On January 30, 2024 Pfizer Inc. (NYSE: PFE) reported financial results for fourth quarter and full-year 2023 and reaffirmed its 2024 financial guidance(5) provided on December 13, 2023 (Press release, Pfizer, JAN 30, 2024, View Source [SID1234639714]).
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The fourth-quarter 2023 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 are encouraged by the strong performance of our non-COVID products in the fourth quarter of 2023, including significant contributions from new launches and robust year-over-year growth for several key in-line brands. In 2023, Pfizer received a record number of nine new molecular entity approvals by the U.S. Food and Drug Administration (FDA)—medicines and vaccines that are expected to favorably impact Pfizer’s performance in the coming years.
"In addition, we completed the acquisition of Seagen in December 2023, a critical step toward our goal to achieve world-class Oncology leadership. With the combined strength of Pfizer’s and Seagen’s talent, portfolios and platforms, we believe we have the potential to transform outcomes by delivering cancer medicines that help patients live better and longer lives. We look forward to sharing the vision of the new Pfizer Oncology Division at our announced Oncology Innovation Day on Thursday, February 29.
"We are entering 2024 with a solid foundation. We believe our commitment to execution, maximizing the performance of our new products, and delivering the next wave of pipeline innovation will fuel Pfizer’s growth and make a difference in the lives of patients everywhere."
David Denton, Chief Financial Officer and Executive Vice President, stated: "We are pleased with the strong 8% operational revenue growth of Pfizer’s non-COVID products in the fourth quarter of 2023, achieving our full-year 2023 non-COVID operational revenue growth target of 6% to 8%. In addition, we are on track to deliver at least $4.0 billion in annual net cost savings by the end of 2024 from our cost realignment program. We are prepared to execute our commercial strategy to drive continued growth from our newly launched and acquired products, and to deliver on our targeted cost savings that we expect will expand our operating margins in 2024 and beyond."
Results for fourth-quarter and full-year 2023 and 2022(6) are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts)
Fourth-Quarter
Full-Year
2023
2022
Change
2023
2022
Change
Revenues
$ 14,249
$ 24,290
(41%)
$ 58,496
$ 100,330
(42%)
Reported(2) Net Income/(Loss)
(3,369)
4,995
*
2,119
31,372
(93%)
Reported(2) Diluted EPS/(LPS)
(0.60)
0.87
*
0.37
5.47
(93%)
Adjusted(3) Income
593
6,551
(91%)
10,501
37,717
(72%)
Adjusted(3) Diluted EPS
0.10
1.14
(91%)
1.84
6.58
(72%)
* Indicates calculation not meaningful.
REVENUES
($ in millions)
Fourth-Quarter
Full-Year
2023
2022
% Change
2023
2022
% Change
Total
Oper.
Total
Oper.
Global Biopharmaceuticals Business (Biopharma)
$ 13,867
$ 23,922
(42%)
(42%)
$ 57,186
$ 98,988
(42%)
(41%)
Primary Care
6,986
17,348
(60%)
(60%)
30,589
73,023
(58%)
(57%)
Specialty Care
3,949
3,566
11%
11%
14,970
13,833
8%
11%
Oncology
2,932
3,007
(3%)
(2%)
11,627
12,132
(4%)
(3%)
Business Innovation
$ 382
$ 368
4%
2%
$ 1,310
$ 1,342
(2%)
(2%)
TOTAL REVENUES
$ 14,249
$ 24,290
(41%)
(42%)
$ 58,496
$ 100,330
(42%)
(41%)
In the first quarter of 2023, Pfizer established an operating segment, Business Innovation, that includes Pfizer CentreOne (PC1), the company’s global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients; and Pfizer Ignite, an offering that provides strategic guidance and end-to-end R&D services to select innovative biotech companies that align with Pfizer’s R&D focus areas. The prior period has been revised to conform to the current period 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(7).
CAPITAL ALLOCATION
During full-year 2023, 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:
$10.7 billion invested in internal research and development projects, and
Approximately $43.8 billion invested in completed business development transactions, net of cash acquired, including approximately $43 billion for the acquisition of Seagen Inc.
