3rd Quarter Results - Part 2 of 2

RNS Number : 9361Q

AstraZeneca PLC

27 October 2011

 



Condensed Consolidated Statement of Comprehensive Income        

For the nine months ended 30 September		2011 $m		2010 $m
Revenue		24,935		24,652
Cost of sales		(4,414)		(4,630)
Gross profit		20,521		20,022
Distribution costs		(261)		(248)
Research and development		(3,656)		(3,388)
Selling, general and administrative costs		(8,020)		(7,923)
Other operating income and expense		2,044		620
Operating profit		10,628		9,083
Finance income		426		376
Finance expense		(739)		(765)
Profit before tax		10,315		8,694
Taxation		(1,792)		(2,245)
Profit for the period		8,523		6,449
Other comprehensive income:
Foreign exchange arising on consolidation		21		13
Foreign exchange differences on borrowings forming net investment hedges		(25)		63
Amortisation of loss on cash flow hedge		2		1
Net available for sale losses taken to equity		(5)		-
Actuarial loss for the period		(53)		(384)
Income tax relating to components of other comprehensive income		4		84
Other comprehensive income for the period, net of tax		(56)		(223)
Total comprehensive income for the period		8,467		6,226
Profit attributable to:
Owners of the parent		8,497		6,432
Non-controlling interests		26		17
		8,523		6,449
Total comprehensive income attributable to:
Owners of the parent		8,429		6,193
Non-controlling interests		38		33
		8,467		6,226
Basic earnings per $0.25 Ordinary Share		$6.17		$4.45
Diluted earnings per $0.25 Ordinary Share		$6.14		$4.43
Weighted average number of Ordinary Shares in issue (millions)		1,377		1,445
Diluted weighted average number of Ordinary Shares in issue (millions)		1,383		1,452

Condensed Consolidated Statement of Comprehensive Income        

For the quarter ended 30 September		2011 $m		2010 $m
Revenue		8,213		7,898
Cost of sales		(1,593)		(1,524)
Gross profit		6,620		6,374
Distribution costs		(93)		(82)
Research and development		(1,296)		(1,077)
Selling, general and administrative costs		(2,644)		(3,011)
Other operating income and expense		1,675		202
Operating profit		4,262		2,406
Finance income		153		123
Finance expense		(246)		(271)
Profit before tax		4,169		2,258
Taxation		(684)		(704)
Profit for the period		3,485		1,554
Other comprehensive income:
Foreign exchange arising on consolidation		(225)		391
Foreign exchange differences on borrowings forming net investment hedges		88		(133)
Amortisation of loss on cash flow hedge		1		-
Net available for sale (losses)/gains taken to equity		(23)		5
Actuarial loss for the period		(209)		(56)
Income tax relating to components of other comprehensive income		10		67
Other comprehensive income for the period, net of tax		(358)		274
Total comprehensive income for the period		3,127		1,828
Profit attributable to:
Owners of the parent		3,477		1,548
Non-controlling interests		8		6
		3,485		1,554
Total comprehensive income attributable to:
Owners of the parent		3,111		1,812
Non-controlling interests		16		16
		3,127		1,828
Basic earnings per $0.25 Ordinary Share		$2.56		$1.08
Diluted earnings per $0.25 Ordinary Share		$2.54		$1.07
Weighted average number of Ordinary Shares in issue (millions)		1,354		1,437
Diluted weighted average number of Ordinary Shares in issue (millions)		1,359		1,446

Condensed Consolidated Statement of Financial Position

		At 30 Sep 2011 $m		At 31 Dec 2010 $m		At 30 Sep 2010 $m
ASSETS Non-current assets
Property, plant and equipment		6,526		6,957		7,096
Goodwill		9,874		9,871		9,878
Intangible assets		11,661		12,158		12,945
Derivative financial instruments		355		324		420
Other investments		207		211		205
Deferred tax assets		1,486		1,475		1,277
		30,109		30,996		31,821
Current assets
Inventories		1,955		1,682		1,810
Trade and other receivables		8,308		7,847		7,735
Other investments		924		1,482		1,517
Derivative financial instruments		29		9		49
Income tax receivable		1,391		3,043		3,448
Cash and cash equivalents		9,860		11,068		10,010
		22,467		25,131		24,569
Total assets		52,576		56,127		56,390
LIABILITIES Current liabilities
Interest-bearing loans and borrowings		(2,055)		(125)		(1,376)
Trade and other payables		(8,028)		(8,661)		(7,796)
Derivative financial instruments		-		(8)		(82)
Provisions		(1,083)		(1,095)		(884)
Income tax payable		(3,491)		(6,898)		(6,714)
		(14,657)		(16,787)		(16,852)
Non-current liabilities
Interest-bearing loans and borrowings		(7,394)		(9,097)		(9,231)
Deferred tax liabilities		(2,923)		(3,145)		(3,158)
Retirement benefit obligations		(2,388)		(2,472)		(3,739)
Provisions		(555)		(843)		(799)
Other payables		(505)		(373)		(299)
		(13,765)		(15,930)		(17,226)
Total liabilities		(28,422)		(32,717)		(34,078)
Net assets		24,154		23,410		22,312
EQUITY
Capital and reserves attributable to equity holders of the Company
Share capital		332		352		356
Share premium account		3,048		2,672		2,623
Other reserves		1,937		1,917		1,913
Retained earnings		18,614		18,272		17,233
		23,931		23,213		22,125
Non-controlling interests		223		197		187
Total equity		24,154		23,410		22,312

Condensed Consolidated Statement of Cash Flows

For the nine months ended 30 September		2011 $m		Restated 2010 $m
Cash flows from operating activities
Profit before taxation		10,315		8,694
Finance income and expense		313		389
Depreciation, amortisation and impairment		1,580		1,434
Increase in working capital and short-term provisions		(1,528)		(1,016)
Other non-cash movements1		(1,806)		249
Cash generated from operations		8,874		9,750
Interest paid		(467)		(515)
Tax paid		(3,655)		(2,115)
Net cash inflow from operating activities		4,752		7,120
Cash flows from investing activities
Movement in short-term investments and fixed deposits2		542		(80)
Purchase of property, plant and equipment		(593)		(473)
Disposal of property, plant and equipment		56		67
Purchase of intangible assets		(326)		(1,241)
Disposal of intangible assets		-		210
Purchase of non-current asset investments		(8)		(27)
Disposal of non-current asset investments		-		2
Acquisitions of business operations		-		(348)
Net cash received on disposal of subsidiaries		1,772		-
Interest received		131		126
Payments made by subsidiaries to non-controlling interests		(16)		(10)
Net cash inflow/(outflow) from investing activities		1,558		(1,774)
Net cash inflow before financing activities		6,310		5,346
Cash flows from financing activities
Proceeds from issue of share capital		378		445
Repurchase of shares for cancellation		(4,256)		(1,742)
Repayment of loans		-		(717)
Dividends paid		(3,764)		(3,361)
Movement in derivative financial instruments2		3		(114)
Movement in short-term borrowings		(1)		(25)
Net cash outflow from financing activities		(7,640)		(5,514)
Net decrease in cash and cash equivalents in the period		(1,330)		(168)
Cash and cash equivalents at the beginning of the period		10,981		9,828
Exchange rate effects		(30)		16
Cash and cash equivalents at the end of the period		9,621		9,676
Cash and cash equivalents consists of:
Cash and cash equivalents		9,860		10,010
Overdrafts		(239)		(334)
		9,621		9,676

