-
First-Quarter 2016 Reported Revenues(1) of $13.0 Billion,
Reflecting 26% Operational Growth Driven by 28% Operational Growth
from the Innovative Products Business and the Inclusion of Legacy
Hospira Operations -
First-Quarter 2016 Reported Revenues(1) for Pfizer
Standalone (Excluding Legacy Hospira) of $11.8 Billion, Reflecting 15%
Operational Growth -
First-Quarter 2016 Adjusted Diluted EPS(2) of $0.67,
Reported Diluted EPS(1) of $0.49 -
Raised Midpoint of 2016 Financial Guidance Ranges for Reported Revenues(1)
by $2.0 Billion and Adjusted Diluted EPS(2) by $0.18,
Reflecting Strong Performance to Date and Improved Outlook for 2016 as
well as Favorable Impact of Recent Changes in Foreign Exchange Rates
NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) reported financial results for first-quarter
2016 and updated certain components of its 2016 financial guidance.
On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira).
Consequently, first-quarter 2016 financial results include three months
of legacy Hospira global operations while first-quarter 2015 financial
results do not include any contribution from legacy Hospira operations.
The Company manages its commercial operations through two distinct
businesses: an Innovative Products(3) business and an
Established Products(3) business. The Innovative Products(3)
business is composed of two operating segments: the Global Innovative
Pharmaceutical segment (GIP) and the Global Vaccines,
Oncology and Consumer Healthcare segment (VOC). The Established Products(3)
business consists of the Global Established Pharmaceutical
segment (GEP), which includes all legacy Hospira commercial operations.
Financial results for each of these segments are presented in the Operating
Segment Information section.
Some amounts in this press release may not add due to rounding. All
percentages have been calculated using unrounded amounts. References to
operational variances pertain to period-over-period growth rates that
exclude the impact of foreign exchange as well as the negative currency
impact related to Venezuela. Results for first-quarter 2016 and 2015 are
summarized below.
OVERALL RESULTS | ||||||||||||
($ in millions, except
per share amounts) |
First-Quarter | |||||||||||
2016 | 2015 | Change | ||||||||||
Reported Revenues(1) | $ 13,005 | $ 10,864 | 20% | |||||||||
Adjusted Income(2) | 4,155 | 3,196 | 30% | |||||||||
Adjusted Diluted EPS(2) | 0.67 | 0.51 | 32% | |||||||||
Reported Net Income(1) | 3,016 | 2,376 | 27% | |||||||||
Reported Diluted EPS(1) | 0.49 | 0.38 | 29% | |||||||||
REVENUES | ||||||||||||
($ in millions) | First-Quarter | |||||||||||
2016 | 2015 | % Change | ||||||||||
Total | Oper. | |||||||||||
Innovative Products(3) | $ 7,033 | $ 5,738 | 23% | 28% | ||||||||
GIP | 3,640 | 3,075 | 18% | 25% | ||||||||
Global Vaccines | 1,570 | 1,328 | 18% | 22% | ||||||||
Global Oncology | 1,001 | 528 | 90% | 95% | ||||||||
Consumer Healthcare | 822 | 808 | 2% | 10% | ||||||||
Established Products(3)(4) | $ 5,972 | $ 5,125 | 17% | 24% | ||||||||
GEP(4) Standalone | 4,773 | 5,125 | (7%) | 1% | ||||||||
Legacy Hospira | 1,199 | — | * | * | ||||||||
Total Company | $ 13,005 | $ 10,864 | 20% | 26% | ||||||||
Pfizer Standalone
(Excl. Legacy Hospira) |
$ 11,806 | $ 10,864 | 9% | 15% | ||||||||
* Indicates calculation not meaningful. |
||||||||||||
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2) | ||||||||||||
($ in millions)
(Favorable)/Unfavorable |
First-Quarter | |||||||||||
2016 | 2015 |
% Change |
||||||||||
Total | Oper. | |||||||||||
Cost of Sales(2) | $ 2,565 | $ 1,807 | 42% | 45% | ||||||||
Percent of Revenues(1) | 19.7 | % | 16.6 | % | N/A | N/A | ||||||
SI&A Expenses(2) | 3,368 | 3,078 | 9% | 14% | ||||||||
R&D Expenses(2) | 1,723 | 1,877 | (8%) | (8%) | ||||||||
Total | $ 7,656 | $ 6,762 | 13% | 16% | ||||||||
Effective Tax Rate(2) | 23.8 | % | 24.4 | % | ||||||||
2016 FINANCIAL GUIDANCE(5)
The ranges for certain components of Pfizer’s 2016 financial guidance
have been updated today as set forth below, primarily reflecting the
following:
-
Operational Factors: Strong performance to date coupled with an
improved business outlook for 2016, which favorably impacted the
midpoint of the guidance range for reported revenue(1) by
approximately $1.0 billion and for reported(1) and adjusted(2)
diluted EPS by $0.12. -
Foreign Exchange: Favorable changes in foreign exchange rates since
mid-January 2016, which favorably impacted the midpoint of the
guidance range for reported revenue(1) by approximately
$1.0 billion and for reported(1) and adjusted(2)
diluted EPS by $0.06.
