Full Press Release Details
Pfizer Reports Strong Third-Quarter 2024 Results And Raises 2024 Guidance
Third-Quarter Performance Driven by Focused Commercial Execution and Robust Double-Digit Revenue Growth Across Product Portfolio
Raises Full-Year 2024 Revenue Guidance(1) to a Range of $61.0 to $64.0 Billion and Raises Adjusted(2) Diluted EPS Guidance to a Range of $2.75 to $2.95
Third-Quarter 2024 Revenues of $17.7 Billion, Representing 32% Year-over-Year Operational Growth
-Excluding Contributions from Paxlovid and Comirnaty(3), Revenues Grew 14% Operationally
Third-Quarter 2024 Reported(4) Diluted EPS of $0.78 and Adjusted(2) Diluted EPS of $1.06
On Track to Deliver Net Cost Savings of At Least $5.5 Billion from Previously Announced Cost Reduction Initiatives
-At Least $4 Billion Anticipated by End of 2024 from Cost Realignment Program(5)
-Approximately $1.5 Billion Expected by End of 2027 from First Phase of Manufacturing Optimization Program
NEW YORK, Tuesday, October 29, 2024 - Pfizer Inc. (NYSE PFE) reported financial results for the third quarter of 2024 and raised its full-year 2024 guidance(1) for both Revenues and Adjusted(2) diluted EPS.
The third-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 "We delivered another strong quarter of results as we continued to execute with discipline, strengthen our commercial position and advance our pipeline. I am pleased with the performance of our product portfolio in the third quarter as we continued to achieve exceptional growth with our Oncology products, including strong revenue growth contributions from Padcev, Xtandi, Lorbrena and Braftovi Mektovi, and as we delivered on heightened demand for Paxlovid during the recent COVID-19 wave.
"Our performance through the first three quarters of the year is the result of our focus on our most important strategic priorities. I'm confident that we will deliver on our financial commitments in 2024 and that we are well positioned to continue advancing scientific breakthroughs meaningful to our patients and our company, as well as creating long-term shareholder value, in the years to come."
David Denton, Chief Financial Officer and Executive Vice President, stated "We are extremely pleased with the strong 14% operational revenue growth of Pfizer's non-COVID products in the third quarter. This follows our strong first-half performance, which demonstrates our continued focus on commercial execution and confidence in our ability to deliver on our financial guidance this year. Importantly, we believe our ongoing cost reduction efforts set the company on a path toward future margin expansion."
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 the third quarter and first nine months of 2024 and 2023(7) are summarized below.
| ($ in millions, except per share amounts) | Third-Quarter | Nine Months | ||||||||
| 2024 | 2023 | Change | 2024 | 2023 | Change | |||||
| Revenues | $ 17,702 | $ 13,491 | 31% | $ 45,864 | $ 44,984 | 2% | ||||
| Reported (4) Net Income (Loss) | 4,465 | (2,382) | * | 7,621 | 5,488 | 39% | ||||
| Reported (4) Diluted EPS (LPS) | 0.78 | (0.42) | * | 1.34 | 0.96 | 39% | ||||
| Adjusted (2) Income (Loss) | 6,050 | (968) | * | 14,124 | 9,908 | 43% | ||||
| Adjusted (2) Diluted EPS (LPS) | 1.06 | (0.17) | * | 2.48 | 1.73 | 43% | ||||
| * Indicates calculation not meaningful or results are greater than 100%. |
| ($ in millions) | Third-Quarter | Nine Months | |||||||||||
| 2024 | 2023 | % Change | 2024 | 2023 | % Change | ||||||||
| Total | Oper. | Total | Oper. | ||||||||||
| Global Biopharmaceuticals Business (Biopharma) | $ 17,392 | $ 13,188 | 32% | 33% | $ 44,987 | $ 44,051 | 2% | 3% | |||||
| Pfizer CentreOne (PC1) | 285 | 293 | (3%) | (2%) | 820 | 908 | (10%) | (9%) | |||||
| Pfizer Ignite | 25 | 10 | * | * | 56 | 25 | * | * | |||||
| TOTAL REVENUES | $ 17,702 | $ 13,491 | 31% | 32% | $ 45,864 | $ 44,984 | 2% | 3% | |||||
| * Indicates calculation not meaningful or results are greater than 100%. |
2024 FINANCIAL GUIDANCE(1)
Pfizer raises full-year 2024 revenue guidance by $1.5 billion at the midpoint to a range of $61.0 to $64.0 billion and raises Adjusted(2) diluted EPS guidance by $0.30 at the midpoint to $2.75 to $2.95. The company's updated guidance for revenue includes approximately $10.5 billion in anticipated revenues for Comirnaty(3) and Paxlovid, approximately $5 billion and $5.5 billion, respectively. Including the contribution from Seagen and excluding revenues from Comirnaty(3) and Paxlovid, Pfizer continues to expect full-year 2024 operational revenue growth of 9% to 11% compared to 2023 revenues and this growth guidance takes into consideration the reduction of sales associated with the previously announced global withdrawal of Oxbryta.
