- Solid Third-Quarter 2022 Revenues of $22.6 Billion
- Due to Exceptionally Strong Growth Achieved in the Prior-Year
Quarter, Revenues Declined 2% Operationally
- Excluding Contributions from Paxlovid and Comirnaty(1),
Revenues Grew 2% Operationally
- Third-Quarter 2022 Reported Diluted EPS(2) of $1.51, Reflecting
6% Growth Over Third-Quarter 2021, Including a $0.15 Incremental
Benefit in the Current Period Related to Tax Resolutions for
Multiple Years Impacting Both Reported(2) and Adjusted(3) Diluted
EPS
- Third-Quarter 2022 Adjusted Diluted EPS(3) of $1.78, Reflecting
40% Growth Over Third-Quarter 2021; Excluding Foreign Exchange
Impacts, Adjusted Diluted EPS(3) Grew 44%
- Raises Lower End of Full-Year 2022 Revenue Guidance(4) to a
Range of $99.5 to $102.0 Billion, Reflecting an Improved
Operational Outlook Combined with Incremental Unfavorable Foreign
Exchange Impacts
- Raises 2022 Revenue Guidance for Comirnaty(1) by $2 Billion to
~$34 Billion and Reaffirms Revenue Guidance for Paxlovid of ~$22
Billion, Despite Unfavorable Impacts from Foreign Exchange
- Raises and Narrows Full-Year 2022 Adjusted Diluted EPS(3)
Guidance from $6.30 to $6.45 to $6.40 to $6.50
- Pipeline Programs That Have Achieved Positive Phase 3 Readouts
Since Previous Earnings Release Include RSVpreF Vaccine in Older
Adults & Maternal, Prevnar 20/Apexxnar in Pediatrics,
Talzenna/Xtandi Combination in mCRPC and Pentavalent Meningococcal
Vaccine in Adolescents and Young Adults
- Pfizer to Host Analyst Event on December 12 in New York City,
Where It Will Showcase Its Portfolio of Upcoming Product Launches
and Other Pipeline Programs with High-Value Potential
Pfizer Inc. (NYSE: PFE) reported solid financial results for
third-quarter 2022 and updated certain components of 2022 financial
guidance(4). Pfizer raised the lower end of its 2022 revenue
guidance range, while raising and narrowing its Adjusted diluted
EPS(3) guidance, despite unfavorable impacts from foreign exchange.
Revenue guidance for Comirnaty(1) was raised by $2 billion, and was
reaffirmed for Paxlovid.
The third-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:
“I continue to be proud of our colleagues’ excellence, ingenuity
and unwavering commitment to bringing breakthroughs to patients.
Over the next 18 months, we expect to have up to 19 new products or
indications in the market – including the five for which we have
already begun co-promotion or commercialization earlier this year.
Many of these 19 programs are already largely de-risked from a
clinical perspective, the majority were discovered in-house, and
nearly all would be for indications outside of COVID-19. This
quarter, we set the stage for these potential launches by
reorganizing our commercial operations to better capitalize on
these opportunities. We also reported positive pivotal data for
several of these exciting pipeline programs, including our RSV
vaccine candidate for older adults and for infants through maternal
vaccination, Prevnar 20 for children, the potential combination
treatment of Talzenna and Xtandi in men with metastatic
castration-resistant prostate cancer, and our pentavalent
meningococcal vaccine candidate for adolescents and young adults.
If approved, we expect each of these to be key contributors to our
growth aspirations through 2025 and beyond.”
David Denton, Chief Financial Officer and Executive Vice
President, stated: “Third-quarter results demonstrated commercial
strength across many areas of our business, but was somewhat
obscured by the incredibly strong performance in the prior year. We
saw strong operational performance this quarter from key brands
such as Paxlovid and Eliquis, particularly in the U.S., as well as
the continued impressive launch of Prevnar 20 for adults in the
U.S. In addition, we continue to make progress toward our goal of
adding at least $25 billion in risk-adjusted 2030 revenues to
Pfizer’s portfolio through business development. Since we last
reported earnings, we completed the acquisitions of Biohaven and
Global Blood Therapeutics, each of which bring significant
scientific breakthroughs to Pfizer and which present opportunities
where we believe we can add great value. I look forward to
continuing to execute on Pfizer’s strategies to deliver
breakthroughs to patients and value to shareholders.”
Results for the third quarter and the first nine months of 2022
and 2021(5) are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts)
Third-Quarter
Nine Months
2022
2021
Change
2022
2021
Change
Revenues
$
22,638
$
24,035
(6%)
$
76,040
$
57,450
32%
Reported Net Income(2)
8,608
8,146
6%
26,378
18,586
42%
Reported Diluted EPS(2)
1.51
1.42
6%
4.60
3.27
41%
Adjusted Income(3)
10,172
7,279
40%
31,165
18,653
67%
Adjusted Diluted EPS(3)
1.78
1.27
40%
5.44
3.28
66%
REVENUES
($ in millions)
Third-Quarter
Nine Months
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Global Biopharmaceuticals Business
(Biopharma)(6)
$
22,319
$
23,513
(5%)
(1%)
$
75,066
$
56,101
34%
39%
Primary Care(6)
15,846
16,680
(5%)
(1%)
55,676
35,804
56%
62%
Specialty Care(6)
3,404
3,749
(9%)
(3%)
10,267
11,205
(8%)
(4%)
Oncology(6)
3,070
3,085
—
3%
9,124
9,091
—
3%
Pfizer CentreOne
$
319
$
521
(39%)
(35%)
$
974
$
1,348
(28%)
(25%)
TOTAL REVENUES
$
22,638
$
24,035
(6%)
(2%)
$
76,040
$
57,450
32%
38%
Beginning in the first quarter of 2022, Adjusted(3) financial
measures include expenses for all acquired in-process research and
development (IPR&D) costs incurred in connection with upfront
and milestone payments on collaboration and in-license agreements,
including premiums on equity securities, as well as asset
acquisitions of acquired IPR&D and are reported as a separate
income statement line item. Previously, these costs were recorded
within the R&D expenses line item and certain of these costs
were excluded from Adjusted(3) results. The change to include all
acquired IPR&D expenses within Adjusted(3) results negatively
impacted Adjusted(3) diluted EPS in the third quarters of 2022 and
2021 by $0.07 and $0.09, respectively.