Pfizer’s complete 2016 financial guidance, including today’s |
||
Reported Revenues(1) | $51.0 to $53.0 billion | |
(previously $49.0 to $51.0 billion) | ||
Adjusted Cost of Sales(2) as a Percentage of Reported Revenues(1) |
21.0% to 22.0% | |
Adjusted SI&A Expenses(2) | $13.7 to $14.7 billion | |
(previously $13.2 to $14.2 billion) | ||
Adjusted R&D Expenses(2) | $7.4 to $7.8 billion | |
(previously $7.3 to $7.8 billion) | ||
Adjusted Other (Income)/Deductions(2) | Approximately ($500 million) of income | |
(previously approx. ($300 million) of income) | ||
Effective Tax Rate on Adjusted Income(2) | Approximately 24.0% | |
Reported Diluted EPS(1) | $1.72 to $1.85 | |
(previously $1.54 to $1.67) | ||
Adjusted Diluted EPS(2) | $2.38 to $2.48 | |
(previously $2.20 to $2.30) | ||
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, “We began the
year with very strong operational performance across both our Innovative
and Established businesses and this has served as a key driver of an
increase in both our revenue and earnings per share guidance for the
remainder of the year. I believe this performance results from our
Company being well positioned in terms of product portfolio,
organizational structure and leadership, as well as by our continued
strong financial flexibility. In addition, our late stage product
pipeline is increasingly ready to deliver our next set of prospective
growth drivers with competitive positions in high-potential therapeutic
areas where I believe Pfizer can be a leader.
“In addition, we have made excellent progress integrating the legacy
Hospira operations and now expect to achieve $1.0 billion of Hospira
cost savings by 2018, 25% more than our initial cost savings target of
$800 million. Overall, we remain focused on delivering continued revenue
growth both through internal and external opportunities, managing an
efficient operating structure and making shareholder-friendly capital
allocation and business portfolio decisions,” Mr. Read concluded.
Frank D’Amelio, Chief Financial Officer, stated, “Overall, I am very
pleased with our first-quarter 2016 financial results and with our
ability to continue delivering shareholder value through prudent capital
allocation. We grew revenues by 15% operationally, excluding the impact
of foreign exchange and legacy Hospira operations. We also continued to
deliver significant value directly to shareholders by paying $1.9
billion in first-quarter 2016 dividends and executing a $5 billion
accelerated share repurchase agreement in March 2016.
“We raised our 2016 financial guidance for reported revenues(1)
and adjusted diluted EPS(2) to reflect the strong operational
performance to date coupled with an improved business outlook for 2016.
Changes in foreign exchange rates since mid-January 2016 also favorably
impacted our updated guidance. For the remainder of 2016, we expect to
continue to advance the Hospira integration while remaining focused on
delivering strong operating results,” Mr. D’Amelio concluded.
QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2016 vs. First-Quarter
2015)
Reported revenues(1) totaled $13.0 billion, an increase of
$2.1 billion, or 20%, which reflects operational growth of $2.9 billion,
or 26%, partially offset by the unfavorable impact of foreign exchange
of $729 million, or 7%. Excluding the impact of legacy Hospira
operations of $1.2 billion and foreign exchange, Pfizer-standalone
revenues increased by $1.7 billion operationally, or 15%. Compared with
the prior-year quarter, first-quarter 2016 revenues were favorably
impacted by approximately $900 million as a result of first-quarter 2016
having five additional selling days in the U.S. and four additional
selling days in international markets. This imbalance in selling days
will be offset in fourth-quarter 2016 resulting in essentially the same
number of selling days in full-year 2016 as 2015.
