Pfizer (NYSE:PFE)
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PROVIDES 2016 FINANCIAL GUIDANCE
-
Fourth-Quarter 2015 Reported Revenues(1) of $14.0 Billion,
Reflecting 14% Operational Growth Driven by 22% Operational Growth
from the Innovative Products Business
-
Full-Year 2015 Reported Revenues(1) of $48.9 Billion,
Reflecting 6% Operational Growth Driven by 19% Operational Growth from
the Innovative Products Business
-
Fourth-Quarter 2015 Adjusted Diluted EPS(2) of $0.53 and
Reported Diluted EPS(1) of $0.10; Full-Year 2015 Adjusted
Diluted EPS(2) of $2.20 and Reported Diluted EPS(1)
of $1.24
-
Provides 2016 Financial Guidance
Pfizer Inc. (NYSE:PFE) reported financial results for fourth-quarter and
full-year 2015 and provided 2016 financial guidance.
On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira).
Consequently, and in accordance with Pfizer's domestic and international
reporting periods(3), full-year financial results for the
year ended December 31, 2015 reflect four months of legacy Hospira U.S.
operations and three months of legacy Hospira international operations,
while financial results from fourth-quarter 2014 and full-year 2014 do
not include any contribution from legacy Hospira operations.
Fourth-quarter 2015 includes three months of legacy Hospira global
operations.
The Company manages its commercial operations through two distinct
businesses: an Innovative Products business and an Established Products
business. The Innovative Products business is composed of two operating
segments: the Global Innovative Pharmaceutical segment (GIP)(4)
and the Global Vaccines, Oncology and Consumer Healthcare
segment (VOC)(4). The Established Products business
consists of the Global Established Pharmaceutical segment (GEP)(4),
which includes all legacy Hospira commercial operations. Financial
results for each of these segments are presented in the Operating
Segment Information section.
Some amounts in this press release may not add due to rounding. All
percentages have been calculated using unrounded amounts. Results for
fourth-quarter and full-year 2015 and 2014 are summarized below.
OVERALL RESULTS
($ in millions, except
per share amounts)
Fourth-Quarter
Full-Year
2015
2014
Change
2015
2014
Change
Reported Revenues(1)
$ 14,047
$ 13,118
7%
$ 48,851
$ 49,605
(2%)
Adjusted Income(2)
3,306
3,441
(4%)
13,755
14,530
(5%)
Adjusted Diluted EPS(2)
0.53
0.54
(2%)
2.20
2.26
(3%)
Reported Net Income(1)
613
1,228
(50%)
7,745
9,135
(15%)
Reported Diluted EPS(1)
0.10
0.19
(47%)
1.24
1.42
(13%)
REVENUES
($ in millions)
Fourth-Quarter
Full-Year
2015
2014
% Change
2015
2014
% Change
Total
Oper.
Total
Oper.
Innovative Products
$ 7,637
$ 6,628
15%
22%
$ 26,758
$ 24,005
11%
19%
GIP(4)
3,862
3,748
3%
10%
13,954
13,861
1%
9%
Global Vaccines(4)
1,917
1,318
45%
53%
6,454
4,480
44%
51%
Consumer Healthcare(4)
930
953
(2%)
4%
3,395
3,446
(1%)
5%
Global Oncology(4)
928
609
52%
61%
2,954
2,218
33%
43%
Established Products
$ 6,264
$ 6,407
(2%)
5%
$ 21,587
$ 25,149
(14%)
(7%)
GEP(4) Standalone
5,082
6,407
(21%)
(14%)
20,075
25,149
(20%)
(13%)
Legacy Hospira
1,182
—
*
*
1,513
—
*
*
Other(5)
146
83
75%
98%
506
451
12%
20%
Total Company
$ 14,047
$ 13,118
7%
14%
$ 48,851
$ 49,605
(2%)
6%
Pfizer Excluding Legacy
Hospira
$ 12,865
$ 13,118
(2%)
5%
$ 47,339
$ 49,605
(5%)
3%
* Indicates calculation not meaningful.
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2)
($ in millions)
(Favorable)/Unfavorable
Fourth-Quarter
Full-Year
2015
2014
% Change
2015
2014
% Change
Total
Oper.
Total
Oper.
Cost of Sales(2)
$ 2,983
$ 2,584
15%
22%
$ 9,021
$ 9,134
(1%)
10%
Percent of Revenues(1)
21.2
%
19.7
%
N/A
N/A
18.5
%
18.4
%
N/A
N/A
SI&A Expenses(2)
4,598
3,916
17%
24%
14,324
13,721
4%
11%
R&D Expenses(2)
2,318
2,039
14%
16%
7,653
7,153
7%
9%
Total
$ 9,900
$ 8,539
16%
21%
$ 30,998
$ 30,007
3%
10%
Effective Tax Rate(2)
19.6
%
26.2
%
24.0
%
26.5
%
2016 FINANCIAL GUIDANCE(6)
A reconciliation of Pfizer's full-year 2015 financial results to certain
components of its 2016 financial guidance is below. For 2016, the
financial guidance includes the estimated significant negative currency
impact related to Venezuela and excludes any impact from the pending
combination with Allergan plc (Allergan).
