FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For April 2003
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.
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):______
Form 20-F X | Form 40-F __ |
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 Repurchase of Shares in AstraZeneca PLC dated 1 April 2003. |
2 | . | Press release entitled AstraZeneca submits Regulatory Applications for Nexium® in the first of four indications for the management of Nsaid* -Associated GI Side Effects dated 1 April 2003. |
3 | . | Press release entitled New Study demonstrates the potential of ExantaTM (ximelagatran) for Prevention of Stroke in Atrial Fibrillation dated 2 April 2003. |
4 | . | Press release entitled Disclosure of Interest in Voting Shares in Public Companies dated 22 April 2003. |
5 | . | Press release entitled AstraZeneca PLC: Håkan Mogren to become Non-Executive Director dated 30 April 2003. |
6 | . | Press release entitled AstraZeneca PLC: Annual General Meeting: 30 April 2003 dated 30 April 2003. |
7 | . | Press release entitled AstraZeneca PLC: First Quarter Results 2003 Front Half dated 30 April 2003. |
8 | . | Press release entitled AstraZeneca PLC: First Quarter Results 2003 Back Half dated 30 April 2003. |
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: | 12 May 2003 | By: /s/ G H R Musker |
Name: G H R Musker | ||
Title: Company Secretary & Solicitor |
Item 1
REPURCHASE OF SHARES IN ASTRAZENECA PLC
AstraZeneca PLC announces that on 31 March 2003, it purchased for cancellation 500,000 ordinary shares of AstraZeneca PLC at a price of 2158 pence per share. Upon the cancellation of these shares, the number of shares in issue will be 1,713,635,544.
G H R Musker
Company Secretary
1 April 2003
Item 2
ASTRAZENECA SUBMITS REGULATORY APPLICATIONS FOR NEXIUM®
IN THE FIRST OF FOUR INDICATIONS FOR THE MANAGEMENT OF
NSAID*-ASSOCIATED GI SIDE EFFECTS
AstraZeneca today announced the submission of a regulatory application to the United States Food and Drug Administration (FDA) for the first of four indications within the NSAID-associated gastrointestinal (GI) side effect programme for NEXIUM®. This first indication is for the use of NEXIUM® for the treatment of upper GI symptoms in patients taking NSAIDs. Applications for the indication are also currently being filed in Europe and Canada.
The file for the treatment of acute NSAID-associated symptoms is supported by two clinical trials, which show that NEXIUM® provides effective control of NSAID-associated upper GI symptoms and improves quality of life in ulcer-free patients. Abstracts for both studies have been submitted to the annual congress of Digestive Disease Week (DDW), in May, 2003, in Orlando and will be presented as oral presentations.
The other three indications within the NSAID-associated GI side effect programme will be filed next year (2004), namely:
These new indications for NSAID-associated conditions are key elements in the life cycle management plan for NEXIUM®, as they will bring the benefits of the product to a significant, new population of patients. It is estimated that approximately 30 million people worldwide take NSAIDs daily, which are accountable for 20-25 per cent of all reported adverse events in the UK and US. In 2002, NEXIUM® had sales of $1,978m worldwide.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
1 April 2003
For further enquires please contact:
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Åsa Pehrsson, Global PR Manager GI, AstraZeneca
Tel: +46 (0) 31 706 55 20, email: Asa.C.Pehrsson@astrazeneca.com
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Note to News Editors:
* Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to treat pain and inflammation associated with diseases such as arthritis. Their use is associated with gastro-intestinal side effects such as peptic and duodenal ulceration.
- Ends -
Item 3 |
NEW STUDY DEMONSTRATES THE POTENTIAL OF EXANTATM |
(ximelagatran) FOR PREVENTION OF STROKE IN ATRIAL FIBRILLATION |
AstraZeneca today announced results from the first phase III stroke prevention data for ExantaTM (ximelagatran), the first of a new class of oral direct thrombin inhibitors (Oral DTI), presented at the 52nd Scientific Session of the American College of Cardiology (ACC), Chicago. The results show that fixed dose twice daily 36mg oral Exanta compares favourably with dose -adjusted warfarin in preventing stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), meeting the studys primary efficacy endpoint.
