[January 31, 2017] |
|
PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2016 RESULTS
Pfizer Inc. (NYSE:PFE) reported financial results for fourth-quarter and
full-year 2016 and provided 2017 financial guidance.
Pfizer manages its commercial operations through two distinct
businesses: Pfizer Innovative Health (IH)(3) (formerly the
Innovative Products business) and Pfizer Essential Health (EH)(3)(4)
(formerly the Established Products business). Financial results
for each of these businesses are presented in the Operating Segment
Information section located at the hyperlink below.
On September 3, 2015, Pfizer acquired Hospira, Inc. (Hospira).
Consequently, financial results for the year ended December 31, 2016
reflect legacy Hospira global operations for the entire period while
financial results for the year ended December 31, 2015 reflect only four
months of legacy Hospira U.S. operations and three months of legacy
Hospira international operations(5). Financial results for
fourth-quarter 2016 and fourth-quarter 2015 include legacy Hospira
global operations for both periods.
On June 24, 2016, Pfizer acquired Anacor Pharmaceuticals, Inc. (Anacor).
Therefore, financial results for fourth-quarter and full-year 2016
reflect three months and approximately six months of legacy Anacor
operations, respectively, which were immaterial.
On September 28, 2016, Pfizer acquired Medivation, Inc. (Medivation).
Therefore, financial results for fourth-quarter and full-year 2016
reflect three months of legacy Medivation operations.
Some amounts in this press release may not add due to rounding. All
percentages have been calculated using unrounded amounts. References to
operational variances(6) 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 the fourth
quarter and full year 2016 and 2015 are summarized below.
|
OVERALL RESULTS
|
($ in millions, except per share amounts)
|
|
Fourth-Quarter
|
|
|
Full-Year
|
|
|
2016
|
|
2015
|
|
Change
|
|
|
2016
|
|
2015
|
|
Change
|
Revenues
|
|
$
|
13,627
|
|
|
$
|
14,047
|
|
|
(3%)
|
|
|
$
|
52,824
|
|
|
$
|
48,851
|
|
|
8%
|
Reported Net Income/(Loss)(1)
|
|
|
775
|
|
|
|
(172
|
)
|
|
*
|
|
|
|
7,215
|
|
|
|
6,960
|
|
|
4%
|
Reported EPS/(LPS)(1)
|
|
|
0.13
|
|
|
|
(0.03
|
)
|
|
*
|
|
|
|
1.17
|
|
|
|
1.11
|
|
|
5%
|
Adjusted Income(2)
|
|
|
2,894
|
|
|
|
3,306
|
|
|
(12%)
|
|
|
|
14,761
|
|
|
|
13,755
|
|
|
7%
|
Adjusted Diluted EPS(2)
|
|
|
0.47
|
|
|
|
0.53
|
|
|
(11%)
|
|
|
|
2.40
|
|
|
|
2.20
|
|
|
9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Indicates calculation not meaningful or greater than 100%.
|
REVENUES
|
($ in millions)
|
|
Fourth-Quarter
|
|
|
Full-Year
|
|
|
2016
|
|
2015
|
|
% Change
|
|
|
2016
|
|
2015
|
|
% Change
|
|
|
|
|
Total
|
|
Oper.
|
|
|
|
|
Total
|
|
Oper.
|
Innovative Health
|
|
$
|
7,726
|
|
$
|
7,637
|
|
1%
|
|
2%
|
|
|
$
|
29,197
|
|
$
|
26,758
|
|
9%
|
|
11%
|
Essential Health
|
|
$
|
5,902
|
|
$
|
6,410
|
|
(8%)
|
|
(6%)
|
|
|
$
|
23,627
|
|
$
|
22,094
|
|
7%
|
|
11%
|
EH Standalone
(Excl. Legacy Hospira)
|
|
|
4,735
|
|
|
5,228
|
|
(9%)
|
|
(7%)
|
|
|
|
18,994
|
|
|
20,581
|
|
(8%)
|
|
(3%)
|
Legacy Hospira
|
|
|
1,167
|
|
|
1,182
|
|
(1%)
|
|
(1%)
|
|
|
|
4,634
|
|
|
1,513
|
|
*
|
|
*
|
Total Company
|
|
$
|
13,627
|
|
$
|
14,047
|
|
(3%)
|
|
(1%)
|
|
|
$
|
52,824
|
|
$
|
48,851
|
|
8%
|
|
11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pfizer Standalone
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Excl. Legacy Hospira
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and Legacy Medivation)
|
|
$
|
12,322
|
|
$
|
12,865
|
|
(4%)
|
|
(2%)
|
|
|
$
|
48,050
|
|
$
|
47,339
|
|
2%
|
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Indicates calculation not meaningful or greater than 100%.
2017 FINANCIAL GUIDANCE(7)
Pfizer's 2017 financial guidance is presented below. Financial guidance
reflects the pending disposition of Hospira Infusion Systems (HIS),
expected in February 2017, which contributed $1.2 billion of revenues
and $0.03 of adjusted diluted EPS(2) in 2016.
