UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q


X   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934


For the quarterly period ended September 30, 201829, 2019


OR


TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


For the transition period from _______ to _______



COMMISSION FILE NUMBER 1-3619


----


PFIZER INC.INC.
(Exact name of registrant as specified in its charter)

DELAWARE
Delaware
13-5315170
(State of Incorporation)
13-5315170
(I.R.S. Employer Identification No.)


235 East 42nd Street, New York, New York  10017
(Address of principal executive offices)  (zip code)
(212)(212) 733-2323
(Registrant’s telephone number)

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $.05 par valuePFENew York Stock Exchange
0.000% Notes due 2020PFE20ANew York Stock Exchange
0.250% Notes due 2022PFE22New York Stock Exchange
1.000% Notes due 2027PFE27New York Stock Exchange
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES   X 
Yes
NO ___xNo


Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
YES   X 
Yes
NO ___xNo


Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act (check one):Act:


Large Accelerated filer  X  x              Accelerated filer ___                 Non-accelerated filer  ___          Smaller reporting company  ___    Emerging growth company  ___


If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ___


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES ____Yes
NO   X 
Nox


At November 5, 20184, 2019, 5,780,474,5785,534,122,364 shares of the issuer’s voting common stock were outstanding.




Table of Contents
Page
  
 
 
  
Condensed Consolidated Statements of Income for the three and nine months ended September 29, 2019 and
September
30, 2018 and October 1, 2017
  
Condensed Consolidated Statements of Comprehensive Income for the three and nine months ended September 29, 2019
and September
30, 2018 and October 1, 2017
  
Condensed Consolidated Balance Sheets as of September 30, 201829, 2019 and December 31, 20172018
Condensed Consolidated Statements of Equity for the three and nine months ended September 29, 2019 and
September 30, 2018
  
Condensed Consolidated Statements of Cash Flows for the nine months ended September 29, 2019 and
September
30, 2018 and October 1, 2017
  
  
  
 
  
 
  
 
  
 
  
 
  
 
  


GLOSSARY OF DEFINED TERMS


Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this Quarterly Report on Form 10-Q (defined below) refer to Pfizer Inc. and its subsidiaries. We also have used several other terms in this Quarterly Report on Form 10-Q, most of which are explained or defined below:
20172018 Financial ReportFinancial Report for the fiscal year ended December 31, 2017,2018, which was filed as Exhibit 13 to the Annual Report on Form 10-K for the fiscal year ended December 31, 20172018
20172018 Form 10-KAnnual Report on Form 10-K for the fiscal year ended December 31, 20172018
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
ACIPAdvisory Committee on Immunization Practices
AkceaAkcea Therapeutics, Inc.
ALKanaplastic lymphoma kinase
Alliance revenuesRevenues from alliance agreements under which we co-promote products discovered or developed by other companies or us
AllogeneAllogene Therapeutics, Inc.
AMPAα-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid
AnacorAnacor Pharmaceuticals, Inc.
AOCIAccumulated Other Comprehensive Income
ArrayArray BioPharma Inc.
AstellasAstellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc.
ASUAccounting Standards Update
ATM-AVIaztreonam-avibactam
AvillionAvillion LLP
Bain CapitalBain Capital Private Equity and Bain Capital Life Sciences
BiogenBambooBiogenBamboo Therapeutics, Inc.
BiopharmaPfizer Biopharmaceuticals Group
BMSBristol-Myers Squibb Company
BRCABReast CAncer susceptibility gene
CAR Tchimeric antigen receptor T cell
CDCU.S. Centers for Disease Control and Prevention
CellectisCellectis S.A.
CerevelCerevel Therapeutics, LLC
CIAScGMPcognitive impairment associated with schizophreniacurrent Good Manufacturing Practices
CitibankCitibank, N.A.
CMLchronic myelogenous leukemia
Developed MarketsU.S., Western Europe, Japan, Canada, Australia, South Korea, Australia, Scandinavian countries, Finland and
New Zealand
EEAEGFREuropean Economic Areaepidermal growth factor receptor
EHEssential Health
EMAEuropean Medicines Agency
Emerging MarketsIncludes, but is not limited to, the following markets: Asia (excluding Japan and South Korea),
Latin America, Eastern Europe, Africa, the Middle East, Africa, Central Europe and Turkey
EPSearnings per share
EUEuropean Union
Exchange ActSecurities Exchange Act of 1934, as amended
FASBFinancial Accounting Standards Board
FDAU.S. Food and Drug Administration
GAAPGenerally Accepted Accounting Principles
GISTgastrointestinal stromal tumors
GPDGlobal Product Development organization
HER2-GSKhuman epidermal growth factor receptor 2-negativeGlaxoSmithKline plc
GS&Co.Goldman, Sachs & Co. LLC
hGH-CTPhuman growth hormone
HISHospira Infusion Systems
Hisun PfizerHisun Pfizer Pharmaceuticals Company Limited
HospiraHospira, Inc.
HR+hormone receptor-positive
ICU MedicalICU Medical, Inc.
IHInnovative Health
IonisIonis Pharmaceuticals, Inc.
IPR&Din-process research and development
IRSU.S. Internal Revenue Service

IVintravenous
JanssenJanssen Biotech Inc.

J&JJohnson & Johnson
JVJoint Venture
KingKing Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.)
LDLlow density lipoprotein
LEPLegacy Established Products
LIBORLondon Interbank Offered Rate
LillyEli Lilly & Company
LOEloss of exclusivity
MCCMerkel Cell Carcinomacell carcinoma
MCOManaged Care Organizationmanaged care organization
mCRCmetastatic colorectal cancer
MD&AManagement’s Discussion and Analysis of Financial Condition and Results of Operations
MedivationMedivation LLC (formerly Medivation, Inc.)
MerckMerck & Co., Inc.
MeridianMeridian Medical Technologies, Inc.
Moody’sMoody’s Investors Service
MylanMylan N.V.
NDAnew drug application
NovaQuestNovaQuest Co-Investment Fund V, L.P.
NSCLCnon-small cell lung cancer
NYSENew York Stock Exchange
OPKOOPKO Health, Inc.
OTCover-the-counter
PARPpoly ADP ribose polymerase
PBMPharmacy Benefit Managerpharmacy benefit manager
PharmaciaPharmacia Corporation
PP&EProperty,property, plant & equipment
PsApsoriatic arthritis
Quarterly Report on Form 10-QQuarterly Report on Form 10-Q for the quarterly period ended September 30, 201829, 2019
RArheumatoid arthritis
RCCrenal cell carcinoma
R&Dresearch and development
RPIROURPI Finance Trustright of use
SandozSandoz, Inc., a division of Novartis AG
SECU.S. Securities and Exchange Commission
ServierLes Laboratoires Servier SAS
SFJSFJ Pharmaceuticals Group
ShireShire International GmbH
SI&ASelling,selling, informational and administrative
SIPSterile Injectable Pharmaceuticals
S&PStandard and Poor’s
StratCOStrategy and Commercial Operations
Tax Cuts and Jobs Act or TCJALegislationlegislation commonly referred to as the U.S. Tax Cuts and Jobs Act of 2017
TeutoTherachonLaboratório Teuto Brasileiro S.A.Therachon Holding AG
UCulcerative colitis
U.K.United Kingdom
U.S.United States
ViiVViiV Healthcare Limited
WRDVBPVolume-based procurement program
WRDMWorldwide Research, Development and DevelopmentMedical




PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS, EXCEPT PER COMMON SHARE DATA)��September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

 September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Revenues $13,298
 $13,168
 $39,670
 $38,843
 $12,680
 $13,298
 $39,062
 $39,670
Costs and expenses:                
Cost of sales(a)
 2,694
 2,844
 8,173
 7,972
 2,602
 2,694
 7,611
 8,173
Selling, informational and administrative expenses(a)
 3,494
 3,504
 10,448
 10,249
 3,260
 3,494
 10,110
 10,448
Research and development expenses(a)
 2,008
 1,865
 5,549
 5,367
 2,283
 2,008
 5,827
 5,549
Amortization of intangible assets 1,253
 1,177
 3,640
 3,571
 1,212
 1,253
 3,578
 3,640
Restructuring charges and certain acquisition-related costs 85
 114
 172
 267
 365
 85
 295
 172
(Gain) on completion of Consumer Healthcare JV transaction (8,087) 
 (8,087) 
Other (income)/deductions––net (414) 79
 (1,143) 65
 319
 (414) 537
 (1,143)
Income from continuing operations before provision for taxes on income 4,177
 3,585
 12,831
 11,351
 10,727
 4,177
 19,190
 12,831
Provision for taxes on income 66
 727
 1,270
 2,287
 3,047
 66
 2,566
 1,270
Income from continuing operations 4,111
 2,858
 11,562
 9,064
 7,680
 4,111
 16,625
 11,562
Discontinued operations––net of tax 11
 
 10
 1
 4
 11
 4
 10
Net income before allocation to noncontrolling interests 4,122
 2,858
 11,571
 9,066
 7,684
 4,122
 16,628
 11,571
Less: Net income attributable to noncontrolling interests 8
 18
 25
 32
 4
 8
 19
 25
Net income attributable to Pfizer Inc. $4,114
 $2,840
 $11,546
 $9,034
 $7,680
 $4,114
 $16,609
 $11,546
                
Earnings per common share––basic:
  
  
  
  
  
  
  
  
Income from continuing operations attributable to Pfizer Inc. common shareholders $0.70
 $0.48
 $1.96
 $1.51
 $1.38
 $0.70
 $2.98
 $1.96
Discontinued operations––net of tax 
 
 
 
 
 
 
 
Net income attributable to Pfizer Inc. common shareholders $0.70
 $0.48
 $1.96
 $1.51
 $1.38
 $0.70
 $2.98
 $1.96
                
Earnings per common share––diluted:
  
  
  
  
  
  
  
  
Income from continuing operations attributable to Pfizer Inc. common shareholders $0.69
 $0.47
 $1.92
 $1.49
 $1.36
 $0.69
 $2.92
 $1.92
Discontinued operations––net of tax 
 
 
 
 
 
 
 
Net income attributable to Pfizer Inc. common shareholders $0.69
 $0.47
 $1.92
 $1.49
 $1.36
 $0.69
 $2.92
 $1.92
                
Weighted-average shares––basic 5,875
 5,951
 5,899
 5,972
 5,545
 5,875
 5,581
 5,899
Weighted-average shares––diluted 5,986
 6,041
 5,998
 6,057
 5,649
 5,986
 5,690
 5,998
Cash dividends paid per common share $0.34
 $0.32
 $1.02
 $0.96
(a) 
Excludes amortization of intangible assets, except as disclosed in Note 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets.
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(UNAUDITED)
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Net income before allocation to noncontrolling interests $7,684
 $4,122
 $16,628
 $11,571
       
  
Foreign currency translation adjustments, net (468) (567) (628) (507)
Reclassification adjustments(a)
 268
 (2) 270
 (22)
  (200) (569) (358) (530)
Unrealized holding gains on derivative financial instruments, net 150
 222
 241
 236
Reclassification adjustments for (gains)/losses included in net income(b)
 (29) (235) (372) 119
  122
 (13) (131) 355
Unrealized holding gains/(losses) on available-for-sale securities, net 15
 149
 48
 (65)
Reclassification adjustments for (gains)/losses included in net income(b)
 (7) (36) 30
 (67)
Reclassification adjustments for unrealized gains included in Retained earnings(c)
 
 
 
 (462)
  8
 112
 77
 (595)
Benefit plans: actuarial gains/(losses), net (171) 8
 (175) 114
Reclassification adjustments related to amortization 60
 60
 180
 183
Reclassification adjustments related to settlements, net 38
 42
 40
 108
Other 42
 49
 60
 69
  (31) 158
 105
 474
Benefit plans: prior service costs and other, net 
 
 (1) 
Reclassification adjustments related to amortization of prior service costs and other, net (44) (46) (137) (137)
Reclassification adjustments related to curtailments of prior service costs and other, net (46) (4) (46) (18)
Other 3
 
 4
 1
  (88) (50) (180) (154)
Other comprehensive loss, before tax (190) (361) (486) (449)
Tax provision on other comprehensive loss 84
 62
 50
 667
Other comprehensive loss before allocation to noncontrolling interests $(275) $(422) $(536) $(1,116)
Comprehensive income before allocation to noncontrolling interests $7,409
 $3,700
 $16,092
 $10,455
Less: Comprehensive income/(loss) attributable to noncontrolling interests (6) 
 8
 5
Comprehensive income attributable to Pfizer Inc. $7,415
 $3,700
 $16,084
 $10,450
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

Net income before allocation to noncontrolling interests $4,122
 $2,858
 $11,571
 $9,066
       
  
Foreign currency translation adjustments, net (567) 878
 (507) 1,352
Reclassification adjustments (2) (3) (22) 110
  (569) 875
 (530) 1,461
Unrealized holding gains/(losses) on derivative financial instruments, net 222
 (50) 236
 (149)
Reclassification adjustments for (gains)/losses included in net income(a)
 (235) 56
 119
 (393)
  (13) 6
 355
 (542)
Unrealized holding gains/(losses) on available-for-sale securities, net 149
 384
 (65) 698
Reclassification adjustments for gains included in net income(a)
 (36) (278) (67) (181)
Reclassification adjustments for unrealized gains included in Retained earnings(b)
 
 
 (462) 
  112
 106
 (595) 518
Benefit plans: actuarial gains/(losses), net 8
 (103) 114
 (41)
Reclassification adjustments related to amortization 60
 140
 183
 448
Reclassification adjustments related to settlements, net 42
 38
 108
 89
Other 49
 (76) 69
 (111)
  158
 (1) 474
 384
Benefit plans: prior service costs and other, net 
 
