Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions.

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Generic drug manufacturers have filed applications with the FDA seeking approval of product candidates that such companies claim do not infringe patents.

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Pfizer Inc. filed suit in September 2017 against Johnson Johnson (JJ) alleging that JJ’s exclusionary contracts and other anticompetitive practices concerning Remicade (infliximab) violate federal antitrust laws.

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PFIZER INC's product lines must be replenished over time in order to offset revenue losses when products lose their market exclusivity.

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Failure to invest in the right technology platforms, therapeutic segments, product classes, geographic markets and/or in-licensing and out- Licensing opportunities could adversely impact the productivity of the company's pipeline.

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Many emerging markets have experienced growth rates in excess of developed markets.

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Some emerging market countries may be particularly vulnerable to periods of financial or political instability or significant currency fluctuations.

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Difficulties or delays in product manufacturing, sales or marketing could affect future results.

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Regulatory agencies periodically inspect PFIZER INC's drug manufacturing facilities to evaluate compliance with cGMP or other applicable requirements.

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Failure to comply with these requirements may lead to possible legal or regulatory actions, such as warning letters.

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Continued product shortage interruption at these facilities could negatively impact the company's financial results.

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PFIZER INC depend on third-party collaborators, service providers, and others in the research, development, manufacturing and commercialization of its products and product candidates.

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Failure by one or more of these third parties to complete activities on schedule or in accordance with PFIzer INC's expectations, could delay or prevent the development of the company's products.

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Pursuing these opportunities may require P FIZERS INC to obtain additional equity or debt financing.

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Counterfeit medicines continue to pose a significant risk to patient health and safety because of the conditions under which they are manufactured.

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Failure to mitigate this new threat posed by counterfeit biopharma medicines could adversely impact PFIZER INC's business.

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In the U.S., many of PFIZER INC's products are subject to increasing pricing pressures.

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Efforts by government officials or legislators to implement measures to regulate prices or payment for pharmaceutical products could adversely affect the company's business if implemented.

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In certain international markets, such as the different EU member states, governments have significant power as large single payers.

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Other U.S. federal or state legislative or regulatory action and/or policy efforts could adversely affect PFIZER INC's business.

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Failure to comply with all applicable regulatory requirements may lead to operating restrictions and criminal prosecution.

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Innovation is critical to the success of PFIZER INC's Company.

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Drug candidates can and do fail at any stage of the process.

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FDA may require a company to conduct additional clinical trials.

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Risks and uncertainties apply if PFIZER INC provide, offer, or promise something of value to a healthcare professional, other healthcare provider and/or government official.

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If an interaction is found to be improper, government enforcement actions and penalties could result.

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Litigation is inherently unpredictable and excessive verdicts do occur.

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PFIZER INC has incurred significant expense, civil payments, fines and other adverse consequences as a result of these claims, actions and inquiries.

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In connection with the resolution of a U.S. government investigation concerning independent copay assistance organizations, in May 2018, the company entered into a Corporate Integrity Agreement.

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Breaches of the CIA could result in severe sanctions against PFIzer INC.

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In countries that provide some form of regulatory exclusivity, mechanisms exist permitting some sort of challenge to PFIzER Inc's patents.

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Generic companies are increasingly employing aggressive strategies, such as "at risk" launches that challenge P FIZer INC’s patent rights.

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A properly functioning intellectual property regime is essential to PFIZER INC's business model.

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The pursuit of valid business opportunities may require the company to challenge intellectual rights held by other companies.

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Claims of intellectualproperty infringement can be costly and time-consuming to resolve, may delay or prevent product launches, and may result in significant damages.

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The success of any of PFIZER INC's strategic acquisitions will depend, in large part, on the ability to realize anticipated benefits from combining these businesses with Pfizer.

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The accretive impact anticipated from certain of these acquisitions may not be realized or may be delayed.

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Unsuccessful clinical trials, regulatory hurdles and commercialization challenges may adversely impact revenue and income contribution from products and product candidates.

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Even if the Combination is completed as anticipated, Pfizer may not realize some or all of the expected benefits.

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An inability to realize the full extent of the anticipated benefits could have an adverse effect on the revenues, level of expenses and operating results of PFIZER.

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On July 31, 2019, PFIZER INC completed the transaction with GSK to combine their respective consumer healthcare businesses.

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Following the integration of the combined business, G SK intends to separate the joint venture as an independent company via a demerger of its equity interest to its shareholders and a listing on the U.K. equity market.

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The global economic environment has not had, nor do PFIZER INC anticipate that it will have, a material impact on the company's liquidity or capital resources.

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Government financing pressures can lead to negative pricing pressure in markets where governments take an active role in setting prices, access criteria, or other means of cost control.

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Public health epidemics or outbreaks could adversely impact the business.

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54% of the company's total 2019 revenues were derived from international operations.

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The impact of possible currency devaluations in countries experiencing high inflation rates or significant exchange fluctuations, including Venezuela and Argentina, can impact the results and financial guidance.

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Growth in costs and expenses, changes in product, segment and geographic mix and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product withdrawals, recalls and other unusual events could adversely affect future results.

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For IPRD assets, the risk of failure is significant, and there can be no certainty that these assets ultimately will yield successful products.

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