|
|
|
|
Revenues
|
|
|
$52.0 to $54.0 billion
|
Adjusted Cost of Sales(2) as a Percentage of Revenues
|
|
|
20.0% to 21.0%
|
Adjusted SI&A Expenses(2)
|
|
|
$13.7 to $14.7 billion
|
Adjusted R&D Expenses(2)
|
|
|
$7.5 to $8.0 billion
|
Adjusted Other (Income)/Deductions(2)
|
|
|
Approximately $100 million of deductions
|
Effective Tax Rate on Adjusted Income(2)
|
|
|
Approximately 23.0%
|
Adjusted Diluted EPS(2)
|
|
|
$2.50 to $2.60
|
|
|
|
|
A reconciliation of Pfizer's full-year 2016 financial results to certain
components of its 2017 financial guidance, including certain significant
factors impacting 2017 financial guidance, is below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Full-Year 2016 Results
|
|
Full-Year 2016 Contribution from HIS
|
|
Full-Year 2016 Results Excluding HIS Contribution
|
|
2017 Financial Guidance at 2016 FX Rates
|
|
Impact of Mid-January 2017 FX Rates Compared to 2016
FX Rates
|
|
2017 Financial Guidance
|
Revenues
|
|
$52.8 billion
|
|
$1.2 billion
|
|
$51.7 billion
|
|
$52.9 to $54.9 billion
|
|
($0.9 billion)
|
|
$52.0 to $54.0 billion
|
Adjusted Diluted EPS(2)
|
|
$2.40
|
|
$0.03
|
|
$2.37
|
|
$2.55 to $2.65
|
|
($0.05)
|
|
$2.50 to $2.60
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXECUTIVE COMMENTARY
Ian Read, Chairman and Chief Executive Officer, stated, "I was pleased
with the company's overall performance during 2016 and believe both of
our businesses executed well despite a challenging operating
environment. We generated attractive operational revenue and earnings
growth driven by our major products within both the Innovative Health
and Essential Health businesses. In addition to strong business
performance, we allocated our shareholders' capital to a variety of
value-creating initiatives that included company and product portfolio
acquisitions, share repurchases, an increase in our dividend and ongoing
funding for our R&D and commercial organizations.
"We are operating with a highly focused business structure and
management team, providing us with the best opportunity to generate
attractive operating revenue and earnings growth as demonstrated by our
2017 financial guidance. Our strong in-market product portfolio and
broad R&D pipeline include several potential first-in-class or
best-in-class compounds in important therapeutic areas. I believe we are
positioned for continued strong performance in 2017 and beyond, which
will enhance our ability to deliver new therapies to patients and create
value for our shareholders," Mr. Read concluded.
Frank D'Amelio, Executive Vice President, Business Operations and Chief
Financial Officer, stated, "Pfizer-standalone revenues in 2016 grew 5%
operationally, excluding the impact of foreign exchange as well as
legacy Hospira and legacy Medivation operations, reflecting solid
underlying growth despite significant headwinds from product losses of
exclusivity and the decline in revenues for Prevnar 13 Adult in the U.S.
During 2016, we completed the acquisitions of Anacor and Medivation
which added important revenue growth drivers to our Innovative Health
business while we continued to integrate legacy Hospira operations into
our Essential Health business. Finally, during 2016 we returned $12.3
billion directly to shareholders through dividends and share repurchases.
"Our 2017 financial guidance at the midpoint of our ranges implies
revenues slightly above 2016 and a 6% increase to adjusted diluted EPS(2)
compared to 2016 results. We expect to achieve this despite absorbing
revenue headwinds totaling $4.5 billion, comprised of $2.4 billion
resulting from anticipated generic competition, $1.2 billion due to the
pending disposition of HIS and $0.9 billion due to adverse changes in
foreign exchange rates since 2016. Excluding the negative impacts of the
pending disposition of HIS and foreign exchange, the midpoints of our
2017 revenue and adjusted diluted EPS(2) guidance ranges
reflect 4% and 10% operational growth, respectively. Notably, our
guidance for adjusted diluted EPS(2) anticipates share
repurchases totaling $5.0 billion in 2017, which are expected to more
than offset potential dilution related to employee compensation
programs," Mr. D'Amelio concluded.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2016 vs.
Fourth-Quarter 2015)
Fourth-quarter 2016 revenues totaled $13.6 billion, a decline of $420
million, or 3% compared to the prior-year quarter, reflecting an
operational decline of $191 million, or 1%, and the unfavorable impact
of foreign exchange of $228 million, or 2%. Excluding the fourth-quarter
2016 contribution from legacy Medivation operations and foreign
exchange, revenues declined by $330 million, or 2%.
Of note, there were four fewer selling days in the U.S. and three fewer
selling days in international markets during fourth-quarter 2016
compared to fourth-quarter 2015, resulting in a negative impact on
fourth-quarter 2016 revenues of approximately $750 million compared to
the prior-year quarter.
Innovative Health Highlights
-
IH delivered 2% operational revenue growth in fourth-quarter 2016,
driven by continued growth from key brands including Ibrance,
primarily in the U.S., Eliquis globally, the addition of Xtandi
revenues in the U.S. resulting from the acquisition of Medivation in
September 2016, as well as Xeljanz and Lyrica, both primarily in the
U.S. Global Ibrance revenue more than doubled operationally while
global operational revenue growth for Xeljanz and Eliquis was 62% and
50%, respectively. Sequentially, fourth-quarter 2016 Ibrance revenues
in the U.S. increased 15% compared to third-quarter 2016.
-
Global Prevnar/Prevenar 13 revenues declined 23% operationally. In the
U.S., Prevnar 13 revenues decreased 33% due to the continued decline
in revenues for the Adult indication due to a high initial capture
rate of the eligible population following its successful
fourth-quarter 2014 launch, which resulted in a smaller remaining
"catch up" opportunity compared to the prior-year quarter, as well as
the unfavorable impact from the timing of government purchases for the
pediatric indication.
-
Fourth-quarter 2016 operational growth was also negatively impacted by
lower revenues for Enbrel in most developed Europe markets, primarily
due to continued biosimilar competition, as well as the loss of Rebif
alliance revenues resulting from the year-end 2015 expiry of the
collaboration agreement to co-promote Rebif in the U.S.
