PFE Pfizer Inc

• Full-Year 2024 Revenues of $63.6 Billion, Reflecting 7% Year-over-Year Operational Growth
  • Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 12% Operationally
• Full-Year 2024 Reported(2) Diluted EPS of $1.41 and Adjusted(3) Diluted EPS of $3.11
• Fourth-Quarter 2024 Revenues of $17.8 Billion, Reflecting 21% Year-over-Year Operational Growth
  • Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 11% Operationally
• Fourth-Quarter 2024 Reported(2) Diluted EPS of $0.07 and Adjusted(3) Diluted EPS of $0.63
• On Track to Deliver Overall Net Cost Savings of Approximately $4.5 Billion by End of 2025 from Ongoing Cost Realignment Program(4)
• Reaffirms All Components of Full-Year 2025 Financial Guidance(5), including Revenues in a Range of $61.0 to $64.0 Billion and Adjusted(3) Diluted EPS in a Range of $2.80 to $3.00

Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2024 and reaffirmed its 2025 financial guidance(5) provided on December 17, 2024.

The fourth-quarter 2024 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.

EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “2024 was a strong year of execution and performance for Pfizer in which we met or exceeded our strategic and financial commitments, strengthened our company and, most importantly, reached millions of patients with our medicines and vaccines. We made great progress with commercial execution and achieved growth across our product portfolio for full-year 2024, including $3.4 billion in revenue from our legacy Seagen portfolio, as well as robust growth from the Vyndaqel family, Eliquis, Xtandi, Nurtec, and several other products across all categories.

“I’m excited for what’s ahead and confident that we will enhance shareholder value as we sharpen our focus to improve the productivity of our R&D pipeline and advance the clear strategic priorities guiding our company in 2025.”

David Denton, Chief Financial Officer and Executive Vice President, stated: “We are pleased with the 12% operational revenue growth of Pfizer’s non-COVID products in full-year 2024, demonstrating our continued focus on commercial execution. We successfully delivered on our $4 billion net cost savings target from our ongoing cost realignment program, and, as captured in our 2025 financial guidance, we have increased our overall savings target to approximately $4.5 billion by the end of this year. In addition, we remain on track to deliver $1.5 billion of net cost savings from the first phase of our Manufacturing Optimization Program by the end of 2027, with initial savings expected in the latter part of 2025. We remain confident in our ability to return to pre-pandemic operating margins in the coming years.”

OVERALL RESULTS

In the first quarter of 2024, Pfizer reclassified royalty income (substantially all of which is related to our Biopharma segment) from Other (income)/deductions––net to revenues and began presenting Royalty revenues as a separate line item within Total revenues in our consolidated statements of operations. Prior-period amounts have been recast to conform to the current presentation.

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(6).

Results for fourth quarter and full year 2024 and 2023(7) are summarized below.

 

 

 

 

 

 

 

($ in millions, except

per share amounts)

Fourth-Quarter

Full-Year

 

2024

2023

Change

2024

2023

Change

Revenues

$ 17,763

$ 14,570

22%

$ 63,627

$ 59,553

7%

Reported(2) Net Income/(Loss)

410

(3,369)

*

8,031

2,119

*

Reported(2) Diluted EPS/(LPS)

0.07

(0.60)

*

1.41

0.37

*

Adjusted(3) Income

3,592

593

*

17,716

10,501

69%

Adjusted(3) Diluted EPS

0.63

0.10

*

3.11

1.84

69%

 

 

 

 

 

 

 

* Indicates calculation not meaningful or results are greater than 100%.

REVENUES

 

 

 

 

 

 

 

 

 

 

($ in millions)

Fourth-Quarter

 

Full-Year

 

2024

2023

% Change

 

2024

2023

% Change

 

Total

Oper.

 

Total

Oper.

Global Biopharmaceuticals Business (Biopharma)

$ 17,413

$ 14,186

23%

22%

 

$ 62,400

$ 58,237

7%

8%

Pfizer CentreOne (PC1)

325

364

(11%)

(11%)

 

1,146

1,272

(10%)

(10%)

Pfizer Ignite

26

20

30%

30%

 

82

44

85%

85%

TOTAL REVENUES

$ 17,763

$ 14,570

22%

21%

 

$ 63,627

$ 59,553

7%

7%

 

 

 

 

 

 

 

 

 

 

2025 FINANCIAL GUIDANCE(5)

Pfizer’s 2025 financial guidance(5) is presented below.

