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ALK-Abelló

Quarterly Report Aug 16, 2011

3351_ir_2011-08-16_c1b5923c-d382-46d3-beda-d2a17522164e.pdf

Quarterly Report

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TRANSLATION Company release No. 14/2011

Six-month interim report (Q2) 2011 (unaudited)

Performance for the period

(Comparative figures for the same period of last year are shown in brackets / sales growth is measured in local currencies)

In order to give a more true and fair view of the revenue and cost development, ALK has decided to change the presentation of certain income in the financial statements. This means that licence income and other revenues from licence agreements are now presented as revenue. Previously, these revenues were presented as other operating income. Comparative figures have been restated to reflect the new presentation of the financial statements. The change has no impact on ALK's earnings.

The growth in sales and earnings in the first six months was satisfactory and in line with expectations:

  • Total revenue increased by 20% to DKK 1,258 million (1,052).
  • Revenues from partners were DKK 184 million (17).
  • Vaccine sales grew by 8%. Adjusted for political austerity measures in Germany, the growth rate was 14%.
  • The sales growth was driven in particular by the development in France, Spain, the Netherlands and North America.
  • Operating profit (EBITDA) increased by 88% to DKK 285 million (152).
  • Profit for H1 was DKK 140 million (83).
  • Free cash flow was DKK 241 million (an outflow of 4), and cash and cash equivalents totalled DKK 433 million after distribution of ordinary dividends of DKK 50 million.

In addition, ALK has made significant business progress in a number of areas in recent months:

  • ALK has announced successful outcomes of two pivotal clinical Phase III studies with its new ragweed allergy immunotherapy tablet (AIT). Both studies met their primary efficacy endpoints and the efficacy results were consistent between the two studies.
  • ALK's partner in the USA, Merck, submitted a registration application for GRAZAX® in Canada. This event triggered a milestone payment of USD 5 million from Merck to ALK.
  • Merck has initiated an additional clinical study with GRAZAX® in order to provide as robust a submission package as possible. Merck will continue to work with the FDA regarding the registration process in the USA.
  • ALK has entered into a license agreement regarding development and marketing of a new diagnostic product for penicillin allergy with the US company AllerQuest.

Outlook for 2011

For the 2011 financial year, ALK still expects growth in sales of allergy vaccines of 5% measured in local currencies. Revenue, including revenues from the company's partners, is expected to increase to approximately DKK 2.3 billion. Revenue is affected by the phasing-out of the inlicensed adrenaline product and the subsequent launch of ALK's own adrenaline pen, Jext® . In addition, total revenue will be positively affected by revenues from the company's partners. In June, expectations for operating profit (EBITDA) were adjusted upwards to DKK 385 million as a consequence of the submission of the registration application for GRAZAX® in Canada. ALK continues to expect EBITDA for 2011 to be DKK 385 million (287), corresponding to a growth rate of 34%.

Hørsholm, 16 August 2011

ALK-Abelló A/S

Contact:

Jens Bager, President and CEO, tel +45 4574 7576.

ALK is holding a conference call for analysts and investors today at 3.30 p.m. (CET) at which Jens Bager, President and CEO, and Flemming Pedersen, CFO, will review the results. Participants in the conference call are kindly requested to call in before 3.25 p.m. (CET). Danish participants should call in on tel. +45 7014 0453 and international participants should call in on tel. +44 207 108 63 03. The conference call will also be webcast on our website, www.alk-abello.com/investor, where the related presentation will be available shortly before the conference call begins.

FINANCIAL HIGHLIGHTS AND KEY RATIOS FOR THE ALK GROUP (unaudited)

Restated Restated
H1 H1 Full year
Amounts in DKKm 2011 2010 2010
Income statement
Revenue 1,258 1,052 2,159
Operating profit (EBIT)
Net financial items
235
(5)
108
26
192
15
Profit before tax (EBT) 230 134 207
Net profit 140 83 128
Operating profit before depreciation and amortisation (EBITDA) 285 152 287
Average number of employees 1,710 1,563 1,612
Balance sheet
Total assets 2,945 2,680 2,830
Invested capital 1,605 1,649 1,723
Equity 2,090 1,991 2,018
Cash flow and investments
Depreciation, amortisation and impairment 50 44 95
Cash flow from operating activities 287 67 274
Cash flow from investing activities (46) (71) (345)
- of which investment in tangible assets (35) (67) (138)
- of which acquisitions - - (178)
Free cash flow 241 (4) (71)
Information on shares
Share capital 101 101 101
Shares in thousands of DKK 10 each 10,128 10,128 10,128
Share price, end of period – DKK 314 339 322
Net asset value per share – DKK 206 197 200
Key figures
Gross margin – % 74 71 70
EBITDA margin – % 23 14 13
Earnings per share (EPS) – DKK 14.14 8.37 12.91
Earnings per share (DEPS), diluted – DKK 14.14 8.37 12.91
Cash flow per share (CFPS) – DKK 28.99 6.75 27.65
Share price/Net asset value 1.5 1.7 1.6

