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Annual report
2009
Contents
Financial highlights and key ratios for the ALK Group front cover
To our shareholders 1
Highlights 2
Management’s review 3
Global presence 10
Risk management 11
ALK’s Corporate Social Responsibility, (CSR) 15
Shareholder information 18
Corporate governance 21
Board of Directors and Board of Management 23
Statement by Management 24
Independent auditor’s report 25
Income statement 28
Statement of comprehensive income 28
Cash flow statement 29
Balance sheet 30
Equity 32
List of notes to the financial statements 34
Notes to the financial statements 35
List of companies in the ALK Group 71
Definitions 72
Financial highlights and key ratios by the quarter
for the ALK Group back cover
Financial highlights and key ratios for
the ALK Group
Income statement
Revenue 1,935 1,784 260 240
Operating profit before depreciation (EBITDA) 260 205 35 28
Operating profit (EBIT) 175 119 24 16
Net financial items 15 38 2 5
Profit before tax (EBT) 190 157 26 21
Net profit 118 95 16 13
Average number of employees 1,513 1,454 1,513 1,454
Balance sheet
Total assets 2,653 2,538 357 341
Invested capital 1,510 1,367 203 184
Equity 1,928 1,862 259 250
Cash flow and investments
Depreciation, amortization and impairment 85 86 11 12
Cash flow from operating activities 260 189 35 25
Cash flow from investing activities (258) (397) (35) (53)
– of which investment in tangible assets (187) (364) (25) (49)
Free cash flow 2 (208) - (28)
Information on shares
Proposed dividend 51 51 7 7
Share capital 101 101 14 14
Shares in thousands of DKK 10 each 10,128 10,128 10,128 10,128
Share price, at year end – DKK/EUR 409 520 55 70
Net asset value per share – DKK/EUR 191 184 26 25
Key figures
Gross margin – % 70 70 70 70
EBIT margin – % 9 7 9 7
ROAIC – % 12 10 12 10
Pay-out ratio – % 43 54 43 54
Earnings per share (EPS) – DKK/EUR 11.85 9.51 1.59 1.28
Earnings per share (DEPS), diluted – DKK/EUR 11.85 9.51 1.59 1.28
Cash flow per share (CFPS) – DKK/EUR 26.11 18.90 3.51 2.54
Price earnings ratio (PE) 35 55 35 55
Share price/Net asset value 2.1 2.8 2.1 2.8
Revenue growth – %
Organic growth 9 10 9 10
Exchange rate differences (1) (2) (1) (2)
Total growth 8 8 8 8
* ) Financial highlights and key ratios stated in EUR constitute supplementary information to the annual report. The exchange
rate used in translating from DKK to EUR is the exchange rate ruling at December 31, 2009 (EUR 100 = DKK 744).
Income statement
Revenue 1,935 1,784 1,652 1,519 563 1,489
Operating profit before
depreciation (EBITDA) 260 205 298 25 2 126
Exceptional items - - - (40) (40) -
Operating profit/(loss) (EBIT) 175 119 218 (55) (28) 53
Net financial items 15 38 14 27 10 40
Profit/(loss) before tax (EBT) 190 157 232 (28) (18) 93
Net profit/(loss) continuing
operations 118 95 140 (36) (20) 44
Net profit/(loss)* 118 95 177 (36) (20) 44
Average number of employees 1,513 1,454 1,392 1,263 1,314 1,227
Balance sheet
Total assets 2,653 2,538 2,821 2,731 2,731 2,789
Invested capital 1,510 1,367 1,050 1,000 1,000 890
Equity 1,928 1,862 2,112 2,024 2,024 2,094
Cash flow and investments
Depreciation, amortization and
impairment 85 86 80 80 30 73
Cash flow from operating activities 260 189 362 (2) (39) 60
Cash flow from investing activities (258) (397) (172) (389) (41) (370)
– of which investment in
tangible assets (187) (364) (164) (121) (40) (97)
Free cash flow 2 (208) 190 (391) (80) (310)
Information on shares
Proposed dividend 51 51 330 n/a 20 51
Share capital 101 101 101 101 101 101
Shares in thousands of
DKK 10 each 10,128 10,128 10,128 10,128 10,128 10,128
Share price, at year end – DKK 409 520 600 1,410 1,410 765
Net asset value per share – DKK 191 184 209 200 200 207
Key figures
Gross margin – % 70 70 70 67 69 67
EBIT margin – % 9 7 13 (4) (5) 4
ROAIC – % 12 10 21 (7) (3) 7
Pay-out ratio – % 43 54 186 n/a (100) 116
Earnings per share (EPS) – DKK 11.85 9.51 13.96 (3.59) (1.99) 2.38
Earnings per share (DEPS),
diluted – DKK 11.85 9.51 13.91 (3.59) (1.99) 2.38
Cash flow per share (CFPS) – DKK 26.11 18.90 36.10 (0.20) (3.88) 5.90
Price earnings ratio (PE) 35 55 43 (392) (705) 319
Share price/Net asset value 2.1 2.8 2.9 7.0 7.0 3.7
Revenue growth – %
Organic growth 9 10 10 n/a 6 9
Exchange rate differences (1) (2) (1) n/a - -
Acquisitions - - - n/a - 13
Total growth 8 8 9 n/a 6 22
* ) Net profit for 2007 includes profit in connection with the sale of the ingredients business Chr. Hansen.
To our shareholders
A good year with significant progress for our business ALK introduced a new, improved injection-based vaccine prod-
uct, AVANZ®, to further strengthen our product range and market
2009 was a challenging year for the world’s economies, which position, primarily on the important German market.
were hit hard by the recession and the global economic down-
turn. These developments affected most companies; neverthe- However, market conditions also turned more difficult in 2009,
less ALK successfully managed to steer through the period and partly as a result of the global economic downturn, and the
we now stand well prepared to face the future. The company consequences were most pronounced in Italy and Spain. Here,
is well-consolidated with good liquidity, insignificant debt, many allergy patients decided to postpone their treatment
increasingly profitable operations and an expanding free cash because they had to pay a relatively large part of the costs
flow. themselves as they are not fully covered by public or private
reimbursement schemes.
For ALK, 2009 was a good year with significant progress in the
business and robust financial results. We generated 10% or Moreover, the health authorities in a number of European
ganic growth in sales of allergy vaccines and concurrently kept a countries are working to update the rules on the sale and
sharp focus on costs. This enabled us to increase our operating marketing of non-registered vaccine products, resulting in a
profit by 47% to DKK 175 million, which was considerably better number of new regulatory requirements to manufacturers. For
than forecast at the beginning of the year, and we are very satis- ALK, these requirements especially affect sales of drop-based
fied with this performance. products. ALK believes that the growing regulatory require-
ments will be an advantage for patients and the industry as
ALK achieved several key milestones in 2009. ALK’s North a whole. Although they will also affect ALK in the short term,
American partner, Merck (previously Schering-Plough), suc- they will further enhance our competitive strength in the longer
cessfully completed two clinical studies of GRAZAX® in the USA. term. We have already invested substantial resources in the
The studies will form the basis for submission of a registration development and registration of our tablet-based vaccines,
application to the US health authorities (the FDA). This has and ALK is the company with the largest number of registered
strongly accelerated the process of launching the grass tablet products.
on the important North American markets. In addition, Merck is
running a large-scale development programme with the tablet With prospects of sustained sales growth in 2010, ALK is moving
against ragweed allergy and is also planning the further devel- in the right direction. The activity level is expected to be high
opment of the tablet against house dust mite allergy. This makes with a focus on sales growth, on complying with future statutory
us confident that ALK has strong prospects in North America. requirements in Europe, on continuing the development of the
tablet vaccines and on supporting the intensified collaboration
Based on data from a long-term study which demonstrated a with Merck in its efforts to obtain approval and subsequently
sustained effect upon completion of treatment, the health au- launch our tablets on the North American markets.
thorities in Europe approved GRAZAX® as a disease-modifying
therapy. The approval marks the provisional culmination of We therefore believe that ALK is well positioned to further
ALK’s research and development within tablet-based allergy strengthen our leading position within allergy vaccination.
vaccination and supports our ambition of improving the quality
of allergy treatment and expanding the use of vaccine products.
This ambition also includes children and adolescents as an
important target group, and in 2009 GRAZAX® was successfully Jørgen Worning Jens Bager
launched for children in a number of European countries. Chairman President and CEO
2 Management’s review
Highlights
• F
or 2009 as a whole, ALK’s revenue
totalled DKK 1,935 million (1,784), and study of GRAZAX®, which will form the • I n 2009, the principal investments in
sales of allergy vaccines grew by 10%. basis for a registration application new production facilities were com-
and subsequent launch of the tablet in pleted.
• O
perating profit before depreciation North America.
and amortization (EBITDA) was DKK Outlook for the 2010 financial year
260 million (205). • B ased on a long-term study which For the 2010 financial year, ALK forecasts
demonstrated a significant, sustained sustained growth in both sales and earn-
• O
perating profit (EBIT) increased by effect upon completion of treatment, ings. However, earnings will be affected
47% to DKK 175 million (119). EBIT in- the health authorities in Europe by rising costs as a result of increased
cluded net operating income from ALK’s approved GRAZAX® as a disease- regulatory requirements in Europe and
US partner of DKK 33 million (28). modifying therapy. the intensified activity level in the col-
laboration with Merck to develop and
• N
et profit for the year was DKK 118 • In order to strengthen its product launch tablets in North America.
million (95). range and market position, ALK
launched a new, improved injection- See page 5 for further details on the
• A
LK’s North American partner, Merck, based vaccine product (AVANZ®) in outlook for 2010.
successfully completed a US clinical Germany.
* Comparative financial figures for the same period of last year are shown in brackets. In Management’s review, growth rates are organic growth rates
unless otherwise stated.
This annual report contains forward-looking statements, including forecasts of future revenue and operating profit as well as ex-
pected business-related events. Such statements are subject to risks and uncertainties as various factors, some of which are beyond
the control of the ALK Group, may cause actual results and performance to differ materially from the forecasts made in this annual
report. Without being exhaustive, such factors include, among other things, general economic and business conditions, including
legal issues, uncertainty relating to pricing, reimbursement rules and market penetration for GRAZAX®, fluctuations in currencies and
demand, changes in competitive factors and reliance on suppliers, but also factors such as side effects from the use of the company’s
existing and future products since allergy vaccination may be associated with allergic reactions of differing extent, duration and se-
verity. Moreover, ALK cannot rule out that a general economic downturn could have an adverse impact on the use of allergy vaccines.
This annual report has been translated from Danish into English. However, the Danish text is the governing text for all purposes, and
if there is any discrepancy, the Danish wording is applicable.
Management’s review 3
Management’s review*
Income statement
Q4 Q4
2008 % 2009 % Amounts in DKKm 2009 % 2008 %
Financial review Region and North America. Sales of were the main contributors to the growth
injection-based vaccines accounted for in tablet sales. The launch of the tablet for
Revenue in Q4 followed a satisfactory an unchanged 48% (48) of total sales. children and adolescents in the first mar-
trend and increased by 13%. For the year kets contributed especially to this sales
as a whole, sales increased by 9% to DKK Sales of drop-based products (SLIT drop- growth. Tablet sales represent a growing
1,935 million (1,784). The impact from lets) grew by 8% to DKK 573 million (528). share of ALK’s sales and accounted for
exchange rates was negative by one Sales performance was satisfactory in 7% (5) of total revenue. GRAZAX® was
percentage point, primarily as a conse- France, whereas the economic downturn thus the single product contributing the
quence of the GBP/DKK exchange rate. resulted in more subdued growth in Spain most to ALK’s overall sales growth. With
and a drop in sales in Italy. In the Central the approval of GRAZAX® as a disease-
The growth rate in the core business, European Region, sales dropped as a modifying therapy, new launches with
allergy vaccine sales, was 10% for the full consequence of general market develop- the children indication and the generally
year and was driven by broadly founded ments. In the Netherlands, the authorities growing acceptance of the therapy, ALK
growth in sales of injection-based prod- decided to discontinue the reimbursement expects to be able to continue to gener-
ucts and high growth in sales of GRAZAX®. for non-registered allergy vaccines, which ate strong growth in its tablet sales, and
caused a significant drop in sales of SLIT the long-term commercial potential of
In Q4, sales of allergy vaccines showed droplets on the Dutch market. Overall, the product on the European markets is
growth of 11%, and revenue for the quar- sales of SLIT droplets accounted for an un- estimated to be good.
ter totalled DKK 542 million (476). changed 30% (30) of ALK’s global sales.