¹ Included in other non-cash movements is the profit on disposal of Astra Tech (see Note 4).

² 2010 restated to reclassify $114m movement in derivative financial instruments associated with financing activities.

Condensed Consolidated Statement of Changes in Equity

		Share capital $m		Share premium account $m		Other* reserves $m		Retained earnings $m		Total $m		Non- controlling interests $m		Total equity $m
At 1 January 2010		363		2,180		1,919		16,198		20,660		161		20,821
Profit for the period		-		-		-		6,432		6,432		17		6,449
Other comprehensive income		-		-		-		(239)		(239)		16		(223)
Transfer to other reserve		-		-		(15)		15		-		-		-
Transactions with owners:
Dividends		-		-		-		(3,494)		(3,494)		-		(3,494)
Issue of AstraZeneca PLC Ordinary shares		2		443		-		-		445		-		445
Repurchase of AstraZeneca PLC Ordinary shares		(9)		-		9		(1,742)		(1,742)		-		(1,742)
Share-based payments		-		-		-		63		63		-		63
Transfer from non-controlling interests to payables		-		-		-		-		-		(6)		(6)
Dividend paid to non-controlling interest		-		-		-		-		-		(1)		(1)
Net movement		(7)		443		(6)		1,035		1,465		26		1,491
At 30 September 2010		356		2,623		1,913		17,233		22,125		187		22,312
		Share capital $m		Share premium account $m		Other* reserves $m		Retained earnings $m		Total $m		Non- controlling interests $m		Total equity $m
At 1 January 2011		352		2,672		1,917		18,272		23,213		197		23,410
Profit for the period		-		-		-		8,497		8,497		26		8,523
Other comprehensive income		-		-		-		(68)		(68)		12		(56)
Transfer to other reserve		-		-		(2)		2		-		-		-
Transactions with owners:
Dividends		-		-		-		(3,752)		(3,752)		-		(3,752)
Issue of AstraZeneca PLC Ordinary shares		2		376		-		-		378		-		378
Repurchase of AstraZeneca PLC Ordinary shares		(22)		-		22		(4,256)		(4,256)		-		(4,256)
Share-based payments		-		-		-		(81)		(81)		-		(81)
Transfer from non-controlling interests to payables		-		-		-		-		-		(8)		(8)
Dividend paid to non-controlling interests		-		-		-		-		-		(4)		(4)
Net movement		(20)		376		20		342		718		26		744
At 30 September 2011		332		3,048		1,937		18,614		23,931		223		24,154

* Other reserves includes the capital redemption reserve and the merger reserve.

Notes to the Interim Financial Statements

1      BASIS OF PREPARATION AND ACCOUNTING POLICIES

These condensed consolidated interim financial statements ("interim financial statements") for the nine months ended 30 September 2011 have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union.  The annual financial statements of the Group are prepared in accordance with International Financial Reporting Standards (IFRSs) as adopted by the European Union and as issued by the International Accounting Standards Board. As required by the Disclosure and Transparency Rules of the Financial Services Authority, the interim financial statements have been prepared applying the accounting policies and presentation that were applied in the preparation of the Company's published consolidated financial statements for the year ended 31 December 2010, except where new or revised accounting standards have been applied. There has been no significant impact on the Group profit or net assets on adoption of new or revised accounting standards in the period.

The Group has considerable financial resources available.  The Group's revenues are largely derived from sales of products which are covered by patents and for which, historically at least, demand has been relatively unaffected by changes in the general economy.  As a consequence, the Directors believe that the Group is well placed to manage its business risks successfully and as such, the interim financial statements have been prepared on a Going Concern basis.

The information contained in Note 5 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2010.

The comparative figures for the financial year ended 31 December 2010 are not the Company's statutory accounts for that financial year. Those accounts have been reported on by the Company's auditors and delivered to the registrar of companies. The report of the auditors was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498(2) or (3) of the Companies Act 2006.

2      Net FUNDS

The table below provides an analysis of net funds and a reconciliation of net cash flow to the movement in net funds.

		At 1 Jan  2011  $m		Cash  flow  $m		Non-cash  mvmts  $m		Exchange  mvmts  $m		At 30 Sep  2011  $m
Loans due after one year		(9,097)		-		1,729		(26)		(7,394)
Current instalments of loan		-		-		(1,777)		-		(1,777)
Total loans		(9,097)		-		(48)		(26)		(9,171)
Other investments - current		1,482		(542)		(16)		-		924
Net derivative financial instruments		325		(3)		62		-		384
Cash and cash equivalents		11,068		(1,179)		-		(29)		9,860
Overdrafts		(87)		(151)		-		(1)		(239)
Short-term borrowings		(38)		1		-		(2)		(39)
		12,750		(1,874)		46		(32)		10,890
Net funds		3,653		(1,874)		(2)		(58)		1,719

Non-cash movements in the period include fair value adjustments under IAS 39.

3      restructuring costs

Profit before tax for the nine months ended 30 September 2011 is stated after charging restructuring costs of $502 million ($777 million in the first nine months of 2010).  These have been charged to profit as follows:

		3rd Quarter 2011 $m		3rd Quarter 2010 $m		9 Months 2011 $m		9 Months 2010 $m
Cost of sales		(14)		19		18		110
Research and development		124		91		293		463
Selling, general and administrative costs		111		102		191		204
Total		221		212		502		777

 

4      DISPOSAL OF ASTRA TECH

In August 2011, the Group announced the sale of the Astra Tech business to Dentsply International for approximately $1.8 billion in cash. At 30 September 2011, the Group has reported a profit on disposal of $1,483 million and a total cash inflow of $1,772 million as a result of this transaction.