Definitions: see last page

INCOME STATEMENT

Restated Restated
Q2 Q2 H1 H1
2010
%
2011
%
Amounts in DKKm 2011 % 2010 %
477
100
515
100
Revenue 1,258 100 1,052 100
153
32
145
28
Cost of sales 321 26 309 29
324
68
370
72
Gross profit 937 74 743 71
93
19
105
20
Research and development expenses 211 17 180 17
239
50
247
48
Sales, marketing and administrative expenses 493 39 457 43
2
0
-
-
Other operating income and expenses 2 0 2 0
(6)
(1)
18
3
Operating profit/(loss) (EBIT) 235 19 108 10
19
4
3
1
Financial income 4 0 27 3
-
-
(1)
(0)
Financial expenses 9 1 1 0
13
3
22
4
Profit before tax (EBT) 230 18 134 13
5
1
9
2
Tax on profit 90 7 51 5
8
2
13
3
Net profit 140 11 83 8
Operating profit before depreciation
16
3
43
8
and amortisation (EBITDA) 285 23 152 14

FINANCIAL REVIEW

(Growth rates for revenue are stated as growth in local currencies, unless otherwise indicated)

In order to give a more true and fair view of the revenue and cost development, ALK has decided to change the presentation of certain income in the financial statements. This means that licence income and other revenues from licence agreements are now presented as revenue. Previously, these revenues were presented as other operating income. The change has no impact on ALK's earnings. See note 4 for a detailed explanation of the consequences of the change.

Total revenue accordingly consists of sales of allergy vaccines and other products as well as other revenue.

Revenue during H1 increased by 20% to DKK 1,258 million (1,052), with growth in vaccine sales of 8%. The sales growth was driven in particular by the development in France, Spain, the Netherlands and North America. Revenues from ALK's partners were DKK 184 million (17) and mainly consist of licence income relating to the development of ALK's AIT products in North America and Japan.

In 2010, the German authorities implemented a number of political austerity measures on medicine prices, which in the first half of 2011 reduced ALK's sales by approximately DKK 60 million. Company acquisitions affected revenue positively by approximately 7 percentage points. The sales performance was only to a minor extent affected by exchange rates.

Revenue – sales by product line

During H1, sales of SCIT decreased by 3% to DKK 465 million (484). Performance was positive in North America and Northern and Southern Europe, where the launch of the improved SCIT product, AVANZ® , contributed to the growth. The positive performance was offset, however, by declining sales in Germany. The German sales were particularly affected by the political austerity measures, and a mild pollen season in 2010 meant that fewer patients subsequently started vaccination treatments. Sales of injection based vaccines accounted for 37% (46) of the company's total revenue.

Sales of SLIT grew by 23% to DKK 380 million (309). The increase was particularly positive in France, and the acquisition of a Dutch company in 2010 ensured continued overall sales growth in the Netherlands. SLIT products accounted for 30% (29) of the company's total revenue.

Sales of AIT, tablet based products (GRAZAX® ), increased by 16% to DKK 97 million (83). Particularly the sales in France contributed to the growth. Tablet sales accounted for 8% (8) of the company's total revenue.

Sales of other products (adrenaline pens, diagnostics, etc.) decreased by 16% to DKK 132 million (159). The sales decline was due to the phasing out of the sale of an inlicensed adrenaline product at the end of Q1. The distribution of the inlicensed product in a number of European countries has thus ceased. The product will be replaced by ALK's own, improved adrenaline pen, Jext® , which is still expected to be launched in the first markets in the second half of 2011. Sales of other products accounted for 10% (15) of the company's total revenue.

Revenue – sales by market

In the Northern European region, sales grew by 26% to DKK 254 million (202). The growth was positively affected by the acquisition of a Dutch company in 2010 and by increasing sales of GRAZAX® in Scandinavia.

In Central Europe, sales fell by 17% to DKK 352 million (421), mainly due to political austerity measures on medicine prices in Germany.