Impact of Mid-
January 2016 FX
2016 Financial
Rates Compared
Currency Impact
Full-Year
Guidance at 2015
to 2015 FX Rates
Related to
2016 Financial
2015 Results
FX Rates
(Ex Venezuela)
Venezuela
Guidance
Reported Revenues(1)
$48.9 billion
$51.3 to $53.3 billion
($1.5 billion)
($0.8 billion)
$49.0 to $51.0 billion
Reported Diluted EPS(1)
$1.24
$1.70 to $1.83
($0.09)
($0.07)
$1.54 to $1.67
Adjusted Diluted EPS(2)
$2.20
$2.36 to $2.46
($0.09)
($0.07)
$2.20 to $2.30
Pfizer's complete 2016 financial guidance is summarized below.
Reported Revenues(1)
$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)
$13.2 to $14.2 billion
Adjusted R&D Expenses(2)
$7.3 to $7.8 billion
Adjusted Other (Income)/Deductions(2)
Approximately ($300 million) of income
Effective Tax Rate on Adjusted Income(2)
Approximately 24.0%
Reported Diluted EPS(1)
$1.54 to $1.67
Adjusted Diluted EPS(2)
$2.20 to $2.30
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, “The just
completed year was very productive in terms of business momentum,
pipeline advancement and business development activity. I am
particularly pleased with the performance of our Prevnar 13 adult and
Ibrance launches in the U.S. In addition, Eliquis, Xeljanz and the
Hospira portfolio, among other assets, along with operational growth in
emerging markets, meaningfully enhanced the strength of our businesses.
“I believe that we are well positioned to deliver another strong year in
2016 as we expect that our key in-line products will continue to perform
well while we expect to advance our product pipeline, notably our
potential registrational programs in key therapeutic areas such as
oncology, vaccines, cardiovascular and metabolic diseases, inflammation
and rare diseases.”
Mr. Read continued, “The integration of Hospira is well underway and we
now look forward to completing the combination with Allergan, which we
still expect to occur during the second half of this year. We see this
transaction as a very effective driver of accelerating the
growth potential of our Innovative business, strengthening our
Established business and more efficiently allocating our capital
globally, all factors which remain consistent with our overarching
strategy of value creation.
“I want to thank our colleagues for their continued tireless work in an
environment, that while challenging, continues to be very rewarding for
our stakeholders,” Mr. Read concluded.
Frank D’Amelio, Chief Financial Officer, stated, “2015 was a truly
transformational year for Pfizer. In addition to our strong financial
performance, we completed the Hospira acquisition, announced the pending
combination with Allergan and continued to deliver shareholder value
through prudent capital allocation. Regarding our financial performance,
we exceeded our 2015 financial guidance for reported revenue(1) and
met the top end of our 2015 financial guidance range for adjusted
diluted EPS(2) despite an operating environment that remains
challenging. Importantly, Pfizer-standalone revenues increased 3%
operationally, marking Pfizer's first year of operational revenue growth
since entering a period of significant product losses of exclusivity. We
believe the completion of the Hospira acquisition and the pending
Allergan combination will strengthen our core businesses and better
position the Company for sustainable revenue growth in the future.
“Today we are also providing our 2016 financial guidance, including
ranges for reported revenues(1) of $49.0 to $51.0 billion and
for adjusted diluted EPS(2) of $2.20 to $2.30. Our guidance
for reported revenues(1) reflects anticipated
mid-to-high-single digit operational revenue growth on an enterprise
basis offset by the anticipated negative impact of $2.3 billion due to
generic competition for products that recently lost or are expected to
soon lose marketing exclusivity as well as $2.3 billion as a result of
adverse changes in foreign exchange rates relative to the U.S. dollar
compared to foreign exchange rates from last year, including $0.8
billion due to the estimated significant currency impact related to
Venezuela. Our 2016 financial guidance excludes any impact from the
pending combination with Allergan. Finally, our guidance for reported(1)
and adjusted(2) diluted EPS also reflects anticipated share
repurchases totaling $5 billion this year, consisting of our
previously-announced plans to enter into a $5 billion accelerated share
repurchase agreement that we expect to execute in the first half of
2016. These planned repurchases are expected to more than offset the
potential dilution related to employee compensation programs,” Mr.
D'Amelio concluded.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2015 vs.
Fourth-Quarter 2014)
Reported revenues(1) totaled $14.0 billion, an increase of
$930 million, or 7%, which reflects operational growth of $1.9 billion,
or 14%, partially offset by the unfavorable impact of foreign exchange
of $934 million, or 7%. Excluding the impact of legacy Hospira
operations of $1.2 billion, foreign exchange and, to a lesser extent,
the vaccines acquired from Baxter International Inc. (Baxter) of $35
million, Pfizer-standalone revenues increased by $646 million
operationally, or 5%.
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
Prevnar 13 in adults and Ibrance in the U.S., Eliquis globally as well
as Xeljanz and Lyrica primarily in the U.S. In emerging markets,
revenues increased 5% operationally, favorably impacted by the addition
of legacy Hospira operations, which contributed $73 million, as well as
the performance of Prevenar 13 and certain other products.
Operational revenue growth was partially offset primarily by the loss of
exclusivity and associated generic competition for Celebrex in the U.S.
and certain other developed markets, Lyrica in certain developed Europe
markets and Zyvox in the U.S.
