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Pfizer Inc.
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== Risks == The risks or uncertainties associated with the business include the following: # '''Risks related to business, industry and operations''' The company faces competitions from other competitors including Johnson & Johnson and generic drug manufacturers which can erode sales and market share. Competition for the top drugs including Lyrica, which made 4.6 billion in 2018 has lost patent inclusivity. Pfizer relies heavily on key products, where concentration product risk can pose a problem with the example of Comirnaty developed for COVID-19, which has seen a steep decline in sales due to reduced demand. Pzfier's total annual sales crossed the $100 billion mark for the first time in 2022 although $56 billion of the sales came from Cormirnaty, meaning a potential decline in sales over the upcoming years. {| class="wikitable" |+ !Risk |- |The outcome to meet anticipated pre-clinical and clinical endpoints, and to be able to meet regulatory approval with the possibility of potential unfavourable pre-clinical or clinical data. |- |Able to address comments and concerns from regulatory authorities and to be able to obtain approval for new products. |- |Claims and concerns in regards to the safety of efficiacy of products and product candidates. |- |Competition from new product entrants, including but not limited to; generic products, private label products and biosimilars. |- |Impact of public health outbreaks impacting on business, operations and financial conditions. |- |Impact of increased presence of counterfeit medicines or vaccines in the pharmaceutical supply chain. |- |Impact of increased presence of counterfeit medicines or vaccines in the pharmaceutical supply chain. |} '''2. Risks related to Government Regulation and Legal Proceedings''' Legislations involving Medicare and other U.S healthcare reform influencing spending reductions on health programs that may be implemented can significantly impact future sales. Any regulation on pharmaceutical product pricing, IP, restrictions on interactions with industry stakeholders and pricing pressures for Pfzier products. {| class="wikitable" |+ !Risks |- |The impact of any U.S. healthcare reform involving cost controls affecting publicly funded health programs that may be implemented. |- |Governmental regulations affecting operations. |} '''3. Risks involving Intellectual Property, Technology and Security''' Potential breakdown of the IT infrastructure can cause significant risk. Another risk that could be taken in consideration is patent applications being granted on a timely basis, and a risk to products, patents and IP under any claims of patent infringement. {| class="wikitable" |+ !Risks |- |Business disruption, theft of information that result in an integrity comprimise resulting from a cyber-attack. |- |Risks to products, patents and other IP including, claims of invalidity, patent infringemen and pressure or regulatory action by the government or large stakeholders. |}
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