SPORTIF III*, a multi-national, randomised, open-label, parallel-group study with blinded event assessment, was designed as a non-inferiority** study to compare oral Exanta with the current standard treatment, dose -adjusted warfarin. While the study was not aimed at demonstrating superiority, the incidence of stroke and SEE seen for Exanta compared with a well-controlled warfarin treatment (average study INR 2.5) was numerically lower (40 Exanta vs 56 warfarin) in the whole population (ITT - including those who stopped treatment). Furthermore, a statistically significant relative risk reduction (RRR) of 41% (p=0.018) was demonstrated for Exanta compared with well-controlled warfarin in patients who remained on treatment for the duration of the study (OT population).
These promising efficacy results need to be considered alongside the safety profile for Exanta emerging from this study and from other ongoing clinical trials, which will define its overall benefit-risk profile. In SPORTIF III, the incidence of liver enzyme (ALT) elevations was 6.5% for Exanta and mostly occurred within the first six months of treatment. These elevations were associated with no specific clinical symptoms and decreased with treatment continuation or discontinuation. With regard to bleeding and recognising that Exanta was used in a fixed dose regimen without coagulation monitoring, the combined rate of major and minor bleeding events was found to be significantly lower for Exanta than warfarin (475 vs 554 events; p=0.007) and there was no significant difference in all cause mortality between the Exanta and warfarin groups.
Todays results confirm the potential of Exanta in stroke prevention for AF patients and highlight the important practical advantages that this unique first-in-class treatment holds over the traditional, standard treatment, says Dr. Hamish Cameron,
Vice President, Head of Exanta, AstraZeneca. These data, together with the results of SPORTIF V and other important studies, will form the basis for the FDA and EU submissions for Exanta in this indication, which are on track for the fourth quarter this year.
SPORTIF is the largest clinical study programme ever undertaken in the prevention of stroke in atrial fibrillation. The SPORTIF III study will be complemented later this year by the North American SPORTIF V study, which only differs to SPORTIF III in that it is a double-blind study.
Exanta is currently under review in Europe for the prevention of venous thromboembolism (VTE) following elective hip or knee replacement surgery and will be submitted for regulatory approval in the US for the same indication in Q4 2003. A regulatory submission for the treatment of VTE is also scheduled to be submitted in Europe in the fourth quarter of this year, following the outcome of studies in this indication.
Stroke is the third leading cause of death in adults worldwide, with five million fatal events per year. Atrial fibrillation has been found to increase the risk of stroke fivefold, yet less than half of eligible patients receive effective treatment. This unmet need may be attributed to the limitations of the current standard treatment, warfarin, which requires regular coagulation monitoring, dose titration and has several food and druginteractions. The current worldwide market for antithrombotics is $9.6 billion.
Exanta is the first of a new class of oral anticoagulants called oral DTIs. The drug is currently under phase III investigation and is the first oral anticoagulant to reach late clinical development in more than 50 years since the development of warfarin.
Exanta is a trademark of the AstraZeneca group of companies.
2 April 2003 |
Media Inquiries: |
Steve Brown, +44 (0) 207 304 5033 |
Emily Denney, +44 (0) 207 304 5034 |
Investor Inquiries: |
Mina Blair-Robinson, +44 (0) 207 304 5084 |
Jonathan Hunt, +44 (0) 207 304 5087 |
Editors Notes:
*SPORTIF : Stroke Prevention by ORal Thrombin Inhibitor in atrial Fibrillation.
SPORTIF III involves 3407 patients from 259 centres in 23 countries across Europe, Australia and Asia. 36mg fixed dose oral Exanta twice daily was compared with dose -adjusted warfarin (INR 2.0-3.0) once daily. Patients in the study had Non-valvular atrial fibrillation (AF) and at least one additional risk factor for stroke, which included: previous cerebral ischaemic attack; previous systemic embolism; hypertension; left ventricular dysfunction; age ≥ 75 years; age ≥ 65 years and coronary artery disease; age ≥ 65 years and diabetes mellitus. Patients were treated for an average of 17 months in SPORTIF III.
The rationale for non-inferiority studies:As many highly effective treatments are now available in various therapeutic areas, placebo -controlled trials are often now considered unethical. Therefore, the concept of non-inferiority testing is now increasingly common where objective of these studies is to demonstrate that a treatment is not inferior to or 'as effective as' a gold standard treatment. This can then enable treatments to be differentiated in terms of their respective additional advantages to the patient and physician, such as predictability and convenience.
