FORM 6-K
Report of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For April 2005
Commission File Number: 001-11960
AstraZeneca PLC
15 Stanhope Gate, London W1K 1LN, England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F X | Form 40-F |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ______
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes | No X |
If Yes is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
AstraZeneca
PLC
INDEX TO EXHIBITS
1. | Press release entitled, FDA Approves Intravenous Formulation for Nexium®, dated 1 April 2005. |
2. | Press release entitled, Dealing by Directors Companies Act 1985 Sections 324/329, dated 7 April 2005. |
3. | Press release entitled, AstraZeneca First Quarter Results 2005, dated 27 April 2005. |
4. | Press release entitled, AstraZeneca PLC First Quarter Results 2005, dated 28 April 2005. |
5. | Press release entitled, AstraZeneca PLC Annual General Meeting: 27 April 2005, dated 28 April 2005. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AstraZeneca PLC | ||||
Date: | 10 May 2005 | By: | /s/ G H R Musker | |
Name: | G H R Musker | |||
Title: | Secretary & Solicitor |
Item 1
FDA APPROVES INTRAVENOUS FORMULATION FOR
NEXIUM®
AstraZeneca today announced that a new administration formulation for its prescription proton pump inhibitor NEXIUM ® (esomeprazole magnesium) has been approved by the US Food and Drug Administration (FDA). NEXIUM I.V. is now approved as an intravenous infusion or injection for the short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) patients, with a history of erosive esophagitis, who are unable to take capsules.
NEXIUM® I.V. (esomeprazole sodium) for injection is administered once daily as either a 10 to 30 minute intravenous infusion or by intravenous injection (no less than 3 minutes). Treatment is given for up to 10 days and does not require an in-line filter.
Hospitalised patients with GERD are often unable to take their oral medication. The availability of NEXIUM in an intravenous formulation provides these patients with an effective alternative route of administration that they can tolerate easily.
The approval of NEXIUM I.V. was based, in part, on the findings of four multi-centre, open-label, two-period crossover studies. These studies compared the pharmacodynamic efficacy of the intravenous formulation with NEXIUM delayed-release capsules at corresponding doses of 20 mg and 40 mg in GERD patients with or without a history of erosive esophagitis. They demonstrated that, after 10 days of once-daily administration, NEXIUM I.V. 20 mg and 40 mg are similar in their ability to suppress acid to the corresponding oral dosage form of NEXIUM.
There were no relevant changes in acid suppression when switching between intravenous and oral dosage forms.
NEXIUM (delayed release capsules) is indicated for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease. The drug was recently approved for reducing the risk of gastric (stomach) ulcers developing among at risk patients on continuous NSAID therapy. It also is approved for healing erosive
esophagitis. Studies show that up to 94 percent of patients were healed with NEXIUM. Most erosions heal in 4 to 8 weeks.
NEXIUM I.V. formulation was first approved via the European Mutual Recognition Process in August 2003 and launches in Europe are ongoing. NEXIUM capsules have been launched in 89 countries. Worldwide NEXIUM sales totalled $3.9 billion in 2004, with US sales reaching $2.7 billion.
1 April 2005
Media Enquiries:
Edel
McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Item 2
Dealing by Directors
Companies Act 1985 Sections 324/329
We hereby inform you that, with effect from 7 April 2005, Marcus Wallenberg, a Director of the Company, is no longer deemed to have an interest in 3,618 AstraZeneca Ordinary Shares of USD0.25 each, held in the name of one of his children who, on 7 April 2005, attained the age of eighteen years. Consequently, Mr Wallenbergs interest in AstraZeneca Ordinary Shares has reduced to 67,264 shares, which represents approximately 0.004 per cent of the number of shares currently in issue.
G H R Musker
Company Secretary
7 April 2005
Item 3
AstraZeneca First Quarter Results 2005
Tomorrow, Thursday, 28 April 2005, AstraZeneca will release First Quarter Results 2005 at 10:00BST.
There will be an analyst teleconference at 13:30BST for which the numbers are: UK: 0800 559 3282, for Europe: +44 (0)20 7784 1017 and for the US: 1 866 239 0750. These numbers, and details of the replay facility available through 09:00BST Thursday, 12 May 2005, are available on the Investor Relations part of the AstraZeneca website at www.astrazeneca.com.
Record quarterly profits, with first quarter Earnings per Share up 33 percent.
Sales up 9 percent.
Financial Highlights (Financial statements prepared in accordance with International Financial Reporting Standards) |
Group | 1st Quarter | 1st Quarter | Actual | CER | ||||
2005 | 2004 | % | % | |||||
$m | $m | |||||||
Sales | 5,743 | 5,074 | +13 | +9 | ||||
Operating Profit | 1,453 | 1,052 | +38 | +34 | ||||
Profit before Tax | 1,486 | 1,084 | +37 | +34 | ||||
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Earnings per Share | $0.63 | $0.47 | +34 | +33 | ||||
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Sir Tom McKillop, Chief Executive, said: These record profits derive from a strong sales performance, especially for our key growth products, and from ongoing productivity improvements in R&D and SG&A. This excellent start to the year has set us on track to deliver our financial targets for the year.