 
 (2)
Reclassification adjustments related to amortization (46) (46) (137) (138)
Reclassification adjustments related to curtailments, net (4) (3) (18) (14)
Other 
 1
 1
 2
  (50) (48) (154) (151)
Other comprehensive income/(loss), before tax (361) 938
 (449) 1,669
Tax provision/(benefit) on other comprehensive income/(loss) 62
 (80) 667
 (218)
Other comprehensive income/(loss) before allocation to noncontrolling interests $(422) $1,018
 $(1,116) $1,888
         
Comprehensive income before allocation to noncontrolling interests $3,700
 $3,876
 $10,455
 $10,953
Less: Comprehensive income attributable to noncontrolling interests 
 19
 5
 48
Comprehensive income attributable to Pfizer Inc. $3,700
 $3,857
 $10,450
 $10,906

(a) 
ReclassifiedFor the third quarter and first nine months of 2019, the foreign currency translation adjustments are primarily reclassified into (Gain) on completion of Consumer Healthcare JV transaction in the condensed consolidated statements of income as a result of the contribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with GSK. See Note 2B. The remaining foreign currency translation adjustments are reclassified into Other (income)/deductions—net in the condensed consolidated statements of income.
(b)
Reclassified into Other (income)/deductions—net and Cost of sales in the condensed consolidated statements of income. For additional information on amounts reclassified into Other (income)/deductions—net and Cost of sales, see Note 7F.7E. Financial Instruments: Derivative Financial Instruments and Hedging Activities.
(b)(c) 
For additional information, see Notes to Consolidated Financial StatementsNote 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards. in 2018 in our 2018 Financial Report.
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(MILLIONS OF DOLLARS) September 29,
2019

 December 31,
2018

  (Unaudited)  
Assets    
Cash and cash equivalents $2,785
 $1,139
Short-term investments 6,302
 17,694
Trade accounts receivable, less allowance for doubtful accounts: 2019—$541; 2018—$541 9,439
 8,025
Inventories 8,222
 7,508
Current tax assets 3,730
 3,374
Other current assets 2,954
 2,461
Assets held for sale 29
 9,725
Total current assets 33,459
 49,926
Equity-method investments 15,999
 181
Long-term investments 2,723
 2,586
Property, plant and equipment, less accumulated depreciation: 2019—$16,728; 2018—$16,591 13,701
 13,385
Identifiable intangible assets, less accumulated amortization 38,995
 35,211
Goodwill 58,665
 53,411
Noncurrent deferred tax assets and other noncurrent tax assets 1,984
 1,924
Other noncurrent assets 4,920
 2,799
Total assets $170,446
 $159,422
     
Liabilities and Equity  
  
Short-term borrowings, including current portion of long-term debt: 2019—$2,431; 2018—$4,776 $16,617
 $8,831
Trade accounts payable 3,942
 4,674
Dividends payable 1,992
 2,047
Income taxes payable 1,892
 1,265
Accrued compensation and related items 2,369
 2,397
Other current liabilities 10,160
 10,753
Liabilities held for sale 
 1,890
Total current liabilities 36,974
 31,858
     
Long-term debt 36,044
 32,909
Pension benefit obligations, net 5,103
 5,272
Postretirement benefit obligations, net 1,321
 1,338
Noncurrent deferred tax liabilities 6,724
 3,700
Other taxes payable 12,504
 14,737
Other noncurrent liabilities 6,381
 5,850
Total liabilities 105,051
 95,664
     
Commitments and Contingencies 


 


     
Preferred stock 18
 19
Common stock 468
 467
Additional paid-in capital 87,099
 86,253
Treasury stock (110,795) (101,610)
Retained earnings 100,113
 89,554
Accumulated other comprehensive loss (11,801) (11,275)
Total Pfizer Inc. shareholders’ equity 65,103
 63,407
Equity attributable to noncontrolling interests 293
 351
Total equity 65,396
 63,758
Total liabilities and equity $170,446
 $159,422
(MILLIONS OF DOLLARS) September 30,
2018

 December 31,
2017

  (Unaudited)  
Assets    
Cash and cash equivalents $3,559
 $1,342
Short-term investments 13,680
 18,650
Trade accounts receivable, less allowance for doubtful accounts: 2018—$567; 2017—$584 10,024
 8,221
Inventories 8,184
 7,578
Current tax assets 3,686
 3,050
Other current assets 2,450
 2,301
Total current assets 41,583
 41,141
Long-term investments 6,444
 7,015
Property, plant and equipment, less accumulated depreciation: 2018—$17,078; 2017—$16,172 14,036
 13,865
Identifiable intangible assets, less accumulated amortization 45,306
 48,741
Goodwill 55,614
 55,952
Noncurrent deferred tax assets and other noncurrent tax assets 1,875
 1,855
Other noncurrent assets 2,980
 3,227
Total assets $167,838
 $171,797
     
Liabilities and Equity  
  
Short-term borrowings, including current portion of long-term debt: 2018—$4,255; 2017—$3,546 $7,385
 $9,953
Trade accounts payable 4,297
 4,656
Dividends payable 1,963
 2,029
Income taxes payable 2,781
 477
Accrued compensation and related items 2,096
 2,196
Other current liabilities 10,490
 11,115
Total current liabilities 29,013
 30,427
     
Long-term debt 33,652
 33,538
Pension benefit obligations, net 4,886
 5,926
Postretirement benefit obligations, net 1,455
 1,504
Noncurrent deferred tax liabilities 5,512
 3,900
Other taxes payable 15,289
 18,697
Other noncurrent liabilities 6,367
 6,149
Total liabilities 96,174
 100,141
     
Commitments and Contingencies 

 

     
Preferred stock 20
 21
Common stock 466
 464
Additional paid-in capital 85,828
 84,278
Treasury stock (96,574) (89,425)
Retained earnings 91,995
 85,291
Accumulated other comprehensive loss (10,417) (9,321)
Total Pfizer Inc. shareholders’ equity 71,319
 71,308
Equity attributable to noncontrolling interests 346
 348
Total equity 71,664
 71,656
Total liabilities and equity $167,838
 $171,797

Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.

PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF EQUITY

  PFIZER INC. SHAREHOLDERS    
  Preferred Stock Common Stock   Treasury Stock          
(MILLIONS, EXCEPT PREFERRED SHARES) Shares
 Stated Value
 Shares
 Par Value
 
Add’l
Paid-In Capital

 Shares
 Cost
 Retained Earnings
 
Accum. Other Comp.
Loss

 
Share-
holders’ Equity

 Non-controlling interests
 Total Equity
Balance, June 30, 2019 458
 $18
 9,363
 $468
 $86,963
 (3,801) $(110,786) $94,440
 $(11,535) $59,568
 $357
 $59,924
Net income               7,680
   7,680
 4
 7,684
Other comprehensive income/(loss), net of tax                 (265) (265) (9) (275)
Cash dividends declared:                   

   

Common stock               (2,006)   (2,006)   (2,006)
Preferred stock               
   
   
Noncontrolling interests                   
 2
 2
Share-based payment transactions     3
 
 136
 
 (8)     128
   128
Purchases of common stock           (34) 
     
   
Preferred stock conversions and redemptions (8) 
     
 
 
     (1)   (1)
Other(a)
   

   

 
 
 
 
 
 
 (61) (61)
Balance, September 29, 2019 449
 $18
 9,366
 $468
 $87,099
 (3,835) $(110,795) $100,113
 $(11,801) $65,103
 $293
 $65,396
 
  PFIZER INC. SHAREHOLDERS    
  Preferred Stock Common Stock   Treasury Stock          
(MILLIONS, EXCEPT PREFERRED SHARES) Shares
 Stated Value
 Shares
 Par Value
 
Add’l
Paid-In Capital

 Shares
 Cost
 Retained Earnings
 
Accum. Other Comp.
Loss

 
Share-
holders’ Equity

 Non-controlling interests
 Total Equity
Balance July 1, 2018 502
 $20
 9,303
 $465
 $84,898
 (3,438) $(95,463) $89,860
 $(10,003) $69,778
 $346
 $70,124
Net income               4,114
   4,114
 8
 4,122
Other comprehensive income/(loss), net of tax               

 (414) (414) (9) (422)
Cash dividends declared:                        
Common stock               (1,977)   (1,977)   (1,977)
Preferred stock               
   
   
Noncontrolling interests               

   
 
 
Share-based payment transactions     23
 1
 930
 
 (6) 

   926
   926
Purchases of common stock           (47) (1,105) 

   (1,105)   (1,105)
Preferred stock conversions and redemptions (14) (1)     (1) 
 
 

   (1)   (1)
Other   

     
 
 

 (2) 
 (2) 
 (2)
Balance, September 30, 2018 488
 $20
 9,326
 $466
 $85,828
 (3,484) $(96,574) $91,995
 $(10,417) $71,319
 $346
 $71,664

Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.

PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF EQUITY
  PFIZER INC. SHAREHOLDERS    
  Preferred Stock Common Stock   Treasury Stock          
(MILLIONS, EXCEPT PREFERRED SHARES) Shares
 Stated Value
 Shares
 Par Value
 
Add’l
Paid-In Capital

 Shares
 Cost
 Retained Earnings
 
Accum. Other Comp.
Loss

 
Share-
holders’ Equity

 Non-controlling interests
 Total Equity
Balance, January 1, 2019 478
 $19
 9,332
 $467
 $86,253
 (3,615) $(101,610) $89,554
 $(11,275) $63,407
 $351
 $63,758
Net income               16,609
   16,609
 19
 16,628
Other comprehensive income/(loss), net of tax                 (525) (525) (11) (536)
Cash dividends declared:                       

Common stock               (6,068)   (6,068)   (6,068)
Preferred stock               (1)   (1)   (1)
Noncontrolling interests                   
 (5) (5)
Share-based payment transactions     34
 2
 848
 (7) (320)     530
   530
Purchases of common stock           (213) (8,865)     (8,865)   (8,865)
Preferred stock conversions and redemptions (28) (1)     (2) 
 
     (3)   (3)
Other(a)
   

   

 
 
 

 19
 

 19
 (61) (42)
Balance, September 29, 2019 449
 $18
 9,366
 $468
 $87,099
 (3,835) $(110,795) $100,113
 $(11,801) $65,103
 $293
 $65,396
 
  PFIZER INC. SHAREHOLDERS    
  Preferred Stock Common Stock   Treasury Stock          
(MILLIONS, EXCEPT PREFERRED SHARES) Shares
 Stated Value
 Shares
 Par Value
 
Add’l
Paid-In Capital

 Shares
 Cost
 Retained Earnings
 
Accum. Other Comp.
Loss

 
Share-
holders’ Equity

 Non-controlling interests
 Total Equity
Balance, January 1, 2018 524
 $21
 9,275
 $464
 $84,278
 (3,296) $(89,425) $85,291
 $(9,321) $71,308
 $348
 $71,656
Net income               11,546
   11,546
 25
 11,571
Other comprehensive income/(loss), net of tax               

 (1,096) (1,096) (20) (1,116)
Cash dividends declared:                        
Common stock               (6,012)   (6,012)   (6,012)
Preferred stock               (1)   (1)   (1)
Noncontrolling interests                   
 (7) (7)
Share-based payment transactions     51
 3
 1,551
 3
 19
     1,573
   1,573
Purchases of common stock           (192) (7,168)     (7,168)   (7,168)
Preferred stock conversions and redemptions (36) (1)     (2) 
 
     (3)   (3)
Other(b)
   

   

 
 
 
 1,171
 
 1,171
 
 1,171
Balance, September 30, 2018 488
 $20
 9,326
 $466
 $85,828
 (3,484) $(96,574) $91,995
 $(10,417) $71,319
 $346
 $71,664
(a)
The increase to Retained earnings in the first nine months of 2019 includes the cumulative effect of the adoption of a new accounting standard for leases in the first quarter of 2019. For additional information, see Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards. The decrease in Equity attributable to noncontrolling interests resulted from the deconsolidation of our Consumer Healthcare business in connection with the formation of the GSK Consumer Healthcare joint venture. For additional information, see Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Equity-Method Investment and Assets and Liabilities Held for Sale.
(b)
Represents the cumulative effect of the adoption of new accounting standards in the first quarter of 2018 for revenues, financial assets and liabilities, income tax accounting, and the reclassification of certain tax effects from Accumulated other comprehensive income. For additional information, see Notes to Consolidated Financial Statements––Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards in 2018 in our 2018 Financial Report.
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.

PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)



  Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

Operating Activities    
Net income before allocation to noncontrolling interests $16,628
 $11,571
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities:  
  
Depreciation and amortization 4,626
 4,743
Asset write-offs and impairments 224
 88
TCJA impact(a)
 (319) (410)
Gain on completion of Consumer Healthcare JV transaction, net of cash conveyed(b)
 (8,233) 
Deferred taxes from continuing operations(c)
 2,067
 (974)
Share-based compensation expense 448
 682
Benefit plan contributions in excess of income (429) (1,000)
Other adjustments, net (622) (1,170)
Other changes in assets and liabilities, net of acquisitions and divestitures (5,571) (2,441)
Net cash provided by operating activities 8,819
 11,089
     
Investing Activities  
  
Purchases of property, plant and equipment (1,504) (1,357)
Purchases of short-term investments (4,583) (7,364)
Proceeds from redemptions/sales of short-term investments 7,766
 12,752
Net proceeds from redemptions/sales of short-term investments with original maturities of three months or less 8,307
 385
Purchases of long-term investments (134) (1,503)
Proceeds from redemptions/sales of long-term investments 116
 2,174
Acquisition of business, net of cash acquired (10,861) 
Acquisitions of intangible assets (364) (47)
Other investing activities, net(b)
 145
 248
Net cash provided by/(used in) investing activities (1,112) 5,289
     
Financing Activities  
  
Proceeds from short-term borrowings 11,582
 1,945
Principal payments on short-term borrowings (4,088) (4,239)
Net proceeds from/(payments on) short-term borrowings with original maturities of three months or less 2,604
 (973)
Proceeds from issuance of long-term debt 4,942
 4,974
Principal payments on long-term debt (5,806) (3,104)
Purchases of common stock (8,865) (7,168)
Cash dividends paid (6,051) (6,015)
Proceeds from exercise of stock options 303
 1,099
Other financing activities, net (667) (553)
Net cash used in financing activities (6,045) (14,034)
Effect of exchange-rate changes on cash and cash equivalents and restricted cash and cash equivalents (41) (116)
Net increase in cash and cash equivalents and restricted cash and cash equivalents 1,620
 2,227
Cash and cash equivalents and restricted cash and cash equivalents, beginning 1,225
 1,431
Cash and cash equivalents and restricted cash and cash equivalents, end $2,846
 $3,658
- continued -


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
  Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

Operating Activities    
Net income before allocation to noncontrolling interests $11,571
 $9,066
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities:  
  
Depreciation and amortization 4,743
 4,695
Asset write-offs and impairments 88
 326
Adjustments to loss on sale of HIS net assets (1) 52
TCJA impact(a)
 (410) 
Deferred taxes from continuing operations (974) 241
Share-based compensation expense 682
 595
Benefit plan contributions in excess of income––2018 and expense––2017
 (1,000) (1,042)
Other adjustments, net (1,169) (604)
Other changes in assets and liabilities, net of acquisitions and divestitures (2,441) (3,616)
Net cash provided by operating activities 11,089
 9,713
     
Investing Activities  
  
Purchases of property, plant and equipment (1,357) (1,256)
Purchases of short-term investments (7,364) (6,469)
Proceeds from redemptions/sales of short-term investments 12,752
 5,778
Net proceeds from redemptions/sales of short-term investments with original maturities of three months or less 385
 2,758
Purchases of long-term investments (1,503) (2,526)
Proceeds from redemptions/sales of long-term investments 2,174
 2,403
Acquisitions of businesses, net of cash acquired 
 (1,000)
Acquisitions of intangible assets (47) (188)
Other investing activities, net 248
 519
Net cash provided by investing activities 5,289
 19
     
Financing Activities  
  
Proceeds from short-term borrowings 1,945
 7,003
Principal payments on short-term borrowings (4,239) (7,659)
Net (payments on)/proceeds from short-term borrowings with original maturities of three months or less (973) 566
Proceeds from issuance of long-term debt 4,974
 5,273
Principal payments on long-term debt (3,104) (4,474)
Purchases of common stock (7,168) (5,000)
Cash dividends paid (6,015) (5,750)
Proceeds from exercise of stock options 1,099
 656
Other financing activities, net (553) (223)
Net cash used in financing activities (14,034) (9,607)
Effect of exchange-rate changes on cash and cash equivalents and restricted cash and cash equivalents (116) 67
Net increase in cash and cash equivalents and restricted cash and cash equivalents 2,227
 193
Cash and cash equivalents and restricted cash and cash equivalents, beginning 1,431
 2,666
Cash and cash equivalents and restricted cash and cash equivalents, end $3,658
 $2,858
   
  
Supplemental Cash Flow Information    
Non-cash transactions:    
Receipt of ICU Medical common stock(b)
 $
 $428
Promissory note from ICU Medical(b)
 
 75
Equity investment in Cerevel Therapeutics, Inc. in exchange for Pfizer’s portfolio of clinical and preclinical neuroscience assets(b)
 343
 
Equity investment in Allogene received in exchange for Pfizer's allogeneic CAR T developmental program assets(b)
 92
 
Cash paid (received) during the period for:  
  
Income taxes $1,666
 $1,424
Interest 968
 1,101
Interest rate hedges (104) (183)

 
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

Supplemental Cash Flow Information    
Non-cash transactions:    
32% equity-method investment in GSK Consumer Healthcare JV in exchange for contributing Pfizer’s Consumer Healthcare business(b)
 $15,711
 $
Equity investment in Cerevel Therapeutics, Inc. in exchange for Pfizer’s portfolio of clinical and pre-clinical neuroscience assets(d)
 
 343
Equity investment in Allogene received in exchange for Pfizer's allogeneic CAR T developmental program assets(d)
 
 92
Cash paid (received) during the period for:  
  
Income taxes 2,636
 1,666
Interest paid 1,246
 968
Interest rate hedges (78) (104)

(a) 
As a result of the enactment of the TCJA in December 2017, Pfizer’s Provision for taxes on income for (i) the nine months ended September 29, 2019 was favorably impacted by approximately $319 million, primarily as a result of additional guidance issued by the U.S. Department of Treasury and (ii) the nine months ended September 30, 2018 was favorably impacted by approximately $410 million, primarily related to certain tax initiatives associated with the TCJA,lower U.S. tax rate as well as favorable adjustmentsa result of the TCJA.
(b)
The $8.2 billion Gain on completion of Consumer Healthcare JV transaction, net of cash conveyed reflects the receipt of a 32% equity-method investment in the new company valued at $15.7 billion in exchange for net assets contributed of $7.6 billion and is presented in operating activities net of $146 million cash conveyed that is reflected in Other investing activities, net. For additional information, see Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement:Equity-Method Investment and Assets and Liabilities Held for Sale.
(c)
Includes tax expense of $2.7 billion associated with the gain related to the provisional estimatescompletion of the legislation. See Consumer Healthcare joint venture transaction with GSK. For additional information, see Note 5A. 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement:Equity-Method Investment and Assets and Liabilities Held for Saleand Note 5A. Tax Matters: Taxes on Income from Continuing Operations.
(b)(d)  
For additional information, see Notes to Consolidated Financial Statements––Note 2B. Acquisition,2B. Acquisitions, Divestitures, Assets and Liabilities Held for Sale, Licensing Arrangements, Research and Development and Collaborative Arrangements, Equity-Method Investments and Privately Held Investment: Divestitures.Investment: Divestitures: Divestitures in our 2018 Financial Report.
Amounts may not add due to rounding.
See Notes to Condensed Consolidated Financial Statements.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)




Note 1. Basis of Presentation and Significant Accounting Policies


A. Basis of Presentation


See the Glossary of Defined Terms at the beginning of this Quarterly Report on Form 10-Q for terms used throughout the condensed consolidated financial statements and related notes in this Quarterly Report on Form 10-Q.


We prepared the condensed consolidated financial statements following the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted.


The financial information included in our condensed consolidated financial statements for subsidiaries operating outside the U.S. is as of and for the three and nine months ended August 26, 201825, 2019 and August 27, 2017.26, 2018. The financial information included in our condensed consolidated financial statements for U.S. subsidiaries is as of and for the three and nine months ended September 29, 2019 and September 30, 2018 and October 1, 2017.


Revenues, expenses, assets and liabilities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year.


We are responsible for the unaudited financial statements included in this Quarterly Report on Form 10-Q. The interim financial statements include all normal and recurring adjustments that are considered necessary for the fair statement of our condensed consolidated balance sheets and condensed consolidated statements of income.results for the interim periods presented. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our 20172018 Financial Report.


WeAt the beginning of our 2019 fiscal year, we began to manage our commercial operations through two distincta new global structure consisting of 3 business segments: segments––Pfizer Innovative Health (IH)Biopharmaceuticals Group (Biopharma), Upjohn and Pfizer Essential Health (EH).through July 31, 2019, Consumer Healthcare. Biopharma and Upjohn are the only reportable segments. We have revised prior-period segment information to reflect the reorganization. For additional information, see Note 13 and Notes. In addition, certain amounts within Long-term investments in the December 31, 2018 condensed consolidated balance sheet have been reclassified to Consolidated Financial Statements––Equity-method investments to conform to the current presentation. For additional information, see Note 18. Segment, Geographic and Other Revenue Information in Pfizer’s 2017 Financial Report.2B.


Certain amounts in the condensed consolidated financial statements and associated notes may not add due to rounding. All percentages have been calculated using unrounded amounts.


In the first quarter of 2018,2019, as of January 1, 2018,2019, we adopted eleven4 new accounting standards. See Note 1B for further information.


Our recent significant business development activities include:
Formation of a New Consumer Healthcare Joint Venture––On July 31, 2019, we completed the transaction in which we and GSK combined our respective consumer healthcare businesses into a new consumer healthcare joint venture that operates globally under the GSK Consumer Healthcare name. In accordance with our domestic and international reporting periods, our financial results, and our Consumer Healthcare segment’s operating results, for the third quarter of 2019 reflect only one month of Consumer Healthcare segment domestic operations and two months of Consumer Healthcare segment international operations. Likewise, our financial results, and our Consumer Healthcare segment’s operating results, for the first nine months of 2019 reflect seven months of Consumer Healthcare segment domestic operations and eight months of Consumer Healthcare segment international operations. Assets and liabilities associated with our Consumer Healthcare business were reclassified as held for sale in the consolidated balance sheet as of December 31, 2018.
Acquisition of Array BioPharma Inc.––On July 30, 2019, we acquired Array for $48 per share in cash. The total fair value of the consideration transferred for Array was approximately $11.2 billion ($10.9 billion, net of cash acquired). Our financial statements for the third quarter and first nine months of 2019 reflect the assets, liabilities, operating results and cash flows of Array, commencing from the acquisition date.
Agreement to Combine Upjohn with Mylan N.V.––On July 29, 2019, we announced that we entered into a definitive agreement to combine Upjohn with Mylan, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, Upjohn is expected to be spun-off or split-off to Pfizer’s shareholders and, immediately thereafter, combined with Mylan. Pfizer shareholders would own 57% of the combined new company, and former Mylan shareholders would own 43%. The transaction is expected to be tax free to Pfizer
On February 3, 2017, we completed the sale of our global infusion systems net assets, HIS, to ICU Medical. The operating results of HIS are included in our condensed consolidated statement of income and EH’s operating results through February 2, 2017 and, therefore, our financial results, and EH’s operating results, for the third quarter of 2017 do not reflect any contribution from HIS global operations, while our financial results, and EH’s operating results, for the first nine months of 2017 reflect approximately one month of HIS domestic operations and approximately two months of HIS international operations. Our financial results, and EH’s operating results, for 2018 do not reflect any contribution from HIS global operations.
On December 22, 2016, which fell 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 financial results, EH’s operating results, and cash flows for the third quarter and first nine months of 2017 reflect approximately three months and eight months, respectively, of the small molecule anti-infectives business acquired from AstraZeneca. Our financial results, EH’s operating results, and cash flows for the third quarter and first nine months of 2018 reflect three months and nine months, respectively, of the small molecule anti-infectives business acquired from AstraZeneca.
For additional information, see Note 2 and Notes to Consolidated Financial Statements––Note 2. Acquisitions, Sale of Hospira Infusion Systems Net Assets, Research and Development and Collaborative Arrangements, Equity-Method Investments and Cost-Method Investment inPfizer’s 2017 Financial Report.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


and Pfizer shareholders. The transaction is anticipated to close in mid-2020, subject to Mylan shareholder approval and satisfaction of other customary closing conditions, including receipt of regulatory approvals.
Acquisition of Therachon Holding AG––On July 1, 2019, we acquired all the remaining shares of Therachon for $340 million upfront, plus potential milestone payments of up to $470 million, contingent on the achievement of key milestones in the development and commercialization of the lead asset. The total fair value of the consideration transferred for Therachon was approximately $322 million. Our financial statements for the third quarter and first nine months of 2019 reflect the assets, liabilities, operating results and cash flows of Therachon, commencing from the acquisition date and, in accordance with our international reporting period, reflect two months of Therachon operations and cash flows.
For additional information, see Note 2 below and Notes to Consolidated Financial Statements––Note 2. Acquisitions, Divestitures, Assets and Liabilities Held for Sale, Licensing Arrangements, Research and Development and Collaborative Arrangements, Equity-Method Investments and Privately Held Investment inPfizer’s 2018 Financial Report.
B. Adoption of New Accounting Standards
On January 1, 2018,2019, we adopted eleven4 new accounting standards. The quantitative impacts on our prior period condensed consolidated financial statements of adopting the following new standards are summarized in the tables within the section titled Impacts to our Condensed Consolidated Financial Statements, further below.
RevenuesLeases––WeOn January 1, 2019, we adopted a new accounting standard for revenue recognitionleases and changed our revenue recognitionlease policies accordingly. Generally, the previous revenue recognition standards permitted recognition when persuasive evidence of a contract existed, delivery had occurred, and the seller's price to the buyer was fixed or determinable. Under the new standard, revenuethe most significant change is recognized upon transferthe requirement of controlbalance sheet recognition of the product to our customer in an amount that reflects the consideration we expect to receive in exchange.ROU assets and lease liabilities by lessees for those leases classified as operating leases. We adopted the new accounting standard utilizing the modified retrospective method using a simplified transition approach, and, therefore, no adjustments were made to amounts in our prior period financial statements. We have elected the package of practical expedients for transition which are permitted in the new standard. Accordingly, we did not reassess whether (i) any expired or existing contracts are or contain leases under the new standard, (ii) classification of leases as operating leases or capital leases would be different under the new standard, or (iii) any initial direct costs would have met the definition of initial direct costs under the new standard. Additionally, we did not elect to use hindsight in determining the lease term for existing leases as of January 1, 2019. We recorded noncurrent ROU assets of $1.4 billion and current and noncurrent operating lease liabilities of $1.4 billion as of January 1, 2019. We also recorded the cumulative effect of adopting the standard as an adjustment to increase the opening balance of Retained earnings by $584$30 million on a pre-tax basis ($45020 million after-tax). This amount includes $500 million (pre-tax), relating to previously deferred sale-leaseback gains that can be recognized under the new rules.
Adopting the standard related to leases impacted our prior period condensed consolidated balance sheet as follows:
(MILLIONS OF DOLLARS) 
As Previously Reported Balance at
December 31, 2018