Sales of other products (adrenaline, di-
Sales of injection-based allergy vaccines The tablet-based product GRAZAX® con- agnostics, etc.) totalled DKK 301 million
(SCIT) grew by 7% to DKK 928 million tinued its satisfactory sales performance, (305) and grew by 2%, net of the effects
(864) in 2009. This favourable sales and sales increased by 56% to DKK 133 of exchange rate fluctuations. This was
performance was driven by the Northern million (87). The Northern European the result of a natural variation in the sale
European Region, the Central European Region and the Central European Region of adrenaline products. Compared to
* Management’s review comprises pages 1-23 as well as Financial highlights and key ratios by the quarter for the ALK Group.
4 Management’s review
exchange rate fluctuations and increas- exchange gains on intercompany bal- trend is thus expected to continue in
ing procurement prices of some of ALK’s ances in and holdings of foreign currency. 2010, albeit at a slightly lower level than
trade goods, including adrenaline pens. in previous years as a consequence of
Income tax for the year amounted to the general economic downturn and new
Total capacity costs increased by 3% DKK 72 million (62), corresponding to an regulatory conditions in Europe which
to DKK 1,209 million (1,163). Research effective tax rate of 38%. Net profit for the especially affect sales of non-registered
and development expenses for the year year was DKK 118 million (95). drop-based products.
totalled DKK 349 million (327), equiva-
lent to 18% (18) of revenue. These ex- The cash flow from operating activities It is expected that the gross margin will
penses primarily related to the continued followed a satisfactory trend and was an be slightly lower than last year as a con-
development of tablet-based vaccines, inflow of DKK 260 million (189). The cash sequence of changes in the product and
including increased support for the part- flow was affected by changes in working country mix of sales and growing depre-
nership with Merck. Sales, marketing and capital and a subsequent adjustment to an ciation as new production facilities are
administrative expenses were DKK 860 installment of corporate income tax paid brought into use. To this should be added
million (836). on account. The cash flow from investing costs of preparing for FDA approval of
activities was an outflow of DKK 258 million tablet production prior to the planned
Operating profit was very satisfactory and (an outflow of 397) relating to planned launch of GRAZAX® in North America.
better than expected as a consequence investments in buildings and production
of strong earnings towards the end of the facilities and ongoing maintenance. The A high level of activity is forecast for 2010
year. Operating profit before deprecia- free cash flow for the year was an inflow of with a number of important strategic initia-
tion and amortization (EBITDA)was DKK 2 million (an outflow of 208). The cash tives with a view to strengthening the com-
DKK 260 million (205). Reported operat- flow from financing activities was an out- pany’s position in the longer term. These
ing profit (EBIT) increased by 47% to DKK flow of DKK 61 million (an outflow of 374), include the initiation by ALK of a number of
175 million (119), corresponding to an primarily relating to the distribution of ordi- major clinical studies of the tablet-based
EBIT margin of 9%. Exchange rates had an nary dividends of DKK 50 million in respect vaccines, including the GAP (GRAZAX®
adverse impact on EBIT as compared to of the 2008 financial year. At the end of the Asthma Prevention) study. To this should
2008. EBIT included net operating income year, cash totalled DKK 389 million (449). be added extensive and growing sup-
of DKK 33 million from Merck, ALK’s US port for the collaboration with Merck with
partner. This related to the pharmaceuti- Equity stood at DKK 1,928 million at the a view to developing and launching the
cal development activities concerning end of the year (1,862), corresponding to tablets in North America and new regula-
the new tablet-based vaccine against an equity ratio of 73%. tory conditions in Europe which involve
ragweed allergy. increased demand for documentation of
Outlook for the 2010 financial year the non-registered product portfolio.
Net financials were an income of DKK For the 2010 financial year, ALK forecasts
15 million (38) and consisted of interest an increase in sales of allergy vaccines As a consequence, a minor improvement
income as well as realized and unrealized of 5-8% in local currencies. The growth is expected in EBITDA and EBIT. The earn-
** In 2006, the company’s financial year was changed to follow the calendar year. The figures for the 2006 calendar year are unaudited.
6 Management’s review
ings forecast for 2010 includes agreed ALK intends to specify new financial ob- non-registered products that may be
milestone payments from the US partner, jectives when the Board of Directors has removed from the market can be replaced
Merck. approved a revised strategic plan, which by these tablets.
is scheduled to take place in the second
Investments are expected to total approx half of 2010. The new long-term objec- The continuing development of the tab
imately DKK 140 million in 2010, which is tives will be updated taking into account lets therefore represents a significant
significantly lower than in previous years. Merck’s plans for product launches in strengthening of ALK’s competitive
The free cash flow is expected to be an in- North America. position.
flow in 2010 and to be higher than in 2009.
Research and development
The outlook is based on the current Operating review The development of GRAZAX® reached a
exchange rates. ALK’s revenue and earn- milestone in 2009 with the approval of the
ings are exposed to exchange rate fluc- ALK focuses on improving the treatment product’s disease-modifying effect. ALK’s
tuations. The company has estimated the of allergy through the introduction of new, efforts to develop the grass tablet will
following exchange rate sensitivity based effective and user-friendly tablet-based continue in the years ahead through the
on the current exchange rates: A 10% in- vaccines which treat the actual cause of five-year GAP (GRAZAX® Asthma Preven-
crease in the exchange rate of USD would allergy instead of just relieving symptoms. tion) study, which is expected to document
increase revenue by approximately DKK The company’s key research and develop- that treatment with GRAZAX® can reduce
15 million. The same would apply to GBP. ment priority continues to be the intro- the risk of children developing asthma.
All things being equal, a 10% increase in duction of a portfolio of tablets covering
the exchange rate of USD would reduce the most widespread allergies. GRAZAX® In 2010, the key research and develop-
EBIT by an estimated DKK 15 million net, is the first tablet-based allergy vaccine ment activities will be focused on ac-
primarily because purchases of adrena- developed and launched in Europe. celerating the development of the tablets
line products are denominated in USD. A against house dust mite and tree pollen
10% increase in the exchange rate of GBP The experience with GRAZAX® in Europe allergy. ALK plans to initiate a major Phase
would increase EBIT by approximately has emphasized the importance of III clinical study of the house dust mite
DKK 10 million. A drop in the exchange introducing a well-documented and re tablet. It is expected that the study will be
rates would have the opposite effect. gistered portfolio of tablets covering the completed late 2011 and that it will then
medical needs among a broader group form the basis for a European registration
Long-term ambitions of patients and prescribing physicians application with a view to launching the
ALK’s basic strategic ambition is to to be able to treat the most common product in the subsequent years. More
expand the use of allergy vaccination allergies. over, ALK intends to prepare the further
through the introduction of new, well- development of the tree tablet.
documented, effective and user-friendly The close strategic partnership with
tablet-based allergy vaccines that have Merck opens the opportunity for a long- New injection-based vaccine
received regulatory approval. term commercial success with the tablet ALK has introduced a new, improved
programmes, also in North America. As injection-based vaccine product, aim-
In the shorter term, it must be expected part of the partnership agreement with ing to strengthen its product range and
that the total growth in allergy vaccine Merck, ALK has undertaken to provide market position, especially in Germany.
sales will be more subdued than previ- extensive development support for The new product, AVANZ®, builds on
ously anticipated as a consequence of the introduction of the tablets in North ALK’s conventional vaccines and is more
the general economic downturn and new America. In particular, this will influence convenient to patients, partly because it
regulatory conditions in Europe. the level of research and development allows for faster updosing. The product is
activity over the coming years. initially being marketed on a named pa-
Going forward, the EBITDA and EBIT mar- tient basis. Based on a number of planned
gins are expected to continue to increase Growing regulatory requirements in a clinical activities, AVANZ® is expected to be
and eventually reach the pharmaceutical number of European countries for the registered within a number of years.
industry average. Moreover, from 2011, registration of older, non-registered
annual investments are expected to be products have concurrently emphasized Recombinant vaccine against cat
on a level with annual depreciation and that it will be necessary to complete the allergy
amortization, and a steadily rising cash development of tablets against the most ALK and Novozymes have signed an
inflow is expected. widespread allergies so that any older, agreement regarding the production
Management’s review 7
ALK’s pipeline
* ALK’s US partner, Merck, holds product rights for the North American markets.
of industrially produced (recombinant) GRAZAX® versus placebo and the study ticals, but are used under the responsibil-
allergens for use in ALK’s future tablet- included 439 adult patients. The adverse ity of the prescribing physician and pro-
based allergy vaccines. Initially, ALK will events in patients receiving the grass duced and supplied directly to a named
develop a recombinant tablet against tablet in this study were similar to previ- patient. More than 15 different allergy
cat allergy. The product is at the early ous studies in adult patients, and there companies, including ALK, market NP
research stage. were no new or unexpected findings. It products, especially drop-based allergy
is expected that additional data will be vaccines, which are more widely used in
Merck partnership presented at a medical conference to be southern and central Europe. ALK esti-
In 2007, ALK entered into a strategic held in the USA in 2010. mates that sales of NP products account
partnership with Schering-Plough to for about two thirds of the industry’s total
ensure the efficient introduction of the A similar GRAZAX® Phase III clinical study European vaccine sales of approximately
tablets in North America. In Q4 2009, including 345 children and adolescents DKK 5 billion.
Schering-Plough was merged with Merck, has also been conducted in the USA.
which thereby assumed the rights to ALK’s The study successfully met its primary The health authorities in a number of
tablet programmes on the North American endpoint and the data will be presented countries have worked on modernizing
markets. The collaboration is progress- at the annual meeting of the American their rules for NP products for a number
ing satisfactorily and with an increased Academy of Allergy Asthma & Immunol- of years in order to ensure the highest
activity level. ogy (AAAAI), February 26 to March 2, possible documentation and quality in
2010, in New Orleans, USA. treatment. It is primarily the regulatory
In 2009, Merck and ALK reached a authorities in Germany, the Netherlands,
number of key milestones in their joint Merck has initiated the further clinical Spain and Italy who have started updating
efforts to launch the tablets in North development of the tablet against rag- the regulations. In France, the authorities
America. weed allergy, which is a very widespread established an updated system for ap-
allergy in North America. In late 2009, proving NP products already in 2004/05.
In early November, positive GRAZAX® the company initiated two major Phase
results were announced which demon- III clinical studies approved to include In 2009, the Dutch regulatory authorities
strated that the tablet had successfully up to 1,400 patients and expected to be decided to modify the reimbursement
met the primary endpoint of a major clini- completed in early 2011. schemes for allergy vaccines with a view
cal study. The study forms the basis for a to rationalizing the use of NP products.
later registration application to the FDA, In addition, ALK and Merck are discuss- This decision will have an adverse
which can be submitted in the second ing the further development programme impact on ALK’s current sales, as the
half of 2010. The product will be eligible for the house dust mite tablet. drop-based SLIT products are not regis-
for launch immediately after the FDA has tered in the Netherlands. ALK’s sales of
processed and approved the application. New regulatory requirements in Europe the affected products in the Netherlands
For many years, certain allergy vac- totalled approximately DKK 50 million
The US study of GRAZAX® was a multi- cines have been supplied on a ‘named in 2009 and are expected to fade over
center, randomized, placebo-controlled, patient’ (NP) or individual patient basis the next couple of years. The modifica-
double-blind Phase III clinical study. The in a number of European countries. These tion of the reimbursement schemes has
objective was to evaluate the efficacy of products are not registered pharmaceu- caused a general and substantial ad-
8 Management’s review
verse trend in the Dutch market. In this ing that, going forward, all significant most of the market for allergy vaccines.
market, GRAZAX® is the only registered allergen-based products must be regis- For ALK, it applies to drop-based prod-
SLIT product and the modification of the tered and receive marketing approval. ucts and the new AVANZ® product contain-
reimbursement schemes does not affect The affected products are all allergy ing the said allergens. ALK’s bee/wasp
GRAZAX®. vaccines sold as NP products and contain venom products only exist as registered
pollen from grasses and trees, extracts injection-based products. The allergen
In Germany, the authorities have im- from house dust mites or bee/wasp decree also contains a number of transi-
plemented an allergen decree requir- venom. The affected products make up tion schemes for products that were on
the market before the decree came into Other business-related events in 2009 diagnostic product, PRE-PEN®, in the
force. ALK plans to conduct a number of USA. This product allows physicians to ef-
clinical activities in order to comply with Investment in DBV Technologies ficiently test whether a patient is allergic
the German allergen decree and main- In January, ALK invested DKK 15 million in to penicillin. PRE-PEN® is produced by the
tain its sales of drop-based products on a French biotech company, DBV Tech- company AllerQuest and was approved
the German market. nologies, as part of a follow-up equity by the FDA in September.
financing of the company. The investment
The authorities in Spain and Italy have provides an opportunity for ALK to later Completion of investment programme
also announced that they intend to enter into a partnership to develop a new In 2009, ALK completed significant in-
implement requirements for increased vaccine against peanut allergy. vestments in new tablet production facili-
clinical documentation. However, no ties in Denmark, the USA and the UK.
requirements or processes have yet been Takeover of German distributor
communicated by the authorities. In the second half of 2009, ALK signed The investments include a new raw
an agreement to take over the activities materials production unit in Idaho, USA,
ALK believes that, overall, setting high of ThemoCare Allergiedienst, a small and a new tablet production line in Swin-
statutory standards will benefit patients allergy operator in Germany. This previ- don, UK. In addition, ALK has completed
and the industry as a whole. Throughout ously privately owned company was the construction of a new building at
its history, ALK has worked to promote the distributor of ALK’s French products Hørsholm, Denmark, which has made it
the greatest possible documentation on the German market since 1999. The possible to locate all Danish employees in
of the use of allergy vaccines, and its acquisition strengthens ALK’s market the Science Park in Hørsholm.
portfolio of registered allergy vaccines position and geographic presence in cer-
is the largest in the industry. In connec- tain areas of Germany. The effective date Upon completion of these investments, ALK
tion with the development and registra- of the acquisition was October 1. expects to have sufficient tablet production
tion of the new tablet-based vaccines, capacity for the coming years. The overall
ALK has conducted the most extensive New diagnostic product in the USA investment level is therefore expected to
clinical studies ever within allergy vac- In the second half of 2009, ALK has be substantially lower going forward than
cination. acquired the rights to introduce a it has been in the last few years.
