6,901 7,839 7,492 6,765 7,185<br />
Non-current liabilities 667 867 900 2,171 2,502<br />
Current liabilities 3,502 2,803 3,236 2,695 2,639<br />
Total equity and liabilities 11,070 11,509 11,628 11,631 12,326<br />
Cash flow statement (DKKm) 2003 2004 2005 2006 <strong>2007</strong><br />
Cash flows from operating activities 1,900 2,678 2,074 1,394 2,705<br />
Cash flows from investing activities 1 (1,816) (1,794) (487) 239 (1,095)<br />
Cash flows from operating and investing activities 1 84 884 1,587 1,633 1,610<br />
Cash flows from financing activities 55 (863) (1,682) (901) (1,012)<br />
Interest-bearing net cash at year end 788 2,391 2,240 876 1,405<br />
Key figures 2003 2004 2005 2006 <strong>2007</strong><br />
EBIT margin (%) 21.6 26.2 23.9 19.3 24.5<br />
Return on capital employed (%) 37.3 37.0 32.0 25.2 34.9<br />
Return on equity (%) 21.9 23.2 20.7 15.6 25.3<br />
Research and development costs as a percentage of revenue 19.4 18.2 19.6 21.2 19.9<br />
Solvency ratio (%) 62.3 68.1 64.4 58.2 58.3<br />
Capital employed (DKKm) 7,447 8,351 7,920 8,267 9,088<br />
Capital turnover (%) 89.8 84.6 78.0 79.3 89.1<br />
Intangible assets investments, gross (DKKm) 913 8 159 190 274<br />
Property, plant and equipment investments, gross (DKKm) 962 305 447 567 474<br />
Financial investments, gross (DKKm) 1 2,992 5,211 4,059 3,556 844<br />
Average number of employees 5,223 5,155 5,022 5,111 5,134<br />
1) Comparative figures have been restated so that securities are included in cash flows from investing activities.<br />
60
Share data 2003 2004 2005 2006 <strong>2007</strong><br />
Average number of shares, excl. treasury shares (million) 1 231.4 229.6 224.6 211.1 205.0<br />
Earnings per share (EPS) (DKK) 1 5.98 7.42 7.04 5.24 8.63<br />
Diluted earnings per share (DEPS) (DKK) 1 5.98 7.42 7.02 5.23 8.63<br />
Proposed dividend per share (DKK) 1 1.77 2.21 2.10 1.57 2.56<br />
Cash flow per share (DKK) 1 8.19 11.62 9.20 6.59 13.18<br />
Net asset value per share (DKK) 1 29.71 34.21 33.99 32.40 35.81<br />
Market capitalisation (DKKm) 23,098 28,517 29,630 33,060 28,605<br />
Price/Earnings (DKK) 16.53 16.45 18.57 29.80 16.00<br />
Price/Cash flow (DKK) 12.07 10.50 14.18 23.66 10.47<br />
Price/Net asset value (DKK) 3.33 3.57 3.84 4.81 3.85<br />
Definitions<br />
Interest-bearing net cash<br />
EBIT margin 2<br />
Return on capital employed<br />
2, 4, 5<br />
Return on equity Profit<br />
Solvency ratio 2<br />
Capital employed<br />
Capital turnover<br />
2, 3, 5<br />
Earnings per share (EPS) Profit<br />
2, 3, 5<br />
Diluted earnings per share (DEPS) Profit<br />
Cash flow per share 2<br />
Net asset value per share 2, 4<br />
Market capitalisation<br />
Price/Earnings 2<br />
Price/Cash flow 2<br />
Price/Net asset value 2<br />
Cash and securities less interest-bearing debt<br />
Profit from operations as a percentage of revenue<br />
Profit from operations plus financial income as a percentage of average capital employed<br />
attributable to shareholders in the parent company as a percentage of average equity, H. Lundbeck A/S’ shareholders<br />
Equity, year-end, as a percentage of equity and liabilities, year-end<br />
Total equity and liabilities less non-interest bearing liabilities<br />
Revenue as a percentage of total assets, year-end<br />
attributable to shareholders in the parent company divided by average number of shares, excl. treasury shares<br />
attributable to shareholders in the parent company divided by average number of shares, excl. treasury shares,<br />
incl. warrants, fully diluted<br />
Cash flow from operating activities divided by average number of shares, excl. treasury shares, incl. warrants, fully diluted<br />
Equity, H. Lundbeck A/S’ shareholders, year-end, divided by number of shares, year-end, excl. treasury shares, incl.<br />
warrants, fully diluted<br />
Total number of shares, year-end, multiplied by the official price quoted on OMX Nordic Exchange Copenhagen,<br />
year-end<br />
The official price quoted on OMX Nordic Exchange Copenhagen, year-end, divided by diluted earnings per share<br />
The official price quoted on OMX Nordic Exchange Copenhagen, year-end, divided by cash flow per share<br />
The official price quoted on OMX Nordic Exchange Copenhagen, year-end, divided by equity per share<br />
1) Calculation is based on a share denomination of DKK 5.<br />
2) Definitions according to the Danish Society of Financial Analysts’ Recommendations & Financial Ratios 2005.<br />
3) Calculated according to IAS 33 Earnings per share.<br />
4) Equity, H. Lundbeck A/S’ shareholders equals the Group’s total equity in <strong>2007</strong> and 2006.<br />
5) In <strong>2007</strong> and 2006, profit attributable to shareholders in the parent company equals the Group’s consolidated profit.<br />
Comparative figures involving number of shares have been adjusted by an adjustment factor of 0.9988 for the effect of employees exercising warrants.<br />
61
Financial review <strong>2007</strong><br />
Income statement<br />
The Group generated revenue of DKK 10,985<br />
million in <strong>2007</strong>, an increase of 19% relative to<br />
the previous year. Revenue was positively affected<br />
by two non-recurring payments from<br />
Takeda Pharmaceutical Company Limited totalling<br />
DKK 420 million. The payments relate<br />
to the collaboration formed in <strong>2007</strong> concerning<br />
the development and commercialisation of<br />
new products in the US and Japanese markets.<br />
Net of these payments, revenue amounted to<br />
DKK 10,565 million, corresponding to an increase<br />
of 17% on 2006.<br />
Sales of Lundbeck’s new products in own markets,<br />
primarily of Cipralex® and Ebixa®, continued<br />
the positive trends, contributing DKK 1 billion<br />
to the revenue increase, which was 74% of<br />
the Group’s combined revenue improvement<br />
exclusive of income from Takeda. Also, revenue<br />
was positively impacted by higher income<br />
from sales of Lexapro® in the USA relative to<br />
2006. The increase in income from Lexapro®<br />
amounted to DKK 671 million, or 35%, and<br />
was partly attributable to a low level of income<br />
in 2006 due to Forest’s inventory reductions,<br />
partly to rising Lexapro® sales in the US<br />
market in <strong>2007</strong>.<br />
Foreign currency hedging had an adverse DKK<br />
53 million impact on revenue. Of this amount,<br />
DKK 48 million related to a hedging loss concerning<br />
hedging of USD income from Lexapro®.<br />
The realised hedging loss on USD relates to<br />
hedging of the inventories consumed at Forest,<br />
which Lundbeck hedged against exchange rate<br />
fluctuations and delivered in 2005 and 2006.<br />
Lundbeck’s total expenses, exclusive of net<br />
financials and tax, were DKK 8,290 million, up<br />
from DKK 7,437 million in 2006. The increase<br />
was driven primarily by higher cost of sales due<br />
to a DKK 381 million impairment loss on production<br />
assets in the Group’s manufacturing<br />
unit in Seal Sands, UK, and higher cost of<br />
goods sold due to the higher revenue.<br />
Administrative expenses were DKK 1,514 million,<br />
a 7% increase on 2006. The increase was<br />
due to factors such as costs of closing down<br />
Lundbeck’s commercial office in Philadelphia,<br />
USA, the continuing expansion of the Group’s<br />
information technology infrastructure and expenses<br />
relating to the establishment of a warrant<br />
programme.<br />
Research and development costs accounted<br />
for 20% of consolidated revenue compared to<br />
21% in 2006. Adjusted for the DKK 420 million<br />
income from Takeda, research and development<br />
costs represented 21% of revenue in<br />
<strong>2007</strong>. Overall, there was a high level of activity<br />
in <strong>2007</strong> with several pipeline projects being<br />
advanced to the next phase.<br />
The Group’s net financials were positively<br />
affected by higher return on bonds and cash,<br />
while exchange rate losses and interest<br />
expenses were higher than in 2006.<br />
Tax on profit for <strong>2007</strong> amounted to DKK 792<br />
million, corresponding to an effective tax rate<br />
of 30.9%, against 32.2% in 2006. The effective<br />
tax rate was influenced by factors such as the<br />
lowering of the Danish corporate tax rate from<br />
28% to 25%.<br />
At DKK 1,770 million, profit for the year was<br />
up 60% compared with 2006. Earnings per<br />
share increased 65% to DKK 8.63.<br />
Balance sheet<br />
The increase in intangible assets of DKK 114<br />
million was driven primarily by the addition of<br />
product rights on the conclusion of partnership<br />
agreements, including with Biotie Therapies<br />
Corp. and Neurim Pharmaceuticals Ltd., and<br />
the continuing expansion of the Group’s IT<br />
infrastructure.<br />
Property, plant and equipment fell by DKK 292<br />
million, or 8%, relative to 2006 due to impairment<br />
of assets in the Group’s manufacturing<br />
facility in Seal Sands, UK.<br />
Financial assets amounted to DKK 457 million,<br />
which was DKK 200 million lower than in<br />
2006. The decline was due partly to an impairment<br />
loss on the investment in and receivables<br />
from the associate CF Pharma Gyógyszergyártó<br />
Kft., partly to a drop in the Group’s<br />
deferred tax assets.<br />
Inventories were reduced by DKK 231 million<br />
to DKK 924 million. The reduction was partly<br />
the result of a dedicated effort to reduce inventories,<br />
partly an impairment loss on inventories<br />
at the manufacturing facility in Seal<br />
Sands, UK.<br />
The DKK 374 million increase in receivables to<br />
DKK 2,368 million was attributable to higher<br />
revenue in <strong>2007</strong> compared with the year before<br />
and a DKK 248 million receivable from<br />
Takeda concerning the alliance formed.<br />
Equity rose to DKK 7,185 million, which was<br />
an increase of DKK 420 million, or 6%. Acquisition<br />
of treasury shares and dividends paid reduced<br />
equity by a total of DKK 1,516 million<br />
in <strong>2007</strong>.<br />
Non-current liabilities were up by DKK 331<br />
million to DKK 2,502 million. The increase was<br />
due to a mortgage loan, and combined with<br />
the share buyback programme it reflects<br />
Lundbeck’s aim of optimising the Group’s<br />
capital structure.<br />
Cash flow statement<br />
Cash flows from operating activities improved<br />
by DKK 1,311 million in <strong>2007</strong> compared with<br />
the year before. The improvement was attributable<br />
to a higher profit from operations and<br />
positive trends in working capital relative to<br />
2006.<br />
Net investments in intangible assets and property,<br />
plant and equipment were DKK 739 million,<br />
which was in line with 2006. The investments<br />
were driven primarily by maintenance<br />
and expansion of the Group’s facilities in Denmark<br />
and the USA.<br />
Net investments in financial assets were DKK<br />
345 million against a net sale of DKK 1,007<br />
million in 2006. Investments in financial assets<br />
consist primarily of buying and selling of<br />
Danish listed bonds, which are recognised as<br />
investments in the cash flow statement as<br />
from <strong>2007</strong>. The comparative figures have been<br />
restated.<br />
Cash outflows from financing activities<br />
amounted to DKK 1,012 million against an<br />
outflow of DKK 901 million the year before<br />
and were primarily affected by lower proceeds<br />
from loans in <strong>2007</strong>, which were however offset<br />
by lower share buybacks than in 2006.<br />
The Group generated a net cash inflow of DKK<br />
597 million compared with an inflow of DKK<br />
732 million in 2006.<br />
62
Income statement<br />
for the year ended 31 December <strong>2007</strong><br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm Notes DKKm DKKm<br />
5,976.7 7,741.7 Revenue 2, 24 10,984.9 9,221.0<br />
1,597.1 2,239.2 Cost of sales 3, 4 2,197.8 1,645.8<br />
4,379.6 5,502.5 Gross profit 8,787.1 7,575.2<br />
359.9 262.3 Distribution costs 3, 4 2,408.7 2,418.7<br />
670.1 798.7 Administrative expenses 3-5 1,513.9 1,418.9<br />
3,349.6 4,441.5 Profit before research and development costs 4,864.5 3,737.6<br />
2,063.5 2,232.9 Research and development costs 3, 4 2,187.2 1,957.7<br />
1,286.1 2,208.6 Profit before other operating items 2,677.3 1,779.9<br />
7.9 7.2 Other operating income 38.5 26.1<br />
17.0 9.1 Other operating expenses 20.4 22.0<br />
1,277.0 2,206.7 Profit from operations 2,695.4 1,784.0<br />
75.6 120.2 Income from investments in subsidiaries 9 - -<br />
- (57.0) Income from investments in associates 10 (84.0) (87.4)<br />
213.9 225.0 Financial income 6 337.1 250.1<br />
212.4 213.4 Financial expenses 6 387.0 313.9<br />
1,354.1 2,281.5 Profit before tax 2,561.5 1,632.8<br />
386.4 530.8 Tax on profit for the year 7 792.0 525.9<br />
967.7 1,750.7 Net profit for the year 1,769.5 1,106.9<br />
Proposed distribution<br />
333.1 530.6 Proposed dividend for the year 14 530.6 333.1<br />
634.6 1,220.1 Transferred to distributable reserves 1,238.9 773.8<br />
967.7 1,750.7 1,769.5 1,106.9<br />
Earnings per share (EPS) (DKK) 25 8.63 5.24<br />
Diluted earnings per share (DEPS) (DKK) 25 8.63 5.23<br />
Proposed dividend per share (DKK) 14 2.56 1.57<br />
63
Balance sheet at 31 December <strong>2007</strong><br />
Assets<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm Notes DKKm DKKm<br />
- - Goodwill 882.2 882.2<br />
410.4 363.8 Patent rights 312.8 342.7<br />
287.5 405.4 Product rights 467.9 352.5<br />
- - Other rights 7.7 5.6<br />
72.7 118.9 IT projects 124.6 78.1<br />
- - Process projects 5.1 11.1<br />
105.1 84.8 Projects in progress 94.5 108.5<br />
875.7 972.9 Intangible assets 8 1,894.8 1,780.7<br />
1,822.8 1,804.7 Land and buildings 2,047.6 2,126.6<br />
206.9 256.3 Plant and machinery 393.2 592.3<br />
263.4 246.6 Other fixtures and fittings, tools and equipment 334.4 364.0<br />
459.1 541.0 Prepayments and plant and equipment in progress 599.5 583.8<br />
2,752.2 2,848.6 Property, plant and equipment 8 3,374.7 3,666.7<br />
2,732.0 2,735.1 Investments in subsidiaries 9 - -<br />
154.4 97.4 Investments in associates 10 82.9 166.9<br />
745.9 609.0 Receivables from subsidiaries 11 - -<br />
19.2 - Receivables from associates 11 - 19.2<br />
125.7 149.1 Available-for-sale financial assets 11 150.7 127.6<br />
41.7 31.5 Other receivables 11 60.6 63.6<br />
- - Value of deferred tax assets 16 162.7 279.1<br />
3,818.9 3,622.1 Financial assets 456.9 656.4<br />
7,446.8 7,443.6 Non-current assets 5,726.4 6,103.8<br />
315.7 364.3 Raw materials and consumables 76.3 161.6<br />
576.9 346.0 Work in progress 676.4 770.4<br />
159.8 154.2 Manufactured goods and goods for resale 171.6 223.0<br />
1,052.4 864.5 Inventories 12 924.3 1,155.0<br />
256.9 179.9 Trade receivables 13 1,560.1 1,463.2<br />
407.3 485.9 Receivables from subsidiaries - -<br />
- - Income taxes receivable 36.8 56.8<br />
249.0 486.9 Other receivables 13 582.2 359.4<br />
60.4 133.2 Prepayments 188.5 114.6<br />
973.6 1,285.9 Receivables 2,367.6 1,994.0<br />
1,182.0 1,517.3 Securities 29 1,535.7 1,201.6<br />
772.4 1,389.2 Cash 29 1,772.0 1,176.6<br />
3,980.4 5,056.9 Current assets 6,599.6 5,527.2<br />
11,427.2 12,500.5 Assets 12,326.0 11,631.0<br />
64
Balance sheet at 31 December <strong>2007</strong><br />
Equity and liabilities<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm Notes DKKm DKKm<br />
1,060.8 1,036.4 Share capital 14 1,036.4 1,060.8<br />
121.6 223.9 Share premium 14 223.9 121.6<br />
5,423.1 5,750.1 Retained earnings 5,924.6 5,582.4<br />
6,605.5 7,010.4 Equity 7,184.9 6,764.8<br />
- - Pension obligations and similar obligations 15 188.7 204.5<br />
251.7 176.9 Deferred tax liabilities 16 327.3 431.5<br />
84.2 80.4 Provisions 17 92.4 92.7<br />
1,424.8 1,858.6 Mortgage debt 18 1,858.6 1,427.8<br />
12.6 31.5 Employee bonds 31.5 12.6<br />
886.7 1,067.3 Payables to subsidiaries - -<br />
1.1 1.2 Other long-term debt 3.5 1.8<br />
2,661.1 3,215.9 Non-current liabilities 2,502.0 2,170.9<br />
- 311.2 Provisions 3,17 15.4 2.4<br />
2.8 - Bank debt 18 4.4 55.0<br />
2.1 2.1 Mortgage debt 18 5.1 5.1<br />
555.6 579.6 Trade payables 773.9 743.2<br />
394.6 296.4 Payables to subsidiaries - -<br />
94.2 6.2 Income taxes 72.2 130.0<br />
117.1 126.8 VAT, taxes and holiday pay commitments 268.0 251.8<br />
138.6 112.1 Other payables 660.3 652.2<br />
854.7 839.5 Prepayments from Forest 839.5 854.7<br />
0.9 0.3 Deferred income 0.3 0.9<br />
2,160.6 2,274.2 Current liabilities 2,639.1 2,695.3<br />
4,821.7 5,490.1 Liabilities 5,141.1 4,866.2<br />
11,427.2 12,500.5 Equity and liabilities 12,326.0 11,631.0<br />
65
Statement of changes in equity<br />
at 31 December <strong>2007</strong> – Group<br />
Share Share Retained Equity<br />
capital premium earnings Group 1<br />
<strong>2007</strong> DKKm DKKm DKKm DKKm<br />
Equity at 01.01.<strong>2007</strong> 1,060.8 121.6 5,582.4 6,764.8<br />
Adjustment, deferred gains/losses, hedging - - 157.9 157.9<br />
Realised gains/losses, hedging - - (122.0) (122.0)<br />
Realised gains/losses, trading (transferred from hedging) - - (0.4) (0.4)<br />
Fair value adjustment of available-for-sale financial assets - - 12.8 12.8<br />
Tax on equity entries - - (5.5) (5.5)<br />
Recognised directly in equity - - 42.8 42.8<br />
Net profit for the year less proposed dividend - - 1,238.9 1,238.9<br />
Proposed dividend for the financial year - - 530.6 530.6<br />
Net income - - 1,812.3 1,812.3<br />
Distribution of dividend, gross - - (333.8) (333.8)<br />
Distribution of dividend, treasury shares - - 9.2 9.2<br />
Capital increase through exercise of warrants 5.0 102.3 - 107.3<br />
Capital reduction (29.4) - - (29.4)<br />
Nominal value of cancelled treasury shares - - 29.4 29.4<br />
Buyback of treasury shares - - (1,191.3) (1,191.3)<br />
Incentive plans - - 16.4 16.4<br />
Other transactions (24.4) 102.3 (1,470.1) (1,392.2)<br />
Equity at 31.12.<strong>2007</strong> 1,036.4 223.9 5,924.6 7,184.9<br />
2006<br />
Equity at 01.01.2006 1,136.1 69.5 6,286.1 7,491.7<br />
Adjustment, deferred gains/losses, hedging - - 173.5 173.5<br />
Realised gains/losses, hedging - - 41.3 41.3<br />
Realised gains/losses, trading (transferred from hedging) - - 33.2 33.2<br />
Exchange adjustment, associates - - (0.5) (0.5)<br />
Fair value adjustment of available-for-sale financial assets - - (31.5) (31.5)<br />
Tax on equity entries - - (68.9) (68.9)<br />
Recognised directly in equity - - 147.1 147.1<br />
Net profit for the year less proposed dividend - - 773.8 773.8<br />
Proposed dividend for the financial year - - 333.1 333.1<br />
Net income - - 1,254.0 1,254.0<br />
Distribution of dividend, gross - - (477.2) (477.2)<br />
Distribution of dividend, treasury shares - - 32.7 32.7<br />
Capital increase through exercise of warrants 2.6 52.1 - 54.7<br />
Capital reduction (77.9) - - (77.9)<br />
Nominal value of cancelled treasury shares - - 77.9 77.9<br />
Buyback of treasury shares - - (1,591.1) (1,591.1)<br />
Other transactions (75.3) 52.1 (1,957.7) (1,980.9)<br />
Equity at 31.12.2006 1,060.8 121.6 5,582.4 6,764.8<br />
1) The Group’s equity equals equity, H. Lundbeck A/S’ shareholders.<br />
66
Statement of changes in equity<br />
at 31 December <strong>2007</strong> – Parent company<br />
Share Share Retained Equity<br />
capital premium earnings Parent<br />
<strong>2007</strong> DKKm DKKm DKKm DKKm<br />
Equity at 01.01.<strong>2007</strong> 1,060.8 121.6 5,423.1 6,605.5<br />
Adjustment, deferred gains/losses, hedging - - 157.9 157.9<br />
Realised gains/losses, hedging - - (122.0) (122.0)<br />
Realised gains/losses, trading (transferred from hedging) - - (0.4) (0.4)<br />
Fair value adjustment of available-for-sale financial assets - - 12.8 12.8<br />
Tax on equity entries - - (8.9) (8.9)<br />
Recognised directly in equity - - 39.4 39.4<br />
Net profit for the year less proposed dividend - - 1,220.1 1,220.1<br />
Proposed dividend for the financial year - - 530.6 530.6<br />
Net income - - 1,790.1 1,790.1<br />
Distribution of dividend, gross - - (333.8) (333.8)<br />
Distribution of dividend, treasury shares - - 9.2 9.2<br />
Capital increase through exercise of warrants 5.0 102.3 - 107.3<br />
Capital reduction (29.4) - - (29.4)<br />
Nominal value of cancelled treasury shares - - 29.4 29.4<br />
Buyback of treasury shares - - (1,191.3) (1,191.3)<br />
Incentive plans - - 23.4 23.4<br />
Other transactions (24.4) 102.3 (1,463.1) (1,385.2)<br />
Equity at 31.12.<strong>2007</strong> 1,036.4 223.9 5,750.1 7,010.4<br />
2006<br />
Equity at 01.01.2006 1,136.1 69.5 6,262.4 7,468.0<br />
Adjustment, deferred gains/losses, hedging - - 173.5 173.5<br />
Realised gains/losses, hedging - - 41.3 41.3<br />
Realised gains/losses, trading (transferred from hedging) - - 33.2 33.2<br />
Fair value adjustment of available-for-sale financial assets - - (31.5) (31.5)<br />
Tax on equity entries - - (69.4) (69.4)<br />
Recognised directly in equity - - 147.1 147.1<br />
Net profit for the year less proposed dividend - - 634.6 634.6<br />
Proposed dividend for the financial year - - 333.1 333.1<br />
Net income - - 1,114.8 1,114.8<br />
Distribution of dividend, gross - - (477.2) (477.2)<br />
Distribution of dividend, treasury shares - - 32.7 32.7<br />
Capital increase through exercise of warrants 2.6 52.1 - 54.7<br />
Capital reduction (77.9) - - (77.9)<br />
Nominal value of cancelled treasury shares - - 77.9 77.9<br />
Buyback of treasury shares - - (1,591.1) (1,591.1)<br />
Incentive plans - - 3.6 3.6<br />
Other transactions (75.3) 52.1 (1,954.1) (1,977.3)<br />
Equity at 31.12.2006 1,060.8 121.6 5,423.1 6,605.5<br />
67
Cash flow statement<br />
1 January – 31 December <strong>2007</strong><br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm Notes DKKm DKKm<br />
1,277.0 2,206.7 Profit from operations 2,695.4 1,784.0<br />
465.6 774.8 Adjustments 26 929.1 377.8<br />
(424.8) 154.4 Working capital changes 27 (100.8) (352.2)<br />
1,317.8 3,135.9 Cash flows from operations before net financials 3,523.7 1,809.6<br />
123.9 164.6 Financial receipts 165.8 137.6<br />
(151.9) (150.6) Financial payments (150.2) (178.4)<br />
1,289.8 3,149.9 Cash flows from ordinary activities 3,539.3 1,768.8<br />
(226.6) (619.4) Income tax paid for the year (784.4) (382.0)<br />
46.9 (83.1) Income tax paid for previous years (50.1) 7.2<br />
1,110.1 2,447.4 Cash flows from operating activities 2,704.8 1,394.0<br />
(32.4) (3.1) Capital contributions to subsidiaries 9 - -<br />
75.6 120.2 Dividends from subsidiaries 9 - -<br />
(61.8) 6.4 Change in payables to/receivables from subsidiaries - -<br />
- - Business combinations 28 - 3.1<br />
(19.2) (12.0) Change in payables to/receivables from associates 11 (12.0) (19.2)<br />
(175.3) (254.1) Investments in intangible assets (273.9) (190.5)<br />
- - Sale of intangible assets 1.1 -<br />
(326.0) (388.1) Investments in property, plant and equipment (474.2) (567.1)<br />
- 4.6 Sale of property, plant and equipment 8.5 5.6<br />
(3,555.6) (843.7) Investments in financial assets (843.7) (3,556.0)<br />