 
Effect of Change
Higher/(Lower)

 
Balance at
January 1, 2019

Other current assets $2,461
 $(1) $2,460
Noncurrent deferred tax assets and other noncurrent tax assets 1,924
 (11) 1,913
Other noncurrent assets 2,799
 1,351
 4,149
Other current liabilities 10,753
 258
 11,011
Other noncurrent liabilities 5,850
 1,060
 6,910
Retained earnings 89,554
 20
 89,574

Adoption of the standard related to the timing of recognizing Other (income)/deductions––net primarily for upfront and milestone payments on our collaboration arrangements ($394 million, pre-tax) and, to a lesser extent, product rights and out-licensing arrangements, and $84 million (pre-tax) related to the timing of recognizing Revenues and Cost of sales on certain product shipments. The impact of adoptionleases did not have a material impact toon our condensed consolidated statements of income for the three and nine months ended September 30, 2018or our condensed consolidated balance sheet as of September 30, 2018. For additional information, see Note 1C.
Financial Assets and Liabilities––The new accounting standard related to the recognition and measurement of financial assets and liabilities makes the following changes to prior guidance and requires:
certain equity investments to be measured at fair value with changes in fair value now recognized in net income. However, equity investments that do not have readily determinable fair values may be measured 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;
a qualitative assessment of equity investments without readily determinable fair values to identify impairment; and
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.
We adopted the new accounting standard utilizing the modified retrospective method, and, therefore, no adjustments were made to amounts in our prior period financial statements. We recorded the cumulative effect of adopting the standard as an adjustment to increase the opening balance of Retained earnings by $462 million on a pre-tax basis ($419 million after-tax) related to the net impact of unrealized gains and losses primarily on available-for-sale equity securities, restricted stock and private equity securities. In the third quarter of 2018, we recorded net unrealized gains on equity securities of $8 million and in the first nine months of 2018, we recorded net unrealized gains on equity securities of $344 million, in Other (income)/deductions––net. For additional information, see Note 4 and Note 7.

Presentation of Net Periodic Pension and Postretirement Benefit Cost––We adopted a new accounting standard that requires the net periodic pension and postretirement benefit costs other than the service costs be presented in Other (income)/deductions––net, and that the presentation be applied retrospectively. We adopted the presentation of the net periodic benefit costs other than service costs by reclassifying these costs from Cost of sales, Selling, informational and administrative expenses, Research and development expenses and Restructuring charges and certain acquisition-related costs to Other (income)/deductions––net. We elected to apply the practical expedient as it is impracticable to determine the disaggregation of the cost components for amounts capitalized within Inventories and property, plant and equipment and amortized in each of those periods. We have therefore reclassified the prior period net periodic benefit costs/(credits) disclosed in Note 10 to apply the retrospective presentation for comparative periods.
As of January 1, 2018, only service costs will be included in amounts capitalized in Inventories or property, plant and equipment, while the other components of net periodic benefit costs will be included in Other (income)/deductions––net. For additional information, see Note 4 and Note 10.
Income Tax Accounting––The new guidance removes the prohibition against recognizing current and deferred income taxes for an intra-entity asset transfer until the asset has been sold to a third party, unless the asset transferred is inventory. We adopted the standard utilizing the modified retrospective method, and, therefore, no adjustments were made to amounts in our prior period financial statements. We recorded the cumulative effect of adopting the standard as an adjustment to decrease the opening balance of Retained earnings by $189 million.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Accounting for Hedging Activities––The standard includes the following changes:
Permits hedge accounting for risk components in hedging relationships involving nonfinancial risk and interest rate risk;
Changes the guidance for designating fair value hedges of interest rate risk and for measuring the change in fair value of the hedged item in fair value hedges of interest rate risk;
No longer requires the separate measurement and reporting of hedge ineffectiveness, but requires the income statement presentation of the earnings effect of the hedging instrument with the earnings effect of the hedged item;
Permits us to exclude the portion of the change in fair value of a currency swap that is attributable to a cross-currency basis spread from the assessment of hedge effectiveness; and
Simplifies hedge effectiveness testing.
We early adopted the new accounting standard on January 1, 2018 on a prospective basis. In the third quarter of 2018, we recorded income of $23 million and in the first nine months of 2018, we recorded income of $68 million in Other (income)/deductions––net, whereas this item would have been classified in interest income in prior periods. For additional information, see Note 7F.
Reclassification of Certain Tax Effects from AOCI––We early adopted a new accounting standard that provides guidance on the reclassification of certain tax effects from AOCI. Under the new guidance, we elected to reclassify the stranded tax amounts related to the TCJA from AOCI to Retained earnings. We adopted the new accounting standard utilizing the modified retrospective method, and recorded the cumulative effect of adopting the standard as an adjustment to increase the opening balance of Retained earnings by $495 million, primarily due to the effect of the change in the U.S. Federal corporate tax rate. The impact on other stranded tax amounts related to the application of the TCJA was not material to our condensed consolidated financial statements.
Classification of Certain Transactions in the Statement of Cash Flows––We retrospectively adopted an accounting standard that changed the presentation of certain information in the condensed consolidated statements of cash flows including the classification of:
debt prepayment and extinguishment costs, resulting in an increase in Operating activities––Other adjustments, net and a decrease in Financing activities––Other financing activities, net of $7 million for the nine months ended September 30, 2018; and
29, 2019. For additional information, see Note 1D.
accreted interest on the settlement of commercial paper debt instruments, resulting inAmortization Period for Certain Callable Debt Securities Held at a decrease in Operating activities––Other adjustments, net, and an increase in Financing activities––Other financing activities, net of $69 million for the nine months ended September 30, 2018.
The new standard also establishes guidance on the classification of certain cash flows related to contingent consideration in a business acquisition. Cash payments made soon after a business acquisition date will be classified as Investing activities, while payments made thereafter will be classified as Financing activities. Payments made in excess of the amount of the original contingent consideration liability will be classified as Operating activities. The adoption of this guidance did not have a material impact to our condensed consolidated financial statements.
Presentation of Restricted Cash in the Statement of Cash Flows––We adopted, on a retrospective basis, the new accounting standard, which requires that restricted cash and restricted cash equivalents be included with Cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown in the condensed consolidated statements of cash flows. As a result, for the nine months ended September 30, 2018, $10 million is presented as an increase in Cash, cash equivalents, restricted cash and restricted cash equivalents.
Definition of a BusinessPremium––We prospectively adopted the standard, which shortens the amortization period for determining whether business development transactions should be accounted for as acquisitions (or disposals) of assets or businesses. If substantially all of 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. To be considered a business, a set of integrated activities and assets must include,certain callable debt securities held at a minimum, an input and a substantive process that together significantly contributepremium. The new guidance requires the premium to be amortized to the abilityearliest call date. We do not have any investments with features subject to create outputs, without regard as to whether a purchaser could replace missing elements. In addition, the definition of the term “output” has been narrowed to make it consistent with the updated revenue recognition guidance. In the third quarterthis standard and, first nine months of 2018,therefore, there was no impact to our condensed consolidated financial statements from the adoption of this new standard.
DerecognitionAccounting for Certain Financial Instruments with Characteristics of Nonfinancial AssetsLiabilities and Equity and Accounting for Certain Financial Instruments with Down Round Features––We prospectively adopted the standard, which applieschanges the accounting for warrants or convertible instruments that include a down round feature. We do not have any financial instruments with features subject to the full or partial sale or transfer of nonfinancial assets, including intangible assets, real estatethis standard and, inventory. The standard provides that the gain or loss is determined by the difference between the consideration received and the carrying value of the asset. In the third quarter and

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

first nine months of 2018,therefore, there was no impact to our condensed consolidated financial statements from the adoption of this new standard.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Accounting for Modifications of Share-Based Payment AwardsPayments to Nonemployees––We prospectively adopted the standard, which clarifies thatsimplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain changes inexceptions. Under the terms or conditionsguidance, the measurement of aequity-classified nonemployee awards will be fixed at the grant date. We do not have any share-based payment award be accounted for as a modification. Thereawards issued to nonemployees and, therefore, there was no impact to our condensed consolidated financial statements from the adoption of this new standard.
Impacts to our Condensed Consolidated Financial Statements––The impacts on our prior period condensed consolidated financial statements of adopting the new standards described above are summarized in the following tables:
Adoption of the standard related to pension and postretirement benefit costs impacted our prior period condensed consolidated statements of income as follows:
  Three Months Ended October 1, 2017
(MILLIONS OF DOLLARS) As Previously Reported
 
Effect of Change
Higher/(Lower)

 As Restated
Cost of sales $2,847
 $(3) $2,844
Selling, informational and administrative expenses 3,500
 4
 3,504
Research and development expenses 1,859
 6
 1,865
Restructuring charges and certain acquisition-related costs 149
 (35) 114
Other (income)/deductions––net 51
 28
 79
Income from continuing operations before provision for taxes on income 3,585
 
 3,585
       
  Nine Months Ended October 1, 2017
(MILLIONS OF DOLLARS) As Previously Reported
 
Effect of Change
Higher/(Lower)

 As Restated
Cost of sales $7,980
 $(9) $7,972
Selling, informational and administrative expenses 10,233
 16
 10,249
Research and development expenses 5,346
 21
 5,367
Restructuring charges and certain acquisition-related costs 377
 (110) 267
Other (income)/deductions––net (16) 81
 65
Income from continuing operations before provision for taxes on income
 11,351
 
 11,351
Adoption of the standards impacted our condensed consolidated balance sheet as follows:
    Effect of New Accounting Standards Higher/(Lower)  
(MILLIONS OF DOLLARS) As Previously Reported Balance at December 31, 2017
 Revenues
 Financial Assets and Liabilities
 
Income
Tax Accounting

 Reclassification of Certain Tax Effects from AOCI
 Balance at January 1, 2018
Trade accounts receivable $8,221
 $13
 $
 $
 $
 $8,234
Inventories 7,578
 (11) 
 
 
 7,567
Current tax assets 3,050
 (11) 
 (3) 
 3,036
Noncurrent deferred tax assets and other noncurrent tax assets 1,855
 (17) 
 
 
 1,838
Other noncurrent assets 3,227
 
 
 (204) 
 3,023
Other current liabilities 11,115
 (123) 
 
 
 10,992
Noncurrent deferred tax liabilities 3,900
 106
 
 (18) 
 3,988
Other noncurrent liabilities 6,149
 (459) 
 
 
 5,690
Retained earnings 85,291
 450
 419
 (189) 495
 86,466
Accumulated other comprehensive loss (9,321) 
 (419) 
 (495) (10,235)

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Adoption of the standards related to the classification of certain transactions in the statement of cash flows and the presentation of restricted cash in the statement of cash flows impacted our condensed consolidated statement of cash flows as follows:
  Nine Months Ended October 1, 2017
    Effect of New Accounting Standards Inflow/(Outflow)  
(MILLIONS OF DOLLARS) As Previously Reported
 Cash Flow Classification
 Restricted Cash
 As Restated
Operating Activities        
Other adjustments, net $(561) $(43) $
 $(604)
Other changes in assets and liabilities, net of acquisitions and divestitures (3,644) 
 28
 (3,616)
Investing Activities        
Proceeds from redemptions/sales of short-term investments 5,783
 
 (5) 5,778
Proceeds from redemptions/sales of long-term investments 2,417
 
 (14) 2,403
Financing Activities        
Principal payments on short-term borrowings (7,691) 33
 
 (7,659)
Net proceeds from short-term borrowings with original maturities of three months or less 555
 10
 
 566
Net increase in cash and cash equivalents and restricted cash and cash equivalents 184
 
 9
 193
Cash and cash equivalents and restricted cash and cash equivalents, beginning 2,595
 
 70
 2,666
Cash and cash equivalents and restricted cash and cash equivalents, ending 2,779
 
 79
 2,858
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheet that sum to the total of the same amounts shown in the condensed consolidated statements of cash flows:
(MILLIONS OF DOLLARS) September 30, 2018
 December 31,
2017

Cash and cash equivalents $3,559
 $1,342
Restricted cash and cash equivalents in Short-term investments
 40
 
Restricted cash and cash equivalents in Long-term investments
 59
 
Restricted cash and cash equivalents in Other current assets
 
 14
Restricted cash and cash equivalents in Other noncurrent assets
 
 75
Total cash and cash equivalents and restricted cash and cash equivalents shown in the condensed consolidated balance sheets $3,658
 $1,431
Amounts included in restricted cash represent those required to be set aside by a contractual agreement in connection with ongoing litigation or to secure delivery of Pfizer medicines at the agreed upon terms. The restriction will lapse upon the resolution of the litigation or the proper delivery of the medicines.

