Pfizer (PFE) 10-K risk factor changes: FY2023 vs FY2022
The 2023-12-31 10-K against the 2022-12-31 one, compared heading by heading and sentence by sentence.
Item 1A139 rewritten69 added29 removed223 unchanged
All filing items1,869 rewritten1,025 added595 removed2,912 unchanged
Summary
counted, not written
- Item 1A lists 3 risk factor headings: 0 new, 0 reworded and 3 unchanged since FY2022. 0 headings from FY2022 no longer appear.
- Sentence by sentence, 1,025 added, 595 removed, 1,869 rewritten and 2,912 unchanged across 17 items that differ.
- New this year: Item 1C. CYBERSECURITY; Item 9B. OTHER INFORMATION.
New Item 1A headings (0)
No risk factor heading in this filing is absent from FY2022.
Removed Item 1A headings (0)
Every FY2022 risk factor heading is still here, word for word or reworded.
A heading is new when no FY2022 heading matches it after ignoring case and punctuation, and reworded when it shares at least 60 percent of its words with one that went away. All current risk factor headings.
Sentences by item
21 items, with every count and a link to each item that changed
Underlined words on a shaded ground are new in FY2023; struck-through words were in FY2022. Sentences that are wholly new or wholly gone are labelled rather than marked.
Item 1A. RISK FACTORS
139 rewritten, 69 added, 29 removed, 223 unchanged
The following discussion of risk factors contains forward-looking statements, as discussed in the* *[Forward-Looking Information and Factors that May Affect Future [removed: Results](#i8050b09ca8a0411dbcb0b6576ce1fc7a_19)* *section in this Form 10-K.*][added: Results](#i2a2412fd329d412096454ccea3d9368c_19)* *section.*]
Private [removed: payers,] [added: payors,] such as health plans, and other managed care entities, such as PBMs, continue to take action to manage the utilization and costs of [removed: drugs.][added: drugs in the U.S., the single largest market for biopharmaceutical products.]
The negotiating power of MCOs and other private third-party [removed: payers] [added: payors] has increased due to consolidation, and they, along with [added: state and federal] governments, increasingly employ formularies to control costs and encourage utilization of certain drugs, including through the use of [removed: formulary inclusion] [added: deductibles, utilization management tools, cost sharing] or [removed: favorable] formulary placement.
These initiatives have increased consumers’ interest [added: in drug prices] and input in medication choices, as they pay for a larger portion of their prescription costs and may cause them to favor lower-cost generic alternatives.
We may fail to obtain or maintain timely or adequate pricing or formulary placement of our products, or fail to obtain such formulary placement at favorable [removed: pricing.][added: pricing net of rebates.]
The growing availability and use of innovative specialty pharmaceutical medicines that treat rare or [removed: life-threatening] [added: life threatening] conditions, [removed: which] typically [removed: have smaller patient populations, combined] with [removed: their relative] [added: a relatively] higher cost as compared to other types of pharmaceutical products, also has generated increased [removed: payer] [added: payor] interest in [removed: developing] [added: development of] cost-containment [removed: strategies targeted to this sector.][added: strategies.]
Third-party [removed: payers] [added: payors] also use additional measures such as new-to-market blocks, exclusion lists, indication-based pricing and value-based pricing/contracting to improve their cost containment [removed: efforts.][added: efforts and cost efficiency.]
Such [removed: payers] [added: payors] are also increasingly imposing utilization management [removed: tools, such as clinical protocols,] [added: tools] requiring prior authorization for a branded product [removed: if a generic product is available] or requiring the patient to first fail on one or more [removed: generic] [added: other] products before permitting access to a [added: particular] branded medicine.
As the U.S. private third-party [removed: payer] [added: payor] market consolidates [removed: further] [added: further,] and as [removed: more drugs] [added: the IRA prices] become [removed: available in generic form,] [added: publicly available,] we may face greater pricing pressure from private third-party [removed: payers] [added: payors] as they continue to drive more of their patients to use lower cost [removed: generic alternatives.][added: alternatives]
Competitive product launches [added: have and] may erode future sales of our products, including our existing products and those currently under development, or result in [removed: unanticipated] product obsolescence.
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, [added: exclusionary contracting,] lower prices, equivalent or superior efficacy, better safety profiles, easier administration, earlier market availability or other competitive features.
For additional [removed: information,] [added: information on the IRA,] see the *[Item 1.
Business—Patents and Other Intellectual Property [removed: Rights](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)* section in this Form 10-K.][added: Rights](#i2a2412fd329d412096454ccea3d9368c_46)* section.]
In China, we expect to continue to face intense competition by certain generic manufacturers, which [removed: have] [added: has] resulted, and may result in the future, in price cuts and volume loss of some of our products.
Generic and biosimilar manufacturers have filed or could file applications with the FDA seeking approval of product candidates that they claim do not infringe our [added: or our collaboration and licensing partners’] patents or claim that our [added: or our collaboration and licensing partners’] patents are not valid.
[removed: Our] [added: We and our] licensing and collaboration partners also face challenges [added: in various jurisdictions] by generic drug manufacturers to patents covering products for which we have [added: patent rights,] licenses or co-promotion rights.
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 [removed: innovative] [added: reference] product, or misaligned financial incentives for certain prescribers.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 14] [added: 16] | | |
We recorded direct product and/or Alliance revenues of more than $1 billion for each of [removed: ten] [added: nine] products that collectively accounted for [removed: 82%] [added: 64%] of [removed: our total revenues] [added: *Total revenues*] in [removed: 2022.][added: 2023.]
In particular, Comirnaty [removed: and Paxlovid together] accounted for [removed: 57%] [added: 19%] of [removed: our total revenues] [added: *Total revenues*] in [removed: 2022.][added: 2023.]
If these products or any of our other major products were [added: to, or continue] to [added: (if applicable),] experience loss of patent protection (if applicable), changes in prescription or vaccination purchasing or growth rates, reduced product demand, material product liability litigation, unexpected side effects or safety concerns, regulatory proceedings or investigations, lower governmental and/or regulatory confidence, negative publicity affecting doctor or patient confidence, pressure from 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 [removed: significant.][added: significant and our revenue forecasts and expectations could prove to be inaccurate and we may fail to meet these expectations.]
In particular, certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few [removed: years, and patents covering a number of our best-selling products are, or have been, the subject of pending legal challenges.][added: years.]
[removed: Business](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)*[Patents](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46) [and] [added: Business](#i2a2412fd329d412096454ccea3d9368c_46)*[—](#i2a2412fd329d412096454ccea3d9368c_46)*[Patents and] Other Intellectual Property [removed: Rights](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)* section in this Form 10-K.][added: Rights](#i2a2412fd329d412096454ccea3d9368c_46)* section.]
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 [removed: may not be at similar levels as those generated during] [added: have decreased substantially, and our current expectations for total COVID-19 product revenues in 2024 are lower than] the [removed: pandemic.][added: total 2023 revenues from COVID-19 products.]
[removed: Growth depends in large part on our ability to identify and develop] new products or new indications for existing products that address unmet medical needs and receive reimbursement from [removed: payers.][added: payors.]
The costs of product development continue to be [removed: high,] [added: high and are growing,] as are regulatory requirements in many therapeutic areas, which may affect the [added: complexity of drug trials, and the] number of candidates we are able to fund as well as the sustainability of the R&D portfolio.
Decisions made early in the development process of a drug or vaccine candidate can have a substantial impact on the marketing strategy and [removed: payer] [added: payor] reimbursement possibilities if the candidate receives regulatory approval.
We may fail to correctly identify [added: compounds or] indications for which our science is promising or allocate R&D investment resources efficiently, and failure to invest in the right technology platforms, therapeutic areas, product classes, geographic markets and/or licensing opportunities could adversely impact the productivity of our pipeline.
Further, even if we identify areas with the greatest commercial potential, the scientific approach may not succeed despite the significant investment required for R&D, and the product may not be as competitive as expected because of the highly dynamic [added: regulatory and] market [removed: environment] [added: environments] and the hurdles in terms of [removed: access] [added: access, coverage] and reimbursement.
For example, [added: certain of] our gene therapy product candidates are based on a novel technology with only a [removed: few] [added: handful of] gene therapies approved to date, which [removed: makes] [added: make] it difficult to predict the time and cost of development and the ability to obtain regulatory approval.
We operate on a global scale and could be affected by currency [added: and interest rate] fluctuations; capital and exchange controls; local and global economic conditions including inflation, recession, volatility and/or lack of liquidity in capital markets; expropriation and other restrictive government actions; changes in intellectual property; legal protections and remedies; trade regulations; tax laws and 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 ongoing [removed: conflict] [added: conflicts] between Russia and Ukraine and [removed: its] [added: in the Middle East and their] 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.
Some emerging market countries may be particularly vulnerable to periods of [removed: financial] [added: financial, economic] or political instability or significant currency fluctuations or may have limited resources for healthcare spending.
As a result of these and other factors, our strategy to grow in emerging markets may not be successful, and [added: any] growth rates in these markets may not be sustainable.
Additionally, local economic conditions may adversely affect the ability of [removed: payers,] [added: payors,] 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.
[removed: Business—Government] [added: Business](#i2a2412fd329d412096454ccea3d9368c_58)*[—](#i2a2412fd329d412096454ccea3d9368c_58)*[Government] Regulation and Price [removed: Constraints](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)* section in this Form 10-K.][added: Constraints](#i2a2412fd329d412096454ccea3d9368c_58)* section.]
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 15] [added: 17] | | |
Changes in the value of those currencies relative to the U.S. dollar, or high inflation [added: or deflation] in those countries, can impact our revenues, costs and expenses and our financial guidance.
[removed: 58%] [added: 54%] of our total [removed: 2022] [added: 2023] revenues were derived from international operations, including [removed: 26%] [added: 24%] from Europe and 20% from Japan, China and the rest of the Asia Pacific region.
For additional information about our exposure to foreign currency risk, see the *[Analysis of Financial Condition, Liquidity, Capital Resources and Market [removed: Risk](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)*] [added: Risk](#i2a2412fd329d412096454ccea3d9368c_139)*] section within MD&A.
The risks related to interest-bearing investments and borrowings and the measures we have taken to help contain them are discussed in the *[Analysis of Financial Condition, Liquidity, Capital Resources and Market [removed: Risk](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)*] [added: Risk](#i2a2412fd329d412096454ccea3d9368c_139)*] section within MD&A and *[Note [removed: 7E](#i8050b09ca8a0411dbcb0b6576ce1fc7a_205)*.][added: 7E](#i2a2412fd329d412096454ccea3d9368c_208)*.]
They may demand rebates from biopharmaceutical manufacturers for preferred placement on a drug formulary.
or seek even larger rebates to control costs or offset losses from the IRA.
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.
See the *[Item 1.
See *[Note 16A1](#i2a2412fd329d412096454ccea3d9368c_244).*
Business](#i2a2412fd329d412096454ccea3d9368c_49)*[—](#i2a2412fd329d412096454ccea3d9368c_49)*[Competition](#i2a2412fd329d412096454ccea3d9368c_49)* section.
See *[Notes 1](#i2a2412fd329d412096454ccea3d9368c_172)* and *[17](#i2a2412fd329d412096454ccea3d9368c_247)*.
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.
In addition, patents covering a number of our best-selling products are, or have been, the subject of pending legal challenges.
In addition, certain of our customers account for a significant portion of our revenues.
See *[Note 17C](#i2a2412fd329d412096454ccea3d9368c_549755815813)* for a discussion of our significant customers.
Growth depends in large part on our ability to identify and develop
Regulatory authorities outside the U.S. have issued updated guidance on nitrosamine acceptable intake levels.
With this recently issued guidance, which included an updated intake level for N-nitroso-varenicline, we expect to make regulatory submissions in 2024 to potentially enable Chantix to return to market outside the U.S., and our related discussions with FDA are ongoing.
Our manufacturing facility in Rocky Mount, NC was damaged by a tornado in July 2023.
While manufacturing has resumed, the supply of medicines impacted by the tornado is expected to be affected through 2024.
See the *[Overview of Our](#i2a2412fd329d412096454ccea3d9368c_97) [Performance](#i2a2412fd329d412096454ccea3d9368c_97)[, Operating Environment, Strategy and Outlook](#i2a2412fd329d412096454ccea3d9368c_97)*[—](#i2a2412fd329d412096454ccea3d9368c_97)*[Our Operating Environment](#i2a2412fd329d412096454ccea3d9368c_97) [](#i2a2412fd329d412096454ccea3d9368c_97)* section within MD&A.
We expect to see continued focus by the U.S. Congress and the Biden Administration on regulating pricing and access to medicine.
The drug pricing provisions of the IRA began to be implemented in 2022 and implementation efforts are expected to continue over the next several years.
In August 2023, the Biden Administration unveiled the first round of medicines subject to the Medicare Drug Pricing Negotiation Program, which included Eliquis.
CMS will establish a maximum fair price for Eliquis that will be in effect in 2026.
That maximum fair price will be required to be offered to all Medicare beneficiaries and to covered entities participating in the 340B Program if lower than the 340B price.
Health plans may also require rebates in addition to the maximum fair price for preferred placement on a Medicare plan formulary.
The Medicare Drug Price Negotiation Program is currently subject to legal challenges and therefore, the outcome of the 340B Program remains uncertain.
We continue to evaluate the impact of the IRA on our business, operations, financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain.
Payors may promote generic drugs and biosimilars more aggressively to generate savings and attempt to stimulate additional price competition.
In addition, we expect that consolidation and integration among pharmacy chains, wholesalers and PBMs will increase pricing pressures in the industry.
Measures to regulate prices or payment for pharmaceutical
Additionally, in the EU, the EC proposed the largest reform to drug pricing and access in 20 years, which if enacted would change regulatory exclusivity for our products.
Business](#i2a2412fd329d412096454ccea3d9368c_58)*[—](#i2a2412fd329d412096454ccea3d9368c_58)*[Government Regulation and Price Constraints](#i2a2412fd329d412096454ccea3d9368c_58)* section.
Business––Government Regulation and Price Constraints](#i2a2412fd329d412096454ccea3d9368c_58)* section.
The IRA will be implemented largely through government guidance and as its effect on Medicare and commercial markets evolve, we will continue to evaluate the potential impacts to our business.
We expect additional cost containment measures at both the federal and state levels as efforts to reduce drug costs continue.
Further, commercial payors often follow Medicare coverage policy and payment limitations when setting their own payment rates.
Any reduction in cost or other containment measures may similarly be adopted by commercial plans.
Coverage policies and reimbursement rates for commercial plans may change at any time.
Even if favorable coverage and reimbursement status is attained for one or more products, less favorable coverage policies and reimbursement rates may be implemented in the future.
- We may have difficulties recruiting and enrolling patients for clinical trials on a consistent basis.
Also, certain of our products have received and may in the future receive approvals under accelerated approval pathways where continued approval may be contingent upon confirmatory studies demonstrating the anticipated clinical benefit and/or safety profile.
to granting approval, or increased post-approval requirements.
Business](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49)*[Competition](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49)* section in this Form 10-K.
For additional information, see *[Notes 1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)* and *[17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.
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)*.
Further, gene therapy may face difficulties in gaining the acceptance of patients or the medical community.
We currently also have a voluntary recall across multiple markets and a global pause in shipments of Chantix.
Technical solutions are being pursued to reduce nitrosamine levels in Chantix to enable return to market.
