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DELAWARE
(State of Incorporation)
|
13-5315170
(I.R.S. Employer Identification No.)
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YES
X
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NO ___
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YES
X
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NO ___
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YES ____
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NO
X
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Page
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Condensed Consolidated Statements of Income for the three months ended April 2, 2017 and April 3, 2016
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Condensed Consolidated Statements of Comprehensive Income for the three months ended April 2, 2017 and April 3, 2016
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Condensed Consolidated Balance Sheets as of April 2, 2017 and December 31, 2016
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Condensed Consolidated Statements of Cash Flows for the three months ended April 2, 2017 and April 3, 2016
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2016 Financial Report
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Financial Report for the fiscal year ended December 31, 2016, which was filed as Exhibit 13 to the Annual Report on Form 10-K for the fiscal year ended December 31, 2016
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2016 Form 10-K
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Annual Report on Form 10-K for the fiscal year ended December 31, 2016
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AAV
|
Adeno-Associated Virus
|
ACA (Also referred to as U.S. Healthcare Legislation)
|
U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act
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ACIP
|
Advisory Committee on Immunization Practices
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ALK
|
anaplastic lymphoma kinase
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Allergan
|
Allergan plc
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Alliance revenues
|
Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us
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Anacor
|
Anacor Pharmaceuticals, Inc.
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Astellas
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Astellas Pharma US, Inc.
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ASU
|
Accounting Standards Update
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ATM-AVI
|
aztreonam-avibactam
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Bamboo
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Bamboo Therapeutics, Inc.
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BMS
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Bristol-Myers Squibb Company
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CDC
|
U.S. Centers for Disease Control and Prevention
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Cellectis
|
Cellectis SA
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Citibank
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Citibank N.A.
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Developed Markets
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U.S., Western Europe, Japan, Canada, Australia, South Korea, Scandinavian countries, Finland and New Zealand
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EEA
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European Economic Area
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EH
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Essential Health
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EMA
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European Medicines Agency
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Emerging Markets
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Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Africa, Eastern Europe, Central Europe, the Middle East and Turkey
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EPS
|
earnings per share
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EU
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European Union
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EURIBOR
|
Euro Interbank Offered Rate
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Exchange Act
|
Securities Exchange Act of 1934, as amended
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FASB
|
Financial Accounting Standards Board
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FDA
|
U.S. Food and Drug Administration
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GAAP
|
Generally Accepted Accounting Principles
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GIST
|
gastrointestinal stromal tumors
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GPD
|
Global Product Development organization
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HER2-
|
human epidermal growth factor receptor 2-negative
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HIS
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Hospira Infusion Systems
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Hisun
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Zhejiang Hisun Pharmaceuticals Co., Ltd.
|
Hisun Pfizer
|
Hisun Pfizer Pharmaceuticals Company Limited
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Hospira
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Hospira, Inc.
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HR+
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hormone receptor-positive
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ICU Medical
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ICU Medical, Inc.
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IH
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Innovative Health
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IPR&D
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in-process research and development
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IRS
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U.S. Internal Revenue Service
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IV
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intravenous
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Janssen
|
Janssen Biotech Inc.
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King
|
King Pharmaceuticals, Inc.
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LDL
|
low density lipoprotein
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LIBOR
|
London Interbank Offered Rate
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Lilly
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Eli Lilly & Company
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LOE
|
loss of exclusivity
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MCO
|
Managed Care Organization
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MD&A
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
MDV
|
multi-dose vial
|
Medivation
|
Medivation, Inc.
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Merck
|
Merck & Co., Inc.
|
Meridian
|
Meridian Medical Technologies, Inc.
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Moody’s
|
Moody’s Investors Service
|
NDA
|
new drug application
|
NovaQuest
|
NovaQuest Co-Investment Fund V, L.P.
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NSCLC
|
non-small cell lung cancer
|
NYSE
|
New York Stock Exchange
|
OPKO
|
OPKO Health, Inc.
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OTC
|
over-the-counter
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PBM
|
Pharmacy Benefit Manager
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Pharmacia
|
Pharmacia Corporation
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PP&E
|
Property, plant & equipment
|
Quarterly Report on Form 10-Q
|
Quarterly Report on Form 10-Q for the quarterly period ended April 2, 2017
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RCC
|
renal cell carcinoma
|
R&D
|
research and development
|
RPI
|
RPI Finance Trust
|
Sandoz
|
Sandoz, Inc., a division of Novartis AG
|
SEC
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U.S. Securities and Exchange Commission
|
S&P
|
Standard and Poor’s
|
Teuto
|
Laboratório Teuto Brasileiro S.A.
|
U.K.
|
United Kingdom
|
U.S.
|
United States
|
VAT
|
value added tax
|
WRD
|
Worldwide Research and Development
|
Zoetis
|
Zoetis Inc.
|
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Three Months Ended
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||||||
(MILLIONS, EXCEPT PER COMMON SHARE DATA)
|
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April 2,
2017 |
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April 3,
2016 |
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Revenues
|
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$
|
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$
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Costs and expenses:
|
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||||
Cost of sales
(a)
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Selling, informational and administrative expenses
(a)
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Research and development expenses
(a)
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Amortization of intangible assets
|
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Restructuring charges and certain acquisition-related costs
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Other (income)/deductions––net
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(
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)
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Income from continuing operations before provision for taxes on income
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Provision for taxes on income
(b)
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Income from continuing operations
(b)
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Discontinued operations––net of tax
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Net income before allocation to noncontrolling interests
(b)
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|
|
|
|
|
|
||
Less: Net income attributable to noncontrolling interests
|
|
|
|
|
|
|
||
Net income attributable to Pfizer Inc.
(b)
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
||||
Earnings per common share––basic
(b)
:
|
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|
|
|
|
|
||
Income from continuing operations attributable to Pfizer Inc. common shareholders
|
|
$
|
|
|
|
$
|
|
|
Discontinued operations––net of tax
|
|
|
|
|
|
|
||
Net income attributable to Pfizer Inc. common shareholders
|
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$
|
|
|
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$
|
|
|
|
|
|
|
|
||||
Earnings per common share––diluted
(b)
:
|
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|
|
|
|
|
||
Income from continuing operations attributable to Pfizer Inc. common shareholders
|
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$
|
|
|
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$
|
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Discontinued operations––net of tax
|
|
|
|
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|
||
Net income attributable to Pfizer Inc. common shareholders
|
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$
|
|
|
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$
|
|
|
|
|
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|
||||
Weighted-average shares––basic
|
|
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|
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Weighted-average shares––diluted
|
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|
||
Cash dividends paid per common share
|
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$
|
|
|
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$
|
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(a)
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(b)
|
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Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Net income before allocation to noncontrolling interests
|
|
$
|
|
|
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$
|
|
|
|
|
|
|
|
||||
Foreign currency translation adjustments, net
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Unrealized holding losses on derivative financial instruments, net
|
|
(
|
)
|
|
(
|
)
|
||
Reclassification adjustments for realized gains
(a)
|
|
(
|
)
|
|
(
|
)
|
||
|
|
(
|
)
|
|
(
|
)
|
||
Unrealized holding gains on available-for-sale securities, net
|
|
|
|
|
|
|
||
Reclassification adjustments for realized losses
(a)
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Benefit plans: actuarial gains, net
|
|
|
|
|
|
|
||
Reclassification adjustments related to amortization
(b)
|
|
|
|
|
|
|
||
Reclassification adjustments related to settlements, net
(b)
|
|
|
|
|
|
|
||
Other
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Benefit plans: prior service costs and other, net
|
|
|
|
|
|
|
||
Reclassification adjustments related to amortization
(b)
|
|
(
|
)
|
|
(
|
)
|
||
Reclassification adjustments related to curtailments, net
(b)
|
|
(
|
)
|
|
(
|
)
|
||
Other
|
|
|
|
|
|
|
||
|
|
(
|
)
|
|
(
|
)
|
||
Other comprehensive income/(loss), before tax
|
|
|
|
|
(
|
)
|
||
Tax provision/(benefit) on other comprehensive income/(loss)
(c)
|
|
|
|
|
(
|
)
|
||
Other comprehensive income/(loss) before allocation to noncontrolling interests
|
|
$
|
|
|
|
$
|
(
|
)
|
|
|
|
|
|
||||
Comprehensive income before allocation to noncontrolling interests
|
|
$
|
|
|
|
$
|
|
|
Less: Comprehensive income attributable to noncontrolling interests
|
|
|
|
|
|
|
||
Comprehensive income attributable to Pfizer Inc.
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
December 31,
2016 |
|
||
|
|
(Unaudited)
|
|
|
||||
Assets
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
|
|
|
$
|
|
|
Short-term investments
|
|
|
|
|
|
|
||
Trade accounts receivable, less allowance for doubtful accounts: 2017—$588; 2016—$609
|
|
|
|
|
|
|
||
Inventories
|
|
|
|
|
|
|
||
Current tax assets
|
|
|
|
|
|
|
||
Other current assets
|
|
|
|
|
|
|
||
Assets held for sale
|
|
|
|
|
|
|
||
Total current assets
|
|
|
|
|
|
|
||
Long-term investments
|
|
|
|
|
|
|
||
Property, plant and equipment, less accumulated depreciation: 2017—$15,050; 2016—$14,807
|
|
|
|
|
|
|
||
Identifiable intangible assets, less accumulated amortization
|
|
|
|
|
|
|
||
Goodwill
|
|
|
|
|
|
|
||
Noncurrent deferred tax assets and other noncurrent tax assets
|
|
|
|
|
|
|
||
Other noncurrent assets
|
|
|
|
|
|
|
||
Total assets
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
||||
Liabilities and Equity
|
|
|
|
|
|
|
||
Short-term borrowings, including current portion of long-term debt: 2017—$3,292; 2016—$4,225
|
|
$
|
|
|
|
$
|
|
|
Trade accounts payable
|
|
|
|
|
|
|
||
Dividends payable
|
|
|
|
|
|
|
||
Income taxes payable
|
|
|
|
|
|
|
||
Accrued compensation and related items
|
|
|
|
|
|
|
||
Other current liabilities
|
|
|
|
|
|
|
||
Total current liabilities
|
|
|
|
|
|
|
||
|
|
|
|
|
||||
Long-term debt
|
|
|
|
|
|
|
||
Pension benefit obligations, net
|
|
|
|
|
|
|
||
Postretirement benefit obligations, net
|
|
|
|
|
|
|
||
Noncurrent deferred tax liabilities
|
|
|
|
|
|
|
||
Other taxes payable
|
|
|
|
|
|
|
||
Other noncurrent liabilities
|
|
|
|
|
|
|
||
Total liabilities
|
|
|
|
|
|
|
||
|
|
|
|
|
||||
Commitments and Contingencies
|
|
|
|
|
|
|
||
|
|
|
|
|
||||
Preferred stock
|
|
|
|
|
|
|
||
Common stock
|
|
|
|
|
|
|
||
Additional paid-in capital
|
|
|
|
|
|
|
||
Treasury stock
|
|
(
|
)
|
|
(
|
)
|
||
Retained earnings
|
|
|
|
|
|
|
||
Accumulated other comprehensive loss
|
|
(
|
)
|
|
(
|
)
|
||
Total Pfizer Inc. shareholders’ equity
|
|
|
|
|
|
|
||
Equity attributable to noncontrolling interests
|
|
|
|
|
|
|
||
Total equity
|
|
|
|
|
|
|
||
Total liabilities and equity
|
|
$
|
|
|
|
$
|
|
|
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Operating Activities
|
|
|
|
|
||||
Net income before allocation to noncontrolling interests
|
|
$
|
|
|
|
$
|
|
|
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities:
|
|
|
|
|
|
|
||
Depreciation and amortization
|
|
|
|
|
|
|
||
Asset write-offs and impairments
|
|
|
|
|
|
|
||
Loss on sale of HIS net assets
|
|
|
|
|
|
|
||
Deferred taxes from continuing operations
|
|
|
|
|
(
|
)
|
||
Share-based compensation expense
|
|
|
|
|
|
|
||
Benefit plan contributions in excess of expense
|
|
(
|
)
|
|
(
|
)
|
||
Other adjustments, net
|
|
(
|
)
|
|
|
|
||
Other changes in assets and liabilities, net of acquisitions and divestitures
(a)
|
|
(
|
)
|
|
(
|
)
|
||
Net cash provided by operating activities
|
|
|
|
|
|
|
||
|
|
|
|
|
||||
Investing Activities
|
|
|
|
|
|
|
||
Purchases of property, plant and equipment
|
|
(
|
)
|
|
(
|
)
|
||
Purchases of short-term investments
|
|
(
|
)
|
|
(
|
)
|
||
Proceeds from redemptions/sales of short-term investments
|
|
|
|
|
|
|
||
Net proceeds from redemptions/sales of short-term investments with original maturities of three months or less
|
|
|
|
|
|
|
||
Purchases of long-term investments
|
|
(
|
)
|
|
(
|
)
|
||
Proceeds from redemptions/sales of long-term investments
|
|
|
|
|
|
|
||
Acquisitions of businesses, net of cash acquired
|
|
(
|
)
|
|
(
|
)
|
||
Other investing activities, net
|
|
|
|
|
|
|
||
Net cash provided by investing activities
|
|
|
|
|
|
|
||
|
|
|
|
|
||||
Financing Activities
|
|
|
|
|
|
|
||
Proceeds from short-term borrowings
|
|
|
|
|
|
|
||
Principal payments on short-term borrowings
|
|
(
|
)
|
|
(
|
)
|
||
Net proceeds from/(payments on) short-term borrowings with original maturities of three months or less
|
|
(
|
)
|
|
|
|
||
Proceeds from issuance of long-term debt
|
|
|
|
|
|
|
||
Principal payments on long-term debt
|
|
(
|
)
|
|
(
|
)
|
||
Purchases of common stock
|
|
(
|
)
|
|
(
|
)
|
||
Cash dividends paid
|
|
(
|
)
|
|
(
|
)
|
||
Proceeds from exercise of stock options
|
|
|
|
|
|
|
||
Other financing activities, net
(a)
|
|
(
|
)
|
|
(
|
)
|
||
Net cash used in financing activities
|
|
(
|
)
|
|
(
|
)
|
||
Effect of exchange-rate changes on cash and cash equivalents
|
|
|
|
|
(
|
)
|
||
Net increase/(decrease) in cash and cash equivalents
|
|
|
|
|
(
|
)
|
||
Cash and cash equivalents, beginning
|
|
|
|
|
|
|
||
Cash and cash equivalents, end
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
||
Supplemental Cash Flow Information
|
|
|
|
|
||||
Non-cash transactions:
|
|
|
|
|
||||
Receipt of ICU Medical common stock
(b)
|
|
$
|
|
|
|
$
|
|
|
Promissory note from ICU Medical
(b)
|
|
|
|
|
|
|
||
Cash paid (received) during the period for:
|
|
|
|
|
|
|
||
Income taxes
|
|
$
|
|
|
|
$
|
|
|
Interest
|
|
|
|
|
|
|
||
Interest rate hedges
|
|
|
|
|
(
|
)
|
(a)
|
|
(b)
|
|
•
|
On February 3, 2017, we completed the sale of our global infusion therapy net assets, HIS, to ICU Medical. The operating results of HIS are included in the condensed consolidated statement of income and EH’s operating results through February 2, 2017 and, therefore, our financial results, and EH’s financial results, for the
first quarter
of 2017 reflect approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations, while our financial results, and EH’s financial results, for the
first quarter
of
2016
reflect three months of legacy HIS global operations. Assets and liabilities associated with HIS are presented as held for sale in the condensed consolidated balance sheet as of December 31, 2016. The HIS assets held for sale are reported in
Assets held for sale
and HIS liabilities held for sale are reported in
Other current liabilities.
|
•
|
On December 22, 2016, which falls in the first fiscal quarter of 2017 for our international operations, we acquired the development and commercialization rights to AstraZeneca’s small molecule anti-infectives business, primarily outside the U.S. Commencing from the acquisition date, our financial statements reflect the assets, liabilities, operating results and cash flows of this business, and, in accordance with our international reporting period, our condensed consolidated financial statements and EH’s operating results for the
first quarter
of 2017 reflect approximately two months of legacy AstraZeneca small molecule anti-infectives business international operations, which were immaterial.
|
•
|
On September 28, 2016, we acquired Medivation for
$
|
•
|
On June 24, 2016, we acquired Anacor for
$
|
•
|
In connection with acquisition activity, we typically incur costs associated with executing the transactions, integrating the acquired operations (which may include expenditures for consulting and the integration of systems and processes), and restructuring the combined company (which may include charges related to employees, assets and activities that will not continue in the combined company); and
|
•
|
In connection with our cost-reduction/productivity initiatives, we typically incur costs and charges associated with site closings and other facility rationalization actions, workforce reductions and the expansion of shared services, including the development of global systems.
|
•
|
Optimization of our manufacturing plant network to support IH and EH products and pipelines. During 2017-2019, we expect to incur costs of approximately
$
|
•
|
Activities in non-manufacturing related areas, which include further centralization of our corporate and platform functions, as well as other activities where opportunities are identified. During 2017-2019, we expect to incur costs of approximately
$
|
The following table provides the components of costs associated with acquisitions and cost-reduction/productivity initiatives:
|
||||||||
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Restructuring charges
(a)
:
|
|
|
|
|
|
|
||
Employee terminations
|
|
$
|
|
|
|
$
|
|
|
Asset impairments
|
|
|
|
|
|
|
||
Exit costs
|
|
|
|
|
|
|
||
Total restructuring charges
|
|
|
|
|
|
|
||
Transaction costs
(b)
|
|
|
|
|
|
|
||
Integration costs
(c)
|
|
|
|
|
|
|
||
Restructuring charges and certain acquisition-related costs
|
|
|
|
|
|
|
||
Additional depreciation––asset restructuring
recorded in our condensed consolidated statements of income as follows
(d)
:
|
|
|
|
|
|
|
||
Cost of sales
|
|
|
|
|
|
|
||
Research and development expenses
|
|
|
|
|
|
|
||
Total additional depreciation––asset restructuring
|
|
|
|
|
|
|
||
Implementation costs recorded in our condensed consolidated statements of income as follows
(e)
:
|
|
|
|
|
|
|
||
Cost of sales
|
|
|
|
|
|
|
||
Selling, informational and administrative expenses
|
|
|
|
|
|
|
||
Research and development expenses
|
|
|
|
|
|
|
||
Total implementation costs
|
|
|
|
|
|
|
||
Total costs associated with acquisitions and cost-reduction/productivity initiatives
|
|
$
|
|
|
|
$
|
|
|
(a)
|
In the
three months
ended
April 2, 2017
, restructuring charges are largely associated with cost-reduction and productivity initiatives not associated with acquisitions, as well as our acquisitions of Medivation and Anacor. In
the
three months
ended
April 3, 2016
, restructuring charges are largely associated with cost-reduction and productivity initiatives not associated with acquisitions. In the
three months
ended
April 2, 2017
,
Employee terminations
represent the expected reduction of the workforce by approximately
|
•
|
IH (
$
|
•
|
IH (
$
|
|
|
(c)
|
|
(d)
|
|
(e)
|
|
The following table provides the components of and changes in our restructuring accruals:
|
||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Employee
Termination Costs
|
|
|
Asset
Impairment Charges
|
|
|
Exit Costs
|
|
|
Accrual
|
|
||||
Balance, December 31, 2016
(a)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Provision
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Utilization and other
(b)
|
|
(
|
)
|
|
(
|
)
|
|
|
|
|
(
|
)
|
||||
Balance, April 2, 2017
(c)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
The following table provides components of
Other (income)/deductions––net
:
|
||||||||
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Interest income
(a)
|
|
$
|
(
|
)
|
|
$
|
(
|
)
|
Interest expense
(a)
|
|
|
|
|
|
|
||
Net interest expense
|
|
|
|
|
|
|
||
Royalty-related income
(b)
|
|
(
|
)
|
|
(
|
)
|
||
Certain legal matters, net
(c)
|
|
|
|
|
|
|
||
Net gains on asset disposals
(d)
|
|
(
|
)
|
|
(
|
)
|
||
Loss on sale of HIS net assets
(e)
|
|
|
|
|
|
|
||
Certain asset impairments
(f)
|
|
|
|
|
|
|
||
Business and legal entity alignment costs
(g)
|
|
|
|
|
|
|
||
Other, net
(h)
|
|
(
|
)
|
|
(
|
)
|
||
Other (income)/deductions––net
|
|
$
|
(
|
)
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(f)
|
|
(g)
|
|
(h)
|
|
•
|
the non-recurrence of benefits related to the final resolution of an agreement in principle reached in February 2016 and finalized in April 2016 to resolve certain claims related to Protonix, which resulted in the receipt of information that raised our initial assessment in 2015 of the likelihood of prevailing on the technical merits of our tax position;
|
•
|
the non-recurrence of benefits associated with our Venezuela operations;
|
•
|
a decrease in benefits associated with the resolution of certain tax positions pertaining to prior years primarily with various foreign tax authorities, and the expiration of certain statutes of limitations; as well as
|
•
|
the tax impact on an incremental charge to amounts previously recorded to write down the HIS net assets to fair value less costs to sell related to the sale of HIS net assets to ICU Medical,
|
•
|
the change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business.
|
•
|
With respect to Pfizer, the IRS has issued a Revenue Agent’s Report (RAR) for tax years
2009
-2010. We are not in agreement with the RAR and are currently appealing certain disputed issues. Tax years 2011-2013 are currently under audit. Tax years
2014
-2017 are open, but not under audit. All other tax years are closed.
|
•
|
With respect to Hospira, the IRS is currently auditing tax years 2012-2013 and 2014 through short-year 2015. All other tax years are closed. The tax years under audit for Hospira are not considered material to Pfizer.
|
•
|
With respect to Anacor and Medivation, the open tax years are not considered material to Pfizer.