Also in the first quarter of 2022, Pfizer implemented a change
in policy to exclude all amortization of intangibles from
Adjusted(3) income, which favorably impacted Adjusted(3) diluted
EPS by $0.01 in third-quarter 2022 and by $0.02 in third-quarter
2021.
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 launches. These changes include
establishing a new commercial structure within its Biopharma
operating segment focused on three broad therapeutic areas (primary
care, specialty care and oncology) and realigning certain enabling
and platform functions across the organization to ensure alignment
with this new operating structure(6).
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).
2022 FINANCIAL GUIDANCE(4)
Pfizer raised its 2022 financial guidance, on an operational
basis(8), for revenues and Adjusted diluted EPS(3) by approximately
$1.7 billion and $0.19, respectively. After including the expected
incremental unfavorable impacts of changes in foreign exchange
rates since last quarter’s earnings report, the midpoints of the
guidance ranges for revenues and Adjusted diluted EPS(3) were
increased by $750 million and $0.075, respectively.
Financial guidance ranges now reflect the closing of the
Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) and Global
Blood Therapeutics, Inc. (GBT) acquisitions, which occurred early
in the fourth quarter of 2022.
Previous Guidance (as
of July 28, 2022)
Operational Changes(8)
Impact of Changes in Foreign
Exchange Rates
Current Guidance (as of
November 1, 2022)
Revenues
$98.0 to $102.0
billion
~$1.7 billion
(~$0.7 billion)
$99.5 to $102.0
billion
Operational Growth(8) vs. Prior Year
27% to 32%
29% to 32%
Growth vs. Prior Year
21% to 25%
22% to 25%
Adjusted Diluted EPS(3)
$6.30 to $6.45
~$0.19
(~$0.09)
$6.40 to $6.50
Operational Growth(8) vs. Prior Year
63% to 67%
68% to 71%
Growth vs. Prior Year
55% to 59%
58% to 60%
The midpoint of the guidance range for revenues reflects a 31%
operational increase compared to 2021 revenues of $81.3 billion.
This guidance includes the following assumptions related to
Pfizer’s COVID-19-related products:
- Comirnaty(1) revenues of approximately $34 billion, which
reflects favorable operational updates compared to prior guidance,
partially offset by unfavorable incremental impacts from foreign
exchange. This guidance includes doses expected to be delivered in
fiscal 2022(5), primarily under contracts signed as of mid-October
2022.
- Paxlovid revenues of approximately $22 billion, which remains
unchanged from prior guidance. This guidance includes treatment
courses expected to be delivered in fiscal 2022(5), primarily
relating to supply contracts signed or committed as of mid-October
2022.
The midpoint of the guidance range for Adjusted diluted EPS(3)
was raised by $0.075, despite an unfavorable $0.06 impact due to
incremental acquired IPR&D expenses. This updated guidance
reflects a 70% operational increase at the midpoint over the 2021
Adjusted diluted EPS(3) of $4.06, which has been revised from its
original presentation to exclude all amortization of intangibles
and to include the impact of all acquired IPR&D expenses.
Financial guidance for Adjusted diluted EPS(3) is calculated
using approximately 5.75 billion weighted average shares
outstanding, and assumes no additional share repurchases in 2022.
The expected increase in weighted average shares outstanding
compared to 2021 of approximately 50 million shares has an
unfavorable impact on 2022 Adjusted diluted EPS(3) of $0.04 at the
midpoint of the guidance range.
Other components of Pfizer’s 2022 financial guidance, all of
which are presented with the expected impacts from changes in
foreign exchange rates included, are presented below.
Adjusted(3) Cost of Sales as a Percentage
of Revenues
33.0% to 34.0%
(previously 32.0% to 34.0%)
Adjusted(3) SI&A Expenses
$12.8 to $13.3 billion
(previously $12.2 to $13.2
billion)
Adjusted(3) R&D Expenses
$11.5 to $12.0 billion
Acquired IPR&D Expenses(4)
Approximately $1.4 billion
(previously approximately $0.9
billion)
Adjusted(3) Other (Income)/Deductions
Approximately $1.8 billion of
income
(previously approximately $1.9
billion of income)
Effective Tax Rate on Adjusted(3)
Income
Approximately 12.5%
(previously approximately
15.5%)
Guidance for Adjusted(3) cost of sales as a percentage of
revenues was tightened around the higher end of the previous range,
primarily reflecting the increase in revenue expectations for
Comirnaty(1).
Guidance for Adjusted(3) SI&A expenses was raised by $350
million at the midpoint and now includes additional spending
related to recent acquisitions.
Guidance for acquired IPR&D expenses(4) was increased by
$500 million, primarily as a result of the acquisition of Biohaven
early in the fourth quarter of 2022.
Guidance for the effective tax rate on Adjusted(3) income was
lowered by 3.0 percentage points compared to the previous guidance,
reflecting tax benefits recorded in the third quarter of 2022
related to global income tax resolutions in multiple tax
jurisdictions spanning multiple tax years, among other drivers.