Returning capital directly to shareholders through $9.2 billion of cash dividends, or $1.64 per share of common stock.
No share repurchases were completed in 2023. As of January 30, 2024, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2024.
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.
2024 FINANCIAL GUIDANCE(5)
Pfizer expects full-year 2024 revenues(2) 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), approximately $3.1 billion in anticipated revenues from Seagen and approximately $1 billion related to the reclassification of Pfizer’s royalty income from Other (Income)/Deductions into the Revenue line.
Including the contribution from Seagen and excluding revenues from Comirnaty(1) and Paxlovid, Pfizer expects to achieve full-year 2024 operational revenue growth of 8% to 10% compared to 2023 revenues. Excluding revenues from Comirnaty(1) and Paxlovid and the expected contribution from Seagen, Pfizer expects to achieve full-year 2024 operational revenue growth of 3% to 5% compared to 2023 revenues. While the company will begin reporting royalty income in the revenue line in 2024, for growth rate purposes, the company has included royalty income in revenues in both 2023 and 2024. Consequently, there is no operational revenue growth attributable to the reclassification of royalty income.
Including the impact of Seagen, Pfizer anticipates full-year 2024 Adjusted(3) SI&A expenses to be in the range of $13.8 billion to $14.8 billion and full-year 2024 Adjusted(3) R&D expenses to be in the range of $11.0 to $12.0 billion. Consequently, total 2024 Adjusted(3) SI&A and R&D expenses are expected to be in the range of $24.8 to $26.8 billion. This range reflects an anticipated decline of approximately $4 billion by the end of 2024 versus the midpoint of Pfizer’s SI&A and R&D expense guidance provided on August 1, 2023, solely driven by Pfizer’s cost realignment program, partially offset by the impact of Seagen.
2024 Adjusted(3) diluted EPS is anticipated to be in a range of $2.05 to $2.25, which primarily reflects:
Expected operational revenue growth of 8% to 10% compared to 2023 revenues, excluding Comirnaty(1) and Paxlovid and including the impact of Seagen; and
Anticipated operating margin improvement from the company’s cost realignment activities; partially offset by
An expected $0.40 dilutive impact related to the Seagen acquisition, which is predominantly driven by costs to finance the transaction.
Pfizer’s 2024 financial guidance(5), including the impact of certain significant factors, is presented below.
2023
Results
2024 Legacy
Pfizer
Guidance
Anticipated
Impact of Royalty
Income Reclass
Included in 2024
Guidance
Anticipated 2024
Seagen Impact
Included in 2024
Guidance
2024 Financial
Guidance(5)
Revenues ($ in billions)
$58.5
$54.5 to $57.5
$1.0
$3.1
$58.5 to $61.5
Adjusted(3) SI&A Expenses ($ in billions)
$14.4
$13.8 to $14.8
Adjusted(3) R&D Expenses ($ in billions)
$10.6
$11.0 to $12.0
Effective Tax Rate on Adjusted(3) Income
9.0%
~15.0%
Adjusted(3) Diluted EPS
$1.84
$2.45 to $2.65
–
$(0.40)
$2.05 to $2.25
Financial guidance for Adjusted(3) diluted EPS is calculated using approximately 5.75 billion weighted average shares outstanding and assumes no share repurchases in 2024.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2023 vs. Fourth-Quarter 2022)
Fourth-quarter 2023 revenues totaled $14.2 billion, a decrease of $10.0 billion, or 41%, compared to the prior-year quarter, reflecting an operational decline of $10.1 billion, or 42%, primarily due to a significant decrease in Comirnaty(1) and Paxlovid revenues globally, as well as a de minimis impact of foreign exchange. Excluding contributions from Comirnaty(1) and Paxlovid, company revenues grew $934 million, or 8%, operationally.
Fourth-quarter 2023 Comirnaty(1) revenues declined $6.1 billion, or 54%, operationally compared with the prior-year quarter, largely driven by lower U.S. government contracted deliveries following the transition to traditional U.S. commercial market sales, which began in September 2023, and by lower contracted deliveries and demand in international markets.