Revenues

$61.0 to $64.0 billion

Adjusted(3) SI&A Expenses

$13.3 to $14.3 billion

Adjusted(3) R&D Expenses

$10.7 to $11.7 billion

Effective Tax Rate on Adjusted(3) Income

Approximately 15.0%

Adjusted(3) Diluted EPS

$2.80 to $3.00

CAPITAL ALLOCATION

In 2024, Pfizer deployed its capital in a variety of ways, which primarily included:

• Reinvested capital into initiatives intended to enhance the future growth prospects of the company, including:
  • $10.8 billion invested in internal research and development projects, and
  • Approximately $300 million invested in business development transactions.

• Returned capital directly to shareholders through $9.5 billion of cash dividends, or $1.68 per share of common stock.

No share repurchases were completed in 2024. As of February 4, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. Pfizer expects to sufficiently de-lever its balance sheet by the end of 2025 in order to return to a more balanced capital allocation strategy. This includes the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.

For the fourth quarter of 2024, diluted weighted-average shares outstanding of 5,703 million were used to calculate Reported(2) and Adjusted(3) diluted EPS. For the fourth quarter of 2023, basic weighted-average shares outstanding of 5,647 million were used to calculate Reported(2) LPS and diluted weighted-average shares outstanding of 5,692 million were used to calculate Adjusted(3) diluted EPS.

QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2024 vs. Fourth-Quarter 2023)

Fourth-quarter 2024 revenues totaled $17.8 billion, an increase of $3.2 billion, or 22%, compared to the prior-year quarter, reflecting an operational increase of $3.1 billion, or 21%, primarily due to a one-time, non-cash Paxlovid revenue reversal(8) of $3.5 billion recorded in fourth-quarter 2023 and, to a lesser extent, growth contributions in fourth-quarter 2024 from the legacy Seagen portfolio, the Vyndaqel family, higher Paxlovid sales year-over-year (when excluding the $3.5 billion revenue reversal(8)), higher sales in several other products across all categories, and a favorable impact of foreign exchange of $62 million (or less than 1%); partially offset by a $2.0 billion decline in Comirnaty(1) revenues. Excluding contributions from Paxlovid and Comirnaty(1), fourth-quarter 2024 revenues totaled $13.7 billion, an increase of $1.3 billion, or 11%, operationally compared with the prior-year quarter.

Fourth-quarter 2024 Comirnaty(1) revenues of $3.4 billion decreased $2.0 billion, or 38%, operationally compared with the prior-year quarter, driven primarily by fewer COVID-19 vaccinations globally as well as lower contracted doses.

Fourth-quarter 2024 Paxlovid revenues of $727 million increased $3.9 billion operationally compared with $(3.1) billion of revenues recorded in the prior-year quarter, primarily driven by the transition to traditional commercial market sales in the U.S. including a one-time, non-cash revenue reversal(8) of $3.5 billion recorded in fourth-quarter 2023.

Excluding contributions from Comirnaty(1) and Paxlovid, fourth-quarter 2024 operational revenue growth was driven primarily by:

• Global revenues of $915 million from legacy Seagen compared with $132 million of revenue in fourth-quarter 2023 following the completion of the acquisition in mid-December 2023;

• Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 60% operationally, driven largely by strong demand with continuing uptake in patient diagnosis, primarily in the U.S. and international developed markets, as well as increased affordability in the U.S.;

• Eliquis globally, up 13% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of patent-based exclusivity and generic competition in certain international markets;

• Nurtec ODT/Vydura globally, up 39% operationally, driven primarily by strong demand in the U.S. and, to a much lesser extent, recent launches in international markets, partially offset by lower net price in the U.S. due to unfavorable changes in channel mix; and

• Xtandi, up 24% operationally, driven primarily by strong demand due to uptake of the non-metastatic castration-sensitive prostate cancer (nmCSPC) indication following approval in the fourth quarter of 2023 and increased affordability in the U.S.;

partially offset primarily by lower revenues for:

• Abrysvo globally, down 62% operationally, driven primarily by a significant reduction in vaccination rates in the U.S. for the older adult indication as a result of a narrowing market opportunity given the current recommendations from the Advisory Committee on Immunization Practices (ACIP), partially offset by improved market share for the adult indication and strong demand for the maternal indication (launched in December 2023) as well as launch uptake for both indications in certain international markets;

• Xeljanz globally, down 29% operationally, driven primarily by lower demand globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as lower net price in the U.S. and the impact of regulatory exclusivity expiry in Canada; and

• Oncology biosimilars globally, down 35% operationally, driven primarily by supply constraints in certain products, as well as both lower demand and lower net price in the U.S. and, to a lesser extent, in certain international markets.