Essential Health Highlights
-
Fourth-quarter 2016 EH revenues decreased 6% operationally, resulting
from a 20% operational decline from Peri-LOE Products(8)
and a 3% operational decline from Legacy Established Products (LEP)(8)
partially offset by 3% operational growth from the Sterile Injectable
Pharmaceuticals (SIP)(8) portfolio and 48% operational
growth from Biosimilars(8). EH revenues excluding the
performance of HIS, which Pfizer expects to divest in February 2017,
declined 5% operationally.
-
Revenues from legacy Hospira products declined 1% operationally.
Excluding the performance of HIS, revenues from legacy Hospira
products increased 2% operationally. Revenues from EH-standalone
products (excluding legacy Hospira) declined 7% operationally.
-
Developed markets revenues declined 9% operationally, negatively
impacted by a 28% operational decline from Peri-LOE Products(8)
and a 7% operational decline from the LEP(8) portfolio,
partially offset by 51% operational growth from Biosimilars(8).
-
Revenues in emerging markets grew 4% operationally, primarily driven
by 3% operational growth from the LEP(8) portfolio and 9%
operational growth from the SIP(8) portfolio.
GAAP Reported(1) Income Statement Highlights
SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES(1)
|
($ in millions) (Favorable)/Unfavorable
|
|
Fourth-Quarter
|
|
|
Full-Year
|
|
|
2016
|
|
2015
|
|
% Change
|
|
|
2016
|
|
2015
|
|
% Change
|
|
|
|
|
Total
|
|
Oper.
|
|
|
|
|
Total
|
|
Oper.
|
Cost of Sales(1)
|
|
$ 3,218
|
|
|
$ 3,410
|
|
|
(6%)
|
|
(7%)
|
|
|
$ 12,329
|
|
|
$ 9,648
|
|
|
28%
|
|
23%
|
Percent of Revenues
|
|
23.6
|
%
|
|
24.3
|
%
|
|
N/A
|
|
N/A
|
|
|
23.3
|
%
|
|
19.7
|
%
|
|
N/A
|
|
N/A
|
SI&A Expenses(1)
|
|
4,423
|
|
|
5,048
|
|
|
(12%)
|
|
(11%)
|
|
|
14,837
|
|
|
14,809
|
|
|
-
|
|
3%
|
R&D Expenses(1)
|
|
2,512
|
|
|
2,348
|
|
|
7%
|
|
8%
|
|
|
7,872
|
|
|
7,690
|
|
|
2%
|
|
3%
|
Total
|
|
$ 10,153
|
|
|
$ 10,807
|
|
|
(6%)
|
|
(6%)
|
|
|
$ 35,038
|
|
|
$ 32,147
|
|
|
9%
|
|
9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Income)/Deductions-- net(1)
|
|
$841
|
|
|
$2,190
|
|
|
(62%)
|
|
(27%)
|
|
|
$3,655
|
|
|
$2,860
|
|
|
28%
|
|
53%
|
Effective Tax Rate on
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reported Income/(Loss)(1)
|
|
1.7
|
%
|
|
53.0
|
%
|
|
|
|
|
|
|
13.4
|
%
|
|
22.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in fourth-quarter 2016 Other deductions--net(1)
was primarily driven by the non-recurrence of foreign currency losses
related to Venezuela and a charge to resolve a Protonix-related legal
matter, both of which were incurred in the prior-year quarter, partially
offset primarily by an impairment charge in fourth-quarter 2016 as a
result of the pending HIS transaction, a loss resulting from the early
redemption of certain outstanding debt securities in fourth-quarter 2016
and higher impairment charges compared to the prior-year quarter.
Adjusted(2) Income Statement Highlights
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(2)
|
($ in millions) (Favorable)/Unfavorable
|
|
Fourth-Quarter
|
|
|
Full-Year
|
|
|
2016
|
|
2015
|
|
% Change
|
|
|
2016
|
|
2015
|
|
% Change
|
|
|
|
|
Total
|
|
Oper.
|
|
|
|
|
Total
|
|
Oper.
|
Adjusted Cost of Sales(2)
|
|
$
|
3,046
|
|
|
$
|
2,983
|
|
|
2%
|
|
(2%)
|
|
|
$
|
11,630
|
|
|
$
|
9,021
|
|
|
29%
|
|
24%
|
Percent of Revenues
|
|
|
22.4
|
%
|
|
|
21.2
|
%
|
|
N/A
|
|
N/A
|
|
|
|
22.0
|
%
|
|
|
18.5
|
%
|
|
N/A
|
|
N/A
|
Adjusted SI&A Expenses(2)
|
|
|
4,402
|
|
|
|
4,598
|
|
|
(4%)
|
|
(3%)
|
|
|
|
14,745
|
|
|
|
14,324
|
|
|
3%
|
|
5%
|
Adjusted R&D Expenses(2)
|
|
|
2,505
|
|
|
|
2,318
|
|
|
8%
|
|
9%
|
|
|
|
7,841
|
|
|
|
7,653
|
|
|
2%
|
|
3%
|
Total
|
|
$
|
9,953
|
|
|
$
|
9,900
|
|
|
1%
|
|
-
|
|
|
$
|
34,215
|
|
|
$
|
30,998
|
|
|
10%
|
|
10%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted Other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Income)/Deductions-- net(2)
|
|
|
($182
|
)
|
|
|
$1
|
|
|
*
|
|
*
|
|
|
|
($729
|
)
|
|
|
($409
|
)
|
|
78%
|
|
*
|
Effective Tax Rate on
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted Income(2)
|
|
|
24.1
|
%
|
|
|
19.6
|
%
|
|
|
|
|
|
|
|
23.0
|
%
|
|
|
24.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Indicates calculation not meaningful or greater than 100%.
