Pfizer Reports First-Quarter 2024 Results

  • Solid First-Quarter Results Reflect Continued Growth of Key Products and Progress in Executing 2024 Priorities
  • First-Quarter2024 Revenues of $14.9 Billion
    • Expected Decline in Comirnaty(1) and Paxlovid Revenues Drove a Year-Over-Year Operational Decrease in Revenues of 19%
    • Excluding Contributions from Comirnaty(1) and Paxlovid, Revenues Grew 11% Operationally
  • First-Quarter2024 Reported(2) Diluted EPS of $0.55 and Adjusted(3) Diluted EPS of $0.82
    • Both Include an $0.11 Favorable Impact from Final Revenue Adjustment Reflecting Actual EUA-labeled Treatment Courses of Paxlovid Returned by U.S. Government(4)
  • On Track to Deliver at Least $4 Billion in Net Cost Savings by End of 2024 from Previously Announced Cost Realignment Program(5)
  • Reaffirms Full-Year 2024 Revenue Guidance(6) of $58.5 to $61.5 Billion and Raises Adjusted(3) Diluted EPS Guidance to $2.15 to $2.35

NEW YORK, Wednesday, May 1, 2024 - Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2024 and raised its Adjusted(3) diluted EPS guidance while maintaining all other components of its 2024 financial guidance(6).

The first-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 strong performance in our non- COVID product portfolio in the first quarter of 2024, including increased revenue from several of our recent commercial launches and acquired products, as well as robust year-over-year growth for several key in-line brands, namely the Vyndaqel family, Eliquis, and the Prevnar family. In addition, we had strong oncology revenue contributions from Ibrance, Xtandi, Padcev and Adcetris. Our Paxlovid revenues in the quarter indicate a successful transition into the commercial marketplace in the U.S. and a demonstrated trust in the brand.

"Overall, I am encouraged by a well-executed quarter, setting the tone for the year. Pfizer's commercial leadership is focused on data-driven opportunities across several key growth brands, both in the U.S. and internationally, and we intend to build on this positive momentum in the quarters ahead."

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David Denton, Chief Financial Officer and Executive Vice President, stated: "I am very pleased by the strong 11% operational revenue growth of our non-COVID products in the first quarter, demonstrating our focus on commercial execution. In addition, we continue to progress our cost realignment program and remain on track to deliver on our targeted cost savings goal by the end of the year."

OVERALL RESULTS

In the first quarter of 2024, we reclassified royalty income (substantially all of which is related to Biopharma) 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 income. Prior-period amounts have been recast to conform to the current presentation.

At the beginning of 2024, we made changes in our commercial organization that went into effect on January 1, 2024 to incorporate Seagen Inc. (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. See the Item 1. Business--CommercialOperations section of Pfizer's 2023 Annual Report on Form 10-K (available at www.pfizer.com).

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(7).

Results for the first quarter of 2024 and 2023(8) are summarized below.

($ in millions, except

First-Quarter

per share amounts)

2024

2023

Change

Revenues

$ 14,879

$ 18,486

(20%)

Reported(2) Net Income

3,115

5,543

(44%)

Reported(2) Diluted EPS

0.55

0.97

(44%)

Adjusted(3)

Income

4,674

7,036

(34%)

Adjusted(3)

Diluted EPS

0.82

1.23

(33%)

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REVENUES

($ in millions)

First-Quarter

2024

2023

% Change

Total

Oper.

Global Biopharmaceuticals

$ 14,604

$ 18,173

(20%)

(19%)

Business (Biopharma)

Business Innovation

275

313

(12%)

(12%)

TOTAL REVENUES

$ 14,879

$ 18,486

(20%)

(19%)

2024 FINANCIAL GUIDANCE(6)

Pfizer raises Adjusted(3) diluted EPS Guidance to $2.15 to $2.35 while maintaining all other components of its 2024 Financial Guidance(6). The company still expects full-year 2024 revenues to be in the range of $58.5 to $61.5 billion, which includes approximately $8 billion in anticipated revenues for Comirnaty(1) and Paxlovid (approximately $5 billion and $3 billion, respectively), and approximately $3.1 billion in anticipated revenues from legacy Seagen. Comirnaty(1) revenues continue to perform consistently with our expectations and we anticipate approximately 90% of sales to occur in the second half of the year, mostly in the fourth quarter given the anticipated seasonality of demand for COVID vaccinations.

The updated 2024 Adjusted(3) diluted EPS guidance takes into consideration our confidence in delivering on our cost realignment program target as well as our confidence in the underlying strength in our business.

Pfizer's 2024 financial guidance(6) is presented below.

