Condensed Consolidated Statement of Comprehensive Income
|
For the six months ended 30 June
|
|
|
$2011m |
|
|
|
$2010m |
|
|
Revenue
|
|
|
16,722 |
|
|
|
16,754 |
|
|
Cost of sales
|
|
|
(2,821 |
) |
|
|
(3,106 |
) |
|
Gross profit
|
|
|
13,901 |
|
|
|
13,648 |
|
|
Distribution costs
|
|
|
(168 |
) |
|
|
(166 |
) |
|
Research and development
|
|
|
(2,360 |
) |
|
|
(2,311 |
) |
|
Selling, general and administrative costs
|
|
|
(5,376 |
) |
|
|
(4,912 |
) |
|
Other operating income and expense
|
|
|
369 |
|
|
|
418 |
|
|
Operating profit
|
|
|
6,366 |
|
|
|
6,677 |
|
|
Finance income
|
|
|
273 |
|
|
|
259 |
|
|
Finance expense
|
|
|
(493 |
) |
|
|
(500 |
) |
|
Profit before tax
|
|
|
6,146 |
|
|
|
6,436 |
|
|
Taxation
|
|
|
(1,108 |
) |
|
|
(1,541 |
) |
|
Profit for the period
|
|
|
5,038 |
|
|
|
4,895 |
|
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
|
Foreign exchange arising on consolidation
|
|
|
246 |
|
|
|
(378 |
) |
|
Foreign exchange differences on borrowings forming net investment hedges
|
|
|
(113 |
) |
|
|
196 |
|
|
Amortisation of loss on cash flow hedge
|
|
|
1 |
|
|
|
1 |
|
|
Net available for sale gains/(losses) taken to equity
|
|
|
18 |
|
|
|
(5 |
) |
|
Actuarial gain/(loss) for the period
|
|
|
156 |
|
|
|
(328 |
) |
|
Income tax relating to components of other comprehensive income
|
|
|
(6 |
) |
|
|
17 |
|
|
Other comprehensive income for the period, net of tax
|
|
|
302 |
|
|
|
(497 |
) |
|
Total comprehensive income for the period
|
|
|
5,340 |
|
|
|
4,398 |
|
| |
|
|
|
|
|
|
|
|
|
Profit attributable to:
|
|
|
|
|
|
|
|
|
|
Owners of the parent
|
|
|
5,020 |
|
|
|
4,884 |
|
|
Non-controlling interests
|
|
|
18 |
|
|
|
11 |
|
| |
|
|
5,038 |
|
|
|
4,895 |
|
| |
|
|
|
|
|
|
|
|
|
Total comprehensive income attributable to:
|
|
|
|
|
|
|
|
|
|
Owners of the parent
|
|
|
5,318 |
|
|
|
4,381 |
|
|
Non-controlling interests
|
|
|
22 |
|
|
|
17 |
|
| |
|
|
5,340 |
|
|
|
4,398 |
|
| |
|
|
|
|
|
|
|
|
|
Basic earnings per $0.25 Ordinary Share
|
|
|
$3.61 |
|
|
|
$3.37 |
|
|
Diluted earnings per $0.25 Ordinary Share
|
|
|
$3.60 |
|
|
|
$3.36 |
|
|
Weighted average number of Ordinary Shares in issue (millions)
|
|
|
1,389 |
|
|
|
1,448 |
|
|
Diluted weighted average number of Ordinary Shares in issue (millions)
|
|
|
1,395 |
|
|
|
1,454 |
|
Condensed Consolidated Statement of Comprehensive Income
|
For the quarter ended 30 June
|
|
|
$2011m |
|
|
|
$2010m |
|
|
Revenue
|
|
|
8,430 |
|
|
|
8,178 |
|
|
Cost of sales
|
|
|
(1,482 |
) |
|
|
(1,452 |
) |
|
Gross profit
|
|
|
6,948 |
|
|
|
6,726 |
|
|
Distribution costs
|
|
|
(88 |
) |
|
|
(88 |
) |
|
Research and development
|
|
|
(1,198 |
) |
|
|
(1,320 |
) |
|
Selling, general and administrative costs
|
|
|
(2,868 |
) |
|
|
(2,450 |
) |
|
Other operating income and expense
|
|
|
171 |
|
|
|
166 |
|
|
Operating profit
|
|
|
2,965 |
|
|
|
3,034 |
|
|
Finance income
|
|
|
136 |
|
|
|
126 |
|
|
Finance expense
|
|
|
(243 |
) |
|
|
(243 |
) |
|
Profit before tax
|
|
|
2,858 |
|
|
|
2,917 |
|
|
Taxation
|
|
|
(735 |
) |
|
|
(801 |
) |
|
Profit for the period
|
|
|
2,123 |
|
|
|
2,116 |
|
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
|
Foreign exchange arising on consolidation
|
|
|
38 |
|
|
|
(175 |
) |
|
Foreign exchange differences on borrowings forming net investment hedges
|
|
|
(21 |
) |
|
|
92 |
|
|
Amortisation of loss on cash flow hedge
|
|
|
1 |
|
|
|
1 |
|
|
Net available for sale gains/(losses) taken to equity
|
|
|
7 |
|
|
|
(5 |
) |
|
Actuarial gain/(loss) for the period
|
|
|
174 |
|
|
|
(247 |
) |
|
Income tax relating to components of other comprehensive income
|
|
|
(33 |
) |
|
|
11 |
|
|
Other comprehensive income for the period, net of tax
|
|
|
166 |
|
|
|
(323 |
) |
|
Total comprehensive income for the period
|
|
|
2,289 |
|
|
|
1,793 |
|
| |
|
|
|
|
|
|
|
|
|
Profit attributable to:
|
|
|
|
|
|
|
|
|
|
Owners of the parent
|
|
|
2,113 |
|
|
|
2,107 |
|
|
Non-controlling interests
|
|
|
10 |
|
|
|
9 |
|
| |
|
|
2,123 |
|
|
|
2,116 |
|
| |
|
|
|
|
|
|
|
|
|
Total comprehensive income attributable to:
|
|
|
|
|
|
|
|
|
|
Owners of the parent
|
|
|
2,273 |
|
|
|
1,777 |
|
|
Non-controlling interests
|
|
|
16 |
|
|
|
16 |
|
| |
|
|
2,289 |
|
|
|
1,793 |
|
| |
|
|
|
|
|
|
|
|
|
Basic earnings per $0.25 Ordinary Share
|
|
|
$1.53 |
|
|
|
$1.46 |
|
|
Diluted earnings per $0.25 Ordinary Share
|
|
|
$1.53 |
|
|
|
$1.45 |
|
|
Weighted average number of Ordinary Shares in issue (millions)
|
|
|
1,381 |
|
|
|
1,445 |
|
|
Diluted weighted average number of Ordinary Shares in issue (millions)
|
|
|
1,387 |
|
|
|
1,450 |
|
Condensed Consolidated Statement of Financial Position
| |
|
At 30 Jun 2011
$m
|
|
|
At 31 Dec 2010
$m
|
|
|
At 30 Jun 2010
$m
|
|
|
ASSETS
Non-current assets
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment
|
|
|
6,832 |
|
|
|
6,957 |
|
|
|
6,824 |
|
|
Goodwill
|
|
|
9,877 |
|
|
|
9,871 |
|
|
|
9,846 |
|
|
Intangible assets
|
|
|
12,072 |
|
|
|
12,158 |
|
|
|
12,832 |
|
|
Derivative financial instruments
|
|
|
319 |
|
|
|
324 |
|
|
|
370 |
|
|
Other investments
|
|
|
218 |
|
|
|
211 |
|
|
|
193 |
|
|
Deferred tax assets
|
|
|
1,397 |
|
|
|
1,475 |
|
|
|
1,206 |
|
| |
|
|
30,715 |
|
|
|
30,996 |
|
|
|
31,271 |
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventories
|
|
|
2,021 |
|
|
|
1,682 |
|
|
|
1,689 |
|
|
Trade and other receivables
|
|
|
8,320 |
|
|
|
7,847 |
|
|
|
7,307 |
|
|
Other investments
|
|
|
679 |
|
|
|
1,482 |
|
|
|
1,964 |
|
|
Derivative financial instruments
|
|
|
3 |
|
|
|
9 |
|
|
|
- |
|
|
Income tax receivable
|
|
|
1,538 |
|
|
|
3,043 |
|
|
|
3,328 |
|
|
Cash and cash equivalents
|
|
|
9,613 |
|
|
|
11,068 |
|
|
|
9,088 |
|
|
Assets classified as held for sale*
|
|
|
517 |
|
|
|
- |
|
|
|
- |
|
| |
|
|
22,691 |
|
|
|
25,131 |
|
|
|
23,376 |
|
|
Total assets
|
|
|
53,406 |
|
|
|
56,127 |
|
|
|
54,647 |
|
|
LIABILITIES
Current liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest-bearing loans and borrowings
|
|
|
(372 |
) |
|
|
(125 |
) |
|
|
(1,275 |
) |
|
Trade and other payables
|
|
|
(8,513 |
) |
|
|
(8,661 |
) |
|
|
(7,362 |
) |
|
Derivative financial instruments
|
|
|
- |
|
|
|
(8 |
) |
|
|
(201 |
) |
|
Provisions
|
|
|
(1,097 |
) |
|
|
(1,095 |
) |
|
|
(947 |
) |
|
Income tax payable
|
|
|
(3,660 |
) |
|
|
(6,898 |
) |
|
|
(6,519 |
) |
|
Liabilities classified as held for sale*
|
|
|
(196 |
) |
|
|
- |
|
|
|
- |
|
| |
|
|
(13,838 |
) |
|
|
(16,787 |
) |
|
|
(16,304 |
) |
|
Non-current liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest-bearing loans and borrowings
|
|
|
(9,210 |
) |
|
|
(9,097 |
) |
|
|
(9,043 |
) |
|
Deferred tax liabilities
|
|
|
(3,034 |
) |
|
|
(3,145 |
) |
|
|
(2,851 |
) |
|
Retirement benefit obligations
|
|
|
(2,354 |
) |
|
|
(2,472 |
) |
|
|
(3,478 |
) |
|
Provisions
|
|
|
(685 |
) |
|
|
(843 |
) |
|
|
(491 |
) |
|
Other payables
|
|
|
(470 |
) |
|
|
(373 |
) |
|
|
(215 |
) |
| |
|
|
(15,753 |
) |
|
|
(15,930 |
) |
|
|
(16,078 |
) |
|
Total liabilities
|
|
|
(29,591 |
) |
|
|
(32,717 |
) |
|
|
(32,382 |
) |
|
Net assets
|
|
|
23,815 |
|
|
|
23,410 |
|
|
|
22,265 |
|
|
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital and reserves attributable to equity holders of the Company
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital
|
|
|
341 |
|
|
|
352 |
|
|
|
360 |
|
|
Share premium account
|
|
|
3,010 |
|
|
|
2,672 |
|
|
|
2,372 |
|
|
Other reserves
|
|
|
1,915 |
|
|
|
1,917 |
|
|
|
1,939 |
|
|
Retained earnings
|
|
|
18,340 |
|
|
|
18,272 |
|
|
|
17,420 |
|
| |
|
|
23,606 |
|
|
|
23,213 |
|
|
|
22,091 |
|
|
Non-controlling interests
|
|
|
209 |
|
|
|
197 |
|
|
|
174 |
|
|
Total equity
|
|
|
23,815 |
|
|
|
23,410 |
|
|
|
22,265 |
|
* Assets and liabilities held for sale represent the assets and liabilities of Astra Tech (see Note 1).
Condensed Consolidated Statement of Cash Flows
|
For the six months ended 30 June
|
|
|
$2011m |
|
|
Restated
2010
$m
|
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
Profit before taxation
|
|
|
6,146 |
|
|
|
6,436 |
|
|
Finance income and expense
|
|
|
220 |
|
|
|
241 |
|
|
Depreciation, amortisation and impairment
|
|
|
1,037 |
|
|
|
832 |
|
|
Increase in working capital and short-term provisions
|
|
|
(1,053 |
) |
|
|
(977 |
) |
|
Other non-cash movements
|
|
|
(236 |
) |
|
|
32 |
|
|
Cash generated from operations
|
|
|
6,114 |
|
|
|
6,564 |
|
|
Interest paid
|
|
|
(282 |
) |
|
|
(323 |
) |
|
Tax paid
|
|
|
(3,003 |
) |
|
|
(1,474 |
) |
|
Net cash inflow from operating activities
|
|
|
2,829 |
|
|
|
4,767 |
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
|
Movement in short-term investments and fixed deposits*
|
|
|
852 |
|
|
|
(483 |
) |
|
Purchase of property, plant and equipment
|
|
|
(381 |
) |
|
|
(313 |
) |
|
Disposal of property, plant and equipment
|
|
|
46 |
|
|
|
28 |
|
|
Purchase of intangible assets
|
|
|
(294 |
) |
|
|
(1,172 |
) |
|
Disposal of intangible assets
|
|
|
- |
|
|
|
210 |
|
|
Purchase of non-current asset investments
|
|
|
(6 |
) |
|
|
(23 |
) |
|
Disposal of non-current asset investments
|
|
|
- |
|
|
|
2 |
|
|
Acquisitions of business operations
|
|
|
- |
|
|
|
(348 |
) |
|
Interest received
|
|
|
85 |
|
|
|
77 |
|
|
Payments made by subsidiaries to non-controlling interests
|
|
|
(16 |
) |
|
|
(10 |
) |
|
Net cash inflow/(outflow) from investing activities
|
|
|
286 |
|
|
|
(2,032 |
) |
|
Net cash inflow before financing activities
|
|
|
3,115 |
|
|
|
2,735 |
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
Proceeds from issue of share capital
|
|
|
340 |
|
|
|
193 |
|
|
Repurchase of shares for cancellation
|
|
|
(2,544 |
) |
|
|
(709 |
) |
|
Repayment of loans
|
|
|
- |
|
|
|
(717 |
) |
|
Dividends paid
|
|
|
(2,646 |
) |
|
|
(2,367 |
) |
|
Movement in derivative financial instruments*
|
|
|
41 |
|
|
|
(156 |
) |
|
Movement in short-term borrowings
|
|
|
19 |
|
|
|
(27 |
) |
|
Net cash outflow from financing activities
|
|
|
(4,790 |
) |
|
|
(3,783 |
) |
|
Net decrease in cash and cash equivalents in the period
|
|
|
(1,675 |
) |
|
|
(1,048 |
) |
|
Cash and cash equivalents at the beginning of the period
|
|
|
10,981 |
|
|
|
9,828 |
|
|
Amounts reclassified as held for sale
|
|
|
(47 |
) |
|
|
- |
|
|
Exchange rate effects
|
|
|
40 |
|
|
|
(36 |
) |
|
Cash and cash equivalents at the end of the period
|
|
|
9,299 |
|
|
|
8,744 |
|
|
Cash and cash equivalents consists of:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
9,613 |
|
|
|
9,088 |
|
|
Overdrafts
|
|
|
(314 |
) |
|
|
(344 |
) |
| |
|
|
9,299 |
|
|
|
8,744 |
|
*2010 restated to reclassify $156m movement in derivative financial instruments associated with financing activities.
Condensed Consolidated Statement of Changes in Equity
| |
|
Share
capital
$m
|
|
|
Share
premium
account
$m
|
|
|
Other*
reserves
$m
|
|
|
Retained
earnings
$m
|
|
|
Total
$m
|
|
|
Non-
controlling
interests
$m
|
|
|
Total
equity
$m
|
|
|
At 1 January 2010
|
|
|
363 |
|
|
|
2,180 |
|
|
|
1,919 |
|
|
|
16,198 |
|
|
|
20,660 |
|
|
|
161 |
|
|
|
20,821 |
|
|
Profit for the period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,884 |
|
|
|
4,884 |
|
|
|
11 |
|
|
|
4,895 |
|
|
Other comprehensive income
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(503 |
) |
|
|
(503 |
) |
|
|
6 |
|
|
|
(497 |
) |
|
Transfer to other reserve
|
|
|
- |
|
|
|
- |
|
|
|
16 |
|
|
|
(16 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Transactions with owners:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,484 |
) |
|
|
(2,484 |
) |
|
|
- |
|
|
|
(2,484 |
) |
|
Issue of AstraZeneca PLC Ordinary shares
|
|
|
1 |
|
|
|
192 |
|
|
|
- |
|
|
|
- |
|
|
|
193 |
|
|
|
- |
|
|
|
193 |
|
|
Repurchase of AstraZeneca PLC Ordinary shares
|
|
|
(4 |
) |
|
|
- |
|
|
|
4 |
|
|
|
(709 |
) |
|
|
(709 |
) |
|
|
- |
|
|
|
(709 |
) |
|
Share-based payments
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
50 |
|
|
|
50 |
|
|
|
- |
|
|
|
50 |
|
|
Transfer from non-controlling interests to payables
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3 |
) |
|
|
(3 |
) |
|
Dividend paid to non-controlling interest
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1 |
) |
|
|
(1 |
) |
|
Net movement
|
|
|
(3 |
) |
|
|
192 |
|
|
|
20 |
|
|
|
1,222 |
|
|
|
1,431 |
|
|
|
13 |
|
|
|
1,444 |
|
|
At 30 June 2010
|
|
|
360 |
|
|
|
2,372 |
|
|
|
1,939 |
|
|
|
17,420 |
|
|
|
22,091 |
|
|
|
174 |
|
|
|
22,265 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Share
capital
$m
|
|
|
Share
premium
account
$m
|
|
|
Other*
reserves
$m
|
|
|
Retained
earnings
$m
|
|
|
Total
$m
|
|
|
Non-
controlling
interests
$m
|
|
|
Total
equity
$m
|
|
|
At 1 January 2011
|
|
|
352 |
|
|
|
2,672 |
|
|
|
1,917 |
|
|
|
18,272 |
|
|
|
23,213 |
|
|
|
197 |
|
|
|
23,410 |
|
|
Profit for the period
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,020 |
|
|
|
5,020 |
|
|
|
18 |
|
|
|
5,038 |
|
|
Other comprehensive income
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
298 |
|
|
|
298 |
|
|
|
4 |
|
|
|
302 |
|
|
Transfer to other reserve
|
|
|
- |
|
|
|
- |
|
|
|
(15 |
) |
|
|
15 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Transactions with owners:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,594 |
) |
|
|
(2,594 |
) |
|
|
- |
|
|
|
(2,594 |
) |
|
Issue of AstraZeneca PLC Ordinary shares
|
|
|
2 |
|
|
|
338 |
|
|
|
- |
|
|
|
- |
|
|
|
340 |
|
|
|
- |
|
|
|
340 |
|
|
Repurchase of AstraZeneca PLC Ordinary shares
|
|
|
(13 |
) |
|
|
- |
|
|
|
13 |
|
|
|
(2,544 |
) |
|
|
(2,544 |
) |
|
|
- |
|
|
|
(2,544 |
) |
|
Share-based payments
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(127 |
) |
|
|
(127 |
) |
|
|
- |
|
|
|
(127 |
) |
|
Transfer from non-controlling interests to payables
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(6 |
) |
|
|
(6 |
) |
|
Dividend paid to non-controlling interests
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4 |
) |
|
|
(4 |
) |
|
Net movement
|
|
|
(11 |
) |
|
|
338 |
|
|
|
(2 |
) |
|
|
68 |
|
|
|
393 |
|
|
|
12 |
|
|
|
405 |
|
|
At 30 June 2011
|
|
|
341 |
|
|
|
3,010 |
|
|
|
1,915 |
|
|
|
18,340 |
|
|
|
23,606 |
|
|
|
209 |
|
|
|
23,815 |
|
* Other reserves includes the capital redemption reserve and the merger reserve.
Responsibility Statement of the Directors in Respect of the Half-Yearly Financial Report
We confirm that to the best of our knowledge:
|
·
|
the condensed set of financial statements has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union;
|
|
·
|
the half-yearly management report includes a fair review of the information required by:
|
| |
(a)
|
DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed set of financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and
|
| |
(b)
|
DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the entity during that period; and any changes in the related party transactions described in the last annual report that could do so.
|
The Board
The Board of Directors that served during all or part of the six-month period to 30 June 2011 and their respective responsibilities can be found on pages 106 and 107 of the AstraZeneca Annual Report and Form 20-F Information 2010 with the exception of Baroness Shriti Vadera, who was appointed on 1 January 2011. Jane Henney retired from the Board on 28 April 2011.
Approved by the Board and signed on its behalf by
David R Brennan
Chief Executive Officer
28 July 2011
Independent Review Report to AstraZeneca PLC
Introduction
We have been engaged by the Company to review the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2011 (but not for the quarter ended 30 June 2011) which comprises condensed consolidated statement of comprehensive income, condensed consolidated statement of financial position, condensed consolidated statement of cash flows, condensed consolidated statement of changes in equity and Notes 1 to 5 and 7. We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the condensed set of financial statements.
This report is made solely to the Company in accordance with the terms of our engagement to assist the Company in meeting the requirements of the Disclosure and Transparency Rules ("the DTR") of the UK's Financial Services Authority ("the UK FSA"). Our review has been undertaken so that we might state to the Company those matters we are required to state to it in this report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company for our review work, for this report, or for the conclusions we have reached.
Directors' responsibilities
The half-yearly financial report is the responsibility of, and has been approved by, the Directors. The Directors are responsible for preparing the half-yearly financial report in accordance with the DTR of the UK FSA.
As disclosed in Note 1, the annual financial statements of the group are prepared in accordance with International Financial Reporting Standards (“IFRSs”) as adopted by the European Union (“EU”) and as issued by the International Accounting Standards Board (“IASB”). The condensed set of financial statements included in this half-yearly financial report has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the EU.
Our responsibility
Our responsibility is to express to the Company a conclusion on the condensed set of financial statements in the half-yearly financial report based on our review.
Scope of review
We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410 Review of Interim Financial Information Performed by the Independent Auditor of the Entity issued by the Auditing Practices Board for use in the UK. A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK and Ireland) and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2011 is not prepared, in all material respects, in accordance with IAS 34 as adopted by the EU and the DTR of the UK FSA.
Jimmy Daboo
For and on behalf of KPMG Audit Plc
Chartered Accountants
15 Canada Square
London E14 5GL
28 July 2011
Notes to the Interim Financial Statements
|
1
|
BASIS OF PREPARATION AND ACCOUNTING POLICIES
|
These condensed consolidated interim financial statements (“interim financial statements”) for the six months ended 30 June 2011 have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union. The annual financial statements of the Group are prepared in accordance with International Financial Reporting Standards (IFRSs) as adopted by the European Union and as issued by the International Accounting Standards Board. As required by the Disclosure and Transparency Rules of the Financial Services Authority, the interim financial statements have been prepared applying the accounting policies and presentation that were applied in the preparation of the Company’s published consolidated financial statements for the year ended 31 December 2010, except where new or revised accounting standards have been applied. There has been no significant impact on the Group profit or net assets on adoption of new or revised accounting standards in the period.
