Pfizer Fandnf Jelly
Pfizer Fandnf Jelly
Pfizer Fandnf Jelly
Revenue Highlights
QUARTERLY FINANCIAL DESCRIPTION (Fourth-Quarter 2020 vs. Fourth-Quarter 2019)
According to their report, Fourth-quarter 2020 revenues totaled $11.7 billion, an increase
of $1.2 billion, or 12%, compared to the prior-year quarter, reflecting operational growth of $1.1
billion, or 11%, as well as a favorable impact of foreign exchange of $100 million, or 1%.
Operational growth was primarily driven by:
Vyndaqel/Vyndamax globally, up 96% operationally, driven by the continued strong
performance of the launch of the transthyretin amyloid cardiomyopathy (ATTR-CM)
indication in the U.S. and Japan in 2019 and the European Union (EU) approval of the
ATTR-CM indication in 2020;
Prevnar 13/Prevenar 13, up 10% operationally, primarily driven by:
36% operational growth in developed Europe, reflecting increased adult uptake in
certain markets resulting from greater vaccine awareness for respiratory illnesses,
including specifically pneumococcal disease, due to the COVID-19 pandemic;
and
11% growth in the U.S., due to the favorable impact of timing of government
purchases for the pediatric indication, partially offset by a decline in the adult
indication reflecting the impact of the revised Advisory Committee on
Immunization Practices recommendation for the adult indication to shared clinical
decision making, as well as the continued impact of a lower remaining eligible
adult population;
BNT162b2, which was granted an emergency use authorization (EUA) in the U.S. in
December 2020, and which contributed $154 million in sales in the fourth quarter;
Eliquis, up 14% operationally, led by growth in the emerging markets, developed Europe
and the U.S., driven primarily by continued increased adoption in non-valvular atrial
fibrillation as well as oral anti-coagulant market share gains. In the U.S., strong volume
growth was partially offset by a lower net price due to an increased impact from the
Medicare “coverage gap” and unfavorable channel mix;
Ibrance globally, up 11% operationally, primarily driven by strong cyclin-dependent
kinase (CDK) class penetration and Ibrance’s continued CDK leadership in metastatic
breast cancer;
Xeljanz globally, up 14% operationally, primarily driven by:
13% growth in the U.S., primarily reflecting higher volumes within the
rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ulcerative colitis (UC)
indications, driven by reaching additional patients through improvements in
formulary access, partially offset by increased discounts from recently-signed
contracts which were entered into in order to unlock access to additional patient
lives; and
16% operational growth in international markets, primarily reflecting continued
uptake in the RA indication and, to a lesser extent, the UC indication in certain
developed markets;
Inlyta globally, up 41% operationally, primarily reflecting increased demand in the U.S.
and developed Europe following the approvals in 2019 for combinations of certain
immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with
advanced renal cell carcinoma; and
Xtandi in the U.S., up 16%, primarily driven by continued strong demand in the
metastatic and non-metastatic castration-resistant prostate cancer indications, as well as
the metastatic castration-sensitive prostate cancer indication, which was approved in the
U.S. in December 2019; as well as
Biosimilars, which grew 86% operationally to $525 million, primarily driven by recent
oncology biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and
Trazimera (trastuzumab) in the U.S. and other global markets, as well as continued
growth from Retacrit (epoetin), primarily in the U.S.,
partially offset primarily by lower revenues for:
Chantix in the U.S., down 40%, driven by the loss of patent protection in the U.S. in
November 2020, as well as a negative impact from the COVID-19 pandemic resulting in
a decline in patient visits to doctors for preventative health purposes; and
Enbrel internationally, down 18% operationally, primarily reflecting continued biosimilar
competition in most developed Europe markets as well as in Brazil and Japan.
The table provided by Pfizer, Inc.’s official website shows that the Fourth-quarter 2020
Cost of Sales(3) as a percentage of revenues increased 5.0 percentage points compared with the
prior-year quarter. The primary drivers for the increase include:
the negative impact of changes in foreign exchange rates, which unfavorably impacted
Cost of Sales(3) more than it favorably impacted revenues in the fourth quarter of 2020;
unfavorable changes in product mix, including increased sales of lower margin products
such as BNT162b2, partially offset by the favorable impact of higher alliance revenues;
an unfavorable year-over-year impact of cash flow hedging on inventory; and
additional COVID-19-related expenses.
