FORM 6-K
Report of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For October 2005
Commission File Number: 001-11960
AstraZeneca PLC
15 Stanhope Gate, London W1K 1LN, England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
| Form 20-F X | Form 40-F |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ______
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
| Yes | No X |
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
AstraZeneca
PLC
INDEX TO EXHIBITS
| 1. | Press release entitled, “Repurchase of Shares in AstraZeneca PLC”, dated 3 October 2005. |
| 2. | Press release entitled, “Nexium ANDA”, dated 18 October 2005. |
| 3. | Press release entitled, “BOLDER II Study confirms therapeutic potential of Seroquel in Bipolar Depression”, dated 21 October 2005. |
| 4. | Press release entitled, “AstraZeneca’s third quarter and nine months results 2005”, dated 26 October 2005. |
| 5. | Press release entitled, “AstraZeneca PLC Third Quarter and Nine Months Results 2005” (front half of document), dated 27 October 2005. |
| 6. | Press release entitled, “AstraZeneca PLC Third Quarter and Nine Months Results 2005 Consolidated Statement” (back half of document), dated 27 October 2005. |
| 7. | Press release entitled, “Companies Act 1985 Section 198 Disclosure of Interest in Voting Shares in Public Companies”, dated 28 October 2005. |
| 8. | Press release entitled, “Repurchase of Shares in AstraZeneca PLC”, dated 31 October 2005. |
| 9. | Press release entitled, “FDA grants ZD6474 (ZACTIMATM) Orphan Drug designation for the investigation of rare forms of thyroid cancer”, dated 31 October 2005. |
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: | 8 November 2005 | By: | /s/ A C N Kemp | |
| Name: | A C N Kemp | |||
| Title: | Assistant Secretary | |||
Item 1
REPURCHASE OF SHARES IN ASTRAZENECA PLC
AstraZeneca PLC announced that on 30 September 2005, it purchased for cancellation 500,000 ordinary shares of AstraZeneca PLC at a price of 2643 pence per share. Upon the cancellation of these shares, the number of shares in issue will be 1,597,276,472.
G H R Musker
Company Secretary
3 October 2005
NEXIUM ANDA
AstraZeneca has received a notice from Ranbaxy Pharmaceuticals Inc. that Ranbaxy Laboratories Limited has submitted an Abbreviated New Drug Application (ANDA) for esomeprazole magnesium delayed-release capsules, 20mg and 40mg, containing Paragraph IV Certifications of invalidity and/or non-infringement with respect to certain AstraZeneca US patents listed in the Orange Book in reference to Nexium, the latter of which expires in 2018.
AstraZeneca has 45 days within which to commence a patent infringement lawsuit against Ranbaxy that would automatically stay, or bar, the FDA from approving Ranbaxy’s ANDA for 30 months or until an adverse court decision, whichever may occur earlier.
Ranbaxy has also certified with respect to certain other AstraZeneca US patents listed in the Orange Book in reference to Nexium that Ranbaxy will not launch its product prior to the expiry of those patents, the latter of which expires in October 2007.
AstraZeneca is evaluating Ranbaxy’s notice and continues to have full confidence in its intellectual property protecting Nexium.
Media Enquiries:
Edel McCaffrey, Tel: +44 (0)20 7304
5034
Steve Brown, Tel: +44 (0)20 7304 5033
Investor Enquiries:
Mina Blair, Tel: +44 (0)20 7304 5084
Jonathan
Hunt, Tel: +44 (0)20 7304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth,
Tel + 1 212 579 0506
BOLDER II STUDY CONFIRMS THERAPEUTIC POTENTIAL
OF
SEROQUEL IN BIPOLAR DEPRESSION
Newly released top-line results from the BOLDER II (BipOLar DEpRession) study have underlined the potential for SEROQUEL (quetiapine fumarate) in the treatment of patients with major depressive episodes associated with bipolar disorder. Based on prior discussions with the US Food and Drug Administration (FDA) and the results of BOLDER II, AstraZeneca plans to file for a US licence extension for SEROQUEL in the treatment of depressive episodes associated with bipolar disorder around the end of this year (2005).
BOLDER II - an eight week, multi-centre, placebo-controlled study - found that SEROQUEL 300mg and 600mg doses achieved a statistically significant reduction in levels of bipolar depression compared with placebo (p-value less than or equal to 0.001), as measured by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
The significant reduction in MADRS total score was seen both in patients with bipolar I and bipolar II disorder, in patients with or without a rapid cycling course of illness, and as early as week one after randomisation. Significant improvements were also seen compared with placebo in the various secondary study endpoints among SEROQUEL-treated patients, including reduction of anxiety symptoms. In addition, more than half (53 per cent) of patients receiving SEROQUEL achieved remission from their bipolar depression symptoms.
BOLDER II reinforces the findings of the landmark BOLDER I study published in American Journal of Psychiatry in July 2005, which first indicated a significant effect for SEROQUEL in treating major depressive episodes associated with bipolar disorder. Importantly, SEROQUEL was shown to be well tolerated in BOLDER II with a similar safety profile seen to that in BOLDER I. The rate of serious adverse events was low, and comparable in all treated groups. The most common adverse events reported in the trial were dry mouth, sedation, somnolence, dizziness and constipation. There was a low incidence of treatment-emergent mania in the
SEROQUEL-treated groups. As in BOLDER I, there was a low incidence of EPS (extrapyramidal symptoms) and minimal weight change reported in the study.
Patients with bipolar depression are underserved and understudied. The findings from the BOLDER II study are very encouraging and support the findings of BOLDER I, in showing the potential of SEROQUEL, as monotherapy, for the acute treatment of bipolar depression. Each of these two studies represent the largest placebo-controlled short-term studies ever conducted in bipolar depression. The beneficial risk:benefit profile of Seroquel seen in both studies could offer an important therapeutic value for both patients and physicians as there is currently only one FDA approved therapy to treat depressive episodes associated with bipolar disorder.
Bipolar disorder is a serious mental illness that affects approximately 3-4 per cent of the adult population and is the sixth leading cause of disability in the world. Patients with bipolar disorder are symptomatic almost half of their lives, and approximately two-thirds of that time is spent in the depressed phase of the illness.
SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is available in 85 countries for the treatment of this condition. It is currently licensed for the treatment of mania associated with bipolar
disorder in 73 countries. In the first half of 2005, SEROQUEL sales reached $1,300 million.
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304
5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan
Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth,
Tel + 1 212 579 0506
AstraZeneca’s third quarter and nine months results 2005
Tomorrow, Thursday, 27 October 2005 AstraZeneca will be announce third quarter and nine months results for 2005 at 11:00 (BST), 12:00(CEST), 06:00(EDT).
There will be an analysts teleconference at 13:00(BST), 14:00(CEST) 08:00 (EDT), for which the numbers are in the UK: 0800 559 3282, for International: +44 (0)20 7365 1829 and for the US: 1 866 239 0750. These numbers, as well as details of the replay facility available through Monday, 7 November 2005, are available on the Investors section of the AstraZeneca website at www.astrazeneca.com
Item 5
AstraZeneca PLC
Third
Quarter and Nine Months Results 2005
“A strong third quarter with sales up 9 percent and Earnings per Share up 52
percent: year end targets increased.”
| Financial Highlights |
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| Group | 3 rd Quarter | 3 rd Quarter | Actual | CER | 9 Months | 9 Months | Actual | CER | ||||||||
| 2005 | 2004 | % | % | 2005 | 2004 | % | % | |||||||||
| $m | $m | $m | $m | |||||||||||||
| Sales | 5,789 | 5,265 | +10 | +9 | 17,664 | 15,627 | +13 | +10 | ||||||||
| Operating Profit | 1,695 | 1,172 | +45 | +45 | 4,866 | 3,276 | +49 | +44 | ||||||||
| Profit before Tax | 1,743 | 1,419 | * | +23 | +23 | 4,978 | 3,549 | * | +40 | +36 | ||||||
| Earnings per Share: | ||||||||||||||||
| Before non-recurring items | $0.76 | $0.51 | +49 | +52 | $2.14 | $1.46 | +46 | +42 | ||||||||
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| Statutory | $0.76 | $0.68 | * | +12 | +13 | $2.14 | $1.63 | * | +31 | +27 | ||||||
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* There were two non-recurring items in Q3 2004,
which benefited profit before tax by $219 million and earnings per share by
$0.17. Excluding these benefits, earnings
per share increased 52 percent at CER in the third quarter and 42 percent for
the nine months compared with 2004.