In June 2011, the Group announced the agreement to sell the Astra Tech business to Dentsply International for approximately $1.8 billion in cash. At 30 June 2011, Astra Tech’s assets were $517 million and liabilities were $196 million and, in accordance with IFRS 5, these have been reclassified on the Group’s balance sheet as assets and liabilities held for sale. The transaction is anticipated to be completed during the second half of 2011, subject to receipt of relevant regulatory clearances. Upon closing, a gain will be recorded as “other operating income” and excluded from Core financial measures.
The Group has considerable financial resources available. The Group’s revenues are largely derived from sales of products which are covered by patents and for which, historically at least, demand has been relatively unaffected by changes in the general economy. As a consequence, the Directors believe that the Group is well placed to manage its business risks successfully and as such, the interim financial statements have been prepared on a Going Concern basis.
The information contained in Note 4 updates the disclosures concerning legal proceedings and contingent liabilities in the Group’s Annual Report and Form 20-F Information 2010.
The comparative figures for the financial year ended 31 December 2010 are not the Company's statutory accounts for that financial year. Those accounts have been reported on by the Company's auditors and delivered to the registrar of companies. The report of the auditors was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498(2) or (3) of the Companies Act 2006.
The table below provides an analysis of net funds and a reconciliation of net cash flow to the movement in net funds.
| |
|
At 1 Jan
2011
$m
|
|
|
Cash
flow
$m
|
|
|
Amounts reclassified as held for sale
$m
|
|
|
Non-
cash
mvmts
$m
|
|
|
Exchange
mvmts
$m
|
|
|
At 30
Jun
2011
$m
|
|
|
Loans due after one year
|
|
|
(9,097 |
) |
|
|
- |
|
|
|
- |
|
|
|
(3 |
) |
|
|
(110 |
) |
|
|
(9,210 |
) |
|
Other investments - current
|
|
|
1,482 |
|
|
|
(852 |
) |
|
|
- |
|
|
|
24 |
|
|
|
25 |
|
|
|
679 |
|
|
Net derivative financial instruments
|
|
|
325 |
|
|
|
(41 |
) |
|
|
- |
|
|
|
38 |
|
|
|
- |
|
|
|
322 |
|
|
Cash and cash equivalents
|
|
|
11,068 |
|
|
|
(1,448 |
) |
|
|
(47 |
) |
|
|
- |
|
|
|
40 |
|
|
|
9,613 |
|
|
Overdrafts
|
|
|
(87 |
) |
|
|
(227 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(314 |
) |
|
Short-term borrowings
|
|
|
(38 |
) |
|
|
(19 |
) |
|
|
- |
|
|
|
- |
|
|
|
(1 |
) |
|
|
(58 |
) |
| |
|
|
12,750 |
|
|
|
(2,587 |
) |
|
|
(47 |
) |
|
|
62 |
|
|
|
64 |
|
|
|
10,242 |
|
|
Net funds
|
|
|
3,653 |
|
|
|
(2,587 |
) |
|
|
(47 |
) |
|
|
59 |
|
|
|
(46 |
) |
|
|
1,032 |
|
Non-cash movements in the period include fair value adjustments under IAS 39.
Profit before tax for the six months ended 30 June 2011 is stated after charging restructuring costs of $281 million ($138 million for the second quarter 2011). These have been charged to profit as follows:
| |
|
2nd Quarter
2011
$m
|
|
|
2nd Quarter
2010
$m
|
|
|
Half Year
2011
$m
|
|
|
Half Year
2010
$m
|
|
|
Cost of sales
|
|
|
20 |
|
|
|
63 |
|
|
|
32 |
|
|
|
91 |
|
|
Research and development
|
|
|
79 |
|
|
|
354 |
|
|
|
169 |
|
|
|
372 |
|
|
Selling, general and administrative costs
|
|
|
39 |
|
|
|
53 |
|
|
|
80 |
|
|
|
102 |
|
|
Total
|
|
|
138 |
|
|
|
470 |
|
|
|
281 |
|
|
|
565 |
|
|
4
|
LEGAL PROCEEDINGS AND CONTINGENT LIABILITIES
|
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents, anti-trust law, sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2010. Unless noted otherwise below or in the Annual Report and Form 20-F Information 2010, no provisions have been established in respect of the claims discussed below.
As discussed in the Company's Annual Report and Form 20-F Information 2010, for the majority of claims in which AstraZeneca is involved it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision is made.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we record the loss absorbed or make a provision for our best estimate of the expected loss.
The position could change over time and the estimates that we have made and upon which we have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Annual Report and Form 20-F Information 2010 and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce its intellectual property.
Matters previously disclosed in respect of first quarter of 2011 and April 2011
Atacand
Patent litigation – Canada
As previously reported, in December 2010, AstraZeneca received a second Notice of Allegation from Teva Canada Limited (Teva) in respect of Canadian Atacand substance patent no. 2,040,955 (the ‘955 patent) and formulation patent no. 2,083,305 (the ‘305 patent) listed on the Canadian Patent Register for Atacand. Teva has confirmed it will await the expiry of the ‘955 patent. AstraZeneca did not commence an application in response.
In March 2011, AstraZeneca received a Notice of Allegation from Apotex Inc. (Apotex) in respect of the ‘955 and ‘305 patents listed on the Canadian Patent Register for Atacand. Apotex has confirmed it will await the expiry of the ‘955 patent. AstraZeneca did not commence an application in response.
Patent litigation – Brazil
As previously reported, in October 2010, AstraZeneca filed an infringement action with a request for an interlocutory injunction against Sandoz do Brasil Industria Farmaceutica Ltda (Sandoz) in the Central Court of São Paolo. The Court denied the request for an interlocutory injunction. AstraZeneca appealed the decision and, in February 2011, the Court of Appeal upheld the lower court’s decision to deny the request for an interlocutory injunction. The main infringement action continues.
Patent litigation – EU
As previously reported, in Portugal, a request was filed with the Lisbon Administrative Court of First Instance in December 2009 seeking a preliminary injunction to suspend the marketing authorisations for generic candesartan cilexetil granted to Sandoz Farmacêutica Limitada (Sandoz). The Court denied the preliminary injunction. The decision was appealed and the Court of Appeal ordered the Court of First Instance to hold a hearing. After a hearing in February 2011 the Lisbon Administrative Court of First Instance granted the request for a preliminary injunction and ordered the suspension of the marketing authorisations granted to Sandoz until 24 October 2012, i.e. the date of expiry of the supplementary protection certificate. This decision can be appealed.
Atacand Plus (candesartan cilexetil/hydrochlorothiazide)
Patent litigation – Canada
As previously reported, in April 2010, AstraZeneca received a Notice of Allegation from Pharmascience Inc. (PMS) in respect of the Atacand Plus formulation patent no. 2,083,305 (the ‘305 patent) listed on the Canadian Patent Register for Atacand Plus. AstraZeneca commenced a proceeding in response in June 2010. In February 2011, AstraZeneca discontinued its application.
As previously reported, in December 2010, AstraZeneca received a Notice of Allegation from PMS in respect of the Atacand Plus combination patent no. 2,125,251 (the ‘251 patent). AstraZeneca commenced an application in response in February 2011.
In January 2011, AstraZeneca received two Notices of Allegation from Teva Canada Limited (Teva) in respect of the ‘251 and the ‘305 patents. Teva has agreed to await the expiry of the ‘955 patent. AstraZeneca commenced applications in response in March 2011.
Crestor (rosuvastatin calcium)
Patent litigation – US
US Patent No. RE37,314 (the ‘314 patent)
As previously disclosed, in June 2010, the US District Court for the District of Delaware found the ‘314 patent valid and enforceable and infringed by the eight generic defendants. The defendants appealed the decision to the Court of Appeals for the Federal Circuit. AstraZeneca and Shionogi Seiyaku Kabushiki Kaisha filed a comprehensive responsive brief in March 2011. Defendants filed reply briefs and briefing is now complete. A date for oral argument has not been set.
505(b)(2) New Drug Application for rosuvastatin zinc tablets (the ‘314 patent) and US Patent Nos. 6,858,618 (the ‘618 patent) and 7,030,152 (the ‘152 patent)
As previously reported, in October 2010, AstraZeneca and Shionogi Seiyaku Kabushiki Kaisha commenced a patent infringement action in the US District Court for the District of Delaware against Watson Laboratories, Inc. (Watson) for infringement of the ‘314 patent. In March 2011, the Court entered an order based on a stipulation which precludes Watson from re-litigating the invalidity and unenforceability issues currently pending before the Federal Circuit in the Crestor appeal involving the ‘314 patent. The Court has set a case-schedule for discovery and other litigation events, including a trial date in May 2012. On 19 April 2011, in this case, AstraZeneca moved to amend the complaint to add The Brighams & Women’s Hospital as a co-plaintiff and add claims of infringement of the ‘618 and ‘152 method patents.
Abbreviated New Drug Applications for rosuvastatin calcium tablets (the ‘618 and ‘152 patents)
In 2010, AstraZeneca and The Brighams & Women’s Hospital, AstraZeneca’s licensor of the ‘152 patent (together the Plaintiffs), filed ten patent infringement actions involving Crestor in the US District Court for the District of Delaware, based on the ‘152 patent and the ‘618 patent. As previously reported in December 2010, the Court dismissed nine of the infringement actions for lack of subject-matter jurisdiction. In January 2011, the Plaintiffs appealed the dismissals to the Federal Circuit. The Plaintiffs also asked the District Court to stay the remaining action against Sandoz Inc. pending the outcome of the appeals. In March 2011, the Plaintiffs filed an opening brief in the Federal Circuit.
Palmetto Pharmaceuticals, LLC v. AstraZeneca Pharmaceuticals LP (Infringement Suit)
AstraZeneca Pharmaceuticals LP v. Palmetto Pharmaceuticals, LLC (Declaratory Judgment suit)
On 5 April 2011, Palmetto Pharmaceuticals, LLC (Palmetto) filed a patent infringement suit in the US District Court for the District of South Carolina asserting that AstraZeneca’s sales of Crestor induce infringement of Palmetto’s US patent no. 6,465,516 (the ‘516 patent), for which an Ex Parte Reexamination Certificate was issued on 5 April 2011.
On 7 April 2011, AstraZeneca filed a declaratory judgment action in the US District Court for the District of Delaware against Palmetto seeking a judgment of non-infringement and invalidity of Palmetto’s ‘516 patent.
On 26 April 2011, AstraZeneca filed a motion seeking dismissal or, alternatively, summary judgment of non-infringement in Palmetto’s patent infringement suit in the District of South Carolina.
Patent litigation – Canada
As previously reported, in February 2010, AstraZeneca received a Notice of Allegation from Pharmascience Inc. (PMS) in respect of Crestor substance patent no. 2,072,945 (the ‘945 patent) and formulation patent no. 2,313,783 (the ‘783 patent). AstraZeneca commenced an application in response in April 2010. A 4-day hearing will commence 9 January 2012.
As previously reported, in August 2010, AstraZeneca received a Notice of Allegation from Mylan Pharmaceuticals ULC (Mylan) in respect of the ‘945 and ‘783 patents and formulation patent 2,315,141 listed on the Canadian Patent Register for Crestor. In April 2011, AstraZeneca reached a comprehensive settlement resolving the litigation and as part of the agreement, Mylan may enter the Canadian market in April 2012, or earlier in certain circumstances.
Patent litigation – EU
In Portugal, in February and March 2011, the Appeal Court confirmed the preliminary injunctions to suspend the marketing authorisations granted to Teva Pharma Lda and Sandoz Farmaceutica Lda and dismissed the appeal. The suspension of the marketing authorisations will be maintained until a decision is rendered within the main administrative action.
Patent litigation – Brazil
AstraZeneca filed an administrative action against the administrative body ANVISA for a preliminary injunction for immediate suspension of the decision to grant market approval of Germed Farmacêutica Ltda’s (Germed) generic rosuvastatin and to revoke the marketing approval. The preliminary injunction was partially granted on 4 March 2011. On 15 March 2011, the preliminary injunction was dismissed by the court of first instance. AstraZeneca has appealed the decision. On 18 March 2011, AstraZeneca filed a patent infringement action against Germed with a request for a preliminary injunction. On 31 March 2011 the court denied AstraZeneca’s request. AstraZeneca appealed the decision and on 14 April 2011 the Reporting Judge of the Appeal Court rejected the request. AstraZeneca is awaiting the decision by the panel of the Appeal Court.
Iressa
Both the Osaka and Tokyo courts have issued decisions regarding the Iressa product liability litigation (the details of which have been previously reported). On 25 February 2011, the Osaka District Court issued its decision, dismissing one claim, and ordering AstraZeneca to pay approximately $670,000 for the remaining three claims, plus interest. AstraZeneca is appealing the Osaka decision. On 23 March 2011, the Tokyo District Court issued its decision dismissing one Iressa claim and ordering AstraZeneca and the Japanese Ministry of Health, Labour and Welfare to pay approximately $192,000 on the remaining two claims, plus interest. AstraZeneca is appealing the Tokyo decision.
Nexium (esomeprazole magnesium)
Patent litigation – US
Abbreviated New Drug Applications (ANDAs)
As previously reported, in January 2011, AstraZeneca entered into an agreement to settle the litigation with Dr Reddy’s Laboratories Ltd and Dr Reddy’s Laboratories Inc (together DRL), a prior ANDA filer. As a result of the DRL settlement and entry of a consent judgment, all of the DRL ANDA litigation was dismissed.
As to the remaining ANDA filers, as previously reported, in 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Sandoz Inc. (Sandoz) stating that Sandoz had submitted an ANDA for approval to market esomeprazole magnesium delayed-release capsules. In 2009, AstraZeneca commenced patent infringement litigation in the US District Court for the District of New Jersey. In 2009, the Court stayed the Sandoz patent infringement litigation. In view of the settlement with DRL in January 2011, the Court referred the matter back to Magistrate Judge Bongiovanni for scheduling and further proceedings. On 26 April 2011, the magistrate judge entered an order staying for one month the case-schedule she entered for this case on 14 April 2011.
In addition, as previously reported, in 2009, AstraZeneca received a Paragraph IV Certification notice-letter from Lupin Limited (Lupin) stating that Lupin had submitted an ANDA for approval to market esomeprazole magnesium delayed-release capsules. In October 2009, AstraZeneca commenced patent infringement litigation against Lupin in the US District Court for the District of New Jersey. In March 2010, the Court stayed the Lupin patent infringement litigation. In view of the settlement with DRL in January 2011, the Court has also referred the Lupin matter back to Magistrate Judge Bongiovanni for scheduling and further proceedings.
505(b)(2) New Drug Application for esomeprazole strontium capsules
As previously reported in December 2010, AstraZeneca received a Paragraph IV Certification notice-letter from Hanmi USA Inc. (Hanmi) stating that it had submitted a New Drug Application under section 505(b)(2) for FDA approval to market 20 and 40mg esomeprazole strontium capsules. Hanmi alleges non-infringement or invalidity of 11 patents listed in the FDA’s Orange Book with reference to Nexium. AstraZeneca commenced a patent infringement action against Hanmi in the United States District Court for the District of New Jersey in February 2011.
Patent litigation – Canada
As previously reported, AstraZeneca commenced a patent infringement action against Apotex Inc. (Apotex) in October 2010. Trial is set to begin in September 2013. In response to indications in the Canadian market that Apotex launched its generic esomeprazole magnesium product on 7 March 2011, AstraZeneca brought a motion for interim and interlocutory injunctions on 11 March 2011 to prevent such sales pending determination of the patent infringement action between the parties. On 19 April 2011, the Canadian Federal Court conducted a hearing on the motion. The Court reserved judgment.
In March 2011, Apotex served AstraZeneca with a claim for damages pursuant to Section 8 of the Patented Medicines (Notice of Compliance) Regulations. AstraZeneca is considering its response.
Patent Litigation – EU: 10-year countries
In the UK, Consilient Health Limited (Consilient) was granted approval for a generic esomeprazole product manufactured by Krka, d.d., Novo Mesto (Krka) in Slovenia. AstraZeneca initiated infringement proceedings against both companies in September 2010. Consilient and Krka have agreed not to launch their product pending the outcome of the main infringement case and AstraZeneca has undertaken to be liable for losses of the defendants and third parties if the injunction is lifted at a later date. The trial will start on 23 January 2012.
In the UK, in October 2010 AstraZeneca was served an invalidity case in which Ranbaxy (UK) Ltd (Ranbaxy UK) claimed that the Nexium esomeprazole magnesium patent (EP 1020461) and the esomeprazole magnesium trihydrate patent (EP 0984957) are invalid in the UK. Ranbaxy UK further requested the court to confirm that its generic esomeprazole product does not infringe either patent if launched in the UK. In March 2011, AstraZeneca filed suit against Ranbaxy UK claiming that its generic esomeprazole product infringes the Nexium esomeprazole magnesium patent (EP 1020461). The trial of the non-infringement part will commence on 7 June 2011. The invalidity part has been stayed pending the non-infringement trial.
In Germany, in December 2010 the court rejected AstraZeneca’s request for preliminary injunctions to prevent Krka, d.d., Novo Mesto, TAD Pharma GmbH, Abz-Pharma GmbH, CT Artzneimittel GmbH, ratiopharm GmbH, Teva GmbH, Hexal AG and Sandoz Pharmaceuticals GmbH from marketing and selling generic esomeprazole products in Germany. The decision was published in March 2011. AstraZeneca has decided not to appeal.
In Italy, in the Court of Turin, EG s.p.a. (a company in the Stada group) (EG) filed a law suit in June 2010 claiming the Nexium esomeprazole magnesium patent (EP 1020461) as invalid in Italy. These proceedings are in early stages. AstraZeneca has added a counterclaim of infringement against EG and in February 2011, AstraZeneca filed a request for and received a preliminary injunction against EG. The injunction was revoked in April 2011.
In February and March 2011, in the District Court of Trieste, AstraZeneca was granted preliminary injunctions against Teva Italia s.r.l., ratiopharm GmbH, ratiopharm Italia s.r.l., Doc Generici s.r.l., Sandoz Pharmaceuticals GmbH, Sandoz s.p.a. and Mylan s.p.a. The generic companies appealed and in March 2011 the injunctions were revoked. In February and March 2011 in Milan, generic companies including Mylan s.p.a., Sandoz s.p.a., Crinos s.p.a., Ranbaxy Italia s.p.a., Zentiva ks and Zentiva Italia s.r.l. initiated preliminary proceedings for declaratory judgments of non-infringement regarding esomeprazole magnesium patent (EP 1020461). Initial hearings are scheduled for May 2011. In February in Trieste, Mylan s.p.a. filed law suits claiming the Nexium esomeprazole magnesium patent (EP 1020461) and Nexium formulation patent (EP 0984773) as invalid in Italy. Separate hearings are set for 13 July 2011, and 15 July 2011 respectively.
In France, ratiopharm GmbH and Laboratoire ratiopharm S.A. (together ratiopharm) filed a law suit against AstraZeneca in August 2010 claiming the Nexium esomeprazole magnesium patent (EP 1020461) as invalid in France. ratiopharm has since withdrawn this law suit. Ethypharm S.A. filed a law suit against AstraZeneca in August 2010, claiming the Nexium esomeprazole magnesium patent (EP 1020461) and a cloud-point formulation patent (EP 1124539) as invalid in France. The next hearing in these cases will be in June 2011. In February 2011, Mylan S.A.S. filed a law suit against AstraZeneca claiming the Nexium esomeprazole magnesium patent (EP 1020461) as invalid in France. In April 2011, AstraZeneca filed a patent infringement suit against Ethypharm S.A. for infringement of the Nexium esomeprazole magnesium patent (EP1020461) and the Nexium process patent (EP 0773940) and requested a preliminary injunction against Ethypharm S.A. A preliminary injunction hearing is scheduled for May 2011.
Patent Litigation – EU: 6-year countries
In Denmark, in 2010, the court granted AstraZeneca preliminary injunctions preventing Sandoz from continuing to sell the product based on infringement of the Nexium esomeprazole magnesium patent (EP 1020461) and the Nexium process patent (EP 0773940). The injunctions were upheld by the Appeal Court in February 2011.
In Austria, in February 2011, the court denied AstraZeneca’s request for preliminary injunction to prevent ratiopharm Arzneimittel Vertriebs-GmbH from marketing and selling generic esomeprazole magnesium product in Austria. AstraZeneca has appealed this decision.
In Finland, in March 2011, AstraZeneca initiated a declaratory action requesting the District Court of Helsinki to confirm that Krka Sverige AB and ratiopharm GmbH would infringe a patent relating to esomeprazole if they were to commercialise generic esomeprazole magnesium products in Finland. AstraZeneca initiated a similar declaratory action against Ranbaxy (UK) Limited in December 2009 and the trial has been scheduled for 25 and 26 May 2011.
In Spain, AstraZeneca’s request for a preliminary injunction against Sandoz Farmacéutica S.A., Bexal Farmacéutica S.A., and Acost Comercial Genericpharma, S.L. (all in the Sandoz group) was initially granted by the court but revoked in July 2010 after a hearing. AstraZeneca has appealed this ruling and awaits the appellate decision. Separately, in AstraZeneca’s main patent infringement action against Sandoz Farmacéutica S.A., Bexal Farmacéutica S.A., and Acost Comercial Genericpharma, S.L., trial is scheduled for September 2011.
In Ireland, in August 2010, AstraZeneca initiated a main action against Krka, d.d., Novo Mesto and Pinewood Laboratories Ltd claiming that the sale and marketing of their generic esomeprazole magnesium products infringes the Nexium esomeprazole magnesium patent (EP 1020461). The defendants have filed a counter action claiming that EP 1020461 is invalid in Ireland.
In Lithuania and Estonia in March 2011, the Appeal Courts upheld the interlocutory injunctions against Krka, d.d., Novo Mesto to restrain this company from commercialising generic magnesium esomeprazole product in Lithuania and Estonia.
Patent litigation – Norway
In Norway, in July 2008 Hexal AG, Sandoz AS and Sandoz A/S initiated an invalidity case regarding two esomeprazole-related patents. In December 2009, the Court of Oslo invalidated a formulation patent but upheld a substance patent related to esomeprazole. In March 2011, the Appeal Court confirmed the decision from the Court of Oslo.
Patent Proceedings
As previously disclosed, the European Patent Office (EPO) published the grant of two patents that relate to Nexium (EP 1020461) and Nexium i.v. (EP 1020460) in July 2009. The period for filing Notices of Opposition to the grant of these new patents expired in April 2010. Thirteen Notices of Opposition have been filed in relation to EP 1020461 and six Notices of Opposition in relation to EP 1020460. The EPO has now issued summonses to attend oral hearing proceedings relating to both sets of oppositions. Oral proceedings relating to EP 1020461 will be held on 7, 8 and 9 June 2011. Oral proceedings relating to EP 1020460 will be held on 30 June and 1 July 2011.