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 additional voluntary recalls initiated for other products in 2022, and may lead to additional recalls or other market actions for Pfizer products.
interdicting supply with the help of law enforcement, and advising legislators and regulators.
We expect to see continued focus by the Federal government on regulating pricing which could result in legislative and regulatory changes designed to control costs.
For example, in December 2021, in light of the results from the completed required postmarketing safety study of Xeljanz, ORAL Surveillance (A3921133), the U.S. label for Xeljanz was revised.
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.
We continue to work with regulatory agencies worldwide to review the full results and analyses of ORAL Surveillance and their impact on product labeling.
In the CIA, we agreed to implement and/or maintain certain compliance program elements to promote compliance with federal healthcare program requirements.
Breaches of the CIA could result in severe sanctions against us.
Similarly, any term extensions that we seek may not be granted on a timely basis, if at all.
Once we have final
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
development initiatives; interruptions or delays in the operations of regulatory authorities, which may delay potential approval of new products we are developing, potential label expansions for existing products and the launch of newly-approved products; challenges operating in a virtual or hybrid work environment; increased cyber threats and attack attempts; challenges related to our intellectual property, both domestically and internationally, including in response to any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection for or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid; challenges related to conducting oversight and monitoring of regulated activities in a virtual or hybrid environment; challenges related to our human capital and talent development; challenges related to vaccine mandates; and other challenges presented by disruptions to our normal operations in response to COVID-19, as well as uncertainties regarding the impact of COVID-19, and government or regulatory actions to contain the virus or control the supply of medicines and vaccines.
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.
- uncertainties around future changes to applicable healthcare policies and guidelines issued by the U.S. federal government in connection with the declared termination of the federal government’s COVID-19 public health emergency as of May 11, 2023;
- competitive developments.
We do not anticipate that these risks will have a material financial impact to the company in the near term.
An excerpt. Shown here: 40 of 139 rewritten, 40 of 69 added and all 29 removed. The counts are complete. For every sentence, read Item 1A. RISK FACTORS in the FY2023 filing and the FY2022 filing.
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
314 rewritten, 188 added, 164 removed, 348 unchanged
Financial Statements and Supplementary [removed: Data](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)*] [added: Data](#i2a2412fd329d412096454ccea3d9368c_148)*] in this Form 10-K.
Discussions of [removed: 2020] [added: 2021] items and year-to-year comparisons between [removed: 2021] [added: 2022] and [removed: 2020] [added: 2021] that are not included in this Form 10-K can be found within MD&A in our [removed: 2021] [added: 2022] Form 10-K.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 25] [added: 30] | | |
| [removed: 2022] [added: 2023] Total [removed: Revenues––$100.3] [added: Revenues––$58.5] billion | | | [removed: 2022] [added: 2023] Net Cash Flow from [removed: Operations––$29.3] [added: Operations––$8.7] billion | | |
[removed: ][added: ]
| [removed: 2022] [added: 2023] Reported Diluted [removed: EPS––$5.47] [added: EPS––$0.37] | | | [removed: 2022] [added: 2023] Adjusted Diluted EPS [removed: (Non-GAAP)––$6.58*] [added: (Non-GAAP)––$1.84*] | | |
[removed: ][added: ]
*For additional information regarding Adjusted diluted EPS (which is a non-GAAP financial measure), including reconciliations of certain GAAP Reported to non-GAAP Adjusted information, see the *[Non-GAAP Financial Measure: Adjusted [removed: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_127)*] [added: Income](#i2a2412fd329d412096454ccea3d9368c_130)*] section within MD&A.
See the *[Item [removed: 1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)[.][added: 1.]
We believe that our medicines and vaccines provide significant value for healthcare providers and patients and [removed: seek to enhance their value by] continuously [removed: evaluating] [added: evaluate] how we can best collaborate with patients, physicians and [removed: payers] [added: payors] 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 [removed: acquisitions] [added: business development opportunities] targeted at critical unmet patient needs.
In [removed: the fourth quarter of 2021,] [added: 2023,] we [removed: began managing] [added: managed] our commercial operations through a global structure consisting of two operating segments: Biopharma and [removed: PC1.][added: Business Innovation.]
Biopharma [removed: is] [added: was] the only reportable segment.
See *[Note [removed: 1A](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)*] [added: 1A](#i2a2412fd329d412096454ccea3d9368c_172)*] and [added: the] *[Item 1.
[removed: We expect to incur] [added: Since inception through December 31, 2023, we have incurred substantially all] costs of approximately $700 million in connection with separating Upjohn, [added: including costs and expenses related to separation] of [removed: which approximately 85% has been incurred since inception] [added: legal entities] and [removed: through December 31, 2022.][added: transaction costs.]
In the [removed: 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 [added: through our Transforming] to [added: a More Focused Company restructuring program 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.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 26] [added: 31] | | |
[removed: program,] [added: For a description of savings related to these programs,] see the *[Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity [removed: Initiatives](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*] [added: Initiatives](#i2a2412fd329d412096454ccea3d9368c_118)*] section [removed: of this] [added: within] MD&A*.*
R&D is at the heart of fulfilling our purpose to deliver breakthroughs that change patients’ lives as we work to translate advanced science and technologies into the [removed: therapies] [added: medicines and vaccines] that may be the most impactful for patients.
[removed: Business](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)*[Research] [added: Business](#i2a2412fd329d412096454ccea3d9368c_34)*[—](#i2a2412fd329d412096454ccea3d9368c_34)*[Research] and [removed: Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)*] [added: Development](#i2a2412fd329d412096454ccea3d9368c_34)*] section [removed: in this Form 10-K] for our R&D priorities and strategy.
For [removed: additional information, including] [added: a] discussion of recent significant business development activities, see *[Note [removed: 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*.][added: 2](#i2a2412fd329d412096454ccea3d9368c_175)*.]
Our [removed: 2022] [added: 2023] Performance
The operational [removed: increase] [added: decrease in emerging markets revenues] was primarily driven by [added: declines from Comirnaty and Paxlovid, partially offset by] growth from [removed: Paxlovid] [added: Lorbrena, Zavicefta] and [removed: Comirnaty.][added: Eliquis.]
The following [added: chart] outlines the components of the net change in [removed: revenues:][added: *Total revenues*:]
[removed: ][added: ]
See the [removed: *[Revenues] [added: *[Total Revenues] by [removed: Geography](#i8050b09ca8a0411dbcb0b6576ce1fc7a_109)*] [added: Geography](#i2a2412fd329d412096454ccea3d9368c_109)*] and [removed: *[Revenues](#i8050b09ca8a0411dbcb0b6576ce1fc7a_112)[––](#i8050b09ca8a0411dbcb0b6576ce1fc7a_112)[Selected] [added: *[Total Revenues––Selected] Product [removed: Discussion](#i8050b09ca8a0411dbcb0b6576ce1fc7a_112)*] [added: Discussion](#i2a2412fd329d412096454ccea3d9368c_115)*] sections within MD&A for more information, including a discussion of key drivers of our revenue performance.
See also *The Global Economic Environment––COVID-19* section below for information about our COVID-19 [removed: products, including expectations for 2023.][added: products.]
For information regarding the primary indications or class of certain products, see *[Note [removed: 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)[C](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241).*][added: 17C](#i2a2412fd329d412096454ccea3d9368c_549755815813).*]
*Income from Continuing Operations Before Provision/(Benefit) for Taxes on Income––*The [removed: increase] [added: decrease] in *Income from continuing operations before provision/(benefit) for taxes on income* of [removed: $10.4] [added: $33.7] billion, to [removed: $34.7] [added: $1.1] billion in [removed: 2022] [added: 2023] from [removed: $24.3] [added: $34.7] billion in [removed: 2021,] [added: 2022,] was primarily attributable to [added: (i) lower revenues, (ii)] higher [removed: revenues] [added: intangible asset impairment charges,] and [removed: lower *Acquired in-process research] [added: (iii) increases in *Restructuring charges] and [removed: development expenses*,] [added: certain acquisition-related costs*, *Amortization of intangible assets*, and *Selling, informational and administrative expenses,*] partially offset by [removed: (i) an increase] [added: (iv) a decrease] in *Cost of [removed: sales,* (ii)] [added: sales* and (v)] net [removed: losses] [added: gains] on equity securities in [removed: 2022] [added: 2023] versus net [removed: gains] [added: losses] on equity securities in [removed: 2021, (iii) lower net periodic benefit credits associated with pension and other postretirement plans, and (iv) increases in *Research and development expenses, Selling, informational and administrative expenses,* and *Restructuring charges and certain acquisition-related costs.*][added: 2022*.*]
See the *[Analysis of the Consolidated Statements of [removed: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_106)*] [added: Income](#i2a2412fd329d412096454ccea3d9368c_106)* section] within MD&A and *[Note [removed: 4](#i8050b09ca8a0411dbcb0b6576ce1fc7a_181)* for additional information.][added: 4](#i2a2412fd329d412096454ccea3d9368c_181)*.]
For information on our tax provision and effective tax rate, see the *[Provision/(Benefit) for Taxes on [removed: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_118)*] [added: Income](#i2a2412fd329d412096454ccea3d9368c_121)*] section within MD&A and *[Note [removed: 5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187)*.][added: 5](#i2a2412fd329d412096454ccea3d9368c_187)*.]
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 27] [added: 32] | | |
Business––Government Regulation and Price [removed: Constraints](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)*] [added: Constraints](#i2a2412fd329d412096454ccea3d9368c_58)*] and *[Item 1A.
*Regulatory Environment––Pipeline Productivity––*Our product lines must be replenished 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 [removed: growth.][added: growth, primarily through internal R&D or through collaborations, acquisitions, JVs, licensing or other arrangements.]
Clinical trials are conducted to determine, among other things, whether an investigational [removed: drug] [added: drug, vaccine] or device is safe and effective for a particular patient population.
*Intellectual Property Rights and Collaboration/Licensing Rights––*The loss, expiration or invalidation of intellectual property rights, patent litigation settlements and [added: judgments, and] the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues.
While additional patent expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries from [removed: 2023] [added: 2024] through 2025.
Business––Patents and Other Intellectual Property [removed: Rights](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)* section in this Form 10-K.][added: Rights](#i2a2412fd329d412096454ccea3d9368c_46)* section.]
For a discussion of recent developments with respect to patent litigation, see *[Note [removed: 16](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238)[A1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238).*][added: 16A1](#i2a2412fd329d412096454ccea3d9368c_244).*]
*Regulatory Environment/Pricing and Access––Government and Other [removed: Payer] [added: Payor] Group Pressures––*The pricing of medicines and vaccines by pharmaceutical manufacturers and the cost of healthcare, which includes medicines, vaccines, medical services and hospital services, continues to be important to [removed: payers,] [added: payors,] governments, patients, and other stakeholders.
| A decrease of 42% compared to 2022 | | | A decrease of 70% compared to 2022 | | |
| A decrease of 93% compared to 2022 | | | A decrease of 72% compared to 2022 | | |
Business](#i2a2412fd329d412096454ccea3d9368c_28)[––About Pfizer](#i2a2412fd329d412096454ccea3d9368c_28)* section.
Our 2024 key priorities are:
- Achieve world-class oncology leadership
- Deliver next wave of pipeline innovation
- Maximize performance of our new products
- Expand margins by realigning our cost base
- Allocate capital to enhance shareholder value
Business––Commercial Operations](#i2a2412fd329d412096454ccea3d9368c_31)* section.
In December 2023, we completed our acquisition of Seagen.
At the beginning of 2024, we made changes in our commercial organization that went into effect on January 1, 2024 to incorporate Seagen and improve focus, speed and execution.
Specifically, within our Biopharma reportable segment we created:
- the Pfizer Oncology Division, which brings together U.S. oncology commercial operations from both Pfizer and Seagen and is led by the Chief Oncology Officer, Executive Vice President, who also leads Pfizer’s newly combined global oncology R&D operations;
- the Pfizer U.S. Commercial Division, which focuses on the commercialization of non-oncology products in the U.S. and is led by the Chief U.S. Commercial Officer, Executive Vice President; and
- the Pfizer International Commercial Division, which focuses on the commercialization of Pfizer’s entire product portfolio outside the U.S. and is led by the Chief International Commercial Officer, Executive Vice President.
Beginning in July 2023, in consideration of planned future investments in oncology, including the acquisition of Seagen on December 14, 2023, we reorganized our R&D platform operations.
See *[Note 17A](#i2a2412fd329d412096454ccea3d9368c_247)*.
In the fourth quarter of 2023, we announced that we launched a multi-year, enterprise-wide cost realignment program that aims to realign our costs with our longer-term revenue expectations.
*Total Revenues––Total revenues* decreased $41.8 billion, or 42%, to $58.5 billion in 2023 from $100.3 billion in 2022, reflecting an operational decrease of $40.8 billion, or 41%, as well as an unfavorable impact of foreign exchange of $1.0 billion, or 1%.
The operational decrease was primarily driven by significant declines in revenues from Comirnaty and Paxlovid, including a $3.5 billion non-cash revenue reversal for Paxlovid recorded in the fourth quarter of 2023.
Excluding contributions from Comirnaty and Paxlovid, *Total revenues* increased 7% operationally, reflecting an increase in revenues from Nurtec ODT/Vydura and Oxbryta; revenues from Abrysvo, primarily driven by the launch of the older adult indication in the U.S.; as well as continued growth from the Vyndaqel family and Eliquis; partially offset by a decline in Ibrance.
While royalty income through December 31, 2023 has been recorded in *Other Income/(Deductions)—net*, we will begin reporting such royalty income in *Total revenues* beginning in 2024 and will restate prior periods for consistency with our 2024 presentation.
Additionally, we will no longer record royalties from U.S. sales of Bavencio, as we have irrevocably chosen to donate the right to such royalties to the American Association for Cancer Research.
Risk Factors](#i2a2412fd329d412096454ccea3d9368c_67)* sections.
In the U.S., we expect to see continued focus by Congress and the Biden Administration on regulating pricing.
The drug pricing provisions of the IRA, which was signed into law in August 2022, began to be implemented in 2022 and implementation efforts will continue over the next several years.
In August 2023, the Biden Administration unveiled the first ten medicines subject to the “Medicare Drug Price Negotiation Program,” which requires manufacturers of select drugs to engage in a process with the federal government to set new Medicare prices which would go into effect in 2026.
Among the first ten medicines subject to the Program included Eliquis.
*Impact of the July 2023 Tornado in Rocky Mount, North Carolina (NC)––*Our manufacturing facility in Rocky Mount, NC was damaged by a tornado in July 2023.
The facility is a key producer of sterile injectables and is responsible for manufacturing nearly 25 percent of all our sterile injectables—including anesthesia, analgesia, and micronutrients—which is nearly eight percent of all the sterile injectables used in U.S. hospitals.
While manufacturing has resumed, the supply of medicines impacted by the tornado is expected to be affected through 2024.
In 2023, we recorded $286 million to *Cost of sales* for inventory losses, overhead costs related to the period in which the facility could not operate, and incremental costs resulting from the tornado damage.
Losses incurred in 2023 were partially offset by insurance recoveries received in the fourth quarter of 2023.
We may record additional losses and/or costs and/or insurance recoveries in future periods, but we are unable to predict them with certainty at this time.
In 2021, Pfizer recalled 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.
Regulatory authorities outside the U.S. have issued updated guidance on nitrosamine acceptable intake levels.
With this recently issued guidance, which included an updated intake level for N-nitroso-varenicline, we expect to make regulatory submissions in 2024 to potentially enable Chantix to return to market outside the U.S., and our related discussions with FDA are ongoing.
