- Second-Quarter 2022 Revenues of $27.7 Billion, Reflecting 53%
Operational Growth, Driven Primarily by Strong Contributions from
Paxlovid and Comirnaty(1)
- Second-Quarter 2022 Reported Diluted EPS(2) of $1.73,
Reflecting 77% Growth Over Second-Quarter 2021
- Second-Quarter 2022 Adjusted Diluted EPS(3) of $2.04,
Reflecting 92% Growth Over Second-Quarter 2021; Excluding Foreign
Exchange Impacts, Adjusted Diluted EPS(3) Grew 100%
- Raises Full-Year 2022 Financial Guidance(4) for Revenues and
Adjusted Diluted EPS(3) by $2 Billion and $0.24, Respectively, on
an Operational Basis (Which Excludes the Impact of Foreign
Exchange)
- Including Foreign Exchange Impacts, Pfizer Reaffirms Revenue
Guidance of $98.0 to $102.0 Billion and Raises Lower End of
Adjusted Diluted EPS(3) Guidance by $0.05 to a Range of $6.30 to
$6.45
- Reaffirms 2022 Revenue Guidance for Comirnaty(1) and Paxlovid
of ~$32 Billion and ~$22 Billion, Respectively, Despite Unfavorable
Impacts from Foreign Exchange
- Pipeline Programs That Have Achieved Milestones Since Previous
Earnings Release Include Bivalent mRNA COVID-19 Vaccine, Enhanced
mRNA COVID-19 Vaccine, Paxlovid, modRNA Influenza Vaccine,
Once-Daily Oral GLP-1 Receptor Agonist and Anti-Interferon-β
Pfizer Inc. (NYSE: PFE) reported strong financial results for
second-quarter 2022 and updated certain components of 2022
financial guidance(4). Pfizer reaffirmed its previous 2022 revenue
guidance, despite unfavorable impacts from foreign exchange, while
reaffirming its revenue guidance for Comirnaty(1), the
Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and for Paxlovid,
its oral COVID-19 treatment.
The second-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:
“In multiple meaningful ways, we made significant progress this
quarter on our strategies to bring value to our patients and
shareholders, while also making commitments to prioritize the
broader needs of the world, including those of the environment and
our most vulnerable populations. For example, we set an ambitious
goal for ourselves to achieve the Net-Zero Standard for greenhouse
gas emissions by 2040, ten years ahead of the timeline described in
the standard. We also launched an initiative to help bring all of
our current and future patented medicines and vaccines to the 1.2
billion people living in 45 lower-income countries around the world
at not-for-profit prices, a first in the industry.”
Dr. Bourla continued: “Even while launching these initiatives to
support a healthier, more equitable world, we remain equally
committed to strong financial execution on behalf of our
shareholders. In the second quarter, we recorded the largest amount
of quarterly sales in our history. We also presented potentially
best-in-class data for etrasimod and announced the proposed
strategic acquisition of Biohaven, both of which are closely tied
to our purpose: Breakthroughs that change patients’ lives.”
David Denton, Chief Financial Officer and Executive Vice
President, stated: “I am very pleased with the performance of our
business this quarter, with strong operational revenue and earnings
growth driven by multiple therapeutic areas across the company, and
our COVID-19 franchises continuing to serve patients in need while
also propelling us to an all-time high in quarterly sales. We
continue to prioritize high-value uses for our capital, with an
emphasis on reinvesting in our business by funding both internally
and externally developed science and innovation while also
continuing to grow our dividend and buy back shares, when
appropriate, to help offset dilution. I am confident that Pfizer is
well-positioned to continue to deliver exceptional value for our
patients and shareholders going forward.”
Results for the second quarter and the first six months of 2022
and 2021(5) are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts)
Second-Quarter
Six Months
2022
2021
Change
2022
2021
Change
Revenues
$ 27,742
$ 18,899
47
%
$ 53,402
$ 33,415
60
%
Reported Net Income(2)
9,906
5,563
78
%
17,769
10,440
70
%
Reported Diluted EPS(2)
1.73
0.98
77
%
3.10
1.84
68
%
Adjusted Income(3)
11,656
6,023
94
%
20,993
11,375
85
%
Adjusted Diluted EPS(3)
2.04
1.06
92
%
3.66
2.01
82
%
REVENUES
($ in millions)
Second-Quarter
Six Months
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Pfizer Biopharmaceuticals Group
(Biopharma)
$ 27,425
$ 18,463
49
%
55
%
$ 52,748
$ 32,588
62
%
68
%
Vaccines
10,459
9,234
13
%
20
%
25,399
14,127
80
%
87
%
Hospital
9,714
1,745
*
*
12,905
3,630
*
*
Oncology
3,088
3,145
(2
%)
1
%
6,055
6,007
1
%
3
%
Internal Medicine
2,405
2,403
—
5
%
4,846
4,997
(3
%)
1
%
Rare Disease
909
895
2
%
7
%
1,872
1,720
9
%
15
%
Inflammation & Immunology
850
1,041
(18
%)
(14
%)
1,671
2,107
(21
%)
(17
%)
Pfizer CentreOne
$ 317
$ 437
(27
%)
(25
%)
655
827
(21
%)
(18
%)
TOTAL REVENUES
$ 27,742
$ 18,899
47
%
53
%
$ 53,402
$ 33,415
60
%
66
%
* Indicates calculation not
meaningful.