4,554.8 497.8 Sale of financial assets 499.0 4,562.6<br />
460.1 (872.0) Cash flows from investing activities (1,095.2) 238.5<br />
1,570.2 1,575.4 Cash flows from operating and investing activities 1,609.6 1,632.5<br />
1,059.2 433.2 Loan proceeds 431.1 1,073.6<br />
(2.1) (2.1) Repayments of loans (53.7) (6.1)<br />
(1,591.1) (1,191.3) Buyback of treasury shares (1,191.3) (1,591.1)<br />
12.6 18.9 Employee bonds 18.9 12.6<br />
54.7 107.3 Capital contributions 107.3 54.7<br />
(444.5) (324.6) Dividends paid in the financial year (324.6) (444.5)<br />
(911.2) (958.6) Cash flows from financing activities (1,012.3) (900.8)<br />
659.0 616.8 Change in cash 597.3 731.7<br />
113.4 772.4 Cash at 01.01. 1,176.6 458.1<br />
- - Unrealised exchange differences for the year (1.9) (13.2)<br />
659.0 616.8 Change for the year 597.3 731.7<br />
772.4 1,389.2 Cash at 31.12. 29 1,772.0 1,176.6<br />
Interest-bearing net cash is composed as follows:<br />
772.4 1,389.2 Cash 1,772.0 1,176.6<br />
1,182.0 1,517.3 Securities 1,535.7 1,201.6<br />
(2,330.1) (2,960.7) Interest-bearing debt (1,903.1) (1,502.3)<br />
(375.7) (54.2) Interest-bearing net cash at 31.12. 1,404.6 875.9<br />
68
Notes<br />
to the financial statements<br />
70 Note 1 Accounting policies<br />
77 Note 2 Revenue<br />
78 Note 3 Staff costs<br />
82 Note 4 Amortisation and depreciation<br />
83 Note 5 Audit fees<br />
84 Note 6 Net financials<br />
85 Note 7 Tax on profit for the year<br />
86 Note 8 Intangible assets and property, plant and equipment<br />
91 Note 9 Investments in subsidiaries<br />
92 Note 10 Investments in associates<br />
93 Note 11 Other investments and other receivables<br />
94 Note 12 Inventories<br />
94 Note 13 Trade receivables and other receivables<br />
95 Note 14 Share capital<br />
96 Note 15 Pension obligations and similar obligations<br />
99 Note 16 Deferred tax liabilities<br />
101 Note 17 Provisions<br />
101 Note 18 Mortgage and bank debt<br />
104 Note 19 Treasury shares<br />
104 Note 20 Contractual obligations<br />
105 Note 21 Contingent liabilities<br />
106 Note 22 Financial instruments<br />
111 Note 23 Related parties<br />
112 Note 24 Segment information<br />
112 Note 25 Earnings per share<br />
113 Note 26 Adjustments<br />
113 Note 27 Working capital changes<br />
113 Note 28 Business combinations<br />
114 Note 29 Cash resources<br />
115 Note 30 Releases from H. Lundbeck A/S in <strong>2007</strong><br />
69
1<br />
Notes<br />
1. Accounting policies<br />
The annual report of H. Lundbeck A/S, comprising<br />
the financial statements of the parent company<br />
and the consolidated financial statements, is presented<br />
in accordance with International Financial<br />
Reporting Standards as adopted by the EU and<br />
additional Danish disclosure requirements for annual<br />
reports of listed companies, including the<br />
disclosure requirements imposed by the OMX<br />
Nordic Exchange Copenhagen on annual reports<br />
of listed companies and the Danish Statutory<br />
Order on Adoption of IFRS. The annual report also<br />
complies with the International Financial Reporting<br />
Standards issued by the International Accounting<br />
Standards Board (IASB).<br />
The annual report is presented in Danish kroner<br />
(DKK), which also is the functional currency of the<br />
Group.<br />
Changes in accounting policies<br />
The annual report for <strong>2007</strong> is presented in accordance<br />
with the new and revised standards (IFRS/<br />
IAS) and interpretations (IFRIC) which apply for<br />
the financial year. This has not resulted in any<br />
changes in accounting policies. However, the implementation<br />
of IFRS 7 Financial instruments: Disclosure<br />
and related changes to IAS 1 Presentation<br />
of financial statements has resulted in additional<br />
disclosures in the annual report on financial instruments<br />
and capital structure.<br />
The presentation of short-term securities has<br />
changed so that they are now recognised in cash<br />
flows from investing activities. Comparative figures<br />
have been restated.<br />
Future IFRS changes<br />
At the date of the publication of this annual report,<br />
a number of new and amended standards<br />
and interpretations have not yet entered into<br />
force or been adopted by the EU, and are therefore<br />
not included in this annual report.<br />
Such future IFRS changes are not expected to<br />
materially affect the annual report, except for the<br />
additional disclosure requirements that follow<br />
from the implementation of IFRS 8 Operating<br />
segments, which will be implemented in the<br />
annual report for 2009 at the latest.<br />
Accounting policies critical to financial<br />
reporting<br />
Management believes that the following accounting<br />
policies are most important to the Group’s financial<br />
reporting.<br />
Income from Forest<br />
The invoiced price is agreed between Forest and<br />
Lundbeck at the beginning of each calendar year.<br />
The price is calculated on the basis of expectations<br />
for the coming year’s development in the<br />
elements included in the royalty calculation. These<br />
elements are: Forest’s net selling prices, quantities<br />
used in sold products, quantities used in samples,<br />
quantities wasted during processing, and the various<br />
dosage levels of the finished goods. Income<br />
from sales of citalopram and escitalopram to Forest<br />
is recognised as follows:<br />
• Sales of both citalopram and escitalopram are<br />
invoiced at the agreed price but only a proportion<br />
(the minimum price) of the invoiced price<br />
is recognised as income at the time of delivery.<br />
• The difference between the invoiced price and<br />
the minimum price of Forest’s inventories is recorded<br />
in the balance sheet as prepayments.<br />
• After the end of each quarter, the final settlement<br />
price is calculated. The difference between<br />
the final calculated settlement price and<br />
the invoiced price is recognised as income and<br />
settled with Forest, and the difference between<br />
the invoiced price and the minimum price recorded<br />
in the balance sheet as prepayments at<br />
the time of delivery is recognised as income.<br />
License income and income from research<br />
collaborations<br />
Revenue includes license income and royalties<br />
from outlicensed products as well as non-refundable<br />
down-payments and milestone payments<br />
relating to research collaborations, which are recognised<br />
as income in the income statement when<br />
the rights are obtained, subject to the following<br />
criteria being met:<br />
• The payment relates to research results already<br />
obtained.<br />
• The most significant risks and benefits associated<br />
with the asset sold are transferred to the<br />
buyer.<br />
• Lundbeck does not retain management control<br />
of the asset sold.<br />
• Revenue from the individual payments in an<br />
overall agreement can be clearly separated and<br />
calculated reliably at fair value.<br />
• It is probable that Lundbeck will receive payment<br />
for the asset sold.<br />
• There are no further delivery obligations for<br />
Lundbeck concerning the asset sold.<br />
Development costs<br />
Development costs are capitalised if the criteria<br />
for such capitalisation are deemed to have been<br />
met and it is found to be probable that future<br />
earnings will cover the development costs. Due to<br />
a very long development period and significant<br />
uncertainty in relation to the development of new<br />
products, in the opinion of the Group, development<br />
costs should not normally be capitalised in<br />
the balance sheet until the development of the<br />
product has been completed and all the necessary<br />
public registration and marketing approvals have<br />
been obtained. Otherwise, development costs will<br />
be recognised in the income statement as they<br />
are incurred.<br />
Recognition and measurement<br />
Assets are recognised in the balance sheet if it is<br />
probable that future economic benefits will flow<br />
to the Group and that the value of the asset can<br />
be measured reliably.<br />
Liabilities are recognised in the balance sheet if<br />
they are probable and can be measured reliably.<br />
On initial recognition assets and liabilities are<br />
measured at cost or fair value. Subsequently assets<br />
and liabilities are measured as described for<br />
each item below.<br />
Certain financial assets and liabilities are measured<br />
at amortised cost, implying the recognition<br />
of a constant effective rate of interest to maturity.<br />
Amortised cost is calculated as original cost less<br />
any repayments and plus/less the cumulative<br />
amortisation of the difference between cost and<br />
the nominal amount.<br />
Recognition and measurement take into consideration<br />
gains, losses and risks that arise before the<br />
time of presentation of the annual report and that<br />
confirm or invalidate matters existing at the balance<br />
sheet date.<br />
70
Income is recognised in the income statement as<br />
earned and includes value adjustments of financial<br />
assets and liabilities measured at fair value or<br />
amortised cost. In addition, expenses incurred to<br />
generate the income for the year are recognised,<br />
including depreciation, amortisation, impairment<br />
losses and provisions as well as reversals of<br />
amounts previously recognised in the income<br />
statement as a result of changed accounting estimates.<br />
Consolidated financial statements<br />
The consolidated financial statements comprise<br />
the parent company H. Lundbeck A/S and subsidiaries<br />
controlled by the parent company. Control is<br />
achieved where the parent company directly or<br />
indirectly holds more than 50% of the voting<br />
rights or is otherwise able to exercise or actually<br />
exercises control.<br />
Companies in which the Group holds between<br />
20% and 50% of the voting rights and exercises<br />
significant influence but not control are regarded<br />
as associates.<br />
Basis of consolidation<br />
The consolidated financial statements are prepared<br />
on the basis of the financial statements of<br />
the parent company and the subsidiaries, which<br />
are all prepared in accordance with the Group’s<br />
accounting policies.<br />
The consolidated financial statements are prepared<br />
by adding together uniform items and eliminating<br />
intra-group income and expenses, investments,<br />
balances and dividends as well as realised<br />
and unrealised gains and losses on transactions<br />
between the consolidated companies. Account is<br />
taken of the tax effect of these eliminations.<br />
Business combinations<br />
Newly acquired or newly formed companies are<br />
recognised in the consolidated financial statements<br />
from the date of acquisition. Companies<br />
sold or discontinued are recognised in the consolidated<br />
income statement up to the time of sale<br />
or discontinuance. Expected divestment costs are<br />
included in the calculation of gains or losses.<br />
Newly acquired subsidiaries are accounted for using<br />
the purchase method of accounting, according<br />
to which the identifiable assets, liabilities and<br />
contingent liabilities of the newly acquired companies<br />
are measured at fair value at the time of<br />
acquisition. Account is taken of the tax effect of<br />
the revaluations made.<br />
The cost of a company is the fair value of the<br />
consideration paid plus costs directly attributable<br />
to the business combination.<br />
Positive differences (goodwill) between the cost<br />
of the acquisition and the fair value of the acquired<br />
identifiable assets, liabilities and contingent<br />
liabilities are recognised under intangible assets.<br />
Negative differences (negative goodwill)<br />
between the cost of the acquisition and the fair<br />
value of the acquired identifiable assets, liabilities<br />
and contingent liabilities are recognised in the income<br />
statement at the time of acquisition.<br />
Minority interests are recognised at the time of<br />
acquisition at the proportionate share of the fair<br />
value of the acquired identifiable assets, liabilities<br />
and contingent liabilities.<br />
Goodwill arising from acquired companies is adjusted<br />
until the end of the year following acquisition<br />
if additional information about the fair value<br />
at the time of acquisition of assets, liabilities and<br />
contingent liabilities acquired is obtained after<br />
acquisition. However, goodwill will not be recognised<br />
by an amount exceeding the expectations<br />
of future income from the acquiree.<br />
Goodwill and adjustments to fair value in connection<br />
with the acquisition of independent foreign<br />
entities (subsidiaries or associates) are accounted<br />
for as assets and liabilities in the acquiree and<br />
translated at the exchange rates at the balance<br />
sheet date.<br />
Gains or losses on disposal or discontinuance of<br />
subsidiaries and associates<br />
Gains or losses on the disposal or discontinuance<br />
of subsidiaries and associates are calculated as<br />
the difference between the selling price or the<br />
discontinuance amount and the carrying amount<br />
of net assets at the time of sale as well as anticipated<br />
expenses relating to sale or discontinuance.<br />
Minority interests<br />
The subsidiaries’ items are fully consolidated in<br />
the consolidated financial statements. Minority<br />
interests’ proportionate share of the subsidiaries’<br />
results and equity is shown as separate items in<br />
the income statement and in equity.<br />
Translation of foreign currency<br />
On initial recognition, transactions denominated<br />
in foreign currencies are translated at standard<br />
rates which equal the actual exchange rates at<br />
the transaction date. Exchange differences arising<br />
between the rate at the transaction date and the<br />
rate at the date of payment are recognised in the<br />
income statement as net financials.<br />
Receivables, payables and other monetary items<br />
denominated in foreign currencies that have not<br />
been settled at the balance sheet date are translated<br />
at the exchange rates at the balance sheet<br />
date. The difference between the exchange rates<br />
at the balance sheet date and the rates at the<br />
time the receivable or payable is created or recognised<br />
in the latest annual report is recognised in<br />
the income statement under net financials.<br />
Non-monetary assets acquired in foreign currencies<br />
are translated at the exchange rates at the<br />
time of acquisition.<br />
Where foreign subsidiaries are regarded as an integral<br />
part of the parent’s activities, the transactions<br />
in the subsidiaries will be accounted for as if<br />
they had been executed in the parent company.<br />
On recognition of foreign subsidiaries, monetary<br />
items are translated at the exchange rates at the<br />
balance sheet date. Non-monetary items, including<br />
goodwill in integrated entities, are translated<br />
at the exchange rates at the time of acquisition<br />
or at the time of any subsequent revaluation or<br />
writedown of the asset. Income statement items<br />
are translated at average exchange rates for the<br />
year which approximate the actual exchange<br />
rates at the transaction date. However, items<br />
derived from non-monetary items are translated<br />
at the historical exchange rates that apply to the<br />
non-monetary item.<br />
Exchange differences arising from the translation<br />
of both the balance sheets and the income statements<br />
of the foreign subsidiaries are recognised in<br />
the Group’s income statement as net financials.<br />
When recognising foreign associates that use a<br />
reporting currency different from that used by the<br />
parent company, assets and liabilities are translated<br />
at the exchange rates at the balance sheet<br />
date, while the income statement is translated at<br />
average exchange rates for the year.<br />
71
1<br />
Notes<br />
Exchange differences arising from the translation<br />
of foreign associates are recognised in the Group<br />
directly in equity.<br />
Derivative financial instruments<br />
Forward exchange contracts and other derivative<br />
financial instruments are initially recognised in<br />
the balance sheet at fair value on the value date<br />
and are subsequently remeasured at fair value at<br />
the balance sheet date. Positive and negative fair<br />
values are included in other receivables and other<br />
payables respectively.<br />
Changes in the fair value of derivative financial<br />
instruments classified as hedging instruments and<br />
meeting the criteria for hedging future cash flows<br />
are recognised directly in equity. Income and<br />
expenses related to such hedging transactions are<br />
transferred from equity on realisation of the<br />
hedged item and included in the same item as<br />
the hedged item.<br />
Changes in the fair value of derivative financial<br />
instruments classified as hedging instruments and<br />
meeting the criteria for hedging the fair value of a<br />
recognised asset or liability are recognised in the<br />
income statement together with changes in the<br />
value of the hedged asset or liability.<br />
For derivative financial instruments which do not<br />
qualify for hedge accounting, changes in fair value<br />
are recognised in the income statement under net<br />
financials as they arise.<br />
Changes in the fair value of derivative financial<br />
instruments used to hedge net investments in<br />
independent foreign subsidiaries or associates<br />
and which otherwise meet the relevant criteria<br />
are recognised directly in equity.<br />
Income statement<br />
Revenue<br />
Revenue comprises invoiced sales for the year less<br />
returned goods and revenue-based taxes consisting<br />
mainly of value added taxes and foreign revenue-based<br />
drug taxes.<br />
Sales subject to a price adjustment clause are included<br />
in revenue at the time of delivery at the<br />
minimum price. The balance of the invoiced price<br />
is recognised in the balance sheet as a prepayment<br />
and is subsequently included in revenue<br />
when the price has been finally determined. The<br />
price is finally determined as the product is resold<br />
by the customer.<br />
Moreover, revenue includes license income and<br />
royalties from outlicensed products as well as<br />
non-refundable downpayments and milestone<br />
payments relating to research collaborations.<br />
In addition, income from the reduction of investments<br />
in research enterprises, considered to represent<br />
the sale of research results, is recognised<br />
as revenue.<br />
See Accounting policies critical to financial reporting<br />
on page 70 for a description of the accounting<br />
treatment of income from Forest and of license<br />
income and income from research collaborations.<br />
Cost of sales<br />
Cost of sales comprises the cost of goods sold.<br />
Cost includes the cost of raw materials, consumables<br />
and goods for resale, direct labour and indirect<br />
costs of production, including operating<br />
costs, amortisation/depreciation and impairment<br />
losses relating to manufacturing facilities. Cost of<br />
sales moreover includes expenses in connection<br />
with quality certification of sold products and any<br />
writedown to net realisable value of unsaleable<br />
and slow moving items.<br />
Distribution costs<br />
Distribution costs comprise expenses incurred in<br />
connection with the distribution of the Group’s<br />
products sold during the year and in connection<br />
with sales campaigns, etc. launched during the<br />
year under review, including direct distribution<br />
and marketing costs, salaries etc. for the sales and<br />
marketing functions, as well as amortisation/<br />
depreciation and other indirect costs.<br />
Administrative expenses<br />
Administrative expenses comprise expenses incurred<br />
during the year for the management and<br />
administration of the Group, including expenses in<br />
connection with the administrative functions,<br />
management, office premises and office expenses,<br />
as well as amortisation/depreciation and other<br />
indirect costs.<br />
Research and development costs<br />
Research and development costs comprise expenses<br />
incurred during the year in connection<br />
with the Group’s research and development functions,<br />
including wages and salaries, amortisation/<br />
depreciation and other indirect costs as well as<br />
costs relating to research and development collaborations<br />
on in-licensed products.<br />
Research costs are always recognised in the income<br />
statement as they are incurred.<br />
Development costs are capitalised if a number of<br />
specific criteria for capitalising these costs are<br />
deemed to have been met. Otherwise, development<br />
costs will be recognised in the income<br />
statement as they are incurred.<br />
See Accounting policies critical to financial reporting<br />
on page 70 for a description of conditions for<br />
capitalising development costs.<br />
Other operating income and expenses<br />
Other operating income and expenses comprise<br />
items of a secondary nature in relation to the<br />
Group’s activities.<br />
Results of investments in subsidiaries and<br />
associates in the parent company’s financial<br />
statements<br />
Dividends from subsidiaries and associates are<br />
recognised in the parent company’s income statement<br />
when the shareholder’s right to receive dividend<br />
has been approved, less any writedowns of<br />
the equity investments.<br />
Results of investments in associates in the<br />
consolidated financial statements<br />
The proportionate share of the results of associates<br />
is recognised in the consolidated income<br />
statement after tax and elimination of the proportionate<br />
share of any intra-group gains and<br />
losses and after deduction of any writedowns of<br />
the equity investments.<br />
Net financials<br />
Net financials include interest income and expenses<br />
which are recognised in the income statement<br />
at the amounts relating to the financial<br />
year. Value adjustments of financial assets and<br />
realised and unrealised gains and losses on investments,<br />
items denominated in foreign currencies<br />
as well as forward contracts and other derivative<br />
financial instruments not used for hedging purposes<br />
according to the hedge accounting principle<br />
are also included in net financials.<br />
72
Tax<br />
As from 2005, the Danish companies of the<br />
Group are jointly taxed with the parent company<br />
LFI a/s and are included in the Danish provisional<br />