CAPITAL ALLOCATION
During the first nine months of 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:
- $7.8 billion invested in internal research and development
projects, and
- Approximately $8 billion invested in completed business
development transactions, including approximately $6.4 billion(7)
for the acquisition of Arena Pharmaceuticals, Inc. and
approximately $0.4 billion for the acquisition of ReViral Ltd.
(ReViral).
- Returning capital directly to shareholders through a
combination of:
- $6.7 billion of cash dividends, or $1.20 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.
In addition to the capital investments listed above, early in
the fourth quarter of 2022, Pfizer completed the acquisitions of
Biohaven and GBT requiring total upfront capital deployments of
approximately $12.8 billion and $5.6 billion, respectively, which
includes the amounts paid for the acquired companies’ common
shares, employee stock awards, outstanding debt and any preferred
shares, less any cash acquired.
As of November 1, 2022, Pfizer’s remaining share repurchase
authorization is $3.3 billion. Current financial guidance does not
anticipate any additional share repurchases in 2022.
Third-quarter 2022 diluted weighted-average shares outstanding
used to calculate Reported(2) and Adjusted(3) diluted EPS were
5,718 million shares, a decrease of 7 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 (Third-Quarter 2022 vs.
Third-Quarter 2021)
Third-quarter 2022 revenues totaled $22.6 billion, a decrease of
$1.4 billion, or 6%, compared to the prior-year quarter, reflecting
an operational decline of $441 million, or 2%, as well as an
unfavorable impact of foreign exchange of $957 million, or 4%.
Excluding contributions from Paxlovid and Comirnaty(1), company
revenues grew $213 million, or 2%, operationally.
Third-quarter 2022 operational decline was primarily driven
by:
- Comirnaty(1) outside the U.S., down 86% operationally, driven
primarily by a previously announced amendment to the supply
agreement with the European Commission (EC) whereby all doses
scheduled for delivery in June through August 2022 would instead be
delivered in the fourth quarter of 2022 and similar shifts in
scheduled deliveries to other developed countries, as well as
slower demand in emerging markets;
- Lower revenues for certain Comirnaty-related manufacturing
activities(1) performed on behalf of BioNTech SE (BioNTech), which
decreased 96% operationally compared to the prior-year
quarter;
- Xeljanz globally, down 14% operationally, driven primarily by
decreased prescription volumes resulting from ongoing shifts in
prescribing patterns related to Janus kinase (JAK) class label
changes; and
- Sutent globally, down 43% operationally, primarily driven by
lower volume demand in Europe following its loss of exclusivity in
January 2022,
partially offset primarily by higher revenues for:
- Paxlovid, which contributed $7.5 billion in global revenues,
driven by the U.S. launch under emergency use authorization (EUA)
in December 2021 and international launches in late 2021 and early
2022 following regulatory approvals or EUAs;
- Comirnaty(1) in the U.S., up 83%, driven primarily by
deliveries of the Omicron BA.4/BA.5-adapted bivalent booster,
following its EUA in late-August 2022, as well as the granting of
an EUA in June 2022 for a primary vaccination series for children 6
months to less than 5 years of age;
- Prevnar family (Prevnar 13 & 20) in the U.S., up 28%,
driven by strong patient demand following the launch of Prevnar 20
for the eligible adult population, partially offset by unfavorable
timing of government and private purchasing of Prevnar 13 for the
pediatric indication;
- Eliquis in the U.S., up 33%, driven primarily by continued oral
anti-coagulant adoption and market share gains in non-valvular
atrial fibrillation, as well as favorable changes in channel mix;
and
- Vyndaqel/Vyndamax globally, up 29% operationally, driven by
continued strong uptake of the transthyretin amyloid cardiomyopathy
indication, primarily in the U.S. and developed Europe, partially
offset by a planned price decrease that went into effect in Japan
in second-quarter 2022.
GAAP Reported(2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES(2)
($ in millions)
Third-Quarter
Nine Months
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Cost of Sales(2)
$
6,063
$
9,932
(39%)
(34%)
$
24,696
$
21,085
17%
25%
Percent of Revenues
26.8
%
41.3
%
N/A
N/A
32.5
%
36.7
%
N/A
N/A
SI&A Expenses(2)
3,391
2,899
17%
21%
9,032
8,599
5%
8%
R&D Expenses(2)
2,696
2,681
1%
2%
7,813
6,914
13%
14%
Acquired IPR&D Expenses(2)
524
762
(31%)
(31%)
880
1,000
(12%)
(12%)
Other (Income)/Deductions––net(2)
(59
)
(1,696
)
(97%)
(99%)
1,063
( 4,043
)
*
*
Effective Tax Rate on Reported
Income(2)
4.0
%
(4.2
%)
10.5
%
7.8
%
* Indicates calculation not meaningful.
Third-quarter 2022 Cost of Sales(2) as a percentage of revenues
decreased 14.5 percentage points compared with the prior-year
quarter. The decrease was primarily driven by favorable changes in
sales mix, including significant sales of Paxlovid and lower sales
of Comirnaty(1), as well as favorable impacts resulting from
changes in foreign exchange rates, partially offset by a charge of
approximately $400 million related to excess raw materials for
Paxlovid.
SI&A Expenses(2) increased 21% operationally compared with
the prior-year quarter, primarily reflecting increased spending for
Paxlovid and Comirnaty(1) and a higher provision for U.S.
healthcare reform fees based on sales of Paxlovid and Comirnaty(1),
as well as additional investments to support recently launched
products.
Third-quarter 2022 R&D Expenses(2) increased 2%
operationally compared with the prior-year quarter, primarily
driven by increased costs to develop recently acquired assets, as
well as investments for certain oncology and non-COVID-19 vaccines
programs, partially offset by lower spending on programs to prevent
and treat COVID-19 and various late-stage clinical programs.