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 had no
impact on Adjusted(3) diluted EPS in second-quarter 2022 and
negatively impacted Adjusted(3) diluted EPS by $0.03 in
second-quarter 2021.
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 $0.02 in second-quarter 2022 and by $0.03 in second-quarter
2021.
Prior period amounts have been revised to conform to the current
period presentation for both amortization of intangibles and
acquired IPR&D.
Business development activities(6) 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(7).
2022 FINANCIAL GUIDANCE(4)
Pfizer raised its 2022 financial guidance, on an operational
basis(7), for revenues and Adjusted diluted EPS(3) by approximately
$2 billion and $0.24, respectively. After including the expected
incremental unfavorable impacts of changes in foreign exchange
rates since last quarter’s earnings report, the guidance range for
revenues remains unchanged and the bottom end of the guidance range
for Adjusted diluted EPS(3) was increased by $0.05.
Previous Guidance
(as of May 3, 2022)
Operational
Changes
Impact of
Changes in
Foreign
Exchange
Rates
Current Guidance
(as of July 28, 2022)
Revenues
$98.0 to $102.0
billion
~$2 billion
(~$2 billion)
$98.0 to $102.0
billion
Operational Growth(7) vs. Prior
Year
25% to 30%
27% to 32%
Growth vs. Prior Year
21% to 25%
21% to 25%
Adjusted Diluted
EPS(3)
$6.25 to $6.45
$0.24
($0.19)
$6.30 to $6.45
Operational Growth(7) vs. Prior Year
59% to 64%
63% to 67%
Growth vs. Prior Year
54% to 59%
55% to 59%
The midpoint of the guidance range for revenues reflects a 29%
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 $32 billion, which
reflects favorable operational updates compared to prior guidance,
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-July 2022.
- Paxlovid revenues of approximately $22 billion, which reflects
favorable operational updates compared to prior guidance, offset by
unfavorable incremental impacts from foreign exchange. This
guidance includes treatment courses expected to be delivered in
fiscal 2022(5), primarily relating to supply contracts signed or
committed as of mid-July 2022.
The midpoint of the guidance range for Adjusted diluted EPS(3)
reflects a 65% operational increase 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 $0.03 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
32.0% to 34.0%
Adjusted(3) SI&A Expenses
$12.2 to $13.2 billion
(previously $12.5 to $13.5
billion)
Adjusted(3) R&D Expenses
$11.5 to $12.0 billion
(previously $11.0 to $12.0
billion)
Acquired IPR&D Expenses(4)
Approximately $0.9 billion
Adjusted(3) Other (Income)/Deductions
Approximately $1.9 billion of
income
Effective Tax Rate on Adjusted(3)
Income
Approximately 15.5%
(previously approximately
16.0%)
Guidance for Adjusted(3) SI&A expenses was decreased by $300
million compared to the previous guidance range, primarily
reflecting lower expected selling expenses for certain products and
geographies, as well as a decline in deferred compensation savings
plan expenses, which are tied to market performance.
The midpoint of the guidance range for Adjusted(3) R&D
expenses was increased by $250 million compared to the previous
guidance, primarily as a result of planned incremental investments
in mRNA vaccine programs outside of COVID-19 as well as various
other projects.
Guidance for the effective tax rate on Adjusted(3) income was
lowered by 0.5 percentage points compared to the previous guidance,
reflecting favorability in the jurisdictional mix of earnings,
settlements of global tax examinations and the expiration of local
statutes of limitations, among other drivers.
CAPITAL ALLOCATION
During the first six 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:
- $5.1 billion invested in internal research and development
projects, and
- More than $7 billion invested in completed business development
transactions, including approximately $6.3 billion for the
acquisition of Arena Pharmaceuticals, Inc.
- Returning capital directly to shareholders through a
combination of:
- $4.5 billion of cash dividends, or $0.80 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, in the
first six months of 2022, Pfizer announced the acquisitions of
ReViral Ltd. (ReViral), which closed in the international third
quarter of 2022, and Biohaven Pharmaceutical Holding Company Ltd.
(Biohaven), which, upon completion, will require upfront capital
investments totaling approximately $13.3 billion.
As of July 28, 2022, Pfizer’s remaining share repurchase
authorization is $3.3 billion. Current financial guidance does not
anticipate any additional share repurchases in 2022.
Second-quarter 2022 diluted weighted-average shares outstanding
used to calculate Reported(2) and Adjusted(3) diluted EPS was 5,712
million shares, an increase of 35 million shares, primarily due to
shares issued for employee compensation programs, partially offset
by the impact of shares repurchased in first-quarter 2022, which
resulted in a $0.01 reduction to Reported(2) and Adjusted(3)
diluted EPS compared to the prior-year quarter.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2022 vs.