The updated 2024 Adjusted(2) diluted EPS guidance takes into consideration our strong year-to-date performance as well as our continued confidence in our business.
Pfizer's updated financial guidance(1) is presented below.
| Revenues | $61.0 to $64.0 billion | ||
| (previously $59.5 to $62.5 billion) | |||
| Adjusted (2) SI A Expenses | $13.8 to $14.8 billion | ||
| Adjusted (2) R D Expenses | $11.0 to $12.0 billion | ||
| Effective Tax Rate on Adjusted (2) Income | Approximately 13.0% | ||
| Adjusted (2) Diluted EPS | $2.75 to $2.95 | ||
| (previously $2.45 to $2.65) |
Changes in foreign exchange rates have had a minimal incremental impact since full-year 2024 guidance was updated on July 30, 2024. Please refer to Press Release Footnote (1) for additional information.
During the first nine months of 2024, Pfizer deployed its capital in a variety of ways, which primarily include the following two categories
Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including
$7.8 billion invested in internal research and development projects, and
Approximately $200 million invested in business development transactions.
Returning capital directly to shareholders through $7.1 billion of cash dividends, or $1.26 per share of common stock.
No share repurchases were completed to date in 2024. As of October 29, 2024, Pfizer's remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2024.
Third-quarter 2024 diluted weighted-average shares outstanding used to calculate Reported(4) and Adjusted(2) diluted EPS were 5,705 million shares. For the third quarter of 2023, basic weighted-average shares outstanding of 5,646 million were used to calculate Reported(4) and Adjusted(2) diluted LPS.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2024 vs. Third-Quarter 2023)
Third-quarter 2024 revenues totaled $17.7 billion, an increase of $4.2 billion, or 31%, compared to the prior-year quarter, reflecting an operational increase of $4.3 billion, or 32%, primarily due to growth contributions from Paxlovid as well as several of our acquired products, key in-line products, and recent commercial launches, partially offset by an unfavorable impact of foreign exchange of $133 million, or 1%. Excluding contributions from Paxlovid and Comirnaty(3), revenues totaled $13.6 billion, an increase of $1.7 billion, or 14%, operationally compared with the prior-year quarter.
Third-quarter 2024 Paxlovid revenues of $2.7 billion increased $2.5 billion operationally compared with the prior-year quarter, primarily due to strong demand, particularly in the U.S., driven by higher utilization during a recent global COVID-19 wave the one-time contractual delivery of one million treatment courses to the U.S. Strategic National Stockpile in the third quarter of 2024 that accounted for $442 million in revenue and no U.S. sales in the prior-year quarter in anticipation of the transition to commercial markets in November 2023.
Third-quarter 2024 Comirnaty(3) revenues of $1.4 billion increased $119 million, or 9%, operationally compared with the prior-year quarter, driven primarily by timing of stocking as a result of earlier approval of the new variant vaccine in the U.S. in 2024 compared to 2023, partially offset by lower contractual deliveries and demand in international markets.