In the Southern European region, sales grew by 16% to DKK 336 million (290). The increase was due to a continued highly positive sales performance in France and the launch of the AVANZ® product in Italy and Spain.

Revenue in other markets grew by 15% to DKK 132 million (122). Sales in North America and China of injection based products were the main contributors to the increase.

Revenue – other revenue

Other revenue for H1 totalled DKK 184 million (17), mainly relating to revenues from ALK's partners in Japan and North America. Other revenue accounted for 15% (2) of the company's total revenue.

On entering into the partnership with Torii on the development, registration and commercialisation of, among other things, MITIZAX® in Japan, ALK received an up-front payment of DKK 224 million, DKK 139 million of which was recognised in the first half.

In connection with Merck's submission of a registration application for GRAZAX® in Canada, ALK has recognised a milestone payment of DKK 26 million.

Furthermore, ALK has recognised the reimbursement of expenses relating to development activities carried out by ALK for Merck.

Costs and earnings

During H1, cost of sales totalled DKK 321 million (309) and gross profit rose by 26% to DKK 937 million (743). The reported gross margin was 74% (71). Disregarding other revenues, the gross margin

was unchanged compared with the same period last year. The development was positively affected by acquisitions and the product mix and negatively affected by the price interventions in Germany as well as by rising production costs related to ALK's strategic partnerships in North America and Japan.

Total capacity costs increased by 11% to DKK 704 million (637). Disregarding company acquisitions, the underlying increase in capacity costs was 5%. Research and development expenses for the period increased by 17% to DKK 211 million (180), relating among other things to a number of clinical and pharmaceutical activities, including the GAP study (GRAZAX® Asthma Prevention) and preparations for upcoming clinical activities with MITIZAX® . Added to this were support to the partnership with Merck in North America and new regulatory requirements in Europe imposing stricter requirements for documentation of the company's non-registered product portfolio. Sales, marketing and administrative expenses increased by 8% to DKK 493 million (457). Disregarding company acquisitions, the increase was 1%, mainly due to the launch of GRAZAX® in France, AVANZ® in Spain and Italy, and preparations for the launch of Jext® .

Operating profit before depreciation and

amortisation (EBITDA) increased by 88% to DKK 285 million (152). The increase was positively affected in particular by other revenues, including the payments from Torii and Merck. Operating profit was not significantly affected by exchange rates.

Net financials were a loss of DKK 5 million (a profit of 26), which was due to unrealised exchange losses on intra-group accounts, primarily in USD.

Tax on profit for the period totalled DKK 90 million (51), corresponding to an effective tax rate of 39% (38). The profit for the period was thus DKK 140 million (83).

The cash flow from operating activities was an inflow of DKK 287 million (67) and was positively affected by payments from ALK's partners. Cash flow from investing activities was an outflow of DKK 46 million (71) and related to ongoing maintenance of production, research and development, and IT.

The free cash flow for the period was an inflow of DKK 241 million (an outflow of 4). The cash flow from financing activities was an outflow of DKK 58 million (76), primarily relating to the distribution of ordinary dividends. At the end of the quarter, cash and cash equivalents totalled DKK 433 million against DKK 250 million at the end of 2010.

Equity stood at DKK 2,090 million (1,991) at the end of the period corresponding to an equity ratio of 71% (71).

Outlook for the 2011 financial year

For the 2011 financial year, ALK expects continued growth in sales of allergy vaccines and earnings.

In 2011, ALK expects unchanged growth of 5% in allergy vaccine sales measured in local currencies. Revenue, including revenues from the company's partners, is expected to increase to approximately DKK 2.3 billion.

In June, expectations for operating profit (EBITDA) were adjusted upwards to DKK 385 million as a consequence of the submission of the registration application for GRAZAX® in Canada. ALK continues to expect EBITDA for 2011 to be DKK 385 million (287), corresponding to a growth rate of 34%. In 2011, ALK expects to recognise approximately DKK 150 million of the payment of DKK 224 million which ALK received on entering into the partnership with Torii in Japan. The remainder of the payment is expected to be recognised in 2012.

The outlook is based on the current exchange rates. The company's revenue and earnings are only to a minor extent exposed to foreign exchange fluctuations.

OPERATING REVIEW

Partnerships

An essential part of ALK's strategy is to ensure global access to allergy immunotherapy through partnerships with other pharmaceutical companies. At present, ALK has two strategic partnerships on commercialisation of AIT, which cover the world's two largest pharmaceutical markets, the USA and Japan.

