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 July 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.
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, AstraZeneca PLC appoints two new non-executive directors, dated 1 July 2003. | |
2. | Press release entitled, Dealing by Directors, dated 8 July 2003. | |
3. | Press release entitled, FDA Advisory Committee unanimously recommends approval of Crestor® (rosuvastatin calcium), dated 10 July 2003. | |
4. | Press release entitled, Exanta (ximelagatran) shows efficacy in first study for treatment of venous thromboembolism (VTE) supports regulatory submission, dated 14 July 2003. | |
5. | Press release entitled, Front half of AstraZeneca PLC Second Quarter and Half Year Results 2003, dated 24 July 2003. | |
6. | Press release entitled, Second half of AstraZeneca PLC Second Quarter and Half Year Results 2003, dated 24 July 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: | 28 July 2003 | By: /s/ G H R Musker |
Name: G H R Musker | ||
Title: Company Secretary & Solicitor |
Item 1
ASTRAZENECA PLC APPOINTS TWO NEW
NON-EXECUTIVE DIRECTORS
AstraZeneca PLC today announced that two new Non-Executive Directors are to join the Board of Directors with immediate effect.
They are Ms. Michele Hooper, formerly President and Chief Executive Officer of Stadtlander Drug Company in the US and earlier with Baxter, and Mr Joe Jimenez, President and Chief Executive Officer of Heinz Europe.
Mr. Percy Barnevik, Chairman of AstraZeneca, said: I am very pleased that Michele Hooper and Joe Jimenez are joining us. Michele brings considerable experience of the US healthcare industry and Joe has expertise in brand development and consumer marketing both in the US and Europe. This experience will add great benefit to the work of the Board.
1 July 2003 | ||
Media Enquiries: | ||
Emily Denney, Tel: +44 (0) 207 304 5034 | ||
Steve Brown, Tel: +44 (0) 207 304 5033 | ||
Investor Relations: | ||
Mina Blair Robinson, Tel: +44 (0) 207 304 5084 | ||
Jonathan Hunt, Tel: +44 (0) 207 304 5087 | ||
NOTE TO NEWS EDITORS: | ||
The biographical details of Ms.Hooper and Mr. Jimenez are as follows: | ||
Ms Michele J Hooper (51) | |||
Business experience | |||
Stadtlander Drug Company | |||
President and CEO (1998 - 1999) | |||
Baxter (including Baxter spin-offs) (1976 -1998) | |||
| Caremark International (Now Medpartners Inc.) | ||
Corporate VP And President International Businesses (1992 - 1998) | |||
| Alternate Site International | ||
President (1991 - 1992) | |||
| Baxter Healthcare Corp. | ||
President Canada (1988 - 1991) | |||
| Baxter International, Inc. | ||
VP Corporate Planning (1984 - 1998) | |||
| Baxter Healthcare Corp. | ||
Various Management Positions (1976 - 1984) |
Current Boards | |||
PPG Industries, Inc. | |||
Target Corporation | |||
Davita Inc. | |||
Mr Joe Jimenez (42) | |||
Business Experience | |||
H J Heinz Company | |||
º | Executive Vice President, President and Chief Executive Officer Heinz Europe (2002 to present) | ||
º | Senior Vice President and President Heinz North America (2001 - 2002) | ||
º | Corporate Vice President and President Heinz North America (1998 - 2001) | ||
Conagra | |||
º | President Hunt Wesson/Peter Pan & Orville Redenbacher/Swiss Miss Food Cos. (1997 - 1998) | ||
º | Various positions including Senior Vice President Marketing, Orville Redenbacher/Swiss Miss & Vice President Marketing, La Choy / Rosarita & Vice President Orville Redenbacher Popcorn (1993 - 1997) | ||
Clorox Company | |||
º | Senior Marketing Officer (1984 - 1993) | ||
Current Boards | |||
Hain Celestial Group, Inc. | |||
- Ends - |
Item 2
DEALING BY DIRECTORS
COMPANIES ACT 1985 SECTIONS 324/329
WE HEREBY INFORM YOU THAT, ON 7 JULY 2003, SIR TOM MCKILLOP, A DIRECTOR OF THE COMPANY, ACQUIRED AN INTEREST IN 61 ASTRAZENECA PLC ORDINARY SHARES OF USD0.25 EACH AT A PRICE OF 2439 PENCE PER SHARE. THE INTEREST ARISES AS A RESULT OF THE AUTOMATIC ANNUAL ACQUISITION OF ASTRAZENECA SHARES BY EMPLOYEES PARTICIPATING IN THE COMPANY'S PARTNERSHIP SHARE ARRANGEMENTS. PARTNERSHIP SHARES ARE ACQUIRED AND HELD ON BEHALF OF PLAN PARTICIPANTS BY ASTRAZENECA EMPLOYEE SHARE TRUST LIMITED UNDER THE TERMS OF THE ASTRAZENECA ALL EMPLOYEE SHARE PLAN, WHICH IS OPEN TO ALL UK EMPLOYEES OF THE COMPANY. FOLLOWING THIS ACQUISITION, SIR TOM MCKILLOP HAS A TOTAL INTEREST IN 69,560 ORDINARY SHARES, WHICH REPRESENTS APPROXIMATELY 0.004 PER CENT OF THE NUMBER OF SHARES CURRENTLY IN ISSUE.
G H R MUSKER
COMPANY SECRETARY
8 JULY 2003
Item 3
FDA
ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS
APPROVAL OF CRESTOR® (rosuvastatin
calcium)
AstraZeneca announced today that the Endocrinologic and Metabolic Advisory Committee to the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval for CRESTOR® (rosuvastatin calcium) as an adjunct to diet for the treatment of various lipid disorders including hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. The FDA will now review the Committees recommendation and make its final decision on granting marketing approval for CRESTOR.
The Committees unanimous recommendation to approve CRESTOR represents a vote of confidence in the clinical profile of CRESTOR, said Howard Hutchinson, Vice President of Clinical Research, AstraZeneca. We believe that once approved, CRESTOR will provide patients who are untreated or not at their target cholesterol levels with an important new treatment option in the control of elevated cholesterol.
The clinical development programme for CRESTOR is the largest pre-approval programme ever submitted to evaluate the safety and efficacy of a new statin. More than 12,500 patients are included in the safety database with more than 4,000 patients exposed to the 40 mg dose. The most commonly reported treatment-related adverse events were myalgia, abdominal pain, nausea and asthenia.
CRESTOR belongs to the class of lipid-lowering medications called HMG- CoA reductase inhibitors, or statins and has been studied in more than 24,000 patients worldwide. CRESTOR is being studied in an extensive clinical outcomes programme known as GALAXY, which includes more than 19,000 patients from 23 countries.
AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd. CRESTOR was first approved in the Netherlands in 2002 and approval has recently been granted in 23 other countries. Launches have occurred in a number of countries, including Canada, the Netherlands and the United Kingdom.
