PFIZER REPORTS THIRD-QUARTER 2021 RESULTS

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Overig advies 06/11/2021 07:02
? Third-Quarter 2021 Revenues of $24.1 Billion, Reflecting 130% Operational Growth; Excluding
Comirnaty(1), Revenues Grew 7% Operationally to $11.1 Billion
? Third-Quarter 2021 Reported Diluted EPS(2) of $1.42, Adjusted Diluted EPS(3) of $1.34
? Raises Full-Year 2021 Guidance(4) for Revenues to a Range of $81.0 to $82.0 Billion and Adjusted Diluted
EPS(3) to a Range of $4.13 to $4.18, Reflecting 94% and 84% Year-Over-Year Growth at the Midpoints,
Respectively
– Anticipates 2021 Revenues of Approximately $36 Billion for Comirnaty(1), Reflecting 2.3 Billion Doses
Expected to be Delivered in Fiscal 2021
– Raises Midpoint of Guidance for Adjusted Diluted EPS(3) Excluding Comirnaty(1) to a Range of $2.60 to
$2.65
? Will Highlight Promising New Data on Multiple Novel Compounds in I&I, as Well as Clinical and
Regulatory Updates for Gene Therapy and COVID-19 Development Programs on Conference Call
NEW YORK, NY, Tuesday, November 2, 2021 – Pfizer Inc. (NYSE: PFE) reported financial results for thirdquarter 2021 and raised 2021 guidance(4) for revenues and Adjusted diluted EPS(3) reflecting the net impact of its
updated expectations for contributions to 2021 performance from both Comirnaty(1), the Pfizer-BioNTech SE
(BioNTech) COVID-19 vaccine, as well as its business excluding Comirnaty(1)
.
Additionally, Pfizer published this morning on its website the third-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: “While we are proud of our third quarter
financial performance, we are even more proud of what these financial results represent in terms of the positive
impact we are having on human lives around the world. For example, more than 75% of the revenues we have
recorded up through third-quarter 2021 for Comirnaty(1) have come from supplying countries outside the U.S., and
we remain on track to achieve our goal of delivering at least two billion doses to low- and middle-income
countries by the end of 2022 -- at least one billion to be delivered this year and one billion next year, with the
possibility to increase those deliveries if more orders are placed by these countries for 2022. One billion of these
doses will be supplied to the U.S. government at a not-for-profit price to be donated to the world’s poorest nations
at no charge to those countries. Despite all we have been able to accomplish to date, we remain focused on our
future, not our past. Our ultimate goal is to help bring this pandemic to an end as quickly as possible, but also to
apply the lessons we have learned through our work on the vaccine to all of our therapeutic areas. We look
forward to providing future updates on these efforts.”
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Frank D’Amelio, Chief Financial Officer and Executive Vice President, Global Supply, stated: “I continue to be
very pleased with the way our business is performing in 2021, both including and excluding the significant
contributions of Comirnaty(1) to our results. In addition to raising our expectations for revenues and Adjusted
diluted EPS(3) for the company including Comirnaty(1), today we are also increasing the midpoint of our guidance
range for Adjusted diluted EPS(3) excluding Comirnaty(1) for the second consecutive quarter, demonstrating our
ability to execute on our broader strategies beyond the vaccine. We continue to make progress on advancing our
internal pipeline across all therapeutic areas while also prudently deploying our capital through partnerships and
bolt-on acquisitions to gain access to cutting-edge platforms, science and technologies that could potentially
bolster our growth in the latter half of this decade. I am proud of what we have accomplished so far in 2021 and
look forward to finishing the year strong.”
Results for the third quarter and the first nine months of 2021 and 2020(5) are summarized below.

OVERALL RESULTS
($ in millions, except
per share amounts) Third-Quarter Nine Months
2021 2020 Change 2021 2020 Change
Revenues $ 24,094 $ 10,277 134% $ 57,653 $ 30,224 91%
Reported Net Income(2) 8,146 1,469 * 18,586 8,313 *
Reported Diluted EPS(2) 1.42 0.26 * 3.27 1.48 *
Adjusted Income(3) 7,687 3,303 133% 19,033 10,322 84%
Adjusted Diluted EPS(3) 1.34 0.59 129% 3.35 1.84 82%
* Indicates calculation not meaningful.