Pulmicort Respules (budesonide inhalation suspension)
In January 2011, the Court of Appeals for the Federal Circuit denied Apotex Group’s petition for an en banc rehearing of their appeal of the preliminary injunction entered by the US District Court for the District of New Jersey.
In March 2011, the Court ordered the patent case against Sandoz, Inc. to be consolidated with the already consolidated actions against Breath Ltd. (now Watson Pharmaceuticals, Inc.) and the Apotex Group. A new scheduling order for the consolidated cases was subsequently entered by the Court. No trial date has been set.
Seroquel (quetiapine fumarate)
Sales and marketing practices
In March 2011, AstraZeneca completed a previously announced settlement in principle to resolve Seroquel-related consumer protection and deceptive trade practice claims under state law with 37 states and Washington, DC as part of the National Association of Attorneys General for $68.5m in the aggregate (as to which AstraZeneca previously had established a provision).
As previously reported, the states of Alaska, Arkansas, Mississippi, Montana, New Mexico, South Carolina and Utah have sued AstraZeneca under various state laws generally alleging that AstraZeneca made false and/or misleading statements in connection with the marketing and promotion of Seroquel. In February 2011, the state of Utah filed an amended complaint after a federal judge had dismissed its complaint in December 2010.
In March 2011, the US Court of Appeals for the Eleventh Circuit affirmed the November 2008 dismissal by the Seroquel Multi-District Litigation (MDL) court of a putative nationwide class action lawsuit brought on behalf of all individual and non-governmental third-party payers of Seroquel, which had alleged that AstraZeneca promoted Seroquel for off-label uses and misled class members into believing that Seroquel was superior to lower-cost alternative medicines.
Product liability
As of 31 March 2011, approximately 26,085 claims have been settled in principle.
As of 31 March 2011, AstraZeneca was aware of approximately 2,600 Seroquel US product liability claims that have not been settled in principle. The majority of these remaining claims are pending in the New Jersey, New York and California state courts, although some claims are pending in a handful of other state courts and in the federal MDL.
As of 31 March 2011, legal defence costs of approximately $743m have been incurred in connection with Seroquel-related product liability claims. As previously disclosed, AstraZeneca settled its claims against several of its insurers for a substantial part of those legal defence costs.
As previously disclosed, disputes continue with other insurers about the availability of coverage under certain insurance policies for legal defence costs and potential damages amounts. As of 31 March 2011, out of the legal defence costs of $743m mentioned above, AstraZeneca believes that approximately $128m is covered by these other insurance policies.
Patent litigation – Brazil
As previously reported, in January 2006 AstraZeneca filed a lawsuit before the Federal Courts of Rio de Janeiro seeking judicial declaration extending the term of one of its patents from 2006 to 2012. In March 2011, the Federal Courts of Rio de Janeiro denied AstraZeneca’s request for an extension. AstraZeneca has decided not to appeal.
Seroquel XR
Patent litigation – US
As previously reported, in December 2010, Torrent Pharmaceuticals Ltd. (Torrent) filed a Motion for Clarification and Reconsideration of the decision by the US District Court for the District of New Jersey interpreting claims of the Seroquel XR formulation patent (US patent no. 5,948,437). In February 2011, the Court denied Torrent’s motion.
As previously reported, in July 2010, AstraZeneca received a Paragraph IV Certification notice-letter from Osmotica Pharmaceutical Corporation (Osmotica) indicating that it was seeking approval to market generic versions of 200, 300 and 400mg Seroquel XR tablets before the expiration of US Patent No. 5,948,437 (the '437 patent). In August 2010, AstraZeneca filed a law suit in the US District Court for the District of New Jersey against Osmotica. In April 2011, AstraZeneca received another Paragraph IV Certification notice-letter from Osmotica indicating that it was seeking approval to market generic versions of 50 and 150mg Seroquel XR tablets before the expiration of the '437 patent.
As previously reported, in October 2010, AstraZeneca received a Paragraph IV Certification notice-letter from Mylan Pharmaceuticals Inc. (Mylan) indicating that it was seeking approval to market generic versions of 200mg Seroquel XR tablets before the expiration of the '437 patent. In October 2010, AstraZeneca filed a lawsuit in the US District Court for the District of New Jersey against Mylan. In April 2011, AstraZeneca received another Paragraph IV Certification notice-letter from Mylan indicating that it was seeking approval to market generic versions of 50, 150, 300 and 400mg Seroquel XR tablets before the expiration of the '437 patent.
Patent litigation – EU
In the UK, Teva UK Limited and Teva Pharmaceuticals Limited (together, Teva) issued revocation proceedings against AstraZeneca in December 2010. Teva claims that the formulation patent for Seroquel XR (EP 0907364) is invalid in the UK. Similar revocation actions were filed by Accord Healthcare Limited, Intas Pharmaceuticals Limited, Hexal AG and Sandoz Ltd in March and April 2011.
In Hungary, AstraZeneca was notified that Teva Pharmaceuticals Limited and Teva Gyógyszergyár Zrt (together Teva) had filed a request for nullity of the Hungarian formulation patent for Seroquel XR with the Hungarian Patent Office in January 2011. Teva claims that Hungarian patent no. 225 152 should be declared null and void. AstraZeneca is preparing its response.
In Germany, Teva Deutschland GmbH (Teva) issued revocation proceedings against AstraZeneca in February 2011. Teva claims that the formulation patent for Seroquel XR (EP 0907364) is invalid in Germany. AstraZeneca filed its response in March 2011.
Synagis (palivizumab)
As previously reported, this matter concerned MedImmune’s action seeking a declaratory judgment that the Queen patents owned by PDL BioPharma, Inc. (PDL) are invalid and/or not infringed by either Synagis and/or motavizumab, and that no further royalties are owed under a patent licence MedImmune and PDL signed in 1997. The matter was settled in February 2011 with PDL agreeing to pay MedImmune $92.5m ($65m in February 2011 and $27.5m in February 2012). In addition, PDL agreed to the release of approximately $9m in escrow to MedImmune. MedImmune will pay no further royalties to PDL relative to Synagis.
Vimovo (fixed-dose combination of naproxen and esomeprazole)
In April 2010, the FDA approved Vimovo for marketing in the US. Vimovo was co-developed by POZEN Inc. (Pozen) and AstraZeneca via a collaboration agreement originating in August 2006. AstraZeneca commenced marketing of Vimovo in the US in the third quarter of 2010. Seven patents are listed in the FDA’s Orange Book referencing Vimovo.
In March 2011, the FDA’s web-site reported a filing of a first Abbreviated New Drug Application (ANDA) containing Paragraph IV Certifications and seeking approval to market generic copies of the 375/20 mg and 500/20 mg doses of Vimovo.
On 14 March 2011, AstraZeneca received a Paragraph IV Certification Notice-letter in respect of Vimovo from Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (together, DRL). DRL certified under Paragraph IV in its ANDA that US Patent No. 6,926,907 (the ‘907 patent) is invalid, unenforceable, and/or not infringed. AstraZeneca licenses the ‘907 patent from Pozen and, with a February 2023 expiry, the patent is the last expiring of the seven Orange Book listed patents. On 21 April 2011, AstraZeneca and Pozen sued DRL in the US District Court for the District of New Jersey.
Zomig (zolmitriptan)
Patent litigation – Canada
In April 2011, AstraZeneca received a Notice of Allegation from Apotex Inc. (Apotex) in respect of Canadian Zomig product-by-process patent no. 2,572,508 listed on the Canadian Patent Register for Zomig. Apotex did not address the listed 2,064,815 substance patent (the ‘815 patent), which expires in June 2011. Therefore, Apotex cannot receive a marketing approval before expiration of the ‘815 patent. AstraZeneca is evaluating the allegations.
Other Commercial Litigation
Dr. George Pieczenik v. AstraZeneca Pharmaceuticals LP, AstraZeneca LP, et al.
On 23 March 2011, the District Court granted the defendants' joint motion to dismiss the plaintiff's claims with prejudice. On 24 March 2011, the plaintiff filed a pro forma Notice of Appeal from the order granting dismissal of the patent infringement and Racketeering Institution and Corrupt Organisation Act claims and denying the motion for recusal.
Resonant Biotechnologies, LLC v. AstraZeneca LP, et al.
In April 2011, AstraZeneca LP, a number of AstraZeneca entities (collectively AstraZeneca) and multiple other entities were named in a patent infringement lawsuit filed in the United States District Court for the District of Delaware. Plaintiff purports to be the exclusive licensee of US patent no. 6,218,194 (the ‘194 Patent) which is titled “Analytical Methods And Apparatus Employing An Optical Sensor Device With Refractive Index Modulation.” Specific to AstraZeneca, Plaintiff alleges that AstraZeneca infringes the ‘194 patent “by using the Corning Epic® system”, described in the complaint as a “high-throughput label-free screening device.” Plaintiff seeks monetary relief. AstraZeneca is considering its response.
Network Signatures, Inc. v. AstraZeneca Pharmaceuticals LP
In April 2011, AstraZeneca Pharmaceuticals LP was named in a patent infringement law suit filed in the United States District Court for the Central District of California. The plaintiff purports to have title to United States Patent No. 5,511,122 (the ‘122 patent) entitled “Intermediate Network Authentication.” The plaintiff alleges that AstraZeneca’s use of “digital certificates and digital signatures implemented through the use of public key infrastructure to facilitate communication with its employees and customers” infringes the ‘122 patent. The plaintiff seeks monetary and injunctive relief. AstraZeneca is considering its response.
Other Pricing Litigation
Average Wholesale Price Litigation
In February 2011, the US District Court for the District of Massachusetts granted final approval of two previously announced settlements that resolve class action law suits brought by Massachusetts-only and multi-state classes of payers of Zoladex for $13m and $90m, respectively (which amounts have been paid by AstraZeneca).
340B Class Action Litigation
In March 2011, the US Supreme Court reversed a decision of the US Court of Appeals for the Ninth Circuit and held that covered entities under the 340B program do not have enforceable rights to sue as third party beneficiaries of the Pharmaceutical Pricing Agreement thereby dismissing this case and entitling AstraZeneca, and the other defendants, to judgment as a matter of law.
Other Anti-trust Litigation and Investigations
Drug importation anti-trust litigation
As previously disclosed, in August 2004, Californian retail pharmacy plaintiffs filed an action in the Superior Court of California alleging a conspiracy by AstraZeneca and approximately 15 other pharmaceutical manufacturer defendants to set the price of drugs sold in California at or above the Canadian sales price for those same drugs and otherwise restrict the importation of pharmaceuticals into the US.
In March 2011, the Superior Court of California granted the defendants’ motion for summary judgment on grounds that the plaintiffs failed to prove their allegations of a conspiracy and that the defendants were entitled to judgment as a matter of law. In April 2011, the plaintiffs appealed the decision to the Court of Appeal of the State of California.
Other Actual and Threatened Government Investigations and Related Litigation
Foreign Corrupt Practices Act
As previously reported, AstraZeneca has received inquiries from the US Department of Justice and the Securities and Exchange Commission in connection with an investigation into Foreign Corrupt Practices Act issues in the pharmaceutical industry across several countries. AstraZeneca is co-operating with these inquiries and is investigating, among other things, sales practices, internal controls, certain distributors, and interactions with healthcare providers, institutions, and other government officials. AstraZeneca is investigating inappropriate conduct in certain countries, including China. AstraZeneca's investigations are ongoing and additional governmental authorities could become involved. It is not currently possible to predict the scope, duration or outcome of these matters, which could involve the payment of fines or other penalties.
Tax
Transfer pricing and other international tax contingencies
On 28 March 2011, AstraZeneca announced that HM Revenue & Customs in the UK and the US Internal Revenue Service had agreed the terms of an Advance Pricing Agreement regarding transfer pricing arrangements for AstraZeneca’s US business covering the 13 year period from 2002 to the end of 2014. The Company also announced that an agreement had been reached on a related valuation matter arising on integration of the legacy Astra and legacy Zeneca US businesses in 2000 following the global AstraZeneca merger in 1999. The provision for US transfer pricing and related valuation matters is a substantial proportion of the total net accrual for transfer pricing and other international tax contingencies of $2,310m disclosed in Note 25 of the Financial Statements on page 195 of the AstraZeneca Annual Report and Form 20-F Information 2010.
Based on the above mentioned agreements, AstraZeneca now expects to pay a net amount of $1.1bn to resolve all US transfer pricing and related valuation matters for the period from 2000 to the end of 2010 and $540m of provisions have been released to earnings in the first quarter. The net amount payable of $1.1bn reflects expected US tax payments and updated estimates of corresponding tax refunds in other jurisdictions.
Matters disclosed in respect of the second quarter of 2011 and July 2011
Arimidex
Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) Regulations—Canada (NOC Proceedings)
Between 31 May and 2 June 2011, the Canadian Federal Court conducted a hearing in the previously disclosed NOC Proceeding, filed by AstraZeneca against Mylan Pharmaceuticals ULC in respect of AstraZeneca’s Canadian substance Patent No. 1,337,420 (the ‘420 patent).
In May 2011, AstraZeneca commenced a NOC Proceeding against Teva Canada Limited in respect of the ‘420 patent.
In May 2011, AstraZeneca commenced a NOC Proceeding against Pharmascience Inc. in respect of the ‘420 patent.
In June 2011, AstraZeneca received a Notice of Allegation (NOA) from Apotex Inc. under the Canadian Patented Medicines (Notice of Compliance) regulations with respect to the ‘420 patent. AstraZeneca commenced a NOC Proceeding in response in July 2011.
Atacand
Patent litigation – EU
In Portugal, in addition to the previously disclosed cases regarding Sandoz Farmacêutica Lda. (Sandoz), Teva Pharma – Produtos Farmacêuticos Lda., PTR Pharma Consulting Lda., Laboratórios Azevados – Industria Farmacêutica, Ceamed Servico e Consultadoria Farmacêutica Lda and Labesfal – Laboraórios Almiro S.A. (Labesfal), approvals have been granted for generic candesartan cilexetil and candesartan cilexetil and hydrochlorothiazide products to companies such as Actavis Group PTC ehf, Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Ranbaxy Portugal - Comércio e Desenvolvimento de Produtos Farmacêuticos, Unipessoal Lda., Mylan Lda., Laboratórios Anova - Produtos Farmacêuticos, Lda, Krka d.d., Novo mesto, and Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Preliminary injunctions to suspend those marketing approvals as well as correspondent administrative main actions have been filed during the second quarter of 2011. In July 2011, the Court of Appeal decided to suspend the marketing approvals for Sandoz and Labesfal until the main actions have been decided.
Atacand Plus (candesartan cilexetil / hydrochlorothiazide)
Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) Regulations — Canada (NOC Proceedings)
In May 2011, AstraZeneca settled the previously disclosed NOC Proceeding pending with Sandoz Canada Inc. (Sandoz) with respect to Canadian Patent Nos. 2,040,955 (the ‘955 substance patent), 2,083,305 (the ‘305 formulation patent) and 2,125,251 (the ‘251 patent). The settlement resolves the litigation and allows Sandoz to enter the Canadian market on 23 September 2012, or earlier, in certain circumstances.
Patent proceedings – EU
An Atacand Plus patent, European Patent No. 753 301 (the ’301 patent), has been the subject of opposition proceedings before the European Patent Office (EPO). Takeda owns the ’301 patent and AstraZeneca holds a licence to the patent. The ’301 patent claims a pharmaceutical composition comprising candesartan cilexetil and hydrochlorothiazide. The ’301 patent was maintained as granted by the Opposition Division of the EPO in a decision delivered in September 2007. The two opponents, Hexal AG and Strawman Ltd, appealed the decision of the Opposition Division to a Technical Board of Appeal at the EPO.
Oral proceedings were held before a Technical Board of Appeal at the EPO on 5 July 2011. At the conclusion of the proceedings, the Technical Board of Appeal decided to revoke Takeda's ‘301 patent. A written decision will be issued in due course. Takeda has several patents covering Atacand Plus in Europe and the ‘301 patent is not the only protection for the product in Europe.
Crestor (rosuvastatin calcium)
Patent litigation – US
Section 505(b)(2) New Drug Application for rosuvastatin zinc tablets and US Patent Nos. RE37,314 (the ‘314 patent), 6,858,618 (the ‘618 patent) and 7,030,152 (the ‘152 patent)
The US District Court for the District of Delaware set a modified schedule, including a new trial date of 24 September 2012, in the previously disclosed patent infringement action by AstraZeneca and Shionogi Seiyaku Kabushiki Kaisha against Watson Laboratories, Inc. for alleged infringement of the ‘314 patent.
Palmetto Pharmaceuticals, LLC v. AstraZeneca Pharmaceuticals LP (Infringement action)
AstraZeneca Pharmaceuticals LP v. Palmetto Pharmaceuticals, LLC (Declaratory Judgment action)
In April 2011, AstraZeneca filed a motion in the US District Court for the District of South Carolina seeking dismissal or, alternatively, summary judgment of non-infringement, responding to the patent infringement suit Palmetto Pharmaceuticals, LLC (Palmetto) filed against AstraZeneca in the US District Court for the District of South Carolina in April 2011, with respect to Palmetto’s US Patent No. 6,465,516 and its re-examination certificate (collectively the ‘516 patent). In May 2011, Palmetto filed an Amended Complaint in response to AstraZeneca’s motion. In June 2011, based on the Amended Complaint, AstraZeneca filed a second motion in the South Carolina District Court seeking dismissal or, alternatively, summary judgment of non-infringement of the ‘516 patent.
In April 2011, Palmetto filed with the US District Court for the District of Delaware a motion to dismiss, stay, or in the alternative transfer the declaratory judgment suit to the US District Court for the District of South Carolina. In May 2011, the US District Court for the District of Delaware entered a stipulation and consent order staying the declaratory judgment suit until the South Carolina District Court resolves the pending second motion for dismissal or summary judgment. AstraZeneca and Palmetto also agreed that if the South Carolina motion does not result in a dismissal, AstraZeneca would not oppose a motion to transfer the declaratory judgment suit to the US District Court for the District of South Carolina.
Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) Regulations — Canada (NOC Proceedings)
In July 2011, AstraZeneca received a Notice of Allegation (NOA) from Laboratoire Riva Inc. (Riva) under the Canadian Patented Medicines (Notice of Compliance) regulations respecting the 2,072,945 substance patent (the ‘945 patent), the 2,313,783 formulation patent (the ‘783 patent) and the 2,315,141 formulation patent (the ‘141 patent). AstraZeneca is considering the allegations and whether to commence a proceeding.
Patent litigation/Data exclusivity – Brazil
In May 2011, AstraZeneca filed a patent infringement action against EMS S/A (EMS) with a request for a preliminary injunction. In June 2011, the court granted AstraZeneca’s request. EMS appealed the decision and the Reporting Judge of the Appeal Court suspended the effects of the preliminary injunction. Later in June 2011, the Reporting Judge reinstated the preliminary injunction. In July 2011, the new Reporting Judge suspended the effects of the preliminary injunction. In July 2011, AstraZeneca sued the health authority ANVISA in the first instance court in Brasilia and requested a preliminary injunction. AstraZeneca requests that ANVISA shall not take advantage of the data referring to Crestor (rosuvastatin calcium), refrain from granting new marketing approvals and cancel those previously approved. AstraZeneca claims that AstraZeneca’s exclusivity for the data should last for 10 years beginning from the granting of the marketing approval i.e. until February 2014. On 22 July 2011, the Court denied the request for the preliminary injunction.
Patent litigation – Singapore
AstraZeneca was notified by the Health Sciences Authority in Singapore that Sanofi-Aventis Singapore Pte Ltd. (Sanofi) has applied for a product licence for a generic rosuvastatin product alleging that its product does not infringe AstraZeneca’s Singapore Patent No. SG 89993. In June 2011, AstraZeneca filed an action for a declaration that Singapore Patent No. SG 89993 would be infringed by Sanofi if exercising the product licence.
Entocort (budesonide)
Patent litigation – US
As previously disclosed, in 2008, AstraZeneca sued Mylan Pharmaceuticals, Inc. (Mylan) for infringement of US Patent Nos. 6,423,340 (the ‘340 patent) and 5,643,602 (the ‘602 patent) in the US District Court for the District of Delaware. In May 2010, AstraZeneca proceeded to trial against Mylan before Judge Gregory Sleet on the sole issue of infringement of the ’602 patent. In June 2011, Judge Sleet issued his opinion, finding that Mylan’s generic budesonide product did not infringe the ‘602 patent. On 18 July 2011, AstraZeneca filed a Notice of Appeal.
Faslodex (fulvestrant)
Patent litigation – US
As previously disclosed, in January 2010, AstraZeneca filed a patent infringement action against Teva Parenteral, Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd (together, Teva) in the US District Court for the District of Delaware for infringement of US Patent Nos. 6,774,122 and 7,456,160. In June 2011, the case was dismissed without prejudice due to withdrawal of Teva’s Abbreviated New Drug Application (ANDA) for its fulvestrant injection product.
Nexium (esomeprazole magnesium)
Patent litigation – US
In May 2011, AstraZeneca entered into an agreement with Sandoz Inc. (Sandoz) to settle AstraZeneca’s previously disclosed patent infringement suit against Sandoz in the US District Court for the District of New Jersey for patent infringement in respect of Sandoz’s ANDA for esomeprazole magnesium delayed-release capsules. As part of the settlement agreement, AstraZeneca has granted Sandoz a licence to enter the US market with its generic esomeprazole magnesium on 27 May 2014, subject to regulatory approval, or earlier in certain circumstances.
The terms of AstraZeneca's US Nexium settlement with Sandoz are generally consistent with AstraZeneca's previous US Nexium settlements. The US District Court for the District of New Jersey has dismissed the Nexium patent litigation pending against Sandoz.
Product liability – US
Since April 2011, AstraZeneca has been named as a defendant in three product liability lawsuits involving 99 plaintiffs alleging bone deterioration, loss of bone density, and/or bone fractures caused by Nexium and/or Prilosec. The first lawsuit, filed in the United States District Court for the Southern District of Texas by a single plaintiff, was dismissed. AstraZeneca intends to vigorously defend itself against these claims.
Abbreviated New Drug Applications (ANDAs)
In June 2011, AstraZeneca received a Paragraph IV Certification notice letter from Hetero Drug Limited Unit III (Hetero) stating that it had submitted an ANDA for approval to market 20 and 40mg esomeprazole magnesium capsules. Hetero alleges non-infringement and/or invalidity of 11 patents listed in the FDA’s Orange Book with reference to Nexium.
