Pfizer (PFE) 10-K risk factor changes: FY2022 vs FY2021

Investors should be aware that it is not possible to predict or identify all such factors and that the following [removed: is*][added: is not meant to be a complete discussion of all potential risks or uncertainties.]

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 13] [added: 14] | | |

The following discussion of risk factors contains forward-looking statements, as discussed in [removed: the Forward-Looking] [added: the* *[Forward-Looking] Information and Factors that May Affect Future [removed: Results section] [added: Results](#i8050b09ca8a0411dbcb0b6576ce1fc7a_19)* *section] in this Form 10-K.*

We cannot predict with accuracy the timing or impact of the introduction of competitive products that treat [added: or prevent] diseases and conditions like those treated [added: or prevented] by our in-line products and product candidates.

For additional information, see the [removed: *Item] [added: *[Item] 1.

Business—Patents and Other Intellectual Property [removed: Rights*] [added: Rights](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)*] section in this Form 10-K.

In China, we expect to continue to face intense competition by certain generic manufacturers, which [added: have resulted, and] may result in [added: the future, in] price cuts and volume loss of some of our products.

In addition, our patented products may face generic [added: or biosimilar] competition before patent exclusivity expires, including [removed: upon the] [added: from] “at-risk” launch (despite pending patent infringement litigation against the generic [added: or biosimilar] product) by a manufacturer of a generic [added: or biosimilar] version of one of our patented products.

Generic [added: and biosimilar] manufacturers have filed [added: or could file] applications with the FDA seeking approval of product candidates that they claim do not infringe our patents or claim that our patents are not [removed: valid; these include candidates that would compete with, among other products, Ibrance and Xeljanz.][added: valid.]

Uptake of our biosimilars may be lower due to various factors, such as anti-competitive practices, access challenges where our product may not receive appropriate coverage/reimbursement access or remains in a disadvantaged position relative to an innovator product, physician reluctance to prescribe biosimilars for existing patients taking the innovative product, or misaligned financial [removed: incentives.][added: incentives for certain prescribers.]

For additional information on competition our products face, see the [removed: *Item] [added: *[Item] 1.

[removed: Business*—*Competition*] [added: Business](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49)*[Competition](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49)*] section in this Form 10-K.

We recorded direct product and/or Alliance revenues of more than $1 billion for each of [removed: nine] [added: ten] products that collectively accounted for [removed: 75%] [added: 82%] of our total revenues in [removed: 2021.][added: 2022.]

In particular, [removed: Comirnaty/BNT162b2] [added: Comirnaty and Paxlovid together] accounted for [removed: 45%] [added: 57%] of our total revenues in [removed: 2021.][added: 2022.]

For additional information, see [removed: *Notes 1*] [added: *[Notes 1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)*] and [removed: *17*.][added: *[17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.]

If these products or any of our other major products were to experience loss of patent protection (if applicable), changes in prescription or vaccination [added: purchasing or] growth rates, [added: reduced product demand,] material product liability litigation, unexpected side effects or safety concerns, regulatory [removed: proceedings,] [added: proceedings or investigations, lower governmental and/or regulatory confidence,] negative publicity affecting doctor or patient confidence, pressure from [removed: existing] competitive products, changes in labeling, pricing and access pressures or supply shortages or if a new, more effective product should be introduced, the adverse impact on our revenues could be significant.

For additional information on our patents, see the [removed: *Item] [added: *[Item] 1.

[removed: Business*—*Patents and] [added: Business](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)*[Patents](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46) [and] Other Intellectual Property [removed: Rights*] [added: Rights](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)*] section in this Form 10-K.

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 14] [added: 15] | | |

[added: For Comirnaty and] Paxlovid, while we believe that these products have the potential to provide ongoing revenue streams for Pfizer for the foreseeable future, revenues of these products following the COVID-19 pandemic may not be at [removed: the] similar levels as those [removed: being] generated during the pandemic.

For information on [removed: additional] risks associated with [removed: Comirnaty/BNT162b2] [added: Comirnaty] and Paxlovid, see the [removed: *COVID-19 Pandemic*] [added: *COVID-19*] section below.

If one of our significant [removed: biopharmaceutical wholesalers] [added: customers] should encounter financial or other difficulties, it might decrease the amount of business [removed: the wholesaler] [added: such customer] does with us and/or we might be unable to timely collect all the amounts that [removed: the wholesaler] [added: such customer] owes us or at all, which could negatively impact our results of operations.

Our product lines must be replenished over time to offset revenue losses when products lose exclusivity or market [removed: share,] [added: share or to respond to healthcare and innovation trends,] as well as to provide for earnings growth, primarily through internal R&D or through collaborations, acquisitions, JVs, licensing or other arrangements.

We operate on a global scale and could be affected by currency [removed: fluctuations,] [added: fluctuations;] capital and exchange [removed: controls,] [added: controls; local and] global economic conditions including inflation, [added: recession, volatility and/or lack of liquidity in capital markets;] expropriation and other restrictive government [removed: actions,] [added: actions;] changes in intellectual [removed: property] [added: property;] legal protections and [removed: remedies,] [added: remedies;] trade [removed: regulations,] [added: regulations;] tax laws and [removed: regulations] [added: regulations;] and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including the [removed: current] [added: ongoing] conflict between Russia and [removed: Ukraine,] [added: Ukraine and its economic consequences, geopolitical instability,] terrorist activity, unstable governments and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.

For additional information on government pricing pressures, see the [removed: *Item] [added: *[Item] 1.

Business—Government Regulation and Price [removed: Constraints*] [added: Constraints](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)*] section in this Form 10-K.

We operate in many countries and transact in [removed: over 100] [added: many] different currencies.

Changes in the value of those currencies relative to the U.S. dollar, or high inflation in [removed: these] [added: those] countries, can impact our revenues, costs and expenses and our financial guidance.

[removed: 63%] [added: 58%] of our total [removed: 2021] [added: 2022] revenues were derived from international operations, including [removed: 29%] [added: 26%] from Europe and [removed: 19%] [added: 20%] from [removed: China, Japan] [added: Japan, China] and the rest of [removed: Asia.][added: the Asia Pacific region.]

For additional information about our exposure to foreign currency risk, see the [removed: *Analysis] [added: *[Analysis] of Financial Condition, Liquidity, Capital Resources and Market [removed: Risk*] [added: Risk](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)*] section within MD&A.

In addition, our borrowing, pension benefit and postretirement benefit obligations and interest-bearing [removed: investments,] [added: investments] are subject to risk from changes in interest and exchange rates.

The risks related to interest-bearing investments and borrowings and the measures we have taken to help contain them are discussed in the [removed: *Analysis] [added: *[Analysis] of Financial Condition, Liquidity, Capital Resources and Market [removed: Risk*] [added: Risk](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)*] section within MD&A and [removed: *Note 7E*.][added: *[Note 7E](#i8050b09ca8a0411dbcb0b6576ce1fc7a_205)*.]

For additional details on critical accounting estimates and assumptions for our benefit plans, see the [removed: *Significant] [added: *[Significant] Accounting Policies and Application of Critical Accounting Estimates and [removed: Assumptions—Benefit Plans*] [added: Assumptions—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_103)[Benefit Plans](#i8050b09ca8a0411dbcb0b6576ce1fc7a_103)*] section within MD&A and [removed: *Note 11*.][added: *[Note 11](#i8050b09ca8a0411dbcb0b6576ce1fc7a_220)*.]

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 15] [added: 16] | | |

We could encounter [removed: difficulties or] [added: difficulties,] delays [added: or inefficiencies] in our supply chain, product manufacturing and distribution networks, as well as sales or marketing, due to regulatory actions, shut-downs, work stoppages or strikes, approval delays, withdrawals, recalls, penalties, supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on, reputational harm, the impact to our facilities due to health pandemics or natural or man-made disasters, including as a result of climate change, product liability or unanticipated costs.

Examples of such difficulties or delays include the inability to increase production capacity commensurate with demand; challenges related to component materials to maintain supply and/or appropriate quality standards throughout our supply network and/or comply with applicable regulations; inability to supply certain products due to voluntary product [removed: recalls (as is the case with Chantix);] [added: recalls;] and supply chain disruptions at our facilities or at a supplier or vendor.

In [removed: July and August] 2021, Pfizer recalled [removed: 16] [added: all] lots of Chantix in the U.S. due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit.

In response to requests from various regulatory authorities, manufacturers across the pharmaceutical industry, including Pfizer, are evaluating their product portfolios for the potential [removed: for the] presence or formation of nitrosamines.

This [added: has led to additional voluntary recalls initiated for other products in 2022, and] may lead to additional recalls or other market actions for Pfizer products.

To achieve expected longer-term benefits, we may make substantial upfront payments as part of these transactions, which may negatively impact our [removed: reported] earnings or cash flows.

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, and consolidation among certain pharmaceutical and biotechnology companies can enhance such advantages.

These advantages may make it difficult for us to compete with them successfully to discover, develop and market new products and for our current products to compete with new products or indications they may bring to market.

Our products have been competing and may continue to compete, and our product candidates may compete, against products or product candidates that offer higher rebates or discounts, lower prices, equivalent or superior efficacy, better safety profiles, easier administration, earlier market availability or other competitive features.

If we are unable to compete effectively, this could reduce sales, which could negatively impact our results of operations.

For 2023, our revenue guidance for Comirnaty and Paxlovid as of January 31, 2023 is significantly lower than the 2022 revenues from these products.

In addition, we sell our prescription biopharmaceutical products, with the exception of Paxlovid, principally to wholesalers, but we also sell directly to retailers, hospitals, clinics, government agencies and pharmacies.

In 2022, we principally sold Paxlovid to government agencies.

We primarily sell our vaccines in the U.S. directly to the federal government, CDC, wholesalers, individual provider offices, retail pharmacies and integrated delivery systems.

Outside the U.S., we primarily sell our vaccines to government and non-government institutions.

For additional information, see *[N](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)[ote 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)[C](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.

Additionally, local economic conditions may adversely affect the ability of payers, as well as our distributors, customers, suppliers and service providers, to pay for our products, or otherwise to buy necessary inventory or raw materials, and to perform their obligations under agreements with us.

The prevalence of counterfeit medicines is an industry-wide issue due to a variety of factors, including the adoption of e-commerce.

The increased adoption during the COVID-19 pandemic further exposed consumers to fake prescription treatments via the internet as access to traditional brick and mortar pharmacies or authorized full-service internet pharmacies that offer authentic treatments may have been hindered.

Traffic to these generally deceptive pharmacy sites is largely driven by misplaced trust in sophisticated internet retailers and social media offers coupled with the convenience e-commerce affords consumers.

interdicting supply with the help of law enforcement, and advising legislators and regulators.

For example, in August 2022, the IRA was signed into law, which, among other things, requires manufacturers of certain drugs to engage in price negotiations with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replaces the Part D coverage gap discount program with a new discounting program.

Business––](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)[Government Regulation and Price Constraints](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)* section in this Form 10-K.

In addition, in November 2022, the EMA concluded their assessment of JAK inhibitors authorized for inflammatory diseases in the EU, including Xeljanz and Cibinqo, and recommended that risk minimization measures, including special warnings and precautions for use, should be revised and harmonized for all such JAK inhibitors.

The resulting label changes are expected to be finalized in the first quarter of 2023.

The terms of our EUA for Comirnaty require that we conduct post-observational studies to evaluate the association between the Pfizer-BioNTech Covid-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and a pre-specified list of adverse events of special interest, including myocarditis and pericarditis, along with deaths and hospitalizations, and severe COVID-19.

The required study populations include individuals specified in our December 2022 authorization letter (reissued) as well as populations of interest, such as healthcare workers, pregnant women, immunocompromised individuals and subpopulations with specific comorbidities.

Also, the FDA may require Pfizer to assess the activity of the authorized Paxlovid against any global SARS-CoV-2 variant(s) of interest and complete certain other analyses and studies as identified in our October 2022 EUA.

We are also involved in government investigations that arise in the ordinary course of our business.

There continues to be a significant volume of government investigations and litigation against companies operating in our industry, both in the U.S. and around the world.

This includes the June 2022 Ministerial Decision on the Agreement on Trade-Related Aspects of Intellectual Property Rights, which seeks to make it easier for certain WTO members to issue a compulsory license on COVID-19 vaccines, and discussions continue on whether to expand that decision to COVID-19 therapeutics and diagnostics.

As we expand our mRNA portfolio, such patent-related disputes may increase.

Once we have final

The Company develops and operates digital systems to engage patients, healthcare providers, governments, payers and supply chain partners to conduct business and deliver medicines, digital diagnostics, clinical trials and digital therapies.

Such systems include mobile applications, wearable devices, internet websites and other digital technologies that may be targets of attack.

Such incidents could require disclosure to government authorities and/or regulators and could require notification to impacted individuals and any incident could result in financial, legal, business and reputational harm to us.

The success of our business development transactions depends on our ability to realize the anticipated benefits of the transaction and is subject to numerous risks and uncertainties, many of which are outside of our control.

We may fail to generate expected revenue growth for an acquired product or business or we may fail to achieve anticipated cost savings within expected time frames or at all.

There is no assurance that we will be able to acquire attractive businesses or enter into strategic business relationships on favorable terms ahead of our competitors, or that such acquisitions or strategic business development relationships will be accretive to earnings or improve our competitive position.

Where we invest in or otherwise obtain debt or equity securities of third parties in connection with business development transactions, such as our ownership interest in Haleon, we may be unable to direct or influence the management, operational decisions and policies of such companies and the value of the acquired securities will fluctuate and may lose value.

COVID-19-related risks and challenges for our business, include, among others: decreased product demand, due to reduced new prescriptions or refills of existing prescriptions and reduced demand for products used in procedures, or as a result of unemployment or increased focus on COVID-19 vaccination; impacts due to travel limitations and mobility restrictions in some jurisdictions; manufacturing disruptions and delays; supply chain disruptions and shortages, including challenges related to reliance on third-party suppliers resulting in reduced availability of materials or components used in the development, manufacturing, distribution or administration of our products; disruptions to pipeline development and clinical trials, including challenges related to enrolling certain clinical trials and accruing a sufficient number of cases in certain clinical trials; challenges presented by reallocating resources to assist in responding to COVID-19; costs associated with COVID-19, including increased supply chain costs and additional R&D costs incurred in our efforts to develop Comirnaty and Paxlovid; challenges related to our business

In particular, we believe the ultimate impact on our business, operations and financial condition and results will be affected by, among other things, the emergence, infectiousness and severity of the predominant strains of the SAR-CoV-2 virus, the safety, efficacy, availability and public adherence of vaccines, boosters and treatments for COVID-19, proportion of the population that receives a vaccine or treatment for COVID-19, patient demand and market share for Comirnaty and Paxlovid, timing for delivery, and potential other amendments to the terms, of contracted doses or treatment courses to certain markets, timing and effectiveness for the expected transition to the commercial market for Comirnaty and Paxlovid, the global macroeconomic impact of COVID-19 and governmental responses or regulatory actions to contain the virus or control supply of medicines and vaccines.

- challenges related to a transition to the commercial market for any of our products;

- uncertainties related to the public’s adherence to vaccines, boosters and treatments;

- challenges and risks related to medication errors such as prescribing or dispensing the wrong strength, improper dosing and self-administration errors;

- risks related to our ability to achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments;

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

*not meant to be a complete discussion of all potential risks or uncertainties.

For Comirnaty/BNT162b2 and

In addition, we sell our prescription pharmaceutical products principally through wholesalers in the U.S. For additional information, see *Note 17C*.