tax scheme. The current Danish income tax liability<br />
is allocated among the companies of the<br />
Danish tax pool in proportion to their taxable<br />
income with due consideration to foreign taxes<br />
paid.<br />
Tax for the year, which consists of the year’s current<br />
tax and the change in deferred tax, is recognised<br />
in the income statement as regards the<br />
amount that can be attributed to the net profit or<br />
loss for the year and directly in equity as regards<br />
the amount that can be attributed to equity<br />
items. Exchange rate adjustments of deferred tax<br />
are recognised as part of the movements in deferred<br />
tax.<br />
Balance sheet<br />
Intangible assets<br />
Goodwill<br />
On initial recognition, goodwill is measured and<br />
recognised as the excess of the cost of the acquired<br />
enterprise over the fair value of the acquired<br />
assets, liabilities and contingent liabilities.<br />
On recognition of goodwill, the goodwill amount<br />
is allocated to those of the Group’s activities that<br />
generate separate cash flows (cash-generating<br />
units). The determination of cash-generating units<br />
is based on the Group’s management structure<br />
and the internal financial management and reporting.<br />
Goodwill is not amortised, but is tested for impairment<br />
at least once a year.<br />
Development projects<br />
Clearly defined and identifiable development<br />
projects are recognised as intangible assets where<br />
the technical rate of utilisation of the project, the<br />
availability of adequate resources and a potential<br />
future market or development opportunity in the<br />
company can be demonstrated and where the intention<br />
is to manufacture, market or use the<br />
project if the cost can be measured reliably and it<br />
is probable that the future earnings can cover<br />
production and selling expenses, administrative<br />
expenses as well as the development costs. Other<br />
development costs are recognised in the income<br />
statement as the costs are incurred.<br />
After completion of the development work development<br />
costs are amortised on a straight-line<br />
basis over the expected useful life, however with<br />
a maximum period of 20 years. For development<br />
projects protected by intellectual property rights,<br />
the maximum amortisation period is the remaining<br />
term of the rights concerned, however with a<br />
maximum period of 20 years.<br />
Other intangible assets<br />
Acquired intellectual property rights in the form of<br />
product rights, patents, licenses and software are<br />
measured at cost less accumulated amortisation.<br />
The cost of software comprises the cost of planning,<br />
including direct labour and costs directly attributable<br />
to the project. Product rights are amortised on<br />
a straight-line basis over the economic lives of the<br />
underlying products. Patents are amortised over the<br />
remaining patent period, and licenses are amortised<br />
over the period of agreement, however with a maximum<br />
period of 20 years.<br />
Gains and losses on the disposal of development<br />
projects, patents and licenses are measured as the<br />
difference between the selling price less cost to<br />
sell and the carrying amount at the time of sale.<br />
Property, plant and equipment<br />
Property, plant and equipment are measured at<br />
cost less accumulated depreciation and accumulated<br />
impairment losses. Land is not depreciated.<br />
Cost includes the costs of purchase and expenses<br />
directly attributable to the purchase until the asset<br />
is ready for use. In the case of assets manufactured<br />
by the company, cost includes expenses directly<br />
attributable to the manufacture of the<br />
asset, including materials, components, thirdparty<br />
suppliers and labour.<br />
Interest relating to property, plant and equipment<br />
during the period of building and erection is not<br />
capitalised.<br />
Property, plant and equipment are depreciated on<br />
a straight-line basis over the expected useful lives<br />
of the assets, which are expected to be as follows:<br />
Buildings<br />
Installations<br />
Plant and machinery<br />
Other fixtures and fittings,<br />
tools and equipment<br />
Leasehold improvements<br />
30 years<br />
10 years<br />
3-10 years<br />
3-10 years<br />
max. 10 years<br />
The depreciation base is cost less the estimated<br />
residual value at the end of the expected useful<br />
life. The cost of a total asset is divided into<br />
smaller components that are depreciated separately<br />
if such components have different useful<br />
lives. Depreciation methods, useful lives and residual<br />
values are reassessed annually.<br />
Depreciation is recognised in the income statement<br />
under cost of sales, distribution costs, administrative<br />
expenses and research and development<br />
costs, respectively.<br />
The costs of maintaining property, plant and<br />
equipment are recognised in the income statement<br />
as they are incurred, either directly in the<br />
income statement or as part of indirect costs of<br />
production.<br />
Costs incurred that increase the recoverable<br />
amount of the asset concerned are added to the<br />
asset’s cost as an improvement and are depreciated<br />
over the expected useful life of the improvement.<br />
Gains or losses on the disposal or retirement of<br />
items of property, plant and equipment are calculated<br />
as the difference between the carrying<br />
amount and the selling price reduced by dismantling<br />
expenses and cost to sell. Gains and<br />
losses are recognised in the income statement<br />
under the same items as the associated depreciation.<br />
Impairment losses<br />
The carrying amount of intangible assets and<br />
property, plant and equipment is analysed in connection<br />
with the preparation of the annual report<br />
if there is an indication that the carrying amount<br />
of an asset may exceed the expectations of future<br />
income from the asset (recoverable amount). If<br />
this analysis concludes that the future expected<br />
net income from the asset will be lower than the<br />
carrying amount, the carrying amount will be reduced<br />
to the higher of fair value less cost to sell<br />
and value in use. Impairment losses are recognised<br />
in the income statement under the same<br />
items as the associated depreciation or amortisation.<br />
If the asset does not generate any cash flows independently<br />
of other assets, the recoverable<br />
amount is calculated for the smallest cash-generating<br />
unit that includes the asset.<br />
73
1<br />
Notes<br />
Goodwill is amortised through the income statement<br />
in those cases where the carrying amount<br />
exceeds the future net income expected from the<br />
cash-generating unit to which the goodwill relates<br />
(recoverable amount).<br />
Investments in subsidiaries and associates in<br />
the parent company’s financial statements<br />
Investments in subsidiaries and associates are<br />
measured at cost in the parent company’s financial<br />
statements. Where the recoverable amount of<br />
the investments is lower than cost, the investments<br />
are written down to this lower value. In<br />
addition, cost is written down to the extent that<br />
dividend distributed exceeds the accumulated<br />
earnings in the company since the acquisition date.<br />
Investments in associates in the consolidated<br />
financial statements<br />
Investments in associates are recognised and<br />
measured in the consolidated financial statements<br />
according to the equity method, which entails<br />
that the investments are measured in the<br />
balance sheet at the proportionate share of the<br />
associate’s net asset value calculated in accordance<br />
with the Group’ accounting policies less or<br />
plus unrealised intra-group gains and losses and<br />
plus the carrying amount of goodwill.<br />
The proportionate share of the results of the associate<br />
is recognised in the income statement after<br />
tax and elimination of the proportionate share<br />
of any intra-group gains and losses and after deduction<br />
of any writedowns of the investments.<br />
Consolidated equity includes the proportionate<br />
share of all transactions and events recognised directly<br />
in the equity of the associate.<br />
Investments in associates with a negative carrying<br />
amount are recognised at DKK 0. Receivables<br />
and other long-term financial assets considered<br />
to form part of the overall investment in the associate<br />
are written down by any remaining negative<br />
net asset value. Trade receivables and other<br />
receivables are written down to the extent they<br />
are deemed to be irrecoverable. A provision to<br />
cover the remaining negative net asset value will<br />
only be made if the Group has a legal or constructive<br />
obligation to cover the liabilities of the relevant<br />
associate.<br />
Other financial assets<br />
Other equity investments that are included in the<br />
Group’s documented investment strategy in accordance<br />
with the fair value option of IAS 39<br />
Financial instruments: Recognition and measurement<br />
are recognised on the basis of the value<br />
date and are measured at market price or estimated<br />
fair value at the balance sheet date. Both<br />
realised and unrealised gains and losses are recognised<br />
in the income statement under net financials.<br />
On initial recognition, other investments outside<br />
the scope of the documented investment strategy<br />
are available for sale and measured at fair value<br />
with the addition of directly attributable costs.<br />
Other investments are subsequently measured at<br />
fair value at the balance sheet date, and changes<br />
to the fair value are recognised in equity with the<br />
exception of impairment losses and dividends,<br />
which are taken to the income statement. When<br />
securities are sold or settled, the accumulated fair<br />
value adjustments are recognised in the income<br />
statement.<br />
Other receivables with a fixed maturity are measured<br />
at amortised cost less impairment losses as<br />
a result of diminution in value. Other receivables<br />
without a fixed maturity are recognised at cost.<br />
Inventories<br />
Raw materials, packaging and goods for resale are<br />
measured at the latest known cost at the balance<br />
sheet date, which equals cost computed according<br />
to the FIFO method. The cost of raw materials,<br />
packaging and goods for resale includes the costs<br />
of purchase plus costs incurred in bringing the inventories<br />
to their present location and condition.<br />
Work in progress and finished goods manufactured<br />
by the company are measured at cost, i.e.<br />
the cost of raw materials, consumables, direct labour<br />
and indirect costs of production. Indirect<br />
costs of production include materials and labour<br />
as well as maintenance of and depreciation on<br />
the machines, factory buildings and equipment<br />
used in the manufacturing process as well as the<br />
cost of factory management and administration.<br />
Indirect production overheads are allocated based<br />
on the normal capacity of the production plant.<br />
Writedown to net realisable value is made if it is<br />
lower than cost. The net realisable value of inventories<br />
is calculated as the selling price less costs<br />
of conversion and costs incurred to execute the<br />
sale and it is determined having regard to marketability,<br />
obsolescence and expected selling price<br />
movements.<br />
Receivables<br />
Short-duration receivables arising in the Group’s<br />
normal course of business are measured at nominal<br />
value less impairment losses to counter the<br />
risk of loss calculated on the basis of an individual<br />
evaluation.<br />
Other securities<br />
Other securities, including the bond portfolio, that<br />
are included in the Group’s documented investment<br />
strategy and recognised under current assets<br />
are recognised on the basis of the value date<br />
and are measured at the market price at the balance<br />
sheet date. Both realised and unrealised<br />
gains and losses are recognised in the income<br />
statement under net financials.<br />
On initial recognition, other securities outside the<br />
scope of the documented investment strategy are<br />
measured at fair value with the addition of directly<br />
attributable costs. They are subsequently<br />
measured at fair value at the balance sheet date,<br />
and changes to the fair value are recognised in<br />
equity and dividends are recognised in the income<br />
statement. When securities are sold or<br />
settled, the accumulated fair value adjustments<br />
are recognised in the income statement.<br />
The fair value is calculated according to official<br />
stock exchange listings/OTC listings or estimated<br />
fair value at the most recent round of capital<br />
contributions.<br />
Equity<br />
Dividend<br />
Proposed dividend is recognised as a liability at<br />
the time of adoption of the dividend resolution at<br />
the annual general meeting (the time of declaration).<br />
Dividend expected to be paid for the year is<br />
shown as a separate item in the statement of equity.<br />
Treasury shares<br />
Cost and selling prices of treasury shares as well<br />
as dividends are recognised directly in retained<br />
earnings under equity. Gains and losses on sales<br />
are therefore not recognised in the income statement.<br />
Other equity instruments<br />
Cost and selling prices of other equity instruments,<br />
including option premiums in connection<br />
with option contracts for the purchase of treasury<br />
shares, are recognised directly in retained earnings<br />
under equity.<br />
74
Share-based payment<br />
Share-based incentive plans in which employees<br />
may opt only to buy shares in the parent company<br />
(equity schemes) are measured at the equity<br />
instruments’ fair value at the date of grant<br />
and recognised in the income statement under<br />
staff costs when the employee obtains the right<br />
to buy the shares. The balancing item is recognised<br />
directly in equity.<br />
Share-based incentive plans in which employees<br />
have the difference between the agreed price and<br />
the actual share price settled in cash are measured<br />
at fair value at the date of grant and recognised<br />
in the income statement under staff costs<br />
when the final right of cash-settlement is obtained.<br />
The incentive plans are subsequently remeasured<br />
on each balance sheet date and upon<br />
final settlement, and any changes in the fair value<br />
of the plans are recognised in the income statement<br />
under staff costs. The balancing item is recognised<br />
under liabilities.<br />
Pension obligations<br />
The Group has entered into pension agreements<br />
and similar agreements with most of the Group’s<br />
employees.<br />
Periodical payments to defined contribution plans<br />
are recognised in the income statement at the<br />
due date and any contributions payable are recognised<br />
in the balance sheet under liabilities.<br />
The present value of the Group’s liabilities relating<br />
to future pension payments according to defined<br />
benefit plans is measured on an actuarial basis at<br />
intervals of not more than three years on the basis<br />
of the pensionable period of employment up<br />
to the time of the actuarial valuation. The Projected<br />
Unit Credit Method is applied to determine<br />
the present value. The present value is calculated<br />
based on assumptions of the future developments<br />
of salary, interest, inflation, mortality rates, disability<br />
and other factors. Actuarial gains and losses<br />
are recognised in the income statement as they<br />
are calculated.<br />
The present value of the liability according to defined<br />
benefit plans is measured less the fair value<br />
of the plan assets, and any net obligation is recognised<br />
in the balance sheet under non-current liabilities.<br />
Any net asset is recognised in the balance<br />
sheet as a financial asset.<br />
The year’s changes in the provisions relating to<br />
defined benefit plans are recognised in the income<br />
statement.<br />
Income tax and deferred tax<br />
Current tax liabilities and current tax receivables<br />
are recognised in the balance sheet, computed as<br />
tax calculated on the taxable income for the year,<br />
adjusted for provisional taxes paid. Tax payments<br />
for the jointly taxed companies of the Group are<br />
settled with the parent company LFI a/s.<br />
Deferred tax is recognised according to the balance<br />
sheet liability method on all temporary differences<br />
between the carrying amounts of assets<br />
and liabilities and their tax base, except for temporary<br />
differences arising either on initial recognition<br />
of goodwill or initial recognition of a transaction<br />
that is not a business combination and with<br />
the temporary difference ascertained at the time<br />
of the initial recognition affecting neither the financial<br />
results nor the taxable income.<br />
Deferred income tax is provided on temporary differences<br />
arising on investments in subsidiaries and<br />
associates, unless the parent company has a possibility<br />
of controlling when the deferred tax is to<br />
be realised and it is likely that the deferred tax will<br />
not crystallise as current tax.<br />
Deferred tax is calculated based on the planned<br />
use of each asset and settlement of each liability,<br />
respectively.<br />
Deferred tax is measured by using the tax rates<br />
and tax rules that, based on legislation in force or<br />
in reality in force at the balance sheet date, are<br />
expected to apply in the respective countries<br />
when the deferred tax is expected to crystallise as<br />
current tax. Changes in deferred tax as a result of<br />
changed tax rates or tax rules are recognised in<br />
the income statement.<br />
Deferred tax assets, including the tax value of tax<br />
loss carry-forwards, are recognised in the balance<br />
sheet at the value at which the asset is expected<br />
to be realised, either through a set-off against deferred<br />
tax liabilities or as net assets to be offset<br />
against future positive taxable income.<br />
Deferred tax concerning recaptured losses in<br />
jointly taxed foreign subsidiaries in previous years<br />
is recognised to the extent a tax liability is expected<br />
to arise in connection with future profits<br />
or on the disposal of the asset.<br />
Tax on equity items relating to deferred income<br />
and expenses in connection with financial instruments,<br />
treasury shares and options to purchase<br />
treasury shares as well as payments concerning<br />
share option plans and other share price based<br />
plans is recognised in equity. However, changes in<br />
deferred tax concerning the cost of share-based<br />
payments are generally recognised in the income<br />
statement.<br />
Provisions<br />
Provisions are recognised when the Group has a<br />
legal or constructive obligation that arises from<br />
past events and it is probable that an outflow of<br />
financial resources will be required to settle the<br />
obligation.<br />
Return obligations imposed on the industry are<br />
recognised in the balance sheet under provisions.<br />
Debt<br />
Mortgage debt and debt to credit institutions are<br />
recognised at the time of the raising of the loan<br />
at proceeds received less transaction costs paid.<br />
In subsequent periods the financial liabilities are<br />
measured at amortised cost, equivalent to the<br />
capitalised value when the effective rate of interest<br />
is used, so that the difference between the<br />
proceeds and the nominal value is recognised in<br />
the income statement over the loan period.<br />
Debt included in the short-term financial liquidity<br />
is also measured at amortised cost in subsequent<br />
periods.<br />
Other payables, which include trade payables,<br />
payables to subsidiaries and associates, as well as<br />
other debt are measured at amortised cost.<br />
Cash flow statement<br />
The consolidated cash flow statement is presented<br />
according to the indirect method and<br />
shows the composition of cash flows, divided into<br />
operating, investing and financing activities respectively,<br />
and the cash at the beginning and the<br />
end of the year.<br />
75
1-2<br />
Notes<br />
Cash flows from acquisitions and divestments of<br />
companies are shown separately under cash flows<br />
from investing activities. The cash flow statement<br />
includes cash flows from acquired companies<br />
from the date of acquisition and cash flows from<br />
divested companies until the time of divestment.<br />
Cash flows from operating activities are calculated<br />
as the Group’s results before net financials,<br />
adjusted for non-cash operating items, working<br />
capital changes, financial items paid and received<br />
and income taxes paid.<br />
Cash flows from investing activities include payments<br />
in connection with purchases and sales of<br />
intangible assets, property, plant and equipment<br />
and financial assets, including equity investments<br />
in companies. Also included are securities classified<br />
as current assets.<br />
Cash flows from financing activities include payments<br />
to and from shareholders and related expenses<br />
as well as the raising of and repayments<br />
on mortgage debt and other non-current liabilities.<br />
Cash comprises cash less short-term bank debt<br />
falling due on demand.<br />
Cash flows denominated in foreign currencies, including<br />
cash flows in foreign subsidiaries, are<br />
translated at the average exchange rates during<br />
the year because they approximate the actual<br />
rates at the date of payment. Cash at year-end is<br />
translated at the rates at the balance sheet date,<br />
and the effect of exchange rate changes on cash<br />
is shown as a separate item in the cash flow<br />
statement.<br />
Segment reporting<br />
The Group’s activities are exclusively in the business<br />
segment of ‘pharmaceuticals for the treatment<br />
of illnesses in the field of CNS’. Revenue,<br />
segment assets and additions to intangible assets<br />
and property, plant and equipment in the segment<br />
are disclosed within the secondary geographical<br />
segments. Segment information is provided<br />
in accordance with the Group’s accounting<br />
policies, risks and internal financial management<br />
policies.<br />
Segment assets are those operating assets that are<br />
employed by a segment in its operating activity<br />
and that are either directly attributable or can be<br />
allocated to the segment on a reasonable basis.<br />