|
The following table provides the components of
Tax provision/(benefit) on
other comprehensive income/(loss):
|
||||||||
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Foreign currency translation adjustments, net
(a)
|
|
$
|
(
|
)
|
|
$
|
(
|
)
|
Unrealized holding gains/(losses) on derivative financial instruments, net
|
|
|
|
|
(
|
)
|
||
Reclassification adjustments for realized gains
|
|
(
|
)
|
|
(
|
)
|
||
|
|
(
|
)
|
|
(
|
)
|
||
Unrealized holding gains on available-for-sale securities, net
|
|
|
|
|
|
|
||
Reclassification adjustments for realized losses
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Benefit plans: actuarial gains, net
|
|
|
|
|
|
|
||
Reclassification adjustments related to amortization
|
|
|
|
|
|
|
||
Reclassification adjustments related to settlements, net
|
|
|
|
|
|
|
||
Other
|
|
|
|
|
(
|
)
|
||
|
|
|
|
|
|
|
||
Benefit plans: prior service costs and other, net
|
|
|
|
|
|
|
||
Reclassification adjustments related to amortization
|
|
(
|
)
|
|
(
|
)
|
||
Reclassification adjustments related to curtailments, net
|
|
(
|
)
|
|
(
|
)
|
||
Other
|
|
|
|
|
|
|
||
|
|
(
|
)
|
|
(
|
)
|
||
Tax provision/(benefit) on other comprehensive income/(loss)
|
|
$
|
|
|
|
$
|
(
|
)
|
(a)
|
|
The following table provides the changes, net of tax, in
Accumulated other comprehensive loss
:
|
||||||||||||||||||||||||
|
|
Net Unrealized Gains/(Losses)
|
|
Benefit Plans
|
|
|
||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Foreign Currency Translation Adjustments
|
|
|
Derivative Financial Instruments
|
|
|
Available-For-Sale Securities
|
|
|
Actuarial Gains/(Losses)
|
|
|
Prior Service (Costs)/Credits and Other
|
|
|
Accumulated Other Comprehensive Income/(Loss)
|
|
||||||
Balance, December 31, 2016
|
|
$
|
(
|
)
|
|
$
|
|
|
|
$
|
(
|
)
|
|
$
|
(
|
)
|
|
$
|
|
|
|
$
|
(
|
)
|
Other comprehensive income/(loss)
(a)
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
|
(
|
)
|
|
|
|
||||||
Balance, April 2, 2017
|
|
$
|
(
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(
|
)
|
|
$
|
|
|
|
$
|
(
|
)
|
(a)
|
|
The following table provides additional information about certain of our financial assets and liabilities:
|
||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
December 31,
2016 |
|
||
Selected financial assets measured at fair value on a recurring basis
(a)
|
|
|
|
|
||||
Trading funds and securities
(b)
|
|
$
|
|
|
|
$
|
|
|
Available-for-sale debt securities
(c)
|
|
|
|
|
|
|
||
Money market funds
|
|
|
|
|
|
|
||
Available-for-sale equity securities
(c)
|
|
|
|
|
|
|
||
Derivative financial instruments in a receivable position
(d)
:
|
|
|
|
|
|
|
||
Interest rate swaps
|
|
|
|
|
|
|
||
Foreign currency swaps
|
|
|
|
|
|
|
||
Foreign currency forward-exchange contracts
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Other selected financial assets
|
|
|
|
|
|
|
||
Held-to-maturity debt securities, carried at amortized cost
(c), (e)
|
|
|
|
|
|
|
||
Restricted stock and private equity securities, carried at cost or at equity-method
(e),
(f)
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Total selected financial assets
|
|
$
|
|
|
|
$
|
|
|
Selected financial liabilities measured at fair value on a recurring basis
(a)
|
|
|
|
|
|
|
||
Derivative financial instruments in a liability position
(g)
:
|
|
|
|
|
|
|
||
Interest rate swaps
|
|
$
|
|
|
|
$
|
|
|
Foreign currency swaps
|
|
|
|
|
|
|
||
Foreign currency forward-exchange contracts
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Other selected financial liabilities
|
|
|
|
|
|
|
||
Short-term borrowings:
|
|
|
|
|
||||
Principal amount
|
|
|
|
|
|
|
||
Net fair value adjustments related to hedging and purchase accounting
|
|
|
|
|
|
|
||
Net unamortized discounts, premiums and debt issuance costs
|
|
(
|
)
|
|
(
|
)
|
||
Total short-term borrowings, carried at historical proceeds, as adjusted
(e)
|
|
|
|
|
|
|
||
Long-term debt:
|
|
|
|
|
||||
Principal amount
|
|
|
|
|
|
|
||
Net fair value adjustments related to hedging and purchase accounting
|
|
|
|
|
|
|
||
Net unamortized discounts, premiums and debt issuance costs
|
|
(
|
)
|
|
(
|
)
|
||
Total long-term debt, carried at historical proceeds, as adjusted
(h)
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Total selected financial liabilities
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(f)
|
|
(g)
|
|
(h)
|
|
The following table provides the classification of these selected financial assets and liabilities in our condensed consolidated balance sheets:
|
||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
December 31,
2016 |
|
||
Assets
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
|
|
|
$
|
|
|
Short-term investments
|
|
|
|
|
|
|
||
Other current assets
(a)
|
|
|
|
|
|
|
||
Long-term investments
|
|
|
|
|
|
|
||
Other noncurrent assets
(b)
|
|
|
|
|
|
|
||
|
|
$
|
|
|
|
$
|
|
|
Liabilities
|
|
|
|
|
|
|
||
Short-term borrowings, including current portion of long-term debt
|
|
$
|
|
|
|
$
|
|
|
Other current liabilities
(c)
|
|
|
|
|
|
|
||
Long-term debt
|
|
|
|
|
|
|
||
Other noncurrent liabilities
(d)
|
|
|
|
|
|
|
||
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
The following table provides the contractual maturities, or as necessary, the estimated maturities, of the available-for-sale and held-to-maturity debt securities:
|
||||||||||||||||||||
|
|
Years
|
|
April 2,
2017 |
|
|||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Within 1
|
|
|
Over 1
to 5
|
|
|
Over 5
to 10
|
|
|
Over 10
|
|
|
Total
|
|
|||||
Available-for-sale debt securities
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Corporate debt
(a)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Western European, Scandinavian and other government debt
(b)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Western European, Scandinavian and other government agency debt
(b)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Government National Mortgage Association and other U.S. government guaranteed asset-backed securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Other asset-backed debt
(c)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
U.S. government debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Supranational debt
(b)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Held-to-maturity debt securities
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Time deposits and other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Western European government debt
(b)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total debt securities
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
The following table provides the principal amounts of senior unsecured long-term debt issued in the first quarter of 2017:
|
||||||||||
|
|
|
|
As of April 2, 2017
|
||||||
(MILLIONS)
|
|
Maturity Date
|
|
Euro
|
|
|
U.S. Dollar
|
|
||
3-month EURIBOR + 0.20% floating rate notes (0% floor)
|
|
March 6, 2019
|
|
€
|
|
|
|
$
|
|
|
0.00% euro notes
(a)
|
|
March 6, 2020
|
|
|
|
|
|
|
||
0.25% euro notes
(a)
|
|
March 6, 2022
|
|
|
|
|
|
|
||
1.00% euro notes
(a)
|
|
March 6, 2027
|
|
|
|
|
|
|
||
Total euro long-term debt issued in the first quarter of 2017
(b)
|
|
|
|
€
|
|
|
|
$
|
|
|
4.20% notes
(c)
|
|
March 17, 2047
|
|
|
|
|
|
|||
Total long-term debt issued in the first quarter of 2017
|
|
|
|
|
|
$
|
|
|
(a)
|
|
(c)
|
|
The following table provides the maturity schedule of our
Long-term debt
outstanding as of April 2, 2017:
|
||||||||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
After 2021
|
|
Total
|
||||||||||||
Maturities
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
The following table provides information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk:
|
||||||||||||||||||||||||
|
|
Three Months Ended
|
||||||||||||||||||||||
|
|
Amount of
Gains/(Losses)
Recognized in OID
(a), (b), (c)
|
|
Amount of
Gains/(Losses)
Recognized in OCI
(Effective Portion)
(a), (d)
|
|
Amount of
Gains/(Losses)
Reclassified from
OCI into OID and COS
(Effective Portion)
(a), (d)
|
||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||||||
Derivative Financial Instruments in Cash Flow Hedge Relationships:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign currency swaps
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Foreign currency forward-exchange contracts
|
|
(
|
)
|
|
|
|
|
(
|
)
|
|
(
|
)
|
|
|
|
|
|
|
||||||
Derivative Financial Instruments in Net Investment Hedge Relationships:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Foreign currency forward-exchange contracts
|
|
|
|
|
(
|
)
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Derivative Financial Instruments Not Designated as Hedges:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Foreign currency forward-exchange contracts
|
|
(
|
)
|
|
(
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Foreign currency swaps
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Foreign currency short-term borrowings
|
|
|
|
|
|
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
||||||
Foreign currency long-term debt
|
|
|
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
|
|
|
||||||
|
|
$
|
(
|
)
|
|
$
|
(
|
)
|
|
$
|
(
|
)
|
|
$
|
(
|
)
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
The following table provides the components of
Inventories
:
|
||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
December 31,
2016 |
|
||
Finished goods
|
|
$
|
|
|
|
$
|
|
|
Work-in-process
|
|
|
|
|
|
|
||
Raw materials and supplies
|
|
|
|
|
|
|
||
Inventories
(a)
|
|
$
|
|
|
|
$
|
|
|
Noncurrent inventories not included above
(b)
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
The following table provides the components of
Identifiable intangible assets
:
|
||||||||||||||||||||||||
|
|
April 2, 2017
|
|
December 31, 2016
|
||||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Identifiable
Intangible
Assets, less
Accumulated
Amortization
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Identifiable
Intangible
Assets, less
Accumulated
Amortization
|
|
||||||
Finite-lived intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Developed technology rights
|
|
$
|
|
|
|
$
|
(
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(
|
)
|
|
$
|
|
|
Brands
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
|
(
|
)
|
|
|
|
||||||
Licensing agreements and other
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
|
(
|
)
|
|
|
|
||||||
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
|
(
|
)
|
|
|
|
||||||
Indefinite-lived intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Brands and other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
IPR&D
(a)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Identifiable intangible assets
(b)
|
|
$
|
|
|
|
$
|
(
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(
|
)
|
|
$
|
|
|
(a)
|
|
(b)
|
|
Our identifiable intangible assets are associated with the following, as a percentage of total identifiable intangible assets, less accumulated amortization:
|
|||||||||
|
|
April 2, 2017
|
|||||||
|
|
IH
|
|
EH
|
|
WRD
|
|||
Developed technology rights
|
|
|
%
|
|
|
%
|
|
|
%
|
Brands, finite-lived
|
|
|
%
|
|
|
%
|
|
|
%
|
Brands, indefinite-lived
|
|
|
%
|
|
|
%
|
|
|
%
|
IPR&D
|
|
|
%
|
|
|
%
|
|
|
%
|
The following table provides the components of and changes in the carrying amount of
Goodwill
:
|
||||||||||||
(MILLIONS OF DOLLARS)
|
|
IH
|
|
EH
|
|
Total
|
||||||
Balance, December 31, 2016
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Additions
(a)
|
|
|
|
|
|
|
|
|
|
|||
Other
(b)
|
|
|
|
|
(
|
)
|
|
|
|
|||
Balance, April 2, 2017
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
The following table provides the components of net periodic benefit cost:
|
||||||||||||||||||||||||||||||||
|
|
Three Months Ended
|
||||||||||||||||||||||||||||||
|
|
Pension Plans
|
|
|
||||||||||||||||||||||||||||
|
|
U.S.
Qualified
|
|
U.S.
Supplemental
(Non-Qualified)
|
|
International
|
|
Postretirement
Plans
|
||||||||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Apr 2, 2017
|
|
|
Apr 3, 2016
|
|
|
Apr 2, 2017
|
|
|
Apr 3, 2016
|
|
|
Apr 2, 2017
|
|
|
Apr 3, 2016
|
|
|
Apr 2, 2017
|
|
|
Apr 3, 2016
|
|
||||||||
Net periodic benefit cost/(credit):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Service cost
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Interest cost
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Expected return on plan assets
|
|
(
|
)
|
|
(
|
)
|
|
|
|
|
|
|
|
(
|
)
|
|
(
|
)
|
|
(
|
)
|
|
(
|
)
|
||||||||
Amortization of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Actuarial losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Prior service costs (credits)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(
|
)
|
|
|
|
|
(
|
)
|
|
(
|
)
|
||||||||
Curtailments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(
|
)
|
|
(
|
)
|
||||||||
Settlements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(
|
)
|
|
$
|
(
|
)
|
|
|
Pension Plans
|
|
|
||||||||||||
(MILLIONS OF DOLLARS)
|
|
U.S. Qualified
|
|
U.S. Supplemental (Non-Qualified)
|
|
International
|
|
Postretirement Plans
|
||||||||
Contributions from our general assets for the three months ended April 2, 2017
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Expected contributions from our general assets during 2017
(a)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
The following table provides the detailed calculation of
Earnings per common share (EPS)
:
|
||||||||
|
|
Three Months Ended
|
||||||
(IN MILLIONS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
EPS Numerator––Basic
|
|
|
|
|
||||
Income from continuing operations
|
|
$
|
|
|
|
$
|
|
|
Less: Net income attributable to noncontrolling interests
|
|
|
|
|
|
|
||
Income from continuing operations attributable to Pfizer Inc.
|
|
|
|
|
|
|
||
Less: Preferred stock dividends––net of tax
|
|
|
|
|
|
|
||
Income from continuing operations attributable to Pfizer Inc. common shareholders
|
|
|
|
|
|
|
||
Discontinued operations––net of tax
|
|
|
|
|
|
|
||
Net income attributable to Pfizer Inc. common shareholders
|
|
$
|
|
|
|
$
|
|
|
EPS Numerator––Diluted
|
|
|
|
|
|
|
||
Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions
|
|
$
|
|
|
|
$
|
|
|
Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions
|
|
|
|
|
|
|
||
Net income attributable to Pfizer Inc. common shareholders and assumed conversions
|
|
$
|
|
|
|
$
|
|
|
EPS Denominator
|
|
|
|
|
|
|
||
Weighted-average number of common shares outstanding––Basic
|
|
|
|
|
|
|
||
Common-share equivalents: stock options, stock issuable under employee compensation plans, convertible preferred stock and accelerated share repurchase agreements
(a)
|
|
|
|
|
|
|
||
Weighted-average number of common shares outstanding––Diluted
(a)
|
|
|
|
|
|
|
||
Stock options that had exercise prices greater than the average market price of our common stock issuable under employee compensation plans
(b)
|
|
|
|
|
|
|
(a)
|
|
(b)
|
|
•
|
Patent litigation, which typically involves challenges to the coverage and/or validity of patents on various products, processes or dosage forms. We are the plaintiff in the vast majority of these actions. An adverse outcome in actions in which we are the plaintiff could result in loss of patent protection for a drug, a significant loss of revenues from that drug or impairment of the value of associated assets.
|
•
|
Product liability and other product-related litigation, which can include personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, among others, often involves highly complex issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual, provable injury and other matters.
|
•
|
Commercial and other matters, which can include merger-related and product-pricing claims and environmental claims and proceedings, can involve complexities that will vary from matter to matter.
|
•
|
Government investigations, which often are related to the extensive regulation of pharmaceutical companies by national, state and local government agencies in the U.S. and in other countries.
|
•
|
Personal Injury Actions
|
•
|
Antitrust Actions
|
•
|
Antitrust Actions
|
•
|
Personal Injury Actions
|
Some additional information about our business segments follows:
|
||
IH Segment
|
|
EH Segment
|
IH focuses on developing and commercializing novel, value-creating medicines and vaccines that significantly improve patients’ lives, as well as products for consumer healthcare.
Key therapeutic areas include internal medicine, vaccines, oncology, inflammation & immunology, rare diseases and consumer healthcare.
|
|
EH includes legacy brands that have lost or will soon lose market exclusivity in both developed and emerging markets, branded generics, generic sterile injectable products, biosimilars, select branded products including anti-infectives and, through February 2, 2017, HIS. EH also includes an R&D organization, as well as our contract manufacturing business.
|
Leading brands include:
-
Prevnar 13
-
Xeljanz
-
Eliquis
-
Lyrica
(U.S., Japan and certain other markets)
-
Enbrel
(outside the U.S. and Canada)
-
Viagra
(U.S. and Canada)
-
Ibrance
-
Xtandi
- Several OTC consumer healthcare products (e.g.,
Advil
and
Centrum
)
|
|
Leading brands include:
-
Lipitor
- Premarin
family
- Norvasc
- Lyrica
(Europe, Russia, Turkey, Israel and Central Asia countries)
-
Celebrex
-
Pristiq
-
Several sterile injectable products
|
•
|
WRD, which is generally responsible for research projects for our IH business until proof-of-concept is achieved and then for transitioning those projects to the IH segment via the GPD organization for possible clinical and commercial development. R&D spending may include upfront and milestone payments for intellectual property rights. The WRD organization also has responsibility for certain science-based and other platform-services organizations, which provide technical expertise and other services to the various R&D projects, including EH R&D projects. WRD is also responsible for facilitating all regulatory submissions and interactions with regulatory agencies, including all safety-event activities.
|
•
|
GPD, which is generally responsible for the clinical development of assets that are in clinical trials for our WRD and Innovative portfolios. GPD also provides technical support and other services to Pfizer R&D projects.
|
•
|
Corporate, representing platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance and worldwide procurement) and certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments. Effective in the first quarter of 2017, Corporate also includes the costs associated with our Pfizer Medical organization (Medical), previously reported as part of Other Business Activities. Medical is responsible for the provision of medical information to healthcare providers, patients and other parties, transparency and disclosure activities, clinical trial results publication, grants for healthcare quality improvement and medical education, and partnerships with global public health and medical associations.
|
•
|
Other unallocated costs, representing overhead expenses associated with our manufacturing and commercial operations that are not directly assessed to an operating segment as business unit (segment) management does not manage these costs, (which include manufacturing variances associated with production).
|
•
|
Certain transactions and events such as (i) purchase accounting adjustments, where we incur expenses associated with the amortization of fair value adjustments to inventory, intangible assets and PP&E; (ii) acquisition-related costs, where we incur costs for executing the transaction, integrating the acquired operations and restructuring the combined company; and (iii) certain significant items, which are substantive and/or unusual, and in some cases recurring, items that are evaluated on an individual basis by management and which include non-acquisition-related restructuring costs, as well as costs incurred for legal settlements, asset impairments and disposals of assets or businesses, including, as applicable, any associated transition activities.
|
The following table provides selected income statement information by reportable segment:
|
||||||||||||||||
|
|
Three Months Ended
|
||||||||||||||
|
|
Revenues
|
|
Earnings
(a)
|
||||||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||||
Reportable Segments:
|
|
|
|
|
|
|
|
|
||||||||
IH
(b)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
EH
(c)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total reportable segments
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other business activities
(d), (e)
|
|
—
|
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||
Reconciling Items:
|
|
|
|
|
|
|
|
|
|
|
||||||
Corporate
(e)
|
|
—
|
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||
Purchase accounting adjustments
(e)
|
|
—
|
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||
Acquisition-related costs
(e)
|
|
—
|
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||
Certain significant items
(f)
|
|
—
|
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||
Other unallocated
|
|
—
|
|
|
—
|
|
|
(
|
)
|
|
(
|
)
|
||||
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(f)
|
|
The following table provides revenues by geographic area
(a)
:
|
|||||||||||
|
|
Three Months Ended
|
|||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change
|
|
||
U.S.