Second-Quarter 2021)
Second-quarter 2022 revenues totaled $27.7 billion, an increase
of $8.8 billion, or 47%, compared to the prior-year quarter,
reflecting operational growth of $10.1 billion, or 53%, as well as
an unfavorable impact of foreign exchange of $1.3 billion, or 7%.
Excluding growth from Paxlovid and Comirnaty(1), company revenues
grew $128 million, or 1%, operationally.
Second-quarter 2022 operational growth was primarily driven
by:
- Paxlovid, which contributed $8.1 billion in global sales,
driven by the U.S. launch under emergency use authorization in
December 2021 and international launches in late 2021 and early
2022 following regulatory approvals or emergency use
authorizations;
- Comirnaty(1) globally, up 20% operationally, driven by strong
operational growth in international markets, led by increased sales
of doses to serve emerging markets and increased deliveries to
certain international developed markets, partially offset by a
slower pace of deliveries to the U.S. and Canada;
- Eliquis globally, up 23% operationally, driven primarily by
continued oral anti-coagulant adoption and market share gains in
non-valvular atrial fibrillation, particularly in the U.S. and
certain markets in Europe, as well as favorable changes in channel
mix in the U.S.;
- Prevnar family (Prevnar 13 & 20) in the U.S., up 41%,
driven by strong stocking and patient demand following the launch
of Prevnar 20 for the adult population, partially offset by
unfavorable timing of government and private purchasing of Prevnar
13 for the pediatric indication; and
- Vyndaqel/Vyndamax globally, up 16% 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 which recently went into effect
in Japan,
partially offset primarily by lower revenues for:
- Chantix globally, down 99% operationally, which continues to be
negatively impacted by a global pause in shipments of Chantix due
to the presence of N-nitroso-varenicline above an acceptable level
of intake set by various global regulators, the ultimate timing for
resolution of which may vary by country;
- Xeljanz in the U.S., down 35%, driven primarily by declines in
net price due to unfavorable changes in channel mix, decreased
prescription volumes resulting from ongoing shifts in prescribing
patterns related to Janus kinase (JAK) class label changes, and
unfavorable wholesaler inventory buying patterns; and
- Sutent globally, down 47% operationally, primarily reflecting
lower volume demand in the U.S. and Europe following its loss of
exclusivity in August 2021 and January 2022, respectively.
GAAP Reported(2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES(2)
($ in millions)
Second-Quarter
Six Months
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Cost of Sales(2)
$ 8,648
$ 6,996
24
%
34
%
$ 18,632
$ 11,153
67
%
78
%
Percent of Revenues
31.2
%
37.0
%
N/A
N/A
34.9
%
33.4
%
N/A
N/A
SI&A Expenses(2)
3,048
2,923
4
%
7
%
5,642
5,700
(1
%)
1
%
R&D Expenses(2)
2,815
2,239
26
%
27
%
5,116
4,233
21
%
22
%
Acquired IPR&D Expenses(2)
1
219
(100
%)
(100
%)
356
238
50
%
50
%
Other (Income)/Deductions––net(2)
$772
($1,343
)
*
*
$1,122
($2,347
)
*
*
Effective Tax Rate on Reported
Income(2)
13.7
%
16.2
%
13.4
%
15.3
%
* Indicates calculation not
meaningful.
Second-quarter 2022 Cost of Sales(2) as a percentage of revenues
decreased 5.8 percentage points compared with the prior-year
quarter. The drivers for the decrease include, among other
things:
- favorable changes in sales mix, including significant sales of
Paxlovid as well as higher alliance revenues, which have no
associated cost of sales; and
- favorable impacts resulting from changes in foreign exchange
rates,
partially offset by:
- higher sales of Comirnaty(1), which includes a charge for the
50% gross profit split with BioNTech and applicable royalty
expenses; and
- a $450 million write-off of inventory related to COVID-19
products that have exceeded or are expected to exceed their
approved shelf-lives prior to being used.
SI&A Expenses(2) increased 7% operationally in
second-quarter 2022 compared with the prior-year quarter, primarily
reflecting higher investments for Paxlovid and Comirnaty and a
higher provision for healthcare reform fees based on sales of
Paxlovid and Comirnaty, partially offset by a decrease in deferred
compensation savings plan expenses.
Second-quarter 2022 R&D Expenses(2) increased 27%
operationally compared with the prior-year quarter, primarily
driven by increased investments across multiple late-stage clinical
programs, including development costs and at-risk manufacturing for
programs to prevent and treat COVID-19, as well as costs to develop
recently acquired assets.
Acquired IPR&D Expenses(2) decreased 100% operationally in
second-quarter 2022 compared with the prior-year quarter, primarily
reflecting the acquisition of Amplyx Pharmaceuticals, Inc. in
second-quarter 2021, and no transactions giving rise to acquired
IPR&D expenses in second-quarter 2022.