Transactions between geographical segments are<br />
made at market value.<br />
Key figures<br />
Financial key figures are calculated according<br />
to Recommendations and Financial Ratios 2005<br />
issued by the Danish Society of Financial Analysts.<br />
For definitions of key figures see Summary for the<br />
Group 2003 - <strong>2007</strong>, pages 60-61.<br />
76
2. Revenue<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
306.5 354.2 Denmark 73.7 238.5<br />
3,189.8 3,695.3 Rest of Europe 5,504.4 5,103.2<br />
1,957.6 2,652.0 USA 2,652.0 1,957.6<br />
522.8 1,040.2 Rest of the world 2,754.8 1,921.7<br />
5,976.7 7,741.7 Total 10,984.9 9,221.0<br />
Including<br />
5.5 419.9 Downpayments and milestone payments 419.9 5.5<br />
489.0 657.6 Royalty 658.0 489.2<br />
- - Income from reduction of shareholding in LifeCycle Pharma A/S - 154.6<br />
Income from Forest in the USA<br />
Income from sales of citalopram and escitalopram to Forest amounted to DKK 2,599.3 million in <strong>2007</strong> (DKK 1,930.0 million in 2006) based on the minimum price for<br />
shipments made during the year and adjustments of prepayments concerning prior-year shipments. Prepayments, which is the difference between the invoiced price<br />
and the minimum price, were DKK 839.5 million at 31 December <strong>2007</strong> (DKK 854.7 million in 2006). See Note 1 Accounting policies for a more elaborate description<br />
hereof.<br />
The invoiced price is agreed between Forest and Lundbeck at the beginning of each calendar year. The price is calculated on the basis of expectations for the coming<br />
year’s development in the elements included in the royalty calculation. These elements are: Forest’s net selling prices, quantities used in sold products, quantities used<br />
in samples, quantities wasted during processing, and the various dosage levels of the finished goods.<br />
The agreement with Forest takes into consideration the expiry of the escitalopram patent protection in the USA in 2012. Prior to any launch of generic escitalopram,<br />
Forest is expected to reduce its escitalopram inventories to a low level.<br />
In connection with a launch of generic escitalopram, the agreement allows Forest to convert inventories of escitalopram into generic escitalopram. In connection with<br />
any conversion of escitalopram inventories, the minimum price will be adjusted by any repayment to Forest of part of the recognised minimum payment.<br />
Lundbeck monitors the development in Forest’s inventories and net selling price thoroughly, and regularly assesses the risk of the price adjustment clause and<br />
repayment of the advance payment being applied. Lundbeck believes that there is no repayment risk at 31 December <strong>2007</strong>.<br />
Income from Takeda<br />
Revenue for <strong>2007</strong> includes DKK 419.5 million concerning the strategic alliance formed with Takeda Pharmaceutical Company Limited. In September <strong>2007</strong>,<br />
Lundbeck sold know-how and license rights to develop and market new compounds for the treatment of mood and anxiety disorders. The compounds are<br />
Lu AA21004 and Lu AA24530, which are in Phase III and Phase II clinical development, respectively, and the agreement includes an option under certain conditions<br />
to include two other compounds. Lundbeck has received the preliminary payment in the form of a non-refundable downpayment of USD 40 million in September<br />
<strong>2007</strong>, and a milestone payment of USD 40 million in December <strong>2007</strong>.<br />
In accordance with Lundbeck’s accounting policies, payments for the sale of know-how and license rights are recognised when such know-how and rights are<br />
obtained pursuant to the agreement, and as the conditions for milestone and royalty payments are met, while the estimated value of the option of DKK 10.0 million<br />
to include another two compounds in the collaboration is recognised in the balance sheet and taken to income at a later date.<br />
77
3<br />
Notes<br />
3. Staff costs<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
Wages and salaries, etc.<br />
893.1 947.6 Short-term staff benefits 2,255.0 2,148.6<br />
85.1 89.4 Pension benefits 124.3 144.1<br />
18.5 18.2 Other social security costs 303.6 296.2<br />
996.7 1,055.2 Total 2,682.9 2,588.9<br />
The year’s staff costs are analysed as follows<br />
292.3 312.2 Cost of sales 384.5 363.7<br />
8.5 8.0 Distribution costs 929.0 924.6<br />
258.0 266.9 Administrative expenses 679.2 650.0<br />
437.9 468.1 Research and development costs 690.2 650.6<br />
996.7 1,055.2 Total 2,682.9 2,588.9<br />
Executives<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
28.8 37.0 Short-term staff benefits 47.0 65.0<br />
4.4 5.6 Pension benefits 6.4 7.7<br />
0.3 0.3 Other social security costs 1.3 2.8<br />
- 6.3 Share-based payments 7.2 0.1<br />
33.5 49.2 Total 61.9 75.6<br />
Total remuneration to executives in the Group was lower in <strong>2007</strong> than in 2006 due to an organisational reshuffle at the beginning of <strong>2007</strong>, which reduced the<br />
number of persons falling under the Group category of executives.<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
Executive Management<br />
20.7 18.7 Short-term staff benefits 18.7 20.7<br />
- 7.0 Severance payment 7.0 -<br />
2.0 1.3 Pension benefits 1.3 2.0<br />
- 3.3 Share-based payments 3.3 -<br />
22.7 30.3 Total 30.3 22.7<br />
In January <strong>2007</strong>, the Executive Management was reduced from five to four members.<br />
The total remuneration of the President and CEO, including bonus, which is a combination of company strategic and individual targets, and share-based payment,<br />
for the <strong>2007</strong> financial year amounted to DKK 8.6 million (DKK 6.3 million in 2006). Of this amount, the value of share-based payment amounts to DKK 1.0 million<br />
(DKK 0 in 2006).<br />
The value of the warrant schemes for the Executive Management, calculated according to the Black-Scholes formula, was DKK 3.6 million at 31 December <strong>2007</strong><br />
(DKK 7.4 million in 2006).<br />
For <strong>2007</strong>, the value of the bonus programme for Executive Management will not exceed three months’ salary.<br />
A special severance payment of DKK 7.0 million was agreed for the Executive Vice President who stepped down in <strong>2007</strong>.<br />
78
3. Staff costs – continued<br />
Supervisory Board<br />
Remuneration of members of the Supervisory Board for <strong>2007</strong> amounted to DKK 3.7 million (DKK 3.0 million in 2006). To this amount should be added remuneration<br />
for participation in the Audit Committee of DKK 0.4 million (DKK 0.4 million in 2006), and for participation in the Remuneration Committee of DKK 0.2 million<br />
(DKK 0.2 million in 2006). The members of the Supervisory Board held a total of 29,332 Lundbeck shares at 31 December <strong>2007</strong> (11,910 shares in 2006).<br />
The total remuneration of the chairman of the Supervisory Board amounted to DKK 1.3 million (DKK 0.9 million in 2006) including remuneration for participation<br />
in the Audit Committee and the Remuneration Committee. The total remuneration of the deputy chairman of the Supervisory Board for <strong>2007</strong> amounted to<br />
DKK 0.7 million (DKK 0.6 million in 2006) including remuneration for participation in the Audit Committee. The standard annual remuneration of the chairman of<br />
the Supervisory Board amounts to DKK 1.1 million. Some of the board members were replaced in <strong>2007</strong>, including the chairman.<br />
Employees<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
1,903 1,935 Average number of full-time employees in the financial year 5,134 5,111<br />
Number of full-time employees at 31.12.<br />
1,907 1,963 In Denmark 1,989 1,941<br />
- - Abroad 3,108 3,230<br />
1,907 1,963 Total 5,097 5,171<br />
Incentive plans<br />
Warrant scheme for the Executive Management and key employees (2004 plan)<br />
In 2004, the company established a warrant scheme for the Executive Management and a number of key employees in Denmark and abroad. Approximately 1,100<br />
employees were granted a total of 2,554,092 warrants, including 160,000 granted to the Executive Management at the time. The warrants had vested fully from the<br />
commencement of the scheme and could be exercised during the period from 9 December 2004 to 30 August <strong>2007</strong>. The exercise price was DKK 108.11 throughout the<br />
exercise period.<br />
In <strong>2007</strong>, 992,121 warrants (505,609 in 2006) were exercised under this scheme. Unexercised warrants were cancelled at 1 September <strong>2007</strong>.<br />
The scheme was subject to the transition rules of IFRS 2 Share-based payments as the warrants vested before 1 January 2005 and therefore had not been recognised in<br />
the income statement and the balance sheet. The scheme expired in <strong>2007</strong> and the market value based on the Black-Scholes formula was DKK 0 at 31 December <strong>2007</strong><br />
(DKK 65.1 million in 2006).<br />
Executive Market value Total<br />
Management Executives Other Total per warrant market value<br />
Number Number Number Number DKK DKKm<br />
Outstanding at 01.01.2006 160,000 178,000 1,510,304 1,848,304 27.73 51.3<br />
Exercised (44,500) (95,000) (366,109) (505,609)<br />
Recategorised, granted and cancelled - 10,400 (10,400) -<br />
Outstanding at 31.12.2006 115,500 93,400 1,133,795 1,342,695 48.47 65.1<br />
Exercised (75,500) (77,400) (839,221) (992,121)<br />
Cancelled (40,000) (16,000) (294,574) (350,574)<br />
Outstanding at 31.12.<strong>2007</strong> - - - -<br />
In 2006, the calculated market value per warrant was based on an exercise price of DKK 108.11, a quoted price of DKK 155.83, a volatility of 22.08%, a dividend<br />
payout ratio of 1.44% and a risk-free interest rate of 3.90%.<br />
79
3<br />
Notes<br />
3. Staff costs – continued<br />
Warrant scheme for the Executive Management and Danish and foreign executives (2005 plan)<br />
In 2005, the company established a warrant scheme for the Executive Management and Danish and foreign executives. 76 employees were granted a total of<br />
647,000 warrants, 160,000 of which were allocated to the Executive Management at the time. The warrants had vested fully from the commencement of the<br />
scheme and may be exercised during the period from 2 October 2006 to 31 March 2009. The exercise price is DKK 179.00 throughout the exercise period.<br />
No warrants have been exercised under this scheme.<br />
Executive Market value Total<br />
Management Executives Other Total per warrant market value<br />
Number Number Number Number DKK DKKm<br />
Outstanding at 01.01.2006 160,000 306,000 181,000 647,000 8.83 5.7<br />
Recategorised - 37,000 (37,000) -<br />
Outstanding at 31.12.2006 160,000 343,000 144,000 647,000 11.40 7.4<br />
Recategorised (60,000) (105,000) 165,000 -<br />
Outstanding at 31.12.<strong>2007</strong> 100,000 238,000 309,000 647,000 3.24 2.1<br />
At 31 December <strong>2007</strong>, the calculated market value per warrant was based on the Black-Scholes formula for valuation of options. The calculation is based on an<br />
exercise price of DKK 179.00, a quoted price of DKK 138.00 (DKK 155.83 in 2006), a volatility of 32.13% (24.43% in 2006), a dividend payout ratio of 1.18%<br />
(1.44% in 2006) and a risk-free interest rate of 4.35% (4.19% in 2006).<br />
Warrant scheme for the Executive Management and Danish and foreign executives (<strong>2007</strong> plan)<br />
In <strong>2007</strong>, the company established a warrant scheme for the Executive Management and Danish and foreign executives. 80 employees were granted a total of<br />
844,500 warrants, 173,000 of which were allocated to the Executive Management. The warrants had vested fully from the commencement of the scheme and may<br />
be exercised during the period from 1 August 2008 to 31 March 2011. The exercise price is DKK 156.00 throughout the exercise period.<br />
The market value per warrant at the time of grant is calculated using the Black-Scholes formula and is based on a volatility of the Lundbeck share of 28.60%,<br />
a dividend payout ratio of 1.22%, a risk-free interest rate of 4.25%, an average maturity of approximately 32 months and a quoted price of DKK 132.35. This translates<br />
into a market value of DKK 19.44 per warrant.<br />
The warrants granted are recognised in the income statement for <strong>2007</strong> at an expense of DKK 16.4 million, which corresponds to the market value at the time of<br />
grant calculated according to the Black-Scholes formula.<br />
Executive Market value Total<br />
Management Executives Other Total per warrant market value<br />
Number Number Number Number DKK DKKm<br />
Granted 173,000 366,800 304,700 844,500<br />
Outstanding at 31.12.<strong>2007</strong> 173,000 366,800 304,700 844,500 19.31 16.3<br />
At 31 December <strong>2007</strong>, the calculated market value per warrant was based on the Black-Scholes formula for valuation of options. The calculation is based on an<br />
exercise price of DKK 156.00, a quoted price of DKK 138.00, a volatility of 30.23%, a dividend payout ratio of 1.18% and a risk-free interest rate of 4.25%.<br />
80
3. Staff costs – continued<br />
Share price based plan for employees in foreign subsidiaries (2002 plan)<br />
In 2002, the employees of foreign subsidiaries received a share price based plan, according to which employees employed by the Group throughout the period<br />
1 June 2002 - 2 January 2006 received a cash amount equal to 50% of the value of the plan. The remaining 50% of the value of the plan will be paid if the employees<br />
have been employed by the Group throughout the period 1 June 2002 - 2 January 2008. The size of the amount depends on how much the price of the<br />
Lundbeck share at 2 January 2006 and 2 January 2008 respectively exceeds DKK 81.00 per share (equal to the special price of the Danish employee share plan). The<br />
share price based plan cannot be converted into shares because the value of the plan will be distributed as a cash amount.<br />
The year’s adjustment of the calculation basis of the share price based plan for employees employed by the Group amounted to 10,212 shares and was due to<br />
resignations (143,068 in 2006 due to expiry of 50% of the plan and resignations).<br />
The plan is subject to the rules of IFRS 2 Share-based payments. The value adjustment for the year is recognised in the income statement for <strong>2007</strong> at an income of<br />
DKK 0.7 million (expense of DKK 4.7 million in 2006). The obligation at 31 December <strong>2007</strong> was DKK 7.9 million (DKK 8.6 million in 2006), including social contributions.<br />
The calculation of the obligation is adjusted for anticipated employee attrition until the time of payout.<br />
Executive Other Market value Total<br />
Management Executives employees Total per option obligation<br />
Number Number Number Number DKK DKKm<br />
Obligation at 01.01.2006 1,200 16,660 247,800 265,660 51.03 12.6<br />
Paid out (600) (5,370) (126,860) (132,830)<br />
Cancelled and recategorised - (6,020) (4,218) (10,238)<br />
Obligation at 31.12.2006 600 5,270 116,722 122,592 75.96 8.6<br />
Cancelled and recategorised (600) (3,180) (6,432) (10,212)<br />
Obligation at 31.12.<strong>2007</strong> - 2,090 110,290 112,380 57.01 7.9<br />
At 31 December <strong>2007</strong> the calculated market value per option was based on the Black-Scholes formula for valuation of options. The calculation is based on an<br />
exercise price of DKK 81.00, a quoted price of DKK 138.00 (DKK 155.83 in 2006), a volatility of 21.91% (23.35% in 2006), a dividend payout ratio of 1.18%<br />
(1.44% in 2006) and a risk-free interest rate of 4.25% (4.19% in 2006).<br />
Stock Appreciation Rights for employees of US subsidiaries (2004 plan)<br />
In 2004, key employees of US subsidiaries were granted Stock Appreciation Rights (SARs), a share price based plan with conditions similar to those of the warrant<br />
scheme granted in 2004 to the company’s Executive Management and a number of key employees. The granted SARs were exercisable during the period from<br />
9 December 2004 to 30 August <strong>2007</strong>. The size of the amount depended on how much the price of the Lundbeck share at the exercise date exceeded DKK 108.11<br />
per share (equal to the exercise price of the warrant scheme). The share price based plan for employees of the Group’s US subsidiaries could not be converted into<br />
shares because the value of the plan was distributed as a cash amount.<br />
In <strong>2007</strong>, 46,092 SARs (23,004 in 2006) were exercised under this plan. Unexercised SARs were cancelled at 1 September <strong>2007</strong>.<br />
The plan is subject to the rules of IFRS 2 Share-based payments. The plan is recognised in the income statement for <strong>2007</strong> at an income of DKK 0.8 million (expense<br />
of DKK 1.5 million in 2006). The plan expired in <strong>2007</strong> and the obligation at 31 December <strong>2007</strong> amounted to DKK 0 (DKK 2.4 million in 2006), including social<br />
contributions. The intrinsic value of outstanding SARs was DKK 0 at 31 December <strong>2007</strong> (DKK 2.2 million in 2006).<br />
81
3-5<br />
Notes<br />
3. Staff costs – continued<br />
Executive Market value Total<br />
Management Executives Other Total per SAR obligation<br />
Number Number Number Number DKK DKKm<br />
Obligation at 01.01.2006 - 4,400 67,196 71,596 27.73 2.1<br />
Exercised - - (23,004) (23,004)<br />
Recategorised, granted and cancelled - - (2,000) (2,000)<br />
Obligation at 31.12.2006 - 4,400 42,192 46,592 48.38 2.4<br />
Exercised - (4,400) (41,692) (46,092)<br />
Cancelled - - (500) (500)<br />
Obligation at 31.12.<strong>2007</strong> - - - -<br />
In 2006, the calculated market value per SAR was based on the Black-Scholes formula for valuation of options. The calculation was based on an exercise price of DKK<br />
108.11, a quoted price of DKK 155.83, a volatility of 22.08%, a dividend payout ratio of 1.44% and a risk-free interest rate of 3.90%.<br />
General information applying to all incentive plans<br />
The total number of warrants which are exercisable and in-the-money at 31 December <strong>2007</strong> was 0 (1,342,695 in 2006).<br />
The total expense recognised in the income statement concerning all incentive plans was DKK 14.9 million in <strong>2007</strong> (DKK 6.2 million in 2006), and the total<br />
obligation concerning the debt plans at 31 December <strong>2007</strong> was DKK 7.9 million (DKK 11.0 million in 2006).<br />
The performance of Lundbeck’s shares in <strong>2007</strong> is illustrated in the chart on page 40 in the section The Lundbeck share.<br />
4. Amortisation and depreciation<br />
<strong>2007</strong><br />
Parent Parent Parent Group Group Group<br />
Property,<br />
Property,<br />
Intangible plant and Intangible plant and<br />
assets equipment Total assets equipment Total<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
Amortisation, depreciation and impairment for the year<br />
are analysed as follows<br />
62.3 116.5 178.8 Cost of sales 68.1 571.6 639.7<br />
- 0.4 0.4 Distribution costs 5.3 10.8 16.1<br />
6.3 48.1 54.4 Administrative expenses 8.8 59.7 68.5<br />
88.3 122.1 210.4 Research and development costs 77.2 114.3 191.5<br />
156.9 287.1 444.0 Total 159.4 756.4 915.8<br />
Impairment losses on intangible assets are recognised under research and development costs.<br />
Cost of sales includes a DKK 342.8 million impairment writedown to estimated market value of property, plant and equipment in the manufacturing unit Lundbeck<br />
Pharmaceuticals Ltd. in Seal Sands, UK, following a reassessment of production capacity.<br />
Losses and gains on the sale of intangible assets and property, plant and equipment are recognised in the amount of DKK 15.5 million in respect of the parent company<br />
and DKK 25.7 million in respect of the Group.<br />
82
4. Amortisation and depreciation – continued<br />
2006<br />
Parent Parent Parent Group Group Group<br />
Property,<br />
Property,<br />
Intangible plant and Intangible plant and<br />
assets equipment Total assets equipment Total<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
Amortisation, depreciation and impairment for the year<br />
are analysed as follows<br />
54.8 101.1 155.9 Cost of sales 57.1 163.2 220.3<br />
- 0.5 0.5 Distribution costs 4.9 10.0 14.9<br />
3.6 45.8 49.4 Administrative expenses 11.4 69.1 80.5<br />
142.8 116.7 259.5 Research and development costs 73.8 136.5 210.3<br />
201.2 264.1 465.3 Total 147.2 378.8 526.0<br />
Impairment losses on intangible assets are recognised under research and development costs.<br />
Losses and gains on the sale of intangible assets and property, plant and equipment are recognised in the amount of DKK 0 in respect of the parent company and<br />
DKK 5.0 million in respect of the Group.<br />
5. Audit fees<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
Deloitte<br />
0.9 1.0 Auditing services 5.8 6.0<br />
1.7 1.8 Non-auditing services 2.9 3.0<br />
2.6 2.8 Total 8.7 9.0<br />
Grant Thornton<br />
0.6 0.6 Auditing services 0.6 0.6<br />
0.4 0.9 Non-auditing services 1.0 0.5<br />
1.0 1.5 Total 1.6 1.1<br />
A few small foreign subsidiaries are not audited by the parent company’s auditors, a foreign business partner of the auditors, or by an internationally recognised<br />
accountancy firm.<br />
83
6-7<br />
Notes<br />
6. Net financials<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
73.1 103.8 Interest, cash and securities, etc. 124.5 84.6<br />
26.3 24.2 Interest, subsidiaries - -<br />
99.4 128.0 Total interest 124.5 84.6<br />
45.4 47.4 Exchange gains 163.0 96.4<br />
31.8 45.8 Dividend received 45.8 31.8<br />
Realised and unrealised gains:<br />
9.5 0.9 - Bonds 0.9 9.5<br />
27.8 2.9 - Derivative financial instruments, trading 2.9 27.8<br />
213.9 225.0 Total financial income 337.1 250.1<br />
35.7 73.9 Interest, bank and mortgage debt, etc. 101.9 55.8<br />
30.1 42.7 Interest, subsidiaries - -<br />
65.8 116.6 Total interest 101.9 55.8<br />
2.6 1.8 Other financial expenses 2.7 3.3<br />
- 31.2 Writedown of receivables from associates 31.2 -<br />
52.1 51.9 Exchange losses 239.3 162.9<br />
Realised and unrealised losses:<br />
57.6 11.1 - Bonds 11.1 57.6<br />
34.1 0.8 - Derivative financial instruments, trading 0.8 34.1<br />
0.2 - - Mortgage debt - 0.2<br />
212.4 213.4 Total financial expenses 387.0 313.9<br />
1.5 11.6 Net financials (49.9) (63.8)<br />
The Group’s net realised and unrealised gains/losses on bonds for the year amounted to a loss of DKK 10.2 million (DKK 48.1 million in 2006). The Group’s net<br />
realised and unrealised gains/losses on derivative financial instruments (trading) for the year amounted to a gain of DKK 2.1 million (a loss of DKK 6.3 million in<br />
2006).<br />
84
7. Tax on profit for the year<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
320.2 625.6 Current tax 796.7 434.6<br />
(11.7) (11.1) Prior year adjustment, current tax 1.5 (12.3)<br />