Events after the end of the use of symptomatic medications and The study was conducted by Merck,
financial year consequently, a significant reduction ALK’s strategic partner in North America,
in combined symptom and medication and was a US multicenter, randomized,
Disease-modifying effect of GRAZAX® score was obtained. Furthermore, the placebo-controlled, double-blind,
verified immunological assessment continues to parallel-group clinical trial. The trial was
Early February 2010, ALK announced show a sustained, positive effect on the evaluating the efficacy of the grass tablet
positive top-line results from the second immune system indicating a lasting toler- versus placebo in the treatment of grass
and final follow-up year in a long-term ance to grass pollen. pollen-induced rhinoconjunctivitis based
study (GT-08) with GRAZAX®. The results on the combined rhinoconjunctivitis daily
verify that the disease-modifying effect The positive results were obtained symptom score and rhinoconjunctivitis
of GRAZAX® is sustained after comple- despite a markedly lower grass pollen daily medication score averaged over the
tion of the recommended three-year exposure during 2009 compared to the entire grass pollen season. In the study
treatment regimen. previous pollen seasons in 2005-08. 345 children were randomized to receive
either placebo or grass tablet.
Two years after completed treatment, GRAZAX® paediatric trial in the USA
GRAZAX® reduced hay fever symp- meets primary endpoint The data will be presented by Merck
toms with the same magnitude as in Mid-February, ALK announced that at the annual meeting of the American
the previous year of the clinical study. GRAZAX® successfully met the primary Academy of Allergy Asthma and Immu-
The significant reduction in hay fever endpoint in an American Phase III study nology (AAAAI), February 26 to March 2,
symptoms was accompanied by less of paediatric patients in the USA. 2010, in New Orleans, USA.
10 Management’s review
Global presence
Production
Distributors
Subsidiaries in Austria, Canada, Denmark (Nordic), France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, the UK and
the USA
Sales offices in China, Finland and Norway
Partnership with Merck in Canada, Mexico and the USA
About ALK
ALK is a research-driven global pharmaceutical company focusing on allergy treatment, prevention and diagnosis. Our mission is to
improve the quality of life of persons with allergy by developing pharmaceutical products that target the actual cause of allergy. ALK
is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which
reduces and potentially halts the allergic reaction. Allergy vaccination is traditionally administered as subcutaneous injections or
sublingual droplets. Our aim is to extend the use of allergy vaccination by introducing convenient, tablet-based vaccines, thereby
offering many more patients a causal allergy treatment. Following this strategy, the world’s first tablet-based vaccine against grass
pollen allergy, GRAZAX®, was launched in Europe in 2007 and ALK has entered a strategic partnership with Merck regarding the tab-
let programme in North America. In 2009, GRAZAX® was approved as a disease-modifying allergy treatment and GRAZAX® is now the
only registered tablet treatment against grass pollen allergy with documented sustained effect after completion of treatment. ALK
has approximately 1,500 employees with subsidiaries, production facilities and distributors worldwide. The company is headquar-
tered in Hørsholm, Denmark, and listed on the NASDAQ OMX Copenhagen A/S. Further information is available at
www.alk-abello.com and www.GRAZAX.com.
Management’s review 11
Risk management
Doing business in the pharmaceutical reimbursement from and price control Risks related to dependence on third
industry is subject to risk. ALK’s Board of by national authorities. This often parties
Management is responsible for the on results in major price differences in the ALK has partnership agreements with
going management of risk, including risk individual markets. Regulatory require- third parties with a view to commercializ-
mapping, assessment of probabilities ments and intervention, as well as price ing the company’s products on a number
and potential consequences and launch control, may therefore have a significant of markets and with parties supply-
of risk-reducing measures. Reporting to impact on the company’s earnings ing important input for key production
the Board of Directors’ audit committee is capacity. processes. Although there are financial
done on an annual basis. incentives for all of ALK’s partners to fulfil
Risks related to commercialization their contractual obligations, there can
The following risks are of particular sig- If ALK and its partners succeed in de- be no assurance that they will actually
nificance to ALK. veloping new products and obtaining do so. The factors that motivate ALK’s
regulatory approval for them, the ability partners to develop and commercialize
to generate revenue depends on the products may be affected by conditions
Commercial risks products being accepted by physicians and decisions beyond ALK’s control.
and patients. The degree of market The agreement with Merck (formerly
Risks related to the development of acceptance of a new product or drug Schering-Plough) entitles ALK to receive
new drugs candidate depends on a number of fac- certain milestone payments. These
The future success of ALK depends on the tors, including demonstration of clinical payments will depend on continuing
company’s ability to successfully identify, efficacy and safety, cost-effectiveness, favourable results in the development of
develop and market new, innovative convenience and ease of administration, the pharmaceutical products for which
drugs, which involves significant risks. A potential advantage over alternative ALK’s partner holds the license rights.
pharmaceutical drug must be subjected treatment methods, competition, and Moreover, reliance on suppliers and
to very extensive and lengthy clinical marketing and distribution support. third-party manufacturers entails risks
trials to document aspects such as safety If ALK’s new products fail to achieve which ALK would not be subject to if the
and efficacy before it can be approved for market acceptance, this could have a company possessed the necessary in-
marketing. In the course of the develop- significant influence on the company’s house manufacturing capabilities. Such
ment process, the outcome of these trials ability to generate revenue. ALK regularly risks include but are not limited to:
is subject to significant risks. Even though conducts extensive surveys of market
substantial resources are invested in conditions and similar factors and ex- • R eliance on a third party for regulatory
the development process, the trials may pends significant resources on providing compliance and quality assurance.
produce negative results. Delays in ob- information on its products to physicians • Possible breach of a manufactur-
taining regulatory approvals – or failure and patients. Commercialization is a cru- ing agreement by a third party due
to obtain such approvals – may also have cial part of the company’s strategic basis to factors beyond ALK’s control and
a major impact on the ability of ALK to and strategic activities. influence.
achieve its long-term goals. ALK and its • Reliance on the ability of a third party
collaborative partners perform thorough ALK’s products may be associated with to deliver and scale up the volume of
risk assessments of the research and de- allergic reactions of varying extent, dur production.
velopment programmes throughout the ation and severity. If such events occur
development and registration processes in unexpected situations, they may have ALK manages these risks through con-
to optimize the probability of the products an impact on the company’s earnings tractual relations, thorough planning and
reaching the market. and sales. Due to the potentially serious monitoring and through joint steering
consequences, it is crucial for ALK to keep committees that work together with these
Risks related to regulation and price an eye on product quality and safety, external parties.
control both in clinical development and in sales
ALK’s products are subject to a large and marketing activities. If, despite the Risks related to competition
number of statutory and regulatory high level of quality and safety, a situa- ALK operates in markets characterized
requirements with respect to issues such tion should occur in which it is necessary by intense competition. If, for instance,
as safety, efficacy and production. In to recall a product, ALK has set up pro a competitor launches a new and more
most of the countries in which ALK oper- cedures to ensure that this can be done effective treatment of allergy, it may
ates, prescription drugs are subject to swiftly and efficiently. have a material impact on ALK’s sales.
12 Management’s review
A competitive market may also lead to standards have been developed and ficient control environment and risk man-
market-driven price reductions or price optimized over many years. agement systems in connection with the
reductions dictated by the regulatory financial reporting process. Managers at
authorities. Both competition and price Risks related to key employees various levels are responsible within their
are risks that may have a material ALK is dependent on being able to attract respective areas.
impact on ALK’s ability to achieve its and retain employees in key positions. A
long-term goals. ALK therefore monitors loss of key employees may have a mate- The policies, procedures and manuals
economic developments, the competi- rial impact on the company’s market and that have been adopted are available
tive situation and initiatives on all impor- research efforts. ALK manages this risk, on the Group’s intranet, and the impor-
tant markets. among other things, by continuously of- tance of compliance with these precepts
fering its staff professional development is regularly emphasized. Guidelines for
Risks related to patents and opportunities and competitive compen- persons authorized to sign for the com-
intellectual property rights sation. pany are provided through a formalized
Patents and other intellectual property and documented distribution of respon-
rights are important for developing and sibilities.
retaining ALK’s competitive strength. Risks related to financial
The risk that ALK infringes patents or reporting The risk of fraud is mitigated through or-
trademark rights held by other com- ganizational segregation of incompatible
panies, as well as the risk that other ALK has designed a number of internal functions and the use of preventive and
companies may attempt to infringe the control and risk management systems detective internal controls. The controls
patents and trademark rights of ALK are to ensure that its financial statements are both IT-based and manual.
monitored and, if necessary, suitable provide a true and fair view in accord-
measures are taken. ance with the International Financial ALK’s control environment consists of
Reporting Standards as adopted by the its organizational structure and internal
Risks related to production and quality EU and with a number of other disclosure guidelines, which are based on legisla-
ALK has concentrated most of its pro- requirements to the annual reports of tion and applicable recommendations.
duction capacity at plants in Denmark, listed companies. The systems also sup-
France, Spain and the USA. Although the port appropriate accounting policies and Risk assessment
plants are located in areas that have not accounting estimates. There is a relatively greater risk of er-
historically been hit by natural disasters, ror in items in the financial statements
this geographical diversification calls for ALK’s risk management and internal that are based on estimates or that are
risk planning in order to avoid emerg controls in connection with the financial generated through complex processes.
ency situations, such as lack of or poor reporting process, including IT and tax, ALK performs continual risk assessments
access to raw materials, for instance pol- are designed with a view to managing to identify such items and to assess the
len. This planning includes the preven- rather than eliminating the risk of errors scope of the related risks.
tion of unwanted events and preventive and omissions in the Group’s financial
inventory management; an example is reporting. Note 2 to the financial statements
the build-up of contingency inventories (‘Significant accounting estimates and
in order to ensure an unbroken chain of Control environment judgements’) contains a description of
production. The primary responsibility for the Group’s the estimates and assessments that are
risk management and internal controls in considered material to financial report-
Production and manufacturing processes relation to the financial reporting process ing.
are also subjected to periodic and rou- rests with the Board of Directors and the
tine inspections by the regulatory author Board of Management. These two boards Control activities
ities as a regular part of their monitor- are responsible for establishing and ap- The purpose of the control activities is
ing process in order to ensure that all proving general policies, procedures and to prevent, detect and correct possible
manufacturers observe the prescribed controls in key areas connected with the errors or irregularities. These activities
requirements and standards. Meeting financial reporting process. are integrated in the company’s ac-
these quality standards is a prerequisite counting and reporting procedures and
for the company’s competitive strength. The Board of Management is responsible include procedures such as certification,
ALK’s production processes and quality for the day-to-day maintenance of an ef- authorization, approval, reconciliation,
Management’s review 13
results analysis, segregation of incom- Financial risks GBP exchange rates on revenue and EBIT
patible functions as well as controls levels, respectively.
relating to IT applications and general Due to the nature of its operations, in-
IT controls. The Group Finance function vestments and financing, ALK is exposed A 10% increase in the exchange rate of
also conducts control activities aimed to fluctuations in exchange rates and USD would increase revenue by approxi-
at ALK’s subsidiaries and selected key interest rates. The ALK Group’s financial mately DKK 15 million. The same would
processes. risks are managed from headquarters, apply to GBP. All things being equal, a
based on policies approved by the Board 10% increase in the exchange rate of
Information and communication of Directors. The objective of ALK’s USD is estimated to reduce EBIT by ap-
The company maintains information financial risk management is to reduce proximately DKK 15 million net, primarily
and communications systems to ensure the sensitivity of earnings to fluctuations because purchases of adrenaline prod-
that its financial reporting is correct and in exchange rates, interest rates, liquid- ucts are denominated in USD. A 10%
complete. Guidelines for reporting and ity and changes in credit rating. Group increase in the exchange rate of GBP
end-of-month procedures are updated policy is to refrain from active financial would increase EBIT by approximately
regularly and reviewed at least once speculation. See note 35 of this annual DKK 10 million. A drop in the exchange
a year. These guidelines are available report for a specification of the Group’s rates would have the opposite effect.
to the relevant staff on ALK’s intranet. hedging of currency, interest rate and Exchange rate risks relating to oper
Amendments to accounting proce- credit risks and the use of derivative ations are primarily hedged by match-
dures are announced and explained financial instruments. ing receipts and payments in the same
in instructions from the Group Finance currencies and by forward exchange
function. Foreign exchange risk contracts and options.