|
|
$
|
|
|
|
$
|
|
|
|
|
|
Developed Europe
(b)
|
|
|
|
|
|
|
|
(
|
)
|
||
Developed Rest of World
(c)
|
|
|
|
|
|
|
|
|
|
||
Emerging Markets
(d)
|
|
|
|
|
|
|
|
|
|
||
Revenues
|
|
$
|
|
|
|
$
|
|
|
|
(
|
)
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
The following table provides detailed revenue information:
|
||||||||
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
PFIZER INNOVATIVE HEALTH (IH)
(a)
|
|
$
|
|
|
|
$
|
|
|
Internal Medicine
|
|
$
|
|
|
|
$
|
|
|
Lyrica IH
(b)
|
|
|
|
|
|
|
||
Eliquis alliance revenues and direct sales
|
|
|
|
|
|
|
||
Viagra IH
(c)
|
|
|
|
|
|
|
||
Chantix/Champix
|
|
|
|
|
|
|
||
Toviaz
|
|
|
|
|
|
|
||
BMP2
|
|
|
|
|
|
|
||
All other Internal Medicine
|
|
|
|
|
|
|
||
Vaccines
|
|
$
|
|
|
|
$
|
|
|
Prevnar 13/Prevenar 13
|
|
|
|
|
|
|
||
All other Vaccines
|
|
|
|
|
|
|
||
Oncology
|
|
$
|
|
|
|
$
|
|
|
Ibrance
|
|
|
|
|
|
|
||
Sutent
|
|
|
|
|
|
|
||
Xalkori
|
|
|
|
|
|
|
||
Xtandi alliance revenues
|
|
|
|
|
|
|
||
Inlyta
|
|
|
|
|
|
|
||
All other Oncology
|
|
|
|
|
|
|
||
Inflammation & Immunology (I&I)
|
|
$
|
|
|
|
$
|
|
|
Enbrel (Outside the U.S. and Canada)
|
|
|
|
|
|
|
||
Xeljanz
|
|
|
|
|
|
|
||
Eucrisa
|
|
|
|
|
|
|
||
All othe
r
I&I
|
|
|
|
|
|
|
||
Rare Disease
|
|
$
|
|
|
|
$
|
|
|
BeneFIX
|
|
|
|
|
|
|
||
Refacto AF/Xyntha
|
|
|
|
|
|
|
||
Genotropin
|
|
|
|
|
|
|
||
Somavert
|
|
|
|
|
|
|
||
All other Rare Disease
|
|
|
|
|
|
|
||
Consumer Healthcare
|
|
$
|
|
|
|
$
|
|
|
PFIZER ESSENTIAL HEALTH (EH)
(d)
|
|
$
|
|
|
|
$
|
|
|
Legacy Established Products (LEP)
(e)
|
|
$
|
|
|
|
$
|
|
|
Lipitor
|
|
|
|
|
|
|
||
Norvasc
|
|
|
|
|
|
|
||
Premarin family
|
|
|
|
|
|
|
||
Relpax
|
|
|
|
|
|
|
||
EpiPen
|
|
|
|
|
|
|
||
Zithromax
|
|
|
|
|
|
|
||
Xalatan/Xalacom
|
|
|
|
|
|
|
||
Zoloft
|
|
|
|
|
|
|
||
Effexor
|
|
|
|
|
|
|
||
Xanax
|
|
|
|
|
|
|
||
All other LEP
|
|
|
|
|
|
|
||
Sterile Injectable Pharmaceuticals (SIP)
(f)
|
|
$
|
|
|
|
$
|
|
|
Sulperazon
|
|
|
|
|
|
|
||
Medrol
|
|
|
|
|
|
|
||
Tygacil
|
|
|
|
|
|
|
||
Fragmin
|
|
|
|
|
|
|
||
Precedex
|
|
|
|
|
|
|
||
All other SIP
|
|
|
|
|
|
|
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Peri-LOE Products
(g)
|
|
$
|
|
|
|
$
|
|
|
Celebrex
|
|
|
|
|
|
|
||
Lyrica EH
(b)
|
|
|
|
|
|
|
||
Pristiq
|
|
|
|
|
|
|
||
Vfend
|
|
|
|
|
|
|
||
Viagra EH
(c)
|
|
|
|
|
|
|
||
Zyvox
|
|
|
|
|
|
|
||
Revatio
|
|
|
|
|
|
|
||
All other Peri-LOE Products
|
|
|
|
|
|
|
||
Biosimilars
(h)
|
|
$
|
|
|
|
$
|
|
|
Inflectra/Remsima
|
|
|
|
|
|
|
||
All other Biosimilars
|
|
|
|
|
|
|
||
Pfizer CentreOne
(i)
|
|
$
|
|
|
|
$
|
|
|
Hospira Infusion Systems (HIS)
(j)
|
|
$
|
|
|
|
$
|
|
|
Revenues
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
||||
Total Lyrica
(b)
|
|
$
|
|
|
|
$
|
|
|
Total Viagra
(c)
|
|
$
|
|
|
|
$
|
|
|
Total Alliance revenues
|
|
$
|
|
|
|
$
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
(f)
|
|
(g)
|
|
(h)
|
|
(i)
|
|
(j)
|
|
●
|
Beginning on page
44
|
||||
|
This section provides information about the following: Our Business; our performance during the first quarter of 2017 and 2016; Our Operating Environment; The Global Economic Environment; Our Strategy; Our Business Development Initiatives, such as acquisitions, dispositions, licensing and collaborations; and Our Financial Guidance for 2017.
|
|
|||
●
|
Beginning on page
56
|
||||
|
This section includes a Revenues Overview section as well as the following sub-sections:
|
|
|||
|
Beginning on page
59
|
||||
|
This sub-section provides revenue information for several of our major biopharmaceutical products.
|
|
|||
|
Beginning on page
60
|
||||
|
This sub-section provides an overview of several of our biopharmaceutical products.
|
|
|||
|
Beginning on page
63
|
||||
|
This sub-section provides an overview of important biopharmaceutical product developments.
|
|
|||
|
Beginning on page
67
|
||||
|
This sub-section provides a discussion about our costs and expenses.
|
|
|||
|
Beginning on page
70
|
||||
|
This sub-section provides a discussion of items impacting our tax provisions.
|
|
|||
|
Beginning on page
70
|
||||
|
This sub-section provides a discussion of an alternative view of performance used by management.
|
|
|||
●
|
Beginning on page
75
|
||||
|
This section provides a discussion of the performance of each of our operating segments.
|
|
|||
●
|
Beginning on page
80
|
||||
|
This section provides a discussion of certain balance sheet accounts by Operating Segment.
|
|
|||
●
|
Beginning on page
80
|
||||
|
This section provides a discussion of changes in certain components of other comprehensive income.
|
|
|||
●
|
Beginning on page
81
|
||||
|
This section provides a discussion of changes in certain balance sheet accounts, including
Accumulated other comprehensive loss
.
|
|
|||
●
|
Beginning on page
82
|
||||
|
This section provides an analysis of our cash flows for the first three months of 2017 and 2016.
|
|
|||
●
|
Beginning on page
83
|
||||
|
This section provides an analysis of selected measures of our liquidity and of our capital resources as of April 2, 2017 and December 31, 2016, as well as a discussion of our outstanding debt and other commitments that existed as of April 2, 2017 and December 31, 2016. Included in the discussion of outstanding debt is a discussion of the amount of financial capacity available to help fund Pfizer’s future activities.
|
|
|||
●
|
Beginning on page
87
|
||||
|
This section discusses accounting standards that we have recently adopted, as well as those that recently have been issued, but not yet adopted.
|
|
|||
●
|
Beginning on page
90
|
||||
|
This section provides a description of the risks and uncertainties that could cause actual results to differ materially from those discussed in forward-looking statements presented in this MD&A, relating to, among other things, our anticipated operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans and plans relating to share repurchases and dividends. Also included in this section is a discussion of legal proceedings and contingencies.
|
|
The following table provides the components of the condensed consolidated statements of income:
|
|||||||||||
|
|
Three Months Ended
|
|||||||||
(MILLIONS OF DOLLARS, EXCEPT PER COMMON SHARE DATA)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change
|
|
||
Revenues
|
|
$
|
12,779
|
|
|
$
|
13,005
|
|
|
(2
|
)
|
|
|
|
|
|
|
|
|||||
Cost of sales
|
|
2,470
|
|
|
2,851
|
|
|
(13
|
)
|
||
% of revenues
|
|
19.3
|
%
|
|
21.9
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Selling, informational and administrative expenses
|
|
3,308
|
|
|
3,385
|
|
|
(2
|
)
|
||
% of revenues
|
|
25.9
|
%
|
|
26.0
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Research and development expenses
|
|
1,708
|
|
|
1,731
|
|
|
(1
|
)
|
||
% of revenues
|
|
13.4
|
%
|
|
13.3
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Amortization of intangible assets
|
|
1,186
|
|
|
1,006
|
|
|
18
|
|
||
% of revenues
|
|
9.3
|
%
|
|
7.7
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Restructuring charges and certain acquisition-related costs
|
|
157
|
|
|
141
|
|
|
11
|
|
||
% of revenues
|
|
1.2
|
%
|
|
1.1
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Other (income)/deductions––net
|
|
(1
|
)
|
|
330
|
|
|
*
|
|
||
Income from continuing operations before provision for taxes on income
|
|
3,951
|
|
|
3,561
|
|
|
11
|
|
||
% of revenues
|
|
30.9
|
%
|
|
27.4
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Provision for taxes on income
|
|
821
|
|
|
513
|
|
|
60
|
|
||
Effective tax rate
|
|
20.8
|
%
|
|
14.4
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Income from continuing operations
|
|
3,130
|
|
|
3,048
|
|
|
3
|
|
||
% of revenues
|
|
24.5
|
%
|
|
23.4
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Discontinued operations––net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
||
|
|
|
|
|
|
|
|||||
Net income before allocation to noncontrolling interests
|
|
3,130
|
|
|
3,048
|
|
|
3
|
|
||
% of revenues
|
|
24.5
|
%
|
|
23.4
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Less: Net income attributable to noncontrolling interests
|
|
|
|
|
|
|
|
(8
|
)
|
||
Net income attributable to Pfizer Inc.
|
|
$
|
3,121
|
|
|
$
|
3,038
|
|
|
3
|
|
% of revenues
|
|
24.4
|
%
|
|
23.4
|
%
|
|
|
|
||
|
|
|
|
|
|
|
|||||
Earnings per common share––basic
:
|
|
|
|
|
|
|
|
|
|
||
Income from continuing operations attributable to Pfizer Inc. common shareholders
|
|
$
|
|
|
|
$
|
|
|
|
6
|
|
Net income attributable to Pfizer Inc. common shareholders
|
|
$
|
0.52
|
|
|
$
|
0.49
|
|
|
6
|
|
|
|
|
|
|
|
|
|||||
Earnings per common share––diluted
:
|
|
|
|
|
|
|
|
||||
Income from continuing operations attributable to Pfizer Inc. common shareholders
|
|
$
|
|
|
|
$
|
|
|
|
6
|
|
Net income attributable to Pfizer Inc. common shareholders
|
|
$
|
0.51
|
|
|
$
|
0.49
|
|
|
6
|
|
|
|
|
|
|
|
|
|||||
Cash dividends paid per common share
|
|
$
|
|
|
|
$
|
|
|
|
7
|
|
References to developed and emerging markets in this MD&A include:
|
||
Developed markets
|
|
U.S., Western Europe, Japan, Canada, Australia, South Korea, Scandinavian countries, Finland and New Zealand
|
|
|
|
Emerging markets (includes, but is not limited to)
|
|
Asia (excluding Japan and South Korea), Latin America, Africa, Eastern Europe, Central Europe, the Middle East and Turkey
|
•
|
On February 3, 2017, we completed the sale of Pfizer’s global infusion therapy net assets, HIS, to ICU Medical for up to approximately $900 million, composed of cash and contingent cash consideration, ICU Medical common stock and seller financing.
At closing, we received 3.2 million newly issued shares of ICU Medical common stock, which we valued at approximately
$428 million
, a promissory note in the amount of
$75 million
and net cash of approximately
$200 million
before customary adjustments for net working capital. In addition, we are entitled to receive a contingent amount of up to an additional
$225 million
in cash based on ICU Medical’s achievement of certain cumulative performance targets for the combined company through December 31, 2019. The operating results of HIS are included in the condensed consolidated statement of income and EH’s operating results through February 2, 2017 and, therefore, financial results for the
first quarter
of 2017 reflect approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations, while financial results for the
first quarter
of
2016
reflect three months of legacy HIS global operations. Assets and liabilities associated with HIS are presented as held for sale in the condensed consolidated balance
|
•
|
On December 22, 2016, which falls in the first fiscal quarter of 2017 for our international operations, we acquired the development and commercialization rights to AstraZeneca’s small molecule anti-infectives business, primarily outside the U.S., including 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 ATM-AVI and CXL (ceftaroline fosamil-AVI). The total fair value of the consideration transferred for this business was approximately
$555 million
in cash plus contingent consideration of
$490 million
. Of this cash consideration, approximately
$3 million
was not paid as of April 2, 2017, and was recorded in
Other current liabilities
. Commencing from the acquisition date, our financial statements reflect the assets, liabilities, operating results and cash flows of this business, and, in accordance with our international reporting period, our condensed consolidated financial statements for the
first quarter
of 2017 reflect approximately two months of legacy AstraZeneca small molecule anti-infectives business international operations, which were immaterial.
|
•
|
On September 28, 2016, we acquired Medivation for
$81.50
per share. The total fair value of consideration transferred for Medivation was approximately
$14.3 billion
in cash (
$13.9 billion
, net of cash acquired). Of this consideration, approximately
$365 million
was not paid as of April 2, 2017, and was recorded in
Other current liabilities.
Commencing from the acquisition date, our financial statements reflect the assets, liabilities, operating results and cash flows of Medivation. As a result, legacy Medivation operations are reflected in our results of operations, IH’s operating results, and cash flows for the first quarter of 2017, but not for the first quarter of 2016.
|
•
|
On June 24, 2016, we acquired Anacor for
$99.25
per share. The total fair value of consideration transferred for Anacor was approximately
$4.9 billion
in cash (
$4.5 billion
, net of cash acquired), plus
$698 million
debt assumed. Commencing from the acquisition date, our financial statements reflect the assets, liabilities, operating results and cash flows of Anacor. As a result, legacy Anacor operations are reflected in our results of operations, IH’s operating results, and cash flows for the first quarter of 2017, but not for the first quarter of 2016.
|
The following provides an analysis of the 2017 revenue decline:
|
||||
(MILLIONS OF DOLLARS)
|
|
|
|
|
|
|
|
||
Revenues,
for the three months ended April 3, 2016
|
|
$
|
13,005
|
|
|
|
|
||
Acquisition-related growth
|
|
|
||
Xtandi alliance revenues in the U.S. (September 2016 acquisition of Medivation)
|
|
131
|
|
|
|
|
|
|
|
Disposition-related impact
|
|
|
|
|
Approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of 2017, compared to three months of legacy HIS global operations in the same period in 2016
|
|
(207
|
)
|
|
|
|
|
|
|
Operational growth/(decline)
|
|
|
||
Growth from key brands, including Ibrance and Eliquis (globally), Lyrica (IH) and Xeljanz (both primarily in the U.S.), as well as growth in the Pfizer Sterile Injectable Pharmaceuticals portfolio and Biosimilars
|
|
706
|
|
|
Decline from the Peri-LOE Products portfolio and the Legacy Established Products portfolio, as well as lower revenues for Enbrel (in most developed Europe markets), Prevnar 13/Prevenar 13 (globally) and Viagra (IH) (in the U.S.)
|
|
(688
|
)
|
|
Other operational factors, net
|
|
(53
|
)
|
|
Operational decline, net
|
|
(110
|
)
|
|
|
|
|
||
Operational revenues
|
|
12,895
|
|
|
Unfavorable impact of foreign exchange
|
|
(116
|
)
|
|
Revenues,
for the three months ended April 2, 2017
|
|
$
|
12,779
|
|
(MILLIONS OF DOLLARS)
|
|
|
||
Income from continuing operations before provision for taxes on income,
for the three months ended April 3, 2016
|
|
$
|
3,561
|
|
|
|
|
||
Unfavorable change in revenues
|
|
(226
|
)
|
|
|
|
|
||
Favorable changes:
|
|
|
||
Lower
Cost of sales
(a)
|
|
381
|
|
|
Lower certain legal matters, net
(b)
|
|
266
|
|
|
Higher net gains on asset disposals
(b)
|
|
123
|
|
|
Lower certain asset impairments
(b)
|
|
119
|
|
|
Lower
Selling, informational and administrative expenses
(c)
|
|
76
|
|
|
Lower
Research and development expenses
(d)
|
|
23
|
|
|
Unfavorable changes:
|
|
|
|
|
Higher
Amortization of intangible assets
(e)
|
|
(180
|
)
|
|
Lower royalty-related income
(b)
|
|
(101
|
)
|
|
Loss on sale of HIS net assets
(b)
|
|
(37
|
)
|
|
All other items
|
|
(54
|
)
|
|
Income from continuing operations before provision for taxes on income,
for the three months ended April 2, 2017
|
|
$
|
3,951
|
|
(a)
|
See the “Costs and Expenses––Cost of Sales” section of this MD&A.
|
(b)
|
See the Notes to Condensed Consolidated Financial Statements––
Note 4. Other (Income)/Deductions––Net.
|
(c)
|
See the “Costs and Expenses––Selling, Informational and Administrative Expenses ” section of this MD&A.
|
(d)
|
See the “Costs and Expenses––Research and Development Expenses” section of this MD&A.
|
(e)
|
See the “Costs and Expenses––Amortization of Intangible Assets” section of this MD&A.
|
•
|
$58 million
in the
first
quarter of
2017
and
$96 million
in the
first
quarter of
2016
, recorded as a reduction to
Revenues
related to the Medicare “coverage gap” discount provision; and
|
•
|
$37 million
in the
first
quarter of
2017
and
$32 million
in the
first
quarter of
2016
, recorded in
Selling, informational and administrative expenses
, related to the fee payable to the federal government (which is not deductible for U.S. income tax purposes) based on our prior-calendar-year share relative to other companies of branded prescription drug sales to specified government programs.
|
•
|
Governments, corporations, and insurance companies, which provide insurance benefits to patients, have implemented increases in cost-sharing and restrictions on access to medicines, potentially causing patients to switch to generic products, delay treatments, skip doses or use less effective treatments. Government financing pressures can lead to negative pricing pressure in various markets where governments take an active role in setting prices, access criteria (e.g., through public or private health technology assessments), or other means of cost control. Examples include Europe, Japan, China, Canada, South Korea and a number of other international markets. The U.S. continues to maintain competitive insurance markets, but has also seen significant increases in patient cost-sharing and growing government influence as government programs continue to grow as a source of coverage.
|
•
|
We continue to monitor developments regarding government and government agency receivables in several European markets, including Greece, where economic conditions remain challenging and uncertain. For further information about our
Accounts Receivable
, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this MD&A.
|
•
|
Significant portions of our revenues and earnings, as well as our substantial international net assets, are exposed to changes in foreign exchange rates. We seek to manage our foreign exchange risk in part through operational means, including managing same-currency revenues in relation to same-currency costs and same-currency assets in relation to same-currency liabilities. Depending on market conditions, foreign exchange risk also is managed through the use of derivative financial instruments and foreign currency debt. As we operate in multiple foreign currencies, including the euro, the Japanese yen, the Chinese renminbi, the U.K. pound, the Canadian dollar and approximately 100 other currencies, changes in those currencies relative to the U.S. dollar will impact our revenues and expenses. If the U.S. dollar were to weaken against another currency, assuming all other variables remained constant, our revenues would increase, having a positive impact on
|
•
|
In June 2016, the U.K. electorate voted in a referendum to leave the EU, which is commonly referred to as “Brexit”. In January 2017, the U.K. Prime Minister announced a 12-point plan of negotiating objectives and confirmed that the U.K. government will not seek continued membership of the EU single market. In March 2017, the U.K. government formally notified the European Council of its intention to leave the EU after it triggered Article 50 of the Lisbon Treaty to begin the two-year negotiation process establishing the terms of the exit and outlining the future relationship between the U.K. and the EU. This process is expected to be highly complex and the end result of these negotiations may pose certain implications to our research, commercial and general business operations in the U.K. and the EU.
|
|
Some additional information about our business segments follows:
|
|||
|
IH Segment
|
|
|
EH Segment
|
●
|
IH focuses on developing and commercializing novel, value-creating medicines and vaccines that significantly improve patients’ lives, as well as products for consumer healthcare.
Key therapeutic areas include internal medicine, vaccines, oncology, inflammation & immunology, rare diseases and consumer healthcare.
|
|
●
|
EH includes legacy brands that have lost or will soon lose market exclusivity in both developed and emerging markets, branded generics, generic sterile injectable products, biosimilars, select branded products including anti-infectives and, through February 2, 2017, HIS. EH also includes an R&D organization, as well as our contract manufacturing business.
|
●
|
We expect that the IH biopharmaceutical portfolio of innovative, largely patent-protected, in-line and newly launched products will be sustained by ongoing investments to develop promising assets and targeted business development in areas of focus to help ensure a pipeline of highly-differentiated product candidates in areas of unmet medical need. The assets managed by IH are science-driven, highly differentiated and generally require a high-level of engagement with healthcare providers and consumers.
|
|
●
|
EH is expected to generate strong consistent cash flow by providing patients around the world with access to effective, lower-cost, high-value treatments. EH leverages our biologic development, regulatory and manufacturing expertise to seek to advance its biosimilar development portfolio. Additionally, EH leverages capabilities in formulation development and manufacturing expertise to help advance its generic sterile injectables portfolio. EH may also engage in targeted business development to further enable its commercial strategies.
|
●
|
IH will have continued focus on R&D productivity and pipeline strength while maximizing the value of our recently launched brands and in-line portfolio. Our acquisitions of Anacor and Medivation expanded our pipeline in the high priority therapeutic areas of inflammation and immunology and oncology.
|
|
●
|
For EH, we continue to invest in growth drivers and manage the portfolio to extract additional value while seeking opportunities for operating efficiencies. This strategy includes active management of our portfolio; maximizing growth of core product segments; acquisitions to strengthen core areas of our portfolio further, such as our recent acquisition of AstraZeneca’s small molecule anti-infectives business; and divestitures to increase focus on our core strengths. In line with this strategy, on February 3, 2017, we completed the sale of Pfizer’s global infusion therapy net assets, representing the infusion systems net assets that we acquired as part of the Hospira transaction, HIS, to ICU Medical.
|
|
Leading brands include: - Prevnar 13 - Xeljanz - Eliquis - Lyrica (U.S., Japan and certain other markets) - Enbrel (outside the U.S. and Canada) - Viagra (U.S. and Canada) - Ibrance - Xtandi - Several OTC consumer healthcare products (e.g., Advil and
Centrum
)
|
|
|
Leading brands include: - Lipitor - Premarin family - Norvasc - Lyrica (Europe, Russia, Turkey, Israel and Central Asia countries) - Celebrex - Pristiq - Several sterile injectable products |
•
|
Biosimilars;
|
•
|
Inflammation and Immunology;
|
•
|
Metabolic Disease and Cardiovascular Risks;
|
•
|
Neuroscience;
|
•
|
Oncology;
|
•
|
Rare Diseases; and
|
•
|
Vaccines.
|
•
|
Research Units within our WRD organization are generally responsible for research assets for our IH business (assets that have not yet achieved proof-of-concept). Our Research Units are organized in a variety of ways (by therapeutic area or combinations of therapeutic areas, by discipline, by location, etc.) to enhance flexibility, cohesiveness and focus. Because of our structure, we can rapidly redeploy resources within a Research Unit between various projects as necessary because the workforce shares similar skills, expertise and/or focus.
|
•
|
Our R&D organization within the EH business supports the large base of EH products and is expected to develop potential new sterile injectable drugs and therapeutic solutions, as well as biosimilars.
|
•
|
Our GPD organization is a unified center for late-stage development for our innovative products and is generally responsible for the clinical development of assets that are in clinical trials for our WRD and Innovative portfolios. GPD is expected to enable more efficient and effective development and enhance our ability to accelerate and progress assets through our pipeline. GPD combines certain previously separate development-related functions from the IH business and the WRD organization to achieve a development capability that is expected to deliver high-quality, efficient, and well-executed clinical programs by enabling greater speed, greater cost efficiencies, and reduced complexity across our development portfolio. GPD also provides technical support and other services to Pfizer R&D projects.