All
narrative in this section refers to growth rates at constant exchange rates
(CER) unless otherwise indicated
Sir Tom McKillop, Chief Executive, said: “A continued strong sales performance, especially for the five key growth products, together with benefits arising from productivity initiatives across the entire Company has produced an outstanding result for the nine months, and is reflected in an increase in our financial targets for the full year.”
| London, 27 October 2005 | ||||
| Media Enquiries: | Steve Brown/Edel McCaffrey (London) | (020) 7304 5033/5034 | ||
| Staffan Ternby (Södertälje) | (8) 553 26107 | |||
| Rachel Bloom-Baglin (Wilmington) | (302) 886 7858 | |||
| Analyst/Investor Enquiries: | Mina Blair (London)/ Jonathan Hunt (London) | (020) 7304 5084/ 5087 | ||
| Staffan Ternby (Södertälje) | (8) 553 26107 | |||
| Ed Seage/Jörgen Winroth (US) | (302) 886 4065/(212) 579 0506 | |||
| Photos of Jonathan Symonds, Chief Financial Officer are available on www.newscast.co.uk. Broadcast footage of AstraZeneca products and activities is available on www.thenewsmarket.com/astrazeneca | ||||
AstraZeneca PLC
Business Highlights All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated
Third Quarter
Sales in the third quarter increased by 9 percent at CER, or 10 percent on an as reported basis (including an exchange benefit of 1 percent), with good sales growth in all regions (US up 9 percent; Europe up 8 percent; Japan up 6 percent; Rest of World up 13 percent).
Combined expenditures in R&D and SG&A were up 2 percent at CER and as reported, with currency having no impact. Operating profit in the third quarter was up 45 percent. Earnings per share were $0.76 versus $0.68 in 2004, which included $0.17 in non-recurring benefits from a disposal gain and a tax credit. Excluding these items from last year, third quarter earnings per share increased 52 percent.
Sales growth was driven by the strong performance of 5 key growth products (NexiumTM, CrestorTM, SymbicortTM, ArimidexTM and SeroquelTM) whose combined sales increased 25 percent to $2,701 million.
NexiumTM sales were up 18 percent to $1,127 million on good growth in the US (up 17 percent) and in other markets (up 19 percent).
CrestorTM sales in the quarter increased 23 percent to $325 million, including $189 million in the US. CrestorTM share of new prescriptions in the US statin market was 6.8 percent in the week ending 14 October, up from 5.9 percent for the month of June.
SymbicortTM sales were $240 million, up 28 percent. The US regulatory application for the pMDI formulation of SymbicortTM for the treatment of asthma was submitted on 23 September.
Quarterly sales for ArimidexTM exceeded $300 million for the first time (up 36 percent to $303 million), building upon its market leading position among aromatase inhibitors for the treatment of breast cancer.
SeroquelTM sales were $706 million, on strong growth in the US (up 30 percent) and in other markets (up 41 percent).
Since September, the Company has received notifications containing paragraph IV certifications alleging invalidity and non-infringement in respect of certain of AstraZeneca’s patents relating to PulmicortTM RespulesTM, SeroquelTM, and NexiumTM. The Company continues to have full confidence in its intellectual property protecting these products.
Nine Months
For the nine months, sales increased 10 percent at CER, or 13 percent on an as reported basis (including an exchange benefit of 3 percent). Sales increased 13 percent in the US and were up 8 percent in other markets. Sales growth for the nine months was fuelled by NexiumTM (up 20 percent), CrestorTM (up 51 percent), SymbicortTM (up 22 percent), ArimidexTM (up 45 percent) and SeroquelTM (up 35 percent). Combined sales for these five products were $7,905 million, up 29 percent.
The sustained focus on productivity throughout the organization continues to yield benefits ahead of initial expectations. The 44 percent increase in operating profit derives from strong sales growth and the impact of ongoing productivity gains. Activity-related costs, particularly in R&D, are lower year to date, but will increase as larger scale clinical trials commence in support of an emerging late stage product pipeline, including ZactimaTM and AZD2171. Earnings per share were $2.14 compared with $1.63 last year. Excluding the $0.17 in non-recurring gains in 2004, earnings per share increased by 42 percent for the nine months.
Future Prospects
The Company continues to anticipate sales growth around the double digits mark for the full year in constant currency terms. This sales growth, combined with excellent progress in improving productivity, should result in earnings per share for the full year between $2.85 and $2.95.
Disclosure Notice: The preceding forward-looking statements relating to expectations for earnings and business prospects for AstraZeneca PLC are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the forward-looking statements. These include, but are not limited to: the rate of growth in sales of generic omeprazole in the US, continued growth in currently marketed products (in particular CrestorTM, NexiumTM, SeroquelTM, SymbicortTM, ArimidexTM and CasodexTM), the growth in costs and expenses, interest rate movements, exchange rate fluctuations and the tax rate. For further details on these and other risks and uncertainties, see AstraZeneca PLC’s Securities and Exchange Commission filings, including the 2004 Annual Report on Form 20-F.
2
AstraZeneca PLC
| Sales |
|
|
| All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated |
Gastrointestinal
| Third Quarter | CER % | Nine Months | CER % | |||||||||
|
|
||||||||||||
| 2005 | 2004 | 2005 | 2004 | |||||||||
|
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| Losec ™ / Prilosec ™ | 376 | 430 | -15 | 1,241 | 1,501 | -20 | ||||||
| Nexium ™ | 1,127 | 951 | +18 | 3,386 | 2,777 | +20 | ||||||
|
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||||||||||||
| Total | 1,518 | 1,407 | +7 | 4,678 | 4,342 | +6 | ||||||
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Cardiovascular
| Third Quarter | CER % | Nine Months | CER % | |||||||||
|
|
|
|||||||||||
| 2005 | 2004 | 2005 | 2004 | |||||||||
|
|
||||||||||||
| Seloken ™ / Toprol-XL ™ | 437 | 353 | +23 | 1,280 | 1,006 | +26 | ||||||
| Atacand ™ | 238 | 214 | +9 | 727 | 639 | +10 | ||||||
| Plendil ™ | 82 | 102 | -22 | 287 | 361 | -22 | ||||||
| Zestril ™ | 83 | 105 | -22 | 248 | 327 | -27 | ||||||
| Crestor ™ | 325 | 260 | +23 | 915 | 596 | +51 | ||||||
|
|
||||||||||||
| Total | 1,327 | 1,208 | +9 | 3,954 | 3,456 | +11 | ||||||
|
|
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3
AstraZeneca PLC
Respiratory
| Third Quarter | CER % | Nine Months | CER % | |||||||||
|
|
|
|||||||||||
| 2005 | 2004 | 2005 | 2004 | |||||||||
|
|
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| Symbicort ™ | 240 | 185 | +28 | 742 | 578 | +22 | ||||||
| Pulmicort ™ | 234 | 211 | +10 | 824 | 737 | +10 | ||||||
| Rhinocort ™ | 91 | 87 | +4 | 295 | 268 | +9 | ||||||
| Accolate ™ | 14 | 31 | -55 | 55 | 84 | -36 | ||||||
| Oxis ™ | 23 | 25 | -12 | 69 | 76 | -14 | ||||||
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| Total | 636 | 574 | +10 | 2,100 | 1,861 | +10 | ||||||
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Oncology
| Third Quarter | CER % | Nine Months | CER % | |||||||||
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|
|||||||||||
| 2005 | 2004 | 2005 | 2004 | |||||||||
|
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| Casodex ™ | 276 | 258 | + 7 | 840 | 736 | + 11 | ||||||
| Zoladex ™ | 258 | 236 | + 7 | 752 | 675 | + 7 | ||||||
| Arimidex ™ | 303 | 221 | + 36 | 856 | 578 | + 45 | ||||||
| Iressa ™ | 61 | 113 | -46 | 201 | 309 | -36 | ||||||
| Faslodex ™ | 37 | 24 | + 50 | 101 | 73 | + 35 | ||||||
| Nolvadex ™ | 26 | 30 | -13 | 86 | 99 | -15 | ||||||
|
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| Total | 963 | 885 | + 8 | 2,844 | 2,481 | + 12 | ||||||
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4
AstraZeneca PLC
Neuroscience
| Third Quarter | CER % | Nine Months | CER % | |||||||||
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| 2005 | 2004 | 2005 | 2004 | |||||||||
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| Seroquel ™ | 706 | 529 | +32 | 2,006 | 1,465 | +35 | ||||||
| Zomig ™ | 86 | 81 | +5 | 258 | 267 | -6 | ||||||
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| Total | 1,001 | 880 | +13 | 2,975 | 2,558 | +14 | ||||||
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Geographic Sales
| Third Quarter | CER % | Nine Months | CER % | |||||||||
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| 2005 | 2004 | 2005 | 2004 | |||||||||
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| US | 2,621 | 2,407 | +9 | 7,864 | 6,974 | +13 | ||||||
| Europe | 2,012 | 1,858 | +8 | 6,374 | 5,661 | +8 | ||||||
| Japan | 367 | 352 | +6 | 1,103 | 1,018 | +8 | ||||||
| RoW | 789 | 648 | +13 | 2,323 | 1,974 | +11 | ||||||
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AstraZeneca PLC
| Operating Review |
All narrative in this section refers to growth rates at constant exchange rates (CER) unless otherwise indicated
Third Quarter
Reported sales increased by 10 percent and operating profit by 45 percent. At constant exchange rates, sales increased by 9 percent and operating profit by 45 percent. Following the successful introduction of Distribution Service Agreements in the US, reported Group and US sales reflect underlying demand. Wholesaler buying patterns in the prior year, however, continue to affect some individual product performances.