Pfizer recorded $772 million of other deductions––net(2) in
second-quarter 2022 compared with $1.3 billion of other
income––net(2) in second-quarter 2021. The period-over-period
change was primarily driven by:
- net losses on equity securities in second-quarter 2022 versus
net gains on equity securities recognized in the prior-year
quarter; and
- net periodic benefit costs associated with pension and
postretirement plans incurred in second-quarter 2022 versus net
periodic benefit credits recognized in second-quarter 2021.
Pfizer’s effective tax rate on Reported income(2) for
second-quarter 2022 decreased compared to the prior-year quarter
primarily due to a favorable change in the jurisdictional mix of
earnings.
Adjusted(3) Income Statement Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions)
Second-Quarter
Six Months
2022
2021
% Change
2022
2021
% Change
Total
Oper.
Total
Oper.
Adjusted(3) Cost of Sales
$ 8,625
$ 6,949
24
%
35
%
$ 18,582
$ 11,076
68
%
79
%
Percent of Revenues
31.1
%
36.8
%
N/A
N/A
34.8
%
33.1
%
N/A
N/A
Adjusted(3) SI&A Expenses
2,900
2,778
4
%
7
%
5,396
5,421
—
2
%
Adjusted(3) R&D Expenses
2,811
2,237
26
%
27
%
5,106
4,229
21
%
22
%
Adjusted(3) Other
(Income)/Deductions––net
($377
)
($576
)
(34
%)
(16
%)
($783
)
($1,177
)
(33
%)
(22
%)
Effective Tax Rate on Adjusted
Income(3)
15.4
%
17.1
%
15.1
%
16.3
%
* Indicates calculation not
meaningful.
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 May 3, 2022)
Product Developments
- Comirnaty (COVID-19 vaccine, mRNA)(8)
- Clinical and Research Developments
- In May 2022, Pfizer and BioNTech announced topline safety,
immunogenicity and vaccine efficacy data from a Phase 2/3 trial
evaluating a third 3-µg dose of the vaccine in children 6 months to
under 5 years of age. Following a third dose in this age group, the
vaccine was found to elicit a strong immune response, with a
favorable safety profile similar to placebo. A formal analysis will
be performed when at least 21 cases have accrued from seven days
after the third dose, and will be shared once available.
- In June 2022, Pfizer and BioNTech announced positive data
evaluating the safety, tolerability and immunogenicity of two
Omicron-adapted COVID-19 vaccine candidates: one monovalent and the
other bivalent, a combination of the current COVID-19 vaccine and a
vaccine candidate targeting the spike protein of the Omicron BA.1
variant of concern. Data from the Phase 2/3 trial found that a
booster dose of both Omicron-adapted vaccine candidates elicited a
substantially higher immune response against Omicron BA.1 as
compared to the companies’ current COVID-19 vaccine. The robust
immune response was seen across two investigational dose levels,
30-µg and 60-µg. One month after administration, a booster dose of
the Omicron-adapted monovalent candidates (30-µg and 60-µg)
increased neutralizing geometric mean titers (GMT) against Omicron
BA.1 13.5 and 19.6-fold above pre-booster dose levels, while a
booster dose of the Omicron-adapted bivalent candidates conferred a
9.1 and 10.9-fold increase in neutralizing GMTs against Omicron
BA.1. Both Omicron-adapted vaccine candidates were well-tolerated
in participants who received one or the other Omicron-adapted
vaccine.
- In July 2022, Pfizer and BioNTech announced the initiation of a
randomized, active-controlled, observer-blind, Phase 2 study to
evaluate the safety, tolerability, and immune response of an
enhanced COVID-19 mRNA-based vaccine candidate at a 30-µg dose
level. This next-generation bivalent COVID-19 vaccine candidate,
BNT162b5, consists of RNAs encoding enhanced prefusion spike
proteins for the SARS-CoV-2 ancestral strain (wild-type) and an
Omicron variant. The enhanced spike protein encoded from the mRNAs
in BNT162b5 have been modified with the aim of increasing the
magnitude and breadth of the immune response that could better
protect against COVID-19. This is the first of multiple vaccine
candidates with an enhanced design which the companies plan to
evaluate as part of a long-term scientific COVID-19 vaccine
strategy to potentially generate more robust, longer-lasting and
broader immune responses against SARS-CoV-2 infections and
associated COVID-19.
- Regulatory Developments
- In May 2022, Pfizer and BioNTech announced that the U.S. Food
and Drug Administration (FDA) expanded the emergency use
authorization (EUA) for Comirnaty to include a booster dose after
completion of the primary series of the vaccine in children 5
through 11 years of age. The 10-µg booster dose is given at least
five months after the second dose of the two-dose 10-µg primary
series.
