AstraZeneca Annual Report and Form 20-F Information 2011

Product pipeline risks continuedFailure to obtain and enforce effective IP protectionOur ability to obtain and enforce patents and other IP rights in relation to our products is animportant element of our ability to protect our investment in R&D and create long-term value forthe business. A number of the countries in which we operate are still developing their IP laws ormay even be limiting the applicability of these laws to pharmaceutical inventions. Adversepolitical perspectives on the desirability of strong IP protection for pharmaceuticals in certainemerging and even developed markets may limit the scope for us to obtain effective IPprotection for our products. As a result, certain countries may seek to limit or deny effective IPprotection for pharmaceuticals.Delay to new product launchesOur continued success depends on the development and successful launch of innovative newdrugs. The anticipated launch dates of major new products have a significant impact on anumber of areas of our business, including investment in large clinical studies, the manufactureof pre-launch product stocks, investment in marketing materials pre-launch, sales force trainingand the timing of anticipated future revenue streams from new product sales. These launchdates are primarily driven by the development programmes that we run and the demands ofthe regulatory authorities in the approvals process, as well as pricing negotiations. Delays toanticipated launch dates can result from a number of factors including adverse findings inpreclinical or clinical studies, regulatory demands, competitor activity and technology transfer.Strategic alliances and acquisitions may be unsuccessfulWe seek technology licensing arrangements and strategic collaborations to expand our productportfolio and geographical presence as part of our business strategy.Such licensing arrangements and strategic collaborations are key, enabling us to grow andstrengthen the business. The success of such arrangements is largely dependent on thetechnology and other IP we acquire and the resources, efforts and skills of our partners. Also,under many of our strategic alliances, we make milestone payments well in advance of thecommercialisation of the products, with no assurance that we will recoup these payments.Furthermore, we experience strong competition from other pharmaceutical companies inrespect of licensing arrangements and strategic collaborations, and therefore may beunsuccessful in establishing some of our intended projects.We may also seek to acquire complementary businesses as part of our business strategy.The integration of an acquired business could involve incurring significant debt and unknownor contingent liabilities, as well as having a negative effect on our reported results of operationsfrom acquisition related charges, amortisation of expenses related to intangibles and chargesfor the implementation of long-term assets. We may also experience difficulties in integratinggeographically separated organisations, systems and facilities, and personnel with differentorganisational cultures.ImpactLimitations on the availability of patent protection orthe use of compulsory licensing in certain countriesin which we operate could have a material adverseeffect on the pricing and sales of our products and,consequently, could materially adversely affect ourrevenues from those products. More informationabout protecting our IP is contained in the IntellectualProperty section from page 34. Information aboutthe risk of patent litigation and the early loss of IPrights is contained in the Expiry or loss of, orlimitations on, IP rights section on page 132.ImpactSignificant delays to anticipated launch dates ofnew products could have a material adverse effecton our financial condition and results of operations.For example, for the launch of products that areseasonal in nature, delays in regulatory approvalsor manufacturing difficulties may delay launch to thenext season which, in turn, may significantly reducethe return on costs incurred in preparing for thelaunch for that season. In addition, a delay in thelaunch may lead to increased costs if, for example,marketing and sales efforts need to be rescheduledor protracted for longer than expected.ImpactIf we fail to complete these types of collaborativeprojects in a timely manner, on a cost effectivebasis, or at all, this may limit our ability to accessa greater portfolio of products, IP, technology andshared expertise.Additionally, disputes or difficulties in our relationshipwith our collaborators or partners may arise, oftendue to conflicting priorities or conflicts of interestbetween parties, which may erode or eliminate thebenefits of these alliances.The incurrence of significant debt or liabilities as aresult of integration of an acquired business couldcause deterioration in our credit rating and result inincreased borrowing costs and interest expense.Further, if, following an acquisition, liabilities areuncovered in the acquired business, the Group maysuffer losses and may not have remedies against theseller or third parties. The integration process mayalso result in business disruption, diversion ofmanagement resources, the loss of key employees,and other issues such as a failure to integrate IT andother systems.Corporate GovernanceAstraZeneca Annual Report and Form 20-F Information 2011Risk 131