ALK has close and committed partnerships with both Merck and Torii, and extensive work is being carried out to ensure the success of the AIT development programmes in North America and Japan.

North America: Partnership with Merck

The partnership with Merck covers the development, registration and commercialisation of a portfolio of tablet based allergy vaccines (AIT) against grass pollen, ragweed and house dust mite allergy, respectively, in the USA, Canada and Mexico.

In recent months, ALK and Merck have made important progress in a number of areas:

In June, Merck submitted a registration application for GRAZAX® in Canada. The submission of the registration application to the Canadian health authorities triggered a milestone payment of USD 5 million from Merck to ALK. ALK expects that Merck will launch GRAZAX® in Canada after regulatory approval of the registration application.

Merck has decided to initiate an additional clinical study with GRAZAX® in order to provide as robust a submission package in the USA as possible. The new study is planned to be a North American Phase III, multicenter, randomised, placebo-controlled, double-blind, parallel-group clinical trial evaluating the efficacy of GRAZAX® versus placebo in the treatment of grass pollen-induced rhinoconjunctivitis in 1,500 subjects. Screening of subjects for the study will be initiated in Q3 2011. Merck anticipates that the study will be completed in the autumn of 2012. Merck will continue to work with the FDA regarding the registration process in the USA.

After the end of the accounting period, ALK announced successful outcomes of two clinical Phase III studies with the new innovative ragweed tablet (AIT). Both studies met their primary efficacy endpoints and the efficacy results were consistent between the two studies. The studies also showed that the treatment was well tolerated with adverse events similar to previous studies in adults, with no new or unexpected findings. A total of approximately 1,350 subjects were included in the studies. The studies were conducted by Merck.

Japan: Partnership with Torii

The partnership with Torii covers development, registration and commercialisation of, among other things, MITIZAX® in Japan. The agreement also covers ALK's existing injection based vaccine and diagnostic products against house dust mite allergy as well as an agreement on joint research and development of a tablet based vaccine (AIT) against Japanese cedar allergy.

After entering into the partnership, Torii and ALK have begun planning the development programme to secure product registration and subsequent launch in Japan. Torii is in a dialogue with the Japanese authorities, and the development plans are currently being finalised, after which ALK expects that Torii will initiate the first clinical studies of MITIZAX® .

License agreement regarding new and unique diagnostic product for penicillin allergy

In July, ALK entered into an agreement to develop and market a new diagnostic product for penicillin allergy, Minor Determinant Mixture (MDM), with the US company AllerQuest. The new product – currently under development – will provide for a complete and unique penicillin allergy diagnosis.

Improved diagnosis can limit the use of broad spectrum antibiotics, thereby lowering treatment costs and the risk of developing multi drug resistant bacteria.

The clinical development programme is expected to be concluded in 2012, after which a registration application will be submitted to the US health authorities.

In total, ALK will pay up to USD 3.45 million for the exclusive distribution rights to MDM as well as the extension of the exclusive distribution rights of PRE-PEN® .

The combination of PRE-PEN® and the new diagnostic product (MDM) will have global market potential. As with PRE-PEN® , ALK will become exclusive distributor with global rights.

European allergy congress

In June, the annual European allergy congress (EAACI 2010) was held in Istanbul, attended by around 8,000 delegates from 104 countries. Once again this year the congress had a strong focus on allergy vaccination, including the mounting scientific evidence in favour of treatment. The congress commemorated the centenary of the publication of the first scientific article on immunotherapy (allergy vaccination). In this connection, the EAACI organisation issued a declaration on immunotherapy calling on the European politicians to ensure a more effective allergy treatment, among other things, through allergy immunotherapy.

With a total of 30 scientific contributions, ALK was once again the largest scientific contributor to the congress.

Risk factors

This interim report contains forward-looking statements, including forecasts of future revenue and operating profit as well as expected businessrelated 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 interim report. Without being exhaustive, such factors include e.g. general economic and business conditions, including legal issues, uncertainty relating to pricing, reimbursement rules, 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 severity.

This interim 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.

2010 Financial calendar

Silent period 17 October 2011
Nine-month interim report (Q3) 2011 14 November 2011

STATEMENT BY THE MANAGEMENT

Today, the Board of Directors and Board of Management considered and approved the interim report of ALK-Abelló A/S for the period 1 January - 30 June 2011.