- In June 2022, the FDA’s Vaccines and Related Biological
Products Advisory Committee (VRBPAC) voted to include a SARS-CoV-2
Omicron component for COVID-19 boosters in the U.S. for the fall of
2022. Following the meeting, an official recommendation stated that
the FDA has asked manufacturers, including Pfizer, to develop and
begin clinical trials with a modified vaccine containing an Omicron
BA.4/BA.5 component.
- In June 2022, Pfizer and BioNTech announced that the European
Medicines Agency (EMA) has initiated a rolling review for a
variant-adapted version of the companies’ COVID-19 vaccine. This
rolling review is initially based on chemistry, manufacturing, and
controls (CMC) data shared with EMA earlier in June. As clinical
data become available, including data on immunogenicity against
Omicron and its subvariants, it will be added to the rolling
submission.
- In June 2022, Pfizer and BioNTech announced the FDA granted EUA
of Comirnaty as a three 3-µg dose series for children 6 months
through 4 years of age (also referred to as 6 months to less than 5
years of age). The 3-µg dose was carefully selected as the
preferred dose for children under 5 years of age based on safety,
tolerability and immunogenicity data.
- In July 2022, Pfizer and BioNTech announced that the companies
have submitted a variation to the EMA requesting to update the
Conditional Marketing Authorization (CMA) in the European Union
(EU) with data supporting the vaccination of children ages 6 months
to less than 5 years of age with the 3-µg dose of Comirnaty as a
three-dose series.
- In July 2022, Pfizer and BioNTech announced the FDA approved
the companies’ supplemental Biologics License Application (sBLA)
for Comirnaty to include individuals 12 through 15 years of age.
The vaccine was previously made available to this age group in the
U.S. under EUA, and to date more than 9 million 12- to 15-year-old
adolescents in the U.S. have completed a primary series. Pfizer and
BioNTech have also filed for regulatory approval of the vaccine for
this age group with the EMA and other regulatory authorities around
the world.
- Commercial Developments
- In May 2022, Pfizer and BioNTech announced an agreement with
the European Commission (EC) to amend their originally agreed
contractual delivery schedules for Comirnaty. The amendment
rephases planned deliveries to help support the EC and Member
States' ongoing immunization programs and is aligned to the
companies’ commitment to working collaboratively to identify
pragmatic solutions to address the evolving pandemic needs. Doses
scheduled for delivery in June through August 2022 will now be
delivered in September through fourth-quarter 2022. This change of
delivery schedule did not impact the companies’ full-year 2022
revenue guidance or the full-year commitment of doses to be
delivered to EC Member States in 2022.
- In June 2022, Pfizer and BioNTech announced a new vaccine
supply agreement with the U.S. government to provide an additional
105 million COVID-19 doses (30-µg, 10-µg and 3-µg) that may include
adult Omicron-adapted COVID-19 vaccines, subject to authorization
from the FDA. The doses are planned to be delivered as soon as late
summer 2022 and continue into the fourth quarter of this year. The
U.S. government will pay the companies $3.2 billion upon delivery
of the first 105 million doses. The U.S. government also has the
option to purchase up to 195 million additional doses, bringing the
total number of potential doses to 300 million.
- Ibrance (palbociclib)
- In May 2022, Pfizer announced the presentation of real-world
evidence of 2,888 patients demonstrating an associated benefit for
hormone receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) metastatic breast cancer (mBC) patients
treated with Ibrance in combination with an aromatase inhibitor
(AI), as compared to AI alone, in the first-line setting. After
balancing for baseline demographic and clinical characteristics,
palbociclib + AI versus AI alone was associated with a 24%
reduction in the risk of death (HR=0.76 [95% CI, 0.65–0.87]) and a
30% reduction in the risk of disease progression (HR=0.70 [95% CI,
0.62–0.78]) in the observational, retrospective real-world
analysis. Safety data were not collected as part of this
analysis.
- In June 2022, Pfizer announced overall survival (OS) results
from the Phase 3 PALOMA-2 trial, which evaluated Ibrance in
combination with letrozole compared to placebo plus letrozole for
the first-line treatment of postmenopausal women with estrogen
receptor-positive (ER+), HER2- mBC. With a median follow-up of 90
months, patients receiving Ibrance in combination with letrozole
had numerically longer OS compared to placebo plus letrozole
(median (95% CI) 53.9 months (49.8–60.8) vs median 51.2 months
(43.7–58.9)); the results were not statistically significant. The
PALOMA-2 trial was designed for a primary endpoint of
progression-free survival (PFS), which was met in 2016, with OS as
one of the secondary endpoints.
- Myfembree (relugolix 40 mg, estradiol 1.0 mg and
norethindrone acetate 0.5 mg)
- In May 2022, Myovant Sciences (Myovant) and Pfizer announced
the FDA had extended the review period for the supplemental New
Drug Application (sNDA) for Myfembree for the management of
moderate to severe pain associated with endometriosis. The FDA
requires extended time to review additional information it had
requested from the companies regarding bone mineral density. The
extended Prescription Drug User Fee Act (PDUFA) goal date is August
6, 2022.