Currency had a 1 percent benefit to sales and was neutral to operating profit. In comparison to quarter three last year the dollar was slightly weaker against the euro, benefiting sales, and stronger against the Swedish krona (2 percent) and sterling (2 percent), decreasing costs. Overall, currency depressed EPS by 1 cent as the beneficial exchange rate profile was offset by hedging benefits from 2004 not being repeated during the quarter.
Reported operating margin increased by 7.0 percentage points from 22.3 percent to 29.3 percent. Currency reduced margin by 0.3 percentage points and other income increased margin by 0.2 percentage points resulting in an underlying margin improvement of 7.1 percentage points for the quarter.
Gross margin increased by 2.9 percentage points to 78.5 percent of sales. Currency depressed gross margin by 0.7 percentage points and payments to Merck were level with prior year at 4.8 percent of sales. Included in the third quarter last year are ExantaTM inventory and asset provisions of $80 million which depressed gross margin and, when excluded, implies a 1.9 percentage point underlying improvement for the quarter, due mostly to improved product mix and operational efficiencies.
In aggregate, R&D and SG&A expenses of $2,837 million increased 2 percent over last year. In comparison to third quarter last year, R&D and SG&A combined added 3.5 percentage points to operating margin. The sustained focus on productivity, combined with the lower level of late stage clinical trials compared with 2004, resulted in R&D expenditures decreasing by 4 percent for the quarter. SG&A increased by 4 percent for the quarter primarily due to increased investment in the US on NexiumTM, CrestorTM and SeroquelTM over prior year.
The fair value adjustments relating to financial instruments amounted to an $18 million benefit in quarter three; $5 million benefit in cost of sales, $3 million benefit to interest and $10 million benefit to R&D.
Nine Months
Reported sales increased by 13 percent and operating profit by 49 percent. At constant exchange rates, sales increased by 10 percent and operating profit by 44 percent.
Currency benefited reported sales by 3 percent and operating profit by 5 percent. Cumulatively, exchange has benefited EPS by around 6 cents. We expect to see a 2 to 3 cents reduction in the year to date benefit during quarter four based on the current strengthening of the dollar and the hedging benefits realized in quarter four 2004 not being repeated.
Operating margin increased by 6.5 percent from 21.0 percent to 27.5 percent. Underlying margin improvement was 7.0 percentage points for the nine months as the currency benefit of 0.1 percentage points was offset by a reduction in margin of 0.6 percent from other income, due principally to the gain on the disposal of the Durascan business last year.
Gross margin increased by 1.1 percentage points to 77.5 percent of sales. Lower payments to Merck (4.8 percent of sales) and currency each benefited gross margin by 0.1 percentage points. Excluding prior year Exanta™ provisions and the costs associated with the termination of the Medpointe ZomigTM distribution agreement in the first quarter of this year, underlying margin improved by 0.4 percentage points.
Benefits from ongoing productivity initiatives, together with a low point in the R&D and SG&A investment cycle, have resulted in a 2 percent decline (up 1 percent as reported) in combined R&D and SG&A expense year to date. In comparison to the first nine months last year, R&D and SG&A combined added 6.0 percentage points to operating margin.
The fair value adjustments relating to financial instruments amounted to a $61 million charge for the nine months; $52 million charge in cost of sales, $4 million charge to interest and $5 million charge to R&D.
6
AstraZeneca PLC
Interest and Dividend Income
Net interest and dividend income for the third quarter was $48 million (2004 $28 million) and for the nine months was $112 million (2004 $54 million). The increase over 2004 is primarily attributable to higher average investment balances and yields. The reported amount includes net income of $13 million in the first nine months and $3 million in the third quarter arising from employer benefit fund assets and liabilities as required by IAS 19.
Taxation
The effective tax rate for the third quarter was 29.4 percent (2004, rate excluding non-recurring items 28.9 percent) and for the nine months was 29.8 percent (2004, rate excluding non-recurring items 25.9 percent). The increase over 2004 is due to a different geographical mix of profits and no relief in respect of the LosecTM fine. Taxation in 2004 also benefited from a one-off reduction in the deferred tax liability in relation to rolled over gains following agreements with the relevant tax authorities. For the full year, the rate is anticipated to be in the 29 to 30 percent range.
Cash Flow
Cash generated from operating activities was $4,814 million; $2,015 million higher than in the first nine months of 2004. This is as a result of a $1,590 million increase in operating profits and a net $590 million cash improvement in working capital, primarily due to lower inventory levels and higher creditor levels.
Cash outflows from investing activities of $621 million in the first nine months compare with $694 million outflows in the equivalent period in 2004. Capital expenditure fell by $247 million to $586 million. In the comparative period for 2004, $308 million disposal proceeds were received in respect of disposals of business operations.
Free cash flow (which represents net cash flows before financing activities, as adjusted for movements in short term deposits) for the period was $4,294 million. After accounting for net share repurchases of $2,106 million, the $1,717 million dividend payment to shareholders and foreign exchange effects, there is a $362 million increase in cash and cash equivalents.
Net funds at 30 September 2005 of $4,398 million were $433 million higher than 31 December 2004.
| Share Repurchase Programme |
During the third quarter, 21.3 million shares were repurchased for cancellation at a total cost of $1 billion bringing the total repurchase for the first nine months of the year to 49.8 million shares at a total cost of $2,182 million. For the full year share repurchases are expected to exceed $3 billion.
The total number of shares in issue at 30 September 2005 is 1,597 million.
| R&D Update |
Development of AZD2171, a Vascular Endothelial Growth Factor (VEGF) signalling inhibitor for the treatment of solid tumours, is being accelerated into a Phase II/III clinical programme.
In addition to the submission of a US NDA for SymbicortTM pMDI for the treatment of asthma, an EU mutual recognition variation procedure for a new asthma concept, SymbicortTM Maintenance and Reliever Therapy was initiated on 26 October.
A US regulatory submission to support the use of SeroquelTM in bipolar depression will be made around the end of 2005 based on the results of two successful pivotal studies (BOLDER I and II) in this indication.
Regulatory submissions for Cerovive™, a novel free-radical trapping neuroprotective agent for the acute treatment of ischaemic stroke, are now scheduled for H1 2007 subject to the outcome of the CHANT and SAINT II studies. The CHANT study evaluating Cerovive™ in patients with haemorrhagic stroke is now fully recruited and results will be available in Q1 2006.
7
AstraZeneca PLC
The development of the oral extended release formulation of AZD7009 for maintenance of sinus rhythm after conversion of atrial fibrillation has been terminated. The intravenous programme targeted at conversion of patients from atrial fibrillation to sinus rhythm remains in Phase II.
The Phase II project evaluating AZD7371 for the treatment of overactive bladder has also been terminated.
