- Second-Quarter 2021 Revenues of $19.0 Billion, Reflecting 86%
Operational Growth; Excluding BNT162b2(1), Revenues Grew 10%
Operationally to $11.1 Billion
- The 10% Operational Growth Excluding BNT162b2(1) in
Second-Quarter 2021 Builds on the 6% Operational Growth Delivered
by the Comparable Business in Second-Quarter 2020
- Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted
Diluted EPS(3) of $1.07
- Raises Full-Year 2021 Guidance(4) for Revenues to a Range of
$78.0 to $80.0 Billion and Adjusted Diluted EPS(3) to a Range of
$3.95 to $4.05, Reflecting Updates to the Outlook for Pfizer’s
Business, Both Including and Excluding BNT162b2(1)
- Now Anticipates 2021 Revenues of Approximately $33.5 Billion
for BNT162b2(1), Reflecting 2.1 Billion Doses Expected to be
Delivered in 2021 Under Signed Contracts as of Mid-July 2021
- Raises Guidance Ranges Excluding BNT162b2(1) for Revenue by
$400 Million and Adjusted Diluted EPS(3) by $0.05
- 100% Efficacy Observed in Phase 2b Trial of RSV Adult Vaccine
Candidate; Provides New Data Updates on its COVID-19 Vaccine
Booster and Oral COVID-19 Antiviral Programs As Part of a Broader
Review of 8 Potentially First-in-Class Compounds
Pfizer Inc. (NYSE: PFE) reported financial results for
second-quarter 2021 and raised 2021 guidance(4) for revenues and
Adjusted diluted EPS(3) driven by its updated expectations for
contributions to 2021 performance from both BNT162b2, the
Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, as well as its
business excluding BNT162b2(1).
Additionally, Pfizer published this morning on its website the
second-quarter 2021 earnings presentation and accompanying prepared
remarks from management as well as the quarterly update to its
R&D pipeline.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and Chief Executive Officer, stated:
“The second quarter was remarkable in a number of ways. Most
visibly, the speed and efficiency of our efforts with BioNTech to
help vaccinate the world against COVID-19 have been unprecedented,
with now more than a billion doses of BNT162b2 having been
delivered globally. In addition, we are equally proud of the
second-quarter performance of our business excluding BNT162b2(1),
which posted 10% operational revenue growth. Looking forward, we
remain highly confident in our ability to achieve at least a 6%
compound annual growth rate through 2025 and intend to build upon
our recent successes by continuing to follow the science, trust in
our people and remain focused on delivering breakthroughs for the
patients we serve.”
Frank D’Amelio, Chief Financial Officer and Executive Vice
President, Global Supply, stated: “Pfizer’s second quarter
performance highlighted once again the underlying strength of our
business, with consistent and solid growth coming from multiple
products and categories. It is important to point out that the 10%
year-over-year operational revenue growth rate for our business
excluding BNT162b2(1) comes on top of a strong 6% operational
growth rate delivered by the comparable business in the second
quarter of last year. As a result of updates to our expectations
for our business, both including and excluding BNT162b2(1), we are
increasing our 2021 financial guidance ranges for revenues and
Adjusted diluted EPS(3) for the second quarter in a row.”
Results for the second quarter and the first six months of 2021
and 2020(5) are summarized below.
OVERALL RESULTS
($ in millions, except per share
amounts)
Second-Quarter
Six Months
2021
2020
Change
2021
2020
Change
Revenues
$
18,977
$
9,864
92%
$
33,559
$
19,947
68%
Reported Net Income(2)
5,563
3,489
59%
10,440
6,843
53%
Reported Diluted EPS(2)
0.98
0.62
58%
1.84
1.22
51%
Adjusted Income(3)
6,084
3,473
75%
11,346
7,019
62%
Adjusted Diluted EPS(3)
1.07
0.62
73%
2.00
1.25
60%
REVENUES
($ in millions)
Second-Quarter
Six Months
2021
2020
% Change
2021
2020
% Change
Total
Oper.
Total
Oper.
Vaccines
$
9,234
$
1,247
*
*
$
14,127
$
2,857
*
*
Oncology
3,145
2,647
19%
16%
6,007
5,082
18%
16%
Internal Medicine
2,403
2,279
5%
2%
4,997
4,610
8%
6%
Hospital
2,259
1,863
21%
17%
4,602
3,951
16%
13%
Inflammation & Immunology
1,041
1,149
(9%)
(12%)
2,107
2,127
(1%)
(3%)
Rare Disease
895
681
32%
28%
1,720
1,319
30%
27%
Total Revenue
$
18,977
$
9,864
92%
86%
$
33,559
$
19,947
68%
64%
* Indicates calculation not
meaningful.
Following the completion of the spin-off of the Upjohn
Business(6) in the fourth quarter of 2020, Pfizer operates as a
focused innovative biopharmaceutical company engaged in the
discovery, development, manufacturing, marketing, sale and
distribution of biopharmaceutical products worldwide.
Revenues and expenses associated with the Upjohn Business(6) for
the first and second quarters of 2020 have been recategorized as
discontinued operations and excluded from Adjusted(3) results.
Pfizer’s Meridian subsidiary, the manufacturer of EpiPen and other
auto-injector products, which had been reported within the results
of the Upjohn Business(6) in the first three quarters of 2020, is
now included within the Hospital therapeutic area for all periods
presented.
Business development activities completed in 2020 and 2021
impacted financial results in the periods presented(6). 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).