Operational revenue growth in developed markets was driven primarily by
the inclusion of $1.1 billion of revenues from legacy Hospira operations
and continued strong performance of several key products, notably
Ibrance, Prevnar 13, Eliquis, Xeljanz and Lyrica — all primarily in the
U.S. In emerging markets, revenues increased 14% operationally,
favorably impacted by the addition of legacy Hospira operations, which
contributed $78 million, as well as the performance of Enbrel, Prevenar
13 and continued strong volume growth from certain other products.
Operational revenue growth was partially offset primarily by the loss of
exclusivity and associated generic competition for Zyvox, primarily in
the U.S. and certain developed Europe markets, and Lyrica in certain
developed Europe markets.
Innovative Products(3) Business Highlights
Revenues for the Innovative Products(3) business increased
28% operationally, reflecting the following:
-
GIP revenues increased 25% operationally, primarily due to strong
operational growth from Eliquis globally, Lyrica and Xeljanz both
primarily in the U.S., Enbrel in most international markets and
Chantix primarily in the U.S. Operational growth was slightly offset
by the expiration of the collaboration agreement to co-promote Rebif
in the U.S., which expired at the end of 2015. -
VOC revenues increased 33% operationally, reflecting the following:
-
Global Vaccines revenues increased 22% operationally, driven by
growth from Prevnar 13, primarily in the U.S., reflecting the
timing of government purchases for the pediatric indication and
continued strong uptake among adults due to the overall success of
commercial programs. -
Global Oncology revenues increased 95% operationally, primarily
driven by continued strong momentum following the February 2015
U.S. launch of Ibrance for advanced breast cancer and, to a lesser
extent, stronger demand for Sutent and Xalkori in most markets. -
Consumer Healthcare revenues increased 10% operationally,
primarily due to Nexium 24HR and Advil, both in the U.S.,
reflecting strong demand following increased promotion and the
launch of a tablet form for Nexium 24HR in first-quarter 2016.
-
Global Vaccines revenues increased 22% operationally, driven by
Established Products(3)(4) Business
Highlights
-
GEP(4) revenues increased 24% operationally due to the
inclusion of legacy Hospira operations, which contributed $1.2
billion, partially offset by the loss of exclusivity and associated
generic competition for certain Peri-LOE Products(6),
primarily Zyvox in the U.S. and certain developed Europe markets as
well as Lyrica in certain developed Europe markets. Revenues excluding
the contribution from the legacy Hospira portfolio (GEP(4)
Standalone) increased 1% operationally, reflecting 7% operational
growth from Legacy Established Products(6) and 11%
operational growth from the Sterile Injectable Pharmaceuticals(6)
portfolio, partially offset by an 18% operational decline from
Peri-LOE Products(6). GEP(4) revenues in
emerging markets increased 10% operationally, driven by the inclusion
of legacy Hospira operations and reflecting operational growth from
Legacy Established Products(6) and the GEP(4)
Standalone Sterile Injectable Pharmaceuticals(6) portfolio.
Income Statement Highlights
-
Adjusted cost of sales(2), adjusted SI&A expenses(2)
and adjusted R&D expenses(2) in the aggregate increased
$1.1 billion operationally, or 16%, reflecting the inclusion of legacy
Hospira operations in first-quarter 2016 and the following
Pfizer-standalone operational factors:-
higher adjusted cost of sales(2) primarily due to
higher sales volumes; -
higher adjusted SI&A expense(2), primarily
reflecting higher general and administrative expenses as well as
increased investments to support certain recently launched
products and other in-line biopharmaceutical products; and -
lower adjusted R&D expense(2), primarily reflecting
the non-recurrence of a $295 million upfront payment to OPKO
Health, Inc. in first-quarter 2015 associated with a worldwide
development and commercialization agreement.
-
higher adjusted cost of sales(2) primarily due to
-
The effective tax rate on adjusted income(2) declined 0.6
percentage points to 23.8% from 24.4%. This decline was primarily due
to a favorable change in the jurisdictional mix of earnings, an
increase in tax benefits associated with the resolution of certain tax
positions pertaining to prior years with various foreign tax
authorities, as well as an increase in tax benefits due to the
permanent extension of the U.S. R&D tax credit on December 18, 2015. -
The diluted weighted-average shares outstanding declined by 78 million
shares compared to the prior-year quarter due to Pfizer’s share
repurchase program, including the impact of a $5 billion accelerated
share repurchase agreement executed in February 2015 and completed in
July 2015 and another reduction of 136 million shares associated with
an accelerated share repurchase agreement executed in March 2016. -
In addition to the aforementioned factors, first-quarter 2016 reported
earnings were primarily impacted by the following:Favorable
impacts:-
a lower effective tax rate, primarily due to tax benefits related
to the final resolution (pending court approval) of an agreement
in principle reached in February 2016 to resolve certain claims
related to Protonix and tax benefits associated with our Venezuela
operations, partially offset by an unfavorable change in the
jurisdictional mix of earnings; and -
lower charges incurred during first-quarter 2016 for business and
legal entity alignment activities compared with the prior-year
quarter.