SI&A Expenses(3) were essentially flat in fourth-quarter 2020 compared with the prior-
year quarter.
Fourth-quarter 2020 R&D Expenses(3) increased compared with the prior-year quarter,
which primarily reflects, among other things, spending on Pfizer’s efforts to develop BNT162b2
and other potential vaccines and therapeutics to help prevent and treat COVID-19.
Pfizer recorded lower other deductions––net(3) in fourth-quarter 2020 compared with the
prior-year quarter, primarily driven by reductions in asset impairment charges, pension-related
costs and expenses associated with certain legal matters, partially offset by higher net losses on
asset disposals and lower net gains on equity securities.
Pfizer recorded a tax benefit on Reported income (3) of $0.2 billion in the fourth quarter of
2020, compared to a tax benefit of $1.2 billion in the fourth quarter of 2019. The decrease was
primarily related to the non-recurrence of the tax benefits related to certain tax initiatives
associated with the implementation of a new organizational structure as well as lower tax
benefits related to the impairment of intangible assets.
Adjusted Cost of Sales(2) as a percentage of revenues in the fourth quarter increased 4.8
percentage points compared to the prior year quarter, driven primarily by the factors listed in the
Reported(3) section above.
On a full-year basis, Adjusted Cost of Sales (2) as a percentage of revenues increased 0.9
percentage points compared to the prior year.
A full reconciliation of Reported(3) to Adjusted(2) financial measures and associated
footnotes can be found in the press release located at the hyperlink below.
Capital Allocation
There are no figures presented in Pfizer, Inc.’s official website regarding their capital
allocation. However, the following descriptions were given in their annual report:
During full-year 2020, Pfizer paid $8.4 billion of cash dividends, composed of quarterly
dividends of $0.38 per share of common stock.
No share repurchases were made in 2020 and no shares have been repurchased to date in
2021. As of February 2, 2021, Pfizer’s remaining share repurchase authorization is $5.3
billion. Current 2021 financial guidance does not reflect any share repurchases in 2021.
Fourth-quarter 2020 diluted weighted-average shares outstanding used to calculate
Reported(3) and Adjusted(2) diluted EPS was 5,662 million shares, an increase of 31
million shares compared to the prior-year quarter primarily due to shares issued for
employee compensation programs.
The following acquisitions and other business development activity impacted financial
results for the periods presented based on Pfizer, Inc.’s annual financial report:
On December 28, 2020, Myovant Sciences (Myovant) and Pfizer announced a
collaboration to jointly develop and commercialize relugolix in advanced prostate cancer
and women’s health in the U.S. and Canada, beginning in early 2021. Under the terms of
the agreement, Myovant is entitled to receive up to $4.35 billion in total milestone
payments -- including a $650 million up-front payment -- if certain regulatory and
commercial milestones are achieved.
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. Under the terms of the
transaction, which was structured as an all-stock Reverse Morris Trust, Upjohn Inc. was
spun off to Pfizer stockholders by way of a pro rata distribution and immediately
thereafter combined with Mylan. As a result of this transaction, historical contributions
from the Upjohn Business are being treated as a discontinued operation.
On September 30, 2020, Pfizer and CStone Pharmaceuticals (CStone) announced the
formation of a strategic collaboration between CStone and multiple subsidiaries of Pfizer
which encompasses a $200 million equity investment by Pfizer in CStone, a collaboration
for the development and commercialization of CStone’s PD-L1 antibody (sugemalimab)
and a framework between the companies to bring additional oncology assets to the
Greater China market.
On June 8, 2020, Valneva SE (Valneva) announced that the antitrust-related condition
precedent was met and, consequently, the agreement between Valneva and Pfizer that
was previously announced in April 2020 became effective. Under the terms of the
agreement, the companies will co-develop and commercialize Valneva’s Lyme disease
vaccine candidate VLA15, which is currently in Phase 2 clinical studies. In connection
with the agreement, Pfizer paid Valneva an upfront cash payment of $130 million in
second-quarter 2020.
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 July 31, 2019, Pfizer and GlaxoSmithKline plc (GSK) completed a transaction that
combined the two companies’ respective consumer healthcare businesses into a joint
venture (JV), operating under the GSK Consumer Healthcare name. In exchange for
contributing its Consumer Healthcare business to the JV, Pfizer received a 32% equity
stake in the JV and GSK owns the remaining 68% of the JV. Upon the closing of the
transaction, Pfizer deconsolidated its Consumer Healthcare business and began recording
its share of earnings from the Consumer Healthcare JV on a quarterly basis on a one-
quarter lag in Other (income)/deductions––net, commencing from August 1, 2019.