The general objective of ALK’s foreign
Monitoring exchange risk management is to limit and Moreover, ALK is exposed to exchange
ALK uses a comprehensive, standardized delay any adverse impact of exchange rate risks when intercompany balances
financial management system, which rate fluctuations on earnings and cash and net assets of foreign subsidiaries are
contributes to the monitoring of the ALK flows and thus increase the predictability translated into DKK. In accordance with
Group’s results. The system facilitates of the financial results. the accounting policies, such currency
early detection and correction of possible translation adjustments are recognized
errors and irregularities in the Group’s The most significant financial risk in ALK in the income statement and in equity,
financial reporting. relates to exchange rate fluctuations. respectively.
The greatest exposure is to USD and
All companies report detailed monthly GBP. In 2009, 9% of ALK’s revenue was Foreign exchange exposure relating
accounting data that are analyzed and denominated in USD, 7% in GBP and 74% to future transactions and assets and
monitored at Group and regional level. in EUR. ALK’s sales are not deemed to liabilities is evaluated and hedged by
be exposed to EUR due to Denmark’s instruments such as forward exchange
ALK applies a uniform accounting participation in the European exchange contracts. This serves to limit the impact
practice in accordance with IFRS, which rate cooperation. on the financial results of any exchange
is described in the corporate account- rate fluctuations. The exchange rate
ing manual. The accounting manual exposure relating to net investments in
Sensitivities in the event of a 10%
contains accounting and assessment foreign subsidiaries is not hedged by
increase in exchange rates
principles and reporting instructions forward exchange contracts.
which must be strictly observed by all DKKm Revenue EBIT
companies of the Group. The manual is Interest rate and liquidity exposure
updated and reviewed continually, and USD approx. +15 approx. -15 At the end of the financial year, net
compliance with the manual is moni- GBP approx. +15 approx. +10 interest-bearing assets stood at ap-
tored at Group level. proximately DKK 400 million. A change
Note: The sensitivities are estimated on the in the interest rate level by 1 percentage
basis of the current exchange rates.
The Board of Management informs the point would, consequently, correspond to
Board of Directors on the degree of com- a change in interest income of approxi-
pliance with the principles and instruc- The table above shows the estimated mately DKK 4 million. It is not expected
tions in the manual. effect of a 10% increase in the USD and that the interest rate exposure will be
14 Management’s review
ALK’s mission is to improve quality of life The other production sites – in Spain, and identification of potential energy-
by developing pharmaceuticals that treat France, the USA and Canada – comply with saving areas.
the actual cause of allergy instead of just these standards and are part of the close
relieving symptoms. This is considered collaboration to constantly improve Group Moreover, a long-term SHE strategy
a responsible way of managing aller- performance in the SHE field. was defined, with the following areas of
gic diseases from patient and society global focus:
perspectives – not least because allergy In Denmark, ALK received the Nordic Er-
vaccination potentially prevents the gonomics Society (NES) corporate award • R eduction of energy consumption and
development of additional allergies and in 2009 for its ‘extraordinary work to thus CO2 emissions.
asthma. improve the ergonomic working environ- • Job satisfaction.
ment’.
In ALK’s products and product develop- Energy consumption will be reduced
ment, nature’s own allergen compounds Employee safety, health and welfare are through a systematic implementation of
are used as raw materials. Pollen from crucial parameters for a sound organiza- energy-saving projects at all production
grasses and trees, insect venoms, house tion, and ALK is working systematically to sites over the next few years.
dust mites, etc. are cultivated, puri- reduce work-related absence. ALK’s oc-
fied and further processed into active cupational injury rate for 2009 for injuries In 2009, ALK’s total energy consumption
ingredients for allergy vaccines. These with more than one day’s absence from rose by 18% year-on-year, primarily
vaccines are then used by patients to work was 1.5 injuries per million working because of the relocation to a new plant
re-programme their immune system and hours, equivalent to three accidents with in Post Falls, Idaho, that is three times
rebuild tolerance – making it possible to absence from work in all of ALK. This the size of the old plant. To this should be
enjoy nature and withstand the natural represents a significant reduction on the added the relocation to a new admin-
exposure to those same substances. previous years. istration building in Hørsholm, Den-
mark, and extreme weather conditions
The amounts of biological and chemi- in a number of places. ALK’s energy
CSR focus areas at ALK
cal materials used in the production of reduction target (measured in absolute
allergy vaccines are very small, thus • Safety, Health and Environment (SHE). consumption figures) is to reduce CO2
affecting the environment at a very low • Employee and Leadership Development. emissions by 15% or more in 2014 com-
scale compared to most industries. The • Business ethics (Code of Conduct). pared with the 2008 level.
gradual paradigm shift in physicians’
general treatment of allergy away from SHE strategy, focus areas and energy To achieve these targets, ALK and DONG
short-range symptomatic treatment reduction targets up to 2014 Energy have signed an energy partner-
towards using allergy vaccines to treat The primary focus in 2009 was on a ship agreement covering operations in
the actual cause of allergy is, however, general mapping of energy consumption Denmark.
creating sustained growth in the produc-
tion of ALK’s allergy vaccines.
The 2009 survey showed very good Revenue per employee in DKK ‘000 1,129 1,154 1,198 1,245
results and progress in almost all areas
compared with the results from the previ-
ous survey. When comparing ALK’s re-
sults with those of other companies in our
Overview of ALK’s organizational development processes
countries of operation, our performance
is generally above average. Ninety per
cent of all staff submitted their opinions embe
r Janua
ry
on ALK as a workplace in the employee Dec
ua
an d Performance
No
ry
en
al
G
ssm
s
workplace with room for employee per- es
er
oc
Mar
sse
Octob
ch
Leadership A
et
Employ
Budg
view
roc
ber
na
r for id Year g
and career and we want to strengthen ma
nce Re Or
Au
view
collaboration across departments and us a
y
g
t M
national borders.
July
June
ALK performs organizational reviews
every year to determine whether our
strategic goals are aligned with the re- Organizational reviews are carried out every year. The leadership assessments, the overall employee
survey and the strategy process are conducted every two years.
sources available to the various depart-
Management’s review 17
ments of the company. Based on these ment areas and lay the foundations of Business ethics
reviews, various initiatives such as sup- individual development plans. For the ALK’s Code of Conduct aims to support a
plementary training, talent development company as a whole, the leadership working environment where daily busi-
and career planning are taken. assessment is used to direct overall lead- ness is conducted with professionalism,
ership development initiatives according honesty and integrity, and in the best
On the basis of an increased focus on to the results. In 2009, ALK completed a interest of ALK and our stakeholders. In
talent development, ALK developed a global management training programme our Code of Conduct, we adhere to the
‘High-Potential Programme’ in 2009 which was conducted over a four-year UN Global Compact ten principles in the
that is aimed at ensuring that we have period and included all management lev- areas of human and labour rights, envi-
sufficient in-house talent to fill strategic els. The programme comprised training ronment and anti-corruption.
positions that provide optimal support to in Strategy Understanding and Execu-
our business and culture. Each year, we tion, Change Management and Personal ALK’s Code of Conduct was published in
identify a small group of employees with Leadership. the form of a folder and distributed to all
the potential to fill these key strategic employees in connection with a general
positions. In 2010, ALK will continue to focus on a presentation of these standards of busi-
further strengthening of its performance ness conduct. The Code was presented in
Every two years, ALK performs a global culture, with the objectives of: all parts of the organization, including all
leadership assessment of all managers production sites and subsidiaries; it now
followed by a verbal feedback proce- • S etting a clear direction and creating a forms part of the training and education
dure, and the outcome is a personal strong focus throughout the organiza- generally provided to employees.
development plan for each manager. On tion, both horizontally and vertically.
the individual level, the purpose of the • Developing and motivating employees ALK’s Code of Conduct is available
leadership assessment is to help manag- through a development process based at the corporate website:
ers define their strengths and develop- on strategic requirements. www.alk-abello.com/aboutalk/csr.
18 Management’s review
Shareholder information
It is ALK’s goal to provide timely, accurate ALK seeks to maintain an active dia- shareholders and to sign up for news
and relevant information on its strategy, logue on company performance with releases on the corporate website.
operations, performance, expectations, its current and potential investors.
the progress of its clinical research and Management therefore recommends A telephone conference accessible via
development programmes and on risk all shareholders to have their shares the corporate website is held follow-
factors. registered in the company’s register of ing each publication of interim financial
statements. Members of the Board of
Management and Investor Relations hold
a number of meetings with investors and
Shareholders holding 5% or more of the company’s shares
analysts during the year and participate
A shares, B shares, in a number of investor conferences. The
Registered office number number Interest Votes website is updated regularly to include
the latest investor presentations.
LFI a/s Hellerup, Denmark 919,620 2,906,139 37.8% 65.7%
ATP* Hillerød, Denmark - 657,673 6.5% 3.6% Ownership
Total 44.3% 69.2% As at December 31, 2009, two share
holders had notified the company pursu-
* The Danish Labour Market Supplementary Pension.
ant to section 28(a) and (b) of the Danish
Public Companies Act that they hold 5%
or more of the company’s shares.
100
Share price performance
50
As at December 31, 2009, the price
of ALK’s shares was DKK 409 (520 in
0 2008), representing a 21% year-on-year
2005 2006 2007 2008 2009 decline.