|
•
|
Our science-based and other platform-services organizations, where a significant portion of our R&D spending occurs, provide technical expertise and other services to the various R&D projects, and are organized into science-based functions (which are part of our WRD organization), such as Pharmaceutical Sciences, Medicinal Chemistry, Regulatory and Drug Safety, and non-science-based functions, such as Facilities, Business Technology and Finance. As a result, within each of these functions, we are able to migrate resources among projects, candidates and/or targets in any therapeutic area and in most phases of development, allowing us to react quickly in response to evolving needs.
|
•
|
Sale of Hospira Infusion Systems Net Assets to ICU Medical, Inc. (EH)
––On February 3, 2017, we completed the sale of our global infusion therapy net assets, HIS, to ICU Medical. In connection with this transaction, we recognized a loss of approximately
$37 million
in
Other (income)/deductions––net
in the
first
quarter of
2017
, representing an incremental charge to amounts previously recorded to write down the HIS net assets to fair value less costs to sell. We may record additional adjustments to the loss on the sale of HIS net assets in future periods, pending final working capital adjustments, local market closes, among other agreement provisions, which we do not expect to have a material impact on our consolidated financial statements.
|
•
|
Acquisition of AstraZeneca’s Small Molecule Anti-Infectives Business (EH)
––On December 22, 2016, which falls in the first fiscal quarter of 2017 for our international operations, we acquired the development and commercialization rights to AstraZeneca’s small molecule anti-infectives business, primarily outside the U.S., including 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 ATM-AVI and CXL (ceftaroline fosamil-AVI). The total fair value of the consideration transferred for this business was approximately
$555 million
in cash plus contingent consideration of
$490 million
.
|
•
|
Acquisition of Medivation, Inc. (IH)
––On September 28, 2016, we acquired Medivation for
$81.50
per share. The total fair value of consideration transferred for Medivation was approximately
$14.3 billion
in cash (
$13.9 billion
, net of cash acquired). Medivation’s portfolio includes Xtandi (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within tumor cells. Xtandi is being developed and commercialized through a collaboration with Astellas. Astellas has exclusive commercialization rights for Xtandi outside the U.S. In addition, Medivation has two development-stage oncology assets in its pipeline: talazoparib, which is currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, and pidilizumab, an immuno-oncology asset.
|
•
|
Acquisition of Bamboo Therapeutics, Inc. (R&D)
––On August 1, 2016, we acquired all the remaining equity in Bamboo, a privately-held biotechnology company, focused on developing gene therapies for the potential treatment of patients with certain rare diseases relating to neuromuscular conditions and those affecting the central nervous system, for $150 million, plus potential milestone payments of up to $495 million contingent upon the progression of key assets through development, regulatory approval and commercialization. We previously purchased a minority stake in Bamboo in the first quarter of 2016 for a payment of approximately $43 million. This acquisition provides us with several clinical and pre-clinical assets that complement our rare disease portfolio, an advanced recombinant AAV vector design and production technology, and a fully functional Phase I/II gene therapy manufacturing facility.
|
•
|
Acquisition of Anacor Pharmaceuticals, Inc. (IH)
––On June 24, 2016, we acquired Anacor for
$99.25
per share. The total fair value of consideration transferred for Anacor was approximately
$4.9 billion
in cash (
$4.5 billion
net of cash acquired) plus
$698 million
debt assumed. Anacor’s crisaborole, a non-steroidal topical PDE-4 inhibitor with anti-inflammatory properties, was approved by the FDA on December 14, 2016 under the trade name, Eucrisa, for the treatment of mild-to-moderate atopic dermatitis in patients two years of age and older, commonly referred to as a type of eczema. Anacor also holds the rights to Kerydin, a topical treatment for onychomycosis (toenail fungus) that is distributed and commercialized by Sandoz
in the U.S
.
|
•
|
Research and Development Arrangement with NovaQuest Co-Investment Fund V, L.P.
––In April 2016, Pfizer entered into an agreement with NovaQuest under which NovaQuest will fund up to $200 million in development costs related to certain Phase III clinical trials of Pfizer’s rivipansel compound and Pfizer will use commercially reasonable efforts to develop and obtain regulatory approvals for such compound. NovaQuest’s development funding is expected to cover up to 100% of the development costs and will be received over approximately twelve quarters from 2016 to 2019. As there is a substantive and genuine transfer of risk to NovaQuest, the development funding is recognized by us as an obligation to perform contractual services and therefore is a reduction of
Research and development expenses
as incurred. The reduction to
Research and development expenses
for the
first
quarter of
2017
totaled
$17.2 million
. Following potential regulatory approval, NovaQuest will be eligible to receive a combination of fixed milestone payments of up to approximately $267 million in total, based on achievement of first commercial sale and certain levels of cumulative net sales as well as royalties on rivipansel net sales over approximately eight years. Fixed sales-based milestone payments will be recorded as intangible assets and amortized to
Amortization of intangible assets
over the estimated commercial life of the rivipansel product and royalties on net sales will be recorded as
Cost of sales
when incurred.
|
•
|
Research and Development Arrangement with RPI Finance Trust
––In January 2016, Pfizer entered into an agreement with RPI, a subsidiary of Royalty Pharma, under which RPI will fund up to
$300 million
in development costs related to certain Phase III clinical trials of Pfizer’s Ibrance (palbociclib) product primarily for adjuvant treatment of hormone receptor positive early breast cancer (the Indication). RPI’s development funding is expected to cover up to 100% of the costs primarily for the applicable clinical trials through 2021. As there is a substantive and genuine transfer of risk to RPI, the development funding is recognized by us as an obligation to perform contractual services and therefore is a reduction of
Research and development expenses
as incurred. The reduction to
Research and development expenses
for the
first
quarter of
2017
and 2016 totaled
$14.5 million
and
$8.8 million
, respectively. If successful and upon approval of Ibrance in the U.S. or certain major markets in the EU for the Indication based on the applicable clinical trials, RPI will be eligible to receive a combination of approval-based fixed milestone payments of up to $250 million dependent upon results of the clinical trials and royalties on certain Ibrance sales over approximately seven years. Fixed milestone payments due upon approval will be recorded as intangible assets and amortized to
Amortization of intangible assets
over the estimated commercial life of the Ibrance product and sales-based royalties will be recorded as
Cost of sales
when incurred.
|
Pfizer’s complete 2017 financial guidance is summarized below
(a), (b)
:
|
|
Revenues
|
$52.0 to $54.0 billion
|
Adjusted cost of sales as a percentage of revenues
|
20.0% to 21.0%
|
Adjusted selling, informational and administrative expenses
|
$13.7 to $14.7 billion
|
Adjusted research and development expenses
|
$7.5 to $8.0 billion
|
Adjusted other (income)/deductions
|
Approximately $100 million of deductions
|
Effective tax rate on adjusted income
|
Approximately 23.0%
|
Adjusted diluted EPS
|
$2.50 to $2.60
|
(a)
|
T
he
financial guidance reflects the following:
|
•
|
Does not assume the completion of any business development transactions not completed as of
April 2, 2017
, including any one-time upfront payments associated with such transactions.
|
•
|
Exchange rates assumed are a blend of the actual exchange rates in effect through first-quarter 2017 and mid-April 2017 exchange rates for the remainder of the year.
|
•
|
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
$0.5 billion
on revenues and
$0.03
on adjusted diluted EPS 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 assumes diluted weighted-average shares outstanding of between
6.0 to 6.1
billion shares, which reflects our $5.0 billion accelerated share repurchase agreement executed in February 2017.
|
(b)
|
For an understanding of Adjusted income and its components and Adjusted diluted EPS (all of which are non-GAAP financial measures), see the “Non-GAAP Financial Measure (Adjusted Income)” section of this MD&A.
|
The following table provides worldwide revenues by operating segment and geographic area:
|
|||||||||||||||||||||||||||||||||
|
|
Three Months Ended
|
|||||||||||||||||||||||||||||||
|
|
Worldwide
|
|
U.S.
|
|
International
|
|
World-wide
|
|
U.S.
|
|
Inter-national
|
|||||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Apr 2, 2017
|
|
|
Apr 3, 2016
|
|
|
Apr 2, 2017
|
|
|
Apr 3, 2016
|
|
|
Apr 2, 2017
|
|
|
Apr 3, 2016
|
|
|
% Change in Revenues
|
|||||||||||||
Operating Segments
(a)
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
IH
|
|
$
|
7,415
|
|
|
$
|
7,033
|
|
|
$
|
4,493
|
|
|
$
|
4,114
|
|
|
$
|
2,922
|
|
|
$
|
2,919
|
|
|
5
|
|
|
9
|
|
|
—
|
|
EH
|
|
5,364
|
|
|
5,972
|
|
|
2,144
|
|
|
2,547
|
|
|
3,220
|
|
|
3,425
|
|
|
(10
|
)
|
|
(16
|
)
|
|
(6
|
)
|
||||||
Total revenues
|
|
$
|
12,779
|
|
|
$
|
13,005
|
|
|
$
|
6,637
|
|
|
$
|
6,661
|
|
|
$
|
6,142
|
|
|
$
|
6,344
|
|
|
(2
|
)
|
|
—
|
|
|
(3
|
)
|
(a)
|
IH = the Innovative Health segment; and EH = the Essential Health segment. For additional information about each operating segment, see the “Our Strategy––Commercial Operations” and “Analysis of Operating Segment Information” sections of this MD&A and Notes to Condensed Consolidated Financial Statements––
Note 13A. Segment, Geographic and Other Revenue Information: Segment Information.
|
The following provides an analysis of the change in revenues by geographic areas in the first quarter of 2017:
|
||||||||||||
(MILLIONS OF DOLLARS)
|
|
Three Months Ended April 2, 2017
|
||||||||||
|
|
Worldwide
|
|
U.S.
|
|
International
|
||||||
|
|
|
|
|
|
|
||||||
Acquisition-related growth:
|
|
|
|
|
|
|
||||||
Xtandi alliance revenues in the U.S. (September 2016 acquisition of Medivation)
|
|
$
|
131
|
|
|
$
|
131
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
||||||
Disposition-related impact:
|
|
|
|
|
|
|
||||||
Approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of 2017, compared to three months of legacy HIS global operations in the same period in 2016
|
|
(207
|
)
|
|
(175
|
)
|
|
(32
|
)
|
|||
|
|
|
|
|
|
|
||||||
Operational growth/(decline):
|
|
|
|
|
|
|
||||||
Continued growth from key brands, including Ibrance and Eliquis globally, as well as Lyrica (IH) and Xeljanz, both primarily in the U.S.
|
|
620
|
|
|
446
|
|
|
174
|
|
|||
Growth/(decline) in the Pfizer Sterile Injectable Pharmaceuticals portfolio
|
|
45
|
|
|
(13
|
)
|
|
58
|
|
|||
Growth in Biosimilars, primarily driven by Inflectra in certain developed Europe markets and in the U.S.
|
|
41
|
|
|
17
|
|
|
24
|
|
|||
Decline from Peri-LOE Products, including Pristiq in the U.S., which lost marketing exclusivity in the U.S. in March 2017, Lyrica in most developed Europe markets and Zyvox in developed Europe markets and in the U.S.
|
|
(253
|
)
|
|
(79
|
)
|
|
(174
|
)
|
|||
Growth/(decline) in the Legacy Established Products portfolio
|
|
(153
|
)
|
|
(162
|
)
|
|
8
|
|
|||
Lower revenues for Enbrel in most developed Europe markets, primarily due to continued biosimilar competition
|
|
(117
|
)
|
|
—
|
|
|
(117
|
)
|
|||
Decline in Prevnar 13/Prevenar 13 revenues, primarily driven by the continued decline in revenues for the adult indication in the U.S. due to a smaller remaining “catch up” opportunity compared to the same period in 2016, partially offset by the favorable impact from the timing of government purchases for the pediatric indication. International revenues decreased primarily due to the unfavorable timing of government purchases in certain emerging markets for the pediatric indication, partially offset by modest growth of the adult indication in certain developed Europe markets
|
|
(113
|
)
|
|
(93
|
)
|
|
(20
|
)
|
|||
Decline in Viagra (IH) revenues in the U.S. primarily due to lower market demand
|
|
(51
|
)
|
|
(51
|
)
|
|
—
|
|
|||
Other operational factors, net
|
|
(53
|
)
|
|
(44
|
)
|
|
(9
|
)
|
|||
Operational decline, net
|
|
(110
|
)
|
|
(24
|
)
|
|
(87
|
)
|
|||
|
|
|
|
|
|
|
|
|||||
Unfavorable impact of foreign exchange
|
|
(116
|
)
|
|
—
|
|
|
(116
|
)
|
|||
Revenues
decrease
|
|
$
|
(226
|
)
|
|
$
|
(24
|
)
|
|
$
|
(203
|
)
|
The following table provides information about revenue deductions:
|
||||||||
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Medicare rebates
(a)
|
|
$
|
260
|
|
|
$
|
276
|
|
Medicaid and related state program rebates
(a)
|
|
445
|
|
|
371
|
|
||
Performance-based contract rebates
(a),
(b)
|
|
729
|
|
|
589
|
|
||
Chargebacks
(c)
|
|
1,498
|
|
|
1,439
|
|
||
Sales allowances
(d)
|
|
1,111
|
|
|
976
|
|
||
Sales returns and cash discounts
|
|
324
|
|
|
364
|
|
||
Total
(e)
|
|
$
|
4,367
|
|
|
$
|
4,015
|
|
(a)
|
Rebates are product-specific and, therefore, for any given year are impacted by the mix of products sold.
|
(b)
|
Performance-based contract rebates include contract rebates with MCOs within the U.S., including health maintenance organizations and PBMs, who receive rebates based on the achievement of contracted performance terms and claims under these contracts. Outside the U.S., performance-based contract rebates include rebates to wholesalers/distributors based on achievement of contracted performance for specific products or sales milestones.
|
(c)
|
Chargebacks primarily represent reimbursements to U.S. wholesalers for honoring contracted prices to third parties.
|
(d)
|
Sales allowances primarily represent price reductions that are contractual or legislatively mandated outside the U.S., discounts and distribution fees.
|
(e)
|
For the three months ended
April 2, 2017
, associated with the following segments: IH (
$1.9 billion
) and EH (
$2.5 billion
). For the three months ended
April 3, 2016
, associated with the following segments: IH (
$1.6 billion
); and EH (
$2.4 billion
).
|
•
|
an increase in performance-based contract rebates primarily due to sales to managed care customers in the U.S. and higher rebates in certain markets outside the U.S. due to competitive pressures post-loss of exclusivity for certain products and volume-based rebates;
|
•
|
an increase in sales allowances;
|
•
|
an increase in Medicaid and related state program rebates, primarily as a result of updated estimates of sales related to these programs; and
|
•
|
an increase in chargebacks from EH products, primarily legacy Pfizer Sterile Injectable Pharmaceuticals.
|
The following table provides revenue information for several of our major products:
|
||||||||||||
|
|
Three Months Ended
|
||||||||||
(MILLIONS OF DOLLARS)
|
|
|
|
% Change
(a)
|
||||||||
PRODUCT
|
|
PRIMARY INDICATIONS OR CLASS
|
|
April 2,
2017 |
|
Total
|
|
|
Oper.
|
|
||
TOTAL REVENUES
|
|
|
|
$
|
12,779
|
|
|
(2
|
)
|
|
(1
|
)
|
PFIZER INNOVATIVE HEALTH (IH)
(b)
|
|
$
|
7,415
|
|
|
5
|
|
|
6
|
|
||
Internal Medicine
|
|
$
|
2,377
|
|
|
12
|
|
|
12
|
|
||
Lyrica IH
(c)
|
|
Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury
|
|
1,131
|
|
|
12
|
|
|
12
|
|
|
Eliquis alliance revenues and direct sales
|
|
Atrial fibrillation, deep vein thrombosis, pulmonary embolism
|
|
564
|
|
|
51
|
|
|
52
|
|
|
Viagra IH
(d)
|
|
Erectile dysfunction
|
|
249
|
|
|
(17
|
)
|
|
(17
|
)
|
|
Chantix/Champix
|
|
An aid to smoking cessation treatment in adults 18 years of age or older
|
|
239
|
|
|
9
|
|
|
9
|
|
|
Toviaz
|
|
Overactive bladder
|
|
63
|
|
|
—
|
|
|
—
|
|
|
BMP2
|
|
Development of bone and cartilage
|
|
62
|
|
|
21
|
|
|
21
|
|
|
All other Internal Medicine
|
|
Various
|
|
69
|
|
|
(35
|
)
|
|
(35
|
)
|
|
Vaccines
|
|
$
|
1,465
|
|
|
(7
|
)
|
|
(6
|
)
|
||
Prevnar 13/Prevenar 13
|
|
Vaccines for prevention of pneumococcal disease
|
|
1,392
|
|
|
(8
|
)
|
|
(7
|
)
|
|
All other Vaccines
|
|
Various
|
|
73
|
|
|
18
|
|
|
21
|
|
|
Oncology
|
|
$
|
1,347
|
|
|
35
|
|
|
36
|
|
||
Ibrance
|
|
Advanced breast cancer
|
|
679
|
|
|
58
|
|
|
59
|
|
|
Sutent
|
|
Advanced and/or metastatic RCC, refractory GIST (after disease progression on, or intolerance to, imatinib mesylate) and advanced pancreatic neuroendocrine tumor
|
|
250
|
|
|
(10
|
)
|
|
(9
|
)
|
|
Xalkori
|
|
ALK-positive NSCLC and ROS1-positive NSCLC
|
|
142
|
|
|
2
|
|
|
4
|
|
|
Xtandi alliance revenues
|
|
Advanced prostate cancer
|
|
131
|
|
|
*
|
|
|
*
|
|
|
Inlyta
|
|
Advanced RCC
|
|
85
|
|
|
(16
|
)
|
|
(15
|
)
|
|
All other Oncology
|
|
Various
|
|
61
|
|
|
10
|
|
|
10
|
|
|
Inflammation & Immunology (I&I)
|
|
$
|
871
|
|
|
(8
|
)
|
|
(7
|
)
|
||
Enbrel (Outside the U.S. and Canada)
|
|
Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, pediatric plaque psoriasis, ankylosing spondylitis and nonradiographic axial spondyloarthritis
|
|
588
|
|
|
(20
|
)
|
|
(18
|
)
|
|
Xeljanz
|
|
Rheumatoid arthritis
|
|
250
|
|
|
27
|
|
|
27
|
|
|
Eucrisa
|
|
Mild to moderate atopic dermatitis (eczema)
|
|
9
|
|
|
*
|
|
|
*
|
|
|
All other I&I
|
|
Various
|
|
24
|
|
|
38
|
|
|
36
|
|
|
Rare Disease
|
|
$
|
507
|
|
|
(11
|
)
|
|
(9
|
)
|
||
BeneFIX
|
|
Hemophilia
|
|
149
|
|
|
(19
|
)
|
|
(18
|
)
|
|
Refacto AF/Xyntha
|
|
Hemophilia
|
|
130
|
|
|
1
|
|
|
5
|
|
|
Genotropin
|
|
Replacement of human growth hormone
|
|
104
|
|
|
(17
|
)
|
|
(16
|
)
|
|
Somavert
|
|
Acromegaly
|
|
56
|
|
|
3
|
|
|
5
|
|
|
All other Rare Disease
|
|
Various
|
|
67
|
|
|
(11
|
)
|
|
(10
|
)
|
|
Consumer Healthcare
|
|
$
|
848
|
|
|
3
|
|
|
3
|
|
||
PFIZER ESSENTIAL HEALTH (EH)
(e)
|
|
$
|
5,364
|
|
|
(10
|
)
|
|
(9
|
)
|
||
Legacy Established Products (LEP)
(f)
|
|
$
|
2,606
|
|
|
(7
|
)
|
|
(5
|
)
|
||
Lipitor
|
|
Reduction of LDL cholesterol
|
|
404
|
|
|
(2
|
)
|
|
2
|
|
|
Norvasc
|
|
Hypertension
|
|
228
|
|
|
(3
|
)
|
|
—
|
|
|
Premarin family
|
|
Symptoms of menopause
|
|
228
|
|
|
(11
|
)
|
|
(11
|
)
|
|
Relpax
|
|
Symptoms of migraine headache
|
|
82
|
|
|
6
|
|
|
6
|
|
|
EpiPen
|
|
Epinephrine injection used in treatment of life-threatening allergic reactions
|
|
81
|
|
|
(16
|
)
|
|
(17
|
)
|
|
Zithromax
|
|
Bacterial infections
|
|
79
|
|
|
(1
|
)
|
|
4
|
|
|
Xalatan/Xalacom
|
|
Glaucoma and ocular hypertension
|
|
77
|
|
|
(13
|
)
|
|
(15
|
)
|
|
Zoloft
|
|
Depression and certain anxiety disorders
|
|
68
|
|
|
(14
|
)
|
|
(13
|
)
|
|
Effexor
|
|
Depression and certain anxiety disorders
|
|
66
|
|
|
(5
|
)
|
|
(4
|
)
|
|
Xanax
|
|
Anxiety disorders
|
|
55
|
|
|
5
|
|
|
6
|
|
|
All other LEP
|
|
Various
|
|
1,238
|
|
|
(8
|
)
|
|
(7
|
)
|
|
Sterile Injectable Pharmaceuticals (SIP)
(g)
|
|
$
|
1,552
|
|
|
2
|
|
|
3
|
|
||
Sulperazon
|
|
Antibiotic
|
|
122
|
|
|
27
|
|
|
34
|
|
|
Medrol
|
|
Adrenocortical steroid
|
|
120
|
|
|
6
|
|
|
7
|
|
|
Tygacil
|
|
Antibiotic
|
|
74
|
|
|
(2
|
)
|
|
(1
|
)
|
|
Fragmin
|
|
Anticoagulant
|
|
71
|
|
|
(8
|
)
|
|
(6
|
)
|
|
Precedex
|
|
Sedative
|
|
64
|
|
|
(7
|
)
|
|
(9
|
)
|
|
All other SIP
|
|
Various
|
|
1,100
|
|
|
1
|
|
|
2
|
|
|
Peri-LOE Products
(h)
|
|
$
|
822
|
|
|
(25
|
)
|
|
(23
|
)
|
||
Celebrex
|
|
Arthritis pain and inflammation, acute pain
|
|
175
|
|
|
2
|
|
|
2
|
|
|
Lyrica EH
(c)
|
|
Epilepsy, neuropathic pain and generalized anxiety disorder
|
|
141
|
|
|
(35
|
)
|
|
(32
|
)
|
|
Pristiq
|
|
Depression
|
|
116
|
|
|
(35
|
)
|
|
(36
|
)
|
|
Vfend
|
|
Fungal infections
|
|
107
|
|
|
(32
|
)
|
|
(30
|
)
|
|
Viagra EH
(d)
|
|
Erectile dysfunction
|
|
89
|
|
|
(7
|
)
|
|
(3
|
)
|
|
Zyvox
|
|
Bacterial infections
|
|
77
|
|
|
(39
|
)
|
|
(39
|
)
|
|
Revatio
|
|
Pulmonary arterial hypertension
|
|
65
|
|
|
(3
|
)
|
|
(2
|
)
|
|
All other Peri-LOE Products
|
|
Various
|
|
53
|
|
|
(30
|
)
|
|
(28
|
)
|
|
|
Three Months Ended
|
||||||||||
(MILLIONS OF DOLLARS)
|
|
|
|
% Change
(a)
|
||||||||
PRODUCT
|
|
PRIMARY INDICATIONS OR CLASS
|
|
April 2,
2017 |
|
Total
|
|
|
Oper.