Fourth-quarter 2023 Paxlovid revenues declined $5.0 billion, to $(3.1) billion, compared with the prior-year quarter, primarily driven by a non-cash revenue reversal of $3.5 billion recorded in the fourth quarter of 2023, 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; partially offset by sales under traditional commercial markets following transition, primarily in the U.S.
Excluding contributions from Comirnaty(1) and Paxlovid, fourth-quarter 2023 operational revenue growth was primarily driven by:
Abrysvo, which contributed $515 million in global revenues, driven primarily by launch of the older adult indication in the U.S. in July 2023;
Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 39% operationally, driven largely by continued strong uptake of the transthyretin amyloid cardiomyopathy (ATTR-CM) indication, primarily in the U.S. and developed Europe; and
Eliquis globally, up 9% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of exclusivity and generic competition in certain international markets;
partially offset primarily by lower revenues for:
Ibrance globally, down 13% operationally, driven primarily by lower demand globally due to competitive pressure and lower clinical trial purchases in certain international markets; and
Prevnar family (Prevnar 13 & 20) globally, down 7% operationally, driven primarily by the pediatric indication in emerging markets due to lower demand and unfavorable timing of customer orders.
GAAP Reported(2) Statement of Operations Highlights
SELECTED REPORTED(2) COSTS AND EXPENSES
($ in millions)
Fourth-Quarter
Full-Year
2023
2022
% Change
2023
2022
% Change
Total
Oper.
Total
Oper.
Cost of Sales(2)
$ 7,562
$ 9,648
(22%)
(24%)
$ 24,954
$ 34,344
(27%)
(29%)
Percent of Revenues
53.1%
39.7%
N/A
N/A
42.7%
34.2%
N/A
N/A
SI&A Expenses(2)
4,575
4,644
(1%)
(2%)
14,771
13,677
8%
9%
R&D Expenses(2)
2,815
3,615
(22%)
(22%)
10,679
11,428
(7%)
(6%)
Acquired IPR&D Expenses(2)
73
73
—
—
194
953
(80%)
(80%)
Other (Income)/Deductions––net(2)
(480)
(846)
(43%)
(51%)
(835)
217
*
*
Effective Tax Rate on Reported(2) Income/(Loss)
19.2%
4.4%
(105.4%)
9.6%
* Indicates calculation not meaningful.
Fourth-quarter 2023 Cost of Sales(2) as a percentage of revenues increased by 13.4 percentage points compared with the prior-year quarter, driven primarily by the $3.5 billion non-cash Paxlovid revenue reversal; unfavorable changes in sales mix, primarily due to lower sales of Paxlovid and Comirnaty(1); and the unfavorable impact of foreign exchange.
Fourth-quarter 2023 SI&A Expenses(2) decreased 2% operationally compared with the prior-year quarter, driven primarily by a decrease in marketing and promotional expenses for Paxlovid, a lower provision for U.S. healthcare reform fees related to Paxlovid and Comirnaty(1), and lower compensation-related expenses, partially offset by increases in marketing and promotional expenses, including those related to recently launched and acquired products, as well as increased investments to build new internal marketing capabilities.
Fourth-quarter 2023 R&D Expenses(2) decreased 22% operationally compared with the prior-year quarter, driven primarily by lower compensation-related expenses, as well as by lower spending across (i) vaccine programs, (ii) certain acquired assets and (iii) for ongoing rare disease programs.
The unfavorable period-over-period change in Other income—net(2) of $366 million for the fourth quarter of 2023, compared to the fourth quarter of 2022, was driven primarily by higher intangible asset impairment charges, partially offset by an increase in net gains on equity securities.
Pfizer’s positive effective tax rate for the fourth quarter of 2023 reflects a tax benefit on a pre-tax Reported(2) loss and includes changes in the jurisdictional mix of earnings and the resolution of uncertain tax positions in various markets.
Adjusted(3) Statement of Operations Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions)
Fourth-Quarter
Full-Year
2023
2022
% Change
2023
2022
% Change
Total
Oper.
Total
Oper.