Analysts
Corporate governance
The Board of Directors is elected by the are not eligible for election to the Board Directors includes these in its consider
shareholders in general meeting and by of Directors. ations on corporate governance to the
the company’s employees, respectively effect that both the company’s and the
and is ALK’s supreme management. The The Board of Directors is composed in other stakeholders’ interests are safe-
Board of Directors defines the objec- such a way that its directors are able to guarded in the best possible way.
tives, goals and strategies of the com- act independently of special interests.
pany and makes decisions on matters Two of the members elected by the com- General guidelines for the company’s
of major significance or of an unusual pany’s shareholders are also members remuneration of members of the
nature. On behalf of the shareholders, of the Board of Directors of The Lundbeck Board of Directors and the Board of
the Board of Directors furthermore Foundation and LFI a/s. The other mem- Management
supervises the organization and sees bers elected by the shareholders are In accordance with Danish company law,
that the company is managed appropri- independent and have no interest in ALK the annual general meeting of ALK shall
ately and in accordance with legislation other than the interests they may have as adopt general guidelines for incentive
and the articles of association. The shareholders. pay to members of the Board of Direc-
Board of Directors does not participate tors and the Board of Management.
in the day-to-day management of the Guidelines Below is a description of the general
company. In 2005, the NASDAQ OMX Copenhagen principles for the combined remunera-
A/S adopted a set of recommendations tion to the Board of Directors and the
In addition to undertaking the overall on corporate governance, the contents Board of Management adopted at the
management of the company, it is the of which companies are required to annual general meeting of ALK in April
primary responsibility of the Board of consider in accordance with the ‘comply 2008. See the corporate website for ad-
Directors to define the strategic frame- or explain’ principle. The recommenda- ditional details.
work for the activities and action plans of tions were updated in 2008. On the basis
the company and to maintain a construc- of these recommendations, the Board of Board of Directors
tive dialogue with the Board of Manage- Directors of ALK continuously discusses The members of the Board of Directors
ment regarding the implementation of the general implementation of corporate receive a fixed fee and are not offered
the strategies. In addition, the Board of governance. The general principles for any share options, warrants or other
Directors appoints the Board of Manage- the specific recommendations in the incentive plans.
ment, sets out its terms and tasks and reports have been applied in the Board’s
supervises its work and the company’s regular work for a number of years. ALK Board of Management
procedures and responsibilities. meets the recommendations but has General principles
chosen different practices in the following The Board of Directors believes that a
The Board of Directors also functions as areas: combination of fixed and performance-
the audit committee. based compensation to the Board of
• A LK does not, as proposed in the re Management helps ensure that ALK can
The audit committee monitors the finan- commendations, have any guidelines attract and retain key persons. At the
cial reporting process, monitors the ef- on how many directorships a board same time, the Board of Management is
ficiency of the company’s internal control member may hold. What is important given an incentive to create shareholder
system and risk management systems, is each individual member’s capacity, value. The guidelines on remuneration
monitors the statutory audit, and moni- competences and contribution. to the Board of Management contain
tors and verifies the independence of the • The recommendations propose that a fixed framework for the variable pay
auditors. the remuneration paid to Manage- component, thereby safeguarding ALK’s
ment be disclosed in detail. ALK short-term and long-term objectives
The Board of Directors consists of six believes that focus should be on the whilst ensuring that the remuneration
members elected by the company’s total remuneration and any increase or structure does not lead to carelessness,
shareholders at the annual general decrease in it. The remuneration paid unreasonable conduct or acceptance of
meeting and three members elected by to the Board of Directors and the Board unnecessary risk.
the company’s employees. According to of Management is disclosed in the an-
article 9.3 of the articles of association, nual report. Remuneration components
members appointed by the company’s The terms of employment and the remun
shareholders who have attained the age With respect to the other specific recom- eration of the members of the Board of
of 70 at the time of the general meeting mendations in the reports, the Board of Management are agreed specifically
22 Management’s review
between each member of the Board of primarily relate to the fulfilment of ALK’s be lower than the market price of ALK’s
Management and the Board of Direc- budgeted results or the achievement of shares at, or immediately before, the
tors, and the remuneration will normally financial key figures or other measur- date of grant. At December 31, 2009, the
include the following components: able individual performance indicators, five members of the Board of Manage-
whether of a financial or non-financial ment held a total of 91,450 outstanding
a. Fixed salary (‘gross salary’), includ- nature. options exercisable in the period from
ing pension. January 1, 2009 until November 1, 2016.
b. Usual non-pay benefits, such as car, Share options See note 6 to the financial statements for
phone, newspaper, etc. Members of the Board of Management additional details.
c. Cash bonus, see below. are eligible for options. The aim of option
d. Share options, see below. grants is to ensure value creation and No agreement has been made with the
fulfilment of ALK’s long-term objectives. members of the company’s Board of
Cash bonus The option plan is based on shares, and Management for severance pay exceed-
Individual members of the Board of grants may be made annually, usually ing usual severance terms.
Management may receive an annual in connection with the presentation of
bonus not to exceed 30% of their gross the Q3 financial statements. The present Facts on the company’s corporate gov-
salaries for the year. The aim of the cash value at the date of grant of options ernance, including information on annual
bonus is to ensure fulfilment of ALK’s granted in any one year may not exceed general meetings, management, articles
short-term objectives. Bonus grants and 30% of the employee’s gross salary. of association, reporting, remunera-
the amount thereof therefore depend on Normally, options are exercisable no tion and dealings in treasury shares,
the fulfilment of objectives agreed upon earlier than three years after grant, and are available at the company’s website:
for one year at a time. The objectives the exercise price of the options may not www.alk-abello.com/investor.
Management’s review 23
Board of Directors
Statement by Management
The Board of Directors and the Board of Management today cial position, results of operations and cash flows. Furthermore,
considered and adopted the annual report for the financial year the Management’s review gives a true and fair view of develop-
January 1 to December 31, 2009. The annual report is pre- ments in the activities and financial position of the Group and
sented in accordance with the International Financial Reporting describes the significant risks and uncertainties pertaining to
Standards (IFRS) as adopted by the EU and additional Danish the Group.
disclosure requirements for the annual reports of listed com
panies. We recommend that the annual report be adopted by the share-
holders at the annual general meeting.
We consider the accounting policies to be adequate to the effect
that the annual report gives a true and fair view of the Group’s Hørsholm, February 23, 2010
and the Parent Company’s assets, equity and liabilities, finan-
To the shareholders of ALK-Abelló A/S procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of
Report on the consolidated financial statements and the entity’s internal control. An audit also includes evaluating
financial statements the appropriateness of accounting policies used and the rea-
We have audited the consolidated financial statements and sonableness of accounting estimates made by Management, as
financial statements of ALK-Abelló A/S for the financial year well as evaluating the overall presentation of the consolidated
January 1 to December 31, 2009, which comprise the income financial statements and financial statements.
statement, statement of comprehensive income, balance sheet,
statement of changes in equity, cash flow statement and notes, We believe that the audit evidence we have obtained is sufficient
including the accounting policies, for the Group as well as the and appropriate to provide a basis for our audit opinion.
Parent. The consolidated financial statements and financial
statements have been prepared in accordance with Interna- Our audit has not resulted in any qualification.
tional Financial Reporting Standards as adopted by the EU and
additional Danish disclosure requirements for listed companies. Opinion
In our opinion, the consolidated financial statements and
Management’s responsibility for the consolidated financial financial statements give a true and fair view of the Group’s
statements and financial statements and the Parent’s financial position at December 31, 2009,
Management is responsible for the preparation and fair pre and of their financial performance and their cash flows for the
sentation of consolidated financial statements and financial financial year January 1 to December 31, 2009 in accordance
statements in accordance with International Financial Reporting with International Financial Reporting Standards as adopted
Standards as adopted by the EU and additional Danish dis- by the EU and additional Danish disclosure requirements for
closure requirements for listed companies. This responsibility listed companies.
includes: designing, implementing and maintaining internal
control relevant to the preparation and fair presentation of Statement on the management report
consolidated financial statements and financial statements that Management is responsible for preparing a management
are free from material misstatement, whether due to fraud or report that contains a fair review in accordance with the Danish
error, selecting and applying appropriate accounting policies, Financial Statements Act.
and making accounting estimates that are reasonable in the
circumstances. Our audit did not include the management report, but we have
read it pursuant to the Danish Financial Statements Act. We did
Auditor’s responsibility and basis of opinion not perform any procedures other than those performed during
Our responsibility is to express an opinion on these consolidated the audit of the consolidated financial statements and financial
financial statements and financial statements based on our statements.
audit. We conducted our audit in accordance with Danish and
International Standards on Auditing. Those Standards require Based on this, we believe that the disclosures in the manage-
that we comply with ethical requirements and plan and perform ment report are consistent with the consolidated financial state-
the audit to obtain reasonable assurance whether the consoli- ments and financial statements.
dated financial statements and financial statements are free
from material misstatement.
An audit involves performing procedures to obtain audit evi- Copenhagen, February 23, 2010
dence about the amounts and disclosures in the consolidated
financial statements and financial statements. The procedures Deloitte
selected depend on the auditor’s judgement, including the as- Statsautoriseret Revisionsaktieselskab
sessment of the risks of material misstatement of the consoli-
dated financial statements and financial statements, whether
due to fraud or error. In making those risk assessments, the
auditor considers internal control relevant to the entity’s Anders O. Gjelstrup Kirsten Aaskov Mikkelsen
preparation and fair presentation of consolidated financial State Authorised State Authorised
statements and financial statements in order to design audit Public Accountant Public Accountant
26 Fighting the cause of allergy
Fighting the cause of allergy 27
28 Income statement / Statement of comprehensive income
Income statement
Balance sheet
Non-current assets
Intangible assets
- - 14 Goodwill 369 364
18 19 15 Other intangible assets 80 50
18 19 449 414
Tangible assets
193 331 16 Land and buildings 530 300
96 104 17 Plant and machinery 153 128
5 6 18 Other fixtures and equipment 62 61
355 284 19 Property, plant and equipment in progress 349 487
649 725 1,094 976
Other non-currents assets
760 774 20 Investment in affiliates - -
189 264 21 Receivables from affiliates - -
2 20 22 Securities and receivables 22 4
31 23 23 Deferred tax assets 53 91
982 1,081 75 95
1,649 1,825 Total non-current assets 1,618 1,485
Current assets
130 119 24 Inventories 300 292
5 5 25 Trade receivables 228 188
114 98 21 Receivables from affiliates 51 28
- - Income tax receivables 17 43
20 9 25 Other receivables 21 31
5 7 25 Prepayments 29 22
347 230 26 Cash and cash equivalents 389 449
621 468 Total currents assets 1,035 1,053
2,270 2,293 Total assets 2,653 2,538
Balance sheet 31
Equity
101 101 27 Share capital 101 101
1,677 1,723 Other reserves 1,827 1,761
1,778 1,824 Total equity 1,928 1,862
Liabilities
Non-current liabilities
29 28 28 Mortgage debt 28 29
- - 28 Bank loans and financial loans 13 15
1 1 7 Pensions and similar liabilities 77 73
140 140 29 Other provisions 148 142
- - 23 Deferred tax liabilities 1 -
3 - Other payables - 8
173 169 267 267
Current liabilities
1 1 28 Mortgage debt 1 1
- - 28 Bank loans and financial loans 4 4
57 54 30 Trade payables 134 128
154 117 Payables to affiliates - -
- - Income taxes 35 31
107 128 30 Other payables 284 245
319 300 458 409
492 469 Total liabilities 725 676
2,270 2,293 Total equity and liabilities 2,653 2,538
32 Equity
Equity
ALK Group
Hedges of Currency
Share future trans- translation Retained Total other Total
capital actions adjustment earnings reserves equity
Share-based payments - - - 8 8 8
Dividend paid - - - (50) (50) (50)
Other transactions - - - (42) (42) (42)
Equity at December 31, 2009 101 1 (39) 1,865 1,827 1,928
Equity at January 1, 2008 101 (3) (22) 2,036 2,011 2,112
Total comprehensive income - 3 (6) 95 92 92
Share-based payments - - - 10 10 10
Tax related to items recognized directly in equity - - - (1) (1) (1)
Purchase of treasury shares - - - (21) (21) (21)
Dividend paid - - - (330) (330) (330)
Other transactions - - - (342) (342) (342)
Equity at December 31, 2008 101 - (28) 1,789 1,761 1,862
Equity 33
ALK-Abelló A/S
Hedges of
Share future trans- Retained Total other Total
capital actions earnings reserves equity
1 Accounting policies
Acquisitions are accounted for using the Gains or losses on disposal of is considered to belong to the acquired
purchase method, according to which subsidiaries company in question and is translated at
the identifiable assets, liabilities and con- Gains or losses on disposal of subsidiar- the exchange rate at the balance sheet
tingent liabilities of companies acquired ies are stated as the difference between date.
are measured at fair value at the date of the disposal amount and the carrying
acquisition. Non-current assets held for amount of net assets including goodwill Exchange rate differences arising on the
sale are, however, measured at fair value at the date of disposal, accumulated translation of foreign subsidiaries’ open-
less expected costs to sell. foreign exchange adjustments taken di- ing balance sheet items to the exchange
rectly to equity and anticipated disposal rates at the balance sheet date and
Restructuring costs are only recognized costs. The disposal amount is measured on the translation of the income state-
in the take-over balance sheet if they as the fair value of the consideration ments from average exchange rates to
represent a liability to the acquired received. exchange rates at the balance sheet date
company. The tax effect of revaluations is are taken directly to equity. Similarly,
taken into account. Foreign currency translation exchange rate differences arising as a
On initial recognition, transactions result of changes made directly in the
The cost of a company is the fair value of denominated in currencies other than the equity of the foreign subsidiary are also
the consideration paid plus costs directly Group’s functional currency are trans- taken directly to equity.
attributable to the business combination. lated at average exchange rates, which
If the final determination of the consid- are an approximation of the exchange Foreign exchange rate adjustment of
eration is conditional on one or more rates at the transaction date. Receiva- receivables or debt to subsidiaries which
future events, these adjustments are only bles and debt and other monetary items are considered part of the parent com-
recognized in cost if the event in question not settled at the balance sheet date are pany’s overall investment in the subsidi-
is likely to occur and its effect on cost can translated at the closing rate. ary in question are also taken directly
be reliably measured. to equity in the consolidated financial
Exchange rate differences between the statements.