Acquired IPR&D Expenses(2) decreased 31% operationally
compared with the prior-year quarter. In third-quarter 2022,
Acquired IPR&D Expenses(2) primarily included the upfront
payment related to the closing of the acquisition of ReViral. In
third-quarter 2021, it mainly included an upfront payment related
to Pfizer’s global collaboration agreement with Arvinas, Inc.
Other income––net(2) decreased 99% operationally in
third-quarter 2022 compared with third-quarter 2021, primarily
driven by:
- lower net periodic benefit credits associated with pension and
postretirement plans incurred in third-quarter 2022 compared to the
prior-year quarter;
- net losses on equity securities in third-quarter 2022 versus
net gains on equity securities recognized in the prior-year
quarter; and
- a $200 million intangible asset impairment charge in
third-quarter 2022 associated with the discontinuation of the
PF-07265803 (lamin A/C protein (LMNA)-related dilated
cardiomyopathy) clinical program.
Pfizer’s effective tax rate on Reported income(2) for
third-quarter 2022 was impacted by tax benefits related to global
income tax resolutions in multiple tax jurisdictions spanning
multiple tax years that included the closing of U.S. Internal
Revenue Service audits covering five tax years. Pfizer’s effective
tax rate for third-quarter 2021 was negative, primarily as a result
of certain initiatives executed in third-quarter 2021 associated
with Pfizer’s investment in the Consumer Healthcare joint venture
with GlaxoSmithKline plc.
Adjusted(3) Income Statement Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions)
Third-Quarter
Nine Months
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Adjusted(3) Cost of Sales
$
6,038
$
9,899
(39%)
(34%)
$
24,621
$
20,975
17%
25%
Percent of Revenues
26.7
%
41.2
%
N/A
N/A
32.4
%
36.5
%
N/A
N/A
Adjusted(3) SI&A Expenses
3,239
2,719
19%
23%
8,635
8,140
6%
9%
Adjusted(3) R&D Expenses
2,693
2,679
1%
2%
7,799
6,908
13%
14%
Adjusted(3) Other
(Income)/Deductions––net
($515
)
($570
)
(10%)
(15%)
($1,298
)
($1,747
)
(26%)
(19%)
Effective Tax Rate on Adjusted
Income(3)
4.4
%
14.7
%
11.9
%
15.7
%
Reconciliations of certain Reported(2) to Adjusted(3) financial
measures and associated footnotes can be found in the financial
tables section of the press release located at the hyperlink
below.
RECENT NOTABLE DEVELOPMENTS (Since July 28, 2022)
Product Developments
- Comirnaty (COVID-19 vaccine, mRNA)(9)
- Clinical and Research Developments
- In August 2022, Pfizer and BioNTech announced updated efficacy
results from a Phase 2/3 trial evaluating a three 3-µg dose series
of Comirnaty in children 6 months through 4 years of age,
reinforcing previously reported interim vaccine efficacy data
collected in March and April 2022. Vaccine efficacy, a secondary
endpoint in the trial, was 73.2% (2-sided 95% CI: 43.8%, 87.6%)
among children 6 months through 4 years of age without evidence of
prior COVID-19 infection. This analysis was based on 13 cases in
the vaccine group (n=794) and 21 cases in the placebo group
(n=351), diagnosed from March to June 2022. Three 3-µg doses of
Comirnaty continued to be well-tolerated in this age group.
- In October 2022, Pfizer and BioNTech announced early data from
a Phase 2/3 clinical trial evaluating the safety, tolerability and
immunogenicity of the companies’ Omicron BA.4/BA.5-adapted bivalent
vaccine. A 30-µg booster dose of the Omicron BA.4/BA.5-adapted
bivalent vaccine demonstrated a substantial increase in the Omicron
BA.4/BA.5 neutralizing antibody response above pre-booster levels
based on sera taken 7 days after administration, with similar
responses seen across individuals aged 18 to 55 years of age and
those older than 55 years of age (40 participants in each age
group). Together, these data suggest a 30-µg booster dose of the
Omicron BA.4/BA.5-adapted bivalent vaccine is anticipated to
provide better protection against the Omicron BA.4 and BA.5
variants than the original vaccine for younger and older adults.
The Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated
with early data indicating a favorable safety profile, similar to
that of the original vaccine.
- U.S. Regulatory Developments
- In August 2022, Pfizer and BioNTech announced the U.S. Food and
Drug Administration (FDA) granted EUA of a 30-µg booster dose of an
Omicron-adapted bivalent vaccine for individuals ages 12 years and
older. The authorization of the bivalent COVID-19 vaccine is based
on clinical data from Pfizer and BioNTech’s Omicron BA.1-adapted
bivalent vaccine as well as pre-clinical and manufacturing data
from their Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical
data from a Phase 2/3 trial showed a booster dose of the Omicron
BA.1-adapted bivalent vaccine elicited a superior immune response
against the Omicron BA.1 subvariant compared to Comirnaty, with a
favorable safety profile. Additionally, pre-clinical data showed a
booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a
strong neutralizing antibody response against the Omicron BA.1,
BA.2, BA.4 and BA.5 subvariants, as well as the original
virus.
- In October 2022, Pfizer and BioNTech announced the FDA granted
EUA for a 10-µg booster dose of the companies’ Omicron
BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5
through 11 years of age. The EUA is supported by safety and
immunogenicity data from the companies’ 30-µg bivalent Omicron
BA.1-adapted bivalent vaccine, non-clinical and manufacturing data
from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent
vaccine, and pre-clinical data from the 30-µg Omicron
BA.4/BA.5-adapted bivalent vaccine. The companies will supply the
original and bivalent vaccines under their existing supply
agreement with the U.S. government.
