Pfizer Inc.

Core operations · Quality control and product defects

In response to requests from various regulatory authorities, manufacturers across the pharmaceutical industry, including Pfizer, are evaluating their product portfolios for the potential presence or formation of nitrosamines. If nitrosamines are detected in products, this may lead to market action for such products.

Core operations · Facility damage and equipment failure

We could encounter difficulties, delays or inefficiencies in our supply chain, product manufacturing and distribution networks due to the impact to our facilities due to health pandemics or natural or man-made disasters, including as a result of climate change.

Supply chain and procurement · Transportation and logistics disruption

We could encounter difficulties, delays or inefficiencies in our supply chain, product manufacturing and distribution networks, as well as sales or marketing, due to supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on.

Industry regulation · Licensing and permits

We may not be able to receive or maintain favorable recommendations by technical or advisory committees, such as the ACIP or an FDA Advisory Committee, which may impact the availability or commercial potential, or insurance coverage of our products and product candidates.

Tax and financial reporting · Financial reporting and accounting standards

Our future results could be adversely affected by changes in laws, regulations or policies, or their interpretation, including, among others, new or changes in accounting standards. For additional information on changes in accounting standards, see the New Accounting Standards section within MD&A.

Industry regulation · Regulatory compliance and changes

Regulatory agencies periodically inspect our manufacturing facilities, as well as third-party facilities that we rely on, to evaluate compliance with cGMP or other applicable requirements. Failure to comply with these requirements may subject us to possible legal or regulatory actions, such as warning letters, suspension of manufacturing, seizure of product.

Legal and litigation · Employment and labor law compliance

We could encounter difficulties in our supply chain due to work stoppages or strikes. Changes in labor markets, including challenges related to our human capital and talent development, may impact our business operations.

Legal and litigation · Litigation and legal proceedings

We are and may be involved in various legal proceedings, including patent litigation, product liability and other product-related litigation, including personal injury, consumer fraud, off-label promotion, securities, antitrust and breach of contract claims. Litigation is inherently unpredictable, and excessive verdicts do occur.

Tax and financial reporting · Tax compliance and changes in tax law

Our future results could be adversely affected by changes in laws, regulations or policies, or their interpretation, including, among others, new or changes in accounting standards, tariffs, tax laws and regulations internationally and in the U.S., including, without limitation, the IRA, and the OBBBA.

Reputation and brand · Product recalls and public safety

Claims and concerns that may arise regarding the safety and/or efficacy of in-line products and product candidates can negatively impact current or future product sales, as applicable, and potentially lead to regulator-directed risk evaluations and assessments, asset impairments, and/or consumer fraud, product liability and other litigation and claims, as well as product recalls or withdrawals.

Reputation and brand · Esg environmental social governance performance

Certain governmental authorities, non-governmental organizations, customers, investors, employees, and other stakeholders have differing views on matters perceived to be related to responsible business practices, such as equitable access to medicines and vaccines, product quality and safety, human capital, diversity, equity and inclusion, environmental stewardship.

International and currency · Emerging markets exposure

Some emerging market countries may be particularly vulnerable to periods of financial, economic or political instability or significant currency fluctuations or may have limited resources for healthcare spending. As a result of these and other factors, our strategy to grow in emerging markets may not be successful.

International and currency · International operations and emerging markets

We operate on a global scale and could be affected by currency and interest rate fluctuations; global trade tensions; capital and exchange controls; local and global economic conditions including inflation, recession, volatility and/or lack of liquidity in capital markets; expropriation and other restrictive government actions.

Market and investment · Interest rate and yield curve risk

Our borrowing, pension benefit and postretirement benefit obligations and interest-bearing investments are subject to risk from changes in interest and exchange rates. The risks related to interest-bearing investments and borrowings are discussed in the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk section.

Customer and revenue · Customer concentration and key customer dependence

We recorded revenues of more than $1 billion for each of 12 products that collectively accounted for 65% of Total revenues in 2025. For example, Eliquis accounted for 13% of Total revenues in 2025. If these products or any of our other major products were to experience loss of patent protection or reduced product demand, the adverse impact on our revenues could be significant.

Market position and competition · Competitive pressure and market share loss

Competitive product launches have and may erode future sales of our products, including our existing products and those currently under development, or result in product obsolescence. Such launches continue to occur, and potentially competitive products are in various stages of development.

Market position and competition · Disruptive competitors and new market entrants

We are facing an increasing number of potential competitors worldwide, including from China, that have expanded R&D capabilities. Some of our competitors may have competitive, technical or other advantages over us for the development of technologies and processes or greater experience in particular therapeutic areas.

Market position and competition · Pricing pressure and margin compression

The negotiating power of MCOs, PBMs and other private third-party payors has increased due to consolidation, and they, along with state and federal governments, increasingly employ tools to control costs and encourage utilization of certain drugs, including through the use of deductibles, utilization management tools, cost sharing or formulary placement.

Digital transformation and innovation · Technology obsolescence and evolution

Failure to invest in the right technology platforms, therapeutic areas, product classes, geographic markets and/or licensing opportunities could adversely impact the productivity of our pipeline. The scientific approach may not succeed despite the significant investment required for R&D.

Natural and catastrophic events · Force majeure and business interruption

We could be affected by natural or man-made disasters, including as a result of climate change, product liability or unanticipated costs. The impact to our facilities due to health pandemics or natural or man-made disasters, including as a result of climate change, could cause difficulties or delays.