The interim report has been prepared in accordance with IAS 34 "Interim financial reporting" as adopted by the EU and additional Danish disclosure requirements for the interim reports of listed companies. As in previous years, the interim report has not been subject to audit or review.

In our opinion, the interim report gives a true and fair view of the Group's assets, equity and liabilities, financial position, results of operations and cash flows for the period 1January - 30 June 2011. Moreover, in our opinion, the interim report gives a true and fair view of developments in the Group's activities and financial position and describes significant risk and uncertainty factors that may affect the Group.

Hørsholm, 16 August 2011

Board of Management

Jens Bager
(President and CEO)
Jørgen Damsbo Andersen Henrik Jacobi
Flemming Steen Jensen Flemming Pedersen
Board of Directors
Thorleif Krarup
(Chairman)
Lars Holmqvist
(Vice Chairman)
Jacob Kastrup
Anders Gersel Pedersen Brian Petersen Steen Riisgaard
Dorthe Seitzberg Katja Barnkob Thalund Jes Østergaard

INCOME STATEMENT (unaudited)

ALK Group ALK Group
Restated Restated
Q2 Q2 H1 H1
2010 2011 Amounts in DKKm 2011 2010
477 515 Revenue 1,258 1,052
153 145 Cost of sales 321 309
324 370 Gross profit 937 743
93 105 Research and development expenses 211 180
190 194 Sales and marketing expenses 391 363
49 53 Administrative expenses 102 94
2 - Other operating income 2 2
(6) 18 Operating profit/(loss) (EBIT) 235 108
19 3 Financial income 4 27
- (1) Financial expenses 9 1
13 22 Profit before tax (EBT) 230 134
5 9 Tax on profit 90 51
8 13 Net profit 140 83
0.81 1.31 Earnings per share (EPS) – DKK 14.14 8.37
0.81 1.31 Diluted earnings per share (DEPS) – DKK 14.14 8.37

STATEMENT OF COMPREHENSIVE INCOME (unaudited)

ALK Group ALK Group
Restated
Q2
2010
Q2
2011
Amounts in DKKm H1
2011
Restated
H1
2010
8 13 Net profit for the period 140 83
Other comprehensive income
34 (5) Foreign currency translation adjustment of foreign subsidiaries (26) 56
(3) - Adjustment of derivative financial instruments for hedging - (2)
1 - Tax related to other comprehensive income 3 (5)
32 (5) Other comprehensive income (23) 49
40 8 Total comprehensive income 117 132

CASH FLOW STATEMENT (unaudited)

ALK Group
Amounts in DKKm H1
2011
H1
2010
Net profit 140 83
Adjustments:
Tax on profit 90 51
Financial income and expenses 5 (26)
Share-based payments 5 5
Depreciation, amortisation and impairment 50 44
Change in provisions (1) 1
Net financial items, paid 2 1
Income taxes, paid (76) (49)
Cash flow before change in working capital 215 110
Change in inventories 25 (11)
Change in receivables 13 24
Change in short-term payables 34 (56)
Cash flow from operating activities 287 67
Additions, intangible assets (11) (6)
Additions, tangible assets
Change in other financial assets
(35)
-
(67)
2
Cash flow from investing activities (46) (71)
Free cash flow 241 (4)
Dividend paid to shareholders of the parent (50) (50)
Purchase of treasury shares - (24)
Change in financial liabilities (8) (2)
Cash flow from financing activities (58) (76)
Net cash flow 183 (80)
Cash and cash equivalents at 1 January 250 389
Unrealised gain on foreign currency carried as cash
and cash equivalents - 3
Net cash flow 183 (80)
Cash and cash equivalents at 30 June 433 312

The cash flow statement has been adjusted to the effect that exchange rate adjustments in foreign subsidiaries are not included in the statement. As a result, the individual figures in the cash flow statement cannot be reconciled directly to the income statement and balance sheet.