Excluding contributions from Comirnaty(3) and Paxlovid, third-quarter 2024 operational revenue growth was driven primarily by
Global revenues of $854 million from legacy Seagen, which was acquired in December of 2023
Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 63% operationally, driven largely by continued strong demand, primarily in the U.S. and international developed markets
Eliquis globally, up 9% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of patent-based exclusivity and generic competition in certain international markets
Xtandi, up 28% operationally, driven primarily by strong demand due to uptake of the non-metastatic castration-sensitive prostate cancer (nmCSPC) indication following approval in the fourth quarter of 2023 and
Nurtec ODT Vydura globally, up 45% operationally, driven primarily by strong demand in the U.S. and, to a much lesser extent, recent launches in international markets
partially offset primarily by lower revenues for
Xeljanz globally, down 35% operationally, driven primarily by decreased prescription volumes globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as lower net price in the U.S. and the impact of regulatory exclusivity expiry in Canada and
Ibrance globally, down 12% operationally, driven primarily by lower demand due to competitive pressure globally and price decreases in certain international developed markets, partially offset by increased clinical trial supply orders in certain international developed markets versus prior year.
GAAP Reported(4) Statement of Operations Highlights
SELECTED REPORTED(4) COSTS AND EXPENSES
| ($ in millions) | Third-Quarter | Nine Months | ||||||||||||
| 2024 | 2023 | % Change | 2024 | 2023 | % Change | |||||||||
| Total | Oper. | Total | Oper. | |||||||||||
| Cost of Sales (4) | $ 5,263 | $ 9,269 | (43%) | (43%) | $ 11,942 | $ 17,391 | (31%) | (30%) | ||||||
| Percent of Revenues | 29.7 | % | 68.7 | % | N A | N A | 26.0 | % | 38.7 | % | N A | N A | ||
| SI A Expenses (4) | 3,244 | 3,281 | (1%) | - | 10,456 | 10,196 | 3% | 3% | ||||||
| R D Expenses (4) | 2,598 | 2,711 | (4%) | (4%) | 7,787 | 7,864 | (1%) | (1%) | ||||||
| Acquired IPR D Expenses (4) | 13 | 67 | (80%) | (80%) | 20 | 122 | (84%) | (84%) | ||||||
| Other (Income) Deductions-net (4) | 243 | 181 | 34% | 57% | 2,030 | 381 | * | * | ||||||
| Effective Tax Rate on Reported (4) Income (Loss) | 5.0 | % | 28.8 | % | 4.9 | % | (6.2 | %) |
* Indicates calculation not meaningful or results are greater than 100%.
Third-quarter 2024 Cost of Sales(4) as a percentage of revenues decreased by 39.0 percentage points compared to the prior-year quarter, driven primarily by the non-recurrence of a non-cash charge of $5.6 billion recorded in the third quarter of 2023 for inventory write-offs and related charges ($4.7 billion for Paxlovid and $0.9 billion for Comirnaty(3)).
Third-quarter 2024 SI A Expenses(4) were relatively flat operationally compared with the prior-year quarter, reflecting a decrease due to lower U.S. healthcare reform fees primarily related to Paxlovid and Comirnaty(3), largely offset by an increase in spending related to marketing and promotional expenses for recently launched and acquired products.
Third-quarter 2024 R D Expenses(4) decreased 4% operationally compared with the prior-year quarter, driven primarily by lower spending on certain ongoing vaccine programs and, to a lesser extent, lower spending as a result of our cost realignment program, partially offset by a net increase in spending mainly to develop certain product candidates acquired from Seagen.
The unfavorable period-over-period change in Other deductions-net(4) of $62 million for the third quarter of 2024, compared with the prior-year quarter, was driven primarily by higher net interest expense and a charge in the third quarter of 2024 related to the expected sale of one of our facilities resulting from the discontinuation of our Duchenne muscular dystrophy (DMD) program, partially offset by net gains on equity securities in the third quarter of 2024 versus net losses on equity securities in the prior-year quarter.
Pfizer's effective tax rate on Reported(4) income for the third quarter of 2024 is primarily a result of its jurisdictional mix of earnings. Pfizer's positive effective tax rate for the third quarter of 2023 reflects a tax benefit on a pre-tax Reported(4) loss.