|
|
||
Biosimilars
(i)
|
|
Various
|
|
$
|
105
|
|
|
57
|
|
|
62
|
|
Inflectra/Remsima
|
|
Inflammatory diseases
|
|
78
|
|
|
*
|
|
|
*
|
|
|
All other Biosimilars
|
|
Various
|
|
27
|
|
|
(12
|
)
|
|
(8
|
)
|
|
Pfizer CentreOne
(j)
|
|
|
|
$
|
182
|
|
|
(3
|
)
|
|
(3
|
)
|
Hospira Infusion Systems (HIS)
(k)
|
|
Various
|
|
$
|
97
|
|
|
(68
|
)
|
|
(68
|
)
|
Total Lyrica
(c)
|
|
Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury
|
|
$
|
1,271
|
|
|
3
|
|
|
4
|
|
Total Viagra
(d)
|
|
Erectile dysfunction
|
|
$
|
339
|
|
|
(14
|
)
|
|
(14
|
)
|
Total Alliance revenues
|
|
Various
|
|
$
|
656
|
|
|
82
|
|
|
83
|
|
(a)
|
As compared to the three months ended April 3, 2016.
|
(b)
|
The IH business encompasses Internal Medicine, Vaccines, Oncology, Inflammation & Immunology, Rare Disease and Consumer Healthcare and includes all legacy Medivation and Anacor commercial operations. Medivation’s and Anacor’s commercial operations are included in IH’s operating results in our consolidated statements of income, commencing from their respective acquisition dates of September 28, 2016 and June 24, 2016. Therefore, our first-quarter 2016 results of operations, and IH’s operating results, do not include financial results from Medivation or Anacor. Through December 31, 2016, includes Duavive/Duavee and Viviant (recorded in All other Internal Medicine in 2016), which were transferred from Innovative Health to Essential Health effective January 1, 2017 (recorded in All other LEP (EH) beginning January 1, 2017), in order to align these products with our management of the women’s health portfolio within EH.
|
(c)
|
Lyrica revenues from all of Europe, Russia, Turkey, Israel and Central Asia countries are included in Lyrica EH. All other Lyrica revenues are included in Lyrica IH. Total Lyrica revenues represent the aggregate of worldwide revenues from Lyrica IH and Lyrica EH.
|
(d)
|
Viagra revenues from the U.S. and Canada are included in Viagra IH. All other Viagra revenues are included in Viagra EH. Total Viagra revenues represent the aggregate of worldwide revenues from Viagra IH and Viagra EH.
|
(e)
|
The EH business encompasses Legacy Established Products, Sterile Injectable Pharmaceuticals, Peri-LOE Products, HIS (through February 2, 2017), Biosimilars and Pfizer CentreOne and includes all legacy Hospira commercial operations. On February 3, 2017, we completed the sale of our global infusion therapy net assets, HIS, to ICU Medical. The operating results of HIS are included in EH’s operating results through February 2, 2017, and, therefore, financial results for EH for the first quarter of 2017 reflect approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations, while financial results for EH for the first quarter of 2016 reflect three months of legacy HIS global operations.
|
(f)
|
Legacy Established Products primarily include products that have lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE Products). Effective January 1, 2017, All other LEP includes Duavive/Duavee and Viviant, which were transferred from Innovative Health (recorded in All other Internal Medicine (IH) in 2016), in order to align these products with our management of the women’s health portfolio within EH. See note (b) above.
|
(g)
|
Sterile Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables (excluding Peri-LOE Products).
|
(h)
|
Peri-LOE Products include products that have recently lost or are anticipated to soon lose patent protection. These products include: Lyrica in Europe, Russia, Turkey, Israel and Central Asia; Viagra in all countries (excluding the U.S. and Canada); and worldwide revenues for Celebrex, Pristiq, Zyvox, Vfend, Revatio and Inspra.
|
(i)
|
Biosimilars include Inflectra/Remsima (biosimilar infliximab) in the U.S. and certain international markets, Nivestim (biosimilar filgrastim) in certain European, Asian and Africa/Middle East markets and Retacrit (biosimilar epoetin zeta) in certain European and Africa/Middle East markets.
|
(j)
|
Pfizer CentreOne includes revenues from our contract manufacturing and active pharmaceutical ingredient sales operation, including sterile injectables contract manufacturing, and revenues related to our manufacturing and supply agreements, including with Zoetis.
|
(k)
|
HIS (through February 2, 2017) includes Medication Management Systems products composed of infusion pumps and related software and services, as well as IV Infusion Products, including large volume IV solutions and their associated administration sets.
|
*
|
Calculation not meaningful or greater than 100%.
|
•
|
Prevnar 13/Prevenar 13
(IH) worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
, compared to the same period in
2016
.
|
•
|
Lyrica
(EH (revenues from all of Europe, Russia, Turkey, Israel and Central Asia)/IH (revenues from all other geographies)) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
compared to the same period in
2016
.
|
•
|
Ibrance
(IH) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, most of which were recorded in the U.S. The significant revenues relate to our scientific/clinical data, continued positive patient experience as well as Ibrance being the first (in the U.S.) and only (outside of the U.S.) registered product in this class of medicines. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Enbrel
(IH, outside the U.S. and Canada) worldwide revenues, excluding the U.S. and Canada,
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily due to continued biosimilar competition, which is expected to continue. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Lipitor
(EH) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
. In the U.S., revenues
decrease
d
27%
in the
first quarter
of
2017
, compared to the same period in
2016
, primarily due to lower volumes.
|
•
|
Viagra
(IH (U.S. and Canada revenues)/EH (all other revenues excluding U.S. and Canada)) worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily due to lower market demand. Foreign exchange had
a de minimis
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
. Revenues in the U.S.
decrease
d
17%
in the
first quarter
of
2017
, compared to the same period in
2016
, primarily due to lower market demand. International revenues
decreased
3%
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily from lower volumes in China. Foreign exchange had
an unfavorable
impact on international revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Xeljanz
(IH) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. In the U.S., Xeljanz revenues
increase
d
21%
in the
first quarter
of
2017
, compared to the same period in
2016
, driven by increased adoption among rheumatologists, growing awareness among patients, improvements in payer access and price increases. Foreign exchange had
a de minimis
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Sutent
(IH) worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily due to competitive pressure in the U.S. and Europe and cost containment measures in certain developed international markets, partially offset by price increases in the U.S. and strong demand in Japan and certain emerging markets. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Chantix/Champix
(IH) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. Foreign exchange had
a de minimis
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Norvasc
(EH) worldwide revenues
were flat
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. Results for the
first quarter
of
2017
were impacted by lower volumes in certain Middle East markets, generic competition in Japan and pricing pressures in China, offset by strong demand in China. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
The
Premarin
family of products (EH) worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. Revenues in the U.S.
decrease
d
12%
in the
first quarter
of
2017
, compared to the same period in
2016
, primarily driven by prescription volume declines and lower market growth, partially offset by price increases.
|
•
|
Celebrex
(EH) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily driven by favorable rebates in the U.S. and volume growth in emerging markets, primarily China and certain Middle East markets. This was partially offset by the loss of exclusivity and associated generic competition in the U.S. and most developed international markets. Foreign exchange had
a de minimis
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
BeneFIX and ReFacto AF/Xyntha
(IH)
––
BeneFIX worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily as a result of erosion of market share in the U.S. and European countries due to increasing adoption of extended half-life treatment options. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Xalkori
(IH) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, driven by international markets, as a result of a steady increase in diagnostic rates for the ALK gene mutation across key markets outside the U.S., which has led to more patients being treated. This increase was partially offset by declines in the U.S. and Japan due to competitive pressure partially mitigated by the March 2016 FDA approval of the supplemental NDA to treat patients with metastatic NSCLC whose tumors are ROS1-positive. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Pristiq
(EH) worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily due to loss of exclusivity in the U.S. in March 2017. Foreign exchange had
a favorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Inlyta
(IH) worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, primarily due to increased competition in the U.S. and Europe, partially offset by performance in key emerging markets. Foreign exchange had
an unfavorable
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Inflectra/Remsima
(EH) worldwide revenues
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, due to continued uptake in developed markets in Europe, and the U.S. launch in the fourth quarter of 2016, partially offset by pricing pressures in Europe.
|
•
|
Zyvox
(EH) worldwide revenues
decreased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, due to generic competition in developed international markets and the U.S. and corresponding pricing pressures, partially offset by strong volume growth in China. Foreign exchange had
a de minimis
impact on worldwide revenues in the
first quarter
of
2017
, compared to the same period in
2016
.
|
•
|
Eucrisa
(IH) is approved in the U.S. for the treatment of mild to moderate atopic dermatitis for patients two years of age and older. The FDA approved Eucrisa on December 14, 2016, and Eucrisa was launched in the U.S. late in the first quarter of 2017. Eucrisa is a novel non-steroidal topical ointment and is the first new prescription treatment for atopic dermatitis approved in over 10 years.
|
•
|
Alliance revenues
(IH/EH)
increased
operationally in the
first quarter
of
2017
, compared to the same period in
2016
, mainly due to:
|
◦
|
an increase in Eliquis alliance revenues due to higher demand resulting from increased market penetration of novel oral anticoagulants and market share gains; and
|
◦
|
the inclusion of Xtandi alliance revenues of
$131 million
in the U.S. resulting from the September 2016 acquisition of Medivation.
|
•
|
Eliquis
(IH) has been jointly developed and is commercialized by Pfizer and BMS. Pfizer funds between 50% and 60% of all development costs depending on the study. Profits and losses are shared equally on a global basis except for in certain countries where Pfizer commercializes Eliquis and pays BMS compensation based on a percentage of net sales. We have full commercialization rights in certain smaller markets, beginning in the third quarter of 2015. BMS supplies the product to us at cost plus a percentage of the net sales to end-customers in these markets. Eliquis is part of the Novel Oral Anticoagulant (NOAC) market; the agents in this class were developed as alternative treatment options to warfarin in appropriate patients.
|
•
|
Xtandi
(IH) is being developed and commercialized through a collaboration with Astellas. The two companies share equally in the gross profits (losses) related to U.S. net sales of Xtandi. Subject to certain exceptions, Pfizer and Astellas also share equally all Xtandi commercialization costs attributable to the U.S. market. Pfizer and Astellas also share certain development and other collaboration expenses and Pfizer receives tiered royalties as a percentage of international Xtandi net sales (recorded in Other (income)/deductions—net). While there has been some displacement in Xtandi revenues relative to demand growth in the U.S., reflecting an increase in utilization of patient assistance programs which provide free medicines to patients, we expect patient assistance program utilization as a percentage of total demand to stabilize and moderate gradually throughout 2017.
|
•
|
delivering a pipeline of differentiated therapies with the greatest scientific and commercial promise;
|
•
|
innovating new capabilities that can position Pfizer for long-term leadership; and
|
•
|
creating new models for biomedical collaboration that will expedite the pace of innovation and productivity.
|
•
|
Biosimilars;
|
•
|
Inflammation and Immunology;
|
•
|
Metabolic Disease and Cardiovascular Risks;
|
•
|
Neuroscience;
|
•
|
Oncology
|
•
|
Rare Diseases; and
|
•
|
Vaccines.
|
RECENT FDA APPROVALS
|
||
PRODUCT
|
INDICATION
|
DATE APPROVED
|
Bavencio (Avelumab)
|
Treatment for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy, which is being developed in collaboration with Merck KGaA, Germany
|
May 2017
|
Bavencio (Avelumab)
|
Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, which is being developed in collaboration with Merck KGaA, Germany
|
March 2017
|
Eucrisa (Crisaborole)
|
A non-steroidal topical anti-inflammatory PDE-4 inhibitor for the treatment of mild-to-moderate atopic dermatitis
|
December 2016
|
Troxyca (oxycodone HCI/
naltrexone/HCI)
|
Extended-release capsules for the management of pain severe enough to require daily, around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate
|
August 2016
|
PENDING U.S. NDAs AND SUPPLEMENTAL FILINGS
|
||
PRODUCT
|
PROPOSED INDICATION
|
DATE FILED
*
|
Xeljanz (Tofacitinib)
|
Treatment of adult patients with active psoriatic arthritis
|
May 2017
|
PF-06438179
(a)
|
A potential biosimilar to Remicade® (infliximab)
|
April 2017
|
Ertugliflozin
|
Treatment of type 2 diabetes, which is being developed in collaboration with Merck
|
March 2017
|
Inotuzumab ozogamicin
|
Treatment of acute lymphoblastic leukemia
|
February 2017
|
Lyrica (Pregabalin)
|
Controlled Release (once-a-day) dosing
|
February 2017
|
Mylotarg (Gemtuzumab
ozogamicin)
|
Treatment of acute myeloid leukemia
|
January 2017
|
Retacrit
(b)
|
A potential biosimilar to Epogen® and Procrit® (epotein alfa)
|
February 2015
|
Tafamidis meglumine
(c)
|
Treatment of transthyretin familial amyloid polyneuropathy
|
February 2012
|
*
|
The dates set forth in this column are the dates on which the FDA accepted our submissions.
|
(a)
|
Remicade® is a registered trademark of Janssen. In February 2016, we divested the rights for development and commercialization of PF-06438179, a potential biosimilar to Remicade® (infliximab) in the 28 countries that form the EEA to Sandoz, which was a condition to the European Commission’s approval of the Hospira transaction. We retain commercialization rights to PF-06438179 in all countries outside of the EEA.
|
(b)
|
Epogen® is a registered U.S. trademark of Amgen Inc.; Procrit® is a registered U.S. trademark of Johnson & Johnson. In October 2015, we received a “complete response” letter from the FDA with respect to our biologics license application for Retacrit, our proposed biosimilar to epoetin alfa, which was submitted for all indications of the reference product. In December 2016, we completed the resubmission of the biologics license application to the FDA for Retacrit in response to the “complete response” letter. We are continuing to work closely with the FDA on next steps.
|
(c)
|
In May 2012, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted that the tafamidis meglumine data provide substantial evidence of efficacy for a surrogate endpoint that is reasonably likely to predict a clinical benefit. In June 2012, the FDA issued a “complete response” letter with respect to the tafamidis NDA. The FDA has requested the completion of a second efficacy study, and also has asked for additional information on the data within the current tafamidis NDA. Pfizer initiated study B3461028 in December 2013, a global Phase 3 study to support a potential new indication in transthyretin cardiomypathy, which includes transthyretin familial amyloid cardiomyopathy (TTR-FAC) and wild-type cardiomyopathy (WT-CM). We anticipate results from this study in 2018, and continue to work with the FDA to identify next steps.
|
REGULATORY APPROVALS AND FILINGS IN THE EU AND JAPAN
|
|||
PRODUCT
|
DESCRIPTION OF EVENT
|
DATE APPROVED
|
DATE FILED
*
|
Sutent (Sunitinib)
|
Application filed in the EU for the adjuvant treatment of renal cell carcinoma
|
—
|
April 2017
|
Xeljanz (Tofacitinib)
|
Approval in the EU for Xeljanz in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis 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 methotrexate or when treatment with methotrexate is inappropriate
|
March 2017
|
—
|
Ertugliflozin
|
Application filed in the EU for the treatment of type 2 diabetes, which is being developed in collaboration with Merck
|
—
|
February 2017
|
Mylotarg (Gemtuzumab ozogamicin)
|
Application filed in the EU for the treatment of acute myeloid leukemia
|
—
|
December 2016
|
Ibrance (Palbociclib)
|
Approval in the EU for palbociclib in combination with
endocrine therapy for the treatment of HR+, HER2- advanced or
metastatic breast cancer, as well as for the treatment of recurrent
advanced breast cancer
|
November 2016
|
—
|
Ibrance (Palbociclib)
|
Application filed in Japan for palbociclib in combination with
endocrine therapy for the treatment of inoperable or recurrent breast cancer
|
—
|
October 2016
|
Bavencio (Avelumab)
|
Application filed in the EU for the treatment of metastatic
Merkel cell carcinoma, which is being developed in collaboration with Merck KGaA, Germany
|
—
|
October 2016
|
Xalkori (Crizotinib)
|
Approval in the EU for the treatment of ROS1-positive non-small cell lung cancer
|
August 2016
|
—
|
Xalkori (Crizotinib)
|
Application filed in Japan for the treatment of ROS1-positive
non-small cell lung cancer
|
—
|
August 2016
|
Inotuzumab ozogamicin
(a)
|
Application filed in the EU for the treatment of acute lymphoblastic leukemia
|
—
|
May 2016
|
Trumenba
(b)
|
Application filed in the EU for a prophylactic vaccine for active immunization to prevent invasive disease caused by
Neisseria meningitidis
serogroup B in individuals 10 through 25 years of age
|
—
|
May 2016
|
*
|
For applications in the EU, the dates set forth in this column are the dates on which the EMA validated our submissions.
|
(a)
|
In April 2017, the EMA’s Committee for Medicinal Products for Human Use issued an opinion recommending that inotuzumab ozogamicin be granted approval as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) and Philadelphia chromosome positive (Ph+) ALL, who have previously failed treatment with at least one tyrosine kinase inhibitor (TKI).
|
(b)
|
In March 2017, the EMA’s Committee for Medicinal Products for Human Use issued an opinion recommending that Trumenba be granted approval for active immunization of individuals 10 years and older to prevent invasive meningococcal disease caused by
Neisseria meningitidis
serogroup B.
|
LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS
FOR IN-LINE AND IN-REGISTRATION PRODUCTS
|
|
PRODUCT
|
PROPOSED INDICATION
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor,
for the first-line treatment of advanced renal cell carcinoma, which is being developed in collaboration with
Merck KGaA, Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for the first-line treatment of stage IIIb/IV non-small cell lung
cancer, which is being developed in collaboration with Merck KGaA, Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for treatment of stage IIIb/IV non-small cell lung cancer that has
progressed after a platinum-containing doublet, which is being developed in collaboration with Merck KGaA,
Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for treatment of platinum-resistant/refractory ovarian cancer,
which is being developed in collaboration with Merck KGaA, Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for the first-line treatment of ovarian cancer, which is being
developed in collaboration with Merck KGaA, Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for maintenance treatment, in the first-line setting, for patients
with urothelial cancer, which is being developed in collaboration with Merck KGaA, Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for maintenance treatment of advanced or metastatic gastric/
gastro-esophageal junction cancers, which is being developed in collaboration with Merck KGaA, Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for the third-line treatment of advanced or metastatic gastric/
gastro-esophageal junction cancers, which is being developed in collaboration with Merck KGaA, Germany
|
Bavencio (Avelumab)
|
A monoclonal antibody that inhibits PD-L1 for treatment of locally advanced squamous cell carcinoma of the
head and neck, which is being developed in collaboration with Merck KGaA, Germany
|
Bosulif (Bosutinib)
|
First-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia, which is being developed in collaboration with Avillion Group
|
Inlyta (Axitinib)
|
Adjuvant treatment of renal cell carcinoma, which is being developed in collaboration with SFJ Pharmaceuticals Group
|
Ibrance (Palbociclib)
|
Treatment of high-risk early breast cancer, in collaboration with the German Breast Group
|
Ibrance (Palbociclib)
|
Treatment of HR+ early breast cancer, in collaboration with the Alliance Foundation Trials, LLC, and the Austrian Breast Colorectal Cancer Study Group
|
Sutent (Sunitinib)
|
Adjuvant treatment of renal cell carcinoma (ex-EU)
|
Xtandi (Enzalutamide)
|
Treatment of non-metastatic castrate resistant prostate cancer
|
Xtandi (Enzalutamide)
|
Treatment of non-metastatic high risk hormone-sensitive prostate cancer
|
Xtandi (Enzalutamide)
|
Treatment of metastatic hormone-sensitive prostate cancer
|
Xtandi (Enzalutamide)
|
Treatment of triple negative breast cancer
|
Xeljanz (Tofacitinib)
|
Treatment of ulcerative colitis
|
Xeljanz (Tofacitinib)
|
Treatment of psoriatic arthritis (ex-U.S.)