See the *[Product Developments](#i2a2412fd329d412096454ccea3d9368c_127)* section within MD&A.
Due to the commercial market transition as well as the anticipated seasonal nature of COVID vaccination, we expect more than 80% of our 2024 global revenues for Comirnaty to be recorded in the second half of the year.
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | | |
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.
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.
With the formation of the Consumer Healthcare JV in 2019, the spin-off of our former Upjohn Business in the fourth quarter of 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 engaged in the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide.
Business––Commercial Operations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_31)* in this Form 10-K for additional information.
These charges include costs and expenses related to separation of legal entities and transaction costs.
Beginning in 2019, we took action through our Transforming to a More Focused Company restructuring program to ensure our cost base and support model aligned appropriately with our operating structure.
See *[Note 3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_178)* for additional information.
For a description of savings related to this
*Revenues––Revenues* increased $19.0 billion, or 23%, to $100.3 billion in 2022 from $81.3 billion in 2021, reflecting an operational increase of $24.6 billion, or 30%, as well as an unfavorable impact of foreign exchange of $5.5 billion, or 7%.
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.
Risk Factors](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)* sections in this Form 10-K.
In the U.S., we expect to see continued focus by Congress and the Biden Administration on regulating pricing, which could result in legislative and regulatory changes designed to control costs, such as the IRA that was signed into law in August 2022.
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.
investments in breakthrough science and global manufacturing.
For additional information, including our continuing late-stage development efforts for Paxlovid, see the *[Product Developments](#i8050b09ca8a0411dbcb0b6576ce1fc7a_124)* section within MD&A.
For Paxlovid, we expect 2023 to be a transitional year as we expect to start selling Paxlovid through the commercial channels in the second half of 2023 rather than significant government purchases.
We also remain committed to helping ensure broad and equitable access to our COVID-19 products to eligible patients around the world.
Revenues from our COVID-19 products are expected to go from their peak in 2022 to their low point in 2023 before potentially returning to growth in 2024.
While patient demand for our COVID-19 products is expected to remain strong throughout 2023, much of that demand is expected to be fulfilled by existing supply of products that were delivered to governments and recorded as revenues in 2022.
As of January 31, 2023, we forecasted Comirnaty revenues of approximately $13.5 billion in 2023, down 64% from actual 2022 results, with gross profit to be split evenly with BioNTech, and Paxlovid revenues of approximately $8 billion in 2023, down 58% from actual 2022 results.
Guidance for both products includes, among other things, anticipated sales through traditional commercial markets in the U.S. in the second half of 2023 and assumes prior absorption of existing government supply from advanced purchase agreements from 2022.
These forecasts are based on estimates and assumptions that are subject to significant uncertainties, including, among others, patient demand which could be significantly impacted by the infectiousness and severity of the predominant strains of the SAR-CoV-2 virus during 2023, proportion of the population that receives a vaccine or is treated with an oral antiviral treatment, the number of doses per vaccinated person per year, number of symptomatic infections, market share of Comirnaty and Paxlovid, timing and terms for delivery of the contracted doses of Comirnaty to the EC, Paxlovid sales to China and the timing for transitioning Comirnaty and Paxlovid sales to the commercial market in the U.S.
In addition to our introduction of Comirnaty and Paxlovid, COVID-19 has impacted our business, operations and financial condition and results.
For example, COVID-19 had varying impacts on patient visits, vaccinations, elective surgeries, cancer screenings and routine testing, which affected prescriptions or refills of existing prescriptions and demand for products used in procedures.
As part of our on-going monitoring and assessment, we have made certain assumptions regarding COVID-19 for purposes of our operational planning and financial projections, including assumptions regarding the global macroeconomic impact of COVID-19, as well as the demand, revenues, supply, contracts and commercial markets for our COVID-19 products, which remain dynamic.
Despite careful tracking and planning, we are unable to accurately predict the extent of the impact of COVID-19 on our business, operations and financial condition and results due to the uncertainty of future developments.
We will continue to pursue efforts to maintain the continuity of our operations while monitoring for new developments related to COVID-19.
Future developments could result in additional favorable or unfavorable impacts on our business, operations or financial condition and results.
Consistent with our commitment to putting patients first, we are maintaining the supply of medicines to Russia, including the provision of needed medicines to patients already enrolled in clinical trials.
Effective March 14, 2022, Pfizer began donating profits of our Russian subsidiary to causes that provide direct humanitarian support to the people of Ukraine, in addition to our ongoing efforts to support the humanitarian response in the region.
In 2022, we have donated approximately $25 million to support humanitarian relief and response efforts.
We will continue to support Ukrainian relief efforts through this method until peace is achieved.
An excerpt. Shown here: 40 of 314 rewritten, 40 of 188 added and 40 of 164 removed. The counts are complete. For every sentence, read Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS in the FY2023 filing and the FY2022 filing.
Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
2 rewritten, 0 added, 0 removed, 4 unchanged
The information required by this Item is incorporated by reference to the discussion in the *[Analysis of [removed: Financial](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136) [Condition](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)[,] [added: Financial Condition,] Liquidity, Capital Resources and Market [removed: Risk](#i8050b09ca8a0411dbcb0b6576ce1fc7a_136)*] [added: Risk](#i2a2412fd329d412096454ccea3d9368c_139)*] section within MD&A.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 44] [added: 49] | | |
Item 1. BUSINESS
196 rewritten, 205 added, 51 removed, 241 unchanged
[removed: ][added: ]
We believe that our medicines and vaccines provide significant value for healthcare providers and [removed: patients,] [added: patients] through improved treatment of [removed: diseases,] [added: diseases and] improvements in health, wellness and productivity as well as by reducing other healthcare costs, such as emergency room [added: visits] or [removed: hospitalization.][added: hospitalizations.]
We seek to enhance the value of our medicines and vaccines and actively engage in dialogues about how we can best work with patients, physicians and [removed: payers] [added: payors] to prevent and treat disease and improve outcomes.
We seek to maximize patient access and evaluate our pricing arrangements and contracting methods with [removed: payers] [added: payors] to minimize adverse impact on our revenues within the current legal and pricing structures.
In addition, [removed: Pfizer continues to enhance its] [added: Pfizer’s] ESG strategy, which is [removed: focused] [added: integrated into our corporate strategy, focuses] on six areas where we see opportunities to create a meaningful impact: product innovation; equitable access and pricing; product quality and safety; diversity, equity and inclusion; climate change; and business ethics.
We view our business development activity as an enabler of our strategies and seek to generate growth by pursuing opportunities and transactions that have the potential to strengthen our business and our [removed: capabilities.]
For a further discussion of our strategy and our business development initiatives, see the *[Overview of Our Performance, Operating Environment, Strategy and [removed: Outlook](#i8050b09ca8a0411dbcb0b6576ce1fc7a_97)*] [added: Outlook](#i2a2412fd329d412096454ccea3d9368c_97)*] section within MD&A and *[Note [removed: 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*.][added: 2](#i2a2412fd329d412096454ccea3d9368c_175)*.]
In [removed: the fourth quarter of 2021,] [added: 2023,] we [removed: began managing] [added: managed] our commercial operations through a global structure consisting of two operating segments, each led by a single manager: Biopharma, our innovative science-based biopharmaceutical business, and [added: Business Innovation, an operating segment established in the first quarter of 2023 that includes] PC1, our [removed: global] contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical [removed: ingredients.][added: ingredients, and Pfizer Ignite, an offering that provides strategic guidance and end-to-end R&D services to select innovative biotech companies that align with our R&D focus areas.]
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | 3 | | |
For additional information on our operating segments and products, including product revenues, see *[Note [removed: 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241),*] [added: 17](#i2a2412fd329d412096454ccea3d9368c_247),*] and for additional information on the key operational revenue drivers of our business, see the *[Analysis of the Consolidated Statements of [removed: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_106)*] [added: Income](#i2a2412fd329d412096454ccea3d9368c_106)*] section within MD&A.
R&D is at the heart of fulfilling our purpose to deliver breakthroughs that change patients’ lives as we work to translate advanced science and technologies into the [removed: therapies] [added: medicines and vaccines] that may be the most impactful for patients.
In addition to discovering and developing new products, our R&D efforts seek to add value to our existing products by improving their [removed: effectiveness] [added: safety, efficacy] and ease of dosing and by discovering potential new indications.
For information on certain of these collaborations, alliances and license arrangements and investments, see *[Note [removed: 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*.][added: 2](#i2a2412fd329d412096454ccea3d9368c_175)*.]
*Our R&D Operations.* In [removed: 2022,] [added: 2023,] 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.
Our R&D activity is conducted through various platform functions that [removed: operate in parallel within] [added: support] our global [removed: operations, including the following:][added: operations.]
[removed: - GPD. Our] [added: ORD and PRD replace our former WRDM and] GPD [removed: organization is a unified center] [added: organizations, where, prior to July 2023, research units within WRDM were generally responsible] for [removed: clinical development] [added: research] and [removed: regulatory activities that is] [added: early-stage development assets and, prior to July 2023, GPD was] generally responsible for the clinical development strategy and operational execution of clinical trials for both early- and late-stage clinical assets in Pfizer’s pipeline.
We manage R&D operations on a total-company basis through our [removed: platform functions] [added: PRD and ORD organizations] described above.
Specifically, the Portfolio Management [removed: Team (PMT),] [added: Team, currently led by our Chairman and Chief Executive Officer and] composed of [added: other] senior executives, is accountable for aligning resources [removed: among all of our WRDM, GPD] [added: across PRD] and [removed: R&D projects] [added: ORD,] and for [removed: seeking] [added: helping] to ensure optimal capital allocation across the innovative R&D portfolio.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | 4 | | |
For additional [removed: information,] [added: information on our R&D operations, including R&D related costs and expenses,] see the *[Costs and [removed: Expenses](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*[—](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*[Research] [added: Expenses](#i2a2412fd329d412096454ccea3d9368c_118)*[—](#i2a2412fd329d412096454ccea3d9368c_118)*[Research] and [removed: Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115) [Expense](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)[s](#i8050b09ca8a0411dbcb0b6576ce1fc7a_115)*] [added: Development Expenses](#i2a2412fd329d412096454ccea3d9368c_118)*] section within MD&A and *[Note [removed: 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.][added: 17](#i2a2412fd329d412096454ccea3d9368c_247)*.]
As of January [removed: 31, 2023,] [added: 30, 2024,] we had the following number of projects in various stages of R&D:
[removed: ][added: ]
While our [removed: drug] [added: product] candidates may or may not receive regulatory approval, new candidates entering clinical development phases are the foundation for future products.
Information concerning several of our drug [added: and vaccine] candidates in development, as well as supplemental filings for existing products, is set forth in the *[Product [removed: Developments](#i8050b09ca8a0411dbcb0b6576ce1fc7a_124)*] [added: Developments](#i2a2412fd329d412096454ccea3d9368c_127)*] section within MD&A.
Risk Factors—Research [removed: and](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70) [Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)* section in this Form 10-K.][added: and Development](#i2a2412fd329d412096454ccea3d9368c_67)* section.]
COLLABORATION AND [removed: CO-PROMOTION][added: CO-PROMOTION AGREEMENTS]
For discussion on Comirnaty, see the *[Overview of Our Performance, Operating Environment, Strategy and [removed: Outlook—COVID-19](#i8050b09ca8a0411dbcb0b6576ce1fc7a_97)*] [added: Outlook—COVID-19](#i2a2412fd329d412096454ccea3d9368c_97)*] section within MD&A.
[removed: In] certain smaller markets we have full commercialization rights and BMS supplies the product to us at cost plus a percentage of the net sales to end-customers.
[removed: *•*Xtandi] [added: - Xtandi] (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within tumor cells that is being developed and commercialized in collaboration with Astellas.
- [removed: Orgovyx] [added: Orgovyx] (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer that is being developed and commercialized with [removed: Myovant.][added: SMPA.]
The companies equally share profits and allowable expenses in the U.S. for Orgovyx, and in the U.S. and Canada for [removed: Myfembree, with Myovant bearing our share of allowable expenses up to a maximum of $50 million in 2022.][added: Myfembree.]
[removed: Myovant] [added: SMPA] remains responsible for regulatory interactions and drug supply and continues to lead clinical development for the relugolix combination tablet.
Revenues associated with these arrangements are included in [removed: Alliance revenues] [added: *Alliance revenues*] (except in certain markets where we have direct sales and except for the majority of revenues for [removed: Comirnaty,] [added: Comirnaty and Padcev,] which are included [removed: as direct product revenues).][added: in *Product revenues*).]
In addition, we have collaboration arrangements for the development and commercialization of certain pipeline products that are in development stage, including, among [removed: others, (i) with BioNTech to develop a modified mRNA-based vaccine for the prevention] [added: others certain] of [removed: varicella zoster (Shingles), and (ii) with Valneva to co-develop and commercialize Valneva’s Lyme disease vaccine candidate, VLA15.][added: those described in the *[Product Development](#i2a2412fd329d412096454ccea3d9368c_127)[s](#i2a2412fd329d412096454ccea3d9368c_127)* section within MD&A.]
For further discussion of collaboration and co-promotion agreements, see the *[Item [removed: 1A.][added: 1.]
Risk Factors—Collaborations and Other Relationships with Third [removed: Parties](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)*] [added: Parties](#i2a2412fd329d412096454ccea3d9368c_67)*] section [removed: in this Form 10-K] and *[Notes [removed: 2](#i8050b09ca8a0411dbcb0b6576ce1fc7a_172)*] [added: 2](#i2a2412fd329d412096454ccea3d9368c_175)*] and [removed: *[17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.][added: *[17](#i2a2412fd329d412096454ccea3d9368c_247)*.]
Our operations are conducted globally, and we supply our medicines and vaccines to [removed: over 185] [added: approximately 200] countries and territories.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | 5 | | |
Revenues from operations outside the U.S. of [removed: $57.9] [added: $31.4] billion accounted for [removed: 58%] [added: 54%] of [removed: our total revenues] [added: *Total revenues*] in [removed: 2022.][added: 2023.]
Revenues exceeded $500 million in each of [removed: 24, 21] [added: 14, 24] and [removed: 8] [added: 21] countries outside the U.S. in [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020,] [added: 2021,] respectively.
We also sell products for the detection of certain illnesses and provide end-to-end R&D services to select innovative biotech companies.
Our core business principles are:
*1.Trust is Everything*
*2.Science Will Win*
*3.Disruption Calls for Innovation*
*4.Time is Life*
*5.Execution Makes the Difference.*
capabilities.
On December 14, 2023, we completed our acquisition of Seagen, a global biotechnology company that discovers, develops and commercializes transformative cancer medicines.
With the addition of Seagen’s pipeline and its four in-line medicines (Padcev, Adcetris, Tukysa and Tivdak), Pfizer’s oncology portfolio spans multiple modalities, including ADCs, small molecules, bispecifics and other immunotherapies.
In addition to the acquisition of Seagen, our significant recent business development activities in 2023 include, among others, the September 2023 divestiture of our early-stage rare disease gene therapy portfolio to Alexion.
In 2023, Biopharma was the only reportable segment.
The commercial structure within Biopharma included three broad customer groups in 2023: Primary Care, Specialty Care and Oncology.
At the beginning of 2024, we made changes in our commercial organization to incorporate Seagen and improve focus, speed and execution.