Adjusted(2) Statement of Operations Highlights
SELECTED ADJUSTED(2) COSTS AND EXPENSES
| ($ in millions) | Third-Quarter | Nine Months | ||||||||||||||
| 2024 | 2023 | % Change | 2024 | 2023 | % Change | |||||||||||
| Total | Oper. | Total | Oper. | |||||||||||||
| Adjusted (2) Cost of Sales | $ 4,874 | $ 8,906 | (45 | %) | (45 | %) | $ 10,678 | $ 16,723 | (36%) | (35%) | ||||||
| Percent of Revenues | 27.5 | % | 66.0 | % | N A | N A | 23.3 | % | 37.2 | % | N A | N A | ||||
| Adjusted (2) SI A Expenses | 3,219 | 3,205 | - | 1 | % | 10,342 | 9,974 | 4% | 4% | |||||||
| Adjusted (2) R D Expenses | 2,561 | 2,679 | (4 | %) | (4 | %) | 7,708 | 7,797 | (1%) | (1%) | ||||||
| Adjusted (2) Other (Income) Deductions-net | 243 | (128) | * | * | 797 | (730) | * | * | ||||||||
| Effective Tax Rate on Adjusted (2) Income (Loss) | 10.8% | 22.3 | % | 13.3 | % | 10.4 | % | |||||||||
| * Indicates calculation not meaningful or results are greater than 100%. |
See the reconciliations of certain Reported(4) to non-GAAP Adjusted(2) financial measures and associated footnotes in the financial tables section of this press release.
RECENT NOTABLE DEVELOPMENTS (Since July 30, 2024)
Product Developments
| Product Project | Recent Development | Link |
| Abrysvo (respiratory syncytial virus vaccine) | October 2024. Announced the U.S. Food and Drug Administration (FDA) approved Abrysvo for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Abrysvo now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age. | Full Release |
| August 2024. Announced positive top-line safety and immunogenicity results from substudy B of the pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), evaluating two doses of Abrysvo vaccine in immunocompromised adults aged 18 and older at risk of developing severe RSV-associated LRTD. Results showed Abrysvo was well-tolerated and generated strong neutralizing responses after a single 120 g dose in adults 18 years of age. | Full Release | |
| Braftovi (encorafenib) + Mektovi (binimetinib) | September 2024. Presented longer-term follow-up results from the Phase 2 single-arm PHAROS clinical trial evaluating the efficacy and safety of Braftovi in combination with Mektovi for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) Congress 2024, in which the combination of Braftovi + Mektovi continued to show substantial antitumor activity after a minimum follow up of approximately three years, and while there are no head-to-head studies, this corresponds to the longest duration of response and progression-free survival in treatment-na ve patients compared to historical outcomes. | Full Release |
| Product Project | Recent Development | Link |
| Comirnaty (3) (COVID-19 Vaccine, mRNA) | September 2024. Announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Pfizer and BioNTech's Omicron KP.2-adapted monovalent COVID-19 vaccine (Comirnaty KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Subsequently, the European Commission (EC) authorized the vaccine on September 27, 2024. | Full Release |
| August 2024. Announced the FDA approved the supplemental Biologics License Application for Pfizer and BioNTech's Comirnaty (3) for individuals 12 years of age and older and granted emergency use authorization for individuals 6 months through 11 years of age both for the companies' Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. | Full Release | |
| Eliquis (apixaban) | August 2024. Announced the U.S. Department of Health and Human Services released the "maximum fair price" (MFP) for Eliquis, which was selected in the first round of government price setting as part of the Inflation Reduction Act (IRA). The imposed MFP for a 30-day equivalent supply of Eliquis, which is the price that Medicare will pay for Eliquis as of January 1, 2026, is $231. | Full Release |
| Hympavzi (marstacimab-hncq) | October 2024. Announced the FDA approved Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors. Hympavzi is Pfizer's second hemophilia treatment to receive FDA approval this year. | Full Release |
| September 2024. Announced the CHMP of the EMA adopted a positive opinion for marstacimab for the routine prophylaxis of bleeding episodes in adults and adolescents 12 years and older 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 | |
| Oxbryta (voxelotor) | September 2024. Announced the voluntary withdrawal of all lots of Oxbryta for the treatment of sickle cell disease (SCD) in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide. The decision is based on the totality of clinical data that now indicates the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population. The data suggest an imbalance in vaso-occlusive crises and fatal events, which requires further assessment. | Full Release |
| Prevnar 20 (20-valent pneumococcal conjugate vaccine) | October 2024. Announced the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including Prevnar 20 for all adults aged 50 and older and for adults aged 19-49 years with certain underlying conditions or risk factors who have not received a pneumococcal conjugate vaccine (PCV) or whose vaccination history is unknown. This recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. | Full Release |