|
Vyndaqel (Tafamidis meglumine)
|
Adult symptomatic transthyretin cardiomyopathy
|
NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT
|
|
CANDIDATE
|
PROPOSED INDICATION
|
Dacomitinib
|
A pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor for the first-line treatment of patients with advanced non-small cell lung cancer with estimated glomerular filtration rate (eGFR) activating mutations, which is being developed in collaboration with SFJ Pharmaceuticals Group
|
Lorlatinib (PF-06463922)
|
A next generation ALK/ROS1 tyrosine kinase inhibitor for the treatment of patients with ALK-positive metastatic non-small cell lung cancer, previously treated with one or more ALK inhibitors
|
PF-06425090
|
A prophylactic vaccine for active immunization to prevent clostridium difficile colitis
|
PF-05280014
(a)
|
A potential biosimilar to Herceptin®
(trastuzumab)
|
PF-05280586
(b)
|
A potential biosimilar to Rituxan®
(rituximab)
|
PF-06439535
(c)
|
A potential biosimilar to Avastin® (bevacizumab)
|
PF-06410293
(d)
|
A potential biosimilar to Humira® (adalimumab)
|
Rivipansel (GMI-1070)
|
A pan-selectin inhibitor for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease, which was licensed from GlycoMimetics Inc.
|
Somatrogon (PF-06836922
|
A long-acting hGH-CTP for the treatment of growth hormone deficiency in adults, which is being developed
in collaboration with OPKO
|
Talazoparib (MDV3800)
|
An oral PARP inhibitor for the
treatment of patients with germline breast cancer susceptibility gene BRCA mutated advanced breast cancer
|
Tanezumab
|
An anti-nerve growth factor monoclonal antibody for the treatment of pain, which is being developed in collaboration with Lilly
|
(a)
|
Herceptin® is a registered trademark of Genentech, Inc.
|
(b)
|
Rituxan® is a registered trademark of Biogen MA Inc.
|
(c)
|
Avastin® is a registered trademark of Genentech, Inc.
|
(d)
|
Humira® is a registered trademark of AbbVie Biotechnology Ltd.
|
|
|
Three Months Ended
|
|||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change
|
|
||
Cost of sales
|
|
$
|
|
|
|
$
|
|
|
|
(13
|
)
|
As a percentage of
Revenues
|
|
19.3
|
%
|
|
21.9
|
%
|
|
|
•
|
the $193 million nonrecurring 2016 unfavorable impact of acquired Hospira inventory, which is measured at fair value on the acquisition date and was amortized over the turn of the related inventory in 2016;
|
•
|
a decrease in costs associated with our cost-reduction/productivity initiatives;
|
•
|
the inclusion of approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the
first
quarter of
2017
, compared to the inclusion of three months of legacy HIS global operations in the first quarter of 2016; and
|
•
|
the favorable impact of foreign exchange,
|
•
|
an unfavorable change in product mix, including products that have lost exclusivity.
|
•
|
the non-recurrence of the unfavorable impact of acquired Hospira inventory, which is measured at fair value on the acquisition date and amortized over the turn of the related inventory in 2016;
|
•
|
a decrease in costs associated with our cost-reduction/productivity initiatives;
|
•
|
the inclusion of approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the
first
quarter of
2017
, compared to the inclusion of three months of legacy HIS global operations in the
first
quarter of
2016
; and
|
•
|
an increase in alliance revenues, which have no associated cost of sales,
|
•
|
an unfavorable change in product mix, including products that have lost exclusivity.
|
|
|
Three Months Ended
|
|||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change |
|
||
Selling, informational and administrative expenses
|
|
$
|
|
|
|
$
|
|
|
|
(2
|
)
|
As a percentage of
Revenues
|
|
25.9
|
%
|
|
26.0
|
%
|
|
|
•
|
the non-recurrence of an allowance for doubtful trade accounts receivable of approximately $280 million, resulting from unfavorable developments with a distributor that was recorded in the first quarter of 2016; and
|
•
|
the inclusion of approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of
2017
, compared to the inclusion of three months of legacy HIS global operations in the
first
quarter of
2016
,
|
•
|
additional investments across several of our key products; and
|
•
|
an increase in charitable contributions.
|
|
|
Three Months Ended
|
|||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change |
|
||
Research and development expenses
|
|
$
|
|
|
|
$
|
|
|
|
(1
|
)
|
As a percentage of
Revenues
|
|
13.4
|
%
|
|
13.3
|
%
|
|
|
•
|
the discontinuation of the global clinical development program for bococizumab in the fourth quarter of 2016; and
|
•
|
the inclusion of approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of 2017, compared to the inclusion of three months of legacy HIS global operations in the first quarter of 2016,
|
•
|
increased costs associated with our oncology programs, including Medivation operations.
|
|
|
Three Months Ended
|
||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change |
||
Amortization of intangible assets
|
|
$
|
1,186
|
|
|
$
|
1,006
|
|
|
18
|
As a percentage of
Revenues
|
|
9.3
|
%
|
|
7.7
|
%
|
|
|
|
|
Three Months Ended
|
|||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change |
|
||
Restructuring charges and certain acquisition-related costs
|
|
$
|
157
|
|
|
$
|
141
|
|
|
11
|
|
Total additional depreciation—asset restructuring
|
|
14
|
|
|
49
|
|
|
(71
|
)
|
||
Total implementation costs
|
|
31
|
|
|
62
|
|
|
(50
|
)
|
||
Costs associated with acquisitions and cost-reduction/productivity initiatives
(a)
|
|
$
|
202
|
|
|
$
|
252
|
|
|
(20
|
)
|
(a)
|
Comprises
Restructuring charges and certain acquisition-related costs
as well as costs associated with our cost-reduction/productivity initiatives included in
Cost of sales
,
Research and development expenses
and/or
Selling, informational and administrative expenses
, as appropriate.
|
|
|
Three Months Ended
|
||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change |
||
Other (income)/deductions––net
|
|
$
|
(1
|
)
|
|
$
|
330
|
|
|
*
|
*
|
Calculation not meaningful.
|
|
|
Three Months Ended
|
||||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change |
||
Provision for taxes on income
|
|
$
|
821
|
|
|
$
|
513
|
|
|
60
|
Effective tax rate on continuing operations
|
|
20.8
|
%
|
|
14.4
|
%
|
|
|
•
|
senior management receives a monthly analysis of our operating results that is prepared on an Adjusted income and Adjusted diluted earnings per share basis;
|
•
|
our annual budgets are prepared on an Adjusted income and Adjusted diluted earnings per share basis; and
|
•
|
senior management’s annual compensation is derived, in part, using Adjusted income and Adjusted diluted earnings per share measures. See the “Non-GAAP Financial Measure (Adjusted Income)––General Description of Non-GAAP Financial Measure (Adjusted Income)” section of our
2016
Financial Report for additional information.
|
|
|
Three Months Ended April 2, 2017
|
||||||||||||||||||||||
IN MILLIONS, EXCEPT PER COMMON SHARE DATA
|
|
GAAP Reported
|
|
|
Purchase Accounting Adjustments
(a)
|
|
|
Acquisition-Related Costs
(a)
|
|
|
Discontinued Operations
(a)
|
|
|
Certain Significant Items
(a)
|
|
|
Non-GAAP Adjusted
|
|
||||||
Revenues
|
|
$
|
12,779
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,779
|
|
Cost of sales
|
|
2,470
|
|
|
(7
|
)
|
|
(3
|
)
|
|
—
|
|
|
(26
|
)
|
|
2,434
|
|
||||||
Selling, informational and administrative expenses
|
|
3,308
|
|
|
(6
|
)
|
|
—
|
|
|
—
|
|
|
(14
|
)
|
|
3,288
|
|
||||||
Research and development expenses
|
|
1,708
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
(7
|
)
|
|
1,705
|
|
||||||
Amortization of intangible assets
|
|
1,186
|
|
|
(1,151
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
35
|
|
||||||
Restructuring charges and certain acquisition-related costs
|
|
157
|
|
|
—
|
|
|
(121
|
)
|
|
—
|
|
|
(36
|
)
|
|
—
|
|
||||||
Other (income)/deductions––net
|
|
(1
|
)
|
|
(13
|
)
|
|
—
|
|
|
—
|
|
|
(74
|
)
|
|
(88
|
)
|
||||||
Income from continuing operations before provision for taxes on income
|
|
3,951
|
|
|
1,172
|
|
|
124
|
|
|
—
|
|
|
157
|
|
|
5,404
|
|
||||||
Provision for taxes on income
(b)
|
|
821
|
|
|
340
|
|
|
43
|
|
|
—
|
|
|
(1
|
)
|
|
1,204
|
|
||||||
Income from continuing operations
|
|
3,130
|
|
|
832
|
|
|
82
|
|
|
—
|
|
|
157
|
|
|
4,201
|
|
||||||
Discontinued operations––net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net income attributable to noncontrolling interests
|
|
9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9
|
|
||||||
Net income attributable to Pfizer Inc.
|
|
3,121
|
|
|
832
|
|
|
82
|
|
|
—
|
|
|
157
|
|
|
4,192
|
|
||||||
Earnings per common share attributable to Pfizer Inc.––diluted
|
|
0.51
|
|
|
0.14
|
|
|
0.01
|
|
|
—
|
|
|
0.03
|
|
|
0.69
|
|
|
|
|
Three Months Ended April 3, 2016
|
||||||||||||||||||||||
IN MILLIONS, EXCEPT PER COMMON SHARE DATA
|
|
GAAP Reported
|
|
|
Purchase Accounting Adjustments
(a)
|
|
|
Acquisition-Related Costs
(a)
|
|
|
Discontinued Operations
(a)
|
|
|
Certain Significant Items
(a)
|
|
|
Non-GAAP Adjusted
|
|
||||||
Revenues
|
|
$
|
13,005
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
13,005
|
|
Cost of sales
|
|
2,851
|
|
|
(200
|
)
|
|
—
|
|
|
—
|
|
|
(87
|
)
|
|
2,565
|
|
||||||
Selling, informational and administrative expenses
|
|
3,385
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
(15
|
)
|
|
3,368
|
|
||||||
Research and development expenses
|
|
1,731
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
1,723
|
|
||||||
Amortization of intangible assets
|
|
1,006
|
|
|
(975
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
31
|
|
||||||
Restructuring charges and certain acquisition-related costs
|
|
141
|
|
|
—
|
|
|
(116
|
)
|
|
—
|
|
|
(26
|
)
|
|
—
|
|
||||||
Other (income)/deductions––net
|
|
330
|
|
|
20
|
|
|
—
|
|
|
—
|
|
|
(500
|
)
|
|
(149
|
)
|
||||||
Income from continuing operations before provision for taxes on income
|
|
3,561
|
|
|
1,153
|
|
|
116
|
|
|
—
|
|
|
638
|
|
|
5,468
|
|
||||||
Provision for taxes on income
(b), (c)
|
|
513
|
|
|
324
|
|
|
(99
|
)
|
|
—
|
|
|
544
|
|
|
1,282
|
|
||||||
Income from continuing operations
(c)
|
|
3,048
|
|
|
829
|
|
|
215
|
|
|
—
|
|
|
94
|
|
|
4,186
|
|
||||||
Discontinued operations––net of tax
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Net income attributable to noncontrolling interests
|
|
9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9
|
|
||||||
Net income attributable to Pfizer Inc.
(c)
|
|
3,038
|
|
|
829
|
|
|
215
|
|
|
—
|
|
|
94
|
|
|
4,177
|
|
||||||
Earnings per common share attributable to Pfizer Inc.––diluted
|
|
0.49
|
|
|
0.13
|
|
|
0.03
|
|
|
—
|
|
|
0.02
|
|
|
0.67
|
|
(a)
|
For details of adjustments, see “Details of Income Statement Items Included in GAAP Reported but Excluded from Non-GAAP Adjusted Income” below.
|
(b)
|
The effective tax rate on Non-GAAP Adjusted income was
22.3%
in the
first quarter
of
, compared with
23.4%
in the
first quarter
of
2016
. This decline was primarily due to a favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, partially offset by a decrease in tax benefits associated with the resolution of certain tax positions pertaining to prior years primarily with various foreign tax authorities, and the expiration of certain statutes of limitations.
|
(c)
|
GAAP Reported and Non-GAAP Adjusted amounts for the three months ended
April 3, 2016
have been revised from previously reported amounts to reflect the adoption of a new accounting standard in the fourth quarter of 2016, as of January 1, 2016, requiring: (i) excess tax benefits or deficiencies (including tax benefits of dividend equivalents) of share-based compensation to be recognized as a component of the
Provision for taxes on income
(the net tax benefit was $22 million in the first quarter of 2016) and (ii) in the diluted net earnings per share calculation, when applying the treasury stock method for shares that could be repurchased, the assumed proceeds no longer include the amount of excess tax benefit. For additional information, see Notes to Consolidated Financial Statements––
Note 1B. Adoption of New Accounting Standards
in Pfizer’s
2016
Financial Report.
|
|
Adjusted income, as shown above, excludes the following items:
|
||||||||
|
|
Three Months Ended
|
||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
||
Purchase accounting adjustments
|
|
|
|
|
||||
Amortization, depreciation and other
(a)
|
|
$
|
1,165
|
|
|
$
|
954
|
|
Cost of sales
|
|
7
|
|
|
200
|
|
||
Total purchase accounting adjustments––pre-tax
|
|
1,172
|
|
|
1,153
|
|
||
Income taxes
(b)
|
|
(340
|
)
|
|
(324
|
)
|
||
Total purchase accounting adjustments––net of tax
|
|
832
|
|
|
829
|
|
||
Acquisition-related costs
|
|
|
|
|
|
|||
Restructuring charges
(c)
|
|
9
|
|
|
4
|
|
||
Transaction costs
(c)
|
|
12
|
|
|
24
|
|
||
Integration costs
(c)
|
|
101
|
|
|
87
|
|
||
Additional depreciation––asset restructuring
(d)
|
|
3
|
|
|
—
|
|
||
Total acquisition-related costs––pre-tax
|
|
124
|
|
|
116
|
|
||
Income taxes
(e)
|
|
(43
|
)
|
|
99
|
|
||
Total acquisition-related costs––net of tax
|
|
82
|
|
|
215
|
|
||
Discontinued operations
|
|
|
|
|
|
|||
Total discontinued operations––net of tax, attributable to Pfizer Inc.
(f)
|
|
—
|
|
|
—
|
|
||
Certain significant items
|
|
|
|
|
|
|||
Restructuring charges
(g)
|
|
36
|
|
|
26
|
|
||
Implementation costs and additional depreciation––asset restructuring
(h)
|
|
42
|
|
|
111
|
|
||
Certain legal matters, net
(i)
|
|
8
|
|
|
286
|
|
||
Loss on sale of HIS net assets
(i)
|
|
37
|
|
|
—
|
|
||
Certain asset impairments
(i)
|
|
—
|
|
|
131
|
|
||
Business and legal entity alignment costs
(j)
|
|
21
|
|
|
51
|
|
||
Other
(k)
|
|
13
|
|
|
34
|
|
||
Total certain significant items––pre-tax
|
|
157
|
|
|
638
|
|
||
Income taxes
(l)
|
|
1
|
|
|
(544
|
)
|
||
Total certain significant items––net of tax
|
|
157
|
|
|
94
|
|
||
Total purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items––net of tax, attributable to Pfizer Inc.
|
|
$
|
1,071
|
|
|
$
|
1,138
|
|
(a)
|
Included primarily in
Amortization of intangible assets.
|
(b)
|
Included in
Provision for taxes on income.
Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate.
|
(c)
|
Included in
Restructuring charges and certain acquisition-related costs
. Restructuring charges include employee termination costs, asset impairments and other exit costs associated with business combinations. Transaction costs primarily represent external costs for banking, legal, accounting and other similar services. Integration costs represent external, incremental costs directly related to integrating acquired businesses, and primarily include expenditures for consulting and the integration of systems and processes. For additional information, see Notes to Condensed Consolidated Financial Statements—
Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.
|
(d)
|
Included in
Cost of sales.
Represents the impact of changes in estimated useful lives of assets involved in restructuring actions related to acquisitions.
|
(e)
|
Included in
Provision for taxes on income
. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. The first quarter of
2016
was unfavorably impacted by the remeasurement of certain deferred tax liabilities resulting from plant network restructuring activities.
|
(f)
|
Included in
Discontinued operations––net of tax.
|
(g)
|
Amounts relate to our cost-reduction/productivity initiatives not related to acquisitions. Included in
Restructuring charges and certain acquisition-related costs
(see Notes to Condensed Consolidated Financial Statements—
Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
).
|
(h)
|
Amounts relate to our cost-reduction/productivity initiatives not related to acquisitions (see Notes to Condensed Consolidated Financial Statements—
Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
). For the three months ended
April 2, 2017
, included in
Cost of sales
(
$26 million
),
Selling, informational and administrative expenses
(
$9 million
) and
Research and development expenses
(
$7 million
). For the three months ended
April 3, 2016
, virtually all included in
Cost of
|
(i)
|
Included in
Other (income)/deductions
—
net
(see Notes to Condensed Consolidated Financial Statements—
Note 4.
)
.
|
(j)
|
Included in
Other (income)/deductions––net.
Represents expenses for changes to our infrastructure to align our commercial operations, including costs to internally separate our businesses into distinct legal entities as well as to streamline our intercompany supply operations to better support each business.
|
(k)
|
For the three months ended
April 2, 2017
, included in
Other (income)/deductions––net
(
$7 million
) and
Selling, informational and administrative expenses
(
$5 million
). For the three months ended
April 3, 2016
, primarily all included in
Other (income)/deductions––net.
|
(l)
|
Included in
Provision for taxes on income
. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. The three months ended
April 2, 2017
was unfavorably impacted by the taxes on an incremental charge to amounts previously recorded to write down the HIS net assets to fair value less costs to sell related to the sale of HIS net assets to ICU Medical. The three months ended
April 3, 2016
was favorably impacted by benefits related to the final resolution of an agreement in principle reached in February 2016 and finalized in April 2016 to resolve certain claims related to Protonix, which resulted in the receipt of information that raised our initial assessment in 2015 of the likelihood of prevailing on the technical merits of our tax position, as well as benefits associated with our Venezuela operations.
|
The following tables provide revenue and cost information by reportable operating segment and a reconciliation of that information to our condensed consolidated statements of income:
|
||||||||||||||||||||||||
|
|
Three Months Ended April 2, 2017
|
||||||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Innovative Health (IH)
(a)
|
|
|
Essential Health (EH)
(a)
|
|
|
Other
(b)
|
|
|
Non-GAAP
Adjusted
(c)
|
|
|
Reconciling Items
(d)
|
|
|
GAAP Reported
|
|
||||||
Revenues
|
|
$
|
7,415
|
|
|
$
|
5,364
|
|
|
$
|
—
|
|
|
$
|
12,779
|
|
|
$
|
—
|
|
|
$
|
12,779
|
|
Cost of sales
|
|
849
|
|
|
1,450
|
|
|
136
|
|
|
2,434
|
|
|
36
|
|
|
2,470
|
|
||||||
% of revenue
|
|
11.4
|
%
|
|
27.0
|
%
|
|
*
|
|
|
19.1
|
%
|
|
*
|
|
|
19.3
|
%
|
||||||
Selling, informational and administrative expenses
|
|
1,514
|
|
|
708
|
|
|
1,066
|
|
|
3,288
|
|
|
20
|
|
|
3,308
|
|
||||||
Research and development expenses
|
|
523
|
|
|
252
|
|
|
930
|
|
|
1,705
|
|
|
3
|
|
|
1,708
|
|
||||||
Amortization of intangible assets
|
|
26
|
|
|
9
|
|
|
—
|
|
|
35
|
|
|
1,151
|
|
|
1,186
|
|
||||||
Restructuring charges and certain acquisition-related costs
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
157
|
|
|
157
|
|
||||||
Other (income)/deductions––net
|
|
(146
|
)
|
|
(61
|
)
|
|
119
|
|
|
(88
|
)
|
|
87
|
|
|
(1
|
)
|
||||||
Income/(loss) from continuing operations before provision for taxes on income
|
|
$
|
4,649
|
|
|
$
|
3,006
|
|
|
$
|
(2,251
|
)
|
|
$
|
5,404
|
|
|
$
|
(1,453
|
)
|
|
$
|
3,951
|
|
|
|
|
Three Months Ended April 3, 2016
|
||||||||||||||||||||||
(MILLIONS OF DOLLARS)
|
|
Innovative Health (IH)
(a)
|
|
|
Essential Health (EH)
(a)
|
|
|
Other
(b)
|
|
|
Non-GAAP
Adjusted (c) |
|
|
Reconciling Items
(d)
|
|
|
GAAP Reported
|
|
||||||
Revenues
|
|
$
|
7,033
|
|
|
$
|
5,972
|
|
|
$
|
—
|
|
|
$
|
13,005
|
|
|
$
|
—
|
|
|
$
|
13,005
|
|
Cost of sales
|
|
894
|
|
|
1,453
|
|
|
217
|
|
|
2,565
|
|
|
287
|
|
|
2,851
|
|
||||||
% of revenue
|
|
12.7
|
%
|
|
24.3
|
%
|
|
*
|
|
|
19.7
|
%
|
|
*
|
|
|
21.9
|
%
|
||||||
Selling, informational and administrative expenses
|
|
1,686
|
|
|
737
|
|
|
946
|
|
|
3,368
|
|
|
16
|
|
|
3,385
|
|
||||||
Research and development expenses
|
|
562
|
|
|
276
|
|
|
885
|
|
|
1,723
|
|
|
8
|
|
|
1,731
|
|
||||||
Amortization of intangible assets
|
|
24
|
|
|
7
|
|
|
—
|
|
|
31
|
|
|
975
|
|
|
1,006
|
|
||||||
Restructuring charges and certain acquisition-related costs
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
141
|
|
|
141
|
|
||||||
Other (income)/deductions––net
|
|
(235
|
)
|
|
(160
|
)
|
|
246
|
|
|
(149
|
)
|
|
480
|
|
|
330
|
|
||||||
Income/(loss) from continuing operations before provision for taxes on income
|
|
$
|
4,103
|
|
|
$
|
3,659
|
|
|
$
|
(2,294
|
)
|
|
$
|
5,468
|
|
|
$
|
(1,907
|
)
|
|
$
|
3,561
|
|
(a)
|
Amounts represent the revenues and costs managed by each of our operating segments. The expenses generally include only those costs directly attributable to the operating segment.