Patent litigation – Canada
As previously disclosed, in October 2010, AstraZeneca commenced a patent infringement action against Apotex Inc. alleging infringement of five Canadian patents related to Nexium. AstraZeneca brought a motion seeking both interim and interlocutory injunctions. The Court denied the motion and AstraZeneca’s appeal, heard in June 2011, was dismissed.
Patent Litigation – EU: 10-year countries
As previously disclosed, in the UK, in October 2010, AstraZeneca was served an invalidity case in which Ranbaxy (UK) Ltd (Ranbaxy UK) claimed that the Nexium esomeprazole magnesium patent (EP 1020461) and the esomeprazole magnesium trihydrate patent (EP 0984957) are invalid in the UK. Ranbaxy UK further requested the court to confirm that its generic esomeprazole product would not infringe either patent if launched in the UK. In March 2011, AstraZeneca filed suit against Ranbaxy UK claiming that its generic esomeprazole product infringes the Nexium esomeprazole magnesium patent (EP 1020461). The trial of the non-infringement/infringement part took place in June 2011. On 15 July 2011, the court confirmed that Ranbaxy’s generic esomeprazole product does not infringe EP 1020461. The invalidity part has been stayed pending the non-infringement trial.
As previously disclosed, in France, in April 2011, AstraZeneca filed patent infringement suit against Ethypharm S.A. (Ethypharm) for infringement of the Nexium esomeprazole magnesium patent (EP 1020461) and the Nexium process patent (EP 0773940) and requested a preliminary injunction against Ethypharm to enjoin the manufacture and sale of Ethypharm’s generic esomeprazole magnesium products. A preliminary injunction hearing regarding EP 0773940 took place in May 2011, and in June 2011 the court denied the request. AstraZeneca has appealed. A preliminary injunction hearing against Ethypharm regarding the esomeprazole magnesium trihydrate patent (EP 0984957) took place in June 2011, and in July 2011 the court denied the request. In July 2011, AstraZeneca filed a patent infringement suit against Ethypharm for infringement of EP 0984957.
In Sweden, AstraZeneca’s request for a preliminary injunction prohibiting Krka Sverige AB from commercialising its generic esomeprazole product in Sweden was rejected by the court in June 2011. AstraZeneca has decided not to appeal this decision.
In the Netherlands, on 6 July 2011, the District Court of the Hague upheld the Optical Purity patent (EP 1020461) as valid. Sandoz B.V./Hexal AG (both within the Sandoz group) and Stada Arzneimittel AG/Centrafarm Services B.V. (both within the Stada group) are able to appeal within three months.
Patent Litigation – EU: 6-year countries
As previously disclosed, in Austria, in February 2011, the court denied AstraZeneca’s request for a preliminary injunction to prevent ratiopharm Arzneimittel Vertriebs-GmbH from marketing and selling a generic esomeprazole magnesium product in Austria. In June 2011, the Appeal Court rejected AstraZeneca’s appeal and AstraZeneca has decided not to appeal this decision. As previously disclosed, AstraZeneca requested a preliminary injunction against Krka, d.d., Novo Mesto. In June 2011, the court denied AstraZeneca’s request and AstraZeneca has decided not to appeal this decision.
As previously disclosed, in Finland, AstraZeneca initiated a declaratory action requesting the District Court of Helsinki to confirm that Ranbaxy (UK) Limited would infringe a patent relating to esomeprazole if commercialising generic esomeprazole magnesium products in Finland. The trial took place in May 2011. In June 2011, the Court denied AstraZeneca’s claim. AstraZeneca has the opportunity to appeal until the end of July. In July 2009, AstraZeneca initiated similar declaratory actions against Sandoz Oy AB and Sandoz A/S. In September 2009, Hexal AG, Sandoz Oy AB and Sandoz A/S (all in the Sandoz group) initiated an invalidity case requesting the court to invalidate the same patent. These cases will be heard together in September 2011.
Patent litigation – Norway
As previously disclosed, in Norway, in December 2010, the Court of Oslo granted a preliminary injunction prohibiting Krka Sverige AB from commercialising its generic esomeprazole product in Norway. In June 2011, the Appeal Court confirmed the decision of the Court of Oslo.
Patent litigation – Singapore
In July 2011, AstraZeneca initiated patent infringement proceedings against Ranbaxy (Malaysia) SDN BHD based on an esomeprazole-related patent.
Patent litigation – Turkey
In July 2011, AstraZeneca initiated patent infringement proceedings against Logus Ilac, Integri Ilac, Vem Ilac, Biofarma Ilac and Sandoz Ilac San.ve Tic.AS based on esomeprazole-related patents.
Patent Proceedings – EU
As previously disclosed, the European Patent Office (EPO) published the grant of two patents that relate to Nexium (EP 1020461) and Nexium i.v. (EP 1020460) in July 2009. The period for filing Notices of Opposition to the grant of these new patents expired in April 2010. Thirteen Notices of Opposition were filed in relation to EP 1020461 and six Notices of Opposition in relation to EP 1020460.
Oral proceedings relating to EP 1020461 were held before the Opposition Division of the EPO in June 2011, when the Opposition Division of the EPO decided to revoke EP 1020461 following thirteen oppositions from generic drug manufacturers. The decision is appealable. A written decision will be delivered in due course by the EPO.
Oral proceedings relating to EP 1020460 were held on 30 June and 1 July 2011. On 1 July 2011, the Opposition Division of the EPO decided to revoke EP 1020461 following six oppositions from generic drug manufacturers. The decision is appealable. A written decision will be delivered in due course by the EPO.
Pulmicort Respules (budesonide)
Patent litigation – US
In May 2011, AstraZeneca received a Paragraph IV Certification notice letter from Watson Laboratories, Inc. (Watson) indicating that it is seeking approval to market a generic version of the 1.0 mg/2.0 ml dosage form of Pulmicort Respules before the expiration of US Patent Nos. 6,598,603, 6,899,099 and 7,524,834. In June 2011, AstraZeneca filed a patent infringement suit against Watson in the US District Court for the District of New Jersey.
Seroquel (quetiapine fumarate)
Product liability
As of July 2011, approximately 28,461 claims have been settled in principle, 28,446 of which are subject to written agreements.
As of July 2011, AstraZeneca was aware of approximately 250 Seroquel US product liability claims that have not been settled in principle. The majority of these remaining claims are pending in California courts, although some claims are pending in other state and federal courts including the multi-district litigation court. The Company has increased its provision by $55m to account for the current and anticipated future settlement costs regarding the Seroquel product liability claims, past and future defence costs associated with defending the claims since the fourth quarter 2010, and the previously disclosed provision regarding certain Seroquel state attorney general claims. The amount of this provision remains subject to a number of significant uncertainties, as previously disclosed. It is not possible at this time to provide any reasonable indication as to when remaining claims may be settled. Furthermore, it is possible that the actual cost of ultimately settling or adjudicating the Seroquel product liability claims may differ significantly from the total amount provided.
As of 30 June 2011, legal defence costs of approximately $749m have been incurred in connection with Seroquel-related product liability claims. As previously disclosed, AstraZeneca settled its claims against several of its insurers for a substantial part of those legal defence costs.
As previously disclosed, disputes continue with other insurers about the availability of coverage under certain insurance policies for legal defence costs and potential damages amounts. As of 30 June 2011, out of the legal defence costs of $749m mentioned above, AstraZeneca believes that approximately $134m is covered by these other insurance policies.
While no insurance receivable can be recognised under applicable accounting standards at this time, AstraZeneca believes that it is more likely than not that further insurance recoveries will be secured under the additional policies, but there can be no assurance of this or the amount of any potential future recovery.
Patent litigation – EU
In Portugal, as previously disclosed, in July and November 2010, AstraZeneca filed preliminary injunction proceedings with the aim of suspending the effect of the retail price decision granted to Bluescience Unipessoal Lda and Cinfa Portugal Lda as well as corresponding main actions. In June 2011, a negative decision on the suspension of the retail prices was granted. AstraZeneca has appealed the decision. In another case, where the parties are waiting for a final decision regarding the suspension of the marketing approvals and the suspension of the retail prices granted to Generis Farmacêutica S.A., KRKA Farmacêutica Sociedade Unipessoal Lda (KRKA) and Mer Medicamentos Lda, KRKA has obtained reimbursement approval and now launched its product. AstraZeneca is evaluating its options.
In Italy, AstraZeneca found out in June 2011, that the Italian Patent Office (IPO) had erroneously decided that AstraZeneca’s supplementary protection certificate for the Seroquel substance patent had lapsed due to non-payment. After AstraZeneca had informed the IPO of its mistake, the IPO issued a Certificate of Correction. AstraZeneca was informed of generics preparing for launch and filed a motion for a preliminary injunction in the Court of Milan against Teva Italia S.p.A, Mylan S.p.A, Doc Generici s.r.l, EG S.p.A and Sandoz S.p.A. A hearing is scheduled for 23 August 2011.
Seroquel XR
Patent litigation – US
In April 2011, AstraZeneca filed a lawsuit in the US District Court for the District of New Jersey against Osmotica Pharmaceutical Corporation, which had sent a Paragraph IV Certification notice letter to AstraZeneca indicating that it was seeking approval to market generic versions of Seroquel XR before the expiration of US Patent No. 5,948,437 (the ‘437 patent).
In April 2011, AstraZeneca filed a lawsuit in the US District Court for the District of New Jersey against Mylan Pharmaceuticals Inc. and Mylan Inc. (Mylan), which had sent a Paragraph IV Certification notice letter to AstraZeneca indicating that it was seeking approval to market generic versions of Seroquel XR before the expiration of the ‘437 patent.
In May 2011, following conversion of the Paragraph IV Certification of Biovail Laboratories International SRL, Biovail Corporation and BTA Pharmaceuticals, Inc. (together, Biovail) to a Paragraph III Certification, the Court entered a consent order dismissing without prejudice the pending patent infringement case against Biovail in the US District Court for the District of New Jersey for Biovail’s Abbreviated New Drug Application (ANDA) seeking approval to market generic copies of Seroquel XR.
In May 2011, AstraZeneca received a Paragraph IV Certification notice letter from Intellipharmaceutics Corp. (IPC) seeking approval to market generic versions of 150, 200, 300 and 400mg Seroquel XR before the expiration of the ‘437 patent. In its notice letter, IPC claims that certain of the claims of the ‘437 patent will not be infringed by its proposed ANDA products and that the ’437 patent is invalid. In May 2011, AstraZeneca filed a lawsuit in the US District Court for the District of New Jersey against IPC alleging infringement of the ‘437 patent. In June 2011, IPC filed a motion seeking to have the case dismissed for lack of personal jurisdiction or alternatively, for the action to be transferred to New York. AstraZeneca filed an amended complaint in the New Jersey suit against IPC adding Intellipharmaceutics International Inc. (IPC-I) as a co-defendant.
Also in June 2011, AstraZeneca filed a second, essentially identical lawsuit in the US District Court for the Southern District of New York against IPC and IPC-I alleging infringement of the ‘437 patent.
Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) regulations—Canada (NOC Proceedings)
In June 2011, AstraZeneca received a Notice of Allegation from Teva Canada Limited (Teva) in respect of Seroquel XR Canadian formulation Patent No. 2,251,944 listed on the Canadian Patent Register. Teva alleges certain of the claims will not be infringed by its generic version of 50mg Seroquel XR and that the patent is invalid. AstraZeneca is considering the allegations and whether to initiate a NOC Proceeding.
Patent litigation – EU
In the Netherlands, Accord Healthcare B.V., Accord Healthcare Ltd, Sandoz B.V. and Hexal AG issued revocation proceedings against AstraZeneca in June 2011, claiming that the formulation patent for Seroquel XR (EP 0907364) is invalid in the Netherlands. The court has scheduled a trial in January 2012.
Symbicort (fixed-dose combination of budesonide and formoterol)
Patent litigation – Turkey
In July 2011, AstraZeneca initiated patent infringement proceedings against Logus Ilac in relation to a budesonide/formoterol related patent.
Vimovo (fixed-dose combination of naproxen and esomeprazole)
In April 2011, AstraZeneca and Pozen, Inc (AstraZeneca’s licensor) filed a patent infringement suit in the US District Court for the District of New Jersey against Dr. Reddy’s Laboratories and Dr. Reddy’s Laboratories, Ltd. (together, DRL), which had sent a Paragraph IV Certification notice letter indicating that they were seeking approval to market generic versions of Vimovo tablets before expiration of US Patent No. 6,926,907. In June 2011, DRL filed an answer to the patent infringement suit.
AstraZeneca received a Paragraph IV Certification notice letter from Lupin Ltd. (Lupin) dated 10 June 2011, indicating that it is seeking approval to market generic versions of 375/20mg and 500/20mg Vimovo tablets before expiration of US Patent Nos. 5,714,504; 5,900,424; 6,369,085; 6,875,872; 6,926,907; 7,411,070; and 7,745,466. AstraZeneca is evaluating Lupin’s certifications. On 25 July 2011, AstraZeneca and Pozen, Inc (AstraZeneca’s licensor) filed a patent infringement suit in the US District Court for the District of New Jersey against Lupin for patent infringement.
Zomig (zolmitriptan)
Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) regulations—Canada (NOC Proceedings)
In June 2011, AstraZeneca discontinued the NOC Proceeding brought in response to the Notice of Allegation from Apotex Inc. respecting Canadian Zomig product-by-process Patent No. 2,572,508.
Other Commercial Litigation
Verus Pharmaceuticals litigation
As previously disclosed, in May 2009, Verus Pharmaceuticals Inc. (Verus) filed a lawsuit against AstraZeneca AB and its subsidiary, Tika Läkemedel AB (Tika), alleging breaches of several related collaboration agreements to develop novel paediatric asthma treatments. In August 2010, the United States District Court for the Southern District of New York granted AstraZeneca AB and Tika’s motion to dismiss the case in its entirety. On 24 June 2011, the United States Court of Appeals for the Second Circuit affirmed the Federal District Court’s decision and upheld the dismissal of all of Verus’ claims.
Dr. George Pieczenik v. AstraZeneca Pharmaceuticals LP, AstraZeneca LP, et al.
As previously disclosed, in March 2011, the District Court granted the defendants' joint motion to dismiss the plaintiff's claims with prejudice. In March 2011, the plaintiff filed a pro forma Notice of Appeal from the order granting dismissal of the patent infringement and Racketeering Institution and Corrupt Organisation Act claims and denying the motion for recusal. The appeals were dismissed by the Federal Circuit for ripeness. A new Notice of Appeal was filed with the Federal Circuit in June 2011.
Other Pricing Litigation
Average Wholesale Price Litigation
As previously disclosed, AstraZeneca is a defendant, along with many other pharmaceutical manufacturers, in several sets of cases involving allegations that, by causing the publication of allegedly inflated wholesale list prices, the defendants caused entities to overpay for prescription drugs. In June 2011, AstraZeneca agreed in principle to settle those lawsuits brought by the Attorneys General of the States of Alaska, Idaho, and Illinois, subject to documentation. Provision has been made for these settlements.
Other Actual and Threatened Government Investigations and Related Litigation
AstraZeneca understands that the US Attorney’s Office for the District of Delaware, Criminal Division is conducting an investigation relating to AstraZeneca’s relationship with MedCo and sales of Nexium, Plendil, Toprol XL, and Prilosec. The precise parameters of this investigation are unknown, and AstraZeneca is not in a position at this time to predict its scope, duration or outcome, including whether it will result in any liability to AstraZeneca.
On 30 June 2011, and 1 July 2011 respectively, AstraZeneca’s biologics unit, MedImmune received a Civil Investigative Demand from the US Attorney's Office for the Southern District of New York and a subpoena duces tecum from the Office of the Attorney General for the State of New York Medicaid and Fraud Control Unit pursuant to what the government attorneys advised was a joint investigation relating to the sales and marketing of Synagis. In addition, AstraZeneca has received a subpoena duces tecum from the Office of the Attorney General for the State of New York Medicaid and Fraud Control Unit. The precise parameters of this investigation are unknown, and AstraZeneca is not in a position at this time to predict its scope, duration or outcome, including whether it will result in any liability to AstraZeneca.
Tax
Transfer pricing and other international tax contingencies
As previously disclosed, in March 2011, AstraZeneca announced that HM Revenue & Customs in the UK and the US Internal Revenue Service had agreed the terms of an Advance Pricing Agreement regarding transfer pricing arrangements for AstraZeneca’s US business covering the 13 year period from 2002 to the end of 2014. The Company also announced that an agreement had been reached on a related valuation matter arising on integration of the legacy Astra and legacy Zeneca US businesses in 2000 following the global AstraZeneca merger in 1999. The provision for US transfer pricing and related valuation matters is a substantial proportion of the total net accrual for transfer pricing and other international tax contingencies of $2,310m disclosed in Note 25 of the Financial Statements on page 195 of AstraZeneca’s Annual Report and Form 20-F Information 2010.
Based on the above mentioned agreements, AstraZeneca now expects to pay a net amount of $1.1bn to resolve all US transfer pricing and related valuation matters for the period from 2000 to the end of 2010 and $520m of provisions have been released to earnings in the first half. The net amount payable of $1.1bn reflects expected US tax payments and updated estimates of corresponding tax refunds in other jurisdictions. During the second quarter a net amount of $1.1bn was paid. Further US tax payments in respect of state taxes are required in respect of the period from 2000 to the end of 2010 but are expected to be offset by amounts recoverable from the US and other jurisdictions.