Specifically, within our Biopharma reportable segment we created the Pfizer Oncology Division, the Pfizer U.S. Commercial Division, and the Pfizer International Commercial Division:
| *Division* | | | *Description* | | |
| | | | | | |
| Pfizer Oncology Division | | | Combines the U.S. Oncology commercial organizations, global Oncology marketing organizations and global and U.S. Oncology medical affairs from both Pfizer and Seagen. Includes innovative oncology product portfolio of ADCs, small molecules, bispecifics and other immunotherapies that treat a wide range of cancers including certain types of breast cancer, genitourinary cancer and hematologic malignancies, as well as certain types of melanoma, gastrointestinal, gynecological and thoracic cancers, which includes lung cancer. | | |
| Pfizer U.S. Commercial Division | | | Includes the U.S. Primary Care and U.S. Specialty Care customer groups, the Chief Marketing Office, the Global Chief Medical Affairs Office and Global Access & Value. | | |
| U.S. Primary Care includes: | | | | | |
| •Internal medicine product portfolio of brands in cardiovascular metabolic, bone graft for spinal fusion and women’s health, as well as post-LOE brands. | | | | | |
| •Migraine product portfolio. | | | | | |
| •Vaccines product portfolio across all ages with a pipeline focus on infectious diseases with significant unmet medical need, including COVID-19. | | | | | |
| •Treatment for COVID-19. | | | | | |
| •Products for detection of COVID-19 and influenza. | | | | | |
| U.S. Specialty Care includes: | | | | | |
| •Inflammation & immunology product portfolio of brands and biosimilars for chronic immune and inflammatory diseases. | | | | | |
| •Rare disease product portfolio of brands for a number of therapeutic areas with rare diseases, including amyloidosis, hemophilia, endocrine diseases and sickle cell disease. | | | | | |
| •Hospital product portfolio of sterile injectable and immunoglobulin medicines. | | | | | |
| Pfizer International Commercial Division | | | Includes the ex-U.S. commercial and medical affairs organizations covering Pfizer’s entire product portfolio in all international markets. | | |
Select products within Oncology, Primary Care and Specialty Care include:
- Oncology: Ibrance, Xtandi, Inlyta, Bosulif, Lorbrena, Braftovi, Mektovi, Padcev, Adcetris, Talzenna, Tukysa, Elrexfio and Tivdak
- Primary Care:
◦*Internal medicine*: Eliquis, the Premarin family and BMP2
◦*Migraine*: Nurtec ODT/Vydura and Zavzpret
◦*Vaccines*: Comirnaty, the Prevnar family, Abrysvo, FSME/IMMUN-TicoVac, Nimenrix and Trumenba
◦*Treatment for COVID-19*: Paxlovid
◦*Detection of COVID-19 and influenza*: Lucira by Pfizer
- Specialty Care:
◦*Inflammation & immunology*: Xeljanz, Enbrel (outside the U.S. and Canada), Inflectra, Cibinqo, Litfulo and Velsipity
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:
| *Customer Groups* | | | *Description* | | | *Key Products* | | |
| 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 | | |
| Oncology | | | Includes innovative oncology brands of biologics, small molecules, immunotherapies and biosimilars across a wide range of cancers. | | | Ibrance, Xtandi, Inlyta, Retacrit, Lorbrena and Braftovi | | |
Risk Factors—Concentration](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)* section in this Form 10-K.
- WRDM. Research units within WRDM are generally responsible for research and early-stage development assets for our business (assets that have not yet achieved proof-of-concept) and are organized by therapeutic area to enhance flexibility, cohesiveness and focus.
We can rapidly redeploy resources within a research unit and between various projects to leverage, as necessary, common skills, expertise or focus.
Science-based platform-services organizations within WRDM provide technical expertise and other services to various R&D projects and are organized into science-based functions.
These organizations allow us to react more quickly and effectively to evolving needs by sharing resources among projects, candidates and targets across therapeutic areas and phases of development.
- Bavencio (avelumab) is a human anti-programmed death ligand-1 (PD-L1) antibody that is being developed and commercialized in collaboration with Merck KGaA.
We jointly fund the majority of development and commercialization costs and split profits equally related to net sales generated from any products containing avelumab.
To date, we primarily sold Comirnaty and Paxlovid globally under government contracts.
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.
| Xalkori | | | | | | 2029 | | | | | | 2027 | | | | | | 2028 | | |
The date at which generic or
For example, the basic product patent for Sutent expired in the U.S. in 2021 and in Europe in 2022.
MCOs that focus primarily on the immediate cost of drugs often favor generics over brand-name drugs.
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.
As a result, providers may weigh their ability to take on the financial risk of downside value-based payment models.
business.
*In the United States*
The Anti-Kickback Statute prohibits corruptly soliciting, offering, receiving, or paying anything of value to generate business.
In addition, in order to have our products covered by Medicaid, we must offer discounts or rebates on purchases of pharmaceutical products under various federal and state programs.
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).
In addition, changes to the Medicaid program or the federal 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for medications sold to certain health care facilities, could have a material impact on our business.
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.
States’ budgets were impacted less by the COVID-19 pandemic than expected and are generally growing.
States may also advance drug-pricing initiatives with a focus on affordability review boards, financial penalties related to pricing practices, manufacturer pricing and reporting requirements, as well as regulation of prescription drug assistance, copay accumulator, or copay maximizer programs in the commercial market.
*Data Privacy.* The collection and use of personal data by us is increasingly important to our business and is subject to various federal and state privacy and data security laws and regulations, including oversight by various regulatory and other governmental bodies.
Such laws and regulations continue to evolve and are increasingly being enforced vigorously.
In the off-patent space, numerous local generics have been officially deemed bioequivalent under a QCE process that required generic drugs to pass a test to assess their bioequivalence to a qualified reference drug (typically the originator drug).
Furthermore, the Chinese government has promulgated price bidding rules in June 2022 for enlisting off-patent products (excluding VBP products and certain products directly priced by government) onto the NRDL with the goal of unifying the reimbursement price between QCE-approved generic medicines and the applicable original medicines.
Certain of our products, such as Sulperazon and Vfend injectables, are likely to be included in future rounds.
The WTO continues to address the role of intellectual property in the context of the COVID-19 pandemic response.
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.
*Data Privacy.* Outside of the U.S., many countries have privacy and data security laws and regulations concerning the collection and use of personal data, including but not limited to, the EU’s General Data Protection Regulations and China’s Personal Information Protection Law.
An excerpt. Shown here: 40 of 196 rewritten, 40 of 205 added and 40 of 51 removed. The counts are complete. For every sentence, read Item 1. BUSINESS in the FY2023 filing and the FY2022 filing.
Item 3. LEGAL PROCEEDINGS
13 rewritten, 5 added, 5 removed, 22 unchanged
Certain legal proceedings in which we are involved are discussed in *[Note [removed: 16](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238)[A](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238)*.][added: 16A](#i2a2412fd329d412096454ccea3d9368c_244)*.]
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: 2023] [added: 2024] Annual Meeting of Shareholders, or until his or her earlier death, resignation or removal.
| Albert Bourla | | | | | | [removed: 61] [added: 62] | | | | | | 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. | | |
| David M. Denton | | | | | | [removed: 57] [added: 58] | | | | | | 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. [removed: Effective March 1, 2023,] [added: from 2014 to 2023.] Director of Haleon plc. | | |
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 23] [added: 27] | | |
| Mikael Dolsten | | | | | | [removed: 64] [added: 65] | | | | | | Chief Scientific [added: Officer, President, Pfizer Research and Development since July 2023. Chief Scientific] Officer and President, Worldwide Research, Development and Medical [removed: since] [added: from] January [removed: 2019.] [added: 2019 until July 2023.] 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. [removed: Director of Karyopharm Therapeutics Inc. from 2015 to 2021.] | | |
| Lidia Fonseca | | | | | | [removed: 54] [added: 55] | | | | | | 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. [removed: and] [added: from 2014 to 2023. Director of] Medtronic plc. | | |
| Rady A. Johnson | | | | | | [removed: 61] [added: 62] | | | | | | 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: 57] [added: 58] | | | | | | 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. [removed: Executive Vice President, Chief Compliance Officer from December 2010 until February 2011.] | | |
| Aamir Malik | | | | | | [removed: 47] [added: 48] | | | | | | Chief [added: U.S. Commercial Officer, Executive Vice President since December 2023. Chief] Business Innovation Officer, Executive Vice President [removed: since] [added: from] August [removed: 2021.] [added: 2021 until December 2023.] 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: 57] [added: 58] | | | | | | 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: 48] [added: 49] | | | | | | 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: 61] [added: 62] | | | | | | 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. [removed: Director of WPP plc from 2013 to 2022.] | | |
| Chris Boshoff | | | | | | 60 | | | | | | Chief Oncology Officer, Executive Vice President since December 2023. Chief Oncology Research and Development Officer and Executive Vice President from July 2023 until December 2023. Senior Vice President, Oncology, from 2017 until 2023. | | |
| Alexandre de Germay | | | | | | 56 | | | | | | Chief International Commercial Officer, Executive Vice President since December 2023. Chief Executive Officer, Laboratoires Majorelle (a specialty pharma company based in France dedicated to women’s health and urology) from 2021 until January 2024 (assisting with transition matters after December 15, 2023). From 2020 until 2021 was Senior Vice President; Global Franchise Head of Cardiology, Transplant and Established Products, and from 2016 until 2020 was Head of Mature Markets General Medicines of Sanofi. Regional President of Asia-Pacific of Pfizer Inc. from 2013 until 2016. | | |
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pfizer Inc. | | | 2023 Form 10-K | | | 28 | | |
| | | | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Name | | | | | | Age | | | | | | Position | | |
| Angela Hwang | | | | | | 57 | | | | | | Chief Commercial Officer since October 2022 and President, 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 Primary Care from September 2011 until December 2013. Director of United Parcel Service, Inc. | | |
| 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. | | |
Cover and table of contents
102 rewritten, 37 added, 24 removed, 251 unchanged
For the fiscal year ended December 31, [removed: 2022][added: 2023]
[removed: ][added: ]
| Common Stock, [removed: $.05] [added: $0.05] par value | | | PFE | | | New York Stock Exchange | | |
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 [removed: quarter, July 3, 2022,] [added: quarter] was approximately [removed: $294] [added: $207] billion.
This excludes shares of common stock held by directors and executive [removed: officers at July 3, 2022.][added: officers.]
The number of shares outstanding of the registrant’s common stock as of February [removed: 21, 2023] [added: 15, 2024] was [removed: 5,619,074,621] [added: 5,646,778,425] shares of common stock, all of one class.
| Portions of the Proxy Statement for the [removed: 2023] [added: 2024] Annual Meeting of Shareholders | | | Part III | | |
| [Defined [removed: Terms](#i8050b09ca8a0411dbcb0b6576ce1fc7a_13)] [added: Terms](#i2a2412fd329d412096454ccea3d9368c_13)] | | | [removed: [i](#i8050b09ca8a0411dbcb0b6576ce1fc7a_13)] [added: [i](#i2a2412fd329d412096454ccea3d9368c_13)] | | |
| [Available [removed: Information](#i8050b09ca8a0411dbcb0b6576ce1fc7a_16)] [added: Information](#i2a2412fd329d412096454ccea3d9368c_16)] | | | [removed: [iii](#i8050b09ca8a0411dbcb0b6576ce1fc7a_16)] [added: [iii](#i2a2412fd329d412096454ccea3d9368c_16)] | | |
| [Forward-Looking Information and Factors that May Affect Future [removed: Results](#i8050b09ca8a0411dbcb0b6576ce1fc7a_19)] [added: Results](#i2a2412fd329d412096454ccea3d9368c_19)] | | | [removed: [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_19)] [added: [1](#i2a2412fd329d412096454ccea3d9368c_19)] | | |
| [ITEM 1. [removed: BUSINESS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_25)] [added: BUSINESS](#i2a2412fd329d412096454ccea3d9368c_25)] | | | [removed: [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)] [added: [3](#i2a2412fd329d412096454ccea3d9368c_28)] | | |
| [About [removed: Pfizer](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)] [added: Pfizer](#i2a2412fd329d412096454ccea3d9368c_28)] | | | [removed: [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_28)] [added: [3](#i2a2412fd329d412096454ccea3d9368c_28)] | | |
| [Commercial [removed: Operations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_31)] [added: Operations](#i2a2412fd329d412096454ccea3d9368c_31)] | | | [removed: [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_31)] [added: [4](#i2a2412fd329d412096454ccea3d9368c_31)] | | |
| [Research and [removed: Development](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)] [added: Development](#i2a2412fd329d412096454ccea3d9368c_34)] | | | [removed: [4](#i8050b09ca8a0411dbcb0b6576ce1fc7a_37)] [added: [4](#i2a2412fd329d412096454ccea3d9368c_34)] | | |
| [Collaboration and Co-Promotion [removed: Agreements](#i8050b09ca8a0411dbcb0b6576ce1fc7a_34)] [added: Agreements](#i2a2412fd329d412096454ccea3d9368c_37)] | | | [removed: [5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_34)] [added: [5](#i2a2412fd329d412096454ccea3d9368c_37)] | | |
| [International [removed: Operations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_40)] [added: Operations](#i2a2412fd329d412096454ccea3d9368c_40)] | | | [removed: [5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_40)] [added: [6](#i2a2412fd329d412096454ccea3d9368c_40)] | | |
| [Sales and [removed: Marketing](#i8050b09ca8a0411dbcb0b6576ce1fc7a_43)] [added: Marketing](#i2a2412fd329d412096454ccea3d9368c_43)] | | | [removed: [6](#i8050b09ca8a0411dbcb0b6576ce1fc7a_43)] [added: [6](#i2a2412fd329d412096454ccea3d9368c_43)] | | |
| [Patents and Other Intellectual Property [removed: Rights](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)] [added: Rights](#i2a2412fd329d412096454ccea3d9368c_46)] | | | [removed: [6](#i8050b09ca8a0411dbcb0b6576ce1fc7a_46)] [added: [7](#i2a2412fd329d412096454ccea3d9368c_46)] | | |
| [Pricing Pressures and Managed Care [removed: Organizations](#i8050b09ca8a0411dbcb0b6576ce1fc7a_52)] [added: Organizations](#i2a2412fd329d412096454ccea3d9368c_52)] | | | [removed: [9](#i8050b09ca8a0411dbcb0b6576ce1fc7a_52)] [added: [10](#i2a2412fd329d412096454ccea3d9368c_52)] | | |