Abstracts will be available online at www.acc.org and once these data have been presented media materials will be available on www.astrazenecapressoffice.com
- Ends -
ITEM 4
COMPANIES ACT 1985 SECTION 198
DISCLOSURE OF INTEREST IN VOTING SHARES IN PUBLIC
COMPANIES
ON 22 APRIL 2003 WE WERE INFORMED BY THE CAPITAL GROUP COMPANIES, INC., A REGISTERED INVESTMENT MANAGER IN THE U.S., THAT ON 16 APRIL 2003 ITS INTEREST IN THE USD0.25 ORDINARY SHARES OF ASTRAZENECA PLC HAD INCREASED TO 205,903,068 SHARES (12.01 PER CENT OF THE CURRENT ISSUED ORDINARY CAPITAL) FROM THE PREVIOUSLY NOTIFIED LEVEL OF 204,812,653 SHARES (11.92 PER CENT OF THE ORDINARY CAPITAL THEN IN ISSUE).
G H R MUSKER
COMPANY SECRETARY
22 APRIL 2003
Item 5
AstraZeneca PLC: Håkan Mogren to become Non-Executive Director
AstraZeneca PLC announced today that Dr Håkan Mogren, currently Executive Deputy Chairman, will cease to be an Executive Director of the Company on 31 August 2003. With effect from that date, he will become Non-Executive Deputy Chairman.
Dr Mogren, 58, was the Chief Executive Officer of Astra AB between 1988 and 1999. On the merger with Zeneca Group PLC in April 1999, Dr Mogren became Executive Deputy Chairman of the merged group.
Graeme Musker
Company Secretary
30 April 2003
Item 6
ASTRAZENECA PLC
ANNUAL GENERAL MEETING: 30 APRIL 2003
AstraZeneca PLC announced the results of the polls taken at its Annual General Meeting today in respect of Items 5(e), 9 and 10 on the Agenda, as follows:
Item 5(e): Ordinary Resolution
to re-elect Sir Peter Bonfield as a Director:
VOTES FOR: 830,994,339
(95.57%)
VOTES AGAINST: 38,475,456 (4.43%)
This Resolution was passed as an Ordinary Resolution at the AGM.
Percy Barnevik, Chairman of AstraZeneca PLC, said My Board colleagues and I are delighted that Sir Peter Bonfield has been re-elected as a Director with such overwhelming support following the poll held at todays Annual General Meeting. Sir Peter is making a key contribution to AstraZeneca in his role both as the senior Non-Executive Director and also as Chairman of the Remuneration Committee.
Item 9: Special Resolution to authorise the Directors to allot unissued shares:
VOTES FOR: 813,215,344 (95.90%)
VOTES AGAINST: 34,776,305 (4.10%)
This Resolution was passed as a Special Resolution at the AGM.
Item 10: Special Resolution
to authorise the Company to purchase its own shares:
VOTES FOR: 890,748,684
(99.86%)
VOTES AGAINST: 1,261,770 (0.14%)
This Resolution was passed as a Special Resolution at the AGM.
Under the Companys Articles of Association, voting on all Special Resolutions is conducted by poll.
G H R Musker
Company Secretary
30 April 2003
Item 7
AstraZeneca PLC
First Quarter Results 2003
Earnings per Share $0.54. Targets for the year maintained.
Financial Highlights (before Exceptional Items)
Group (Continuing operations) |
1st
Quarter 2003 $m |
1st
Quarter 2002 $m |
Reported % |
Constant Currency % |
||||||
Sales | 4,735 | 4,346 | +9 | +4 | ||||||
Operating Profit | 1,272 | 1,297 | -2 | -3 | ||||||
Profit before Tax | 1,293 | 1,318 | -2 | -3 | ||||||
Earnings per Share Group | $0.54 | $0.55 | -2 | -3 | ||||||
Group (Statutory FRS3) | $0.54 | $0.55 |
All narrative in this section refers to growth rates at constant exchange rates (CER)
Tom McKillop, Chief Executive, said: "The transformation of our product portfolio is proceeding as anticipated, with strong demand for the growth and recently launched products balancing the expected declines due to patent expiries. With this sales performance and the planned programme of product launches we are well placed to achieve the financial targets for the year we communicated in January."