AstraZeneca (AZN: NYSE) 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 cardiovascular, gastrointestinal, oncology, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
10 July 2003
Media
Enquiries:
Emily
Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Gary Bruell, Tel: +1 302-885-1554
Rachel Bloom-Baglin, Tel: +1 302-886-7858
Investor
Relations:
Mina
Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan
Hunt, Tel: +44 (0) 207 304 5087
- Ends -
Item 4
EXANTATM
(ximelagatran) SHOWS EFFICACY IN FIRST STUDY FOR
TREATMENT
OF VENOUS THROMBOEMBOLISM (VTE) SUPPORTS
REGULATORY SUBMISSION
AstraZeneca announced today that data from the THRIVE Treatment study show that ExantaTM (ximelagatran), the first in a new class of oral anticoagulants called oral direct thrombin inhibitors (oral DTIs), is as effective as the current standard of care treatment regimen, enoxaparin/warfarin, in the treatment of acute venous thromboembolism (VTE; deep vein thrombosis with or without pulmonary embolism) and secondary prevention of recurrent VTE events. Importantly, the six month long study, presented today at the XIX Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Birmingham, UK, also showed a favourable trend for Exanta in bleeding and mortality rates compared with the standard therapy regimen.
THRIVE Treatment, an international, randomised, multicentre, double-blind study, was designed as a non-inferiority study to compare fixed dose oral Exanta 36mg twice daily with the current standard treatment, enoxaparin (1mg/kg) followed by dose-adjusted warfarin (INR 2.0-3.0). The primary endpoint of the study was achieved, demonstrating the equivalent efficacy of oral Exanta to the standard treatment regimen in the prevention of recurrent VTE over six months. The incidence of recurrent VTE events was 26 Exanta vs 24 enoxaparin/warfarin (estimated cumulative risk 2.1% vs 2.0%), in the ITT (Intention To Treat) analysis.
The impact of thrombosis is often underestimated, despite the fact that it is the third most common cardiovascular disease worldwide, affecting over five million people each year, said Dr. Hamish Cameron, Vice President, Head of Exanta, AstraZeneca. The results of THRIVE Treatment complement the earlier findings of THRIVE III, and further demonstrate the promise of Exanta to be at least as effective as the best type of standard treatment currently available. These studies will form the basis for the regulatory submission for Exanta in the treatment and long-term prevention of VTE, which remains on track for late this year.
Safety and mortality outcomes also showed a favourable trend for Exanta over enoxaparin/warfarin with respect to the risk of major bleeding: 14 Exanta vs 25 standard treatment, (estimated cumulative risk 1.3% vs 2.2%) in the OT (On Treatment) analysis and all-cause mortality: 28 Exanta vs 42 standard treatment, (estimated cumulative risk 2.3% vs 3.4%), ITT analysis.
Laboratory blood tests in the study showed an incidence of liver enzyme elevations in 9.6% of patients receiving Exanta, compared with 2% of patients receiving enoxaparin/warfarin. These elevations decreased spontaneously whether treatment continued or was stopped. As has been seen in previous studies, these elevations were typically transient and not associated with any specific clinical symptoms.
Patients taking Exanta benefit from at least as effective anti-thrombotic protection as those treated with well-controlled warfarin, but without the limitations of warfarin treatment or its requirement for time and cost-intensive coagulation monitoring and dose titration. These promising efficacy results need to be considered alongside the safety profile for Exanta emerging from this study and from other clinical trials, which will define its overall benefit-risk profile.
Exanta has completed phase III studies in a number of indications and is the first oral anticoagulant to reach late stage clinical trials since the development of warfarin more than 50 years ago. To date more than 30,000 patients have been enrolled in the Exanta clinical trial programme. Of the 17,000 patients who have been treated with Exanta, over a third (7,000) have received Exanta treatment for at least six months. The current worldwide market for anti-thrombotics is $9.6 billion.
Exanta is being reviewed 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. In addition to the regulatory submission for the treatment of VTE, scheduled for submission in Europe in the fourth quarter of this year, submissions in the EU and US for the prevention of stroke in atrial fibrillation patients are also planned for the 4Q of 2003.
Exanta is a trademark of the AstraZeneca group of companies.
14 July 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:
The THRIVE Treatment study was established from study groups from the THRIVE II & V studies.
The THRombin Inhibitor in Venous thromboEmbolism (THRIVE) Treatment study involved 2,489 patients with acute deep vein thrombosis (DVT), of whom 37% had confirmed pulmonary embolism. Patients were randomly assigned to, and received, either oral ximelagatran 36mg bid for six months, or subcutaneous enoxaparin 1mg/kg bid for a minimum of five days followed by warfarin (target INR of 2.0-3.0) for six months.
The rationale for non-inferiority studies: As many highly effective treatments are available in various therapeutic areas, placebo-controlled trials are often now considered unethical. Therefore, the concept of non-inferiority testing is increasingly common where the 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 convenience or benefit-risk. Exanta met the non-inferiority criterion in the THRIVE Treatment study.
- Ends -
Item 5
AstraZeneca PLC First
half results ahead of expectations. Interim dividend
increased by 10
percent. EPS targets for the year increased.
Group | 2nd
Quarter 2003 |
2nd
Quarter 2002 |
Actual % | CER % | Half
Year 2003 |
Half
Year 2002 |
Actual % |
CER % |
|
$m | $m | $m | $m | ||||||
Sales | 4,436 | 4,312 | +3 | -4 | 9,171 | 8,658 | +6 | - | |
Operating Profit | 889 | 1,064 | -16 | -18 | 2,161 | 2,361 | -8 | -10 | |
Profit before Tax | 921 | 1,065 | -14 | -17 | 2,214 | 2,383 | -7 | -9 | |
Earnings per Share | $ 0.39 | $ 0.45 | -13 | -16 | $ 0.93 | $ 1.00 | -6 | -8 | |
All narrative in this section refers to growth rates at constant exchange rates (CER)
Sir Tom McKillop, Chief Executive, said: "The successful transformation of our product range is shown by the replacement of $1.2 billion US sales of Prilosec, Zestril and Nolvadex lost to generics by new and high growth products, leaving sales unchanged for the first half. As a result of this strong sales performance and prospects for the rest of the year we have raised our earnings target for the year to the range of $1.65 to $1.75 per share. We have also increased the interim dividend by 10 percent to $0.255.
London, 24 July 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/Jörgen Winroth (USA) | (302) 886 4065/(212) 581 8720 |
AstraZeneca PLC
Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated.
First Half
First half sales were unchanged from the prior year in CER terms. The strengthening of exchange rates versus the US dollar lifted the actual sales growth rate to 6 percent. Operating profit was down 10 percent, chiefly on significantly lower other operating income in comparison to last year, which included a disposal gain. Costs were well managed as SG&A and R&D costs grew by 4 percent in CER terms. The currency benefit on operating profit was 2 percentage points positive. Earnings per share declined by 8 percent to $0.93. In view of the increased expectations for the year and the progress of the portfolio transformation, the Board has recommended an increased first interim dividend of $0.255 (15.9 pence; SEK 2.07) to be paid on 6 October 2003.
Sales for the first half were up 5 percent in markets outside the US, and were down by 4 percent in the US market. The portfolio transformation is progressing well. Global sales of the cohort of ten recently launched and growth products increased by 48 percent to $3.7 billion, and now comprise 40 percent of sales. This strong growth offset the loss of $1.2 billion US sales of Prilosec, Zestril and Nolvadex, leaving total first half sales unchanged compared to 2002.