| [Raw [removed: Materials](#i8050b09ca8a0411dbcb0b6576ce1fc7a_55)] [added: Materials](#i2a2412fd329d412096454ccea3d9368c_55)] | | | [removed: [9](#i8050b09ca8a0411dbcb0b6576ce1fc7a_55)] [added: [11](#i2a2412fd329d412096454ccea3d9368c_55)] | | |
| [Government Regulation and Price [removed: Constraints](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)] [added: Constraints](#i2a2412fd329d412096454ccea3d9368c_58)] | | | [removed: [10](#i8050b09ca8a0411dbcb0b6576ce1fc7a_58)] [added: [11](#i2a2412fd329d412096454ccea3d9368c_58)] | | |
| [Environmental [removed: Matters](#i8050b09ca8a0411dbcb0b6576ce1fc7a_61)] [added: Matters](#i2a2412fd329d412096454ccea3d9368c_61)] | | | [removed: [12](#i8050b09ca8a0411dbcb0b6576ce1fc7a_61)] [added: [14](#i2a2412fd329d412096454ccea3d9368c_61)] | | |
| [ITEM 1A. RISK [removed: FACTORS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)] [added: FACTORS](#i2a2412fd329d412096454ccea3d9368c_67)] | | | [removed: [14](#i8050b09ca8a0411dbcb0b6576ce1fc7a_70)] [added: [16](#i2a2412fd329d412096454ccea3d9368c_67)] | | |
| [ITEM 2. [removed: PROPERTIES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_73)] [added: PROPERTIES](#i2a2412fd329d412096454ccea3d9368c_70)] | | | [removed: [23](#i8050b09ca8a0411dbcb0b6576ce1fc7a_73)] [added: [27](#i2a2412fd329d412096454ccea3d9368c_70)] | | |
| [ITEM 3. LEGAL [removed: PROCEEDINGS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_76)] [added: PROCEEDINGS](#i2a2412fd329d412096454ccea3d9368c_73)] | | | [removed: [23](#i8050b09ca8a0411dbcb0b6576ce1fc7a_76)] [added: [27](#i2a2412fd329d412096454ccea3d9368c_73)] | | |
| [INFORMATION ABOUT OUR EXECUTIVE [removed: OFFICERS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_79)] [added: OFFICERS](#i2a2412fd329d412096454ccea3d9368c_76)] | | | [removed: [23](#i8050b09ca8a0411dbcb0b6576ce1fc7a_79)] [added: [28](#i2a2412fd329d412096454ccea3d9368c_76)] | | |
| [ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY [removed: SECURITIES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_85)] [added: SECURITIES](#i2a2412fd329d412096454ccea3d9368c_82)] | | | [removed: [24](#i8050b09ca8a0411dbcb0b6576ce1fc7a_85)] [added: [29](#i2a2412fd329d412096454ccea3d9368c_82)] | | |
| [ITEM [removed: 6.](#i8050b09ca8a0411dbcb0b6576ce1fc7a_91) [\[RESERVED\]](#i8050b09ca8a0411dbcb0b6576ce1fc7a_91)] [added: 6. \[RESERVED\]](#i2a2412fd329d412096454ccea3d9368c_88)] | | | [removed: [25](#i8050b09ca8a0411dbcb0b6576ce1fc7a_91)] [added: [29](#i2a2412fd329d412096454ccea3d9368c_88)] | | |
| [ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_94)] [added: OPERATIONS](#i2a2412fd329d412096454ccea3d9368c_91)] | | | [removed: [25](#i8050b09ca8a0411dbcb0b6576ce1fc7a_94)] [added: [30](#i2a2412fd329d412096454ccea3d9368c_91)] | | |
| [ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET [removed: RISK](#i8050b09ca8a0411dbcb0b6576ce1fc7a_142)] [added: RISK](#i2a2412fd329d412096454ccea3d9368c_145)] | | | [removed: [44](#i8050b09ca8a0411dbcb0b6576ce1fc7a_142)] [added: [49](#i2a2412fd329d412096454ccea3d9368c_145)] | | |
| [ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY [removed: DATA](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)] [added: DATA](#i2a2412fd329d412096454ccea3d9368c_148)] | | | [removed: [45](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)] [added: [50](#i2a2412fd329d412096454ccea3d9368c_148)] | | |
| [ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL [removed: DISCLOSURE](#i8050b09ca8a0411dbcb0b6576ce1fc7a_253)] [added: DISCLOSURE](#i2a2412fd329d412096454ccea3d9368c_259)] | | | [removed: [101](#i8050b09ca8a0411dbcb0b6576ce1fc7a_253)] [added: [107](#i2a2412fd329d412096454ccea3d9368c_259)] | | |
| [ITEM 9A. CONTROLS AND [removed: PROCEDURES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_256)] [added: PROCEDURES](#i2a2412fd329d412096454ccea3d9368c_262)] | | | [removed: [101](#i8050b09ca8a0411dbcb0b6576ce1fc7a_256)] [added: [107](#i2a2412fd329d412096454ccea3d9368c_262)] | | |
| [removed: ITEM] [added: [ITEM] 9B. OTHER [removed: INFORMATION] [added: INFORMATION](#i2a2412fd329d412096454ccea3d9368c_1781)] | | | [removed: N/A] [added: [110](#i2a2412fd329d412096454ccea3d9368c_1781)] | | |
| [ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE [removed: GOVERNANCE](#i8050b09ca8a0411dbcb0b6576ce1fc7a_268)] [added: GOVERNANCE](#i2a2412fd329d412096454ccea3d9368c_274)] | | | [removed: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_268)] [added: [110](#i2a2412fd329d412096454ccea3d9368c_274)] | | |
| [ITEM 11. EXECUTIVE [removed: COMPENSATION](#i8050b09ca8a0411dbcb0b6576ce1fc7a_271)] [added: COMPENSATION](#i2a2412fd329d412096454ccea3d9368c_277)] | | | [removed: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_271)] [added: [110](#i2a2412fd329d412096454ccea3d9368c_277)] | | |
| [ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER [removed: MATTERS](#i8050b09ca8a0411dbcb0b6576ce1fc7a_274)] [added: MATTERS](#i2a2412fd329d412096454ccea3d9368c_280)] | | | [removed: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_274)] [added: [110](#i2a2412fd329d412096454ccea3d9368c_280)] | | |
| [ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR [removed: INDEPENDENCE](#i8050b09ca8a0411dbcb0b6576ce1fc7a_277)] [added: INDEPENDENCE](#i2a2412fd329d412096454ccea3d9368c_283)] | | | [removed: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_277)] [added: [110](#i2a2412fd329d412096454ccea3d9368c_283)] | | |
| [ITEM 14. PRINCIPAL ACCOUNTING FEES AND [removed: SERVICES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_280)] [added: SERVICES](#i2a2412fd329d412096454ccea3d9368c_286)] | | | [removed: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_280)] [added: [110](#i2a2412fd329d412096454ccea3d9368c_286)] | | |
| [ITEM 15. EXHIBITS, FINANCIAL STATEMENT [removed: SCHEDULES](#i8050b09ca8a0411dbcb0b6576ce1fc7a_286)] [added: SCHEDULES](#i2a2412fd329d412096454ccea3d9368c_292)] | | | [removed: [104](#i8050b09ca8a0411dbcb0b6576ce1fc7a_286)] [added: [110](#i2a2412fd329d412096454ccea3d9368c_292)] | | |
| [PART I](#i2a2412fd329d412096454ccea3d9368c_22) | | | [3](#i2a2412fd329d412096454ccea3d9368c_25) | | |
| [Competition](#i2a2412fd329d412096454ccea3d9368c_49) | | | [10](#i2a2412fd329d412096454ccea3d9368c_49) | | |
| [Our People](#i2a2412fd329d412096454ccea3d9368c_64) | | | [15](#i2a2412fd329d412096454ccea3d9368c_64) | | |
| [ITEM 1C.](#i2a2412fd329d412096454ccea3d9368c_1792) [CYBERSECURITY](#i2a2412fd329d412096454ccea3d9368c_1792) | | | [26](#i2a2412fd329d412096454ccea3d9368c_1792) | | |
| [PART II](#i2a2412fd329d412096454ccea3d9368c_79) | | | [29](#i2a2412fd329d412096454ccea3d9368c_79) | | |
| [PART III](#i2a2412fd329d412096454ccea3d9368c_271) | | | [110](#i2a2412fd329d412096454ccea3d9368c_271) | | |
| [PART IV](#i2a2412fd329d412096454ccea3d9368c_289) | | | [110](#i2a2412fd329d412096454ccea3d9368c_289) | | |
| [15(a)(1) Financial Statements](#i2a2412fd329d412096454ccea3d9368c_295) | | | [110](#i2a2412fd329d412096454ccea3d9368c_295) | | |
| [15(a)(2) Financial Statement Schedules](#i2a2412fd329d412096454ccea3d9368c_298) | | | [110](#i2a2412fd329d412096454ccea3d9368c_298) | | |
| [15(a)(3) Exhibits](#i2a2412fd329d412096454ccea3d9368c_301) | | | [111](#i2a2412fd329d412096454ccea3d9368c_301) | | |
| [SIGNATURES](#i2a2412fd329d412096454ccea3d9368c_307) | | | [115](#i2a2412fd329d412096454ccea3d9368c_307) | | |
| *ADC* | | | Antibody-Drug Conjugate | | |
| *Alexion* | | | Alexion Pharma International Operations Limited, a subsidiary of AstraZeneca PLC | | |
| *Blackstone* | | | Blackstone Life Sciences | | |
| *Genmab* | | | Genmab A/S | | |
| *Nimbus* | | | NimbusTherapeutics, LLC | | |
| *nmCSPC* | | | non-metastatic castration-sensitive prostate cancer | | |
| *ODT* | | | oral disintegrating tablet | | |
| *ORD* | | | Oncology Research and Development | | |
| *PIE* | | | Pfizer Investment Enterprises Pte. Ltd. (a wholly-owned finance subsidiary of Pfizer) | | |
| *PP&E* | | | Property, plant and equipment | | |
| *PRD* | | | Pfizer Research and Development | | |
| *RSV* | | | respiratory syncytial virus | | |
| *Seagen* | | | Seagen Inc. and its subsidiaries | | |
| *SMPA* | | | Sumitomo Pharma America, Inc. | | |
| *Takeda* | | | Takeda Pharmaceutical Company Limited | | |
| *Wyeth* | | | Wyeth LLC (formerly Wyeth) | | |
communicate by e-mail with our Directors; information concerning our Board Committees; Committee Charters; Charter of the Lead Independent Director; and transactions in Pfizer securities by Directors and Officers are available on our website.
- our anticipated operating and financial performance, including financial guidance and projections;
- our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all;
- any significant issues related to our JVs and other third-party business arrangements, including modifications related to supply agreements or other contracts with customers including governments or other payors;
- the impact of disruptions related to climate change and natural disasters, including uncertainties related to the impact of the tornado at our manufacturing facility in Rocky Mount, NC in 2023;
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pfizer Inc. | | | 2023 Form 10-K | | | 2 | | |
interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive biopharmaceutical markets;
- risks and challenges related to the use of artificial intelligence-based software;
| [PART I](#i8050b09ca8a0411dbcb0b6576ce1fc7a_22) | | | [3](#i8050b09ca8a0411dbcb0b6576ce1fc7a_25) | | |
| [Competition](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49) | | | [8](#i8050b09ca8a0411dbcb0b6576ce1fc7a_49) | | |
| [Human Capital](#i8050b09ca8a0411dbcb0b6576ce1fc7a_64) | | | [12](#i8050b09ca8a0411dbcb0b6576ce1fc7a_64) | | |
| [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) | | |
Pfizer's fiscal year-end for U.S. subsidiaries is as of and for the year ended December 31 for each year presented.
| *AbbVie* | | | AbbVie Inc. | | |
| *CMA* | | | conditional marketing authorisation | | |
| *Cond. J-NDA* | | | Conditional Japan New Drug Application | | |
| *CStone* | | | CStone Pharmaceuticals | | |
| *JAK* | | | Janus kinase | | |
| *Lilly* | | | Eli Lilly and Company | | |
| *MTM* | | | mark-to-market | | |
| *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). | | |
| *Myovant* | | | Myovant Sciences Ltd. | | |
| *sNDA* | | | supplemental new drug application | | |
- the success and impact of external business development activities, including the ability to identify and execute on potential business development opportunities; the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all; the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all; the
- risks and uncertainties related to our efforts to continue to develop and commercialize Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments, as well as challenges related to their manufacturing, supply and distribution;
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.
An excerpt. Shown here: 40 of 102 rewritten, all 37 added and all 24 removed. The counts are complete. For every sentence, read Cover and table of contents in the FY2023 filing and the FY2022 filing.
Item 1C. CYBERSECURITY
0 rewritten, 42 added, 0 removed, 0 unchanged
New section this year
Managing cybersecurity risk is a crucial part of our overall strategy for safely operating our business.
We incorporate cybersecurity practices into our Enterprise Risk Management (ERM) approach, which is subject to oversight by our BOD.
Our cybersecurity policies and practices are aligned with relevant industry standards.
Consistent with our overall ERM program and practices, our cybersecurity program includes:
- *Vigilance*: We maintain a global cybersecurity operation that endeavors to detect, prevent, contain, and respond to cybersecurity threats and incidents in a prompt and effective manner with the goal of minimizing business disruptions.
- *External Collaboration*: We collaborate with public and private entities, including intelligence and law enforcement agencies, industry groups and third-party service providers to identify, assess and mitigate cybersecurity risks.
- *Systems Safeguards*: We deploy technical safeguards that are designed to protect our information systems, products, operations and sensitive information from cybersecurity threats.
These include firewalls, intrusion prevention and detection systems, disaster recovery capabilities, malware and ransomware prevention, access controls and data protection.
We continuously conduct vulnerability assessments to identify new risks and periodically test the efficacy of our safeguards through both internal and external penetration tests.
- *Education*: We provide periodic training for all personnel regarding cybersecurity threats, with such training appropriate to the roles, responsibilities and access of the relevant Company personnel.
Our policies require all workers to report any real or suspected cybersecurity events.
- *Supplier Ecosystem Management*: We extend our cybersecurity management control expectations to our supply chain ecosystem, as applicable.
This includes identifying cybersecurity risks presented by third parties.
- *Incident Response Planning*: We have established, and maintain and periodically test, incident response plans that direct our response to cybersecurity events and incidents.
Such plans include the protocol by which material incidents would be communicated to executive management, our BOD, external regulators and shareholders.
- *Enterprise-Wide Coordination*: We engage experts from across the Company to identify emerging risks and respond to cybersecurity threats.
This cross-functional approach includes personnel from our R&D, manufacturing, commercial, technology, legal, compliance, internal audit and other business functions.
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pfizer Inc. | | | 2023 Form 10-K | | | 26 | | |
- *Governance*: Our BOD’s oversight of cybersecurity risk management is led by the Audit Committee, which oversees our ERM program.
Cybersecurity threats, risks and mitigation are periodically reviewed by the Audit Committee and such reviews include both internal and independent assessment of risks, controls and effectiveness.
Our risk assessment efforts have indicated that we are a target for theft of intellectual property, financial resources, personal information, and trade secrets from a wide range of actors including nation states, organized crime, malicious insiders and activists.
The impacts of attacks, abuse and misuse of Pfizer’s systems and information include, without limitation, loss of assets, operational disruption and damage to Pfizer’s reputation.
A key element of managing cybersecurity risk is the ongoing assessment and testing of our processes and practices through auditing, assessments, drills and other exercises focused on evaluating the sufficiency and effectiveness of our risk mitigation.
We regularly engage third parties to perform assessments of our cybersecurity measures, including information security maturity assessments and independent reviews of our information security control environment and operating effectiveness.
Certain results of such assessments and reviews are reported to the Audit Committee and the BOD, as appropriate, and we make adjustments to our cybersecurity processes and practices as necessary based on the information provided by the third-party assessments and reviews.
The Audit Committee oversees cybersecurity risk management, including the policies, processes and practices that management implements to prevent, detect and address risks from cybersecurity threats.
The Audit Committee receives regular briefings on cybersecurity risks and risk management practices, including, for example, recent developments in the external cybersecurity threat landscape, evolving standards, vulnerability assessments, third-party and independent reviews, technological trends and considerations arising from our supplier ecosystem.
The Audit Committee may also promptly receive information regarding any material cybersecurity incident that may occur, including any ongoing updates regarding the same.