From time to time, we issued variable rate debt based on LIBOR, or undertook interest rate swaps that contain a variable element based on LIBOR.

The U.K. Financial Conduct Authority announced in 2017 that it will no longer compel banks to submit rates used to calculate LIBOR after 2021.

This deadline was extended until June 2023 for a number of key U.S. dollar benchmark maturities (including the 1-month and 3-month

LIBOR rates).

The U.S. Federal Reserve has selected the Secured Overnight Funding Rate (SOFR) as the preferred alternate rate and the transition away from LIBOR will continue despite the extended timeline.

We are planning for this transition and will amend any contracts to accommodate the SOFR rate where required.

We do not expect the transition to have significant impact on our business or financial condition.

In September 2021, Pfizer expanded its voluntary recall in the U.S. to include all lots of Chantix.

Nitrosamines are impurities common in water and foods and everyone is exposed to some level of nitrosamines.

For information on additional risks specific to our Consumer Healthcare JV, see the *Consumer Healthcare JV with GSK* section below.

The prevalence of counterfeit medicines is an industry-wide issue due to a variety of factors, including the adoption of e-commerce, which increased during the COVID-19 pandemic, greatly enhancing consumers’ ability to obtain prescriptions and other medical treatments via the internet in lieu of traditional brick and mortar pharmacies or authorized full-service internet pharmacies.

assessments, and/or consumer fraud, product liability and other litigation and claims.

Updates include a new boxed warning for major adverse cardiovascular events (MACE) and updated boxed warnings regarding mortality, malignancies and thrombosis (with corresponding updates to applicable warnings and precautions).

In addition, indications for the treatment of adults with moderately to severely active RA or active PsA, and patients who are two years of age and older with active polyarticular course juvenile idiopathic arthritis have been revised; Xeljanz is now indicated in patients who have had inadequate response or intolerance to one or more tumor necrosis factor blockers.

In addition, at the request of the EC, the PRAC of the EMA has adopted a referral procedure under Article 20 of Regulation (EC) No 726/2004 to assess safety information relating to oral JAK inhibitors authorized for inflammatory diseases, including Xeljanz and Cibinqo, which is ongoing.

The terms of our EUA for Comirnaty require that we conduct post-authorization observational studies in patients at least 5 years of age or older who received a booster dose, or other populations of interest including healthcare workers, pregnant women, immunocompromised individuals, and subpopulations with specific comorbidities.

Additionally, in relation to the potential FDA approval for Paxlovid, we are required to complete certain other analyses and studies as identified in the December 2021 authorization letter.

For example, in May 2021, the Brazilian Supreme Court voted to invalidate Article 40 of Brazil’s Patent Law, which guaranteed a minimum 10-year patent term from patent grant, and to give retroactive effect to such decision.

This includes a proposal that would release WTO members from their obligation under WTO-TRIPS to grant and enforce various types of intellectual property protection on health products and technology in relation to the prevention, containment or treatment of COVID-19.

In May 2021 and again in November 2021, the Biden Administration called on countries to waive intellectual property protections on COVID-19 vaccines.

RISKS RELATED TO BUSINESS DEVELOPMENT:

Where we acquire debt or equity securities as all or part of the consideration for business development activities, the value of those securities will fluctuate, and may depreciate.

We may not control a company in which we invest, and, as a result, we will have limited ability to determine its management, operational decisions and policies.

The success of any of our acquisitions will depend, when applicable, on our ability to realize anticipated benefits from integrating these businesses with us.

We, for example, may fail to achieve cost savings anticipated with certain of these acquisitions, or such cost savings within the expected time frame.

We also may fail to generate the expected revenue growth for the acquired business.

Expected revenue from acquired products and product candidates also may be constrained by developments outside of our control.

SPIN-OFF AND COMBINATION OF UPJOHN WITH MYLAN

We may not realize some or all of the expected benefits of the spin-off and combination (the Transactions) of the Upjohn Business with Mylan, which resulted in the creation of Viatris in November 2020, due to many factors, including, among others, strategic adjustments required to reflect the nature of our business following the Transactions, increased risks resulting from us becoming a company that is a more focused, innovative science-based biopharmaceutical products business and the possibility that we may not achieve our strategic objectives.

In addition, we have agreed to provide certain transition services to Viatris, generally for an initial period of 24 months following the completion of the Transactions (with certain possibilities for extension).

CONSUMER HEALTHCARE JV WITH GSK

In 2019, we and GSK combined our respective consumer healthcare businesses into a JV that operates globally under the GSK Consumer Healthcare name.

Although we have certain consent, board representation and other governance rights, we are a minority owner of the JV and do not control the JV, its management or its policies.

As a result, our ability to realize the anticipated benefits of the transaction depend upon GSK’s operation and management of the JV.

In addition, the JV is subject to risks that are different than the risks associated with our business.

[removed: The] [added: Financial Highlights*––*The] following is a summary of certain financial performance metrics (in billions, except per share data):

| [removed: 2021] [added: 2022] Total [removed: Revenues––$81.3] [added: Revenues––$100.3] billion | | | [removed: 2021] [added: 2022] Net Cash Flow from [removed: Operations––$32.6] [added: Operations––$29.3] billion | | |

[removed: ][added: ]

| [removed: 2021] [added: 2022] Reported Diluted [removed: EPS––$3.85] [added: EPS––$5.47] | | | [removed: 2021] [added: 2022] Adjusted Diluted EPS [removed: (Non-GAAP)––$4.42*] [added: (Non-GAAP)––$6.58*] | | |

[removed: ][added: ]

*For additional information regarding Adjusted diluted EPS (which is a non-GAAP financial measure), including reconciliations of certain GAAP [removed: reported] [added: Reported] to non-GAAP [removed: adjusted] [added: Adjusted] information, see the [removed: *Non-GAAP] [added: *[Non-GAAP] Financial Measure: Adjusted [removed: Income*] [added: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_127)*] section within MD&A.

With the formation of the Consumer Healthcare JV in [removed: 2019 and] [added: 2019,] the spin-off of our former Upjohn Business in the fourth quarter of [removed: 2020,] [added: 2020 and the sale of our Meridian subsidiary in the fourth quarter of 2021,] Pfizer transformed into a more focused, global leader in science-based innovative medicines and vaccines [removed: and beginning in the fourth quarter of 2020 operated as a single operating segment] engaged in the discovery, development, [removed: manufacturing,] [added: manufacture,] marketing, sale and distribution of biopharmaceutical products worldwide.

[removed: At] [added: In] the [removed: beginning of our fiscal] fourth quarter of 2021, we [removed: reorganized our commercial operations and] began [removed: to manage] [added: managing] our commercial operations through a [removed: new] global structure consisting of two operating segments: Biopharma and PC1.

See [removed: *Note 1A*] [added: *[Note 1A](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)*] and [removed: *Item] [added: *[Item] 1.

Business––Commercial [removed: Operations* of] [added: Operations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_31)* in] this Form 10-K for additional information.

We expect to incur costs of approximately $700 million in connection with separating Upjohn, of [removed: which,] [added: which] approximately [removed: 75%] [added: 85%] has been incurred since inception and through December 31, [removed: 2021.][added: 2022.]

[removed: Transforming] [added: Beginning in 2019, we took action through our Transforming] to a More Focused [removed: Company: We have undertaken efforts] [added: Company restructuring program] to ensure our cost base and support model [removed: align] [added: aligned] appropriately with our [removed: new] operating structure.

[removed: See] [added: program, see] the [removed: *Costs] [added: *[Costs] and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity [removed: Initiatives*] [added: Initiatives](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*] section of this MD&A*.*

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 26] [added: 25] | | |

[added: In addition to discovering and developing new] products, our R&D efforts seek to add value to our existing products by improving their effectiveness and ease of dosing and by discovering potential new indications.

See the [removed: *Item] [added: *[Item] 1.

[removed: Business*—*Research] [added: Business](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)*[Research] and [removed: Development*] [added: Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)*] section [removed: of] [added: in] this Form 10-K for our R&D priorities and strategy.

- an aging global population that is generating increased demand for innovative medicines and vaccines that address patients’ unmet needs; [added: and]

- advances in both biological science and [removed: digital technology] [added: platform technologies] that are enhancing the delivery of breakthrough new medicines and [removed: vaccines; and][added: vaccines.]

[removed: We] [added: Our Business Development Initiatives*––*We] are committed to strategically capitalizing on growth opportunities, primarily by advancing our own product pipeline and maximizing the value of our existing products, but also through various business development activities.

For additional information, including discussion of recent significant business development activities, see [removed: *Note 2*.][added: *[Note 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*.]

Our [removed: 2021] [added: 2022] Performance

[removed: *Revenues*] [added: *Revenues––Revenues*] increased [removed: $39.6] [added: $19.0] billion, or [removed: 95%,] [added: 23%,] to [removed: $81.3] [added: $100.3] billion in [removed: 2021] [added: 2022] from [removed: $41.7] [added: $81.3] billion in [removed: 2020,] [added: 2021,] reflecting an operational increase of [removed: $38.4] [added: $24.6] billion, or [removed: 92%,] [added: 30%,] as well as [removed: a favorable] [added: an unfavorable] impact of foreign exchange of [removed: $1.2] [added: $5.5] billion, or [removed: 3%.][added: 7%.]

[removed: ][added: ]

See the [removed: *Analysis of the Consolidated Statements of Income––Revenues] [added: *[Revenues] by [removed: Geography*] [added: Geography](#i8050b09ca8a0411dbcb0b6576ce1fc7a_109)*] and [removed: *Revenues––Selected] [added: *[Revenues](#i8050b09ca8a0411dbcb0b6576ce1fc7a_112)[––](#i8050b09ca8a0411dbcb0b6576ce1fc7a_112)[Selected] Product [removed: Discussion*] [added: Discussion](#i8050b09ca8a0411dbcb0b6576ce1fc7a_112)*] sections within MD&A for more information, including a discussion of key drivers of our revenue performance.

For information regarding the primary indications or class of certain products, see [removed: *Note 17C.*][added: *[Note 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)[C](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241).*]

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 27] [added: 26] | | |

[removed: *Income from Continuing Operations Before Provision/(Benefit)] [added: | *Provision/(benefit)] for [removed: Taxes] [added: taxes] on [removed: Income*][added: income* | | | | | | $ | 3,328 | | | | | $ | 1,852 | | | | | $ | 370 | | | | | 80 | | | | | | * | | |]

[removed: The] [added: *Income from Continuing Operations Before Provision/(Benefit) for Taxes on Income––*The] increase in *Income from continuing operations before provision/(benefit) for taxes on income* of [removed: $17.3] [added: $10.4 billion, to $34.7] billion in [added: 2022 from $24.3 billion in] 2021, [removed: compared to 2020,] was primarily attributable [removed: to: (i)] [added: to] higher [removed: revenues,] [added: revenues and lower *Acquired in-process research and development expenses*, partially offset by (i) an increase in *Cost of sales,*] (ii) net [removed: periodic benefit credits] [added: losses on equity securities] in [removed: 2021] [added: 2022] versus net [removed: periodic benefit costs] [added: gains on equity securities] in [removed: 2020,] [added: 2021,] (iii) lower [removed: asset impairment charges,] [added: net periodic benefit credits associated with pension] and [added: other postretirement plans, and] (iv) [removed: higher net gains on equity securities, partially offset by (v)] increases [removed: in: *Cost of sales, Research] [added: in *Research] and development [removed: expenses* and *Selling,] [added: expenses, Selling,] informational and administrative [removed: expenses.*][added: expenses,* and *Restructuring charges and certain acquisition-related costs.*]

See the [removed: *Analysis] [added: *[Analysis] of the Consolidated Statements of [removed: Income*] [added: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_106)*] within MD&A and [removed: *Note 4*] [added: *[Note 4](#i8050b09ca8a0411dbcb0b6576ce1fc7a_181)*] for additional information.

For information on our tax provision and effective tax rate, see the [removed: *Provision/(Benefit)] [added: *[Provision/(Benefit)] for Taxes on [removed: Income*] [added: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_118)*] section within MD&A and [removed: *Note 5*.][added: *[Note 5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187)*.]

[removed: We,] [added: Our Operating Environment––We,] like other businesses in our industry, are subject to certain industry-specific challenges.

See also the [removed: *Item] [added: *[Item] 1.

Business––Government Regulation and Price [removed: Constraints*] [added: Constraints](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)*] and [removed: *Item] [added: *[Item] 1A.

Risk [removed: Factors*] [added: Factors](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*] sections [removed: of] [added: in] this Form 10-K.

[removed: Our] [added: *Regulatory Environment––Pipeline Productivity––*Our] product lines must be replenished [added: over time] to offset revenue losses when products lose exclusivity or market share or to respond to healthcare and innovation trends, as well as to provide for earnings growth.

[removed: In addition, after] [added: After] a product has been approved or authorized and launched, we continue to monitor its safety as long as it is available to [removed: patients.][added: patients, including conducting postmarketing trials, voluntarily or pursuant to a regulatory request.]

For the entire life of the product, we collect safety data and report safety information to the FDA and other [removed: regulatory authorities.][added: regulators.]

[removed: Regulatory authorities] [added: Such action(s)] may [removed: evaluate potential safety concerns and take regulatory actions in response, such as] [added: include:] updating a product’s labeling, restricting its use, communicating new safety information [removed: to the public,] or, in rare cases, [removed: requiring us] [added: seeking] to suspend or remove a product from the market.

[removed: The] [added: *Intellectual Property Rights and Collaboration/Licensing Rights––*The] loss, expiration or invalidation of intellectual property rights, patent litigation settlements [removed: with manufacturers] and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues.

GENERAL

The following MD&A is intended to assist the reader in understanding our financial condition and results of operations, including an evaluation of the amounts and certainty of cash flows from operations and from outside sources, and is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes in *[Item 8.

Financial Statements and Supplementary Data](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)* in this Form 10-K.

Discussions of 2020 items and year-to-year comparisons between 2021 and 2020 that are not included in this Form 10-K can be found within MD&A in our 2021 Form 10-K.

| An increase of 23% compared to 2021 | | | A decrease of 10% compared to 2021 | | |

| An increase of 42% compared to 2021 | | | An increase of 62% compared to 2021 | | |

Our Business and Strategy*––*Pfizer Inc. is a research-based, global biopharmaceutical company.

We apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

See the *[Item 1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)[.

Business](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)[––](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)[About Pfizer](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)* section in this Form 10-K.

Pfizer is committed to working towards equitable and affordable access to our medicines and vaccines for people around the world.

As a science-driven global biopharmaceutical company, we remain focused on advancing our pipeline, supporting our marketed brands and deploying capital responsibly, with a focus on initiatives that can help contribute to our long-term revenue and future growth.

Our ability to fulfill our purpose, *Breakthroughs that change patients’ lives*, remains a core focus and underscores our commitment to addressing the needs of society to help sustain long-term value creation for all stakeholders.

We believe that our medicines and vaccines provide significant value for healthcare providers and patients and seek to enhance their value by continuously evaluating how we can best collaborate with patients, physicians and payers to support and expand patient access to reliable, affordable healthcare around the world.

In addition, we continually seek to expand and broaden our product portfolio offerings through prioritized development of our pipeline and acquisitions targeted at critical unmet patient needs.

As a result, our commercial organizational structure and R&D operations are critical to the successful execution of our business strategy.

In 2023, we are making additional investments in both R&D and SI&A to support Pfizer’s near- and longer-term growth plans, including to support anticipated new launches, commercial launch of COVID-19 products, potential high-value pipeline programs and recently acquired assets.