			$m
Consideration			1,795
Net assets			(279)
Fees and other disposal costs			(59)
Exchange recycled on disposal			26
Profit on disposal			1,483

			$m
Consideration			1,795
Cash held in Astra Tech on disposal			(23)
Cash inflow on disposal			1,772

 

5      LEGAL PROCEEDINGS AND CONTINGENT LIABILITIES

AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2010 and Interim Management Statement 2011 as part of the Company's Half-Yearly Financial Report for the six-month period to 30 June 2011. Unless noted otherwise below or in the Annual Report and Form 20-F Information 2010 and Interim Management Statement 2011 as part of the Company's Half-Yearly Financial Report for the six-month period to 30 June 2011, no provisions have been established in respect of the claims discussed below.

As discussed in the Company's Annual Report and Form 20-F Information 2010, for the majority of claims in which AstraZeneca is involved it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision is made.

In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we record the loss absorbed or make a provision for our best estimate of the expected loss.

The position could change over time and the estimates that we have made and upon which we have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Annual Report and Form 20-F Information 2010 and herein.

AstraZeneca has full confidence in, and will vigorously defend and enforce its intellectual property.

Matters disclosed in respect of the third quarter of 2011 and October 2011

Arimidex (anastrozole)

Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) Regulations-Canada (NOC Proceedings)

As previously disclosed, the Canadian Federal Court conducted a hearing in the NOC Proceeding filed by AstraZeneca against Mylan Pharmaceuticals ULC (Mylan) in respect of AstraZeneca's Canadian substance Patent No. 1,337,420 (the '420 patent).  In August 2011, the Court granted a Prohibition Order preventing the Minister of Health from granting a marketing authorisation to Mylan until the expiry of the '420 patent on 24 October 2012.  Mylan has appealed.

As previously disclosed, in May 2011, AstraZeneca commenced a NOC Proceeding against Pharmascience Inc. in respect of the '420 patent.  In August 2011, the proceeding was stayed until a final decision, including on appeal, is reached in the above-noted Mylan NOC Proceeding.

As previously disclosed, in May 2011, AstraZeneca commenced a NOC Proceeding against Teva Canada Limited in respect of the '420 patent.  In September 2011, the proceeding was stayed until the expiry of the '420 patent.

As previously disclosed, in July 2011, AstraZeneca commenced a NOC Proceeding against Apotex Inc. (Apotex) in respect of the '420 patent.  In September 2011, the proceeding was discontinued after Apotex withdrew its Notice of Allegation.

Atacand (candesartan cilexetil)

Patent litigation - EU

As previously disclosed, in Portugal, in addition to the previously disclosed cases, approvals for generic candesartan cilexetil or candesartan cilexetil and hydrochlorothiazide have been granted to Pharmakern Portugal - Produtos Farmacêuticos, Sociedade Unipessoal, Lda. (Pharmakern); Sandoz Farmacêutica Lda. (Sandoz); Bluepharma Genéricos Comércio de Medicamentos S.A. and Bluepharma Indústria Pharmacêutica S.A (together Bluepharma); and Sanofi-Aventis - Produtos Farmacêuticos, Lda (Sanofi). AstraZeneca filed preliminary injunctions to suspend those marketing approvals as well as corresponding administrative main actions during the third quarter of 2011.

In the cases against Laboratórios Azevados - Industria Farmacêutica; Ceamed Servico e Consultadoria Farmacêutica Lda; Teva Pharma - Produtos Farmacêuticos Lda; Mylan Lda; Laboratórios Anova - Produtos Farmacêuticos, Lda; Ranbaxy Portugal - Comércio e Desenvolvimento de Produtos Farmacêuticos, Unipessoal Lda; and Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos the Court of First Instance issued negative decisions, denying the preliminary injunction requests. Appeals have been filed and we await decisions from the Court of Appeal. 

Atacand Plus (candesartan cilexetil / hydrochlorothiazide)

Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) Regulations - Canada (NOC Proceedings)

In August 2011, AstraZeneca settled the previously disclosed NOC Proceeding pending with Pharmascience Inc. (PMS) with respect to Canadian Patent Nos. 2,040,955 (the '955 patent), 2,083,305 (the '305 patent) and 2,125,251 (the '251 patent).  The settlement resolves the litigation and allows PMS to enter the Canadian market on 23 September 2012, or earlier, in certain circumstances.

In August 2011, AstraZeneca settled the previously disclosed NOC Proceeding pending with Teva Canada Limited (Teva) with respect to the '955 patent, the '305 patent and the '251 patent.  The settlement resolves the litigation and allows Teva to enter the Canadian market on 23 September 2012, or earlier, in certain circumstances.

Crestor (rosuvastatin calcium)

Patent litigation - US

Abbreviated New Drug Applications (ANDAs)-US Patent No. RE37.314 (the '314 patent)

On 5 October 2011, the US Court of Appeals for the Federal Circuit held oral argument on the appeal of the June 2010 decision by the US District Court for the District of Delaware, which found the '314 patent valid, enforceable and infringed by the eight generic defendants.

Abbreviated New Drug Applications (ANDAs)-US Patent Nos. 6,858,618 (the '618 patent) and 7,030,152 (the '152 patent)

The US Court of Appeals for the Federal Circuit scheduled oral argument for 7 November 2011, on the appeal by AstraZeneca and The Brighams & Women's Hospital (BWH) (AstraZeneca's licensor of the '152 patent) (together the Plaintiffs) of the dismissal by the US District Court for the District of Delaware of the Crestor ANDA patent infringement actions based on the '152 and the '618 patents for lack of subject matter jurisdiction. 

Teva Pharmaceutical Industries LTD. (Teva LTD) Infringement suit in the Eastern District of Pennsylvania

On 6 October 2011, the US Court of Appeals for the Federal Circuit held oral argument on the appeal of the decision by the US District Court for the District of Pennsylvania granting AstraZeneca's motion for summary judgment and invalidating Teva LTD's formulation patent.

Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) Regulations - Canada (NOC Proceedings)

As previously disclosed, in July 2010, AstraZeneca received a Notice of Allegation from Ranbaxy Pharmaceuticals Canada Inc. (Ranbaxy) regarding Canadian Patent Nos. 2,072,945 (the '945 patent), 2,313,783 (the '783 patent) and 2,315,141 (the '141 patent). In July 2011, AstraZeneca reached a comprehensive settlement agreement resolving the litigation and as part of the agreement, Ranbaxy may enter the Canadian market in April 2012, or earlier, in certain circumstances. 