Unfavorable impacts:-
higher acquisition-related costs, legal charges and purchase
accounting adjustments in first-quarter 2016 compared with the
prior-year quarter; and -
higher asset impairment charges associated with losses on certain
equity-method investments in first-quarter 2016.
-
a lower effective tax rate, primarily due to tax benefits related
RECENT NOTABLE DEVELOPMENTS
Product Developments
-
Chantix/Champix (varenicline) — In April 2016, Pfizer
announced publication in The Lancet of results from the largest
clinical trial of approved smoking cessation medicines, called EAGLES
(Evaluating Adverse Events in a Global Smoking Cessation Study). This
smoking cessation trial included 8,144 adult smokers and was designed
to compare the neuropsychiatric safety of Chantix/Champix
(varenicline) and bupropion with placebo and nicotine patch in adult
smokers with and without a history of psychiatric disorders. The
authors concluded that the trial did not show a significant increase
in serious neuropsychiatric adverse events with Chantix/Champix or
bupropion compared to placebo and nicotine patch. There were more
neuropsychiatric adverse events in the psychiatric cohort than the
non-psychiatric cohort across all treatment arms including placebo.
Results also showed that smokers treated with Chantix/Champix had
significantly higher quit rates than those treated with bupropion,
nicotine patch or placebo. Full results of the EAGLES trial were
published in The Lancet on April 22, 2016. -
Ibrance (palbociclib)
-
In April 2016, Pfizer announced positive top-line results from the
Phase 3 PALOMA-2 trial for Ibrance. The study met its primary
endpoint by demonstrating an improvement in progression-free
survival (PFS) for the combination of Ibrance plus letrozole
compared with letrozole plus placebo in post-menopausal women with
estrogen receptor-positive, human epidermal growth factor receptor
2-negative (HER2-) advanced or metastatic breast cancer who had
not received previous systemic treatment for their advanced
disease. The PALOMA-2 trial provides confirmatory evidence for
Ibrance in combination with letrozole in the first-line setting,
which was first studied in the Phase 2 PALOMA-1 trial. These data
will support additional planned global regulatory submissions and
a request for conversion of the accelerated approval for Ibrance
to regular approval in the U.S. Detailed efficacy and safety
results from the PALOMA-2 trial will be presented at the American
Society of Clinical Oncology (ASCO) 2016 Annual Meeting. -
Pfizer announced in February 2016 that the U.S. Food and Drug
Administration (FDA) approved a supplemental New Drug Application
(sNDA) expanding the use of Ibrance 125 mg capsules to include the
treatment of hormone receptor-positive, HER2- advanced or
metastatic breast cancer in combination with fulvestrant in women
with disease progression following endocrine therapy.