If the fair value of the acquired assets or exchange rate at the date of the trans-
liabilities subsequently proves different action and the exchange rate at the Derivative financial instruments
from the values calculated at the acquisi- date of payment or the balance sheet Derivative financial instruments are
tion date, cost is adjusted for up to 12 date, respectively, are recognized in the measured at fair value on initial recogni-
months after the date of acquisition. income statement under financial items. tion. Subsequently, they are measured at
Property, plant and equipment and fair value at the balance sheet date.
Any excess of the cost of an acquired intangible assets, inventories and other
company over the fair value of the ac- non-monetary assets acquired in foreign Changes in the fair value of derivative
quired assets, liabilities and contingent currency and measured based on histori- financial instruments designated as
liabilities (goodwill) is recognized as an cal cost are translated at the exchange and qualifying for recognition as fair
asset under intangible assets and tested rates at the transaction date. Non- value hedges of a recognized asset or
for impairment at least once a year. If the monetary items revalued at fair value are a recognized liability are recognized in
carrying amount of an asset exceeds its translated at the exchange rates at the the income statement together with any
recoverable amount, the asset is written revaluation date. changes in the value of the hedged asset
down to the lower recoverable amount. or hedged liability.
On recognition in the consolidated finan-
In connection with the transition to IFRS cial statements of subsidiaries whose Changes in the fair value of derivative
in 2005/06 the ALK Group chose to apply financial statements are presented in a financial instruments designated as and
the optional exemption in IFRS 1, under functional currency other than DKK, the qualifying for recognition as effective
which business combinations effected income statements are translated at av- hedges of future transactions are recog-
before September 1, 2004 are not ad- erage exchange rates for the respective nized directly in equity. When the hedged
justed in accordance with the provisions months, unless these deviate materially transactions are realized, cumulative
of IFRS, except that identifiable intangible from the actual exchange rates at the changes are recognized as part of the
assets acquired in business combina- transaction dates. In that case, the actual cost of the transactions in question.
tions are separated from the calculated exchange rates are used. Balance sheet
goodwill and recognized as separate items are translated at the exchange Changes in the fair value of derivative
items under intangible assets. rates at the balance sheet date. Goodwill financial instruments used to hedge net
Notes to the financial statements 37
investments in foreign subsidiaries are expected tax on the taxable income for a/s and its Danish subsidiaries. The tax
recognized directly in equity to the extent the year, adjusted for tax paid on ac- charge for the year is allocated among
that the hedge is effective. On disposal count. the jointly taxed companies in proportion
of the foreign subsidiary in question, the to the taxable incomes of individual com-
cumulative changes are transferred to The current tax charge for the year is cal- panies, taking into account taxes paid.
the income statement. culated based on the tax rates and rules
enacted at the balance sheet date. Discontinued operations
For derivative financial instruments that Discontinued operations are major busi-
do not qualify for hedge accounting, Deferred tax is measured using the ness areas or geographical areas which
changes in fair value are recognized as balance sheet liability method on all tem- have been sold or which are held for sale
financial items in the income statement porary differences between the carrying according to an overall plan.
as they occur. amount and the tax base of assets and
liabilities. However, deferred tax is not The results of discontinued operations
Share-based incentive plans recognized on temporary differences re- are presented as a separate item in the
Share-based incentive plans (equity- lating to the initial recognition of goodwill income statement, consisting of the activ-
settled share-based payments) which or the initial recognition of a transaction, ity’s operating profit/loss after tax and
comprise share option plans and em- apart from business combinations, and any gains or losses on fair value adjust-
ployee share plans are measured at the where the temporary difference existing ments or sale of the related assets.
grant date at fair value and recognized in at the date of initial recognition affects
the income statement under the respec- neither profit/loss for the year nor tax-
tive functions over the vesting period. The able income. Income statement
balancing item is recognized in equity.
Deferred tax is calculated based on the Revenue
The fair value of share options is deter- planned use of each asset and settlement Revenue from the sale of goods for resale
mined using the Black & Scholes-model of each liability, respectively. and manufactured goods is recognized
with the parameters stated in note 6. in the income statement if delivery and
Deferred tax is measured using the tax the transfer of risk to the purchaser have
Share-based incentive plans (cash- rates and tax rules that, based on legisla- taken place.
settled share-based payments) which tion enacted or in reality enacted at the
comprise employee share-like plans balance sheet date, are expected to ap- Revenue is measured as the fair value of
in specific countries are measured at ply in the respective countries when the the consideration received or receivable.
fair value at the grant date and at each deferred tax is expected to crystallize as
subsequent balance sheet date and rec- current tax. Changes in deferred tax as Revenue is measured exclusive of VAT,
ognized in the income statement under a result of changed tax rates or rules are taxes etc. charged on behalf of third
the respective functions over the vesting recognized in the income statement or in parties and less any commissions and
period. The balancing item is recognized equity, depending on where the deferred discounts in connection with sales.
as liabilities. tax was originally recognized.
Cost of sales
Tax Deferred tax assets, including the tax The item comprises cost of sales and
Tax on the profit for the year comprises value of tax loss carry-forwards, are production costs incurred in generat-
the year’s current tax and changes in recognized in the balance sheet at the ing the revenue for the year. Costs for
deferred tax. The tax expense relating to value at which the asset is expected to be raw materials, consumables, goods for
the profit/loss for the year is recognized realized, either through a set-off against resale, production staff and a propor-
in the income statement, and the tax deferred tax liabilities or as net assets to tion of production overheads, including
expenses relating to items recognized be offset against future positive taxable maintenance and depreciation, amorti-
directly in equity is recognized in equity. income. At each balance sheet date, it is zation and impairment of property, plant
Exchange rate adjustments of deferred reassessed whether it is likely that there and equipment and intangible assets
tax are recognized as part of the adjust- will be sufficient future taxable income for used in production as well as operation,
ment of deferred tax for the year. the deferred tax asset to be utilized. administration and management of fac-
tories are recognized in cost of sales and
Current tax payable and receivable is The parent company is taxed jointly with production costs. In addition, the costs
recognized in the balance sheet as the the company’s principal shareholder, LFI and write-down to net realizable value
38 Notes to the financial statements
of obsolete and slow-moving goods are secondary nature relative to the principal Balance sheet
recognized. activities of the ALK Group.
Goodwill
Research and development expenses The item includes up-front payments, On initial recognition, goodwill is meas-
The item comprises research and devel- milestone payments and other revenue ured and recognized as the excess of
opment expenses, including expenses in- in connection with research and develop- the cost of the acquired company over
curred for wages and salaries, amortiza- ment partnerships and the sale of intel- the fair value of the acquired assets,
tion and other overheads as well as costs lectual property rights. These revenues liabilities and contingent liabilities, as
relating to research partnerships. are recognized when it is probable that described under Business Combinations.
future economic benefits will flow to In addition, goodwill on acquisition of
Research expenses are recognized in the the ALK Group and these benefits can investments in subsidiaries from minority
income statement when incurred. be measured reliably. Non-refundable interests is recognized.
payments that are not attributable to
Due to the long development periods and subsequent research and development On recognition of goodwill, the goodwill
significant uncertainties in relation to the activities are recognized when the relat- amount is allocated to those of the ALK
development of new products, including ed right is obtained, whereas payments Group’s activities that generate separate
risk regarding clinical trials and regula- attributable to subsequent research and cash flows (cash-generating units). The
tory approvals, it is the assessment that development activities are recognized determination of cash-generating units is
most of the ALK Group’s development over the term of the activities. When based on the ALK Group’s management
expenses do not meet the capitaliza- combined contracts are entered into, the structure and internal financial manage-
tion criteria in IAS 38, Intangible Assets. elements of the contracts are identified ment and reporting.
Consequently, development expenses and assessed separately for accounting
are generally recognized in the income purposes. Goodwill is not amortized, but is tested
statement when incurred. Development for impairment at least once a year, as
expenses relating to individual minor de- Financial items described below.
velopment projects running for short-term Financial items comprise interest receiv-
periods and subject to limited risk are able and interest payable, the interest Intangible assets
capitalized under other intangible assets. element of finance lease payments, Acquired intellectual property rights in
realized and unrealized gains and losses the form of patents, brands, licenses,
Sales and marketing expenses on securities, cash and cash equivalents, software, customer base and similar
The item comprises selling and market- liabilities and foreign currency transac- rights are measured at cost less accumu-
ing expenses, including salaries and ex- tions, mortgage amortization premium/ lated amortization and impairment.
penses relating to sales staff, advertising allowance etc. and supplements/allow-
and exhibitions, depreciation, amortiza- ances under the on-account tax scheme. Interest expenses on loans to finance
tion and impairment losses on the prop- the manufacture of intangible assets
erty, plant and equipment and intangible Interest income and expenses are ac- is included in cost if they relate to the
assets used in the sales and marketing crued based on the principal and the ef- production period. Other borrowing costs
process as well as other indirect costs. fective rate of interest. The effective rate are taken to the income statement.
of interest is the discount rate to be used
Administrative expenses on discounting expected future payments The cost of software includes costs of
The item comprises expenses incurred in relation to the financial asset or the planning work, including direct salaries.
for management and administration, in- financial liability so that their present val-
cluding expenses for administrative staff ue corresponds to the carrying amount of Such acquired intellectual property rights
and management, office expenses and the asset or liability, respectively. are amortized on a straight-line basis
depreciation, amortization and impair- over the contract period, not exceeding
ment losses on the property, plant and Dividends from investments in subsidiar- 10 years. If the actual useful life is shorter
equipment and intangible assets used in ies are recognized in the parent company than either the remaining life or the con-
administration. financial statements when the right to tract period, the asset is amortized over
the dividend finally vests, typically at this shorter useful life.
Other operating income and expenses the date of the company’s approval in
Other operating income and expenses general meeting of the dividend of the Acquired intellectual property rights are
comprise income and expenses of a company in question. written down to their recoverable amount
Notes to the financial statements 39
where this is lower than the carrying The cost of an asset is divided into the time value of money as well as risks
amount, as described below. smaller components that are depreci- that are specific to the asset or the cash-
ated separately if such components have generating unit and which have not been
Individual minor development projects different useful lives. taken into account in the estimated future
running for short-term periods and sub- cash flows.
ject to limited risk are capitalized under Assets are depreciated on a straight-line
other intangible assets as described un- basis over their estimated useful lives as If the recoverable amount of the asset or
der “Research and development costs” follows: the cash-generating unit is lower than the
and are measured at cost less accumu- carrying amount, the carrying amount is
lated amortization and impairment. Buildings 25-50 years written down to the recoverable amount.
Plant and machinery 5-10 years For cash-generating units, the write-
Intangible assets with indeterminable Other fixtures and equipment 5-10 years down is allocated in such a way that
useful lives are not amortized, but are goodwill amounts are written down first,
tested for impairment at least once a Depreciation methods, useful lives and re- and any remaining need for write-down
year. To the extent that the carrying sidual values are reassessed once a year. is allocated to other assets in the unit,
amount of the assets exceeds the recov- although no individual assets are writ-
erable amount, the assets are written Property, plant and equipment are writ- ten down to a value lower than their fair
down to this lower amount, as described ten down to the recoverable amount, if value less costs to sell.
below. lower, cf. below.
Impairment write-downs are recognized
Tangible assets Impairment of property, plant and in the income statement. If write-downs
Land and buildings, plant and machin- equipment and intangible assets are subsequently reversed as a result of
ery and other fixtures and equipment The carrying amounts of property, plant changes in the assumptions on which the
are measured at cost less accumulated and equipment and intangible as- calculation of the recoverable amount is
depreciation and impairment. Land is not sets with determinable useful lives are based, the carrying amount of the asset
depreciated. reviewed at the balance sheet date to or the cash-generating unit is increased
determine whether there are any indica- to the adjusted recoverable amount, not,
Cost comprises the purchase price and tions of impairment. If such indications however, exceeding the carrying amount
any costs directly attributable to the are found, the recoverable amount of that the asset or cash-generating unit
acquisition and any preparation costs the asset is calculated to determine any would have had, had the write-down not
incurred until the date when the asset is need for an impairment write-down and, been made. Impairment of goodwill is
available for use. if so, the amount of the write-down. For not reversed.
intangible assets with indeterminable
The cost of assets held under finance useful lives and goodwill, the recoverable Investments in subsidiaries in the
leases is determined as the lower of the amount is calculated annually, regard- financial statements of the parent
fair value of the assets and the present less of whether any indications of impair- company
value of future minimum lease payments. ment have been found. Investments in subsidiaries are meas-
ured at cost.