- European Union (EU) Regulatory Developments
- In September 2022, Pfizer and BioNTech announced a 30-µg
booster dose of the Omicron BA.1 bivalent vaccine (Comirnaty
Original/Omicron BA.1 15/15 µg) was recommended for conditional
marketing authorisation (CMA) by the European Medicines Agency’s
(EMA) Committee for Medicinal Products for Human Use (CHMP) for
individuals 12 years and older. The recommendation was subsequently
endorsed by the EC.
- In September 2022, Pfizer and BioNTech announced a 30-µg
booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent
vaccine (Comirnaty Original/Omicron BA.4/BA.5 15/15 µg) was
recommended for CMA by the EMA’s CHMP for individuals ages 12 years
and older. The recommendation was subsequently endorsed by the
EC.
- In September 2022, Pfizer and BioNTech announced that the CHMP
of the EMA has recommended converting the CMA for Comirnaty to
standard (also referred to as “full”) marketing authorization for
all authorized indications and formulations. The EC subsequently
endorsed the CHMP’s recommendation. The conversion to full
marketing authorization applies to all existing Comirnaty
indications and formulations authorized in the EU, including the
companies’ bivalent vaccines (Comirnaty Original/Omicron BA.1 and
Comirnaty Original/Omicron BA.4/BA.5) as booster doses for
individuals aged 12 and older in the EU.
- In September 2022, Pfizer and BioNTech announced they have
completed a submission to the EMA for a 10-µg booster dose of the
companies’ Omicron BA.4/BA.5-adapted bivalent vaccine (Comirnaty
Original/Omicron BA.4/BA.5 5/5 µg) for children 5 through 11 years
of age.
- In October 2022, the CHMP recommended marketing authorization
for a 3-µg dose of Comirnaty as a three-dose series for children
ages 6 months to less than 5 years of age. The recommendation was
subsequently endorsed by the EC.
- Myfembree (relugolix 40 mg, estradiol 1.0 mg and
norethindrone acetate 0.5 mg) -- In August 2022, Myovant
Sciences (Myovant) and Pfizer announced the FDA approved Myfembree
as a one-pill, once-a-day therapy for the management of moderate to
severe pain associated with endometriosis in pre-menopausal women,
with a treatment duration of up to 24 months. Myovant and Pfizer
will continue to jointly commercialize Myfembree in the U.S.
- Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir
tablets)(9) -- In September 2022, Pfizer announced an agreement
to supply up to six million treatment courses of Paxlovid to Global
Fund as part of its COVID-19 Response Mechanism. Paxlovid treatment
courses will be available for procurement through this mechanism,
subject to local regulatory authorization or approval, by the 132
grant-eligible countries determined by Global Fund based on income
classification and disease burden. Through Global Fund’s framework
and mechanism, eligible countries will be offered treatment courses
according to Pfizer’s tiered pricing approach, where all low- and
lower-middle-income countries will pay a not-for-profit price while
upper-middle-income countries will pay the price defined in
Pfizer’s tiered pricing approach.
- Prevnar 20/Apexxnar (pneumococcal 20-valent conjugate
vaccine)
- In August 2022, Pfizer announced positive top-line results from
its pivotal U.S. Phase 3 study in infants evaluating its 20-valent
pneumococcal conjugate vaccine candidate (20vPnC) for the
prevention of invasive pneumococcal disease (IPD) caused by the 20
Streptococcus pneumoniae (pneumococcus) serotypes contained in the
vaccine for the pediatric population. The study had two co-primary
objectives, associated with immunogenicity responses one month
after the third and fourth doses of the four-dose vaccination
series.
- All 20 serotypes met the co-primary objective of
non-inferiority (NI) of immunoglobin G (IgG) geometric mean
concentrations (GMCs) after Dose 4.
- Fourteen of the 20 serotypes met the co-primary objective of NI
of the percentage of participants with predefined serotype-specific
IgG concentrations after Dose 3 (two serotypes missed by a wider
margin while four narrowly missed).
- All serotypes met NI for the key secondary objective of IgG
GMCs after Dose 3.
- All 20 serotypes elicited robust functional responses (OPA) and
increases in antibody responses after Dose 4, with the totality of
data supporting the potential benefit of all serotypes in this
20-valent vaccine candidate.
- Overall, the safety profile of the 20vPnC candidate was
consistent with Prevnar 13 given in the same schedule.
- In September 2022, Pfizer announced positive top-line results
from its pivotal EU Phase 3 study in infants evaluating 20vPnC for
the prevention of IPD, pneumonia, and acute otitis media caused by
the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained
in the vaccine for the pediatric population. The study had three
co-primary outcomes, associated with immunogenicity responses one
month after the second and third doses of a three-dose vaccination
series.
- For the NI co-primary objective of IgG GMCs one month after
Dose 3 at 11-12 months of age, 19 of the 20 serotypes met the NI
criteria with only one serotype narrowly missing.
- For the NI co-primary objective of IgG GMCs one month after
Dose 2, 16 of the 20 serotypes met NI.
- For the NI co-primary objective of the percentage of
participants with predefined serotype-specific IgG concentrations
one month after Dose 2, nine of the 20 serotypes met the NI
criteria.
- All 20 serotypes showed increased booster responses from post
dose 2 to post dose 3, which are indicative of immunological memory
and long-term protection. All 20 vaccine serotypes also showed
strong functional antibody responses (OPA) post-dose 2 and post
dose 3 similar to Prevenar and Prevenar 13.
- The safety profile of 20vPnC was similar to Prevenar 13 in this
schedule.