Nexium sales increased by 76 percent in the first half, with strong growth in the US (up 74 percent) and in the rest of the world (up 83 percent). During the second quarter, Nexium share of new prescriptions in the US PPI market surpassed those of Prilosec and generic omeprazole combined. Nexium now ranks second in new prescriptions share of the overall US PPI market, and first in new prescriptions by gastroenterologists.
Symbicort sales were $249 million in the first half (up 79 percent) on market share gains in the rapidly growing market for fixed combination asthma treatments.
Sales for Iressa reached $66 million in the first half, including $18 million in sales in the US since launch in mid-May. Through the end of June nearly 5,000 retail prescriptions have been dispensed for Iressa in the US and, including patients still in the expanded access programme, it is estimated that as many as 10,000 patients may be currently taking Iressa in this market.
Crestor continues to perform well in its first launch markets. Sales were $12 million in the first half. Crestor share of the dynamic segment of the statin market (defined as new and switch patients but excluding from the data pool patients who are simply continuing their existing treatment) is around 30 percent in Canada (private payer segment only) and in the Netherlands. On 9 July the Endocrinology and Metabolic Advisory Committee to the US Food and Drug Administration voted unanimously to recommend approval for Crestor.
Second Quarter
Sales in the second quarter were down 4 percent in CER terms. The weaker US dollar lifted the reported actual sales growth to 3 percent. Operating profit was down 18 percent as costs grew against a sales decline. R&D and SG&A costs continue to be tightly managed, growing by 3 percent in CER terms. The currency effect on operating profit was 2 percentage points positive. Earnings per share in the second quarter were 16 percent lower, at $0.39.
Sales outside the US increased by 4 percent in the quarter, as sales growth from Nexium, Symbicort and Oncology products more than offset declines in Losec and Zestril.
US sales were down 11 percent as a result of wholesaler destocking and as generic erosion continued on Prilosec (down 52 percent), Nolvadex (down 94 percent) and Zestril (down 86 percent). US sales excluding these three products grew by 23 percent (or by an estimated 35 percent on an underlying demand basis, adjusted for the net destocking effect).
As expected, wholesaler stocks declined from the levels seen in the first quarter. Estimated inventory levels at the end of the second quarter are now at or below normal for Nexium and Seroquel and are trending down for Atacand. Wholesaler purchasing in excess of underlying demand continued for Toprol-XL in the second quarter. Across the entire product range, the company estimates the value of inventory in the distribution channels has been reduced to around $200 million above normal (half the level at the end of the first quarter), the majority of which is Toprol-XL.
2
AstraZeneca PLC
Future Prospects All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated.
Based on the strong performance to date, prospects for the second half, and assuming current exchange rates hold for the remainder of the year, the company has increased its expectations for earnings per share for the full year to the range of $1.65 to $1.75 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 in the forward looking statements. These include, but are not limited to: the rate of growth in sales of generic omeprazole in the USA, 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 changes in the 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.
3
AstraZeneca PLC
SalesGastrointestinal
Second Quarter | Half Year | |||||
CER % | CER % | |||||
2003 | 2002 | 2003 | 2002 | |||
Losec/Prilosec | 742 | 1,116 | -39 | 1,434 | 2,308 | -42 |
Nexium | 631 | 464 | +31 | 1,466 | 811 | +76 |
Total | 1,390 | 1,597 | -18 | 2,935 | 3,149 | -11 |
Cardiovascular
Second Quarter | Half Year | |||||||||||
|
CER % | |
CER % | |||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
||||||||||||
Seloken / Toprol-XL | 380 | 206 | +79 | 748 | 437 | +67 | ||||||
Atacand | 152 | 129 | +6 | 358 | 278 | +20 | ||||||
Plendil | 129 | 97 | +26 | 239 | 203 | +12 | ||||||
Zestril | 118 | 269 | -61 | 226 | 546 | -63 | ||||||
Crestor | 9 | - | n/m | 12 | - | n/m | ||||||
|
||||||||||||
Total | 967 | 889 | +1 | 1,936 | 1,835 | - | ||||||
|
4
AstraZeneca PLC
Respiratory
Second Quarter | CER % | Half Year | CER % | |||||||||
|
|
|||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
||||||||||||
Symbicort | 127 | 68 | +61 | 249 | 122 | +79 | ||||||
Pulmicort | 239 | 199 | +13 | 490 | 426 | +9 | ||||||
Rhinocort | 96 | 81 | +17 | 186 | 144 | +26 | ||||||
Accolate | 25 | 33 | -27 | 56 | 65 | -16 | ||||||
Oxis | 29 | 30 | -16 | 60 | 61 | -13 | ||||||
|
||||||||||||
Total | 552 | 448 | +13 | 1,115 | 890 | +16 | ||||||
|
5
AstraZeneca PLC
Oncology
Second Quarter | Half Year | |||||||||||
|
CER % | |
CER % | |||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
||||||||||||
Casodex | 228 | 148 | +41 | 417 | 271 | +43 | ||||||
Zoladex | 213 | 195 | - | 406 | 382 | -1 | ||||||
Arimidex | 143 | 79 | +70 | 236 | 144 | +54 | ||||||
Iressa | 47 | - | n/m | 66 | - | n/m | ||||||
Faslodex | 15 | 8 | +88 | 37 | 8 | n/m | ||||||
Nolvadex | 39 | 117 | -70 | 100 | 257 | -63 | ||||||
|
||||||||||||
Total | 690 | 553 | +15 | 1,271 | 1,073 | +10 | ||||||
|
· |
Casodex
sales in markets outside
the US were up 19 percent in the quarter, and
by 22 percent in the first half. The second quarter
sales growth rate in the US (up 118 percent) reflects
wholesaler stocking in the current quarter coupled
with destocking in the same period last year. |
· |
Sales
for Arimidex
outside the US increased
by 50 percent in the quarter and by 46 percent
at the half year. The indication for adjuvant
treatment for early breast cancer is now approved
in 25 countries. Arimidex
share
of the global market for aromatase inhibitors
has increased by 15 percentage points since the
clinical data supporting its use for early breast
cancer were first presented in December 2001. |
· |
Total
prescriptions for Arimidex
in the US are up 54
percent through June. Sales were up 66 percent
in the first half, but were up 94 percent in the
second quarter, indicating some wholesaler stockbuilding
in the quarter. |
· |
In
May it was announced that clinical trials in the
US and in Europe will evaluate the efficacy and
safety of Arimidex
in patients with very
early breast cancer and in women at high risk
of developing the disease. |
· |
Sales
of Iressa
reached $66 million
in the first half, including $18 million in the
US since launch in mid-May. Through June nearly
5,000 retail prescriptions have been dispensed
for Iressa in the US. Sales in
Japan in the second quarter returned to a more
normal trend line from that seen in the first
quarter. |
· |
Faslodex
sales increased to $37
million in the first half, indicating that Faslodex
is a welcome addition to treatment options
for the management of advanced breast cancer. |
· |
The
global sales decline in Nolvadex
reflects the entry of
multiple generic tamoxifen products in the US
market since the end of February. |
CNS |
Second Quarter | Half Year | |||||||||||
|
CER % | |
CER % | |||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
||||||||||||
Seroquel | 270 | 263 | -1 | 714 | 592 | +18 | ||||||
Zomig | 54 | 74 | -35 | 162 | 166 | -8 | ||||||
|
||||||||||||
Total | 331 | 345 | -9 | 891 | 773 | +11 | ||||||
|
· |
Total
prescriptions for Seroquel
in the US continue to
grow strongly, up 35 percent through June. Market
share in June was 19.6 percent, up 2 points this
year. Seroquel is the only product
among the top three in the atypical antipsychotic
class to gain market share this year. |
· |
In
contrast to the prescription trend, Seroquel
sales in the US have
been distorted by wholesaler stocking patterns.