A complete update of the AstraZeneca development pipeline will be provided as a part of the 2005 Annual Results presentation.
| Calendar | ||
|
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|
|
| 2 February 2006 | Announcement of fourth quarter and full year 2005 results | |
| 27 April 2006 | Announcement of first quarter 2006 results | |
| 27 April 2006 | Annual General Meeting 2006 | |
| 27 July 2006 | Announcement of second quarter and half year 2006 results | |
| 26 October 2006 | Announcement of third quarter and nine months 2006 results | |
| Sir Tom McKillop | ||
| Chief Executive |
8
Item 6
Consolidated Income Statement
| For the nine months ended 30 September | 2005 $m |
As restated 2004 $m |
||||||
| Sales | 17,664 | 15,627 | ||||||
| Cost of sales | (3,968 | ) | (3,695 | ) | ||||
| Distribution costs | (155 | ) | (132 | ) | ||||
| Research and development | (2,506 | ) | (2,568 | ) | ||||
| Selling, general and administrative expenses | (6,292 | ) | (6,130 | ) | ||||
| Other operating income | 123 | 174 | ||||||
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| Operating profit | 4,866 | 3,276 | ||||||
| Profit on sale of interest in joint venture | - | 219 | ||||||
| Finance income | 484 | 396 | ||||||
| Finance expense | (372 | ) | (342 | ) | ||||
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| Profit before tax | 4,978 | 3,549 | ||||||
| Taxation | (1,481 | ) | (795 | ) | ||||
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| Profit for the period | 3,497 | 2,754 | ||||||
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| Attributable to: | ||||||||
| Equity holders of the Company | 3,482 | 2,741 | ||||||
| Minority interests | 15 | 13 | ||||||
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| 3,497 | 2,754 | |||||||
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|
||
| Basic earnings before non-recurring items per | $ | 2.14 | $ | 1.46 | ||||
| $0.25 Ordinary Share | ||||||||
| Basic earnings per $0.25 Ordinary Share | $ | 2.14 | $ | 1.63 | ||||
| Diluted earnings per $0.25 Ordinary Share | $ | 2.14 | $ | 1.63 | ||||
|
|
|
|
|
|
|
|
||
| Weighted average number of Ordinary Shares in issue (millions) | 1,626 | 1,679 | ||||||
| Diluted average number of Ordinary Shares in issue (millions) | 1,627 | 1,681 | ||||||
|
|
|
|
|
|
|
|
Non-recurring items in 2004 comprised profit on sale of interest in joint venture ($219 million) and non-recurring tax credits ($67 million).
9
Consolidated Income Statement
| For the quarter ended 30 September | 2005 $m |
As
restated 2004 $m |
||||||
| Sales | 5,789 | 5,265 | ||||||
| Cost of sales | (1,245 | ) | (1,286 | ) | ||||
| Distribution costs | (51 | ) | (46 | ) | ||||
| Research and development | (781 | ) | (823 | ) | ||||
| Selling, general and administrative expenses | (2,056 | ) | (1,965 | ) | ||||
| Other operating income | 39 | 27 | ||||||
|
|
|
|
|
|
|
|
||
| Operating profit | 1,695 | 1,172 | ||||||
| Profit on sale of interest in joint venture | - | 219 | ||||||
| Finance income | 168 | 124 | ||||||
| Finance expense | (120 | ) | (96 | ) | ||||
|
|
|
|
|
|
|
|
||
| Profit before tax | 1,743 | 1,419 | ||||||
| Taxation | (513 | ) | (280 | ) | ||||
|
|
|
|
|
|
|
|
||
| Profit for the period | 1,230 | 1,139 | ||||||
|
|
|
|
|
|
|
|
||
| Attributable to: | ||||||||
| Equity holders of the Company | 1,223 | 1,133 | ||||||
| Minority interests | 7 | 6 | ||||||
|
|
|
|
|
|
|
|
||
| 1,230 | 1,139 | |||||||
|
|
|
|
|
|
|
|
||
| Basic earnings before non-recurring items per | $ | 0.76 | $ | 0.51 | ||||
| $0.25 Ordinary Share | ||||||||
| Basic earnings per $0.25 Ordinary Share | $ | 0.76 | $ | 0.68 | ||||
| Diluted earnings per $0.25 Ordinary Share | $ | 0.76 | $ | 0.68 | ||||
|
|
|
|
|
|
|
|
||
| Weighted average number of Ordinary Shares in issue (millions) | 1,611 | 1,669 | ||||||
| Diluted average number of Ordinary Shares in issue (millions) | 1,613 | 1,671 | ||||||
|
|
|
|
|
|
|
|
Non-recurring items in 2004 comprised profit on sale of interest in joint venture ($219 million) and non-recurring tax credits ($67 million).
10
Consolidated Balance Sheet
| As at 30 September | 2005 $m |
As
restated 2004 $m |
||||
|
|
|
|
|
|
||
| ASSETS | ||||||
| Non-current assets | ||||||
| Property, plant and equipment | 7,262 | 7,628 | ||||
| Goodwill and intangible assets | 2,763 | 2,907 | ||||
| Other investments | 239 | 134 | ||||
| Deferred tax assets | 1,168 | 1,549 | ||||
|
|
|
|
|
|
||
| 11,432 | 12,218 | |||||
|
|
|
|
|
|
||
| Current assets | ||||||
| Inventories | 2,493 | 3,080 | ||||
| Trade and other receivables | 4,960 | 4,986 | ||||
| Short term investments | 1,242 | 3,167 | ||||
| Cash and cash equivalents | 4,400 | 1,020 | ||||
|
|
|
|
|
|
||
| 13,095 | 12,253 | |||||
|
|
|
|
|
|
||
| Total assets | 24,527 | 24,471 | ||||
|
|
|
|
|
|
||
| LIABILITIES | ||||||
| Current liabilities | ||||||
| Short term borrowings and overdrafts | (122 | ) | (170 | ) | ||
| Other creditors | (6,619 | ) | (6,590 | ) | ||
|
|
|
|
|
|
||
| (6,741 | ) | (6,760 | ) | |||
|
|
|
|
|
|
||
| Non-current liabilities | ||||||
| Loans | (1,122 | ) | (1,095 | ) | ||
| Deferred tax liabilities | (1,217 | ) | (1,371 | ) | ||
| Retirement benefit obligations | (1,678 | ) | (1,505 | ) | ||
| Provisions | (316 | ) | (263 | ) | ||
| Other liabilities | (84 | ) | (63 | ) | ||
|
|
|
|
|
|
||
| (4,417 | ) | (4,297 | ) | |||
|
|
|
|
|
|
||
| Total liabilities | (11,158 | ) | (11,057 | ) | ||
|
|
|
|
|
|
||
| Net assets | 13,369 | 13,414 | ||||
|
|
|
|
|
|
||
| EQUITY | ||||||
| Capital and reserves attributable to equity holders | ||||||
| Share capital | 399 | 415 | ||||
| Share premium account | 638 | 524 | ||||
| Other reserves | 1,866 | 1,949 | ||||
| Retained earnings | 10,372 | 10,444 | ||||
|
|
|
|
|
|
||
| 13,275 | 13,332 | |||||
| Minority equity interests | 94 | 82 | ||||
|
|
|
|
|
|
||
| Total equity and reserves | 13,369 | 13,414 | ||||
|
|
|
|
|
|
Consolidated Cash Flow Statement
| For the nine months ended 30 September | 2005 $m |
As
restated 2004 $m |
||||
|
|
|
|
|
|
||
| Cash flows from operating activities | ||||||
| Operating profit before taxation | 4,866 | 3,276 | ||||
| Depreciation and amortisation | 933 | 896 | ||||
| Decrease/(increase) in working capital | 72 | (518 | ) | |||
| Other non-cash movements | 175 | 177 | ||||
|
|
|
|
|
|
||
| Cash from operating activities | 6,046 | 3,831 | ||||
| Interest paid | (15 | ) | (21 | ) | ||
| Tax paid | (1,217 | ) | (1,011 | ) | ||
|
|
|
|
|
|
||
| Net cash inflow from operating activities | 4,814 | 2,799 | ||||
|
|
|
|
|
|
||
| Cash flows from investing activities | ||||||
| Disposal of business operations | - | 308 | ||||
| Movement in short term investments and fixed deposits | (101 | ) | (150 | ) | ||
| Purchases of property, plant and equipment | (586 | ) | (833 | ) | ||
| Disposals of property, plant and equipment | 77 | 17 | ||||
| Purchase of intangible assets | (137 | ) | (125 | ) | ||
| Purchase of fixed asset investments | (6 | ) | (7 | ) | ||
| Interest received | 137 | 96 | ||||
| Dividends paid by subsidiaries to minority interests | (5 | ) | (5 | ) | ||
| Dividends received | - | 5 | ||||
|
|
|
|
|
|
||
| Net cash outflow from investing activities | (621 | ) | (694 | ) | ||
|
|
|
|
|
|
||
| Net cash inflow before financing activities | 4,193 | 2,105 | ||||
|
|
|
|
|
|
||
| Cash flows from financing activities | ||||||
| Proceeds from issue of share capital | 76 | 75 | ||||
| Repurchase of shares | (2,182 | ) | (1,550 | ) | ||
| Increase in loans | - | 734 | ||||
| Dividends paid | (1,717 | ) | (1,378 | ) | ||
| Movement in short term borrowings | 8 | (1 | ) | |||
|
|
|
|
|
|
||
| Net cash outflow from financing activities | (3,815 | ) | (2,120 | ) | ||
|
|
|
|
|
|
||
| Net increase/(decrease) in cash and cash equivalents in the period | 378 | (15 | ) | |||