London, 28 April 2005
Media Enquiries: | Steve Brown/Edel McCaffrey (London) | (020) 7304 5033/5034 | |||
Staffan Ternby (Södertälje) | (8) 553 26107 | ||||
Rachel Bloom-Baglin (Wilmington) | (302) 886 7858 | ||||
Analyst/Investor Enquiries: | Mina Blair (London) | (020) 7304 5084 | |||
Jonathan Hunt (London) | (020) 7304 5087 | ||||
Staffan Ternby (Södertälje) | (8) 553 26107 | ||||
Ed Seage/Jörgen Winroth (US) | (302) 886 4065/(212) 579 0506 |
Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated
Sales in the first quarter increased 9 percent at CER, or 13 percent on an as reported basis (including positive exchange rate benefit of 4 percent). Sales outside the US were up 9 percent. Sales in the US in the first quarter were up 10 percent. Adjusted for inventory movements (principally wholesaler stockbuilding in the first quarter 2004) estimated underlying sales growth in the US was 17 percent.
Good management of expenditure in R&D and SG&A continues to benefit operating results. In aggregate, these expenses were 4 percent lower at CER than first quarter 2004 (and broadly unchanged as reported). Operating profit was up 34 percent. Earnings per share in the first quarter were $0.63 versus $0.47 in 2004, an increase of 33 percent.
Nexium sales were $1,055 million in the first quarter, up 11 percent. Dispensed tablet volume in the US was up 15 percent, whereas reported sales growth was up 3 percent as a consequence of wholesaler stockbuilding in the first quarter 2004. Nexium sales outside the US were up 30 percent.
Crestor sales in the first quarter were $273 million, more than double the sales in the first quarter last year. In March, Crestor share of new prescriptions in the US statin market was 6.0 percent, up from 5.8 percent in January 2005. On 14 March, based on a thorough analysis of clinical trial safety data and post-marketing data, the US Food and Drug Administration (FDA) formally denied Public Citizens Health Research Groups (HRG) petition to remove Crestor from the market, and as part of their formal response, reaffirmed that Crestor is safe and effective when used according to the prescribing information.
Sales of Iressa were $81 million in the first quarter. Sales in Asia Pacific were up 18 percent which includes sales made since launch in China in February. Sales in Japan were down 8 percent. Sales declined by 41 percent in the US since the announcement of the ISEL trial results, where promotion of Iressa remains voluntarily suspended whilst the FDA completes its assessment of the implications of the full ISEL trial data set.
Good sales growth in the first quarter was achieved for Symbicort (up 23 percent), Casodex (up 16 percent), and Seroquel (up 39 percent). Arimidex sales were up 49 percent to $256 million. In the US, Arimidex new prescription share of hormonal treatments for breast cancer reached 31.4 percent in March, a market-leading 1.3 percentage point increase since December 2004.
Future ProspectsThe Company continues to anticipate full year earnings per share in the range of $2.35 to $2.50. In contrast to the quarterly progression of earnings last year, the growth rate in earnings per share in 2005 is anticipated to be stronger in the first half than in the second half of the year.
Disclosure Notice: The preceding forward-looking statements relating to expectations for earnings and business prospects for AstraZeneca PLC are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the forward-looking statements. These include, but are not limited to: the rate of growth in sales of generic omeprazole in the US, continued growth in currently marketed products (in particular CrestorTM, NexiumTM, SeroquelTM, SymbicortTM, ArimidexTM and CasodexTM), the growth in costs and expenses, interest rate movements, exchange rate fluctuations and the tax rate. For further details on these and other risks and uncertainties, see AstraZeneca PLCs Securities and Exchange Commission filings, including the 2004 Annual Report on Form 20-F.