As previously disclosed, in July 2011, AstraZeneca received a Notice of Allegation (NOA) from Laboratoire Riva Inc. (Riva) under the Canadian Patented Medicines (Notice of Compliance) Regulations in respect of the '945 patent, the '783 patent and the '141 patent.  AstraZeneca commenced a proceeding in response in August 2011.

Patent litigation/Data exclusivity - Brazil

As previously disclosed, the court denied AstraZeneca's request for data exclusivity for Crestor. AstraZeneca requested an interlocutory appeal of the decision, which was denied.  AstraZeneca filed a motion for reconsideration in September 2011.

Nexium (esomeprazole magnesium)

Patent litigation - US

Abbreviated New Drug Applications (ANDAs)

As previously disclosed, in June 2011, AstraZeneca received a Paragraph IV Certification notice-letter from Hetero Drug Limited Unit III (Hetero) stating that Hetero had submitted an ANDA for approval to market 20 and 40mg esomeprazole magnesium delayed-release capsules.  In August 2011, AstraZeneca filed an ANDA patent infringement action against Hetero in the US District Court for the District of New Jersey.  In September 2011, the proceeding was stayed.

Patent Litigation - EU: 10-year countries

As previously disclosed, in the UK, in October 2010, AstraZeneca was served an invalidity case in which Ranbaxy (UK) Ltd (Ranbaxy) claimed that the Nexium esomeprazole magnesium patent (the EP 1020461 patent) and the esomeprazole magnesium trihydrate patent (the EP 0984957 patent) were invalid in the UK. Ranbaxy further requested the court to find that its generic esomeprazole product would not infringe either patent if launched in the UK. In March 2011, AstraZeneca filed a suit against Ranbaxy claiming that its generic esomeprazole product infringes the EP 1020461 patent. The trial of the non-infringement/infringement part took place in June 2011. In July 2011, the court held that Ranbaxy's generic esomeprazole product does not infringe the EP 1020461 patent. AstraZeneca has not appealed. The invalidity part of the proceedings had been stayed pending the non-infringement trial. There has been no update as to when the invalidity part will be heard.

In September 2011, in the Netherlands, AstraZeneca was served a declaratory action in which Ranbaxy (UK) Ltd requests the court to find that its generic esomeprazole product would not infringe the EP 1020461 patent or the EP 0984957 patent if commercialised in the Netherlands. In September 2011, AstraZeneca was served a nullity action in which Actavis Group PTC ehf claims that two esomeprazole formulation patents (EP 984773 and EP 1124539) are invalid. AstraZeneca is preparing its responses.

Patent Litigation - EU: 6-year countries

As previously disclosed, in Finland, AstraZeneca initiated a declaratory action requesting the District Court of Helsinki to find that Ranbaxy (UK) Ltd would infringe a patent relating to esomeprazole if commercialising its generic esomeprazole magnesium products. The trial took place in May 2011. In June 2011, the Court denied AstraZeneca's claim. AstraZeneca has appealed. In July 2009, AstraZeneca initiated similar declaratory actions against Sandoz Oy AB and Sandoz A/S.  In September 2009, Hexal AG, Sandoz Oy AB and Sandoz A/S (all in the Sandoz group) initiated an invalidity case requesting the court to invalidate the same patent. These cases were heard together in September 2011. On 18 July 2011, AstraZeneca applied for an interlocutory injunction to be granted against Sandoz A/S and Novartis Finland Oy and the interlocutory injunction was granted on 26 July 2011.

On 13 July 2011, in Poland, AstraZeneca filed an application for an interlocutory injunction to be granted against Krka d.d.Novo Mesto (Krka). On 4 August 2011, the Regional Court of Lodz granted the interlocutory injunction. Krka can appeal. On 8 August 2011, the Regional Court of Warsaw dismissed the declaratory action of Lek Farmacevtska Druzba d.d. (Lek) and Sandoz GmbH (Sandoz) (both in the Sandoz group). Lek and Sandoz can appeal.

As previously disclosed, in Ireland, AstraZeneca reached a settlement with Krka, d.d. Novo Mesto and Pinewood Laboratories Ltd (together Krka), in October 2011, discontinuing the legal actions under which AstraZeneca claimed that Krka's generic esomeprazole magnesium product infringes EP 1020461 and under which Krka claimed that EP 1020461 is invalid in Ireland.

Patent litigation - Norway

As previously disclosed, in Norway, the Appeal Court held the esomeprazole magnesium patent as valid. Hexal AG, Sandoz AS and Sandoz A/S (all in the Sandoz group) applied for leave to appeal to the Supreme Court. On 29 August 2011, the Supreme Court denied the requested leave to appeal.

Patent litigation - Singapore

As previously disclosed, in July 2011, AstraZeneca initiated patent infringement proceedings against Ranbaxy (Malaysia) SDN BHD (Ranbaxy) based on an esomeprazole related patent. In August 2011, Ranbaxy initiated an invalidity case regarding the esomeprazole magnesium patent.

Patent litigation - Turkey

In July 2011, AstraZeneca initiated patent infringement proceedings against Logus Ilac, Integri Ilac, Vem Ilac, Biofarma Ilac and Sandoz Ilac San.ve Tic.AS based on esomeprazole related patents. In September 2011, the court rejected AstraZeneca's claim in the case against Integri Ilac. AstraZeneca cannot appeal.

Patent litigation - Australia

In September 2011, AstraZeneca was served an invalidity case in which Ranbaxy (UK) Ltd claimed that the esomeprazole magnesium patent and a formulation patent relating to esomeprazole are invalid in Australia.

Patent Proceedings - EU

As previously disclosed, the Opposition Division of the European Patent Office (EPO) decided to revoke two patents that relate to Nexium (the EP 1020461 patent) and Nexium i.v. (the EP 1020460 patent) in June and July 2011 following Notices of Opposition filed by parties opposed to the grant of these patents. AstraZeneca has now appealed these decisions.  Formal Notices of Appeal were filed for the EP 1020460 patent on 15 July 2011 and for the EP 1020461 patent on 1 August 2011.

Patent Proceedings - China

In September 2011, AstraZeneca received notice that an individual had filed a request with the Chinese Patent Office for invalidation of a Chinese substance patent relating to Nexium (Chinese Patent for Invention No. 94190335.4).