| Cash and cash equivalents at beginning of the period | 3,927 | 872 | ||||
| Exchange rate effects | (16 | ) | (5 | ) | ||
|
|
|
|
|
|
||
| Cash and cash equivalents at the end of the period | 4,289 | 852 | ||||
|
|
|
|
|
|
||
| Cash and cash equivalents consists of: | ||||||
| Cash and cash equivalents | 4,400 | 1,020 | ||||
| Overdrafts | (111 | ) | (168 | ) | ||
|
|
|
|
|
|
||
| 4,289 | 852 | |||||
|
|
|
|
|
|
12
Statement of Recognised Income and Expense
| For the nine months ended 30 September | 2005 $m |
As
restated 2004 $m |
||||
|
|
|
|
|
|
||
| Net profit for the period (excluding minority interests) | 3,482 | 2,741 | ||||
| Foreign exchange adjustments on consolidation | (854 | ) | 425 | |||
| Tax on foreign exchange adjustments | (49 | ) | 370 | |||
| Valuation gains taken to equity, net of tax | - | 1 | ||||
| Actuarial losses, net of tax | (22 | ) | (4 | ) | ||
|
|
|
|
|
|
||
| Recognised income and expense for the period | 2,557 | 3,533 | ||||
|
|
13
Notes to the Interim Financial Statements
1 BASIS OF PREPARATION AND ACCOUNTING POLICIES
The unaudited financial statements for the nine months ended 30 September 2005 have been prepared in accordance with International Accounting Standards and International Financial Reporting Standards (collectively “IFRS”) expected to be endorsed by the European Union (EU) and available for use by European companies at 31 December 2005. These IFRSs are subject to ongoing review and possible amendment or interpretive guidance and are therefore still subject to change. Details of the accounting policies applied are set out in the IFRS Restatement information in AstraZeneca PLC’s Annual Report and Form 20-F Information 2004, except that, in the period under review, the amendment to IAS 39 ‘Financial Instruments: Recognition and Measurement – The Fair Value Option’ has been adopted. As a result, the accounting for long term loans has been changed; such loans are now categorised as fair value through profit and loss with changes in value recognised in the income statement. Previously these loans had been recognised at cost except where hedge accounting had been applied. The comparative information has been restated accordingly. The effect of adoption on comparative results was not significant: net assets at 30 September 2004 were reduced by $21m. The policies assume that this amendment, together with the amendments to IAS 19 “Employee Benefits” published in December 2004 by the International Accounting Standards Board, allowing actuarial gains and losses to be recognised in full through reserves, will be endorsed by the EU.
The new information contained in Note 3 updates the disclosures concerning legal proceedings in the Company’s Annual Report and Form 20-F Information 2004 and Half Year Results 2005.
These interim financial statements do not constitute statutory accounts of the Group within the meaning of Section 240 of the Companies Act 1985. Statutory accounts for the year ended 31 December 2004, which were prepared under accounting practices generally accepted in the UK, 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.
2 NET FUNDSThe table below provides an analysis of net funds and a reconciliation of net cash flow to the movement in net funds.
| As restated 1 Jan 2005 $m |
Cash flow $m |
Other non-cash $m |
Exchange movements $m |
At 30 Sep 2005 $m |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
| Loans due after 1 year | (1,127 | ) | - | 5 | - | (1,122 | ) | ||||||||
| Current instalments of loans | - | - | - | - | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
| Total loans | (1,127 | ) | - | 5 | - | (1,122 | ) | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
| Short term investments | 1,167 | 101 | (24 | ) | (2 | ) | 1,242 | ||||||||
| Cash and cash equivalents | 4,067 | 351 | - | (18 | ) | 4,400 | |||||||||
| Overdrafts | (140 | ) | 27 | - | 2 | (111 | ) | ||||||||
| Short term borrowings | (2 | ) | (8 | ) | - | (1 | ) | (11 | ) | ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
| 5,092 | 471 | (24 | ) | (19 | ) | 5,520 | |||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
| Net funds | 3,965 | 471 | (19 | ) | (19 | ) | 4,398 | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|
Other non-cash movements in the period consist of fair value adjustments under IAS 39.
14
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation relating to employment matters, product liability, commercial disputes, infringement of intellectual property rights and the validity of certain patents. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company’s Annual Report and Form 20-F Information 2004 and Half Year Results 2005.
Diprivan™ (propofol)
In September 2005, AstraZeneca received
notification from Amphastar Pharmaceuticals, Inc. under section 505(b)(2) of
the US Food, Drug, and Cosmetic Act that it intends to manufacture and sell propofol
in the US prior to the expiration of certain of AstraZeneca’s propofol-related
patents. Amphastar contends that these patents would not be infringed by such
manufacture and sale.
AstraZeneca is evaluating Amphastar’s notification and continues to have full confidence in its intellectual property protecting Diprivan™.
Losec™ (omeprazole)
As previously disclosed, in June 2005
the European Commission notified AstraZeneca PLC and AstraZeneca AB of its Decision
to impose fines totaling €60m on the companies for infringements of European competition law
(Article 82 of the EC Treaty and Article 54 of the EEA Agreement). The fine was fully provided for in the half year results through a charge to operating profit of $75m. AstraZeneca does not accept the Commission’s Decision and has appealed
it to the Court of First Instance. AstraZeneca denies that it had a dominant position or that it engaged in the behaviours as characterised by the Commission. It is alleged by the Commission that these activities had the effect of hindering the
entry of the generic version of Losec™ and of parallel trade. It is possible
that third parties could seek damages for alleged losses arising from this. Any
such claims would be vigorously resisted.
Nexium™ (esomeprazole magnesium)
In October 2005, AstraZeneca received
a notice from Ranbaxy Pharmaceuticals Inc. that Ranbaxy Laboratories Limited
has submitted an Abbreviated New Drug Application to the US Food and Drug Administration
for esomeprazole magnesium delayed-release capsules, 20mg and 40mg, containing
paragraph IV certifications of invalidity and/or non-infringement with respect
to certain AstraZeneca US patents listed in the FDA’s Orange Book in reference to Nexium™,
the latter of which expires in 2018.
The 45 day time period within which AstraZeneca can commence a patent infringement lawsuit against Ranbaxy that would automatically stay, or bar, the FDA from approving Ranbaxy’s ANDA for 30 months (or until an adverse court decision, whichever occurs earlier) has not yet expired.
Ranbaxy has also certified with respect to certain other AstraZeneca US patents listed in the Orange Book in reference to Nexium™ that Ranbaxy will not launch its product prior to the expiry of those patents, the latter of which expires in October 2007.
AstraZeneca is evaluating Ranbaxy’s notice and continues to have full confidence in its intellectual property protecting Nexium™.
Pulmicort™ Respules™ (budesonide inhalation suspension)
In September 2005, AstraZeneca received
a notice from IVAX Pharmaceuticals, Inc. that IVAX has submitted an Abbreviated
New Drug Application to the US Food and Drug Administration for a budesonide
inhalation suspension containing a paragraph IV certification alleging invalidity
and non-infringement in respect of certain of AstraZeneca’s patents relating
to budesonide inhalation suspension.