Sales in the second quarter were down 11 percent
as the above normal wholesaler inventories carried
from the first quarter were unwound. First half
sales were up 10 percent, with inventories at
the end of the period back to normal levels. |
6
AstraZeneca PLC
Pain, Infection and Other Pharma
Second Quarter | CER % | Half Year | CER % | |||||||||
|
|
|||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
||||||||||||
Merrem | 80 | 74 | +5 | 154 | 141 | +8 | ||||||
Diprivan | 98 | 111 | -17 | 234 | 222 | - | ||||||
Xylocaine | 50 | 45 | +9 | 88 | 85 | +2 | ||||||
Marcaine | 23 | 18 | +22 | 42 | 35 | +14 | ||||||
|
||||||||||||
Total | 369 | 357 | -2 | 746 | 699 | +2 | ||||||
|
Geographic Sales
Second Quarter | CER % | Half Year | CER % | |||||||||
|
|
|||||||||||
2003 | 2002 | 2003 | 2002 | |||||||||
|
||||||||||||
USA | 1,962 | 2,214 | -11 | 4,432 | 4,597 | -4 | ||||||
Europe | 1,646 | 1,401 | -2 | 3,201 | 2,788 | -1 | ||||||
Japan | 293 | 240 | +11 | 536 | 412 | +20 | ||||||
RoW | 535 | 457 | +17 | 1,002 | 861 | +18 | ||||||
|
AstraZeneca PLC
Operating
Review
Half Year
Reported sales were up 6 percent (unchanged CER) and operating profits down 8 percent (CER down 10 percent). The weaker US dollar increased sales growth by 6 percentage points but also increased costs so that the effect at the profit level was reduced to 2 points. Gross margin increased by 0.5 points due to favourable mix, including lower proportional payments to Merck. Operating margins declined by 3.7 points to 23.6 percent. R&D and SG&A continue to be tightly managed, growing by 4 percent in CER terms. Other operating income is significantly lower in comparison with last year, which included a disposal gain and accounts for around 1.6 points of the margin decline.
Second Quarter
Reported sales grew by 3 percent, operating profits fell by 16 percent. At constant exchange rates, sales fell by 4 percent and operating profit by 18 percent. Operating margin at 20.0 percent fell by 4.7 percentage points as a result of declining sales while costs increased. Currency also depressed margins. R&D and SG&A costs remained well controlled in the quarter increasing by only 3 percent in CER terms. Also, in the quarter, the disposal of Marlow Foods was completed and a small gain was included in other income.
Currency for the year is expected to have a small positive effect on earnings per share (around 4 cents) as the relative strength of the Euro has a positive effect on sales, outweighing the negative effect on costs as a result of the stronger sterling and Swedish Krona.
Wholesaler Stocking
Sales in the first quarters results were increased by speculative wholesaler purchases made ahead of anticipated price increases. At the end of the first quarter it was estimated that wholesaler inventories were approximately $400 million above normal. As expected, during the second quarter, inventory levels reduced and at the end of June it was estimated that wholesaler inventories had fallen to around $200 million above normal, a significant part of which was Toprol-XL with most other major products affected including Nexium and Seroquel having returned to normal or below normal levels.
Interest and Dividend Income
Net interest and dividend income for the first half of 2003 was $53 million, $32 million in the second quarter, with higher overall cash balances compensating for lower yields on investments together with a reduction in exchange losses (particularly in the second quarter) compared with the same periods last year.
Taxation
The effective tax rate for the second quarter and half year was 27.5 percent compared with 27.0 percent for the comparative periods in 2002.
Cash Flow
Cash generated from operating activities before exceptional items in the first half of the year fell to $2,473 million from $3,149 million in the comparative period, a decline caused by a combination of lower operating profits, inventory increase and the timing of creditor settlements. Cash expenditure on exceptional items was $381 million, compared to $55 million in 2002 the Zoladex settlement in the second quarter was the major element. Tax paid in the first six months was $762 million, $347 million higher than the same period in 2002 due to earlier payment of US taxes. Net capital expenditure was broadly comparable with the comparative period, totalling $673 million in the six months. The cash inflow of $80 million in respect of acquisitions and disposals represents the disposal of Marlow Foods in the second quarter. Share repurchases totalled $311 million and in the second quarter indebtedness of $319 million was repaid. Net cash funds fell by $235 million from the beginning of the year to stand at $3,609 million at 30 June 2003.
8
AstraZeneca
PLC
Dividends
A
first interim dividend of $0.255 (15.9 pence, SEK
2.07) will be paid on 6 October 2003 to all shareholders
on the register on 22 August 2003.
Share
Repurchase Programme
During
the second quarter 4.6 million ordinary shares were
repurchased for cancellation at a cost of $182 million
bringing the total repurchases for the first half
of the year to 8.6 million shares at a total cost
of $311 million. Since the start of this programme
74.2 million shares have been repurchased at a total
cost of $3,116 million. The total number of shares
in issue (as at 30 June 2003) is 1,710 million. Approximately
$900 million remains available under the previously
announced share repurchase programme.