In the third quarter of 2022, we made several organizational changes to further transform our operations to better leverage our expertise in certain areas and in anticipation of potential future new product or indication launches, and in the fourth quarter of 2022, we began taking steps to optimize our end-to-end R&D operations to reduce costs and cycle times as well as to further prioritize our internal R&D portfolio in areas where our capabilities are differentiated while increasing external innovation efforts to leverage an expanding and productive biotech sector.

For a description of savings related to this

The operational increase was primarily driven by growth from Paxlovid and Comirnaty.

Excluding the impact of Paxlovid and Comirnaty, revenues increased 2% operationally, reflecting strong growth in the Prevnar family, Eliquis and the Vyndaqel family, as well as revenue from recently acquired products, Nurtec ODT/Vydura and Oxbryta, partially offset by declines in Xeljanz, Chantix/Champix, Sutent, certain Comirnaty-related manufacturing activities performed on behalf of BioNTech (which are included in the PC1 contract development and manufacturing organization) and Ibrance.

As of January 31, 2023, on a total company basis, we forecasted revenues in 2023 of $67 billion to $71 billion, reflecting an operational decline of 31% at the midpoint from 2022 results, which we expect will also have an unfavorable impact on *Income from continuing operations before provision/(benefit) for taxes on income*.

The total company expected revenue declines in 2023 are driven by an expected reduction in sales of our COVID-19 products, partially offset by expected operational growth from our non-COVID-19 in-line portfolio, anticipated new product launches, and recently acquired products.

See also *The Global Economic Environment––COVID-19* section below for information about our COVID-19 products, including expectations for 2023.

See also *The Global Economic Environment––COVID-19* section below for information about our COVID-19 products, including expectations for 2023.

Clinical trials are conducted to determine, among other things, whether an investigational drug or device is safe and effective for a particular patient population.

Regulatory authorities evaluate potential safety concerns and take any regulatory action deemed necessary and appropriate.

We anticipate a more significant impact of reduced revenues from patent expiries in 2026 through 2030 as several of our in-line products experience patent-based expirations.

We continue to evaluate the impact of the IRA on our business, operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain.

In addition, changes to the Medicaid program or the federal 340B drug pricing program, including legal or legislative developments at the federal or state level with respect to the 340B program, could have a material impact on our business.

Risk Factors](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*[––](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*[Pricing and Reimbursement](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)* sections in this Form 10-K.

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.

This has led to recalls, including our voluntary recall of Chantix in 2021 and additional voluntary recalls initiated for other products in 2022 due to the presence of nitrosamines above the FDA interim acceptable intake limit, and may lead to additional recalls or other market actions for Pfizer products.

*COVID-19*––In response to COVID-19, we have developed Paxlovid and collaborated with BioNTech to jointly develop Comirnaty, including booster doses of an Omicron-adapted bivalent vaccine.

As part of our strategy for COVID-19, we are continuing to make significant additional

investments in breakthrough science and global manufacturing.

This includes continuing to evaluate Comirnaty and Paxlovid, including against new variants of concern, developing monovalent, bivalent and variant adapted vaccine candidates and booster doses and developing potential combination respiratory vaccines and potential next generation vaccines and therapies.

We are also evaluating Paxlovid for additional populations.

For additional information, including our continuing late-stage development efforts for Paxlovid, see the *[Product Developments](#i8050b09ca8a0411dbcb0b6576ce1fc7a_124)* section within MD&A.

In 2022 and to date, we principally sold Comirnaty and Paxlovid globally under government contracts.

Financial Highlights

| An increase of 95% compared to 2020 | | | An increase of 126% compared to 2020 | | |

| An increase of 137% compared to 2020 | | | An increase of 96% compared to 2020 | | |

Our Business and Strategy

On December 31, 2021, we completed the sale of our Meridian subsidiary, and beginning in the fourth quarter of 2021, the financial results of Meridian are reflected as discontinued operations for all periods presented.

Beginning in the fourth quarter of 2020, the financial results of the Upjohn Business and the Mylan-Japan collaboration were reflected as discontinued operations for all periods presented.

Prior-period information has been restated to reflect our current organizational structure.

While certain direct costs transferred to the Consumer Healthcare JV and to the Upjohn Business in connection with the spin-off, there are indirect costs which did not transfer.

We are taking steps to restructure our corporate enabling functions to appropriately support our business, R&D and PGS platform functions.

In addition, we are transforming our commercial go-to market model in the way we engage patients and physicians.

In addition to discovering and developing new

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

- the increasingly significant role of hospitals in healthcare systems.

Our Business Development Initiatives

Our significant recent business development activities that closed or are targeted to close in 2022 include:

Acquisition of Arena

In December 2021, we and Arena announced that the companies entered into a definitive agreement under which we will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.

Under the terms of the agreement, we will acquire all outstanding shares of Arena for $100 per share in an all-cash transaction for a total equity value of approximately $6.7 billion.

On February 2, 2022, Arena shareholders voted to approve the proposed acquisition, which is targeted to close in the first half of 2022, subject to review under antitrust laws and other customary closing conditions.

Collaboration with Biohaven

In November 2021, we entered into a collaboration and license agreement and related sublicense agreement with Biohaven Pharmaceutical Holding Company Ltd., Biohaven Pharmaceutical Ireland DAC and BioShin Limited (collectively, Biohaven) pursuant to which we acquired rights to commercialize rimegepant and zavegepant for the treatment and prevention of migraines outside of the U.S., subject to regulatory approval.

Rimegepant is currently commercialized in the U.S., Israel, and the U.A.E. under the brand name Nurtec® ODT, with certain additional applications pending outside of the U.S. Biohaven will continue to lead R&D globally and we have the exclusive right to commercialization globally, outside of the U.S. Upon the closing of the transaction, which occurred on January 4, 2022, we paid Biohaven $500 million, including an upfront payment of $150 million and an equity investment of $350 million.

Biohaven is also eligible to receive up to $740 million in non-U.S. commercialization milestone payments, in addition to tiered double-digit royalties on net sales outside of the U.S. In addition to the milestone payments and royalties above, we will also reimburse Biohaven for the portion of certain additional milestone payments and royalties due to third parties in accordance with preexisting Biohaven agreements, which are attributed to ex-U.S. sales.

*Revenues*

Excluding direct sales and alliance revenues of Comirnaty and sales of Paxlovid, revenues increased 6% operationally, reflecting strong growth in Eliquis, Biosimilars, PC1, Vyndaqel/Vyndamax, the Hospital therapeutic area, Inlyta and Xtandi, partially offset by declines in the Prevnar family, Chantix/Champix, Enbrel and Sutent.

Our Operating Environment

*Regulatory Environment––Pipeline Productivity*

We conduct clinical trials to provide data on safety and efficacy to support the evaluation of a product’s overall benefit-risk profile for a particular patient population.

This includes postmarketing trials that may be conducted voluntarily or pursuant to a regulatory request to gain additional medical knowledge.

The commercial potential of in-line products may be negatively impacted by post-marketing developments.

*Intellectual Property Rights and Collaboration/Licensing Rights*

*Regulatory Environment/Pricing and Access––Government and Other Payer Group Pressures*

For example, there is proposed legislation that, if enacted, would allow Medicare to negotiate prices for certain prescription drugs, as well as require that penalties be paid by manufacturers who raise drug prices faster than inflation.

Also, certain changes proposed by the CMS in December 2020 to the Medicaid program and 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities, could increase our Medicaid rebate obligations and increase the discounts we extend to 340B covered entities if they go into effect.

Additional changes to the 340B program are undergoing review and their status is unclear.

*Product Supply*

production, pricing, and marketing of, reimbursement for and access to our products, as well as impacts of political or civil unrest or military action, including the current conflict between Russia and Ukraine, terrorist activity, unstable governments and legal systems, inter-governmental disputes, public health outbreaks, epidemics, pandemics, natural disasters or disruptions related to climate change.

COVID-19 Pandemic

*Our Response to COVID-19*

Pfizer has helped lead the global effort to confront the COVID-19 pandemic by advancing a vision for industry-wide collaboration while making significant investments in breakthrough science and global manufacturing.

The information required by this Item is incorporated by reference to the discussion in the [removed: *Analysis] [added: *[Analysis] of [removed: Financial Condition,] [added: Financial](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136) [Condition](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)[,] Liquidity, Capital Resources and Market [removed: Risk*] [added: Risk](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)*] section within MD&A.

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 48] [added: 44] | | |

[removed: ][added: ]

In addition, Pfizer continues to enhance its ESG strategy, which is focused on six areas where we see opportunities to create a meaningful [removed: impact over the next decade:] [added: impact:] product innovation; equitable access and pricing; product quality and safety; diversity, equity and inclusion; climate change; and business ethics.

For a further discussion of our strategy and our business development initiatives, see the [removed: *Overview] [added: *[Overview] of Our Performance, Operating Environment, Strategy and [removed: Outlook*] [added: Outlook](#i8050b09ca8a0411dbcb0b6576ce1fc7a_97)*] section within MD&A and [removed: *Note 2*.][added: *[Note 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*.]

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | 3 | | |

For [removed: additional information,] [added: discussion on Comirnaty,] see the [removed: *Overview] [added: *[Overview] of Our Performance, Operating Environment, Strategy and [removed: Outlook—COVID-19 Pandemic*] [added: Outlook—COVID-19](#i8050b09ca8a0411dbcb0b6576ce1fc7a_97)*] section within [removed: MD&A and the *Item 1A.][added: MD&A.]

Risk [removed: Factors—COVID-19 Pandemic*] [added: Factors—Concentration](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*] section in this Form 10-K.

[removed: At] [added: In] the [removed: beginning of our fiscal] fourth quarter [added: of] 2021, we [removed: reorganized our commercial operations and] began [removed: to manage] [added: managing] our commercial operations through a [removed: new] global structure consisting of two operating segments, each led by a single manager: Biopharma, our innovative science-based biopharmaceutical business, and PC1, our global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients.

| [removed: *Therapeutic Area*] [added: *Customer Groups*] | | | *Description* | | | *Key Products* | | |

| Oncology | | | Includes innovative oncology brands of biologics, small molecules, immunotherapies and biosimilars across a wide range of cancers. | | | [removed: Ibrance*, Xtandi*, Inlyta*, Sutent,] [added: Ibrance, Xtandi, Inlyta,] Retacrit, Lorbrena and Braftovi | | |

For additional information on our operating segments and products, [added: including product revenues,] see [removed: *Note 17*] [added: *[Note 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241),*] and for additional information on the key operational revenue drivers of our business, see the [removed: *Analysis] [added: *[Analysis] of the Consolidated Statements of [removed: Income*] [added: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_106)*] section within MD&A.

For a discussion of the risks associated with our dependence on certain of our major products, see the [removed: *Item] [added: *[Item] 1A.

Risk [removed: Factors—Concentration*] [added: Factors—Research and](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70) [Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*] section in this Form 10-K.

- [removed: Comirnaty/BNT162b2] [added: Comirnaty] is an mRNA-based coronavirus vaccine to help prevent COVID-19, which is being jointly developed and commercialized with BioNTech.

[removed: Comirnaty/BNT162b2] [added: Comirnaty] has been granted an approval or an authorization in many countries around the world in populations varying by country.

We also share gross profits equally from commercialization of [removed: Comirnaty/BNT162b2] [added: Comirnaty] and are working jointly with BioNTech in our respective territories to commercialize the vaccine worldwide (excluding China, Hong Kong, Macau and Taiwan), subject to regulatory authorizations or approvals market by market.

For [removed: discussion] [added: additional information] on [removed: Comirnaty/BNT162b2,] [added: the impact of LOEs on our revenues,] see the [removed: *Overview] [added: *[Overview] of Our Performance, Operating Environment, Strategy and [removed: Outlook—COVID-19 Pandemic*] [added: Outlook—Our 2022 Performance](#i8050b09ca8a0411dbcb0b6576ce1fc7a_97)*] section within MD&A.

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | 4 | | |

[added: The companies are also collaborating on Myfembree (relugolix 40] mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for heavy menstrual bleeding associated with uterine fibroids in premenopausal women and the management of moderate to severe pain associated with [removed: endometriosis.][added: endometriosis in premenopausal women.]

The companies [removed: will] equally share profits and allowable expenses in the U.S. [added: for Orgovyx,] and [added: in the U.S. and] Canada for [removed: Orgovyx and] Myfembree, with Myovant bearing our share of allowable expenses up to a maximum of $50 million in 2022.

Myovant [removed: will remain] [added: remains] responsible for regulatory interactions and drug supply and [removed: continue] [added: continues] to lead clinical development for the relugolix combination tablet.

Revenues associated with these arrangements are included in Alliance revenues (except in certain markets where we have direct sales and except for the majority of revenues for [removed: Comirnaty/BNT162b2,] [added: Comirnaty,] which are included as direct product revenues).

For further discussion of collaboration and co-promotion agreements, see the [removed: *Item] [added: *[Item] 1A.

Risk Factors—Collaborations and Other Relationships with Third [removed: Parties*] [added: Parties](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*] section in this Form 10-K and [removed: *Notes 2*] [added: *[Notes 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*] and [removed: *17*.][added: *[17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.]

While a significant portion of our R&D is internal, we also seek promising chemical and biological lead molecules and innovative technologies developed by others to incorporate into our discovery and development processes or projects, as well as our [removed: product lines.][added: portfolio.]

For information on certain of these collaborations, alliances and license arrangements and investments, see [removed: *Note 2*.][added: *[Note 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*.]

*Our R&D Operations.* In [removed: 2021,] [added: 2022,] we continued to strengthen our global R&D operations and pursue strategies to improve R&D productivity to achieve a sustainable pipeline that is positioned to deliver value in the near term and over time.

- GPD. Our GPD organization is a unified center for clinical development and regulatory activities that is generally responsible for the clinical development strategy and operational execution of clinical trials for [added: both early- and] late-stage clinical assets in Pfizer’s pipeline.

[removed: -] Science-based platform-services organizations within [removed: WRDM. These organizations] [added: WRDM] provide technical expertise and other services to various R&D [removed: projects,] [added: projects] and are organized into science-based functions.

Specifically, the Portfolio [removed: Strategy & Investment committee,] [added: Management Team (PMT),] composed of senior executives, is accountable for aligning resources among all of our WRDM, GPD and R&D projects and for seeking to ensure optimal capital allocation across the innovative R&D portfolio.

We do not disaggregate total R&D expense by development phase or by therapeutic area since, as described above, we do not manage [added: all of] our R&D operations by development phase or by therapeutic area.

For additional information, see the [removed: *Costs] [added: *[Costs] and [removed: Expenses*—*Research] [added: Expenses](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*[Research] and [removed: Development (R&D) Expenses*] [added: Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115) [Expense](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)[s](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*] section within MD&A and [removed: *Note 17*.][added: *[Note 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.]

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | 5 | | |

As of [removed: February 8, 2022,] [added: January 31, 2023,] we had the following number of projects in various stages of R&D:

[removed: ][added: ]

Information concerning several of our drug candidates in development, as well as supplemental filings for existing products, is set forth in the [removed: *Product Developments*] [added: *[Product Developments](#i8050b09ca8a0411dbcb0b6576ce1fc7a_124)*] section within MD&A.

For information on the risks associated with R&D, see the [removed: *Item] [added: *[Item] 1A.

Risk [removed: Factors—Research] [added: Factors](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*[Pricing] and [removed: Development*] [added: Reimbursement](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*] section [removed: of] [added: in] this Form 10-K.

