3rd Quarter Results - Part 2 of 2

Condensed Consolidated Statement of Comprehensive Income

Condensed Consolidated Statement of Comprehensive Income

Condensed Consolidated Statement of Financial Position

Condensed Consolidated Statement of Cash Flows

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

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

Notes to the Interim Financial Statements

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.

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

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

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:

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.

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.

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.

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.