Upcoming
Milestones and Key Events
2 October | Annual Business Review, Wilmington, USA |
23 October | Announcement of third quarter results |
Sir Tom McKillop | |
Chief Executive |
9
Item 6
Consolidated Profit & Loss Account
2003 | 2002 | |||||
For the six months ended 30 June | $m | $m | ||||
|
|
|
|
|
||
Sales | 9,171 | 8,658 | ||||
Cost of sales | (2,237 | ) | (2,154 | ) | ||
Distribution costs | (75 | ) | (65 | ) | ||
Research and development | (1,597 | ) | (1,420 | ) | ||
Selling, general and administrative expenses | (3,163 | ) | (2,869 | ) | ||
Other operating income | 62 | 211 | ||||
|
|
|
|
|
||
Operating profit | 2,161 | 2,361 | ||||
Net interest and dividend income | 53 | 22 | ||||
|
|
|
|
|
||
Profit on ordinary activities before taxation | 2,214 | 2,383 | ||||
Taxation | (609 | ) | (644 | ) | ||
|
|
|
|
|
||
Profit on ordinary activities after taxation | 1,605 | 1,739 | ||||
Attributable to minorities | (7 | ) | (6 | ) | ||
|
|
|
|
|
||
Net profit for the period | 1,598 | 1,733 | ||||
|
|
|
|
|
||
Dividends to shareholders | (436 | ) | (398 | ) | ||
|
|
|
|
|
||
Retained profit for the period | 1,162 | 1,335 | ||||
|
|
|
|
|
||
Earnings per Ordinary Share | $ | 0.93 | $ | 1.00 | ||
Diluted earnings per Ordinary Share | $ | 0.93 | $ | 1.00 | ||
|
|
|
|
|
||
Weighted average number of Ordinary Shares in issue (millions) | 1,714 | 1,741 | ||||
|
|
|
|
|
||
Diluted average number of Ordinary Shares in issue (millions) | 1,716 | 1,743 | ||||
|
|
|
|
|
10
Consolidated Profit & Loss Account
For the quarter ended 30 June | 2003 $m |
2002 $m |
||||||
Sales | 4,436 | 4,312 | ||||||
Cost of sales | (1,102 | ) | (1,060 | ) | ||||
Distribution costs | (40 | ) | (35 | ) | ||||
Research and development | (815 | ) | (723 | ) | ||||
Selling, general and administrative expenses | (1,637 | ) | (1,485 | ) | ||||
Other operating income | 47 | 55 | ||||||
Operating profit | 889 | 1,064 | ||||||
Net interest and dividend income | 32 | 1 | ||||||
Profit on ordinary activities before taxation | 921 | 1,065 | ||||||
Taxation | (253 | ) | (288 | ) | ||||
Profit on ordinary activities after taxation | 668 | 777 | ||||||
Attributable to minorities | (2 | ) | (2 | ) | ||||
Net profit for the period | 666 | 775 | ||||||
Dividends to shareholders | (436 | ) | (398 | ) | ||||
Retained profit for the period | 230 | 377 | ||||||
Earnings per Ordinary Share | $ | 0.39 | $ | 0.45 | ||||
Diluted earnings per Ordinary Share | $ | 0.39 | $ | 0.45 | ||||
Weighted average number of Ordinary Shares in issue (millions) | 1,712 | 1,736 | ||||||
Diluted average number of Ordinary Shares in issue (millions) | 1,714 | 1,738 | ||||||
11
Consolidated Balance Sheet
30 June | 30 June | |||||||
2003 | 2002 | |||||||
$m | $m | |||||||
Fixed assets | ||||||||
Tangible fixed assets | 7,005 | 6,079 | ||||||
Goodwill and intangible assets | 2,863 | 2,748 | ||||||
Fixed asset investments | 47 | 22 | ||||||
9,915 | 8,849 | |||||||
Current assets | ||||||||
Stocks | 2,765 | 2,460 | ||||||
Debtors | 5,479 | 4,648 | ||||||
Cash and short-term investments | 3,987 | 4,247 | ||||||
12,231 | 11,355 | |||||||
Total assets | 22,146 | 20,204 | ||||||
Creditors due within one year | ||||||||
Short-term borrowings and current instalments of loans | (55 | ) | (476 | ) | ||||
Other creditors | (7,047 | ) | (6,646 | ) | ||||
(7,102 | ) | (7,122 | ) | |||||
Net current assets | 5,129 | 4,233 | ||||||
Total assets less current liabilities | 15,044 | 13,082 | ||||||
Creditors due after more than one year | ||||||||
Loans | (323 | ) | (337 | ) | ||||
Other creditors | (42 | ) | (153 | ) | ||||
Provisions for liabilities and charges | (1,922 | ) | (1,547 | ) | ||||
(2,287 | ) | (2,037 | ) | |||||
Net assets | 12,757 | 11,045 | ||||||
Capital and reserves | ||||||||
Shareholders' funds - equity interests | 12,696 | 10,994 | ||||||
Minority equity interests | 61 | 51 | ||||||
Shareholders' funds and minority interests | 12,757 | 11,045 | ||||||
Statement of Total Recognised Gains and Losses | ||||||||
2003 | 2002 | |||||||
For the six months ended 30 June | $m | $m | ||||||
Net profit for the period | 1,598 | 1,733 | ||||||
Exchange adjustments on net assets | 647 | 797 | ||||||
Translation differences on foreign currency borrowings | - | (5 | ) | |||||
Tax on translation differences on foreign currency borrowings | - | - | ||||||
Other movements | - | 3 | ||||||
Total recognised gains and losses relating to the period | 2,245 | 2,528 | ||||||
12
Consolidated Cash Flow Statement
2003 | 2002 | |||||||
For the six months ended 30 June | $m | $m | ||||||
|
|
|||||||
Cash flow from operating activities | ||||||||
Operating profit | 2,161 | 2,361 | ||||||
Depreciation | 417 | 328 | ||||||
Amortisation | 141 | 131 | ||||||
(Increase)/decrease in working capital | (346 | ) | 251 | |||||
Other non-cash movements | 100 | 78 | ||||||
|
|
|||||||
Net cash inflow from operating activities before exceptional | ||||||||
items | 2,473 | 3,149 | ||||||
Outflow related to exceptional items | (381 | ) | (55 | ) | ||||
|
|
|||||||
Net cash inflow from operating activities | 2,092 | 3,094 | ||||||
|
|
|||||||
Returns on investments and servicing of finance | 33 | 3 | ||||||
|
|
|||||||
Tax paid | (762 | ) | (415 | ) | ||||
|
|
|||||||
Capital expenditure and financial investment | ||||||||
Net cash expenditure on fixed assets | (673 | ) | (632 | ) | ||||
Cash expenditure on fixed asset investments | - | (1 | ) | |||||
|
|
|||||||
(673 | ) | (633 | ) | |||||
|
|
|||||||
Acquisitions and disposals | 80 | - | ||||||
|
|
|||||||
Equity dividends paid to Shareholders | (770 | ) | (820 | ) | ||||
|
|
|||||||
Net cash inflow before management of liquid | ||||||||
resources and financing | - | 1,229 | ||||||
|
|
|||||||
Management of liquid resources | ||||||||
Movement in short-term investments and fixed deposits (net) | 487 | (428 | ) | |||||
|
|
|||||||
Financing | (604 | ) | (815 | ) | ||||
|
|
|||||||
Decrease in cash in the period | (117 | ) | (14 | ) | ||||
|
|
|||||||
Net cash funds | ||||||||
|
|
|||||||
Net cash inflow before management of liquid resources and financing | - | 1,229 | ||||||
AstraZeneca PLC Ordinary Shares | ||||||||
Issued for cash | 26 | 26 | ||||||
Repurchased for cash | (311 | ) | (748 | ) | ||||
|
|
|||||||
(Outflow)/inflow of net cash funds in the period | (285 | ) | 507 | |||||
|
|
13
Independent Review Report by KPMG Audit Plc to AstraZeneca PLC
Introduction
We have been engaged by the Company to review the financial information for the six month period ended 30 June 2003 set out on pages 10 and 12 to 16 and we have read the other information contained in the interim report and considered whether it contains any apparent misstatements or material inconsistencies with the financial information.
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 Listing Rules of the Financial Services Authority. 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 interim report, including the financial information contained therein, is the responsibility of, and has been approved by, the Directors. The Directors are responsible for preparing the interim report in accordance with the Listing Rules which require that the accounting policies and presentation applied to the interim figures should be consistent with those applied in preparing the preceding annual accounts except where they are to be changed in the next annual accounts in which case any changes, and the reasons for them, are disclosed.