The Audit Committee periodically discusses our approach to cybersecurity risk management with our Chief Information Security Officer (CISO).
Our CISO is a member of our management team who is principally responsible for overseeing our cybersecurity risk management program, in partnership with other business leaders across the Company.
The CISO works in coordination with other members of the management team, including, among others, the Chief Digital Officer, the Chief Financial Officer, the Chief Compliance and Risk Officer and the General Counsel and their designees.
We believe our business leaders have the appropriate expertise, background and depth of experience to manage risks arising from cybersecurity threats.
Our CISO, along with leaders from our privacy and corporate compliance functions, collaborate to implement a program designed to manage our exposure to cybersecurity risks and to promptly respond to cybersecurity incidents.
Prompt response to incidents is delivered by multi-disciplinary teams in accordance with our incident response plan.
Through ongoing communications with these teams during incidents, the CISO monitors the triage, mitigation and remediation of cybersecurity incidents, and reports such incidents to executive management, the Audit Committee and other Pfizer colleagues in accordance with our cybersecurity policies and procedures, as is appropriate.
As of the date of this Form 10-K, we are not aware of any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company, including our business strategy, results of operations, or financial condition at this time.
For further discussion of the risks associated with cybersecurity incidents, see the *[Item 1A.
Risk Factors—Information Technology and Security](#i2a2412fd329d412096454ccea3d9368c_67)* section in this Form 10-K.
An excerpt. Shown here: all 0 rewritten, 40 of 42 added and all 0 removed. The counts are complete. For every sentence, read Item 1C. CYBERSECURITY in the FY2023 filing.
Item 2. PROPERTIES
3 rewritten, 1 added, 2 removed, 8 unchanged
As of December 31, [removed: 2022,] [added: 2023,] we had [removed: 301] [added: 284] owned and leased [removed: properties,] [added: properties (including properties acquired in the Seagen acquisition),] amounting to approximately [removed: 40] [added: 38] million square feet.
As of December 31, [removed: 2022,] [added: 2023, of the 284 properties,] PGS had responsibility for [removed: 36] [added: 37] plants around the world, which manufacture products for our commercial divisions, including in Belgium, Germany, India, Ireland, Italy, Japan, Singapore and the U.S. [removed: Our] [added: The leadership team for] PGS [removed: division expects to exit the Perth, Australia site] [added: is primarily located] in [removed: early 2023.][added: New York City.]
See *[Note [removed: 9](#i8050b09ca8a0411dbcb0b6576ce1fc7a_214)*] [added: 9](#i2a2412fd329d412096454ccea3d9368c_217)*] for amounts invested in land, buildings and equipment.
The recent Seagen acquisition has increased our real estate portfolio by 14 sites totaling 1 million square feet.
In February 2023, we relocated our global headquarters to the Spiral, an office building in the Hudson Yards neighborhood of New York City.
Our PGS division is headquartered in various locations, with leadership teams primarily in New York City and in Peapack, New Jersey.
Item 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
9 rewritten, 6 added, 9 removed, 11 unchanged
As of February [removed: 21, 2023,] [added: 15, 2024,] there were [removed: 128,767] [added: 123,387] holders of record of our common stock.
The following summarizes purchases of our common stock during the fourth quarter of [removed: 2022(a):][added: 2023(a):]
| October [removed: 3] [added: 2] through October [removed: 30, 2022] [added: 29, 2023] | | | [removed: 19,483] [added: 12,222] | | | | | | $ | [removed: 43.68] [added: 32.93] | | | | | — | | | | | | $ | 3,292,882,444 | |
| October [removed: 31] [added: 30] through November 30, [removed: 2022] [added: 2023] | | | [removed: 39,821] [added: 25,825] | | | | | | $ | [removed: 47.85] [added: 29.95] | | | | | — | | | | | | $ | 3,292,882,444 | |
| December 1 through December 31, [removed: 2022] [added: 2023] | | | [removed: 415,886] [added: 14,449] | | | | | | $ | [removed: 51.29] [added: 28.58] | | | | | — | | | | | | $ | 3,292,882,444 | |
(b)Represents (i) [removed: 473,126] [added: 49,685] 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: 2,064] [added: 2,811] 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.
The following graph assumes a $100 investment on December 31, [removed: 2017,] [added: 2018,] and reinvestment of all dividends, in each of the Company’s Common Stock, 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, [removed: GlaxoSmithKline] [added: GSK] plc, Johnson & Johnson, Merck & Co., Inc., Novartis AG, [added: Novo Nordisk,] Roche Holding AG and Sanofi SA, the S&P 500 Index and the NYSE Arca Pharmaceutical Index (DRG index).
[removed: ][added: ]
| | | | | | | [removed: 2017] [added: 2018] | | | | | | [removed: 2018] [added: 2019] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2022] [added: 2023] | | |
| Total | | | 52,496 | | | | | | $ | 30.26 | | | | | — | | | | | | | | |
(a)See *[Note 12](#i2a2412fd329d412096454ccea3d9368c_229)*.
| PFIZER | | | | | | $100.0 | | | | | | $93.1 | | | | | | $96.3 | | | | | | $160.5 | | | | | | $143.8 | | | | | | $84.5 | | |
| PEER GROUP | | | | | | $100.0 | | | | | | $122.0 | | | | | | $128.7 | | | | | | $154.4 | | | | | | $179.9 | | | | | | $207.8 | | |
| S&P 500 | | | | | | $100.0 | | | | | | $131.5 | | | | | | $155.6 | | | | | | $200.3 | | | | | | $164.0 | | | | | | $207.0 | | |
| DRG Index | | | | | | $100.0 | | | | | | $118.4 | | | | | | $128.7 | | | | | | $158.8 | | | | | | $171.1 | | | | | | $184.3 | | |
| Total | | | 475,190 | | | | | | $ | 50.69 | | | | | — | | | | | | | | |
(a)See *[Note 12](#i8050b09ca8a0411dbcb0b6576ce1fc7a_226)*.
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pfizer Inc. | | | 2022 Form 10-K | | | 24 | | |
| 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 | | |
Item 6. [RESERVED]
0 rewritten, 3 added, 0 removed, 2 unchanged
| | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pfizer Inc. | | | 2023 Form 10-K | | | 29 | | |
Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
987 rewritten, 449 added, 299 removed, 1,536 unchanged
We have audited the accompanying consolidated balance sheets of Pfizer Inc. and Subsidiary Companies (the Company) as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] 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: 2022,] [added: 2023,] 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: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, [removed: 2022,] [added: 2023,] 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: 2022,] [added: 2023,] 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: 23, 2023] [added: 22, 2024] expressed an unqualified opinion on the effectiveness of the Company’s internal control over financial reporting.
As discussed in [removed: [Note](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169) [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)[G](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)] [added: [Note 1G](#i2a2412fd329d412096454ccea3d9368c_172)] 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](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187) [5](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187)[D](#i8050b09ca8a0411dbcb0b6576ce1fc7a_187)] [added: [Notes 5D](#i2a2412fd329d412096454ccea3d9368c_187)] and [removed: [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)[Q](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169),] [added: [1Q](#i2a2412fd329d412096454ccea3d9368c_172),] 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: 2022,] [added: 2023,] the Company has recorded gross unrecognized tax benefits, excluding associated interest, of [removed: $4.5] [added: $4.8] billion.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 45] [added: 50] | | |
We evaluated the design and tested the operating effectiveness of an internal control over the Company’s liability for unrecognized tax position process related to (1) interpretation of tax law, (2) evaluation of which of the Company’s tax positions may not be sustained upon audit, and (3) estimation and recording of the gross [removed: unrecognized tax benefits.]
[added: As discussed in [Notes 1S](#i2a2412fd329d412096454ccea3d9368c_172)] and [removed: [16](#i8050b09ca8a0411dbcb0b6576ce1fc7a_238)] [added: [16](#i2a2412fd329d412096454ccea3d9368c_244)] 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.
[removed: ][added: ]
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 46] [added: 51] | | |
| (MILLIONS, EXCEPT PER SHARE DATA) | | | | | | | | | | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |
| [removed: Revenues] [added: Total revenues] | | | | | | | | | | | | | | | [removed: $] [added: 58,496] | [removed: 100,330] | | | | | [removed: $] [added: 100,330] | [removed: 81,288] | | | | | [removed: $] [added: 81,288] | [removed: 41,651] | |
| Cost of [removed: sales(a)] [added: sales(b), (c)] | | | | | | | | | | | | | | | [removed: 34,344] [added: 24,954] | | | | | | [removed: 30,821] [added: 34,344] | | | | | | [removed: 8,484] [added: 30,821] | | |
| Selling, informational and administrative [removed: expenses(a)] [added: expenses(b)] | | | | | | | | | | | | | | | [removed: 13,677] [added: 14,771] | | | | | | [removed: 12,703] [added: 13,677] | | | | | | [removed: 11,597] [added: 12,703] | | |
| Research and development [removed: expenses(a)] [added: expenses(b)] | | | | | | | | | | | | | | | [removed: 11,428] [added: 10,679] | | | | | | [removed: 10,360] [added: 11,428] | | | | | | [removed: 8,709] [added: 10,360] | | |
| Acquired in-process research and development [removed: expenses(b)] [added: expenses] | | | | | | | | | | | | | | | [removed: 953] [added: 194] | | | | | | [removed: 3,469] [added: 953] | | | | | | [removed: 684] [added: 3,469] | | |
| Amortization of intangible assets | | | | | | | | | | | | | | | [removed: 3,609] [added: 4,733] | | | | | | [removed: 3,700] [added: 3,609] | | | | | | [removed: 3,348] [added: 3,700] | | |
| Restructuring charges and certain acquisition-related costs | | | | | | | | | | | | | | | [removed: 1,375] [added: 2,943] | | | | | | [removed: 802] [added: 1,375] | | | | | | [removed: 579] [added: 802] | | |
| Other (income)/deductions––net | | | | | | | | | | | | | | | [removed: 217] [added: (835)] | | | | | | [removed: (4,878)] [added: 217] | | | | | | [removed: 1,213] [added: (4,878)] | | |
| Income from continuing operations before provision/(benefit) for taxes on income | | | | | | | | | | | | | | | [removed: 34,729] [added: 1,058] | | | | | | [removed: 24,311] [added: 34,729] | | | | | | [removed: 7,036] [added: 24,311] | | |
| Provision/(benefit) for taxes on income | | | | | | | | | | | | | | | [removed: 3,328] [added: (1,115)] | | | | | | [removed: 1,852] [added: 3,328] | | | | | | [removed: 370] [added: 1,852] | | |
| Income from continuing operations | | | | | | | | | | | | | | | [removed: 31,401] [added: 2,172] | | | | | | [removed: 22,459] [added: 31,401] | | | | | | [removed: 6,666] [added: 22,459] | | |
| Discontinued operations––net of tax | | | | | | | | | | | | | | | [removed: 6] [added: (15)] | | | | | | [removed: (434)] [added: 6] | | | | | | [removed: 2,529] [added: (434)] | | |
| Net income before allocation to noncontrolling interests | | | | | | | | | | | | | | | [removed: 31,407] [added: 2,158] | | | | | | [removed: 22,025] [added: 31,407] | | | | | | [removed: 9,195] [added: 22,025] | | |
| Less: Net income attributable to noncontrolling interests | | | | | | | | | | | | | | | [removed: 35] [added: 39] | | | | | | [removed: 45] [added: 35] | | | | | | [removed: 36] [added: 45] | | |
| Net income attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 31,372] [added: 2,119] | | | | | $ | [removed: 21,979] [added: 31,372] | | | | | $ | [removed: 9,159] [added: 21,979] | |
| Income from continuing operations attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 5.59] [added: 0.38] | | | | | $ | [removed: 4.00] [added: 5.59] | | | | | $ | [removed: 1.19] [added: 4.00] | |
| Discontinued operations––net of tax | | | | | | | | | | | | | | | — | | | | | | [removed: (0.08)] [added: —] | | | | | | [removed: 0.46] [added: (0.08)] | | |
| Net income attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 5.59] [added: 0.38] | | | | | $ | [removed: 3.92] [added: 5.59] | | | | | $ | [removed: 1.65] [added: 3.92] | |
| Income from continuing operations attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 5.47] [added: 0.37] | | | | | $ | [removed: 3.93] [added: 5.47] | | | | | $ | [removed: 1.18] [added: 3.93] | |
| Discontinued operations––net of tax | | | | | | | | | | | | | | | — | | | | | | [removed: (0.08)] [added: —] | | | | | | [removed: 0.45] [added: (0.08)] | | |
| Net income attributable to Pfizer Inc. common shareholders | | | | | | | | | | | | | | | $ | [removed: 5.47] [added: 0.37] | | | | | $ | [removed: 3.85] [added: 5.47] | | | | | $ | [removed: 1.63] [added: 3.85] | |
| Weighted-average shares––basic | | | | | | | | | | | | | | | [removed: 5,608] [added: 5,643] | | | | | | [removed: 5,601] [added: 5,608] | | | | | | [removed: 5,555] [added: 5,601] | | |
| Weighted-average shares––diluted | | | | | | | | | | | | | | | [removed: 5,733] [added: 5,709] | | | | | | [removed: 5,708] [added: 5,733] | | | | | | [removed: 5,632] [added: 5,708] | | |
[removed: (a)Exclusive] [added: (b)Exclusive] of amortization of intangible assets.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 47] [added: 52] | | |
| (MILLIONS) | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |
| Net income before allocation to noncontrolling interests | | | | | | $ | [removed: 31,407] [added: 2,158] | | | | | $ | [removed: 22,025] [added: 31,407] | | | | | $ | [removed: 9,195] [added: 22,025] | |
| Foreign currency translation adjustments, net | | | | | | [removed: (2,328)] [added: 452] | | | | | | [removed: (682)] [added: (2,328)] | | | | | | [removed: 772] [added: (682)] | | |
unrecognized tax benefits.
*Evaluation of the fair value measurement of the developed technology rights and in-process research and development intangible assets acquired in the Seagen business combination*
As discussed in [Note 2A](#i2a2412fd329d412096454ccea3d9368c_175) to the consolidated financial statements, on December 14, 2023, the Company acquired Seagen Inc. and its subsidiaries (Seagen).
The total fair value of consideration transferred was $44.2 billion.
Of that, the Company provisionally recorded $7.5 billion of developed technology rights with an estimated weighted-average life of approximately 18 years and $20.8 billion of in-process research and development (IPR&D).
We identified the evaluation of the fair value measurement of the acquired developed technology rights and IPR&D as a critical audit matter.
A high degree of subjective auditor judgment was required to evaluate certain key assumptions used to estimate the acquisition-date fair value of the acquired developed technology rights and IPR&D.
Specifically, the key assumptions for certain IPR&D assets, including revenue growth rates, probability of technical and regulatory success (PTRS) rates, and the discount rate, and the key assumptions for certain developed technology rights, including revenue growth rates and the discount rate, represented subjective determinations of future market and economic conditions.
Changes to those assumptions could have had a significant effect on the determination of the fair value measurements.
The following are the primary procedures we performed to address this critical audit matter.
We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s acquisition-date valuation process, including controls related to the development of the key assumptions for certain IPR&D assets and developed technology rights.
We performed sensitivity analyses over the key assumptions for certain IPR&D assets and developed technology rights to assess the impact of changes in those key assumptions on the Company’s determination of the fair value of the IPR&D and developed technology rights, respectively.
We evaluated the reasonableness of the Company’s forecasted revenue growth rates by comparing them to historical results for comparable products and peer companies, analyst expectations, and industry related third-party data.