Innovative Products Business Highlights
Revenues for the Innovative Products business increased 22%
operationally, reflecting the following:
-
GIP(4) revenues increased 10% operationally, primarily due
to the strong operational performance of Eliquis globally, Lyrica in
the U.S. and Japan as well as Xeljanz primarily in the U.S.
-
VOC(4) revenues increased 38% operationally, reflecting the
following:
-
Global Vaccines(4) revenues increased 53%
operationally, driven by 102% growth of Prevnar 13 in the U.S.,
reflecting continued strong uptake among adults due to the
continued success of commercial programs and increased demand
during the flu season as well as by the timing of government
purchases for the pediatric indication compared to the year-ago
quarter.
-
Global Oncology(4) revenues increased 61%
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 globally.
-
Consumer Healthcare(4) revenues increased 4%
operationally, primarily due to Nexium 24HR in the U.S., driven by
strong demand following increased promotion and lower revenues in
fourth-quarter 2014 as retailers reduced initial stocking levels
following the May 2014 launch.
Established Products Business Highlights
-
GEP(4) revenues increased 5% 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 Celebrex in the U.S. and certain other
developed markets, Lyrica in certain developed Europe markets and
Zyvox in the U.S. Emerging markets revenues were flat operationally,
driven by the inclusion of legacy Hospira operations and continued
strong growth in China offset by declines in certain Middle East
markets.
Income Statement Highlights
-
Adjusted cost of sales(2), adjusted SI&A expenses(2)
and adjusted R&D expenses(2) in the aggregate increased
$1.8 billion operationally, or 21%, reflecting the inclusion of legacy
Hospira operations in fourth-quarter 2015 and the following
Pfizer-standalone operational factors:
-
slightly lower adjusted cost of sales(2);
-
higher adjusted SI&A expense(2), primarily
reflecting increased investments to support recently launched
products, other in-line biopharmaceutical products and certain
Consumer Healthcare brands; and
-
higher adjusted R&D expense(2), primarily due to
incremental investments in certain late-stage pipeline programs.
-
The effective tax rate on adjusted income(2) declined 6.6
percentage points to 19.6% from 26.2%. This decline was primarily due
to a favorable change in the jurisdictional mix of earnings as well as
an increase in tax benefits associated with the resolution of certain
tax positions pertaining to prior years primarily with various foreign
tax authorities.
-
The diluted weighted-average shares outstanding declined by 125
million shares compared to the prior-year quarter due to Pfizer’s
share repurchase program, including the impact of the $5 billion
accelerated share repurchase agreement executed in February 2015 and
completed in July 2015.
-
In addition to the aforementioned factors, fourth-quarter 2015
reported earnings were primarily impacted by the following:Unfavorable
impacts:
-
foreign currency losses related to Venezuela;
-
higher purchase accounting adjustments, acquisition-related costs,
restructuring charges and asset impairment charges in
fourth-quarter 2015 compared with the prior year quarter; and
-
non-recurring charges related to pension settlements.
Favorable impacts:
-
the non-recurrence of a charge associated with a collaborative
arrangement with Merck KGaA, Darmstadt, Germany (Merck KGaA),
announced in November 2014, to jointly develop and commercialize
avelumab(7);
-
lower charges for certain legal matters, primarily the
non-recurrence of a charge to resolve a securities class action in
New York federal court that was incurred in the prior year
quarter; and
-
a lower effective tax rate, primarily due to the aforementioned
factors impacting the fourth-quarter 2015 effective tax rate on
adjusted income(2) as well as benefits associated with
certain tax initiatives, partially offset by the non-tax
deductible charge for the aforementioned foreign currency losses
related to Venezuela.
FULL-YEAR FINANCIAL HIGHLIGHTS (Full-Year 2015 vs. Full-Year 2014)
Reported revenues(1) decreased $754 million, or 2%, which
reflects operational growth of $3.0 billion, or 6%, more than offset by
the unfavorable impact of foreign exchange of $3.8 billion, or 8%.
Excluding the impact of legacy Hospira operations of $1.5 billion,
foreign exchange and, to a lesser extent, the vaccines acquired from
Baxter of $178 million, Pfizer-standalone revenues increased by $1.3
billion operationally, or 3%, which reflects operational revenue growth
from certain key products partially offset by product losses of
exclusivity and co-promotion expirations that negatively impacted 2015
reported revenues(1) by $3.2 billion operationally.
Income Statement Highlights
-
Adjusted cost of sales(2), adjusted SI&A expenses(2)
and adjusted R&D expenses(2) in the aggregate increased
$3.0 billion operationally, or 10%, reflecting the inclusion of legacy
Hospira operations from September 2015 and the following
Pfizer-standalone operational factors:
-
higher adjusted cost of sales(2), primarily reflecting
an increase in sales volume, partially offset by manufacturing
efficiencies and a decrease in royalty expense associated with
products that recently lost marketing exclusivity;
-
higher adjusted SI&A expense(2), primarily
reflecting increased investments to support recently launched
products, other in-line biopharmaceutical products and certain
Consumer Healthcare brands, partially offset by lower expenses
associated with certain products that have recently lost marketing
exclusivity, continued benefits from cost-reduction and
productivity initiatives as well as a lower cost for the Branded
Prescription Drug Fee compared to the prior year; and
-
higher adjusted R&D expense(2), primarily due to
higher clinical trial spend for certain oncology and GIP(4)
pipeline programs, an upfront payment to OPKO Health, Inc. in
first-quarter 2015 associated with a worldwide development and
commercialization agreement and increased investment in biosimilar
and sterile injectable development programs, partially offset by
the non-recurrence of upfront payments associated with certain
agreements entered into during third-quarter 2014.