C. Revenues

On January 1, 2018, we adopted a11 new accounting standard for revenue recognition.standards. For furtheradditional information, see Notes to Consolidated Financial Statements––Note 1B.1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards in 2018 included in our 2018 Financial Report.
We recorded direct product sales and/or alliance revenues of more than $1 billion for each of nine products in 2017. These direct products sales and/or alliance product revenues represented 46% of our revenues in 2017. The loss or expiration of intellectual property rights can have a significant adverse effect on our revenues as our contracts with customers will generally be at lower selling prices due to added competition
C. Revenues and we generally provide for higher sales returns during the period in which individual markets begin to near the loss or expiration of intellectual property rights. Our Consumer Healthcare business includes OTC brands with a focus on dietary supplements, pain management, gastrointestinal and respiratory and personal care. According to Euromonitor International’s retail sales data, in 2017, our Consumer Healthcare business was the fifth-largest branded multi-national, OTC consumer healthcare business in the world and produced two of the ten largest selling consumerTrade Accounts Receivable

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

healthcare brands (Centrum and Advil) in the world. We sell biopharmaceutical products after patent expiration, and under patent, and, to a much lesser extent, consumer healthcare products worldwide to developed and emerging market countries.
Revenue Recognition––We record revenues from product sales when there is a transfer of control of the product from us to the customer. We determine transfer of control based on when the product is shipped or delivered and title passes to the customer.
Customers––Our biopharmaceutical products are sold principally to wholesalers but we also sell directly to retailers, hospitals, clinics, government agencies and pharmacies, and, in the case of our vaccine products in the U.S., we primarily sell directly to the CDC, wholesalers and individual provider offices. Our consumer healthcare customers include retailers and, to a lesser extent, wholesalers and distributors.
Biopharmaceutical products that ultimately are used by patients are generally covered under governmental programs, managed care programs and insurance programs, including those managed through pharmacy benefit managers, and are subject to sales allowances and/or rebates payable directly to those programs. Those sales allowances and rebates are generally negotiated, but government programs may have legislated amounts by type of product (e.g., patented or unpatented).
Our Sales Contracts––Sales on credit are typically under short-term contracts. Collections are based on market payment cycles common in various markets, with shorter cycles in the U.S. Salesare adjusted for sales allowances, chargebacks, rebates and sales returns and cash discounts. Sales returns occur due to loss of exclusivity, product recalls or a changing competitive environment.
Deductions from Revenues––Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, sales allowances and sales returns. These deductions represent estimates of the related obligations and, as such, knowledge and judgment is required when estimating the impact of these revenue deductions on gross sales for a reporting period.
Specifically:
In the U.S., we sell our products to distributors and hospitals under our sales contracts. However, we also have contracts with managed care or pharmacy benefit managers and legislatively mandated contracts with the federal and state governments under which we provide rebates to them based on medicines utilized by the lives they cover. We record provisions for Medicare, Medicaid, and performance-based contract pharmaceutical rebates based upon our experience ratio of rebates paid and actual prescriptions written during prior quarters. We apply the experience ratio to the respective period’s sales to determine the rebate accrual and related expense. This experience ratio is evaluated regularly to ensure that the historical trends are as current as practicable. We estimate discounts on branded prescription drug sales to Medicare Part D participants in the Medicare “coverage gap,” also known as the “doughnut hole,” based on the historical experience of beneficiary prescriptions and consideration of the utilization that is expected to result from the discount in the coverage gap. We evaluate this estimate regularly to ensure that the historical trends and future expectations are as current as practicable. For performance-based contract rebates, we also consider current contract terms, such as changes in formulary status and rebate rates.
Outside the U.S., the majority of our pharmaceutical sales allowances are contractual or legislatively mandated and our estimates are based on actual invoiced sales within each period, which reduces the risk of variations in the estimation process. In certain European countries, rebates are calculated on the government’s total unbudgeted pharmaceutical spending or on specific product sales thresholds and we apply an estimated allocation factor against our actual invoiced sales to project the expected level of reimbursement. We obtain third-party information that helps us to monitor the adequacy of these accruals.
Provisions for pharmaceutical chargebacks (primarily reimbursements to U.S. wholesalers for honoring contracted prices to third parties) closely approximate actual amounts incurred, as we settle these deductions generally within two to five weeks of incurring the liability.
Provisions for pharmaceutical sales returns are based on a calculation for each market that incorporates the following, as appropriate: local returns policies and practices; historical returns as a percentage of sales; an understanding of the reasons for past returns; estimated shelf life by product; an estimate of the amount of time between shipment and return or lag time; and any other factors that could impact the estimate of future returns, such as loss of exclusivity, product recalls or a changing competitive environment. Generally, returned products are destroyed, and customers are refunded the sales price in the form of a credit.
We record sales incentives as a reduction of revenues at the time the related revenues are recorded or when the incentive is offered, whichever is later. We estimate the cost of our sales incentives based on our historical experience with similar incentives programs to predict customer behavior.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Our accruals for Medicare rebates, Medicaid and related state program rebates, performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts totaled $5.5$5.6 billion as of September 30, 201829, 2019 and $4.9$5.4 billion as of December 31, 20172018.
The following table provides information about the balance sheet classification of these accruals:
(MILLIONS OF DOLLARS) September 30, 2018
 December 31, 2017
 September 29,
2019

 December 31, 2018
Reserve against Trade accounts receivable, less allowance for doubtful accounts
 $1,297
 $1,352
 $1,203
 $1,288
    
Other current liabilities:
        
Accrued rebates 3,235
 2,674
 3,275
 3,208
Other accruals 641
 512
 617
 531
    
Other noncurrent liabilities 374
 385
 463
 399
Total accrued rebates and other accruals $5,548
 $4,923
 $5,557
 $5,426

Amounts recorded for revenue deductions can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. On a quarterly basis, our adjustments of estimates to reflect actual results generally have been less than 1% of revenues, and have resulted in either a net increase or a net decrease in Revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product growth trends.D. Leases


Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from Revenues.
D. Collaborative Arrangements
Payments to and from our collaboration partners are presented in our condensed consolidated statements of income based on the nature of the arrangement (including its contractual terms), the nature of the payments and applicable accounting guidance. Under co-promotion agreements, we record the amounts received from our collaboration partners as alliance revenues, a component of Revenues, when our collaboration partners are the principal in the transaction and we receive a share of their net sales or profits. Alliance revenues are recorded as we perform co-promotion services for the collaboration and the collaboration partners sell the products to their customers within the applicable period. The related expenses for selling and marketing these products are included in Selling, informational and administrative expenses. In collaborative arrangements where we manufacture a product for our collaboration partners, we record revenues when we transfer control of the product to our collaboration partners. All royalty payments to collaboration partners are included in Cost of sales. Royalty payments received from collaboration partners are included in Other (income)/deductions—net.
Reimbursements to or from our collaboration partners for development costs are recorded net in Research and development expenses. Upfront payments and pre-approval milestone payments due from us to our collaboration partners in development stage collaborations are recorded as Research and development expenses. Milestone payments due from us to our collaboration partners after regulatory approval has been attained for a medicine are recorded in Identifiable intangible assets—Developed technology rights. Upfront and pre-approval milestone payments earned from our collaboration partners by us are recognized in Other (income)/deductions—net over the development period for the collaboration products, when our performance obligations include providing R&D services to our collaboration partners. Upfront, pre-approval and post-approval milestone payments earned by us may be recognized in Other (income)/deductions—net immediately when earned or over other periods depending upon the nature of our performance obligations in the applicable collaboration. Where the milestone event is regulatory approval for a medicine, we generally recognize milestone payments due to us in the transaction price when regulatory approval in the applicable jurisdiction has been attained. We may recognize milestone payments due to us in the transaction price earlier than the milestone event in certain circumstances when recognition of the income would not be probable of a significant reversal.
On January 1, 2018,2019, we adopted a new accounting standard on revenue recognition (see for leases. For further information, see Note 1B). As
We lease real estate, fleet, and equipment for use in our operations. Our leases generally have lease terms of 1 to 30 years, some of which include options to terminate or extend leases for up to 5 to 10 years or on a resultmonth-to-month basis. We include options that are reasonably certain to be exercised as part of the adoption, we recognizeddetermination of lease terms. We may negotiate termination clauses in anticipation of any changes in market conditions, but generally these termination options are not exercised. Residual value guarantees are generally not included within our operating leases with the following cumulative effect adjustments relatedexception of some fleet leases. In addition to collaboration arrangementsbase rent payments, the leases may require us to Retained earnings:
$394pay directly for taxes and other non-lease components, such as insurance, maintenance and other operating expenses, which may be dependent on usage or vary month-to-month. Variable lease payments amounted to $74 million (pre-tax) for collaborative arrangements where upfront, pre-approvalthe three months ended September 29, 2019 and regulatory approval milestone payments received from our collaboration partners are recognized$192 million for the nine months ended September 29, 2019. We have elected the practical expedient inOther (income)/deductions—net over a reduced period. Under the new standard to not separate non-lease components from lease components in calculating the incomeamounts of ROU assets and lease liabilities for all underlying asset classes.
We determine if an arrangement is a lease at inception of the contract in accordance with guidance detailed in the new standard and we perform the lease classification test as of the lease commencement date. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from upfrontthe lease. Operating lease ROU assets and pre-approval milestoneliabilities are recognized at commencement date based on the present value of lease payments due to us is typically recognized over the development period forlease term. As most of our leases do not provide an implicit rate, we use our estimated incremental borrowing rate based on the collaboration when our performance obligation,information available at commencement date in addition to granting a license, is to provide research and development services to our collaboration partners, and major regulatory approval milestones are typically recognized immediately when earned asdetermining the related development period has ended. The income from upfront and milestone payments is typically recognized immediately as earned if our performance obligation, in addition to granting a license, is
present value of future payments.

For operating leases, the ROU assets and liabilities are presented in our condensed consolidated balance sheet as follows:
    Balance at
(MILLIONS OF DOLLARS) Balance Sheet Classification September 29,
2019

ROU assets Other noncurrent assets $1,306
Lease liabilities (short-term) Other current liabilities 281
Lease liabilities (long-term) Other noncurrent liabilities 1,037


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

only for commercialization activities. Under the old standard, this income was recognized over the combined development and estimated commercialization (including co-promotion) period for the collaboration products.
$82 million (pre-tax) for collaborative arrangements where
Our total lease costs are as follows:
  Three Months Ended
 Nine Months Ended
(MILLIONS OF DOLLARS) September 29, 2019
 September 29, 2019
Operating lease cost $111
 $310
Variable lease cost 74
 192
Sublease income (10) (31)
Total lease cost $174
 $471
Other supplemental information includes the following:
  Weighted-Average Remaining Contractual Lease Term (Years) as of Weighted-Average Discount Rate as of
  
(MILLIONS OF DOLLARS) September 29,
2019
 September 29,
2019

 Nine Months Ended September 29, 2019
Operating leases 6.8 3.6%  
Cash paid for amounts included in the measurement of lease liabilities:      
Operating cash flows from operating leases     $244
(Gains)/losses on sale and leaseback transactions, net     (32)
ROU assets obtained in exchange for new operating lease liabilities     $250

The table below reconciles the undiscounted cash flows for the first five years and total of the remaining years to the operating lease liabilities recorded in the condensed consolidated balance sheet as of September 29, 2019:
(MILLIONS OF DOLLARS)  
Period Operating Lease Liabilities
Next one year(a)
 $322
1-2 years 279
2-3 years 222
3-4 years 176
4-5 years 110
Thereafter 406
Total undiscounted lease payments 1,516
Less: Imputed interest 197
Present Value of Minimum Lease Payments 1,319
Less: Current portion 281
Noncurrent portion $1,037
(a)
Reflects lease payments due within 12 months subsequent to the balance sheet date.
In April 2018, we manufacture products for our collaboration partners and recognize Revenues and Cost of sales for product shipments atentered an earlier pointagreement to lease space in time. Under the new standard, revenue is recognized when we transferan office building in New York City. We expect to take control of the productsproperty in 2021 and relocate our global headquarters to this new office building in 2022. Our future minimum rental commitment under this 20-year lease is approximately $1.7 billion.
Prior to our collaboration partners. Underadoption of the oldnew lease standard, revenuerental expense, net of sublease income, was recognized when our collaboration partners sell the products$301 million in 2018, $314 million in 2017 and transfer title to their third party customers.$292 million in 2016.
As of December 31, 2018, the future minimum rental commitments under non-cancelable operating leases follow:
(MILLIONS OF DOLLARS) 2019
 2020
 2021
 2022
 2023
 After 2023
Lease commitments $300
 $252
 $210
 $267
 $248
 $2,040

Note 2. Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangements and Privately Held Investment