Our operations are conducted globally, and we [removed: sell] [added: supply] our [removed: products in] [added: medicines and vaccines to] over [removed: 125 countries.][added: 185 countries and territories.]

Revenues from operations outside the U.S. of [removed: $51.5] [added: $57.9] billion accounted for [removed: 63%] [added: 58%] of our total revenues in [removed: 2021.][added: 2022.]

Revenues exceeded $500 million in each of [removed: 21, 8] [added: 24, 21] and [removed: 10] [added: 8] countries outside the U.S. in [removed: 2021, 2020 and 2019, respectively, with the increase in the number of countries in] [added: 2022,] 2021 [removed: primarily driven by Comirnaty/BNT162b2.][added: and 2020, respectively.]

Our significant recent business development activities in 2022 include, among others: (i) the March 2022 acquisition of Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases; (ii) the October 2022 acquisition of GBT, a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities, starting with sickle cell disease; and (iii) the October 2022 acquisition of Biohaven, the maker of Nurtec ODT/Vydura (rimegepant), an innovative therapy for both acute treatment of migraine and prevention of episodic migraine in adults.

Beginning in the third quarter of 2022, we made several organizational changes to further transform our operations to better leverage our expertise in certain areas and in anticipation of potential future new product or indication launches.

The changes include establishing a new commercial structure within Biopharma, optimizing our end-to-end R&D operations and further prioritizing our internal R&D portfolio, as well as realigning certain enabling and platform functions across the organization to ensure alignment with this new operating structure, which is designed to better support and optimize performance across three broad customer groups as follows:

| Primary Care | | | Includes: •Former Internal Medicine product portfolio (innovative brands in cardiovascular metabolic, migraine and women’s health, as well as regional brands) •Former Vaccines product portfolio (innovative vaccines across all ages with a pipeline focus on infectious diseases with significant unmet medical need) •Products for COVID-19 prevention and treatment, and potential future mRNA and antiviral products | | | •Eliquis, Nurtec ODT/Vydura and the Premarin family •The Prevnar family, Nimenrix, FSME/IMMUN-TicoVac and Trumenba •Comirnaty •Paxlovid | | |

| Specialty Care | | | Includes: •Former Inflammation & Immunology product portfolio (innovative brands and biosimilars for chronic immune and inflammatory diseases) •Former Rare Disease product portfolio (innovative brands for a number of therapeutic areas with rare diseases, including amyloidosis, hemophilia, endocrine diseases and sickle cell disease) •Former Hospital portfolio (global portfolio of sterile injectable and anti-infective medicines, excluding Paxlovid) | | | •Xeljanz, Enbrel (outside the U.S. and Canada), Inflectra, Eucrisa/Staquis and Cibinqo •The Vyndaqel family, Oxbryta, BeneFIX and Genotropin •Sulperazon, Medrol, Zavicefta, Zithromax, Vfend and Panzyga | | |

To that end, our R&D primarily focuses on our main therapeutic areas, which are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines, and anti-infectives.

Pfizer does not have rights outside of these markets.

The increase in the number of countries exceeding $500 million in revenues in 2022 and 2021 was primarily driven by Comirnaty as well as, in 2022, Paxlovid.

In 2022, we principally sold Paxlovid to government agencies.

To date, we primarily sold Comirnaty and Paxlovid globally under government contracts.

We expect sales of Comirnaty and Paxlovid in the U.S. will transition to commercial channels in the second half of 2023.

As part of our commitment to engaging our customers in the manner they prefer, we took a hybrid approach of virtual and in person engagements and see positive customer response to both approaches.

During the COVID-19 pandemic, we adapted our promotional platform by amplifying our digital capabilities to reach healthcare professionals and customers to provide critical education and information, including increasing the scale of our remote engagement.

| Nurtec ODT/Vydura | | | | | | 2030 (2034 pending PTE) | | | | | | 2030 (2035 pending SPC) | | | | | | 2030(7) | | |

| Ngenla(10) | | | | | | (7)(11) | | | | | | 2032(2) | | | | | | 2030(2) | | |

| Oxbryta | | | | | | 2033 | | | | | | 2032 (2037 pending SPC) | | | | | | 2032(7) | | |

| Pfizer-BioNTech COVID-19 Vaccine | | | | | | (12) | | | | | | (12)(13) | | | | | | (12) | | |

| Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)/ Comirnaty Original/Omicron BA.1 Vaccine | | | | | | (12) | | | | | | (12)(13) | | | | | | (12) | | |

In the U.S., we and BMS previously settled certain patent litigations with a number of generic companies permitting their launch of a generic version of Eliquis on April 1, 2028 (the settled generic companies).

Both the composition of matter patent expiring in November 2026 and the formulation patent expiring in 2031 may be subject to future challenges.

(8)We have exclusive rights to Braftovi and Mektovi in the U.S., Canada and certain emerging markets.

(11)Expiry expected to be provided by regulatory exclusivity in this market.

The date at which generic or

For additional information, see the *[Item 1A.

There is no assurance that a particular product will enjoy market exclusivity for the full time period that appears in the estimates included in this Form 10-K or that we assume when we provide our financial guidance.

Further, these models may also encourage payors and their pharmacy benefits managers to cover higher cost drugs where coverage is tied to patient outcomes and other quality incentives.

Both payors and providers may resist adopting such models or choose to adopt such models at a slower pace if the incentives available do not outweigh the financial risk involved.

Unprecedented pressures on critical care and the reductions in elective surgeries during the COVID-19 pandemic undermined revenue predictability for hospitals and other institutional providers.

Going forward, we expect continued focus on value-based payment models that support financial resiliency and advance health care equity by incorporating features intended to reduce disparities in health care quality and access experienced by underrepresented and underserved populations.

We expect payment reforms for MCOs will continue to evolve with increased emphasis on expanded participation and on removing barriers to equitable health care.

At the same time, MCOs may seek to exclude high-cost drugs from formularies in their efforts to manage and lower their costs.

We continue to seek to ensure that our major products are included on MCO formularies.

For additional information, see the *[Item 1A.

business.

For additional information, see the *[Item 1A.

Innovator biologics, or reference products, are entitled to 12 years exclusivity.

For example, in August 2022, the IRA was signed into law, which, among other things, requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).

We continue to evaluate the impact of the IRA on our business, operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain.

For example,

certain changes finalized by the CMS in December 2020 for the Medicaid Drug Rebate Program may increase our Medicaid liability, including for drugs that are considered to be “new formulations” of existing drugs.

Pfizer’s growth strategy is driven by five “Bold Moves” that help us deliver breakthroughs for patients and create value for shareholders and other stakeholders:

*1.Unleash the power of our people*;

*2.Deliver first-in-class science*;

*3.Transform our go-to-market model*;

*4.Win the digital race in pharma*; and

*5.Lead the conversation*.

Our significant recent business development activities in 2021 include, among others: (i) the July 2021 global collaboration with Arvinas to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader (the estrogen receptor is a well-known disease driver in most breast cancers); (ii) the November 2021 collaboration and license agreement with Biohaven to acquire rights to commercialize rimegepant and zavegepant for the treatment and prevention of migraines outside of the U.S. upon approval; (iii) the November 2021 acquisition of Trillium, a clinical stage immuno-oncology company developing innovative potential therapies for the treatment of cancer; and (iv) the December 2021 research collaboration with Beam to utilize Beam’s in vivo base editing programs, which use mRNA and lipid nanoparticles, for three targets for rare genetic diseases of the liver, muscle and central nervous system.

In addition, in December 2021, we entered into a definitive agreement to acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.

On February 2, 2022, Arena shareholders voted to approve the proposed acquisition, which is targeted to close in the first half of 2022, subject to review under antitrust laws and other customary closing conditions.

In 2020 and 2021, our business, operations and financial condition and results were impacted by the COVID-19 pandemic.

To confront the public health challenge posed by the pandemic, we have made some important advances, including, the development of a vaccine to help prevent

COVID-19 and an oral COVID-19 treatment.

Following (i) the spin-off and combination of the Upjohn Business (which was our global, primarily off-patent branded and generics business) with Mylan in 2020, which created a new global pharmaceutical company, Viatris, and (ii) the formation of the Consumer Healthcare JV with GSK in 2019, we saw the culmination of Pfizer’s transformation into a more focused, global leader in science-based innovative medicines and vaccines, and beginning in the fourth quarter of 2020, we operated as a single operating segment engaged in the discovery, development, manufacturing, marketing, sale and distribution of biopharmaceutical products worldwide.

Our Biopharma business includes the following therapeutic areas and key products:

| Vaccines | | | Includes innovative vaccines across all ages—infants, adolescents and adults—in pneumococcal disease, meningococcal disease, tick-borne encephalitis and COVID-19, with a pipeline focus on infectious diseases with significant unmet medical need. | | | Comirnaty/BNT162b2*, the Prevnar family*, Nimenrix, FSME/IMMUN-TicoVac and Trumenba | | |

| Internal Medicine | | | Includes innovative brands in cardiovascular metabolic and women’s health, as well as regional brands. | | | Eliquis* and the Premarin family | | |

| Hospital | | | Includes our global portfolio of sterile injectable and anti-infective medicines, as well as an oral COVID-19 treatment. | | | Sulperazon, Medrol, Zavicefta, Zithromax, Vfend, Panzyga and Paxlovid | | |

| Inflammation & Immunology | | | Includes innovative brands and biosimilars for chronic immune and inflammatory diseases. | | | Xeljanz*, Enbrel (outside the U.S. and Canada)*, Inflectra, Eucrisa/Staquis and Cibinqo | | |

| Rare Disease | | | Includes innovative brands for a number of therapeutic areas with rare diseases, including amyloidosis, hemophilia and endocrine diseases. | | | Vyndaqel/Vyndamax*, BeneFIX and Genotropin | | |

*Each of Prevnar 13/Prevenar 13, Ibrance, Eliquis, Xeljanz and Enbrel recorded direct product and/or Alliance revenues of more than $1 billion in 2021, 2020 and 2019.

Each of Comirnaty/BNT162b2 and Inlyta recorded direct product and/or Alliance revenues of more than $1 billion in 2021.

Each of Xtandi and Vyndaqel/Vyndamax recorded direct product and/or Alliance revenues of more than $1 billion in 2021 and 2020.

Comirnaty/BNT162b2, Eliquis and Xtandi include Alliance revenues and direct sales.

Prevnar family include revenues from Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20 (adult).

Prior to the fourth quarter of 2021, PC1 had been managed within the Hospital therapeutic area.

Also, on December 31, 2021, we completed the sale of our Meridian subsidiary, which was part of the Hospital therapeutic area prior to its sale.

See *Note 1A* for additional information.

The companies are also collaborating on Myfembree (relugolix 40

To that end, our R&D primarily focuses on our main therapeutic areas.

Examples of these platform organizations include Pharmaceutical Sciences and Medicine Design, and Worldwide Medical and Safety.

| Chantix/Champix | | | | | | 2020(2) | | | | | | 2021(2) | | | | | | 2022 | | |

| Sutent | | | | | | 2021(3) | | | | | | 2022(3) | | | | | | 2024 | | |

| Besponsa | | | | | | 2030 | | | | | | 2028 | | | | | | 2028(4) | | |

| Bavencio(11) | | | | | | 2033 | | | | | | 2032 | | | | | | 2033 | | |

| Comirnaty | | | | | | (14) | | | | | | (14), (15) | | | | | | (14) | | |

(3)The basic product patent for Sutent expired in the U.S. in August 2021 and in Europe in January 2022.

For Eliquis in the U.S., two patents listed in the FDA Orange Book, the composition of matter patent claiming apixaban specifically and a formulation patent, were challenged by numerous generic companies and were the subject of patent infringement litigation.

Prior to the resolution of the litigation in our favor on both challenged patents, we and BMS settled with a number of these generic companies (settled generic companies) while continuing to litigate against three remaining generic companies (remaining generic companies).

Under the terms of the settlement agreements, the permitted date of launch for the settled generic companies under these patents is April 1, 2028.

Both patents may be subject to subsequent challenges.

Certain legal proceedings in which we are involved are discussed in [removed: *Note 16A*.][added: *[Note 16](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238)[A](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238)*.]

Each holds the office or offices indicated until his or her successor is chosen and qualified at the regular meeting of the BOD to be held on the date of the [removed: 2022] [added: 2023] Annual Meeting of Shareholders, or until his or her earlier death, resignation or removal.

| Albert Bourla | | | | | | [removed: 60] [added: 61] | | | | | | Chairman of the Board since January 2020 and Chief Executive Officer since January 2019. Chief Operating Officer from January 2018 until December 2018. Group President, Pfizer Innovative Health from June 2016 until December 2017. Group President, Global Innovative Pharma Business (responsible for Vaccines, Oncology and Consumer Healthcare since 2014) from February 2016 until June 2016. President and General Manager of Established Products Business Unit from December 2010 until December 2013. Our Director since February 2018. | | |

| Mikael Dolsten | | | | | | [removed: 63] [added: 64] | | | | | | Chief Scientific [removed: Officer,] [added: Officer and] President, Worldwide Research, Development and Medical since January 2019. President of Worldwide Research and Development from December 2010 until December 2018. Senior Vice President; President of Worldwide Research and Development from May 2010 until December 2010. Senior Vice President; President of Pfizer BioTherapeutics Research & Development Group from October 2009 until May 2010. Director of Agilent Technologies, Inc, and Vimian Group AB. [added: Director of Karyopharm Therapeutics Inc. from 2015 to 2021.] | | |