Nexium i.v. (esomeprazole sodium)

Patent litigation - US

Abbreviated New Drug Applications (ANDAs)

In October 2011, AstraZeneca entered into an agreement with Sun Pharma Global FZE and affiliates (together Sun) to settle the previously disclosed patent infringement suit that AstraZeneca filed against Sun in the US District Court for the District of New Jersey with respect to Sun's ANDA for esomeprazole sodium intravenous formulation.  As part of the settlement agreement, AstraZeneca has granted Sun a licence to enter the US market with its generic esomeprazole sodium formulation on 1 January 2014, subject to regulatory approval, or earlier in certain circumstances.

Seroquel (quetiapine fumarate)

Product liability

As of October 2011, approximately 28,618 claims have been settled in principle, 28,450 of which are subject to written agreements and AstraZeneca was aware of approximately 75 Seroquel US product liability claims that have not been settled in principle.

As of 30 September 2011, legal defence costs of approximately $759m have been incurred in connection with Seroquel-related product liability claims. As previously disclosed, AstraZeneca settled its claims against several of its insurers for a substantial part of those legal defence costs.

As previously disclosed, disputes continue with other insurers about the availability of coverage under other insurance policies for legal defence costs and settlements. These policies have aggregate coverage limits of $300m.  On 5 September 2011, AstraZeneca Insurance Company Limited commenced formal legal proceedings in the High Court in London against certain of these insurers for recovery of money which AstraZeneca believes is due under certain of these policies which have aggregate coverage limits of $200m.

As of 30 September 2011, out of the legal defence costs of $759m mentioned above, AstraZeneca believes that approximately $144m is covered by these insurance policies.

While no insurance receivable can be recognised under applicable accounting standards at this time, AstraZeneca believes that it is more likely than not that further insurance recoveries will be secured under the additional policies, but there can be no assurance of this or the amount of any potential future recovery.

Regulatory Related Matters - US 

On 9 September 2011, AstraZeneca filed a Citizen Petition with the US Food and Drug Administration (FDA) for Seroquel asking the FDA not to approve any generic quetiapine drug product that omits certain hyperglycemia and suicidality warning language from its label that the FDA required AstraZeneca to include in the Seroquel labelling. The FDA is required to issue a decision on this petition by 7 March 2012.

Patent litigation - EU 

In Portugal, in addition to the previously disclosed cases, approvals were granted to Germed Farmacêutica Lda (Germed) and ToLife Produtos Farmacêuticos S.A. in September 2011. Preliminary injunctions to suspend those marketing approvals as well as corresponding administrative main actions were filed in October 2011. In the cases against Alter S.A. and Mepha Investigacão, Desenvolvimento e Fabricacão Farmacêutica, Lda, the Court of First Instance issued negative decisions, denying the preliminary injunction requests. Appeals were filed early in October 2011 and AstraZeneca is waiting for the decision of the Court of Appeal. 

In Italy, as previously disclosed, after a mistake by the Italian Patent Office, AstraZeneca filed motions for preliminary injunctions against five generic companies. In September 2011, the parties agreed to settle the cases.

Seroquel XR

Patent litigation - US

Abbreviated New Drug Applications (ANDAs)

As previously disclosed, in May 2011, AstraZeneca filed an ANDA patent infringement action in the US District Court for the District of New Jersey against Intellipharmaceutics Corp. (IPC) alleging infringement of US Patent No. 5,948,437 (the '437 patent).  After IPC filed a motion seeking to have the case dismissed for lack of personal jurisdiction or alternatively, for the action to be transferred to New York, AstraZeneca filed a second, essentially identical lawsuit in the US District Court for the Southern District of New York.  In August 2011, the US District Court for the Southern District of New York dismissed the second suit without prejudice.  AstraZeneca filed a motion for reconsideration and reinstatement of the original filing date for the action, which was granted in September 2011.

As previously reported, AstraZeneca filed patent infringement actions in the US District Court for the District of New Jersey against various entities of Handa Pharmaceuticals, LLC (Handa), Accord Healthcare Inc. (Accord), Anchen Pharmaceuticals, Inc. (Anchen), Torrent Pharmaceuticals Ltd. (Torrent), Osmotica Pharmaceutical Corporation (Osmotica), and Mylan Pharmaceuticals Inc. (Mylan).

On 29 September 2011, AstraZeneca settled its patent infringement action against Handa by granting Handa a licence to the '437 patent effective 1 November 2016, or earlier under certain circumstances.  On 4 October 2011, the Court dismissed the action against Handa. 

Beginning 3 October 2011, the US District Court for the District of New Jersey conducted a trial of the pending patent infringement actions against Accord, Anchen, Torrent, Osmotica and Mylan.  On 5 October 2011, AstraZeneca settled its patent infringement action against Accord by granting Accord a licence to the '437 patent effective 1 November 2016, or earlier under certain circumstances.  On 7 October 2011, the Court dismissed the action against Accord.

Patent Proceedings pursuant to Patented Medicines (Notice of Compliance) regulations-Canada (NOC Proceedings) 

In August 2011, AstraZeneca commenced a NOC Proceeding in response to the June 2011 Notice of Allegation from Teva Canada Limited under the Patented Medicines (Notice of Compliance) Regulations respecting Canadian Patent No. 2,251,944. 

Patent litigation - EU

In Spain, Accord Healthcare S.L.U. and Sandoz Farmaceutica S.A. issued revocation proceedings against AstraZeneca in July 2011, which AstraZeneca received notification of in August 2011. A trial date has not yet been scheduled.

In Romania, Teva Pharmaceuticals S.R.L. issued revocation proceedings against AstraZeneca in September 2011, which AstraZeneca received notification of in October 2011.

Patent litigation - Turkey

In Turkey, Sanovel İlaç San. ve Tic.A.Ş, has filed a negative declaratory action for non-infringement. A trial date has not yet been scheduled. 

Regulatory Related Matters - US 

On 9 September 2011, AstraZeneca filed a Citizen Petition with the US Food and Drug Administration (FDA) for Seroquel XR that asks the FDA not to approve any generic quetiapine drug product that omits certain hyperglycemia and suicidality warning language from its label that the FDA required AstraZeneca to include in the Seroquel XR labelling. The FDA is required to issue a decision on this petition by 7 March 2012.