-
The full-year 2015 effective tax rate on adjusted income(2)
declined 2.5 percentage points to 24.0% from 26.5% in 2014. This
decline was primarily due to a favorable change in the jurisdictional
mix of earnings.
-
The diluted weighted-average shares outstanding declined by 167
million shares compared to the prior-year, primarily due to Pfizer’s
share repurchase program, including the impact of the $5 billion
accelerated share repurchase agreement executed in February 2015 and
completed in July 2015.
-
In addition to the aforementioned full-year 2015 factors and the
factors impacting fourth-quarter 2015 reported earnings, full-year
2015 reported earnings were primarily impacted by the following:Unfavorable
impacts:
-
higher acquisition-related costs, purchase accounting adjustments
and restructuring charges, all primarily associated with the
acquisition of Hospira in third-quarter 2015;
-
higher asset impairment charges, including an impairment loss
related to Pfizer's 49%-owned equity-method investment with
Zhejiang Hisun Pharmaceuticals Co., Ltd. (Hisun) in China recorded
in third-quarter 2015; and
-
higher charges incurred during 2015 for business and legal entity
alignment activities.
Favorable impacts:
-
lower legal charges, primarily as a result of the non-recurrence
of the aforementioned charge to resolve a securities class action
recorded in fourth-quarter 2014 and the non-recurrence of a charge
to resolve Neurontin-related matters recorded in first-quarter
2014;
-
lower implementation costs associated with restructuring
activities and amortization expense related to intangible assets;
-
the non-recurrence of a charge incurred in third-quarter 2014 for
an additional year of the Branded Prescription Drug Fee in
accordance with final regulations issued in third-quarter 2014 by
the U.S. Internal Revenue Service; and
-
a lower effective tax rate, primarily due to the aforementioned
factors impacting the fourth-quarter and full-year 2015 effective
tax rate as well as the non-recurrence in 2015 of the non-tax
deductible charge for the aforementioned additional year of the
Branded Prescription Drug Fee incurred in third-quarter 2014.
RECENT NOTABLE DEVELOPMENTS
Product Developments
-
Eliquis (apixaban)
-
Bristol-Myers Squibb Company (BMS) and Pfizer announced in
December 2015 results from a post-hoc early time course
subanalysis of the Phase 3 AMPLIFY (Apixaban for the Initial
Management of Pulmonary Embolism and Deep Vein Thrombosis as
First-Line Therapy) trial. The subanalysis demonstrated Eliquis
was comparable to conventional therapy (subcutaneous enoxaparin
overlapped and followed by oral warfarin dose-adjusted to an
international normalized ratio of 2.0 to 3.0) in recurrent venous
thromboembolism (VTE) and VTE-related death with significantly
less major bleeding during the first 7, 21 and 90 days after
starting treatment. The results of the subanalyses at each
pre-specified time interval were consistent with the overall
results of the AMPLIFY trial at six months.
-
In November 2015, BMS and Pfizer presented 22 abstracts at the
American Heart Association (AHA) Scientific Sessions 2015. The new
data, including four oral presentations, contribute to the BMS and
Pfizer Alliance’s research in nonvalvular atrial fibrillation and
VTE in patients treated with Eliquis. Abstracts included new data
analyses from the pivotal Phase 3 study, ARISTOTLE, as well as a
number of real-world data analyses.
-
Ibrance (palbociclib) -- Pfizer announced in December
2015 that the U.S. Food and Drug Administration (FDA) has accepted for
filing and granted Priority Review for a supplemental New Drug
Application (sNDA) for Ibrance. If approved, the sNDA would expand the
approved use of Ibrance to reflect findings from the Phase 3 PALOMA-3
trial, which evaluated Ibrance in combination with fulvestrant versus
fulvestrant plus placebo in women with hormone receptor-positive,
human epidermal growth factor receptor 2-negative metastatic breast
cancer, regardless of menopausal status, whose disease progressed
after endocrine therapy, including those with and without prior
treatment for their metastatic disease. The Prescription Drug User Fee
Act (PDUFA) goal date for a decision by the FDA is April 2016.
-
Lyrica (pregabalin) -- Pfizer announced in November 2015
top-line results of a Phase 3 study evaluating the efficacy and safety
of Lyrica Capsules CV in adults with chronic post-traumatic peripheral
neuropathic pain. The study did not meet its primary efficacy
endpoint. The study was conducted as a 15-week, double-blind,
placebo-controlled, parallel group study with a primary objective to
evaluate the efficacy of pregabalin in the treatment of chronic
post-traumatic peripheral neuropathic pain. The primary efficacy
endpoint was mean pain reduction from baseline compared with placebo
based on pain scores from patients’ daily pain diaries. The safety
profile observed in this study was consistent with that known for
pregabalin. The most common adverse events with pregabalin in this
study were dizziness, somnolence, nausea and fatigue. There is
currently no treatment approved by the FDA for post-traumatic
neuropathic pain.