2021 FINANCIAL GUIDANCE(4)
Financial guidance reflects management’s current expectations
for operational performance, foreign exchange rates and
management’s current projections as to the severity, duration and
global macroeconomic impact of the COVID-19 pandemic.
Key guidance assumptions included in these projections broadly
reflect a continued recovery in global macroeconomic and healthcare
activity throughout 2021 as more of the population becomes
vaccinated against COVID-19.
Pfizer is raising its financial guidance ranges primarily to
reflect higher expected revenues and related expenses for
BNT162b2(1) and anticipated incremental spending on other
COVID-19-related and mRNA-based programs, as well as increased
expected contributions from its business excluding BNT162b2(1). The
increase to guidance for the effective tax rate on Adjusted
income(3) resulted from updates to the anticipated jurisdictional
mix of earnings, primarily related to BNT162b2(1). Current 2021
financial guidance is presented below.
Revenues
$78.0 to $80.0 billion
(previously $70.5 to $72.5
billion)
Adjusted Cost of Sales(3) as a
Percentage of Revenues
39.0% to 40.0%
(previously 38.0% to 39.0%)
Adjusted SI&A Expenses(3)
$11.5 to $12.5 billion
(previously $11.0 to $12.0
billion)
Adjusted R&D Expenses(3)
$10.0 to $10.5 billion
(previously $9.8 to $10.3
billion)
Adjusted Other
(Income)/Deductions(3)
Approximately $2.2 billion of
income
Effective Tax Rate on Adjusted
Income(3)
Approximately 16.0%
(previously approximately
15.0%)
Adjusted Diluted EPS(3)
$3.95 to $4.05
(previously $3.55 to $3.65)
The midpoint of the guidance range for revenues represents 89%
growth from 2020 revenues, including an expected $1.5 billion, or
4%, favorable impact from changes in foreign exchange rates
compared to 2020. The midpoint of the updated guidance range for
Adjusted diluted EPS(3) reflects a 77% increase over 2020 actual
results(8), including an expected $0.10, or 4%, benefit due to
favorable changes in foreign exchange rates compared to 2020.
Financial guidance for Adjusted diluted EPS(3) is calculated
using approximately 5.7 billion weighted average shares
outstanding, and does not currently assume any share repurchases in
2021.
Update to Assumptions Related to BNT162b2(1) Within
Guidance
Due to additional supply agreements that have been signed from
mid-April to mid-July, Pfizer is updating the revenue assumptions
related to BNT162b2(1) incorporated within the above guidance
ranges. The updated assumptions are summarized below.
Revenues for BNT162b2(1)
Approximately $33.5 billion
(previously approximately $26
billion)
Adjusted Income(3) Before Tax (IBT) Margin
for BNT162b2(1)
High-20s as a Percentage of
Revenues
The BNT162b2(1) revenue projection incorporated within Pfizer’s
2021 financial guidance includes 2.1 billion doses that are
expected to be delivered in 2021(5) under contracts signed through
mid-July 2021. This guidance may be adjusted in the future as
additional contracts are signed. Based on current projections,
Pfizer and BioNTech expect to manufacture in total up to 3 billion
doses by the end of December 2021, subject to continuous process
improvements, expansion at current facilities and adding new
suppliers and contract manufacturers.
Adjusted(3) IBT margin guidance for BNT162b2(1) incorporates the
current expectation for revenues for the product, less anticipated
Adjusted(3) costs to manufacture, market and distribute
BNT162b2(1), including applicable royalty expenses and a 50% gross
profit split with BioNTech, as well as shared R&D expenses
related to BNT162b2(1) and costs associated with other assets
currently in development for the prevention and treatment of
COVID-19. It also includes R&D expenses related to other
mRNA-based development programs. It does not include an allocation
of corporate or other overhead costs.
Selected Financial Guidance Ranges Excluding
BNT162b2(1)
Pfizer is raising its financial guidance ranges for revenues and
Adjusted diluted EPS(3) excluding contributions from
BNT162b2(1).
Revenues
$45.0 to $47.0 billion
(previously $44.6 to $46.6
billion)
Adjusted Cost of Sales(3) as a Percentage
of Revenues
21% to 22%
Adjusted Diluted EPS(3)
$2.55 - $2.65
(previously $2.50 to $2.60)
The midpoint of the revenue guidance range above reflects
approximately 7% operational growth compared to 2020 when sales of
BNT162b2(1) are excluded from both periods, which is in line with
the company’s stated goal of at least a 6% revenue compound annual
growth rate through 2025. The midpoint of Pfizer’s Adjusted diluted
EPS(3) guidance range excluding BNT162b2(1) reflects approximately
11% operational growth compared to the prior year(8).
CAPITAL ALLOCATION
- During the first six months of 2021, Pfizer paid $4.4 billion
of cash dividends, or $0.78 per share of common stock, which
represents an increase in dividends per share of 3% compared to the
same period last year.
- No share repurchases have been completed to date in 2021. As of
July 28, 2021, Pfizer’s remaining share repurchase authorization is
$5.3 billion. Current 2021 financial guidance does not reflect any
share repurchases in 2021.
- Second-quarter 2021 diluted weighted-average shares outstanding
used to calculate Reported(2) and Adjusted(3) diluted EPS was 5,678
million shares, an increase of 59 million shares compared to the
prior-year quarter primarily due to shares issued for employee
compensation programs.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2021 vs.