The diluted weighted-average shares outstanding used to calculate
adjusted diluted EPS(2) declined by 105 million shares
compared to the prior-year quarter due to Pfizer's share repurchase
program, reflecting the impact of a $5 billion accelerated share
repurchase agreement executed in March 2016 and completed in June 2016.
A full reconciliation of Reported(1) to Adjusted(2)
financial measures and associated footnotes can be found starting on
page 21 of the press release located at the hyperlink below.
FULL-YEAR FINANCIAL SUMMARY (Full-Year 2016 vs. Full-Year 2015)
Full-year 2016 revenues increased $4.0 billion, or 8%, reflecting
operational growth of $5.5 billion, or 11%, partially offset by the
unfavorable impact of foreign exchange of $1.5 billion, or 3%.
Excluding the 2015 and 2016 contributions from legacy Hospira
operations, the unfavorable impact of foreign exchange and, to a lesser
extent, legacy Medivation operations of $140 million, Pfizer-standalone
revenues increased by $2.2 billion operationally, or 5%, reflecting
operational growth from certain key products partially offset by product
losses of exclusivity and co-promotion expirations that negatively
impacted 2016 revenues by $1.8 billion operationally.
There was one additional selling day in international markets during
full-year 2016 compared to full-year 2015, resulting in a favorable
impact on full-year 2016 revenues of approximately $100 million compared
to the prior year. In the U.S., there was no difference in selling days
in full-year 2016 compared to full-year 2015.
RECENT NOTABLE DEVELOPMENTS (Since November 1, 2016)
Product Developments
-
Bosulif (bosutinib) -- In December 2016, Pfizer and its partner
Avillion LLP announced results from the Phase 3 BFORE (Bosutinib trial
in First line chrOnic myelogenous leukemia tREatment) trial
demonstrating superiority of Bosulif over imatinib as a first-line
treatment for patients with chronic phase Philadelphia chromosome
positive (Ph+) chronic myeloid leukemia (CML). Based on the results of
the study, Pfizer will work with the U.S. Food and Drug Administration
(FDA) and other regulatory authorities to potentially make Bosulif
available for Ph+ CML patients in the first-line setting.
-
Celebrex (celecoxib) -- In November 2016, Pfizer announced
results of the PRECISION (Prospective Randomized Evaluation of
Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, which
demonstrated similar rates of cardiovascular risk in patients treated
with prescription doses of celecoxib, ibuprofen and naproxen who had a
clinical diagnosis of osteoarthritis (OA) or rheumatoid arthritis
(RA), were at high risk for cardiovascular disease, and required daily
treatment with non-steroidal anti-inflammatory drugs (NSAIDs) to
control symptoms of arthritis. In addition, patients treated with
celecoxib experienced significantly fewer gastrointestinal events as
compared with those receiving prescription doses of ibuprofen or
naproxen. However, it is important to note that given the trial's
design - prescription doses and chronic use in patients with
cardiovascular risk factors - no inferences are possible regarding the
safety of intermittent use of low-dose, over-the-counter NSAIDs. The
results of the PRECISION study were presented at the annual meeting of
the American Heart Association by Dr. Steve Nissen, chairman of
cardiovascular medicine at the Cleveland Clinic and principal
investigator of the PRECISION trial. In addition, the results were
published in The New England Journal of Medicine.
-
Chantix/Champix (varenicline) -- In December 2016, the FDA
approved updates to the Chantix labeling, including removal of the
boxed warning regarding serious neuropsychiatric events. The removal
of the boxed warning is based on the outcomes of EAGLES (Evaluating
Adverse Events in a Global Smoking Cessation Study), the largest
smoking cessation clinical trial in patients without and with a
history of psychiatric disorder, and is consistent with the
recommendation of the FDA Psychopharmacologic Drugs and Drug Safety
and Risk Management Advisory Committees. Additional labeling revisions
based on EAGLES include updates to the corresponding warning regarding
neuropsychiatric safety and the addition of information on the
superior efficacy of Chantix compared to bupropion or nicotine patch.
-
Eucrisa (crisaborole ointment 2%) -- Pfizer announced in
December 2016 that the FDA approved Eucrisa, a novel non-steroidal
topical phosphodieterase-4 (PDE-4) inhibitor for the treatment of mild
to moderate atopic dermatitis (AD) in patients two years of age and
older. AD, often called eczema, is a chronic condition impacting
nearly 18 million children and adults in the U.S. Approximately 90% of
people living with AD have the mild to moderate form of the condition.
Eucrisa is expected to be available by prescription starting in early
February 2017.
-
Ibrance (palbociclib)
-
In December 2016, the FDA accepted for review a supplemental New
Drug Application (sNDA) for Ibrance that supports the conversion
of the accelerated approval of Ibrance in combination with
letrozole to regular approval and includes data from the Phase 3
PALOMA-2 trial, which evaluated Ibrance as initial therapy in
combination with letrozole for postmenopausal women with estrogen
receptor-positive, human epidermal growth factor receptor
2-negative (ER+, HER2-) metastatic breast cancer. This is the same
patient population as the randomized Phase 2 PALOMA-1 trial upon
which the accelerated approval of Ibrance plus letrozole was
granted in February 2015. The sNDA was granted Priority Review
status and has a Prescription Drug User Fee Act (PDUFA) goal date
for a decision by the FDA in April 2017.