Revenues

$58.5 to $61.5 billion

Adjusted(3)

SI&A Expenses

$13.8 to $14.8 billion

Adjusted(3)

R&D Expenses

$11.0 to $12.0 billion

Effective Tax Rate on Adjusted(3) Income

Approximately 15.0%

Adjusted(3)

Diluted EPS

$2.15 to $2.35

(previously $2.05 to $2.25)

Changes in foreign exchange rates have had a minimal incremental impact since full-year 2024 guidance was reaffirmed on January 30, 2024. Please refer to Press Release Footnote (6) for additional information.

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CAPITAL ALLOCATION

During the first three 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:
    • $2.5 billion invested in internal research and development projects, and
    • Approximately $100 million invested in business development transactions.
  • Returning capital directly to shareholders through $2.4 billion of cash dividends, or $0.42 per share of common stock.

No share repurchases were completed to date in 2024. As of May 1, 2024, Pfizer's remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2024.

First-quarter 2024 diluted weighted-average shares outstanding used to calculate Reported(2) and Adjusted(3) diluted EPS were 5,697 million shares.

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

First-quarter 2024 revenues totaled $14.9 billion, a decrease of $3.6 billion, or 20%, compared to the prior-year quarter, reflecting an operational decline of $3.5 billion, or 19%, primarily due to a significant decrease in Comirnaty(1) and Paxlovid revenues globally, as well as an unfavorable impact of foreign exchange of

$107 million, or 1%. Excluding contributions from Comirnaty(1) and Paxlovid, revenues totaled $12.5 billion, an increase of $1.2 billion, or 11%, operationally compared with the prior-year quarter.

First-quarter 2024 Comirnaty(1) revenues of $354 million declined $2.7 billion, or 88%, operationally compared with the prior-year quarter, driven largely by lower contractual deliveries and demand in international markets as well as lower U.S. volumes, reflecting the anticipated seasonality of demand for vaccinations and as certain markets, including the U.S., transition to traditional commercial market sales.

First-quarter 2024 Paxlovid revenues of $2.0 billion declined $2.0 billion, or 50%, operationally compared with the prior-year quarter, driven primarily by lower contractual deliveries in most international markets and in the U.S. as a result of the transition to traditional commercial market sales, as well as lower demand in China due to the non-recurrent surge in COVID-19 infection during the first quarter of 2023, partially offset by a $771 million favorable final adjustment to the estimated non-cash revenue reversal of $3.5 billion recorded in the fourth quarter of 2023.

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

  • Global revenues of $742 million from legacy Seagen, which was acquired in December of 2023;
  • Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 66% operationally, driven largely by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed markets in Europe;
  • Eliquis globally, up 10% 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 exclusivity and generic competition in certain international markets;
  • Abrysvo, which contributed $145 million in global revenues, driven primarily by the launch of the older adult indication in the U.S. in July 2023; and
  • Prevnar family (Prevnar 20 & 13) globally, up 7% operationally, driven primarily by the pediatric indication in the U.S. due to favorable timing of government purchases and higher patient demand in the private market, as well as strong uptake of the adult indication in certain international markets, partially offset by fewer adult vaccinations in the U.S.;

partially offset primarily by lower revenues for:

  • Oncology biosimilars in the U.S., down 47% operationally, largely due to lower net price;
  • Sulperazon internationally, down 45% operationally, driven largely by lower demand in China in the first quarter of 2024 as compared to the first quarter of 2023; and
  • Ibrance globally, down 7% operationally, driven primarily by lower demand globally due to competitive pressure and price decreases in certain international developed markets.

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GAAP Reported(2) Income Statement Highlights

SELECTED REPORTED(2) COSTS AND EXPENSES

($ in millions)

First-Quarter

2024

2023

% Change

Total

Oper.

Cost of Sales(2)

$ 3,379

$ 4,886

(31%)

(29%)

Percent of Revenues

22.7%

26.4%

N/A

N/A

SI&A Expenses(2)

3,495

3,418

2%

3%

R&D Expenses(2)

2,493

2,505

-

-

Acquired IPR&D Expenses(2)

-

21

(100%)

(100%)

Other (Income)/Deductions

680

275

*

*

-net(2)

Effective Tax Rate on

8.6%

11.4%

Reported(2) Income

* Indicates calculation not meaningful.

First-quarter 2024 Cost of Sales(2) as a percentage of revenues decreased by 3.7 percentage points compared with the prior-year quarter, driven primarily by favorable changes in sales mix, including lower sales of Comirnaty(1), which resulted in a lower related charge for the 50% gross profit split with BioNTech and applicable royalty expenses; and, to a much lesser extent, the impact of a $771 million favorable final adjustment to the non-cash Paxlovid revenue reversal, partially offset by the amortization of the fair value step-up of inventory related to the Seagen acquisition, as well as lower sales of Paxlovid.