Second-Quarter 2020)
Second-quarter 2021 revenues totaled $19.0 billion, an increase
of $9.1 billion, or 92%, compared to the prior-year quarter,
reflecting operational growth of $8.5 billion, or 86%, as well as a
favorable impact of foreign exchange of $637 million, or 6%.
Second-quarter 2021 operational growth was primarily driven
by:
- BNT162b2(1), which contributed $7.8 billion in direct sales and
alliance revenues;
- Vyndaqel/Vyndamax globally, up 77% operationally, primarily
driven by continued strong uptake of the transthyretin amyloid
cardiomyopathy indication in the U.S., developed Europe and
Japan;
- Eliquis, up 13% operationally, led by growth in the U.S. and
emerging markets, driven primarily by continued increased adoption
in non-valvular atrial fibrillation and oral anti-coagulant market
share gains;
- Prevnar 13 in the U.S., up 34%, driven by:
- 35% growth in the pediatric indication primarily due to higher
levels of healthcare activity and wellness visits compared to the
prior-year quarter, which was heavily impacted by COVID-19-related
mobility restrictions and limitations, and favorable timing of
government purchases, partially offset by a lower year-over-year
birth rate(9), and
- 24% growth in the adult indication, which was primarily driven
by higher levels of healthcare activity compared to the prior-year
quarter, as described above, partially offset by the impact of a
lower remaining eligible unvaccinated population;
- Ibrance outside of the U.S., up 21% operationally, driven by
accelerating demand as the delays in diagnosis and treatment
initiations caused by COVID-19 show signs of recovery across
several international markets;
- Inlyta globally, up 29% operationally, primarily reflecting
increased adoption in the U.S. and developed Europe of combinations
of certain immune checkpoint inhibitors and Inlyta for the
first-line treatment of patients with advanced renal cell
carcinoma;
- Xtandi in the U.S., up 14%, primarily driven by strong demand
across the metastatic and non-metastatic castration-resistant
prostate cancer indications and the metastatic castration-sensitive
prostate cancer indication; as well as
- Hospital products globally, which grew 17% operationally to
$2.3 billion, primarily driven by Pfizer CentreOne, Pfizer’s
contract manufacturing operation, reflecting manufacturing of
legacy Upjohn products for Viatris(6), certain BNT162b2
manufacturing activities performed on behalf of BioNTech(1) and
remdesivir for Gilead Sciences Inc., as well as growth from recent
anti-infective product launches in international markets, partially
offset by a decline in U.S. sales of certain sterile injectable
products utilized in the intubation and mechanical ventilation of
patients being treated for COVID-19 due to high demand for these
products in the prior-year quarter; and
- Biosimilars globally, which grew 88% operationally to $559
million, primarily driven by recent oncology monoclonal antibody
biosimilar launches of Zirabev (bevacizumab), Ruxience (rituximab)
and Trazimera (trastuzumab) globally, as well as continued growth
from Retacrit (epoetin) in the U.S.,
partially offset primarily by lower revenues for:
- Xeljanz in the U.S., down 15%, despite 2% year-over-year growth
in U.S. prescription volume, reflecting an unfavorable change in
channel mix toward lower-priced channels and continued investments
to improve formulary positioning and unlock access to additional
patient lives, as well as a negative impact on new patient starts
resulting from an ongoing review by the Food and Drug
Administration (FDA) of safety data from the post-marketing ORAL
Surveillance study of Xeljanz in subjects with rheumatoid arthritis
who were 50 years of age or older and had at least one additional
cardiovascular risk factor;
- Ibrance in the U.S., down 7%, despite maintaining a strong
leadership position in the CDK 4/6 class with 73% share of
first-line new patient starts, reflecting an increase in the
proportion of patients accessing Ibrance through Pfizer’s Patient
Assistance Program;
- Enbrel internationally, down 19% operationally, primarily
reflecting continued biosimilar competition in developed Europe and
Japan; and
- Prevenar 13 in developed Europe, down 35% operationally,
reflecting significantly increased adult demand in the prior-year
quarter in Germany and certain other markets resulting from greater
vaccine awareness for respiratory illnesses due to the COVID-19
pandemic.
GAAP Reported(2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES(2)
($ in millions)
Second-Quarter
Six Months
2021
2020
% Change
2021
2020
% Change
Total
Oper.
Total
Oper.
Cost of Sales(2)
$
7,049
$
1,826
*
*
$
11,259
$
3,766
*
*
Percent of Revenues
37.1
%
18.5
%
N/A
N/A
33.6
%
18.9
%
N/A
N/A
SI&A Expenses(2)
2,928
2,659
10
%
8
%
5,712
5,200
10
%
8
%
R&D Expenses(2)
2,459
2,078
18
%
17
%
4,473
3,750
19
%
18
%
Total
$
12,436
$
6,563
89
%
82
%
$
21,444
$
12,717
69
%
63
%
Other (Income)/Deductions––net(2)
($
998
)
($
955
)
5
%
(5
%)
($
2,001
)
($
764
)
*
*
Effective Tax Rate on Reported
Income(2)
15.8
%
14.0
%
15.0
%
13.3
%
* Indicates calculation not
meaningful.
Second-quarter 2021 Cost of Sales(2) as a percentage of revenues
increased 18.6 percentage points compared with the prior-year
quarter. The drivers for the increase include, among other
things:
- an increase of approximately 15 percentage points associated
with sales of BNT162b2(1), which includes a charge for the 50%
gross profit split with BioNTech and applicable royalty
expenses;
- unfavorable changes in product mix, reflecting higher sales of
lower margin products including revenues from the Pfizer CentreOne
operation, partially offset by the favorable impact of higher
alliance revenues; and
- unfavorable foreign exchange impacts.