GAAP Reported(2) Statement of Operations Highlights

SELECTED REPORTED(2) COSTS AND EXPENSES

 

 

 

 

 

 

 

 

 

 

 

($ in millions)

Fourth-Quarter

 

 

Full-Year

 

2024

2023

% Change

 

 

2024

2023

% Change

 

Total

Oper.

 

 

Total

Oper.

Cost of Sales(2)

$ 5,909

$ 7,562

(22%)

(22%)

 

 

$ 17,851

$ 24,954

(28%)

(28%)

Percent of Revenues

33.3%

51.9%

N/A

N/A

 

 

28.1%

41.9%

N/A

N/A

SI&A Expenses(2)

4,274

4,575

(7%)

(7%)

 

 

14,730

14,771

—

—

R&D Expenses(2)

3,035

2,815

8%

8%

 

 

10,822

10,679

1%

1%

Acquired IPR&D Expenses(2)

88

73

21%

21%

 

 

108

194

(44%)

(44%)

 

 

 

 

 

 

 

 

 

 

 

Other (Income)/Deductions—net(2)

2,358

(159)

*

*

 

 

4,388

222

*

*

Effective Tax Rate on Reported(2) Income/(Loss)

*

19.2%

 

 

 

 

(0.4%)

*

 

 

 

 

 

 

 

 

 

 

 

 

 

* Indicates calculation not meaningful or results are greater than 100%.

Fourth-quarter 2024 Cost of Sales(2) as a percentage of revenues decreased by 18.6 percentage points compared to the prior-year quarter, driven primarily by favorable changes in sales mix as a result of significantly lower sales of Comirnaty(1), which resulted in a lower related charge for the 50% gross profit split with BioNTech and applicable royalty expenses in the quarter; and the favorable year-over-year impact related to the $3.5 billion non-cash Paxlovid revenue reversal(8) recorded in fourth-quarter 2023.

Fourth-quarter 2024 SI&A Expenses(2) decreased 7% operationally compared with the prior-year quarter, driven primarily by a decrease in marketing and promotional spend for various products, including Comirnaty(1) and Paxlovid, partially offset by an increase in spending for certain oncology and recently launched and acquired products.

Fourth-quarter 2024 R&D Expenses(2) increased 8% operationally compared with the prior-year quarter, driven primarily by a net increase in spending mainly to develop certain product candidates acquired from Seagen, as well as increased compensation-related expenses; partially offset by lower spending on certain ongoing vaccine programs and as a result of our cost realignment program.

The unfavorable period-over-period change in Other (income)/deductions—net(2) of $2.5 billion for the fourth quarter of 2024, compared with the prior-year quarter, was driven primarily by (i) lower net gains on equity securities, (ii) net periodic benefit costs associated with pension and postretirement plans incurred in the fourth quarter of 2024 versus net periodic benefit credits incurred in the fourth quarter of 2023 and (iii) higher net interest expense; partially offset by gains on the partial sale of our investment in Haleon plc (Haleon). Included in Other (income)/deductions—net(2) are total non-cash intangible asset impairment charges of $2.9 billion that were taken in the fourth quarter of 2024 due to changes in development plans and updated long-range commercial forecasts.

Pfizer’s effective tax rate on Reported(2) income for the fourth quarter of 2024 is primarily due to changes in the jurisdictional mix of earnings, partially offset by a tax benefit related to the Transition Tax liability under the Tax Cuts and Jobs Act of 2017.

Adjusted(3) Statement of Operations Highlights

SELECTED ADJUSTED(3) COSTS AND EXPENSES

 

 

 

 

 

 

 

 

 

 

 

($ in millions)

Fourth-Quarter

 

 

Full-Year

 

2024

2023

% Change

 

 

2024

2023

% Change

 

Total

Oper.

