- 2023 Sets Stage for Future Growth Potential: Completed Seagen
Acquisition, Creating World-Class Oncology Organization; Launched
Significant Number of New Products and Indications; and Realigned
Commercial Organization to Improve Focus, Speed and Execution
- Full-Year 2023 Revenues of $58.5 Billion
- Expected Decline in Comirnaty(1) and Paxlovid Revenues Drove
41% Operational Decrease in Year-Over-Year Revenues
- Excluding Contributions from Comirnaty(1) and Paxlovid,
Revenues Grew 7% Operationally, Driven by a Combination of New
Product and Indication Launches and In-Line Product Growth
- Full-Year 2023 Reported(2) Diluted EPS of $0.37, Down 93%
Year-Over-Year, and Adjusted(3) Diluted EPS of $1.84, Down 72%
Year-Over-Year, Significantly Impacted by One-Time Events(4)
- Fourth-Quarter 2023 Revenues of $14.2 Billion
- Expected Decline in Comirnaty(1) and Paxlovid Revenues Drove
42% Operational Decrease in Fourth-Quarter Revenues
- Excluding Contributions from Comirnaty(1) and Paxlovid,
Revenues Grew 8% Operationally
- Fourth-Quarter 2023 Reported(2) Diluted Loss Per Share (LPS) of
$(0.60) and Adjusted(3) Diluted EPS of $0.10, Significantly
Impacted by One-Time Events(4)
- On Track to Deliver at Least $4 Billion in Annual Net Cost
Savings by End of 2024 from Previously Announced Cost Realignment
Program
- Reaffirms Full-Year 2024 Guidance(5) Provided on December 13,
2023, of Revenues of $58.5 to $61.5 Billion and Adjusted(3) Diluted
EPS of $2.05 to $2.25
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.
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 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. 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:
https://investors.pfizer.com/Q4-2023-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 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, the Pfizer-BioNTech COVID-19
Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Comirnaty
(COVID-19 Vaccine, mRNA, 2023-2024 Formula), the Pfizer-BioNTech
COVID-19 Vaccine (2023-2024 Formula), Comirnaty Original/Omicron
BA.1, Comirnaty Original/Omicron BA.4/BA.5 and Comirnaty XBB.1.5.
“Comirnaty” includes direct sales and alliance revenues related to
sales of the above-mentioned vaccines, which are recorded within
Pfizer’s Primary Care customer group. It does not include revenues
for certain Comirnaty-related manufacturing activities performed on
behalf of BioNTech, which are included in the Pfizer CentreOne
contract development and manufacturing organization. Revenues
related to these manufacturing activities totaled $33 million for
full-year 2023 and $188 million for full-year 2022.
(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 Reported 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 2023 and 2022.
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 2022 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) Significant one-time impacts to Reported(2) and
Adjusted(3) diluted EPS/LPS:
- Full-year 2023 Reported(2) and Adjusted(3) diluted EPS were
significantly impacted by $5.6 billion of non-cash COVID product
inventory write-offs and related charges in third-quarter 2023 and
by a $3.5 billion non-cash Paxlovid revenue reversal in
fourth-quarter 2023, which together unfavorably impacted
Reported(2) and Adjusted(3) diluted EPS by $(1.36).
- Fourth-quarter 2023 Reported(2) and Adjusted(3) diluted LPS/EPS
were significantly impacted by a $3.5 billion non-cash Paxlovid
revenue reversal in fourth quarter 2023, which unfavorably impacted
Reported(2) and Adjusted(3) diluted LPS/EPS by approximately
$(0.54).
(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 2024 reflects the
following:
- Does not assume the completion of any business development
transactions not completed as of December 31, 2023.
- An anticipated immaterial impact in fiscal-year 2024 of recent
and expected generic and biosimilar competition for certain
products that have recently lost patent protection or that are
anticipated to lose patent protection.
- Exchange rates assumed are actual rates at mid-November 2023.
Financial guidance reflects the anticipated unfavorable impact of
approximately $0.3 billion on revenues and approximately $0.01 on
Adjusted(3) 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(3) diluted EPS assumes diluted
weighted-average shares outstanding of approximately 5.75 billion
shares, and assumes no share repurchases in 2024.
(6) 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, 2023 and December 31, 2022, 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, 2023 and
November 30, 2022. (7) References to operational variances
in this press release pertain to period-over-period changes that
exclude the impact of foreign exchange rates. Although 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. (8) Keytruda is a
registered trademark of Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Rahway, NJ, USA. (9) Bavencio is a
registered trademark of Merck KGaA.
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is
as of January 30, 2024. 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; our Environmental, Social and
Governance (ESG) priorities, strategy and goals; 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
patient 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); dividends and share repurchases; plans for and prospects
of our acquisitions, dispositions and other business development
activities, including our recent 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, including our plans and expectations regarding
Comirnaty (as defined in this earnings release) and our oral
COVID-19 treatment (Paxlovid); and our expectations regarding the
impact of COVID-19 on our business, operations and financial
results. 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; and 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;
- 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,
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, 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 outcome of
post-approval clinical trials, 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 recent 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 could result in increased
leverage and/or a further downgrade of our credit ratings;
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 our efforts to develop and
commercialize our COVID-19 products, as well as challenges related
to their manufacturing, supply and distribution, including, among
others, the risk that as the market for COVID-19 products becomes
more endemic and seasonal, demand for any of our COVID-19 products
has and may continue to be reduced or not meet expectations, or may
no longer exist, which has and may continue to lead to reduced
revenues, excess inventory on-hand and/or in the channel which, for
Paxlovid and Comirnaty, has resulted in significant inventory
write-offs in 2023 and could continue to result in inventory
write-offs or other unanticipated charges; challenges related to
the transition to the commercial market for our COVID-19 products;
uncertainties related to the public’s demand for vaccines, boosters
and COVID-19 treatments; risks related to our ability to accurately
forecast and achieve our revenue forecasts for Comirnaty and
Paxlovid or any potential future COVID-19 vaccines or treatments;
uncertainties inherent in R&D, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for clinical trials, regulatory submission dates, regulatory
approval dates and/or launch dates, as well as risks associated
with pre-clinical and clinical data (including Phase 1/2/3 or Phase
4 data for Comirnaty or any vaccine candidate in the BNT162 program
or Paxlovid or any future COVID-19 treatment) in any of our studies
in pediatrics, adolescents or adults or real world evidence,
including the possibility of unfavorable new pre-clinical, clinical
or safety data and further analyses of existing pre-clinical,
clinical or safety data or further information regarding the
quality of pre-clinical, clinical or safety data, including by
audit or inspection; the ability to produce comparable clinical or
other results for Comirnaty, any vaccine candidate or other
vaccines that may result from the BNT162 program, Paxlovid or any
future COVID-19 treatment or any other COVID-19 program, including
the rate of effectiveness and/or efficacy, safety and tolerability
profile observed to date, in additional analyses of the Phase 3
trial for any such products and additional studies, in real-world
data studies or in larger, more diverse populations following
commercialization; the ability of Comirnaty or any future vaccine
to prevent, or Paxlovid or any future COVID-19 treatment to be
effective against, COVID-19 caused by emerging virus variants; the
risk that use of Comirnaty or Paxlovid will lead to new information
about efficacy, safety or other developments, including the risk of
additional adverse reactions, some of which may be serious; 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 the BNT162 program, Paxlovid or other COVID-19
programs will be published in scientific journal publications and,
if so, when and with what modifications and interpretations;
whether regulatory authorities will be satisfied with the design of
and results from existing or future pre-clinical and clinical
studies; whether and when submissions to request emergency use or
conditional marketing authorizations for Comirnaty or any future
vaccines in additional populations, for a potential booster dose
for Comirnaty, or any potential future vaccine or vaccine
candidates (including potential future annual boosters or
re-vaccinations), and/or biologics license and/or EUA applications
or amendments to any such applications may be filed in particular
jurisdictions for Comirnaty or any other potential vaccine or
vaccine candidates, and if obtained, whether or when such EUA or
licenses, or existing EUAs, will expire or terminate; whether and
when submissions to request emergency use or conditional marketing
authorizations for Paxlovid or any future COVID-19 treatment and/or
any drug applications and/or EUA applications or amendments to any
such applications for any indication for Paxlovid or any future
COVID-19 treatment may be filed in particular jurisdictions, and if
obtained, whether or when such EUA or licenses, or existing EUAs,
will expire or terminate; whether and when any application that may
be pending or filed for Comirnaty, any vaccine candidate or other
vaccines that may result from the BNT162 program, Paxlovid or any
future COVID-19 treatment or any other COVID-19 program may be
approved by particular regulatory authorities, which will depend on
myriad factors, including making a determination as to whether the
vaccine’s or drug’s benefits outweigh its known risks and
determination of the vaccine’s or drug’s efficacy and, if approved,
whether it will be commercially successful; decisions by regulatory
authorities impacting labeling or marketing, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of any vaccine or drug,
including the authorization or approval of products or therapies
developed by other companies; disruptions in the relationships
between us and our collaboration partners, clinical trial sites or
third-party suppliers, including our relationship with BioNTech;
the risk that other companies may produce competitive products that
may be superior in terms of efficacy, safety, affordability,
convenience, or a number of other competitive factors; risks
related to the availability or cost of raw materials to manufacture
or test any such products; challenges related to our vaccine’s
formulation and attendant storage, distribution and administration
requirements, including risks related to storage and handling after
delivery by us; challenges and risks related to medication errors
such as prescribing or dispensing the wrong strength, improper
dosing and self-administration errors; the risk that we may not be
able to successfully develop other vaccine formulations, booster
doses or potential future vaccines, potential combination
respiratory vaccines or next generation COVID-19 treatments; the
risk that we may not be able to recoup costs associated with our
R&D and manufacturing efforts; risks associated with any
changes in the way we approach or provide research funding for the
BNT162 program, Paxlovid or any other COVID-19 program; challenges
and risks associated with the pace of our development programs; the
risk that we may not be able to maintain manufacturing capacity or
access to logistics or supply channels commensurate with global
demand for our COVID-19 products, which would negatively impact our
ability to supply our COVID-19 products within the projected time
periods; whether and when additional supply or purchase agreements
will be reached or existing agreements will be modified;
uncertainties regarding the ability to obtain recommendations from
vaccine or treatment advisory or technical committees and other
public health authorities and uncertainties regarding the
commercial impact of any such recommendations; pricing and access
challenges for such products; challenges related to public
confidence in, or awareness of Comirnaty, Paxlovid or any future
COVID-19 product candidates, including challenges driven by
misinformation or disinformation, access, concerns about clinical
data integrity, or prescriber and pharmacy education; trade
restrictions; potential third-party royalties or other claims
related to Comirnaty or Paxlovid; and competitive
developments;
- 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 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
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, including uncertainties related to the impact of the
tornado at our manufacturing facility in Rocky Mount, NC in
2023;
- 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, including our ongoing evaluation of
our product portfolio for the potential presence or formation of
nitrosamines;
- 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, 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 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 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
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 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 law by the current U.S. Presidential administration
and Congress, including the proposed “Tax Relief for American
Families and Workers Act of 2024”;
Risks Related to Intellectual Property,
Technology and Security:
- 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 or
other malfeasance by, but not limited to, nation states, employees,
business partners or others;
- risks and challenges related to the use of artificial
intelligence-based software;
- 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; and
- risks to our products, patents and other intellectual property,
such as: (i) claims of invalidity that could result in loss of
exclusivity; (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.
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, 2022 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.
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