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | 23 | | |

| Lidia Fonseca | | | | | | [removed: 53] [added: 54] | | | | | | Chief Digital and Technology Officer, Executive Vice President since January 2019. Chief Information Officer and Senior Vice President of Quest Diagnostics Incorporated from 2014 to 2018. Senior Vice President of Laboratory Corporation of America Holdings from 2008 until March 2013. Director of Tegna, Inc. [added: and Medtronic plc.] | | |

| Angela Hwang | | | | | | [removed: 56] [added: 57] | | | | | | [removed: Group] [added: Chief Commercial Officer since October 2022 and] President, [removed: Pfizer] [added: Global] Biopharmaceuticals Group since January 2019. Group President, Pfizer Essential Health from January 2018 until December 2018. Global President, Pfizer Inflammation and Immunology from January 2016 until December 2017. Regional Head, U.S. Vaccines from January 2014 until December 2015. Vice President, Emerging Markets for [removed: the] Primary Care [removed: therapeutic area] from September 2011 until December 2013. Director of United Parcel Service, Inc. | | |

| Rady A. Johnson | | | | | | [removed: 60] [added: 61] | | | | | | Chief Compliance, Quality and Risk Officer, Executive Vice President since January 2019. Executive Vice President, Chief Compliance and Risk Officer from December 2013 until December 2018. Senior Vice President and Associate General Counsel from October 2006 until December 2013. | | |

| Douglas M. Lankler | | | | | | [removed: 56] [added: 57] | | | | | | General Counsel, Executive Vice President since December 2013. Corporate Secretary from January 2014 until February 2014. Executive Vice President, Chief Compliance and Risk Officer from February 2011 until December 2013. Executive Vice President, Chief Compliance Officer from December 2010 until February 2011. | | |

| Aamir Malik | | | | | | [removed: 46] [added: 47] | | | | | | Chief Business Innovation Officer, Executive Vice President since August 2021. Various U.S. geographic leadership roles with McKinsey & Company from 2019 to 2021; previously co-led McKinsey & Company’s Global Pharmaceuticals & Medical Products practice from 2015 to 2018. | | |

| Michael McDermott | | | | | | [removed: 56] [added: 57] | | | | | | Chief Global Supply Officer, Executive Vice President since January 2022. President of Pfizer Global Supply from 2018 until 2021. Vice President of Pfizer Global Supply from 2014 until 2018. Vice President of the Biotechnology Unit from 2012 until 2014. | | |

| Payal Sahni | | | | | | [removed: 47] [added: 48] | | | | | | Chief People Experience Officer, Executive Vice President since January 2022. Chief Human Resources Officer, Executive Vice President from June 2020 to December 2021. From May 2016 until June 2020 served as Senior Vice President of Human Resources for multiple operating units. Vice President of Human Resources, Vaccines, Oncology & Consumer from 2015 until 2016. Ms. Sahni has served in a number of positions in the Human Resources organization with increasing responsibility since joining Pfizer in 1997. | | |

| Sally Susman | | | | | | [removed: 60] [added: 61] | | | | | | Chief Corporate Affairs Officer, Executive Vice President since January 2019. Executive Vice President, Corporate Affairs (formerly Policy, External Affairs and Communications) from December 2010 until December 2018. Senior Vice President, Policy, External Affairs and Communications from December 2009 until December 2010. Director of WPP [removed: plc.] [added: plc from 2013 to 2022.] | | |

| David M. Denton | | | | | | 57 | | | | | | Chief Financial Officer, Executive Vice President since May 2022. Executive Vice President, Chief Financial Officer, Lowe’s Companies, Inc., from November 2018 until April 2022; Executive Vice President and Chief Financial Officer, CVS Health Corporation (a diversified health solutions company), from January 2010 until November 2018. Director of Tapestry, Inc. Effective March 1, 2023, Director of Haleon plc. | | |

| William Pao | | | | | | 56 | | | | | | Chief Development Officer, Executive Vice President since March 2022. Head of Roche Pharma Research & Early Development (pRED) and member of Roche’s Enlarged Corporate Executive Committee from 2018 until March 2022; Senior Vice President, Global Head Oncology Discovery and Translational Area at Roche pRED from 2014 until 2018. Vanderbilt University Medical Center Adjunct Professor from 2014 to present. | | |

| William Carapezzi | | | | | | 64 | | | | | | Executive Vice President, Global Business Services and Transformation since June 2020. Senior Vice President of Global Business Operations from June 2013 until June 2020. Senior Vice President of Global Tax from 2008 until June 2013. | | |

| Frank A. D’Amelio | | | | | | 64 | | | | | | Chief Financial Officer, Executive Vice President since January 2022. Chief Financial Officer and Executive Vice President, Global Supply from June 2020 until December 2021. Chief Financial Officer, Executive Vice President, Business Operations and Global Supply from November 2018 until June 2020. Executive Vice President, Business Operations and Chief Financial Officer from December 2010 until October 2018. Senior Vice President and Chief Financial Officer from September 2007 until December 2010. Director of Zoetis Inc. and Humana Inc. and Chair of the Humana Inc. Board of Directors’ Audit Committee. | | |

For the fiscal year ended December 31, [removed: 2021][added: 2022]

[removed: ][added: ]

The aggregate market value of the voting stock held by non-affiliates of the registrant, computed by reference to the closing price as of the last business day of the registrant’s most recently completed second fiscal quarter, July [removed: 4, 2021,] [added: 3, 2022,] was approximately [removed: $223] [added: $294] billion.

This excludes shares of common stock held by directors and executive officers at July [removed: 4, 2021.][added: 3, 2022.]

The number of shares outstanding of the registrant’s common stock as of February [removed: 22, 2022] [added: 21, 2023] was [removed: 5,623,346,471] [added: 5,619,074,621] shares of common stock, all of one class.

| Portions of the Proxy Statement for the [removed: 2022] [added: 2023] Annual Meeting of Shareholders | | | Part III | | |

| [Defined [removed: Terms](#i4bff405b2205487eb835dd4cd589f5c6_13)] [added: Terms](#i8050b09ca8a0411dbcb0b6576ce1fc7a_13)] | | | [removed: [i](#i4bff405b2205487eb835dd4cd589f5c6_13)] [added: [i](#i8050b09ca8a0411dbcb0b6576ce1fc7a_13)] | | |

| [Available [removed: Information](#i4bff405b2205487eb835dd4cd589f5c6_1754)] [added: Information](#i8050b09ca8a0411dbcb0b6576ce1fc7a_16)] | | | [removed: [iii](#i4bff405b2205487eb835dd4cd589f5c6_1754)] [added: [iii](#i8050b09ca8a0411dbcb0b6576ce1fc7a_16)] | | |

| [Forward-Looking Information and Factors that May Affect Future [removed: Results](#i4bff405b2205487eb835dd4cd589f5c6_16)] [added: Results](#i8050b09ca8a0411dbcb0b6576ce1fc7a_19)] | | | [removed: [1](#i4bff405b2205487eb835dd4cd589f5c6_16)] [added: [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_19)] | | |

| [removed: ITEM] [added: [ITEM] 1. [removed: BUSINESS] [added: BUSINESS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_25)] | | | [removed: [3](#i4bff405b2205487eb835dd4cd589f5c6_25)] [added: [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)] | | |

| [About [removed: Pfizer](#i4bff405b2205487eb835dd4cd589f5c6_25)] [added: Pfizer](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)] | | | [removed: [3](#i4bff405b2205487eb835dd4cd589f5c6_25)] [added: [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)] | | |

| [Commercial [removed: Operations](#i4bff405b2205487eb835dd4cd589f5c6_28)] [added: Operations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_31)] | | | [removed: [4](#i4bff405b2205487eb835dd4cd589f5c6_28)] [added: [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_31)] | | |

| [Collaboration and Co-Promotion [removed: Agreements](#i4bff405b2205487eb835dd4cd589f5c6_31)] [added: Agreements](#i8050b09ca8a0411dbcb0b6576ce1fc7a_34)] | | | [removed: [4](#i4bff405b2205487eb835dd4cd589f5c6_31)] [added: [5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_34)] | | |

| [Research and [removed: Development](#i4bff405b2205487eb835dd4cd589f5c6_34)] [added: Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)] | | | [removed: [5](#i4bff405b2205487eb835dd4cd589f5c6_34)] [added: [4](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)] | | |

| [International [removed: Operations](#i4bff405b2205487eb835dd4cd589f5c6_37)] [added: Operations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_40)] | | | [removed: [6](#i4bff405b2205487eb835dd4cd589f5c6_37)] [added: [5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_40)] | | |

| [Sales and [removed: Marketing](#i4bff405b2205487eb835dd4cd589f5c6_40)] [added: Marketing](#i8050b09ca8a0411dbcb0b6576ce1fc7a_43)] | | | [removed: [6](#i4bff405b2205487eb835dd4cd589f5c6_40)] [added: [6](#i8050b09ca8a0411dbcb0b6576ce1fc7a_43)] | | |

| [Patents and Other Intellectual Property [removed: Rights](#i4bff405b2205487eb835dd4cd589f5c6_43)] [added: Rights](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)] | | | [removed: [7](#i4bff405b2205487eb835dd4cd589f5c6_43)] [added: [6](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)] | | |

| [Pricing Pressures and Managed Care [removed: Organizations](#i4bff405b2205487eb835dd4cd589f5c6_49)] [added: Organizations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_52)] | | | [removed: [9](#i4bff405b2205487eb835dd4cd589f5c6_49)] [added: [9](#i8050b09ca8a0411dbcb0b6576ce1fc7a_52)] | | |

| [Raw [removed: Materials](#i4bff405b2205487eb835dd4cd589f5c6_52)] [added: Materials](#i8050b09ca8a0411dbcb0b6576ce1fc7a_55)] | | | [removed: [10](#i4bff405b2205487eb835dd4cd589f5c6_52)] [added: [9](#i8050b09ca8a0411dbcb0b6576ce1fc7a_55)] | | |

| [Government Regulation and Price [removed: Constraints](#i4bff405b2205487eb835dd4cd589f5c6_55)] [added: Constraints](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)] | | | [removed: [10](#i4bff405b2205487eb835dd4cd589f5c6_55)] [added: [10](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)] | | |

| [Environmental [removed: Matters](#i4bff405b2205487eb835dd4cd589f5c6_58)] [added: Matters](#i8050b09ca8a0411dbcb0b6576ce1fc7a_61)] | | | [removed: [12](#i4bff405b2205487eb835dd4cd589f5c6_58)] [added: [12](#i8050b09ca8a0411dbcb0b6576ce1fc7a_61)] | | |

| [Human [removed: Capital](#i4bff405b2205487eb835dd4cd589f5c6_61)] [added: Capital](#i8050b09ca8a0411dbcb0b6576ce1fc7a_64)] | | | [removed: [12](#i4bff405b2205487eb835dd4cd589f5c6_61)] [added: [12](#i8050b09ca8a0411dbcb0b6576ce1fc7a_64)] | | |

| [ITEM 1A. RISK [removed: FACTORS](#i4bff405b2205487eb835dd4cd589f5c6_67)] [added: FACTORS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)] | | | [removed: [13](#i4bff405b2205487eb835dd4cd589f5c6_67)] [added: [14](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)] | | |

| [ITEM 2. [removed: PROPERTIES](#i4bff405b2205487eb835dd4cd589f5c6_70)] [added: PROPERTIES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_73)] | | | [removed: [23](#i4bff405b2205487eb835dd4cd589f5c6_70)] [added: [23](#i8050b09ca8a0411dbcb0b6576ce1fc7a_73)] | | |

| [ITEM 3. LEGAL [removed: PROCEEDINGS](#i4bff405b2205487eb835dd4cd589f5c6_73)] [added: PROCEEDINGS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_76)] | | | [removed: [23](#i4bff405b2205487eb835dd4cd589f5c6_73)] [added: [23](#i8050b09ca8a0411dbcb0b6576ce1fc7a_76)] | | |

| [INFORMATION ABOUT OUR EXECUTIVE [removed: OFFICERS](#i4bff405b2205487eb835dd4cd589f5c6_76)] [added: OFFICERS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_79)] | | | [removed: [23](#i4bff405b2205487eb835dd4cd589f5c6_76)] [added: [23](#i8050b09ca8a0411dbcb0b6576ce1fc7a_79)] | | |

| [ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i4bff405b2205487eb835dd4cd589f5c6_82)] [added: SECURITIES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_85)] | | | [removed: [24](#i4bff405b2205487eb835dd4cd589f5c6_82)] [added: [24](#i8050b09ca8a0411dbcb0b6576ce1fc7a_85)] | | |

| [ITEM [removed: 6.](#i4bff405b2205487eb835dd4cd589f5c6_88) \[RESERVED\]] [added: 6.](#i8050b09ca8a0411dbcb0b6576ce1fc7a_91) [\[RESERVED\]](#i8050b09ca8a0411dbcb0b6576ce1fc7a_91)] | | | [removed: [25](#i4bff405b2205487eb835dd4cd589f5c6_88)] [added: [25](#i8050b09ca8a0411dbcb0b6576ce1fc7a_91)] | | |

| [ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i4bff405b2205487eb835dd4cd589f5c6_91)] [added: OPERATIONS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_94)] | | | [removed: [26](#i4bff405b2205487eb835dd4cd589f5c6_91)] [added: [25](#i8050b09ca8a0411dbcb0b6576ce1fc7a_94)] | | |

| [ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i4bff405b2205487eb835dd4cd589f5c6_139)] [added: RISK](#i8050b09ca8a0411dbcb0b6576ce1fc7a_142)] | | | [removed: [48](#i4bff405b2205487eb835dd4cd589f5c6_139)] [added: [44](#i8050b09ca8a0411dbcb0b6576ce1fc7a_142)] | | |

| [ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i4bff405b2205487eb835dd4cd589f5c6_142)] [added: DATA](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)] | | | [removed: [49](#i4bff405b2205487eb835dd4cd589f5c6_142)] [added: [45](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)] | | |

| [ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i4bff405b2205487eb835dd4cd589f5c6_247)] [added: DISCLOSURE](#i8050b09ca8a0411dbcb0b6576ce1fc7a_253)] | | | [removed: [107](#i4bff405b2205487eb835dd4cd589f5c6_247)] [added: [101](#i8050b09ca8a0411dbcb0b6576ce1fc7a_253)] | | |

| [ITEM 9A. CONTROLS AND [removed: PROCEDURES](#i4bff405b2205487eb835dd4cd589f5c6_250)] [added: PROCEDURES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_256)] | | | [removed: [107](#i4bff405b2205487eb835dd4cd589f5c6_250)] [added: [101](#i8050b09ca8a0411dbcb0b6576ce1fc7a_256)] | | |

| [ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i4bff405b2205487eb835dd4cd589f5c6_262)] [added: GOVERNANCE](#i8050b09ca8a0411dbcb0b6576ce1fc7a_268)] | | | [removed: [110](#i4bff405b2205487eb835dd4cd589f5c6_262)] [added: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_268)] | | |

| [ITEM 11. EXECUTIVE [removed: COMPENSATION](#i4bff405b2205487eb835dd4cd589f5c6_265)] [added: COMPENSATION](#i8050b09ca8a0411dbcb0b6576ce1fc7a_271)] | | | [removed: [110](#i4bff405b2205487eb835dd4cd589f5c6_265)] [added: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_271)] | | |

| [ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i4bff405b2205487eb835dd4cd589f5c6_268)] [added: MATTERS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_274)] | | | [removed: [110](#i4bff405b2205487eb835dd4cd589f5c6_268)] [added: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_274)] | | |

| [ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR [removed: INDEPENDENCE](#i4bff405b2205487eb835dd4cd589f5c6_271)] [added: INDEPENDENCE](#i8050b09ca8a0411dbcb0b6576ce1fc7a_277)] | | | [removed: [110](#i4bff405b2205487eb835dd4cd589f5c6_271)] [added: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_277)] | | |

| [ITEM 14. PRINCIPAL ACCOUNTING FEES AND [removed: SERVICES](#i4bff405b2205487eb835dd4cd589f5c6_274)] [added: SERVICES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_280)] | | | [removed: [110](#i4bff405b2205487eb835dd4cd589f5c6_274)] [added: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_280)] | | |

| [ITEM 15. EXHIBITS, FINANCIAL STATEMENT [removed: SCHEDULES](#i4bff405b2205487eb835dd4cd589f5c6_280)] [added: SCHEDULES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_286)] | | | [removed: [111](#i4bff405b2205487eb835dd4cd589f5c6_280)] [added: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_286)] | | |

| [ITEM 16. FORM 10-K [removed: SUMMARY](#i4bff405b2205487eb835dd4cd589f5c6_292)] [added: SUMMARY](#i8050b09ca8a0411dbcb0b6576ce1fc7a_298)] | | | [removed: [114](#i4bff405b2205487eb835dd4cd589f5c6_292)] [added: [108](#i8050b09ca8a0411dbcb0b6576ce1fc7a_298)] | | |