BALANCE SHEET (unaudited)

Assets ALK Group
30 June 31 Dec. 30 June
Amounts in DKKm 2011 2010 2010
Non-current assets
Intangible assets
Goodwill 406 408 373
Other intangible assets 197 199 84
603 607 457
Tangible assets
Land and buildings 549 572 546
Plant and machinery 165 169 156
Other fixtures and equipment 65 72 64
Property, plant and equipment in progress 391 382 397
1,170 1,195 1,163
Other non-current assets
Securities and receivables 28 28 21
Deferred tax assets 63 65 53
91 93 74
Total non-current assets 1,864 1,895 1,694
Current assets
Inventories 279 310 329
Trade receivables 214 261 224
Receivables from affiliates 27 27 53
Income tax receivables 44 34 27
Other receivables 52 19 17
Prepayments 32 34 24
Cash and cash equivalents 433 250 312
Total current assets 1,081 935 986
Total assets 2,945 2,830 2,680

BALANCE SHEET (unaudited)

Equity and liabilities ALK Group
Amounts in DKKm 30 June
2011
31 Dec.
2010
30 June
2010
Equity
Share capital 101 101 101
Other reserves 1,989 1,917 1,890
Total equity 2,090 2,018 1,991
Liabilities
Non-current liabilities
Mortgage debt 26 27 27
Bank loans and financial loans 9 10 12
Pensions and similar liabilities 87 84 78
Other provisions 146 150 148
Deferred tax liabilities 26 25 3
294 296 268
Current liabilities
Mortgage debt 1 1 1
Bank loans and financial loans 3 10 4
Trade payables 83 140 71
Income taxes 82 62 50
Other payables 308 303 295
Deferred income 84 - -
561 516 421
Total liabilities 855 812 689
Total equity and liabilities 2,945 2,830 2,680

EQUITY (unaudited)

ALK Group

Other reserves
Amounts in DKKm Share
capital
Hedges of
future
transactions
Currency
translation
adjustment
Retained
earnings
Total
other
reserves
Total
equity
Equity at 1 January 2011 101 - (10) 1,927 1,917 2,018
Net profit - - - 140 140 140
Other comprehensive income - - (23) - (23) (23)
Total comprehensive income - - (23) 140 117 117
Share-based payments - - - 5 5 5
Dividend paid - - - (50) (50) (50)
Other transactions - - - (45) (45) (45)
Equity at 30 June 2011 101 - (33) 2,022 1,989 2,090
Equity at 1 January 2010 101 1 (39) 1,865 1,827 1,928
Net profit - - - 83 83 83
Other comprehensive income - (7) 56 - 49 49
Total comprehensive income - (7) 56 83 132 132
Share-based payments - - - 5 5 5
Purchase of treasury shares - - - (24) (24) (24)
Dividend paid - - - (50) (50) (50)
Other transactions - - - (69) (69) (69)
Equity at 30 June 2010 101 (6) 17 1,879 1,890 1,991

1 ACCOUNTING POLICIES

The interim report for the period 1 January to 30 June 2011 is presented in accordance with IAS 34 "Interim financial reporting" as adopted by the EU and additional Danish disclosure requirements for interim reports of listed companies. The additional Danish disclosure requirements are defined in the Danish Executive Order on Interim Reports issued under the Danish Financial Statements Act.

Compared to the annual report 2010, the accounting policies have been changed with respect to the presentation of revenue and other operating income and other operating expenses.

License income and other revenues in connection with agreements on research and development partnerships are presented as revenue. Previously, these revenues were presented as other operating income. Certain costs resulting directly from the above mentioned revenues are presented as cost of sales. Previously, these costs were presented as other operating expenses.

The change in presentation has been made as:

  • partnerships and related income constitute an increasing share of the ALK Group's activities,

  • considerable research, development and production costs are related to these activities, and

  • the presentation is in line with accounting policies in other pharmaceutical companies and thus results in an improved comparability.

No other changes have been made to the accounting policies or presentation, and reference is made to the annual report 2010 for a more detailed description of the remaining accounting policies.

The changes in accounting policies only effect the presentation of revenue, cost of sales, other operating income and other operating expenses, whereas operating profit (EBITDA), the cash flow statement and the balance sheet remain unchanged. The effect is presented in note 4.

The effect in H1 2011 of the change in presentation is an increase in revenue of DKK 184 million, an increase in cost of sales of DKK 1 million, a reduction in other operating income of DKK 184 million and a reduction in other operating expenses of DKK 1 million.

"Actual accounting policies:

Revenue

Revenue from the sale of goods for resale and manufactured goods is recognised in the income statement if delivery and the transfer of risk to the purchaser have taken place.

Revenue is measured at the fair value of the consideration received or receivable.

Revenue is measured exclusive of VAT, taxes etc. charged on behalf of third parties and less any commissions and discounts in connection with sales.