2.3 9.5 Prior year adjustment, deferred tax (5.2) 5.0<br />
145.0 (62.9) Change of deferred tax for the year 28.7 170.5<br />
- (21.4) Change of deferred tax as a result of changed income tax rates (24.2) (3.0)<br />
455.8 539.7 Total tax for the year 797.5 594.8<br />
Tax for the year is composed of<br />
69.4 8.9 Tax on equity entries 5.5 68.9<br />
386.4 530.8 Tax on profit for the year 792.0 525.9<br />
455.8 539.7 Total tax for the year 797.5 594.8<br />
Explanation of the Group’s effective tax rate relative to the Danish tax rate<br />
<strong>2007</strong> <strong>2007</strong> 2006 2006<br />
DKKm<br />
DKKm<br />
Profit before tax 2,561.5 1,632.8<br />
Calculated tax on pre-tax profit, 25% (28% in 2006) 640.3 25.0% 457.2 28.0%<br />
Tax effect of:<br />
Differences in the tax rates of foreign subsidiaries from the Danish rate of 25% (28% in 2006) 43.5 1.7% 35.6 2.2%<br />
Non-deductible expenses/non-taxable income and other permanent differences 124.6 4.8% 72.0 4.4%<br />
Change of deferred tax as a result of changed income tax rates (24.2) -0.9% (3.0) -0.2%<br />
Prior year tax adjustments, etc., total effect on operations (3.7) -0.1% (7.3) -0.4%<br />
Effective tax for the year before market value adjustment of other investments 780.5 30.5% 554.5 34.0%<br />
Non-deductible losses/non-taxable gains on shares and other equity investments (9.5) -0.4% (9.8) -0.6%<br />
Tax effect of result in associates 21.0 0.8% (18.8) -1.2%<br />
Effective tax for the year 792.0 30.9% 525.9 32.2%<br />
Explanation of the parent company’s effective tax rate<br />
<strong>2007</strong> <strong>2007</strong> 2006 2006<br />
DKKm<br />
DKKm<br />
Profit before tax 2,281.5 1,354.1<br />
Calculated tax on pre-tax profit, 25% (28% in 2006) 570.4 25.0% 379.1 28.0%<br />
Tax effect of:<br />
Non-deductible expenses/non-taxable income and other permanent differences (21.5) -0.9% 26.5 2.0%<br />
Change of deferred tax as a result of changed income tax rates (21.4) -0.9% - -<br />
Prior year tax adjustments, etc., total effect on operations (1.6) -0.1% (9.4) -0.7%<br />
Effective tax for the year before market value adjustment of other investments 525.9 23.1% 396.2 29.3%<br />
Non-deductible losses/non-taxable gains on shares and other equity investments (9.5) -0.4% (9.8) -0.7%<br />
Tax effect of result in associates 14.4 0.6% - -<br />
Effective tax for the year 530.8 23.3% 386.4 28.6%<br />
Tax on equity entries comprises the tax effect of deferred gains on hedging contracts and the tax effect of exercised warrants.<br />
85
8<br />
Notes<br />
8. Intangible assets and property, plant and equipment<br />
Group<br />
Patent Product Other Process Projects Intangible<br />
Goodwill rights rights rights IT projects 1 projects in progress 1 assets<br />
<strong>2007</strong> DKKm DKKm DKKm DKKm DKKm DKKm DKKm DKKm<br />
Cost at 01.01.<strong>2007</strong> 882.2 489.5 574.6 154.5 273.7 13.2 108.5 2,496.2<br />
Exchange differences - - - (0.7) 0.1 - - (0.6)<br />
Reclassification - - - - 8.1 - - 8.1<br />
Additions - 16.8 151.9 6.2 112.2 0.8 36.6 324.5<br />
Disposals - - - (7.0) - (7.5) (50.6) (65.1)<br />
Cost at 31.12.<strong>2007</strong> 882.2 506.3 726.5 153.0 394.1 6.5 94.5 2,763.1<br />
Amortisation at 01.01.<strong>2007</strong> - 146.8 222.1 148.9 195.6 2.1 - 715.5<br />
Exchange differences - - - (0.7) 0.1 - - (0.6)<br />
Reclassification - - - - 7.4 - - 7.4<br />
Amortisation during the year - 34.7 36.5 4.1 66.4 0.7 - 142.4<br />
Impairment during the year - 12.0 - - - - - 12.0<br />
Amortisation on disposals - - - (7.0) - (1.4) - (8.4)<br />
Amortisation at 31.12.<strong>2007</strong> - 193.5 258.6 145.3 269.5 1.4 - 868.3<br />
Carrying amount at 31.12.<strong>2007</strong> 882.2 312.8 467.9 7.7 124.6 5.1 94.5 1,894.8<br />
2006<br />
Cost at 01.01.2006 882.6 487.0 435.2 149.0 256.5 2.0 26.9 2,239.2<br />
Exchange differences - - (0.1) (0.5) - - 0.1 (0.5)<br />
Reclassification - - - 1.5 1.4 - - 2.9<br />
Additions - 2.5 74.6 4.8 15.9 11.2 103.8 212.8<br />
Additions through company acquisition - - 64.9 - - - - 64.9<br />
Disposals (0.4) - - (0.3) (0.1) - (22.3) (23.1)<br />
Cost at 31.12.2006 882.2 489.5 574.6 154.5 273.7 13.2 108.5 2,496.2<br />
Amortisation at 01.01.2006 - 94.2 191.5 141.6 140.5 0.2 - 568.0<br />
Exchange differences - - (0.1) (0.2) (0.1) - - (0.4)<br />
Reclassification - - - 1.4 0.7 - - 2.1<br />
Amortisation during the year - 35.7 30.7 6.6 54.5 1.9 - 129.4<br />
Impairment during the year - 16.9 - - - - - 16.9<br />
Amortisation on disposals - - - (0.5) - - - (0.5)<br />
Amortisation at 31.12.2006 - 146.8 222.1 148.9 195.6 2.1 - 715.5<br />
Carrying amount at 31.12.2006 882.2 342.7 352.5 5.6 78.1 11.1 108.5 1,780.7<br />
1) IT projects and projects in progress primarily comprise SAP. The amounts include capitalised internal expenses.<br />
86
8. Intangible assets and property, plant and equipment – continued<br />
Group Other fixtures Prepayments<br />
and fittings, and plant and Property,<br />
Land and Plant and tools and equipment in plant and<br />
buildings machinery equipment 1 progress equipment<br />
<strong>2007</strong> DKKm DKKm DKKm DKKm DKKm<br />
Cost at 01.01.<strong>2007</strong> 2,967.3 1,531.0 1,075.6 583.8 6,157.7<br />
Exchange differences 13.8 (6.4) (0.8) (14.4) (7.8)<br />
Reclassification - 0.3 (8.4) - (8.1)<br />
Additions 190.1 146.7 106.0 398.9 841.7<br />
Disposals (7.4) (74.4) (47.4) (367.5) (496.7)<br />
Cost at 31.12.<strong>2007</strong> 3,163.8 1,597.2 1,125.0 600.8 6,486.8<br />
Depreciation at 01.01.<strong>2007</strong> 840.7 938.7 711.6 - 2,491.0<br />
Exchange differences (0.4) (3.6) (3.2) - (7.2)<br />
Reclassification - 0.1 (7.5) - (7.4)<br />
Depreciation during the year 143.4 121.4 128.1 - 392.9<br />
Impairment during the year 137.3 204.1 0.1 1.3 342.8<br />
Depreciation on disposals (4.8) (56.7) (38.5) - (100.0)<br />
Depreciation at 31.12.<strong>2007</strong> 1,116.2 1,204.0 790.6 1.3 3,112.1<br />
Carrying amount at 31.12.<strong>2007</strong> 2,047.6 393.2 334.4 599.5 3,374.7<br />
2006<br />
Cost at 01.01.2006 2,793.7 1,490.7 1,023.7 313.1 5,621.2<br />
Exchange differences 9.9 (1.2) (8.0) 1.0 1.7<br />
Reclassification 31.3 (31.3) (2.9) - (2.9)<br />
Additions 136.1 74.7 86.2 423.2 720.2<br />
Additions through company acquisition - - - - -<br />
Disposals (3.7) (1.9) (23.4) (153.5) (182.5)<br />
Cost at 31.12.2006 2,967.3 1,531.0 1,075.6 583.8 6,157.7<br />
Depreciation at 01.01.2006 702.9 828.1 609.8 - 2,140.8<br />
Exchange differences - 0.5 (3.8) - (3.3)<br />
Reclassification - - (2.1) - (2.1)<br />
Depreciation during the year 138.5 112.0 124.2 - 374.7<br />
Impairment during the year - - - - -<br />
Depreciation on disposals (0.7) (1.9) (16.5) - (19.1)<br />
Depreciation at 31.12.2006 840.7 938.7 711.6 - 2,491.0<br />
Carrying amount at 31.12.2006 2,126.6 592.3 364.0 583.8 3,666.7<br />
1) Including leasehold improvements.<br />
87
8<br />
Notes<br />
8. Intangible assets and property, plant and equipment – continued<br />
Parent company<br />
Patent Product Other Process Projects Intangible<br />
Goodwill rights rights rights IT projects 1 projects in progress 1 assets<br />
<strong>2007</strong> DKKm DKKm DKKm DKKm DKKm DKKm DKKm DKKm<br />
Cost at 01.01.<strong>2007</strong> - 628.7 448.6 - 260.8 - 105.1 1,443.2<br />
Reclassification - - - - - - - -<br />
Additions - 16.4 150.0 - 108.0 - 26.4 300.8<br />
Disposals - - - - - - (46.7) (46.7)<br />
Cost at 31.12.<strong>2007</strong> - 645.1 598.6 - 368.8 - 84.8 1,697.3<br />
Amortisation at 01.01.<strong>2007</strong> - 218.3 161.1 - 188.1 - - 567.5<br />
Reclassification - - - - - - - -<br />
Amortisation during the year - 41.3 32.1 - 61.8 - - 135.2<br />
Impairment during the year - 21.7 - - - - - 21.7<br />
Amortisation on disposals - - - - - - - -<br />
Amortisation at 31.12.<strong>2007</strong> - 281.3 193.2 - 249.9 - - 724.4<br />
Carrying amount at 31.12.<strong>2007</strong> - 363.8 405.4 - 118.9 - 84.8 972.9<br />
2006<br />
Cost at 01.01.2006 - 626.5 374.1 - 247.5 - 19.8 1,267.9<br />
Reclassification - - - - - - - -<br />
Additions - 2.2 74.5 - 13.3 - 95.2 185.2<br />
Additions through company acquisition - - - - - - - -<br />
Disposals - - - - - - (9.9) (9.9)<br />
Cost at 31.12.2006 - 628.7 448.6 - 260.8 - 105.1 1,443.2<br />
Amortisation at 01.01.2006 - 96.4 132.5 - 137.4 - - 366.3<br />
Reclassification - - - - - - - -<br />
Amortisation during the year - 48.2 28.6 - 50.7 - - 127.5<br />
Impairment during the year - 73.7 - - - - - 73.7<br />
Amortisation on disposals - - - - - - - -<br />
Amortisation at 31.12.2006 - 218.3 161.1 - 188.1 - - 567.5<br />
Carrying amount at 31.12.2006 - 410.4 287.5 - 72.7 - 105.1 875.7<br />
1) IT projects and projects in progress primarily comprise SAP. The amounts include capitalised internal expenses.<br />
88
8. Intangible assets and property, plant and equipment – continued<br />
Parent company Other fixtures Prepayments<br />
and fittings, and plant and Property,<br />
Land and Plant and tools and equipment in plant and<br />
buildings machinery equipment 1 progress equipment<br />
<strong>2007</strong> DKKm DKKm DKKm DKKm DKKm<br />
Cost at 01.01.<strong>2007</strong> 2,601.2 627.2 801.6 459.1 4,489.1<br />
Reclassification - 0.5 (0.5) - -<br />
Additions 111.8 118.0 76.4 332.4 638.6<br />
Disposals (7.3) (46.1) (15.9) (250.5) (319.8)<br />
Cost at 31.12.<strong>2007</strong> 2,705.7 699.6 861.6 541.0 4,807.9<br />
Depreciation at 01.01.<strong>2007</strong> 778.4 420.3 538.2 - 1,736.9<br />
Reclassification - 0.2 (0.2) - -<br />
Depreciation during the year 127.3 53.1 91.2 - 271.6<br />
Impairment during the year - - - - -<br />
Depreciation on disposals (4.7) (30.3) (14.2) - (49.2)<br />
Depreciation at 31.12.<strong>2007</strong> 901.0 443.3 615.0 - 1,959.3<br />
Carrying amount at 31.12.<strong>2007</strong> 1,804.7 256.3 246.6 541.0 2,848.6<br />
2006<br />
Cost at 01.01.2006 2,570.0 583.0 747.5 262.6 4,163.1<br />
Reclassification - - - - -<br />
Additions 31.2 44.2 54.1 302.4 431.9<br />
Additions through company acquisition - - - - -<br />
Disposals - - - (105.9) (105.9)<br />
Cost at 31.12.2006 2,601.2 627.2 801.6 459.1 4,489.1<br />
Depreciation at 01.01.2006 654.6 367.1 451.1 - 1,472.8<br />
Reclassification - - - - -<br />
Depreciation during the year 123.8 53.2 87.1 - 264.1<br />
Impairment during the year - - - - -<br />
Depreciation on disposals - - - - -<br />
Depreciation at 31.12.2006 778.4 420.3 538.2 - 1,736.9<br />
Carrying amount at 31.12.2006 1,822.8 206.9 263.4 459.1 2,752.2<br />
1) Including leasehold improvements.<br />
The carrying amount of mortgaged fixed assets in the parent company was DKK 1,790.7 million at 31 December <strong>2007</strong> (DKK 1,810.9 million in 2006).<br />
89
8-9<br />
Notes<br />
8. Intangible assets and property, plant and equipment – continued<br />
Goodwill impairment test<br />
The carrying amount of goodwill of DKK 882.2 million (DKK 882.2 million in 2006) relates to the acquisition of Lundbeck Research USA, Inc., USA (DKK 257.5<br />
million), Lundbeck Pharmaceuticals Italy S.p.A., Italy (DKK 163.0 million) and 50% of Lundbeck GmbH, Germany (DKK 461.7 million). The annual impairment tests<br />
are submitted to the Audit Committee for subsequent approval by the Supervisory Board. Based on the impairment tests performed in <strong>2007</strong>, it was concluded that<br />
there is no need for writing down the goodwill amount. Lundbeck Pharmaceuticals, Italy S.p.A. and Lundbeck GmbH are defined as independent cash-generating<br />
units (CGU). In the impairment test, the discounted expected future cash flows (value in use) for each CGU are compared to the carrying amounts. The future cash<br />
flows are based on the companies’ business plans for 2008 - 2012. The key parameters in the calculation of the value in use are sales, EBITDA, working capital and<br />
capital investments. The business plans are based on management’s specific assessment of the business units’ expected development during the period 2008 -<br />
2012. For Lundbeck GmbH and Lundbeck Pharmaceuticals, Italy S.p.A., the terminal value for the period after 2012 has been fixed on the assumption of future<br />
growth of 2% p.a. The calculation of the value in use is based on a WACC of 8% before tax (8% in 2006). The WACC applied has been calculated on the basis of an<br />
analysis performed by an external collaboration partner. Lundbeck Research USA, Inc. is not defined as an independent CGU due to its capacity as a research unit.<br />
Goodwill related to the acquisition of the company has therefore been allocated to the uppermost group level along with the other research and development<br />
units. The impairment test of goodwill allocated to the uppermost group level is not carried out as a calculation of the value in use but as an assessment of the ratio<br />
between the carrying amount of goodwill and the Group’s current market value.<br />
Impairment of patents<br />
In <strong>2007</strong>, an impairment loss of DKK 21.7 million (DKK 73.7 million in 2006) was recognised concerning a patent in the parent company’s financial statements and<br />
DKK 12.0 million (DKK 16.9 million in 2006) in the consolidated financial statements. In the income statement the impairment loss is recognised under research<br />
and development costs. The impairment loss is higher in the parent company as the patents acquired in connection with the acquisition of Lundbeck Research USA,<br />
Inc. in 2003 were subsequently transferred to the parent company at a value higher than the cost. The patent, which will no longer be used, has been written down<br />
to DKK 0.<br />
Impairment of property, plant and equipment<br />
In <strong>2007</strong>, a DKK 342.8 million writedown for impairment to estimated market value was recognised on property, plant and equipment in the manufacturing unit<br />
Lundbeck Pharmaceuticals Ltd. in Seal Sands, UK, following a reassessment of production capacity.<br />
90
9. Investments in subsidiaries<br />
Parent Parent<br />
<strong>2007</strong> 2006<br />
DKKm DKKm<br />
Cost at 01.01. 2,732.0 2,699.6<br />
Capital contribution 3.1 32.4<br />
Cost at 31.12. 2,735.1 2,732.0<br />
Income from investments in subsidiaries is dividends and amounted to DKK 120.2 million (DKK 75.6 million in 2006).<br />
Share of voting rights<br />
and ownership<br />
Lundbeck Argentina S.A., Argentina 100%<br />
Lundbeck Australia Pty Ltd, Australia, including 100%<br />
- CNS Pharma Pty Ltd, Australia 100%<br />
Lundbeck S.A., Belgium 100%<br />
Lundbeck Brasil Ltda., Brazil 100%<br />
Lundbeck Canada Inc., Canada 100%<br />
Lundbeck Chile Farmaceútica Ltda., Chile 100%<br />
Lundbeck Cognitive Therapeutics A/S, Denmark 100%<br />
Lundbeck Export A/S, Denmark 100%<br />
Lundbeck Insurance A/S, Denmark 100%<br />
Lundbeck Pharma A/S, Denmark 100%<br />
Lundbeck Group Limited, UK, including 100%<br />
- Lundbeck Limited, UK 100%<br />
- Lundbeck Pharmaceuticals Ltd., UK 100%<br />
Lundbeck Eesti A/S, Estonia 100%<br />
OY H. Lundbeck AB, Finland 100%<br />
Lundbeck SA, France 100%<br />
Lundbeck Hellas S.A., Greece 100%<br />
Lundbeck B.V., The Netherlands 100%<br />
Lundbeck (Hong Kong) Limited, Hong Kong 100%<br />
Lundbeck India Private Limited, India 100%<br />
Lundbeck (Ireland) Limited, Ireland 100%<br />
Lundbeck Israel Ltd., Israel 100%<br />
Lundbeck Italia S.p.A., Italy 100%<br />
Lundbeck Pharmaceuticals, Italy S.p.A., Italy, including 100%<br />
- Archid S.a., Luxembourg 100%<br />
Lundbeck Japan Kabushiki Kaisha, Japan 100%<br />
Lundbeck (Beijing) Pharmaceuticals Consulting Co., Ltd., China 100%<br />
Lundbeck Korea Co., Ltd., Korea 100%<br />
Share of voting rights<br />
and ownership<br />
Lundbeck Croatia d.o.o., Croatia 100%<br />
SIA Lundbeck Latvia, Latvia 100%<br />
UAB Lundbeck Lietuva, Lithuania 100%<br />
Lundbeck México, SA de CV, Mexico 100%<br />
Lundbeck New Zealand Limited, New Zealand 100%<br />
H. Lundbeck AS, Norway, including 100%<br />
- CNS Pharma AS, Norway 100%<br />
Lundbeck Pakistan (Private) Limited, Pakistan 100%<br />
Lundbeck Poland Sp.z.o.o., Poland 100%<br />
Lundbeck Portugal - Produtos Farmacêuticos Lda, Portugal 100%<br />
Lundbeck RUS OOO, Russia 100%<br />
Lundbeck (Schweiz) AG, Switzerland 100%<br />
Lundbeck Pharmaceutical GmbH, Switzerland 100%<br />
Lundbeck Slovensko s.r.o., Slovakia 100%<br />
Lundbeck Pharma d.o.o., Slovenia 100%<br />
Axofarma Lab, S.A., Spain 100%<br />
Farmaglia S.A., Spain 100%<br />
Lundbeck España S.A., Spain 100%<br />
H. Lundbeck AB, Sweden, including 100%<br />
- CNS Pharma AB, Sweden 100%<br />
Lundbeck South Africa (Pty) Limited, South Africa 100%<br />
Lundbeck CZ s.r.o., Czech Republic 100%<br />
Lundbeck Ìlac Ticaret Limited Sirketi, Turkey 100%<br />
Lundbeck GmbH, Germany 100%<br />
Lundbeck Hungária KFT, Hungary 100%<br />
Lundbeck Inc., USA 100%<br />
Lundbeck Research USA, Inc., USA 100%<br />
Lundbeck de Venezuela, C.A., Venezuela 100%<br />
Lundbeck Austria GmbH, Austria 100%<br />
91
10-11<br />
Notes<br />
10. Investments in associates<br />
<strong>2007</strong><br />
Parent Parent Parent Group Group Group<br />
Accumulated<br />
Accumulated<br />
revaluation/<br />
revaluation/<br />
impairment<br />
impairment<br />
Cost losses Total Cost losses Total<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
181.1 (26.7) 154.4 Carrying amount at 01.01.<strong>2007</strong> 181.1 (14.2) 166.9<br />
- - - Losses in associates - (53.3) (53.3)<br />
- (57.0) (57.0) Impairment on investment - (30.7) (30.7)<br />
181.1 (83.7) 97.4 Carrying amount at 31.12.<strong>2007</strong> 181.1 (98.2) 82.9<br />
Based on an impairment test, the value of the investment in CF Pharma Gyógyszergyártó Kft. has been written down to DKK 0. The fair value of the investment in<br />
Lifecycle Pharma A/S was DKK 312.4 million at 31 December <strong>2007</strong>.<br />
Share of voting rights and ownership<br />
CF Pharma Gyógyszergyártó Kft., Hungary 47.1%<br />
LifeCycle Pharma A/S, Denmark 27.5%<br />
2006<br />
Parent Parent Parent Group Group Group<br />
Accumulated<br />
Accumulated<br />
revaluation/<br />
revaluation/<br />
impairment<br />
impairment<br />
Cost losses Total Cost losses Total<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
181.1 (26.7) 154.4 Carrying amount at 01.01.2006 181.1 (80.9) 100.2<br />
- - - Income from reduced ownership interest - 154.6 154.6<br />
- - - Losses in associates - (87.4) (87.4)<br />
- - - Exchange differences - (0.5) (0.5)<br />
181.1 (26.7) 154.4 Carrying amount at 31.12.2006 181.1 (14.2) 166.9<br />
The shares of LifeCycle Pharma A/S were listed on 20 November 2006. In this connection, Lundbeck’s ownership interest was reduced to 28.8%. The fair value of<br />
the investment was DKK 490.0 million at 31 December 2006.<br />
Share of voting rights and ownership<br />
CF Pharma Gyógyszergyártó Kft., Hungary 47.1%<br />
LifeCycle Pharma A/S, Denmark 28.8%<br />
Financial highlights of associates<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
717.3 678.7 Assets 678.7 717.3<br />
139.2 275.7 Liabilities 275.7 139.2<br />
578.1 403.0 Net assets 403.0 578.1<br />
188.6 134.9 Share of net assets 134.9 188.6<br />
65.2 100.8 Revenue 100.8 65.2<br />
(179.8) (174.3) Profit/(loss) for the year (174.3) (179.8)<br />
Group’s share of profit/(loss) for the year (53.3) (87.4)<br />
92
11. Other investments and other receivables<br />
Group<br />
Receivables Available-for-sale<br />
from financial Other<br />
<strong>2007</strong><br />
associates assets receivables 1<br />
DKKm DKKm DKKm<br />
Carrying amount at 01.01.<strong>2007</strong> 19.2 127.6 63.6<br />
Additions 12.0 10.6 11.2<br />
Disposals - - (13.3)<br />
Value adjustment - 12.8 (0.1)<br />
Writedown of receivables (31.2) - -<br />
Exchange differences - (0.3) (0.8)<br />
Carrying amount at 31.12.<strong>2007</strong> - 150.7 60.6<br />
2006<br />
Carrying amount at 01.01.2006 - 157.1 60.7<br />
Additions 19.2 4.5 9.5<br />
Disposals - (2.1) (4.9)<br />
Value adjustment - (31.5) -<br />
Exchange differences - (0.4) (1.7)<br />
Carrying amount at 31.12.2006 19.2 127.6 63.6<br />
Parent company<br />
Receivables Receivables Available-for-sale<br />
from from financial Other<br />
<strong>2007</strong><br />
subsidiaries associates assets receivables 1<br />
DKKm DKKm DKKm DKKm<br />
Carrying amount at 01.01.<strong>2007</strong> 745.9 19.2 125.7 41.7<br />
Additions - 12.0 10.6 2.1<br />
Disposals (118.6) - - (12.5)<br />
Value adjustment - - 12.8 -<br />
Writedown of receivables - (31.2) - -<br />
Exchange differences (18.3) - - 0.2<br />
Carrying amount at 31.12.<strong>2007</strong> 609.0 - 149.1 31.5<br />
2006<br />
Carrying amount at 01.01.2006 826.0 - 153.1 41.1<br />
Additions - 19.2 4.1 2.2<br />
Disposals (55.4) - - (0.2)<br />
Value adjustment - - (31.5) -<br />
Exchange differences (24.7) - - (1.4)<br />
Carrying amount at 31.12.2006 745.9 19.2 125.7 41.7<br />
Fair value adjustment of available-for-sale financial assets<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
(150.0) (181.5) Fair value adjustment at 01.01. (181.4) (149.9)<br />
17.2 21.6 Revaluation during the year 21.6 17.2<br />
(48.7) (8.8) Impairment losses during the year (8.8) (48.7)<br />
(181.5) (168.7) Fair value adjustment at 31.12. (168.6) (181.4)<br />
1) At 31 December <strong>2007</strong>, other receivables are not believed to involve any credit risk.<br />
93
12-14<br />
Notes<br />
12. Inventories<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
207.7 220.2 Indirect costs of production 364.5 387.6<br />
15.8 42.0 Impairment loss for the year 97.9 51.1<br />
- - Inventories calculated at net realisable value 11.5 26.5<br />
The total cost of goods sold included in cost of sales for <strong>2007</strong> amounted to DKK 1,124.4 million.<br />
13. Trade receivables and other receivables<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
Trade receivables<br />
256.9 179.9 Receivables 1,567.9 1,470.0<br />
- - Impairment of trade receivables (7.8) (6.8)<br />
256.9 179.9 Total 1,560.1 1,463.2<br />
Specification of trade receivables by due date<br />
244.5 173.3 Receivables not due 1,359.5 1,305.2<br />
11.0 - Receivables falling due within 3 months 157.0 115.4<br />
- 6.2 Receivables falling due after more than 3 months and up to 6 months 15.3 28.1<br />
- 0.4 Receivables falling due after more than 6 months and up to 12 months 15.7 7.8<br />
1.4 - Receivables falling due after more than 12 months 20.4 13.5<br />
256.9 179.9 Total 1,567.9 1,470.0<br />
Development in impairment of trade receivables<br />
- - Impairment of trade receivables at 01.01. 6.8 6.5<br />
- - Impairment of receivables during the year (0.1) (0.1)<br />
- - Reversed, unrealised impairment of receivables - (0.1)<br />
- - Change in impairment of receivables 1.0 0.6<br />
- - Exchange differences 0.1 (0.1)<br />
- - Impairment of trade receivables at 31.12. 7.8 6.8<br />
Other receivables<br />
249.0 486.9 Receivables 582.2 359.4<br />
- - Impairment of other receivables - -<br />
249.0 486.9 Total 582.2 359.4<br />
Specification of other receivables by due date<br />
249.0 486.7 Receivables not due 575.5 350.9<br />