Therefore, Pfizer recorded its share of the JV’s earnings generated in third-quarter 2020
in its fourth-quarter 2020 operating results. Likewise, Pfizer recorded its share of the JV’s
earnings generated in fourth-quarter 2019 and in the first three quarters of 2020 in its
operating results for full-year 2020.
On July 30, 2019, Pfizer announced the successful completion of its acquisition of Array
BioPharma Inc. (Array). Array’s portfolio included two approved products, Braftovi
(encorafenib) and Mektovi (binimetinib).
On July 1, 2019, Pfizer announced the successful completion of its acquisition of the
privately held clinical-stage biotechnology company, Therachon Holding AG.
2020 NONFINANCIAL PERFORMANCE OF PFIZER, Inc.
Pipeline Developments
Pfizer, Inc. published a comprehensive update of their development pipeline 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.
As of the end of 2020, Pfizer achieved Phase 1, Phase 2, Phase 3/registration and end-to-
end clinical success rates beyond the industry averages. These metrics also demonstrate a
significant improvement in Pfizer’s clinical success rate metrics compared to the same metrics
from 5 years ago, leading to an end-to-end clinical success rate of 21% as of the end of 2020, up
from 5% as of the end of 2015.
Below are specific updates on pipeline assets since Pfizer, Inc.’s previous earnings
announcement on October 27, 2020:
Abrocitinib (PF-04965842) -- In November 2020, Pfizer announced positive top-line
results from the fifth Phase 3 trial of abrocitinib, JADE REGIMEN, a 52-week study
which investigated abrocitinib in patients 12 and older with moderate to severe atopic
dermatitis (AD) following response to initial open label induction treatment with
abrocitinib 200 mg. Patients were randomized into one of three arms: 200 mg, 100 mg or
placebo. Both doses of abrocitinib met the primary endpoint, resulting in significantly
fewer patients experiencing a loss of response requiring rescue treatment compared to
those randomized to placebo. Both doses also met the key secondary endpoint of a larger
percentage of patients maintaining an Investigator’s Global Assessment (IGA) response
of clear or almost clear relative to placebo.
BNT162b2 (COVID-19 Vaccine) Development Program
Clinical and Research Developments
o In November 2020, Pfizer and BioNTech announced that BNT162b2 met
both of the Phase 3 study’s primary efficacy endpoints at the final efficacy
analysis. Analysis of the data indicated a vaccine efficacy rate of 95% for
the prevention of COVID-19, measured from 7 days after the second dose.
Efficacy was consistent across age, gender, race and ethnicity
demographics. The observed efficacy in adults over 65 years of age was
over 94%. Of the 10 severe cases of COVID-19 observed in the trial at the
time of the analysis, nine of the cases occurred in the placebo group and
one in the BNT162b2 vaccinated group. No serious safety concerns
related to the vaccine were observed in the trial, with most solicited
adverse events resolving shortly after vaccination.
o In January 2021, Pfizer and BioNTech announced results from an in vitro
study that provides additional data on the capability of sera from
individuals immunized with BNT162b2 to neutralize the SARS-CoV-2
U.K. strain, also known as B.1.1.7 lineage or VOC 202012/01. The study
found that sera of participants from the previously reported German Phase
1/2 trial inhibited pseudovirus bearing the full set of U.K. strain spike
mutations in a neutralization range that is regarded as biologically
equivalent to the unmutated Wuhan SARS-CoV-2 spike, making it likely
that COVID-19 caused by the U.K. virus variant will also be prevented by
immunization with BNT162b2. However, further data are needed to
monitor BNT162b2’s effectiveness in preventing COVID-19 caused by
new virus variants.
o In January 2021, Pfizer and BioNTech announced results from in vitro
neutralization studies in which three engineered viruses with key
mutations present in the U.K. and South Africa variants were tested
against a panel of human sera from 20 participants vaccinated with
BNT162b2 in the previously reported Phase 3 trial. Of the three
recombinant variants, one has a mutation common to both the U.K. and
South Africa variants (N501Y), one has mutations common to the U.K.
variant (Δ69/70+N501Y+D614G), and the third has mutations common to
the South Africa variant (E484K+N501Y+D614G). The sera from
individuals vaccinated with BNT162b2 neutralized all the SARS-CoV-2
strains tested, although neutralization against the virus with the three key
mutations present in the South African variant was slightly lower when
compared to neutralization of virus containing the other mutations that
were evaluated. While these findings do not indicate the need for a new
vaccine to address the emerging variants, Pfizer and BioNTech are
prepared to respond if a variant of SARS-CoV-2 demonstrates evidence of
escaping immunity by BNT162b2.