- In October 2022, Pfizer announced the Centers for Disease
Control and Prevention (CDC)’s Advisory Committee on Immunization
Practices (ACIP) voted to recommend a single dose of Prevnar 20 to
help protect adults previously vaccinated with Prevnar 13 or both
Prevnar 13 and PPSV23 against invasive disease and pneumonia caused
by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in
Prevnar 20.
- In October 2022, Pfizer submitted and is awaiting acceptance of
a supplemental Biologics License Application (sBLA) to the FDA for
the pediatric population, based on the results of the Phase 3
clinical program, and is looking forward to working with the FDA on
their review of the application.
- Talzenna (talazoparib) -- In October 2022, Pfizer
announced positive topline results from the Phase 3 TALAPRO-2 study
of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor,
in combination with Xtandi (enzalutamide) compared to placebo plus
Xtandi in men with metastatic castration-resistant prostate cancer
(mCRPC), with or without homologous recombination repair (HRR) gene
mutations. The study met its primary endpoint with a statistically
significant and clinically meaningful improvement in radiographic
progression-free survival (rPFS) compared with placebo plus Xtandi,
exceeding the pre-specified hazard ratio of 0.696. At the time of
topline analysis, the safety of Talzenna plus Xtandi were generally
consistent with the known safety profile of each medicine.
- Xeljanz (tofacitinib) -- In October 2022, Pfizer
announced that the Pharmacovigilance Risk Assessment Committee
(PRAC) of the EMA has concluded their assessment of JAK inhibitors
authorized for the treatment of certain inflammatory diseases in
the EU and has provided updated recommendations for their use. PRAC
recommended that risk minimization measures, including special
warnings and precautions for use, should be revised for all JAK
inhibitors approved in the EU, including Xeljanz and Cibinqo. No
changes were recommended to the currently approved indications for
all JAK inhibitors.
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.
- Giroctocogene fitelparvovec (Hemophilia A Gene Therapy)
-- In September 2022, Pfizer and Sangamo Therapeutics announced
that the Phase 3 AFFINE study evaluating giroctocogene
fitelparvovec, an investigational gene therapy for patients with
moderately severe to severe hemophilia A, has re-opened
recruitment. Trial sites resumed enrollment in September, and
dosing is expected to resume shortly. All trial sites are
anticipated to be active by the end of 2022 and a pivotal readout
is expected in the first half of 2024.
- PF-06760805 (GBS6, Group B Streptococcus Vaccine
Candidate) -- In September 2022, Pfizer announced its
investigational Group B Streptococcus (GBS) vaccine candidate,
PF-06760805, received Breakthrough Therapy Designation from the FDA
for the prevention of invasive GBS disease due to the vaccine
serotypes in newborns and young infants by active immunization of
their mothers during pregnancy. The FDA decision was informed by
the interim analysis of a placebo-controlled Phase 2 study,
evaluating the safety and immunogenicity of PF-06760805 in healthy
pregnant women aged 18 to 40 years, who were vaccinated during the
second or early third trimester of pregnancy. The study remains
ongoing, and Pfizer will publish outcomes from this clinical trial
when it is completed.
- PF-06886992 (Pentavalent (MenABCWY) Meningococcal Vaccine
Candidate) -- In September 2022, Pfizer announced positive
top-line results from the pivotal Phase 3 trial assessing the
safety, tolerability, and immunogenicity of its investigational
pentavalent meningococcal vaccine (MenABCWY) in healthy individuals
10 through 25 years of age. The trial met all primary and secondary
endpoints, with the investigational vaccine demonstrating
non-inferiority to licensed vaccines for the five meningococcal
serogroups that cause the majority of invasive meningococcal
disease. Based on these Phase 3 results, which meet pre-determined
criteria for licensure, Pfizer intends to submit a Biologics
License Application (BLA) to the FDA in the fourth quarter of this
year. Submissions to additional regulatory authorities outside the
U.S. are also planned. If approved, PF-06886992 could help simplify
the meningococcal vaccination schedule and provide the broadest
serogroup coverage of any meningococcal vaccine.
- PF-07252220 (Influenza mRNA Vaccine Candidate) -- In
September 2022, Pfizer announced that the first participants have
been dosed in a pivotal Phase 3 clinical trial to evaluate the
efficacy, safety, tolerability and immunogenicity of the company’s
quadrivalent modified RNA (modRNA) influenza vaccine candidate in
approximately 25,000 healthy U.S. adults. The quadrivalent modRNA
vaccine candidate will encode World Health Organization recommended
strains for the Northern Hemisphere 2022-23 cell culture- or
recombinant-based influenza vaccines.
- PF-07265803 (LMNA-Related Dilated Cardiomyopathy) -- In
August 2022, Pfizer announced that an interim futility analysis of
the global Phase 3 trial, REALM-DCM, designed to evaluate the
efficacy and safety of PF-07265803 in patients with symptomatic
dilated cardiomyopathy (DCM) due to a mutation of the gene encoding
the lamin A/C protein (LMNA), indicated the trial is unlikely to
meet its primary endpoint upon completion. Based on these results,
the Phase 3 trial and further development of PF-07265803 have been
discontinued. This decision was not based on safety concerns.
- Ritlecitinib (PF-06651600) -- In September 2022, Pfizer
announced the FDA accepted for filing the New Drug Application
(NDA) for ritlecitinib for adults and adolescents 12 years of age
and older with alopecia areata. The FDA is expected to make a
decision in the second-quarter 2023. The EMA has also accepted the
Marketing Authorisation Application for ritlecitinib in the same
patient population with a decision anticipated in fourth-quarter
2023. Additionally, Pfizer has completed regulatory submissions for
ritlecitinib in the United Kingdom, China and Japan, and expects
decisions in 2023. Ritlecitinib is an investigational oral
once-daily treatment that is the first in a new class of oral
highly selective kinase inhibitors that is a dual inhibitor of the
TEC family of tyrosine-protein kinases and of Janus kinase 3
(JAK3).