- In June 2022, Myovant and Pfizer announced that the FDA
accepted for review a sNDA for Myfembree proposing updates to
Myfembree’s U.S. Prescribing Information based on safety and
efficacy data from the Phase 3 LIBERTY randomized withdrawal study
in premenopausal women with heavy menstrual bleeding associated
with uterine fibroids for up to two years. The PDUFA goal date for
this sNDA is January 29, 2023.
- In June 2022, Myovant and Pfizer announced that results of the
Phase 3 SPIRIT 1 and SPIRIT 2 studies of investigational once-daily
Myfembree in over 1,200 women with moderate to severe pain
associated with endometriosis were published in The Lancet. SPIRIT
1 and 2 each met their co-primary endpoints with 75% of women in
the relugolix combination therapy group in both studies achieving a
clinically meaningful reduction in dysmenorrhea compared with 27%
and 30% of women in the placebo groups at Week 24, respectively
(both p < 0.0001). For non-menstrual pelvic pain, relugolix
combination therapy achieved a clinically meaningful reduction in
59% and 66% of women, compared with 40% and 43% of women in the
placebo groups (p < 0.0001). In both studies, relugolix
combination therapy was associated with a generally well-tolerated
safety profile, including bone mineral density loss of <1% over
24 weeks.
- Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir
tablets)(8)
- Clinical and Research Developments
- In June 2022, Pfizer announced data from the Phase 2/3 EPIC-SR
(Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study evaluating the use of
Paxlovid in patients who are at standard risk for developing severe
COVID-19. In the EPIC-SR study, the novel primary endpoint of
self-reported, sustained alleviation of all symptoms for four
consecutive days was not met, as previously reported. While not all
statistically significant, data from standard-risk patients, both
vaccinated and unvaccinated, are supportive of efficacy data
observed in the EPIC-HR study. Due to a very low rate of
hospitalization or death observed in the standard-risk patient
population, Pfizer decided to cease enrollment into EPIC-SR and
include available data in the New Drug Application (NDA) submission
to the FDA to support the use of Paxlovid in appropriate
individuals at high risk of progression to severe illness.
- Regulatory Developments
- In June 2022, Pfizer announced the submission of an NDA to the
FDA for approval of Paxlovid for the treatment of COVID-19 in both
vaccinated and unvaccinated individuals who are at high risk for
progression to severe illness from COVID-19, consistent with
current emergency use authorization. The submission provides the
longer-term follow-up data necessary for acceptance and potential
approval. According to the U.S. Centers for Disease Control and
Prevention’s (CDC) defined risk factors, 50-60% of the U.S.
population aged 12 and older is estimated to have one or more risk
factors for progressing to severe COVID-19 illness.
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 June 2022, Pfizer
announced new data from a planned interim analysis of the Phase 2
MagnetisMM-3 registration-enabling trial of elranatamab, an
investigational B-cell maturation antigen (BCMA) CD3-targeted
bispecific antibody, in people with relapsed/refractory multiple
myeloma whose disease is refractory to at least one agent in each
of three major classes of medications approved for the disease.
With a median follow up of 3.71 months, initial efficacy results
showed that the objective response rate for elranatamab was 60.6%.
The trial is still ongoing to the primary endpoint analysis with
results expected later this year, which, if positive, would form
the basis of potential regulatory filings.
- Etrasimod (Selective S1P Receptor Modulator) -- In May
2022, Pfizer presented detailed results from two pivotal studies
that make up the ELEVATE UC Phase 3 registrational program
evaluating etrasimod, a once-daily, oral, selective sphingosine
1-phosphate (S1P) receptor modulator candidate for the treatment of
moderately-to-severely active ulcerative colitis (UC). Both Phase
3, multi-center, randomized, placebo-controlled trials achieved all
primary and key secondary endpoints, with etrasimod demonstrating a
safety profile consistent with previous studies. In the 52-week
ELEVATE UC 52 study, clinical remission was 27.0% for patients
receiving etrasimod compared to 7.4% for patients receiving placebo
at week 12 (19.8% differential, P=˂.001) and was 32.1% compared to
6.7% at week 52 (25.4% differential, P=˂.001). In the 12-week
ELEVATE UC 12 study, clinical remission was achieved among 24.8% of
patients receiving etrasimod compared to 15.2% of patients
receiving placebo (9.7% differential, P=.0264). The data are
expected to form the basis for planned future regulatory filings,
which will be initiated later this year.
- Ervogastat (PF-06865571)/Clesacostat (PF-05221304)
Combination Therapy -- In May 2022, Pfizer announced the FDA
had granted Fast Track designation to its investigational
combination therapy of ervogastat (a diacylglycerol
O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (an
acetyl-CoA carboxylase inhibitor, or ACCi) for the treatment of
non-alcoholic steatohepatitis (NASH) with liver fibrosis. Pfizer is
currently studying the combination in an ongoing Phase 2 clinical
trial evaluating the impact of treatment on resolution of NASH or
improvement in liver fibrosis, expected to complete in 2024.