-
Xalkori (crizotinib)
-
In December 2015, the FDA accepted and granted Priority Review for
a sNDA for Xalkori for the treatment of patients with metastatic
non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
In April 2015, Xalkori received Breakthrough Therapy designation
by the FDA for this potential indication. If approved, Xalkori
would be the first FDA-approved biomarker-driven therapy for the
treatment of ROS1-positive metastatic NSCLC. Xalkori is currently
indicated in the U.S. for patients with metastatic NSCLC whose
tumors are anaplastic lymphoma kinase (ALK)-positive as detected
by an FDA-approved test. The PDUFA goal date for a decision by the
FDA is April 2016.
-
Pfizer announced in November 2015 that the European Commission
(EC) approved a label update to expand use of Xalkori to
first-line treatment of adults with ALK-positive advanced NSCLC.
The Summary of Product Characteristics also has been updated to
include efficacy data from PROFILE 1014, which demonstrated that
Xalkori significantly prolonged progression-free survival (PFS) in
previously untreated patients with ALK-positive advanced
nonsquamous NSCLC when compared to standard platinum-based
chemotherapy regimens.
-
In November 2015, Pfizer announced that PROFILE 1029, a Phase 3
study of Xalkori met its primary objective of significantly
prolonging PFS in previously untreated East Asian patients with
ALK-positive advanced NSCLC when compared to a standard
chemotherapy doublet. In this study, Xalkori was used as the first
systemic therapy for patients with advanced ALK-positive NSCLC,
and patients could have received therapy and/or surgery for early
stage disease before they were diagnosed with metastatic disease.
The adverse events observed with Xalkori in the study were
generally consistent with findings from previous trials. No
unexpected adverse events were observed. Efficacy and safety data
from PROFILE 1029 will be submitted for presentation at a future
medical meeting.
-
Xeljanz (tofacitinib citrate) -- Pfizer presented in November
2015 26 new scientific abstracts, including 20 presentations for
Xeljanz in rheumatoid arthritis (RA) at the American College of
Rheumatology/Association of Rheumatology Health Professionals Annual
Meeting. The new data continue to characterize the safety and efficacy
of Xeljanz in the treatment of RA.
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.
-
ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride)
-- The FDA has not taken action on Pfizer’s New Drug Application (NDA)
for ALO-02, which had a PDUFA date in January 2016. The delay is not
related to anything specific in the ALO-02 NDA, and no additional data
analyses or data requests have been identified by the FDA. Pfizer is
continuing discussions with the FDA to finalize the label. Pfizer
cannot speculate on timing for the FDA decision.
-
Avelumab(7) (MSB0010718C)
-
Merck KGaA and Pfizer announced during fourth-quarter 2015 the
initiation of five Phase 3 trials of avelumab(7), an
investigational fully human anti-PD-L1 IgG1 monoclonal antibody,
in various cancers, including:
-
JAVELIN Lung 100 is designed to assess the safety and efficacy
of avelumab(7), compared with platinum-based
doublet chemotherapy, in patients with late-stage NSCLC who
have not previously received any treatment for their systemic
lung cancer.
-
JAVELIN Gastric 100 is designed to compare the switch from
first-line chemotherapy to maintenance therapy with avelumab(7)
versus continuation of chemotherapy in patients with
unresectable, locally advanced or metastatic
gastric/gastro-esophageal junction cancers whose disease has
not progressed with first-line platinum-based chemotherapy.
-
JAVELIN Gastric 300 is designed to evaluate the superiority
(based on overall survival) of avelumab(7) in
patients with unresectable, recurrent or metastatic
gastric/gastro-esophageal junction cancers, compared with
investigator’s choice of chemotherapy from a pre-specified
list of therapeutic options.
-
JAVELIN Ovarian 200 is designed to evaluate the superiority of
avelumab(7) as a monotherapy or in combination with
pegylated liposomal doxorubicin (PLD), compared with PLD
alone, in treating patients with platinum-resistant/refractory
ovarian cancer. The JAVELIN Ovarian 200 trial is the first
Phase 3 study of a PD-L1 inhibitor investigated in this
setting.
-
JAVELIN Bladder 100 is designed to evaluate the safety and
efficacy of avelumab(7) plus best supportive care
(BSC) as a maintenance treatment, compared with BSC alone, in
patients with unresectable, locally advanced or metastatic
urothelial cancer whose disease did not progress on (or
following) completion of first-line treatment with a
platinum-containing chemotherapy.
-
Merck KGaA and Pfizer announced in November 2015 that the European
Medicines Agency’s Committee for Orphan Medicinal Products issued
a positive opinion for Orphan Drug designation for avelumab(7)
for the treatment of patients with Merkel cell carcinoma
(MCC), a rare and aggressive type of skin cancer. An official
decision by the EC was granted in December 2015.
-
Merck KGaA and Pfizer announced in November 2015 that the FDA
granted Breakthrough Therapy designation for avelumab(7)
for the treatment of patients with metastatic MCC who have
progressed after at least one previous chemotherapy regimen.