Adjusted(3) Cost of Sales
$ 7,265
$ 9,475
(23%)
(26%)
$ 23,988
$ 34,096
(30%)
(31%)
Percent of Revenues
51.0%
39.0%
N/A
N/A
41.0%
34.0%
N/A
N/A
Adjusted(3) SI&A Expenses
4,471
4,414
1%
1%
14,446
13,049
11%
12%
Adjusted(3) R&D Expenses
2,770
3,610
(23%)
(24%)
10,568
11,409
(7%)
(7%)
Adjusted(3) Other (Income)/Deductions––net
(815)
(656)
24%
14%
(2,281)
(1,954)
17%
8%
Effective Tax Rate on Adjusted(3) Income/(Loss)
(24.0%)
11.1%
9.0%
11.7%
Reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes can be found in the financial tables section of the press release located at the hyperlink below.
FULL-YEAR REVENUE SUMMARY (Full-Year 2023 vs. Full-Year 2022)
Full-year 2023 revenues totaled $58.5 billion, a decrease of $41.8 billion, or 42%, compared to full-year 2022, reflecting an operational decline of $40.8 billion, or 41%, and an unfavorable impact of foreign exchange of $1.0 billion, or 1%. Excluding contributions from Comirnaty(1) and Paxlovid, revenues for the full-year grew 7% operationally.
The operational revenue decline compared to the prior year was driven primarily by significantly lower global revenues for Comirnaty(1) and Paxlovid and, to a much lesser extent, lower revenues for Ibrance, partially offset by an increase in revenues from Nurtec ODT/Vydura and Oxbryta, which were acquired in the fourth quarter of 2022; revenues from Abrysvo, primarily driven by the launch of the older adult indication in the U.S.; and continued growth from the Vyndaqel family and Eliquis.
RECENT NOTABLE DEVELOPMENTS (Since October 31, 2023)
Product Developments
Elrexfio (elranatamab-bcmm) – In December 2023, Pfizer announced the European Commission (EC) granted conditional marketing authorization for Elrexfio for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Padcev (enfortumab vedotin-ejfv)
In January 2024, Pfizer and Astellas Pharma Inc. (Astellas) announced that the European Medicines Agency (EMA) validated for review a Type II variation application for Padcev, an antibody-drug conjugate (ADC), with Keytruda(8) (pembrolizumab, a PD-1 inhibitor) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The EMA’s Committee for Medicinal Products for Human Use (CHMP), and subsequently the EC, are expected to share their opinions and decisions on the Type II variation application in calendar year 2024.
In December 2023, Pfizer and Astellas announced that the FDA approved Padcev with Keytruda(8) for the treatment of adult patients with la/mUC based on the results from the Phase 3 EV-302 clinical trial. This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.
Prevnar 20 (20-valent pneumococcal conjugate vaccine) – In January 2024, Pfizer announced the CHMP of the EMA adopted a positive opinion, recommending the granting of a marketing authorization for its 20-valent pneumococcal conjugate vaccine candidate for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. The CHMP’s positive opinion will now be reviewed by the EC to decide whether to approve the vaccine. This decision is expected in the coming weeks and will apply to all 27 European Union (EU) member states plus Iceland, Liechtenstein and Norway.
Talzenna (talazoparib) – In January 2024, Pfizer announced that the EC approved Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. With this approval, Talzenna is now the first and only PARP inhibitor licensed in the EU for use with Xtandi for patients with mCRPC, with or without gene mutations. The approval is valid in all 27 EU member states plus Iceland, Liechtenstein and Norway.
Tivdak (tisotumab vedotin-tftv) – In January 2024, Pfizer and Genmab A/S announced the FDA accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of Tivdak, an ADC, to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The sBLA is supported by efficacy and safety data from the global, randomized, Phase 3 innovaTV 301 trial. The application was granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.
Velsipity (etrasimod) – In December 2023, Pfizer announced the EMA’s CHMP adopted a positive opinion for Velsipity, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological agent. The EC will review the CHMP recommendation and is expected to make a final decision in the coming months.