-
In April 2016, Pfizer announced positive top-line results from the
-
Inflectra (infliximab-dyyb) — In April 2016, the FDA approved
Celltrion’s Inflectra (infliximab-dyyb) across all eligible
indications of the reference product, Remicade(7)
(infliximab). Inflectra is now the first and only biosimilar
monoclonal antibody therapy to be approved in the U.S. Hospira, now a
Pfizer company, entered into an agreement with Celltrion Inc. and
Celltrion Healthcare, Co., Ltd. in 2009 for several potential
biosimilar products, including Inflectra. As a result, Pfizer holds
exclusive commercialization rights to Inflectra in the U.S. -
Xalkori (crizotinib) — Pfizer announced in March 2016 that the
FDA approved a sNDA for Xalkori to treat patients with metastatic
non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
Additionally, the European Medicines Agency (EMA) is reviewing an
application to extend the marketing authorization of Xalkori to
include the treatment of adult patients with ROS1-positive advanced
NSCLC. -
Xeljanz (tofacitinib citrate)
-
Pfizer announced in April 2016 top-line results from its first
Phase 3 study investigating tofacitinib for the treatment of
psoriatic arthritis (PsA), Oral Psoriatic Arthritis triaL (OPAL)
Broaden. This study evaluated the efficacy and safety of
tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients
with active PsA who had an inadequate response to at least one
conventional synthetic disease-modifying antirheumatic drug and
who were tumor necrosis factor inhibitor-naïve. OPAL Broaden met
its primary efficacy endpoints demonstrating that both tofacitinib
5 mg BID and 10 mg BID were superior to treatment with placebo at
3 months as measured by American College of Rheumatology 20
response and Health Assessment Questionnaire Disability Index
score. Overall safety findings in this study were consistent with
those observed in the broader rheumatology clinical development
program for tofacitinib. -
In March 2016, Pfizer announced that the EMA has accepted for
review the Marketing Authorization Application for Xeljanz 5 mg
tablets twice daily for the treatment of patients with moderate to
severe rheumatoid arthritis (RA) who have had an inadequate
response or intolerance to methotrexate (MTX). -
In February 2016, Pfizer announced that the FDA has approved
Xeljanz XR extended-release 11 mg tablets for the once-daily
treatment of moderate to severe RA in patients who have had an
inadequate response or intolerance to MTX. Xeljanz XR is the first
and only once-daily oral RA treatment in its class, known as Janus
kinase (JAK) inhibitors.
-
Pfizer announced in April 2016 top-line results from its first
Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published
today and is now available at www.pfizer.com/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 candidates from Phase 2 through registration.
-
Avelumab (MSB0010718C) — Merck KGaA, Darmstadt, Germany (Merck
KGaA) and Pfizer announced in April 2016 the treatment of the first
patient in a Phase 3 study of avelumab, an investigational fully human
anti-PD-L1 IgG1 monoclonal antibody, in an advanced renal cell
carcinoma (RCC) setting. The study, JAVELIN Renal 101, is the first
pivotal trial investigating avelumab in combination with Inlyta
(axitinib), Pfizer’s tyrosine kinase inhibitor (TKI), in patients with
previously untreated advanced RCC, and the only Phase 3 trial
currently evaluating an anti-PD-L1 immunotherapy in combination with a
vascular endothelial growth factor-receptor TKI in this setting.
JAVELIN Renal 101 is a multicenter, international, randomized (1:1),
open-label trial designed to evaluate the potential superiority,
assessed by PFS, of first-line avelumab combined with Inlyta compared
with Sutent (sunitinib malate) monotherapy, Pfizer’s oral,
small-molecule, multi-targeted receptor TKI, in patients with
unresectable, locally advanced or metastatic RCC with clear cell
component. The study is expected to enroll 583 patients across
approximately 170 sites in Asia, Europe, Latin America and North
America. -
Bococizumab (PF-04950615, RN316)
-
Pfizer announced in April 2016 the completion of patient
enrollment for the global SPIRE-2 cardiovascular outcome trial for
bococizumab, an investigational Proprotein Convertase Subtilisin
Kexin type 9 inhibitor (PCSK9i). SPIRE-2 is evaluating the
efficacy and safety of bococizumab compared to placebo in reducing
the risk of major cardiovascular events among 10,600 patients at
high risk for cardiovascular disease – including those without a
prior history of cardiovascular events – who are on
highly-effective statins or with documented statin intolerance.
Many factors impact the duration of cardiovascular outcome
studies, including that they are time-to-event trials, which can
make it difficult to predict when the studies will accrue the
required number of events. Based on current estimates, the SPIRE-2
study is expected to complete in the second half of 2017. -
In April 2016, Pfizer announced positive top-line results from the
second of six Phase 3 studies evaluating the low-density
lipoprotein cholesterol (LDL-C) reduction activity of bococizumab.
The SPIRE-AI (AutoInjector) trial of bococizumab administered with
a pre-filled pen met its co-primary endpoints: percent change from
baseline in LDL-C reduction at 12 weeks compared to placebo and
proportion of patients successfully operating the pre-filled pen.
The results of the SPIRE-AI trial are expected to be part of a
potential regulatory filing for bococizumab.