-
Merck KGaA and Pfizer announced in October 2015 that the FDA
granted avelumab(7) Fast Track designation for the
treatment of metastatic MCC.
-
Bococizumab (PF-04950615, RN316) -- In January 2016, Pfizer
received positive top-line results from the first of six Phase 3
studies evaluating the low-density lipoprotein cholesterol (LDL-C)
reduction activity of bococizumab. The SPIRE-SI study evaluated the
efficacy, safety, and tolerability of bococizumab in adults with
dyslipidemia who are intolerant to statins. A total of 184 patients
were randomized to receive either 150 mg of bococizumab every two
weeks by subcutaneous injection, atorvastatin 40 mg once-daily or
placebo once-daily for 12 weeks. The trial met its primary endpoint,
as measured by the percent change in baseline LDL-C level at 12 weeks.
No new or unexpected safety findings for bococizumab were observed in
the study. Complete study results of the SPIRE-SI trial will be
presented at an upcoming scientific congress. Results from other Phase
3 studies evaluating LDL-C reduction are expected throughout 2016.
Corporate Developments
-
BMS and Pfizer announced in February 2016 that the companies have
entered into a collaboration agreement with Portola Pharmaceuticals
Inc. (Portola) to develop and commercialize the investigational agent
andexanet alfa in Japan. Andexanet alfa, which is in Phase 3 clinical
development in the U.S. and Europe, is designed to reverse the
anticoagulant activity of Factor Xa inhibitors, including Eliquis.
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Pfizer announced in January 2016 an expansion of its R&D investment
strategy to include early-stage companies on the leading edge of
scientific innovation, providing them with both equity and access to
resources for research in promising areas aligned with Pfizer’s core
interests. The first four investments of the newly focused initiative
include $46 million in financing to companies at early stages of the
discovery process that are actively exploring Conditionally Active
Biologics, immuno-oncology, neurodegenerative technologies and gene
therapy. Additional opportunities will continue to be identified by
Pfizer’s scientific leadership through their active involvement, and
Pfizer will help recipient companies fully explore their platforms in
the hopes of advancing new therapeutic pathways.
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Pfizer and Adaptive Biotechnologies Corporation (Adaptive) announced
in January 2016 that they have entered into a translational research
collaboration to leverage next generation sequencing of the adaptive
immune system to advance Pfizer’s growing immuno-oncology franchise.
Under the terms of the agreement, Pfizer and Adaptive will seek to
combine drug development and platform technology biomarker expertise
to identify patients who may preferentially benefit from immunotherapy.
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Merck KGaA, Pfizer and Syndax Pharmaceuticals, Inc. (Syndax) announced
in January 2016 that they have entered into a collaboration agreement
to evaluate avelumab(7) in combination with Syndax’s
entinostat, an investigational oral small molecule that targets immune
regulatory cells (myeloid-derived suppressor cells and regulatory
T-cells), in patients with heavily pre-treated, recurrent ovarian
cancer. This is an exclusive agreement between the Merck KGaA-Pfizer
alliance and Syndax to study the combination of these two
investigational agents in ovarian cancer. Syndax will be responsible
for conducting the Phase 1b/2 clinical trial.
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In December 2015, Pfizer announced that its Board of Directors
declared a 30-cent first-quarter 2016 dividend on the Company’s common
stock, payable March 2, 2016, to shareholders of record at the close
of business on February 5, 2016. This represents an increase of 7% in
the quarterly dividend per share, compared to 28 cents per share in
first-quarter 2015.
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In December 2015, the Board of Directors authorized a new $11 billion
share repurchase program to be utilized over time. In November 2015,
Pfizer announced that, consistent with 2015, it expects to execute an
approximately $5 billion accelerated share repurchase program in the
first half of 2016. As of December 31, 2015, Pfizer had $16.4 billion
in aggregate remaining under its share repurchase authorizations.
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In November 2015, Pfizer announced that it entered into a definitive
merger agreement with Allergan, a global pharmaceutical company
incorporated in Ireland, under which Pfizer agreed to combine with
Allergan in a stock transaction valued at $363.63 per Allergan share,
for a total enterprise value of approximately $160 billion, based on
the closing price of Pfizer common stock of $32.18 on November 20,
2015 (the last trading day prior to the announcement). Allergan
shareholders will receive 11.3 shares of the combined company for each
of their Allergan shares by virtue of a share split, and Pfizer
stockholders will have the option of receiving one share of the
combined company for some or all of their Pfizer shares or to receive
cash instead of shares of the combined company for some or all of
their Pfizer shares, provided that the aggregate amount of cash to be
paid in the merger will not be less than $6 billion or greater
than $12 billion. In the event that elections to receive cash and
shares in the merger would otherwise result in an aggregate of less
than $6 billion or greater than $12 billion of cash being paid out in
the merger, then the share elections and cash elections will be
subject to proration. The completion of the transaction, which is
expected in the second half of 2016, is subject to certain conditions,
including receipt of regulatory approval in certain jurisdictions,
including the U.S. and EU, the receipt of necessary approvals from
both Pfizer and Allergan shareholders, and the completion of
Allergan’s pending divestiture of its generics business to Teva
Pharmaceuticals Industries Ltd. The merger agreement also provides
that the businesses of Pfizer and Allergan will be combined under the
existing Allergan entity, which, subject to approval by Allergan
shareholders, will be renamed “Pfizer plc.”
