- Full-Year 2022 Revenues of $100.3 Billion, An All-Time High for
Pfizer, Reflecting 30% Operational Growth
- Excluding Contributions from Paxlovid and Comirnaty(1),
Revenues Grew 2% Operationally
- Strong Fourth-Quarter 2022 Revenues of $24.3 Billion,
Reflecting 13% Operational Growth
- Excluding Contributions from Paxlovid and Comirnaty(1),
Revenues Grew 5% Operationally
- Full-Year 2022 Reported Diluted EPS(2) of $5.47, Up 42%
Year-Over-Year, and Adjusted Diluted EPS(3) of $6.58, Up 62%
Year-Over-Year, Both of Which Represent All-Time Highs for
Pfizer
- Fourth-Quarter 2022 Reported Diluted EPS(2) of $0.87, Up 48%
Year-Over-Year, and Adjusted Diluted EPS(3) of $1.14, Up 45%
Year-Over-Year
- Includes a $0.32 Benefit from Lower Acquired IPR&D Expenses
Compared to Fourth-Quarter 2021
- Provides Full-Year 2023 Revenue Guidance(4) of $67.0 to $71.0
Billion and Adjusted Diluted EPS(3) Guidance of $3.25 to $3.45
- Full-Year 2023 Revenues Excluding COVID-19 Products Expected to
Grow 7% to 9% Operationally Compared to Full-Year 2022
- Full-Year 2023 Revenue Guidance for Comirnaty(1) of ~$13.5
Billion and Paxlovid of ~$8 Billion
- Revenues from COVID-19 Products Expected to Grow in 2024 After
Reaching a Low Point in 2023 Due to Significant Government Supply
on Hand to Start the Year
- Company Plans to Make Significant Incremental Investments in
2023 to Support Launch Products and R&D Projects that are
Expected to Drive its Long-Term Growth Ambitions
- Continues to Make Progress on Pfizer’s Unprecedented Number of
Anticipated Launches of New Products and Indications, Including
Recent Regulatory Filing Acceptances for Prevnar 20 Pediatric, its
RSV Vaccine for Older Adults, Etrasimod, and its Pentavalent
Meningococcal Vaccine
Pfizer Inc. (NYSE: PFE) reported exceptional financial results
for fourth-quarter and full-year 2022 and provided 2023 financial
guidance(4).
The fourth-quarter 2022 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:
“2022 was a record-breaking year for Pfizer, not only in terms of
revenue and earnings per share, which were the highest in our long
history, but more importantly, in terms of the percentage of
patients who have a positive perception of Pfizer and the work we
do. As proud as we are about what we have accomplished, our focus
is always on what is next. As we turn to 2023, we expect to once
again set records, with potentially the largest number of new
product and indication launches that we’ve ever had in such a short
period of time. We believe that the combination of these expected
near-term launches, additional pipeline products that could
potentially come to market in the medium-term, and anticipated
contributions from business development, has the potential to set
the company up for continued robust growth through the rest of this
decade and beyond.”
David Denton, Chief Financial Officer and Executive Vice
President, stated: “I am very pleased with our fourth-quarter
performance, which was highlighted by strong operational growth
from Paxlovid, Prevnar 20, Comirnaty, Vyndaqel and Eliquis, as well
as the inclusion of Nurtec ODT/Vydura and Oxbryta. For the
full-year, we achieved revenues of over $100 billion, including 10
medicines or vaccines that generated revenues of more than $1
billion each, and all of this was accomplished despite operating in
an environment in which foreign exchange reduced our revenues by
7%. Looking forward to 2023, we expect strong topline growth of 7%
to 9% excluding our COVID-19 products and anticipated foreign
exchange impacts. We are also increasing our investments behind our
launch products and pipeline in order to help realize our growth
goals for 2023 and beyond.”
Results for the fourth-quarter and full-year 2022 and 2021(5)
are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts)
Fourth-Quarter
Full-Year
2022
2021
Change
2022
2021
Change
Revenues
$
24,290
$
23,838
2
%
$
100,330
$
81,288
23
%
Reported Net Income(2)
4,995
3,393
47
%
31,372
21,979
43
%
Reported Diluted EPS(2)
0.87
0.59
48
%
5.47
3.85
42
%
Adjusted Income(3)
6,551
4,543
44
%
37,717
23,196
63
%
Adjusted Diluted EPS(3)
1.14
0.79
45
%
6.58
4.06
62
%
REVENUES
($ in millions)
Fourth-Quarter
Full-Year
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Global Biopharmaceuticals Business
(Biopharma)(6)
$
23,922
$
23,456
2
%
13
%
$
98,988
$
79,557
24
%
31
%
Primary Care(6)
17,348
16,225
7
%
20
%
73,023
52,029
40
%
49
%
Specialty Care(6)
3,566
3,989
(11
%)
(3
%)
13,833
15,194
(9
%)
(4
%)
Oncology(6)
3,007
3,242
(7
%)
(3
%)
12,132
12,333
(2
%)
2
%
Pfizer CentreOne
$
368
$
382
(4
%)
1
%
$
1,342
$
1,731
(22
%)
(19
%)
TOTAL REVENUES
$
24,290
$
23,838
2
%
13
%
$
100,330
$
81,288
23
%
30
%
Beginning in the first quarter of 2022, Pfizer implemented
changes to its Adjusted(3) financial measures with respect to
acquired in-process research and development (IPR&D) costs and
amortization of intangibles. More information about these changes
and their impact on the periods presented can be found in the
Non-GAAP Financial Measure: Adjusted Income section of the press
located at the hyperlink below.
Beginning in the third quarter of 2022, Pfizer has made several
organizational changes to further transform its operations to
better leverage its expertise in certain areas and in anticipation
of potential future new product or indication launches. These
changes include establishing a new commercial structure within
Biopharma focused on three broad customer groups (primary care,
specialty care and oncology)(6), optimizing our end-to-end R&D
operations and further prioritizing our internal R&D portfolio,
as well as realigning certain enabling and platform functions
across the organization to ensure alignment with this new operating
structure.
Prior period amounts have been revised to conform to the current
period presentation for all changes discussed above.
Business development activities(7) completed in 2021 and 2022(5)
impacted financial results in the periods presented. 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(8).
2023 FINANCIAL GUIDANCE(4)
Pfizer’s 2023 financial guidance is presented below. This
guidance includes management’s expectations for contributions from
the entire company, including Comirnaty(1) and Paxlovid.
2022 Actual Results
2023 Financial
Guidance
Revenues
$100.3 billion
$67.0 to $71.0 billion
Operational(8) Growth/(Decline) vs. Prior
Year
30%
(33%) to (29%)
Growth/(Decline) vs. Prior Year
23%
(33%) to (29%)
Adjusted(3) Diluted EPS
$6.58
$3.25 to $3.45
Operational(8) Growth/(Decline) vs. Prior
Year
71%
(50%) to (47%)
Growth/(Decline) vs. Prior Year
62%
(51%) to (48%)
The midpoint of the guidance range for revenues reflects a 31%
operational decrease compared to 2022 revenues. Company revenues
are anticipated to be lower in 2023 than in 2022 due entirely to
expected revenue declines for Pfizer’s COVID-19 products.
Excluding COVID-19 products, the Company continues to expect 7%
to 9% operational revenue growth in 2023.
Revenue guidance for Pfizer’s COVID-19 products is as
follows:
- Comirnaty(1) revenues of approximately $13.5 billion, down 64%
from actual 2022 results.
- Paxlovid revenues of approximately $8 billion, down 58% from
actual 2022 results.
- In contrast to previous years, guidance for both products is no
longer based primarily on expected deliveries under existing signed
or committed supply contracts, but now also includes, among other
things, anticipated sales through traditional commercial markets in
the U.S. in the second half of 2023.
The midpoint of the guidance range for Adjusted(3) diluted EPS
reflects a 49% operational decrease compared to 2022, primarily
driven by anticipated lower revenues from COVID-19 products, higher
spending to support anticipated near-term launches and greater
investments in certain late-stage pipeline projects.
Financial guidance for Adjusted diluted EPS(3) is calculated
using approximately 5.75 billion weighted average shares
outstanding, and assumes no share repurchases in 2023.
Other components of Pfizer’s 2023 financial guidance are
presented below.
Adjusted(3) Cost of Sales as a Percentage
of Revenues
28.0% to 30.0%
Adjusted(3) SI&A Expenses
$13.8 to $14.8 billion
Adjusted(3) R&D Expenses
$12.4 to $13.4 billion
Acquired IPR&D Expenses(4)
Approximately $0.1 billion
Adjusted(3) Other (Income)/Deductions
Approximately $1.5 billion of
income
Effective Tax Rate on Adjusted(3)
Income
Approximately 15.0%
Pfizer's 2023 financial guidance is based on estimates and
assumptions which are subject to significant uncertainties,
particularly with regard to the anticipated performance of
Comirnaty(1) and Paxlovid, for which patient demand could be
significantly impacted by the infectiousness and severity of the
predominant strains of the virus during 2023.
Key assumptions incorporated within the guidance follow.
Key Assumptions for 2023
Guidance
Commentary
Operational revenue growth compared to
2022 excluding COVID-19 products
7% to 9%
Growth expected to be split among each of
three categories: launch, acquired and in-line products
Incremental SI&A spend to support
anticipated new launches, acquired assets and commercial launch of
COVID-19 products
~$1.3 billion
Investments to support short- and
long-term growth aspirations
Incremental R&D spend to support
high-value pipeline programs and acquired assets
~$1.5 billion
Includes, among others: GLP-1,
elranatamab, respiratory combination vaccines
Comirnaty - 2023 Guidance
Assumptions
Commentary
Estimated proportion of U.S. population
that receives a vaccine
~24%
Compared to ~31%† in 2022; Decrease due to
fewer primary vaccinations and lower compliance
Estimated number of doses per vaccinated
person per year, on average
~1.3 doses
Compared to ~1.4 doses† in 2022; Decrease
due to fewer primary vaccinations
Estimated Comirnaty market share -
U.S.
~64%
Consistent with share achieved with most
recent bivalent booster in 2022†
Estimated total demand for Comirnaty doses
- U.S. (includes use of existing government supply)
~65 million doses
Compared to ~92 million doses† in 2022
Assumed timing for delivery of the
contracted doses of Comirnaty to the European Commission
Re-phased over multiple years
(not all in 2023)
Negotiations on re-phasing of delivery
timelines are ongoing
Paxlovid - 2023 Guidance
Assumptions
Commentary
Estimated number of total reported
symptomatic infections - global*, excluding China
~112 million
Compared to ~110 million† in 2022;
Increase due to expected waning of population immune protection due
to reduced vaccination rates
Estimated proportion of symptomatic
COVID-19 patients treated with an oral antiviral treatment -
global*, excluding China
~17%
Compared to ~12%† in 2022 (partial year
only); Increase due to greater awareness/education and full-year
implementation
Estimated Paxlovid share of oral antiviral
market - global*, excluding China
~90%
Consistent with share achieved in
2022†
Estimated total demand for Paxlovid -
global*, excluding China (includes use of existing government
supply)
~17 million courses
Compared to ~12 million courses† in 2022
(partial year only); Increase due to broad product availability,
greater awareness/education and full-year implementation
Paxlovid sales to China
Assumes no sales after April 1,
2023
Temporary National Reimbursement Drug List
currently set to end on April 1, 2023
General - 2023 Guidance
Assumption
Commentary
Estimated timing for transitioning
Comirnaty and Paxlovid to commercial market in the U.S.
Second half of 2023
Assumes prior absorption of existing
government supply
* Only includes markets where Paxlovid is available, and only
includes individuals age 12+/18+ where authorized/approved in
accordance with local labeling. † Actual 2022 market data is
derived from a combination of public data sources and internal
market research.
CAPITAL ALLOCATION
During full-year 2022, Pfizer deployed its capital in a variety
of ways, which primarily include the following two broad
categories:
- Reinvesting capital into initiatives intended to enhance the
future growth prospects of the company, including:
- $11.4 billion invested in internal research and development
projects, and
- Approximately $26 billion invested in completed business
development transactions, net of cash acquired, including
approximately $12.7 billion(7) for the acquisition of Biohaven
Pharmaceutical Holding Company Ltd. (Biohaven), $6.4 billion(7) for
the acquisition of Arena Pharmaceuticals, Inc. and approximately
$5.6 billion(7) for the acquisition of Global Blood Therapeutics,
Inc. (GBT).
- Returning capital directly to shareholders through a
combination of:
- $9.0 billion of cash dividends, or $1.60 per share of common
stock, and
- $2.0 billion, which was used to repurchase 39.1 million shares
on the open market in March 2022, at an average cost of $51.10 per
share.
As of January 31, 2023, Pfizer’s remaining share repurchase
authorization is $3.3 billion. Current financial guidance does not
anticipate any share repurchases in 2023.
Fourth-quarter 2022 diluted weighted-average shares outstanding
used to calculate Reported(2) and Adjusted(3) diluted EPS were
5,743 million shares, a decrease of 26 million shares compared to
the prior-year quarter, primarily due to shares repurchased in
first-quarter 2022, partially offset by shares issued for employee
compensation programs.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2022 vs.
Fourth-Quarter 2021)
Fourth-quarter 2022 revenues totaled $24.3 billion, an increase
of $452 million, or 2%, compared to the prior-year quarter,
reflecting operational growth of $3.0 billion, or 13%, as well as
an unfavorable impact of foreign exchange of $2.5 billion, or 11%.
Excluding contributions from Paxlovid and Comirnaty(1), company
revenues grew $571 million, or 5%, operationally.
Fourth-quarter 2022 operational growth was primarily driven
by:
- Comirnaty(1) in developed markets, up 67% operationally, driven
primarily by the resumption of deliveries of the Omicron-adapted
bivalent booster following a previously announced period of
significantly lower deliveries of the original vaccine during
third-quarter 2022, primarily involving the European Union (EU) and
Japan;
- Paxlovid outside the U.S., which contributed $1.8 billion in
revenues, driven by international launches in late 2021 and early
2022 following regulatory approvals or emergency use authorizations
(EUAs);
- Prevnar family (Prevnar 13 & 20) in the U.S., up 79%,
driven primarily by strong patient demand following the launch of
Prevnar 20 for the eligible adult population and favorable timing
of Centers for Disease Control and Prevention (CDC) purchasing of
the pediatric indication, partially offset by a reduction in
revenues due to a one-time CDC inventory return program for the
pediatric indication, the revenue impact of which is expected to be
reversed in 2023 upon replenishment;
- Revenues from recently acquired products, Nurtec ODT/Vydura and
Oxbryta, which contributed $211 million and $73 million in global
revenues, respectively;
- Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 31%
operationally, driven by continued strong uptake of the
transthyretin amyloid cardiomyopathy indication, primarily in
developed Europe and the U.S., partially offset by a planned price
decrease that went into effect in Japan in second-quarter
2022;
- Eliquis in the U.S., up 17%, driven primarily by continued oral
anti-coagulant adoption and market share gains in non-valvular
atrial fibrillation, as well as favorable changes in channel mix;
and
- Prevenar 13 in emerging markets, up 22% operationally, driven
primarily by strong growth in China and favorable timing of sales
to GAVI, the Vaccine Alliance,
partially offset primarily by lower revenues for:
- Comirnaty(1) in emerging markets, down 81% operationally,
primarily due to lower demand for COVID-19 vaccines;
- Xeljanz globally, down 28% operationally, driven primarily by
declines in net price due to unfavorable changes in channel mix in
the U.S. and decreased prescription volumes globally resulting from
ongoing shifts in prescribing patterns related to label
changes;
- Sutent globally, down 50% operationally, primarily driven by
lower volume demand in Europe following its loss of exclusivity in
January 2022;
- Ibrance globally, down 4% operationally, driven primarily by
increases in the proportion of patients accessing Ibrance through
the U.S. Patient Assistance Program, planned price decreases that
recently went into effect in international developed markets and
prior-year clinical trial purchases internationally, partially
offset by higher volumes across multiple regions; and
- Eliquis internationally, down 7% operationally, primarily
driven by declines in certain emerging markets.
GAAP Reported(2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES(2)
($ in millions)
Fourth-Quarter
Full-Year
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Cost of Sales(2)
$
9,648
$
9,736
(1
%)
11
%
$
34,344
$
30,821
11
%
21
%
Percent of Revenues
39.7
%
40.8
%
N/A
N/A
34.2
%
37.9
%
N/A
N/A
SI&A Expenses(2)
4,644
4,104
13
%
17
%
13,677
12,703
8
%
11
%
R&D Expenses(2)
3,615
3,445
5
%
7
%
11,428
10,360
10
%
12
%
Acquired IPR&D Expenses(2)
73
2,469
(97
%)
(97
%)
953
3,469
(73
%)
(73
%)
Other (Income)/Deductions––net(2)
(846
)
(835
)
1
%
13
%
217
(4,878
)
*
*
Effective Tax Rate on Reported
Income(2)
4.4
%
6.5
%
9.6
%
7.6
%
* Indicates calculation not meaningful.
Fourth-quarter 2022 Cost of Sales(2) as a percentage of revenues
decreased 1.1 percentage points compared with the prior-year
quarter. The decrease was primarily driven by favorable changes in
sales mix, including increased sales of Paxlovid and higher
alliance revenues, as well as favorable impacts resulting from
changes in foreign exchange rates, partially offset by
approximately $600 million and approximately $200 million of
inventory write-offs related to Paxlovid and Comirnaty(1),
respectively, and higher operational revenues for Comirnaty(1).
SI&A Expenses(2) increased 17% operationally compared with
the prior-year quarter, primarily reflecting increased investments
to support Paxlovid, Comirnaty(1) and recently acquired and
launched products.
Fourth-quarter 2022 R&D Expenses(2) increased 7%
operationally compared with the prior-year quarter, primarily
driven by increased costs to support various vaccine and oncology
programs, as well as spending related to recently acquired assets,
partially offset by lower spending on programs to treat COVID-19
and certain other late-stage clinical programs.
Acquired IPR&D Expenses(2) decreased 97% operationally
compared with the prior-year quarter. The acquisitions of Biohaven
and GBT in fourth-quarter 2022 qualified as business combinations
under U.S. Generally Accepted Accounting Principles (GAAP),
resulting in no Acquired IPR&D Expenses(2), while the
acquisition of Trillium Therapeutics Inc. in fourth-quarter 2021
was accounted for as an asset acquisition, giving rise to
approximately $2.1 billion in Acquired IPR&D Expenses.
Other income––net(2) increased 13% operationally in
fourth-quarter 2022 compared with fourth-quarter 2021, primarily
driven by net gains on equity securities in fourth-quarter 2022
versus net losses on equity securities recognized in the prior-year
quarter and lower net interest expense, partially offset by lower
net periodic benefit credits associated with pension and
postretirement plans and higher asset impairment charges.
Pfizer’s effective tax rate on Reported income(2) for
fourth-quarter 2022 decreased compared to the prior-year quarter
primarily due to a favorable change in the jurisdictional mix of
earnings and global income tax resolutions, partially offset by the
non-recurrence of tax benefits associated with certain tax
initiatives.
Adjusted(3) Income Statement Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions)
Fourth-Quarter
Full-Year
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Adjusted(3) Cost of Sales
$
9,475
$
9,710
(2
%)
9
%
$
34,096
$
30,685
11
%
20
%
Percent of Revenues
39.0
%
40.7
%
N/A
N/A
34.0
%
37.7
%
N/A
N/A
Adjusted(3) SI&A Expenses
4,414
3,932
12
%
17
%
13,049
12,071
8
%
11
%
Adjusted(3) R&D Expenses
3,610
3,436
5
%
7
%
11,409
10,344
10
%
12
%
Adjusted(3) Other
(Income)/Deductions––net
($656
)
($728
)
(10
%)
2
%
($1,954
)
($2,475
)
(21
%)
(13
%)
Effective Tax Rate on Adjusted
Income(3)
11.1
%
9.5
%
11.7
%
14.5
%
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 2022 vs. Full-Year
2021)
Full-year 2022 revenues totaled $100.3 billion, an increase of
$19.0 billion, or 23%, compared to full-year 2021, reflecting
operational growth of $24.6 billion, or 30%, and an unfavorable
impact of foreign exchange of $5.5 billion, or 7%. Excluding the
revenue growth contributed by Paxlovid and Comirnaty(1), revenues
for the full-year grew 2% operationally. Operational growth
compared to the prior year was driven primarily by:
- Global sales of Paxlovid;
- Strong growth of Comirnaty(1) in developed markets;
- The launch of Prevnar 20 in the U.S. for the adult
population;
- Continued strong growth of Eliquis globally;
- Vyndaqel family globally, partially offset by a planned price
decrease in Japan; and
- Newly acquired products Nurtec ODT/Vydura and Oxbryta,
partially offset primarily by lower revenues for:
- Comirnaty(1) in emerging markets;
- Xeljanz, Chantix and Sutent globally; and
- Ibrance in developed Europe and the U.S.
RECENT NOTABLE DEVELOPMENTS (Since November 1, 2022)
Product Developments
- Comirnaty (COVID-19 vaccine, mRNA)(9)
- Clinical and Research Developments
- In November 2022, Pfizer and BioNTech SE (BioNTech) announced
updated clinical data from a Phase 2/3 clinical trial demonstrating
a robust neutralizing immune response one-month after a 30-µg
booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent
(Original and Omicron BA.4/BA.5)). Immune responses against
BA.4/BA.5 sublineages were substantially higher for those who
received the bivalent vaccine compared to the companies’ original
COVID-19 vaccine, with a similar safety and tolerability profile
between both vaccines.
- In November 2022, Pfizer and BioNTech announced results from an
analysis examining the immune response induced by their Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine against newer Omicron
sublineages, including BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1. These
data were posted on the preprint server bioRxiv and indicate that
the companies’ bivalent vaccine elicits a greater increase in
neutralizing antibody titers than the companies’ original COVID-19
vaccine against these emerging Omicron sublineages.
- In November 2022, Pfizer and BioNTech announced that the
companies have initiated a Phase 1 study to evaluate the safety,
tolerability and immunogenicity of a next-generation COVID-19
vaccine candidate that aims to enhance SARS-CoV-2 T cell responses
and potentially broaden protection against COVID-19. This
candidate, BNT162b4, is composed of a T cell antigen mRNA encoding
for SARS-CoV-2 non-spike proteins that are highly conserved across
a broad range of SARS-CoV-2 variants and will be evaluated in
combination with the companies’ Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine.
- In December 2022, Pfizer and BioNTech announced the companies
have received Fast Track Designation from the U.S. Food and Drug
Administration (FDA) for their mRNA-based combination vaccine
candidate for influenza and COVID-19, which aims to help prevent
two respiratory diseases with a single injection. The vaccine
candidate is based on BioNTech’s proprietary mRNA platform
technology and contains mRNA strands encoding the wild-type spike
protein of SARS-CoV-2 and the spike protein of the Omicron
sublineages BA.4/BA.5, as well as mRNA strands encoding the
hemagglutinin of four different influenza strains, recommended for
the Northern Hemisphere 2022/23 by the World Health Organization. A
Phase 1 trial to examine the safety, tolerability, and
immunogenicity of the combined influenza and COVID-19 candidate
vaccine among healthy adults was initiated in November 2022.
- Regulatory Developments
- In November 2022, Pfizer and BioNTech announced the European
Medicines Agency (EMA) Committee for Medicinal Products for Human
Use (CHMP) recommended marketing authorization for a 10-µg booster
dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19
vaccine (Comirnaty Original/Omicron BA.4/BA.5 5-µg/5-µg) for
children 5 through 11 years of age. The recommendation was
subsequently endorsed by the European Commission (EC).
- In December 2022, Pfizer and BioNTech announced the FDA granted
Emergency Use Authorization (EUA) of the companies’ Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose
in the three-dose primary series for children 6 months through 4
years of age. Children in this age group can receive a primary
series consisting of two 3-µg doses of the original Pfizer-BioNTech
COVID-19 vaccine followed by a third 3-µg dose of the bivalent
vaccine to complete the primary series.
- Ibrance (palbociclib) -- In December 2022, the FDA
expanded the indication for Ibrance to include its use in
combination with an aromatase inhibitor (AI) for the treatment of
HR+/HER2- metastatic breast cancer (mBC), regardless of menopausal
status. The approval expands on Ibrance’s existing indication for
use in combination with an AI as initial endocrine-based therapy in
postmenopausal women or in men, and for use with fulvestrant in
patients with disease progression following endocrine therapy.
Ibrance is now the only CDK 4/6 inhibitor that is FDA-approved for
the treatment of HR+/HER2- mBC in combination with either an AI or
fulvestrant regardless of menopausal status.
- Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir
tablets)(9)
- In November 2022, Pfizer announced an agreement with the EC to
supply Paxlovid to countries participating in the Joint Procurement
Agreement across Europe. This agreement is in addition to the
bilateral agreements Pfizer has previously signed with 17 EU Member
States and will supply participating countries up to 3.4 million
treatment courses upon orders being placed. Pfizer began delivery
of the initial treatment quantities ordered by the participating
countries in November.
- In December 2022, Pfizer announced it had reached an agreement
with the U.S. Government for the purchase of an additional 3.7
million treatment courses of Paxlovid. This purchase supplements
the 20 million treatment courses previously contracted by and
already delivered to the U.S. Government. The additional 3.7
million treatment courses are planned for delivery in early
2023.
- In December 2022, Pfizer announced the FDA has extended the
review period for the New Drug Application (NDA) for Paxlovid. At
the request of the FDA, Pfizer recently submitted additional
analyses of efficacy and safety data from the pivotal EPIC-HR
(Evaluation of Protease Inhibition for COVID-19 in High-Risk
Patients) and supportive EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) trials to be considered as part
of its NDA for Paxlovid. Results from these analyses are consistent
with previously disclosed efficacy and safety data for the trials.
In order to allow time for a full review of the application,
including the additional data analyses submitted, the FDA has
extended the Prescription Drug User Fee Act (PDUFA) goal date by
three months to May 2023. Pfizer submitted its original NDA seeking
approval of Paxlovid in June 2022 and was granted priority review
by the FDA.
- In January 2023, Pfizer announced that the CHMP of the EMA has
recommended converting the conditional Marketing Authorization for
Paxlovid to standard (also referred to as “full”) Marketing
Authorization for the treatment of COVID-19 in adults who do not
require supplemental oxygen and who are at increased risk of the
disease becoming severe. The EC will review the CHMP recommendation
and is soon expected to make a final decision.
- Prevnar 20 (20-valent pneumococcal conjugate vaccine) --
In January 2023, Pfizer announced that the FDA accepted for review
a supplemental Biologics License Application (sBLA) for its
20-valent pneumococcal conjugate vaccine candidate for the
prevention of invasive pneumococcal disease (IPD) caused by the 20
Streptococcus pneumoniae serotypes contained in the vaccine in
infants and children 6 weeks through 17 years of age, and for the
prevention of otitis media caused by seven of the 20 Streptococcus
pneumoniae serotypes contained in the vaccine. The PDUFA goal date
for a decision by the FDA is anticipated in April 2023.
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.
- Elranatamab (PF-06863135)
- In November 2022, Pfizer announced its investigational cancer
immunotherapy, elranatamab, received Breakthrough Therapy
Designation from the FDA for the treatment of people with relapsed
or refractory multiple myeloma (RRMM). Elranatamab is a B-cell
maturation antigen (BCMA)-CD3-targeted bispecific antibody
(BsAb).
- In December 2022, Pfizer announced 10.4 month follow-up data
from the pivotal Phase 2 MagnetisMM-3 clinical trial suggesting
elranatamab is efficacious and has a manageable safety profile in
patients with RRMM in a heavily pretreated population, who have
received at least three classes of prior therapies including a
proteasome inhibitor, an immunomodulatory agent, and an anti-CD38
monoclonal antibody (i.e., triple-class refractory or exposed).
These data were presented in an oral session at the 64th American
Society of Hematology Annual Meeting and Exposition 2022. Data from
the ongoing MagnetisMM-3 trial continue to be collected and will be
shared as they mature.
- Etrasimod (Selective S1P Receptor Modulator) -- In
December 2022, Pfizer announced that the FDA accepted for review an
NDA for etrasimod for individuals living with
moderately-to-severely active ulcerative colitis (UC). The FDA’s
decision is expected in the second half of 2023. Pfizer also
announced that the EMA accepted the Marketing Authorization
Application (MAA) for etrasimod in the same patient population with
a decision anticipated in the first half of 2024.
- Fidanacogene elaparvovec (Hemophilia B Gene Therapy) --
In December 2022, Pfizer announced positive top-line results from
the Phase 3 BENEGENE-2 study (NCT03861273) evaluating fidanacogene
elaparvovec for the treatment of adult males with moderately severe
to severe hemophilia B. The BENEGENE-2 study met its primary
endpoint of non-inferiority and superiority in the annualized
bleeding rate of total bleeds post-fidanacogene elaparvovec
infusion versus prophylaxis regimen with Factor IX, administered as
part of usual care. Fidanacogene elaparvovec was generally
well-tolerated in the study, with a safety profile consistent with
Phase 1/2 results.
- PF-06886992 (Pentavalent (MenABCWY) Meningococcal Vaccine
Candidate) -- In December 2022, Pfizer announced the FDA
accepted for review a Biologics License Application (BLA) for its
investigational pentavalent meningococcal vaccine candidate,
MenABCWY. Pfizer submitted MenABCWY for the prevention of
meningococcal disease caused by the most common serogroups in
individuals 10 through 25 years of age. If approved and
recommended, the vaccine could help simplify the meningococcal
vaccination schedule and provide the broadest serogroup coverage of
any meningococcal vaccine. The PDUFA goal date for a decision by
the FDA is in October 2023.
- RSVpreF (Respiratory Syncytial Virus (RSV) Bivalent Vaccine
Candidate) -- In December 2022, Pfizer announced that the FDA
accepted for priority review a BLA for its RSV vaccine candidate,
PF-06928316 or RSVpreF, as submitted for the prevention of lower
respiratory tract disease caused by RSV in individuals 60 years of
age and older. The PDUFA goal date for a decision by the FDA is in
May 2023.
- VLA15 (Lyme Disease Vaccine Candidate) -- In December
2022, Pfizer and Valneva SE (Valneva) reported antibody persistence
data six months after the completion of a three-dose (Month 0-2-6)
or a two-dose (Month 0-6) vaccination schedule with their Lyme
disease vaccine candidate, VLA15, in both children and adults. The
data showed antibody levels declined over time, but remained above
baseline six months after completion of a three-dose (Month 0-2-6)
or a two-dose (Month 0-6) vaccination schedule, with higher
antibody levels observed in the three-dose vaccination schedule
versus the two-dose vaccination schedule. No safety concerns were
observed in the six-month observational follow-up. The three-dose
vaccination schedule is being used in the Phase 3 protocols for all
participants.
Corporate Developments
- In December 2022, Pfizer business executives and scientific
leadership provided updates on the company’s potential near-term
product launches, including investigational therapies and vaccines
in migraine, RSV, ulcerative colitis, alopecia, multiple myeloma
and prostate cancer. Also discussed were key high-value pipeline
programs around sickle cell disease, dermatomyositis, hematological
malignancies, obesity and type 2 diabetes, as well as Pfizer’s
portfolio of mRNA vaccine candidates. If successful and approved,
the company anticipates these will be key drivers of Pfizer’s
growth through 2030 and beyond.
- In January 2023, Pfizer announced a significant expansion of
its commitment to An Accord for a Healthier World (the Accord) by
offering the full portfolio of medicines and vaccines for which it
has global rights on a not-for-profit basis to enable greater
health for 1.2 billion people living in 45 lower-income countries.
The Accord, which was first launched in May 2022, originally
included only patented products available in the U.S. and EU, but
now includes both patented and off-patent medicines and vaccines
that treat or prevent many of the greatest infectious and
non-communicable disease threats faced today in lower-income
countries. As Pfizer launches new medicines and vaccines, those
products will also be included in the Accord portfolio on a
not-for-profit basis.
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/Q4-2022-PFE-Earnings-Release
(Note: If clicking on the above link does not open up a new web
page, 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 referred to 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), the Comirnaty Original/Omicron
BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine.
“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 $80 million and
$188 million for the fourth-quarter and full-year 2022,
respectively, and $46 million and $320 million for the
fourth-quarter and full-year 2021, respectively.
(2) Revenues is defined as revenues in accordance with U.S.
generally accepted accounting principles (GAAP). Reported net
income and its components are defined as net income attributable to
Pfizer Inc. and its components in accordance with U.S. GAAP.
Reported diluted earnings per share (EPS) is defined as diluted EPS
attributable to Pfizer Inc. common shareholders in accordance with
U.S. GAAP.
(3) Adjusted income and Adjusted diluted EPS are defined as U.S.
GAAP net income attributable to Pfizer Inc. common shareholders and
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 reconciliations of certain
GAAP Reported to Non-GAAP Adjusted information for fourth-quarter
and full-year 2022 and 2021 at the hyperlink above. Adjusted income
and its components and Adjusted diluted EPS measures are not, and
should not be viewed as, substitutes for U.S. GAAP net income and
its components and diluted EPS(2). See the Non-GAAP Financial
Measure: Adjusted Income sections of Management’s Discussion and
Analysis of Financial Condition and Results of Operations in
Pfizer’s 2021 Annual Report on Form 10-K and Quarterly Report on
Form 10-Q for the quarterly period ended October 2, 2022 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) Pfizer does not provide guidance for GAAP Reported financial
measures (other than revenues and acquired IPR&D expenses) 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 2023 reflects the
following:
- Does not assume the completion of any business development
transactions not completed as of December 31, 2022, except for
signed transactions, if any, through mid-January 2023, which are
expected to give rise to acquired in-process R&D (IPR&D)
expenses during fiscal 2023.
- Reflects an anticipated negative revenue impact of $0.3 billion
due to recent and expected generic and biosimilar competition for
certain products that have recently lost patent protection or that
are anticipated to lose patent protection during fiscal-year
2023.
- Exchange rates assumed are as of mid-January 2023. Financial
guidance reflects the anticipated unfavorable impact of
approximately $0.2 billion on revenues and approximately $0.02 on
Adjusted diluted EPS(3) as a result of changes in foreign exchange
rates relative to the U.S. dollar compared to foreign exchange
rates from 2022.
- Guidance for Adjusted diluted EPS(3) assumes diluted
weighted-average shares outstanding of approximately 5.75 billion
shares, and assumes no share repurchases in 2023.
(5) 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, 2022 and December 31, 2021, 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, 2022 and
November 30, 2021.
(6) Beginning in the third quarter of 2022, Pfizer made several
organizational changes to further transform its operations to
better leverage its expertise in certain areas and in anticipation
of potential future new product or indication launches. Biopharma,
Pfizer’s innovative science-based biopharmaceutical business, is
operating under a new commercial structure which is designed to
better support and optimize performance across three broad customer
groups:
- Primary Care, consisting of the former Internal Medicine and
Vaccines product portfolios, products for COVID-19 prevention and
treatment, and potential future mRNA and antiviral products.
- Specialty Care, consisting of the former Inflammation &
Immunology, Rare Disease and Hospital (excluding Paxlovid) product
portfolios.
- Oncology, consisting of the former Oncology product
portfolio.
(7) The following business development activity, among others,
impacted financial results for the current or prior fiscal
year:
- On October 5, 2022, Pfizer announced the completion of its
acquisition of Global Blood Therapeutics, Inc. (GBT) for $68.50 per
share in cash, for payments of approximately $5.3 billion, net of
cash acquired, plus repayment of third-party debt of $331 million
for a total net cash deployment of approximately $5.6 billion.
- On October 3, 2022, Pfizer announced the completion of its
acquisition of all the outstanding shares of Biohaven
Pharmaceutical Holding Company Ltd. (Biohaven) not already owned by
Pfizer for $148.50 per share in cash, for payments of approximately
$11.4 billion, net of cash acquired, plus repayment of third-party
debt of $863 million and redemption of Biohaven’s redeemable
preferred stock for $495 million, for a total net cash deployment
of approximately $12.7 billion. Effective immediately prior to the
closing of the acquisition, Biohaven completed the spin-off of
Biohaven Ltd. (NYSE: BHVN), a new company that retained Biohaven’s
non-calcitonin gene-related peptide (CGRP) development stage
pipeline compounds. Shares of Biohaven Ltd. were distributed to
Biohaven’s shareholders. Pfizer, a Biohaven shareholder, received a
pro rata portion of the company’s shares in the distribution and
currently owns approximately 1.5% of Biohaven Ltd.
- On July 18, 2022, GlaxoSmithKline plc. (GSK) completed its
demerger of the Consumer Healthcare joint venture which became
Haleon, an independent, publicly traded company listed on the
London Stock Exchange that holds the joint Consumer Healthcare
business of GSK and Pfizer following the demerger. For additional
information, see Note 2C to the condensed consolidated financial
statements in Pfizer's Quarterly Report on Form 10-Q for the
quarterly period ended October 2, 2022.
- On June 9, 2022, Pfizer announced the completion of its
acquisition of ReViral Ltd., a privately held, clinical-stage
biopharmaceutical company focused on discovering, developing and
commercializing novel antiviral therapeutics that target
respiratory syncytial virus, for a total consideration of up to
$536 million, including upfront and development milestones. In
connection with the closing of the transaction, Pfizer recorded
$426 million of acquired IPR&D expenses in its international
third-quarter 2022.
- On March 11, 2022, Pfizer announced the completion of its
acquisition of Arena Pharmaceuticals, Inc., a clinical-stage
company developing innovative potential therapies for the treatment
of several immuno-inflammatory diseases, for $100 per share, in
cash. The total fair value of the consideration transferred was
$6.6 billion ($6.2 billion, net of cash acquired), plus $138
million in payments to Arena employees for previously unvested
equity compensation awards recognized as an expense, for a total
net cash deployment of $6.4 billion.
- On December 31, 2021, Pfizer completed the sale of its Meridian
subsidiary, the manufacturer of EpiPen and other auto-injector
products, which generated approximately $300 million in annual
revenues and which previously had been managed within the former
Hospital therapeutic area. Beginning in the fourth quarter of 2021,
the financial results of Meridian are reflected as discontinued
operations for all periods presented.
- On December 24, 2021, Pfizer entered into a multi-year research
collaboration with Beam Therapeutics Inc. (Beam) to utilize Beam’s
in vivo base editing programs, which use mRNA and lipid
nanoparticles, for three targets for rare genetic diseases of the
liver, muscle and central nervous system. Under the terms of the
agreement, Pfizer paid Beam a $300 million upfront payment. If
Pfizer elects to opt in to licenses for all three targets, Beam
would be eligible for up to an additional $1.05 billion in
development, regulatory and commercial milestone payments for a
potential total deal consideration of up to $1.35 billion. Beam is
also eligible to receive royalties on global net sales for each
licensed program.
- On November 17, 2021, Pfizer acquired all outstanding shares,
warrants, options and deferred shares not already owned by Pfizer
of Trillium Therapeutics Inc., a clinical-stage immuno-oncology
company developing therapies targeting cancer immune evasion
pathways and specific cell targeting approaches, for a price of
$18.50 per share in cash, for total consideration of $2.0 billion,
net of cash acquired. Pfizer accounted for the transaction as an
asset acquisition since the lead asset, TTI-622, represented
substantially all of the fair value of the gross assets acquired.
As a result, Pfizer recorded a $2.1 billion charge in
fourth-quarter 2021, representing the acquired in-process R&D
asset.
- On November 9, 2021, Pfizer and Biohaven announced a strategic
collaboration and license agreement for Pfizer to commercialize
rimegepant and zavegepant for the treatment and prevention of
migraines outside of the U.S., subject to regulatory approval. Upon
the closing of the transaction on January 4, 2022, Pfizer paid
Biohaven $500 million, including an upfront payment of $150 million
and an equity investment of $350 million. Pfizer recognized $263
million for the upfront payment and premium paid on its equity
investment in acquired IPR&D expenses.
- On July 22, 2021, Arvinas Inc. (Arvinas) and Pfizer announced a
global collaboration to develop and commercialize ARV-471, an
investigational oral PROTAC® (PROteolysis TArgeting Chimera)
estrogen receptor protein degrader. The estrogen receptor is a
well-known disease driver in most breast cancers. Under the terms
of the agreement, Pfizer paid Arvinas $650 million upfront and made
a $350 million equity investment in Arvinas. Arvinas is also
eligible to receive up to $400 million in approval milestones and
up to $1 billion in commercial milestones. The companies will
equally share worldwide development costs, commercialization
expenses and profits.
(8) 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 since
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.
(9) Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19
Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original
and Omicron BA.4/BA.5), have not been approved or licensed by the
FDA. Paxlovid has not been approved, but has been authorized for
emergency use by the FDA under an EUA, for the treatment of
mild-to-moderate COVID-19 in adults and pediatric patients (12
years of age and older weighing at least 40 kg [88 lbs]) with
positive results of direct SARS-CoV-2 viral testing, and who are at
high-risk for progression to severe COVID-19, including
hospitalization or death. Emergency uses of the Pfizer-BioNTech
COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent
have been authorized by the FDA under an EUA to prevent COVID-19 in
individuals aged 6 months and older. The emergency uses are only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of the medical
product during the COVID-19 pandemic under Section 564(b)(1) of the
FFDCA unless the declaration is terminated or authorization revoked
sooner. Please see the EUA Fact Sheets at www.covid19oralrx.com and
www.cvdvaccine-us.com.
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is
as of January 31, 2023. 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; reorganizations;
business plans, strategy 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, pricing and
reimbursement, potential market dynamics and size, growth,
performance, timing of exclusivity and potential benefits;
strategic reviews; capital allocation objectives; dividends and
share repurchases; plans for and prospects of our acquisitions,
dispositions and other business development activities, and our
ability to successfully capitalize on these opportunities;
manufacturing and product supply; our ongoing efforts to respond to
COVID-19, including the Pfizer-BioNTech COVID-19 Vaccine
(Comirnaty), the Pfizer-BioNTech COVID-19 Omicron BA.4/BA.5
Vaccine, Bivalent (the Pfizer-BioNTech COVID-19 bivalent vaccine),
other vaccines that may result from the BNT162 program, including
new variant-based or next-generation vaccines, and our oral
COVID-19 treatment (Paxlovid); and our expectations regarding the
impact of COVID-19 on our business, operations and financial
results that involve substantial risks and uncertainties. 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.
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; the impact of, or uncertainties
regarding the ability to obtain, recommendations by technical or
advisory committees; and the timing of pricing approvals and
product launches;
- 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, including uncertainties regarding the commercial or
other impact of the results of the Xeljanz ORAL Surveillance
(A3921133) study or actions by regulatory authorities based on
analysis of ORAL Surveillance or other data, including on other
Janus kinase (JAK) inhibitors in our portfolio;
- the success and impact of external business development
activities, 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 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 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 the COVID-19 pandemic) on our business, operations and
financial condition and results, including impacts on our
employees, manufacturing, supply chain, sales and marketing,
research and development 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, uncertainties inherent in research and development,
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,
the Pfizer-BioNTech COVID-19 bivalent vaccine, any monovalent,
bivalent or variant-adapted vaccine candidates or any other 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, the
Pfizer-BioNTech COVID-19 bivalent vaccine, any monovalent, bivalent
or variant-adapted vaccine candidates 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, the Pfizer-BioNTech
COVID-19 bivalent vaccine, any monovalent, bivalent or
variant-adapted vaccine candidates 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 more widespread use of Comirnaty, the Pfizer-BioNTech
COVID-19 bivalent vaccine 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 mRNA vaccine 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, the Pfizer-BioNTech COVID-19 bivalent vaccine, or any
future vaccines in additional populations, for a potential booster
dose for Comirnaty, the Pfizer-BioNTech COVID-19 bivalent vaccine,
any monovalent or bivalent vaccine candidates or any potential
future vaccines (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, the Pfizer-BioNTech COVID-19 bivalent
vaccine, any monovalent or bivalent vaccine candidates or any other
potential vaccines that may arise from the BNT162 program,
including a potential variant-based, higher dose, or bivalent
vaccine or any other potential vaccines, and if obtained, whether
or when such EUA or licenses 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 will expire or
terminate; whether and when any application that may be pending or
filed for Comirnaty, the Pfizer-BioNTech COVID-19 bivalent vaccine,
any monovalent, bivalent or variant-adapted vaccine candidates 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 a 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 superior or competitive
products; the risk that demand for any products may be reduced, no
longer exist or not meet expectations which may lead to excess
inventory on-hand and/or in the channel or reduced revenues;
challenges related to a transition to the commercial market for any
of the products; risks related to the availability of raw materials
to manufacture or test any such products; challenges related to our
vaccine’s formulation, dosing schedule and attendant storage,
distribution and administration requirements, including risks
related to storage and handling after delivery by Pfizer;
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 annual boosters or re-vaccinations or new
variant-based or next generation vaccines or next generation
COVID-19 treatments; uncertainties related to vaccine adherence;
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; risks related to our ability to achieve our revenue
forecasts for Comirnaty, the Pfizer-BioNTech COVID-19 bivalent
vaccine and Paxlovid or any potential future COVID-19 vaccines or
treatments; whether and when additional supply or purchase
agreements will be reached or existing agreements will be
completed; 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, the
Pfizer-BioNTech COVID-19 bivalent vaccine or Paxlovid, 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 possible currency devaluations in countries
experiencing high inflation 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
or vaccines in the pharmaceutical supply chain;
- any significant issues related to the outsourcing of certain
operational and staff functions to third parties; and any
significant issues related to our JVs and other third-party
business arrangements;
- 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, and recent and possible
future changes in global financial markets;
- any changes in business, political and economic conditions due
to actual or threatened terrorist activity, geopolitical
instability, civil unrest or military action;
- 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;
- 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, each of which requires
upfront costs but may fail to yield anticipated benefits and may
result in unexpected costs or organizational disruption;
- the ability to successfully achieve our climate goals and
progress our environmental sustainability priorities;
Risks Related to Government Regulation and
Legal Proceedings:
- the impact of any U.S. healthcare reform or legislation or any
significant spending reductions or cost controls 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 insurance markets;
- legislation or regulatory action in markets outside of the
U.S., including China, affecting pharmaceutical product pricing,
intellectual property, 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;
- the exposure of our operations globally to possible capital and
exchange controls, economic conditions, expropriation and other
restrictive government actions, changes in intellectual property
legal protections and remedies, the impact of political or civil
unrest or military action, including the ongoing conflict between
Russia and Ukraine and its economic consequences, unstable
governments and legal systems, inter-governmental disputes and
natural disasters or disruptions related to climate change;
- legal defense costs, insurance expenses, settlement costs and
contingencies, including those related to actual or alleged
environmental contamination;
- the risk and impact of an adverse decision or settlement and
the risk related to 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 recently enacted 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. and potential
changes to existing tax law by the current U.S. Presidential
administration and Congress;
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;
- 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
- our ability to protect our products, patents and other
intellectual property, such as: (i) against claims of invalidity
that could result in loss of exclusivity; (ii) claims of patent
infringement; (iii) challenges faced by our collaboration or
licensing partners to the validity of their patent rights; and (iv)
in response to 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, the
Pfizer-BioNTech COVID-19 bivalent vaccine and Paxlovid.
We cannot guarantee that any forward-looking statement will be
realized. 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, 2021 and in our subsequent report 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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Pfizer (NYSE:PFE)
過去 株価チャート
から 11 2023 まで 12 2023
Pfizer (NYSE:PFE)
過去 株価チャート
から 12 2022 まで 12 2023