First-quarter 2024 SI&A Expenses(2) increased 3% operationally compared with the prior-year quarter, driven primarily by an increase in marketing and promotional expenses for recently acquired and launched products, partially offset by a decrease in marketing and promotional expenses for Paxlovid and Comirnaty(1).

First-quarter 2024 R&D Expenses(2) were relatively flat operationally compared with the prior-year quarter, primarily due to lower spending as a result of our cost realignment program as well as lower spending on certain ongoing vaccine programs, largely offset by increased investments mainly to develop certain medicines acquired from Seagen.

The unfavorable period-over-period change in Other deductions-net(2) of $406 million for the first quarter of 2024, compared with the prior-year quarter, was driven primarily by higher net interest expense and lower dividend income, partially offset by net gains on equity securities in the first quarter of 2024 versus net losses on equity securities in the first quarter of 2023.

Pfizer's effective tax rate on Reported(2) income for the first quarter of 2024 decreased compared to the prior-year quarter primarily due to a favorable change in the jurisdictional mix of earnings.

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Adjusted(3) Income Statement Highlights

SELECTED ADJUSTED(3) COSTS AND EXPENSES

($ in millions)

Adjusted(3) Cost of Sales

Percent of Revenues

Adjusted(3) SI&A Expenses

Adjusted(3) R&D Expenses

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

Effective Tax Rate on Adjusted(3) Income

First-Quarter

2024

2023

% Change

Total

Oper.

$ 3,036

$ 4,746

(36%)

(34%)

20.4%

25.7%

N/A

N/A

3,454

3,350

3%

3%

2,477

2,491

(1%)

(1%)

296

(324)

*

*

16.6%

14.0%

* Indicates calculation not meaningful.

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.

RECENT NOTABLE DEVELOPMENTS (Since January 30, 2024)

Product Developments

Product/Project

Recent Development

Link

April 2024. Reported positive top-line immunogenicity and safety data from the ongoing

Full Release

pivotal Phase 3 clinical trial, MONeT (RSV IMmunizatiON Study for AdulTs at Higher

Risk of Severe Illness), evaluating a single dose of Abrysvo versus placebo in adults 18

to 59 years of age at risk of developing severe RSV-associated lower respiratory tract

disease (LRTD). Participants demonstrated RSV-A and RSV-B subgroup neutralizing

responses non-inferior to the response seen in the Phase 3 RENOIR study of Abrysvo in

adults aged 60 or older where vaccine efficacy was previously demonstrated. The vaccine

was well-tolerated during the trial, and safety findings were consistent with those from

previous investigations of Abrysvo in other populations.

The company intends to submit these data to regulatory agencies and request expansion

Abrysvo

of the age group from the current indication to 18 years of age and older.

(respiratory

February 2024. Reported positive top-line efficacy and safety data for Abrysvo in adults

Full Release

syncytial virus

60 years of age and older following a second season in the Northern and Southern

vaccine)

Hemispheres from the ongoing pivotal Phase 3 clinical trial RENOIR. The vaccine

demonstrated durable efficacy after two seasons against RSV-associated LRTD.

Consistent vaccine efficacy was demonstrated for both RSV-A and RSV-B after season

two with vaccine efficacy against each subtype of ≥80% for LRTD with three or more

symptoms. Vaccine efficacy was also sustained against less severe LRTD, defined by two

or more symptoms after the end of season two. No new adverse events were reported

through the second RSV season beyond what was reported in the clinical trial during the

first season.

Pfizer intends to submit the data to regulatory authorities and vaccine technical

committees as well as publish the findings in a peer-reviewed scientific journal and share

them at an upcoming scientific congress.

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Product/Project

Recent Development

Link

March 2024. The Phase 3 study, ECHELON-3, of Adcetris in combination with

Full Release

lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse

large B-cell lymphoma (DLBCL) showed a statistically significant and clinically

Adcetris

meaningful improvement in overall survival (OS) compared to lenalidomide and

rituximab plus placebo. Positive outcomes were also observed in key secondary

(brentuximab

endpoints. The safety and tolerability of Adcetris in the ECHELON-3 trial were

vedotin)

consistent with what has been previously presented for patients with relapsed/refractory

DLBCL treated with Adcetris in clinical trials.

Pfizer plans to share the ECHELON-3 data with the U.S. Food and Drug Administration

(FDA) to potentially support regulatory filing in the U.S.

April 2024. The FDA approved Beqvez, a one-time gene therapy for adults with

Full Release

moderate to severe hemophilia B who currently use factor IX prophylaxis therapy, or

have current or historical life-threatening hemorrhage, or have repeated, serious

Beqvez

spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-

associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-

(fidanacogene

approved test. Beqvez has provided sustained bleed protection relative to standard of

elaparvovec-

care. In the Phase 3 study, BENEGENE-2, bleeds were eliminated in 60% of patients

dzkt)

compared to 29% in the prophylaxis arm, and a median annualized bleeding rate (ABR)

of zero was observed after up to three years of follow up (range of 0 to 19) compared to

the lead-inpre-treatment period in which a median ABR of 1.3 was observed (range of 0

to 53.9).