-
Pfizer announced in December 2016 results from a sub-analysis
studying Asian patients from the Phase 3 PALOMA-2 trial. Results
showed the combination of Ibrance and letrozole significantly
extended progression-free survival (PFS) by more than 11 months
compared with letrozole plus placebo, and demonstrated that the
median PFS exceeded two years in these patients. Data from this
sub-analysis was shared in an oral presentation at the 2nd
European Society for Medical Oncology Asia (ESMO Asia) Congress in
Singapore.
-
In November 2016, Pfizer announced that detailed results from the
Phase 3 PALOMA-2 trial were published in The New England
Journal of Medicine. These data, initially presented at the 52nd
American Society of Clinical Oncology (ASCO) Annual Meeting in
June 2016, demonstrate the clinical benefit of Ibrance as initial
therapy for postmenopausal women with ER+, HER2- metastatic breast
cancer.
-
Pfizer announced in November 2016 that the European Commission
(EC) has approved Ibrance for the treatment of women with hormone
receptor-positive, human epidermal growth factor receptor
2-negative (HR+/HER2-) locally advanced or metastatic breast
cancer. The approval is for Ibrance to be used in combination with
an aromatase inhibitor. The approval also covers the use of
Ibrance in combination with fulvestrant in women who have received
prior endocrine therapy.
-
Lyrica (pregabalin) -- Pfizer announced in December 2016
positive top-line results of a study that evaluated the use of Lyrica
Capsules CV and Oral Solution CV as adjunctive therapy for pediatric
epilepsy patients four to 16 years of age with partial onset seizures.
Results showed that adjunctive treatment with Lyrica 10 mg/kg/day
resulted in a statistically significant reduction in seizure frequency
versus placebo, the primary efficacy endpoint. Treatment with Lyrica
2.5 mg/kg/day resulted in a numerical reduction in seizure frequency,
which was not statistically significant. Lyrica is not approved as
adjunctive therapy for pediatric epilepsy patients with partial onset
seizures.
-
Mylotarg (gemtuzumab ozogamicin) -- A Biologics License
Application (BLA) for Mylotarg was accepted for filing by the FDA in
January 2017 and a Marketing Authorization Application (MAA) was
validated for review by the European Medicines Agency (EMA) in
December 2016. Mylotarg is being evaluated for the potential treatment
of adult patients with acute myeloid leukemia (AML). Mylotarg was
originally approved under the FDA's accelerated approval program in
2000 for use as a single agent in first relapse patients with
CD33-positive AML who were 60 years or older. In 2010, Pfizer
voluntarily withdrew Mylotarg after a confirmatory Phase 3 trial did
not show a clinical benefit and the fatal induction toxicity rate was
significantly higher in the Mylotarg arm. The recent regulatory
submissions are based on additional data from a Phase 3 randomized,
open-label study (ALFA-0701) that evaluated the addition of Mylotarg
to standard induction chemotherapy using an alternative fractionated
dosing schedule in 280 adult, de novo, AML patients aged 50-70 years
old, as well as a meta-analysis of patient-level data from over 3,000
patients in five randomized Phase 3 studies (including ALFA-0701)
spanning 10 years of research. The PDUFA goal date for a decision by
the FDA is in September 2017. Mylotarg originates from a collaboration
between Pfizer and Celltech, now UCB. Pfizer has sole responsibility
for all manufacturing and clinical development activities for this
molecule.
-
Nimenrix (Meningococcal group A, C, W-135, and Y conjugate vaccine)
-- In December 2016, the EC approved an expanded indication for
Nimenrix for active immunization against invasive meningococcal
disease (IMD) caused by Neisseria meningitidis serogroups A, C,
W-135, and Y (MenACWY) in infants as early as six weeks of age.
Nimenrix is now the first and only MenACWY conjugate vaccine in the
European Union (EU) that can be administered from six weeks of age
with no upper age limit. Nimenrix was approved for administration in
infants as a two dose primary series, with the first dose given from
six weeks of age and with an interval of two months between doses,
followed by a booster dose at 12 months.
-
Prevnar 13/Prevenar 13 (Pneumococcal 13-valent conjugate vaccine)
-- In November 2016, Pfizer China announced that it received approval
from the Chinese Food and Drug Administration to market its
pneumococcal 13-valent conjugate vaccine, Prevenar 13, in China for
active immunization for the prevention of invasive diseases (including
bacteremic pneumonia, meningitis, septicemia, and bacteremia) caused
by Streptococcus pneumoniae (S. Pneumoniae) serotypes 1,
3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and
children aged 6 weeks to 15 months. S. pneumoniae is the most
common cause of invasive disease as well as pneumonia and upper
respiratory tract infections. In China, the recommended Prevenar 13
immunization series is a primary series administered at 2, 4 and 6
months of age with a fourth (booster) dose administered at
approximately 12-15 months of age.
-
Retacrit (epoetin alpha) -- In December 2016, Pfizer completed
the resubmission of the BLA to the FDA for Retacrit, its proposed
biosimilar of Epogen®(9) and Procrit®(10). This
resubmission is in response to the FDA Complete Response Letter
received in October 2015. Pfizer will continue to work closely with
the agency on next steps and remains committed to bringing this
important medicine to patients in the U.S. as quickly as possible.
-
Xeljanz (tofacitinib)
-
Pfizer announced in January 2017 that the Committee for Medicinal
Products for Human Use (CHMP) of the EMA adopted a positive
opinion recommending Xeljanz 5 mg twice daily (BID) for the
treatment of patients with moderate to severe active rheumatoid
arthritis (RA). If approved, Xeljanz in combination with
methotrexate (MTX) will be indicated for the treatment of moderate
to severe active RA in adult patients who have responded
inadequately to, or who are intolerant to one or more
disease-modifying antirheumatic drugs. Xeljanz can be given as
monotherapy in case of intolerance to MTX or when treatment with
MTX is inappropriate. The CHMP's opinion will now be reviewed by
the EC, which has the authority to approve medicines for the EU.