- RSVpreF (Respiratory Syncytial Virus (RSV) Bivalent Vaccine
Candidate)
- In August 2022, Pfizer announced positive top-line data from
the Phase 3 clinical trial RENOIR (RSV vaccine Efficacy study iN Older
adults Immunized against
RSV disease) investigating its
bivalent RSV prefusion F vaccine candidate, RSVpreF, when
administered to adults 60 years of age or older. The bivalent
vaccine candidate is composed of two preF proteins selected to
optimize protection against RSV A and B strains. A pre-planned,
interim analysis of efficacy conducted by an independent, external
Data Monitoring Committee (DMC) to assess protection against
RSV-associated lower respiratory tract illness (LRTI-RSV) defined
by two or more symptoms demonstrated vaccine efficacy of 66.7%
(96.66% CI: 28.8%, 85.8%). This positive result enabled Pfizer to
look at the more severe disease primary endpoint of LRTI-RSV
defined by three or more symptoms, where vaccine efficacy of 85.7%
(96.66% CI: 32.0%, 98.7%) was observed. The DMC also indicated the
investigational vaccine was well-tolerated, with no safety
concerns.
- Earlier today, Pfizer announced positive top-line data from the
Phase 3 MATISSE (MATernal
Immunization Study for Safety and Efficacy) trial investigating RSVpreF when
administered to pregnant participants to help protect their infants
from RSV disease after birth. The observed efficacy for severe
medically attended lower respiratory tract illness (severe MA-LRTI)
was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life.
Substantial efficacy of 69.4% (CI: 44.3%, 84.1%) was demonstrated
for infants over the six-month follow-up period. Although the
statistical success criterion was not met for the second primary
endpoint, clinically meaningful efficacy was observed for MA-LRTI
of 57.1% (CI: 14.7%, 79.8%) in infants from birth through the first
90 days of life. Efficacy for MA-LRTI of 51.3% (CI: 29.4%, 66.8%)
was observed over the six-month follow up period. Pre-planned
safety reviews indicate the investigational vaccine is
well-tolerated with no safety concerns for both the vaccinated
individuals and their newborns. Based on these positive results,
Pfizer plans to submit a BLA to the FDA by the end of 2022,
followed by other regulatory authorities in the coming months.
Pfizer is the only company with an investigational vaccine being
prepared for regulatory applications for both infants through
maternal immunization and older adults to help protect against
RSV.
- TTI-622 (Signal-Regulatory Protein α-Fc Fusion Protein)
-- In August 2022, Pfizer and Sanofi U.S. Services Inc. (Sanofi)
entered into a clinical trial collaboration and supply agreement to
investigate the immunotherapeutic combination of Pfizer’s TTI-622,
a novel SIRPα-Fc fusion protein, and SARCLISA(10) (isatuximab-irfc)
plus carfilzomib and dexamethasone in patients with relapsed or
refractory multiple myeloma (RRMM) after 1-3 prior lines of
therapy. Under the terms of the agreement, Pfizer will determine
the recommended dose of TTI-622 in the multicenter, Phase 1b/2
study of TTI-622 with SARCLISA plus carfilzomib and dexamethasone
for patients with RRMM. Sanofi will provide SARCLISA for the study,
which is sponsored and funded by Pfizer and conducted in North
America.
- VLA15 (Lyme Disease Vaccine Candidate) -- In August
2022, Pfizer and Valneva SE (Valneva) announced the initiation of a
Phase 3 clinical study, Vaccine Against Lyme for Outdoor
Recreationists (VALOR), to investigate the efficacy, safety and
immunogenicity of their investigational Lyme disease vaccine
candidate, VLA15. The randomized, placebo-controlled, Phase 3 VALOR
study is planned to enroll approximately 6,000 participants 5 years
of age and older at up 50 sites located in areas where Lyme disease
is highly endemic, including Finland, Germany, the Netherlands,
Poland, Sweden and the U.S.
Corporate Developments
- In October 2022, Pfizer announced the completion of its
acquisition of all the outstanding shares of Biohaven not already
owned by Pfizer for $148.50 per share in cash, for payments of
approximately $11.5 billion, plus repayment of third-party debt of
$863 million and redemption of Biohaven’s redeemable preferred
stock for $495 million. Biohaven brings to Pfizer a portfolio of
promising calcitonin gene-related peptide (CGRP) antagonists
including rimegepant (marketed as Nurtec ODT in the U.S. and Vydura
in Europe), zavegepant (currently under FDA review with a potential
regulatory decision expected in the first quarter of 2023) and a
portfolio of pre-clinical CGRP assets. 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-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.
- In October 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.
The acquisition reinforces Pfizer’s commitment to patients with
sickle cell disease (SCD), building on a 30-year legacy in the rare
hematology space. GBT brings to Pfizer a portfolio and pipeline
that has the potential to address the full spectrum of critical
needs for this underserved community, including Oxbryta (voxelotor)
tablets, a first-in-class medicine that directly targets the root
cause of SCD, as well as GBT021601 (GBT601) and inclaclumab, both
of which have received Orphan Drug and Rare Pediatric Disease
designations from the FDA.