|
5
|
HALF YEAR TERRITORIAL REVENUE ANALYSIS
|
| |
|
|
|
|
|
|
|
% Growth
|
|
| |
|
1st Half
2011
$m
|
|
|
1st Half
2010
$m
|
|
|
Actual
|
|
|
Constant
Currency
|
|
|
US
|
|
|
6,596 |
|
|
|
7,094 |
|
|
|
(7 |
) |
|
|
(7 |
) |
|
Western Europe1
|
|
|
4,429 |
|
|
|
4,672 |
|
|
|
(5 |
) |
|
|
(8 |
) |
|
Canada
|
|
|
840 |
|
|
|
723 |
|
|
|
16 |
|
|
|
10 |
|
|
Japan
|
|
|
1,367 |
|
|
|
1,222 |
|
|
|
12 |
|
|
|
1 |
|
|
Other Established ROW
|
|
|
590 |
|
|
|
494 |
|
|
|
19 |
|
|
|
4 |
|
|
Established ROW2
|
|
|
2,797 |
|
|
|
2,439 |
|
|
|
15 |
|
|
|
4 |
|
|
Emerging Europe
|
|
|
636 |
|
|
|
596 |
|
|
|
7 |
|
|
|
5 |
|
|
China
|
|
|
625 |
|
|
|
511 |
|
|
|
22 |
|
|
|
18 |
|
|
Emerging Asia Pacific
|
|
|
484 |
|
|
|
429 |
|
|
|
13 |
|
|
|
7 |
|
|
Other Emerging ROW
|
|
|
1,155 |
|
|
|
1,013 |
|
|
|
14 |
|
|
|
14 |
|
|
Emerging ROW3
|
|
|
2,900 |
|
|
|
2,549 |
|
|
|
14 |
|
|
|
11 |
|
|
Total Revenue
|
|
|
16,722 |
|
|
|
16,754 |
|
|
|
- |
|
|
|
(3 |
) |
|
1 Western Europe comprises France, Germany, Italy, Sweden, UK and others.
|
|
2 Established ROW comprises Australia, Canada, Japan and New Zealand.
|
|
3 Emerging ROW comprises Brazil, China, India, Mexico, Russia, Turkey and all other ROW countries.
|
|
6
|
SECOND QUARTER TERRITORIAL REVENUE ANALYSIS
|
| |
|
|
|
|
|
|
|
% Growth
|
|
| |
|
2nd Quarter
2011
$m
|
|
|
2nd Quarter
2010
$m
|
|
|
Actual
|
|
|
Constant
Currency
|
|
|
US
|
|
|
3,292 |
|
|
|
3,396 |
|
|
|
(3 |
) |
|
|
(3 |
) |
|
Western Europe1
|
|
|
2,194 |
|
|
|
2,213 |
|
|
|
(1 |
) |
|
|
(9 |
) |
|
Canada
|
|
|
423 |
|
|
|
371 |
|
|
|
14 |
|
|
|
8 |
|
|
Japan
|
|
|
736 |
|
|
|
644 |
|
|
|
14 |
|
|
|
2 |
|
|
Other Established ROW
|
|
|
317 |
|
|
|
262 |
|
|
|
21 |
|
|
|
3 |
|
|
Established ROW2
|
|
|
1,476 |
|
|
|
1,277 |
|
|
|
16 |
|
|
|
4 |
|
|
Emerging Europe
|
|
|
316 |
|
|
|
286 |
|
|
|
10 |
|
|
|
5 |
|
|
China
|
|
|
303 |
|
|
|
252 |
|
|
|
20 |
|
|
|
15 |
|
|
Emerging Asia Pacific
|
|
|
242 |
|
|
|
210 |
|
|
|
15 |
|
|
|
9 |
|
|
Other Emerging ROW
|
|
|
607 |
|
|
|
544 |
|
|
|
11 |
|
|
|
10 |
|
|
Emerging ROW3
|
|
|
1,468 |
|
|
|
1,292 |
|
|
|
13 |
|
|
|
10 |
|
|
Total Revenue
|
|
|
8,430 |
|
|
|
8,178 |
|
|
|
3 |
|
|
|
(2 |
) |
|
1 Western Europe comprises France, Germany, Italy, Sweden, UK and others.
|
2 Established ROW comprises Australia, Canada, Japan and New Zealand.
3 Emerging ROW comprises Brazil, China, India, Mexico, Russia, Turkey and all other ROW countries.
|
7
|
FIRST HALF PRODUCT REVENUE ANALYSIS
|
| |
|
World |
|
|
US |
|
|
Western Europe |
|
|
Established ROW |
|
|
Emerging ROW |
|
| |
|
1st Half
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
1st Half
2011
$m
|
|
|
Actual
Growth
%
|
|
|
1st Half
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
1st Half
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
1st Half
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
Gastrointestinal:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium
|
|
|
2,273 |
|
|
|
(9 |
) |
|
|
(10 |
) |
|
|
1,213 |
|
|
|
(10 |
) |
|
|
454 |
|
|
|
(28 |
) |
|
|
(29 |
) |
|
|
239 |
|
|
|
9 |
|
|
|
- |
|
|
|
367 |
|
|
|
23 |
|
|
|
22 |
|
|
Losec/Prilosec
|
|
|
474 |
|
|
|
(7 |
) |
|
|
(14 |
) |
|
|
21 |
|
|
|
(33 |
) |
|
|
127 |
|
|
|
(8 |
) |
|
|
(13 |
) |
|
|
213 |
|
|
|
1 |
|
|
|
(9 |
) |
|
|
113 |
|
|
|
(14 |
) |
|
|
(17 |
) |
|
Others
|
|
|
75 |
|
|
|
7 |
|
|
|
6 |
|
|
|
47 |
|
|
|
12 |
|
|
|
22 |
|
|
|
- |
|
|
|
(5 |
) |
|
|
4 |
|
|
|
33 |
|
|
|
33 |
|
|
|
2 |
|
|
|
(33 |
) |
|
|
(33 |
) |
|
Total Gastrointestinal
|
|
|
2,822 |
|
|
|
(8 |
) |
|
|
(10 |
) |
|
|
1,281 |
|
|
|
(10 |
) |
|
|
603 |
|
|
|
(24 |
) |
|
|
(26 |
) |
|
|
456 |
|
|
|
6 |
|
|
|
(4 |
) |
|
|
482 |
|
|
|
11 |
|
|
|
10 |
|
|
Cardiovascular:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Crestor
|
|
|
3,192 |
|
|
|
17 |
|
|
|
13 |
|
|
|
1,478 |
|
|
|
17 |
|
|
|
613 |
|
|
|
10 |
|
|
|
7 |
|
|
|
766 |
|
|
|
25 |
|
|
|
15 |
|
|
|
335 |
|
|
|
12 |
|
|
|
8 |
|
|
Atacand
|
|
|
740 |
|
|
|
(1 |
) |
|
|
(4 |
) |
|
|
95 |
|
|
|
(17 |
) |
|
|
360 |
|
|
|
(4 |
) |
|
|
(8 |
) |
|
|
122 |
|
|
|
13 |
|
|
|
4 |
|
|
|
163 |
|
|
|
8 |
|
|
|
7 |
|
|
Seloken/Toprol-XL
|
|
|
477 |
|
|
|
(30 |
) |
|
|
(32 |
) |
|
|
192 |
|
|
|
(55 |
) |
|
|
41 |
|
|
|
(11 |
) |
|
|
(15 |
) |
|
|
19 |
|
|
|
- |
|
|
|
(11 |
) |
|
|
225 |
|
|
|
14 |
|
|
|
11 |
|
|
Plendil
|
|
|
130 |
|
|
|
1 |
|
|
|
(3 |
) |
|
|
4 |
|
|
|
(50 |
) |
|
|
12 |
|
|
|
(20 |
) |
|
|
(20 |
) |
|
|
6 |
|
|
|
- |
|
|
|
(17 |
) |
|
|
108 |
|
|
|
8 |
|
|
|
4 |
|
|
Tenormin
|
|
|
134 |
|
|
|
(4 |
) |
|
|
(9 |
) |
|
|
6 |
|
|
|
(14 |
) |
|
|
30 |
|
|
|
(6 |
) |
|
|
(9 |
) |
|
|
60 |
|
|
|
(2 |
) |
|
|
(11 |
) |
|
|
38 |
|
|
|
(3 |
) |
|
|
(5 |
) |
|
Zestril
|
|
|
72 |
|
|
|
(12 |
) |
|
|
(15 |
) |
|
|
5 |
|
|
|
(17 |
) |
|
|
36 |
|
|
|
(14 |
) |
|
|
(17 |
) |
|
|
9 |
|
|
|
- |
|
|
|
- |
|
|
|
22 |
|
|
|
(12 |
) |
|
|
(16 |
) |
|
OnglyzaTM
|
|
|
81 |
|
|
|
350 |
|
|
|
350 |
|
|
|
59 |
|
|
|
321 |
|
|
|
15 |
|
|
|
275 |
|
|
|
275 |
|
|
|
2 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
5 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Brilinta/Brilique
|
|
|
3 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
- |
|
|
|
- |
|
|
|
2 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Others
|
|
|
129 |
|
|
|
(5 |
) |
|
|
(9 |
) |
|
|
- |
|
|
|
(100 |
) |
|
|
63 |
|
|
|
5 |
|
|
|
2 |
|
|
|
12 |
|
|
|
(8 |
) |
|
|
(15 |
) |
|
|
54 |
|
|
|
13 |
|
|
|
8 |
|
|
Total Cardiovascular
|
|
|
4,958 |
|
|
|
6 |
|
|
|
3 |
|
|
|
1,839 |
|
|
|
- |
|
|
|
1,172 |
|
|
|
4 |
|
|
|
- |
|
|
|
996 |
|
|
|
20 |
|
|
|
10 |
|
|
|
951 |
|
|
|
10 |
|
|
|
7 |
|
|
Respiratory:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
|
|
1,554 |
|
|
|
14 |
|
|
|
10 |
|
|
|
403 |
|
|
|
14 |
|
|
|
724 |
|
|
|
2 |
|
|
|
(1 |
) |
|
|
198 |
|
|
|
62 |
|
|
|
48 |
|
|
|
229 |
|
|
|
28 |
|
|
|
25 |
|
|
Pulmicort
|
|
|
484 |
|
|
|
5 |
|
|
|
3 |
|
|
|
166 |
|
|
|
(6 |
) |
|
|
103 |
|
|
|
(10 |
) |
|
|
(13 |
) |
|
|
59 |
|
|
|
13 |
|
|
|
4 |
|
|
|
156 |
|
|
|
34 |
|
|
|
30 |
|
|
Rhinocort
|
|
|
110 |
|
|
|
(8 |
) |
|
|
(11 |
) |
|
|
43 |
|
|
|
(19 |
) |
|
|
21 |
|
|
|
(5 |
) |
|
|
(9 |
) |
|
|
9 |
|
|
|
50 |
|
|
|
33 |
|
|
|
37 |
|
|
|
(5 |
) |
|
|
(8 |
) |
|
Others
|
|
|
110 |
|
|
|
(17 |
) |
|
|
(21 |
) |
|
|
4 |
|
|
|
(83 |
) |
|
|
56 |
|
|
|
(8 |
) |
|
|
(13 |
) |
|
|
12 |
|
|
|
- |
|
|
|
- |
|
|
|
38 |
|
|
|
6 |
|
|
|
- |
|
|
Total Respiratory
|
|
|
2,258 |
|
|
|
9 |
|
|
|
5 |
|
|
|
616 |
|
|
|
1 |
|
|
|
904 |
|
|
|
- |
|
|
|
(4 |
) |
|
|
278 |
|
|
|
45 |
|
|
|
33 |
|
|
|
460 |
|
|
|
24 |
|
|
|
21 |
|
|
Oncology:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arimidex
|
|
|
414 |
|
|
|
(56 |
) |
|
|
(58 |
) |
|
|
29 |
|
|
|
(93 |
) |
|
|
161 |
|
|
|
(48 |
) |
|
|
(48 |
) |
|
|
147 |
|
|
|
7 |
|
|
|
(3 |
) |
|
|
77 |
|
|
|
- |
|
|
|
(4 |
) |
|
Zoladex
|
|
|
577 |
|
|
|
6 |
|
|
|
2 |
|
|
|
22 |
|
|
|
5 |
|
|
|
132 |
|
|
|
(9 |
) |
|
|
(12 |
) |
|
|
234 |
|
|
|
8 |
|
|
|
(3 |
) |
|
|
189 |
|
|
|
16 |
|
|
|
21 |
|
|
Casodex
|
|
|
271 |
|
|
|
(8 |
) |
|
|
(14 |
) |
|
|
(1 |
) |
|
|
(109 |
) |
|
|
45 |
|
|
|
(26 |
) |
|
|
(28 |
) |
|
|
172 |
|
|
|
2 |
|
|
|
(8 |
) |
|
|
55 |
|
|
|
2 |
|
|
|
- |
|
|
Iressa
|
|
|
260 |
|
|
|
48 |
|
|
|
39 |
|
|
|
1 |
|
|
|
(50 |
) |
|
|
59 |
|
|
|
293 |
|
|
|
280 |
|
|
|
94 |
|
|
|
12 |
|
|
|
1 |
|
|
|
106 |
|
|
|
41 |
|
|
|
35 |
|
|
Others
|
|
|
312 |
|
|
|
57 |
|
|
|
53 |
|
|
|
131 |
|
|
|
93 |
|
|
|
97 |
|
|
|
56 |
|
|
|
52 |
|
|
|
31 |
|
|
|
15 |
|
|
|
4 |
|
|
|
53 |
|
|
|
26 |
|
|
|
24 |
|
|
Total Oncology
|
|
|
1,834 |
|
|
|
(15 |
) |
|
|
(19 |
) |
|
|
182 |
|
|
|
(66 |
) |
|
|
494 |
|
|
|
(16 |
) |
|
|
(18 |
) |
|
|
678 |
|
|
|
7 |
|
|
|
(3 |
) |
|
|
480 |
|
|
|
17 |
|
|
|
17 |
|
|
Neuroscience:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Seroquel IR
|
|
|
2,156 |
|
|
|
3 |
|
|
|
1 |
|
|
|
1,643 |
|
|
|
6 |
|
|
|
280 |
|
|
|
(3 |
) |
|
|
(7 |
) |
|
|
109 |
|
|
|
(10 |
) |
|
|
(19 |
) |
|
|
124 |
|
|
|
(6 |
) |
|
|
(11 |
) |
|
Seroquel XR
|
|
|
726 |
|
|
|
30 |
|
|
|
28 |
|
|
|
381 |
|
|
|
19 |
|
|
|
239 |
|
|
|
45 |
|
|
|
39 |
|
|
|
43 |
|
|
|
59 |
|
|
|
44 |
|
|
|
63 |
|
|
|
37 |
|
|
|
37 |
|
|
Local Anaesthetics
|
|
|
305 |
|
|
|
- |
|
|
|
(5 |
) |
|
|
9 |
|
|
|
(50 |
) |
|
|
126 |
|
|
|
(8 |
) |
|
|
(12 |
) |
|
|
96 |
|
|
|
9 |
|
|
|
(2 |
) |
|
|
74 |
|
|
|
21 |
|
|
|
18 |
|
|
Zomig
|
|
|
204 |
|
|
|
(5 |
) |
|
|
(8 |
) |
|
|
77 |
|
|
|
(13 |
) |
|
|
85 |
|
|
|
(3 |
) |
|
|
(7 |
) |
|
|
35 |
|
|
|
9 |
|
|
|
- |
|
|
|
7 |
|
|
|
- |
|
|
|
- |
|
|
Diprivan
|
|
|
156 |
|
|
|
- |
|
|
|
(5 |
) |
|
|
12 |
|
|
|
(52 |
) |
|
|
23 |
|
|
|
(18 |
) |
|
|
(21 |
) |
|
|
42 |
|
|
|
31 |
|
|
|
19 |
|
|
|
79 |
|
|
|
11 |
|
|
|
7 |
|
|
Vimovo
|
|
|
10 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
8 |
|
|
|
n/m |
|
|
|
- |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Others
|
|
|
19 |
|
|
|
(5 |
) |
|
|
(10 |
) |
|
|
1 |
|
|
|
- |
|
|
|
11 |
|
|
|
(29 |
) |
|
|
(36 |
) |
|
|
3 |
|
|
|
- |
|
|
|
- |
|
|
|
4 |
|
|
|
100 |
|
|
|
100 |
|
|
Total Neuroscience
|
|
|
3,576 |
|
|
|
7 |
|
|
|
4 |
|
|
|
2,131 |
|
|
|
6 |
|
|
|
764 |
|
|
|
6 |
|
|
|
2 |
|
|
|
329 |
|
|
|
9 |
|
|
|
(2 |
) |
|
|
352 |
|
|
|
10 |
|
|
|
7 |
|
|
Infection & Other:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synagis
|
|
|
456 |
|
|
|
(9 |
) |
|
|
(9 |
) |
|
|
301 |
|
|
|
(16 |
) |
|
|
154 |
|
|
|
8 |
|
|
|
8 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
|
|
- |
|
|
|
- |
|
|
Merrem
|
|
|
330 |
|
|
|
(23 |
) |
|
|
(26 |
) |
|
|
28 |
|
|
|
(61 |
) |
|
|
112 |
|
|
|
(39 |
) |
|
|
(40 |
) |
|
|
33 |
|
|
|
14 |
|
|
|
3 |
|
|
|
157 |
|
|
|
8 |
|
|
|
4 |
|
|
FluMist
|
|
|
3 |
|
|
|
- |
|
|
|
- |
|
|
|
2 |
|
|
|
(33 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Others
|
|
|
74 |
|
|
|
(20 |
) |
|
|
(23 |
) |
|
|
45 |
|
|
|
(37 |
) |
|
|
7 |
|
|
|
(14 |
) |
|
|
(14 |
) |
|
|
7 |
|
|
|
17 |
|
|
|
(67 |
) |
|
|
15 |
|
|
|
100 |
|
|
|
125 |
|
|
Total Infection & Other
|
|
|
863 |
|
|
|
(16 |
) |
|
|
(17 |
) |
|
|
376 |
|
|
|
(26 |
) |
|
|
273 |
|
|
|
(18 |
) |
|
|
(19 |
) |
|
|
40 |
|
|
|
14 |
|
|
|
(9 |
) |
|
|
174 |
|
|
|
13 |
|
|
|
11 |
|
|
Aptium Oncology
|
|
|
113 |
|
|
|
(8 |
) |
|
|
(8 |
) |
|
|
113 |
|
|
|
(8 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Astra Tech
|
|
|
298 |
|
|
|
12 |
|
|
|
8 |
|
|
|
58 |
|
|
|
16 |
|
|
|
219 |
|
|
|
11 |
|
|
|
6 |
|
|
|
20 |
|
|
|
5 |
|
|
|
(5 |
) |
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Total
|
|
|
16,722 |
|
|
|
- |
|
|
|
(3 |
) |
|
|
6,596 |
|
|
|
(7 |
) |
|
|
4,429 |
|
|
|
(5 |
) |
|
|
(8 |
) |
|
|
2,797 |
|
|
|
15 |
|
|
|
4 |
|
|
|
2,900 |
|
|
|
14 |
|
|
|
11 |
|
|
8
|
SECOND QUARTER PRODUCT REVENUE ANALYSIS
|
| |
|
World
|
|
|
US
|
|
|
Western Europe
|
|
|
Established ROW
|
|
|
Emerging ROW
|
|
| |
|
2nd Quarter
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
2nd Quarter
2011
$m
|
|
|
Actual
Growth
%
|
|
|
2nd Quarter
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
2nd Quarter
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
2nd Quarter
2011
$m
|
|
|
Actual
Growth
%
|
|
|
Constant
Currency
Growth
%
|
|
|
Gastrointestinal:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium
|
|
|
1,112 |
|
|
|
(12 |
) |
|
|
(14 |
) |
|
|
613 |
|
|
|
(12 |
) |
|
|
191 |
|
|
|
(36 |
) |
|
|
(42 |
) |
|
|
117 |
|
|
|
5 |
|
|
|
(5 |
) |
|
|
191 |
|
|
|
26 |
|
|
|
24 |
|
|
Losec/Prilosec
|
|
|
239 |
|
|
|
(8 |
) |
|
|
(17 |
) |
|
|
8 |
|
|
|
(42 |
) |
|
|
64 |
|
|
|
(10 |
) |
|
|
(20 |
) |
|
|
117 |
|
|
|
5 |
|
|
|
(5 |
) |
|
|
50 |
|
|
|
(25 |
) |
|
|
(28 |
) |
|
Others
|
|
|
36 |
|
|
|
(5 |
) |
|
|
(8 |
) |
|
|
22 |
|
|
|
(8 |
) |
|
|
11 |
|
|
|
- |
|
|
|
(9 |
) |
|
|
3 |
|
|
|
50 |
|
|
|
50 |
|
|
|
- |
|
|
|
(100 |
) |
|
|
(100 |
) |
|
Total Gastrointestinal
|
|
|
1,387 |
|
|
|
(11 |
) |
|
|
(14 |
) |
|
|
643 |
|
|
|
(12 |
) |
|
|
266 |
|
|
|
(30 |
) |
|
|
(37 |
) |
|
|
237 |
|
|
|
6 |
|
|
|
(4 |
) |
|
|
241 |
|
|
|
10 |
|
|
|
8 |
|
|
Cardiovascular:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Crestor
|
|
|
1,714 |
|
|
|
20 |
|
|
|
15 |
|
|
|
796 |
|
|
|
17 |
|
|
|
324 |
|
|
|
17 |
|
|
|
7 |
|
|
|
420 |
|
|
|
31 |
|
|
|
19 |
|
|
|
174 |
|
|
|
12 |
|
|
|
8 |
|
|
Atacand
|
|
|
385 |
|
|
|
2 |
|
|
|
(4 |
) |
|
|
49 |
|
|
|
(16 |
) |
|
|
188 |
|
|
|
4 |
|
|
|
(6 |
) |
|
|
61 |
|
|
|
11 |
|
|
|
- |
|
|
|
87 |
|
|
|
6 |
|
|
|
5 |
|
|
Seloken/Toprol-XL
|
|
|
232 |
|
|
|
(27 |
) |
|
|
(29 |
) |
|
|
91 |
|
|
|
(51 |
) |
|
|
21 |
|
|
|
(5 |
) |
|
|
(14 |
) |
|
|
10 |
|
|
|
- |
|
|
|
(20 |
) |
|
|
110 |
|
|
|
11 |
|
|
|
7 |
|
|
Plendil
|
|
|
62 |
|
|
|
(2 |
) |
|
|
(6 |
) |
|
|
3 |
|
|
|
(25 |
) |
|
|
6 |
|
|
|
(14 |
) |
|
|
(14 |
) |
|
|
3 |
|
|
|
- |
|
|
|
(33 |
) |
|
|
50 |
|
|
|
2 |
|
|
|
(2 |
) |
|
Tenormin
|
|
|
71 |
|
|
|
(1 |
) |
|
|
(10 |
) |
|
|
3 |
|
|
|
(25 |
) |
|
|
15 |
|
|
|
(6 |
) |
|
|
(19 |
) |
|
|
30 |
|
|
|
(6 |
) |
|
|
(16 |
) |
|
|
23 |
|
|
|
15 |
|
|
|
10 |
|
|
Zestril
|
|
|
39 |
|
|
|
(3 |
) |
|
|
(8 |
) |
|
|
2 |
|
|
|
- |
|
|
|
19 |
|
|
|
(5 |
) |
|
|
(15 |
) |
|
|
5 |
|
|
|
25 |
|
|
|
25 |
|
|
|
13 |
|
|
|
(7 |
) |
|
|
(7 |
) |
|
OnglyzaTM
|
|
|
46 |
|
|
|
228 |
|
|
|
228 |
|
|
|
33 |
|
|
|
230 |
|
|
|
9 |
|
|
|
125 |
|
|
|
125 |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
3 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Brilinta/Brilique
|
|
|
2 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Others
|
|
|
68 |
|
|
|
- |
|
|
|
(7 |
) |
|
|
- |
|
|
|
(100 |
) |
|
|
34 |
|
|
|
13 |
|
|
|
3 |
|
|
|
6 |
|
|
|
(14 |
) |
|
|
(29 |
) |
|
|
28 |
|
|
|
12 |
|
|
|
8 |
|
|
Total Cardiovascular
|
|
|
2,619 |
|
|
|
10 |
|
|
|
5 |
|
|
|
977 |
|
|
|
3 |
|
|
|
617 |
|
|
|
11 |
|
|
|
2 |
|
|
|
536 |
|
|
|
24 |
|
|
|
12 |
|
|
|
489 |
|
|
|
10 |
|
|
|
7 |
|
|
Respiratory:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort
|
|
|
802 |
|
|
|
21 |
|
|
|
14 |
|
|
|
206 |
|
|
|
14 |
|
|
|
378 |
|
|
|
13 |
|
|
|
3 |
|
|
|
103 |
|
|
|
72 |
|
|
|
57 |
|
|
|
115 |
|
|
|
31 |
|
|
|
24 |
|
|
Pulmicort
|
|
|
236 |
|
|
|
9 |
|
|
|
4 |
|
|
|
88 |
|
|
|
5 |
|
|
|
49 |
|
|
|
(4 |
) |
|
|
(12 |
) |
|
|
30 |
|
|
|
7 |
|
|
|
(4 |
) |
|
|
69 |
|
|
|
30 |
|
|
|
23 |
|
|
Rhinocort
|
|
|
55 |
|
|
|
(15 |
) |
|
|
(18 |
) |
|
|
19 |
|
|
|
(34 |
) |
|
|
12 |
|
|
|
9 |
|
|
|
- |
|
|
|
5 |
|
|
|
67 |
|
|
|
33 |
|
|
|
19 |
|
|
|
(14 |
) |
|
|
(14 |
) |
|
Others
|
|
|
55 |
|
|
|
(14 |
) |
|
|
(22 |
) |
|
|
2 |
|
|
|
(82 |
) |
|
|
30 |
|
|
|
- |
|
|
|
(10 |
) |
|
|
6 |
|
|
|
- |
|
|
|
- |
|
|
|
17 |
|
|
|
- |
|
|
|
(12 |
) |
|
Total Respiratory
|
|
|
1,148 |
|
|
|
14 |
|
|
|
7 |
|
|
|
315 |
|
|
|
3 |
|
|
|
469 |
|
|
|
10 |
|
|
|
- |
|
|
|
144 |
|
|
|
48 |
|
|
|
35 |
|
|
|
220 |
|
|
|
22 |
|
|
|
16 |
|
|
Oncology:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arimidex
|
|
|
181 |
|
|
|
(59 |
) |
|
|
(62 |
) |
|
|
10 |
|
|
|
(95 |
) |
|
|
55 |
|
|
|
(62 |
) |
|
|
(65 |
) |
|
|
76 |
|
|
|
6 |
|
|
|
(4 |
) |
|
|
40 |
|
|
|
5 |
|
|
|
(5 |
) |
|
Zoladex
|
|
|
302 |
|
|
|
8 |
|
|
|
3 |
|
|
|
10 |
|
|
|
(17 |
) |
|
|
69 |
|
|
|
1 |
|
|
|
(7 |
) |
|
|
123 |
|
|
|
9 |
|
|
|
(4 |
) |
|
|
100 |
|
|
|
15 |
|
|
|
21 |
|
|
Casodex
|
|
|
138 |
|
|
|
(9 |
) |
|
|
(17 |
) |
|
|
(3 |
) |
|
|
(138 |
) |
|
|
22 |
|
|
|
(27 |
) |
|
|
(33 |
) |
|
|
91 |
|
|
|
5 |
|
|
|
(7 |
) |
|
|
28 |
|
|
|
8 |
|
|
|
8 |
|
|
Iressa
|
|
|
139 |
|
|
|
49 |
|
|
|
38 |
|
|
|
- |
|
|
|
(100 |
) |
|
|
33 |
|
|
|
267 |
|
|
|
233 |
|
|
|
51 |
|
|
|
9 |
|
|
|
(2 |
) |
|
|
55 |
|
|
|
53 |
|
|
|
44 |
|
|
Others
|
|
|
162 |
|
|
|
56 |
|
|
|
48 |
|
|
|
67 |
|
|
|
91 |
|
|
|
53 |
|
|
|
66 |
|
|
|
53 |
|
|
|
17 |
|
|
|
21 |
|
|
|
7 |
|
|
|
25 |
|
|
|
9 |
|
|
|
- |
|
|
Total Oncology
|
|
|
922 |
|
|
|
(14 |
) |
|
|
(19 |
) |
|
|
84 |
|
|
|
(65 |
) |
|
|
232 |
|
|
|
(18 |
) |
|
|
(25 |
) |
|
|
358 |
|
|
|
8 |
|
|
|
(4 |
) |
|
|
248 |
|
|
|
18 |
|
|
|
16 |
|
|
Neuroscience:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Seroquel IR
|
|
|
1,150 |
|
|
|
10 |
|
|
|
7 |
|
|
|
889 |
|
|
|
13 |
|
|
|
144 |
|
|
|
4 |
|
|
|
(5 |
) |
|
|
55 |
|
|
|
(13 |
) |
|
|
(22 |
) |
|
|
62 |
|
|
|
(2 |
) |
|
|
(8 |
) |
|
Seroquel XR
|
|
|
387 |
|
|
|
28 |
|
|
|
23 |
|
|
|
205 |
|
|
|
14 |
|
|
|
129 |
|
|
|
59 |
|
|
|
44 |
|
|
|
23 |
|
|
|
53 |
|
|
|
40 |
|
|
|
30 |
|
|
|
11 |
|
|
|
7 |
|
|
Local Anaesthetics
|
|
|
156 |
|
|
|
1 |
|
|
|
(8 |
) |
|
|
4 |
|
|
|
(60 |
) |
|
|
63 |
|
|
|
(3 |
) |
|
|
(12 |
) |
|
|
51 |
|
|
|
4 |
|
|
|
(10 |
) |
|
|
38 |
|
|
|
23 |
|
|
|
23 |
|
|
Zomig
|
|
|
103 |
|
|
|
(6 |
) |
|
|
(11 |
) |
|
|
38 |
|
|
|
(17 |
) |
|
|
44 |
|
|
|
5 |
|
|
|
(5 |
) |
|
|
18 |
|
|
|
6 |
|
|
|
(6 |
) |
|
|
3 |
|
|
|
(25 |
) |
|
|
(25 |
) |
|
Diprivan
|
|
|
86 |
|
|
|
6 |
|
|
|
(1 |
) |
|
|
6 |
|
|
|
(54 |
) |
|
|
11 |
|
|
|
(15 |
) |
|
|
(23 |
) |
|
|
21 |
|
|
|
11 |
|
|
|
(5 |
) |
|
|
48 |
|
|
|
33 |
|
|
|
28 |
|
|
Vimovo
|
|
|
6 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
5 |
|
|
|
n/m |
|
|
|
- |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
- |
|
|
|
n/m |
|
|
|
n/m |
|
|
Others
|
|
|
9 |
|
|
|
(10 |
) |
|
|
(20 |
) |
|
|
1 |
|
|
|
- |
|
|
|
5 |
|
|
|
(43 |
) |
|
|
(57 |
) |
|
|
2 |
|
|
|
(50 |
) |
|
|
(50 |
) |
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Total Neuroscience
|
|
|
1,897 |
|
|
|
11 |
|
|
|
7 |
|
|
|
1,148 |
|
|
|
11 |
|
|
|
396 |
|
|
|
14 |
|
|
|
4 |
|
|
|
171 |
|
|
|
4 |
|
|
|
(8 |
) |
|
|
182 |
|
|
|
13 |
|
|
|
9 |
|
|
Infection & Other:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Synagis
|
|
|
48 |
|
|
|
12 |
|
|
|
12 |
|
|
|
6 |
|
|
|
(25 |
) |
|
|
42 |
|
|
|
23 |
|
|
|
23 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Merrem
|
|
|
158 |
|
|
|
(20 |
) |
|
|
(24 |
) |
|
|
12 |
|
|
|
(56 |
) |
|
|
52 |
|
|
|
(37 |
) |
|
|
(41 |
) |
|
|
19 |
|
|
|
12 |
|
|
|
- |
|
|
|
75 |
|
|
|
6 |
|
|
|
1 |
|
|
FluMist
|
|
|
- |
|
|
|
(100 |
) |
|
|
(100 |
) |
|
|
- |
|
|
|
(100 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Others
|
|
|
34 |
|
|
|
31 |
|
|
|
19 |
|
|
|
17 |
|
|
|
13 |
|
|
|
4 |
|
|
|
- |
|
|
|
(33 |
) |
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
|
12 |
|
|
|
63 |
|
|
|
38 |
|
|
Total Infection & Other
|
|
|
240 |
|
|
|
(10 |
) |
|
|
(15 |
) |
|
|
35 |
|
|
|
(31 |
) |
|
|
98 |
|
|
|
(18 |
) |
|
|
(23 |
) |
|
|
20 |
|
|
|
18 |
|
|
|
6 |
|
|
|
87 |
|
|
|
10 |
|
|
|
4 |
|
|
Aptium Oncology
|
|
|
60 |
|
|
|
2 |
|
|
|
2 |
|
|
|
60 |
|
|
|
2 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Astra Tech
|
|
|
157 |
|
|
|
17 |
|
|
|
8 |
|
|
|
30 |
|
|
|
20 |
|
|
|
116 |
|
|
|
17 |
|
|
|
6 |
|
|
|
10 |
|
|
|
- |
|
|
|
(20 |
) |
|
|
1 |
|
|
|
n/m |
|
|
|
n/m |
|
|
Total
|
|
|
8,430 |
|
|
|
3 |
|
|
|
(2 |
) |
|
|
3,292 |
|
|
|
(3 |
) |
|
|
2,194 |
|
|
|
(1 |
) |
|
|
(9 |
) |
|
|
1,476 |
|
|
|
16 |
|
|
|
4 |
|
|
|
1,468 |
|
|
|
13 |
|
|
|
10 |
|
Shareholder Information
ANNOUNCEMENTS AND MEETINGS
|
Announcement of third quarter and nine months 2011 results
|
|
27 October 2011
|
|
Announcement of fourth quarter and full year 2011 results
|
|
2 February 2012
|
DIVIDENDS
The record date for the first interim dividend payable on 12 September 2011 is 5 August 2011. Shares will trade ex-dividend from 3 August 2011.
Future dividends will normally be paid as follows:
|
First interim
|
Announced in July and paid in September
|
|
Second interim
|
Announced in January and paid in March
|
TRADEMARKS
Trademarks of the AstraZeneca group of companies appear throughout this document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca appear with a ® or ™ sign and include: ONGLYZA™ and KOMBIGLYZE XR™, trademarks of Bristol-Myers Squibb Company.
ADDRESSES FOR CORRESPONDENCE
|
Registrar and
Transfer Office
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
UK
|
US Depositary
JP Morgan Chase & Co
PO Box 64504
St Paul
MN 55164-0504
US
|
Registered Office
2 Kingdom Street
London
W2 6BD
UK
|
Swedish Central Securities Depository
Euroclear Sweden AB
PO Box 7822
SE-103 97 Stockholm
Sweden
|
|
Tel (freephone in UK):
0800 389 1580
Tel (outside UK):
+44 (0)121 415 7033
|
Tel (toll free in US):
800 990 1135
Tel (outside US):
+1 (651) 453 2128
|
Tel: +44 (0)20 7604 8000
|
Tel: +46 (0)8 402 9000
|
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: The interim financial statements contain certain forward-looking statements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of the interim financial statements and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of patents, marketing exclusivity or trademarks; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of product counterfeiting; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; and the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation.
Item 27
AstraZeneca Development Pipeline
28 July 2011
Line Extensions
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Estimated Filing |
| |
|
|
|
US
|
EU
|
Japan
|
Emerging
|
|
Cardiovascular
|
|
Axanum
|
proton pump inhibitor + low dose aspirin FDC
|
low dose aspirin associated peptic ulcer
|
III
|
Withdrawn
|
Filed
|
2014
|
Filed
|
|
Brilinta PEGASUS-TIMI
|
ADP receptor antagonist
|
outcomes study
|
III
|
2014
|
2014
|
2014
|
2014
|
|
Crestor
|
statin
|
outcomes in subjects with elevated CRP
|
III
|
Launched
|
Launched
|
NA
|
Filed
|
|
Dapagliflozin/ metformin FDC#
|
SGLT2 inhibitor + metformin FDC
|
diabetes
|
III
|
2H 2012
|
2H 2012
|
|
|
|
Kombiglyze XR/ Onglyza/ metformin IR FDC#*
|
DPP-4 inhibitor + metformin FDC
|
diabetes
|
III
|
Launched
|
Filed
|
|
Filed
|
|
Onglyza
SAVOR-TIMI#
|
DPP-4 inhibitor
|
outcomes study
|
III
|
2016
|
|
|
|
|
Gastrointestinal
|
|
Nexium
|
proton pump inhibitor
|
peptic ulcer bleeding
|
III
|
Filed**
|
Launched
|
|
Launched
|
|
Nexium
|
proton pump inhibitor
|
GERD
|
III
|
Launched
|
Launched
|
Approved
|
Launched
|
|
Neuroscience
|
|
Diprivan#
|
sedative and anaesthetic
|
conscious sedation
|
III
|
|
Launched
|
2H 2012
|
Launched
|
|
EMLA#
|
local anaesthetic
|
topical anaesthesia
|
III
|
|
Launched
|
Filed
|
Launched
|
|
Oncology
|
|
Faslodex
|
oestrogen receptor antagonist
|
high dose (500mg) 2nd line advanced breast cancer
|
III
|
Launched
|
Launched
|
Filed
|
Launched
|
|
Faslodex
|
oestrogen receptor antagonist
|
1st line advanced breast cancer
|
III
|
2016
|
2016
|
2016
|
2016
|
|
Iressa
|
EGFR tyrosine kinase inhibitor
|
1st line EGFR mut+ NSCLC
|
III
|
|
Launched
|
Filed
|
Launched
|
|
Iressa
|
EGFR tyrosine kinase inhibitor
|
treatment beyond progression
|
III
|
|
2015
|
2015
|
2015
|
|
Infection
|
|
FluMist/Fluenz
|
live, attenuated, intranasal influenza virus vaccine
|
influenza
|
III
|
Launched
|
Approved
|
|
Launched
|
|
Respiratory & Inflammation
|
|
Oxis
|
long-acting β2 agonist
|
COPD
|
III
|
|
Launched
|
3Q 2011
|
|
|
Symbicort
|
inhaled steroid/ long-acting β2 agonist
|
COPD
|
III
|
Launched
|
Launched
|
4Q 2011
|
Launched
|
|
Symbicort
|
inhaled steroid/ long-acting β2 agonist
|
SMART
|
III
|
|
Launched
|
3Q 2011
|
Launched
|
#Partnered product
*Kombiglyze XR US; Onglyza/metformin IR FDC EU
**(2nd) CRL Received
NCEs
Phase III/Registration
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Estimated Filing
|
| |
|
|
|
US
|
EU
|
Japan
|
Emerging
|
|
Cardiovascular
|
|
|
|
|
|
|
|
|
Brilinta/Brilique
|
ADP receptor antagonist
|
arterial thrombosis
|
III
|
Approved
|
Launched
|
2013
|
Launched
|
|
Dapagliflozin#
|
SGLT2 inhibitor
|
diabetes
|
III
|
Filed
|
Filed
|
2013
|
Filed
|
|
Neuroscience
|
|
Vimovo#
|
naproxen + esomeprazole
|
signs and symptoms of OA, RA and AS
|
III
|
Launched
|
Launched
|
|
Launched
|
|
TC-5214#
|
neuronal nicotinic channel modulator
|
major depressive disorder (adjunct)
|
III
|
2H 2012
|
2015
|
|
|
|
NKTR-118#
|
oral peripherally-acting opioid antagonist
|
opioid-induced constipation
|
III
|
2013
|
2013
|
|
|
|
Oncology
|
|
Caprelsa
(vandetanib)
|
VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity
|
medullary thyroid cancer
|
III
|
Launched
|
Filed
|
1H 2012
|
3Q 2011
|
|
Infection
|
|
MEDI-3250*
|
live, attenuated, intranasal influenza virus vaccine (quadrivalent)
|
seasonal influenza
|
III
|
Filed
|
TBD
|
|
|
|
Zinforo# (ceftaroline)
|
extended spectrum cephalosporin with affinity to penicillin- binding proteins
|
pneumonia/skin infections
|
III
|
|
Filed
|
|
3Q 2011
|
|
Respiratory & Inflammation
|
|
Fostamatinib#
|
spleen tyrosine kinase (SYK) inhibitor
|
rheumatoid arthritis
|
III
|
2013
|
2013
|
|
2013
|
#Partnered product
*sBLA in US, MAA in EU
NCEs
Phases I and II
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Estimated Filing |
| |
|
|
|
US
|
EU
|
Japan
|
Emerging
|
|
Cardiovascular
|
|
|
|
|
|
|
|
|
AZD2820
|
melanocortin receptor type 4 (MC4r) partial agonist peptide
|
obesity
|
I
|
|
|
|
|
|
AZD2927
|
ion channel blocker/inhibitor
|
atrial fibrillation
|
I
|
|
|
|
|
|
AZD4017
|
11BHSD inhibitor
|
glaucoma
|
I
|
|
|
|
|
|
AZD7687
|
diacylglycerol acyl transferase –1 inhibitor
|
diabetes
|
I
|
|
|
|
|
|
AZD8329
|
11BHSD inhibitor
|
diabetes
|
I
|
|
|
|
|
|
CAT-354
|
anti-IL-13 MAb
|
ulcerative colitis
|
I
|
|
|
|
|
|
MEDI-2338
|
anti-IL-18 MAb
|
post ACS
|
I
|
|
|
|
|
|
Neuroscience
|
|
AZD2066
|
metabotropic glutamate receptor 5 antagonist
|
chronic neuropathic pain
|
II
|
|
|
|
|
|
AZD2423
|
CCR2b antagonist
|
chronic neuropathic pain
|
II
|
|
|
|
|
|
AZD3480#
|
alpha4/beta2 neuronal nicotinic receptor agonist
|
Alzheimer’s disease
|
II
|
|
|
|
|
|
AZD6765
|
NMDA receptor antagonist
|
major depressive disorder
|
II
|
2016
|
2016
|
|
|
|
TC-5214#
|
neuronal nicotinic channel modulator
|
major depressive disorder (monotherapy)
|
II
|
|
|
|
|
|
AZD1446#
|
alpha4/beta2 neuronal nicotinic receptor agonist
|
Alzheimer’s disease
|
I
|
|
|
|
|
|
AZD3241
|
myeloperoxidase (MPO) inhibitor
|
Parkinson’s disease
|
I
|
|
|
|
|
|
AZD3839#
|
beta-secretase (BACE) inhibitor
|
Alzheimer’s disease
|
I
|
|
|
|
|
|
AZD5213
|
H3AN
|
Alzheimer’s disease/ADHD
|
I
|
|
|
|
|
|
MEDI-578
|
anti-NGF MAb
|
OA pain
|
I
|
|
|
|
|
#Partnered product
NCEs
Phases I and II (continued)
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Estimated Filing |
| |
|
|
|
US
|
EU
|
Japan
|
Emerging
|
|
Oncology
|
|
|
|
|
|
|
|
|
AZD1152
|
Aurora kinase inhibitor
|
haematological malignancies
|
II
|
|
|
|
|
|
AZD8931
|
erbB kinase inhibitor
|
breast cancer chemo combi/solid tumours
|
II
|
2015
|
2015
|
|
|
|
MEDI-575#
|
anti-PDGFR-alpha mAb
|
solid tumours
|
II
|
|
|
|
|
|
Olaparib
|
PARP inhibitor
|
serous ovarian cancer
|
II
|
2015
|
2015
|
2015
|
2015
|
|
Selumetinib# (AZD6244)
(ARRY-142886)
|
MEK inhibitor
|
solid tumours
|
II
|
2015
|
2015
|
|
|
|
AZD1480
|
JAK1, 2 inhibitor
|
solid tumours with options in myeloproliferative diseases
|
I
|
|
|
|
|
|
AZD2014
|
TOR kinase inhibitor
|
solid tumours
|
I
|
|
|
|
|
|
AZD3514
|
androgen receptor downregulator
|
prostate cancer
|
I
|
|
|
|
|
|
AZD4547
|
FGFR tyrosine kinase inhibitor
|
solid tumours
|
I
|
|
|
|
|
|
AZD5363
|
AKT inhibitor
|
solid tumours
|
I
|
|
|
|
|
|
AZD8330#
(ARRY 424704)
|
MEK inhibitor
|
solid tumours
|
I
|
|
|
|
|
|
Selumetinib (AZD6244) (ARRY-142886)
/MK2206#
|
MEK/AKT inhibitor
|
solid tumours
|
I
|
|
|
|
|
|
CAT-8015
|
anti-CD22 recombinant immunotoxin
|
haematological malignancies
|
I
|
|
|
|
|
|
MEDI-551
|
anti-CD19 MAb
|
haematological malignancies
|
I
|
|
|
|
|
|
MEDI-565
|
anti-CEA BiTE
|
solid tumours
|
I
|
|
|
|
|
|
MEDI-573#
|
anti-IGF MAb
|
solid tumours
|
I
|
|
|
|
|
|
MEDI-3617#
|
anti-ANG-2 MAb
|
solid tumours
|
I
|
|
|
|
|
|
Infection
|
|
AZD9773#
|
anti-TNF-alpha polyclonal antibody
|
severe sepsis
|
II
|
2015
|
2015
|
2015
|
2015
|
|
CAZ104#
|
beta lactamase inhibitor/
cephalosporin
|
serious infections
|
II
|
NA
|
2014
|
2014
|
2014
|
|
CXL104# (CEF104)
|
beta lactamase inhibitor/
cephalosporin
|
MRSA
|
II
|
NA
|
2015
|
|
2015
|
|
AZD5099
|
Gyrase B
|
serious infections
|
I
|
|
|
|
|
|
AZD5847
|
oxazolidinone antibacterial inhibitor
|
tuberculosis
|
I
|
|
|
|
|
|
MEDI-534
|
RSV/PIV-3 vaccine
|
RSV/PIV prophylaxis
|
I
|
|
|
|
|
|
MEDI-550
|
pandemic influenza virus vaccine
|
pandemic influenza prophylaxis
|
I
|
|
|
|
|
|
MEDI-557
|
RSV MAb – extended half-life
|
RSV prevention in high-risk adults (COPD/CHF/
Other)
|
I
|
|
|
|
|
|
MEDI-559
|
RSV vaccine
|
RSV prophylaxis
|
I
|
|
|
|
|
#Partnered product
NCEs
Phases I and II (continued)
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Estimated Filing |
| |
|
|
|
US
|
EU
|
Japan
|
Emerging
|
|
Respiratory & Inflammation
|
|
|
|
|
|
|
AZD1981
|
CRTh2 receptor antagonist
|
asthma/COPD
|
II
|
|
|
|
|
|
AZD2423
|
CCR2b antagonist
|
COPD
|
II
|
|
|
|
|
|
AZD3199
|
iLABA
|
asthma/COPD
|
II
|
|
|
|
|
|
AZD5069
|
CXCR2
|
COPD
|
II
|
|
|
|
|
|
AZD5423
|
inhaled SEGRA
|
COPD
|
II
|
|
|
|
|
|
AZD8848
|
Toll like receptor 7 agonist
|
asthma
|
II
|
|
|
|
|
|
CAM-3001#
|
anti-GM-CSFR MAb
|
rheumatoid arthritis
|
II
|
|
|
|
|
|
CAT-354
|
anti-IL-13 MAb
|
asthma
|
II
|
|
|
|
|
|
MEDI-528#
|
anti-IL-9 MAb
|
asthma
|
II
|
|
|
|
|
|
MEDI-545#
|
anti-IFN-alpha MAb
|
SLE
|
II
|
|
|
|
|
|
MEDI-563#
|
anti-IL-5R MAb
|
asthma
|
II
|
|
|
|
|
|
AZD2115
|
MABA
|
COPD
|
I
|
|
|
|
|
|
AZD8683
|
muscarinic antagonist
|
COPD
|
I
|
|
|
|
|
|
MEDI-546#
|
anti-IFN-alphaR MAb
|
scleroderma
|
I
|
|
|
|
|
|
MEDI-551
|
anti-CD19 MAb
|
scleroderma
|
I
|
|
|
|
|
|
MEDI-570#
|
anti-ICOS MAb
|
SLE
|
I
|
|
|
|
|
|
MEDI-2338
|
anti-IL-18 MAb
|
COPD
|
I
|
|
|
|
|
|
MEDI-8968#
|
anti-IL-1R
|
COPD
|
I
|
|
|
|
|
#Partnered product
Development Pipeline - Discontinued Projects vs 27 January 2011
Cardiovascular/Gastrointestinal
|
NCE/Line Extension
|
Compound
|
Area Under Investigation
|
|
NCE
|
AZD1656
|
diabetes
|
|
NCE
|
AZD5658
|
diabetes
|
|
NCE
|
AZD6714
|
diabetes
|
Neuroscience
|
NCE/Line Extension
|
Compound
|
Area Under Investigation
|
|
NCE
|
AZD2066
|
major depressive disorder
|
|
NCE
|
AZD3043
|
short acting sedative/anaesthetic
|
|
NCE
|
TC-5619
|
cognitive disorders in schizophrenia
|
Oncology
|
NCE/Line Extension
|
Compound
|
Area Under Investigation
|
|
NCE
|
AZD2461
|
solid tumours
|
|
NCE
|
AZD7762
|
solid tumours
|
|
NCE
|
AZD8055
|
range of tumours
|
|
NCE
|
RECENTIN
|
NSCLC
|
|
NCE
|
Zibotentan
|
castrate resistant prostate cancer
|
Infection
|
NCE/Line Extension
|
Compound
|
Area Under Investigation
|
|
NCE
|
AZD9742
|
MRSA
|
|
NCE
|
Motavizumab
|
early and late treatment of RSV in paeds
>1 yr
|
Respiratory & Inflammation
|
NCE/Line Extension
|
Compound
|
Area Under Investigation
|
|
NCE
|
AZD9819
|
COPD
|
Comments
As disclosure of compound information is balanced by the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
Compounds in development are displayed by phase.
AstraZeneca PLC
SECOND QUARTER AND HALF YEAR RESULTS 2011
Revenue for the second quarter was $8,430 million, down 2 percent at constant exchange rates (CER).
-Strong double-digit growth at CER for Crestor, Symbicort and Seroquel XR.
-Emerging Markets revenue increased by 10 percent at CER.
-Revenue performance reflects the loss of more than $0.5 billion of revenue from generic competition, as well as the impact of government price interventions.