66 Hudson Boulevard East, New York, New York 10001-2192

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

| [PART I](#i8050b09ca8a0411dbcb0b6576ce1fc7a_22) | | | [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_25) | | |

| [Competition](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49) | | | [8](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49) | | |

| [PART II](#i8050b09ca8a0411dbcb0b6576ce1fc7a_82) | | | [24](#i8050b09ca8a0411dbcb0b6576ce1fc7a_82) | | |

| [PART III](#i8050b09ca8a0411dbcb0b6576ce1fc7a_265) | | | [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_265) | | |

| [PART IV](#i8050b09ca8a0411dbcb0b6576ce1fc7a_283) | | | [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_283) | | |

| [15(a)(1) Financial Statements](#i8050b09ca8a0411dbcb0b6576ce1fc7a_289) | | | [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_289) | | |

| [15(a)(2) Financial Statement Schedules](#i8050b09ca8a0411dbcb0b6576ce1fc7a_292) | | | [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_292) | | |

| [15(a)(3) Exhibits](#i8050b09ca8a0411dbcb0b6576ce1fc7a_295) | | | [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_295) | | |

| [SIGNATURES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_301) | | | [109](#i8050b09ca8a0411dbcb0b6576ce1fc7a_301) | | |

| *2021 Form 10-K* | | | Our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 | | |

| *Biopharma* | | | Global Biopharmaceuticals Business | | |

| *CGRP* | | | calcitonin gene-related peptide | | |

| *CMS* | | | Centers for Medicare & Medicaid Services | | |

| *Comirnaty | | | Unless otherwise noted, refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine | | |

| *Cond. J-NDA* | | | Conditional Japan New Drug Application | | |

| *ESG* | | | Environmental, Social and Governance | | |

| *GBT* | | | Global Blood Therapeutics, Inc. | | |

| *Haleon* | | | Haleon plc | | |

| *HHS* | | | U.S. Department of Health and Human Services | | |

| *HIPAA* | | | Health Insurance Portability and Accountability Act of 1996 | | |

| *IRA* | | | Inflation Reduction Act of 2022 | | |

| *IT* | | | information technology | | |

| *MDL* | | | Multi-District Litigation | | |

| *MSA* | | | Manufacturing Supply Agreement | | |

| *MTM change in accounting principle* | | | In the first quarter of 2021, we adopted a change in accounting principle to a more preferable policy under U.S. GAAP to immediately recognize actuarial gains and losses arising from the remeasurement of our pension and postretirement plans (MTM Accounting). | | |

| *Ono* | | | Ono Pharmaceutical Co., Ltd. | | |

| *Prevnar family* | | | Includes Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20 (adult) | | |

| *ReViral* | | | ReViral Ltd. | | |

| *SI&A* | | | selling, informational and administrative | | |

| *sNDA* | | | supplemental new drug application | | |

| *Vyndaqel family* | | | Includes Vyndaqel, Vyndamax and Vynmac | | |

*Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), have not been approved or licensed by the FDA.

- risks related to our ability to achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments, including, among other things, whether and when additional supply or purchase agreements will be reached and the risk that demand for any products may be reduced, no longer exist or not meet expectations, which may lead to excess inventory on-hand and/or in the channel or reduced revenues;

- the ability to successfully achieve our climate goals and progress our environmental sustainability priorities;

the adoption of global minimum taxation requirements outside the U.S. and potential changes to existing tax law by the current U.S. Presidential administration and Congress.

235 East 42nd Street, New York, New York 10017

| 0.250% Notes due 2022 | | | PFE22 | | | New York Stock Exchange | | |

| [PART I](#i4bff405b2205487eb835dd4cd589f5c6_19) | | | [3](#i4bff405b2205487eb835dd4cd589f5c6_22) | | |

| [Competition](#i4bff405b2205487eb835dd4cd589f5c6_46) | | | [8](#i4bff405b2205487eb835dd4cd589f5c6_46) | | |

| [PART II](#i4bff405b2205487eb835dd4cd589f5c6_79) | | | [24](#i4bff405b2205487eb835dd4cd589f5c6_79) | | |

| [PART III](#i4bff405b2205487eb835dd4cd589f5c6_259) | | | [110](#i4bff405b2205487eb835dd4cd589f5c6_259) | | |

| [PART IV](#i4bff405b2205487eb835dd4cd589f5c6_277) | | | [111](#i4bff405b2205487eb835dd4cd589f5c6_277) | | |

| [15(a)(1) Financial Statements](#i4bff405b2205487eb835dd4cd589f5c6_283) | | | [111](#i4bff405b2205487eb835dd4cd589f5c6_283) | | |

| [15(a)(2) Financial Statement Schedules](#i4bff405b2205487eb835dd4cd589f5c6_286) | | | [111](#i4bff405b2205487eb835dd4cd589f5c6_286) | | |

| [15(a)(3) Exhibits](#i4bff405b2205487eb835dd4cd589f5c6_289) | | | [111](#i4bff405b2205487eb835dd4cd589f5c6_289) | | |

| *ACA (also referred to as U.S. Healthcare Legislation)* | | | U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act | | |

| *Akcea* | | | Akcea Therapeutics, Inc. | | |

| *Anacor* | | | Anacor Pharmaceuticals, Inc. | | |

| *ASR* | | | accelerated share repurchase agreement | | |

| *Biogen* | | | Biogen Inc. | | |

| *Biopharma* | | | Pfizer Biopharmaceuticals Group | | |

| *BNT162b2 | | | Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty | | |

| *BRCA* | | | BReast CAncer susceptibility gene | | |

| *Comirnaty | | | Pfizer-BioNTech COVID-19 Vaccine, also known as BNT162b2 | | |

| *GIST* | | | gastrointestinal stromal tumors | | |

| *Ionis* | | | Ionis Pharmaceuticals, Inc. | | |

| *NMPA* | | | National Medical Product Administration in China | | |

| *PMDA* | | | Pharmaceuticals and Medical Device Agency in Japan | | |

| *Sandoz* | | | Sandoz, Inc., a division of Novartis AG | | |

| *Therachon* | | | Therachon Holding AG | | |

| *WHO* | | | World Health Organization | | |

*This Form 10-K includes discussion of the COVID-19 vaccine that Pfizer has co-developed with BioNTech (BNT162b2) and our oral COVID-19 treatment (Paxlovid).

This Form 10-K may refer to the vaccine by its brand name, Comirnaty (approved under a BLA), or as BNT162b2 (authorized under EUA).

The vaccine is FDA-approved to prevent COVID-19 in individuals 16 years of age and older.

In addition, Comirnaty/BNT162b2 is authorized by the FDA for a third dose in certain immunocompromised individuals 5 years of age and older and as a booster dose in individuals 12 years of age and older.

The FDA has issued EUAs to certain other companies for products intended for the prevention or treatment of COVID-19 and may continue to do so during the duration of the Declaration.

As of December 31, [removed: 2021,] [added: 2022,] we had [removed: 327] [added: 301] owned and leased properties, amounting to approximately [removed: 41] [added: 40] million square feet.

[removed: We expect to relocate] [added: In February 2023, we relocated] our global headquarters to the Spiral, an office building in the Hudson Yards neighborhood of New York [removed: City, with occupancy expected beginning in the second half of 2022.][added: City.]

Our PGS [removed: platform function] [added: division] is headquartered in various locations, with leadership teams primarily in New York City and in Peapack, New Jersey.

As of December 31, [removed: 2021,] [added: 2022,] PGS had responsibility for [removed: 39] [added: 36] plants around the world, [added: which manufacture products for our commercial divisions,] including in Belgium, Germany, India, Ireland, Italy, Japan, Singapore and the [removed: U.S., which manufacture products for our business.][added: U.S. Our PGS division expects to exit the Perth, Australia site in early 2023.]

See [removed: *Note 9*] [added: *[Note 9](#i8050b09ca8a0411dbcb0b6576ce1fc7a_214)*] for amounts invested in land, buildings and equipment.

In April 2018, we entered into an agreement to lease space at this property.

In July 2018, we completed the sale of our current headquarters in New York City.

We remain in a lease-back arrangement with the buyer while we complete our relocation.

PGS expects to exit three of these sites over the next several years.

As of February [removed: 22, 2022,] [added: 21, 2023,] there were [removed: 133,758] [added: 128,767] holders of record of our common stock.

The following summarizes purchases of our common stock during the fourth quarter of [removed: 2021(a):][added: 2022(a):]

(a)See [removed: *Note 12*.][added: *[Note 12](#i8050b09ca8a0411dbcb0b6576ce1fc7a_226)*.]

(b)Represents (i) [removed: 44,604] [added: 473,126] shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive programs and (ii) the open market purchase by the trustee of [removed: 2,086] [added: 2,064] shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who deferred receipt of performance share awards.

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | 24 | | |

The following graph assumes a $100 investment on December 31, [removed: 2016,] [added: 2017,] and reinvestment of all dividends, in each of the Company’s Common Stock, [removed: the S&P 500 Index, and] a composite peer group of the major U.S. and European-based pharmaceutical companies, which are: AbbVie Inc., Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Company, Eli Lilly and Company, GlaxoSmithKline plc, Johnson & Johnson, Merck & Co., Inc., Novartis AG, Roche Holding AG and Sanofi [removed: SA.][added: SA, the S&P 500 Index and the NYSE Arca Pharmaceutical Index (DRG index).]

[removed: ][added: ]

| | | | | | | [removed: 2016] [added: 2017] | | | | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | |

| October 3 through October 30, 2022 | | | 19,483 | | | | | | $ | 43.68 | | | | | — | | | | | | $ | 3,292,882,444 | |

| October 31 through November 30, 2022 | | | 39,821 | | | | | | $ | 47.85 | | | | | — | | | | | | $ | 3,292,882,444 | |

| December 1 through December 31, 2022 | | | 415,886 | | | | | | $ | 51.29 | | | | | — | | | | | | $ | 3,292,882,444 | |

| Total | | | 475,190 | | | | | | $ | 50.69 | | | | | — | | | | | | | | |

| PFIZER | | | | | | $100.0 | | | | | | $124.8 | | | | | | $116.2 | | | | | | $120.2 | | | | | | $200.4 | | | | | | $179.5 | | |

| PEER GROUP | | | | | | $100.0 | | | | | | $108.0 | | | | | | $131.3 | | | | | | $136.7 | | | | | | $159.3 | | | | | | $184.3 | | |

| S&P 500 | | | | | | $100.0 | | | | | | $95.6 | | | | | | $125.7 | | | | | | $148.8 | | | | | | $191.5 | | | | | | $156.8 | | |

| DRG Index | | | | | | $100.0 | | | | | | $107.5 | | | | | | $127.3 | | | | | | $138.4 | | | | | | $170.7 | | | | | | $183.9 | | |

| October 4 through October 31, 2021 | | | 8,817 | | | | | | $ | 44.74 | | | | | — | | | | | | $ | 5,292,881,709 | |

| November 1 through November 30, 2021 | | | 4,687 | | | | | | $ | 44.71 | | | | | — | | | | | | $ | 5,292,881,709 | |

| December 1 through December 31, 2021 | | | 33,186 | | | | | | $ | 55.35 | | | | | — | | | | | | $ | 5,292,881,709 | |

| Total | | | 46,690 | | | | | | $ | 52.27 | | | | | — | | | | | | | | |

| PFIZER | | | | | | $100.0 | | | | | | $115.8 | | | | | | $144.5 | | | | | | $134.5 | | | | | | $139.1 | | | | | | $232.0 | | |

| PEER GROUP | | | | | | $100.0 | | | | | | $117.3 | | | | | | $126.7 | | | | | | $154.0 | | | | | | $160.4 | | | | | | $186.9 | | |

| S&P 500 | | | | | | $100.0 | | | | | | $121.8 | | | | | | $116.5 | | | | | | $153.1 | | | | | | $181.3 | | | | | | $233.3 | | |

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Pfizer Inc. | | | 2021 Form 10-K | | | 25 | | |

We have audited the accompanying consolidated balance sheets of Pfizer Inc. and Subsidiary Companies (the Company) as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of income, comprehensive income, equity, and cash flows for each of the years in the three-year period ended December 31, [removed: 2021,] [added: 2022,] and the related notes (collectively, the consolidated financial statements).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, [removed: 2021,] [added: 2022,] in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in *Internal Control* \- *Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission, and our report dated February [removed: 24, 2022] [added: 23, 2023] expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.

As discussed in [removed: Note 1H] [added: [Note](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169) [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)[G](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)] to the consolidated financial statements, the Company records estimated deductions for Medicare, Medicaid, and performance-based contract rebates (collectively, U.S. rebates) as a reduction to gross product revenues.

As discussed in [removed: Notes 5D] [added: [Notes](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187) [5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187)[D](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187)] and [removed: 1*Q*,] [added: [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)[Q](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169),] the Company’s tax positions are subject to audit by local taxing authorities in each respective tax jurisdiction, and the resolution of such audits may span multiple years.

As of December 31, [removed: 2021,] [added: 2022,] the Company has recorded gross unrecognized tax benefits, excluding associated interest, of [removed: $6.1] [added: $4.5] billion.

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 49] [added: 45] | | |

We identified the evaluation of [added: certain of] the Company’s gross unrecognized tax benefits as a critical audit matter because a high degree of audit effort, including specialized skills and knowledge, and complex auditor judgment was required in evaluating the Company’s interpretation of tax law and its estimate of the ultimate resolution of its tax positions.

*Evaluation of product [added: liability] and other product-related litigation*

[removed: As discussed in Notes 1S] and [removed: 16] [added: [16](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238)] to the consolidated financial statements, the Company is involved in product liability and other product-related litigation, which can include personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, among others.

The accrued liability and/or disclosure for the pending product [added: liability] and other product-related legal proceedings requires a complex series of judgments by the Company about future events, which involves a number of uncertainties.

We identified the evaluation of product [added: liability] and other product-related litigation as a critical audit matter.

We read letters received directly from the Company’s external and internal legal counsel that described the Company’s probable or reasonably possible legal contingency to pending product [added: liability] and other product-related legal proceedings.