-
Pfizer announced in April 2016 the completion of patient
Corporate Developments
-
In April 2016, Pfizer announced that the merger agreement between
Pfizer and Allergan plc (Allergan) entered into on November 22, 2015
was terminated by mutual agreement of the companies. The decision was
driven by the actions announced by the U.S. Department of Treasury on
April 4, 2016, which the companies concluded qualified as an “Adverse
Tax Law Change” under the merger agreement. In connection with the
termination of the merger agreement, on April 8, 2016 (which falls
into Pfizer’s second fiscal quarter), Pfizer paid Allergan $150
million for reimbursement of Allergan’s expenses associated with the
terminated transaction. -
Pfizer announced in March 2016 that it entered into an accelerated
share repurchase agreement with Goldman, Sachs & Co. (GS&Co.) to
repurchase $5 billion of Pfizer’s common stock. Pursuant to the terms
of the agreement, on March 10, 2016, Pfizer paid $5 billion to GS&Co.
and received an initial delivery of approximately 136 million shares
of Pfizer common stock from GS&Co. At settlement of the agreement,
which is expected to occur during the second quarter of 2016, GS&Co.
may be required to deliver additional shares of common stock to
Pfizer, or, under certain circumstances, Pfizer may be required to
deliver shares of its common stock or may elect to make a cash payment
to GS&Co., with the number of shares to be delivered or the amount of
such payment based on the volume-weighted average price, less a
discount, of Pfizer’s common stock during the term of the transaction. -
Pfizer reported in February 2016 that its Wyeth subsidiary reached an
agreement in principle to resolve claims alleging that Wyeth’s
practices relating to the calculation of Medicaid rebates for its drug
Protonix (pantoprazole sodium) between 2001 and 2006, several years
before Pfizer acquired Wyeth in 2009, violated the Federal Civil False
Claims Act and other laws. As a result, in February 2016, Pfizer
reissued its fourth-quarter and full-year 2015 financial results
prepared in accordance with U.S. generally accepted accounting
principles (GAAP) to reflect a charge of $784.6 million. In April
2016, this agreement was finalized and Wyeth made a payment of this
amount to resolve these claims. The final agreement is subject to
court approval and does not include an admission of liability by
Wyeth. As previously mentioned, a tax benefit related to this
resolution was recorded in Pfizer’s first-quarter 2016 GAAP financial
results.
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:
http://www.pfizer.com/system/files/presentation/Q1_2016_PFE_Earnings_Press_Release_nvewlnavd.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) |
Reported revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income is defined as net income attributable to Pfizer Inc. in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as reported diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP. |
|
(2) |
Adjusted income and its components and Adjusted diluted EPS are |
|
(3) |
For a description of the revenues in each business, see the “Our |
|
(4) |
Effective as of the beginning of 2016, Pfizer’s entire contract manufacturing business, Pfizer CentreOne, is now part of GEP. Pfizer CentreOne consists of (i) the revenues and expenses of legacy Pfizer’s contract manufacturing and active pharmaceutical ingredient sales operation, including the revenues and expenses related to our manufacturing and supply agreements with Zoetis Inc. (collectively Pfizer CentreSource or PCS); and (ii) the revenues and expenses of legacy Hospira’s One-2-One sterile injectables contract manufacturing operation. Prior to 2016, PCS was managed outside of our operating segments as part of Pfizer Global Supply and reported as « Other Business Activities ». Prior period PCS operating results have been reclassified to conform to the current period presentation as part of GEP. The legacy Hospira One-2-One contract manufacturing business has been a part of GEP commencing from the acquisition date of September 3, 2015. |
|
(5) | The 2016 financial guidance reflects the following: |
-
Does not assume the completion of any business development
transactions not completed as of April 3, 2016, including any one-time
upfront payments associated with such transactions. -
Excludes the potential effects of the resolution of litigation-related
matters not substantially resolved as of April 3, 2016. -
Exchange rates assumed are a blend of the actual exchange rates in
effect during first-quarter 2016 and mid-April 2016 exchange rates for
the remainder of the year. -
Guidance for 2016 reported revenues(1) reflects the
anticipated negative impact of $2.3 billion due to recent and expected
generic competition for certain products that have recently lost or
are anticipated to soon lose patent protection. -
Guidance for 2016 reported revenues(1) also reflects the
anticipated negative impact of $1.3 billion as a result of unfavorable
changes in foreign exchange rates relative to the U.S. dollar compared
to foreign exchange rates from 2015, including $0.8 billion due to the
estimated significant negative currency impact related to Venezuela.