- TTI-622 (Signal-Regulatory Protein α-Fc Fusion Protein)
-- In June 2022, Pfizer, MorphoSys U.S. Inc. (MorphoSys) and Incyte
announced a clinical trial collaboration and supply agreement to
investigate the immunotherapeutic combination of Pfizer’s TTI-622,
a novel SIRPα-Fc fusion protein, and Monjuvi(9) (tafasitamab-cxix)
plus lenalidomide in patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) who are not eligible for autologous
stem cell transplantation (ASCT). Under the terms of the agreement,
Pfizer will initiate a multicenter, international Phase 1b/2 study
of TTI-622 with Monjuvi and lenalidomide for patients with relapsed
or refractory DLBCL who are not eligible for ASCT. MorphoSys and
Incyte will provide Monjuvi for the study, which will be sponsored
and funded by Pfizer and is planned to be conducted in North
America, Europe and Asia-Pacific.
Corporate Developments
- In May 2022, Pfizer and Biohaven announced that the companies
have entered into a definitive agreement under which Pfizer will
acquire Biohaven and its calcitonin gene-related peptide (CGRP)
programs, including rimegepant, zavegepant and a portfolio of five
pre-clinical CGRP assets. Under the terms of the agreement, Pfizer
will acquire all outstanding common shares of Biohaven not already
owned by Pfizer for $148.50 per share in cash. Biohaven common
shareholders, including Pfizer, will also receive 0.5 of a share of
New Biohaven, a new publicly traded company that will retain
Biohaven’s non-CGRP development stage pipeline compounds, per
Biohaven common share. Pfizer will pay transaction consideration
totaling approximately $11.6 billion in cash. Pfizer will also make
payments at closing to settle Biohaven’s third party debt and for
the redemption of all outstanding shares of Biohaven’s redeemable
preferred stock. New Biohaven will also have the right to receive
tiered royalties from Pfizer on any annual net sales of rimegepant
and zavegepant in the U.S. in excess of $5.25 billion. The proposed
transaction is expected to close by early 2023, subject to the
completion of the New Biohaven spin-off transaction and other
customary closing conditions. All required antitrust clearances
have been received.
- In May 2022, Pfizer launched ‘An Accord for a Healthier World’,
a groundbreaking initiative that seeks to greatly reduce the health
inequities that exist between many lower-income countries and the
rest of the world. The initiative aims to provide all of Pfizer’s
current and future patented, high-quality medicines and vaccines
available in the U.S. or the EU on a not-for-profit basis to 1.2
billion people in 45 lower-income countries.
- In June 2022, Pfizer provided an update on its ownership
interest in Haleon plc (Haleon), the newly independent company
which holds the joint Consumer Healthcare business of GSK plc (GSK)
and Pfizer following the demerger of approximately 80% of GSK’s
ownership interest in the business to GSK’s shareholders and the
listing of Haleon on the London Stock Exchange, which occurred in
July 2022. In addition, Haleon listed American Depositary Shares
(ADSs) representing Haleon ordinary shares on the New York Stock
Exchange. In keeping with Pfizer’s transformation into a more
focused, global leader in science-based innovative medicines and
vaccines, Pfizer intends to exit its 32% ownership interest in
Haleon in a disciplined manner, with the objective of maximizing
value for Pfizer shareholders.
- In June 2022, which falls in Pfizer’s international(5) third
quarter of 2022, Pfizer completed its acquisition of ReViral, a
privately held, clinical-stage biopharmaceutical company focused on
discovering, developing, and commercializing novel antiviral
therapeutics that target respiratory syncytial virus (RSV). ReViral
brings to Pfizer a portfolio of promising therapeutic candidates,
including sisunatovir, an orally administered inhibitor designed to
block fusion of the RSV virus to the host cell currently in Phase 2
clinical development for both adult and pediatric populations.
- In June 2022, Valneva SE (Valneva) and Pfizer announced the
companies have entered into an equity subscription agreement and
have updated the terms of their collaboration and license agreement
for Lyme disease vaccine candidate VLA15. As part of the equity
subscription agreement, which closed on June 22, 2022, Pfizer
invested €90.5 ($95) million in Valneva, representing 8.1% of
Valneva’s share capital at a price of €9.49 per share, through a
reserved capital increase. Valneva will fund 40% of the remaining
shared development costs compared to 30% in the initial agreement.
Pfizer will pay Valneva tiered royalties ranging from 14% to 22% of
net sales of VLA15, compared to royalties starting at 19% in the
initial agreement. In addition, the royalties will be complemented
by up to $100 million in milestones payable to Valneva based on
cumulative sales. Other development and early commercialization
milestones are unchanged, of which $168 million remain, including a
$25 million payment to Valneva upon Pfizer’s initiation of the
Phase 3 study.