[removed: ][added: ]

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 50] [added: 46] | | |

| (MILLIONS, EXCEPT PER [removed: COMMON] SHARE DATA) | | | | | | | | | | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Revenues | | | | | | | | | | | | | | | $ | [removed: 81,288] [added: 100,330] | | | | | $ | [removed: 41,651] [added: 81,288] | | | | | $ | [removed: 40,905] [added: 41,651] | |

| Cost of sales(a) | | | | | | | | | | | | | | | [removed: 30,821] [added: 34,344] | | | | | | [removed: 8,484] [added: 30,821] | | | | | | [removed: 8,054] [added: 8,484] | | |

| Selling, informational and administrative expenses(a) | | | | | | | | | | | | | | | [removed: 12,703] [added: 13,677] | | | | | | [removed: 11,597] [added: 12,703] | | | | | | [removed: 12,726] [added: 11,597] | | |

| [removed: Research] [added: *Research] and development [removed: expenses(a)] [added: expenses*] | | | | | | | | | | | | | | | [removed: 13,829] | | | [added: —] | | | [removed: 9,393] | | | [added: —] | | | [removed: 8,385] | | | [added: (3) | | |]

| Amortization of intangible assets | | | | | | | | | | | | | | | [removed: 3,700] [added: 3,609] | | | | | | [removed: 3,348] [added: 3,700] | | | | | | [removed: 4,429] [added: 3,348] | | |

| Restructuring charges and certain acquisition-related costs | | | | | | | | | | | | | | | [removed: 802] [added: 1,375] | | | | | | [removed: 579] [added: 802] | | | | | | [removed: 601] [added: 579] | | |

| Other (income)/deductions––net | | | | | | | | | | | | | | | [removed: (4,878)] [added: 217] | | | | | | [removed: 1,219] [added: (4,878)] | | | | | | [removed: 3,497] [added: 1,213] | | |

| Income from continuing operations before provision/(benefit) for taxes on income | | | | | | | | | | | | | | | [removed: 24,311] [added: 34,729] | | | | | | [removed: 7,036] [added: 24,311] | | | | | | [removed: 11,321] [added: 7,036] | | |

| Provision/(benefit) for taxes on income | | | | | | | | | | | | | | | [removed: 1,852] [added: 3,328] | | | | | | [removed: 370] [added: 1,852] | | | | | | [removed: 583] [added: 370] | | |

| Income from continuing operations | | | | | | | | | | | | | | | [removed: 22,459] [added: 31,401] | | | | | | [removed: 6,666] [added: 22,459] | | | | | | [removed: 10,738] [added: 6,666] | | |

| Discontinued operations––net of tax | | | | | | | | | | | | | | | [removed: (434)] [added: 6] | | | | | | [removed: 2,529] [added: (434)] | | | | | | [removed: 5,318] [added: 2,529] | | |

| Net income before allocation to noncontrolling interests | | | | | | | | | | | | | | | [removed: 22,025] [added: 31,407] | | | | | | [removed: 9,195] [added: 22,025] | | | | | | [removed: 16,056] [added: 9,195] | | |

| Less: Net income attributable to noncontrolling interests | | | | | | | | | | | | | | | [removed: 45] [added: 35] | | | | | | [removed: 36] [added: 45] | | | | | | [removed: 29] [added: 36] | | |

| Net income attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 21,979] [added: 31,372] | | | | | $ | [removed: 9,159] [added: 21,979] | | | | | $ | [removed: 16,026] [added: 9,159] | |

| Income from continuing operations attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 4.00] [added: 5.59] | | | | | $ | [removed: 1.19] [added: 4.00] | | | | | $ | [removed: 1.92] [added: 1.19] | |

| Discontinued operations––net of tax | | | | | | | | | | | | | | | [removed: (0.08)] [added: —] | | | | | | [removed: 0.46] [added: (0.08)] | | | | | | [removed: 0.95] [added: 0.46] | | |

| Net income attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 3.92] [added: 5.59] | | | | | $ | [removed: 1.65] [added: 3.92] | | | | | $ | [removed: 2.88] [added: 1.65] | |

| Income from continuing operations attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 3.93] [added: 5.47] | | | | | $ | [removed: 1.18] [added: 3.93] | | | | | $ | [removed: 1.89] [added: 1.18] | |

| Discontinued operations––net of tax | | | | | | | | | | | | | | | [removed: (0.08)] [added: —] | | | | | | [removed: 0.45] [added: (0.08)] | | | | | | [removed: 0.94] [added: 0.45] | | |

| Net income attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 3.85] [added: 5.47] | | | | | $ | [removed: 1.63] [added: 3.85] | | | | | $ | [removed: 2.82] [added: 1.63] | |

| Weighted-average shares––basic | | | | | | | | | | | | | | | [removed: 5,601] [added: 5,608] | | | | | | [removed: 5,555] [added: 5,601] | | | | | | [removed: 5,569] [added: 5,555] | | |

| Weighted-average shares––diluted | | | | | | | | | | | | | | | [removed: 5,708] [added: 5,733] | | | | | | [removed: 5,632] [added: 5,708] | | | | | | [removed: 5,675] [added: 5,632] | | |

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 51] [added: 47] | | |

| | | | | | | [removed: Year Ended December 31,] | | | | | | | | | | | | | | | [added: | | | | | | | | | Year Ended | | |]

As discussed in [Notes](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169) [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)[S](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169).

| *February 23, 2023* | | |

| Research and development expenses(a) | | | | | | | | | | | | | | | 11,428 | | | | | | 10,360 | | | | | | 8,709 | | |

| Acquired in-process research and development expenses(b) | | | | | | | | | | | | | | | 953 | | | | | | 3,469 | | | | | | 684 | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

(a)Exclusive of amortization of intangible assets.

| Pension and postretirement benefit obligations | | | | | | 2,250 | | | | | | 3,724 | | |

| Net income | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 31,372 | | | | | | | | | | | | 31,372 | | | | | | 35 | | | | | | 31,407 | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Balance, December 31, 2022 | | | | | | — | | | | | | $ | — | | | | | 9,519 | | | | | | $ | 476 | | | | | $ | 91,802 | | | | | (3,903) | | | | | | $ | (113,969) | | | | | $ | 125,656 | | | | | $ | (8,304) | | | | | $ | 95,661 | | | | | $ | 256 | | | | | $ | 95,916 | |

| Dividend received from the Consumer Healthcare JV(b) | | | | | | 3,960 | | | | | | — | | | | | | — | | |

Beginning in the third quarter of 2022, we made several additional organizational changes to further transform our operations to better leverage our expertise in certain areas and in anticipation of potential future new product or indication launches.

These changes include establishing a new commercial structure within Biopharma, optimizing our end-to-end R&D operations and further prioritizing our internal R&D portfolio, as well as realigning certain enabling and platform functions across the organization to ensure alignment with this new operating structure.

We have made certain reclassification adjustments to conform prior-period amounts to the current presentation, mainly for acquired IPR&D expenses (see *[Note 1L](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)*).

On January 1, 2022, we early adopted a new accounting standard for contract assets and contract liabilities acquired in a business combination.

Under the new standard, acquired contract assets and contract liabilities are required to be recognized and measured by the acquirer on the acquisition date in accordance with Accounting Standards Codification 606.

This new guidance generally results in the acquirer recognizing contract assets and contract liabilities at the same amounts that were recorded by the acquiree.

Previously, these amounts were recognized by the acquirer at fair value as of the acquisition date.

We adopted this new standard on a prospective basis and there was no impact to our consolidated financial statements.

For certain contracts, the finished product may temporarily be stored at our or our third-party subcontractors’ locations under a bill-and-hold arrangement.

Revenue is recognized on bill-and-hold arrangements at the point in time when the customer obtains control of the product and all of the following criteria have been met: the arrangement is substantive; the product is identified separately as belonging to the customer; the product is ready for physical transfer to the customer; and we do not have the ability to use the product or direct it to another customer.

In determining when the customer obtains control of the product, we consider certain indicators, including whether we have a present right to payment from

the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received.

In 2022, we principally sold Paxlovid to government agencies.

| (MILLIONS) | | | | | | 2022 | | | | | | 2021 | | |

Inventories that are not expected to be sold within 12 months are classified as *Other noncurrent assets*.

In the first quarter of 2022, we began reporting acquired IPR&D expense as a separate line item in our consolidated statements of income.

*Acquired in-process research and development expenses* includes costs incurred in connection with (a) all upfront and milestone payments on

collaboration and in-license agreements, including premiums on equity securities and (b) asset acquisitions of acquired IPR&D.

These costs were previously recorded in *Research and development expenses*.

Amortization of finite-lived acquired intangible assets is included in *Amortization of intangible assets.*

For equity-method investments, an impairment charge is recorded only if and when a decline in fair value is determined to be other-than-temporary.

materially affect our financial statements in the period of settlement or when the statutes of limitations expire, as we treat these events as discrete items in the period of resolution.

*GBT––*On October 5, 2022, we acquired GBT, a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities, starting with sickle cell disease, for $68.50 per share in cash.

The total fair value of the consideration transferred was $5.7 billion ($5.2 billion, net of cash acquired).

In addition, $136 million in payments to GBT employees for the fair value of previously unvested long-term incentive awards was recognized as post-closing compensation expense and recorded in *Restructuring charges and certain acquisition-related costs* (see *[Note 3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_178)*).

In connection with this business combination, we provisionally recorded: (i) $4.4 billion in *Identifiable intangible assets*, consisting of $3.0 billion of IPR&D and $1.4 billion of developed technology rights with a useful life of six years, (ii) $1.1 billion of *Goodwill,* (iii) $681 million of inventories to be sold over approximately three years, (iv) $570 million of net deferred tax liabilities and (v) $331 million of assumed long-term debt that was paid in full in the fourth quarter of 2022.

The allocation of the consideration transferred to the assets acquired and liabilities assumed has not yet been finalized.

*Biohaven––*On October 3, 2022, we acquired Biohaven, the maker of Nurtec ODT/Vydura (rimegepant), an innovative therapy approved for both acute treatment of migraine and prevention of episodic migraine in adults.

*Change in Accounting Principle*

As discussed in Note 1C to the consolidated financial statements, the Company has elected to change its method of accounting for pension and postretirement plans in 2021 to immediately recognize actuarial gains and losses in the consolidated statements of income.

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| *February 24, 2022* | | |

Pfizer Inc. and Subsidiary Companies

| (Gain) on completion of Consumer Healthcare JV transaction | | | | | | | | | | | | | | | — | | | | | | (6) | | | | | | (8,107) | | |

(a)Exclusive of amortization of intangible assets, except as disclosed in *Note 1M.*

| | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Pension benefit obligations | | | | | | 3,489 | | | | | | 4,766 | | |

| Postretirement benefit obligations | | | | | | 235 | | | | | | 645 | | |

| Balance, January 1, 2019 | | | | | | 478 | | | | | | $ | 19 | | | | | 9,332 | | | | | | $ | 467 | | | | | $ | 86,253 | | | | | (3,615) | | | | | | $ | (101,610) | | | | | $ | 83,527 | | | | | $ | (5,249) | | | | | $ | 63,407 | | | | | $ | 351 | | | | | $ | 63,758 | |

| Net income | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 16,026 | | | | | | | | | | | | 16,026 | | | | | | 29 | | | | | | 16,056 | | |

| Preferred stock | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (1) | | | | | | | | | | | | (1) | | | | | | | | | | | | (1) | | |

| Preferred stock conversions and redemptions | | | | | | (47) | | | | | | (2) | | | | | | | | | | | | | | | | | | (3) | | | | | | — | | | | | | 1 | | | | | | | | | | | | | | | | | | (4) | | | | | | | | | | | | (4) | | |

| Preferred stock | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | — | | | | | | | | | | | | — | | |

| Other | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | (85) | | | | | | | | | | | | (85) | | | | | | (7) | | | | | | (92) | | |

| TCJA impact | | | | | | — | | | | | | — | | | | | | (323) | | |

| Gain on completion of Consumer Healthcare JV transaction, net of cash conveyed(a) | | | | | | — | | | | | | (6) | | | | | | (8,254) | | |

| 32% equity-method investment in the Consumer Healthcare JV received in exchange for contributing Pfizer’s Consumer Healthcare business(a) | | | | | | — | | | | | | — | | | | | | 15,711 | | |

(a)The $8.3 billion *Gain on completion of Consumer Healthcare JV transaction, net of cash conveyed* reflects the receipt of a 32% equity-method investment in the new company initially valued at $15.7 billion in exchange for net assets contributed of $7.6 billion and is presented in operating activities net of $146 million cash conveyed that is reflected in *Other investing activities, net*.

Notes to Consolidated Financial Statements

The assets and liabilities associated with Meridian and the Mylan-Japan collaboration are classified as assets and liabilities of discontinued operations as of December 31, 2020.

Certain prior year amounts have been reclassified to conform with the current year presentation.

On January 1, 2021, we adopted a new accounting standard for income tax that eliminates certain exceptions to the guidance related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences.

The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill.

The adoption of this guidance did not have a material impact on our consolidated financial statements.

Change in Accounting Principle*

Under the prior policy, we deferred recognition of these gains and losses in *Accumulated other comprehensive loss*.

The accumulated actuarial gains/losses outside of a “corridor” were then amortized into net periodic benefit costs over the average remaining service period or the average life expectancy of participants.

This change has been applied to all pension and postretirement plans on a retrospective basis for all prior periods presented, and as of January 1, 2019, resulted in a cumulative effect decrease to *Retained earnings* of $6.0 billion, with a corresponding offset to *Accumulated other comprehensive loss*.

We believe that MTM Accounting is a more preferable policy as it provides improved transparency of results and performance, better alignment with fair value accounting principles and a better reflection of current economic and interest rate trends on plan investments and assumptions and the actuarial impact of plan remeasurements.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| The impacts of the adjustments on our consolidated financial statements are summarized as follows: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (MILLIONS, EXCEPT PER COMMON SHARE DATA) | | | | | | Previous Accounting Principle | | | | | | Impact of Change | | | | | | As Reported | | | | | | Previous Accounting Principle | | | | | | Impact of Change | | | | | | As Adjusted | | | | | | Previous Accounting Principle | | | | | | Impact of Change | | | | | | As Adjusted | | |

| Consolidated Statements of Income: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| *(Gain) on completion of Consumer Healthcare JV transaction* | | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | (6) | | | | | $ | — | | | | | $ | (6) | | | | | $ | (8,086) | | | | | $ | (21) | | | | | $ | (8,107) | |

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 107] [added: 101] | | |

We have audited Pfizer Inc. and Subsidiary Companies’ (the Company) internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in *Internal Control*—*Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2021,] [added: 2022,] based on criteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] the related consolidated statements of income, comprehensive income, equity, and cash flows for each of the years in the three-year period ended December 31, [removed: 2021,] [added: 2022,] and the related notes (collectively, the consolidated financial statements), and our report dated February [removed: 24, 2022] [added: 23, 2023] expressed an unqualified opinion on those consolidated financial statements.

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying [removed: Management’s] [added: [Management’s] Report on Internal Control Over Financial [removed: Reporting.][added: Reporting](#i8050b09ca8a0411dbcb0b6576ce1fc7a_262).]

[removed: ][added: ]

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 108] [added: 102] | | |

Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]

Based on our assessment and those criteria, management believes that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2021.][added: 2022.]

| [removed: ] [added: ] | | | | | | | | |

| [removed: ] [added: ] | | | | | | [removed: ] [added: ] | | |

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 109] [added: 103] | | |

| *February 23, 2023* | | |

| David M. Denton | | | | | | Jennifer B. Damico | | |

| *February 23, 2023* | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| *February 24, 2022* | | |

| Frank D’Amelio | | | | | | Jennifer B. Damico | | |

| *February 24, 2022* | | | | | | | | |

Information about the Pfizer Policies on Business Conduct governing our employees, including our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer, and the Code of Business Conduct and Ethics for Members of the Board of Directors, is incorporated by reference from the discussions under the headings [removed: *Governance*—*Pfizer] [added: *Governance Overview*—*Pfizer] Policies on Business Conduct* and —*Code of Conduct for Directors* in our Proxy Statement.

Information regarding the procedures by which our shareholders may recommend nominees to our Board of Directors is incorporated by reference from the discussion under the headings *Item 1*—*Election of Directors*—*Criteria for Board Membership* and *Annual Meeting Information—Submitting Proxy Proposals and Director Nominations for the [removed: 2023] [added: 2024] Annual Meeting* in our Proxy Statement.

Information about our Audit Committee, including the members of the Committee, and our Audit Committee financial experts, is incorporated by reference from the discussion under the heading [removed: *Governance*—*Board] [added: *Governance Overview*—*Board] and Committee Information*—*Board Committees—The Audit Committee* in our Proxy Statement.

The balance of the information required by this item is contained in the discussion entitled [removed: *Information] [added: *[Information] about Our Executive [removed: Officers*] [added: Officers](#i8050b09ca8a0411dbcb0b6576ce1fc7a_79)*] in this Form 10-K.

Information about Director and executive compensation is incorporated by reference from the discussion under the headings *Non-Employee Director Compensation*; *Executive Compensation*; and [removed: *Governance—Board] [added: *Governance Overview—Board] and Committee Information—Board Committees*—*The Compensation Committee*—*Compensation Committee Interlocks and Insider Participation* in our Proxy Statement.

Information about certain relationships and transactions with related parties is incorporated by reference from the discussion under the headings [removed: *Governance*—*Other] [added: *Governance Overview*—*Other] Governance Practices and Policies—Related Person Transactions and Indemnification* and —*Transactions with Related Persons* in our Proxy Statement.

Information about the fees for professional services rendered by our independent registered public accounting firm in [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] is incorporated by reference from the discussion under the heading *Item 2*—*Ratification of Selection of Independent Registered Public Accounting Firm*—*Audit and Non-Audit Fees* in our Proxy Statement.

| | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Pfizer Inc. | | | 2021 Form 10-K | | | 110 | | |

15(a)(1) Financial Statements. The following consolidated financial statements, related [removed: notes,] [added: notes and] report of independent registered public accounting firm [removed: and supplementary data] are set forth in [removed: *Item] [added: *[Item] 8.

Financial Statements and Supplementary [removed: Data*] [added: Data](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)*] in this Form 10-K:

- [removed: Report] [added: [Report] of Independent Registered Public Accounting Firm on the Consolidated Financial [removed: Statements][added: Statements](#i8050b09ca8a0411dbcb0b6576ce1fc7a_148)]

- [removed: Consolidated] [added: [Consolidated] Statements of [removed: Income][added: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_151)]

- [removed: Consolidated] [added: [Consolidated] Statements of Comprehensive [removed: Income][added: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_154)]

- [removed: Consolidated] [added: [Consolidated] Balance [removed: Sheets][added: Sheets](#i8050b09ca8a0411dbcb0b6576ce1fc7a_157)]

- [removed: Consolidated] [added: [Consolidated] Statements of [removed: Equity][added: Equity](#i8050b09ca8a0411dbcb0b6576ce1fc7a_160)]

- [removed: Consolidated] [added: [Consolidated] Statements of Cash [removed: Flows][added: Flows](#i8050b09ca8a0411dbcb0b6576ce1fc7a_163)]

- [removed: Notes] [added: [Notes] to Consolidated Financial [removed: Statements][added: Statements](#i8050b09ca8a0411dbcb0b6576ce1fc7a_166)]

Requests should be directed to our Corporate Secretary, Pfizer Inc., [removed: 235 East 42nd Street,] [added: 66 Hudson Boulevard East,] New York, New York [removed: 10017.][added: 10001-2192.]

Exhibit numbers 10.1 through [removed: 10.44] [added: 10.47] are management contracts or compensatory plans or arrangements.

| [removed: [3.2](http://www.sec.gov/Archives/edgar/data/78003/000007800317000057/exh31_by-laws20171.htm)] [added: [3.2](https://www.sec.gov/Archives/edgar/data/78003/000007800322000107/bylaws_exh31.htm)] | | | | | | Our By-laws, as amended December [removed: 18, 2017,] [added: 9, 2022,] are incorporated by reference from our Current Report on Form 8-K filed on December [removed: 21, 2017.] [added: 13, 2022.] | | |

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 111] [added: 104] | | |

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 112] [added: 105] | | |

| [removed: *[4.24](https://www.sec.gov/Archives/edgar/data/78003/000007800322000027/pfe-exh424x12312021x10k.htm)] [added: *[4.24](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh424x12312022x10k.htm)] | | | | | | Description of Pfizer’s Securities. | | |

| [removed: [10.11](http://www.sec.gov/Archives/edgar/data/78003/000007800316000096/pfe-4032016x10qexhibit101.htm)] [added: [10.12](http://www.sec.gov/Archives/edgar/data/78003/000007800316000096/pfe-4032016x10qexhibit101.htm)] | | | | | | Pfizer Supplemental Savings Plan is incorporated by reference from our Quarterly Report on Form 10-Q for the period ended April 3, 2016. | | |

| [removed: [10.12](http://www.sec.gov/Archives/edgar/data/78003/000007800317000049/pfe-10012017x10qexhibit101.htm)] [added: [10.13](http://www.sec.gov/Archives/edgar/data/78003/000007800317000049/pfe-10012017x10qexhibit101.htm)] | | | | | | Amendment No. 1 to the Pfizer Supplemental Savings Plan (Amended and Restated as of January 1, 2016), is incorporated by reference from our Quarterly Report on Form 10-Q for the period ended October 1, 2017. | | |

| [removed: [10.13](http://www.sec.gov/Archives/edgar/data/78003/000007800318000027/pfe-exhibit109x1231201.htm)] [added: [10.14](http://www.sec.gov/Archives/edgar/data/78003/000007800318000027/pfe-exhibit109x1231201.htm)] | | | | | | Amendment No. 2 to the Pfizer Supplemental Savings Plan is incorporated by reference from our 2017 Annual Report on Form 10-K. | | |

| [removed: [10.14](http://www.sec.gov/Archives/edgar/data/78003/000007800318000091/pfe-930201810qxexhibit101.htm)] [added: [10.15](http://www.sec.gov/Archives/edgar/data/78003/000007800318000091/pfe-930201810qxexhibit101.htm)] | | | | | | Amendment No. 3 to the Pfizer Supplemental Savings Plan is incorporated by reference from our Quarterly Report on Form 10-Q for the period ended September 30, 2018. | | |

| [removed: [10.15](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1012x12312018x1.htm)] [added: [10.16](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1012x12312018x1.htm)] | | | | | | Amendment No. 4 to the Pfizer Supplemental Savings Plan is incorporated by reference from our 2018 Annual Report on Form 10-K. | | |

| [removed: [10.16](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1013x12312018x1.htm)] [added: [10.17](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1013x12312018x1.htm)] | | | | | | Amendment No. 5 to the Pfizer Supplemental Savings Plan is incorporated by reference from our 2018 Annual Report on Form 10-K. | | |

| [removed: [10.17](http://www.sec.gov/Archives/edgar/data/78003/000007800319000064/pfe-630201910qxexh101.htm)] [added: [10.18](http://www.sec.gov/Archives/edgar/data/78003/000007800319000064/pfe-630201910qxexh101.htm)] | | | | | | Amendment No. 6 to the Pfizer Supplemental Savings Plan is incorporated by reference from our Quarterly Report on Form 10-Q for the period ended June 30, 2019. | | |

| [removed: [10.18](http://www.sec.gov/Archives/edgar/data/78003/000007800320000014/pfe-ex1015x12312019xk.htm)] [added: [10.19](http://www.sec.gov/Archives/edgar/data/78003/000007800320000014/pfe-ex1015x12312019xk.htm)] | | | | | | Amendment No. 7 to the Pfizer Supplemental Savings Plan is incorporated by reference from our 2019 Annual Report on Form 10-K. | | |

| [removed: [10.19](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1019x123120x10k.htm)] [added: [10.20](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1019x123120x10k.htm)] | | | | | | Amendment No. 8 to the Pfizer Supplemental Savings Plan is incorporated by reference from our 2020 Annual Report on Form 10-K. | | |

| [removed: [10.20](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1020x12312020x10k.htm)] [added: [10.21](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1020x12312020x10k.htm)] | | | | | | Amendment No. 9 to the Pfizer Supplemental Savings Plan is incorporated by reference from our 2020 Annual Report on Form 10-K. | | |

| [removed: [10.21](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1021x123120x10k.htm)] [added: [10.27](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1025x123120x10k.htm)] | | | | | | [added: Amendment No. 3 to] Amended and Restated [removed: Pfizer Inc. Global Performance] [added: Deferred Compensation] Plan is incorporated by reference from our 2020 Annual Report on Form 10-K. | | |

| [removed: [10.22](http://www.sec.gov/Archives/edgar/data/78003/000007800313000006/pfe-12312012xex109.htm)] [added: [10.24](http://www.sec.gov/Archives/edgar/data/78003/000007800313000006/pfe-12312012xex109.htm)] | | | | | | Amended and Restated Deferred Compensation Plan is incorporated by reference from our 2012 Annual Report on Form 10-K. | | |

| [removed: [10.23](http://www.sec.gov/Archives/edgar/data/78003/000007800314000018/pfe-12312013xex1011.htm)] [added: [10.25](http://www.sec.gov/Archives/edgar/data/78003/000007800314000018/pfe-12312013xex1011.htm)] | | | | | | Amendment to Amended and Restated Deferred Compensation Plan, dated June 20, 2013, is incorporated by reference from our 2013 Annual Report on Form 10-K. | | |

| [removed: [10.2](http://www.sec.gov/Archives/edgar/data/78003/000007800316000105/pfe-07032016x10qexhibit101.htm)[4](http://www.sec.gov/Archives/edgar/data/78003/000007800316000105/pfe-07032016x10qexhibit101.htm)] [added: [10.26](http://www.sec.gov/Archives/edgar/data/78003/000007800316000105/pfe-07032016x10qexhibit101.htm)] | | | | | | Amendment No. 2 to Amended and Restated Deferred Compensation Plan, dated April 27, 2016, is incorporated by reference from our Quarterly Report on Form 10-Q for the period ended July 3, 2016. | | |

| [removed: [10.2](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1025x123120x10k.htm)[5](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1025x123120x10k.htm)] [added: [10.29](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1027x123120x10k.htm)] | | | | | | Amendment No. [removed: 3] [added: 2] to [removed: Amended and Restated] [added: Wyeth 2005 (409A)] Deferred Compensation Plan is incorporated by reference from our 2020 Annual Report on Form 10-K. | | |

| [removed: [10.26](http://www.sec.gov/Archives/edgar/data/78003/000007800314000018/pfe-12312013xex1014.htm)] [added: [10.28](http://www.sec.gov/Archives/edgar/data/78003/000007800314000018/pfe-12312013xex1014.htm)] | | | | | | Wyeth 2005 (409A) Deferred Compensation Plan (frozen as of January 2012), together with certain Amendments, is incorporated by reference from our 2013 Annual Report on Form 10-K. | | |

| [removed: [10.27](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1027x123120x10k.htm)] [added: [10.38](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1036x123120x10k.htm)] | | | | | | Amendment No. [removed: 2] [added: 3] to [removed: Wyeth 2005 (409A) Deferred Compensation] [added: the Pfizer Inc. Executive Severance] Plan is incorporated by reference from our 2020 Annual Report on Form 10-K. | | |

| [removed: [10.2](http://www.sec.gov/Archives/edgar/data/78003/000119312512085703/d278590dex1011.htm)[8](http://www.sec.gov/Archives/edgar/data/78003/000119312512085703/d278590dex1011.htm)] [added: [10.30](http://www.sec.gov/Archives/edgar/data/78003/000119312512085703/d278590dex1011.htm)] | | | | | | Amended and Restated Wyeth Supplemental Employee Savings Plan (effective as of January 1, 2005 and frozen as of January 2012), together with all material Amendments is incorporated by reference from our 2011 Annual Report on Form 10-K. | | |

| [removed: [10.29](http://www.sec.gov/Archives/edgar/data/78003/000007800314000018/pfe-12312013xex1016.htm)] [added: [10.31](http://www.sec.gov/Archives/edgar/data/78003/000007800314000018/pfe-12312013xex1016.htm)] | | | | | | Amendment to Amended and Restated Wyeth Supplemental Employee Savings Plan, dated June 20, 2013, is incorporated by reference from our 2013 Annual Report on Form 10-K. | | |

| [removed: [10.30](http://www.sec.gov/Archives/edgar/data/78003/0000950116-97-000605.txt)] [added: [10.32](http://www.sec.gov/Archives/edgar/data/78003/0000950116-97-000605.txt)] | | | | | | The form of Indemnification Agreement with each of our non-employee Directors is incorporated by reference from our 1996 Annual Report on Form 10-K. | | |

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 113] [added: 106] | | |

| [removed: [10.31](http://www.sec.gov/Archives/edgar/data/78003/0000940180-98-000332.txt)] [added: [10.33](https://www.sec.gov/Archives/edgar/data/78003/0000940180-98-000332.txt)] | | | | | | The form of Indemnification Agreement with each of the Named Executive Officers identified in our Proxy Statement for the [removed: 2021] [added: 2022] Annual Meeting of Shareholders is incorporated by reference from our 1997 Annual Report on Form 10-K. | | |

| [removed: [10.32](http://www.sec.gov/Archives/edgar/data/78003/000007800307000213/ex101822.htm)] [added: [10.34](https://www.sec.gov/Archives/edgar/data/78003/000007800307000213/ex101822.htm)] | | | | | | Letter to Frank A. D’Amelio regarding replacement pension benefit dated August 22, 2007 is incorporated by reference from our Current Report on Form 8-K filed on August 22, 2007. | | |

| [removed: [10.3](http://www.sec.gov/Archives/edgar/data/78003/000007800309000024/exhf09.htm)[3](http://www.sec.gov/Archives/edgar/data/78003/000007800309000024/exhf09.htm)] [added: [10.35](http://www.sec.gov/Archives/edgar/data/78003/000007800309000024/exhf09.htm)] | | | | | | Pfizer Inc. Executive Severance Plan is incorporated by referenced from our Current Report on Form 8-K filed on February 20, 2009. | | |

| [removed: [10.3](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1026x12312018x1.htm)[4](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1026x12312018x1.htm)] [added: [10.36](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1026x12312018x1.htm)] | | | | | | Amendment No. 1 to the Pfizer Inc. Executive Severance Plan is incorporated by reference from our 2018 Annual Report on Form 10-K. | | |

| *[10.11](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh1011x12312022x10k.htm) | | | | | | Amendment No. 3 to the Pfizer Consolidated Supplemental Pension Plan for United States and Puerto Rico Employees. | | |

| *[10.22](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh1022x12312022x10k.htm) | | | | | | Amendment No. 10 to the Pfizer Supplemental Savings Plan. | | |

| *[10.23](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh1023x12312022x10k.htm) | | | | | | Amended and Restated Pfizer Inc. Global Performance Plan. | | |

| Pfizer Inc. | | | 2022 Form 10-K | | | 107 | | |

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- Selected Quarterly Financial Data (Unaudited)

| Pfizer Inc. | | | [removed: 2021] [added: 2022] Form 10-K | | | [removed: 114] [added: 108] | | |

| Dated: February [removed: 24, 2022] [added: 23, 2023] | | | By: | | | | | | /S/ MARGARET M. MADDEN | | |

| /S/ ALBERT BOURLA Albert Bourla | | | [removed: Chairman and] [added: Chairman,] Chief Executive Officer [added: and Director] (Principal Executive Officer) | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ [removed: FRANK A. D’AMELIO Frank A. D’Amelio] [added: DAVID M. DENTON David M. Denton] | | | Chief Financial Officer, Executive Vice President (Principal Financial Officer) | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ JENNIFER B. DAMICO Jennifer B. Damico | | | Senior Vice President and Controller (Principal Accounting Officer) | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ RONALD E. BLAYLOCK Ronald E. Blaylock | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ SUSAN DESMOND-HELLMANN Susan Desmond-Hellmann | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ JOSEPH J. ECHEVARRIA Joseph J. Echevarria | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ SCOTT GOTTLIEB Scott Gottlieb | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ HELEN H. HOBBS Helen H. Hobbs | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ SUSAN HOCKFIELD Susan Hockfield | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ DAN R. LITTMAN Dan R. Littman | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ SHANTANU NARAYEN Shantanu Narayen | | | Director | | | February [removed: 22, 2022] [added: 23, 2023] | | | | | | | | |

| /S/ SUZANNE NORA JOHNSON Suzanne Nora Johnson | | | Director | | | February [removed: 22, 2022] [added: 21, 2023] | | | | | | | | |

| /S/ JAMES QUINCEY James Quincey | | | Director | | | February 22, [removed: 2022] [added: 2023] | | | | | | | | |