The anticipated negative impact on reported(1) and adjusted(2)
diluted EPS resulting from unfavorable changes in foreign exchange
rates compared to foreign exchange rates from 2015 is approximately
$0.10, including $0.07 due to the estimated significant negative
currency impact related to Venezuela. -
Guidance for reported(1) and adjusted(2) diluted
EPS assumes diluted weighted-average shares outstanding of
approximately 6.2 billion shares. -
Reconciliation of the 2016 Adjusted income(2) and Adjusted
diluted EPS(2) guidance to the 2016 Reported net income
attributable to Pfizer Inc.(1) and Reported diluted EPS
attributable to Pfizer Inc.(1) common shareholders guidance:
($ in billions, except per share amounts) | ||||||
Income/(Expense) | Net Income | Diluted EPS | ||||
Adjusted income/diluted EPS(2) guidance | $14.7 – $15.3 | $2.38 – $2.48 | ||||
Purchase accounting impacts of transactions completed as of April 3, 2016 |
(2.9) | (0.47) | ||||
Restructuring, implementation and other acquisition-related costs | (0.7) – (0.9) | (0.11) – (0.14) | ||||
Business and legal entity alignment costs | (0.3) | (0.05) | ||||
Reported net income attributable to Pfizer Inc./diluted EPS(1) guidance |
$10.6 – $11.4 | $1.72 – $1.85 |
(6) | The following are certain product categories within GEP(4): |
-
Peri-LOE Products include products that have recently lost or are
anticipated to soon lose patent protection. These products primarily
include Celebrex and Zyvox in most developed markets, Lyrica in
certain developed Europe markets, Pristiq globally and Inspra in the
EU. -
Sterile Injectable Pharmaceuticals include generic injectables and
proprietary specialty injectables (excluding Peri-LOE Products). -
Legacy Established Products include products that lost patent
protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE
Products).
Definitions for all GEP(4) product categories can be |
(7) | Remicade is a registered U.S. trademark of Janssen Biotech, Inc. |
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is as of
May 3, 2016. 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 our anticipated future operating and
financial performance, business plans and prospects, in-line products
and product candidates, strategic reviews, capital allocation,
business-development plans, the benefits expected from our recent
acquisition of Hospira and plans relating to share repurchases and
dividends, among other things, 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,” “target,” “forecast,” “goal,” “objective,” “aim” 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:
-
the outcome of research and development activities, including, without
limitation, the ability to meet anticipated pre-clinical and clinical
trial commencement and completion dates, regulatory submission and
approval dates, and launch dates for product candidates, as well as
the possibility of unfavorable pre-clinical and clinical trial
results, including unfavorable new clinical data and additional
analyses of existing clinical data; -
decisions by regulatory authorities regarding whether and when to
approve our drug applications, which will depend on the assessment by
such regulatory authorities of the benefit-risk profile suggested by
the totality of the efficacy and safety information submitted;
decisions by regulatory authorities regarding labeling, ingredients
and other matters that could affect the availability or commercial
potential of our products; and uncertainties regarding our ability to
address the comments in complete response letters received by us with
respect to certain of our drug applications to the satisfaction of the
FDA; -
the speed with which regulatory authorizations, pricing approvals and
product launches may be achieved; -
the outcome of post-approval clinical trials, which could result in
the loss of marketing approval for a product or changes in the
labeling for, and/or increased or new concerns about the safety or
efficacy of, a product that could affect its availability or
commercial potential; -
risks associated with interim data, including the risk that final
results of studies for which interim data have been provided and/or
additional clinical trials may be different from (including less
favorable than) the interim data results and may not support further
clinical development of the applicable product candidate or indication; -
the success of external business-development activities, including the
ability to satisfy the conditions to closing of any announced
transactions in the anticipated time frame or at all; -
competitive developments, including the impact on our competitive
position of new product entrants, in-line branded products, generic
products, private label products and product candidates that treat
diseases and conditions similar to those treated by our in-line drugs
and drug candidates; -
the implementation by the FDA and regulatory authorities in certain
other countries of an abbreviated legal pathway to approve biosimilar
products, which could subject our biologic products to competition
from biosimilar products, with attendant competitive pressures, after
the expiration of any applicable exclusivity period and patent rights; -
the ability to meet generic and branded competition after the loss of
patent protection for our products or competitor products; -
the ability to successfully market both new and existing products
domestically and internationally; - difficulties or delays in manufacturing;
- trade buying patterns;
-
the impact of existing and future legislation and regulatory
provisions on product exclusivity; - trends toward managed care and healthcare cost containment;
-
the impact of 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, and/or any significant
additional taxes or fees that may be imposed on the pharmaceutical
industry as part of any broad deficit-reduction effort; -
the impact of U.S. healthcare legislation enacted in 2010—the Patient
Protection and Affordable Care Act, as amended by the Health Care and