Vimovo (fixed-dose combination of naproxen and esomeprazole)

Abbreviated New Drug Applications (ANDAs)

As previously disclosed, in June 2011, Dr. Reddy's Laboratories and Dr. Reddy's Laboratories, Ltd. (together DRL) answered the ANDA patent infringement suit filed by AstraZeneca and Pozen, Inc. (Pozen) (AstraZeneca's licensor) in the US District Court for the District of New Jersey against DRL alleging infringement of US Patent No 6,926,907 (the '907 patent). AstraZeneca received a Paragraph IV Certification notice-letter from DRL dated 19 September 2011, indicating it also seeks approval to market generic versions of 375/20mg and 500/20mg Vimovo tablets before expiration of US Patent Nos. 5,714,504 (the '504 patent); 6,875,872 (the '872 patent); 5,900,424 (the '424 patent); 6,369,085 (the '085 patent); 7,411,070 (the '070 patent); and 7,745,466 (the '466 patent).  AstraZeneca is evaluating DRL's certifications.

On 26 September 2011, Lupin Ltd. and Lupin Pharmaceuticals, Inc. (together Lupin) answered the ANDA patent infringement complaint filed by AstraZeneca and Pozen in the US District Court for the District of New Jersey against Lupin alleging patent infringement of the '504, '085, '872, '907, '070, and '466 patents.

AstraZeneca received a Paragraph IV Certification notice-letter from Anchen Pharmaceuticals, Inc. (Anchen) dated 16 September 2011, indicating it seeks approval to market generic versions of 375/20mg and 500/20mg Vimovo tablets before expiration of the '085, '424, '907, '070, and '466 patents.   AstraZeneca is evaluating Anchen's certifications. 

Other Commercial Litigation

Synagis (palivizumab)

In August 2011, AstraZeneca's biologics unit MedImmune filed a declaratory action against Abbott International LLC (Abbott) in the Federal District Court in Maryland.  The action sought a declaratory judgment related to a contract dispute between the parties. The parties are disputing when the transfer price of Synagis would revert to a lower amount based on the occurrence of one or more events related to the development of motavizumab (the Reversion Event).  On 15 September 2011, Abbott filed a motion to dismiss the declaratory action filed in the Federal District Court in Maryland. On the same date, Abbott also filed a parallel action in Illinois state court for breach of contract and for a declaratory judgment that the Reversion Event shall be deemed to have occurred on 1 July 2011 or alternatively, shall occur as of 31 December 2011.

On 26 September 2011, MedImmune voluntarily dismissed the complaint in the Federal District Court and re-filed the same declaratory action seeking the same relief in the state court in Montgomery County, Maryland. MedImmune expects to file a motion to dismiss the Illinois action as it believes the contract requires any litigation to be litigated in the Federal or state courts of Maryland. Abbott's response to the state court action in Maryland is not due until late November 2011.

Toprol XL (metoprolol succinate)

As previously disclosed, AstraZeneca is defending anti-trust claims regarding Toprol XL, brought by both direct purchasers and end-payers. AstraZeneca has taken a provision of $21 million in connection with an agreement in principle to settle the claims of the putative class of direct purchasers. AstraZeneca continues to defend against the claims of those who have opted-out of the class and against the claims alleged by end-payers.

Other Pricing Litigation

Average Wholesale Price Litigation 

As previously disclosed, AstraZeneca is a defendant, along with many other pharmaceutical manufacturers, in several sets of cases involving allegations that, by causing the publication of allegedly inflated wholesale list prices, the defendants caused entities to overpay for prescription drugs. In October 2011, AstraZeneca agreed in principle to settle the lawsuits brought by the Attorneys General of the States of Kansas and Mississippi, subject to documentation. Provision has been made in the fourth quarter in respect of these settlements.

Average Manufacturer's Price Qui Tam Litigation (Streck)

AstraZeneca is one of several manufacturers named as a defendant in a lawsuit filed in US federal court in Philadelphia by Ronald J. Streck, under the qui tam (whistleblower) provisions of the federal and certain state False Claims Acts. The action was initially filed in October 2008 but remained under seal until May 2011, following the government's decision not to intervene in the case with regard to certain manufacturers, including AstraZeneca.  AstraZeneca was served with a copy of the amended complaint on 7 September 2011. The lawsuit seeks to recover, among other things, damages, civil penalties, and attorneys' fees for alleged inaccurate reporting of Average Manufacturer's Prices to the Centers for Medicaid and Medicare Services. AstraZeneca intends to vigorously defend against these claims.

Other Actual and Threatened Government Investigations and Related Litigation

On 5 October 2011, AstraZeneca LP and AstraZeneca Pharmaceuticals LP received a subpoena from the Department of Justice in connection with an investigation of the possible submission of false or otherwise improper pricing information to the Centers for Medicare and Medicaid Services. The precise parameters of this inquiry are unknown, and AstraZeneca is not in a position at this time to predict the scope, duration or outcome of this matter, including whether it will result in any liability to AstraZeneca. 

AstraZeneca LP and AstraZeneca Pharmaceuticals LP are also in receipt of a Civil Investigative Demand issued by the Attorney General of Texas in connection with an investigation of the possible submission of false or otherwise improper reporting used to calculate the Medicaid rebates paid to the State of Texas.  The precise parameters of this inquiry are unknown, and AstraZeneca is not in a position at this time to predict the scope, duration or outcome of this matter, including whether it will result in any liability to AstraZeneca.    

Serbia

In August 2011, AstraZeneca UK Limited's Representative Office in Belgrade, Serbia was served with a criminal indictment relating to allegations that local employees of AstraZeneca made allegedly improper payments to physicians at the Institute of Oncology and Radiology of Serbia.  AstraZeneca has filed a number of preliminary procedural objections, which ask the Serbian criminal court to dismiss the indictment against the Representative Office.

6      NINE MONTHS territorial REVENUE analysis            

						% Growth
		9 Months 2011 $m		9 Months 2010 $m		Actual		Constant Currency
US		9,783		10,273		(5)		(5)
Western Europe1		6,496		6,821		(5)		(10)
Canada		1,241		1,102		13		6
Japan		2,138		1,854		15		4
Other Established ROW		922		745		24		6
Established ROW2		4,301		3,701		16		5
Emerging Europe		927		859		8		5
China		947		780		21		16
Emerging Asia Pacific		732		651		12		6
Other Emerging ROW		1,749		1,567		12		11
Emerging ROW3		4,355		3,857		13		10
Total Revenue		24,935		24,652		1		(3)

¹ Western Europe comprises France, Germany, Italy, Sweden, UK and others.

²Established ROW comprises Australia, Canada, Japan and New Zealand.

³ Emerging ROW comprises Brazil, China, India, Mexico, Russia, Turkey and all other ROW countries.