A. Acquisition
AstraZeneca’s Small Molecule Anti-Infectives Business (EH)
On December 22, 2016, which fell 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 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). In 2017, under the terms of the agreement, we made payments of approximately $605 million to AstraZeneca related to the transaction. We made an additional milestone payment of $125 million in our first fiscal quarter of 2018 and we will make a deferred payment of $175 million to AstraZeneca in January 2019. In addition, we may be required to pay an additional milestone payment of $75 million if the related milestone is achieved prior to December 31, 2021, and up to $600 million if sales of Zavicefta™ exceed certain thresholds prior to January 1, 2026, as well as tiered royalties on sales of Zavicefta™ and ATM-AVI in certain markets for a period ending on the later of 10 years from first commercial sale or the loss of patent protection or loss of regulatory exclusivity. The total royalty payments are unlimited during the royalty term and the undiscounted payments are expected to be in the range of approximately $292 million to $512 million. The total fair value of consideration transferred for AstraZeneca’s small molecule anti-infectives business was approximately $1,040 million inclusive of cash paid and the fair value of contingent consideration. In connection with this acquisition, we recorded $894 million in Identifiable intangible assets, consisting of $728 million in Developed technology rights and $166 million in IPR&D. We also recorded $92 million in Other current assets related to the economic value of inventory which was retained by AstraZeneca for sale on our behalf, $73 million in Goodwill and $19 million of net deferred tax liabilities. The final allocation of the consideration transferred to the assets acquired and the liabilities assumed has been completed.
B. Divestitures
Sale of Hospira Infusion Systems Net Assets to ICU Medical, Inc. (EH)
On October 6, 2016, we announced that we entered into a definitive agreement under which ICU Medical agreed to acquire all of our global infusion systems net assets, HIS, for approximately $1 billion in cash and ICU Medical common stock. HIS includes IV pumps, solutions, and devices.As a result of the performance of HIS relative to ICU Medical’s expectations, on January 5, 2017, we entered into a revised agreement with ICU Medical under which ICU Medical would acquire HIS for up to approximately $900 million, composed of cash and contingent cash consideration, ICU Medical common stock and seller financing.
The revised transaction closed on February 3, 2017. At closing, we received 3.2 million newly issued shares of ICU Medical common stock (as originally agreed), which we initially valued at approximately $428 million (based upon the closing price of ICU Medical common stock on the closing date less a discount for lack of marketability) and which are reported as equity securities at fair value in Long-term investments on the condensed consolidated balance sheet. In August 2018, we sold 700,000 shares of ICU Medical common stock for which we recognized a gain during the period of $50 million, reflecting the increase in fair value of the equity investment since the beginning of the year, most of which was previously recognized as 2018 unrealized gains. In addition, we continue to hold 2.5 million shares of ICU Medical common stock and we recognized unrealized gains of $24 million in the third quarter of 2018 and unrealized gains of $229 million in the first nine months of 2018 related to these remaining shares. We also received a promissory note in the amount of $75 million, which was repaid in full as of December 31, 2017, and net cash of approximately $200 million before customary adjustments for net working capital, which is reported in Other investing activities, net on the condensed consolidated statement of cash flows for the nine months ended October 1, 2017. 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. After our recent sale of ICU Medical shares, we own approximately 12% of ICU Medical. We recognized pre-tax income of $2 million in the third quarter of 2018 and pre-tax income of $1 million in the first nine months of 2018, and


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Note 2. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement
A. Acquisitions
Array BioPharma Inc.
On July 30, 2019, we acquired Array, a commercial stage biopharmaceutical company focused on targeted small molecule medicines to treat cancer and other diseases of high unmet need, for $48 per share in cash. The total fair value of the consideration transferred for Array was approximately $11.2 billion ($10.9 billion, net of cash acquired). In addition, approximately $157 million in payments to Array employees for the fair value of previously unvested stock options was recognized as post-closing compensation expense and recorded in Restructuring charges and certain acquisition-related costs in the condensed consolidated statement of income for the three and nine months ended September 29, 2019 (see Note 3). We financed the majority of the transaction with debt and the balance with existing cash.
Array’s portfolio includes the approved combined use of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of BRAFV600E- or BRAFV600K-mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in over 30 clinical trials across several solid tumor indications, including the Phase 3 BEACON trial in BRAF-mutant mCRC, through collaborations with third parties. Pfizer has exclusive rights to commercialize the combination therapy in the U.S. and Canada. In addition to the combination therapy for BRAF-mutant metastatic melanoma, Array brings a broad pipeline of targeted cancer medicines in different stages of research and development, as well as a portfolio of out-licensed medicines, which are expected to generate material milestones and royalties over time.
In connection with this acquisition, we provisionally recorded: (i) $7.2 billion in Identifiable intangible assets, consisting of $1.8 billion of Developed technology rights with a useful life of 16 years, $4.0 billion of IPR&D and $1.4 billion for Licensing agreements ($1.1 billion for technology in development––indefinite-lived licensing agreements and $340 million for developed technology––finite-lived licensing agreements with a useful life of 10 years), (ii) $5.4 billion of Goodwill, (iii) $1.3 billion of net deferred tax liabilities and (iv) $451 million of assumed long-term debt, which was paid in full as of September 29, 2019. The allocation of the consideration transferred to the assets acquired and the liabilities assumed has not yet been finalized.
Therachon Holding AG
On July 1, 2019, we acquired all the remaining shares of Therachon, a privately-held clinical-stage biotechnology company focused on rare diseases, with assets in development for the treatment of achondroplasia, a genetic condition and the most common form of short-limb dwarfism, for $340 million upfront, plus potential milestone payments of up to $470 million contingent on the achievement of key milestones in the development and commercialization of the lead asset. In 2018, we acquired approximately 3% of Therachon’s outstanding shares for $5 million. We accounted for the transaction as an asset acquisition since the lead asset represented substantially all the fair value of the gross assets acquired. The total fair value of the consideration transferred for Therachon was approximately $322 million, which consisted of $317 million of cash and our previous $5 million investment in Therachon. Therachon is a wholly-owned subsidiary of Pfizer. In connection with this asset acquisition, we recorded a charge of $337 million in Research and development expenses.
B. Equity-Method Investment and Assets and Liabilities Held for Sale

On July 31, 2019, we completed the transaction in which we and GSK combined our respective consumer healthcare businesses into a new consumer healthcare joint venture that operates globally under the GSK Consumer Healthcare name. In exchange for contributing our Consumer Healthcare business to the joint venture, we received a 32% equity stake in the new company and GSK owns the remaining 68%. Upon the closing of the transaction, we deconsolidated our Consumer Healthcare business and recognized a pre-tax gain of $8.1 billion ($5.4 billion, net of tax) in our fiscal third quarter of 2019 in (Gain) on completion of Consumer Healthcare JV transaction for the difference in the fair value of our 32% equity stake in the new company and the carrying value of our Consumer Healthcare business. We may record additional adjustments to the gain in future periods, which we do not expect to have a material impact on our consolidated financial statements.
In valuing our investment in GSK Consumer Healthcare, we used discounted cash flow techniques. Some of the more significant estimates and assumptions inherent in this approach include: the amount and timing of the projected net cash flows, which include the expected impact of competitive, legal or regulatory forces on the products; the long-term growth rate, which seeks to project the sustainable growth rate over the long term; the discount rate, which seeks to reflect our best estimate of the various risks inherent in the projected cash flows; and the tax rate, which seeks to incorporate the geographic

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

diversity of the projected cash flows. As part of the joint venture transaction, we agreed to indemnify GSK with respect to certain tax matters related to periods prior to closing of the transaction as well as certain potential environmental or other legal liabilities associated with the previous operation of our Consumer Healthcare business. We recognized a liability of $45 million with respect to the tax matters indemnification. The value of the environmental and legal indemnifications was not considered to be material.
We are accounting for our interest in GSK Consumer Healthcare as an equity-method investment. Our investment in GSK Consumer Healthcare is reported as a private equity investment in the Equity-method investments line in our condensed consolidated balance sheet as of September 29, 2019. Our consolidated statements of income for the third quarter and first nine months of $12 million2019 include revenues and expenses associated with Pfizer’s Consumer Healthcare business through July 31, 2019. We will record our share of earnings from the Consumer Healthcare joint venture on a quarterly basis on a one-quarter lag in Other (income)/deductions––net commencing from August 1, 2019. Therefore, we will record our share of two months of the joint venture’s earnings generated in the third quarter of 2017 and pre-tax losses of $52 million2019 in our operating results in the first nine monthsfourth quarter of 20172019. As of the July 31, 2019 closing date, the fair value of our investment in GSK Consumer Healthcare was approximately $15.7 billion. The excess of the initial fair value of our investment over the underlying equity in the carrying value of the net assets of GSK Consumer Healthcare has not yet been allocated within the investment account. We expect to complete the allocation in our fourth quarter of 2019, and we will record the amortization of identified basis differences, as applicable, on a one-quarter lag in Other (income)/deductions––netrepresenting adjustments to amounts previously recorded commencing August 1, 2019. Therefore, we will record the amortization of identified basis differences for two months of the third quarter of 2019 in 2016 to write downour operating results in the HIS net assets to fair value less costs to sell. For additional information, see Note 4 and Notes to Consolidated Financial Statements––Note 2. Acquisitions, Salefourth quarter of Hospira Infusion Systems Net Assets, Research and Development and Collaborative Arrangements, Equity-Method Investments and Cost-Method Investment inPfizer’s 2017 Financial Report.2019.
While we have received theour full purchase price excluding the contingent amount32% interest in GSK Consumer Healthcare as of the February 3, 2017July 31, 2019 closing and transferred control of our Consumer Healthcare business to GSK Consumer Healthcare, the salecontribution of the HIS net assetsbusiness was not fully completed in certain non-U.S. jurisdictions as of the third quarter of 2018 due to temporary regulatory or operational constraints. In these jurisdictions, which represent a relatively small portion of the HIS net assets, we have continued to operate the net assetsbusiness for the net economic benefit of ICU Medical,GSK Consumer Healthcare, and we wereare indemnified by ICU MedicalGSK Consumer Healthcare against risks associated with such operations during the interim period, subject to our obligations under the definitive transaction agreements. We expect the contribution of our Consumer Healthcare business in these jurisdictions to be fully completed by the first half of 2021. As such, and as we and GSK Consumer Healthcare are contractually obligated to complete the transaction, we have previously treated these jurisdictions as sold for accounting purposes.

In connection with the sale transaction,contribution of our Consumer Healthcare business, we entered into certain transitional agreements designed to facilitate the orderly transition of the HIS net assetsbusiness to ICU Medical.GSK Consumer Healthcare. These agreements primarily relate to administrative services, which are generally to be provided for a period of up to 24 months after the closing date. We will also manufacture and supply certain HISconsumer products for ICU MedicalGSK Consumer Healthcare and ICU MedicalGSK Consumer Healthcare will manufacture and supply certain retained Pfizer products for us after closing, generally for a term of fiveup to six years. These agreements are not material to PfizerPfizer.

Assets and none confers upon us the ability to influence the operating and/or financial policies of ICU Medical subsequent to the sale.
Contribution Agreement Between Pfizer and Allogene Therapeutics, Inc. (WRD)
In April 2018, Pfizer and Allogene announced that the two companies entered into a contribution agreementliabilities associated with our Consumer Healthcare business were reclassified as held for Pfizer’s portfolio of assets related to allogeneic CAR T therapy, an investigational immune cell therapy approach to treating cancer. Under this agreement, Allogene received from Pfizer rights to pre-clinical and clinical CAR T assets, all of which were previously licensed to Pfizer from French cell therapy company, Cellectis, beginning in 2014 and French pharmaceutical company, Servier, beginning in 2015. Allogene assumed responsibility for all potential financial obligations to both Cellectis and Servier. Pfizer will continue to participate financiallysale in the development of the CAR T portfolio through an ownership stake in Allogene. Separately, Pfizer continues to maintain its approximate 7% ownership stake in Cellectis that was obtained in 2014 as part of the licensing agreement in which Pfizer obtained exclusive rights to pursue the development and commercialization of certain Cellectis CAR T therapies in exchange for an upfront payment of $80 million, as well as potential future development, regulatory and commercial milestone payments and royalties. In connection with the Allogene transaction, Pfizer recognized a non-cash $50 million pre-tax gain in Other (income)/deductions––net in the second quarter of 2018, representing the difference between the $127 million fair value of the equity investment received and the book value of assets transferred (including an allocation of goodwill) (see Note 4).
In October 2018, Allogene consummated an initial public offering of new shares of its common stock, which resulted in Pfizer’s preferred stock converting into common stock and a decrease in our ownership percentage from approximately 25% to approximately 19%. The closing price on the day of the initial public offering was $25 per share. Beginningconsolidated balance sheets as of the date of the initial public offering, our investmentDecember 31, 2018. The Consumer Healthcare business assets held for sale are reported in Allogene, which isAssets held for sale and Consumer Healthcare business liabilities held for sale are reported at $127 million in Long-term investments onLiabilities held for sale in the condensed consolidated balance sheet as of September 30, 2018, will be measured at fair value with changes in fair value recognized in net income.
Sale of Phase 2b Ready AMPA Receptor Potentiator for CIASDecember 31, 2018. This includes the Consumer Healthcare business tax assets and liabilities related to Biogen Inc. (WRD)
In April 2018, we sold our Phase 2b ready AMPA receptor potentiator for CIAS to Biogen. We received $75 million upfront and have the opportunity to receive up to $515 million in future development and commercialization milestones, as well as tiered royalties in the low-to-mid-teen percentages. We recognized $75 million in Other (income)/deductions––net in the second quarter of 2018 (see Note 4). We will record the milestones and royalties to Other (income)/deductions––net when due, or earlier if we have sufficient experience to determine such amounts are not probable of significant reversal.
Divestiture of Neuroscience Assets (WRD)
In September 2018, we and Bain Capital entered into a transaction to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and preclinical stage neuroscience assets primarily targeting disorders of the central nervous system including Parkinson’s disease, epilepsy, Alzheimer’s disease, schizophrenia and addiction. These assets were part of the neuroscience discovery and early development efforts, which we announced we were ending in January 2018. In connection with this transaction, we out-licensed the portfolio to Cerevel in exchange for a 25% ownership stake in Cerevel’s parent company, Cerevel Therapeutics, Inc., and potential future regulatory and commercial milestone payments and royalties. Bain Capital has committed to invest $350 million to develop the portfolio, with the potential for additional funding as the assets advance. In connection with the transaction, we recognized a non-cash $343 million pre-tax gain in Other (income)/fully dedicated consumer healthcare subsidiaries.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


deductions––net, representing the fair value
The amounts associated with the Consumer Healthcare business, as well as other assets classified as held for sale consisted of the following:
(MILLIONS OF DOLLARS) December 31,
2018