| Talzenna (talazoparib) | October 2024. Announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in patients with metastatic castration-resistant prostate cancer (mCRPC). Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to Xtandi alone. These data will be shared with global health authorities and detailed results submitted for presentation at an upcoming medical congress. | 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 |
| Combination COVID-19 and Influenza vaccine candidate | August 2024. Announced Phase 3 top-line results for Pfizer and BioNTech's combination mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines. The companies are evaluating adjustments to the candidate and are discussing next steps with health authorities. | Full Release |
| ponsegromab | September 2024. Presented data from the Phase 2 study of ponsegromab, a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), in people with cancer cachexia and elevated levels of GDF-15 at ESMO Congress 2024. The data were also simultaneously published in The New England Journal of Medicine . The study met its primary endpoint of change from baseline in body weight for ponsegromab compared to placebo across all ponsegromab doses tested, reaching 5.6% mean increase at the highest dose evaluated at 12 weeks. At the highest dose evaluated, improvements were seen from baseline in appetite and cachexia symptoms, physical activity, and muscle mass. Ponsegromab was generally considered safe and well-tolerated at all dose levels in the study. Pfizer is discussing late-stage development plans with regulators with the goal of starting registration-enabling studies in 2025. Ponsegromab is also being investigated in a Phase 2 study in patients with heart failure and elevated serum GDF-15 concentrations (NCT05492500). | Full Release |
| Trivalent Influenza vaccine candidate | August 2024. Announced data from a Phase 2 trial with second-generation trivalent (tIRV) influenza mRNA vaccine candidates which showed encouraging data demonstrating robust immunogenicity in individuals 18-64 years of age. The tIRV formulations elicited robust influenza A and B responses, including continued trend of higher influenza A responses versus a licensed influenza vaccine. No safety signals were reported in the trial. Pfizer will continue to evaluate its influenza vaccine program and discuss next steps with health authorities. | Full Release |
| VLA15 (Lyme vaccine candidate) | September 2024. Valneva and Pfizer announced positive immunogenicity and safety data from a Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose. The immune response and safety profile of VLA15 one month after receiving the second booster dose were similar to those reported after receiving the first booster dose, showing compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season. There are currently no approved human vaccines for Lyme disease, and VLA15 is the Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress. | Full Release |
Corporate Developments
| Topic | Recent Development | Link |
| Board Election | October 2024. Announced Tim Buckley was elected to Pfizer's Board of Directors. Mr. Buckley was also appointed to and will join the Governance and Sustainability Committee and the Audit Committee of Pfizer's Board of Directors. | Full Release |
| Haleon Stock Sale | October 2024. Pfizer sold 640 million ordinary shares of its investment in Haleon to institutional investors and sold 60.5 million Haleon ordinary shares directly to Haleon for total net consideration of approximately $3.5 billion. After the share sale, Pfizer's ownership interest in Haleon was reduced from approximately 23% to approximately 15%. | N A |
| "PfizerForAll" | August 2024. Introduced PfizerForAll , a user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across the U.S. The new, end-to-end experience will support Americans affected by common illnesses like migraine, COVID-19 or flu and those seeking to protect themselves with adult vaccinations. By bringing together critical resources and services into a single destination, PfizerForAll helps individuals and their families cut down on the time and steps needed to take important health actions like getting care, filling prescriptions, and finding potential savings on Pfizer medicines. | Full Release |
For additional details, see the attached financial schedules, product revenue tables and disclosure notice.
(1)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 2024 reflects the following
Does not assume the completion of any business development transactions not completed as of September 29, 2024.
An anticipated immaterial impact in fiscal-year 2024 of 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 a blend of actual rates in effect through third-quarter 2024 and mid-October 2024 rates for the remainder of the year. Financial guidance reflects the anticipated unfavorable impact of approximately $0.3 billion on revenues and no impact on Adjusted(2) diluted EPS as a result of changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2023.
Guidance for Adjusted(2) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.7 billion shares, and assumes no share repurchases in 2024.