- 0.1 Receivables falling due within 3 months 5.3 0.2<br />
- 0.1 Receivables falling due after more than 3 months and up to 6 months 0.3 -<br />
- - Receivables falling due after more than 6 months and up to 12 months 0.1 -<br />
- - Receivables falling due after more than 12 months 1.0 8.3<br />
249.0 486.9 Total 582.2 359.4<br />
94
13. Trade receivables and other receivables – continued<br />
Lundbeck’s products are sold mainly to distributors of pharmaceuticals and hospitals. Historically, the losses sustained have been insignificant. This was also the<br />
case in <strong>2007</strong>.<br />
The specific payment conditions for each individual customer, including credit periods and any payment of interest in case of non-payment, vary from one<br />
subsidiary to the next but are based on industry practice in the relevant market. As a result of special trading conditions in specific markets, the credit period<br />
for public hospitals may be up to approximately 200 days.<br />
Changes to the Group’s customer portfolio are limited. When collaboration is established with new customers, a credit assessment is performed, when deemed<br />
necessary. The credit assessment is made either by Lundbeck or through an external credit rating agency.<br />
Undue and due receivables are analysed in an ongoing process. Based on such analyses, historical experience and industry experience, it is estimated whether<br />
the receivables are recoverable. A large part of the due trade receivables relates to public hospitals, for which the risk of losses is considered minimal. In <strong>2007</strong>, no<br />
receivable from one single debtor accounted for more than 5% of total trade receivables. In 2006, receivables from Forest accounted for more than 5% of total<br />
trade receivables. In <strong>2007</strong>, receivables from Takeda Pharmaceutical Company Limited accounted for more than 5% of total other receivables.<br />
A few of the Group’s receivables are secured through bank guarantees or similar arrangements, but as most of the Group’s customers are distributors of pharmaceuticals<br />
and hospitals, the risk of non-payment is considered minimal.<br />
Credit risks<br />
The primary financial instruments shown in the balance sheet are trade receivables, securities and cash. The amounts of these balance sheet items are identical<br />
to the maximum credit risk. The Group has no major concentration of credit risk, as the risk is spread over a large number of creditworthy trading partners.<br />
Accordingly, the Group has not taken out any credit insurance for receivables.<br />
The securities portfolio consists exclusively of Danish government and mortgage credit bonds with a limited credit risk.<br />
The credit risk of cash and derivative financial instruments (forward exchange contracts and options) is limited because the Group deals only with banks with a<br />
high credit rating. Lundbeck’s in-house management and credit exposure to banks are based on internal credit lines for each counterparty. The credit lines are<br />
monitored and reported pursuant to the company’s treasury policy.<br />
14. Share capital<br />
The share capital of DKK 1,036.4 million at 31 December <strong>2007</strong> is divided into 207,279,631 shares of a nominal value of DKK 5 each.<br />
<strong>2007</strong> 2006<br />
DKKm DKKm<br />
Share capital at 01.01. 1,060.8 1,136.1<br />
Exercise of warrants 5.0 2.6<br />
Cancellation of treasury shares (29.4) (77.9)<br />
Share capital at 31.12. 1,036.4 1,060.8<br />
The Supervisory Board recommends distribution of dividend for <strong>2007</strong> of 30% (30% in 2006) of the net profit for the year allocated to the shareholders of the<br />
parent company, equivalent to DKK 530.6 million (DKK 333.1 million in 2006) inclusive of dividend on treasury shares, or DKK 2.56 per share (DKK 1.57 in 2006).<br />
The total share premium of DKK 223.9 million, which relates to the exercise of warrants (see note 3 Staff costs), increased by DKK 102.3 million in <strong>2007</strong> from<br />
DKK 121.6 million in 2006.<br />
The share capital is in compliance with the capital requirements of the Danish Public Companies Act and the rules of OMX Nordic Exchange Copenhagen.<br />
95
15<br />
Notes<br />
15. Pension obligations and similar obligations<br />
The majority of the employees of the Group are covered by pension plans paid for by the companies of the Group. The types of plan vary according to regulatory<br />
requirements, tax rules and economic conditions in the countries in which the employees are employed. A summary of the most important plans is given below.<br />
Defined contribution plans<br />
For defined contribution plans, the employer undertakes to pay a defined contribution (e.g. a fixed amount or a fixed percentage of the pay). Under a defined contribution<br />
plan, the employees will usually bear the risk related to future developments in interest and inflation rates etc.<br />
The major defined contribution plans cover employees in Australia, Belgium, Denmark, the UK, Finland, Ireland and Sweden. The cost of defined contribution plans,<br />
representing contributions to the plans, totalled DKK 128.4 million in <strong>2007</strong> (DKK 135.1 million in 2006).<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
85.1 89.4 Expenses for the financial year 128.4 135.1<br />
Defined benefit plans<br />
For defined benefit plans, the employer undertakes to pay a defined benefit (e.g. a retirement pension at a fixed amount or a fixed percentage of the employee’s<br />
final salary). Under a defined benefit plan, the company usually bears the risk relating to future developments in interest and inflation rates etc.<br />
For defined benefit plans, the present value of future benefits, which the company is liable to pay under the plan, is computed using actuarial principles. The computation<br />
of present value is based on assumptions about discount rates, increases in pay rates and pensions, investment yield, staff resignation rates, mortality and<br />
disability. Present value is computed exclusively for the benefits to which the employees have earned entitlement through their employment with the company up<br />
till now. Actuarial gains and losses are recognised in the income statement as they are calculated.<br />
Group Group Group<br />
<strong>2007</strong> 2006 2005<br />
DKKm DKKm DKKm<br />
Present value of funded pension obligations 190.7 216.9 195.1<br />
Fair value of plan assets (155.4) (161.2) (142.6)<br />
Funded pension obligations, net 35.3 55.7 52.5<br />
Present value of unfunded pension obligations 95.5 94.7 108.2<br />
Pension obligations at 31.12. 130.8 150.4 160.7<br />
Other pension-like obligations 57.9 54.1 30.5<br />
Pension obligations and similar obligations at 31.12. 188.7 204.5 191.2<br />
Experience adjustments to pension obligations 32.8 6.6 (34.2)<br />
Experience adjustments to plan assets (12.8) 2.4 16.2<br />
The Group’s most important defined benefit plans cover employees in the UK and Germany.<br />
The UK defined benefit plan is funded by means of an independent pension fund. The actuarial calculation of the liability as at 31 December <strong>2007</strong> is stated in the<br />
Group’s balance sheet at an amount of DKK 22.9 million (DKK 46.3 million in 2006). The liability is calculated as the present value of the future payments of<br />
DKK 162.9 million (DKK 195.4 million in 2006) less the market value of the pension fund’s assets of DKK 140.0 million (DKK 149.1 million in 2006). The actuarial calculation<br />
was based on a discount rate of 5.80% p.a., a pay rate increase of 4.90% p.a. and a pension increase of 3.00% p.a. The calculation does not include an ageweighted<br />
staff resignation rate. The consolidated income statement for <strong>2007</strong> includes a net income of DKK 12.5 million (a net expense of DKK 7.4 million in 2006).<br />
The German defined benefit plan is not funded. The actuarial calculation of the liability derived from the plan as at 31 December <strong>2007</strong> is stated in the Group’s<br />
balance sheet at an amount of DKK 75.1 million (DKK 78.2 million in 2006). The actuarial calculation was based on a discount rate of 5.25% p.a., a pay rate increase<br />
of 2.75% p.a., a pension increase of 2.00% every third year and an age-weighted staff resignation rate of 0-10% p.a. The consolidated income statement for <strong>2007</strong><br />
includes a net income of DKK 1.0 million (DKK 4.2 million in 2006).<br />
In addition, the Group operates a defined benefit plan in Norway, of which the majority is funded. The actuarial calculation of the liability as at 31 December <strong>2007</strong><br />
is stated in the Group’s balance sheet at an amount of DKK 9.5 million (DKK 6.9 million in 2006). The liability is calculated as the present value of the future payments<br />
of DKK 24.9 million (DKK 19.0 million in 2006) less the market value of the pension fund’s assets of DKK 15.4 million (DKK 12.1 million in 2006). The consolidated<br />
income statement includes a net expense of DKK 4.5 million (DKK 3.5 million in 2006).<br />
96
15. Pension obligations and similar obligations – continued<br />
The pension plan in the USA is funded through an insurance/investment asset, which is recognised in the consolidated balance sheet. At 31 December <strong>2007</strong>, the<br />
total obligation amounted to DKK 3.2 million (DKK 2.5 million in 2006). At 31 December <strong>2007</strong>, the value of the insurance/investment asset was DKK 11.5 million<br />
(DKK 6.3 million in 2006). Lundbeck is obliged, under specific terms and conditions, to make payments and pension disbursements to the employees. In the consolidated<br />
income statement for <strong>2007</strong>, the plan is recognised at a net expense of DKK 1.0 million (DKK 0.8 million in 2006).<br />
In addition, the Group has defined benefit plans in France and Pakistan, which are unfunded. The obligation under these plans is recorded in the consolidated balance<br />
sheet at 31 December <strong>2007</strong> at an amount of DKK 20.1 million (DKK 16.5 million in 2006). In the consolidated income statement for <strong>2007</strong>, the plans are recognised<br />
at a net expense of DKK 3.9 million (DKK 1.5 million in 2006).<br />
There is no defined benefit plans in Denmark and, by extension, no such plans in the parent company.<br />
Group Group<br />
<strong>2007</strong> 2006<br />
% distribution % distribution<br />
The fair value of the plan assets breaks down as follows<br />
Shares 50% 57%<br />
Bonds 28% 23%<br />
Property 15% 15%<br />
Other assets 7% 5%<br />
Total 100% 100%<br />
The expected return is calculated on the basis of investment reports prepared by an international, recognised pension and insurance company.<br />
Group Group<br />
<strong>2007</strong> 2006<br />
DKKm DKKm<br />
Change in present value of funded pension obligations<br />
Present value of funded pension obligations at 01.01. 216.9 195.1<br />
Exchange differences (15.6) 2.4<br />
Transferred from other pension plan - 1.1<br />
Pension expenses 5.3 5.6<br />
Interest expenses relating to the obligation 10.8 9.6<br />
Actuarial (gains)/losses (26.3) 7.1<br />
Disbursements (1.1) (4.9)<br />
Employee contributions 0.7 0.9<br />
Present value of funded pension obligations at 31.12. 190.7 216.9<br />
Change in fair value of plan assets<br />
Fair value of plan assets at 01.01. 161.2 142.6<br />
Exchange differences (12.1) 1.5<br />
Expected return on plan assets 9.7 8.4<br />
Actuarial gains/(losses) (12.8) 2.4<br />
Contributions 9.7 11.0<br />
Disbursements (0.4) (4.9)<br />
Employee contributions 0.1 0.2<br />
Fair value of plan assets at 31.12. 155.4 161.2<br />
97
15-16<br />
Notes<br />
15. Pension obligations and similar obligations – continued<br />
Group Group<br />
<strong>2007</strong> 2006<br />
DKKm DKKm<br />
Change in present value of unfunded pension obligations<br />
Present value of unfunded pension obligations at 01.01. 94.7 108.2<br />
Exchange differences 0.1 (0.4)<br />
Pension expenses 6.2 7.3<br />
Interest expenses relating to the obligations 3.3 3.9<br />
Actuarial (gains)/losses (6.5) (13.7)<br />
Contributions - (10.6)<br />
Disbursements (2.3) -<br />
Present value of unfunded pension obligations at 31.12. 95.5 94.7<br />
Change in obligations for defined benefit plans<br />
Pension obligations at 01.01. 150.4 160.7<br />
Exchange differences (3.4) 0.5<br />
Transferred from other pension plan - 1.1<br />
Recognised as expense (change recognised in the income statement) (4.1) 9.0<br />
Contributions (9.7) (21.6)<br />
Disbursements (3.0) -<br />
Employee contributions 0.6 0.7<br />
Pension obligations at 31.12. 130.8 150.4<br />
Specification of the change recognised in the income statement<br />
Pension expenses 11.5 12.9<br />
Interest expenses relating to the obligations 14.1 13.5<br />
Expected return on plan assets (9.7) (8.4)<br />
Actuarial (gains)/losses (20.0) (9.0)<br />
Total expenses recognised (4.1) 9.0<br />
Realised return on plan assets (4.0) 9.9<br />
The expected contribution for 2008 for the defined benefit plans is DKK 14.4 million (DKK 13.7 million for <strong>2007</strong>).<br />
Other pension-like obligations<br />
An obligation of DKK 57.9 million (DKK 54.1 million in 2006) is recognised in the Group to cover other pension-like obligations, including primarily termination<br />
benefits in a number of subsidiaries. The benefit payments are conditional upon specified requirements being met. Total net expenses for the year were DKK 3.8 million<br />
(DKK 23.6 million in 2006).<br />
98
16. Deferred tax liabilities<br />
Group<br />
Temporary differences between assets and liabilities as stated in the financial statements and as stated in the tax base<br />
Adjustment of<br />
deferred tax<br />
Movement<br />
Balance at at beginning Exchange during Balance at<br />
<strong>2007</strong><br />
01.01. of year differences the year 31.12.<br />
DKKm DKKm DKKm DKKm DKKm<br />
Intangible assets 750.5 (23.4) 1.3 107.0 835.4<br />
Property, plant and equipment 1,050.7 17.8 (18.9) 27.9 1,077.5<br />
Inventories (150.6) - 0.2 12.2 (138.2)<br />
Prepayments (854.7) - - 15.2 (839.5)<br />
Other items 107.4 1.1 28.3 (214.8) (78.0)<br />
Tax reserves in subsidiaries 27.3 (8.4) (2.2) (12.9) 3.8<br />
Tax loss carry-forwards (295.5) 6.6 28.1 114.6 (146.2)<br />
Total temporary differences 635.1 (6.3) 36.8 49.2 714.8<br />
(Deferred tax assets)/deferred tax liabilities 152.4 (5.2) 12.9 4.5 164.6<br />
2006<br />
Intangible assets 565.2 23.5 6.5 155.3 750.5<br />
Property, plant and equipment 1,000.1 1.7 3.8 45.1 1,050.7<br />
Inventories 9.1 (34.5) 8.5 (133.7) (150.6)<br />
Prepayments (1,393.1) - - 538.4 (854.7)<br />
Other items (23.5) 31.4 24.7 74.8 107.4<br />
Tax reserves in subsidiaries 30.4 0.2 3.3 (6.6) 27.3<br />
Tax loss carry-forwards (311.7) (5.8) 30.8 (8.8) (295.5)<br />
Total temporary differences (123.5) 16.5 77.6 664.5 635.1<br />
(Deferred tax assets)/deferred tax liabilities (47.0) 5.0 26.9 167.5 152.4<br />
Deferred tax assets/liabilities<br />
Deferred tax Deferred tax Deferred tax Deferred tax<br />
assets liabilities Net assets liabilities Net<br />
<strong>2007</strong> <strong>2007</strong> <strong>2007</strong> 2006 2006 2006<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
Intangible assets (21.7) 233.0 211.3 (34.4) 250.0 215.6<br />
Property, plant and equipment (8.0) 287.4 279.4 (12.2) 311.1 298.9<br />
Inventories (92.8) 48.8 (44.0) (100.8) 54.8 (46.0)<br />
Prepayments (209.9) - (209.9) (239.3) - (239.3)<br />
Other items (167.7) 149.9 (17.8) (140.9) 172.1 31.2<br />
Tax reserves in subsidiaries (9.4) 11.6 2.2 (6.7) 15.1 8.4<br />
Tax loss carry-forwards (56.6) - (56.6) (116.4) - (116.4)<br />
Tax (assets)/liabilities (566.1) 730.7 164.6 (650.7) 803.1 152.4<br />
Set-off within legal tax entities and jurisdictions 403.4 (403.4) - 371.6 (371.6) -<br />
Total net (tax assets)/liabilities (162.7) 327.3 164.6 (279.1) 431.5 152.4<br />
In <strong>2007</strong>, the tax value of non-capitalised tax losses carried forward in the Group which are not expected to be utilised within five years amounted to DKK 19.8 million<br />
(DKK 0 in 2006).<br />
99
16-18<br />
Notes<br />
16. Deferred tax liabilities – continued<br />
Parent company<br />
Temporary differences between assets and liabilities as stated in the financial statements and as stated in the tax base<br />
Adjustment of<br />
deferred tax Movement<br />
Balance at at beginning during Balance at<br />
<strong>2007</strong><br />
01.01. of year the year 31.12.<br />
DKKm DKKm DKKm DKKm<br />
Intangible assets 621.2 - 38.1 659.3<br />
Property, plant and equipment 836.2 18.8 34.6 889.6<br />
Inventories 195.6 - (0.3) 195.3<br />
Prepayments (854.7) - 15.2 (839.5)<br />
Other items 100.5 15.3 (313.0) (197.2)<br />
Total temporary differences 898.8 34.1 (225.4) 707.5<br />
(Deferred tax assets)/deferred tax liabilities 251.7 9.5 (84.3) 176.9<br />
2006<br />
Intangible assets 765.8 - (144.6) 621.2<br />
Property, plant and equipment 790.0 9.6 36.6 836.2<br />
Inventories 287.6 (34.5) (57.5) 195.6<br />
Prepayments (1,393.1) - 538.4 (854.7)<br />
Other items (77.3) 33.3 144.5 100.5<br />
Total temporary differences 373.0 8.4 517.4 898.8<br />
(Deferred tax assets)/deferred tax liabilities 104.4 2.3 145.0 251.7<br />
Deferred tax assets/liabilities<br />
Deferred tax Deferred tax Deferred tax Deferred tax<br />
assets liabilities Net assets liabilities Net<br />
<strong>2007</strong> <strong>2007</strong> <strong>2007</strong> 2006 2006 2006<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
Intangible assets - 164.9 164.9 - 174.0 174.0<br />
Property, plant and equipment - 222.4 222.4 - 234.1 234.1<br />
Inventories - 48.8 48.8 - 54.8 54.8<br />
Prepayments (209.9) - (209.9) (239.3) - (239.3)<br />
Other items (49.3) - (49.3) - 28.1 28.1<br />
Tax (assets)/liabilities (259.2) 436.1 176.9 (239.3) 491.0 251.7<br />
Amount set off 259.2 (259.2) - 239.3 (239.3) -<br />
Total net tax (assets)/liabilities - 176.9 176.9 - 251.7 251.7<br />
The figures stated above show gross deferred tax assets and deferred tax liabilities respectively at an income tax rate of 25% (28% in 2006).<br />
100
17. Provisions<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
87.5 84.2 Provisions at 01.01. 95.1 102.0<br />
- 311.1 Provisions charged during the year 19.5 6.2<br />
(3.3) (3.7) Provisions used during the year (5.3) (13.1)<br />
- - Unused provisions reversed during the year (1.5) -<br />
84.2 391.6 Provisions at 31.12. 107.8 95.1<br />
Specification of provisions<br />
84.2 80.4 Long-term provisions 92.4 92.7<br />
- 311.2 Short-term provisions 15.4 2.4<br />
84.2 391.6 Provisions at 31.12. 107.8 95.1<br />
The provisions cover expenses associated with the defence of the company’s intellectual property rights, closing down decentralised warehouses and the Group’s<br />
incentive plans.<br />
Pursuant to a production agreement with the manufacturing unit Lundbeck Pharmaceuticals Ltd., Seal Sands, UK, an amount has been provided in the parent<br />
company to cover expected losses and obligations due to impairment of production assets.<br />
Of the total provisions at 31 December <strong>2007</strong>, DKK 7.9 million (DKK 11.0 million in 2006) relates to incentive plans. The total provisions for incentive plans are<br />
short-term. Further details about the incentive plans are provided in note 3 Staff costs.<br />
18. Mortgage and bank debt<br />
Mortgage debt<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
Mortgage debt by maturity<br />
2.1 2.1 Within 1 year from the balance sheet date 5.1 5.1<br />
2.1 2.1 Between 1 and 2 years from the balance sheet date 2.1 5.1<br />
2.1 2.1 Between 2 and 3 years from the balance sheet date 2.1 2.1<br />
2.1 2.1 Between 3 and 4 years from the balance sheet date 2.1 2.1<br />
2.2 1.1 Between 4 and 5 years from the balance sheet date 1.1 2.2<br />
1,416.3 1,851.2 After more than 5 years from the balance sheet date 1,851.2 1,416.3<br />
1,426.9 1,860.7 Mortgage debt at 31.12. 1,863.7 1,432.9<br />
Specification of mortgage debt<br />
1,424.8 1,858.6 Long-term liabilities 1,858.6 1,427.8<br />
2.1 2.1 Short-term liabilities 5.1 5.1<br />
1,426.9 1,860.7 Mortgage debt at 31.12. 1,863.7 1,432.9<br />
101
18<br />
Notes<br />
18. Mortgage and bank debt – continued<br />
Group<br />
Weighted<br />
average<br />
effective Amortised Nominal<br />
<strong>2007</strong><br />
Fixed/ interest cost value Fair value<br />
Currency Expiry floating rate DKKm DKKm DKKm<br />
Mortgage debt DKK 2012 fixed 5.82% 9.6 9.6 9.8<br />
Mortgage debt, bond loan DKK 2035 floating 4.49% 1,404.3 1,646.9 1,428.2<br />
Mortgage debt, bond loan DKK 2037 floating 5.16% 434.4 440.0 440.9<br />
Mortgage debt, bond loan DKK 2034 floating 5.23% 10.2 10.2 10.3<br />
Mortgage debt, bond loan DKK 2034 floating 5.23% 2.2 2.2 2.2<br />
Mortgage debt EUR 2008 fixed 5.82% 3.0 3.0 3.0<br />
Total 1,863.7 2,111.9 1,894.4<br />
2006<br />
Mortgage debt DKK 2012 fixed 5.82% 11.7 11.7 12.2<br />
Mortgage debt, bond loan DKK 2035 floating 3.93% 1,402.8 1,672.4 1,458.7<br />
Mortgage debt, bond loan DKK 2034 floating 3.39% 10.2 10.2 10.2<br />
Mortgage debt, bond loan DKK 2034 floating 3.39% 2.2 2.2 2.2<br />
Mortgage debt EUR 2008 fixed 5.82% 6.0 6.0 6.0<br />
Total 1,432.9 1,702.5 1,489.3<br />
Amortised cost is calculated as the proceeds received less instalments paid plus or minus amortisation of capital losses. Fair value is calculated as the market value<br />
at 31 December.<br />
Parent company<br />
Weighted<br />
average<br />
effective Amortised Nominal<br />
<strong>2007</strong><br />
Fixed/ interest cost value Fair value<br />
Currency Expiry floating rate DKKm DKKm DKKm<br />
Mortgage debt DKK 2012 fixed 5.82% 9.6 9.6 9.8<br />
Mortgage debt, bond loan DKK 2035 floating 4.49% 1,404.3 1,646.9 1,428.2<br />
Mortgage debt, bond loan DKK 2037 floating 5.16% 434.4 440.0 440.9<br />
Mortgage debt, bond loan DKK 2034 floating 5.23% 10.2 10.2 10.3<br />
Mortgage debt, bond loan DKK 2034 floating 5.23% 2.2 2.2 2.2<br />
Total 1,860.7 2,108.9 1,891.4<br />
2006<br />
Mortgage debt DKK 2012 fixed 5.82% 11.7 11.7 12.2<br />
Mortgage debt, bond loan DKK 2035 floating 3.93% 1,402.8 1,672.4 1,458.7<br />
Mortgage debt, bond loan DKK 2034 floating 3.39% 10.2 10.2 10.2<br />
Mortgage debt, bond loan DKK 2034 floating 3.39% 2.2 2.2 2.2<br />
Total 1,426.9 1,696.5 1,483.3<br />
Amortised cost is calculated as the proceeds received less instalments paid plus or minus amortisation of capital losses. Fair value is calculated as the market value<br />
at 31 December.<br />
102
18. Mortgage and bank debt – continued<br />
Bank debt<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
Bank debt by maturity<br />
2.8 - Within 1 year from the balance sheet date 4.4 55.0<br />
2.8 - Bank debt at 31.12. 4.4 55.0<br />
Specification of bank debt<br />
- - Long-term liabilities - -<br />
2.8 - Short-term liabilities 4.4 55.0<br />
2.8 - Bank debt at 31.12. 4.4 55.0<br />
Group<br />
Weighted<br />
average Nominal<br />
Fixed/ effective value<br />