Regulatory Developments
o On December 2, 2020, Pfizer and BioNTech announced that the
Medicines & Healthcare Products Regulatory Agency (MHRA) in the
U.K. granted a temporary authorization for emergency use for BNT162b2
against COVID-19. This constituted the developed world’s first
authorization for emergency use for a vaccine to prevent COVID-19.
o On December 11, 2020, Pfizer and BioNTech announced that the FDA
authorized the emergency use of BNT162b2 against COVID-19 in
individuals 16 years of age or older. The vaccine is authorized under an
Emergency Use Authorization (EUA) while Pfizer and BioNTech gather
additional data and prepare to file a planned Biologics License Application
(BLA) with the FDA for a possible full regulatory approval in 2021(9).
o On December 21, 2020, Pfizer and BioNTech announced the EC has
granted a conditional marketing authorization (CMA) to Pfizer and
BioNTech for BNT162b2 for active immunization to prevent COVID-19
caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
The CMA is valid in all 27 member states of the European Union (EU).
o BNT162b2 has now been granted a CMA, EUA or temporary
authorization in more than 50 countries worldwide.
Commercial Developments
o In December 2020, Pfizer and BioNTech announced a second agreement
with the U.S. government to supply an additional 100 million doses of
BNT162b2 from production facilities in the U.S. This agreement brings
the total number of doses to be delivered to the U.S. to 200 million. The
companies now expect to deliver the full 200 million doses to the U.S.
government by the end of May 2021. Consistent with the original
agreement announced in July 2020, the U.S. government will pay $1.95
billion for the additional 100 million doses.
o In December 2020, Pfizer and BioNTech announced they will supply an
additional 100 million doses of BNT162b2 to the 27 EU member states in
2021. This announcement is a result of the EC’s decision to exercise its
option to purchase an additional 100 million doses under its Advanced
Purchase Agreement signed on November 11, 2020. This agreement
brings the total number of doses to be delivered to the EU to 300 million.
o In January 2021, Pfizer and BioNTech announced an advance purchase
agreement with COVAX for up to 40 million doses, to be delivered
throughout 2021. COVAX is a global initiative to ensure equitable access
to COVID-19 vaccines for all countries, regardless of income levels.
COVAX includes an Advanced Market Commitment (AMC) financial
mechanism that aims to ensure that 92 low- and lower-middle-income
countries will be able to secure access to COVID-19 vaccines at the same
time as higher-income countries. For the COVAX AMC 92 countries,
Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-
profit price. Supply of the vaccine is subject to the negotiation and
execution of additional agreements under the COVAX Facility structure.
Elranatamab (PF-06863135)
In December 2020, Pfizer announced safety and clinical response results from an
ongoing Phase 1 study for elranatamab, a B-cell maturation antigen (BCMA)
CD3-targeted bispecific antibody. Data from 30 patients with relapsed or
refractory multiple myeloma showed manageable safety across all subcutaneous
dose levels with no dose-limiting toxicities observed, and 83% of patients
achieved a clinical response at the highest dose level of 1,000 μg/kg weekly,
which is the recommended Phase 2 dose.
In January 2021, elranatamab received Fast Track Designation from the FDA for
treatment of patients with multiple myeloma who are refractory to at least one
proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody.
Giroctocogene fitelparvovec (SB-525 or PF-07055480) -- In December 2020, Pfizer
and Sangamo Therapeutics, Inc. announced updated follow-up data from the Phase 1/2
Alta study of giroctocogene fitelparvovec, an investigational gene therapy for patients
with severe hemophilia A. All five patients in the high dose 3 x 10 13 vg/kg cohort have
had at least one year of follow-up and showed sustained factor VIII (FVIII) activity
levels, with a group median FVIII activity of 56.9% and a group geometric mean FVIII
activity of 70.4% via chromogenic assay from week 9 to 52.