Review work performed
We conducted our review in accordance with guidance contained in Bulletin 1999/4: Review of Interim Financial Information issued by the Auditing Practices Board for use in the United Kingdom. A review consists principally of making enquiries of group management and applying analytical procedures to the financial information and underlying financial data and, based thereon, assessing whether the accounting policies and presentation have been consistently applied unless otherwise disclosed. A review is substantially less in scope than an audit performed in accordance with Auditing Standards and therefore provides a lower level of assurance than an audit. Accordingly, we do not express an audit opinion on the financial information.
Review conclusion
On the basis of our review we are not aware of any material modifications that should be made to the financial information as presented for the six months ended 30 June 2003.
KPMG Audit Plc
Chartered
Accountants
8 Salisbury Square
London
24 July 2003
Notes to the Interim Financial Statements
1 BASIS OF PREPARATION AND ACCOUNTING POLICIES
The unaudited financial statements for the six months ended 30 June 2003 have been prepared in accordance with UK generally accepted accounting principles. The accounting policies applied are those set out in AstraZeneca PLCs 2002 Annual Report and Form 20-F.
The financial statements are unaudited but have been reveiwed by the auditors and their report is set out above. 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 have been filed with the Registrar of Companies. 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 AstraZenecas 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 $145m in the first half 2002. Neither profits nor net assets were affected.
2 JOINT VENTURES AND ASSOCIATES
The group's share of joint ventures' sales for the half year to 30 June 2003 amounted to $174m and $173m for the comparative period. Share of joint ventures' operating profits for the half year to 30 June 2003, and for the comparative period, were $nil.
14
3 RECONCILIATION OF MOVEMENTS IN SHAREHOLDERS FUNDS
2003 | 2002 | |||||||
For the six months ended 30 June | $m | $m | ||||||
Shareholders' funds at beginning of period | 11,172 | 9,586 | ||||||
Net profit for the period | 1,598 | 1,733 | ||||||
Dividends to Shareholders | (436 | ) | (398 | ) | ||||
1,162 | 1,335 | |||||||
Issue of AstraZeneca PLC Ordinary Shares | 26 | 26 | ||||||
Repurchase of AstraZeneca PLC Ordinary Shares | (311 | ) | (748 | ) | ||||
Foreign currency adjustment | 647 | 792 | ||||||
Other movements | - | 3 | ||||||
Net addition to Shareholders' funds | 1,524 | 1,408 | ||||||
Shareholders' funds at end of period | 12,696 | 10,994 |
4 NET CASH FUNDS
The table below provides an analysis of net cash funds and a reconciliation of net cash flow to the movement in net cash funds.
At 31 Dec | Cash | Other | Exchange | At 30 June | |||||||||||||
2002 | flow | Non-cash | Movements | 2003 | |||||||||||||
$m | $m | $m | $m | $m | |||||||||||||
|
|||||||||||||||||
Loans due after 1 year | (328 | ) | - | 5 | - | (323 | ) | ||||||||||
Current instalments of loans | (314 | ) | 319 | (5 | ) | - | - | ||||||||||
|
|||||||||||||||||
Total loans | (642 | ) | 319 | - | - | (323 | ) | ||||||||||
|
|||||||||||||||||
Short-term investments | 3,962 | (487 | ) | - | 28 | 3,503 | |||||||||||
Cash | 726 | (264 | ) | - | 22 | 484 | |||||||||||
Overdrafts | (202 | ) | 147 | - | - | (55 | ) | ||||||||||
|
|||||||||||||||||
4,486 | (604 | ) | - | 50 | 3,932 | ||||||||||||
|
|||||||||||||||||
Net cash funds | 3,844 | (285 | ) | - | 50 | 3,609 | |||||||||||
|
|||||||||||||||||
Issue of AstraZeneca PLC Ordinary | |||||||||||||||||
Shares | (26 | ) | |||||||||||||||
Repurchase of AstraZeneca PLC | |||||||||||||||||
Ordinary Shares | 311 | ||||||||||||||||
Net cash inflow before | |||||||||||||||||
management of liquid resources | |||||||||||||||||
and financing | - | ||||||||||||||||
5 LEGAL PROCEEDINGS
The Company announced on 20 June 2003 a settlement of the US Department of Justice investigation into the US sales and marketing practices for Zoladex (goserelin acetate implant). Under the terms of the settlement, AstraZeneca Pharmaceuticals LP admitted to violating the Prescription Drug Marketing Act by providing free samples of Zoladex to physicians during the period 1993 through 1996, with the understanding that these physicians would bill Medicare for reimbursement. AstraZeneca also settled, without admitting liability, civil claims involving allegations that the Company provided inducements to physicians to purchase Zoladex and for improperly setting and reporting its price. The total payment associated with the settlement is $355 million, with a portion of the settlement placed in escrow to fund anticipated settlements with the individual states. The settlement also provides for a five-year Corporate Integrity Agreement with the Office of Inspector General (OIG) for the Department of Health and Human Services, under which AstraZeneca Pharmaceuticals LP is required, among other obligations, to keep in place its current Compliance Program and provide periodic reports to the OIG on the status of compliance activities.