<strong>2007</strong> Currency Expiry floating interest rate DKKm<br />
Loan TRY 2008 fixed 17.90% 4.4<br />
Total 4.4<br />
2006<br />
Overdraft facility SEK <strong>2007</strong> floating 4.07% 1.1<br />
Overdraft facility CZK <strong>2007</strong> floating 2.97% 1.7<br />
Loan EUR <strong>2007</strong> fixed 3.87% 52.2<br />
Total 55.0<br />
Parent company<br />
<strong>2007</strong><br />
The parent company had no bank debt at 31 December <strong>2007</strong>.<br />
Weighted<br />
average Nominal<br />
Fixed/ effective value<br />
2006 Currency Expiry floating interest rate DKKm<br />
Overdraft facility SEK <strong>2007</strong> floating 4.07% 1.1<br />
Overdraft facility CZK <strong>2007</strong> floating 2.97% 1.7<br />
Total 2.8<br />
103
19-21<br />
Notes<br />
19. Treasury shares<br />
Parent company and Group<br />
Shares of Nominal Share of<br />
DKK 5 nom. value share capital Cost<br />
<strong>2007</strong> Number DKKm DKKm<br />
Holding at 01.01.<strong>2007</strong> 3,963,353 19.8 1.87% 526.4<br />
Additions 8,557,204 42.8 4.13% 1,191.3<br />
Shares cancelled (5,867,644) (29.4) -2.83% (807.4)<br />
Holding at 31.12.<strong>2007</strong> 6,652,913 33.2 3.21% 910.3<br />
2006<br />
Holding at 01.01.2006 7,523,399 37.6 3.31% 1,016.0<br />
Additions 12,011,862 60.1 5.66% 1,591.1<br />
Shares cancelled (15,571,908) (77.9) -7.34% (2,080.7)<br />
Holding at 31.12.2006 3,963,353 19.8 1.87% 526.4<br />
Additions of treasury shares consist of shares acquired pursuant to the authority granted by the shareholders in general meeting to purchase treasury shares of up<br />
to 10% of the share capital. The shares were purchased in the open market, and the buyback programme has been implemented with due consideration to market<br />
conditions and current legislation and provisions on share buybacks.<br />
At the annual general meeting held on 24 April <strong>2007</strong>, it was resolved to lower the company’s share capital by DKK 29,338,220 nominal value of the company’s<br />
portfolio of treasury shares, corresponding to 5,867,644 shares.<br />
The market value of the entire holding of treasury shares at 31 December <strong>2007</strong> was DKK 918.1 million (DKK 617.9 million in 2006). Deferred tax on shares held<br />
for less than three years was DKK 6.4 million (DKK 25.2 million in 2006).<br />
20. Contractual obligations<br />
Rental and lease obligations<br />
Lundbeck has obligations amounting to DKK 511.1 million (DKK 547.5 million in 2006) in the form of property leases and leasing of operating equipment, primarily<br />
cars. The future rental and lease payments can be analysed as follows:<br />
<strong>2007</strong> <strong>2007</strong> <strong>2007</strong> 2006 2006 2006<br />
Land and Operating Land and Operating<br />
buildings equipment Total buildings equipment Total<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
Less than 1 year 103.4 56.7 160.1 93.7 73.4 167.1<br />
Between 1 and 5 years 236.4 84.6 321.0 235.6 87.0 322.6<br />
More than 5 years 30.0 - 30.0 57.7 0.1 57.8<br />
Total 369.8 141.3 511.1 387.0 160.5 547.5<br />
Rental and lease payments recognised in the income statement in <strong>2007</strong> amounted to DKK 193.0 million (DKK 196.0 million in 2006).<br />
Other purchase obligations<br />
The parent company has undertaken to purchase property, plant and equipment in the amount of DKK 52.7 million (DKK 177.9 million in 2006).<br />
Research collaborations<br />
The Group is part of multi-year research collaboration projects comprising minimum research and contractual obligations in the order of DKK 32 million<br />
(DKK 28 million in 2006). The total amount of the obligations can increase substantially in line with the favourable development of the projects.<br />
Other contractual obligations<br />
The parent company has capital contribution obligations amounting to DKK 33.2 million (DKK 45.2 million in 2006) and has entered into various service agreements<br />
amounting to DKK 33.2 million (DKK 48.6 million in 2006).<br />
104
21. Contingent liabilities<br />
Forest<br />
See note 2 Revenue in respect of the consequences of any launch of generic escitalopram in the USA.<br />
The prepayment from Forest has been translated at the exchange rate at the transaction date or at the forward rate and recognised in the balance sheet at<br />
DKK 839.5 million (DKK 854.7 million in 2006). If the translation had been made at the exchange rate at the balance sheet date, the prepayment would have<br />
amounted to DKK 737.7 million (DKK 738.5 million in 2006).<br />
Letters of intent and bank guarantees<br />
The parent company has entered into agreements to cover operating losses in certain subsidiaries. The parent company has issued letters of intent to subsidiaries<br />
in a total amount of DKK 7.8 million (DKK 67.0 million in 2006). Furthermore, the parent company’s bankers have issued bank guarantees to third parties in<br />
the amount of DKK 10.1 million (DKK 20.1 million in 2006). The Group’s bankers have issued bank guarantees to third parties in the amount of DKK 55.3 million<br />
(DKK 66.6 million in 2006). The parent company has evaluated that the fair value of guarantees is DKK 0 (DKK 0 in 2006).<br />
Pending legal proceedings<br />
The Group is involved in legal proceedings, including cases with generic competitors. In the opinion of management, the outcome of these proceedings will not<br />
have a material impact on the Group’s financial position beyond the amount provided for in the financial statements. Due to uncertainty about the outcome of<br />
the legal proceedings, the final amount of the provision is still unknown. Moreover, as described on page 8, the Group is party to legal proceedings in Germany<br />
against a number of businesses. The company does not expect that this will materially affect its financial position, results of operations or cash flows.<br />
Industry obligations<br />
The Group has return obligations normal for the industry. Management expects no major loss on these obligations.<br />
Joint taxation<br />
The parent company is liable jointly and severally with the other jointly taxed companies for the total income taxes under the joint taxation scheme for the income<br />
year 2004 and earlier. As from 2005, H. Lundbeck A/S and Danish subsidiaries are subject to national joint taxation with LFI a/s and other Danish affiliated<br />
companies. The companies under this joint taxation scheme are separately liable for the payment of own taxes until these have been settled with the administration<br />
company (LFI a/s). After such time, LFI a/s is liable for the combined taxes under the joint taxation scheme.<br />
105
22<br />
Notes<br />
22. Financial instruments<br />
Capital structure<br />
Lundbeck operates in an industry characterised by frequent shifts in market situation that involve a need for in-licensing and acquisition activities. To date, the<br />
company has largely been self-financing in respect of these activities.<br />
Despite a strong cash flow, the company intends to maintain financial resources in the form of cash and binding loan commitments to allow for flexible operations<br />
in case of a rapid shift in the market situation. At 31 December <strong>2007</strong>, the company had binding loan commitments for DKK 1.8 billion from two financial<br />
institutions. In addition, the company has a large number of non-binding credit facilities for use in its day-to-day operations. At 31 December <strong>2007</strong>, these<br />
amounted to DKK 0.4 billion.<br />
Furthermore, Lundbeck manages its capital structure based on a wish to carry an investment-grade rating. The company does not presently hold an actual rating<br />
from a recognised rating agency, but several financial institutions believe that, on the basis of a calculated implied rating at 31 December <strong>2007</strong>, Lundbeck would<br />
be assigned a rating in the A- to BBB+ range using Standard & Poor’s rating scale. The lowest investment-grade rating is BBB-.<br />
The company’s treasury policy, which deals with financial resources, foreign currency exposure, securities portfolio and loan portfolio, is reviewed once a year by<br />
the Supervisory Board. In addition, the Executive Management defines rules concerning selecting financial collaboration partners, commitment lines and types of<br />
business.<br />
Liquidity exceeding the requirement for business development and general business purposes is primarily distributed as dividends or used for share buyback<br />
purposes. The company pursues a policy of distributing between 25% and 35% of the profit for the year as dividends.<br />
Other than small operational changes, no changes were made to the company’s treasury policy compared with 2006.<br />
Foreign currency risks<br />
Foreign currency management is handled centrally by the parent company. The company hedges a significant part of the Group’s anticipated cash flows for a<br />
period of approximately 12 months.<br />
Currency management focuses on risk minimisation and is carried out in conformity with the foreign currency policy approved by the Supervisory Board. The<br />
hedging consists partly of a fixed minimum hedge and partly of a variable part. The fixed part is hedged by forward contracts classified as hedging instruments<br />
and meeting the accounting criteria for hedging future cash flows. Changes in the fair value of these contracts are taken to equity as they arise and - on realisation<br />
of the hedged cash flow - transferred from equity for inclusion in the same item as the hedged cash flow.<br />
The variable part, which is hedged partly by forward contracts and partly by option contracts, is used to hedge the remaining foreign currency risks in the short<br />
term. These contracts are not classified as hedging contracts but as trading contracts, and changes in the fair value are recognised as financials as they arise.<br />
Due to the company’s continuous hedging of net currency flows, a falling exchange rate will not affect the company in the short term. Conversely, the company<br />
will not benefit fully from a rising exchange rate in the short term, either.<br />
106
22. Financial instruments – continued<br />
Net forward exchange contracts and FX swaps outstanding for the Group and the parent company<br />
Hedging part Exchange gain/ Average<br />
Hedge value Market value Exchange (loss) recognised hedge prices<br />
according to (forward gain/(loss) in the income of existing<br />
the hedge exchange recognised in statement/ forward exchange<br />
<strong>2007</strong><br />
principle contracts) equity balance sheet contracts Maturity period<br />
DKKm DKKm DKKm DKKm DKK<br />
AUD 88.4 86.0 2.4 (2.7) 454.32 Jan - Dec 2008<br />
CAD 158.6 160.9 (2.3) 2.9 519.66 Jan - Dec 2008<br />
CHF 57.4 56.5 0.9 2.8 455.62 Jan - Dec 2008<br />
CZK 27.5 28.1 (0.6) (0.3) 27.56 Jan - Dec 2008<br />
EUR 82.1 82.1 - 0.5 746.45 Jan - Dec 2008<br />
GBP 80.0 85.9 (5.9) 1.3 1,061.15 Jan - Dec 2008<br />
HUF - - - (0.5) -<br />
ILS 21.3 21.0 0.3 0.5 133.35 Jan - Dec 2008<br />
JPY 26.2 27.4 (1.2) (3.6) 4.74 Jan - Dec 2008<br />
MXN 73.5 72.7 0.8 0.7 47.66 Jan - Dec 2008<br />
NOK 23.1 23.3 (0.2) (0.4) 92.84 Jan - Dec 2008<br />
SKK 42.3 42.4 (0.1) (0.4) 22.29 Jan - Dec 2008<br />
TRY 87.8 93.7 (5.9) (8.1) 417.91 Jan - Mar 2008<br />
USD 2,442.1 2,337.9 104.2 126.9 530.86 Jan - Dec 2008<br />
ZAR 40.0 39.8 0.2 2.4 72.97 Jan - Sep 2008<br />
Forward contracts 3,250.3 3,157.7 92.6 122.0<br />
2006<br />
AUD 75.4 76.5 (1.1) (1.6) 436.33 Jan - Dec <strong>2007</strong><br />
CAD 183.7 173.6 10.1 (8.8) 514.78 Jan - Dec <strong>2007</strong><br />
CHF 57.3 56.0 1.3 2.0 473.25 Jan - Dec <strong>2007</strong><br />
CZK 21.2 21.8 (0.6) 0.2 26.41 Jan - Dec <strong>2007</strong><br />
EUR 283.9 283.6 0.3 - 746.22 Jan - Dec <strong>2007</strong><br />
GBP 79.7 77.3 2.4 3.3 1,072.68 Jan - Dec <strong>2007</strong><br />
HUF 5.4 5.9 (0.5) 0.2 2.73 Jan - Jul <strong>2007</strong><br />
JPY 29.9 32.2 (2.3) (1.3) 5.17 Jan - Dec <strong>2007</strong><br />
MXN 28.3 28.3 - (0.3) 51.22 Jan - Dec <strong>2007</strong><br />
NOK 27.7 27.1 0.6 0.2 91.76 Jan - Dec <strong>2007</strong><br />
SEK - - - (0.4) -<br />
TRY 45.2 47.5 (2.3) (0.3) 375.55 Jan - Mar <strong>2007</strong><br />
USD 1,848.9 1,801.6 47.3 (35.9) 577.79 Jan - Dec <strong>2007</strong><br />
ZAR 56.0 54.1 1.9 1.4 83.20 Jan - Dec <strong>2007</strong><br />
Forward contracts 2,742.6 2,685.5 57.1 (41.3)<br />
The exchange difference between the contract value and the market value of the concluded forward exchange contracts at 31 December <strong>2007</strong> represented a gain<br />
of DKK 99.0 million (DKK 56.1 million in 2006). There were no currency options or FX swaps under the hedging part at 31 December <strong>2007</strong> and 31 December 2006.<br />
The company’s inefficiency on hedging, cf. IAS 39 Financial instruments: Recognition and measurement, relates to few contracts reclassified to trading contracts.<br />
The profit impact at the date of reclassification was a gain of DKK 0.4 million (loss of DKK 33.2 million in 2006).<br />
107
22<br />
Notes<br />
22. Financial instruments – continued<br />
Trading part<br />
Average<br />
Market value Exchange hedge prices<br />
(forward gain/(loss) of existing<br />
exchange recognised in forward exchange<br />
contracts and the income contracts and<br />
<strong>2007</strong><br />
FX swaps) statement FX swaps Maturity period<br />
DKKm DKKm DKK<br />
CAD 10.4 (0.1) 517.54 Apr 2008<br />
CHF - 0.5 -<br />
GBP - 0.1 -<br />
TRY - 0.2 -<br />
USD - 1.4 -<br />
Forward contracts 10.4 2.1<br />
EUR 186.4 - 745.56 Jan 2008<br />
FX swaps 186.4 -<br />
Total trading 196.8 2.1<br />
2006<br />
CAD 4.9 2.4 493.31 Jan <strong>2007</strong><br />
CHF 7.0 0.1 475.55 Jun <strong>2007</strong><br />
EUR - 0.1 -<br />
TRY - 0.3 -<br />
USD - (10.0) -<br />
ZAR - 0.8 -<br />
Forward contracts 11.9 (6.3)<br />
The exchange difference between the contract value and the market value of the concluded forward exchange contracts and FX swaps at 31 December <strong>2007</strong><br />
was DKK 0 million (loss of DKK 0.7 million in 2006). There were no currency options under the trading part at 31 December <strong>2007</strong> and 31 December 2006.<br />
Deferred recognition of currency gains/losses taken to equity<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
(190.9) 57.1 Deferred exchange gains/losses at 01.01. 57.1 (190.9)<br />
173.5 157.9 Exchange adjustments for the year, hedging, taken to equity 157.9 173.5<br />
5.4 4.9 Realised exchange gains/losses, hedging, transferred to revenue 4.9 5.4<br />
35.9 (126.9) Realised exchange gains/losses, hedging, transferred to prepayments from Forest (balance sheet) (126.9) 35.9<br />
33.2 (0.4) Realised exchange gains/losses, trading, transferred to net financials (transferred from hedging) (0.4) 33.2<br />
57.1 92.6 Deferred exchange gains/losses at 31.12. 92.6 57.1<br />
108
22. Financial instruments – continued<br />
Specification of monetary assets and liabilities for the most important currencies at 31 December<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm Monetary assets DKKm DKKm<br />
3.0 1.3 AUD 34.2 49.5<br />
9.2 0.8 CAD 114.1 94.3<br />
2.6 3.4 CHF 27.6 30.1<br />
5.0 3.2 GBP 72.4 7.3<br />
0.3 0.5 TRY 74.6 53.2<br />
145.3 313.8 USD 343.8 300.0<br />
Monetary liabilities<br />
0.7 - AUD 13.8 11.4<br />
- 0.5 CAD 36.0 21.8<br />
5.2 0.2 CHF 23.7 11.5<br />
31.4 36.2 GBP 81.5 40.5<br />
- - TRY 29.9 24.1<br />
19.5 35.0 USD 96.0 128.2<br />
Due to the long-standing fixed exchange rate policy in Denmark, the foreign currency risk for EUR is considered immaterial, and EUR is therefore not included in<br />
the list above.<br />
At the end of <strong>2007</strong>, 100% of the company’s anticipated cash flows for 2008 in USD were hedged.<br />
Estimated impact on profit and equity from a 5% fluctuation in year-end exchange rates of the most important currencies<br />
<strong>2007</strong><br />
AUD CAD CHF GBP TRY USD<br />
DKKm DKKm DKKm DKKm DKKm DKKm<br />
Profit 2.2 1.0 1.0 24.4 - 39.2<br />
Equity (1.8) (6.4) (1.6) 30.0 (3.5) (77.6)<br />
2006<br />
Profit 1.9 1.3 0.5 11.0 (0.2) 38.0<br />
Equity (1.6) (6.6) (2.0) 14.5 (2.4) (52.1)<br />
The profit impact is included in the impact on equity.<br />
The company’s USD income derives primarily from sales to Forest. According to the Group’s accounting policies, the minimum price is recognised as income<br />
at the time of invoicing, and the excess amount is recognised in the balance sheet as a prepayment. Prepayments and any remaining settlement will be recognised<br />
as Forest subsequently resells the products. Income and expenses relating to hedging contracts covering this part of the hedged cash flows are recognised in the<br />
balance sheet together with the prepayments and subsequently recognised in the income statement as Forest resells the products. At 31 December <strong>2007</strong>, this<br />
amount was a gain of DKK 105.7 million (a loss of DKK 69.4 million in 2006) which has been recognised together with the prepayments.<br />
Exchange adjustment of associates according to the equity method<br />
Group Group<br />
<strong>2007</strong> 2006<br />
DKKm DKKm<br />
Exchange adjustment at 01.01. (1.9) (1.4)<br />
Exchange adjustment for the year - (0.5)<br />
Exchange adjustment at 31.12. (1.9) (1.9)<br />
109
22-23<br />
Notes<br />
22. Financial instruments – continued<br />
Interest rate risks<br />
Interest rate risk management is handled centrally by the parent company. Through the parent company’s treasury policy, the Supervisory Board has approved the limits<br />
for borrowing and investment. Loans secured by real property must be approved by the company’s Supervisory Board. To hedge the interest rate risk on loans, the Supervisory<br />
Board has approved the use of interest rate swaps and forward-rate agreements (FRAs).<br />
Bond investments may only be made in Danish government and mortgage bonds. For managing the interest rate risk on the securities portfolio (the securities portfolio<br />
includes bonds and money market deposits), the company applies a duration target capped at five years for the entire portfolio. The return on the bond portfolio and the<br />
money market deposits in <strong>2007</strong> was DKK 74.5 million (DKK 7.5 million in 2006), corresponding to a return of 3.63% p.a. (0.48% p.a. in 2006). Lundbeck’s benchmark in<br />
<strong>2007</strong> was a bond portfolio with a duration of two years. The return on the benchmark portfolio was 3.47% p.a. in <strong>2007</strong> (1.98% p.a. in 2006). At 31 December <strong>2007</strong>, the<br />
securities portfolio had a duration of 1.02 years, which translates into a gain/loss of DKK 28.6 million if interest rates should fall/rise by 1 percentage point.<br />
Specification of maturity dates for assets and liabilities of the Group<br />
Less than Between More than Effective<br />
1 year 1 and 5 years 5 years Total interest rates<br />
<strong>2007</strong> DKKm DKKm DKKm DKKm<br />
Assets<br />
Receivables 1 2,367.6 60.6 - 2,428.2 0%<br />
Deferred tax assets 162.7 - - 162.7 0%<br />
Securities 2 902.9 400.7 232.1 1,535.7 4-6%<br />
Associates - - 82.9 82.9 0%<br />
Available-for-sale financial assets 3 - 150.7 - 150.7 0%<br />
Fixed-term deposits 1,271.7 - - 1,271.7 3-11%<br />
Other cash resources 500.3 - - 500.3 0-16%<br />
Total financial assets 5,205.2 612.0 315.0 6,132.2<br />
Liabilities<br />
Mortgage debt 5.1 7.4 1,851.2 1,863.7 4-6%<br />
Employee bonds - 12.6 18.9 31.5 4-6%<br />
Other payables 2,614.2 3.5 - 2,617.7 0%<br />
Bank debt 4.4 - - 4.4 18%<br />
Total financial liabilities 2,623.7 23.5 1,870.1 4,517.3<br />
2006<br />
Assets<br />
Receivables 1 2,013.2 63.6 - 2,076.8 0%<br />
Deferred tax assets 279.1 - - 279.1 0%<br />
Securities 2 5.4 1,004.1 192.1 1,201.6 3-6%<br />
Associates - - 166.9 166.9 0%<br />
Available-for-sale financial assets 3 - 127.6 - 127.6 0%<br />
Fixed-term deposits 695.7 - - 695.7 3-9%<br />
Other cash resources 480.9 - - 480.9 0-18%<br />
Total financial assets 3,474.3 1,195.3 359.0 5,028.6<br />
Liabilities<br />
Mortgage debt 5.1 11.5 1,416.3 1,432.9 4-6%<br />
Employee bonds - - 12.6 12.6 4-5%<br />
Other payables 2,632.8 1.8 - 2,634.6 0%<br />
Bank debt 55.0 - - 55.0 3-4%<br />
Total financial liabilities 2,692.9 13.3 1,428.9 4,135.1<br />
1) Including other receivables and receivables from associates.<br />
2) The securities are classified as financial assets measured at fair value with value adjustment through the income statement.<br />
3) The value of available-for-sale financial assets at 31 December <strong>2007</strong> was DKK 150.7 million (DKK 127.6 million in 2006). Of this amount, 84% (89% in 2006) relates to the investments<br />
in Burrill Biotechnology Capital Fund, L.P. and Nordic Biotech K/S.<br />
110
23. Related parties<br />
Lundbeck’s related parties are<br />
- The company’s principal shareholder, LFI a/s, Vestagervej 17, DK-2900 Hellerup, which is wholly owned by the Lundbeck Foundation, and the Lundbeck Foundation<br />
- Companies in which the principal shareholder exercises controlling influence, i.e. ALK-Abelló A/S<br />
- The company’s subsidiaries<br />
- The company’s associates<br />
- Members of the company’s Executive Management and Supervisory Board as well as close relatives of these persons<br />
- Companies in which members of the company’s Executive Management and Supervisory Board as well as close relatives of these persons exercise significant influence<br />
Transactions and balances with the company’s principal shareholder<br />
There have been no transactions or balances with the company’s principal shareholder other than dividends, the share buyback programme, see The Lundbeck share on<br />
page 40, and the payment of on-account tax and residual tax of DKK 664.2 million (repayment of excess tax in the amount of DKK 34.4 million in 2006) concerning the<br />
parent company and Danish subsidiaries, see Joint taxation in note 21 Contingent liabilities. LFI a/s/the Lundbeck Foundation have a controlling influence in H. Lundbeck A/S.<br />
Transactions and balances with ALK-Abelló A/S<br />
There have been no transactions or balance with ALK-Abelló A/S.<br />
Transactions and balances with subsidiaries Parent Parent<br />
<strong>2007</strong> 2006<br />
DKKm DKKm<br />
Sale of goods 4,325.0 3,672.9<br />
Purchase of goods 299.3 383.3<br />
Sale of production services - 2.9<br />
Purchase of production services 14.0 10.8<br />
Cover of impairment losses in subsidiaries 311.1 -<br />
Purchase of distribution services 188.7 279.9<br />
Sale of administrative services 4.5 3.7<br />
Purchase of administrative services 98.1 34.8<br />
Purchase of research and development services 456.0 440.8<br />
Dividend 120.2 75.6<br />
Financial income 24.2 26.3<br />
Financial expenses 42.7 30.1<br />
Long-term receivables from subsidiaries 609.0 745.9<br />
Short-term receivables from subsidiaries 485.9 407.3<br />
Long-term payables to subsidiaries 1,067.3 886.7<br />
Short-term payables to subsidiaries 296.4 394.6<br />
Provision to cover impairment loss in subsidiaries 311.1 -<br />