|
|
(b)
|
Other comprises the costs included in our Adjusted income components (see footnote (c) below) that are managed outside of our two operating segments
and includes the following:
|
|
|
Three Months Ended April 2, 2017
|
||||||||||||||||||
|
|
Other Business Activities
|
|
|
|
|||||||||||||||
(MILLIONS OF DOLLARS)
|
|
WRD
(i)
|
|
|
GPD
(ii)
|
|
Corporate
(iii)
|
|
|
Other Unallocated
(iv)
|
|
Total
|
|
|||||||
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cost of sales
|
|
—
|
|
|
—
|
|
|
(26
|
)
|
|
162
|
|
|
136
|
|
|||||
Selling, informational and administrative expenses
|
|
—
|
|
|
(1
|
)
|
|
1,061
|
|
|
6
|
|
|
1,066
|
|
|||||
Research and development expenses
|
|
526
|
|
|
181
|
|
|
220
|
|
|
5
|
|
|
930
|
|
|||||
Amortization of intangible assets
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Restructuring charges and certain acquisition-related costs
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Other (income)/deductions––net
|
|
(18
|
)
|
|
—
|
|
|
90
|
|
|
48
|
|
|
119
|
|
|||||
Loss from continuing operations before provision for taxes on income
|
|
$
|
(508
|
)
|
|
$
|
(180
|
)
|
|
$
|
(1,344
|
)
|
|
$
|
(219
|
)
|
|
$
|
(2,251
|
)
|
|
|
|
Three Months Ended April 3, 2016
|
||||||||||||||||||
|
|
Other Business Activities
|
|
|
|
|
||||||||||||||
(MILLIONS OF DOLLARS)
|
|
WRD
(i)
|
|
|
GPD
(ii)
|
|
Corporate
(iii)
|
|
|
Other Unallocated
(iv)
|
|
Total
|
|
|||||||
Revenues
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Cost of sales
|
|
—
|
|
|
—
|
|
|
40
|
|
|
177
|
|
|
217
|
|
|||||
Selling, informational and administrative expenses
|
|
—
|
|
|
—
|
|
|
927
|
|
|
18
|
|
|
946
|
|
|||||
Research and development expenses
|
|
528
|
|
|
154
|
|
|
197
|
|
|
6
|
|
|
885
|
|
|||||
Amortization of intangible assets
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Restructuring charges and certain acquisition-related costs
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Other (income)/deductions––net
|
|
(14
|
)
|
|
—
|
|
|
226
|
|
|
34
|
|
|
246
|
|
|||||
Loss from continuing operations before provision for taxes on income
|
|
$
|
(514
|
)
|
|
$
|
(154
|
)
|
|
$
|
(1,390
|
)
|
|
$
|
(235
|
)
|
|
$
|
(2,294
|
)
|
(i)
|
WRD—the R&D expenses managed by our WRD organization, which is generally responsible for research projects for our IH business until proof-of-concept is achieved and then for transitioning those projects to the IH segment via the GPD organization for possible clinical and commercial development. R&D spending may include upfront and milestone payments for intellectual property rights. The WRD organization also has responsibility for certain science-based and other platform-services organizations, which provide technical expertise and other services to the various R&D projects, including EH R&D projects. WRD is also responsible for facilitating all regulatory submissions and interactions with regulatory agencies, including all safety-event activities. In connection with the formation of the GPD organization, effective in the second quarter of 2016, certain development-related functions transferred from WRD to GPD. See note (ii) below for additional information.
|
(ii)
|
GPD
––
the costs associated with our GPD organization, which is generally responsible for the clinical development of assets that are in clinical trials for our WRD and Innovative portfolios. GPD also provides technical support and other services to Pfizer R&D projects. In connection with the formation in early 2016 of the GPD organization, effective in the second quarter of 2016, certain development-related functions transferred from WRD and IH to GPD. We have reclassified approximately
$78 million
of costs from WRD and
$76 million
of costs from IH to GPD in the first quarter of 2016.
|
(iii)
|
Corporate—the costs associated with Corporate, representing platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance and worldwide procurement) and certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments. Effective in the first quarter of 2017, Corporate also includes the costs associated with our Pfizer Medical organization (Medical), previously reported as part of Other Business Activities. Medical is responsible for the provision of medical information to healthcare providers, patients and other parties, transparency and disclosure activities, clinical trial results publication, grants for healthcare quality improvement and medical education, and partnerships with global public health and medical associations. We have reclassified approximately
$27 million
of Medical costs from Other Business Activities to Corporate in the first quarter of 2016 to conform to the current period presentation. In the first quarter of
2017
, we recognized a
$45 million
gain as an offset to
Cost of sales
related to euro, Japanese yen and U.K. pound-denominated forward contacts designated as hedges of foreign exchange-denominated intercompany sales.
|
(iv)
|
Other Unallocated—other unallocated costs, representing overhead expenses associated with our manufacturing and commercial operations that are not directly assessed to an operating segment as business unit (segment) management does not manage these costs (which include manufacturing variances associated with production).
|
|
|
|
Three Months Ended April 2, 2017
|
||||||||||||||
|
|
|
|
Estimated Other Costs Associated with IH
(ii)
|
|
|
||||||||||
(MILLIONS OF DOLLARS)
|
|
Innovative Health Non-GAAP Adjusted
(i), (iii)
|
|
|
Estimated WRD/GPD
(ii)
|
|
|
Estimated Corporate/Other Unallocated
(ii)
|
|
|
Innovative Health with Estimated Other Costs Associated with
Innovative Health Non-GAAP Adjusted (ii), (iii) |
|
||||
Revenues
|
|
$
|
7,415
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,415
|
|
Cost of sales
|
|
849
|
|
|
—
|
|
|
1
|
|
|
850
|
|
||||
Selling, informational and administrative expenses
|
|
1,514
|
|
|
—
|
|
|
637
|
|
|
2,151
|
|
||||
Research and development expenses
|
|
523
|
|
|
700
|
|
|
192
|
|
|
1,415
|
|
||||
Amortization of intangible assets
|
|
26
|
|
|
—
|
|
|
—
|
|
|
26
|
|
||||
Restructuring charges and certain acquisition-related costs
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Other (income)/deductions––net
|
|
(146
|
)
|
|
(18
|
)
|
|
(38
|
)
|
|
(203
|
)
|
||||
Income from continuing operations before provision for taxes on income
|
|
4,649
|
|
|
(681
|
)
|
|
(792
|
)
|
|
3,176
|
|
|
|
Three Months Ended April 2, 2017
|
||||||||||||||
|
|
|
|
Estimated Other Costs Associated with EH
(ii)
|
|
|
||||||||||
(MILLIONS OF DOLLARS)
|
|
Essential Health
Non-GAAP Adjusted (i), (iii) |
|
|
Estimated WRD/GPD
(ii)
|
|
|
Estimated Corporate/Other Unallocated
(ii)
|
|
|
Essential Health with Estimated Other Costs Associated with
Essential Health Non-GAAP Adjusted (ii), (iii) |
|
||||
Revenues
|
|
$
|
5,364
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,364
|
|
Cost of sales
|
|
1,450
|
|
|
—
|
|
|
134
|
|
|
1,584
|
|
||||
Selling, informational and administrative expenses
|
|
708
|
|
|
—
|
|
|
429
|
|
|
1,137
|
|
||||
Research and development expenses
|
|
252
|
|
|
6
|
|
|
32
|
|
|
290
|
|
||||
Amortization of intangible assets
|
|
9
|
|
|
—
|
|
|
—
|
|
|
9
|
|
||||
Restructuring charges and certain acquisition-related costs
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Other (income)/deductions––net
|
|
(61
|
)
|
|
—
|
|
|
(25
|
)
|
|
(86
|
)
|
||||
Income from continuing operations before provision for taxes on income
|
|
3,006
|
|
|
(6
|
)
|
|
(570
|
)
|
|
2,429
|
|
(i)
|
Amount represents the revenues and costs managed by each of our operating segments. The expenses generally include only those costs directly attributable to the operating segment. See note (a) above for more information.
|
(ii)
|
Represents costs not assessed to an operating segment, as business unit (segment) management does not manage these costs. For a description of these other costs and business activities, see note (b) above.
|
•
|
WRD/GPD
––
The information provided for WRD and GPD was substantially all derived from our estimates of the costs incurred in connection with the R&D projects associated with each operating segment.
|
•
|
Corporate/Other Unallocated
––
The information provided for Corporate and Other Unallocated was derived mainly using proportional allocation methods based on global, regional or country revenues or global, regional or country headcount, as well as certain cost metrics, as appropriate, such as those derived from research and development and manufacturing costs, and, to a lesser extent, specific identification and estimates. Management believes that the allocations of Corporate and Other Unallocated costs are reasonable.
|
(iii)
|
See note (c) below for an explanation of our Non-GAAP Adjusted financial measure.
|
(c)
|
See the “Non-GAAP Financial Measure (Adjusted Income)” section of this MD&A for a definition of these “Adjusted Income” components.
|
(d)
|
Includes costs associated with (i) purchase accounting adjustments; (ii) acquisition-related costs; and (iii) certain significant items, which are substantive and/or unusual, and in some cases recurring, items (such as restructuring or legal charges), that are evaluated on an individual basis by management. For additional information about these reconciling items and/or our Non-GAAP adjusted measure of performance, see the “Non-GAAP Financial Measure (Adjusted Income)” section of this MD&A.
|
•
|
IH
Revenues
increase
d
$381 million
, or
5%
, to
$7.4 billion
in the
first quarter
of
2017
, compared to
$7.0 billion
in the same period in 2016. Foreign exchange had
an unfavorable
impact of
1%
on IH revenues in the
first quarter
of
2017
, compared to the same period in
2016
. IH
Revenues
increase
d by
6%
operationally in the
first quarter
of
2017
, compared to the same period in
2016
.
|
The following provides an analysis of the revenue increase for IH:
|
||||
(MILLIONS OF DOLLARS)
|
|
Three Months Ended April 2, 2017
|
|
|
Acquisitions
|
|
|
||
Xtandi alliance revenues in the U.S. (September 2016 acquisition of Medivation)
|
|
$
|
131
|
|
|
|
|
||
Operational growth/(decline)
|
|
|
||
Continued growth from key brands, including Ibrance and Eliquis globally, as well as Lyrica and Xeljanz, both primarily in the U.S.
|
|
620
|
|
|
Lower revenues for Enbrel in most developed Europe markets, primarily due to continued biosimilar competition
|
|
(117
|
)
|
|
Decline in Prevnar 13/Prevenar 13 revenues, primarily driven by the continued decline in revenues for the adult indication in the U.S. due to a smaller remaining “catch up” opportunity compared to the same period in 2016, partially offset by the favorable impact from the timing of government purchases for the pediatric indication. International revenues decreased primarily due to the unfavorable timing of government purchases in certain emerging markets for the pediatric indication, partially offset by modest growth of the adult indication in certain developed Europe markets
|
|
(113
|
)
|
|
Decline in Viagra revenues in the U.S. primarily due to lower market demand
|
|
(51
|
)
|
|
Other operational factors, net
|
|
(47
|
)
|
|
Operational growth, net
|
|
423
|
|
|
|
|
|
||
Unfavorable impact of foreign exchange
|
|
(42
|
)
|
|
IH
Revenues
increase
|
|
$
|
381
|
|
•
|
Cost of sales
as a percentage of
Revenues
decrease
d
1.3
percentage points in the
first
quarter of
2017
, compared to the same period in
2016
, driven by a favorable change in product mix, including an increase in alliance revenues, which have no associated cost of sales. The
decrease
in
Cost of sales
of
5%
in the
first
quarter of
2017
, compared to the same period in
2016
,
was primarily driven by favorable product mix and favorable foreign exchange, partially offset by an increase in royalty expense.
|
•
|
The
decrease
in
Selling, informational and administrative
expenses
of
10%
in the
first
quarter of
2017
, compared to the same period in
2016
,
was primarily driven by the non-recurrence of an allowance for doubtful trade accounts receivable, resulting from unfavorable developments with a distributor that was recorded in the first quarter of 2016, partially offset by additional investment across several of our key products.
|
•
|
The
decrease
in
Research and development
expenses
of
7%
in the
first
quarter of
2017
, compared to the same period in
2016
,
primarily reflects the discontinuation of the global clinical development program for bococizumab in the fourth quarter of 2016, partially offset by increased costs associated with our oncology programs, including legacy Medivation operations.
|
•
|
The
unfavorable
change in
Other (income)/deductions––net
in the
first
quarter of
2017
, compared to the same period in
2016
,
primarily reflects a net decrease in royalty income, due to lower royalty income for Enbrel, resulting from the expiration on October 31, 2016 of the 36-month royalty period under the collaboration agreement for Enbrel in the U.S. and Canada (the collaboration period under the agreement expired on October 31, 2013), partially offset by the addition of Xtandi royalty-related income.
|
•
|
EH
Revenues
decrease
d
$608 million
, or
10%
, to
$5.4 billion
in the
first
quarter of
2017
, compared to
$6.0 billion
in the same period in
2016
. Foreign exchange had
an unfavorable
impact of
1%
on EH revenues in the
first quarter
of
2017
, compared to the same period in
2016
. EH
Revenues
decrease
d by
9%
operationally in the
first quarter
of
2017
, compared to the same period in
2016
. Excluding the performance of HIS in both periods, EH
Revenues
declined
6%
operationally in the
first quarter
of
2017
, compared to the same period in
2016
.
|
The following provides an analysis of the revenue decrease for EH:
|
||||
(MILLIONS OF DOLLARS)
|
|
Three Months Ended April 2, 2017
|
|
|
|
|
|
||
Disposition
|
|
|
||
Approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of 2017, compared to three months of legacy HIS global operations in the first quarter of 2016
|
|
$
|
(207
|
)
|
|
|
|
||
Operational growth/(decline)
|
|
|
||
Decline from Peri-LOE Products, including Pristiq in the U.S., which lost marketing exclusivity in the U.S. in March 2017, Lyrica in most developed Europe markets and Zyvox in developed Europe markets and in the U.S.
|
|
(253
|
)
|
|
Decline in the Legacy Established Products portfolio
|
|
(153
|
)
|
|
Growth in the Pfizer Sterile Injectable Pharmaceuticals portfolio as well as growth in Biosimilars, primarily driven by Inflectra in certain developed Europe markets and in the U.S.
|
|
86
|
|
|
Other operational factors, net
|
|
(6
|
)
|
|
Operational decline, net
|
|
(534
|
)
|
|
|
|
|
||
Unfavorable impact of foreign exchange
|
|
(74
|
)
|
|
EH
Revenues
decrease
|
|
$
|
(608
|
)
|
•
|
Cost of sales
as a percentage of
Revenues
increase
d
2.7
percentage points in the
first
quarter of
2017
, compared to the same period in
2016
, primarily due to:
|
◦
|
cost increases reflecting the shift to EH of certain legacy Hospira costs that were previously unallocated to EH as a result of harmonizing the Hospira cost policy;
|
◦
|
charges related to a product recall that occurred in the first quarter of 2017; and
|
◦
|
the impact of product losses of exclusivity,
|
◦
|
the inclusion of approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of 2017, compared to the inclusion of three months of legacy HIS global operations in the first quarter of 2016.
|
•
|
The slight decrease in
Cost of sales
in the
first
quarter of
2017
, compared to the same period in
2016
, primarily reflects:
|
◦
|
the inclusion of approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of 2017, compared to the inclusion of three months of legacy HIS global operations in the first quarter of 2016;
|
◦
|
the favorable impact of foreign exchange; and
|
◦
|
a net decrease in royalty expense,
|
◦
|
cost increases reflecting the shift to EH of certain legacy Hospira costs that were previously unallocated to EH as a result of harmonizing the Hospira cost policy; and
|
◦
|
charges related to a product recall that occurred in the first quarter of 2017.
|
•
|
Selling, informational and administrative
expenses
decrease
d
4%
in the
first
quarter of
2017
, compared to the same period in
2016
,
primarily due to the inclusion of approximately one month of legacy HIS domestic operations and approximately two
|
•
|
Research and development
expenses
decrease
d
9%
in the
first
quarter of
2017
, compared to the same period in
2016
,
primarily due to the inclusion of approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations in the first quarter of 2017, compared to the inclusion of three months of legacy HIS global operations in the first quarter of 2016, and the close-out of certain post-marketing clinical trials.
|
•
|
The
unfavorable
change in
Other (income)/deductions––net
in the
first
quarter of
2017
, compared to the same period in
2016
,
primarily reflects the non-recurrence of a resolution of a contract disagreement in the first quarter of 2016, partially offset by the favorable impact of foreign exchange.
|
For information purposes only, the following table contains selected balance sheet information by operating segment, reflecting the more meaningful operating accounts at the segment level. This information has been developed for annual disclosure purposes only. Although we manage our assets and liabilities on a total company basis, not by operating segment, as many of our operating assets are shared or commingled, we believe that some investors may find this information useful.
|
||||||||||||||||
|
|
As of December 31, 2016
|
||||||||||||||
(MILLIONS OF DOLLARS)
|
|
IH
(a), (b)
|
|
EH
(a), (b)
|
|
Corporate/Unallocated
(a), (c)
|
|
Total Company
|
||||||||
Trade accounts receivable, less allowance for doubtful accounts
|
|
$
|
4,615
|
|
|
$
|
3,610
|
|
|
$
|
—
|
|
|
$
|
8,225
|
|
Inventories
|
|
3,027
|
|
|
3,756
|
|
|
—
|
|
|
6,783
|
|
||||
Trade accounts payable
|
|
2,808
|
|
|
1,695
|
|
|
34
|
|
|
4,536
|
|
||||
Other selected balance sheet information:
|
|
|
|
|
|
|
|
|
||||||||
Noncurrent inventories
(d)
|
|
53
|
|
|
630
|
|
|
—
|
|
|
683
|
|
(a)
|
The selected balance sheet information is presented as of December 31, 2016 after all significant intercompany balances and transactions between legal entities have been eliminated. For subsidiaries operating outside the U.S., the selected balance sheet information is included as of November 30, 2016.
|
(b)
|
The selected balance sheet information for each operating segment has been developed as follows:
|
•
|
Trade accounts receivable, less allowance for doubtful accounts
––significantly all amounts were derived using specific identification methods.
|
•
|
Inventories
(including noncurrent portion)––these amounts were derived using specific identification methods and with respect to shared inventory components, these amounts were derived using proportional allocation methods based on associated manufacturing costs and related product-specific inventory.
|
•
|
Trade accounts payable
––the amounts were derived using specific identification methods and using proportional allocation methods based on associated manufacturing costs, certain research and development costs or other operating costs, as appropriate.
|
(c)
|
Corporate/Unallocated includes a portion of the following line item:
|
•
|
Trade accounts payable
––
the portion of this account included as Corporate/Unallocated primarily relates to liabilities associated with specific legal entities not identified with operating segments.
|
(d)
|
Included in
Other noncurrent assets
on the consolidated balance sheet.
|
•
|
For
Foreign currency translation adjustments, net,
primarily reflects the weakening of the U.S. dollar against the Australian dollar, Brazilian real and the Canadian dollar, partially offset by the strengthening of the U.S. dollar against the euro.
|
•
|
For
Unrealized holding losses on derivative financial instruments, net
and
Unrealized holding gains on available-for-sale securities, net,
reflect the impact of fair value remeasurements and the reclassification of realized amounts into income. For additional information, see Notes to Condensed Consolidated Financial Statements—
Note 7. Financial Instruments
.
|
•
|
For
Benefit plans: actuarial gains, net,
primarily reflects the reclassification into income for amounts related to (i) the amortization of changes in the pension benefit obligation previously recognized in
Other comprehensive income
; and (ii) settlement activity, as well as the impact of favorable foreign exchange. For additional information, see Notes to Condensed Consolidated Financial Statements—
Note 10. Pension and Postretirement Benefit Plans
.
|
•
|
For
Trade accounts receivable, less allowance for doubtful accounts,
the change reflects the timing of sales and collections in the normal course of business.
|
•
|
For
Inventories,
the change reflects the build of inventory primarily for new product launches and to meet targeted levels for certain products, partially offset by inventory reductions in the normal course of business, including those related to demand.
|
•
|
For
Other current assets,
the change reflects an increase in VAT receivable balances due to a change in our supply chain, partially offset by a decrease in receivables from royalty agreements as a result of contract terminations, as well as the timing of receipts and payments in the normal course of business.
|
•
|
For PP&E,
the change reflects depreciation during the period, partially offset by capital additions in the normal course of business.
|
•
|
For
Identifiable intangible assets, less accumulated amortization
, the change primarily reflects amortization for the period.
|
•
|
For
Other noncurrent assets,
the change reflects a decrease in receivables associated with our derivative financial instruments.
|
•
|
For
Trade accounts payable,
the change reflects the timing of purchases and payments in the normal course of business, including the impact of efforts to improve working capital efficiencies.
|
•
|
For
Accrued compensation and related items,
the decrease reflects normal bonus payments made to employees, partially offset by current year’s accruals.
|
•
|
For
Other current liabilities
, the change reflects an increase due to the timing of payments for accrued interest, security purchases, restructuring and charitable contributions, as well as net funds due to ICU Medical for net economic benefit payments (see Notes to Condensed Consolidated Financial Statements––
Note 2B.
Acquisitions, Sale of Hospira Infusion Systems Net Assets, Collaborative Arrangement, Equity-Method Investments and Cost-Method Investment
:
Sale of Hospira Infusion Systems Net Assets to ICU Medical, Inc. (EH)
), partially offset by payments to settle liabilities related to the closeout of bococizumab clinical studies and restructuring matters, and payments in the normal course of business.
|
•
|
For
Pension benefit obligations, net
, the decrease primarily reflects the $1.0 billion voluntary pension contribution in January 2017
.
|
•
|
For
Other noncurrent liabilities
, the change reflects an increase in deferred revenue from a milestone payment received from Merck for the ertugliflozin collaboration agreement (see Notes to Condensed Consolidated Financial Statements––
Note 2C.