Guidance assumes the seasonal cadence of certain products in our portfolio, and that Paxlovid results trend with infection rates.
(2)Adjusted income (loss) and Adjusted diluted EPS (LPS) are defined as U.S. GAAP net income (loss) attributable to Pfizer Inc. common shareholders and U.S. GAAP diluted EPS (LPS) 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 third quarter and the first nine months of 2024 and 2023. Adjusted income (loss) and its components and Adjusted diluted EPS (LPS) measures are not, and should not be viewed as, substitutes for U.S. GAAP net income (loss) and its components and diluted EPS (LPS)(4). 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 (Loss) section of this press release for a definition of each component of Adjusted income (loss) as well as other relevant information.
(3)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.
(4)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.
(5)The targeted $4 billion in net cost savings is calculated versus the midpoint of Pfizer's 2023 SI A and R D expense guidance provided on August 1, 2023. As an additional reference, see the 2024 Financial Guidance' section of Pfizer's fourth-quarter 2023 earnings release.
(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 third quarter and first nine months for U.S. subsidiaries reflects the three and nine months ended on September 29, 2024 and October 1, 2023, while Pfizer's third quarter and first nine months for subsidiaries operating outside the U.S. reflects the three and nine months ended on August 25, 2024 and August 27, 2023.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONSOLIDATED STATEMENTS OF OPERATIONS(1)
(millions, except per share data)
| Third-Quarter | % Incr. | Nine Months | % Incr. | |||||||||||||||||
| 2024 | 2023 | (Decr.) | 2024 | 2023 | (Decr.) | |||||||||||||||
| Revenues | ||||||||||||||||||||
| Product revenues (1), (2) | $ | 15,417 | $ | 11,587 | 33 | $ | 38,731 | $ | 38,575 | - | ||||||||||
| Alliance revenues (1) | 1,900 | 1,645 | 16 | 6,140 | 5,672 | 8 | ||||||||||||||
| Royalty revenues (1) | 384 | 260 | 48 | 992 | 737 | 35 | ||||||||||||||
| Total revenues | 17,702 | 13,491 | 31 | 45,864 | 44,984 | 2 | ||||||||||||||
| Costs and expenses | ||||||||||||||||||||
| Cost of sales (3) | 5,263 | 9,269 | (43) | 11,942 | 17,391 | (31) | ||||||||||||||
| Selling, informational and administrative expenses (3) | 3,244 | 3,281 | (1) | 10,456 | 10,196 | 3 | ||||||||||||||
| Research and development expenses (3) | 2,598 | 2,711 | (4) | 7,787 | 7,864 | (1) | ||||||||||||||
| Acquired in-process research and development expenses | 13 | 67 | (80) | 20 | 122 | (84) | ||||||||||||||
| Amortization of intangible assets | 1,312 | 1,179 | 11 | 3,927 | 3,466 | 13 | ||||||||||||||
| Restructuring charges and certain acquisition-related costs (4) | 313 | 155 | * | 1,669 | 377 | * | ||||||||||||||
| Other (income) deductions--net (5) | 243 | 181 | 34 | 2,030 | 381 | * | ||||||||||||||
| Income (loss) from continuing operations before provision (benefit) for taxes on income (loss) | 4,715 | (3,352) | * | 8,033 | 5,187 | 55 | ||||||||||||||
| Provision (benefit) for taxes on income (loss) (6) | 234 | (964) | * | 393 | (320) | * | ||||||||||||||
| Income (loss) from continuing operations | 4,481 | (2,388) | * | 7,640 | 5,507 | 39 | ||||||||||||||
| Discontinued operations--net of tax | (8) | 12 | * | 4 | 11 | (63) | ||||||||||||||
| Net income (loss) before allocation to noncontrolling interests | 4,473 | (2,376) | * | 7,644 | 5,518 | 39 | ||||||||||||||
| Less Net income attributable to noncontrolling interests | 8 | 6 | 26 | 23 | 30 | (24) | ||||||||||||||
| Net income (loss) attributable to Pfizer Inc. common shareholders | $ | 4,465 | $ | (2,382) | * | $ | 7,621 | $ | 5,488 | 39 | ||||||||||
| Earnings (loss) per common share--basic | ||||||||||||||||||||
| Income (loss) from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.79 | $ | (0.42) | * | $ | 1.35 | $ | 0.97 | 39 | ||||||||||
| Discontinued operations--net of tax | - | - | - | - | - | - | ||||||||||||||