Further, we evaluated the PTRS rates for certain IPR&D assets by considering the phase of development of the clinical projects and the Company's history of obtaining regulatory approval and comparing them to PTRS rates derived from analyst reports and other industry related third-party data.
We evaluated the data sources used by management in determining the key assumptions for certain IPR&D assets and developed technology rights by comparing to industry standards and evidence obtained in other areas of the audit.
In addition, we involved valuation professionals with specialized skills and knowledge, who assisted in:
(1)evaluating the discount rates used by the Company for certain IPR&D and developed technology rights by comparing them against discount rate ranges that were independently developed using publicly available market data for comparable entities
(2)testing the source information underlying the determination of the discount rates.
| *February 22, 2024* | | |
| Revenues: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Product revenues(a) | | | | | | | | | | | | | | | $ | 50,914 | | | | | $ | 91,793 | | | | | $ | 73,636 | |
(c)See *[Notes 8A](#i2a2412fd329d412096454ccea3d9368c_214)* and *[17A](#i2a2412fd329d412096454ccea3d9368c_247)*.
| Net income | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2,119 | | | | | | | | | | | | 2,119 | | | | | | 39 | | | | | | 2,158 | | |
| Share-based payment transactions | | | | | | | | | | | | | | | | | | 43 | | | | | | 2 | | | | | | 829 | | | | | | (12) | | | | | | (518) | | | | | | (106) | | | | | | | | | | | | 208 | | | | | | | | | | | | 208 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Balance, December 31, 2023 | | | | | | | | | | | | | | | | | | 9,562 | | | | | | $ | 478 | | | | | $ | 92,631 | | | | | (3,916) | | | | | | $ | (114,487) | | | | | $ | 118,353 | | | | | $ | (7,961) | | | | | $ | 89,014 | | | | | $ | 274 | | | | | $ | 89,288 | |
| Net income before allocation to noncontrolling interests | | | | | | $ | 2,158 | | | | | $ | 31,407 | | | | | $ | 22,025 | |
| Inventory write-offs and related charges associated with COVID-19 products(a) | | | | | | 6,199 | | | | | | 1,183 | | | | | | — | | |
| Inventories(a) | | | | | | (1,169) | | | | | | (591) | | | | | | (1,125) | | |
(a)See *[Notes 8A](#i2a2412fd329d412096454ccea3d9368c_214)* and *[1](#i2a2412fd329d412096454ccea3d9368c_247)[7](#i2a2412fd329d412096454ccea3d9368c_247)[A](#i2a2412fd329d412096454ccea3d9368c_247)*.
(b)See *[Note 8A](#i2a2412fd329d412096454ccea3d9368c_214)*.
(c)See *[Note 17](#i2a2412fd329d412096454ccea3d9368c_549755815813)[C](#i2a2412fd329d412096454ccea3d9368c_549755815813)*.
(d)See *[Note 2C](#i2a2412fd329d412096454ccea3d9368c_549755815732).*
See *[Note 17](#i2a2412fd329d412096454ccea3d9368c_247)*.
On December 14, 2023, we completed the acquisition of Seagen.
See *[Note 2](#i2a2412fd329d412096454ccea3d9368c_175).*
On January 1, 2023, we adopted a new accounting standard for supplier finance programs which requires increased disclosures in the notes to our financial statements.
See *[Note 8C](#i2a2412fd329d412096454ccea3d9368c_214).*
In the second quarter of 2023, we adopted new accounting standards on reference rate reform that provide temporary optional expedients and exceptions to the guidance for contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate that were discontinued after June 30, 2023.
We applied certain of the optional expedients related to hedge accounting relationships.
As discussed in [Notes](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169) [1](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)[S](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169).
| *February 23, 2023* | | |
(b)See *[Note 1L](#i8050b09ca8a0411dbcb0b6576ce1fc7a_169)*.
| Reclassification adjustments | | | | | | — | | | | | | — | | | | | | (17) | | |
| | | | | | | (2,328) | | | | | | (682) | | | | | | 755 | | |
See *[Note 7E](#i8050b09ca8a0411dbcb0b6576ce1fc7a_205).*
| | | | | | | | | | | | | | | |
| Balance, January 1, 2020 | | | | | | 431 | | | | | | $ | 17 | | | | | 9,369 | | | | | | $ | 468 | | | | | $ | 87,428 | | | | | (3,835) | | | | | | $ | (110,801) | | | | | $ | 91,397 | | | | | $ | (5,367) | | | | | $ | 63,143 | | | | | $ | 303 | | | | | $ | 63,447 | |
| Net income | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 9,159 | | | | | | | | | | | | 9,159 | | | | | | 36 | | | | | | 9,195 | | |
| Preferred stock | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | — | | | | | | | | | | | | — | | | | | | | | | | | | — | | |
| Preferred stock conversions and redemptions(a) | | | | | | (431) | | | | | | (17) | | | | | | | | | | | | | | | | | | (15) | | | | | | 1 | | | | | | 31 | | | | | | | | | | | | | | | | | | (1) | | | | | | | | | | | | (1) | | |
| Distribution of Upjohn Business(b) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | (1,592) | | | | | | (423) | | | | | | (2,015) | | | | | | (3) | | | | | | (2,018) | | |
| Share-based payment transactions | | | | | | | | | | | | | | | | | | 48 | | | | | | 2 | | | | | | 1,192 | | | | | | (13) | | | | | | (608) | | | | | | (73) | | | | | | | | | | | | 513 | | | | | | | | | | | | 513 | | |
(a)See *[Note 12](#i8050b09ca8a0411dbcb0b6576ce1fc7a_226)*.
| Inventories | | | | | | 592 | | | | | | (1,125) | | | | | | (778) | | |
| Net cash provided by/(used in) financing activities from discontinued operations | | | | | | — | | | | | | — | | | | | | 11,991 | | |
| Net cash provided by/(used in) financing activities | | | | | | (14,834) | | | | | | (9,816) | | | | | | (9,649) | | |
Substantially all unremitted earnings of international subsidiaries are free of legal and contractual restrictions.
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.
See *[Note 17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)*.
Prior to its sale, Meridian was managed within the former Hospital product portfolio.
Beginning in the fourth quarter of 2021, the financial results of Meridian were reflected as discontinued operations for all periods presented.
On December 21, 2020, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (the Mylan-Japan collaboration) pursuant to an agreement dated November 13, 2020, and we transferred related inventories and operations that were part of the Mylan-Japan collaboration to Viatris.
On November 16, 2020, we completed the spin-off and the combination of our Upjohn Business with Mylan to form Viatris.
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.
Upon completion of the spin-off of the Upjohn Business on November 16, 2020, the Upjohn assets and liabilities were derecognized from our consolidated balance sheet and are reflected in *Retained Earnings*–*Distribution of Upjohn Business* in the consolidated statement of equity.
Prior to the spin-off of the Upjohn Business in November 2020, the Upjohn Business, the Mylan-Japan collaboration and Meridian were managed as part of our former Upjohn operating segment.
With the separation of the Upjohn Business, the Mylan-Japan collaboration and Meridian, as well as the formation of the Consumer Healthcare JV in 2019, Pfizer transformed into a more focused, global leader in science-based innovative medicines and vaccines.
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.
the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received.
See *[Note](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241) [17](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)[C](#i8050b09ca8a0411dbcb0b6576ce1fc7a_241)* for additional information.
See *[Note](#i8050b09ca8a0411dbcb0b6576ce1fc7a_211) [](#i8050b09ca8a0411dbcb0b6576ce1fc7a_211)[8](#i8050b09ca8a0411dbcb0b6576ce1fc7a_211)[A](#i8050b09ca8a0411dbcb0b6576ce1fc7a_211)*.
collaboration and in-license agreements, including premiums on equity securities and (b) asset acquisitions of acquired IPR&D.
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.
Arena’s portfolio includes development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including UC, Crohn’s disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.
An excerpt. Shown here: 40 of 987 rewritten, 40 of 449 added and 40 of 299 removed. The counts are complete. For every sentence, read Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA in the FY2023 filing and the FY2022 filing.
Item 9A. CONTROLS AND PROCEDURES
13 rewritten, 8 added, 5 removed, 55 unchanged
[removed: During] [added: Other than the addition of Seagen’s operations to] our [removed: most recent fiscal quarter,] [added: internal control over financial reporting and any related changes in control to integrate Seagen into Pfizer,] there has not been any change in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 101] [added: 107] | | |
We have audited Pfizer Inc. and Subsidiary Companies’ (the Company) internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] 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: 2022,] [added: 2023,] 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: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] 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: 2022,] [added: 2023,] and the related notes (collectively, the consolidated financial statements), and our report dated February [removed: 23, 2023] [added: 22, 2024] 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 [Management’s Report on Internal Control Over Financial [removed: Reporting](#i8050b09ca8a0411dbcb0b6576ce1fc7a_262).][added: Reporting](#i2a2412fd329d412096454ccea3d9368c_268).]
[removed: ][added: ]
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 102] [added: 108] | | |
Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, [removed: 2022.][added: 2023.]
Based on our assessment and those criteria, management believes that the Company maintained effective internal control over financial reporting as of December 31, [removed: 2022.][added: 2023.]
| [removed: ] [added: ] | | | | | | | | |
| [removed: ] [added: ] | | | | | | [removed: ] [added: ] | | |
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 103] [added: 109] | | |
On December 14, 2023, we acquired Seagen.
The scope of management’s assessment of the effectiveness of internal control over financial reporting includes all of the Company’s consolidated operations except for the operations of Seagen Inc. and its subsidiaries (Seagen), which the Company acquired on December 14, 2023.
Seagen’s operations represent 0.2% of the Company’s consolidated revenues for the year ended December 31, 2023, and assets associated with Seagen’s operations represent 22% of the Company’s consolidated total assets, as of December 31, 2023.
Our audit of internal control over financial reporting of the Company also excluded an evaluation of the internal control over financial reporting of Seagen.
| *February 22, 2024* | | |
The scope of management’s assessment of the effectiveness of internal control over financial reporting includes all of the Company’s consolidated operations except for the operations of Seagen Inc. and its subsidiaries (Seagen), which the Company acquired on December 14, 2023.
Seagen’s operations represent 0.2% of the Company’s consolidated revenues for the year ended December 31, 2023, and assets associated with Seagen’s operations represent 22% of the Company’s consolidated total assets, as of December 31, 2023.
| *February 22, 2024* | | | | | | | | |
| | | |
| --- | --- | --- |
| *February 23, 2023* | | |
| *February 23, 2023* | | | | | | | | |
| PART III | | |
Item 9B. OTHER INFORMATION
0 rewritten, 6 added, 0 removed, 0 unchanged
New section this year
During the three months ended December 31, 2023, none of our directors or officers adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
| | | |
| --- | --- | --- |
| PART III | | |
| | | | | | |
| --- | --- | --- | --- | --- | --- |
Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
2 rewritten, 0 added, 0 removed, 5 unchanged
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: 2024] [added: 2025] Annual Meeting* in our Proxy Statement.
The balance of the information required by this item is contained in the discussion entitled *[Information about Our Executive [removed: Officers](#i8050b09ca8a0411dbcb0b6576ce1fc7a_79)*] [added: Officers](#i2a2412fd329d412096454ccea3d9368c_76)*] in this Form 10-K.
Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
1 rewritten, 0 added, 0 removed, 7 unchanged
Information about the fees for professional services rendered by our independent registered public accounting firm in [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] 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.
Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
71 rewritten, 6 added, 7 removed, 153 unchanged
Financial Statements and Supplementary [removed: Data](#i8050b09ca8a0411dbcb0b6576ce1fc7a_145)*] [added: Data](#i2a2412fd329d412096454ccea3d9368c_148)*] in this Form 10-K:
- [Report of Independent Registered Public Accounting Firm on the Consolidated Financial [removed: Statements](#i8050b09ca8a0411dbcb0b6576ce1fc7a_148)][added: Statements](#i2a2412fd329d412096454ccea3d9368c_151)]
- [Consolidated Statements of [removed: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_151)][added: Income](#i2a2412fd329d412096454ccea3d9368c_154)]
- [Consolidated Statements of Comprehensive [removed: Income](#i8050b09ca8a0411dbcb0b6576ce1fc7a_154)][added: Income](#i2a2412fd329d412096454ccea3d9368c_157)]
- [Consolidated Balance [removed: Sheets](#i8050b09ca8a0411dbcb0b6576ce1fc7a_157)][added: Sheets](#i2a2412fd329d412096454ccea3d9368c_160)]
- [Consolidated Statements of [removed: Equity](#i8050b09ca8a0411dbcb0b6576ce1fc7a_160)][added: Equity](#i2a2412fd329d412096454ccea3d9368c_163)]
- [Consolidated Statements of Cash [removed: Flows](#i8050b09ca8a0411dbcb0b6576ce1fc7a_163)][added: Flows](#i2a2412fd329d412096454ccea3d9368c_166)]
- [Notes to Consolidated Financial [removed: Statements](#i8050b09ca8a0411dbcb0b6576ce1fc7a_166)][added: Statements](#i2a2412fd329d412096454ccea3d9368c_169)]
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 104] [added: 110] | | |
Exhibit numbers 10.1 through [removed: 10.47] [added: 10.50] are management contracts or compensatory plans or arrangements.