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In response to the ongoing challenges patients face in paying their
out-of-pocket costs for their prescription medicines, Pfizer announced
in November 2015 that it has doubled the allowable income level for
its patient assistance program, so that even more patients in need
could be eligible to receive their Pfizer medicines for free. With
this change, more than 40 medicines offered for free through the
program are now available to eligible patients earning up to four
times the Federal Poverty Level adjusted for family size ($47,080 for
a single person; $97,000 for a family of four). Through the Pfizer
RxPathways program, Pfizer offers patients, including those with
health insurance and those without, a range of individual services to
help them gain access to Pfizer medicines. From 2010 to 2014, Pfizer
has helped nearly 2.5 million uninsured and underinsured patients get
access to more than 30 million Pfizer prescriptions, making it the
most comprehensive program of its kind.
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/Q4_2015_PFE_Earnings_Press_Release_asdkfsdaf.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
defined as reported U.S. GAAP net income(1) and its
components and reported diluted EPS(1) excluding
purchase accounting adjustments, acquisition-related costs,
discontinued operations and certain significant items. Adjusted
revenue, 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 under Adjusted income in the Management’s Discussion and
Analysis of Financial Condition and Results of Operations section
of Pfizer’s Quarterly Report on Form 10-Q for the fiscal quarter
ended September 27, 2015, management uses Adjusted income, among
other factors, to set performance goals and to measure the
performance of the overall company. We believe that investors’
understanding of our performance is enhanced by disclosing this
measure. See the accompanying reconciliations of certain GAAP
Reported to non-GAAP Adjusted information for the fourth quarter
and twelve months ended 2015 and 2014, as well as reconciliations
of full-year 2016 guidance for Adjusted income and Adjusted
diluted EPS to full-year 2016 guidance for Reported net income(1)
and Reported diluted EPS(1). 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.
(3)
Pfizer's fiscal year-end for international subsidiaries was November
30, 2015, and Pfizer's fiscal year-end for U.S. subsidiaries was
December 31, 2015.
(4)
For a description of the revenues in each business, see the “Our
Strategy––Commercial Operations” sub-section in the Overview of
Our Performance, Operating Environment, Strategy and Outlook
section of Pfizer's Quarterly Report on Form 10-Q for the fiscal
quarter ended September 27, 2015.
(5)
Other includes revenues from Pfizer CentreSource, our contract
manufacturing and bulk pharmaceutical chemical sales organization,
and revenues related to our manufacturing and supply agreements with
Zoetis Inc.
(6)
The 2016 financial guidance reflects the following:
-
Does not assume the completion of any business development
transactions not completed as of December 31, 2015, including any
one-time upfront payments associated with such transactions. 2016
financial guidance excludes any impact from the pending combination
with Allergan. The transaction is expected to close during the second
half of 2016.
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Excludes the potential effects of the resolution of litigation-related
matters not substantially resolved as of December 31, 2015.
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Exchange rates assumed are as of mid-January 2016.
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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.
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Guidance for 2016 reported revenues(1) also reflects the
anticipated negative impact of $2.3 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
$0.16, including $0.07 due to the estimated significant negative
currency impact related to Venezuela.
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Guidance for reported(1) and adjusted diluted EPS(2)
assumes diluted weighted-average shares outstanding of approximately
6.2 billion shares.
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Reconciliation of the 2016 Adjusted income(2) and Adjusted
diluted EPS(2) guidance to the 2016 Reported net income
attributable to Pfizer Inc.(1) and Reported diluted EPS
attributable to Pfizer Inc.(1) common shareholders guidance:
($ in billions, except per share amounts)
Income/(Expense)
Net Income
Diluted EPS
Adjusted income/diluted EPS(2) guidance
$13.6 - $14.2
$2.20 - $2.30
Purchase accounting impacts of transactions completed as of December
31, 2015
(2.8)
(0.46)
Restructuring, implementation and other acquisition-related costs
(0.7) - (0.9)
(0.11) - (0.14)
Business and legal entity alignment costs
(0.4)
(0.06)
Reported net income attributable to Pfizer Inc./diluted EPS(1)
guidance
$9.5 - $10.3
$1.54 - $1.67
(7)
Avelumab is the proposed International Nonproprietary Name for the
anti-PD-L1 monoclonal antibody, MSB0010718C.
DISCLOSURE NOTICE: The information contained in this earnings release
and the attachments is as of February 2, 2016. We assume no obligation
to update forward-looking statements contained in this earnings release
and the attachments as a result of new information or future events or
developments.
