A copy of the Annual Report will be submitted to the National Storage Mechanism and will shortly be available for inspection at www.morningstar.co.uk/uk/nsm. The inability to attract and retain highly skilled personnel may weaken our succession plans for critical positions in the medium term, may materially adversely affect the implementation of our strategic objectives and could ultimately impact our business or results of operations. Any failure to comply with these applicable laws, rules and regulations may result in us being investigated by relevant agencies and authorities and/or in legal proceedings being filed against us. Failure to adhere to applicable laws, rules and regulations. The grounds for these challenges could be the validity of a patent and/or its effective scope and are based on ever-evolving legal precedents. The continued disparities in EU and US pricing systems could lead to marked price differentials between regions, which, by way of the implementation of existing or new reference pricing mechanisms, increases the pricing pressure affecting the industry. PDF 7,964KB View online summary. Claims, regardless of their merits or their outcome, are costly, divert management attention and may adversely affect our reputation. Any such deficiency may also trigger investigations by a number of organisations, for example, the SEC, the DOJ or the UK Serious Fraud Office and may result in fines being levied against the Company or individual directors or officers. Due to the value of the materials used, the carrying amount of biologic products is much higher than that of small molecule products. on page 231, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2017” included as exhibit 15.1 to this Form 20-F dated March 6, 2018 is incorporated by reference. We experience strong competition from other pharmaceutical companies in respect of licensing arrangements, strategic collaborations, and acquisition targets. The Financial Statements, prepared in accordance with the applicable set of accounting standards, give a true and fair view of the assets, liabilities, financial position and profit or loss of the Company and the undertakings included in the consolidation taken as a whole. The Group operates from a global footprint and retains flexibility to adapt to changing circumstances. Sincerely, Since our business model and strategy rely on the success of relatively few compounds, the failure of any compound in our late-stage pipeline or in-line products may have a significant negative effect on our business or results of operations. 6 March 2018 11.00 GMT . Welcome We are a global, science-led, patient-focused biopharmaceutical company. We also have used several other terms in this 2019 Financial Report, most of which are explained or defined below: 2018 Financial Report Financial Report for the fiscal year ended December 31, 2018, which was filed as Exhibit 13 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2018 In addition, eight repeat funded organizations received up to $15,000 each in dissemination grant funding, In Emerging Markets, governments are increasingly controlling pricing in the self-pay sector and favouring locally manufactured drugs. Most of our key markets have experienced the implementation of various cost control or reimbursement mechanisms for pharmaceutical products. A copy of the Annual Report will be submitted to the National Storage Mechanism and will shortly be available for inspection at www.morningstar.co.uk/uk/nsm. Some of our subsidiaries import and export goods and services in currencies other than their own functional currency, and so the financial results of such subsidiaries could be affected by currency fluctuations arising between the transaction and settlement dates. A. Important notice for users AstraZeneca is not responsible for the privacy policy of any third party websites. Any expected gains from productivity initiatives are uncertain. Failure or delay in delivery of pipeline or launch of new products. Failure to obtain, defend and enforce effective IP protection and IP challenges by third parties. Delay of launch can also erode the term of patent exclusivity. The failure to exploit potential opportunities appropriately in Emerging Markets or materialisation of the risks and challenges of doing business in such markets, including inadequate protection against crime (including counterfeiting, corruption and fraud) or inadvertent breaches of local and international law may materially adversely affect our reputation, business or results of operations. We are a global science-led business delivering medicines to patients through innovative science and excellence in development and commercialisation. It is difficult to predict what specific proposals could be enacted and to determine the implications for the healthcare system and pharmaceutical industry. These may include changes to the ACA, modifications to Medicare and other government programmes, and policies aimed at reducing drug prices such as importation schemes. Corporate & Registered Office. Full Annual Report 2018. The Company’s worldwide operations are taxed under laws in the jurisdictions in which they operate. AstraZeneca’s pause in Europe raises doubts in other parts of the world. We may also experience difficulties in integrating geographically separated organisations, systems and facilities, and personnel with different organisational cultures. The criteria for establishing safety, efficacy and