SI&A Expenses(2) increased 8% operationally in
second-quarter 2021 compared with the prior-year quarter, primarily
due to increased product-related spending across multiple
therapeutic categories and other costs associated with a return to
more normal activity levels compared to the prior-year quarter,
partially offset by a reduction in spending for corporate enabling
functions and lower spending for Chantix following its loss of
patent protection in the U.S. in November 2020.
Second-quarter 2021 R&D Expenses(2) increased 17%
operationally compared with the prior-year quarter, which primarily
reflects incremental investments across multiple therapeutic
categories, including additional spending related to the
development of BNT162b2(1) and therapeutics to help treat COVID-19,
as well as a charge for in-process R&D related to an asset
acquisition completed in the second quarter of 2021, partially
offset by the non-recurrence of upfront payments associated with
two R&D agreements executed in second-quarter 2020.
Other income––net(2) in second-quarter 2021 decreased 5%
operationally compared with second-quarter 2020, primarily driven
by higher legal charges and lower income from collaborations,
partially offset by higher transition services agreement income,
higher net gains on both equity securities and asset disposals,
lower interest expense and higher net periodic benefit credits
related to pension and postretirement plans.
Pfizer’s effective tax rate on Reported income(2) for
second-quarter 2021 compared to the prior-year quarter increased
due to an unfavorable change in the jurisdictional mix of earnings
primarily related to BNT162b2(1).
Adjusted(3) Income Statement Highlights
SELECTED ADJUSTED COSTS AND EXPENSES(3)
($ in millions)
Second-Quarter
Six Months
2021
2020
% Change
2021
2020
% Change
Total
Oper.
Total
Oper.
Adjusted Cost of Sales(3)
$
6,997
$
1,795
*
*
$
11,175
$
3,712
*
*
Percent of Revenues
36.9
%
18.2
%
N/A
N/A
33.3
%
18.6
%
N/A
N/A
Adjusted SI&A Expenses(3)
2,792
2,528
10
%
8
%
5,451
4,978
10
%
7
%
Adjusted R&D Expenses(3)
2,273
1,841
23
%
22
%
4,286
3,514
22
%
21
%
Total
$
12,062
$
6,163
96
%
88
%
$
20,911
$
12,204
71
%
66
%
Adjusted Other
(Income)/Deductions––net(3)
($
575
)
($
442
)
30
%
8
%
($
1,175
)
($
704
)
67
%
57
%
Effective Tax Rate on Adjusted
Income(3)
16.6
%
14.5
%
16.0
%
15.3
%
* Indicates calculation not
meaningful.
Changes in Adjusted(3) costs and expenses in second-quarter 2021
compared to the prior-year quarter were driven primarily by the
factors listed in the Reported(2) costs and expenses section
above.
A full reconciliation of 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 4, 2021)
Product Developments
- Chantix (varenicline) -- In July 2021, Pfizer issued a
voluntary recall in the U.S. for twelve lots of Chantix due to the
presence of a nitrosamine, N-nitroso-varenicline, above the
Pfizer-established acceptable daily intake level. Nitrosamines are
common in water and foods and everyone is exposed to some level of
nitrosamines. These impurities may theoretically increase the risk
of cancer if people are exposed to them above acceptable levels
over long periods of time. The health benefits of stopping smoking
outweigh the theoretical potential cancer risk from the nitrosamine
impurity in varenicline.
- Myfembree (relugolix 40 mg, estradiol 1 mg, and
norethindrone acetate 0.5 mg) -- In May 2021, Myovant Sciences
(Myovant) and Pfizer announced that the FDA approved Myfembree, the
first once-daily treatment for the management of heavy menstrual
bleeding associated with uterine fibroids in premenopausal women,
with a treatment duration of up to 24 months. Myovant and Pfizer
are jointly commercializing Myfembree in the U.S.
- Prevnar 20 (pneumococcal 20-valent conjugate vaccine) --
In June 2021, Pfizer announced that the FDA approved Prevnar 20 for
the prevention of invasive disease and pneumonia caused by the 20
Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in
adults ages 18 years and older. The U.S. Centers for Disease
Control and Prevention’s (CDC) Advisory Committee on Immunization
Practices (ACIP) is expected to meet in October to discuss and
update recommendations on the safe and appropriate use of
pneumococcal vaccines in adults.
- Talzenna (talazoparib) -- In June 2021, Pfizer announced
that the first participant had been dosed in the Phase 3 TALAPRO-3
study, which will evaluate the efficacy and safety of talazoparib,
an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in
combination with enzalutamide, an androgen receptor inhibitor,
compared with placebo plus enzalutamide in men with DNA damage
response (DDR)-deficient metastatic castration-sensitive prostate
cancer. The anticipated primary completion date is late-2024.
- Xeljanz (tofacitinib)
- In June 2021, Pfizer announced that the Pharmacovigilance Risk
Assessment Committee (PRAC) of the European Medicines Agency (EMA)
recommended that Xeljanz should only be used in patients over 65
years of age, patients who are current or past smokers, patients
with other cardiovascular risk factors, and patients with other
malignancy risk factors, if no suitable treatment alternative is
available. The recommendation, which has since been adopted by the
EMA’s Committee for Medicinal Products for Human Use (CHMP), is
based on the receipt of safety data from the post-marketing ORAL
Surveillance study of Xeljanz in subjects with rheumatoid arthritis
who were 50 years of age or older and had at least one
cardiovascular risk factor.