REVENUES
($ in millions) Third-Quarter Nine Months
2021 2020
% Change
2021 2020
% Change
Total Oper. Total Oper.
Vaccines $ 14,583 $ 1,717 * * $ 28,711 $ 4,574 * *
Oncology 3,085 2,761 12% 11% 9,091 7,843 16% 14%
Internal Medicine 2,097 2,085 1% (1%) 7,093 6,695 6% 4%
Hospital 2,367 1,790 32% 29% 6,968 5,741 21% 18%
Inflammation & Immunology 1,094 1,173 (7%) (7%) 3,200 3,299 (3%) (5%)
Rare Disease 869 752 16% 15% 2,588 2,071 25% 22%
Total Revenue $ 24,094 $ 10,277 134% 130% $ 57,653 $ 30,224 91% 86%
* 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.
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Revenues and expenses associated with the Upjohn Business(6) for all prior year periods presented 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 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.
Pfizer is raising 2021 total company guidance for revenues and Adjusted diluted EPS(3). This reflects the net
impact of its updated outlook for contributions to 2021 performance from both Comirnaty(1) and its business
excluding Comirnaty(1). The guidance range for Adjusted(3) R&D expenses was increased primarily to reflect
anticipated incremental spending on COVID-19 and mRNA-based projects. Ranges for various other components
of financial guidance were tightened within their previous ranges primarily to reflect the passage of time and
actual performance to date. Current 2021 financial guidance is presented below.
Revenues
$81.0 to $82.0 billion
(previously $78.0 to $80.0 billion)
Adjusted Cost of Sales(3) as a Percentage of Revenues 39.1% to 39.6%
(previously 39.0% to 40.0%)
Adjusted SI&A Expenses(3) $11.6 to $12.1 billion
(previously $11.5 to $12.5 billion)
Adjusted R&D Expenses(3) $10.4 to $10.9 billion
(previously $10.0 to $10.5 billion)
Adjusted Other (Income)/Deductions(3) Approximately $2.3 billion of income
(previously approximately $2.2 billion of income)
Effective Tax Rate on Adjusted Income(3) Approximately 16.0%
Adjusted Diluted EPS(3) $4.13 to $4.18
(previously $3.95 to $4.05)
The midpoint of the guidance range for revenues represents 94% growth from 2020 revenues, including an
expected $1.3 billion, or 3%, favorable impact from changes in foreign exchange rates compared to 2020. The
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midpoint of the updated guidance range for Adjusted diluted EPS(3) reflects an 84% increase over 2020 actual
results(8), including an expected $0.09, 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 continues to assume no share repurchases in 2021.
Update to Assumptions Related to Comirnaty(1) Within 2021 Guidance
Due to additional supply agreements that have been signed since mid-July, Pfizer is updating the revenue
assumptions related to Comirnaty(1) incorporated within the above guidance ranges. The updated assumptions are
summarized below.
Revenues for Comirnaty(1) Approximately $36 billion
(previously approximately $33.5 billion)
Adjusted Income(3) Before Tax (IBT)
Margin for Comirnaty(1) High-20s as a Percentage of Revenues
The Comirnaty(1) revenue projection incorporated within Pfizer’s 2021 financial guidance includes approximately
2.3 billion doses that are expected to be delivered in fiscal 2021(5) based on expected ordering patterns through the
end of December for the U.S. and through the end of November for the rest of the world. Pfizer and BioNTech
continue to expect to manufacture 3 billion doses in total by the end of December 2021. The difference between
the number of doses expected to contribute to 2021 revenues versus the number of doses expected to be
manufactured by year-end relates to anticipated international deliveries in December, which will be recorded as
revenue in 2022 due to our international fiscal calendar(5), and, to a lesser extent, doses expected to be produced
but not yet delivered as of December 31, 2021.