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/Q3-2022-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 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 therapeutic area. 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 $7
million and $108 million for the third quarter and first nine
months of 2022, respectively, and $187 million and $274 million for
the third quarter and the first nine months of 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 EPS attributable to Pfizer Inc. common
shareholders—diluted before the impact of amortization of
intangible assets, certain acquisition-related items, discontinued
operations and certain significant items. See the accompanying
reconciliations of certain GAAP Reported to Non-GAAP Adjusted
information for the third quarter and the first nine months of 2022
and 2021. 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
July 3, 2022 and the accompanying Non-GAAP Financial Measure:
Adjusted Income section of this press release 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 pending litigation,
unusual gains and losses, certain acquisition-related expenses,
gains and losses from equity securities, actuarial gains and losses
from pension and postretirement plan remeasurements and potential
future asset impairments 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 2022 reflects the
following:
- Does not assume the completion of any business development
transactions not completed as of October 2, 2022, except for the
acquisitions of Biohaven Pharmaceutical Holding Company Ltd.
(Biohaven) and Global Blood Therapeutics, Inc., which closed in the
first week of October 2022, as well as signed transactions, if any,
through mid-October 2022, which are expected to give rise to
acquired in-process R&D (IPR&D) expenses during fiscal
2022.
- Reflects an anticipated incremental negative impact of $0.19 on
Adjusted diluted EPS(3) related to the inclusion of all acquired
IPR&D expenses that have been incurred or are expected to be
incurred for transactions signed as of mid-October 2022, which
would have been excluded from Adjusted(3) results under our
previous accounting policy on non-GAAP measures.
- Includes Pfizer’s pro rata share of Haleon plc’s (Haleon)(7)
anticipated earnings, which is recorded in Adjusted other
(income)/deductions(3) on a one-quarter lag, and assumes no changes
to Pfizer’s 32% ownership stake in Haleon in 2022.
- Includes an estimated benefit of approximately $0.06 on
Adjusted diluted EPS(3) resulting from a change in policy for
intangible amortization expense in which Pfizer began excluding all
amortization of intangibles from Adjusted income(3) compared to
excluding only amortization of intangibles related to large mergers
or acquisitions under the prior methodology. This change went into
effect beginning in the first quarter of 2022 and prior period
amounts have been revised to conform to the new policy.
- Reflects an anticipated negative revenue impact of $0.7 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
2022.
- Exchange rates assumed are a blend of actual rates in effect
through third-quarter 2022 and mid-October 2022 rates for the
remainder of the year. Financial guidance reflects the anticipated
unfavorable impact of approximately $5.7 billion on revenues and
approximately $0.44 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 2021.
- Guidance for Adjusted diluted EPS(3) assumes diluted
weighted-average shares outstanding of approximately 5.75 billion
shares, which assumes only share repurchases completed to date in
2022.
(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 third quarter and first nine
months for U.S. subsidiaries reflects the three and nine months
ended on October 2, 2022 and October 3, 2021, 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 28,
2022 and August 29, 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 launches. Biopharma, Pfizer’s
innovative science-based biopharmaceutical business, is operating
under a new commercial structure which is designed to better
support and optimize its performance across three broad therapeutic
areas:
- Primary Care, consisting of the former Internal Medicine and
Vaccines product portfolios, as well as COVID-19 products and
potential future mRNA 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 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 July 3, 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 Emergency Use Authorization
(EUA), for the treatment of mild-to-moderate Coronavirus Disease
2019 (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 vaccines have been authorized by the FDA
under an EUA to prevent COVID-19 in individuals aged 6 months and
older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and
older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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 FD&C Act unless the
declaration is terminated or authorization revoked sooner. Please
see the EUA Fact Sheets at www.covid19oralrx.com and
www.cvdvaccine-us.com.
(10) SARCLISA® is a trademark of Sanofi Corporation.
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is
as of November 1, 2022. 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, 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
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), including the impact of vaccine
mandates where applicable, 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 a vaccine to help prevent COVID-19 and an oral
COVID-19 treatment, 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 other 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 other 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 other future COVID-19 treatment to be
effective against, COVID-19 caused by emerging virus variants; the
risk that more widespread use of the 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 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 these and any 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
potential 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, 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 other future COVID-19 treatment and/or any drug
applications for any indication for Paxlovid or any other 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 other 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 development of products or therapies 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 or no longer exist
which may lead to reduced revenues or excess inventory; the
possibility that COVID-19 will diminish in severity or prevalence,
or disappear entirely; 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; 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;
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 or scale up manufacturing
capacity on a timely basis or maintain access to logistics or
supply channels commensurate with global demand for our vaccine or
any treatment for COVID-19, which would negatively impact our
ability to supply the estimated numbers of doses of our vaccine or
treatment courses of Paxlovid within the projected time periods;
risks related to our ability to achieve our revenue forecasts for
Comirnaty and Paxlovid or any potential future COVID-19 vaccines or
treatments; whether and when additional supply or purchase
agreements will be reached; 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 or awareness of our
COVID-19 vaccine or Paxlovid, including challenges driven by
misinformation, access, concerns about clinical data integrity and
prescriber and pharmacy education; trade restrictions; potential
third-party royalties or other claims related to our COVID-19
vaccine 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 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;
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, as well as the impact of political
unrest or civil unrest or military action, including the ongoing
conflict between Russia and Ukraine and the continued economic
consequences, unstable governments and legal systems and
inter-governmental disputes;
- 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 adequacy of reserves related to legal proceedings;
- the risk and impact of tax related litigation;
- 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 potential adoption
of global minimum taxation requirements 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, extortion or integrity compromise resulting from a
cyber-attack or other malfeasance by third parties, including, 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 patents and other intellectual
property, such as against claims of invalidity that could result in
loss of exclusivity; claims of patent infringement, including
asserted and/or unasserted intellectual property claims; challenges
faced by our collaboration or licensing partners to the validity of
their patent rights; and 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 for or agreeing not to enforce or being restricted from
enforcing intellectual property related to our products, including
our vaccine to help prevent COVID-19 and our oral COVID-19
treatment.
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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