15
6 HALF YEAR TERRITORIAL SALES ANALYSIS
% Growth | ||||||||||||||
1st Half | 1st Half | |||||||||||||
2003 | 2002 | Constant | ||||||||||||
$m | $m | Actual | Currency | |||||||||||
US | 4,432 | 4,597 | (4 | ) | (4 | ) | ||||||||
Canada | 330 | 273 | 21 | 16 | ||||||||||
North America | 4,762 | 4,870 | (2 | ) | (2 | ) | ||||||||
France | 688 | 533 | 29 | 9 | ||||||||||
UK | 274 | 325 | (16 | ) | (24 | ) | ||||||||
Germany | 390 | 329 | 19 | 1 | ||||||||||
Italy | 450 | 379 | 19 | 1 | ||||||||||
Sweden | 152 | 138 | 10 | (7 | ) | |||||||||
Europe others | 1,247 | 1,084 | 15 | (1 | ) | |||||||||
Total Europe | 3,201 | 2,788 | 15 | (1 | ) | |||||||||
Japan | 536 | 412 | 30 | 20 | ||||||||||
Rest of World | 672 | 588 | 14 | 19 | ||||||||||
Total | 9,171 | 8,658 | 6 | - | ||||||||||
7 SECOND QUARTER TERRITORIAL SALES ANALYSIS
% Growth | ||||||||||||||
2nd Half | 2nd Half | |||||||||||||
2003 | 2002 | Constant | ||||||||||||
$m | $m | Actual | Currency | |||||||||||
US | 1,962 | 2,214 | (11 | ) | (11 | ) | ||||||||
Canada | 174 | 144 | 21 | 13 | ||||||||||
North America | 2,136 | 2,358 | (9 | ) | (10 | ) | ||||||||
France | 359 | 270 | 33 | 10 | ||||||||||
UK | 130 | 147 | (12 | ) | (21 | ) | ||||||||
Germany | 207 | 165 | 25 | 4 | ||||||||||
Italy | 242 | 207 | 17 | (3 | ) | |||||||||
Sweden | 73 | 74 | (1 | ) | (16 | ) | ||||||||
Europe others | 635 | 538 | 18 | - | ||||||||||
Total Europe | 1,646 | 1,401 | 17 | (2 | ) | |||||||||
Japan | 293 | 240 | 22 | 11 | ||||||||||
Rest of World | 361 | 313 | 15 | 19 | ||||||||||
Total | 4,436 | 4,312 | 3 | (4 | ) | |||||||||
16
8 HALF YEAR PRODUCT SALES ANALYSIS
World | US | |||||||||||||||||||
Constant | ||||||||||||||||||||
1st Half | 1st Half | Actual | Currency | 1st Half | Actual | |||||||||||||||
2003 | 2002 | Growth | Growth | 2003 | Growth | |||||||||||||||
$m | $m | % | % | $m | % | |||||||||||||||
Gastrointestinal: | ||||||||||||||||||||
Losec | 1,434 | 2,308 | (38 | ) | (42 | ) | 607 | (56 | ) | |||||||||||
Nexium | 1,466 | 811 | 81 | 76 | 1,106 | 74 | ||||||||||||||
Others | 35 | 30 | 17 | 7 | 11 | 22 | ||||||||||||||
Total Gastrointestinal | 2,935 | 3,149 | (7 | ) | (11 | ) | 1,724 | (15 | ) | |||||||||||
Cardiovascular: | ||||||||||||||||||||
Zestril | 226 | 546 | (59 | ) | (63 | ) | 43 | (87 | ) | |||||||||||
Seloken | 748 | 437 | 71 | 67 | 576 | 93 | ||||||||||||||
Atacand | 358 | 278 | 29 | 20 | 137 | 20 | ||||||||||||||
Plendil | 239 | 203 | 18 | 12 | 89 | 24 | ||||||||||||||
Tenormin | 165 | 190 | (13 | ) | (18 | ) | 13 | (65 | ) | |||||||||||
Crestor | 12 | - | n/m | n/m | - | n/m | ||||||||||||||
Others | 188 | 181 | 4 | (8 | ) | 9 | (18 | ) | ||||||||||||
Total Cardiovascular | 1,936 | 1,835 | 6 | - | 867 | (1 | ) | |||||||||||||
Respiratory: | ||||||||||||||||||||
Pulmicort | 490 | 426 | 15 | 9 | 261 | 37 | ||||||||||||||
Rhinocort | 186 | 144 | 29 | 26 | 136 | 39 | ||||||||||||||
Symbicort | 249 | 122 | 104 | 79 | - | - | ||||||||||||||
Accolate | 56 | 65 | (14 | ) | (16 | ) | 38 | (16 | ) | |||||||||||
Oxis | 60 | 61 | (2 | ) | (13 | ) | - | - | ||||||||||||
Others | 74 | 72 | 3 | (8 | ) | - | - | |||||||||||||
Total Respiratory | 1,115 | 890 | 25 | 16 | 435 | 31 | ||||||||||||||
Oncology: | ||||||||||||||||||||
Zoladex | 406 | 382 | 6 | (1 | ) | 84 | (17 | ) | ||||||||||||
Casodex | 417 | 271 | 54 | 43 | 132 | 110 | ||||||||||||||
Nolvadex | 100 | 257 | (61 | ) | (63 | ) | 36 | (81 | ) | |||||||||||
Arimidex | 236 | 144 | 64 | 54 | 101 | 66 | ||||||||||||||
Iressa | 66 | - | n/m | n/m | 18 | n/m | ||||||||||||||
Faslodex | 37 | 8 | n/m | n/m | 37 | n/m | ||||||||||||||
Others | 9 | 11 | (18 | ) | (27 | ) | - | - | ||||||||||||
Total Oncology | 1,271 | 1,073 | 18 | 10 | 408 | (3 | ) | |||||||||||||
CNS: | ||||||||||||||||||||
Seroquel | 714 | 592 | 21 | 18 | 545 | 10 | ||||||||||||||
Zomig | 162 | 166 | (2 | ) | (8 | ) | 78 | (19 | ) | |||||||||||
Others | 15 | 15 | - | (13 | ) | 2 | (33 | ) | ||||||||||||
Total CNS | 891 | 773 | 15 | 11 | 625 | 5 | ||||||||||||||
Pain, Infection and Other Pharma: | ||||||||||||||||||||
Diprivan | 234 | 222 | 5 | - | 123 | 13 | ||||||||||||||
Merrem | 154 | 141 | 9 | 8 | 25 | (22 | ) | |||||||||||||
Local anaesthetics | 223 | 156 | 43 | 34 | 51 | 55 | ||||||||||||||
Other Pharma Products | 135 | 180 | (25 | ) | (31 | ) | 31 | (44 | ) | |||||||||||
Total Pain, Infection and Other | ||||||||||||||||||||
Pharma | 746 | 699 | 7 | 2 | 230 | - | ||||||||||||||
Salick Health Care | 134 | 113 | 19 | 19 | 134 | 19 | ||||||||||||||
Astra Tech | 94 | 71 | 32 | 11 | 7 | 40 | ||||||||||||||
Marlow Foods | 49 | 55 | (11 | ) | (18 | ) | 2 | 100 | ||||||||||||
Total | 9,171 | 8,658 | 6 | - | 4,432 | (4 | ) | |||||||||||||
n/m not meaningful |
17
9 SECOND QUARTER PRODUCT SALES ANALYSIS
World | US | |||||||||||||||||||
2nd Quarter | 2nd Quarter | Actual | Constant Currency | 2nd Quarter | Actual | |||||||||||||||
2003 | 2002 | Growth | Growth | 2003 | Growth | |||||||||||||||
$m | $m | % | % | $m | % | |||||||||||||||
Gastrointestinal: | ||||||||||||||||||||
Losec | 742 | 1,116 | (34 | ) | (39 | ) | 320 | (52 | ) | |||||||||||
Nexium | 631 | 464 | 36 | 31 | 437 | 25 | ||||||||||||||
Others | 17 | 17 | - | (12 | ) | 3 | (40 | ) | ||||||||||||
Total Gastrointestinal | 1,390 | 1,597 | (13 | ) | (18 | ) | 760 | (25 | ) | |||||||||||
Cardiovascular: | ||||||||||||||||||||
Zestril | 118 | 269 | (56 | ) | (61 | ) | 23 | (86 | ) | |||||||||||
Seloken | 380 | 206 | 84 | 79 | 291 | 112 | ||||||||||||||
Atacand | 152 | 129 | 18 | 6 | 35 | (19 | ) | |||||||||||||
Plendil | 129 | 97 | 33 | 26 | 50 | 72 | ||||||||||||||
Tenormin | 81 | 96 | (16 | ) | (23 | ) | - | - | ||||||||||||
Crestor | 9 | - | n/m | n/m | - | n/m | ||||||||||||||
Others | 98 | 92 | 7 | (6 | ) | 5 | - | |||||||||||||
Total Cardiovascular | 967 | 889 | 9 | 1 | 404 | 3 | ||||||||||||||
Respiratory: | ||||||||||||||||||||
Pulmicort | 239 | 199 | 20 | 13 | 128 | 51 | ||||||||||||||