| [removed: [2.7](http://www.sec.gov/Archives/edgar/data/78003/000007800320000070/pfe-exh21x927202010q.htm)] [added: [10.49](http://www.sec.gov/Archives/edgar/data/78003/000007800320000060/pfe-exhibit101x6282020.htm)] | | | | | | [removed: Amendment No. 3 to the Separation and Distribution] [added: Time Sharing] Agreement, dated [removed: as of September 18,] [added: July 9,] 2020, [removed: by and] between [removed: us and Upjohn] [added: Pfizer] Inc. [added: and Albert Bourla] is incorporated by reference from our Quarterly Report on Form 10-Q for the period ended [removed: September 27,] [added: June 28,] 2020. [removed: (Pursuant to Item 601(b)(2) of Regulation S-K, the registrant hereby agrees to supplementally furnish to the SEC upon request any omitted schedule or exhibit to the Amendment No. 3 to the Separation and Distribution Agreement.)] | | |
| [3.2](https://www.sec.gov/Archives/edgar/data/78003/000007800322000107/bylaws_exh31.htm) | | | | | | Our By-laws, as amended [added: on] December 9, 2022, are incorporated by reference from our Current Report on Form 8-K filed on December 13, 2022. | | |
| [4.5](http://www.sec.gov/Archives/edgar/data/78003/000119312514201187/d727538dex42.htm) | | | | | | Fourth Supplemental Indenture, dated as of May 15, 2014, between us and The Bank of New York Mellon (successor to JPMorgan Chase Bank, N.A. (formerly JPMorgan Chase Bank, formerly The Chase Manhattan Bank)), as trustee, to Indenture dated as of January 30, 2001, is incorporated by reference from our Current Report on Form 8-K [removed: report] filed on May 15, 2014. | | |
| [4.6](http://www.sec.gov/Archives/edgar/data/78003/000119312515338599/d37576dex42.htm) | | | | | | Fifth Supplemental Indenture, dated as of October 5, 2015, between us and The Bank of New York Mellon (successor to JPMorgan Chase Bank, N.A. (formerly JPMorgan Chase Bank, formerly The Chase Manhattan Bank)), as trustee, to Indenture dated as of January 30, 2001, is incorporated by reference from our Current Report on Form 8-K [removed: report] filed on October 6, 2015. | | |
| [4.7](http://www.sec.gov/Archives/edgar/data/78003/000119312516612635/d193755dex43.htm) | | | | | | Sixth Supplemental Indenture, dated as of June 3, 2016, between us and The Bank of New York Mellon (formerly The Bank of New York (successor to JPMorgan Chase Bank, N.A. (formerly JPMorgan Chase Bank, formerly The Chase Manhattan Bank (National Association)))), as trustee, to Indenture dated as of January 30, 2001, is incorporated by reference from our Current Report on Form 8-K [removed: report] filed on June 3, 2016. | | |
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 105] [added: 111] | | |
| [4.8](http://www.sec.gov/Archives/edgar/data/78003/000110465916158373/a16-21499_7ex4d2.htm) | | | | | | Seventh Supplemental Indenture, dated as of November 21, 2016, between us and The Bank of New York Mellon (formerly The Bank of New York (successor to JPMorgan Chase Bank, N.A. (formerly JPMorgan Chase Bank, formerly The Chase Manhattan Bank (National Association)))), as trustee, to Indenture dated as of January 30, 2001, is incorporated by reference from our Current Report on Form 8-K [removed: report] filed on November 21, 2016. | | |
| [4.9](http://www.sec.gov/Archives/edgar/data/78003/000119312517087159/d347858dex42.htm) | | | | | | Eighth Supplemental Indenture, dated as of March 17, 2017, among us, The Bank of New York Mellon (formerly The Bank of New York (successor to JPMorgan Chase Bank, N.A. (formerly JPMorgan Chase Bank, formerly The Chase Manhattan Bank (successor to the Chase Manhattan Bank (National Association)))), as trustee, and The Bank of New York Mellon, London Branch, as paying agent, to Indenture dated as of January 30, 2001, is incorporated by reference from our Current Report on Form 8-K [removed: report] filed on March 17, 2017. | | |
| [4.10](http://www.sec.gov/Archives/edgar/data/78003/000119312517071809/d335900dex42.htm) | | | | | | Ninth Supplemental Indenture, dated as of March 6, 2017, among us, The Bank of New York Mellon (formerly The Bank of New York (successor to JPMorgan Chase Bank, N.A. (formerly JPMorgan Chase Bank, formerly The Chase Manhattan Bank (National Association)))), as trustee, and The Bank of New York Mellon, London Branch, as paying agent and calculation agent, to Indenture dated as of January 30, 2001, is incorporated by reference from our Current Report on Form 8-K [removed: report] filed on March 6, 2017. | | |
| [4.11](http://www.sec.gov/Archives/edgar/data/78003/000119312517373738/d476089dex42.htm) | | | | | | Tenth Supplemental Indenture, dated as of December 19, 2017, among us, The Bank of New York Mellon (formerly The Bank of New York (successor to JPMorgan Chase Bank, N.A. (formerly JPMorgan Chase Bank, formerly The Chase Manhattan Bank (National Association)))), as trustee, and The Bank of New York Mellon, London Branch, as paying agent, to Indenture dated as of January 30, 2001, is incorporated by reference from our Current Report on Form 8-K [removed: report] filed on December 19, 2017. | | |
| [removed: [4.23](http://www.sec.gov/Archives/edgar/data/78003/000119312521250347/d340659dex42.htm)] [added: [4](http://www.sec.gov/Archives/edgar/data/78003/000119312521250347/d340659dex42.htm)[.23](http://www.sec.gov/Archives/edgar/data/78003/000119312521250347/d340659dex42.htm)] | | | | | | Fifth Supplemental Indenture, dated as of August 18, 2021 between us and The Bank of New York Mellon, as trustee, is incorporated by reference from our Current Report on Form 8-K filed on August 18, 2021. | | |
| [removed: *[4.24](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh424x12312022x10k.htm)] [added: *[4.26](https://www.sec.gov/Archives/edgar/data/78003/000007800324000039/pfe-exh426x12312023x10k.htm)] | | | | | | Description of Pfizer’s Securities. | | |
| [removed: 4.25] [added: 4.27] | | | | | | Except as set forth in Exhibits [removed: 4.1-24] [added: 4.1-4.26] above, the instruments defining the rights of holders of long-term debt securities of the Company and its subsidiaries have been omitted. We agree to furnish to the SEC, upon request, a copy of each instrument with respect to issuances of long-term debt of the Company and its subsidiaries. | | |
| [removed: [10.6](http://www.sec.gov/Archives/edgar/data/78003/000007800320000037/pfe-exh101x0329202010q.htm)] [added: [1](http://www.sec.gov/Archives/edgar/data/78003/000007800320000037/pfe-exh101x0329202010q.htm)[0.6](http://www.sec.gov/Archives/edgar/data/78003/000007800320000037/pfe-exh101x0329202010q.htm)] | | | | | | Form of Acknowledgment and Consent and Summary of Key Terms for Grants of RSUs, TSRUs, PPSs and PSAs is incorporated by reference from our Quarterly Report on Form 10-Q for the period ended [removed: March 29, 2020.] [added: April 2, 2023.] | | |
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 106] [added: 112] | | |
| [removed: *[10.11](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh1011x12312022x10k.htm)] [added: *[10.12](https://www.sec.gov/Archives/edgar/data/78003/000007800324000039/pfe-exh1012x12312023x10k.htm)] | | | | | | Amendment No. [removed: 3] [added: 4] to the Pfizer Consolidated Supplemental Pension Plan for United States and Puerto Rico Employees. | | |
| [removed: [10.12](http://www.sec.gov/Archives/edgar/data/78003/000007800316000096/pfe-4032016x10qexhibit101.htm)] [added: [10.13](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: [10.13](http://www.sec.gov/Archives/edgar/data/78003/000007800317000049/pfe-10012017x10qexhibit101.htm)] [added: [10.14](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: [10.14](http://www.sec.gov/Archives/edgar/data/78003/000007800318000027/pfe-exhibit109x1231201.htm)] [added: [10.15](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: [10.15](http://www.sec.gov/Archives/edgar/data/78003/000007800318000091/pfe-930201810qxexhibit101.htm)] [added: [10.16](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: [10.16](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1012x12312018x1.htm)] [added: [10.17](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: [10.17](http://www.sec.gov/Archives/edgar/data/78003/000007800319000015/pfe-exhibit1013x12312018x1.htm)] [added: [10.18](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: [10.18](http://www.sec.gov/Archives/edgar/data/78003/000007800319000064/pfe-630201910qxexh101.htm)] [added: [10.19](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: [10.19](http://www.sec.gov/Archives/edgar/data/78003/000007800320000014/pfe-ex1015x12312019xk.htm)] [added: [10.20](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: [10.20](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1019x123120x10k.htm)] [added: [10.21](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: [10.21](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh1020x12312020x10k.htm)] [added: [10.22](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: *[10.22](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh1022x12312022x10k.htm)] [added: [10.23](http://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh1022x12312022x10k.htm)] | | | | | | Amendment No. 10 to the Pfizer Supplemental Savings [removed: Plan.] [added: Plan is incorporated by reference from our 2022 Annual Report on Form 10-K.] | | |
| [removed: *[10.23](https://www.sec.gov/Archives/edgar/data/78003/000007800323000024/pfe-exh1023x12312022x10k.htm)] [added: *[10.29](https://www.sec.gov/Archives/edgar/data/78003/000007800324000039/pfe-exh1029x12312023x10k.htm)] | | | | | | [added: Amendment No. 4 to] Amended and Restated [removed: Pfizer Inc. Global Performance] [added: Deferred Compensation] Plan. | | |
| [removed: [10.24](http://www.sec.gov/Archives/edgar/data/78003/000007800313000006/pfe-12312012xex109.htm)] [added: [10.25](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: [10.25](http://www.sec.gov/Archives/edgar/data/78003/000007800314000018/pfe-12312013xex1011.htm)] [added: [10.26](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. | | |
| [2](http://www.sec.gov/ix?doc=/Archives/edgar/data/78003/000119312523068538/d408093d8k.htm)[.](http://www.sec.gov/ix?doc=/Archives/edgar/data/78003/000119312523068538/d408093d8k.htm)[2](http://www.sec.gov/ix?doc=/Archives/edgar/data/78003/000119312523068538/d408093d8k.htm) | | | | | | Agreement and Plan of Merger, by and among Pfizer Inc., Aris Merger Sub, Inc. and Seagen Inc., dated as of March 12, 2023 is incorporated by reference from our Current Report on Form 8-K filed on March 13, 2023. | | |
| [4.24](http://www.sec.gov/Archives/edgar/data/78003/000119312523149364/d414076dex41.htm) | | | | | | Indenture, dated as of May 19, 2023, among Pfizer Investment Enterprises Pte. Ltd., Pfizer Inc. and The Bank of New York Mellon, as trustee, is incorporated by reference from our Current Report on Form 8-K filed on May 19, 2023. | | |
| [4.25](http://www.sec.gov/Archives/edgar/data/78003/000119312523149364/d414076dex42.htm) | | | | | | First Supplemental Indenture, dated as of May 19, 2023, among Pfizer Investment Enterprises Pte. Ltd., Pfizer Inc. and The Bank of New York Mellon, as trustee, is incorporated by reference from our Current Report on Form 8-K filed on May 19, 2023. | | |
| [10.11](http://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 is incorporated by reference from our 2022 Annual Report on Form 10-K. | | |
| *[22](https://www.sec.gov/Archives/edgar/data/78003/000007800324000039/pfe-exh22x12312023x10k.htm) | | | | | | Subsidiary Issuers of Guaranteed Securities. | | |
| *[97](https://www.sec.gov/Archives/edgar/data/78003/000007800324000039/pfe-exh97x12312023x10k.htm) | | | | | | Pfizer Inc. Recoupment Policy. | | |
| | | | | | | | | |
| [2.2](http://www.sec.gov/Archives/edgar/data/78003/000119312519204818/d769805dex21.htm) | | | | | | Business Combination Agreement, dated as of July 29, 2019, by and among us, Upjohn Inc., Utah Acquisition Sub Inc., Mylan N.V., Mylan I B.V. and Mylan II B.V. is incorporated by reference from our Current Report on Form 8-K filed on July 29, 2019. (Pursuant to Item 601(b)(2) of Regulation S-K, the registrant hereby agrees to supplementally furnish to the SEC upon request any omitted schedule or exhibit to the Business Combination Agreement.) | | |
| [2.3](http://www.sec.gov/Archives/edgar/data/78003/000119312520157434/d904465dex21.htm) | | | | | | Amendment No. 1 to the Business Combination Agreement, dated as of May 29, 2020, by and among us, Upjohn Inc., Utah Acquisition Sub Inc., Mylan N.V., Mylan I B.V. and Mylan II B.V. is incorporated by reference from our Current Report on Form 8-K filed on June 1, 2020. (Pursuant to Item 601(b)(2) of Regulation S-K, the registrant hereby agrees to supplementally furnish to the SEC upon request any omitted schedule or exhibit to the Amendment No. 1 to the Business Combination Agreement.) | | |
| [2.4](http://www.sec.gov/Archives/edgar/data/78003/000119312519204818/d769805dex22.htm) | | | | | | Separation and Distribution Agreement, dated as of July 29, 2019, by and between us and Upjohn Inc. is incorporated by reference from our Current Report on Form 8-K filed on July 29, 2019. (Pursuant to Item 601(b)(2) of Regulation S-K, the registrant hereby agrees to supplementally furnish to the SEC upon request any omitted schedule or exhibit to the Separation and Distribution Agreement.) | | |
| [2.5](http://www.sec.gov/Archives/edgar/data/78003/000007800320000014/pfe-exhibit24x12312019.htm) | | | | | | Amendment No. 1 to the Separation and Distribution Agreement, dated as of February 18, 2020, by and between us and Upjohn Inc. is incorporated by reference from our 2019 Annual Report on Form 10-K. (Pursuant to Item 601(b)(2) of Regulation S-K, the registrant hereby agrees to supplementally furnish to the SEC upon request any omitted schedule or exhibit to the Amendment No. 1 to the Separation and Distribution Agreement.) | | |
| [2.6](http://www.sec.gov/Archives/edgar/data/78003/000119312520157434/d904465dex22.htm) | | | | | | Amendment No. 2 to the Separation and Distribution Agreement, dated as of May 29, 2020, by and between us and Upjohn Inc. is incorporated by reference from our Current Report on Form 8-K filed on June 1, 2020. (Pursuant to Item 601(b)(2) of Regulation S-K, the registrant hereby agrees to supplementally furnish to the SEC upon request any omitted schedule or exhibit to the Amendment No. 2 to the Separation and Distribution Agreement.) | | |
| [2.8](http://www.sec.gov/Archives/edgar/data/78003/000007800321000038/pfe-exh28x12312020x10k.htm) | | | | | | Amendment No. 4 to the Separation and Distribution Agreement, dated as of November 15, 2020, by and between us and Upjohn Inc. is incorporated by reference from our 2020 Annual Report on Form 10-K. (Pursuant to Item 601(b)(2) of Regulation S-K, the registrant hereby agrees to supplementally furnish to the SEC upon request any omitted schedule or exhibit to the Amendment No. 4 to the Separation and Distribution Agreement.) | | |
An excerpt. Shown here: 40 of 71 rewritten, all 6 added and all 7 removed. The counts are complete. For every sentence, read Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES in the FY2023 filing and the FY2022 filing.
Item 16. FORM 10-K SUMMARY
17 rewritten, 0 added, 0 removed, 33 unchanged
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 108] [added: 114] | | |
| Dated: February [removed: 23, 2023] [added: 22, 2024] | | | By: | | | | | | /S/ MARGARET M. MADDEN | | |
| /S/ ALBERT BOURLA Albert Bourla | | | Chairman, Chief Executive Officer and Director (Principal Executive Officer) | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ DAVID M. DENTON David M. Denton | | | Chief Financial Officer, Executive Vice President (Principal Financial Officer) | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ JENNIFER B. DAMICO Jennifer B. Damico | | | Senior Vice President and Controller (Principal Accounting Officer) | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ RONALD E. BLAYLOCK Ronald E. Blaylock | | | Director | | | February 21, [removed: 2023] [added: 2024] | | | | | | | | |
| /S/ SUSAN DESMOND-HELLMANN Susan Desmond-Hellmann | | | Director | | | February 21, [removed: 2023] [added: 2024] | | | | | | | | |
| /S/ JOSEPH J. ECHEVARRIA Joseph J. Echevarria | | | Director | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ SCOTT GOTTLIEB Scott Gottlieb | | | Director | | | February 21, [removed: 2023] [added: 2024] | | | | | | | | |
| /S/ HELEN H. HOBBS Helen H. Hobbs | | | Director | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ SUSAN HOCKFIELD Susan Hockfield | | | Director | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ DAN R. LITTMAN Dan R. Littman | | | Director | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ SHANTANU NARAYEN Shantanu Narayen | | | Director | | | February [removed: 23, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ SUZANNE NORA JOHNSON Suzanne Nora Johnson | | | Director | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| /S/ JAMES QUINCEY James Quincey | | | Director | | | February [removed: 22, 2023] [added: 21, 2024] | | | | | | | | |
| /S/ JAMES C. SMITH James C. Smith | | | Director | | | February [removed: 21, 2023] [added: 20, 2024] | | | | | | | | |
| Pfizer Inc. | | | [removed: 2022] [added: 2023] Form 10-K | | | [removed: 109] [added: 115] | | |