Acquisitions, Sale of Hospira Infusion Systems Net Assets, Collaborative Arrangement, Equity-Method Investments and Cost-Method Investment
: Collaboration Arrangement
) and deferred consideration for transitional and manufacturing service agreements received from ICU Medical (see Notes to Condensed Consolidated Financial Statements––
Note 2B.
|
•
|
For
Treasury stock,
the change reflects $5 billion paid to Citibank in February 2017 pursuant to the terms of an accelerated share repurchase agreement. See Notes to Condensed Consolidated Financial Statements—
Note 12. Commitments and Contingencies
for additional information.
|
|
|
Three Months Ended
|
|
|
|||||||
(MILLIONS OF DOLLARS)
|
|
April 2,
2017 |
|
|
April 3,
2016 |
|
|
%
Change |
|
||
Cash provided by/(used in):
|
|
|
|
|
|
|
|||||
Operating activities
(a)
|
|
$
|
1,589
|
|
|
$
|
1,808
|
|
|
(12
|
)
|
Investing activities
|
|
4,772
|
|
|
4,355
|
|
|
10
|
|
||
Financing activities
(a)
|
|
(4,921
|
)
|
|
(7,171
|
)
|
|
(31
|
)
|
||
Effect of exchange-rate changes on cash and cash equivalents
|
|
21
|
|
|
(73
|
)
|
|
*
|
|
||
Net increase/(decrease) in
Cash and cash equivalents
|
|
$
|
1,461
|
|
|
$
|
(1,080
|
)
|
|
*
|
|
*
|
Calculation not meaningful.
|
(a)
|
Amounts for the three months ended
April 3, 2016
have been revised from previously reported amounts to reflect the adoption of a new accounting standard in the fourth quarter of 2016, as of January 1, 2016, that requires that cash flows present (i) excess tax benefits as
Other tax accounts, net
as part of operating activities, rather than financing activities on a prospective basis beginning in the year of adoption, and (ii) cash paid by us when directly withholding shares for tax-withholding purposes as a cash outflow from financing activities, rather than operating activities and is reflected in the year of adoption. The year-to-date excess tax benefit was
$26 million
in the first quarter of 2016. For cash paid by us for withholding purposes, $131 million for the first quarter of 2016 is presented as financing activities
in the condensed consolidated statements of cash flows. (see Notes to Consolidated Financial Statements—
Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards
).
|
•
|
net proceeds from sales of investments of
$5.4 billion
in the
first three months of
2017
, compared to net proceeds from sales of investments of
$4.8 billion
in the
first three months of
2016
,
|
•
|
an
increase
in cash paid for acquisitions, net of cash acquired, of
$475 million
, primarily for the acquisition of AstraZeneca’s small molecule anti-infectives business in the
first three months of
2017
(see Notes to Condensed Consolidated Financial Statements—
Note 2A.
Acquisitions, Sale of Hospira Infusion Systems Net Assets, Collaborative Arrangement, Equity-Method Investments and Cost-Method Investment
: Acquisitions
).
|
•
|
the issuance of long-term debt of
$5.3 billion
in the
first three months of
2017
(see Notes to Condensed Consolidated Financial Statements––
Note 7D. Financial Instruments: Long-Term Debt
),
|
•
|
net payments on short-term borrowings of
$2.1 billion
in the
first three months of
2017
, compared to net proceeds on short-term borrowings of
$1.1 billion
in the
first three months of
2016
.
|
•
|
the working capital requirements of our operations, including our R&D activities;
|
•
|
investments in our business;
|
•
|
dividend payments and potential increases in the dividend rate;
|
•
|
share repurchases;
|
•
|
the cash requirements associated with our cost-reduction/productivity initiatives;
|
•
|
paying down outstanding debt;
|
•
|
contributions to our pension and postretirement plans; and
|
•
|
business-development activities.
|
The following table provides certain relevant measures of our liquidity and capital resources:
|
||||||||
(MILLIONS OF DOLLARS, EXCEPT RATIOS AND PER COMMON SHARE DATA)
|
|
April 2,
2017 |
|
|
December 31,
2016 |
|
||
Selected financial assets:
|
|
|
|
|
||||
Cash and cash equivalents
(a)
|
|
$
|
4,057
|
|
|
$
|
2,595
|
|
Short-term investments
(a)
|
|
10,503
|
|
|
15,255
|
|
||
Long-term investments
(a)
|
|
7,346
|
|
|
7,116
|
|
||
|
|
21,906
|
|
|
24,967
|
|
||
Debt:
|
|
|
|
|
|
|
||
Short-term borrowings, including current portion of long-term debt
|
|
7,680
|
|
|
10,688
|
|
||
Long-term debt
|
|
36,330
|
|
|
31,398
|
|
||
|
|
44,010
|
|
|
42,085
|
|
||
Selected net financial liabilities
(b)
|
|
$
|
(22,103
|
)
|
|
$
|
(17,118
|
)
|
|
|
|
|
|
||||
Working capital
(c)
|
|
$
|
11,014
|
|
|
$
|
7,834
|
|
Ratio of current assets to current liabilities
|
|
1.44:1
|
|
|
1.25:1
|
|
||
Total Pfizer Inc. shareholders’ equity per common share
(d)
|
|
$
|
9.80
|
|
|
$
|
9.81
|
|
(a)
|
See Notes to Condensed Consolidated Financial Statements––
Note 7. Financial Instruments
for a description of certain assets held and for a description of credit risk related to our financial instruments held.
|
(b)
|
The increase in selected net financial liabilities is predominantly a result of the increase in long term debt. We retain a strong financial liquidity position as a result of our net cash provided by operating activities, our high-quality financial asset portfolio and access to capital markets. Both Moody’s and S&P rating agencies maintained our strong investment-grade corporate debt rating subsequent to the acquisitions of Medivation and Anacor. For additional information, see the “Credit Ratings” section of this MD&A.
|
(c)
|
The increase in working capital is primarily due to a decrease in short-term borrowings, which occurred as a result of our issuance of long-term debt, and the timing of accruals, cash receipts and payments in the ordinary course of business, partially offset by a decrease in short-term investments.
|
(d)
|
Represents total Pfizer Inc. shareholders’ equity divided by the actual number of common shares outstanding (which excludes treasury stock).
|
The following table provides the current ratings assigned by these rating agencies to our commercial paper and senior unsecured long-term debt:
|
||||||
NAME OF RATING AGENCY
|
|
Pfizer
Commercial Paper
|
|
Pfizer
Long-Term Debt
|
Date of Last Rating Change
|
|
|
Rating
|
|
Rating
|
|
||
Moody’s
(a)
|
|
P-1
|
|
A1
|
|
October 2009
|
S&P
(b)
|
|
A-1+
|
|
AA
|
|
October 2009
|
(a)
|
In September 2016, Moody’s updated their credit outlook from negative outlook to stable.
|
(b)
|
In April 2016, S&P updated their credit outlook from negative watch to stable.
|
The following table provides the number of shares of our common stock purchased and the cost of purchases under our publicly announced accelerated share repurchase agreements:
|
||||||||
|
|
Three Months Ended
|
||||||
(SHARES IN MILLIONS, DOLLARS IN BILLIONS)
|
|
April 2
2017
(a)
|
|
|
April 3,
2016
(b)
|
|
||
Shares of common stock purchased
|
|
126
|
|
|
136
|
|
||
Cost of purchase
|
|
$
|
5.0
|
|
|
$
|
5.0
|
|
(a)
|
Represents shares purchased pursuant to an accelerated share repurchase agreement with Citibank. For additional information, see
Notes to Condensed Consolidated Financial Statements––
Note 12
.
Commitments and Contingencies
and “Unregistered Sales of Equity Securities and Use of Proceeds––Issuer Purchases of Equity Securities” in Part II, Item 2 of this Quarterly Report on Form 10-Q.
|
(b)
|
Represents shares purchased pursuant to an accelerated share repurchase agreement entered into on March 8, 2016. For additional information, see
Notes to Consolidated Financial Statements––
Note 12
.
Equity
in our
2016
Financial Report.
|
The following table provides a brief description of recently issued accounting standards, not yet adopted:
|
||||
Standard/Description
|
|
Effective Date
|
|
Effect on the Financial Statements or Other Significant Matters
|
In May 2014, the FASB issued amended guidance related to
revenue from contracts with customers
. The new guidance introduces a new principles-based framework for revenue recognition and disclosure. Since its issuance the FASB has issued six ASUs, amending the guidance and effective date, and the SEC has rescinded certain related SEC guidance; the most recent of these changes was issued in December 2016.
|
|
January 1, 2018.
|
|
We have made substantial progress in completing our review of the impact of this guidance across our various business arrangements and revenue-related activities, and do not expect the adoption of this standard to have a material impact on our financial statements and revenue recognition practices, or our internal controls. Under the development portion of our collaboration agreements, we expect the milestone payments, which are recorded in
Other
(
income
)
/deductions
––
net,
to be amortized over the development period rather than the life of the agreement, as we currently do. We continue to monitor additional changes, modifications, clarifications or interpretations undertaken by the FASB, which may impact our current conclusions. In addition, we continue to monitor other changes, such as changes in our business, new collaboration arrangements, business combinations, etc., which may impact our current conclusions prior to the adoption date.
|
Standard/Description
|
|
Effective Date
|
|
Effect on the Financial Statements or Other Significant Matters
|
In January 2016, the FASB issued an update to its guidance on recognition and measurement of
financial assets and liabilities
.
Among other things, the new guidance makes the following targeted changes to existing guidance:
1. Requires certain equity investments to be measured at fair value with changes in fair value recognized in net income. However, an entity may choose to measure equity investments that do not have readily determinable fair values at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer.
2. Requires a qualitative assessment of equity investments without readily determinable fair values to identify impairment.
3. Requires separate presentation of financial assets and financial liabilities by measurement category and form of financial asset on the balance sheet or in the accompanying notes to the financial statements.
|
|
January 1, 2018.
|
|
We have not yet completed our review of the impact of this new guidance on our consolidated financial statements. However, as of April 2, 2017, we have $553 million in available-for-sale equity securities and approximately $1.2 billion of restricted stock and private equity securities which will be subject to the new rules. Further, for the three months ended April 2, 2017, we recognized $176 million of unrealized holding gains on available-for-sale equity securities in
Other Comprehensive income/(loss)
, which would have been recorded to
Other (income)/deductions––net
under the new rules.
|
In August 2016, the FASB issued new guidance on the
classification of certain transactions in the Statement of Cash Flows.
|
|
January 1, 2018. Earlier application is permitted.
|
|
We have not yet completed our review of the impact of this new guidance on our consolidated financial statements. However, upon adoption, we expect to reclassify approximately $362 million of cash outflows related to debt redemption in 2016 from operating activities to financing activities. We also expect to reclassify approximately $28 million of cash inflows from trust-owned life insurance contracts in 2016 from operating activities to investing activities. In addition, the new guidance may impact the classification of certain cash flows related to contingent consideration in a business acquisition, depending on the ultimate settlement amount of the contingency.
|
In October 2016, the FASB issued new guidance on the presentation of
restricted cash in the Statement of Cash Flows.
|
|
January 1, 2018. Earlier application is permitted.
|
|
We have not yet completed our review of the impact of this new guidance on our consolidated financial statements. However, our restricted cash balances as of the end of 2016 were approximately $18.1 million of short-term restricted cash and $45.3 million of long-term restricted cash.
|
In October 2016, the FASB issued an update to its guidance on
income tax
accounting. The new guidance replaces the prohibition against recognizing current and deferred income taxes for an intra-entity asset transfer until the asset has been sold to an outside party with a requirement to do so, unless the asset transferred is inventory.
|
|
January 1, 2018.
|
|
We have not yet completed our review of the impact of this new guidance on our consolidated financial statements. However, we anticipate that after adoption, our effective tax rate could be impacted by the immediate recognition of the tax consequences of intercompany asset transfers other than inventory. The impact of adoption will be recorded as a cumulative effect adjustment to
Retained earnings.
|
In January 2017, the FASB issued new guidance to clarify the
definition of a business
. The new guidance provides a new framework for determining whether business development transactions should be accounted for as acquisitions (or disposals) of assets or businesses. If the fair value of the gross assets acquired is concentrated in a single identifiable asset, the transaction will not qualify for treatment as a business. The new guidance also requires that to be considered a business, a set of integrated activities and assets must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs, without regard as to whether a market participant could replace missing elements. In addition, the new guidance narrows the definition of the term “output” to make it consistent with how outputs are described in the updated revenue recognition guidance.
|
|
January 1, 2018. Earlier application is permitted.
|
|
We have not yet completed our review of the impact of this guidance. However, we anticipate that after adoption, fewer transactions will be accounted for as business acquisitions (decreasing the amount of goodwill incurred and potentially increasing IPR&D expense) or disposals of a business.
|
In February 2017, the FASB issued amended guidance related to the
derecognition of nonfinancial assets.
|
|
January 1, 2018. Earlier application is permitted.
|
|
We are assessing the impact of the
provisions of this new guidance on our
consolidated financial statements.
|
Standard/Description
|
|
Effective Date
|
|
Effect on the Financial Statements or Other Significant Matters
|
In March 2017, the FASB issued guidance on the presentation of
net periodic pension and postretirement benefit cost.
Under the new rules, entities that sponsor defined benefit plans will present net benefit cost as follows:
1. Service cost will be included in the same income statement line items where other employee compensation costs are reported.
2. The other components of net benefit cost will be presented outside of income from operations, if such a subtotal is presented.
3. Only the service cost component will be capitalized, when applicable (for example, as a cost of inventory, internal-use software, or a self-constructed fixed asset).
If a separate line item is used to present the other components of net benefit cost, it should have an appropriate description. If a separate line item or items is not used, the line item or items in the income statement where the other components of net benefit cost are included must be disclosed.
|
|
January 1, 2018.
|
|
We have not yet completed our review of this new guidance on our consolidated financial statements, although we anticipate that after adoption, the net benefit costs other than service costs will be reclassified to
Other
(
income
)
/deductions
—
net
from their current classification within
Cost of sales, Selling, informational and administrative expenses,
and
Research and development expenses.
Effective January 1, 2018, future accruals under the Pfizer Consolidated Pension Plan (our largest U. S. defined benefit plan), will freeze, and the Pfizer defined contribution savings plan will provide additional annual contributions to those previously accruing benefits under the Pfizer Consolidated Pension Plan. This change will result in elimination of future service costs for the plan.
|
In May 2017, the FASB issued new guidance on the accounting for
modifications of share-based payment awards
. The new guidance clarifies that changes in the terms or conditions of a share-based payment award be accounted for as a modification unless all the following conditions are met:
1.
The fair value of the modified award is the same as the fair value of the original award immediately before the original award is modified.
2.
The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified.
3.
The modification does not change the classification of the award as an equity instrument or a liability instrument.
|
|
January 1, 2018. Early application is permitted, including in interim periods.
|
|
We are assessing the impact of the provisions of this new guidance on our consolidated financial statements.
|
In February 2016, the FASB issued an update to its guidance on
leases
. The new ASU provides guidance for both lessee and lessor accounting models. Among other things, the new guidance requires that a right of use asset and a lease liability be recognized for leases with a duration of greater than one year.
|
|
January 1, 2019. Earlier application is permitted.
|
|
We have not yet completed our review of the impact of this guidance. However, we anticipate recognition of at least $1 billion of additional assets and corresponding liabilities on our balance sheet. We are currently assessing the potential impact of embedded leases on our financial statements.
|
In March 2017, the FASB issued new guidance that shortens the
amortization period for certain callable debt securities held at a premium
. The new guidance requires the premium to be amortized to the earliest call date.
|
|
January 1, 2019. Early application is permitted, including in interim periods, so long as any adjustments are reflected as of the beginning of the fiscal year that includes the interim period in which the guidance is applied.
|
|
We are assessing the impact of the provisions of this new guidance on our consolidated financial statements.
|
In June 2016, the FASB issued new guidance on accounting for
credit losses of financial instruments
. The new guidance replaces the incurred losses methodology in current GAAP with a methodology that reflects expected credit losses using an allowance account.
|
|
January 1, 2020. Earlier application is permitted as of fiscal years beginning after December 15, 2018, including interim periods within that fiscal year.
|
|
We are assessing the impact of the provisions of this new guidance on our consolidated financial statements.
|
In January 2017, the FASB issued new guidance for
goodwill impairment testing
. The new guidance eliminates the requirement to perform a hypothetical purchase price allocation to measure goodwill impairment. Under the new guidance the goodwill impairment test is performed by comparing the fair value of a reporting unit with its carrying amount, and recognizing an impairment charge for the amount by which the carrying amount of the reporting unit exceeds its fair value, although it cannot exceed the total amount of goodwill allocated to that reporting unit.
|
|
January 1, 2020. Earlier application is permitted.
|
|
We have not yet completed our review of the impact of this new guidance on our consolidated financial statements. However, we do not expect this new guidance to have a material impact on our consolidated financial statements.
|
•
|
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;
|
•
|
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 or expiration 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, including possible legal or regulatory actions, such as warning letters, suspension of manufacturing, seizure of product, injunctions or voluntary recall of a product;
|
•
|
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 or 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, and the passage or failure of the American Health Care 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 and settlement costs;
|
•
|
the risk of an adverse decision or settlement and the adequacy of reserves related to legal proceedings, including patent litigation, product liability and other product-related litigation, including personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, commercial, environmental, government investigations, employment and other legal proceedings, including various means for resolving asbestos litigation, as well as tax issues;
|
•
|
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 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;
|
•
|
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;
|
•
|
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 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;
|
•
|
changes in interpretations of existing laws and regulations, or changes in laws and regulations, in the U.S. and other countries;
|
•
|
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 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 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.
|
Period
|
Total Number of
Shares Purchased
(a), (b)
|
|
Average Price
Paid per Share
(a), (b)
|
|
Total Number of Shares Purchased as Part of Publicly Announced Plan
(a)
|
|
Approximate Dollar Value of Shares That May Yet Be Purchased Under the Plan
(a)
|
|
||
January 1, 2017 through January 29, 2017
|
25,427
|
|
$
|
32.59
|
|
—
|
|
$
|
11,355,862,076
|
|
January 30, 2017 through February 26 2017
|
127,312,839
|
|
$
|
31.75
|
|
126,063,662
|
|
$
|
6,355,862,076
|
|
February 27, 2017 through April 2, 2017
|
4,455,187
|
|
$
|
34.45
|
|
—
|
|
$
|
6,355,862,076
|
|
Total
|
131,793,453
|
|
$
|
31.84
|
|
126,063,662
|
|
|
(a)
|
Our October 2014 $11 billion share-purchase plan was exhausted in the first quarter of 2017. In December 2015, the Board of Directors authorized an $11 billion share repurchase program, and share repurchase commenced thereunder in the first quarter of 2017. On February 2, 2017, we entered into an accelerated share repurchase agreement with Citibank to repurchase
$5 billion
of our common stock. Pursuant to the terms of the agreement, on February 6, 2017, we paid
$5 billion
to Citibank and received an initial delivery of approximately
126 million
shares of our common stock from Citibank at a price of
$31.73
per share, which represented, based on the closing price of our common stock on the NYSE on February 2, 2017, approximately
80%
of the notional amount of the accelerated share repurchase agreement. As of April 2, 2017, the common stock received is included in
Treasury Stock
. At settlement of the agreement, which is expected to occur during or prior to the third quarter of 2017, Citibank may be required to deliver additional shares of common stock to us, or, under certain circumstances, we may be required to deliver shares of our common stock or may elect to make a cash payment to Citibank, with the number of shares to be delivered or the amount of such payment, as well as the final average price per share, based on the difference between the volume-weighted average price, less a discount, of Pfizer’s common stock during the term of the transaction. This agreement was entered into pursuant to our previously announced share repurchase authorization. At
April 2, 2017
, our remaining share-purchase authorization was approximately
$6.4 billion
.
|
(b)
|
In addition to the amounts purchased under the accelerated share repurchase agreement, these columns reflect the following transactions during the
first
fiscal quarter of
2017
: (i) the surrender to Pfizer of
3,240,616
shares of common stock to satisfy tax withholding obligations in connection with the vesting of restricted stock units issued to employees; (ii) the surrender to Pfizer of
1,506,981
shares of common stock to satisfy tax withholding obligations in connection with the vesting of performance share awards issued to employees; (iii) the surrender of
976,042
shares of common stock to satisfy withholding obligations in connection with the settlement of total shareholder return units; (iv) the open market purchase by the trustee of
5,467
shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who were granted performance share awards and who deferred receipt of such awards; and (v) the surrender to Pfizer of
685
shares of common stock to satisfy tax withholding obligations in connection with the vesting of stock options issued to employees.
|
|
-
|
Computation of Ratio of Earnings to Fixed Charges.
|
|
|
-
|
Accountants’ Acknowledgment.
|
|
|
-
|
Certification by the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
-
|
Certification by the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
-
|
Certification by the Chief Executive Officer Pursuant to 18 U.S.C. Section
1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
-
|
Certification by the Chief Financial Officer Pursuant to 18 U.S.C. Section
1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
Exhibit 101:
|
|
|
|
EX-101.INS
|
|
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
|
|
EX-101.SCH
EX-101.CAL
EX-101.LAB
EX-101.PRE
EX-101.DEF
|
|
XBRL Taxonomy Extension Schema
XBRL Taxonomy Extension Calculation Linkbase
XBRL Taxonomy Extension Label Linkbase
XBRL Taxonomy Extension Presentation Linkbase
XBRL Taxonomy Extension Definition Document
|
|
|
Pfizer Inc.
|
|
|
(Registrant)
|
|
|
|
|
|
|
Dated:
|
May 11, 2017
|
/s/ Loretta V. Cangialosi
|
|
|
Loretta V. Cangialosi, Senior Vice President and
Controller
(Principal Accounting Officer and
Duly Authorized Officer)
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
---|
DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
---|
No information found
Price
Yield
Owner | Position | Direct Shares | Indirect Shares |
---|