-
In November 2016, Pfizer presented results from the Phase 3 Oral
Psoriatic Arthritis TriaL (OPAL) studies, Broaden and Beyond, at
the 2016 ACR/ARHP Annual Meeting. OPAL Broaden and OPAL Beyond
evaluated the efficacy and safety of Xeljanz in adult patients
with active psoriatic arthritis who had an inadequate response to
conventional synthetic disease-modifying antirheumatic drugs or to
tumor necrosis factor inhibitors, respectively. OPAL Broaden and
OPAL Beyond met their primary efficacy endpoints showing a
statistically significant improvement with tofacitinib 5 mg and 10
mg twice daily compared to treatment with placebo at three months
as measured by American College of Rheumatology 20 (ACR20)
response and change from baseline in Health Assessment
Questionnaire Disability Index score.
-
Xtandi (enzalutamide) -- In December 2016, Pfizer and Astellas
Pharma Inc. announced that the Phase 4 PLATO study, evaluating the
efficacy and safety of continued treatment with Xtandi plus
abiraterone acetate and prednisone compared to treatment with
abiraterone acetate and prednisone alone, did not meet its primary
endpoint of improvement in PFS in patients with chemotherapy-naïve
metastatic castration-resistant prostate cancer whose
prostate-specific antigen has previously progressed on Xtandi.
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 (PF-06834635, MSB0010718C) -- EMD Serono Inc. (EMD
Serono), the biopharmaceutical business of Merck KGaA, Darmstadt,
Germany, in the U.S. and Canada, and Pfizer announced in November 2016
that the FDA has accepted for Priority Review EMD Serono's BLA for
avelumab seeking approval for use in patients with metastatic Merkel
cell carcinoma (MCC), based on results of the JAVELIN Merkel 200
trial. Avelumab is an investigational fully human anti-PD-L1 IgG1
monoclonal antibody and could be the first treatment indicated for
metastatic MCC in the U.S., if approved. MCC is a rare and aggressive
skin cancer, which impacts approximately 2,500 Americans a year.
-
PF-05280014 (proposed biosimilar trastuzumab) -- In
November 2016, Pfizer announced that the pivotal REFLECTIONS B3271002
study, a comparative safety and efficacy study of PF-05280014 versus
Herceptin®(11) (trastuzumab), met its primary endpoint. The
trial demonstrated equivalence in the primary endpoint of objective
response rate of PF-05280014 versus Herceptin®(11), each
taken in combination with paclitaxel, in first-line patients with
HER2-positive metastatic breast cancer. A separate comparative,
randomized, double-blind clinical trial in early breast cancer
patients (REFLECTIONS B3271004) also met its primary endpoint of
steady-state Ctrough concentrations (PK) in patients
treated with PF-05280014 and Herceptin®(11). PF-05280014 is
being developed by Pfizer as a potential biosimilar to Herceptin®(11).
-
PF-06410293 (proposed biosimilar adalimumab) -- In
January 2017, Pfizer announced that the comparative, confirmatory
REFLECTIONS B538-02 study met its primary objective by demonstrating
equivalent efficacy as measured by the ACR20 response rate at Week 12.
This trial evaluated the efficacy, safety, and immunogenicity of
PF-06410293 compared to Humira®(12) (adalimumab), each
taken in combination with methotrexate, in patients with moderate to
severe rheumatoid arthritis. PF-06410293 is being developed by Pfizer
as a potential biosimilar to Humira®(12).
-
PF-06425090 (Clostridium difficile (C. difficile)
vaccine candidate) -- Pfizer announced in January 2017 that its
Phase 2 study evaluating PF-06425090 provided positive data based on a
pre-planned interim analysis. The randomized Phase 2 study examined
the safety, tolerability and immunogenicity of the vaccine in healthy
adults 65 to 85 years of age. PF-06425090 is designed to help prevent C.
difficile infection. Based on these findings, Pfizer will progress
PF-06425090 into Phase 3 in the first half of 2017.
-
PF-06836922 (hGH-CTP, long-acting human growth hormone) -- OPKO
Health, Inc. (OPKO) announced in December 2016 that the primary
endpoint was not met for its Phase 3, double-blind, placebo-controlled
study of its investigational long-acting human growth hormone product
(hGH-CTP) in adults with growth hormone deficiency. OPKO announced
that it is undertaking further review of the study population as
promptly as possible. The safety profile observed in this study was
consistent with that known for growth hormone treatments. In December
2014, OPKO entered into a worldwide collaboration and license
agreement with Pfizer for the development and commercialization of
hGH-CTP.
-
SPK-9001 -- Spark Therapeutics and Pfizer announced in December
2016 updated preliminary data from the ongoing Phase 1/2 clinical
trial of investigational SPK-9001 in hemophilia B was presented during
the Plenary Scientific Session at the 58th American Society
of Hematology Annual Meeting. The results suggested sustained
therapeutic levels of factor IX activity among all study participants.
Together, all nine participants reduced infusions of factor IX
concentrates by 99% over a cumulative 1,650 days.