2
Sales |
All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated
Gastrointestinal
First Quarter | CER % | |||||
2005 | 2004 | |||||
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Nexium | 1,055 | 935 | +11 | |||
Losec/Prilosec | 427 | 540 | -25 | |||
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Total | 1,499 | 1,496 | -3 | |||
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Cardiovascular | ||||||
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First Quarter | CER % | |||||
2005 | 2004 | |||||
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Seloken / Toprol-XL | 408 | 333 | +21 | |||
Atacand | 235 | 209 | +7 | |||
Plendil | 93 | 111 | -19 | |||
Zestril | 87 | 105 | -22 | |||
Crestor | 273 | 129 | +106 | |||
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Total | 1,257 | 1,055 | +15 | |||
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3
Respiratory and Inflammation | ||||||
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First Quarter | CER % | |||||
2005 | 2004 | |||||
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Symbicort | 247 | 188 | +23 | |||
Pulmicort | 314 | 282 | +8 | |||
Rhinocort | 92 | 81 | +13 | |||
Accolate | 28 | 30 | -7 | |||
Oxis | 23 | 25 | -16 | |||
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Total | 746 | 648 | +11 | |||
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Oncology | ||||||
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First Quarter | CER % | |||||
2005 | 2004 | |||||
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Casodex | 277 | 229 | +16 | |||
Zoladex | 231 | 213 | +3 | |||
Arimidex | 256 | 166 | +49 | |||
Iressa | 81 | 93 | -15 | |||
Faslodex | 29 | 26 | +8 | |||
Nolvadex | 28 | 31 | -13 | |||
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Total | 905 | 762 | +14 | |||
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4
Neuroscience | ||||||
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First Quarter | CER % | |||||
2005 | 2004 | |||||
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Seroquel | 633 | 448 | +39 | |||
Zomig | 68 | 95 | -32 | |||
Diprivan | 107 | 122 | -14 | |||
Local anaesthetics | 127 | 130 | -7 | |||
Others | 17 | 17 | -6 | |||
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Total | 952 | 812 | +14 | |||
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5
AstraZeneca PLC
Geographic Sales
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First Quarter | CER % | |||||
2005 | 2004 | |||||
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US | 2,500 | 2,279 | +10 | |||
Europe | 2,165 | 1,875 | +8 | |||
Japan | 337 | 290 | +12 | |||
RoW | 741 | 630 | +11 | |||
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6
AstraZeneca PLC
Financial Review |
All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated
Operating ResultsReported sales increased by 13 percent and operating profit by 38 percent. At constant exchange rates, sales increased by 9 percent and operating profit by 34 percent.
In the US, sales in the quarter were unaffected by wholesaler inventory movements, as inventory levels were near target levels specified in the Inventory Management Agreements. Sales in the first quarter 2004, however, did benefit from inventory movements. Adjusting for these, underlying US sales growth is estimated at 17 percent, compared with 10 percent reported growth. European sales benefited by an estimated $50 million due to accelerated deliveries at the end of the quarter, ahead of a brief shut down to allow a system upgrade.
The weakness of the US dollar benefited EPS by around 1 cent. In comparison to quarter one last year, the dollar weakened against the euro (5 percent), benefiting sales, and also against the Swedish krona (6 percent) and sterling (3 percent), increasing costs. Should the exchange rates stay at current levels for the remainder of the year, no further benefits are expected to accrue.
Reported operating margin increased by 4.6 percentage points from 20.7 percent to 25.3 percent. Currency depressed operating margin by 0.1 percentage points, implying an underlying margin improvement of 4.7 percentage points.
Gross margin decreased by 1.8 percentage points to 75.4 percent of sales. Payments to Merck at 4.5 percent of sales were 0.5 percentage points lower than first quarter last year. Currency benefited gross margin by 0.2 percentage points which, combined with Merck, implies an underlying decline in margin of 2.5 percentage points. The resulting underlying decline in gross margin is attributable to IFRS fair value adjustments of foreign exchange contracts and termination of the Medpointe Zomig distribution agreement in the US.
In aggregate, R&D and SG&A expenses of $2,872 million decreased by 4 percent over last year due to continued disciplined management of expenditure and some phasing to the benefit of the first quarter. In comparison to the first quarter last year, R&D and SG&A expenditure decreased by 3 and 4 percent respectively, and combined added 6.7 percentage points to operating margin.
Fair value adjustments arising from financial instruments amounted to a $44 million charge in the quarter, of which $23 million was charged to cost of sales, $22 million was charged to R&D, with a $1 million benefit to interest income.
Interest and Dividend IncomeNet interest and dividend income for the quarter was $33 million, compared with $32 million for the same period last year. This includes net interest income of $5 million arising from employee benefit fund assets and liabilities as required by IAS 19, Employee Benefits.
TaxationThe tax rate for the quarter is 29.8 percent compared to 26.3 percent for the first quarter of 2004. The increase is attributable to a different geographical mix of profits and the impact of IFRS. For the full year the tax rate is anticipated to be around 29 percent.
Cash FlowCash generated from operating activities in the quarter was $1.5 billion, about $500 million higher than in the corresponding quarter of 2004. Higher trading profits and lower working capital outflows were the main drivers of this improvement, offset by a slight increase in tax paid.
7
Cash outflows from investing activities of $29 million in the first quarter compare with $555 million outflows in the equivalent period in 2004. Net capital expenditure, including fixed asset investments, fell by $73 million to $226 million. However, the change was primarily as a result of short term management of funds on deposit inflows in the current quarter of $158 million contrasted with outflows of $265 million in the first quarter of 2004.