| Net income (loss) attributable to Pfizer Inc. common shareholders | $ | 0.79 | $ | (0.42) | * | $ | 1.35 | $ | 0.97 | 38 | ||||||||||
| Earnings (loss) per common share--diluted | ||||||||||||||||||||
| Income (loss) from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.79 | $ | (0.42) | * | $ | 1.34 | $ | 0.96 | 40 | ||||||||||
| Discontinued operations--net of tax | - | - | - | - | - | - | ||||||||||||||
| Net income (loss) attributable to Pfizer Inc. common shareholders | $ | 0.78 | $ | (0.42) | * | $ | 1.34 | $ | 0.96 | 39 | ||||||||||
| Weighted-average shares used to calculate earnings (loss) per common share | ||||||||||||||||||||
| Basic | 5,667 | 5,646 | 5,663 | 5,642 | ||||||||||||||||
| Diluted (7) | 5,705 | 5,646 | 5,699 | 5,714 |
*Indicates calculation not meaningful or results are greater than 100%.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONSOLIDATED STATEMENTS OF OPERATIONS - (UNAUDITED)
(1)The financial statements present the three and nine months ended September 29, 2024 and October 1, 2023. Subsidiaries operating outside the U.S. are included for the three and nine months ended August 25, 2024 and August 27, 2023.
The financial results for the three and nine months ended September 29, 2024 are not necessarily indicative of the results that ultimately could be achieved for the full year.
Business development activities, including the December 2023 acquisition of Seagen Inc. (Seagen), impacted financial results in the periods presented. See Note 2 to the condensed consolidated financial statements in Pfizer's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, as well as Notes 1A and 2 to the consolidated financial statements in Pfizer's 2023 Annual Report on Form 10-K.
In the fourth quarter of 2023, we began presenting Product revenues and Alliance revenues as separate line items within Total revenues in our consolidated statements of operations. In the first quarter of 2024, we reclassified royalty income from Other (income) deductions--net 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.
Certain amounts in the consolidated statements of operations and associated notes may not add due to rounding. All percentages have been calculated using unrounded amounts.
(2)The third quarter and first nine months of 2024 include $442 million of revenue recorded in connection with the creation of a U.S. Strategic National Stockpile of 1.0 million treatment courses of Paxlovid, which we supplied at no cost to the U.S. government or taxpayers. The first nine months of 2024 also includes a $771 million favorable final adjustment recorded in the first quarter of 2024 to the estimated non-cash Paxlovid revenue reversal of $3.5 billion recorded in the fourth quarter of 2023, reflecting 5.1 million 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. See Note 13C to the condensed consolidated financial statements in Pfizer's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, as well as Note 17C to the consolidated financial statements in Pfizer's 2023 Annual Report on Form 10-K.
(3)Exclusive of amortization of intangible assets. For the third quarter and first nine months of 2023, Cost of sales included a non-cash charge of $5.6 billion for inventory write-offs and related charges ($4.7 billion for Paxlovid and $0.9 billion for Comirnaty).
(4)Restructuring charges and certain acquisition-related costs include the following
| Third-Quarter | Nine Months | |||||||||||||||
| (MILLIONS) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Restructuring charges (credits) -- acquisition-related costs (a) | $ | (6) | $ | 7 | $ | 78 | $ | 41 | ||||||||
| Restructuring charges (credits) -- cost reduction initiatives (b) | 223 | 65 | 1,253 | 124 | ||||||||||||
| Restructuring charges (credits) | 217 | 71 | 1,331 | 165 | ||||||||||||
| Transaction costs (c) | - | 5 | 5 | 14 | ||||||||||||
| Integration pre-integration costs and other (d) | 96 | 78 | 333 | 198 | ||||||||||||
| Restructuring charges and certain acquisition-related costs | $ | 313 | $ | 155 | $ | 1,669 | $ | 377 |
(a)Includes charges (credits) for employee terminations, asset impairments and other exit costs associated with business combinations.