 

7      THIRD QUARTER territorial REVENUE analysis        

						% Growth
		3rd Quarter 2011 $m		3nd Quarter 2010 $m		Actual		Constant Currency
US		3,187		3,179		-		-
Western Europe1		2,067		2,150		(4)		(15)
Canada		401		379		6		(1)
Japan		771		632		22		10
Other Established ROW		332		251		32		11
Established ROW2		1,504		1,262		19		7
Emerging Europe		291		263		11		4
China		322		269		20		13
Emerging Asia Pacific		248		222		12		5
Other Emerging ROW		594		553		7		7
Emerging ROW3		1,455		1,307		11		7
Total Revenue		8,213		7,898		4		(2)

¹ Western Europe comprises France, Germany, Italy, Sweden, UK and others.

²Established ROW comprises Australia, Canada, Japan and New Zealand.

³ Emerging ROW comprises Brazil, China, India, Mexico, Russia, Turkey and all other ROW countries.

8      NINE MONTHS product REVENUE analysis  

		World						US				Western Europe						Established ROW						Emerging ROW
		9 Months 2011 $m		Actual Growth %		Constant  Currency Growth %		9 Months 2011 $m		Actual Growth %		9 Months 2011 $m		Actual Growth %		Constant  Currency Growth %		9 Months 2011 $m		Actual Growth %		Constant  Currency Growth %		9 Months 2011 $m		Actual Growth %		Constant  Currency Growth %
Gastrointestinal:
Nexium		3,362		(10)		(12)		1,783		(12)		617		(32)		(36)		408		24		12		554		19		18
Losec/Prilosec		698		(6)		(13)		30		(24)		185		(7)		(14)		315		1		(9)		168		(14)		(17)
Others		112		5		2		67		3		35		6		-		6		20		20		4		-		(25)
Total Gastrointestinal		4,172		(9)		(12)		1,880		(12)		837		(27)		(31)		729		13		2		726		9		8
Cardiovascular:
Crestor		4,851		18		14		2,231		18		920		12		5		1,197		27		16		503		11		8
Atacand		1,104		-		(5)		139		(16)		548		-		(6)		173		5		(4)		244		5		4
Seloken/Toprol-XL		750		(22)		(24)		315		(45)		63		(6)		(13)		28		(3)		(14)		344		19		14
Plendil		196		2		(2)		7		(42)		18		(14)		(19)		10		-		(10)		161		8		4
Tenormin		202		(2)		(9)		9		(10)		45		(2)		(9)		91		(1)		(11)		57		(2)		(5)
Zestril		109		(7)		(11)		8		-		54		(11)		(16)		12		(8)		(15)		35		-		(3)
OnglyzaTM		140		278		278		103		243		24		380		380		4		300		300		9		800		800
Brilinta/Brilique		16		n/m		n/m		11		n/m		4		n/m		n/m		-		-		-		1		n/m		n/m
Others		190		(3)		(8)		-		(100)		91		6		(1)		18		-		(11)		81		7		4
Total Cardiovascular		7,558		9		5		2,823		5		1,767		7		-		1,533		21		10		1,435		11		7
Respiratory:
Symbicort		2,309		15		10		604		14		1,075		6		-		295		54		39		335		24		20
Pulmicort		669		5		1		218		(8)		143		(9)		(15)		86		10		-		222		34		30
Rhinocort		162		(7)		(11)		58		(22)		29		(3)		(10)		15		36		18		60		-		(5)
Others		162		(16)		(22)		6		(84)		83		(6)		(13)		19		6		-		54		6		-
Total Respiratory		3,302		10		5		886		1		1,330		3		(3)		415		39		26		671		22		18
Oncology:
Arimidex		590		(52)		(55)		37		(92)		215		(51)		(53)		224		8		(2)		114		(1)		(4)
Zoladex		881		8		4		31		(9)		199		(5)		(10)		357		10		(1)		294		20		24
Casodex		408		(5)		(13)		(1)		(107)		63		(28)		(32)		262		4		(6)		84		8		5
Iressa		405		46		35		2		(33)		93		221		200		144		13		2		166		41		33
Others		482		57		52		200		94		151		57		48		47		12		-		84		27		24
Total Oncology		2,766		(10)		(14)		269		(57)		721		(16)		(21)		1,034		8		(2)		742		19		18
Neuroscience:
Seroquel IR		3,190		2		-		2,434		4		418		-		(7)		165		(6)		(16)		173		(10)		(14)
Seroquel XR		1,092		30		26		565		18		363		44		35		66		57		43		98		46		43
Local Anaesthetics		454		2		(5)		10		(58)		185		(5)		(11)		151		14		2		108		16		11
Zomig		312		(2)		(6)		117		(10)		131		2		(5)		52		4		(4)		12		33		22
Diprivan		227		(6)		(12)		12		(68)		33		(15)		(21)		63		19		9		119		7		1
Vimovo		20		300		280		14		180		2		n/m		n/m		3		n/m		n/m		1		n/m		n/m
Others		26		(10)		(14)		1		-		14		(30)		(35)		3		-		-		8		50		50
Total Neuroscience		5,321		6		4		3,153		5		1,146		9		2		503		11		-		519		9		4
Infection & Other:
Synagis		564		(12)		(12)		309		(16)		254		(6)		(6)		-		-		-		1		-		-
Merrem		469		(26)		(29)		33		(69)		151		(42)		(45)		46		12		2		239		6		2
FluMist		127		3		3		126		3		-		-		-		-		-		-		1		-		-
Others		101		(17)		(19)		58		(33)		9		100		50		14		40		(10)		20		(4)		17
Total Infection & Other		1,261		(17)		(18)		526		(23)		414		(23)		(24)		60		18		-		261		5		4
Aptium Oncology		169		2		2		169		2		-		-		-		-		-		-		-		-		-
Astra Tech		386		(1)		(6)		77		3		281		(1)		(7)		27		(7)		(21)		1		-		-
Total		24,935		1		(3)		9,783		(5)		6,496		(5)		(10)		4,301		16		5		4,355		13		10