- In June 2021, Pfizer, in collaboration with The Academic
Research Organization (ARO) from the Hospital Israelita Albert
Einstein, announced that The New England Journal of Medicine had
published positive findings from the STOP-COVID study (NCT04469114)
evaluating the efficacy and safety of its oral Janus kinase (JAK)
inhibitor tofacitinib in 289 hospitalized adult patients with
COVID-19 pneumonia who were not on ventilation. Tofacitinib has not
been approved or authorized for use by any regulatory authority
worldwide for the treatment of COVID-19 and tofacitinib should not
be used in patients with an active serious infection. Pfizer is
assessing next steps.
- In July 2021, the FDA notified Pfizer that it would not meet
the Prescription Drug User Fee Act (PDUFA) goal date for the
supplemental New Drug Applications (sNDA) for Xeljanz/Xeljanz XR
for the treatment of adults with active ankylosing spondylitis. The
FDA cited its ongoing review of Pfizer’s post-marketing safety
study, ORAL Surveillance, evaluating tofacitinib in subjects with
rheumatoid arthritis who were 50 years of age or older and had at
least one additional cardiovascular risk factor, as a factor for
the extension. No revised PDUFA goal date has been set for these
sNDAs.
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.
- Abrocitinib (PF-04965842) -- In July 2021, the FDA
notified Pfizer that it would not meet the PDUFA goal date for the
New Drug Application (NDA) for abrocitinib for the treatment of
adults and adolescents with moderate to severe atopic dermatitis.
The FDA cited its ongoing review of Pfizer’s post-marketing safety
study, ORAL Surveillance, evaluating tofacitinib in subjects with
rheumatoid arthritis who were 50 years of age or older and had at
least one cardiovascular risk factor, as a factor for the
extension. No revised PDUFA goal date has been set for this
NDA.
- BNT162b2 (COVID-19 Vaccine) Development Program
- Clinical and Research Developments
- In June 2021, Pfizer and BioNTech initiated a Phase 2/3 study
to further evaluate the safety, tolerability and immunogenicity of
BNT162b2 in preventing COVID-19 in healthy children between the
ages of 6 months to 11 years old. The companies expect to have the
safety and immunogenicity data that could potentially support an
Emergency Use Authorization (EUA) for use in children ages 5 to 11
years old, if such an EUA is deemed necessary, by the end of
September. The full dataset from this study, which will be required
to support licensure in this age group, is expected by the end of
2021. Similar data packages will be submitted shortly thereafter to
support EUA and licensure in children 6 months to 5 years of
age.
- In July 2021, Pfizer and BioNTech provided an update on the
ongoing Phase 1/2/3 booster trial of a third dose of the current
BNT162b2 vaccine. Initial safety and immunogenicity data from the
study demonstrate that a booster dose given at least 6 months after
the second dose has a consistent tolerability profile while
eliciting high neutralization titers against the wild type and the
Beta (B.1.351) variant, which are 5 to 10 times higher than after
two primary doses. In addition, newly disclosed data demonstrates
that a third dose elicits neutralizing titers against the Delta
(B.1.617.2) variant that are more than five times higher in younger
people and more than 11 times higher in older people than after two
doses. The companies expect to publish more definitive data about
the analysis and all accumulated data will be shared as part of the
ongoing discussions with the FDA, EMA and other regulatory
authorities in the coming weeks.
- In July 2021, Pfizer and BioNTech initiated the global Phase 3
portion of the clinical study to evaluate the efficacy, safety and
tolerability of a third dose of BNT162b2 compared to placebo,
including evaluating the booster’s efficacy at continuing to
prevent COVID-19 infection. The Phase 3 study will enroll 10,000
participants who participated in the original Phase 3 trial.
- Regulatory Developments
- In May 2021, Pfizer and BioNTech received approval from the EMA
to extend the storage period of an unopened thawed vial of BNT162b2
at 2-8°C from five days to one month (31 days) to facilitate the
handling of the vaccine in vaccination centers across the European
Union (EU).
- In May 2021, Pfizer and BioNTech announced expanded
authorization in the EU as part of its Conditional Marketing
Authorization (CMA), and separately expanded authorization in the
U.S. as part of its EUA, for use of BNT162b2 in individuals 12 to
15 years of age. BNT162b2 is the first COVID-19 vaccine to be
authorized for use in this age group(10).
- In July 2021, Pfizer and BioNTech announced that the FDA
granted Priority Review designation for the Biologics License
Application (BLA) for their mRNA vaccine to prevent COVID-19 in
individuals 16 years of age and older. This follows the completion
of the rolling submission of the BLA in May 2021, which includes
data from the pivotal Phase 3 clinical trial of the vaccine, where
the vaccine’s efficacy and favorable safety profile were observed
up to six months after the second dose. The PDUFA goal date for a
decision by the FDA is in January 2022.
- Commercial Developments
- In May 2021, Pfizer and BioNTech announced an agreement with
the European Commission (EC) to supply 900 million doses of
BNT162b2 to the EU, with an option for the EU to request up to an
additional 900 million doses for a total of up to 1.8 billion
doses. The 900 million agreed doses are expected to be delivered on
a monthly schedule beginning in December 2021 and continuing into
2023. This new agreement is in addition to the 600 million doses
that had already been committed to the EU through 2021.