Assets Held for Sale  
Cash and cash equivalents $32
Trade accounts receivable, less allowance for doubtful accounts 532
Inventories 538
Other current assets 56
PP&E 675
Identifiable intangible assets, less accumulated amortization 5,763
Goodwill 1,972
Noncurrent deferred tax assets and other noncurrent tax assets 54
Other noncurrent assets 57
Total Consumer Healthcare assets held for sale 9,678
Other assets held for sale(a)
 46
Assets held for sale $9,725
   
Liabilities Held for Sale  
   
Trade accounts payable $406
Income taxes payable 39
Accrued compensation and related items 93
Other current liabilities 353
Pension benefit obligations, net 39
Postretirement benefit obligations, net 33
Noncurrent deferred tax liabilities 870
Other noncurrent liabilities 56
Total Consumer Healthcare liabilities held for sale $1,890
(a)
Other assets held for sale consist of PP&E.
As a part of the equity investment received as the assets transferredhadPfizer, pre-tax income on a book value of $0 (see Note 4). Our investment in Cerevel Therapeutics, Inc. is reported in Long-term investments on the consolidated balance sheet as of September 30, 2018.
C. Licensing Arrangements
Shire International GmbH (IH)
In 2016, we out-licensed PF-00547659, an investigational biologic being evaluatedmanagement business unit basis for the treatment of moderate-to-severe inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, to ShireConsumer Healthcare business was $100 million for an upfront payment of $90 million, up to $460 million in development and sales-based milestone payments and potential future royalty payments on commercialized products. The $90 million upfront payment was initially deferred and recognized in Other (income)/deductions––net ratably through December 2017. In the firstthird quarter of 2018, we recognized $752019 and $654 million in Other (income)/deductions––net for a milestone payment received from Shire related to their first dosing of a patient in a Phase 3 clinical trial of the compound for the treatment of ulcerative colitis,nine months ended September 29, 2019, through July 31, 2019, and in$211 million for the third quarter of 2018 we recognized $35and $725 million for the nine months ended September 30, 2018.

C. Research and Development Arrangement
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 would fund up to $200 million in Other (income)/deductions––net for a milestone payment received from Shiredevelopment costs related to their first dosing of a patient in acertain Phase 3 clinical trial trials of Pfizer’s rivipansel compound and Pfizer would use commercially reasonable efforts to develop and obtain regulatory approvals for such compound. NovaQuest’s development funding was expected to cover up to 100% of the compounddevelopment costs and was received over approximately 13 quarters from 2016 through the second quarter of 2019 after which Pfizer is responsible for the treatmentremaining development costs. As there is a substantive and genuine transfer of Crohn’s disease (see Note 4).
BionTech AG (WRD)
In August 2018,risk to NovaQuest, the development funding was recognized by us as an obligation to perform contractual services and therefore a multi-year R&D arrangement went into effect between BionTech AG (BionTech), a privately held company, and Pfizer to develop mRNA-based vaccines for preventionreduction of influenza (flu). In September 2018, we made an upfront payment of $50 million to BionTech, which was recorded in Research and development expensesand BionTech is as incurred. The funding cap was reached in 2019. Following potential regulatory approval, NovaQuest would be eligible to receive a combination of fixed milestone payments of up to an additional $325approximately $267 million in future developmenttotal, based on achievement of first commercial sale and certain levels of cumulative net sales based milestonesas well as royalties on rivipansel net sales over approximately eight years. Fixed sales-based milestone payments would be recorded as intangible assets and future royalty payments associated with worldwide sales. As partamortized to Amortization of intangible assets over the estimated commercial life of the transaction, we also purchased 169,670 newly-issued ordinary sharesrivipansel product and royalties on net sales would be recorded as Cost of BionTech for $50 million in the third quarter of 2018, which are reported in Long-term investments in the condensed consolidated balance sheet as of September 30, 2018.
D. Collaboration Arrangements
Collaboration with Merck & Co., Inc. (IH)
Under a worldwide collaboration agreement, except for Japan, we collaborated with Merck on the clinical development of ertugliflozin and ertugliflozin-containing fixed-dose combinations with metformin and Januvia (sitagliptin) tablets, which were approved by the FDA in December 2017 and the European Commission in March 2018 as Steglatro, Segluromet and Steglujan. Merck will exclusively promote Steglatro and the two fixed-dose combination products and we will share revenues and certain costs with Merck on a 60%/40% basis, with Pfizer having the 40% share. Pfizer records its share of the collaboration revenues as product sales as we supply the ertugliflozin active pharmaceutical ingredient to Merck for use in the alliance products.
In the first quarter of 2017, we received a $90 million milestone payment from Merck upon the FDA’s acceptance for review of the NDAs for ertugliflozin and two fixed-dose combinations (ertugliflozin plus Januvia (sitagliptin) and ertugliflozin plus metformin), which, as of December 31, 2017, was deferred and primarily reported in Other noncurrent liabilities, and through December 31, 2017, was being recognized in Other (income)/deductions––net over a multi-year period. As of December 31, 2017, we were due a $60 million milestone payment from Merck, which we received in the first quarter of 2018, in conjunction with the approval of ertugliflozin by the FDA. As of December 31, 2017, the $60 million due from Merck was deferred and primarily reported in Other noncurrent liabilities. In the first quarter of 2018, in connection with the approval of ertugliflozin in the EU, we recognized a $40 million milestone payment from Merck in Other (income)/deductions––net (see Note 4). We are eligible for additional payments associated with the achievement of future commercial milestones. In the first quarter of 2018, in connection with the adoption of a new accounting standard, as of January 1, 2018, the $60 million of deferred income and approximately $85 million of the $90 million of deferred income associated with the above-mentioned milestone payments were recorded to and included in the $584 million cumulative effect adjustment to Retained earnings. See Note 1B for additional information. when incurred.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


CollaborationIn August 2019, we announced that the Phase 3 RESET (Rivipansel Evaluating Safety, Efficacy and Time to Discharge)pivotal study did not meet its primary or key secondary efficacy endpoints. The objective of the trial was to evaluate the efficacy and safety of rivipansel in patients aged six and older with Eli Lilly & Company (IH)
In 2013,sickle cell disease who were hospitalized for a vaso-occlusive crisis and required treatment with IV opioids. As a result, in the third quarter of 2019, we entered intorecorded a collaboration agreement with Lilly$127 million charge in Cost of sales related to jointly develop and globally commercialize Pfizer’s tanezumab, which provides that Pfizer and Lilly will equally share product-development expenses rivipansel, primarily for inventory manufactured for expected future sale, as well as potential revenues$15 million of anticipated clinical development program close-out costs, which were recorded in Research and certain product-related costs. We received a $200 million upfront payment from Lilly in accordance with the collaboration agreement between Pfizer and Lilly, which was deferred and primarily reported in Other noncurrent liabilities, and through December 31, 2017, was being recognized in Other (income)/deductions––net over a multi-year period beginning development costs in the second quartercondensed consolidated statement of 2015. Pfizer and Lilly resumed the Phase 3 chronic pain program for tanezumab in July 2015. The FDA granted Fast Track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis and chronic low back pain in June 2017. Under the collaboration agreement with Lilly, we are eligible to receive additional payments from Lilly upon the achievement of specified regulatory and commercial milestones.
In the first quarter of 2018, in connection with the adoption of a new accounting standard, as of January 1, 2018, approximately $107 million of deferred income associated with the above-mentioned upfront payment was recorded to and included in the $584 million cumulative effect adjustment to Retained earnings. See Note 1B for additional information. Approximately $33 millionincome. Detailed analyses of the upfront payment continues toRESET study, including additional data on efficacy and safety endpoints, are under review and will be deferred, of which approximately $24 million is reported in Other current liabilities and approximately $9 million is reported in Other noncurrent liabilities as of September 30, 2018. This amount is expected to be recognized in Other (income)/deductions––net oversubmitted for presentation at a future scientific meeting. Following those detailed analyses, the remaining development period for the product between 2018 and 2020.
E. Privately Held Investment

AM-Pharma B.V. (WRD)

In April 2015, we acquired a minority equity interest in AM-Pharma B.V., a privately-held Dutch biopharmaceutical company focusedimpact on the development of human recombinant Alkaline Phosphatase (recAP) for inflammatory diseases, and secured an exclusive option to acquire the remaining equity in the company. The option became exercisable after completion of a Phase 2 trial of recAP for the treatment of Acute Kidney Injury related to sepsis in the first quarter of 2018. We declined to exercise the option and the option expired unexercised during the second quarter of 2018.NovaQuest agreement will be evaluated.
Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives


We incur significant costs in connection with acquiring, integrating and restructuring businesses and in connection with our global cost-reduction/productivity initiatives. For example:
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.


All of our businesses and functions may be impacted by these actions, including sales and marketing, manufacturing and R&D, as well as groups such as information technology, shared services and corporate operations.

2017-2019 Initiatives and Organizing for Growth
In connectionDuring 2018, as we reviewed our business opportunities and challenges and the way in which we think about our business operations, we determined that at the start of our 2019 fiscal year, we would begin operating under our new commercial structure, which reorganized our operations into 3 businesses––Biopharma,a science-based innovative medicines business; Upjohn, a global, primarily off-patent branded and generic established medicines business; and through July 31, 2019, a Consumer Healthcare business (see Note 13). To operate effectively in this structure and position ourselves for future growth, we are focused on creating a simpler, more efficient operating structure within each business as well as the functions that support them. Beginning in the fourth quarter of 2018, we reviewed previously planned initiatives and new initiatives to ensure that there was alignment around our new structure and combined the 2017-2019 initiatives with our acquisition of Hospira in September 2015, we focused our efforts on achieving an appropriate cost structurecurrent Organizing for Growth initiatives to form one cohesive plan. Initiatives for the combined company. We expectprogram include activities related to incur costs of approximately $1 billion(not including costs of $215 million associated with the return of acquired IPR&D rights as described in the Current-Period Key Activities section of Notes to Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives in our 2017 Financial Report) associated with the integration of Hospira. The majority of these costs were incurred within the three-year period post-acquisition.
As a result of the evaluation performed in connection with our decision in September 2016 to not pursue, at that time, splitting IH and EH into two separate publicly-traded companies, we identified new opportunities to potentially achieve greater optimization and efficiency to become more competitive in our business. Therefore, in early 2017, we initiated new enterprise-wide cost reduction/productivity initiatives, which we expect to substantially complete by the end of 2019. These initiatives encompass all areas of our cost base and include:

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Optimization of our manufacturing plant network, to support IH and EH products and pipelines. During 2017-2019, we expect to incur costs of approximately $700 million related to this initiative. Through September 30, 2018, we incurred approximately $322 million associated with this initiative.
Activities in non-manufacturing related areas, which include furtherthe centralization of our corporate and platform functions, as well as other activities where opportunities are identified. During 2017-2019, we expect to incur costsand the simplification and optimization of approximately $450 million related to this initiative. Throughour operating business structure and functions that support them. From 2017 through September 30, 2018,29, 2019, we incurred approximately $252$819 million associated with this initiative.
The costs expected to be incurred during 2017-2019, ofmanufacturing optimization, and approximately $1.2 billion for the above-mentioned programs (but not including the costs$945 million associated with the Hospira integration), includeother activities.
In 2019, we expect restructuring, charges, implementation costs and additional depreciation––asset restructuring. Of thisdepreciation charges of about $600 million and, of that amount, we expect that about 20%approximately 15% of the total charges will be non-cash.
Current-Period Key Activities

For the first nine months of 20182019, we incurred costs of $226$452 million composed of $272 million associated with the integration of Array, $300 million associated with the 2017-2019 program, $186and Organizing for Growth initiatives and $74 million associated with the integration of Hospira, and $35partially offset by income of $194 million, associated with allprimarily due to the reversal of certain accruals upon the effective favorable settlement of a U.S. IRS audit for multiple tax years and other acquisition-related initiatives.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The following table provides the components of costs associated with acquisitions and cost-reduction/productivity initiatives:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

Restructuring (credits)/charges:  
  
  
  
Employee terminations $(24) $(55) $(53) $(113)
Asset impairments(a)
 12
 101
 8
 126
Exit costs 14
 10
 14
 16
Restructuring charges/(credits)(b)
 1
 56
 (32) 28
Transaction costs(c)
 1
 (14) 1
 4
Integration costs(d)
 82
 73
 202
 235
Restructuring charges and certain acquisition-related costs 85
 114
 172
 267
Net periodic benefit costs recorded in Other (income)/deductions––net(e)
 41
 35
 103
 110
Additional depreciation––asset restructuring, virtually all of which is recorded in Cost of sales(f)
 12
 39
 43
 74
Implementation costs recorded in our condensed consolidated statements of income as follows(g):
  
  
  
  
Cost of sales 21
 26
 57
 77
Selling, informational and administrative expenses 17
 22
 51
 46
Research and development expenses 9
 9
 22
 26
Total implementation costs 48
 57
 130
 150
Total costs associated with acquisitions and cost-reduction/productivity initiatives $186
 $245
 $447
 $601

The following table provides the components of costs associated with acquisitions and cost-reduction/productivity initiatives:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Restructuring charges/(credits):  
  
  
  