In October 2005, AstraZeneca filed a patent infringement action against IVAX in the US District Court for the District of New Jersey.
Seroquel™ (quetiapine fumarate)
In September 2005, AstraZeneca received a notice from Teva Pharmaceuticals USA that Teva has
submitted an Abbreviated New Drug Application to the US Food and Drug Administration
for quetiapine fumarate tablets (25mg base) containing a paragraph IV certification
alleging invalidity and non-infringement in respect of AstraZeneca’s US patent number 4,879,288. AstraZeneca’s US patent number 4,879,288 is listed in the FDA’s Orange Book in reference to Seroquel™.
AstraZeneca is evaluating Teva’s notice and continues to have full confidence in its intellectual property protecting Seroquel™.
The 45 day time period within which AstraZeneca can commence a patent infringement lawsuit against Teva that would automatically stay, or bar, the FDA from approving Teva’s ANDA for 30 months (or until an adverse court decision, whichever occurs earlier) has not yet expired.
15
AstraZeneca has been served in the US with approximately 40 Seroquel™ cases in which plaintiffs have alleged that they developed diabetes, and in some cases pancreatitis, as a result of taking Seroquel™ or other atypical anti-psychotics made by other pharmaceutical companies. Eli Lilly, the maker of olanzapine, is a defendant in all but four of these cases and Janssen Pharmaceutica is a defendant in more than a dozen of the matters. The vast majority of these cases recently were filed in Missouri. All of the Missouri cases were filed a day or two before Missouri’s tort reform laws became effective. AstraZeneca has been informed that other cases involving Seroquel™ were filed in Missouri but have not yet been served. Only two of the pending Seroquel™ cases involving diabetes allegations have gone beyond the pleadings stage. AstraZeneca intends vigorously to defend the claims in these actions.
Toprol-XL™ (metoprolol succinate)
As disclosed in the Annual Report and
Form 20-F Information 2004, patent litigation is continuing in the US against
KV Pharmaceutical Company, Andrx Pharmaceuticals LLC and Eon Labs Manufacturing
Inc. relating to those companies’ notifications of their intentions to market generic versions of Toprol-XL™ tablets prior to the expiration of AstraZeneca’s relevant patents. All of the patent litigation has been consolidated for pre-trial discovery
purposes and motion practice in the US District Court for the Eastern District of Missouri. As previously disclosed, in January 2005 AstraZeneca filed a terminal disclaimer of the Toprol-XL™ patents-in-suit over one of the other patents raised
by the defendants, which will result in a revision of the expiration date of the Toprol-XL™ patents-in-suit from March 2008 to September 2007. Under the Abbreviated New Drug Application statute, the US Food and Drug Administration may not
approve Andrx’s product before June 2006 or Eon’s product before August 2006, unless there is an earlier adverse court decision. The 30 months’ stay in respect of KV’s
product has expired.
The trial in the proceedings is scheduled to commence in February 2006 and will likely consolidate the cases against KV, Andrx and Eon. Oral arguments on the pending summary judgement motions on the infringement and validity of the patents, those motions having been filed by the defendants in December 2004, are scheduled for November 2005.
In September 2005, AstraZeneca received a paragraph IV notification from KV of its intention to market metoprolol succinate tablets in the 25mg dose prior to the expiration of AstraZeneca’s patents. AstraZeneca has filed a patent infringement suit against KV in the US District Court for the Eastern District of Missouri.
AstraZeneca maintains that its patents are valid, enforceable and infringed by the KV, Andrx and Eon products.
Average wholesale price class action litigation
As disclosed in the Annual Report and Form 20-F Information 2004, AstraZeneca was named as a defendant along with 24 other pharmaceutical manufacturers in a class action suit, in Massachusetts, brought on behalf of a putative
class of plaintiffs alleged to have overpaid for prescription drugs as a result of inflated wholesale list prices. The suit seeks to recover unspecified damages. AstraZeneca was also named as a co-defendant with various other pharmaceutical
manufacturers in similar suits filed in nine other states. Most of these suits were consolidated with the Massachusetts action for pre-trial purposes, pursuant to federal multi-district litigation procedures.
In August 2005, the District Court in Boston issued a decision on class certification favourable to the defendants. The plaintiffs had sought to certify three nationwide classes of plaintiffs: (1) Medicare Part B beneficiaries who paid allegedly inflated co-payments for certain physician-administered (injectable) drugs reimbursed under the Medicare Part B programme; (2) third-party payers offering MediGap coverage for the same physician-administered drugs or otherwise reimbursed outside Medicare for the drugs; and (3) payers for certain non-Part B (self-administered) drugs.
The court denied the self-administered drug class entirely. As to the two proposed classes involving physician-administered drugs, the court conditionally certified a nationwide class of Part B beneficiaries, provided that the plaintiffs can amend the complaint to include as class representatives individual Part B beneficiaries who actually paid Medicare co-payments for the named drugs. The second proposed physician-administered drug class, third-party payers who reimbursed for physician-administered drugs or covered Part B co-payments, was certified only as a Massachusetts state, as opposed to a nationwide, class. In both classes, the only AstraZeneca drug at issue is Zoladex™ (goserelin acetate implant).
Drug importation anti-trust litigation
As disclosed in the Annual Report and
Form 20-F Information 2004 and Half Year Results 2005, AstraZeneca Pharmaceuticals
LP and eight other pharmaceutical manufacturers have been defending a purported
class action filed in the US District Court for Minnesota which alleged that
the defendants conspired to prevent American consumers from purchasing prescription
drugs from Canada, “depriving consumers of the ability to purchase” drugs at competitive prices.
Earlier in 2005, the chief magistrate judge assigned to the case issued a report on the defendants’ motion to dismiss the case, making certain recommendations to the presiding district court judge. The report recommended dismissal of the
plaintiffs’ federal anti-trust claims, but not dismissal of the state statutory and common law claims. In August 2005, the district court dismissed with prejudice the plaintiffs’ federal anti-trust claims. As to the state statutory and
common law claims, the district court declined to exercise supplemental jurisdiction and dismissed them without prejudice. The plaintiffs have appealed the district court’s
decision. In the similar California state court proceedings, the trial is scheduled
to commence in July 2006.
Avorelin
In 1999, AstraZeneca UK Limited entered into a licence agreement with Mediolanum farmaceutici S.p.A. under which Mediolanum licensed to AstraZeneca certain rights in respect of avorelin, a luteinising hormone-releasing hormone agonist. At the end of 2000, AstraZeneca terminated the agreement. Mediolanum has commenced proceedings against AstraZeneca alleging that AstraZeneca breached the terms of the agreement and claiming
16
damages. AstraZeneca denies any breach of the agreement and is vigorously defending the proceedings. The trial in the proceedings is scheduled to commence in the English courts in February 2006.
General
With respect to each of the legal proceedings described above, we are unable to make estimates of the loss or range of losses at this stage, other than where noted in the case of the European Commission fine. We also do not
believe that disclosure of the amount sought by plaintiffs, if that is known, would be meaningful with respect to those legal proceedings.
Arrangements with Merck
As described in more detail in the
Annual Report and Form 20-F Information 2004, AstraZeneca has significant arrangements
with Merck & Co., Inc. relating to certain of our products and development
compounds (the agreement products). These arrangements include exit provisions
from 2008 onwards and we regularly monitor the value of the benefits we expect
to receive.
The exit provisions are subject to a minimum overall net payment of $3.3 billion and will offer AstraZeneca unencumbered discretion in its operations in the US market (except in respect of Prilosec™ and Nexium™) without the restrictions of various contractual obligations that are currently imposed as a result of Merck’s interests, together with relief from contingent payment obligations. The projected value of the benefits obtained in 2008 depends on a number of factors including the future contributions from products that have already been launched, those that are due to be launched in the US and those that are in development together with the further value AstraZeneca can extract from greater freedom to operate in the US.