- In June 2021, Pfizer and BioNTech announced plans to provide
500 million doses of BNT162b2 to the U.S. government at a
not-for-profit price for donation to approximately 100 low- and
lower middle-income countries including those in the African Union
via the COVAX Facility. Deliveries under the agreement will begin
in August 2021, with 200 million doses to be delivered through the
end of 2021 and the remaining 300 million doses to be delivered in
the first half of 2022. The agreement also provides the U.S.
government with an option for additional doses in 2022.
- In July 2021, Pfizer and BioNTech announced the signing of a
letter of intent with The Biovac Institute (Pty) Ltd (Biovac), a
South African biopharmaceutical company, to manufacture BNT162b2
for distribution within the African Union. Biovac will obtain drug
substance from facilities in Europe, and manufacturing of finished
doses will commence in 2022. At full operational capacity, annual
production is estimated to be approximately 100 million finished
doses. All doses will exclusively be distributed within the 55
member states that make up the African Union.
- In July 2021, Pfizer and BioNTech announced that the U.S.
government has agreed to purchase an additional 200 million doses
of BNT162b2, of which 110 million doses are expected to be
delivered from October through December 2021 with the remainder
expected to be delivered from January through April 2022. This
brings the total number of doses to be supplied to the U.S.
government under its existing supply agreement to 500 million. This
agreement is separate from the 500 million doses to be provided to
the U.S. government for donation to the world’s poorest nations,
which was announced in June 2021.
- PF-07304814 (Intravenous Protease Inhibitor for
COVID-19) -- Following a communication from the FDA in July
2021, Pfizer anticipates the initiation of a Phase 2/3 study in
third-quarter 2021 of its intravenous protease inhibitor clinical
candidate, PF-07304814, a potential novel treatment option for
hospitalized patients with COVID-19.
- PF-07321332 (Oral Protease Inhibitor for COVID-19) --
Pfizer today provided further details on its oral protease
inhibitor program for treatment of COVID-19. PF-07321332 exhibits
potent, selective in vitro antiviral activity against SARS-CoV-2
and other coronaviruses. Additionally, it has demonstrated robust
preclinical antiviral effect in human cells in vitro, and in
SARS-CoV-2 infected animals. In a Phase 1 pharmacokinetic study in
healthy volunteers, PF-07321332 has shown high drug exposure over
10 days, exceeding the level of exposure predicted to inhibit
SARS-CoV-2 viral replication by more than five fold. Based on these
data, Pfizer initiated a Phase 2/3 trial in COVID-19 patients in
July 2021. Data from the trial are expected in fourth-quarter
2021.
- Ritlecitinib (PF-06651600) -- In July 2021, Pfizer
presented initial efficacy and safety results from the Phase 2
VIBRATO study evaluating its investigational oral JAK3/TEC
inhibitor ritlecitinib at the European Congress of Crohn’s and
Colitis Organisation (ECCO) annual meeting. At Week 8, once-daily
ritlecitinib 70 and 200 mg demonstrated significant improvement in
remission, modified remission, and endoscopic improvement in
participants with moderate to severe active ulcerative colitis who
had inadequate or loss of response, or intolerance to
corticosteroids, immunosuppressants or biologic therapies.
- RSVpreF (RSV Adult Vaccine Candidate) -- Pfizer today
provided an update on a Phase 2a study to evaluate the safety,
immunogenicity and efficacy of its bivalent protein-based vaccine
candidate, RSVpreF, in a virus challenge model in healthy adults 18
to 50 years of age. RSVpreF showed 100% observed efficacy against
mild to moderate symptomatic infection resulting from respiratory
syncytial virus (RSV). No vaccine related serious adverse events
were observed. Injection site pain was the most frequent mild
adverse event observed. Detailed results from this study will be
shared in a future scientific forum. Based on these data, Pfizer
plans to initiate a global Phase 3 trial in adults in September
2021.
- Tanezumab (PF-04383119) -- In July 2021, Pfizer and Eli
Lilly and Company announced positive top-line results of a Phase 3
study evaluating subcutaneous (SC) administration of tanezumab in
adults with moderate-to-severe cancer pain due to bone metastases
or multiple myeloma. In Study A4091061, 146 patients were
randomized in a 1:1 ratio to receive either tanezumab 20 mg SC or
placebo, each administered at baseline, week eight, and week 16 in
addition to background opioid therapy. The use of background
opioids allowed an appropriate comparison of the efficacy and
safety of tanezumab versus placebo to be made reflective of the
real-world experience. The trial included a 24-week treatment
period, followed by a 24-week safety period, for a total of 48
weeks of observation. The study met its primary endpoint of
demonstrating a statistically significant improvement in daily
average pain intensity at eight weeks for tanezumab compared to
placebo in patients receiving background opioid therapy.
Preliminary safety data showed that during the 24-week treatment
period, the adverse event profile of tanezumab 20 mg was generally
consistent with adverse events expected in patients with cancer
pain due to bone metastasis and the known safety profile of
tanezumab. There were two adjudicated composite joint safety
outcomes, both pathological fractures, which occurred near the site
of bone metastases in tanezumab-treated patients. Detailed results
from this study will be shared in a future scientific forum.