Marstacimab (PF-06741086) -- In November 2020, Pfizer announced that the first
participant has been dosed in the Phase 3 BASIS study of marstacimab, an anti-tissue
factor pathway inhibitor. BASIS is a global Phase 3, open-label, multicenter study
evaluating annualized bleed rate through 12 months on treatment with marstacimab in
approximately 145 adolescent and adult participants between ages 12 to <75 years with
severe hemophilia A or B (defined as factor VIII or factor IX activity <1%, respectively),
with or without inhibitors.
PF-06482077 (20-Valent Pneumococcal Conjugate Vaccine candidate) -- In
December 2020, Pfizer announced that the FDA accepted for priority review a BLA for
its 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention
of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the
vaccine in adults ages 18 years and older. The PDUFA goal date for a decision by the
FDA is in June 2021.
PF-06939926 (Duchenne muscular dystrophy (DMD) gene therapy) -- In January
2021, Pfizer announced that the first participant has been dosed in the Phase 3 CIFFREO
study, which will evaluate the efficacy and safety of PF-06939926, in boys with DMD.
The CIFFREO trial is expected to enroll 99 ambulatory male patients, ages 4 through 7,
across 55 clinical trial sites in 15 countries. The first patient was dosed at a site in
Barcelona, Spain on December 29, 2020.
Recifercept -- In December 2020, Pfizer announced that the first participants were dosed
in the global Phase 2 multiple dose, randomized study to assess the safety, tolerability,
pharmacokinetics and efficacy of recifercept in children with achondroplasia.
Relugolix -- In January 2021, Myovant Sciences (Myovant) and Pfizer announced that
the Phase 3 SPIRIT long-term extension study of the investigational once-daily relugolix
combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5
mg) in women with endometriosis reported clinically meaningful reductions in
dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks)
with minimal and stable bone mineral density loss. The data are consistent with the
efficacy and safety profile observed through 24 weeks in the Phase 3 SPIRIT 1 and
SPIRIT 2 studies. These results will be included in the New Drug Application (NDA) to
the FDA for relugolix combination tablet for the treatment of women with endometriosis,
anticipated to be submitted in the first half of 2021.
Ritlecitinib (PF-06651600) -- In January 2021, ritlecitinib (JAK3-TEC selective) oral
small molecule reported positive top-line results in two Phase 2 studies, one for vitiligo
and one demonstrating strong clinical remission rates in ulcerative colitis. Data from both
studies will be presented at scientific congresses later this year.
Somatrogon (MOD-4023) -- In January 2021, Pfizer and OPKO Health Inc. announced
that the FDA has accepted for filing the initial BLA for somatrogon, a long-acting human
growth hormone that is intended to be administered once-weekly for the treatment of
pediatric patients with growth hormone deficiency. The PDUFA goal date for a decision
by the FDA is in October 2021.
Corporate Developments
In November 2020, Pfizer announced that it completed the transaction to spin off its
Upjohn Business and combine it with Mylan N.V. (Mylan) to form Viatris Inc. (Viatris).
Under the terms of the transaction, which was structured as an all-stock Reverse Morris
Trust, Upjohn Inc. was spun off to Pfizer stockholders by way of a pro rata distribution
and immediately thereafter combined with Mylan. In the distribution, Pfizer stockholders
received approximately 0.124079 shares of Viatris common stock for every one share of
Pfizer common stock held as of the close of business on the record date. As of the closing
of the combination, Pfizer stockholders owned approximately 57% of the outstanding
shares of Viatris common stock, and Mylan shareholders owned approximately 43% of
the outstanding shares of Viatris common stock, in each case on a fully diluted, as-
converted and as-exercised basis.
In December 2020, Myovant and Pfizer announced a collaboration to develop and
commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone receptor
antagonist – in advanced prostate cancer and women’s health in the U.S. and Canada.
Pfizer also received an exclusive option to commercialize relugolix in oncology outside
the U.S. and Canada, excluding certain Asian countries.
Reference
Pfizer, Inc. (2021, Feb. 2) Pfizer Reports Fourth-Quarter and Full-Year 2020 Results and
Releases 5-Year Pipeline Metrics. Investor News. Retrieved from
https://investors.pfizer.com/investor-news/press-release-details/2021/PFIZER-REPORTS-
FOURTH-QUARTER-AND-FULL-YEAR-2020-RESULTS-AND-RELEASES-5-YEAR-
PIPELINE-METRICS/default.aspx