 

 

Total

Oper.

Adjusted(3) Cost of Sales

$ 5,742

$ 7,265

(21%)

(21%)

 

 

$ 16,420

$ 23,988

(32%)

(31%)

Percent of Revenues

32.3%

49.9%

N/A

N/A

 

 

25.8%

40.3%

N/A

N/A

Adjusted(3) SI&A Expenses

4,275

4,471

(4%)

(4%)

 

 

14,617

14,446

1%

2%

Adjusted(3) R&D Expenses

2,986

2,770

8%

8%

 

 

10,694

10,568

1%

1%

 

 

 

 

 

 

 

 

 

 

 

Adjusted(3) Other (Income)/Deductions—net

234

(494)

*

*

 

 

1,031

(1,224)

*

*

Effective Tax Rate on Adjusted(3) Income

18.9%

(24.0%)

 

 

 

 

14.5%

9.0%

 

 

 

 

 

 

 

 

 

 

 

 

 

* Indicates calculation not meaningful or results are greater than 100%.

See the reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below.

FULL-YEAR REVENUE SUMMARY (Full-Year 2024 vs. Full-Year 2023)

Full-year 2024 revenues totaled $63.6 billion, an increase of $4.1 billion, or 7%, compared to full-year 2023, reflecting an operational increase of $4.4 billion, or 7%, partially offset by an unfavorable impact of foreign exchange of $349 million, or approximately 1%. Excluding contributions from Comirnaty(1) and Paxlovid, revenues for the full-year grew 12% operationally.

The operational revenue growth compared to the prior year was driven primarily by significantly higher global revenues for Paxlovid largely due to one-time items(8) recorded in the fourth quarter of 2023 and in 2024, the addition of legacy Seagen revenues in full-year 2024 following the acquisition in December 2023, and continued growth from the Vyndaqel family; partially offset by significantly lower revenues for Comirnaty(1).

RECENT NOTABLE DEVELOPMENTS (Since October 29, 2024)

Product Developments

Product/Project

Recent Development

Link

Braftovi (encorafenib)

February 2025. Announced positive topline results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study of Braftovi in combination with cetuximab (marketed as Erbitux®(9)) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. The trial showed a statistically significant and clinically meaningful improvement in PFS, one of its dual primary endpoints, as assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab. Further, the Braftovi combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint in the trial. At the time of the objective response rate (ORR) analysis, the safety profile of Braftovi in combination with cetuximab and mFOLFOX6 continued to be consistent with the known safety profile of each respective agent. No new safety signals were identified. These results will be shared with the U.S. Food and Drug Administration (FDA) to support potential conversion to full approval.

Full Release

December 2024. Announced the FDA granted accelerated approval to Braftovi in combination with cetuximab (marketed as Erbitux®(9)) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test. Approval was based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with Braftovi in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. Continued approval for this indication is contingent upon verification of clinical benefit. Data from the Phase 3 BREAKWATER trial was recently presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine.

Full Release & Full Release

Hympavzi (marstacimab-hncq)

November 2024. Announced the European Commission (EC) granted marketing authorization for Hympavzi for the routine prophylaxis of bleeding episodes in adults and adolescents 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors, or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors.

Full Release

Ibrance (palbociclib)

December 2024. Pfizer and Alliance Foundation Trials, LLC presented results from the Phase 3 PATINA trial demonstrating that the addition of Ibrance to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in PFS by investigator assessment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). The safety and tolerability of Ibrance in the PATINA study was consistent with its known safety profile in HR+, human epidermal growth factor receptor 2-negative (HER2-) MBC; no new safety signals were identified.

Full Release

Pipeline Developments

A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.

Product/Project

Recent Development

Link

sasanlimab

January 2025. Announced positive topline results from the pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance). The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors.

Full Release

vepdegestrant

December 2024. Arvinas, Inc. and Pfizer presented preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer at the 2024 San Antonio Breast Cancer Symposium (SABCS). Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity in patients previously treated with a CDK4/6 inhibitor with safety and tolerability of the combination generally consistent with the profile of abemaciclib and what has been observed in other clinical trials of vepdegestrant; no significant drug-drug interactions were observed between vepdegestrant and abemaciclib. The findings support the ongoing Phase 2 portion of the study, which is evaluating full dose abemaciclib 150 mg twice daily (BID) in combination with vepdegestrant 200 mg once daily (QD) in post-CDK4/6 advanced breast cancer.