- VLA15 (Lyme Disease Vaccine Candidate) -- In July 2021,
Valneva SE and Pfizer announced that they have completed
recruitment for the Phase 2 trial, VLA15-221, of the Lyme disease
vaccine candidate, VLA15. The trial builds on previous positive
Phase 2 trials and includes both adult and pediatric participants
with the aim to support acceleration of the vaccine candidate’s
pediatric program. The objective of the trial is to show safety and
immunogenicity down to 5 years of age and to evaluate the optimal
vaccination schedule for use in Phase 3.
Corporate Developments
- In July 2021, Pfizer and Arvinas, Inc. (Arvinas) 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. ARV-471 is
currently in a Phase 2 dose expansion clinical trial for the
treatment of patients with estrogen receptor positive / human
epidermal growth factor receptor 2 negative (ER+/HER2-) locally
advanced or metastatic breast cancer. Under the terms of the
agreement, Pfizer will pay Arvinas $650 million upfront.
Separately, Pfizer will make 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.
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/files/doc_financials/2021/q2/Q2-2021-PFE-Earnings-Release.pdf
(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 associated financial
schedules and product revenue tables attached to the press release
located at the hyperlink referred to above and the attached
disclosure notice.
(1) BNT162b2 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 BNT162b2 manufacturing
activities performed on behalf of BioNTech related to the COVID-19
vaccine, which are included in the Pfizer CentreOne contract
manufacturing operation within the Hospital area.
(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 its components and Adjusted diluted EPS
are defined as reported U.S. GAAP net income(2) and its components
and reported diluted EPS(2) excluding purchase accounting
adjustments, acquisition-related costs, discontinued operations and
certain significant items (some of which may recur, such as
actuarial gains and losses from pension and postretirement plan
remeasurements, gains on the completion of joint venture
transactions, restructuring charges, legal charges or gains and
losses from equity securities, but which management does not
believe are reflective of ongoing core operations). Adjusted cost
of sales, Adjusted selling, informational and administrative
(SI&A) expenses, Adjusted research and development (R&D)
expenses and Adjusted other (income)/deductions are income
statement line items prepared on the same basis as, and therefore
components of, the overall Adjusted income measure.
As described in the Non-GAAP Financial Measure: Adjusted Income
section of Management’s Discussion and Analysis of Financial
Condition and Results of Operations in Pfizer’s 2020 Annual Report
on Form 10-K, management uses Adjusted income, among other factors,
to set performance goals and to measure the performance of the
overall company. Because Adjusted income is an important internal
measurement for Pfizer, management believes that investors’
understanding of our performance is enhanced by disclosing this
measure. Pfizer reports Adjusted income, certain components of
Adjusted income, and Adjusted diluted EPS in order to present the
results of the company’s major operations––the discovery,
development, manufacture, marketing, sale and distribution of
prescription medicines and vaccines––prior to considering certain
income statement elements. See the accompanying reconciliations of
certain GAAP Reported to Non-GAAP Adjusted information for the
second quarter and first six months of 2021 and 2020. The 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).
(4) Pfizer does not provide guidance for GAAP Reported financial
measures (other than revenues) or a reconciliation of
forward-looking non-GAAP financial measures to the most directly
comparable GAAP Reported financial measures on a forward-looking
basis because it is unable to predict with reasonable certainty the
ultimate outcome of pending litigation, unusual gains and losses,
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 2021 reflects the
following:
- Does not assume the completion of any business development
transactions not completed as of July 4, 2021, including any
one-time upfront payments associated with such transactions.
- Includes Pfizer’s pro rata share of the Consumer Healthcare
joint venture anticipated earnings, which is recorded in Adjusted
other (income)/deductions(3) on a one-quarter lag.
- 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 or are anticipated to soon
lose patent protection.
- Exchange rates assumed are a blend of actual rates in effect
through second-quarter 2021 and mid-July 2021 rates for the
remainder of the year. Financial guidance reflects the anticipated
favorable impact of approximately $1.5 billion on revenues and
approximately $0.10 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 2020.
- Guidance for Adjusted diluted EPS(3) assumes diluted
weighted-average shares outstanding of approximately 5.7 billion
shares, which currently assumes no share repurchases in 2021.
- Guidance for Adjusted other (income)/deductions(3) includes an
estimated benefit of approximately $300 million resulting from a
change in accounting principle to a more preferable policy under
U.S. GAAP to immediately recognize actuarial gains and losses
arising from the remeasurement of our pension and postretirement
plans. This change went into effect in the first quarter of 2021
and prior period amounts have been recast to conform to the new
accounting policy.
(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 4, 2021 and June 28, 2020 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 30, 2021 and
May 24, 2020.
(6) The following business development activity, among others,
impacted financial results for the periods presented:
- On November 16, 2020, Pfizer completed the transaction to spin
off its Upjohn Business and combine it with Mylan N.V. (Mylan) to
form Viatris Inc. (Viatris). On December 21, 2020, which fell in
Pfizer’s international first-quarter 2021, Pfizer and Viatris
completed the termination of a pre-existing strategic collaboration
between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan
collaboration) and Pfizer transferred related operations that were
part of the Mylan-Japan collaboration to Viatris. As a result of
the spin-off of the Upjohn Business and the termination of the
Mylan-Japan collaboration, the results of operations of the Upjohn
Business and the Mylan-Japan collaboration are presented as
discontinued operations.