- In June 2022, Roivant Sciences (Roivant) and Pfizer announced
the unveiling of Priovant Therapeutics (Priovant), a clinical-stage
biotechnology company dedicated to developing and commercializing
novel therapies for autoimmune diseases with the greatest morbidity
and mortality. Priovant was established in September 2021 through a
transaction between Roivant and Pfizer, in which Pfizer granted an
exclusive license to brepocitinib and ropsacitinib to Priovant.
Pfizer holds a 25% equity ownership interest in Priovant.
- In June 2022, Pfizer announced a commitment to further reduce
Greenhouse Gas (GHG) emissions and aims to achieve the voluntary
Net-Zero Standard by 2040, ten years earlier than the timeline
described in the standard. As part of the commitment, Pfizer aims
to decrease its GHG emissions by 95% and its value chain emissions
by 90% from 2019 levels by 2040 through accelerating the transition
away from fossil fuels and engaging suppliers to catalyze
equivalent action. Pfizer also signed a pledge by the U.S.
Department of Health & Human Services (HHS) that calls on
stakeholders in the U.S. healthcare system – including hospitals,
health systems, payers, suppliers and pharmaceutical companies – to
reduce GHG emissions and build a more climate resilient healthcare
infrastructure.
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/Q2-2022-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,
product revenue tables attached to the press release located at the
hyperlink referred to above and the attached disclosure
notice.
(1)
Comirnaty includes direct sales and alliance revenues related to
sales of the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, which
are recorded within Pfizer’s Vaccines 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 $55 million and $101 million for second-quarter and the
first six months of 2022, respectively, and $87 million for both
second-quarter and the first six months of 2021.
(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 second quarter and the first six 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
April 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 July 3, 2022, with the exception
of signed transactions through mid-July 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 $0.11 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-July 2022, which would
have been excluded from Adjusted(3) results under our previous
accounting policy on non-GAAP measures. This excludes any impact
from the proposed acquisition of Biohaven, which is expected to
close by early 2023.
- Includes Pfizer’s pro rata share of Haleon plc's (Haleon)
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 $0.6 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 second-quarter 2022 and mid-July 2022 rates for the
remainder of the year. Financial guidance reflects the anticipated
unfavorable impact of approximately $5.0 billion on revenues and
approximately $0.31 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 second quarter and first six
months for U.S. subsidiaries reflects the three and six months
ended on July 3, 2022 and July 4, 2021, while Pfizer’s second
quarter and first six months for subsidiaries operating outside the
U.S. reflects the three and six months ended on May 29, 2022 and
May 30, 2021.
(6)
The following business development activity, among others,
impacted financial results for the current or prior fiscal
year:
- 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).
- 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 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. (Trillium), 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 Pharmaceutical Holding
Company Ltd. (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. Biohaven is also eligible to receive
up to $740 million in non-U.S. commercialization milestone
payments, in addition to tiered double-digit royalties on net sales
outside of the U.S. In addition to the milestone payments and
royalties above, Pfizer will also reimburse Biohaven for the
portion of certain additional milestone payments and royalties due
to third parties in accordance with preexisting Biohaven
agreements, which are attributed to ex-U.S. sales.
- 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.
(7)
References to operational variances in this press release
pertain to period-over-period changes that exclude the impact of
foreign exchange rates. Although exchange rate changes are part of
Pfizer’s business, they are not within Pfizer’s control and 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.
(8)
Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19
Vaccine have not been approved or licensed by the FDA. Emergency
uses of Comirnaty have been authorized by the FDA, under an
Emergency Use Authorization (EUA) to prevent Coronavirus Disease
2019 (COVID-19) in individuals 6 months of age and older. Comirnaty
is licensed by the FDA for individuals 12 years of age and older.
In addition, Comirnaty is under EUA for individuals 6 months of age
and older, a third dose for certain immunocompromised individuals 5
years of age and older, a booster dose for individuals 5 years of
age and older, and a second booster dose for individuals 50 years
of age and older and for certain immunocompromised individuals 12
years of age and older. Paxlovid 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.
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 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.cvdvaccine-us.com and www.covid19oralrx.com.
(9)
Monjuvi® is a registered trademark of MorphoSys AG.
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is
as of July 28, 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 and goals; expectations for our
product pipeline, in-line products and product candidates,
including anticipated regulatory submissions, data read-outs, study
starts, approvals, 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) 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 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; 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 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, 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, 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 Comirnaty or Paxlovid and additional studies,
in real-world data studies or in larger, more diverse populations
following commercialization; the ability of Comirnaty, 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 or any potential future vaccines in
additional populations, for a booster dose for Comirnaty, any
monovalent, bivalent or variant-adapted 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, any monovalent, bivalent or
variant-adapted vaccine candidates 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 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,
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, 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 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, changes in laws and regulations or
their interpretation, including, among others, changes in tax laws
and regulations internationally and in the U.S., including, among
others, 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, including challenges faced by our
collaboration or licensing partners to the validity of their patent
rights, unasserted intellectual property claims 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220728005077/en/
Media
PfizerMediaRelations@Pfizer.com 212.733.1226
Investors IR@Pfizer.com
212.733.4848
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2023 to Apr 2024