This earnings release and the 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, the
pending combination with Allergan 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 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 announced transactions
in the anticipated timeframe 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;
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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;
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the ability to successfully market both new and existing products
domestically and internationally;
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difficulties or delays in manufacturing;
-
trade buying patterns;
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the impact of existing and future legislation and regulatory
provisions on product exclusivity;
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trends toward managed care and healthcare cost containment;
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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;
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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;
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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;
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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 protection, government investigations,
consumer, commercial, securities, antitrust, environmental and 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;
-
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;
and
-
risks and uncertainties related to our pending combination with
Allergan, including, without limitation, the failure to obtain
necessary regulatory approvals (and the risk that such approvals may
result in the imposition of conditions that could adversely affect the
combined company or the expected benefits of the transaction) and
shareholder approvals or to satisfy any of the other conditions to the
transaction on a timely basis or at all, the occurrence of events that
may give rise to a right of one or both of the parties to terminate
the merger agreement, adverse effects on the market price of Pfizer’s
common stock and on Pfizer’s operating results because of a failure to
complete the transaction in the anticipated time frame or at all,
failure to realize the expected benefits and synergies of the
transaction, restructuring in connection with the transaction and
subsequent integration of Pfizer and Allergan, negative effects of the
announcement or the consummation of the transaction on the market
price of Pfizer’s common stock and on Pfizer’s operating results,
risks relating to the value of the Allergan shares to be issued in the
transaction, significant transaction costs and/or unknown liabilities,
the risk of litigation and/or regulatory actions, the loss of key
senior management or scientific staff, general economic and business
conditions that affect the companies following the transaction,
changes in global, political, economic, business, competitive, market
and regulatory forces, future exchange and interest rates, changes in
tax and other laws, regulations, rates and policies, future business
combinations or disposals, competitive developments and the
uncertainties inherent in research and development.
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, 2014 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.
The operating segment information provided in this earnings release and
the 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.
NO OFFER OR SOLICITATION
This communication is not intended to and does not constitute an offer
to sell or the solicitation of an offer to subscribe for or buy or an
invitation to purchase or subscribe for any securities or the
solicitation of any vote or approval in any jurisdiction, nor shall
there be any sale, issuance or transfer of securities in any
jurisdiction in contravention of applicable law.
This communication is not intended to be and is not a prospectus for the
purposes of Part 23 of the Companies Act 2014 of Ireland (the “2014
Act”), Prospectus (Directive 2003/71/EC) Regulations 2005 (S.I. No. 324
of 2005) of Ireland (as amended from time to time) or the Prospectus
Rules issued by the Central Bank of Ireland pursuant to section 1363 of
the 2014 Act, and the Central Bank of Ireland (“CBI”) has not approved
this communication.
IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC
In connection with the pending combination between Pfizer Inc.
(“Pfizer”) and Allergan plc (“Allergan”), Allergan will file with the
U.S. Securities and Exchange Commission (the “SEC”) a registration
statement on Form S-4 that will include a Joint Proxy Statement of
Pfizer and Allergan that also constitutes a Prospectus of Allergan (the
“Joint Proxy Statement/Prospectus”). Pfizer and Allergan plan to mail to
their respective shareholders the definitive Joint Proxy
Statement/Prospectus in connection with the transaction. INVESTORS AND
SECURITY HOLDERS OF PFIZER AND ALLERGAN ARE URGED TO READ THE JOINT
PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR TO BE
FILED WITH THE SEC CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION ABOUT PFIZER, ALLERGAN, THE
TRANSACTION AND RELATED MATTERS. Investors and security holders will be
able to obtain free copies of the Joint Proxy Statement/Prospectus (when
available) and other documents filed with the SEC by Pfizer and Allergan
through the website maintained by the SEC at www.sec.gov.
In addition, investors and security holders will be able to obtain free
copies of the documents filed with the SEC by Pfizer by contacting
Pfizer Investor Relations at Bryan.Dunn@pfizer.com
or by calling (212) 733-8917, and will be able to obtain free copies of
the documents filed with the SEC by Allergan by contacting Allergan
Investor Relations at investor.relations@actavis.com
or by calling (862) 261-7488.
PARTICIPANTS IN THE SOLICITATION
Pfizer, Allergan and certain of their respective directors, executive
officers and employees may be considered participants in the
solicitation of proxies in connection with the pending combination.
Information regarding the persons who may, under the rules of the SEC,
be deemed participants in the solicitation of the respective
shareholders of Pfizer and Allergan in connection with the pending
combination, including a description of their direct or indirect
interests, by security holdings or otherwise, will be set forth in the
Joint Proxy Statement/Prospectus when it is filed with the SEC.
Information regarding Pfizer’s directors and executive officers is
contained in Pfizer’s proxy statement for its 2015 annual meeting of
stockholders, which was filed with the SEC on March 12, 2015, and
certain of Pfizer’s Current Reports on Form 8-K. Information regarding
Allergan’s directors and executive officers is contained in Allergan’s
proxy statement for its 2015 annual meeting of shareholders, which was
filed with the SEC on April 24, 2015, and certain of Allergan’s Current
Reports on Form 8-K.
Statement Required by the Irish Takeover Rules
The directors of Pfizer accept responsibility for the information
contained in this communication. To the best of the knowledge and belief
of the directors of Pfizer (who have taken all reasonable care to ensure
that such is the case), the information contained in this communication
for which they accept responsibility is in accordance with the facts and
does not omit anything likely to affect the import of such information.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160202005763/en/
Pfizer Inc.MediaJoan Campion, 212-733-2798orInvestorsChuck
Triano, 212-733-3901Ryan Crowe, 212-733-8160Bryan Dunn,
212-733-8917