Furthermore, revenue includes license income and royalties from outlicensed products as well as up-front payments, milestone payments and other revenues in connection with research and development partnerships. These revenues are recognised when it is probable that future economic benefits will flow to the ALK Group and these benefits can be measured reliably. Non-refundable payments that are not attributable to subsequent research and development activities are recognised when the related right is obtained, whereas payments attributable to subsequent research and development activities are recognised over the term of the activities. When combined contracts are entered into, the elements of the contracts are identified and assessed separately for accounting purposes.

Other operating income and other operating expenses

Other operating income and other operating expenses comprise income and expenses of a secondary nature relative to the principal activities of the ALK Group."

2 REVENUE
Restated
Q2
Q2
H1
2010
2011
Amounts in DKKm
2011
Net sales by product line
220
204
SCIT
465
140
175
SLIT
380
40
46
AIT
97
400
425
Total vaccines
942
77
40
Other products
132
477
465
Total net sales
1,074
-
50
Other revenue
184
477
515
Total revenue
1,258
ALK Group 2 REVENUE ALK Group
Restated
H1
2010
484
309
83
876
159
1,035
17
1,052
Revenue by market
94
Northern Europe
104
254
202
190
153
Central Europe
352
421
128
142
Southern Europe
336
290
65
66
Other markets
132
122
477
465
Total net sales
1,074
1,035
-
50
Other revenue
184
17
477
515
Total revenue
1,258
1,052

Q2 2011 H1 2011

Growth local Growth local
Growth currencies currencies Growth
-7% -5% SCIT -3% -4%
25% 25% SLIT 23% 23%
15% 16% AIT 16% 17%
6% 7% Total vaccines 8% 8%
-48% -45% Other products -16% -17%
-3% -1% Total net sales 4% 4%
n/a n/a Other revenue 981% 982%
8% 11% Total revenue 20% 20%
11% 14% Northern Europe 26% 26%
-19% -20% Central Europe -17% -16%
11% 11% Southern Europe 16% 16%
2% 14% Other markets 15% 8%
-3% -1% Total net sales 4% 4%
n/a n/a Other revenue 981% 982%
8% 11% Total revenue 20% 20%

3 KEY CURRENCIES AND CURRENCY SENSITIVITY

Average exchange rates
H1
2011
H1
2010
USD
GBP
5.29
8.53
5.68
8.62

Sensitivity in the event of a 10% increase in exchange rates (full year effect)

Amounts in DKKm Net sales EBITDA
USD approx. + 20 approx. 0
GBP approx. + 5 approx. 0

The sensitivities are estimated on the basis of current exchange rates.

4 EFFECT OF CHANGES IN ACCOUNTING POLICIES

INCOME STATEMENT (unaudited)

ALK Group H1 2011 ALK Group H1 2010
Amounts in DKKm Previous
accounting
policies
Change New
accounting
policies
Previous
accounting
policies
Change New
accounting
policies
Revenue 1,074 184 1,258 1,035 17 1,052
Cost of sales 320 1 321 308 1 309
Gross profit 754 183 937 727 16 743
Research and development expenses 211 - 211 180 - 180
Sales and marketing expenses 391 - 391 363 - 363
Administrative expenses 102 - 102 94 - 94
Other operating income 186 (184) 2 19 (17) 2
Other operating expenses 1 (1) - 1 (1) -
Operating profit (EBIT) 235 - 235 108 - 108
Financial income 4 - 4 27 - 27
Financial expenses 9 - 9 1 - 1
Profit before tax (EBT) 230 - 230 134 - 134
Tax on profit 90 - 90 51 - 51
Net profit 140 - 140 83 - 83

Cash flow statement, balance sheet and equity are not affected

4 EFFECT OF CHANGES IN ACCOUNTING POLICIES (continued)

INCOME STATEMENT (unaudited)

ALK Group Q1 2011 ALK Group Q1 2010
Amounts in DKKm Previous
accounting
policies
Change New
accounting
policies
Previous
accounting
policies
Change New
accounting
policies
Revenue 609 134 743 558 17 575
Cost of sales 176 - 176 155 1 156
Gross profit 433 134 567 403 16 419
Research and development expenses 106 - 106 87 - 87
Sales and marketing expenses 197 - 197 173 - 173
Administrative expenses 49 - 49 45 - 45
Other operating income 136 (134) 2 17 (17) -
Other operating expenses - - - 1 (1) -
Operating profit (EBIT) 217 - 217 114 - 114
Financial income 1 - 1 8 - 8
Financial expenses 10 - 10 1 - 1
Profit before tax (EBT) 208 - 208 121 - 121
Tax on profit 81 - 81 46 - 46
Net profit 127 - 127 75 - 75