quality, which are essential for securing marketing approvals, may vary by country and by region. This comes as payers and policymakers attempt to increase efficiencies in the use and choice of pharmaceutical products. There is a trend towards increasing transparency and comparison of prices among EU Member States which may eventually lead to a change in the overall pricing and reimbursement landscape. The Company’s Annual General Meeting (AGM) will take place on 18 May 2018 in London, UK and the Notice of AGM and Shareholders’ Circular will be published and distributed to … While we invest heavily in the protection of our data and IT, we may be unable to prevent breakdowns or breaches in our systems that could result in disclosure of confidential or other sensitive information, damage to our reputation, regulatory penalties, financial losses and/or other costs. A pharmaceutical product competes with other products marketed by research-based pharmaceutical companies and with generic or biosimilar drugs marketed by generic drug manufacturers. The Annual Report will be dispatched to shareholders on or about 15 March 2018. We and our vendors could be susceptible to third-party attacks on our information security systems. Reliance on third-party goods and services. This Annual Report quick-read provides top-level information on our business and the progress we have made in 2018 in pushing the boundaries of science to deliver life-changing medicines and demonstrating what science can do. The best opportunity to achieve sustained remission, with potential for a cure, is to treat patients when they are newly diagnosed. Home. The business faces threats to business continuity from many directions. This material is not a substitute for reading the full Annual Report. This website is intended for people seeking information on AstraZeneca's worldwide business. In addition, patients are seeing changes in the design of their health plan benefits and may experience variation in how their plans cover their medications, including increases in the out-of-pocket payments for their branded medications. AstraZeneca Pharma India Limited Annual Report 2019-20. See the Financial risk management policies section of the Financial Review on page 79 for tax risk management policies and Note 28 to the Financial Statements from page 182 for details of current tax disputes. > Difficulties in cash repatriation due to strict foreign currency controls and lack of hard currency reserves in some Emerging Markets. In addition, we must ensure that the personal data which we, or third-party vendors operating on our behalf, hold and process is protected in a manner that complies with the EU GDPR which was approved by the EU on 28 May 2016, and will enter into force in May 2018. The size and complexity of our IT systems, and those of our third-party vendors (including outsource providers) with whom we contract, have significantly increased over the past decade and this makes such systems potentially vulnerable to service interruptions and security breaches from attacks by malicious third parties, or from intentional or inadvertent actions by our employees or vendors. In addition, unsuccessful assertion of our IP rights may lead to damages or other liabilities to third parties that could materially adversely affect our financial performance. There is also a direct financial loss when, for example, counterfeit and/or illegally diverted products replace sales of genuine products in a market or genuine products are recalled following discovery of counterfeit products. We are evolving our culture and simplifying our business. You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. Such investigations or proceedings could result in us becoming subject to civil or criminal sanctions and/or being forced to pay fines or damages. Annual. This website is intended for people seeking information on AstraZeneca's worldwide business. Pieces of DNA are shed from a tumour and circulate in the bloodstream where they can be analysed to give genetic information about a patient’s tumour. A pharmaceutical product may be protected from being copied for a limited period of time under certain patent rights and/or related IP rights, such as Regulatory Data Protection or Orphan Drug status. > Cyber threats similar to those detailed in the Failure of information security, data protection and cybercrime section above. - 13 Oncology approvals for Imfinzi, Lumoxiti, Lynparza and Tagrisso, - 6 CVRM approvals for Bydureon, Bydureon BCise, Lokelma and roxadustat, - 3 Respiratory approvals for Bevespi and Fasenra. ANNUAL FINANCIAL REPORT . Significant product liability claims could also arise which could be costly, divert management attention or damage our reputation and demand for our products. We have environmental and/or occupational health and safety-related liabilities at some current, formerly owned, leased and third-party sites. AstraZeneca has pioneered the use of circulating tumour DNA (ctDNA) for the detection of biomarkers in cancer. The largest obligation is in the UK. Some countries in which we operate do not offer robust IP protection. Authorities and the public expect us to help reduce opportunities for illegal trade in our products through securing our supply chains, surveillance, investigation and supporting legal action against those found to be engaged in illegal trade. All bar chart scales start from zero.
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