Transactions and balances with subsidiaries include on-account tax payments made by the parent company on behalf of the subsidiaries. Transactions and balances<br />
with subsidiaries are eliminated on consolidation.<br />
Transactions and balances with associates<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
0.6 0.7 Sale of administrative services 0.7 0.6<br />
0.6 0.8 Financial income 0.8 0.6<br />
19.2 - Long-term receivables from associates - 19.2<br />
Associates comprise CF Pharma Gyógyszergyártó Kft., Hungary, and LifeCycle Pharma A/S, Denmark.<br />
Transactions and balances with the company’s Executive Management and Supervisory Board<br />
In addition to the transactions with members of the company’s Executive Management and Supervisory Board outlined in note 3 Staff costs, the company has paid<br />
dividend on shares in H. Lundbeck A/S held by members of the Executive Management and Supervisory Board. There are no balances with the company’s Executive<br />
Management and Supervisory Board.<br />
Transactions and balances with other related parties<br />
Lundbeck has granted contributions of DKK 4.0 million (DKK 3.4 million in 2006) to Lundbeck International Neuroscience Foundation. Other than this, there have been no<br />
material transactions and balances with related parties.<br />
111
24-28<br />
Notes<br />
24. Segment information<br />
Primary segments<br />
The Group’s activities are exclusively in the business segment of ‘pharmaceuticals for the treatment of illnesses in the field of CNS’.<br />
Secondary segments<br />
The Group’s revenue is divided into the following secondary geographical segments:<br />
Revenue Revenue<br />
<strong>2007</strong> 2006<br />
DKKm DKKm<br />
Denmark 73.7 238.5<br />
Rest of Europe 5,504.4 5,103.2<br />
USA 2,652.0 1,957.6<br />
Rest of the world 2,754.8 1,921.7<br />
Total 10,984.9 9,221.0<br />
The Group’s assets and additions to intangible assets and property, plant and equipment, analysed by secondary geographical segment, are as follows:<br />
Additions to Additions to<br />
intangible intangible<br />
assets and assets and<br />
property, plant property, plant<br />
Assets 1 Assets 1 and equipment and equipment<br />
<strong>2007</strong> 2006 <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
Denmark 8,795.8 7,691.2 644.2 566.3<br />
Rest of Europe 2,185.5 2,572.6 34.5 58.9<br />
USA 526.8 485.8 62.8 184.3<br />
Rest of the world 655.2 602.3 6.6 13.0<br />
Total 12,163.3 11,351.9 748.1 822.5<br />
1) Exclusive of deferred tax assets.<br />
25. Earnings per share<br />
<strong>2007</strong> 2006<br />
Profit for the year (DKKm) 1,769.5 1,106.9<br />
Average number of outstanding shares (’000 shares) 210,402 221,129<br />
Average number of treasury shares (’000 shares) (5,412) (10,036)<br />
Average number of shares exclusive of treasury shares (’000 shares) 204,990 211,093<br />
Average number of warrants, fully diluted (’000 warrants) 163 346<br />
Average number of shares, fully diluted (’000 shares) 205,153 211,439<br />
Earnings per share (EPS) (DKK) 8.63 5.24<br />
Diluted earnings per share (DEPS) (DKK) 8.63 5.23<br />
The net profit for the year equals the profit allocated to shareholders of the parent company.<br />
Warrants comprised by the warrant scheme established in 2005 for the Executive Management and Danish and foreign executives, a total of 647,000 warrants, were<br />
not in the money in <strong>2007</strong> and were therefore not exercised. Warrants covered by the warrant scheme established in <strong>2007</strong> for the Executive Management and Danish<br />
and foreign executives, a total of 844,500 warrants, are exercisable from 1 August 2008. The warrants are not included in the calculation of earnings per share (EPS)<br />
and diluted earnings per share (DEPS). The warrants may have a longer term dilutive effect on earnings per share and diluted earnings per share.<br />
112
25. Earnings per share – continued<br />
Warrants comprised by the warrant schemes established in 2005 and <strong>2007</strong>, respectively, may be exercised within the given subscription periods if the price of the<br />
Lundbeck share exceeds the fixed exercise price of DKK 179.00 for the 2005 plan and DKK 156.00 for the <strong>2007</strong> plan. At 31 December <strong>2007</strong>, 647,000 warrants from<br />
the 2005 plan and 844,500 warrants from the <strong>2007</strong> plan remained outstanding.<br />
See note 3 Staff costs for additional information on incentive plans.<br />
26. Adjustments<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
465.3 444.0 Amortisation and depreciation 915.8 526.0<br />
- - Income from reduced ownership interest - (154.6)<br />
3.6 23.4 Incentive plans 16.4 -<br />
- - Change in pension obligations (15.8) 13.3<br />
(3.3) 307.4 Change in provisions 12.7 (6.9)<br />
465.6 774.8 Adjustments 929.1 377.8<br />
27. Working capital changes<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
(35.0) 187.9 Change in inventories 219.3 108.3<br />
114.9 (302.1) Change in receivables (397.3) (75.7)<br />
(504.7) 268.6 Change in short-term debt 77.2 (384.8)<br />
(424.8) 154.4 Change in working capital (100.8) (352.2)<br />
28. Business combinations<br />
<strong>2007</strong><br />
There were no business combinations in <strong>2007</strong>.<br />
2006<br />
In 2006, Lundbeck acquired the SGS-518 development project by way of the company Saegis Pharmaceuticals, Inc. In 2006, the company merged into Cognitive<br />
Therapeutics, LLC, which was wound up in <strong>2007</strong>. The development project was in this connection legally assigned to Lundbeck Cognitive Therapeutics A/S in Denmark.<br />
Date of Shareholding Voting Cost<br />
Name Primary activity acquisition acquired share acquired DKKm<br />
Saegis Pharmaceuticals, Inc., Delaware, USA Development of pharmaceuticals 20.12.2006 100% 100% 48.5<br />
Carrying amount Fair value<br />
under IFRS adjustment Fair value<br />
DKKm DKKm DKKm<br />
Ongoing development projects - 66.7 66.7<br />
Tools and equipment 0.1 (0.1) -<br />
Other receivables 0.4 - 0.4<br />
Cash 3.1 - 3.1<br />
Total assets 3.6 66.6 70.2<br />
Trade payables 7.2 - 7.2<br />
Non-interest-bearing debt 0.4 14.1 14.5<br />
Total liabilities 7.6 14.1 21.7<br />
Net assets (4.0) 52.5 48.5<br />
113
28-30<br />
Notes<br />
28. Acquisition of company – continued<br />
Cost of acquisition<br />
Fair value<br />
DKKm<br />
Cash payment in January <strong>2007</strong> 18.5<br />
Deferred, expected milestone payment in <strong>2007</strong> 28.2<br />
46.7<br />
Transaction costs 1.8<br />
Total cost of acquisition 48.5<br />
Goodwill on acquisition of company -<br />
Cost, paid in cash -<br />
Cash acquired, see above 3.1<br />
Net cash flow impact 3.1<br />
The acquisition price of Saegis Pharmaceuticals Inc., nominally DKK 161.5 million, will be paid in four instalments as the acquired project SGS-518 develops positively<br />
and the regulatory approvals are obtained. The first instalment fell due in January <strong>2007</strong>, while the remaining instalments are expected to be paid over a period of<br />
six years. The opening balance sheet and the cost of the company only included the instalments expected to fall due in <strong>2007</strong>, a total of DKK 46.7 million. In <strong>2007</strong>,<br />
a total of DKK 21.3 million was paid. If the project progresses as expected, and the remaining part of the acquisition price falls due, these payments will be added<br />
to the acquired project.<br />
In the consolidated profit for 2006, Saegis Pharmaceuticals Inc. is recognised at DKK 0, as the company was aquired immediately prior to the balance sheet date.<br />
If the company had been acquired effective 1 January 2006, revenue for 2006 would have been DKK 9,227.8 million and profit for the year DKK 1,085.4 million.<br />
29. Cash resources<br />
Parent Parent Group Group<br />
2006 <strong>2007</strong> <strong>2007</strong> 2006<br />
DKKm DKKm DKKm DKKm<br />
695.7 1,271.0 Fixed-term deposits 1,271.7 695.7<br />
76.7 118.2 Other cash resources 500.3 480.9<br />
772.4 1,389.2 Cash at 31.12. 1,772.0 1,176.6<br />
1.2 641.3 Securities with a maturity of less than 3 months 1 641.3 5.4<br />
1,180.8 876.0 Securities with a maturity of more than 3 months 1 894.4 1,196.2<br />
1,954.4 2,906.5 Cash and securities at 31.12. 3,307.7 2,378.2<br />
1,748.9 1,750.0 Unused guaranteed credit facilities at 31.12. 2 1,750.0 1,748.9<br />
226.7 310.1 Unused credit facilities at 31.12. 419.3 327.9<br />
3,930.0 4,966.6 Cash resources at 31.12. 5,477.0 4,455.0<br />
1) The securities holding consists exclusively of Danish government and mortgage bonds, which are classified as financial assets measured at fair value with value adjustments through the income statement.<br />
2) The unused guaranteed credit facilities consist of a 364-day credit facility of DKK 1 billion and a long-term credit facility of DKK 750 million expiring in 2010. Both credit facilities are guaranteed by<br />
Danish banks.<br />
114
30. Releases from H. Lundbeck A/S in <strong>2007</strong><br />
No. Date<br />
Subject<br />
317 21.12.<strong>2007</strong> Lundbeck expands agreement with PAION for<br />
desmoteplase<br />
316 20.12.<strong>2007</strong> Financial calendar 2008<br />
315 18.12.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
314 18.12.<strong>2007</strong> Lu AA21004 for the treatment of mood and anxiety<br />
disorders enters into clinical phase III<br />
313 06.12.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
312 29.11.<strong>2007</strong> Forest Laboratories and Lundbeck announce positive<br />
results of Lexapro® phase III study in adolescents with<br />
major depression<br />
311 27.11.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
310 27.11.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
309 23.11.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
308 22.11.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
307 21.11.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
306 20.11.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
305 19.11.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
304 16.11.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
303 14.11.<strong>2007</strong> Interim report for the third quarter of <strong>2007</strong><br />
302 13.11.<strong>2007</strong> Novel agent for treatment of Parkinson’s disease in<br />
clinical development<br />
301 07.11.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
300 24.10.<strong>2007</strong> Lu AA24530 for the treatment of mood and anxiety<br />
disorders enters into clinical phase II<br />
299 18.10.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
298 18.10.<strong>2007</strong> Novel agent for treatment of cerebral stroke and other<br />
diseases with neuronal damage in clinical phase I<br />
297 09.10.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
296 02.10.<strong>2007</strong> Lu AA21004 shows highly significant results in clinical<br />
phase II trial<br />
295 24.09.<strong>2007</strong> Lundbeck in-licenses Circadin®, a drug approved for<br />
the treatment of primary insomnia from Neurim<br />
Pharmaceuticals<br />
294 12.09.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
293 05.09.<strong>2007</strong> Federal appeals court upholds Lexapro® patent decision<br />
292 05.09.<strong>2007</strong> Lundbeck and Takeda form alliance to develop and<br />
commercialize a portfolio of novel compounds in the<br />
US and Japan for the treatment of mood and anxiety<br />
disorders<br />
291 31.08.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
290 31.08.<strong>2007</strong> Total number of voting rights and size of share capital<br />
in H. Lundbeck A/S as of 31 August <strong>2007</strong><br />
289 30.08.<strong>2007</strong> Share capital increase as a result of employees<br />
exercising warrants<br />
No. Date<br />
Subject<br />
288 27.08.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
287 24.08.<strong>2007</strong> Flemming Lindeløv is leaving the Lundbeck Supervisory<br />
Board<br />
286 23.08.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
285 21.08.<strong>2007</strong> Share capital increase as a result of employees<br />
exercising warrants<br />
284 15.08.<strong>2007</strong> Interim report for the second quarter of <strong>2007</strong><br />
283 13.08.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
282 03.08.<strong>2007</strong> Reduction of the share capital of H. Lundbeck A/S<br />
281 02.08.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
280 04.07.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
279 20.06.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
278 13.06.<strong>2007</strong> New incentive plan in the Lundbeck Group<br />
277 11.06.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
276 04.06.<strong>2007</strong> Cipralex® demonstrates superiority to duloxetine for<br />
acute treatment of depression in new study<br />
275 01.06.<strong>2007</strong> Total number of voting rights and size of share capital<br />
in H. Lundbeck A/S as of 1 June <strong>2007</strong><br />
274 31.05.<strong>2007</strong> Top line results of phase III study in acute ischemic<br />
stroke (DIAS-2) do not demonstrate difference<br />
between desmoteplase and placebo<br />
273 24.05.<strong>2007</strong> Share capital increase as a result of employees<br />
exercising warrants<br />
272 23.05.<strong>2007</strong> Nalmefene license enters into force<br />
271 21.05.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
270 18.05.<strong>2007</strong> Announcement of transactions with shares and linked<br />
securities in H. Lundbeck A/S made by executives and<br />
their closely associated persons and legal entities<br />
269 15.05.<strong>2007</strong> Share capital increase as a result of employees<br />
exercising warrants<br />
268 10.05.<strong>2007</strong> New Executive Vice President, CFO, in H. Lundbeck A/S<br />
267 09.05.<strong>2007</strong> Interim report for the first quarter of <strong>2007</strong><br />
266 24.04.<strong>2007</strong> H. Lundbeck A/S held its Annual General Meeting on<br />
24 April <strong>2007</strong> at SAS Radisson Falconer Hotel &<br />
Conference Center<br />
265 04.04.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
264 04.04.<strong>2007</strong> Notice of annual general meeting<br />
263 28.03.<strong>2007</strong> Merck & Co., Inc. and Lundbeck discontinue joint<br />
development program for gaboxadol, an investigational<br />
compound for insomnia<br />
262 21.03.<strong>2007</strong> Share capital increase as a result of employees<br />
exercising warrants<br />
261 13.03.<strong>2007</strong> Share capital increase as a result of employees<br />
exercising warrants<br />
260 07.03.<strong>2007</strong> Annual Report 2006<br />
259 01.03.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
258 20.02.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
257 31.01.<strong>2007</strong> Share Buyback in H. Lundbeck A/S<br />
256 22.01.<strong>2007</strong> Change in H. Lundbeck A/S Executive Management<br />
255 12.01.<strong>2007</strong> Cipralex® approved for the treatment of obsessive<br />
compulsive disorder (OCD)<br />
254 04.01.<strong>2007</strong> Financial calendar <strong>2007</strong><br />
115
Management<br />
statement<br />
We have today presented the annual report of H. Lundbeck A/S for the financial year 1 January - 31 December <strong>2007</strong>.<br />
The annual report is prepared in accordance with the International Financial Reporting Standards (IFRS) as issued by the IASB as well as IFRS as adopted<br />
by the EU and additional Danish disclosure requirements for annual reports of listed companies. We consider the accounting policies to be appropriate.<br />
Accordingly, the annual report gives a true and fair view of the Group’s and the parent company’s financial position, cash flows and results of operations.<br />
We recommend that the annual report be approved at the Annual General Meeting.<br />
Copenhagen, 4 March 2008<br />
Executive Management<br />
Claus Bræstrup<br />
President and CEO<br />
Anders Götzsche<br />
Executive Vice President, CFO<br />
Lars Bang<br />
Executive Vice President<br />
Stig Løkke Pedersen<br />
Executive Vice President<br />
Supervisory Board<br />
Per Wold-Olsen Thorleif Krarup Kim Rosenville Christensen<br />
Chairman<br />
Deputy Chairman<br />
Peter Kürstein Mats Pettersson Birgit Bundgaard Rosenmeier<br />
William Watson<br />
Jes Østergaard<br />
116
Independent<br />
auditors’ report<br />
To the shareholders of H. Lundbeck A/S<br />
We have audited the annual report of H. Lundbeck A/S for the financial year 1 January to 31 December <strong>2007</strong>. The annual report comprises the statement<br />
by management on the annual report, management’s review, the income statement, the balance sheet, the statement of changes in equity, the<br />
cash flow statement and the notes to the financial statements, including the accounting policies. The annual report has been prepared in accordance<br />
with International Financial Reporting Standards (IFRS) as issued by the IASB as well as IFRS as adopted by the EU and additional Danish disclosure<br />
requirements for listed companies.<br />
Management’s responsibility for the annual report<br />
Management is responsible for the preparation and fair presentation of an annual report in accordance with International Financial Reporting Standards<br />
(IFRS) as issued by the IASB as well as IFRS as adopted by the EU and additional Danish disclosure requirements for listed companies. This responsibility<br />
includes: designing, implementing and maintaining internal control relevant to the preparation and fair presentation of an annual report that is free<br />
from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies; and making accounting estimates<br />
that are reasonable in the circumstances.<br />
Auditor’s responsibility and basis of opinion<br />
Our responsibility is to express an opinion on the annual report based on our audit. We conducted our audit in accordance with Danish and International<br />
Standards on auditing. Those standards require that we comply with ethical requirements and plan and perform the audit to obtain reasonable<br />
assurance that the annual report is free from material misstatement.<br />
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the annual report. The procedures selected<br />
depend on the auditor’s judgement, including the assessment of the risks of material misstatement of the annual report, whether due to fraud or error.<br />
In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of an annual report<br />
in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of<br />
the entity’s internal control. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting<br />
estimates made by management, as well as evaluating the overall presentation of the annual report.<br />
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.<br />
Our audit has not resulted in any qualification.<br />
Opinion<br />
In our opinion, the annual report gives a true and fair view of the Group’s and the parent company’s financial position at 31 December <strong>2007</strong> and of<br />
their financial performance and their cash flows for the financial year 1 January to 31 December <strong>2007</strong> in accordance with International Financial<br />
Reporting Standards (IFRS) as issued by the IASB as well as IFRS as adopted by the EU and additional Danish disclosure requirements for listed companies.<br />
Copenhagen, 4 March 2008<br />
Deloitte<br />
Statsautoriseret Revisionsaktieselskab<br />
Grant Thornton<br />
Statsautoriseret Revisionsaktieselskab<br />
Stig Enevoldsen Anders Dons Svend Ørjan Jensen Ole Fabricius<br />
State Authorised State Authorised State Authorised State Authorised<br />
Public Accountant Public Accountant Public Accountant Public Accountant<br />
117
Supervisory<br />
Board<br />
At 31 December <strong>2007</strong><br />
Mats Pettersson<br />
Elected at the 2003 General Meeting<br />
Born 7 November 1945<br />
Member, Remuneration Committee<br />
Directorships<br />
Ablynx NV<br />
SwedenBio AB (deputy chairman)<br />
to-BBB Holding B.V.<br />
Kim Rosenville Christensen<br />
Kim Rosenville Christensen<br />
Elected by the employees in 2006<br />
Born 17 April 1959<br />
Synthesis Operator<br />
Birgit Bundgaard Rosenmeier<br />
Elected by the employees in 1993<br />
Born 12 August 1952<br />
Qualified Person 1st Deputy<br />
Peter Kürstein<br />
Elected at the 2001 General Meeting<br />
Born 28 January 1956<br />
President and CEO, Radiometer A/S<br />
Chairman, Audit Committee<br />
Directorships<br />
Foss A/S (chairman)<br />
Radiometer Medical ApS<br />
118
William Watson<br />
Elected by the<br />
employees in 2006<br />
Born 28 October 1968<br />
Head of Scientific<br />
Licensing<br />
Per Wold-Olsen<br />
Chairman<br />
Elected at the <strong>2007</strong> General Meeting<br />
Born 6 November 1947<br />
Chairman, Remuneration Committee<br />
Member, Audit Committee<br />
Directorships<br />
BankInvest Biomedical Venture Advisory Board<br />
Gilead Global Advisory Board (chairman)<br />
Glyconics (deputy chairman)<br />
PharmaNet<br />
Thorleif Krarup<br />
Deputy chairman<br />
Elected at the 2004 General Meeting<br />
Born 28 August 1952<br />
Member, Audit Committee<br />
Directorships<br />
ALK-Abelló A/S (deputy chairman)<br />
Bang & Olufsen A/S<br />
Brightpoint, Inc.<br />
Exiqon A/S (chairman)<br />
Group 4 Securicor plc<br />
LFI a/s (deputy chairman)<br />
Lundbeck Foundation<br />
Sport One Danmark A/S (chairman)<br />
Jes Østergaard<br />
Elected at the 2003 General Meeting<br />
Born 5 March 1948<br />
President, ilochip A/S<br />
(until 1 February 2008)<br />
Member, Remuneration Committee<br />
Directorships<br />
aCROnordic A/S<br />
Aresa A/S<br />
ilochip A/S<br />
LFI a/s<br />
Lundbeck Foundation<br />
Scion-DTU a/s<br />
119
Executive<br />
Management<br />
At 31 December <strong>2007</strong><br />
Claus Bræstrup<br />
Born 18 January 1945<br />
President and CEO<br />
Directorships<br />
LifeCycle Pharma A/S (chairman)<br />
Santaris Pharma A/S<br />
University of Copenhagen<br />
Anders Götzsche<br />
Born 31 December 1967<br />
Corporate Finance & IT<br />
Directorships<br />
OL Holding ApS<br />
Stig Løkke Pedersen<br />
Born 17 July 1961<br />
Commercial Operations<br />
Lars Bang<br />
Born 31 July 1962<br />
Supply Operations &<br />
Engineering<br />
Directorships<br />
Nuevolution A/S (chairman)<br />
Vernal A/S (chairman)<br />
Directorships<br />
DentoFit A/S<br />
Fertin Pharma A/S<br />
120
Design: Bysted A/S<br />
Annual Report photos: Nicky Bonne and Lars Bech<br />
Print: Quickly Tryk A/S<br />
March 2008<br />
DESTINATION<br />
NEXT DECADE
The specialist in psychiatry<br />
and pioneer in neurology<br />
H. Lundbeck A/S<br />
Ottiliavej 9<br />
2500 Copenhagen - Valby<br />
Denmark<br />
Corporate Reporting<br />
Tel. +45 36 30 13 11<br />
Fax +45 36 30 19 40<br />
information@lundbeck.com<br />
www.lundbeck.com<br />
CVR nr. 56759913