London, 30 April 2003
Media Enquiries: | Steve Brown/Emily Denney (London) | (020) 7304 5033/5034 |
Staffan Ternby (Södertälje) | (8) 553 26107 | |
Rachel Bloom (Wilmington) | (302) 886 7858 | |
Analyst/Investor Enquiries: | Mina Blair-Robinson (London) | (020) 7304 5084 |
Jonathan Hunt (London) | (020) 7304 5087 | |
Staffan Ternby (Södertälje) | (8) 553 26107 | |
Ed Seage (Wilmington) | (302) 886 4065 | |
Jörgen Winroth (New York) | (212) 581 8720 |
AstraZeneca PLC
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 by 4 percent. Operating profit decreased by 3 percent. Earnings per Share were down by 3 percent to $0.54. The weaker US dollar increased the reported sales growth rate by 5 percent. Nearly all the currency benefit on reported sales was offset by the adverse currency impact on operating costs, with the overall result that reported operating profits and earnings per share benefited by just 1 percent from currency movements.
Other operating income for the first quarter 2003 ($15 million) was significantly lower than the first quarter 2002 ($156 million) which included proceeds from the sale of Sular marketing rights to First Horizon. Costs in R&D and SG&A combined increased by 4 percent in CER terms.
Sales growth in the first quarter was 4 percent in the US and 5 percent in the rest of the world. As expected, sales in the US reflected significant generic competition for Prilosec, Zestril, and Nolvadex. In aggregate, sales of these three products were $669 million lower than the first quarter 2002. This was more than offset by a continued strong performance in the rest of the portfolio, with sales up 55 percent. The company estimates that underlying demand for these products grew by around 35 percent. The balance of the growth is attributable to favourable effects from wholesaler stock movements in the US market in this quarter compared to the first quarter 2002, which also benefited from stock building. At the end of the first quarter 2003, the company estimates that trade inventories are some $400 million higher than normal (and some $200 million higher than at the end of the first quarter 2002). This inventory should be worked off in the normal course of business over the next two quarters, with no adverse effect on our estimates for revenue for the year as a whole. The products chiefly affected include Nexium, Seroquel, Toprol-XL and Atacand.
Nexium sales were up 136 percent on strong prescription demand and wholesaler stock building in the US. Prilosec sales in the US were $287 million in the first quarter, a decline of 60 percent, broadly in line with the trend in prescriptions. Generic omeprazole market share has been holding steady at around 60 percent of total prescriptions for the omeprazole molecule in recent weeks.
Sales of Cardiovascular products were down just 3 percent, despite the significant decline in Zestril, as good prescription growth in the US continues for Toprol-XL (up 31 percent) and Atacand (up 19 percent). The first sales for Crestor were recorded in the quarter ($3 million), with the mid-February launch in Canada followed by the first European launches in the Netherlands and in the UK.
Oncology product sales grew by 6 percent, as growth in Casodex, Arimidex, Faslodex and Iressa more than offset generic erosion on Nolvadex. Iressa sales of $19 million in the quarter were affected by label changes and some market adjustment following the rapid up-take in the fourth quarter 2002. The regulatory submission in the EU for Iressa in the treatment of locally advanced or metastatic non-small cell lung cancer was announced 11 February. The target date for completion of the review by the US FDA is May 5. Faslodex sales were $22 million in the quarter, and the file for second-line treatment of advanced breast cancer was submitted in the EU in February.
Other product development highlights in the quarter included regulatory submissions in the US and Europe for the use of Seroquel for the treatment of manic episodes associated with bipolar disorder, and for the use of Nexium for the treatment of upper GI symptoms in patients taking non-steroidal anti-inflammatory drugs (NSAIDs).
Future Prospects All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated.
After adjusting for wholesaler buying patterns, the underlying sales revenue for the quarter was in line with the companys expectations, with expected declines due to patent expiries balanced by strong demand in the growth and recently launched products. Therefore the company has not changed its targets for the full year, and continues to anticipate earnings per share in the range of $1.50 to $1.65 per share.