Adjusted(3) IBT margin guidance for Comirnaty(1) incorporates the expectation for revenues for the product, less
anticipated Adjusted(3) costs to manufacture, market and distribute Comirnaty(1)
, including applicable royalty
expenses, and a 50% gross profit split with BioNTech, as well as shared R&D expenses related to ongoing
Comirnaty(1) development efforts 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 Comirnaty(1)
Pfizer is updating its financial guidance ranges for revenues and Adjusted diluted EPS(3) excluding contributions
from Comirnaty(1). Both financial guidance components were tightened within their previous guidance ranges
primarily to reflect the passage of time and actual performance to date. In addition, guidance for revenues
excluding Comirnaty(1) was tightened around the lower end of the previous range as a result of the Chantix recall
and pause in global shipments.
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Revenues
$45.0 to $46.0 billion
(previously $45.0 to $47.0 billion)
Adjusted Cost of Sales(3) as a Percentage of Revenues 21% to 22%
Adjusted Diluted EPS(3) $2.60 to $2.65
(previously $2.55 to $2.65)
The midpoint of the revenue guidance range above reflects approximately 6% operational growth compared to
2020 when sales of Comirnaty(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 Comirnaty(1) reflects approximately 12% operational growth compared to the
prior year(8)
.
CAPITAL ALLOCATION
? During the first nine months of 2021, Pfizer paid $6.5 billion of cash dividends, or $1.17 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 November 2, 2021, Pfizer’s remaining
share repurchase authorization is $5.3 billion. Current 2021 financial guidance does not reflect any share
repurchases in 2021.
? Third-quarter 2021 diluted weighted-average shares outstanding used to calculate Reported(2) and Adjusted(3)
diluted EPS was 5,725 million shares, an increase of 92 million shares, primarily due to shares issued for
employee compensation programs, which resulted in a $0.02 reduction to both Reported(2) and Adjusted(3)
diluted EPS compared to the prior-year quarter.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2021 vs. Third-Quarter 2020)
Third-quarter 2021 revenues totaled $24.1 billion, an increase of $13.8 billion, or 134%, compared to the prioryear quarter, reflecting operational growth of $13.4 billion, or 130%, as well as a favorable impact of foreign
exchange of $421 million, or 4%.
Third-quarter 2021 operational growth was primarily driven by:
? Comirnaty(1), which contributed $13.0 billion in direct sales and alliance revenues;
? Eliquis globally, up 19% operationally, driven primarily by continued increased adoption in non-valvular
atrial fibrillation and oral anti-coagulant market share gains;
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? Vyndaqel/Vyndamax, up 42% operationally, primarily driven by continued strong uptake of the transthyretin
amyloid cardiomyopathy indication in the U.S., developed Europe and Japan;
? Inlyta globally, up 30% operationally, primarily reflecting continued 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 16%, primarily driven by strong demand across the metastatic and non-metastatic
castration-resistant prostate cancer indications and the metastatic castration-sensitive prostate cancer
indication;
? Ibrance outside of the U.S., up 9% 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;
as well as
? Hospital products globally, which grew 29% operationally to $2.4 billion, primarily driven by Pfizer
CentreOne, Pfizer’s contract manufacturing operation, reflecting certain Comirnaty-related manufacturing
activities performed on behalf of BioNTech(1) and manufacturing of legacy Upjohn products for Viatris(6), as
well as growth from international markets, primarily driven by the anti-infectives portfolio; and
? Biosimilars, which grew 34% operationally to $575 million, primarily driven by recent oncology monoclonal
antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab),
as well as continued growth from Retacrit (epoetin) in the U.S.,
partially offset primarily by lower revenues for:
? Chantix globally, down 97% operationally, driven by the voluntary recall across multiple markets and the
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;
? Prevnar family (Prevnar/Prevenar 13 & 20) globally, down 7% operationally, driven primarily by a 36%
decline in the adult indication in the U.S. due to the ongoing prioritization of primary and booster
vaccination campaigns for COVID-19 by U.S. health authorities and a later start to the flu season compared
to the prior year, as well as the continued impact of the lower remaining unvaccinated eligible adult
population and the June 2019 change to the Advisory Committee on Immunization Practices (ACIP)
recommendation for the Prevnar 13 adult indication to shared clinical decision-making;
? Sutent globally, down 31% operationally, primarily reflecting lower volume demand in the U.S. resulting from its loss of exclusivity in August 2021;

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