Full Release

Corporate Developments

Topic

Recent Development

Link

Executive Leadership

November 2024. Announced Chris Boshoff, M.D., Ph.D., as Chief Scientific Officer and President, Research & Development effective January 1, 2025. In his new role, Dr. Boshoff remains a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Dr. Albert Bourla, and oversees all functions of R&D across all therapeutic areas.

 

Pfizer’s Oncology R&D organization maintains its fully integrated structure with Roger Dansey, M.D. serving as Interim Chief Oncology Officer, reporting to Dr. Boshoff. Dr. Dansey will assist Dr. Boshoff in selecting a permanent Chief Oncology Officer, after which time he will retire from Pfizer. Dr. Dansey will also facilitate a smooth transition of his responsibilities as Chief Development Officer, Oncology to his successor, Johanna Bendell, M.D., who will join Pfizer from Roche in 2025.

Full Release

Haleon Stock Sale

January 2025. Pfizer sold 700 million ordinary shares of its investment in Haleon to institutional investors for total net consideration of approximately $3.0 billion. After the share sale, Pfizer’s ownership interest in Haleon was reduced from approximately 15% to approximately 7%.

N/A

Sangamo Therapeutics

December 2024. Terminated a global collaboration and license agreement with Sangamo Therapeutics, returning development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy candidate for the treatment of adults with moderately severe to severe hemophilia A, to Sangamo. The agreement will terminate effective April 21, 2025, at which time Pfizer will transition the giroctocogene fitelparvovec program back to Sangamo.

N/A

U.S. Commercial Model

December 2024. Announced Pfizer’s Commercial Oncology organization, previously reporting to Chris Boshoff, M.D., Ph.D., will move into Pfizer’s U.S. Commercial organization under Aamir Malik, Executive Vice President and Chief U.S. Commercial Officer effective January 1, 2025, creating a single U.S. commercial division.

N/A

Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink:

https://investors.pfizer.com/Q4-2024-PFE-Earnings-Release

(Note: If clicking on the above link does not open a new webpage, you may need to cut and paste the above URL into your browser's address bar.)

For additional details, see the attached financial schedules and product revenue tables attached to the press release located at the hyperlink above, and the attached disclosure notice.

(1)

As used in this document, “Comirnaty” refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine; Comirnaty (COVID-19 Vaccine, mRNA) original monovalent formula; the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5); the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula); Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula; Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula; Comirnaty Original/Omicron BA.1; Comirnaty Original/Omicron BA.4/BA.5; Comirnaty Omicron XBB.1.5; Comirnaty JN.1 and Comirnaty KP.2. “Comirnaty” includes product revenues and alliance revenues related to sales of the above-mentioned vaccines.

(2)

Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income/(loss) and its components are defined as net income/(loss) attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) and reported diluted loss per share (LPS) are defined as diluted EPS or LPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.

(3)

Adjusted income and Adjusted diluted EPS are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and U.S. GAAP diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the fourth quarter and full-year 2024 and 2023 in the press release at the hyperlink above. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income/(loss) and its components and diluted EPS/(LPS)(2). See the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2023 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income section of the press release located at the hyperlink above for a definition of each component of Adjusted income as well as other relevant information.

(4)

Approximately $4.5 billion of overall net cost savings from Pfizer’s ongoing cost realignment program are expected to be achieved by the end of 2025. The net cost savings are calculated versus the midpoint of Pfizer’s 2023 SI&A and R&D expense guidance provided on August 1, 2023.

(5)

Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.

Financial guidance for full-year 2025 reflects the following:

• Does not assume the completion of any business development transactions not completed as of December 31, 2024.

• An anticipated unfavorable revenue impact of approximately $0.6 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent or regulatory protection or that are anticipated to lose patent or regulatory protection.

• Exchange rates assumed are actual rates at mid-January 2025.

• Guidance for Adjusted(3) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.74 billion shares, and assumes no share repurchases in 2025.

(6)

References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results.