17
4 NINE MONTHS TERRITORIAL SALES ANALYSIS
| % Growth | ||||||||
| 9 Months 2005 $m |
9 Months 2004 $m |
Actual | Constant Currency |
|||||
|
|
|
|
|
|
||||
| US | 7,864 | 6,974 | 13 | 13 | ||||
| Canada | 719 | 651 | 10 | 1 | ||||
|
|
|
|
|
|
||||
| North America | 8,583 | 7,625 | 13 | 12 | ||||
|
|
|
|
|
|
||||
| France | 1,265 | 1,208 | 5 | 1 | ||||
| UK | 561 | 432 | 30 | 26 | ||||
| Germany | 917 | 717 | 28 | 23 | ||||
| Italy | 878 | 809 | 9 | 4 | ||||
| Sweden | 232 | 222 | 5 | 1 | ||||
| Europe others | 2,521 | 2,273 | 11 | 6 | ||||
|
|
|
|
|
|
||||
| Total Europe | 6,374 | 5,661 | 13 | 8 | ||||
|
|
|
|
|
|
||||
| Japan | 1,103 | 1,018 | 8 | 8 | ||||
| Rest of World | 1,604 | 1,323 | 21 | 18 | ||||
|
|
|
|
|
|
||||
| Total | 17,664 | 15,627 | 13 | 10 | ||||
|
|
|
|
|
|
||||
5 THIRD QUARTER TERRITORIAL SALES ANALYSIS
| % Growth | ||||||||
| 3rd
Quarter 2005 $m |
3rd
Quarter 2004 $m |
Actual | Constant Currency |
|||||
|
|
|
|
|
|
||||
| US | 2,621 | 2,407 | 9 | 9 | ||||
| Canada | 231 | 202 | 14 | 2 | ||||
|
|
|
|
|
|
||||
| North America | 2,852 | 2,609 | 9 | 8 | ||||
|
|
|
|
|
|
||||
| France | 391 | 361 | 8 | 8 | ||||
| UK | 181 | 151 | 20 | 22 | ||||
| Germany | 296 | 250 | 18 | 18 | ||||
| Italy | 269 | 266 | 1 | 1 | ||||
| Sweden | 70 | 69 | 1 | 4 | ||||
| Europe others | 805 | 761 | 6 | 5 | ||||
|
|
|
|
|
|
||||
| Total Europe | 2,012 | 1,858 | 8 | 8 | ||||
|
|
|
|
|
|
||||
| Japan | 367 | 352 | 4 | 6 | ||||
| Rest of World | 558 | 446 | 25 | 18 | ||||
|
|
|
|
|
|
||||
| Total | 5,789 | 5,265 | 10 | 9 | ||||
|
|
|
|
|
|
||||
18
6 NINE MONTHS PRODUCT SALES ANALYSIS
| World | US | |||||||||||||||
| 9 Months 2005 $m |
9 Months 2004 $m |
Actual Growth % |
Constant Currency Growth % |
9 Months 2005 $m |
Actual Growth % |
|||||||||||
| Gastrointestinal: | ||||||||||||||||
| Losec | 1,241 | 1,501 | (17 | ) | (20 | ) | 191 | (33 | ) | |||||||
| Nexium | 3,386 | 2,777 | 22 | 20 | 2,276 | 18 | ||||||||||
| Others | 51 | 64 | (20 | ) | (23 | ) | 8 | (64 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Total Gastrointestinal | 4,678 | 4,342 | 8 | 6 | 2,475 | 10 | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Cardiovascular: | ||||||||||||||||
| Zestril | 248 | 327 | (24 | ) | (27 | ) | (4 | ) | (108 | ) | ||||||
| Seloken/Toprol-XL | 1,280 | 1,006 | 27 | 26 | 945 | 33 | ||||||||||
| Atacand | 727 | 639 | 14 | 10 | 179 | (5 | ) | |||||||||
| Plendil | 287 | 361 | (20 | ) | (22 | ) | 78 | (44 | ) | |||||||
| Tenormin | 262 | 271 | (3 | ) | (6 | ) | 17 | (35 | ) | |||||||
| Crestor | 915 | 596 | 54 | 51 | 527 | 52 | ||||||||||
| Others | 235 | 256 | (8 | ) | (12 | ) | 3 | (75 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Total Cardiovascular | 3,954 | 3,456 | 14 | 11 | 1,745 | 19 | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Respiratory: | ||||||||||||||||
| Pulmicort | 824 | 737 | 12 | 10 | 470 | 21 | ||||||||||
| Rhinocort | 295 | 268 | 10 | 9 | 214 | 11 | ||||||||||
| Symbicort | 742 | 578 | 28 | 22 | - | - | ||||||||||
| Accolate | 55 | 84 | (35 | ) | (36 | ) | 35 | (42 | ) | |||||||
| Oxis | 69 | 76 | (9 | ) | (14 | ) | - | - | ||||||||
| Others | 115 | 118 | (3 | ) | (7 | ) | - | - | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Total Respiratory | 2,100 | 1,861 | 13 | 10 | 719 | 12 | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Oncology: | ||||||||||||||||
| Zoladex | 752 | 675 | 11 | 7 | 94 | (20 | ) | |||||||||
| Casodex | 840 | 736 | 14 | 11 | 179 | 6 | ||||||||||
| Nolvadex | 86 | 99 | (13 | ) | (15 | ) | 3 | 50 | ||||||||
| Arimidex | 856 | 578 | 48 | 45 | 345 | 59 | ||||||||||
| Iressa | 201 | 309 | (35 | ) | (36 | ) | 49 | (69 | ) | |||||||
| Faslodex | 101 | 73 | 38 | 35 | 67 | 8 | ||||||||||
| Others | 8 | 11 | (27 | ) | (36 | ) | - | - | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Total Oncology | 2,844 | 2,481 | 15 | 12 | 737 | 1 | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Neuroscience: | ||||||||||||||||
| Seroquel | 2,006 | 1,465 | 37 | 35 | 1,450 | 33 | ||||||||||
| Zomig | 258 | 267 | (3 | ) | (6 | ) | 82 | (27 | ) | |||||||
| Diprivan | 281 | 374 | (25 | ) | (27 | ) | 112 | (44 | ) | |||||||
| Local anaesthetics | 380 | 398 | (5 | ) | (8 | ) | 48 | (49 | ) | |||||||
| Others | 50 | 54 | (7 | ) | (11 | ) | 13 | (13 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total Neuroscience | 2,975 | 2,558 | 16 | 14 | 1,705 | 13 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Infection and Other: | ||||||||||||||||
| Merrem | 375 | 310 | 21 | 16 | 61 | 13 | ||||||||||
| Other Products | 262 | 207 | 27 | 26 | 154 | 71 | ||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Total Infection and Other | 637 | 517 | 23 | 20 | 215 | 49 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Aptium Oncology | 247 | 226 | 9 | 9 | 247 | 9 | ||||||||||
| Astra Tech | 229 | 186 | 23 | 19 | 21 | 62 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total | 17,664 | 15,627 | 13 | 10 | 7,864 | 13 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
19
7 THIRD QUARTER PRODUCT SALES ANALYSIS
| World | US | |||||||||||||||
| 3rd Quarter 2005 $m |
3rd Quarter 2004 $m |
Actual Growth % |
Constant Currency Growth % |
3rd Quarter 2005 $m |
Actual Growth % |
|||||||||||
| Gastrointestinal: | ||||||||||||||||
| Losec | 376 | 430 | (13 | ) | (15 | ) | 59 | (25 | ) | |||||||
| Nexium | 1,127 | 951 | 19 | 18 | 762 | 17 | ||||||||||
| Others | 15 | 26 | (42 | ) | (46 | ) | 2 | (82 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total Gastrointestinal | 1,518 | 1,407 | 8 | 7 | 823 | 11 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Cardiovascular: | ||||||||||||||||
| Zestril | 83 | 105 | (21 | ) | (22 | ) | 1 | (94 | ) | |||||||
| Seloken/Toprol-XL | 437 | 353 | 24 | 23 | 334 | 31 | ||||||||||
| Atacand | 238 | 214 | 11 | 9 | 57 | (11 | ) | |||||||||
| Plendil | 82 | 102 | (20 | ) | (22 | ) | 16 | (53 | ) | |||||||
| Tenormin | 87 | 93 | (6 | ) | (7 | ) | 7 | (36 | ) | |||||||
| Crestor | 325 | 260 | 25 | 23 | 189 | 17 | ||||||||||
| Others | 75 | 81 | (7 | ) | (8 | ) | 1 | (67 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total Cardiovascular | 1,327 | 1,208 | 10 | 9 | 605 | 11 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Respiratory: | ||||||||||||||||
| Pulmicort | 234 | 211 | 11 | 10 | 134 | 24 | ||||||||||
| Rhinocort | 91 | 87 | 5 | 4 | 66 | 2 | ||||||||||
| Symbicort | 240 | 185 | 30 | 28 | - | - | ||||||||||
| Accolate | 14 | 31 | (55 | ) | (55 | ) | 8 | (67 | ) | |||||||
| Oxis | 23 | 25 | (8 | ) | (12 | ) | - | - | ||||||||
| Others | 34 | 35 | (3 | ) | (3 | ) | - | - | ||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||
| Total Respiratory | 636 | 574 | 11 | 10 | 208 | 6 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Oncology: | ||||||||||||||||
| Zoladex | 258 | 236 | 9 | 7 | 33 | 27 | ||||||||||
| Casodex | 276 | 258 | 7 | 7 | 61 | (2 | ) | |||||||||
| Nolvadex | 26 | 30 | (13 | ) | (13 | ) | - | (100 | ) | |||||||
| Arimidex | 303 | 221 | 37 | 36 | 122 | 40 | ||||||||||
| Iressa | 61 | 113 | (46 | ) | (46 | ) | 12 | (80 | ) | |||||||
| Faslodex | 37 | 24 | 54 | 50 | 23 | 21 | ||||||||||