Corporate Developments
-
In January 2017, ICU Medical, Inc. (ICU Medical) and Pfizer modified
the terms of the definitive agreement entered into on October 6, 2016,
under which ICU Medical will acquire HIS from Pfizer. These
modifications are a result of recent changes in performance of HIS
that affect ICU Medical's previously announced expectations for the
transaction. Under the terms of the modified agreement, the aggregate
purchase price will be adjusted to be up to $900 million (versus $1
billion as originally agreed). Upon closing, Pfizer will receive
approximately $400 million in equity (based upon the 30-day volume
weighted average price through October 5, 2016, the day prior to
announcement of the proposed transaction) in the form of 3.2 million
newly issued shares of ICU Medical common stock (as originally agreed)
and $275 million in cash (versus $600 million as originally agreed),
which will be financed with ICU Medical's existing cash balances and a
$75 million seller note. Pfizer is entitled to up to an additional
$225 million based on achievement of performance targets for the
combined company through December 31, 2019, which would be payable
after that date if performance is within the agreed target range. The
transaction is expected to close in February 2017.
-
In December 2016, Pfizer's board of directors declared a 32-cent
first-quarter 2017 dividend on the company's common stock,
representing an increase of approximately 7% compared to the company's
first-quarter 2016 dividend. The dividend is payable on March 1, 2017
to shareholders of record at the close of business on February 3, 2017.
-
In December 2016, which falls in the first fiscal quarter of 2017 for
Pfizer's international operations, Pfizer completed the acquisition of
the development and commercialization rights to AstraZeneca's small
molecule anti-infective business, primarily outside the U.S. The
agreement includes the commercialization and development rights to the
newly approved EU drug Zavicefta™ (ceftazidime-avibactam), the
marketed agents Merrem™/Meronem™ (meropenem) and Zinforo™ (ceftaroline
fosamil), and the clinical development assets aztreonam-avibactam
(ATM-AVI) and CXL (ceftaroline fosamil-AVI).
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_2016_PFE_Earnings_Press_Release_dwerfks.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)
|
|
Revenues is defined as revenues in accordance with U.S. generally
accepted accounting principles (GAAP). Reported net income/(loss) is
defined as net income/(loss) attributable to Pfizer Inc. in
accordance with U.S. GAAP. Reported diluted earnings per share (EPS)
and reported loss per share (LPS) are defined as reported diluted
EPS or LPS 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 (some of
which may recur, such as restructuring or legal charges, but which
management does not believe are reflective of ongoing core
operations). Adjusted cost of sales, Adjusted selling,
informational and administrative (SI&A) expenses, Adjusted
research and development (R&D) expenses and Adjusted other
(income)/deductions are income statement line items prepared on
the same basis as, and therefore components of, the overall
Adjusted income measure. As described in the Management's
Discussion and Analysis of Financial Condition and Results of
Operations--Non-GAAP Financial Measure (Adjusted Income) section
of Pfizer's Quarterly Report on Form 10-Q for the fiscal quarter
ended October 2, 2016, management uses Adjusted income, among
other factors, to set performance goals and to measure the
performance of the overall company. Because Adjusted income is an
important internal measurement for Pfizer, management believes
that investors' understanding of our performance is enhanced by
disclosing this performance measure. Pfizer reports Adjusted
income, and certain components of Adjusted income, in order to
portray the results of major operations--the discovery,
development, manufacture, marketing and sale of prescription
medicines, vaccines and consumer healthcare (OTC) products--prior
to considering certain income statement elements. See the
accompanying reconciliations of certain GAAP Reported to Non-GAAP
Adjusted information for the fourth quarter and twelve months
ended December 31, 2016 and 2015. 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)
|
|
Effective in second-quarter 2016, Pfizer's operating structure was
reorganized from three segments to two to reflect changes to how
the innovative pharmaceutical, vaccine and consumer healthcare
operations are managed. Pfizer Innovative Health was previously
known as the Innovative Products business, which was comprised of
the Global Innovative Pharmaceutical (GIP) and Global Vaccines,
Oncology and Consumer Healthcare (VOC) segments. Additionally, the
name of Pfizer's Established Products business, which consisted of
the Global Established Pharmaceutical (GEP) segment, was changed
to Pfizer Essential Health. For a description of each business,
see the Notes to Operating Segment Information section of
this press release, which can be found on page 27 of the press
release located at the hyperlink above. Prior period segment
operating results have been reclassified to conform to the current
period presentation.
|
|
|
|
(4)
|
|
Beginning in 2016, Pfizer's contract manufacturing business, Pfizer
CentreOne, is now part of Pfizer Essential Health. Pfizer CentreOne
consists of (i) legacy Pfizer's contract manufacturing and active
pharmaceutical ingredient sales operation, including manufacturing
and supply agreements with Zoetis Inc. (previously known as Pfizer
CentreSource or PCS); and (ii) legacy Hospira's One-2-One sterile
injectables contract manufacturing operation. Prior to 2016, PCS was
managed outside of Pfizer's operating segments and its revenues were
reported as other business activities. Prior period PCS operating
results have been reclassified to conform to the current period
presentation as part of Essential Health.
|
|
|
|
(5)
|
|
Pfizer's fiscal year-end for international subsidiaries is November
30 while Pfizer's fiscal year-end for U.S. subsidiaries is December
31. Therefore, in accordance with Pfizer's domestic and
international reporting periods, Pfizer's consolidated financial
statements for the three and twelve months ended December 31, 2015
reflect only four months of legacy Hospira U.S. operations and three
months of legacy Hospira international operations.
|
|
|
|
(6)
|
|
References to operational variances in this press release pertain to
period-over-period growth rates that exclude the impact of foreign
exchange as well as the negative currency impact related to
Venezuela. The operational variances are determined by multiplying
or dividing, as appropriate, the current period U.S. dollar results
by the current period average foreign exchange rates and then
multiplying or dividing, as appropriate, those amounts by the
prior-year period average foreign exchange rates. Pfizer believes
that presenting these operational variances provides useful
information in evaluating business results because exchange rate
changes, while part of its ongoing business, can mask positive or
negative trends in the business and are not within its control.
|
|
|
|
(7)
|
|
The 2017 financial guidance reflects the following:
|
-
Pfizer does not provide guidance for GAAP Reported financial measures
(other than Revenues) or a reconciliation of forward-looking non-GAAP
financial measures to the most directly comparable GAAP Reported
financial measures on a forward-looking basis because it is unable to
predict with reasonable certainty the ultimate outcome of pending
litigation, unusual gains and losses, acquisition-related expenses and
potential future asset impairments without unreasonable effort. These
items are uncertain, depend on various factors, and could have a
material impact on GAAP Reported results for the guidance period.