Interest expenses on loans to finance If the asset does not generate any cash
the manufacture of property, plant and flows independently of other assets, the Where the recoverable amount of the
equipment are included in cost if they recoverable amount is calculated for investments is lower than cost, the invest-
relate to the production period. Other the smallest cash-generating unit that ments are written down to this lower value.
borrowing costs are taken to the income includes the asset.
statement. Dividend from subsidiaries is recognized
The recoverable amount is calculated as in the income statement. In the event of
The depreciation base is cost less the the higher of the fair value less costs to indications of impairment, an impair-
estimated residual value at the end of the sell and the value in use of the asset or ment test is performed of investments in
useful life. The residual value, estimated the cash-generating unit, respectively. In subsidiaries.
at the acquisition date and reassessed determining the value in use, the estimat-
annually, is determined as the amount ed future cash flows are discounted to Other long-term financial assets
the company expects to obtain for the their present value, using a discount rate Other securities and receivables that
asset less costs of disposal. reflecting current market assessments of are accounted for as long-term finan-
40 Notes to the financial statements
cial assets are measured at fair value. and dividends on treasury shares are gains or losses occur. These gains and
Adjustments are recognized directly in recognized directly in retained earnings losses are only recognized if the accumu-
equity. under equity. lated gains and losses at the beginning
of a financial year exceed the higher
Inventories Pension liabilities etc. numerical value of 10% of the pension
Inventories are measured at cost de- The ALK Group has entered into pension liabilities or 10% of the fair value of plan
termined under the FIFO method or net agreements and similar agreements with assets (the corridor method). If this is the
realizable value where this is lower. some of the Group’s employees. case, the excess amount is recognized in
the income statement, distributed on the
Cost comprises raw materials, goods for In respect of defined contribution plans, expected remaining average working life
resale, consumables and direct payroll the Group pays in fixed contributions to of the employees covered by the plan.
costs as well as fixed and variable pro- independent pension funds etc. The con-
duction overheads. Variable production tributions are recognized in the income If the pension plan represents a net as-
overheads comprise indirect materi- statement during the period in which the set, the asset is only recognized to the
als and payroll costs and are allocated employee renders the related service. extent that it does not exceed the sum of
based on predetermined costs of the Payments due are recognized as a liabil- unrecognized actuarial losses, unrecog-
goods actually produced. Fixed produc- ity in the balance sheet. nized past service costs and the present
tion overheads comprise maintenance value of any refunds from the plan or
of and depreciation on the machines, In respect of defined benefit plans, the reductions in future contributions to the
factory buildings and equipment used in Group is required to pay an agreed ben- plan.
the manufacturing process as well as the efit in connection with the retirement of
cost of factory management and admin- the employees covered by the plan, e.g. If the benefits relating to the employees’
istration. Fixed production overheads are in the form of a fixed amount or a percent- service in prior periods change, this
allocated based on the normal capacity age of the salary at retirement. results in a change to the actuarial net
of the production plant. present value which is considered a past
For defined benefit plans, an annual service cost. If the employees covered by
The net realizable value of inventories is actuarial assessment is made of the net the plan have already earned the right
calculated as the expected selling price present value of future benefits to which to the changed benefits, the change is
less completion costs and costs incurred the employees have earned the right made in the income statement immedi-
in making the sale. through their past service for the Group ately. Otherwise, the change is recog-
and which will have to be paid under the nized in the income statement over the
Receivables plan. The Projected Unit Credit Method is period during which the employees earn
On initial recognition, receivables are applied to determine value in use. the right to the benefits.
measured at fair value, and subse-
quently they are measured at amortized The net present value is calculated based In connection with the transition to IFRS
cost. Receivables are written down for on assumptions of the future develop- in 2005/06 the ALK Group chose to apply
anticipated losses. ments of salary, interest, inflation, mor- the optional exemption in IFRS 1, under
tality and disability rates. which actuarial gains and losses accord-
Prepayments ing to the corridor method are stated as
Prepayments are recognized as an asset The net present value of pension liabili- a net loss at September 1, 2004, which is
and comprise incurred costs relating ties is recognized in the balance sheet, reduced to nil by increasing the pension
to subsequent financial years. Prepay- after deduction of the fair value of any as- provision and adjusting equity accord-
ments are measured at cost. sets attached to the plan, as either plan ingly in the opening balance sheet.
assets or pension liabilities, depending
Dividend on whether the net amount is an asset or Provisions
Dividend is recognized as a liability when a liability, as described below. Provisions are recognized when, as a
adopted by the shareholders at the an- consequence of a past event during the
nual general meeting. If the assumptions made with respect to financial year or previous years, the
discount factor, inflation, mortality and Group has a legal or constructive obliga-
Treasury shares disability are changed, or if there is a tion, and it is likely that settlement of the
Acquisition and sales sums arising on discrepancy between the expected and obligation will require an outflow of the
the purchase and sale of treasury shares realized return on plan assets, actuarial company’s financial resources.
Notes to the financial statements 41
Provisions are measured as the best value. The liabilities are subsequently share capital and related costs as well
estimate of the costs required to settle measured at amortized cost. as the raising and repayment of loans,
the obligations at the balance sheet date. instalments on interest-bearing debt, ac-
Provisions with an expected term of more Deferred income quisition of treasury shares and payment
than a year after the balance sheet date Deferred income comprises income of dividends.
are measured at present value. received relating to subsequent financial
years. Deferred income is measured at Cash flows in currencies other than the
In connection with a planned restructur- cost. functional currency are recognized in
ing of the Group, provision is made only the cash flow statement using average
for liabilities relating to restructurings exchange rates for the individual months
that at the balance sheet date have Other accounting information if these are a reasonable approxima-
been set out in a specific plan and where tion of the actual exchange rates at the
those affected have been informed of the Cash flow statement transaction dates. If this is not the case,
overall plan. The cash flow statement of the Group and the actual exchange rates for the specific
the parent company is presented using days in questions are used.
Mortgage debt the indirect method and shows cash flows
Mortgage debt is recognized on the from operating, investing and financ- Cash and cash equivalents comprise
raising of a loan at cost, equalling fair ing activities as well as cash and cash cash and short-term securities subject
value of the proceeds received, net of equivalents at the beginning and the end to an insignificant risk of changes in
transaction costs incurred. Subsequently, of the financial year. value less any overdraft facilities that
mortgage debt is measured at amortized are an integral part of the Group’s cash
cost. The cash effect of acquisitions and management.
divestments is shown separately under
Lease liabilities cash flows from investing activities. In the Segment reporting
Lease liabilities regarding assets held cash flow statement, cash flows concern- Based on the internal reporting used
under finance leases are recognized in ing acquired companies are recognized by the Board of Management to assess
the balance sheet as liabilities and meas- from the date of acquisition, while cash the results of operations and allocation
ured at the inception of the lease at the flows concerning divested companies are of resources, the company has identi-
lower of the fair value of the leased asset recognized until the date of divestment. fied one operating segment “Allergy
and the present value of future lease pay- treatment”, which is in accordance with
ments. Cash flows from operating activities are the way the activities are organized and
stated as operating profit, adjusted for managed.
On subsequent recognition, lease li- non-cash operating items and changes in
abilities are measured at amortized working capital, less the income tax paid In addition, the disclosures in the finan-
cost. The difference between the present during the year attributable to operating cial statements include a breakdown of
value and the nominal value of lease activities. revenue by product line and a geographi-
payments is recognized in the income cal breakdown of revenue and non-cur-
statement over the term of the lease as Cash flows from investing activities rent assets.
a finance charge. comprise payments in connection with
acquisition and divestment of companies Definitions and ratios
Lease payments regarding operating and financial assets as well as purchase, The key ratios have been calculated in
leases are recognized in the income development, improvement and sale of accordance with “Recommendations and
statement on a straight-line basis over intangible assets and property, plant Financial Ratios 2005” issued by the Dan-
the term of the lease. and equipment. Also recognized are cash ish Association of Financial Analysts.
flows from assets held under finance
Other financial liabilities lease in the form of lease payments made. Key ratios and definitions are shown on
Other financial liabilities, including bank the covers of the annual report and page
and financial loans and trade payables, Cash flows from financing activities com- 72, respectively.
are on initial recognition measured at fair prise changes to the parent company’s
42 Notes to the financial statements
Based on the internal reporting which Management uses to assess profit and allocation of resources, the company has identified one business area
“allergy treatment” which is in compliance with the organization and management of the activities. Even though revenue within the business area
“allergy treatment” can be divided by product lines and markets, the main part of the activities within production, research and development, sales
and marketing and administration are shared by the ALK Group as a whole.
ALK Group
Non-current assets by market
The ALK Group’s non-current assets except non-current financial assets are distributed among
the following geographical markets:
Dec. 31 Dec. 31
2009 2008
4 Staff costs
In 2009, ALK took over the activities of its former distributor in Germany, ThemoCARE GmbH, with a view to strengthening ALK’s market position and
presence in the German market. The acquisition was made with effect from October 1, 2009, through a newly established German subsidiary, which
takes over the name ThemoCARE GmbH.
The transaction was accounted for using the purchase method.
In 2008, ALK took over the allergy vaccination activities of its former distributor in Canada, Western Allergy Services Ltd. with a view to strengthening
ALK’s global presence and ensuring continuing growth in the Canadian market. The acquisition was made through ALK’s Canadian subsidiary, ALK-
Abelló Pharmaceuticals Inc.
The transaction was accounted for using the purchase method.
Notes to the financial statements 45
After recognition of identifiable assets and liabilities at fair value, goodwill related to the acquisition in 2009 amounts to DKK 4 million (2008: DKK 7 mil-
lion). The balance represents the value of the assets that could not be measured reliably at fair value, future growth potential and the value of acquired
employees. Part of the purchase price is contingent and is recognized as provisions.
Out of the ALK Group’s revenue and profit for 2009 of DKK 1,935 million (2008: DKK 1,784 million) and DKK 118 million (2008: DKK 95 million), respec-
tively, a profit of DKK 9 million (2008: DKK 0 million) and DKK 3 million (2008: DKK (1) million), respectively was generated by the acquired operations
after the acqusition date.
The ALK Group’s revenue and profit made up pro forma as if ThemoCARE GmbH was acquired on January 1, 2009, amounts to DKK 1,955 million and
DKK 122 million, respectively. Management’s assessment is that a fair value adjustment as of January 1, 2009, would have been the same as the fair
value adjustment as of the acquisition date.
Information on acquired activities in 2008 stated as if they had been owned for the entire year of acquisition is not possible due to differences in the
financial years of the acquired activities and the ALK Group.
46 Notes to the financial statements
6 Share-based payments
Outstanding options at January 1, 2008 48,750 74,525 123,275 914
Additions 19,100 28,500 47,600 556
Cancellations - (2,050) (2,050) 900
Outstanding options at December 31, 2008 67,850 100,975 168,825 789
2009 2008
Average remaining life of outstanding share options at year end (years) 1.2 1.3
Exercise prices for outstanding share options at year end (DKK) 501-1,020 543-1,025
The assumptions for the calculation of the market price of share options at the grant date are as follows:
2009 2008
plan plan
Employee shares
In August 2006, it was decided to offer employee shares (free shares) to the ALK Group’s employees. In certain countries, the plan was structured as a
share-like plan, but with cash payments calculated based on the price performance of the company’s share. For this part of the plan, the cost is accrued
over the vesting period of three years as from August 31, 2006. The costs is calculated on the basis of the assessed number of employees expected to
meet the criteria and the officially quoted price of the company’s shares. The cost in 2009 was less than DKK 1 million (2008: less than DKK 1 million).
The ALK Group has entered into defined contribution plans as well as defined benefit plans.
In defined contribution plans, the employer is obliged to pay a certain contribution to a pension fund or the like but bears no risks regarding the future
development in interest, inflation, mortality, disability rates, etc. regarding the amount to be paid to the employee.
In defined benefit plans, the employer is obliged to make a certain payment when a pre-agreed event occurs. The employer bears the risks regarding
the future development in interest, inflation, mortality, disability rates, etc. regarding the amount to be paid to the employee.