9      third QUARTER product REVENUE analysis              

		World						US				Western Europe						Established ROW						Emerging ROW
		3rd Quarter 2011 $m		Actual Growth %		Constant  Currency Growth %		3rd Quarter 2011 $m		Actual Growth %		3rd Quarter 2011 $m		Actual Growth %		Constant  Currency Growth %		3rd Quarter 2011 $m		Actual Growth %		Constant  Currency Growth %		3rd Quarter 2011 $m		Actual Growth %		Constant  Currency Growth %
Gastrointestinal:
Nexium		1,089		(12)		(16)		570		(16)		163		(42)		(50)		169		52		35		187		12		12
Losec/Prilosec		224		(4)		(13)		9		13		58		(3)		(15)		102		-		(11)		55		(13)		(17)
Others		37		-		(5)		20		(13)		13		18		9		2		-		-		2		100		-
Total Gastrointestinal		1,350		(11)		(15)		599		(16)		234		(34)		(42)		273		27		13		244		6		4
Cardiovascular:
Crestor		1,659		21		14		753		20		307		16		2		431		31		17		168		10		7
Atacand		364		1		(8)		44		(15)		188		11		(4)		51		(9)		(20)		81		-		(2)
Seloken/Toprol-XL		273		-		(4)		123		(17)		22		5		(10)		9		(10)		(20)		119		28		20
Plendil		66		5		-		3		(25)		6		-		(17)		4		-		-		53		8		4
Tenormin		68		1		(7)		3		-		15		7		(7)		31		-		(10)		19		-		(5)
Zestril		37		6		(3)		3		50		18		(5)		(16)		3		(25)		(50)		13		30		30
OnglyzaTM		59		211		211		44		175		9		350		350		2		100		100		4		n/m		n/m
Brilinta/Brilique		13		n/m		n/m		11		n/m		2		n/m		n/m		-		-		-		-		-		-
Others		61		3		(5)		-		-		28		8		(8)		6		20		-		27		(4)		(4)
Total Cardiovascular		2,600		16		9		984		15		595		14		-		537		22		9		484		12		8
Respiratory:
Symbicort		755		18		9		201		15		351		16		3		97		39		23		106		15		9
Pulmicort		185		3		(3)		52		(15)		40		(7)		(19)		27		4		(8)		66		32		28
Rhinocort		52		(5)		(13)		15		(29)		8		-		(13)		6		20		-		23		10		-
Others		52		(15)		(23)		2		(85)		27		-		(11)		7		17		-		16		7		-
Total Respiratory		1,044		12		4		270		-		426		12		(1)		137		28		13		211		19		12
Oncology:
Arimidex		176		(38)		(44)		8		(81)		54		(59)		(65)		77		10		(1)		37		(3)		(5)
Zoladex		304		13		8		9		(31)		67		5		(5)		123		14		4		105		27		29
Casodex		137		-		(9)		-		(100)		18		(31)		(42)		90		7		(4)		29		21		17
Iressa		145		42		29		1		-		34		143		114		50		14		2		60		40		30
Others		168		56		47		68		94		53		56		38		16		7		(7)		31		29		25
Total Oncology		930		3		(4)		86		(9)		226		(17)		(26)		356		11		-		262		24		21
Neuroscience:
Seroquel IR		1,034		1		(2)		791		1		138		6		(7)		56		4		(9)		49		(18)		(22)
Seroquel XR		366		31		24		184		18		124		43		25		23		53		40		35		67		57
Local Anaesthetics		149		7		(4)		1		(83)		59		4		(9)		55		25		11		34		6		(3)
Zomig		108		5		(3)		40		(5)		46		12		(2)		17		(6)		(11)		5		150		100
Diprivan		71		(16)		(24)		-		(100)		10		(9)		(18)		21		-		(5)		40		-		(10)
Vimovo		10		100		80		6		20		2		n/m		n/m		2		n/m		n/m		-		-		-
Others		7		(22)		(22)		-		-		3		(33)		(33)		-		-		-		4		-		-
Total Neuroscience		1,745		6		2		1,022		2		382		15		1		174		14		3		167		6		(3)
Infection & Other:
Synagis		108		(22)		(22)		8		(27)		100		(22)		(22)		-		-		-		-		-		-
Merrem		139		(32)		(37)		5		(86)		39		(50)		(56)		13		8		-		82		4		(1)
FluMist		124		3		3		124		4		-		-		-		-		-		-		-		-		-
Others		29		(3)		-		14		(7)		3		n/m		n/m		7		75		75		5		(60)		(40)
Total Infection & Other		400		(19)		(21)		151		(16)		142		(30)		(33)		20		25		19		87		(7)		(9)
Aptium Oncology		56		33		33		56		33		-		-		-		-		-		-		-		-		-
Astra Tech		88		(28)		(36)		19		(24)		62		(29)		(37)		7		(30)		(50)		-		(100)		(100)
Total		8,213		4		(2)		3,187		-		2,067		(4)		(15)		1,504		19		7		1,455		11		7

Shareholder Information

ANNOUNCEMENTS AND MEETINGS

Announcement of fourth quarter and full year 2011 results	2 February 2012
Announcement of first quarter 2012 results	26 April 2012
Annual General Meeting	26 April 2012
Announcement of second quarter and half year 2012 results	26 July 2012
Announcement of third quarter and nine months 2012 results	25 October 2012

DIVIDENDS

The record date for the first interim dividend payable on 12 September 2011 was 5 August 2011. Shares traded ex-dividend from 3 August 2011.

The record date for the second interim dividend for 2011, payable on 19 March 2012 will be 17 February 2012. Shares will trade ex-dividend from 15 February 2012.

Future dividends will normally be paid as follows:

First interim	Announced in July and paid in September
Second interim	Announced in January and paid in March

TRADEMARKS

Trademarks of the AstraZeneca group of companies appear throughout this document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca appear with a ® or ™ sign and include: ONGLYZA™, KOMBOGLYZE™ and KOMBIGLYZE XR™, trademarks of Bristol-Myers Squibb Company.

ADDRESSES FOR CORRESPONDENCE

Registrar and Transfer Office Equiniti Limited Aspect House Spencer Road Lancing West Sussex BN99 6DA UK	US Depositary JP Morgan Chase & Co PO Box 64504 St Paul MN 55164-0504 US	Registered Office 2 Kingdom Street London W2 6BD UK	Swedish Central Securities Depository Euroclear Sweden AB PO Box 7822 SE-103 97 Stockholm Sweden
Tel (freephone in UK): 0800 389 1580 Tel (outside UK): [phone]	Tel (toll free in US): 800 990 1135 Tel (outside US): [phone]	Tel: [phone]	Tel: [phone]

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: The interim financial statements contain certain forward-looking statements with respect to the operations, performance and financial condition of the Group. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of the interim financial statements and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of patents, marketing exclusivity or trademarks; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; the impact of any failure by third parties to supply materials or services; the risk of failure to manage a crisis; the risk of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; the risk of failure to observe ongoing regulatory oversight; the risk that new products do not perform as we expect; the risk of environmental liabilities; the risks associated with conducting business in emerging markets; the risk of reputational damage; the risk of product counterfeiting; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; and the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation.

 

END

 

 

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