-
Does not assume the completion of any business development
transactions not completed as of December 31, 2016, including any
one-time upfront payments associated with such transactions, except
for the pending disposition of HIS, expected in February 2017.
-
Exchange rates assumed are as of mid-January 2017.
-
Reflects an anticipated negative revenue impact of $2.4 billion due to
recent and expected generic and biosimilar competition for certain
products that have recently lost or are anticipated to soon lose
patent protection.
-
Reflects the anticipated negative impact of $0.9 billion on revenues
and $0.05 on adjusted diluted EPS(2) as a result of
unfavorable changes in foreign exchange rates relative to the U.S.
dollar compared to foreign exchange rates from 2016.
-
Guidance for adjusted diluted EPS(2) assumes diluted
weighted-average shares outstanding of approximately 6.1 billion
shares, including anticipated share repurchases totaling $5.0 billion
in 2017, which are expected to more than offset potential dilution
related to employee compensation programs.
(8)
|
|
The following are certain product categories within Essential Health:
|
-
Sterile Injectable Pharmaceuticals include generic injectables and
proprietary specialty injectables (excluding Peri-LOE Products).
-
Peri-LOE Products include products that have recently lost or are
anticipated to soon lose patent protection. These products primarily
include Lyrica in certain developed Europe markets, Pristiq globally,
Celebrex, Zyvox and Revatio in most developed markets, Vfend and
Viagra in certain developed Europe markets and Japan, and Inspra in
the EU.
-
Legacy Established Products include products that have lost patent
protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE
Products).
-
Biosimilars include Inflectra/Remsima (biosimilar infliximab) in the
U.S. and certain international markets, Nivestim (biosimilar
filgrastim) in certain Asian markets and Retacrit (biosimilar epoetin
zeta) in certain international markets.
Definitions for all Essential Health product categories can be found in
the footnotes to the product revenue tables on page 39 of the press
release located at the hyperlink above.
(9)
|
|
Epogen® is a registered U.S. trademark of Amgen Inc.
|
|
|
|
(10)
|
|
Procrit® is a registered U.S. trademark of Johnson &
Johnson Corporation.
|
|
|
|
(11)
|
|
Herceptin® is a registered U.S. trademark of Genentech,
Inc.
|
|
|
|
(12)
|
|
Humira® is a registered U.S. trademark of Abbvie
Biotechnology Ltd.
|
DISCLOSURE NOTICE: Except where otherwise noted, the information
contained in this earnings release and the related attachments is as of
January 31, 2017. 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 acquisitions
of Hospira, Inc. (Hospira), Anacor Pharmaceuticals, Inc. (Anacor),
Medivation, Inc. (Medivation) and AstraZeneca's small molecule
anti-infectives business and the pending disposition of Hospira Infusion
Systems, 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 announced transactions
in the anticipated time frame or at all, including our ability and the
ability of ICU Medical, Inc. (ICU) to satisfy the conditions to
closing the sale of Hospira Infusion Systems to ICU;
-
competitive developments, including the impact on our competitive
position of new product entrants, in-line branded products, generic
products, private label products, biosimilars and product candidates
that treat diseases and conditions similar to those treated by our
in-line 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;
-
risks related to our ability to develop and launch biosimilars,
including risks associated with "at risk" launches, defined as the
marketing of a product by Pfizer before the final resolution of
litigation (including any appeals) brought by a third party alleging
that such marketing would infringe one or more patents owned or
controlled by the third party;
-
the ability to meet competition from generic, branded and biosimilar
products 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, and our
ability to obtain or maintain timely or adequate pricing or formulary
placement for our products;
-
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 any U.S. healthcare reform and legislation, including
any repeal, substantial modification or invalidation of any or all of
the provisions of the U.S. Patient Protection and Affordable Care Act,
as amended by the Health Care and Education Reconciliation Act;
-
U.S. federal or state legislation or regulatory action and/or policy
efforts affecting, among other things, pharmaceutical product pricing,
reimbursement or access, including under Medicaid, Medicare and other
publicly funded or subsidized health programs; patient out-of-pocket
costs for medicines, manufacturer prices and/or price increases that
could result in new mandatory rebates and discounts or other pricing
restrictions; 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 and the volatility following the
United Kingdom (U.K.) referendum in which voters approved the exit
from the EU;
-
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;
-
the end result of any negotiations between the U.K. government and the
EU regarding the terms of the U.K.'s exit from the EU, which could
have implications on our research, commercial and general business
operations in the U.K. and the EU;
-
any significant issues involving our largest wholesale distributors,
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 acquisitions of Hospira,
Anacor, Medivation and AstraZeneca's small molecule anti-infectives
business, including, among other things, the ability to realize the
anticipated benefits of the acquisitions of Hospira, Anacor,
Medivation and AstraZeneca's small molecule anti-infectives business,
including the possibility that expected cost savings related to the
acquisition of Hospira and accretion related to the acquisitions of
Hospira, Anacor and Medivation 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 transactions
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.
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 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 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/20170131005638/en/
[ Back To TMCnet.com's Homepage ]
|