- On April 9, 2020, Pfizer signed a global agreement with
BioNTech to co-develop a first-in-class, mRNA-based coronavirus
vaccine program, BNT162, aimed at preventing COVID-19 infection. In
connection with the agreement, Pfizer paid BioNTech an upfront cash
payment of $72 million in second-quarter 2020. Pfizer also made an
equity investment of $113 million in BioNTech common stock. Pfizer
made an additional investment of $50 million in common stock of
BioNTech as part of an underwritten equity offering by BioNTech,
which closed in July 2020. On January 29, 2021, Pfizer and BioNTech
signed an amended version of the April 2020 agreement. Under the
January 2021 agreement, BioNTech paid Pfizer its 50 percent share
of prior development costs in a lump sum payment during the first
quarter of 2021. Further R&D costs are being shared
equally.
(7) References to operational variances in this press release
pertain to period-over-period growth rates 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) As described in footnote (4) above, in the first quarter of
2021, Pfizer adopted a change in accounting principle to a more
preferable approach under U.S. GAAP related to its pension and
postretirement plans. Prior period financial results have been
recast to reflect this change. The recast comparable full-year 2020
Adjusted diluted EPS(3) is $2.26, versus $2.22 previously
reported.
(9) The U.S. birth rate decline is 4% compared to 2020 levels,
according to Demographic Intelligence.
(10) BNT162b2 has not been approved or licensed by the U.S. Food
and Drug Administration (FDA), but has been authorized for
emergency use by the FDA under an Emergency Use Authorization (EUA)
to prevent Coronavirus Disease 2019 (COVID-19) for use in
individuals 12 years of age and older. The emergency use of this
product is 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 Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) including full EUA
prescribing information available at www.cvdvaccine.com.
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is
as of July 28, 2021. 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 and prospects; 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 that
become available, 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 (BNT162b2) and our investigational protease
inhibitors; 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” 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 or indications from regulators on a
timely basis or at all; regulatory decisions impacting labeling,
manufacturing processes, safety and/or other matters; 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 any potential actions by regulatory authorities
based on analysis of ORAL Surveillance or other data;
- 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 diseases and
conditions similar to those treated 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 or our third
party suppliers’ facilities; and legal or regulatory actions;
- the impact of public health outbreaks, epidemics or pandemics
(such as the COVID-19 pandemic) on our business, operations and
financial condition and results, including impacts on our
employees, manufacturing, supply chain, sales and marketing,
research and development and clinical trials;
- risks and uncertainties related to our efforts to develop and
commercialize a vaccine to help prevent COVID-19 and potential
treatments for COVID-19, 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 or clinical data (including the Phase
3 data for BNT162b2), including the possibility of unfavorable new
pre-clinical, clinical or safety data and further analyses of
existing pre-clinical, clinical or safety data; the ability to
produce comparable clinical or other results, including the rate of
vaccine effectiveness and safety and tolerability profile observed
to date, in additional analyses of the Phase 3 trial and additional
studies or in larger, more diverse populations following
commercialization; the ability of BNT162b2 to prevent COVID-19
caused by emerging virus variants; the risk that more widespread
use of the vaccine 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 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 biologics license and/or EUA applications or amendments to any
such applications may be filed in particular jurisdictions for
BNT162b2 or any other potential vaccines that may arise from the
BNT162 program, and if obtained, whether or when such EUA or
licenses will expire or terminate; whether and when any
applications that may be pending or filed for BNT162b2 (including
the Biologics License Application in the U.S. or any requested
amendments to the emergency use or conditional marketing
authorizations) or other vaccines that may result from the BNT162
program may be approved by particular regulatory authorities, which
will depend on myriad factors, including making a determination as
to whether the vaccine’s benefits outweigh its known risks and
determination of the vaccine’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, 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; risks related to
the availability of raw materials to manufacture or test any such
products; challenges related to our vaccine’s ultra-low temperature
formulation, two-dose 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 new variant-specific 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 or potential
treatment for COVID-19; 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 potential approved treatment,
which would negatively impact our ability to supply the estimated
numbers of doses of our vaccine within the projected time periods
as previously indicated; whether and when additional supply
agreements will be reached; uncertainties regarding the ability to
obtain recommendations from vaccine 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 vaccine confidence or awareness; trade restrictions; 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, which account for a substantial portion of our
revenues;
- the impact of the increased presence of counterfeit medicines
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 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;
- 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 political unrest,
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, including, among others, any potential changes to
the existing tax law by the current U.S. Presidential
administration and Congress increasing the corporate tax rate
and/or the tax rate on foreign earnings;
Risks Related to Intellectual Property,
Technology and Security:
- any significant breakdown, infiltration or interruption of our
information technology systems and infrastructure;
- 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, including against claims of invalidity that could result
in loss of exclusivity, 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 potential treatments for COVID-19.
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, 2020 and in our subsequent reports on Form 10-Q, in
each case including in the sections thereof captioned
“Forward-Looking Information and Factors That May Affect Future
Results” and “Item 1A. Risk Factors,” and in our subsequent reports
on Form 8-K.
This earnings release may include discussion of certain clinical
studies relating to various in-line products and/or product
candidates. These studies typically are part of a larger body of
clinical data relating to such products or product candidates, and
the discussion herein should be considered in the context of the
larger body of data. In addition, clinical trial data are subject
to differing interpretations, and, even when we view data as
sufficient to support the safety and/or effectiveness of a product
candidate or a new indication for an in-line product, regulatory
authorities may not share our views and may require additional data
or may deny approval altogether.
The information contained on our website or any third-party
website is not incorporated by reference into this earnings
release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210728005318/en/
Media Amy Rose 212.733.7410
Investors Christopher Stevo
212.733.0437 Chuck Triano 212.733.3901 Bryan Dunn 212.733.8917
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