Core operating profit in the second quarter declined by 10 percent at CER to $3,322 million.
-Core R&D expense increased by 8 percent at CER, reflecting the impact of several late stage clinical programme starts which commenced late 2010 and early 2011.
-Core SG&A expense increased by 9 percent at CER, which includes the impact of the excise tax related to US healthcare reform and a one-time expense for termination of a marketing and distribution contract in the US, in addition to investments in Emerging Markets and product launches.
Core EPS in the second quarter was down 5 percent at CER to $1.73.
-Core EPS benefited from the lower number of shares outstanding resulting from share repurchases.
Reported EPS in the second quarter was up 3 percent at CER to $1.53.
-Reported EPS growth was largely the result of lower restructuring costs compared with the prior year.
On 20 July, the Company announced the US FDA approval for Brilinta.
The Board has recommended a first interim dividend of $0.85. Net share repurchases totalled $2.2 billion in the first half. When completed, the entire net proceeds from the sale of Astra Tech will augment share repurchases; depending on the timing, net share repurchases in 2011 could increase to $5 billion.
Core EPS target for the full year increased to the range of $7.05 to $7.35.
Financial Summary
|
Group
|
2nd Quarter
2011
$m
|
2nd Quarter
2010
$m
|
Actual
%
|
CER
%
|
|
Half Year
2011
$m
|
Half Year
2010
$m
|
Actual
%
|
CER
%
|
|
Revenue
|
8,430
|
8,178
|
+3
|
-2
|
|
16,722
|
16,754
|
-
|
-3
|
|
Reported
|
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
2,965
|
3,034
|
-2
|
-4
|
|
6,366
|
6,677
|
-5
|
-5
|
|
Profit before Tax
|
2,858
|
2,917
|
-2
|
-4
|
|
6,146
|
6,436
|
-5
|
-5
|
|
Earnings per Share
|
$1.53
|
$1.46
|
+5
|
+3
|
|
$3.61
|
$3.37
|
+7
|
+7
|
|
Core*
|
|
|
|
|
|
|
|
|
|
|
Operating Profit
|
3,322
|
3,650
|
-9
|
-10
|
|
7,000
|
7,507
|
-7
|
-7
|
|
Profit before Tax
|
3,215
|
3,533
|
-9
|
-11
|
|
6,780
|
7,266
|
-7
|
-7
|
|
Earnings per Share
|
$1.73
|
$1.79
|
-3
|
-5
|
|
$3.96
|
$3.82
|
+4
|
+3
|
| |
|
|
|
|
|
|
|
|
|
|
*
|
Core financial measures are supplemental non-GAAP measures which management believe enhance understanding of the Company’s performance; it is upon these measures that financial guidance for 2011 is based. See page 11 for a definition of Core financial measures and pages 11 and 12 for a reconciliation of Core to Reported financial measures.
|
David Brennan, Chief Executive Officer, said: “Despite the anticipated impact of generic competition and government pricing interventions in the quarter, we are able to raise our Core earnings per share guidance and increase our shareholder cash return targets for the full year. The approval of Brilinta in 41 countries around the world, most recently in the US, demonstrates our commitment to deliver our global, innovation-driven biopharmaceuticals strategy.”
Interim Management Report
Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated.
Second Quarter
Revenue in the second quarter was down 2 percent at CER, but was up 3 percent on an actual basis as a result of the positive impact of exchange rate movements. This global revenue performance reflects government price interventions as well as the impact of more than $0.5 billion in revenue lost to generic competition, with the impact from generics in the US and Rest of World broadly similar. US revenue declined by 3 percent, largely on generic competition for Arimidex and Toprol-XL. Group revenue in the Rest of World was down 1 percent, reflecting generic competition for Nexium, chiefly in Western Europe, and for Arimidex. Revenue in Western Europe was down 9 percent. Revenue in Emerging Markets increased 10 percent. Revenue in Established Rest of World was up 4 percent.
Core operating profit in the second quarter was $3,322 million, down 10 percent. Besides lower revenue, the decline is largely the result of a 9 percent increase in Core SG&A expense. Around half of this increase is attributable to two items that are not present in the prior year quarter. The excise tax arising from US healthcare reform amounts to around 2.5 percent of the SG&A increase. Around 2 percent of the increase is due to a one-time payment of a contractually required termination fee associated with the termination of a marketing and distribution contract in the US as a consequence of the launch of an FDA approved generic version of Entocort. The remainder of the increase is the result of investments in Emerging Markets and new product launches partially offset by ongoing sales and marketing efficiencies. SG&A expense growth is anticipated to moderate in the second half of the year. Core R&D expense was up 8 percent, reflecting spending on late stage clinical projects that were initiated in the latter part of 2010 and early 2011. Adjustments to Core operating profit totalled $357 million in the quarter, $259 million lower than last year, chiefly on lower restructuring costs. As a result, the 4 percent decline in reported operating profit, to $2,965 million, was less than the decline on a Core basis.
Core earnings per share in the second quarter were $1.73 compared with $1.79 in the second quarter 2010, a 5 percent decline at CER. Core earnings per share benefited from a lower number of shares outstanding arising from share repurchases. Reported earnings per share in the second quarter were $1.53, up 3 percent compared with the second quarter 2010, reflecting the lower restructuring costs that benefited the reported operating profit growth rate.
First Half
Revenue in the first half was down 3 percent at CER, but was unchanged on an actual basis as a result of the positive impact of exchange rate movements. Revenue in the US was down 7 percent. Revenue in the Rest of World was unchanged at CER. Revenue in Emerging Markets was up 11 percent in the first half. Revenue in Western Europe was down 8 percent. Revenue in Established Rest of World markets increased by 4 percent.
Core operating profit for the first half was down 7 percent to $7,000 million, as the increases in R&D and SG&A in the second quarter were partially offset by the $131 million benefit to Core gross margin in the first quarter arising from settlement of patent disputes between MedImmune and PDL Biopharma, Inc. Reported operating profit was $6,366 million, a 5 percent decline, smaller than the decline in Core operating profit largely due to lower restructuring costs compared with the first half of 2010.
Core earnings per share for the first half were $3.96, an increase of 3 percent, which reflects benefits from share repurchases as well as a $0.37 per share benefit to first half 2011 earnings related to net adjustments to tax provisions. These adjustments were a consequence of agreements reached between the UK and the US governments’ tax authorities regarding transfer pricing and a related valuation matter arising on integration of the Company’s US businesses following the global AstraZeneca merger in 1999. Core EPS in the first half of 2010 benefited from net adjustments to tax provisions totalling $0.13 in the first quarter of 2010. Reported earnings per share in the first half were up 7 percent to $3.61.
Dividends and Share Repurchases
In conjunction with the Full Year 2009 results announcement, the Company announced that the Board has adopted a progressive dividend policy, intending to maintain or grow the dividend each year. In adopting this policy, the Board recognised that some earnings fluctuations are to be expected as the Company’s revenue base transitions through this period of exclusivity losses and new product launches. The Board’s view is that the annual dividend will not just reflect the financial performance of a single year taken in isolation, but reflect its view of the earnings prospects for the Group over the entirety of the investment cycle. As a result, dividend cover may vary during the period, but with the target of an average dividend cover of 2 times (ie, a payout ratio of 50 percent), based on reported earnings (before restructuring costs).
The Board has recommended a first interim dividend of $0.85 (51.9 pence, 5.33 SEK), an increase of 21 percent over last year’s first interim dividend of $0.70. The amount of the first interim dividend is a reflection of the Board’s intent to rebalance the first and second interim dividends, with the aim of setting the first interim dividend at around a third of the prior year dividend, which last year was $2.55.
In setting the distribution policy and the overall financial strategy, the Board’s aim is to continue to strike a balance between the interests of the business, our financial creditors and our shareholders. After providing for business investment, funding the progressive dividend policy and meeting our debt service obligations, the Board will keep under review the opportunity to return cash in excess of these requirements to shareholders through periodic share repurchases.
In the first half, the Company completed net share repurchases of $2,204 million towards its target of $4 billion for 2011. The Group has repurchased 51.6 million shares for a total of $2,544 million in the first half, whilst 9.0 million shares were issued in consideration of share option exercises for a total of $340 million. The total number of shares in issue at 30 June 2011 was 1,366 million.
The Board has determined that net proceeds from the disposal of Astra Tech, when completed, are to be used to augment the share repurchase programme to levels above the current $4 billion target. Depending on the timing of the transaction, the Company estimates that net share repurchases could increase to $5 billion in 2011; with repurchases from any remaining balance of the Astra Tech proceeds to be completed in 2012.
Enhancing Productivity
Good progress continues on the previously announced business reshaping programmes. In the second quarter, $138 million in restructuring costs were charged, with more than half of this related to R&D restructuring activities.
In aggregate, restructuring costs of $281 million have been incurred in the first half. The programmes remain on track for costs incurred and benefits achieved.
Research and Development Update
A comprehensive update of the AstraZeneca R&D pipeline is presented in conjunction with this Half Year 2011 results announcement, and is available on the Company’s website, www.astrazeneca.com, under information for investors.
The AstraZeneca pipeline now includes 88 projects in the clinical phase of development. There are 9 NME projects currently in late stage development, either in Phase III or under regulatory review. In the first half of 2011, 15 projects have successfully progressed to their next phase (including 6 projects entering first human testing); 14 projects have been withdrawn.
Significant pipeline developments since the first quarter update include:
Brilinta
On 20 July 2011, AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Brilinta (ticagrelor) tablets to reduce the rate of heart attack (myocardial infarction [MI]) and cardiovascular (CV) death in adult patients with acute coronary syndrome (ACS), compared to clopidogrel.
Brilinta, a new oral antiplatelet medicine, is indicated to reduce the rate of thrombotic cardiovascular events in patients with ACS (unstable angina, non-ST-elevation myocardial infarction, or ST-elevation myocardial infarction). Brilinta has been shown to reduce the rate of a combined endpoint of CV death, MI or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), Brilinta reduces the rate of stent thrombosis. Brilinta has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100mg decreased the effectiveness of Brilinta. Avoid maintenance doses of aspirin above 100mg daily.
Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal, bleeding. In PLATO, there was no statistical difference in patients treated with Brilinta compared to patients treated with clopidogrel in total major bleeding events (11.6% vs. 11.2%), including fatal and fatal/life-threatening bleeding events. Non-CABG (coronary artery bypass graft) major + minor bleeding events (8.7% vs. 7%) were more common with Brilinta versus clopidogrel.
The most commonly observed adverse reactions associated with the use of Brilinta vs. clopidogrel were bleeding
(11.6% vs.11.2%) and a feeling of breathlessness called dyspnoea (14% vs. 8%).
As with all AstraZeneca products, the Company will work to ensure that physicians and patients understand both the benefits and risks associated with Brilinta. For Brilinta, one of the ways AstraZeneca will help ensure physicians and patients are appropriately informed about bleeding risk and the impact of aspirin dose on the effectiveness of Brilinta is through a Risk Evaluation Mitigation Strategy (REMS).
Now that Brilinta is approved in the US, AstraZeneca will begin the process of working with hospital formularies, protocol committees, government and managed care reimbursement bodies to bring this medicine to patients. Navigating these steps, which are necessary before Brilinta will be available to a substantial number of incident ACS patients, will be a key focus for the next 12 months.
Brilinta is now approved in 41 countries, including the US, Brazil, Australia, and Canada under the trade name Brilinta and in the European Union under the trade name Brilique. Brilinta is currently under regulatory review in an additional 43 countries, including Russia, India and China. Brilinta is currently reimbursed in 7 countries.
Dapagliflozin
On 19 July 2011, the US FDA Endocrinologic and Metabolic Drugs Advisory Committee met to discuss the New Drug Application for the investigational compound dapagliflozin.
On the question: “Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus?”, the Advisory Committee voted 6 yes and 9 no. Bristol-Myers Squibb and AstraZeneca remain committed to the dapagliflozin clinical development programme and will continue to work closely with the FDA to support the review of this investigational compound.
The FDA is not bound by the Advisory Committee’s recommendation but takes its advice into consideration when reviewing New Drug Applications. The Prescription Drug User Fee Act (PDUFA) goal date for dapagliflozin is 28 October 2011.
Nexium
On 1 July 2011, AstraZeneca announced that Nexium 10mg and 20mg capsules received regulatory approval in Japan for the treatment of acid-related conditions including non-erosive reflux disease (NERD), reflux esophagitis, and peptic ulcer disease (PUD). Nexium also received regulatory approval for prevention of recurrence of gastric ulcer and duodenal ulcer in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs).
AstraZeneca plans to launch Nexium in Japan in the second half of 2011.
Zibotentan
Preliminary results of the third and final Phase III trial for zibotentan (ENTHUSE study 33), which evaluated zibotentan in combination with standard chemotherapy in a metastatic castrate resistant prostate cancer (CRPC) setting indicate that the addition of zibotentan to treatment with docetaxel provided no improvement in overall survival. In light of these and results of previous trials in the ENTHUSE programme, the Company will discontinue the development of zibotentan for CRPC.
Axanum
Following a comprehensive review of the Complete Response Letter (CRL) received from the US FDA for its Axanum new drug application (NDA), the Company has decided to withdraw the NDA in the US for commercial reasons.
A regulatory application for Axanum was submitted in the European Union via the decentralised procedure in April 2010, and remains under review.
Recentin
Study BR 29, a National Cancer Institute of Canada – Clinical Trials Group sponsored Phase II/III study, exploring Recentin (cediranib) 20mg in combination with carboplatin/paclitaxel in patients with non small cell lung cancer (NSCLC), has been stopped. The decision was made after an analysis of the Phase II part of the trial indicated that cediranib did not meet pre-specified progression-free survival efficacy criteria. The tolerability profile for cediranib was broadly consistent with findings in the overall clinical programme.
Based on these findings, the Recentin NSCLC development programme has been removed from the updated pipeline table, although clinical trial collaborations in a number of other tumours are ongoing.
FluMist
The Company has received confirmation from the US FDA that the Agency has filed the Company’s supplemental Biologics License Application (sBLA) for a quadrivalent (four-strain) version of FluMist (Influenza Vaccine Live, Intranasal). The Company submitted the sBLA early in the second quarter of this year.
Currently licensed seasonal influenza vaccines are trivalent, containing three strains (two strains of type A influenza (A/H1N1 and A/H3N2) and one B lineage strain). However, as influenza B strains from 2 different lineages have circulated in recent years (B/Yamagata and B/Victoria) the quadrivalent vaccine contains four strains: A/H1N1, A/H3N2, and B strains from both of the B lineages. The quadrivalent vaccine is designed to offer protection against a broader range of B strains and reinforces our commitment to innovation within the infectious disease area.
Future Prospects
Revenue performance in the first half was in line with our expectations, reflecting the expected impact from generic competition as well as the effects from government price interventions. The Company continues to anticipate that revenue for the full year could range from flat to a low single-digit decline compared with 2010 on a constant currency basis.
The Company has increased its target for full year Core EPS by a further $0.10 due to the re-phasing and expected increase in net share repurchases and a beneficial impact from exchange rate movements realised in the first half compared to guidance rates. As a result, the Company’s target for full year Core earnings per share is now in the range of $7.05 to $7.35. Compared with 2010, this implies somewhat stronger growth in Core EPS in the second half compared with the first half, which is consistent with expectations for the phasing of Core SG&A expenditures, particularly in the fourth quarter.
This Core EPS guidance has been based on the January 2011 average exchange rates for our principal currencies; actual Core EPS in the first half benefited by around $0.04 compared with these guidance rates. The target takes no account of the likelihood that average exchange rates for the remainder of 2011 may differ materially from the January 2011 average rates upon which our earnings guidance is based. An estimate of the sales and earnings sensitivity to movements of our major currencies versus the US dollar was provided in conjunction with the Full Year 2010 results announcement, and can be found on the AstraZeneca website.
Principal risks and uncertainties
It is not anticipated that the nature of the principal risks and uncertainties that affect the business, and which are set out on pages 96 to 103 of the Annual Report and Form 20-F Information 2010, will change in respect of the second six months of the financial year.
In summary, the principal risks and uncertainties listed in the Annual Report and 20-F Information 2010 are:
Product pipeline risks
Failure to meet development targets, difficulties of obtaining and maintaining regulatory approvals for new products, failure to obtain effective intellectual property protection, delay to new product launches and strategic alliances formed as part of our externalisations strategy may be unsuccessful.
Commercialisation and business execution risks
Challenges to achieving commercial success of new products, performance of new products, product counterfeiting, developing our business in Emerging Markets, expiry of intellectual property rights, patent litigation and early loss of intellectual property rights, biosimilars, expiry or earlier loss of patents covering competing products, competition, price controls and price reductions, increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation, expected gains from productivity initiatives are uncertain, acquisitions may be unsuccessful, failure to manage a crisis, failure of information technology and failure of outsourcing.
Supply chain and delivery risks
Manufacturing biologics and reliance on third parties for goods.
Legal, regulatory and compliance risks
Adverse outcome of litigation and/or governmental investigations, legal proceedings regarding business practices, substantial product liability claims, failure to adhere to applicable laws, rules and regulations and environmental/occupational health and safety liabilities.
Economic and financial risks
Adverse impact of a sustained economic downturn, impact of fluctuations in exchange rates, credit and return on substantial investments, limited third party insurance coverage, taxation and pensions.
All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated.
Gastrointestinal
| |
Second Quarter
|
CER %
|
Half Year
|
CER %
|
| |
2011
$m
|
2010
$m
|
|
2011
$m
|
2010
$m
|
|
|
Nexium
|
1,112
|
1,257
|
-14
|
2,273
|
2,496
|
-10
|
|
Losec/Prilosec
|
239
|
261
|
-17
|
474
|
510
|
-14
|
|
Total
|
1,387
|
1,556
|
-14
|
2,822
|
3,076
|
-10
|
|
·
|
In the US, Nexium sales in the second quarter were $613 million, down 12 percent compared with the second quarter last year. Dispensed retail tablet volume declined around 7 percent. Average realised selling prices for Nexium were down 5 percent compared with the second quarter last year, including the impact of US healthcare reform.
|
|
·
|
Nexium sales in the US in the first half were down 10 percent to $1,213 million.
|
|
·
|
Nexium sales in other markets in the second quarter were down 17 percent to $499 million, largely the result of generic launches in some Western European markets, where sales were down 42 percent. Sales in Emerging Markets increased by 24 percent, including 39 percent growth in China. Sales in Established Rest of World were down 5 percent, impacted by generic competition in some provinces in Canada.
|
|
·
|
Nexium sales in other markets were down 10 percent in the first half to $1,060 million.
|
|
·
|
Prilosec sales in the US were down 33 percent in the first half to $21 million.
|
|
·
|
Sales of Losec in the Rest of World were down 16 percent in the second quarter to $231 million, as sales declined in all major regions. Losec sales in the Rest of World were down 12 percent in the first half to $453 million.
|
Cardiovascular
| |
Second Quarter
|
CER %
|
Half Year
|
CER %
|
| |
2011
$m
|
2010
$m
|
|
2011
$m
|
2010
$m
|
|
|
Crestor
|
1,714
|
1,430
|
+15
|
3,192
|
2,730
|
+13
|
|
Atacand
|
385
|
376
|
-4
|
740
|
749
|
-4
|
|
Seloken /Toprol-XL
|
232
|
317
|
-29
|
477
|
684
|
-32
|
|
Plendil
|
62
|
63
|
-6
|
130
|
129
|
-3
|
|
Zestril
|
39
|
40
|
-8
|
72
|
82
|
-15
|
|
ONGLYZATM
|
46
|
14
|
+228
|
81
|
18
|
+350
|
|
Brilinta/Brilique
|
2
|
-
|
n/m
|
3
|
-
|
n/m
|
|
Total
|
2,619
|
2,380
|
+5
|
4,958
|
4,667
|
+3
|
|
·
|
In the US, Crestor sales in the second quarter were up 17 percent to $796 million. Crestor total prescriptions increased by 2.4 percent compared with 1 percent for the statin market overall in the US. Crestor share of total prescriptions was 12 percent in June 2011. Crestor dynamic share (new and switch patients) has increased by 2.9 percentage points in recent weeks following the labelling changes to simvastatin restricting use of 80mg.
|
|
·
|
US sales for Crestor for the first half increased by 17 percent to $1,478 million.
|
|
·
|
Crestor sales in the Rest of World were up 12 percent to $918 million in the second quarter, with volume growth continuing to outpace the market. Volume grew by double digits in Western Europe, although lower prices reduced reported sales growth to 7 percent. Sales in Established ROW were up 19 percent as sales in Japan, Australia and Canada all grew at double digit rates. Sales in Emerging Markets were up 8 percent, which reflects the impact of generic rosuvastatin in some Eastern European Markets.
|
|
·
|
Crestor sales in the Rest of World were up 10 percent to $1,714 million in the first half.
|
|
·
|
US sales of the Toprol-XL product range, which includes sales of the authorised generic, declined by 51 percent in the second quarter to $91 million. Total prescriptions for the franchise were down 31 percent.
|
|
·
|
Toprol-XL franchise sales in the US in the first half were down 55 percent to $192 million.
|
|
·
|
Sales of Seloken in other markets were up 2 percent in the second quarter and increased 5 percent in the first half. Sales in Emerging Markets increased by 7 percent in the second quarter and 11 percent in the first half.
|
|
·
|
US sales for Atacand were down 16 percent in the second quarter to $49 million, and were down 17 percent in the first half.
|
|
·
|
Atacand sales in Rest of World were down 2 percent in the second quarter to $336 million. For the year to date, sales were also down 2 percent, although sales in Emerging Markets were up 7 percent.
|
|
·
|
Alliance revenue from the ONGLYZATM collaboration with Bristol-Myers Squibb totalled $46 million in the second quarter and $81 million in the first half. Alliance revenue in the US was $33 million in the second quarter. ONGLYZATM franchise share of total prescriptions in the US DPP4 market reached 14.1 percent in June (including 2.7 percent share for KOMBIGLYZE XRTM) up 4.1 percentage points since December 2010. Franchise share of patients newly starting DPP4 treatment was 24.9 percent in the week ending 8 July.
|
Respiratory and Inflammation
| |
Second Quarter
|
CER %
|
Half Year
|
CER %
|
| |
2011
$m
|
2010
$m
|
|
2011
$m
|
2010
$m
|
|
|
Symbicort
|
802
|
664
|
+14
|
1,554
|
1,365
|
+10
|
|
Pulmicort
|
236
|
216
|
+4
|
484
|
459
|
+3
|
|
Rhinocort
|
55
|
65
|
-18
|
110
|
120
|
-11
|
|
Oxis
|
14
|
16
|
-25
|
28
|
33
|
-21
|
|
Accolate
|
7
|
16
|
-56
|
12
|
33
|
-64
|
|
Total
|
1,148
|
1,009
|
+7
|
2,258
|
2,077
|
+5
|
|
·
|
Symbicort sales in the US were $206 million in the second quarter, a 14 percent increase over last year. Total prescriptions for Symbicort were up 10 percent over the second quarter last year, compared with a 3 percent decline for the fixed combination product class. Symbicort share of total prescriptions for fixed combination products increased to 19.2 percent in June 2011, up 2 percentage points compared with June 2010, despite the launch of a new entrant to the market.