| Others | 2 | 3 | (33 | ) | (66 | ) | - | - | ||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total Oncology | 963 | 885 | 9 | 8 | 251 | - | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Neuroscience: | ||||||||||||||||
| Seroquel | 706 | 529 | 33 | 32 | 517 | 30 | ||||||||||
| Zomig | 86 | 81 | 6 | 5 | 27 | (7 | ) | |||||||||
| Diprivan | 76 | 126 | (40 | ) | (41 | ) | 26 | (64 | ) | |||||||
| Local anaesthetics | 118 | 128 | (8 | ) | (10 | ) | 17 | (50 | ) | |||||||
| Others | 15 | 16 | (6 | ) | (6 | ) | 3 | (40 | ) | |||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total Neuroscience | 1,001 | 880 | 14 | 13 | 590 | 9 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Infection and Other: | ||||||||||||||||
| Merrem | 117 | 101 | 16 | 13 | 13 | (28 | ) | |||||||||
| Other Products | 73 | 71 | 3 | 10 | 42 | 35 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total Infection and Other | 190 | 172 | 10 | 11 | 55 | 12 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Aptium Oncology | 82 | 78 | 5 | 5 | 82 | 5 | ||||||||||
| Astra Tech | 72 | 61 | 18 | 18 | 7 | 40 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
| Total | 5,789 | 5,265 | 10 | 9 | 2,621 | 9 | ||||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
20
Shareholder Information
| ANNOUNCEMENTS AND MEETINGS | |
| Announcement of fourth quarter and full year 2005 results | 2 February 2006 |
| Announcement of first quarter 2006 results | 27 April 2006 |
| Annual General Meeting 2006 | 27 April 2006 |
| Announcement of second quarter and half year 2006 results | 27 July 2006 |
| Announcement of third quarter and nine months 2006 results | 26 October 2006 |
| DIVIDENDS |
The record date for the first interim dividend paid on 19 September 2005 was 12 August 2005. Ordinary Shares traded ex-dividend on the London and Stockholm Stock Exchanges from 10 August 2005. ADRs traded ex-dividend on the New York Stock Exchange from the same date.
The record date for the second interim dividend for 2005 payable on 20 March 2006 (in the UK, Sweden and the US) will be 10 February 2006. Ordinary Shares will trade ex-dividend on the London and Stockholm Stock Exchanges from 8 February 2006. 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 September | |
| Second interim | Announced in January/February and paid in March |
| TRADEMARKS |
The following brand names used in this interim report are trademarks of the AstraZeneca group of companies:
Accolate Arimidex Astra Tech Atacand Casodex Cerovive Crestor Diprivan Exanta Faslodex Galida Iressa Losec Merrem Nexium Nolvadex Oxis Plendil Prilosec Pulmicort Pulmicort Respules Rhinocort Rhinocort Aqua Seloken Seroquel Symbicort Tenormin Toprol-XL Zactima Zestril Zoladex Zomig
| ADDRESSES FOR CORRESPONDENCE |
| Registrar and | Depositary | Registered Office | Swedish Securities | |||
| Transfer Office | for ADRs | Registration Centre | ||||
| The AstraZeneca Registrar | JPMorgan Chase Bank | 15 Stanhope Gate | VPC AB | |||
| Lloyds TSB Registrars | PO Box 43013 | London | PO Box 7822 | |||
| The Causeway | Providence | W1K 1LN | SE-103 97 Stockholm | |||
| Worthing | RI 02940-3013 | UK | Sweden | |||
| West Sussex | US | |||||
| BN99 6DA | ||||||
| UK | Tel (toll free in US): | Tel: +44 (0)20 7304 5000 | Tel: +46 (0)8 402 9000 | |||
| Tel (freephone in UK): | 888 697 8018 | |||||
| 0800 389 1580 | Tel (outside US): | |||||
| Tel (outside UK): | +1(781) 575 4328 | |||||
| +44 (0)121 415 7033 |
| CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS |
In order to utilise the ‘Safe Harbor’ provisions of the United States Private Securities Litigation Reform Act of 1995, AstraZeneca is providing the following cautionary statement. These interim financial statements contain forward-looking statements with respect to the financial condition, results of operations and businesses of AstraZeneca. By their nature, forward-looking statements and forecasts involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially from that expressed or implied by these forward-looking statements. These factors include, among other things, the loss or expiration of patents, marketing exclusivity or trade marks; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of delay to new product launches; the difficulties of obtaining and maintaining governmental approvals for products; and the risk of environmental liabilities.
21
Companies Act 1985 Section 198
Disclosure of Interest in Voting Shares in Public Companies
On 28 October 2005, we were informed by The Capital Group Companies, Inc., a registered investment manager in the US, that on 26 October 2005 its interest in the USD0.25 Ordinary Shares of AstraZeneca PLC had decreased to 191,083,356 shares (11.96 per cent of the current issued ordinary capital) from the previously notified level of 211,948,875 shares (12.94 per cent).
G H R Musker
Company Secretary
28 October 2005
REPURCHASE OF SHARES IN ASTRAZENECA PLC
AstraZeneca PLC announced that on 28 October 2005, it purchased for cancellation 2,000,000 ordinary shares of AstraZeneca PLC at a price of 2478 pence per share. Upon the cancellation of these shares, the number of shares in issue will be 1,595,440,917.
G H R Musker
Company Secretary
31 October 2005
FDA GRANTS ZD6474 (ZACTIMATM) ORPHAN DRUG DESIGNATION
FOR THE INVESTIGATION OF RARE FORMS OF THYROID CANCER
AstraZeneca announced today that the US Food and Drug Administration (FDA) has granted ZD6474 (ZACTIMA™) Orphan Drug designation for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer. ZD6474 is a unique once-daily oral therapy that selectively targets key cell signalling pathways involved in tumour growth and spread including VEGF (Vascular endothelial growth factor) receptor signalling and EGF (Epidermal growth factor) receptor signalling. ZD6474 also inhibits RET kinase, which drives the growth and survival of certain tumours, and is believed to be an important pathway in medullary thyroid cancer.
ZD6474 is currently being developed in a Phase II clinical trial in medullary thyroid cancer and Phase III clinical trials in advanced non-small cell lung cancer are scheduled to start in the next few months.
Advanced hereditary medullary thyroid cancer, a rare malignancy, has a poor prognosis and there are currently very limited therapeutic options available. Medullary thyroid cancer is a specific form of thyroid cancer that comprises 2-3 per cent of the 25,000 new cases of the disease in the US each year. Neither standard chemotherapeutic regimens, nor radiation therapy, provide substantial benefits in patients with advanced hereditary medullary thyroid carcinoma.
Orphan-drug designation was designed to promote the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions, specifically, those that affect less than 200,000 people in the US.
ZD6474 is the first oncology orphan-drug designation AstraZeneca has received. AstraZeneca has also applied for Orphan Drug designation for ZD6474 in medullary thyroid cancer in Europe.
For more information about AstraZeneca, please visit: www.astrazeneca.com
31st October 2005
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel + 1 212 579 0506