Rhinocort | 96 | 81 | 19 | 17 | 68 | 24 | ||||||||||||||
Symbicort | 127 | 68 | 87 | 61 | - | - | ||||||||||||||
Accolate | 25 | 33 | (24 | ) | (27 | ) | 15 | (35 | ) | |||||||||||
Oxis | 29 | 30 | (3 | ) | (16 | ) | - | - | ||||||||||||
Others | 36 | 37 | (3 | ) | (17 | ) | - | - | ||||||||||||
Total Respiratory | 552 | 448 | 23 | 13 | 211 | 29 | ||||||||||||||
Oncology: | ||||||||||||||||||||
Zoladex | 213 | 195 | 9 | - | 42 | (24 | ) | |||||||||||||
Casodex | 228 | 148 | 54 | 41 | 72 | 118 | ||||||||||||||
Nolvadex | 39 | 117 | (67 | ) | (70 | ) | 5 | (94 | ) | |||||||||||
Arimidex | 143 | 79 | 81 | 70 | 68 | 94 | ||||||||||||||
Iressa | 47 | - | n/m | n/m | 18 | n/m | ||||||||||||||
Faslodex | 15 | 8 | 88 | 88 | 15 | 88 | ||||||||||||||
Others | 5 | 6 | (17 | ) | (34 | ) | - | - | ||||||||||||
Total Oncology | 690 | 553 | 25 | 15 | 220 | 4 | ||||||||||||||
CNS: | ||||||||||||||||||||
Seroquel | 270 | 263 | 3 | (1 | ) | 185 | (11 | ) | ||||||||||||
Zomig | 54 | 74 | (27 | ) | (35 | ) | 9 | (76 | ) | |||||||||||
Others | 7 | 8 | (13 | ) | (38 | ) | - | - | ||||||||||||
Total CNS | 331 | 345 | (4 | ) | (9 | ) | 194 | (21 | ) | |||||||||||
Pain, Infection and Other Pharma: | ||||||||||||||||||||
Diprivan | 98 | 111 | (12 | ) | (17 | ) | 42 | (25 | ) | |||||||||||
Merrem | 80 | 74 | 8 | 5 | 12 | (29 | ) | |||||||||||||
Local anaesthetics | 122 | 60 | 103 | 90 | 31 | 182 | ||||||||||||||
Other Pharma Products | 69 | 112 | (38 | ) | (41 | ) | 14 | (62 | ) | |||||||||||
Total Pain, Infection and Other | ||||||||||||||||||||
Pharma | 369 | 357 | 3 | (2 | ) | 99 | (18 | ) | ||||||||||||
Salick Health Care | 69 | 59 | 17 | 17 | 69 | 17 | ||||||||||||||
Astra Tech | 50 | 37 | 35 | 13 | 4 | 33 | ||||||||||||||
Marlow Foods | 18 | 27 | (33 | ) | (37 | ) | 1 | - | ||||||||||||
Total | 4,436 | 4,312 | 3 | (4 | ) | 1,962 | (11 | ) | ||||||||||||
n/m not meaningful |
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Information for US Investors
RECONCILIATION TO UNITED STATES ACCOUNTING PRINCIPLES
The profit and loss account and balance sheet set out on pages 10 to 12 are prepared in accordance with generally accepted accounting principles in the United Kingdom (UK GAAP) which differ in certain material respects from those generally accepted in the United States (US GAAP). The differences as they apply to AstraZeneca PLC are explained in the 2002 Annual Report and Form 20-F. The approximate effects on income and shareholders equity of the GAAP differences are shown below.
1st Half | 1st Half | |||||||
2003 | 2002 | |||||||
Income attributable to Shareholders $m | $m | $m | ||||||
|
||||||||
Net income for the period under UK GAAP from continuing | ||||||||
operations | 1,598 | 1,733 | ||||||
Adjustments to conform to US GAAP | ||||||||
Purchase accounting adjustments (including goodwill and | ||||||||
intangibles): | ||||||||
- deemed acquisition of Astra (amortisation and other acquisition adjustments) | (461 | ) | (419 | ) | ||||
- others | 28 | 26 | ||||||
Capitalisation less amortisation of interest | 3 | - | ||||||
Capitalisation less amortisation of software costs | (45 | ) | (42 | ) | ||||
Deferred taxation | ||||||||
- on fair values of Astra | 129 | 115 | ||||||
- others | (49 | ) | (83 | ) | ||||
Pension expense | (16 | ) | (27 | ) | ||||
Post-retirement benefits/plan amendment | 2 | 2 | ||||||
Share based compensation | (4 | ) | 32 | |||||
Fair value of derivative financial instruments | (11 | ) | 37 | |||||
Deferred income recognition | 12 | (47 | ) | |||||
Unrealised gains on foreign exchange and others | (1 | ) | 4 | |||||
Net income in accordance with US GAAP | 1,185 | 1,331 | ||||||
Net income per Ordinary Share under US GAAP basic and diluted | $ | 0.69 | $ | 0.77 | ||||
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RECONCILIATION TO UNITED STATES ACCOUNTING PRINCIPLES (CONTINUED)
30 June | 30 June | |||||||
Shareholders' equity | 2003 | 2003 | ||||||
$m | $m | |||||||
Shareholders' equity under UK GAAP | 12,696 | 10,994 | ||||||
Adjustments to conform to US GAAP | ||||||||
Purchase accounting adjustments (including goodwill and | ||||||||
intangibles): | ||||||||
- deemed acquisition of Astra | ||||||||
- goodwill | 13,406 | 12,355 | ||||||
- tangible and intangible fixed assets | 7,658 | 7,737 | ||||||
- others | 114 | 57 | ||||||
Capitalisation, less disposals and amortisation of interest | 241 | 192 | ||||||
Deferred taxation | ||||||||
- on fair value of Astra | (2,300 | ) | (2,310 | ) | ||||
- others | (218 | ) | (156 | ) | ||||
Dividend | 436 | 398 | ||||||
Pension expense | (287 | ) | (189 | ) | ||||
Post-retirement benefits/plan amendment | (22 | ) | (26 | ) | ||||
Software costs capitalised | 19 | 68 | ||||||
Fair value of derivative financial instruments | 101 | 87 | ||||||
Deferred income recognition | (2 | ) | (122 | ) | ||||
Others | 96 | 93 | ||||||
Shareholders' equity in accordance with US GAAP | 31,938 | 29,178 | ||||||
20
Shareholder Information
ANNOUNCEMENTS AND MEETINGS | |
Annual Business Review | 2 October 2003 |
Announcement of third quarter and nine months results | 23 October 2003 |
DIVIDENDS | |
The record date for the first interim dividend payable on 6 October 2003 (in the UK, Sweden and the US) is 22 August 2003. Ordinary Shares will trade ex-dividend on the London and Stockholm Stock Exchanges from 20 August 2003. ADRs will trade 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 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 Pulmicort Turbuhaler 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 | Register 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 | S-103 97 Stockholm |
Worthing | RI 02940-3013 | UK | Sweden |
West Sussex | US | ||
BN99 6DA | |||
Tel: +44 (0)121 433 8000 | Tel: (781) 575 4328 | Tel: +44 (0)20 7304 5000 | Tel: +46 (0)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. |
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