Free cash flow (which represents cash flows before returns to shareholders and financing and which therefore excludes the effects of short term management of funds) for the period was $1,322 million compared to $721 million in the first quarter of 2004. After accounting for net issues and repurchases of shares of $477 million, the $1,079 million dividend payment to shareholders and foreign exchange effects, there was a $88 million decrease in cash and cash equivalents.
Cash and cash equivalents at 31 March 2005 amounted to $3,839 million compared to $742 million at 31 March 2004. The apparent increase reflects a movement of short term deposits into cash equivalents in the latter part of 2004.
Share Repurchase ProgrammeDuring the quarter 11.95 million shares were repurchased for cancellation at a total cost of $481 million.
The total number of shares in issue at 31 March 2005 was 1,633 million.
Calendar | ||
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28 April | Annual General Meeting | |
28 July | Announcement of second quarter and half year results | |
27 October | Announcement of third quarter and nine months results | |
Sir Tom McKillop | ||
Chief Executive |
8
2005 | 2004 | ||||
For the quarter ended 31 March | $m | $m | |||
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Sales | 5,743 | 5,074 | |||
Cost of sales | (1,410 | ) | (1,158 | ) | |
Distribution costs | (50 | ) | (42 | ) | |
Research and development | (865 | ) | (857 | ) | |
Selling, general and administrative expenses | (2,007 | ) | (2,003 | ) | |
Other operating income | 42 | 38 | |||
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Operating profit | 1,453 | 1,052 | |||
Net finance income | 33 | 30 | |||
Income from dividends | - | 2 | |||
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Profit before tax | 1,486 | 1,084 | |||
Taxation | (443 | ) | (285 | ) | |
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Profit for the period | 1,043 | 799 | |||
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Attributable to: | |||||
Equity holders of the Company | 1,040 | 797 | |||
Minority interest | 3 | 2 | |||
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1,043 | 799 | ||||
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Basic earnings per $0.25 Ordinary Share | $ 0.63 | $0.47 | |||
Diluted earnings per $0.25 Ordinary Share | $0.63 | $0.47 | |||
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Weighted average number of Ordinary Shares in issue (millions) | 1,640 | 1,688 | |||
Diluted average number of Ordinary Shares in issue (millions) | 1,640 | 1,690 | |||
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9
2005 | 2004 | ||||
As at 31 March | $m | $m | |||
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ASSETS | |||||
Non-current assets | |||||
Property, plant and equipment | 7,800 | 7,556 | |||
Goodwill and intangible assets | 2,901 | 2,910 | |||
Other investments | 221 | 58 | |||
Deferred tax assets | 1,229 | 1,407 | |||
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12,151 | 11,931 | ||||
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Current assets | |||||
Inventories | 2,903 | 3,099 | |||
Trade and other receivables | 4,932 | 4,555 | |||
Short term investments | 958 | 3,386 | |||
Cash and cash equivalents | 3,905 | 814 | |||
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12,698 | 11,854 | ||||
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Total assets | 24,849 | 23,785 | |||
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LIABILITIES | |||||
Current liabilities | |||||
Short term borrowings and overdrafts | (66 | ) | (72 | ) | |
Other creditors | (6,770 | ) | (7,675 | ) | |
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(6,836 | ) | (7,747 | ) | ||
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Non-current liabilities | |||||
Loans | (1,070 | ) | (305 | ) | |
Deferred tax liabilities | (1,171 | ) | (1,423 | ) | |
Retirement benefit obligations and provisions | (1,995 | ) | (1,811 | ) | |
Other liabilities | (91 | ) | (84 | ) | |
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(4,327 | ) | (3,623 | ) | ||
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Total liabilities | (11,163 | ) | (11,370 | ) | |
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Net assets | 13,686 | 12,415 | |||
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EQUITY | |||||
Capital and reserves attributable to equity holders | |||||
Share capital | 408 | 420 | |||
Share premium account | 555 | 477 | |||
Other reserves | 1,850 | 1,866 | |||
Retained earnings | 10,780 | 9,556 | |||
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13,593 | 12,319 | ||||
Minority equity interests | 93 | 96 | |||
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Total equity and reserves | 13,686 | 12,415 | |||
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10
2005 | 2004 | ||||
For the quarter ended 31 March | $m | $m | |||
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Cash flows from operating activities | |||||
Operating profit before taxation | 1,453 | 1,052 | |||
Depreciation and amortisation | 309 | 302 | |||
Increase in working capital | (111 | ) | (163 | ) | |
Other non-cash movements | 170 | 91 | |||
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Cash from operating activities | 1,821 | 1,282 | |||
Interest paid | (6 | ) | (5 | ) | |
Tax paid | (306 | ) | (266 | ) | |
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Net cash inflow from operating activities | 1,509 | 1,011 | |||
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Cash flows from investing activities | |||||
Movement in short term investments and fixed deposits | 158 | (265 | ) | ||
Purchases of property, plant and equipment | (213 | ) | (290 | ) | |
Disposals of property, plant and equipment | 8 | 6 | |||
Purchase of intangible assets | (19 | ) | (10 | ) | |
Purchase of fixed asset investments | (2 | ) | (5 | ) | |
Interest received | 43 | 12 | |||
Dividends paid by subsidiaries to minority interests | (4 | ) | (5 | ) | |
Dividends received | - | 2 | |||
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Net cash outflow from investing activities | (29 | ) | (555 | ) | |
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Net cash inflow before financing activities | 1,480 | 456 | |||
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Cash flows from financing activities | |||||
Proceeds from issue of share capital | 4 | 28 | |||
Repurchase of shares | (481 | ) | (608 | ) | |
Dividends paid | (1,079 | ) | - | ||
Repayment of short term borrowings | (2 | ) | - | ||
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Net cash outflow from financing activities | (1,558 | ) | (580 | ) | |
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Net decrease in cash and cash equivalents in the period | (78 | ) | (124 | ) | |
Cash and cash equivalents at beginning of the period | 3,927 | 872 | |||
Exchange rate effects | (10 | ) | (6 | ) | |
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Cash and cash equivalents at the end of the period | 3,839 | 742 | |||
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Cash and cash equivalents consists of: | |||||
Cash and cash equivalents | 3,905 | 814 | |||
Overdrafts | (66 | ) | (72 | ) | |
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3,839 | 742 | ||||
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11
2005 | 2004 | ||||
For the quarter ended 31 March | $m | $m | |||
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Net funds at the beginning of the period | 3,994 | 3,696 | |||
Decrease in cash and cash equivalents | (78 | ) | (124 | ) | |
Cash (inflow)/outflow from (decrease)/increase in short term | |||||
investments and fixed deposits | (158 | ) | 265 | ||
Cash outflow from decrease in short-term borrowings | 2 | - | |||
Exchange movements | (10 | ) | (2 | ) | |
Fair value adjustments | (23 | ) | (12 | ) | |
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Net funds at the end of the period | 3,727 | 3,823 | |||
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Statement of Recognised Income and Expense
2005 | 2004 | ||||
For the quarter ended 31 March | $m | $m | |||
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Net profit for the period (excluding minority interests) | 1,040 | 797 | |||
Foreign exchange adjustments on consolidation | (381 | ) | (97 | ) | |
Tax on foreign exchange adjustments | (14 | ) | (33 | ) | |
Valuation (losses)/gains taken to equity, net of tax | (15 | ) | 3 | ||
Actuarial gains/(losses), net of tax | 20 | (3 | ) | ||
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Recognised income and expense for the period | 650 | 667 | |||
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12
Notes to the Interim Financial Statements
1 BASIS OF PREPARATION AND ACCOUNTING POLICIES
2 LEGAL PROCEEDINGSThe unaudited financial statements for the quarter ended 31 March 2005 have been prepared in accordance with International Accounting Standards and International Financial Reporting Standards (collectively IFRS) expected to be endorsed by the European Union (EU) and available for use by European companies at 31 December 2005. These IFRSs are subject to ongoing review and possible amendment or interpretive guidance and are therefore still subject to change. Details of the accounting policies applied are set out in the IFRS Restatement information in AstraZeneca PLCs Annual Report and Form 20-F Information 2004. The policies assume that the amendments to IAS 19 Employee Benefits published in December 2004 by the International Accounting Standards Board, allowing actuarial gains and losses to be recognised in full through reserves, will be endorsed by the EU.
The new information contained in Note 2 below updates the disclosures concerning legal proceedings in the Companys Annual Report and Form 20-F Information 2004.
These interim financial statements do not constitute statutory accounts of the Group within the meaning of Section 240 of the Companies Act 1985. Statutory accounts for the year ended 31 December 2004 will be filed with the Registrar of Companies following the Companys Annual General Meeting. The auditor's report on those accounts was unqualified and did not contain any statement under Section 237 of the Companies Act 1985.
Crestor (rosuvastatin)Of the two individual lawsuits served on AstraZeneca Pharmaceuticals LP and/or AstraZeneca LP in the US during 2004, involving alleged injury in association with the use of Crestor, one has now been dismissed. AstraZeneca has recently been served with a complaint filed in the Federal District Court in Puerto Rico and a complaint filed in Ohio making similar allegations. AstraZeneca is vigorously defending the pending Crestor litigation.
Exanta (ximelagatran)As previously disclosed, on or about 27 January 2005, a putative class action was filed in the US District Court for the District of Massachusetts on behalf of purchasers of AstraZeneca publicly traded securities during the period 2 April 2003 to 11 October 2004 against AstraZeneca PLC, Percy Barnevik, Håkan Mogren, Sir Tom McKillop and Jonathan Symonds. The lawsuit asserted claims under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5, alleging that the defendants made false and misleading statements regarding Exanta clinical trials and the status of the New Drug Application for Exanta in the US.
Since then, three additional, but essentially similar, lawsuits have been filed in US District Courts in Delaware and the Southern District of New York. The litigation may ultimately be consolidated in one forum. The defendants deny the allegations made in the lawsuits and are vigorously defending the actions.
Seroquel (quetiapine fumarate)The putative class action suit filed in August 2003 in the US District Court for the Middle District of Florida naming AstraZeneca PLC and AstraZeneca Pharmaceuticals LP as defendants and seeking damages and injunctive relief on behalf of a purported class consisting of all persons in the United States who purchased and/or used Seroquel has been dismissed with prejudice.
13
1st Quarter 2005 $m |
1st Quarter 2004 $m |
% Growth
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Actual | Constant Currency |
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US | 2,500 | 2,279 | 10 | 10 | |||||
Canada | 248 | 218 | 14 | 6 | |||||
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North America | 2,748 | 2,497 | 10 | 9 | |||||
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France | 451 | 442 | 2 | (4 | ) | ||||
UK | 188 | 132 | 42 | 32 | |||||
Germany | 315 | 226 | 39 | 31 | |||||
Italy | 285 | 255 | 12 | 5 | |||||
Sweden | 80 | 79 | 1 | (5 | ) | ||||
Europe others | 846 | 741 | 14 | 7 | |||||
|
|
|
|
|
|||||
Total Europe | 2,165 | 1,875 | 15 | 8 | |||||
|
|
|
|
|
|
||||
Japan | 337 | 290 | 16 | 12 | |||||
Rest of World | 493 | 412 | 20 | 14 | |||||
|
|
|
|
|
|||||
Total | 5,743 | 5,074 | 13 | 9 | |||||
|
|
|
|
|
14
World
|
US
|
||||||||||||
1st Quarter 2005 $m |
1st Quarter 2004 $m |
Actual Growth % |
Constant Currency Growth % |
1st Quarter 2005 $m |
Actual Growth% |
||||||||
|
|
|
|
|
|
|
|||||||
Gastrointestinal: | |||||||||||||
Losec/Prilosec | 427 | 540 | (21 | ) | (25 | ) | 60 | (34 | ) | ||||
Nexium | 1,055 | 935 | 13 | 11 | 691 | 3 | |||||||
Others | 17 | 21 | (19 | ) | (24 | ) | 3 | (57 | ) | ||||
|
|
|
|
|
|
|
|||||||
Total Gastrointestinal | 1,499 | 1,496 | - | (3 | ) | 754 | (2 | ) | |||||
|
|
|
|
|
|
|
|||||||
Cardiovascular: | |||||||||||||
Zestril | 87 | 105 | (17 | ) | (22 | ) | 2 | (83 | ) | ||||
Seloken/Toprol-XL | 408 | 333 | 23 | 21 | 293 | 24 | |||||||
Atacand | 235 | 209 | 12 | 7 | 56 | (18 | ) | ||||||
Plendil | 93 | 111 | (16 | ) | (19 | ) | 22 | (33 | ) | ||||
Tenormin | 83 | 85 | (2 | ) | (7 | ) | 3 | (73 | ) | ||||
Crestor | 273 | 129 | 112 | 106 | 154 | 114 | |||||||
Others | 78 | 83 | (6 | ) | (12 | ) | 2 | - | |||||
|
|
|
|
|
|
|
|||||||
Total Cardiovascular | 1,257 | 1,055 | 19 | 15 | 532 | 22 | |||||||
|
|
|
|
|
|
|
|||||||
Respiratory & Inflammation: | |||||||||||||
Pulmicort | 314 | 282 | 11 | 8 | 174 | 11 | |||||||
Rhinocort | 92 | 81 | 14 | 13 | 67 | 20 | |||||||
Symbicort | 247 | 188 | 31 | 23 | - | - | |||||||
Accolate | 28 | 30 | (7 | ) | (7 | ) | 21 | (5 | ) | ||||
Oxis | 23 | 25 | (8 | ) | (16 | ) | - | - | |||||
Others | 42 | 42 | - | (5 | ) | - | - | ||||||
|
|
|
|
|
|
|
|||||||
Total Respiratory & Inflammation | 746 | 648 | 15 | 11 | 262 | 11 | |||||||
|
|
|
|
|
|
|
|||||||
Oncology: | |||||||||||||
Zoladex | 231 | 213 | 8 | 3 | 32 | (32 | ) | ||||||
Casodex | 277 | 229 | 21 | 16 | 62 | 11 | |||||||
Nolvadex | 28 | 31 | (10 | ) | (13 | ) | - | (100 | ) | ||||
Arimidex | 256 | 166 | 54 | 49 | 101 | 63 | |||||||
Iressa | 81 | 93 | (13 | ) | (15 | ) | 30 | (41 | ) | ||||
Faslodex | 29 | 26 | 12 | 8 | 20 | (17 | ) | ||||||
Others | 3 | 4 | (25 | ) | (25 | ) | - | - | |||||
|
|
|
|
|
|
|
|||||||
Total Oncology | 905 | 762 | 19 | 14 | 245 | 2 | |||||||
|
|
|
|
|
|
|
|||||||
Neuroscience: | |||||||||||||
Seroquel | 633 | 448 | 41 | 39 | 456 | 35 | |||||||
Zomig | 68 | 95 | (28 | ) | (32 | ) | 9 | (80 | ) | ||||
Diprivan | 107 | 122 | (12 | ) | (14 | ) | 45 | (29 | ) | ||||
Local anaesthetics | 127 | 130 | (2 | ) | (7 | ) | 17 | (43 | ) | ||||
Others | 17 | 17 | - | (6 | ) | 5 | 67 | ||||||
|
|
|
|
|
|
|
|||||||
Total Neuroscience | 952 | 812 | 17 | 14 | 532 | 11 | |||||||
|
|
|
|
|
|
|
|||||||
Infection and Other: | |||||||||||||
Merrem | 131 | 97 | 35 | 29 | 29 | 61 | |||||||
Other Products | 97 | 72 | 35 | 29 | 57 | 111 | |||||||
|
|
|
|
|
|
|
|||||||
Total Infection and Other | 228 | 169 | 35 | 29 | 86 | 91 | |||||||
|
|
|
|
|
|
|
|||||||
Salick Health Care | 83 | 71 | 17 | 17 | 83 | 17 | |||||||
Astra Tech | 73 | 61 | 20 | 13 | 6 | 50 | |||||||
|
|
|
|
|
|
|
|||||||
Total | 5,743 | 5,074 | 13 | 9 | 2,500 | 10 | |||||||
|
|
|
|
|
|
|
15
|
|
|
Annual General Meeting | 28 April 2005 | |
Announcement of second quarter and half year 2005 results | 28 July 2005 | |
Announcement of third quarter and nine months 2005 results | 27 October 2005 |
DIVIDENDS |
The record date for the second interim dividend for 2004 paid on 21 March 2005 (in the UK, Sweden and the US) was 11 February 2005. Ordinary shares traded ex-dividend on the London and Stockholm Stock Exchanges from 9 February 2005. ADRs traded ex-dividend on the New York Stock Exchange from the same date.
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 |
The following brand names used in these interim financial statements are trademarks of the AstraZeneca group of companies:
Accolate Arimidex Astra Tech Atacand Casodex Crestor Diprivan Exanta Faslodex Iressa Losec Merrem Nexium Nolvadex Oxis Plendil Prilosec Pulmicort Pulmicort Respules Rhinocort Rhinocort Aqua Seloken Seroquel Symbicort Tenormin Toprol-XL Zestril Zoladex Zomig
ADDRESSES FOR CORRESPONDENCE |
Registrar and | Depositary | Registered Office | Swedish Securities | |||
Transfer Office | for ADRs | Registration Centre | ||||
The AstraZeneca Registrar | JPMorgan Chase Bank | 15 Stanhope Gate | VPC AB | |||
Lloyds TSB Registrars | PO Box 43013 | London | PO Box 7822 | |||
The Causeway | Providence | W1K 1LN | SE-103 97 Stockholm | |||
Worthing | RI 02940-3013 | UK | Sweden | |||
West Sussex | US | |||||
BN99 6DA | ||||||
UK | Tel (toll free in US): | Tel: +44 (0)20 7304 5000 | Tel: +46 (0)8 402 9000 | |||
Tel (in UK): 0870 600 3956 | 888 697 8018 | |||||
Tel (outside UK): +44 (0)121 415 7033 | Tel: +1 (781) 575 4328 | |||||
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS |
In order to utilise the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995, AstraZeneca is providing the following cautionary statement. These interim financial statements contain forward-looking statements with respect to the financial condition, results of operations and businesses of AstraZeneca. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, the loss or expiration of patents, marketing exclusivity or trade marks; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; 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 delay to new product launches; the difficulties of obtaining and maintaining governmental approvals for products; and the risk of environmental liabilities.
16
Item 5
ASTRAZENECA PLC
ANNUAL GENERAL MEETING : 28 APRIL 2005
AstraZeneca PLC announced the results of the voting at its Annual General Meeting today. As proposed in the Notice of AGM, all Resolutions were decided by poll vote.
Resolution 1: Ordinary Resolution to receive the Companys Accounts and the
Reports of the Directors and Auditor for the year ended 31 December 2004:
VOTES FOR: | 873,031,244 (99.51%) |
VOTES AGAINST: | 4,257,688 (0.49%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 2: Ordinary Resolution to confirm dividends: | |
VOTES FOR: | 937,709,945 (99.99%) |
VOTES AGAINST: | 74,287 (0.01%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 3: Ordinary Resolution to re-appoint KPMG Audit Plc, London as Auditor:
VOTES FOR: | 926,972,277 (99.60%) |
VOTES AGAINST: | 3,696,073 (0.40%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 4: Ordinary Resolution to authorise the Directors to agree the remuneration of the Auditor:
VOTES FOR: | 936,624,068 (99.85%) |
VOTES AGAINST: | 1,406,275 (0.15%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(a): Ordinary Resolution to re-elect Louis Schweitzer as a Director:
VOTES FOR: | 924,631,833 (99.31%) |
VOTES AGAINST: | 6,423,939 (0.69%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(b): Ordinary Resolution to re-elect Håkan Mogren as a Director:
VOTES FOR: | 899,672,968 (98.23%) |
VOTES AGAINST: | 16,216,453 (1.77%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(c): Ordinary Resolution to re-elect Sir Tom McKillop as a Director:
VOTES FOR: | 929,646,493 (99.27%) |
VOTES AGAINST: | 6,827,088 (0.73%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(d): Ordinary Resolution to re-elect Jonathan Symonds as a Director:
VOTES FOR: | 931,173,277 (99.43%) |
VOTES AGAINST: | 5,334,090 (0.57%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(e): Ordinary Resolution to elect John Patterson as a Director:
VOTES FOR: | 931,197,427 (99.43%) |
VOTES AGAINST: | 5,296,636 (0.57%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(f): Ordinary Resolution to elect David R Brennan as a Director:
VOTES FOR: | 931,020,554 (99.44%) |
VOTES AGAINST: | 5,217,080 (0.56%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(g): Ordinary Resolution to re-elect Sir Peter Bonfield as a Director:
VOTES FOR: | 916,239,994 (99.33%) |
VOTES AGAINST: | 6,152,000 (0.67%) |
The Resolution was passed as an Ordinary Resolution. |
Item 5(h): Ordinary Resolution to re-elect John Buchanan as a Director:
VOTES FOR: | 934,419,882 (99.81%) |
VOTES AGAINST: | 1,751,260 (0.19%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(i): Ordinary Resolution to re-elect Jane Henney as a Director:
VOTES FOR: | 934,840,524 (99.82%) |
VOTES AGAINST: | 1,673,320 (0.18%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(j): Ordinary Resolution to re-elect Michele Hooper as a Director:
VOTES FOR: | 934,831,960 (99.82%) |
VOTES AGAINST: | 1,681,189 (0.18%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(k): Ordinary Resolution to re-elect Joe Jimenez as a Director:
VOTES FOR: | 927,440,873 (99.81%) |
VOTES AGAINST: | 1,804,049 (0.19%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(l): Ordinary Resolution to re-elect Erna Möller as a Director:
VOTES FOR: | 917,440,168 (99.47%) |
VOTES AGAINST: | 4,884,711 (0.53%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(m): Ordinary Resolution to re-elect Dame Bridget Ogilvie as a Director:
VOTES FOR: | 934,660,569 (99.80%) |
VOTES AGAINST: | 1,840,452 (0.20%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 5(n): Ordinary Resolution to re-elect Marcus Wallenberg as a Director:
VOTES FOR: | 731,241,309 (80.74%) |
VOTES AGAINST: | 174,378,097 (19.26%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 6: Ordinary Resolution to approve the Directors Remuneration Report for the year ended 31 December 2004:
VOTES FOR: | 873,578,574 (93.64%) |
VOTES AGAINST: | 59,346,291 (6.36%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 7: Ordinary Resolution to approve the AstraZeneca Performance Share Plan:
VOTES FOR: | 879,318,037 (96.14%) |
VOTES AGAINST: | 35,312,192 (3.86%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 8: Ordinary Resolution to authorise limited EU political donations:
VOTES FOR: | 918,271,672 (98.53%) |
VOTES AGAINST: | 13,724,698 (1.47%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 9: Ordinary Resolution to authorise the Directors to allot unissued shares:
VOTES FOR: | 918,895,155 (98.23%) |
VOTES AGAINST: | 16,533,339 (1.77%) |
The Resolution was passed as an Ordinary Resolution. |
Resolution 10: Special Resolution to authorise the Directors to disapply pre-emption rights:
VOTES FOR: | 931,126,544 (99.24%) |
VOTES AGAINST: | 7,165,828 (0.76%) |
The Resolution was passed as a Special Resolution. |
Resolution 11: Special Resolution to authorise the Company to purchase its own shares:
VOTES FOR: | 934,858,897 (99.94%) |
VOTES AGAINST: | 559,704 (0.06%) |
The Resolution was passed as a Special Resolution. |
G H R Musker |
Company Secretary |
28 April 2005 |