(7)

Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s fourth quarter and full year for U.S. subsidiaries reflects the three and twelve months ended on December 31, 2024 and December 31, 2023, while Pfizer’s fourth quarter and full year for subsidiaries operating outside the U.S. reflects the three and twelve months ended on November 30, 2024 and November 30, 2023.

(8)

Paxlovid-specific one-time items in fourth-quarter 2023 and in 2024:

• Fourth-quarter 2023 Paxlovid revenues included a non-cash revenue reversal of $3.5 billion, of which a portion was associated with sales recorded in 2022, related to the expected return of an estimated 6.5 million treatment courses of Emergency Use Authorization (EUA)-labeled U.S. government inventory; and

• Full-year 2024 Paxlovid revenues include $1.2 billion from two one-time items: (i) a $771 million favorable final adjustment recorded in first-quarter 2024 to the estimated non-cash Paxlovid revenue reversal of $3.5 billion recorded in fourth-quarter 2023, reflecting 5.1 million Emergency Use Authorization (EUA)-labeled treatment courses returned by the U.S. government through February 29, 2024 versus the estimated 6.5 million treatment courses that were expected to be returned as of December 31, 2023; and (ii) $442 million from the fulfillment of our obligated delivery of one million treatment courses to the U.S. Strategic National Stockpile.

(9)

Erbitux® is a registered trademark of ImClone LLC.

DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of February 4, 2025. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments.

This earnings release and the related attachments contain forward-looking statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; reorganizations; business plans, strategy, goals and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data, revenue contribution and projections, potential pricing and reimbursement, potential market dynamics, including demand, market size and utilization rates and growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; an enterprise-wide cost realignment program, which we launched in October 2023 (including anticipated costs, savings and potential benefits); a Manufacturing Optimization Program to reduce our cost of goods sold, which we announced in May 2024 (including anticipated costs, savings and potential benefits); dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our December 2023 acquisition of Seagen, and our ability to successfully capitalize on growth opportunities and prospects; manufacturing and product supply; our ongoing efforts to respond to COVID-19; our expectations regarding the impact of COVID-19 on our business, operations and financial results; and the expected seasonality of demand for certain of our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions and we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Pfizer’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties.

Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:

Risks Related to Our Business, Industry and Operations, and Business Development:

• the outcome of research and development (R&D) activities, including, the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; risks associated with preliminary, early stage or interim data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from our pipeline programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; and uncertainties regarding the future development of our product candidates, including whether or when our product candidates will advance to future studies or phases of development or whether or when regulatory applications may be filed for any of our product candidates;
• 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;
• regulatory decisions impacting labeling, approval or authorization, including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; uncertainties regarding the ability to obtain or maintain, and the scope of, recommendations by technical or advisory committees; and the timing of, and ability to obtain, pricing approvals and product launches, all of which could impact the availability or commercial potential of our products and product candidates;
• claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the conduct or outcome of post-approval clinical trials, pharmacovigilance or Risk Evaluation and Mitigation Strategies, which could impact marketing approval, product labeling, and/or availability or commercial potential;
• the success and impact of external business development activities, such as the December 2023 acquisition of Seagen, 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 potential need for and impact of additional equity or debt financing to pursue these opportunities, which has in the past and could in the future result in increased leverage and/or a downgrade of our credit ratings and could limit our ability to obtain future financing; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain acquired or partnered products; significant transaction costs; and unknown liabilities;
• competition, including from new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented by our in-line products and product candidates;
• the ability to successfully market both new and existing products, including biosimilars;
• difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our facilities or third-party facilities that we rely on; and legal or regulatory actions;
• the impact of public health outbreaks, epidemics or pandemics (such as COVID-19) on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
• risks and uncertainties related to Comirnaty and Paxlovid or any potential future COVID-19 vaccines, treatments or combinations, including, among others, the risk that as the market for COVID-19 products continues to become more endemic and seasonal, demand for our COVID-19 products has and may continue to be reduced or not meet expectations, which has in the past and may continue to lead to reduced revenues, excess inventory on-hand and/or in the channel, or other unanticipated charges; risks related to our ability to develop and commercialize variant adapted vaccines, combinations and/or treatments; uncertainties related to recommendations and coverage for, and the public’s adherence to, vaccines, boosters, treatments or combinations; and potential third-party royalties or other claims related to Comirnaty and Paxlovid;
• trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;
• interest rate and foreign currency exchange rate fluctuations, including the impact of currency devaluations and monetary policy actions in countries experiencing high inflation or deflation rates;
• any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
• the impact of the increased presence of counterfeit medicines, vaccines or other products in the pharmaceutical supply chain;
• any significant issues related to the outsourcing of certain operational and staff functions to third parties;
• any significant issues related to our JVs and other third-party business arrangements, including modifications or disputes related to supply agreements or other contracts with customers including governments or other payors;
• uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions, such as inflation or interest rate fluctuations, and recent and possible future changes in global financial markets;
• the exposure of our operations globally to possible capital and exchange controls, economic conditions, expropriation, sanctions, tariffs and/or other restrictive government actions, changes in intellectual property legal protections and remedies, unstable governments and legal systems and inter-governmental disputes;
• the impact of disruptions related to climate change and natural disasters;
• any changes in business, political and economic conditions due to actual or threatened terrorist activity, geopolitical instability, political or civil unrest or military action, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences;
• the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments, such as our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines, and our voluntary withdrawal of all lots of Oxbryta in all markets where it is approved and any regulatory or other impact on other sickle cell disease assets;
• trade buying patterns;
• the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
• the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, as well as any other corporate strategic initiatives and growth strategies, and cost-reduction and productivity initiatives, including any potential future phases, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs, organizational disruption, adverse effects on employee morale, retention issues or other unintended consequences;
• the ability to successfully achieve our climate goals and progress our environmental sustainability and other ESG priorities;