|
|
·
|
US sales of Symbicort in the first half were $403 million, an increase of 14 percent.
|
|
·
|
Symbicort sales in other markets in the second quarter were $596 million, 13 percent ahead of the second quarter last year. Sales in Established ROW increased by 57 percent, reflecting continued strong growth in Japan as well as double digit growth in Canada and Australia. Sales in Emerging Markets were up 24 percent. Sales in Western Europe were up 3 percent despite the impact of price cuts in Germany.
|
|
·
|
Symbicort sales in the Rest of World in the first half were up 9 percent to $1,151 million.
|
|
·
|
US sales for Pulmicort in the second quarter were up 5 percent to $88 million.
|
|
·
|
US sales of Pulmicort in the first half were down 6 percent to $166 million.
|
|
·
|
Sales of Pulmicort in the Rest of World in the first half were up 8 percent to $318 million on a 30 percent increase in Emerging Markets.
|
Oncology
| |
Second Quarter
|
CER %
|
Half Year
|
CER %
|
| |
2011
$m
|
2010
$m
|
|
2011
$m
|
2010
$m
|
|
|
Arimidex
|
181
|
439
|
-62
|
414
|
950
|
-58
|
|
Zoladex
|
302
|
280
|
+3
|
577
|
545
|
+2
|
|
Casodex
|
138
|
151
|
-17
|
271
|
294
|
-14
|
|
Iressa
|
139
|
93
|
+38
|
260
|
176
|
+39
|
|
Faslodex
|
135
|
79
|
+63
|
258
|
150
|
+69
|
|
Nolvadex
|
24
|
22
|
-
|
47
|
43
|
+2
|
|
Total
|
922
|
1,067
|
-19
|
1,834
|
2,164
|
-19
|
|
·
|
In the US, sales of Arimidex were down 95 percent in the second quarter to $10 million, as a result of generic competition which commenced in June of 2010. US sales in the first half were down 93 percent to $29 million.
|
|
·
|
Arimidex sales in other markets were down 39 percent in the second quarter to $171 million. Sales in Western Europe were down 65 percent, reflecting loss of exclusivity from February 2011. Sales in Established ROW and Emerging ROW were down 4 percent and 5 percent respectively.
|
|
·
|
Sales for Casodex in the second quarter were $138 million, down 17 percent. US reported revenue was actually negative in the quarter, reflecting product returns (as the market has become largely generic). More than half of Casodex revenue comes from Japan, where sales were down 7 percent in the quarter. Sales in Western Europe were down 33 percent. Sales in Emerging Markets were up 8 percent.
|
|
·
|
Casodex sales in the first half were down 14 percent to $271 million.
|
|
·
|
Iressa sales increased by 38 percent to $139 million in the second quarter, including $33 million of sales in Western Europe. Sales in Emerging Markets were up 44 percent, including a 58 percent increase in China. Sales in Japan were down 4 percent.
|
|
·
|
Iressa sales in the first half reached $260 million, a 39 percent increase.
|
|
·
|
Continued rapid adoption of the new 500mg dosage regimen for Faslodex is responsible for the strong growth in the second quarter. Sales in the US were up 91 percent to $65 million, and sales were up 42 percent in the Rest of World to $70 million.
|
|
·
|
Faslodex sales in the first half increased by 95 percent in the US to $127 million and grew by 49 percent in the Rest of World to $131 million.
|
Neuroscience
| |
Second Quarter
|
CER %
|
Half Year
|
CER %
|
| |
2011
$m
|
2010
$m
|
|
2011
$m
|
2010
$m
|
|
|
Seroquel
|
1,537
|
1,352
|
+11
|
2,882
|
2,659
|
+7
|
|
Seroquel IR
|
1,150
|
1,049
|
+7
|
2,156
|
2,100
|
+1
|
|
Seroquel XR
|
387
|
303
|
+23
|
726
|
559
|
+28
|
|
Zomig
|
103
|
109
|
-11
|
204
|
215
|
-8
|
|
Vimovo
|
6
|
-
|
n/m
|
10
|
-
|
n/m
|
|
Total
|
1,897
|
1,707
|
+7
|
3,576
|
3,354
|
+4
|
|
·
|
In the US, Seroquel franchise sales were up 13 percent to $1,094 million in the second quarter. Total prescriptions for Seroquel XR were up 19 percent in the second quarter compared with last year and well ahead of the 4 percent growth in the atypical antipsychotic market. Although total prescriptions for Seroquel IR were down 2.6 percent, total franchise prescriptions were up 0.5 percent compared with the second quarter last year. Seroquel XR accounted for 16.9 percent of total prescriptions and 18.7 percent of sales revenue for the franchise in the US in the second quarter.
|
|
·
|
US sales for Seroquel in the first half were $2,024 million, 8 percent ahead of last year.
|
|
·
|
Seroquel franchise sales in the Rest of World were $443 million in the second quarter, a 5 percent increase. Sales of Seroquel XR increased by 36 percent, and now account for 41 percent of franchise sales outside the US. Franchise sales were up 13 percent in Western Europe on a 44 percent increase for Seroquel XR. Seroquel franchise sales were down 10 percent in Established ROW, on a 29 percent sales decline in Japan, which reflects lower shipments to our marketing partner rather than the underlying market demand which is stable. Seroquel franchise sales were down 3 percent in Emerging Markets.
|
|
·
|
For the first half, Seroquel sales in the Rest of World increased by 5 percent to $858 million.
|
|
·
|
Sales of Vimovo in the first half were $10 million, of which $8 million were in the US.
|
Infection and Other
| |
Second Quarter
|
CER %
|
Half Year
|
CER %
|
| |
2011
$m
|
2010
$m
|
|
2011
$m
|
2010
$m
|
|
|
Synagis
|
48
|
43
|
+12
|
456
|
502
|
-9
|
|
Merrem
|
158
|
197
|
-24
|
330
|
430
|
-26
|
|
FluMist
|
-
|
1
|
-100
|
3
|
3
|
-
|
|
Non seasonal flu vaccine
|
-
|
-
|
-
|
7
|
39
|
-82
|
|
Total
|
240
|
266
|
-15
|
863
|
1,027
|
-17
|
|
·
|
In the US, sales of Synagis in the first half were down 16 percent to $301 million, the majority of which were recorded during the RSV season in the first quarter, which was negatively impacted by lower shipments to wholesalers and the impact of higher rebates from US healthcare reform measures. Outside the US, sales were up 8 percent to $155 million.
|
|
·
|
In line with the usual seasonality, there were negligible sales of FluMist recorded in the first half.
|
|
·
|
Sales of Merrem were down 24 percent in the second quarter as a result of generic competition in the US and Western Europe.
|
Geographic Sales
| |
Second Quarter
|
CER %
|
Half Year
|
CER %
|
| |
2011
$m
|
2010
$m
|
|
2011
$m
|
2010
$m
|
|
|
US
|
3,292
|
3,396
|
-3
|
6,596
|
7,094
|
-7
|
|
Western Europe
|
2,194
|
2,213
|
-9
|
4,429
|
4,672
|
-8
|
|
Established ROW*
|
1,476
|
1,277
|
+4
|
2,797
|
2,439
|
+4
|
|
Emerging ROW
|
1,468
|
1,292
|
+10
|
2,900
|
2,549
|
+11
|
|
*
|
Established ROW comprises Canada, Japan, Australia and New Zealand.
|
|
·
|
In the US, revenue was down 3 percent in the second quarter. There was good double-digit growth for Crestor, Symbicort and the Seroquel franchise, but this was more than offset by generic competition for Arimidex and Toprol-XL as well as the pricing impact from US healthcare reform measures.
|
|
·
|
Revenue in Western Europe was down 9 percent in the second quarter, as generic competition for Nexium and Arimidex and price declines related to government interventions more than offset the volume growth in the rest of the portfolio, which was driven by Seroquel XR, Crestor, Iressa and Faslodex.
|
|
·
|
Revenue in Established Rest of World was up 4 percent in the second quarter, with more than half the growth attributable to Canada, where Crestor grew strongly. Sales in Japan were up 2 percent in the quarter, as strong growth for Symbicort and Crestor more than offset some sales declines for oncology products and Seroquel.
|
|
·
|
Revenue in Emerging Rest of World was up 10 percent in the second quarter. Nexium and Symbicort accounted for 45 percent of this revenue growth, with the oncology and cardiovascular products also contributing good growth. Revenue in China was up 15 percent, in line with recent trends for market growth.
|
Operating and Financial Review
All narrative in this section refers to growth rates at constant exchange rates (CER) and on a Core basis unless otherwise indicated. These measures, which are presented in addition to our Reported financial information, are non-GAAP measures which management believe useful to enhance understanding of the Group’s underlying financial performance of our ongoing businesses and the key business drivers thereto. Core financial measures are adjusted to exclude certain items, such as charges and provisions related to our global restructuring programmes, amortisation and impairment of the significant intangibles relating to our acquisition of MedImmune Inc. in 2007 and our current and future exit arrangements with Merck in the US, and other specified items. More detail on the nature of these measures is given on page 80 of our Annual Report and Form 20-F Information 2010.
Second Quarter
All financial figures, except earnings per share, are in $ millions. Weighted average shares in millions.
| |
Reported
2011
|
Restructuring
|
Merck &
MedImmune
Amortisation
|
Intangible
Impairments
|
Legal
Provisions
|
Core
2011
|
Core
2010
|
Actual
%
|
CER
%
|
|
Revenue
|
8,430
|
-
|
-
|
-
|
-
|
8,430
|
8,178
|
3
|
(2)
|
|
Cost of Sales
|
(1,482)
|
20
|
-
|
-
|
-
|
(1,462)
|
(1,389)
|
|
|
|
Gross Profit
|
6,948
|
20
|
-
|
-
|
-
|
6,968
|
6,789
|
3
|
(2)
|
|
% sales
|
82.4%
|
|
|
|
|
82.7%
|
83.0%
|
-0.3
|
+0.1
|
|
Distribution
|
(88)
|
-
|
-
|
-
|
-
|
(88)
|
(88)
|
-
|
(8)
|
|
% sales
|
1.0%
|
|
|
|
|
1.0%
|
1.1%
|
+0.1
|
+0.1
|
|
R&D
|
(1,198)
|
79
|
-
|
-
|
-
|
(1,119)
|
(966)
|
16
|
8
|
|
% sales
|
14.2%
|
|
|
|
|
13.3%
|
11.8%
|
-1.5
|
-1.1
|
|
SG&A
|
(2,868)
|
39
|
118
|
-
|
84
|
(2,627)
|
(2,271)
|
16
|
9
|
|
% sales
|
34.0%
|
|
|
|
|
31.2%
|
27.8%
|
-3.4
|
-3.1
|
|
Other Income
|
171
|
-
|
17
|
-
|
-
|
188
|
186
|
1
|
(2)
|
|
% sales
|
2.0%
|
|
|
|
|
2.2%
|
2.3%
|
-0.1
|
-
|
|
Operating Profit
|
2,965
|
138
|
135*
|
-
|
84
|
3,322
|
3,650
|
(9)
|
(10)
|
|
% sales
|
35.2%
|
|
|
|
|
39.4%
|
44.6%
|
-5.2
|
-4.0
|
|
Net Finance Expense
|
(107)
|
-
|
-
|
-
|
-
|
(107)
|
(117)
|
|
|
|
Profit before Tax
|
2,858
|
138
|
135
|
-
|
84
|
3,215
|
3,533
|
(9)
|
(11)
|
|
Taxation
|
(735)
|
(34)
|
(24)*
|
-
|
(22)
|
(815)
|
(945)
|
|
|
|
Profit after Tax
|
2,123
|
104
|
111
|
-
|
62
|
2,400
|
2,588
|
(7)
|
(9)
|
|
Non-controlling Interests
|
(10)
|
-
|
-
|
-
|
-
|
(10)
|
(9)
|
|
|
|
Net Profit
|
2,113
|
104
|
111
|
-
|
62
|
2,390
|
2,579
|
(7)
|
(9)
|
|
Weighted Average Shares
|
1,381
|
1,381
|
1,381
|
|
1,381
|
1,381
|
1,445
|
|
|
|
Earnings per Share
|
1.53
|
0.08
|
0.08
|
-
|
0.04
|
1.73
|
1.79
|
(3)
|
(5)
|
|
*
|
Of the $135 million amortisation adjustment, $94 million is related to MedImmune, with a corresponding tax adjustment of $24 million; Merck related amortisation was $41 million, which carries no tax adjustment.
|
Revenue declined by 2 percent to $8,430 million.
Core gross margin of 82.7 percent was 0.1 percentage points higher than last year. Higher royalty payments (0.4 percentage points) and Merck amortisation (0.1 percentage points) was more than offset by cost phasing (0.6 percentage points).
Core SG&A costs of $2,627 million were 9 percent higher than last year. The US healthcare reform excise tax, the one-time payment for termination of a marketing and distribution contract in the US and investment in Emerging Markets and product launches were the main drivers of the increase.
Core other income of $188 million was 2 percent lower than last year.
Core Pre-R&D operating margin was 52.7 percent, down 2.9 percentage points, largely due to the previously mentioned excise tax and contract termination fee and investments in Emerging Markets and product launches.
Core R&D expenditure was $1,119 million, 8 percent higher than last year, due to an increase in late stage development spend, investment in Biologics and intangible asset impairments.
Core operating profit was $3,322 million, down 10 percent.
Core earnings per share in the second quarter were $1.73, down 5 percent, with the decline in Core operating profit offset by lower net finance expense, a lower tax rate and a lower number of shares in issue.
Reported operating profit was down 4 percent to $2,965 million. Reported earnings per share were $1.53, up 3 percent reflecting lower restructuring costs.
First Half
All financial figures, except earnings per share, are in $ millions. Weighted average shares in millions.
| |
Reported
2011
|
Restructuring
|
Merck &
MedImmune
Amortisation
|
Intangible
Impairments
|
Legal
Provisions
|
Core
2011
|
Core
2010
|
Actual
%
|
CER
%
|
|
Revenue
|
16,722
|
-
|
-
|
-
|
-
|
16,722
|
16,754
|
-
|
(3)
|
|
Cost of Sales
|
(2,821)
|
32
|
-
|
-
|
-
|
(2,789)
|
(3,015)
|
|
|
|
Gross Profit
|
13,901
|
32
|
-
|
-
|
-
|
13,933
|
13,739
|
1
|
(1)
|
|
% sales
|
83.1%
|
|
|
|
|
83.3%
|
82.0%
|
+1.3
|
+1.6
|
|
Distribution
|
(168)
|
-
|
-
|
-
|
-
|
(168)
|
(166)
|
1
|
(4)
|
|
% sales
|
1.0%
|
|
|
|
|
1.0%
|
1.0%
|
-
|
-
|
|
R&D
|
(2,360)
|
169
|
-
|
-
|
-
|
(2,191)
|
(1,939)
|
13
|
7
|
|
% sales
|
14.1%
|
|
|
|
|
13.1%
|
11.6%
|
-1.5
|
-1.2
|
|
SG&A
|
(5,376)
|
80
|
235
|
-
|
84
|
(4,977)
|
(4,583)
|
9
|
5
|
|
% sales
|
32.1%
|
|
|
|
|
29.7%
|
27.3%
|
-2.4
|
-2.2
|
|
Other Income
|
369
|
-
|
34
|
-
|
-
|
403
|
456
|
(12)
|
(13)
|
|
% sales
|
2.2%
|
|
|
|
|
2.4%
|
2.7%
|
-0.3
|
-0.3
|
|
Operating Profit
|
6,366
|
281
|
269*
|
-
|
84
|
7,000
|
7,507
|
(7)
|
(7)
|
|
% sales
|
38.1%
|
|
|
|
|
41.9%
|
44.8%
|
-2.9
|
-2.1
|
|
Net Finance Expense
|
(220)
|
-
|
-
|
-
|
-
|
(220)
|
(241)
|
|
|
|
Profit before Tax
|
6,146
|
281
|
269
|
-
|
84
|
6,780
|
7,266
|
(7)
|
(7)
|
|
Taxation
|
(1,108)
|
(74)
|
(50)*
|
-
|
(22)
|
(1,254)
|
(1,725)
|
|
|
|
Profit after Tax
|
5,038
|
207
|
219
|
-
|
62
|
5,526
|
5,541
|
-
|
(1)
|
|
Non-controlling Interests
|
(18)
|
-
|
-
|
-
|
-
|
(18)
|
(11)
|
|
|
|
Net Profit
|
5,020
|
207
|
219
|
-
|
62
|
5,508
|
5,530
|
-
|
(1)
|
|
Weighted Average Shares
|
1,389
|
1,389
|
1,389
|
1,389
|
1,389
|
1,389
|
1,448
|
|
|
|
Earnings per Share
|
3.61
|
0.15
|
0.16
|
-
|
0.04
|
3.96
|
3.82
|
4
|
3
|
|
*
|
Of the $269 million amortisation adjustment, $187 million is related to MedImmune, with a corresponding tax adjustment of $50 million; Merck related amortisation was $82 million, which carries no tax adjustment.
|
Revenue declined by 3 percent to $16,722 million.
Core gross margin of 83.3 percent was 1.6 percentage points higher than last year, due to the PDL settlement (0.8 percentage points) and cost phasing (0.8 percentage points).
Core SG&A costs of $4,977 million were 5 percent higher than last year with continued investment in Emerging Markets and the impact of the US healthcare reform excise tax driving most of the increase.
Core other income of $403 million was $53 million lower than last year, chiefly on movements in provisions which are taken through other income.
Core Pre-R&D operating margin was 55.0 percent, down 0.9 percentage points, with higher gross margin more than offset by higher SG&A costs and lower other income.
Core R&D expense was $2,191 million, 7 percent higher than last year, driven by higher project spend, investment in Biologics and, to a lesser extent, intangible asset write downs.
Core operating profit was $7,000 million, a decrease of 7 percent. Core operating margin declined by 2.1 percentage points to 41.9 percent as a result of higher R&D and SG&A combined with lower other operating income.
Core earnings per share in the first half were $3.96, up 3 percent, with the operating performance offset by the lower tax rate and lower number of shares in issue.
Reported operating profit was down 5 percent to $6,366 million. Reported earnings per share were up 7 percent to $3.61.
Finance Income and Expense
Net finance expense was $107 million for the quarter, versus $117 million in 2010, reflecting reduced interest payable on lower debt balances, and slightly increased returns from higher cash and cash equivalent balances.
Taxation
The effective tax rate for the second quarter is 25.7 percent (2010 27.5 percent) and 18.0 percent for the first half (2010 23.9 percent). As previously disclosed, the effective tax rate has benefited from an adjustment in respect of prior periods following the announcement in March that HM Revenue & Customs in the UK and the US Internal Revenue Service agreed the terms of an Advance Pricing Agreement regarding transfer pricing arrangements for AstraZeneca’s US business for the period from 2002 to the end of 2014 and a related valuation matter arising on integration of the legacy Astra and legacy Zeneca US businesses in 2000 following the global AstraZeneca merger in 1999. The adjustment in respect of prior periods relating to these matters resulted in a $520 million benefit to earnings in the first half. Excluding this benefit, the effective tax rate for the first half was 26.5 percent on a reported basis. This 26.5 percent tax rate is applied to the taxable Core adjustments to operating profit, resulting in an effective Core tax rate in the first half of 18.5 percent. The effective tax rate for the first half last year of 23.9 percent benefited from $194 million of net adjustments to tax provisions related to a settlement with HM Revenue & Customs in the UK and developments in other transfer pricing matters. The full year effective tax rate for 2011 is now anticipated to be around 19 percent on a reported basis, due to negligible tax cost on the expected gain on the sale of Astra Tech announced in June. The Core effective tax rate is expected to be higher at between 21 and 22 percent.
Cash Flow
Cash generated from operating activities was $2,829 million in the first half to 30 June 2011, compared with $4,767 million in the same period of 2010. The decrease of $1,938 million is primarily driven by higher tax payments made this year, including a net amount of $1.1 billion paid during the second quarter in relation to the Advance Pricing Agreement between the UK and US governments’ tax authorities and the settlement of a related valuation matter (see Note 4).
Net cash inflows from investing activities were $286 million in the first half compared with an outflow of $2,032 million in 2010. The increase of $2,318 million is due primarily to the movement in short-term investments and fixed deposits of $1,335 million, and $995 million cash outflows for the Merck First Option Intangible and the acquisition of Novexel in the prior year.
Cash distributions to shareholders were $4,850 million through net share repurchases of $2,204 million and $2,646 million through the payment of the second interim dividend from 2010.
Debt and Capital Structure
As at 30 June 2011, outstanding gross debt (including loans, short-term borrowings and overdrafts) was $9,582 million (31 December 2010: $9,222 million). Of the gross debt outstanding at 30 June 2011, $372 million is due within one year (31 December 2010: $125 million). Net Funds of $1,032 million have decreased by $2,621 million during the year as a result of the net cash outflow during the six months to 30 June 2011 as described above.
Related Party Transactions
There have been no significant related party transactions in the period.
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27 October 2011
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Announcement of third quarter and nine months 2011 results
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2 February 2012
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Announcement of fourth quarter and full year 2011 results
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David Brennan
Chief Executive Officer
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Media Enquiries:
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Esra Erkal-Paler (London)
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+44 20 7604 8032
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Abigail Baron (London)
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+44 20 7604 8034
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Tony Jewell (Wilmington)
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+1 302 885 4594
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Anne-Charlotte Knutsson (Södertälje)
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+46 8 553 213 75/+46 70 685 4295
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Analyst/Investor Enquiries:
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Karl Hård (London)
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+44 20 7604 8123
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Jonathan Hunt (London)
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+44 20 7604 8122
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Nicklas Westerholm (London)
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+44 20 7604 8124
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Ed Seage/Jörgen Winroth (US)
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+1 302 886 4065/+1 212 579 0506
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Item 29
REPURCHASE OF SHARES IN ASTRAZENECA PLC
Further to the announcement of its irrevocable, non-discretionary share repurchase programme for the period 9 May 2011 to 26 August 2011, AstraZeneca PLC announced that under the terms of that programme it purchased for cancellation 142,869 ordinary shares of AstraZeneca PLC at a price of 3009 pence per share on 28 July 2011. Upon the cancellation of these shares, the number of shares in issue will be 1,363,998,673.
A C N Kemp
Company Secretary
29 July 2011