INCOME STATEMENT (unaudited)

ALK Group Q2 2011 ALK Group Q2 2010
Amounts in DKKm Previous
accounting
policies
Change New
accounting
policies
Previous
accounting
policies
Change New
accounting
policies
Revenue 465 50 515 477 - 477
Cost of sales 144 1 145 153 - 153
Gross profit 321 49 370 324 - 324
Research and development expenses 105 - 105 93 - 93
Sales and marketing expenses 194 - 194 190 - 190
Administrative expenses 53 - 53 49 - 49
Other operating income 50 (50) - 2 - 2
Other operating expenses 1 (1) - - - -
Operating profit (EBIT) 18 - 18 (6) - (6)
Financial income 3 - 3 19 - 19
Financial expenses (1) - (1) - - -
Profit before tax (EBT) 22 - 22 13 - 13
Tax on profit 9 - 9 5 - 5
Net profit 13 - 13 8 - 8

Cash flow statement, balance sheet and equity are not affected

4 EFFECT OF CHANGES IN ACCOUNTING POLICIES (continued)

AFFECTED FINANCIAL HIGHLIGHTS AND KEY RATIOS (unaudited)

ALK Group
Amounts in DKKm Previous
accounting
policies
Change New
accounting
policies
Q1 2011
Income statement
Revenue 609 134 743
Key figures
Gross margin – % 71 5 76
Q1 2010
Income statement
Revenue 558 17 575
Key figures
Gross margin – % 72 1 73
H1 2011
Income statement
Revenue 1,074 184 1,258
Key figures
Gross margin – % 70 4 74
H1 2010
Income statement
Revenue 1,035 17 1,052
Key figures
Gross margin – % 70 1 71
2010
Income statement
Revenue 2,140 19 2,159
Key figures
Gross margin – % 69 1 70

4 EFFECT OF CHANGES IN ACCOUNTING POLICIES (continued)

AFFECTED FINANCIAL HIGHLIGHTS AND KEY RATIOS 2010 BY THE QUARTER (unaudited)

Amounts in DKKm Restated
2010
Restated
Q4
Restated
Q3
Restated
Q2
Restated
Q1
unaudited unaudited unaudited unaudited
Income statement
Total revenue 2,159 588 519 477 575
Cost of sales 654 173 172 153 156
Net other operating income/
(Other operating expenses) 4 2 - 2 -
Revenue growth local currency – %
Other revenue (46) (95) (86) (98) 90
Total revenue 8 5 7 6 14
Key figures
Gross margin – % 70 71 67 68 73
EBITDA margin – % 13 14 10 3 24

AFFECTED FINANCIAL HIGHLIGHTS AND KEY RATIOS 5 YEAR OVERVIEW (unaudited)

Amounts in DKKm Restated
2010
Restated
2009
Restated
2008
Restated
2007
Restated
2006
(12M)
unaudited
Restated
2006
(4M)
Income statement
Total revenue 2,159 1,972 1,815 1,867 1,531 575
Revenue growth – %
Organic growth 4 9 10 10 n/a 6
Exchange rate differences 2 (1) (2) (1) n/a -
Acquisitions 5 - - - n/a -
Total growth net sales 11 8 8 9 n/a 6
Other revenue (2) 1 (11) 13 n/a 2
Total growth revenue 9 9 (3) 22 n/a 8
Key figures
Gross margin – % 70 70 71 73 67 70
EBITDA margin – % 13 13 11 16 2 -

DEFINITIONS

Intangible assets, tangible assets, inventories and current receivables
reduced by liabilities except for mortgage debt, bank loans and financial
loans
Gross profit x 100 / Revenue
Operating profit before depreciation and amortisation x 100 / Revenue
Equity at end of period / Number of shares at end of period
Net profit/(loss) for the period / Average number of outstanding shares
Net profit/(loss) for the period / Diluted average number of outstanding
shares
Cash flow from operating activities / Average number of outstanding shares
Geographical markets (based on customer location):
o Northern Europe comprises the Nordic region, the UK and the Netherlands
o Central Europe comprises Germany, Austria, Switzerland, Poland and
minor selected markets in Eastern Europe
o Southern Europe comprises Spain, Italy, France, Greece, Portugal and
minor markets in Southern Europe
o Other markets comprise the USA, Canada, China and rest of world

Key figures are calculated in accordance with "Recommendations and Ratios 2010" issued by the Danish Society of Financial Analysts.

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