Xtandi (enzalutamide) – In November 2023, Astellas and Pfizer announced the FDA approved a supplemental New Drug Application (sNDA) for Xtandi following FDA expedited development and review programs (Priority Review designation, Fast Track designation, Real-time Oncology Review), based on results from the Phase 3 EMBARK trial. With this approval, Xtandi becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). Patients with nmCSPC with high-risk BCR may be treated with Xtandi with or without a gonadotropin-releasing hormone (GnRH) analog therapy.
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.
Danuglipron – In December 2023, Pfizer announced topline data from the Phase 2b clinical trial investigating its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate danuglipron in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline. While the most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed. High discontinuation rates were seen across all doses compared to placebo. No new safety signals were reported, and treatment with danuglipron was not associated with increased incidence of liver enzyme elevation compared to placebo. Future development of danuglipron will be focused on a once-daily formulation, with pharmacokinetic data anticipated in the first half of 2024, which will help to inform a potential path forward.
Marstacimab
In December 2023, Pfizer announced the FDA had accepted the company’s Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). A marketing authorization application for marstacimab is also currently under review by the EMA. The FDA has set a PDUFA action date in the fourth quarter of 2024, and a decision from the EC is anticipated by the first quarter of 2025.
In December 2023, Pfizer presented results from the pivotal Phase 3 BASIS clinical trial evaluating marstacimab for the treatment of people with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors to FVIII or FIX. Results from the BASIS trial, which were presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, demonstrated a statistically significant and clinically meaningful effect on annualized bleeding rate. The safety profile for marstacimab was consistent with Phase 1/2 results, and treatment was generally well-tolerated in the study. No deaths were reported, and there have been no thromboembolic events or events of consumptive coagulopathy recorded in hemophilia patients in clinical trials investigating marstacimab.
Vepdegestrant (ARV-471) – In December 2023, Arvinas, Inc. and Pfizer presented interim results from the Phase 1b trial evaluating vepdegestrant, a novel oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with palbociclib (Ibrance). Study data from the combination cohort demonstrated encouraging clinical activity in heavily pre-treated patients with a median of four lines of therapy across disease settings with locally advanced or metastatic ER positive/human epidermal growth factor 2 (HER2) negative (ER+/HER2-) breast cancer. These data were presented in a spotlight presentation at the 2023 San Antonio Breast Cancer Symposium.
VLA15 (Lyme Disease Vaccine Candidate) – In December 2023, Pfizer and Valneva SE announced the completion of recruitment for the Phase 3 VALOR trial evaluating VLA15, an investigational multivalent protein subunit vaccine for Lyme disease. The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency and immunogenicity of VLA15. The VALOR trial is expected to be concluded by the end of 2025.
Corporate Developments
In December 2023, Pfizer announced the completion of its acquisition of Seagen for $229 per share, in cash. The total fair value of the consideration transferred was $44 billion ($43 billion, net of cash acquired). To address U.S. Federal Trade Commission concerns, Pfizer has chosen to irrevocably donate the rights of royalties from sales of Bavencio(9) (avelumab) in the U.S. to the American Association for Cancer Research (AACR) (Free AACR Whitepaper). With the addition of Seagen’s four in-line medicines, Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin), Tivdak (tisotumab vedotin) and Tukysa (tucatinib), Pfizer’s industry-leading Oncology portfolio now includes over 25 approved medicines and biosimilars across more than 40 indications, including nine medicines that are either blockbuster or have the potential to be blockbuster.
In December 2023, Pfizer announced changes in its commercial organization to incorporate Seagen and improve focus, speed and quality of execution, effective January 1, 2024. Three new organizations have been created, each led by a member of Pfizer’s executive leadership team reporting to Dr. Albert Bourla, Chairman and Chief Executive Officer: (1) the Pfizer Oncology Division, which brings together U.S. oncology commercial operations from both Pfizer and Seagen and is led by Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President, who also leads Pfizer’s newly combined global oncology R&D operations; (2) the Pfizer U.S. Commercial Division, led by Aamir Malik, Chief U.S. Commercial Officer, Executive Vice President; and (3) the Pfizer International Commercial Division, led by Alexandre de Germay, who has joined Pfizer as Chief International Commercial Officer, Executive Vice President.
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: