- Third-Quarter Performance Driven by Focused Commercial
Execution and Robust Double-Digit Revenue Growth Across Product
Portfolio
- Raises Full-Year 2024 Revenue Guidance(1) to a Range of $61.0
to $64.0 Billion and Raises Adjusted(2) Diluted EPS Guidance to a
Range of $2.75 to $2.95
- Third-Quarter 2024 Revenues of $17.7 Billion, Representing 32%
Year-over-Year Operational Growth
- Excluding Contributions from Paxlovid and
Comirnaty(3), Revenues Grew 14% Operationally
- Third-Quarter 2024 Reported(4) Diluted EPS of $0.78 and
Adjusted(2) Diluted EPS of $1.06
- On Track to Deliver Net Cost Savings of At Least $5.5 Billion
from Previously Announced Cost Reduction Initiatives
- At Least $4 Billion Anticipated by End of
2024 from Cost Realignment Program(5)
- Approximately $1.5 Billion Expected by End
of 2027 from First Phase of Manufacturing Optimization Program
Pfizer Inc. (NYSE: PFE) reported financial results for the third
quarter of 2024 and raised its full-year 2024 guidance(1) for both
Revenues and Adjusted(2) diluted EPS.
The third-quarter 2024 earnings presentation and accompanying
prepared remarks from management as well as the quarterly update to
Pfizer’s R&D pipeline can be found at www.pfizer.com.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and Chief Executive Officer, stated:
“We delivered another strong quarter of results as we continued to
execute with discipline, strengthen our commercial position and
advance our pipeline. I am pleased with the performance of our
product portfolio in the third quarter as we continued to achieve
exceptional growth with our Oncology products, including strong
revenue growth contributions from Padcev, Xtandi, Lorbrena and
Braftovi/Mektovi, and as we delivered on heightened demand for
Paxlovid during the recent COVID-19 wave.
“Our performance through the first three quarters of the year is
the result of our focus on our most important strategic priorities.
I’m confident that we will deliver on our financial commitments in
2024 and that we are well positioned to continue advancing
scientific breakthroughs meaningful to our patients and our
company, as well as creating long-term shareholder value, in the
years to come.”
David Denton, Chief Financial Officer and Executive Vice
President, stated: “We are extremely pleased with the strong 14%
operational revenue growth of Pfizer’s non-COVID products in the
third quarter. This follows our strong first-half performance,
which demonstrates our continued focus on commercial execution and
confidence in our ability to deliver on our financial guidance this
year. Importantly, we believe our ongoing cost reduction efforts
set the company on a path toward future margin expansion.”
OVERALL RESULTS
In the first quarter of 2024, Pfizer reclassified royalty income
(substantially all of which is related to our Biopharma segment)
from Other (income)/deductions––net to revenues and began
presenting Royalty revenues as a separate line item within Total
revenues in our consolidated statements of operations. Prior-period
amounts have been recast to conform to the current
presentation.
Some amounts in this press release may not add due to rounding.
All percentages have been calculated using unrounded amounts.
References to operational variances pertain to period-over-period
changes that exclude the impact of foreign exchange rates(6).
Results for the third quarter and first nine months of 2024 and
2023(7) are summarized below.
($ in millions, except
per share amounts)
Third-Quarter
Nine Months
2024
2023
Change
2024
2023
Change
Revenues
$ 17,702
$ 13,491
31%
$ 45,864
$ 44,984
2%
Reported(4) Net Income/(Loss)
4,465
(2,382)
*
7,621
5,488
39%
Reported(4) Diluted EPS/(LPS)
0.78
(0.42)
*
1.34
0.96
39%
Adjusted(2) Income/(Loss)
6,050
(968)
*
14,124
9,908
43%
Adjusted(2) Diluted EPS/(LPS)
1.06
(0.17)
*
2.48
1.73
43%
* Indicates calculation not meaningful or
results are greater than 100%.
REVENUES
($ in millions)
Third-Quarter
Nine Months
2024
2023
% Change
2024
2023
% Change
Total
Oper.
Total
Oper.
Global Biopharmaceuticals Business
(Biopharma)
$ 17,392
$ 13,188
32%
33%
$ 44,987
$ 44,051
2%
3%
Pfizer CentreOne (PC1)
285
293
(3%)
(2%)
820
908
(10%)
(9%)
Pfizer Ignite
25
10
*
*
56
25
*
*
TOTAL REVENUES
$ 17,702
$ 13,491
31%
32%
$ 45,864
$ 44,984
2%
3%
* Indicates calculation not meaningful or
results are greater than 100%.
2024 FINANCIAL GUIDANCE(1)
Pfizer raises full-year 2024 revenue guidance by $1.5 billion at
the midpoint to a range of $61.0 to $64.0 billion and raises
Adjusted(2) diluted EPS guidance by $0.30 at the midpoint to $2.75
to $2.95. The company’s updated guidance for revenue includes
approximately $10.5 billion in anticipated revenues for
Comirnaty(3) and Paxlovid, approximately $5 billion and $5.5
billion, respectively. Including the contribution from Seagen and
excluding revenues from Comirnaty(3) and Paxlovid, Pfizer continues
to expect full-year 2024 operational revenue growth of 9% to 11%
compared to 2023 revenues; and this growth guidance takes into
consideration the reduction of sales associated with the previously
announced global withdrawal of Oxbryta.
The updated 2024 Adjusted(2) diluted EPS guidance takes into
consideration our strong year-to-date performance as well as our
continued confidence in our business.
Pfizer’s updated financial guidance(1) is presented below.
Revenues
$61.0 to $64.0 billion
(previously $59.5 to $62.5
billion)
Adjusted(2) SI&A Expenses
$13.8 to $14.8 billion
Adjusted(2) R&D Expenses
$11.0 to $12.0 billion
Effective Tax Rate on Adjusted(2)
Income
Approximately 13.0%
Adjusted(2) Diluted EPS
$2.75 to $2.95
(previously $2.45 to $2.65)
Changes in foreign exchange rates have had a minimal incremental
impact since full-year 2024 guidance was updated on July 30, 2024.
Please refer to Press Release Footnote (1) for additional
information.
CAPITAL ALLOCATION
During the first nine months of 2024, Pfizer deployed its
capital in a variety of ways, which primarily include the following
two categories:
- Reinvesting capital into initiatives intended to enhance the
future growth prospects of the company, including:
- $7.8 billion invested in internal research and development
projects, and
- Approximately $200 million invested in business development
transactions.
- Returning capital directly to shareholders through $7.1 billion
of cash dividends, or $1.26 per share of common stock.
No share repurchases were completed to date in 2024. As of
October 29, 2024, Pfizer’s remaining share repurchase authorization
is $3.3 billion. Current financial guidance does not anticipate any
share repurchases in 2024.
Third-quarter 2024 diluted weighted-average shares outstanding
used to calculate Reported(4) and Adjusted(2) diluted EPS were
5,705 million shares. For the third quarter of 2023, basic
weighted-average shares outstanding of 5,646 million were used to
calculate Reported(4) and Adjusted(2) diluted LPS.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2024 vs.
Third-Quarter 2023)
Third-quarter 2024 revenues totaled $17.7 billion, an increase
of $4.2 billion, or 31%, compared to the prior-year quarter,
reflecting an operational increase of $4.3 billion, or 32%,
primarily due to growth contributions from Paxlovid as well as
several of our acquired products, key in-line products, and recent
commercial launches, partially offset by an unfavorable impact of
foreign exchange of $133 million, or 1%. Excluding contributions
from Paxlovid and Comirnaty(3), revenues totaled $13.6 billion, an
increase of $1.7 billion, or 14%, operationally compared with the
prior-year quarter.
Third-quarter 2024 Paxlovid revenues of $2.7 billion increased
$2.5 billion operationally compared with the prior-year quarter,
primarily due to strong demand, particularly in the U.S., driven by
higher utilization during a recent global COVID-19 wave; the
one-time contractual delivery of one million treatment courses to
the U.S. Strategic National Stockpile in the third quarter of 2024
that accounted for $442 million in revenue; and no U.S. sales in
the prior-year quarter in anticipation of the transition to
commercial markets in November 2023.
Third-quarter 2024 Comirnaty(3) revenues of $1.4 billion
increased $119 million, or 9%, operationally compared with the
prior-year quarter, driven primarily by timing of stocking as a
result of earlier approval of the new variant vaccine in the U.S.
in 2024 compared to 2023, partially offset by lower contractual
deliveries and demand in international markets.
Excluding contributions from Comirnaty(3) and Paxlovid,
third-quarter 2024 operational revenue growth was driven primarily
by:
- Global revenues of $854 million from legacy Seagen, which was
acquired in December of 2023;
- Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 63%
operationally, driven largely by continued strong demand, primarily
in the U.S. and international developed markets;
- Eliquis globally, up 9% operationally, driven primarily by
continued oral anti-coagulant adoption and market share gains in
the non-valvular atrial fibrillation indication in the U.S. and
certain markets in Europe, partially offset by declines due to loss
of patent-based exclusivity and generic competition in certain
international markets;
- Xtandi, up 28% operationally, driven primarily by strong demand
due to uptake of the non-metastatic castration-sensitive prostate
cancer (nmCSPC) indication following approval in the fourth quarter
of 2023; and
- Nurtec ODT/Vydura globally, up 45% operationally, driven
primarily by strong demand in the U.S. and, to a much lesser
extent, recent launches in international markets;
partially offset primarily by lower revenues for:
- Xeljanz globally, down 35% operationally, driven primarily by
decreased prescription volumes globally resulting from ongoing
shifts in prescribing patterns related to label changes, as well as
lower net price in the U.S. and the impact of regulatory
exclusivity expiry in Canada; and
- Ibrance globally, down 12% operationally, driven primarily by
lower demand due to competitive pressure globally and price
decreases in certain international developed markets, partially
offset by increased clinical trial supply orders in certain
international developed markets versus prior year.
GAAP Reported(4) Statement of Operations Highlights
SELECTED REPORTED(4) COSTS AND EXPENSES
($ in millions)
Third-Quarter
Nine Months
2024
2023
% Change
2024
2023
% Change
Total
Oper.
Total
Oper.
Cost of Sales(4)
$ 5,263
$ 9,269
(43%)
(43%)
$ 11,942
$ 17,391
(31%)
(30%)
Percent of Revenues
29.7%
68.7%
N/A
N/A
26.0%
38.7%
N/A
N/A
SI&A Expenses(4)
3,244
3,281
(1%)
—
10,456
10,196
3%
3%
R&D Expenses(4)
2,598
2,711
(4%)
(4%)
7,787
7,864
(1%)
(1%)
Acquired IPR&D Expenses(4)
13
67
(80%)
(80%)
20
122
(84%)
(84%)
Other (Income)/Deductions—net(4)
243
181
34%
57%
2,030
381
*
*
Effective Tax Rate on Reported(4)
Income/(Loss)
5.0%
28.8%
4.9%
(6.2%)
* Indicates calculation not meaningful or
results are greater than 100%.
Third-quarter 2024 Cost of Sales(4) as a percentage of revenues
decreased by 39.0 percentage points compared to the prior-year
quarter, driven primarily by the non-recurrence of a non-cash
charge of $5.6 billion recorded in the third quarter of 2023 for
inventory write-offs and related charges ($4.7 billion for Paxlovid
and $0.9 billion for Comirnaty(3)).
Third-quarter 2024 SI&A Expenses(4) were relatively flat
operationally compared with the prior-year quarter, reflecting a
decrease due to lower U.S. healthcare reform fees primarily related
to Paxlovid and Comirnaty(3), largely offset by an increase in
spending related to marketing and promotional expenses for recently
launched and acquired products.
Third-quarter 2024 R&D Expenses(4) decreased 4%
operationally compared with the prior-year quarter, driven
primarily by lower spending on certain ongoing vaccine programs
and, to a lesser extent, lower spending as a result of our cost
realignment program, partially offset by a net increase in spending
mainly to develop certain product candidates acquired from
Seagen.
The unfavorable period-over-period change in Other
deductions—net(4) of $62 million for the third quarter of 2024,
compared with the prior-year quarter, was driven primarily by
higher net interest expense and a charge in the third quarter of
2024 related to the expected sale of one of our facilities
resulting from the discontinuation of our Duchenne muscular
dystrophy (DMD) program, partially offset by net gains on equity
securities in the third quarter of 2024 versus net losses on equity
securities in the prior-year quarter.
Pfizer’s effective tax rate on Reported(4) income for the third
quarter of 2024 is primarily a result of its jurisdictional mix of
earnings. Pfizer’s positive effective tax rate for the third
quarter of 2023 reflects a tax benefit on a pre-tax Reported(4)
loss.
Adjusted(2) Statement of Operations Highlights
SELECTED ADJUSTED(2) COSTS AND EXPENSES
($ in millions)
Third-Quarter
Nine Months
2024
2023
% Change
2024
2023
% Change
Total
Oper.
Total
Oper.
Adjusted(2) Cost of Sales
$ 4,874
$ 8,906
(45%)
(45%)
$ 10,678
$ 16,723
(36%)
(35%)
Percent of Revenues
27.5%
66.0%
N/A
N/A
23.3%
37.2%
N/A
N/A
Adjusted(2) SI&A Expenses
3,219
3,205
—
1%
10,342
9,974
4%
4%
Adjusted(2) R&D Expenses
2,561
2,679
(4%)
(4%)
7,708
7,797
(1%)
(1%)
Adjusted(2) Other
(Income)/Deductions—net
243
(128)
*
*
797
(730)
*
*
Effective Tax Rate on Adjusted(2)
Income/(Loss)
10.8%
22.3%
13.3%
10.4%
* Indicates calculation not meaningful or
results are greater than 100%.
See the reconciliations of certain Reported(4) to non-GAAP
Adjusted(2) financial measures and associated footnotes in the
financial tables section of this press release located at the
hyperlink below.
RECENT NOTABLE DEVELOPMENTS (Since July 30, 2024)
Product Developments
Product/Project
Recent Development
Link
Abrysvo
(respiratory syncytial virus
vaccine)
October 2024. Announced the U.S.
Food and Drug Administration (FDA) approved Abrysvo for the
prevention of lower respiratory tract disease (LRTD) caused by
respiratory syncytial virus (RSV) in individuals 18 through 59
years of age who are at increased risk for LRTD caused by RSV.
Abrysvo now offers the broadest RSV vaccine indication for adults,
which previously included those 60 years and older. Additionally,
it remains the only RSV immunization approved for pregnant
individuals at 32 through 36 weeks of gestation to protect infants
from birth up to 6 months of age.
Full Release
August 2024. Announced positive
top-line safety and immunogenicity results from substudy B of the
pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV
IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness),
evaluating two doses of Abrysvo vaccine in immunocompromised adults
aged 18 and older at risk of developing severe RSV-associated LRTD.
Results showed Abrysvo was well-tolerated and generated strong
neutralizing responses after a single 120 µg dose in adults ≥ 18
years of age.
Full Release
Braftovi (encorafenib) +
Mektovi (binimetinib)
September 2024. Presented
longer-term follow-up results from the Phase 2 single-arm PHAROS
clinical trial evaluating the efficacy and safety of Braftovi in
combination with Mektovi for patients with BRAF V600E-mutant
metastatic non-small cell lung cancer (NSCLC) at the European
Society for Medical Oncology (ESMO) Congress 2024, in which the
combination of Braftovi + Mektovi continued to show substantial
antitumor activity after a minimum follow up of approximately three
years, and while there are no head-to-head studies, this
corresponds to the longest duration of response and
progression-free survival in treatment-naïve patients compared to
historical outcomes.
Full Release
Comirnaty(3)
(COVID-19 Vaccine,
mRNA)
September 2024. Announced the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recommended marketing authorization
for Pfizer and BioNTech’s Omicron KP.2-adapted monovalent COVID-19
vaccine (Comirnaty KP.2) for active immunization to prevent
COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and
older. Subsequently, the European Commission (EC) authorized the
vaccine on September 27, 2024.
Full Release
August 2024. Announced the FDA
approved the supplemental Biologics License Application for Pfizer
and BioNTech’s Comirnaty(3) for individuals 12 years of age and
older and granted emergency use authorization for individuals 6
months through 11 years of age both for the companies’ Omicron
KP.2-adapted 2024-2025 Formula COVID-19 vaccine.
Full Release
Eliquis
(apixaban)
August 2024. Announced the U.S.
Department of Health and Human Services released the “maximum fair
price” (MFP) for Eliquis, which was selected in the first round of
government price setting as part of the Inflation Reduction Act
(IRA). The imposed MFP for a 30-day equivalent supply of Eliquis,
which is the price that Medicare will pay for Eliquis as of January
1, 2026, is $231.
Full Release
Hympavzi
(marstacimab-hncq)
October 2024. Announced the FDA
approved Hympavzi for routine prophylaxis to prevent or reduce the
frequency of bleeding episodes in adults and pediatric patients 12
years of age and older with hemophilia A (congenital factor VIII
deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B
(congenital factor IX deficiency) without factor IX (FIX)
inhibitors. Hympavzi is Pfizer’s second hemophilia treatment to
receive FDA approval this year.
Full Release
September 2024. Announced the CHMP
of the EMA adopted a positive opinion for marstacimab for the
routine prophylaxis of bleeding episodes in adults and adolescents
12 years and older with severe hemophilia A (congenital factor VIII
[FVIII] deficiency, FVIII <1%) without FVIII inhibitors, or
severe hemophilia B (congenital factor IX [FIX] deficiency, FIX
<1%) without FIX inhibitors.
Full Release
Oxbryta (voxelotor)
September 2024. Announced the
voluntary withdrawal of all lots of Oxbryta for the treatment of
sickle cell disease (SCD) in all markets where it is approved.
Pfizer is also discontinuing all active voxelotor clinical trials
and expanded access programs worldwide. The decision is based on
the totality of clinical data that now indicates the overall
benefit of Oxbryta no longer outweighs the risk in the approved
sickle cell patient population. The data suggest an imbalance in
vaso-occlusive crises and fatal events, which requires further
assessment.
Full Release
Prevnar 20
(20-valent pneumococcal
conjugate vaccine)
October 2024. Announced the U.S.
Centers for Disease Control and Prevention’s (CDC) Advisory
Committee on Immunization Practice (ACIP) voted to expand its
recommendation for the use of certain pneumococcal vaccines,
including Prevnar 20 for all adults aged 50 and older and for
adults aged 19-49 years with certain underlying conditions or risk
factors who have not received a pneumococcal conjugate vaccine
(PCV) or whose vaccination history is unknown. This recommendation
is pending final approval by the director of the CDC and the
Department of Health and Human Services.
Full Release
Talzenna (talazoparib)
October 2024. Announced positive
topline results from the final prespecified overall survival (OS)
analysis of the TALAPRO-2 study of Talzenna, an oral poly
ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi
(enzalutamide), an androgen receptor pathway inhibitor (ARPI), in
patients with metastatic castration-resistant prostate cancer
(mCRPC). Results showed a statistically significant and clinically
meaningful improvement in the final OS in all-comers (cohort 1) as
well as in those patients with homologous recombination repair
(HRR) gene-mutated mCRPC (cohort 2), compared to Xtandi alone.
These data will be shared with global health authorities and
detailed results submitted for presentation at an upcoming medical
congress.
Full Release
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was
published today and is now available at
www.pfizer.com/science/drug-product-pipeline. It includes an
overview of Pfizer’s research and a list of compounds in
development with targeted indication and phase of development, as
well as mechanism of action for some candidates in Phase 1 and all
candidates from Phase 2 through registration.
Product/Project
Recent Development
Link
Combination COVID-19 and
Influenza vaccine candidate
August 2024. Announced Phase 3
top-line results for Pfizer and BioNTech’s combination mRNA vaccine
candidate against influenza and COVID-19 in healthy individuals
18-64 years of age. The trial did not meet one of its primary
immunogenicity objectives of non-inferiority against the influenza
B strain despite obtaining higher influenza A responses and
comparable COVID-19 responses versus the comparator vaccines. The
companies are evaluating adjustments to the candidate and are
discussing next steps with health authorities.
Full Release
ponsegromab
September 2024. Presented data from
the Phase 2 study of ponsegromab, a monoclonal antibody directed
against growth differentiation factor-15 (GDF-15), in people with
cancer cachexia and elevated levels of GDF-15 at ESMO Congress
2024. The data were also simultaneously published in The New
England Journal of Medicine. The study met its primary endpoint of
change from baseline in body weight for ponsegromab compared to
placebo across all ponsegromab doses tested, reaching 5.6% mean
increase at the highest dose evaluated at 12 weeks. At the highest
dose evaluated, improvements were seen from baseline in appetite
and cachexia symptoms, physical activity, and muscle mass.
Ponsegromab was generally considered safe and well-tolerated at all
dose levels in the study. Pfizer is discussing late-stage
development plans with regulators with the goal of starting
registration-enabling studies in 2025. Ponsegromab is also being
investigated in a Phase 2 study in patients with heart failure and
elevated serum GDF-15 concentrations (NCT05492500).
Full Release
Trivalent Influenza vaccine
candidate
August 2024. Announced data from a
Phase 2 trial with second-generation trivalent (tIRV) influenza
mRNA vaccine candidates which showed encouraging data demonstrating
robust immunogenicity in individuals 18-64 years of age. The tIRV
formulations elicited robust influenza A and B responses, including
continued trend of higher influenza A responses versus a licensed
influenza vaccine. No safety signals were reported in the trial.
Pfizer will continue to evaluate its influenza vaccine program and
discuss next steps with health authorities.
Full Release
VLA15
(Lyme vaccine
candidate)
September 2024. Valneva and Pfizer
announced positive immunogenicity and safety data from a Phase 2
study following a second booster vaccination of their Lyme disease
vaccine candidate, VLA15, given one year after receiving the first
booster dose. The immune response and safety profile of VLA15 one
month after receiving the second booster dose were similar to those
reported after receiving the first booster dose, showing
compatibility with the anticipated benefit of a booster vaccination
prior to each Lyme season. There are currently no approved human
vaccines for Lyme disease, and VLA15 is the Lyme disease vaccine
candidate which has advanced the furthest along the clinical
development timeline, with two Phase 3 trials in progress.
Full Release
Corporate Developments
Topic
Recent Development
Link
Board Election
October 2024. Announced Tim Buckley
was elected to Pfizer’s Board of Directors. Mr. Buckley was also
appointed to and will join the Governance and Sustainability
Committee and the Audit Committee of Pfizer’s Board of
Directors.
Full Release
Haleon Stock Sale
October 2024. Pfizer sold 640
million ordinary shares of its investment in Haleon to
institutional investors and sold 60.5 million Haleon ordinary
shares directly to Haleon for total net consideration of
approximately $3.5 billion. After the share sale, Pfizer’s
ownership interest in Haleon was reduced from approximately 23% to
approximately 15%.
N/A
“PfizerForAll”
August 2024. Introduced
PfizerForAll™, a user-friendly digital platform designed to make
access to healthcare and managing health and wellness more seamless
for people across the U.S. The new, end-to-end experience will
support Americans affected by common illnesses like migraine,
COVID-19 or flu and those seeking to protect themselves with adult
vaccinations. By bringing together critical resources and services
into a single destination, PfizerForAll helps individuals and their
families cut down on the time and steps needed to take important
health actions like getting care, filling prescriptions, and
finding potential savings on Pfizer medicines.
Full Release
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/Q3-2024-PFE-Earnings-Release
(Note: If clicking on the above link does not open a new
webpage, you may need to cut and paste the above URL into your
browser's address bar.)
For additional details, see the attached financial schedules
and product revenue tables attached to the press release located at
the hyperlink above, and the attached disclosure notice.
(1)
Pfizer does not provide guidance
for GAAP Reported financial measures (other than revenues) or a
reconciliation of forward-looking non-GAAP financial measures to
the most directly comparable GAAP Reported financial measures on a
forward-looking basis because it is unable to predict with
reasonable certainty the ultimate outcome of unusual gains and
losses, certain acquisition-related expenses, gains and losses from
equity securities, actuarial gains and losses from pension and
postretirement plan remeasurements, potential future asset
impairments and pending litigation without unreasonable effort.
These items are uncertain, depend on various factors, and could
have a material impact on GAAP Reported results for the guidance
period.
Financial guidance for full-year
2024 reflects the following:
- Does not assume the completion of any business development
transactions not completed as of September 29, 2024.
- An anticipated immaterial impact in fiscal-year 2024 of recent
and expected generic and biosimilar competition for certain
products that have recently lost patent or regulatory protection or
that are anticipated to lose patent or regulatory protection.
- Exchange rates assumed are a blend of actual rates in effect
through third-quarter 2024 and mid-October 2024 rates for the
remainder of the year. Financial guidance reflects the anticipated
unfavorable impact of approximately $0.3 billion on revenues and no
impact on Adjusted(2) diluted EPS as a result of changes in foreign
exchange rates relative to the U.S. dollar compared to foreign
exchange rates from 2023.
- Guidance for Adjusted(2) diluted EPS assumes diluted
weighted-average shares outstanding of approximately 5.7 billion
shares, and assumes no share repurchases in 2024.
- Guidance assumes the seasonal cadence of certain products in
our portfolio, and that Paxlovid results trend with infection
rates.
(2)
Adjusted income/(loss) and
Adjusted diluted EPS/(LPS) are defined as U.S. GAAP net
income/(loss) attributable to Pfizer Inc. common shareholders and
U.S. GAAP diluted EPS/(LPS) attributable to Pfizer Inc. common
shareholders before the impact of amortization of intangible
assets, certain acquisition-related items, discontinued operations
and certain significant items. See the reconciliations of certain
GAAP Reported to Non-GAAP Adjusted information for the third
quarter and the first nine months of 2024 and 2023 in the press
release located at the hyperlink above. Adjusted income/(loss) and
its components and Adjusted diluted EPS/(LPS) measures are not, and
should not be viewed as, substitutes for U.S. GAAP net
income/(loss) and its components and diluted EPS/(LPS)(4). See the
Non-GAAP Financial Measure: Adjusted Income section of Management’s
Discussion and Analysis of Financial Condition and Results of
Operations in Pfizer’s 2023 Annual Report on Form 10-K and the
accompanying Non-GAAP Financial Measure: Adjusted Income/(Loss)
section of the press release located at the hyperlink above for a
definition of each component of Adjusted income/(loss) as well as
other relevant information.
(3)
As used in this document,
“Comirnaty” refers to, as applicable, and as authorized or
approved, the Pfizer-BioNTech COVID-19 Vaccine; Comirnaty (COVID-19
Vaccine, mRNA) original monovalent formula; the Pfizer-BioNTech
COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5); the
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula); Comirnaty
(COVID-19 Vaccine, mRNA) 2023-2024 Formula; Comirnaty (COVID-19
Vaccine, mRNA) 2024-2025 Formula; Comirnaty Original/Omicron BA.1;
Comirnaty Original/Omicron BA.4/BA.5; Comirnaty Omicron XBB.1.5;
Comirnaty JN.1 and Comirnaty KP.2. “Comirnaty” includes product
revenues and alliance revenues related to sales of the
above-mentioned vaccines.
(4)
Revenues is defined as revenues
in accordance with U.S. generally accepted accounting principles
(GAAP). Reported net income/(loss) and its components are defined
as net income/(loss) attributable to Pfizer Inc. common
shareholders and its components in accordance with U.S. GAAP.
Reported diluted earnings per share (EPS) and reported diluted loss
per share (LPS) are defined as diluted EPS or LPS attributable to
Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(5)
The targeted $4 billion in net
cost savings is calculated versus the midpoint of Pfizer’s 2023
SI&A and R&D expense guidance provided on August 1, 2023.
As an additional reference, see the ‘2024 Financial Guidance’
section of Pfizer’s fourth-quarter 2023 earnings release.
(6)
References to operational
variances in this press release pertain to period-over-period
changes that exclude the impact of foreign exchange rates. Although
foreign exchange rate changes are part of Pfizer’s business, they
are not within Pfizer’s control and because they can mask positive
or negative trends in the business, Pfizer believes presenting
operational variances excluding these foreign exchange changes
provides useful information to evaluate Pfizer’s results.
(7)
Pfizer’s fiscal year-end for
international subsidiaries is November 30 while Pfizer’s fiscal
year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s
third quarter and first nine months for U.S. subsidiaries reflects
the three and nine months ended on September 29, 2024 and October
1, 2023, while Pfizer’s third quarter and first nine months for
subsidiaries operating outside the U.S. reflects the three and nine
months ended on August 25, 2024 and August 27, 2023.
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is
as of October 29, 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; expectations for our product
pipeline, in-line products and product candidates, including
anticipated regulatory submissions, data read-outs, study starts,
approvals, launches, clinical trial results and other developing
data, revenue contribution and projections, potential pricing and
reimbursement, potential market dynamics, including demand, market
size and utilization rates and growth, performance, timing of
exclusivity and potential benefits; strategic reviews; capital
allocation objectives; an enterprise-wide cost realignment program,
which we launched in October 2023 (including anticipated costs,
savings and potential benefits); a Manufacturing Optimization
Program to reduce our cost of goods sold, which we announced in May
2024 (including anticipated costs, savings and potential benefits);
dividends and share repurchases; plans for and prospects of our
acquisitions, dispositions and other business development
activities, including our December 2023 acquisition of Seagen, and
our ability to successfully capitalize on growth opportunities and
prospects; manufacturing and product supply; our ongoing efforts to
respond to COVID-19, including our plans and expectations regarding
Comirnaty (as defined in this earnings release) and our oral
COVID-19 treatment (Paxlovid); our expectations regarding the
impact of COVID-19 on our business, operations and financial
results; and our Environmental, Social and Governance (ESG)
priorities, strategies and goals. Given their forward-looking
nature, these statements involve substantial risks, uncertainties
and potentially inaccurate assumptions and we cannot assure that
any outcome expressed in these forward-looking statements will be
realized in whole or in part. You can identify these statements by
the fact that they use future dates or use words such as “will,”
“may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,”
“expect,” “project,” “intend,” “plan,” “believe,” “assume,”
“target,” “forecast,” “guidance,” “goal,” “objective,” “aim,”
“seek,” “potential,” “hope” and other words and terms of similar
meaning. Pfizer’s financial guidance is based on estimates and
assumptions that are subject to significant uncertainties.
Among the factors that could cause actual results to differ
materially from past results and future plans and projected future
results are the following:
Risks Related to Our Business, Industry
and Operations, and Business Development:
- the outcome of research and development (R&D) activities,
including, the ability to meet anticipated pre-clinical or clinical
endpoints, commencement and/or completion dates for our
pre-clinical or clinical trials, regulatory submission dates,
and/or regulatory approval and/or launch dates; the possibility of
unfavorable pre-clinical and clinical trial results, including the
possibility of unfavorable new pre-clinical or clinical data and
further analyses of existing pre-clinical or clinical data; risks
associated with preliminary, early stage or interim data; the risk
that pre-clinical and clinical trial data are subject to differing
interpretations and assessments, including during the peer
review/publication process, in the scientific community generally,
and by regulatory authorities; whether and when additional data
from our pipeline programs will be published in scientific journal
publications and, if so, when and with what modifications and
interpretations; and uncertainties regarding the future development
of our product candidates, including whether or when our product
candidates will advance to future studies or phases of development
or whether or when regulatory applications may be filed for any of
our product candidates;
- our ability to successfully address comments received from
regulatory authorities such as the FDA or the EMA, or obtain
approval for new products and indications from regulators on a
timely basis or at all;
- regulatory decisions impacting labeling, 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 conduct or outcome of
post-approval clinical trials, pharmacovigilance or Risk Evaluation
and Mitigation Strategies, which could impact marketing approval,
product labeling, and/or availability or commercial potential;
- the success and impact of external business development
activities, such as the December 2023 acquisition of Seagen,
including the ability to identify and execute on potential business
development opportunities; the ability to satisfy the conditions to
closing of announced transactions in the anticipated time frame or
at all; the ability to realize the anticipated benefits of any such
transactions in the anticipated time frame or at all; the potential
need for and impact of additional equity or debt financing to
pursue these opportunities, which has in the past and could in the
future result in increased leverage and/or a downgrade of our
credit ratings and could limit our ability to obtain future
financing; challenges integrating the businesses and operations;
disruption to business and operations relationships; risks related
to growing revenues for certain acquired or partnered products;
significant transaction costs; and unknown liabilities;
- competition, including from new product entrants, in-line
branded products, generic products, private label products,
biosimilars and product candidates that treat or prevent diseases
and conditions similar to those treated or intended to be prevented
by our in-line products and product candidates;
- the ability to successfully market both new and existing
products, including biosimilars;
- difficulties or delays in manufacturing, sales or marketing;
supply disruptions, shortages or stock-outs at our facilities or
third-party facilities that we rely on; and legal or regulatory
actions;
- the impact of public health outbreaks, epidemics or pandemics
(such as COVID-19) on our business, operations and financial
condition and results, including impacts on our employees,
manufacturing, supply chain, sales and marketing, R&D and
clinical trials;
- risks and uncertainties related to our efforts to continue to
develop and commercialize Comirnaty and Paxlovid or any potential
future COVID-19 vaccines, treatments or combinations, as well as
challenges related to their manufacturing, supply and distribution,
including, among others, the risk that as the market for COVID-19
products continues to become more endemic and seasonal, demand for
our COVID-19 products has and may continue to be reduced or not
meet expectations, 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, resulted
in significant inventory write-offs in 2023 and could continue to
result in inventory write-offs, or other unanticipated charges;
risks related to our ability to develop and commercialize variant
adapted vaccines; challenges related to the transition to the
commercial market for our COVID-19 products; uncertainties related
to the public’s adherence to vaccines, boosters, treatments or
combinations; risks related to our ability to accurately predict or
achieve our revenue forecasts for Comirnaty and Paxlovid or any
potential future COVID-19 vaccines or treatments; and potential
third-party royalties or other claims related to Comirnaty or
Paxlovid;
- trends toward managed care and healthcare cost containment, and
our ability to obtain or maintain timely or adequate pricing or
favorable formulary placement for our products;
- interest rate and foreign currency exchange rate fluctuations,
including the impact of currency devaluations and monetary policy
actions in countries experiencing high inflation or deflation
rates;
- any significant issues involving our largest wholesale
distributors or government customers, which account for a
substantial portion of our revenues;
- the impact of the increased presence of counterfeit medicines,
vaccines or other products in the pharmaceutical supply chain;
- any significant issues related to the outsourcing of certain
operational and staff functions to third parties;
- any significant issues related to our JVs and other third-party
business arrangements, including modifications or disputes related
to supply agreements or other contracts with customers including
governments or other payors;
- uncertainties related to general economic, political, business,
industry, regulatory and market conditions including, without
limitation, uncertainties related to the impact on us, our
customers, suppliers and lenders and counterparties to our
foreign-exchange and interest-rate agreements of challenging global
economic conditions, such as inflation or interest rate
fluctuations, and recent and possible future changes in global
financial markets;
- the exposure of our operations globally to possible capital and
exchange controls, economic conditions, expropriation, sanctions
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, such as our ongoing evaluation of our
product portfolio for the potential presence or formation of
nitrosamines, and our voluntary withdrawal of all lots of Oxbryta
in all markets where it is approved and any potential regulatory or
other impact on other sickle cell disease assets;
- trade buying patterns;
- the risk of an impairment charge related to our intangible
assets, goodwill or equity-method investments;
- the impact of, and risks and uncertainties related to,
restructurings and internal reorganizations, as well as any other
corporate strategic initiatives and growth strategies, and
cost-reduction and productivity initiatives, including any
potential future phases, each of which requires upfront costs but
may fail to yield anticipated benefits and may result in unexpected
costs, organizational disruption, adverse effects on employee
morale, retention issues or other unintended consequences;
- the ability to successfully achieve our climate goals and
progress our environmental sustainability and other ESG
priorities;
Risks Related to Government Regulation and
Legal Proceedings:
- the impact of any U.S. healthcare reform or legislation or any
significant spending reduction or cost control efforts affecting
Medicare, Medicaid 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 legal
proceedings and actual or alleged environmental contamination;
- the risk and impact of an adverse decision or settlement and
risk related to the adequacy of reserves related to legal
proceedings;
- the risk and impact of tax related litigation and
investigations;
- governmental laws and regulations affecting our operations,
including, without limitation, the Inflation Reduction Act of 2022,
changes in laws and regulations or their interpretation, including,
among others, changes in tax laws and regulations internationally
and in the U.S., the adoption of global minimum taxation
requirements outside the U.S. generally effective in most
jurisdictions since January 1, 2024, and potential changes to
existing tax laws following the November 2024 U.S. elections;
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,
which may include those using adversarial artificial intelligence
techniques, or other malfeasance by, but not limited to, nation
states, employees, business partners or others;
- risks and challenges related to the use of software and
services that include artificial intelligence-based functionality
and other emerging technologies;
- 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 patent
revocation; (ii) claims of patent infringement, including asserted
and/or unasserted intellectual property claims; (iii) claims we may
assert against intellectual property rights held by third parties;
(iv) challenges faced by our collaboration or licensing partners to
the validity of their patent rights; or (v) any pressure, or legal
or regulatory action by, various stakeholders or governments that
could potentially result in us not seeking intellectual property
protection or agreeing not to enforce or being restricted from
enforcing intellectual property rights related to our products,
including Comirnaty and Paxlovid.
Should known or unknown risks or uncertainties materialize or
should underlying assumptions prove inaccurate, actual results
could vary materially from past results and those anticipated,
estimated or projected. Investors are cautioned not to put undue
reliance on forward-looking statements. A further list and
description of risks, uncertainties and other matters can be found
in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2023 and in our subsequent reports on Form 10-Q, in
each case including in the sections thereof captioned
“Forward-Looking Information and Factors That May Affect Future
Results” and “Item 1A. Risk Factors,” and in our subsequent reports
on Form 8-K.
This earnings release may include discussion of certain clinical
studies relating to various in-line products and/or product
candidates. These studies typically are part of a larger body of
clinical data relating to such products or product candidates, and
the discussion herein should be considered in the context of the
larger body of data. In addition, clinical trial data are subject
to differing interpretations, and, even when we view data as
sufficient to support the safety and/or effectiveness of a product
candidate or a new indication for an in-line product, regulatory
authorities may not share our views and may require additional data
or may deny approval altogether.
The information contained on our website or any third-party
website is not incorporated by reference into this earnings
release. All trademarks mentioned are the property of their
owners.
Certain of the products and product candidates discussed in this
earnings release are being co-researched, co-developed and/or
co-promoted in collaboration with other companies for which
Pfizer’s rights vary by market or are the subject of agreements
pursuant to which Pfizer has commercialization rights in certain
markets.
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