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. These include, but are not limited to: the rate of growth in sales of generic omeprazole in the US, the successful registration and launch of new products (in particular Crestor, Iressa, and Exanta), continued growth of currently marketed products, the growth in costs and expenses, interest rate movements, exchange rate fluctuations, and the effective tax rate. For further details on these and other risks and uncertainties, see AstraZeneca PLCs Securities and Exchange Commission filings, including the 2002 annual report on Form 20-F.
2
AstraZeneca PLC
Sales
Gastrointestinal
First Quarter | CER % | |||||
|
||||||
2003 | 2002 | |||||
|
|
|||||
Losec/Prilosec | 692 | 1,192 | -45 | |||
Nexium | 835 | 347 | +136 | |||
Total | 1,545 | 1,552 | -3 | |||
Cardiovascular | ||||||
First Quarter | CER % | |||||
|
||||||
2003 | 2002 | |||||
|
||||||
Zestril | 108 | 277 | -64 | |||
Atacand | 206 | 149 | +31 | |||
Seloken / Toprol-XL | 368 | 231 | +56 | |||
Plendil | 110 | 106 | -1 | |||
Total | 969 | 946 | -3 | |||
3
AstraZeneca PLC
Respiratory | ||||||
First Quarter | CER % | |||||
2003 | 2002 | |||||
Pulmicort | 251 | 227 | +6 | |||
Accolate | 31 | 32 | -3 | |||
Rhinocort | 90 | 63 | +40 | |||
Oxis | 31 | 31 | -10 | |||
Symbicort | 122 | 54 | +102 | |||
Total | 563 | 442 | +20 | |||
Oncology | ||||||
First Quarter | CER % | |||||
2003 | 2002 | |||||
|
||||||
Casodex | 189 | 123 | +44 | |||
Arimidex | 93 | 65 | +35 | |||
Nolvadex | 61 | 140 | -57 | |||
Iressa | 19 | - | n/m | |||
Faslodex | 22 | - | n/m | |||
Zoladex | 193 | 187 | -2 | |||
Total | 581 | 520 | +6 | |||
4
AstraZeneca PLC
CNS | ||||||
First Quarter | CER % | |||||
2003 | 2002 | |||||
Seroquel | 444 | 329 | +33 | |||
Zomig | 108 | 92 | +13 | |||
Total | 560 | 428 | +28 | |||
Pain, Infection and Other Pharma | ||||||
First Quarter | CER % | |||||
2003 | 2002 | |||||
Merrem | 74 | 67 | +10 | |||
Diprivan | 136 | 111 | +19 | |||
Local anaesthetics | 101 | 96 | -1 | |||
Total | 377 | 342 | +5 | |||
5
AstraZeneca PLC
Geographic Sales | ||||||
First Quarter | CER % | |||||
2003 | 2002 | |||||
US | 2,470 | 2,383 | +4 | |||
Europe | 1,555 | 1,387 | -2 | |||
Japan | 243 | 172 | +32 | |||
RoW | 467 | 404 | +19 | |||
6
AstraZeneca PLC
Operating Review
Sales grew by 4 percent. Operating profit declined by 3 percent. The operating margin decline of 2.9 percentage points is almost entirely explained by the absence of disposal gains, which in the first quarter of 2002 included a gain on the sale of Sular marketing rights for the US. Without this gain, operating margin for the first quarter of 2002 would have been 26.8 percent of sales, and operating profit would have increased by 8 percent this quarter.
The other elements of operating margin showed a net improvement of 0.4 percentage points, as small increases in R&D and SG&A as a percent of sales (0.5 and 0.3 points respectively) were more than offset by improvements in gross margin. Gross margin increased by 1.2 points to 76 percent of sales through mix benefits as well as lower proportional payments to Merck.
The weaker US dollar increased sales by 5 percent and operating profits by 1 percent, accounting for around 0.7 percentage points of the margin decline. Currency for the year is expected to have a broadly neutral effect on profits.
In recent years the first quarter results have been marked by speculative wholesaler purchases ahead of anticipated price increases. At the end of the first quarter 2003 it was estimated that wholesaler inventories were some $400 million above normal, compared to $200 million at the end of the first quarter 2002. The products principally affected in 2003 were Nexium, Seroquel, Toprol-XL and Atacand. It is expected that these excess inventories will unwind over the next two quarters with no overall impact on sales for the year.
Interest
Interest income was $21 million in the quarter, with higher overall cash balances compensating for lower yield on investments.
Taxation
The effective tax rate for the first quarter 2003 was 27.5 percent compared with 27.0 percent for the same period in 2002.
Cash Flow
Cash generated from operating activities after exceptional items amounted to $1.2 billion for the first quarter, compared with $1.9 billion for the same quarter 2002. Much of this variance arises
from a timing difference in payments made to Merck (the first quarter 2002 benefited from the absence of such payment) and receivables arising from the strong first quarter sales. In the first quarter 2003 capital expenditures were $0.3 billion,
taxation paid was $0.2 billion, and share repurchases were $0.1 billion, resulting in an increase in net cash funds of just under $0.5 billion. Net cash funds at the end of the quarter amounted to $4.3 billion ($3.8 billion in fourth quarter
2002).
Share Repurchase Programme
During the quarter, 4.04 million ordinary shares were re-purchased (nominal value $0.25 each) for cancellation at a total cost of $129 million.
Since the commencement of the programme, 70.6 million shares have been repurchased for cancellation at a total cost of $2,968 million. The total number of shares in issue (as at 31 March 2003) is 1,715 million. Approximately $1.0 billion remains available under the previously announced share repurchase programme.
7
AstraZeneca PLC
Upcoming Milestones and Key Events | |
24 July | Announcement of second quarter and half year results |
2 October | Annual Business Review |
23 October | Announcement of third quarter and nine months results |
Tom McKillop | |
Chief Executive |
8
Item 8 | ||||||||||
Consolidated Profit & Loss Account |
For the quarter ended 31 March | 2003 | 2002 | ||
$m | $m | |||
Sales | 4,735 | 4,346 | ||
Cost of sales | (1,135 | ) | (1,094 | ) |
Distribution costs | (35 | ) | (30 | ) |
Research and development | (782 | ) | (697 | ) |
Selling, general and administrative expenses | (1,526 | ) | (1,384 | ) |
Other operating income | 15 | 156 | ||
Operating profit | 1,272 | 1,297 | ||
Net interest and dividend income | 21 | 21 | ||
Profit on ordinary activities before taxation | 1,293 | 1,318 | ||
Taxation | (356 | ) | (356 | ) |
Profit on ordinary activities after taxation | 937 | 962 | ||
Attributable to minorities | (5 | ) | (4 | ) |
Net profit for the period | 932 | 958 | ||
Earnings per Ordinary Share before exceptional items | $0.54 | $0.55 | ||
Earnings per Ordinary Share | $0.54 | $0.55 | ||
Diluted earnings per Ordinary Share | $0.54 | $0.55 | ||
Weighted average number of Ordinary Shares in issue (millions) | 1,717 | 1,745 | ||
Diluted average number of Ordinary Shares in issue (millions) | 1,718 | 1,747 | ||
9
Consolidated Balance Sheet | ||||
At 31 March | 2003 | 2002 | ||
$m | $m | |||
Fixed assets | 9,566 | 8,205 | ||
Current assets | 12,929 | 11,754 | ||
Total assets | 22,495 | 19,959 | ||
Creditors due within one year | (8,146 | ) | (7,220 | ) |
Net current assets | 4,783 | 4,534 | ||
Total assets less current liabilities | 14,349 | 12,739 | ||
Creditors due after more than one year | (363 | ) | (788 | ) |
Provisions for liabilities and charges | (1,832 | ) | (1,473 | ) |
Net assets | 12,154 | 10,478 | ||
Capital and reserves | ||||
Shareholders funds and minority interests | 12,154 | 10,478 | ||
Consolidated Cash Flow Statement | ||||
For the quarter ended 31 March | 2003 | 2002 | ||
$m | $m | |||
Cash flow from operating activities | ||||
Operating profit | 1,272 | 1,297 | ||
Depreciation and amortisation | 272 | 227 | ||
(Increase)/decrease in working capital and other non-cash movements | (370 | ) | 409 | |
Net cash inflow from operating activities before exceptional items | 1,174 | 1,933 | ||
Outflow related to exceptional items | (12 | ) | (28 | ) |
Net cash inflow from operating activities | 1,162 | 1,905 | ||
Returns on investments and servicing of finance | (9 | ) | (6 | ) |
Tax paid | (252 | ) | (54 | ) |
Capital expenditure and financial investment | (330 | ) | (285 | ) |
Net cash inflow before management of liquid resources and financing | 571 | 1,560 | ||
Net purchase of shares | (129 | ) | (133 | ) |
Exchange and other movements | 13 | (2 | ) | |
Increase in net cash funds in the period | 455 | 1,425 | ||
Net cash funds at beginning of period | 3,844 | 2,867 | ||
Net cash funds at end of period | 4,299 | 4,292 | ||
Notes to the Interim Financial Statements
1 | BASIS OF PREPARATION AND ACCOUNTING POLICIES |
The results for the quarter ended 31 March 2003 have been prepared in accordance with UK generally accepted accounting principles. The accounting policies applied are those set out in AstraZeneca PLC’s 2002 Annual Report and Form 20-F. These interim financial statements do not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985. Statutory accounts for the year ended 31 December 2002 will be filed with the Registrar of Companies following the Company’s 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. As part of AstraZeneca’s objective to align with best accounting practice, cash discounts arising from prompt payments of invoices were reclassified from cost of sales to sales for the year ended 31 December 2002. Comparatives were reclassified and additional detail at product and territorial level are available on the AstraZeneca website. Both sales and cost of sales were reduced by $75m in the first quarter 2002. Neither profits nor net assets were affected. |
|
2 | TERRITORIAL SALES ANALYSIS |
% Growth | ||||||
1st Quarter | 1st Quarter | |||||
2003 | 2002 | Constant | ||||
$m | $m | Actual | Currency | |||
|
|
|||||
US | 2,470 | 2,383 | 4 | 4 | ||
Canada | 156 | 129 | 21 | 19 | ||
|
|
|||||
North America | 2,626 | 2,512 | 5 | 5 | ||
|
|
|||||
France | 329 | 263 | 25 | 9 | ||
UK | 144 | 178 | (19 | ) | (27 | ) |
Germany | 183 | 164 | 12 | (3 | ) | |
Italy | 208 | 172 | 21 | 5 | ||
Sweden | 79 | 64 | 23 | 3 | ||
Europe others | 612 | 546 | 12 | (2 | ) | |
|
|
|||||
Total Europe | 1,555 | 1,387 | 12 | (2 | ) | |
|
|
|||||
Japan | 243 | 172 | 41 | 32 | ||
Rest of World | 311 | 275 | 13 | 18 | ||
|
|
|||||
Total | 4,735 | 4,346 | 9 | 4 | ||
|
|
3 | PRODUCT SALES ANALYSIS | ||||||||||||
World | US | ||||||||||||
1st | 1st | Constant | 1st | ||||||||||
Quarter | Quarter | Actual | Currency | Quarter | Actual | ||||||||
2003 | 2002 | Growth | Growth | 2003 | Growth | ||||||||
$m | $m | % | % | $m | % | ||||||||
|
|||||||||||||
Gastrointestinal: | |||||||||||||
Losec | 692 | 1,192 | (42 | ) | (45 | ) | 287 | (60 | ) | ||||
Nexium | 835 | 347 | 141 | 136 | 669 | 135 | |||||||
Others | 18 | 13 | 38 | 30 | 8 | 100 | |||||||
|
|||||||||||||
Total Gastrointestinal | 1,545 | 1,552 | - | (3 | ) | 964 | (5 | ) | |||||
|
|||||||||||||
Cardiovascular: | |||||||||||||
Zestril | 108 | 277 | (61 | ) | (64 | ) | 20 | (89 | ) | ||||
Seloken | 368 | 231 | 59 | 56 | 285 | 76 | |||||||
Atacand | 206 | 149 | 38 | 31 | 102 | 44 | |||||||
Plendil | 110 | 106 | 4 | (1 | ) | 39 | (9 | ) | |||||
Tenormin | 84 | 94 | (11 | ) | (14 | ) | 13 | (41 | ) | ||||
Crestor | 3 | - | n/m | n/m | - | - | |||||||
Others | 90 | 89 | 1 | (9 | ) | 4 | (33 | ) | |||||
|
|||||||||||||
Total Cardiovascular | 969 | 946 | 2 | (3 | ) | 463 | (4 | ) | |||||
|
|||||||||||||
Respiratory: | |||||||||||||
Pulmicort | 251 | 227 | 11 | 6 | 133 | 27 | |||||||
Rhinocort | 90 | 63 | 43 | 40 | 68 | 58 | |||||||
Symbicort | 122 | 54 | 126 | 102 | - | - | |||||||
Accolate | 31 | 32 | (3 | ) | (3 | ) | 23 | 5 | |||||
Oxis | 31 | 31 | - | (10 | ) | - | - | ||||||
Others | 38 | 35 | 9 | - | - | - | |||||||
|
|||||||||||||
Total Respiratory | 563 | 442 | 27 | 20 | 224 | 32 | |||||||
|
|||||||||||||
Oncology: | |||||||||||||
Zoladex | 193 | 187 | 3 | (2 | ) | 42 | (9 | ) | |||||
Casodex | 189 | 123 | 54 | 44 | 60 | 100 | |||||||
Nolvadex | 61 | 140 | (56 | ) | (57 | ) | 31 | (71 | ) | ||||
Arimidex | 93 | 65 | 43 | 35 | 33 | 27 | |||||||
Iressa | 19 | - | n/m | n/m | - | - | |||||||
Faslodex | 22 | - | n/m | n/m | 22 | n/m | |||||||
Others | 4 | 5 | (20 | ) | (20 | ) | - | - | |||||
|
|||||||||||||
Total Oncology | 581 | 520 | 12 | 6 | 188 | (10 | ) | ||||||
|
|||||||||||||
CNS: | |||||||||||||
Seroquel | 444 | 329 | 35 | 33 | 360 | 26 | |||||||
Zomig | 108 | 92 | 17 | 13 | 69 | 17 | |||||||
Others | 8 | 7 | 14 | 14 | 2 | - | |||||||
|
|||||||||||||
Total CNS | 560 | 428 | 31 | 28 | 431 | 24 | |||||||
|
|
||||||||||||
Pain, Infection and Other Pharma: | |||||||||||||
Diprivan | 136 | 111 | 23 | 19 | 81 | 53 | |||||||
Merrem | 74 | 67 | 10 | 10 | 13 | (13 | ) | ||||||
Local anaesthetics | 101 | 96 | 5 | (1 | ) | 20 | (9 | ) | |||||
Other Pharma Products | 66 | 68 | (3 | ) | (13 | ) | 17 | (6 | ) | ||||
|
|||||||||||||
Total Pain, Infection and Other | |||||||||||||
Pharma | 377 | 342 | 10 | 5 | 131 | 21 | |||||||
|
|||||||||||||
Salick Health Care | 65 | 54 | 20 | 20 | 65 | 20 | |||||||
Astra Tech | 44 | 34 | 29 | 8 | 3 | 50 | |||||||
Marlow Foods | 31 | 28 | 11 | - | 1 | - | |||||||
|
|||||||||||||
Total | 4,735 | 4,346 | 9 | 4 | 2,470 | 4 | |||||||
|
|||||||||||||
n/m not meaningful |
12
Shareholder Information | |
ANNOUNCEMENTS AND MEETINGS | |
Annual General Meeting | 30 April 2003 |
Announcement of half year results | 24 July 2003 |
Annual Business Review | 2 October 2003 |
Announcement of third quarter and nine month results | 23 October 2003 |
DIVIDENDS | |
The record date for the second interim dividend payable on 7 April 2003 (in the UK, Sweden and the US) was 21 February 2003. Ordinary Shares traded ex-dividend on the London and Stockholm Stock Exchanges from 19 February 2003. 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 end of July and paid in October. |
Second interim | Announced in January and paid in April. |
TRADEMARKS | |
The following brand names used in this interim report are trade marks 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 Transfer Office |
Depositary for ADRs |
Registered Office | Swedish Securities Register Centre |
The AstraZeneca Registrar | JPMorgan Chase Bank | 15 Stanhope Gate | VPC AB |
Lloyds TSB Registrars | ADR Service Center | London | PO Box 7822 |
The Causeway | PO Box 43013 | W1K 1LN | S-103 97 Stockholm |
Worthing | Providence, RI 02940-3013 | Sweden | |
West Sussex | |||
BN99 6DA | |||
Tel: (0870) 600 3956 | Tel: (781) 575 4328 | Tel: (020) 7304 5000 | Tel: (8) 402 9000 |
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. This Interim Report contains 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.
13