Education Reconciliation Act—and of any modification, repeal or
invalidation of any of the provisions thereof; -
U.S. federal or state legislation or regulatory action affecting,
among other things, pharmaceutical product pricing, reimbursement or
access, including under Medicaid, Medicare and other publicly funded
or subsidized health programs; the importation of prescription drugs
from outside the U.S. at prices that are regulated by governments of
various foreign countries; restrictions on direct-to-consumer
advertising; limitations on interactions with healthcare
professionals; or the use of comparative effectiveness methodologies
that could be implemented in a manner that focuses primarily on the
cost differences and minimizes the therapeutic differences among
pharmaceutical products and restricts access to innovative medicines;
as well as pricing pressures for our products as a result of highly
competitive insurance markets; -
legislation or regulatory action in markets outside the U.S. affecting
pharmaceutical product pricing, 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 outside the U.S. to possible capital
and exchange controls, 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; - contingencies related to actual or alleged environmental contamination;
-
claims and concerns that may arise regarding the safety or efficacy of
in-line products and product candidates; -
any significant breakdown, infiltration or interruption of our
information technology systems and infrastructure; -
legal defense costs, insurance expenses, settlement costs, the risk of
an adverse decision or settlement and the adequacy of reserves related
to product liability, patent matters, government investigations,
consumer, commercial, securities, antitrust, environmental,
employment, tax issues, ongoing efforts to explore various means for
resolving asbestos litigation, and other legal proceedings; -
our ability to protect our patents and other intellectual property,
both domestically and internationally; -
interest rate and foreign currency exchange rate fluctuations,
including the impact of possible currency devaluations in countries
experiencing high inflation rates; -
governmental laws and regulations affecting domestic and foreign
operations, including, without limitation, tax obligations and changes
affecting the tax treatment by the U.S. of income earned outside the
U.S. that may result from pending and possible future proposals; -
any significant issues involving our largest wholesaler customers,
which account for a substantial portion of our revenues; -
the possible impact of the increased presence of counterfeit medicines
in the pharmaceutical supply chain on our revenues and on patient
confidence in the integrity of our medicines; -
any significant issues that may arise related to the outsourcing of
certain operational and staff functions to third parties, including
with regard to quality, timeliness and compliance with applicable
legal requirements and industry standards; -
any significant issues that may arise related to our joint ventures
and other third-party business arrangements; - changes in U.S. generally accepted accounting principles;
-
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; and
the related risk that our allowance for doubtful accounts may not be
adequate; -
any changes in business, political and economic conditions due to
actual or threatened terrorist activity in the U.S. and other parts of
the world, and related U.S. military action overseas; - growth in costs and expenses;
- changes in our product, segment and geographic mix;
-
the impact of purchase accounting adjustments, acquisition-related
costs, discontinued operations and certain significant items; -
the impact of acquisitions, divestitures, restructurings, internal
reorganizations, product recalls, withdrawals and other unusual items,
including our ability to realize the projected benefits of our
cost-reduction and productivity initiatives, including those related
to our research and development organization, and of the internal
separation of our commercial operations into our current operating
structure; -
the risk of an impairment charge related to our intangible assets,
goodwill or equity-method investments; - risks related to internal control over financial reporting; and
-
risks and uncertainties related to our recent acquisition of Hospira,
including, among other things, the ability to realize the anticipated
benefits of the acquisition of Hospira, including the possibility that
expected synergies and accretion will not be realized or will not be
realized within the expected time frame; the risk that the businesses
will not be integrated successfully; disruption from the transaction
making it more difficult to maintain business and operational
relationships; significant transaction costs; and unknown liabilities.
We cannot guarantee that any forward-looking statement will be realized,
although we believe we have been prudent in our plans and assumptions.
Achievement of anticipated results is subject to substantial risks,
uncertainties and inaccurate assumptions. 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 should bear this in
mind as they consider forward-looking statements, and 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,
2015, 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.
The operating segment information provided in this earnings release and
the related attachments does not purport to represent the revenues,
costs and income from continuing operations before provision for taxes
on income that each of our operating segments would have recorded had
each segment operated as a standalone company during the periods
presented.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160503005899/en/
Contacts
Pfizer Inc.
Media
Joan Campion,
212-733-2798
or
Investors
Chuck
Triano, 212-733-3901
or Ryan Crowe, 212-733-8160
or Bryan
Dunn, 212-733-8917
Source: Pfizer Inc.
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