April 2024. The European Commission (EC) granted marketing authorization for

Full Release

Emblaveo for the treatment of adult patients with complicated intra-abdominal infections

Emblaveo

(cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia

(VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is

(aztreonam-

also indicated for the treatment of infections due to aerobic Gram-negative organisms in

avibactam)

adult patients with limited treatment options. It combines aztreonam, a monobactam β-

lactam, with avibactam, a recent broad-spectrumβ-lactamase inhibitor. Pfizer holds the

global rights to commercialize this therapy outside of the U.S. and Canada, where the

rights are held by AbbVie Inc.

Prevnar 20

March 2024. The EC granted marketing authorization for the company's 20-valent

Full Release

pneumococcal conjugate vaccine, marketed in the European Union (EU) under the brand

(20-valent

name Prevenar 20, for active immunization for the prevention of invasive disease,

pneumococcal

pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants,

conjugate

children and adolescents from 6 weeks to less than 18 years of age. The authorization is

vaccine)

valid in all 27 EU member states plus Iceland, Liechtenstein and Norway.

April 2024. The FDA granted Pfizer and Genmab A/S full approval for Tidvak for the

Full Release

treatment of patients with recurrent or metastatic cervical cancer with disease progression

on or after chemotherapy. Conversion to full approval from accelerated approval was

based on positive results from the global Phase 3 innovaTV 301 study which

Tivdak

demonstrated an overall survival (OS) benefit of Tidvak compared to chemotherapy.

(tisotumab

February 2024. The European Medicines Agency (EMA) validated for review the

Full Release

vedotin-tftv)

marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug

conjugate (ADC) developed for the treatment of adult patients with recurrent or

metastatic cervical cancer with disease progression on or after first-line therapy.

If approved, tisotumab vedotin would be the first ADC granted EU marketing

authorization for people living with cervical cancer.

February 2024. The EC granted marketing authorization for Velsipity in the EU to treat

Full Release

patients 16 years of age and older with moderately to severely active ulcerative colitis

Velsipity

(UC) who have had an inadequate response, lost response, or were intolerant to either

(etrasimod)

conventional therapy, or a biological agent.

The marketing authorization for Velsipity is valid in all 27 EU member states as well as

Iceland, Liechtenstein, and Norway.

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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

Vepdegestrant

February 2024. The FDA granted Fast Track designation for the investigation of

Full Release

vepdegestrant for monotherapy in the treatment of adults with estrogen receptor (ER)

(ARV-471)

positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally

advanced or metastatic breast cancer previously treated with endocrine-based therapy.

Corporate Developments

Topic

Recent Development

Link

February 2024. Pfizer hosted a meeting with the investment community where it

Full Release

outlined its strategic priorities for its Oncology organization. Pfizer's Oncology portfolio

"Oncology

is focused on three core scientific modalities: small molecules, ADCs, and bispecific

antibodies, including other immuno-oncology biologics; and is focused on expanding its

Innovation Day"

leadership in four main cancer types: breast cancer, genitourinary cancer, hematology-

oncology, and thoracic cancers. By 2030, the company anticipates eight or more potential

blockbusters in Oncology alone.

"Change the

February 2024. Pfizer and the American Cancer Society announced the launch of a

Full Release

three-year initiative to bridge the gap in cancer care disparities. Through $15 million in

Odds: Uniting to

funding from Pfizer, the initiative aims to improve health outcomes in medically

Improve Cancer

underrepresented communities across the U.S. by enhancing awareness of and access to

Outcomes™"

cancer screenings, clinical trial opportunities, and patient support and comprehensive

navigation.

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For additional details, see the attached financial schedules, product revenue tables and 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-BioNTechCOVID-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 Original/Omicron BA.1; Comirnaty Original/Omicron BA.4/BA.5; and Comirnaty Omicron XBB.1.5. "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 and its components are defined as net income attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as diluted EPS 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 first quarter of 2024 and 2023. 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 and its components and diluted EPS(2). See the Non-GAAPFinancial 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-GAAPFinancial Measure: Adjusted Income section of this press release for a definition of each component of Adjusted income as well as other relevant information.
  4. First-quarter2024 Reported(2) and Adjusted(3) diluted EPS were favorably impacted by $0.11 resulting from a $771 million final adjustment 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.
  5. The targeted $4 billion in net cost savings is calculated versus the midpoint of Pfizer's 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.

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Pfizer Inc. published this content on 01 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 10:07:38 UTC.