1 1 Pensions 62 57
- - Similar liabilities 15 16
1 1 Total 77 73
25 27 Costs related to defined contribution plans 50 47
Defined benefit plans
- - Pension costs in the current financial year 2 3
- - Calculated interest on the obligations 3 3
- - Costs releted to defined benefit plans 5 6
1 1 Provisions for defined benefit plans at beginning of year 57 51
- - Recognized in the current financial year 5 6
1 1 Obligations, defined benefit plan at year end 62 57
The pension obligations are specified as follows:
1 1 Present value of unfunded pension obligations 68 51
- - Unrecognized actuarial profit / (loss) (6) 6
1 1 Total 62 57
The latest actuarial calculation of the pension obligations related to the defined benefit plans was made at December 31, 2009.
The actuarial calculations at the balance sheet date are based on the following factors:
2009 2008
Other operating income and other operating expenses relate to income and expenses of a secundary nature in relation to ALK’s main activities. The
item includes income and expenses amounting to net DKK 33 million (2008: DKK 28 million) in relation to an agreement with Merck (former Schering-
Plough) on a strategic alliance to develop and commercialize ALK’s tablet-based allergy vaccines against grass pollen allergy (GRAZAX®), house dust
mite allergy and ragweed allergy for the North American markets.
Notes to the financial statements 51
10 Financial income
11 Financial expenses
ALK Group
2009 2008
Amounts in DKKm
The calculation of earnings per share is based on the following:
Net profit 118 95
Number in units
Average number of issued shares 10,128,360 10,128,360
Average number of treasury shares 168,975 134,561
Average number of shares used for calculation of earnings per share 9,959,385 9,993,799
Average dilutive effect of outstanding share options 233 688
Average number of shares used for calculation of diluted earnings per share 9,959,618 9,994,487
Amounts in DKK
Earnings per share (EPS) 11.85 9.51
Earnings per share (DEPS), diluted 11.85 9.51
14 Goodwill
Amounts in DKKm
Cost at beginnig of year 384 396
Currency adjustments - 1
Additions 4 7
Adjustments - (20)
Cost at year end 388 384
Amortization and impairment at beginning of year 20 20
Currency adjustments (1) -
Amortization and impairment at year end 19 20
Carrying amount at year end 369 364
The adjustment in 2008 is related to a change in the cost of a subsidiary acquired in 2005.
Goodwill has been subjected to an impairment test, which revealed no need for an impairment write-down. In the calculation of the value in use of cash-
generating units, the cash flows in the latest, Management-approved budget for the coming financial year have been used. For financial years after the
budget period, the cash flows in the most recent budget period have been extrapolated adjusted for a growth factor of 2% during the terminal period.
The growth rate applied does not exceed the average expected long-term growth rate for the markets in question.
Software
113 119 Cost at beginning of year 174 168
3 3 Additions 4 3
(1) (4) Disposals (5) (1)
4 9 Transfer to/from other groups 10 4
119 127 Cost at year end 183 174
92 103 Amortization and impairment at beginning of year 148 132
12 10 Amortization and impairment for the year 15 17
(1) (3) Amortization and impairment on disposals (3) (1)
103 110 Amortization and impairment at year end 160 148
20 Investments in affiliates
2009
Carrying amount at beginning of year 8 42 14 27 91
Transfer from income taxes at beginning of year - - (8) - (8)
Recognized in the income statement, net (25) (7) (1) 2 (31)
Recognized in equity, net - - - - -
Carrying amount at year end (17) 35 5 29 52
Deferred tax at year end consists of deferred tax assets of DKK 53 million and deferred tax liabilities of DKK 1 million.
2008
Carrying amount at beginning of year 26 29 12 28 95
Recognized in the income statement, net (18) 14 2 (1) (3)
Recognized in equity, net - (1) - - (1)
Carrying amount at year end 8 42 14 27 91
ALK-Abelló A/S
2009
Carrying amount at beginning of year 12 (1) (7) 27 31
Recognized in the income statement, net (19) 2 9 - (8)
Recognized in equity, net - - - - -
Carrying amount at year end (7) 1 2 27 23
2008
Carrying amount at beginning of year 29 2 (6) 27 52
Recognized in the income statement, net (17) (2) (1) - (20)
Recognized in equity, net - (1) - - (1)
Carrying amount at year end 12 (1) (7) 27 31
Deferred tax in both ALK-Abelló A/S and the ALK Group is recognized as tax assets in the balance sheet, since it is assessed to be probable that suf-
ficient future taxable income will be generated for the deferred tax asset to be utilized. Deferred tax in Denmark is recognized at a tax rate of 25%.
ALK-Abelló A/S is jointly taxed with LFI a/s.
58 Notes to the financial statements
24 Inventories
27 Share capital
Effective Carrying
Fixed/ interest amount Fair value
Currency Expiry date Floating rate % DKKm DKKm
Effective Carrying
Fixed/ interest amount Fair value
Currency Expiry date Floating rate % DKKm DKKm
29 Other provisions
31 Treasury shares
131,432 168,975 Treasury shares at beginning of year (B-shares), units 168,975 131,432
37,543 - Purchase of treasury shares, units - 37,543
168,975 168,975 Treasury shares at year end (B-shares), units 168,975 168,975
1.7% 1.7% Proportion of share capital at year end 1.7% 1.7%
1.7 1.7 Nominal value at year end 1.7 1.7
86 69 Market value at year end 69 86
According to a resolution passed by the company in general meeting,
the company is allowed to purchase treasury shares, equal to 10% of the
share capital. The company has purchased treasury shares in connection
with the issuance of share options and employee shares.
35 Exchange rate, interest rate and credit exposure and the use of derivative financial instruments
December 31, 2008
DKK 321 62 (294) - 89
USD 10 29 (68) - (29)
EUR 96 199 (276) - 19
GBP - 13 (23) - (10)
SEK 8 6 (8) - 6
Other 14 7 (7) - 14
Total 449 316 (676) - 89
Notes to the financial statements 65
35 Exchange rate, interest rate and credit exposure and the use of derivative financial instruments (continued)
ALK-Abelló A/S
December 31, 2008
DKK 314 56 (287) - 83
USD (3) 143 (16) - 124
EUR 33 94 (165) - (38)
GBP - 13 (15) - (2)
SEK - - (3) - (3)
Other 3 29 (6) - 26
Total 347 335 (492) - 190
At December 31, 2009, the fair value of derivative financial instruments entered into to hedge recognized financial assets and liabilities against
exchange rate exposure totalled DKK 0 million (2008: DKK 0 million) for the ALK Group and DKK 0 million (2008:DKK 0 million) for ALK-Abelló A/S. The
fair value of the derivative financial instruments is recognized under other payables/other receivables and set off in the income statement against
exchange rate adjustments of the hedged assets and liabilities.
66 Notes to the financial statements
35 Exchange rate, interest rate and credit exposure and the use of derivative financial instruments (continued)
December 31, 2008
Forward exchange contracts, USD 1-2 (26) 1 1
Currency options, USD 1-3 (39) - -
Currency options, GBP 1 (11) (1) (1)
Total (76) - -
ALK-Abelló A/S
35 Exchange rate, interest rate and credit exposure and the use of derivative financial instruments (continued)
December 31, 2008
Securities and receivables - - 4 4 -
Trade receivables 188 - - 188 -
Other receivables 124 - - 124 -
Cash and cash equivalents 449 - - 449 309 2.7-6.7
Financial assets 761 - 4 765 309
35 Exchange rate, interest rate and credit exposure and the use of derivative financial instruments (continued)
ALK-Abelló A/S
December 31, 2008
Securities and receivables - - 2 2 -
Trade receivables 5 - - 5 -
Other receivables 139 189 - 328 -
Cash and cash equivalents 347 - - 347 290 6.2-6.7
Financial assets 491 189 2 682 290
Mortgage debt, bank loans and financial loans 1 6 23 30 30 4.3
Trade payables 57 - - 57 -
Other financial liabilities 171 93 - 264 -
Financial liabilities 229 99 23 351 30
*) Effective interest rate of fixed interest-bearing financial assets and financial liabilities.
Notes to the financial statements 69
35 Exchange rate, interest rate and credit exposure and the use of derivative financial instruments (continued)
Credit exposure
The ALK Group’s primary credit exposure is related to trade receivables and cash and cash equivalents. The ALK Group has no major exposure relating
to any one customer or business partner. According to the ALK Group’s policy for assuming credit exposure, all customers and business partners are
credit rated regularly.
Embedded derivative financial instruments
The ALK Group has made a systematic review of contracts that might contain terms that would make the contract or parts thereof a derivative financial
instrument. The review did not lead to recognition of derivative financial instruments relating to the contracts.
Categories of financial instruments
ALK-Abelló A/S ALK Group
2008 2009 Note Amounts in DKKm 2009 2008
36 Related parties
December 31, 2009 (wholly owned unless otherwise stated). Nominal capital in 1,000.
Denmark Switzerland
ALK-Abelló A/S DKK 101,284 ALK-Abelló AG CHF 100
CVR no. 63 71 79 16 Volketswil
Hørsholm
ALK AG
ALK-Abelló Nordic A/S DKK 500 Volketswil CHF 1,000
CVR no. 31 50 12 96
Hørsholm Netherlands
Definitions
Invested capital Intangible assets, tangible assets, inventories and current receivables reduced by liabilities
except for mortgage debt, bank loans and financial loans
Net asset value per share Equity at end of period / Number of shares at end of period
ROAIC – % Return on average invested capital (Operating profit x 100 / Average invested capital)
Pay-out ratio – % Proposed dividend x 100 / Net profit for the year
Earnings per share (EPS) Net profit/(loss) for period / Average number of outstanding shares
Cash flow per share (CFPS) Cash flow from operating activities / Average number of outstanding shares
Key figures are calculated in accordance with “Recommendations and Ratios 2005” issued by the Danish Society of Financial Ana-
lysts.
Financial highlights and key ratios by the quarter
for the ALK Group
Income statement
Revenue 1,935 542 466 434 493
Cost of sales 587 159 142 152 134
Research and development expenses 349 105 82 81 81
Sales and marketing expenses 672 174 159 173 166
Administrative expenses 188 55 46 43 44
Net other operating income/
(other operating expenses) 36 9 9 9 9
Operating profit/(loss) (EBIT) 175 58 46 (6) 77
Net financial items 15 - (1) 4 12
Profit/(loss) before tax (EBT) 190 58 45 (2) 89
Net profit/(loss) 118 36 28 (1) 55
Operating profit before depreciation
(EBITDA) 260 84 66 14 96
Average number of employees 1,513 1,545 1,516 1,494 1,491
Revenue by market:
Northern Europe 394 100 109 100 85
Central Europe 793 230 196 170 197
Southern Europe 542 160 111 114 157
Other markets 206 52 50 50 54
Revenue by product line:
SCIT 928 262 230 195 241
SLIT-droplets 573 172 118 125 158
SLIT-tablets 133 39 29 32 33
Other products 301 69 89 82 61
Growth in revenue by product line – %:
SCIT 7 4 6 5 15
SLIT-droplets 9 16 6 - 10
SLIT-tablets 53 63 53 60 38
Vaccines, total 10 11 9 6 15
Other products (1) 36 (2) (14) (10)
Total 8 14 7 2 11
Balance sheet
Total assets 2,653 2,653 2,578 2,580 2,640
Invested capital 1,510 1,510 1,452 1,383 1,403
Equity 1,928 1,928 1,882 1,863 1,930
Cash flow and investments
Depreciation, amortization and impairment 85 26 20 20 19
Cash flow from operating activities 260 124 (6) 36 106
Cash flow from investing activities (258) (99) (37) (39) (83)
– of which investment in tangible assets (187) (67) (35) (26) (59)
Free cash flow 2 25 (43) (3) 23
Information on shares
Share capital 101 101 101 101 101
Shares in thousands of DKK 10 each 10,128 10,128 10,128 10,128 10,128
Share price, at year end – DKK 409 409 474 415 293
Net asset value per share – DKK 191 191 186 184 191
Key figures
Gross margin – % 70 71 70 65 73
EBIT margin – % 9 11 10 (1) 16
Earnings per share (EPS) - DKK 11.85 3.61 2.81 (0.10) 5.52
Earnings per share (DEPS), diluted – DKK 11.85 3.61 2.81 (0.10) 5.52
Cash flow per share (CFPS) – DKK 26.11 12.45 (0.60) 3.61 10.64
Share price/Net asset value 2.1 2.1 2.5 2.3 1.5
Definitions: see page 72
Graphic production: meyer & bukdahl as
ALK · Bøge Allé 6-8 · DK–2970 Hørsholm, Denmark · CVR no. 63 71 79 16 · Tel. +45 45 74 75 76 · www.alk-abello.com