Risks Related to Government Regulation and Legal Proceedings:

• the impact of any U.S. healthcare reform or legislation or any significant spending reduction or cost control efforts affecting Medicare, Medicaid, the 340B Drug Pricing Program or other publicly funded or subsidized health programs, including the Inflation Reduction Act of 2022, or changes in the tax treatment of employer-sponsored health insurance that may be implemented;
• U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access to our medicines and vaccines or restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive biopharmaceutical markets;
• legislation or regulatory action in markets outside of the U.S., such as China or Europe, including, without limitation, laws related to pharmaceutical product pricing, intellectual property, medical regulation, environmental protections, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;
• legal defense costs, insurance expenses, settlement costs and contingencies, including without limitation, those related to legal proceedings and actual or alleged environmental contamination;
• the risk and impact of an adverse decision or settlement and risk related to the adequacy of reserves related to legal proceedings;
• the risk and impact of tax related litigation and investigations;
• governmental laws and regulations affecting our operations, including, without limitation, the Inflation Reduction Act of 2022, changes in laws and regulations or their interpretation, including, among others, changes in tariffs, tax laws and regulations internationally and in the U.S., the adoption of global minimum taxation requirements outside the U.S. generally effective in most jurisdictions since January 1, 2024, and potential changes to existing tax laws, tariffs, or changes to other laws and regulations in the U.S., including by the U.S. Presidential administration and Congress, as well as in other countries;

Risks Related to Intellectual Property, Technology and Cybersecurity:

• the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all;
• risks to our products, patents and other intellectual property, such as: (i) claims of invalidity that could result in patent revocation; (ii) claims of patent infringement, including asserted and/or unasserted intellectual property claims; (iii) claims we may assert against intellectual property rights held by third parties; (iv) challenges faced by our collaboration or licensing partners to the validity of their patent rights; or (v) any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related to our products, including Comirnaty and Paxlovid;
• any significant breakdown or interruption of our information technology systems and infrastructure (including cloud services);
• any business disruption, theft of confidential or proprietary information, security threats on facilities or infrastructure, extortion or integrity compromise resulting from a cyber-attack, which may include those using adversarial artificial intelligence techniques, or other malfeasance by, but not limited to, nation states, employees, business partners or others; and
• risks and challenges related to the use of software and services that include artificial intelligence-based functionality and other emerging technologies.

Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K.

This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.

The information contained on our website or any third-party website is not incorporated by reference into this earnings release. All trademarks mentioned are the property of their owners.

Certain of the products and product candidates discussed in this earnings release are being co-researched, co-developed and/or co-promoted in collaboration with other companies for which Pfizer’s rights vary by market or are the subject of agreements pursuant to which Pfizer has commercialization rights in certain markets.

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