Employee terminations $82
 $(24) $(86) $(53)
Asset impairments 3
 12
 3
 8
Exit costs/(credits) (1) 14
 33
 14
Restructuring charges/(credits)(a)
 83
 1
 (50) (32)
Transaction costs(b)
 65
 1
 65
 1
Integration costs and other(c)
 217
 82
 281
 202
Restructuring charges and certain acquisition-related costs 365
 85
 295
 172
Net periodic benefit costs recorded in Other (income)/deductions––net
 9
 41
 19
 103
Additional depreciation––asset restructuring recorded in our condensed consolidated statements of income as follows(d):
  
  
  
  
Cost of sales 6
 12
 21
 43
Selling, informational and administrative expenses 
 
 2
 
Research and development expenses 
 
 6
 
Total additional depreciation––asset restructuring 6
 12
 29
 43
Implementation costs recorded in our condensed consolidated statements of income as follows(e):
  
  
  
  
Cost of sales 14
 21
 45
 57
Selling, informational and administrative expenses 23
 17
 48
 51
Research and development expenses 3
 9
 16
 22
Total implementation costs 40
 48
 109
 130
Total costs associated with acquisitions and cost-reduction/productivity initiatives $420
 $186
 $452
 $447

(a) 
The asset impairment charges for the three and nine months ended October 1, 2017 are largely associated with our acquisitions of Hospira and Medivation.
(b)
In the third quarter of 20182019, restructuring charges mainly represent employee termination costs associated with cost-reduction and productivity initiatives as well as our acquisition of Array. In the first nine months of 2019, restructuring credits mostly represent the reversal of certain accruals related to our acquisition of Wyeth upon the effective favorable settlement of a U.S. IRS audit for multiple tax years (see Note 5B), partially offset by employee termination costs associated with cost-reduction and productivity initiatives, as well as our acquisition of Array. In the third quarter of 2018, restructuring charges arewere primarily due to accruals for exit costs and asset write downs related to our acquisition of Hospira, partially offset by the reversal of previously recorded accruals for employee termination costs. In the first nine months of 2018,, restructuring credits arewere mostly related to the reversal of previously recorded accruals for employee termination costs. In the three and nine months ended October 1, 2017, restructuring charges were mainly associated with our acquisitions of Hospira and Medivation, partially offset by credits associated with cost-reduction and productivity initiatives not associated with acquisitions that mostly related to the reversal of previously recorded accruals for employee termination costs. Employee terminations primarily include revisions of our estimates of severance benefits. Employee termination costs are generally recorded when the actions are probable and estimable and include accrued severance benefits, many of which may be paid out during periods after termination.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

The restructuring activities for 20182019 are associated with the following:
For the third quarter of 2019, Biopharma ($10 million charge); Upjohn ($6 million credit); and Other ($79 million charge).
For the first nine months of 2019, Biopharma ($38 million credit); Upjohn ($27 million credit); and Other ($15 million charge).
The restructuring activities for 2018 are associated with the following:
For the third quarter of 2018,, IH total reportable segments ($136 million credit); EHand Other ($7 million charge); manufacturing operations ($1 million charge); WRD/GPD ($3 million charge); and Corporate ($3 million charge).
For the first nine months of 2018,, IH total reportable segments ($2530 million credit); EH ($5 million credit); WRD/GPD ($1 million charge); manufacturing operations ($16 million charge); and Corporate ($19 million credit).
The restructuring activities for 2017 are associated with the following:
For the third quarter of 2017, IH ($1 million charge); EH ($1 million charge); WRD/GPDOther ($2 million charge); manufacturing operations ($40 million charge);credit). At the beginning of fiscal 2019, we revised our operating segments and Corporate ($12 million charge).
Forare unable to directly associate these prior-period restructuring charges with the first nine months of 2017, IH ($1 million credit); EH ($11 million credit); WRD/GPD ($24 million credit); manufacturing operations ($48 million charge); and Corporate ($15 million charge).
new individual segments.
(c)(b) 
Transaction costs represent external costs for banking, legal, accounting and other similar services, which inservices. In the third quarter of 2017 reflect the reversal of an accrual related to the acquisition of Medivation. Transaction costs for theand first nine months of 2017 were directly related2019, transaction costs relate to our acquisitionsacquisition of Hospira, Anacor and Medivation.Array.
(d)(c) 
Integration costs and other represent external, incremental costs directly related to integrating acquired businesses, and primarily includesuch as expenditures for consulting and the integration of systems and processes.processes, and certain other qualifying costs. In the third quarter and first nine months of 2018,2019, integration costs wereand other primarily relatedincludes $157 million in payments to our acquisitionArray employees for the fair value of Hospira.previously unvested stock options that was recognized as post-closing compensation expense (see Note 2A). In the third quarter and first nine months of 2017,2018, integration costs and other were primarily relaterelated to our acquisitionsacquisition of Hospira and Medivation. The first nine months of 2017 also include a net gain of $12 million related to the settlement of the Hospira U.S. qualified defined benefit pension plan (see Note 10).Hospira.
(e)(d) 
In the three and nine months ended September 30, 2018, primarily represents the net pension curtailments and settlements included in Other (income)/deductions––net upon the adoption of a new accounting standard in the first quarter of 2018. In the three and nine months ended October 1, 2017, primarily represents the net pension curtailments and settlements, partially offset by net periodic benefit credits, excluding service costs, related to our acquisition of Hospira, both of which were reclassified to Other (income)/deductions––net as a result of the retrospective adoption of a new accounting standard in the first quarter of 2018. These credits included a net settlement gain, partially offset by accelerated amortization of actuarial losses and prior service costs upon the settlement of the remaining obligation associated with the Hospira U.S. qualified defined benefit pension plan. For additional information, see Note 1B and Note 10.
(f)
Additional depreciation––asset restructuring represents the impact of changes in the estimated useful lives of assets involved in restructuring actions.
(g)(e) 
Implementation costs represent external, incremental costs directly related to implementing our non-acquisition-related cost-reduction/productivity initiatives.
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, 2017(a)
 $1,039
 $
 $66
 $1,105
Provision/(Credit) (53) 8
 14
 (32)
Utilization and other(b)
 (235) (8) (34) (277)
Balance, September 30, 2018(c)
 $750
 $
 $46
 $796
(a)
Included in Other current liabilities ($643 million) and Other noncurrent liabilities ($462 million).
(b)
Includes adjustments for foreign currency translation.
(c)
Included in Other current liabilities ($397 million) and Other noncurrent liabilities ($399 million).


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


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, 2018(a)
 $1,203
 $
 $49
 $1,252
Provision/(credit)(b)
 (86) 3
 33
 (50)
Utilization and other(c)
 (431) (3) (33) (467)
Balance, September 29, 2019(d)
 $686
 $
 $48
 $734

(a)
Included in Other current liabilities ($823 million) and Other noncurrent liabilities ($428 million).
(b)
Includes the reversal of certain accruals related to our acquisition of Wyeth upon the effective favorable settlement of a U.S. IRS audit for multiple tax years. See Note 5B for additional information.
(c)
Includes adjustments for foreign currency translation.
(d)
Included in Other current liabilities ($535 million) and Other noncurrent liabilities ($199 million).
Note 4. Other (Income)/Deductions—Net
The following table provides components of Other (income)/deductions––net:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019


September 30,
2018

 September 29,
2019

 September 30,
2018

Interest income(a)
 $(60) $(82) (185) (240)
Interest expense(a)
 409
 310
 1,158
 946
Net interest expense 348
 228
 973
 706
Royalty-related income(b)
 (155) (143) (475) (360)
Net gains on asset disposals (32) (4) (33) (19)
Net gains recognized during the period on investments in equity securities(c)
 (6)
(85)
(153)
(460)
Net realized losses on sales of investments in debt securities 

8



19
Income from collaborations, out-licensing arrangements and sales of compound/product rights(d)
 (20) (139) (124) (455)
Net periodic benefit credits other than service costs(e)
 (19) (65) (110) (231)
Certain legal matters, net(f)
 64
 37
 84
 (70)
Certain asset impairments(g)
 28
 (1) 188
 40
Business and legal entity alignment costs(h)
 87
 1
 343
 5
Net losses on early retirement of debt(i)
 
 
 138
 3
Other, net(j)
 24

(252)
(294)
(322)
Other (income)/deductions––net $319
 $(414) $537
 $(1,143)
The following table provides components of Other (income)/deductions––net:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018


October 1,
2017

 September 30,
2018

 October 1,
2017

Interest income(a)
 $(82) $(99) $(240) $(275)
Interest expense(a)
 310
 320
 946
 940
Net interest expense 228
 220
 706
 666
Royalty-related income (143) (140) (360) (331)
Net gains on asset disposals(b)
 (4) (13) (19) (36)
Net gains recognized during the period on investments in equity securities(c)
 (94) (45) (460) (111)
Net realized (gains)/losses on sales of investments in debt securities 8
 (23) 12
 (45)
Income from collaborations, out-licensing arrangements and sales of compound/product rights(d)
 (139) (78) (455) (163)
Net periodic benefit costs/(credits) other than service costs(e)
 (65) 28
 (231) 81
Certain legal matters, net(f)
 37
 183
 (70) 194
Certain asset impairments(g)
 (1) 130
 40
 143
Adjustments to loss on sale of HIS net assets(h)
 (2) (12) (1) 52
Business and legal entity alignment costs(i)
 
 16
 4
 54
Other, net(j)
 (239) (186) (309) (439)
Other (income)/deductions––net $(414) $79
 $(1,143) $65

(a) 
Interest income decreased in the third quarter and first nine months of 2018,2019, primarily driven by a lower investment balance. Interest expense decreasedincreased in the third quarter and first nine months of 2018, primarily2019, mainly as a result of refinancing activity that occurred in the fourth quarter of 2017 and a credit to interest expensean increased commercial paper balance due to settlementthe acquisition of Array, as well as the retirement of lower-coupon debt and the issuance of new debt with a tax indemnification case. Interest expense increasedhigher coupon than the debt outstanding for the first nine months of 2018, primarily as a result of higher short-term interest rates, offset, in part, by refinancing activity that occurred in the fourth quarter of 2017.
(b)
In the first nine months of 2017, primarily includes a realized gain on sale of property of $52 million, partially offset by a realized net loss of $30 million related to the sale of our 40% ownership investment in Teuto, including the extinguishment of a put option for the then remaining 60% ownership interest.
(c)
The net gains on investments in equity securities for the third quarter of 2018 include unrealized net gains on equity securities of $8 million and, for the first nine months of 2018, include unrealized net gains on equity securities of $344 million, reflecting the adoption of a new accounting standard in the first quarter of 2018. We continue to hold 2.5 million shares of ICU Medical common stock and we recognized unrealized gains of $24 million in the third quarter of 2018 and unrealized gains of $229 million in the first nine months of 2018 related to these remaining shares. Prior to the adoption of a new accounting standard in the first quarter of 2018, net unrealized gains and losses on virtually all equity securities with readily determinable fair values were reported in Accumulated other comprehensive income. For additional information, see Note 1B,Note 2B and Note 7B.comparative prior year periods.
(b)
The increase in royalty-related income for the first nine months of 2019 is primarily due to a one-time favorable resolution in the second quarter of 2019 of a legal dispute for $82 million.
(c)
The third quarter of 2018 included gains of $24 million and the first nine months of 2018 included gains of $229 million related to our investment in ICU Medical stock.For additional information on investments, see Note 7B.
(d) 
Includes income from upfront and milestone payments from our collaboration partners and income from out-licensing arrangements and sales of compound/product rights. In the first nine months of 2019, mainly includes, among other things, $70 million in milestone income from Mylan Pharmaceuticals Inc. related to the FDA’s approval and launch of Wixela Inhub®, a generic of Advair Diskus®(fluticasone propionate and salmeterol inhalation powder) and $26 million in milestone income from multiple licensees. In the third quarter of 2018, primarily includes,included, among other things, (i) $40 million in milestone income from a certain licensee, (ii) a $35 million milestone payment received from Shire related to their first dosing of a patient in a Phase 3 clinical trial of a compound out-licensed by Pfizer to Shire for the treatment of Crohn’s disease and (iii) $45 million in gains related to sales of compound/product rights. In the first nine months of 2018, primarily includes,mainly included, among other things, (i) approximately $128 million in milestone income from multiple licensees, (ii) an upfront payment to us of $75 million for the sale of an AMPAα-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor potentiator for CIAScognitive impairment associated with schizophrenia (CIAS) to Biogen Inc., (iii) $110 million in milestone payments received from Shire, of which $75 million was received in the first quarter of 2018 related to their first dosing of a patient in a Phase 3 clinical trial of a compound out-licensed by Pfizer to Shire for the treatment of ulcerative colitis and $35 million was received from Shire related to their first dosing of a patient in a Phase 3 clinical trial for the treatment of Crohn’s disease, (iv) a $40 million milestone payment from Merck in conjunction with the approval of ertugliflozin in the EU and (v) $45 million in gains related to sales of compound/product rights. In the third quarter of 2017, primarily includes, among other things, $50 million in milestone income from a certain licensee and a $15 million gain related to the sale of compound/product rights. In the first nine months of 2017, primarily includes, among other things, approximately $81 million in milestone income from multiple licensees and a $43 million gain related to the sale of compound/product rights. For additional information, see Note 2B, Note 2C and Note 2D.
(e) 
Represents the net periodic benefit costs/(credits), excluding service costs, as a result of the adoption of a new accounting standard in the first quarter of 2018. Effective January 1, 2018, the U.S. Pfizer Consolidated Pension Plan was frozen to future benefit accruals and for the third quarter and first nine months of 2018, resulted in the recognition of lower net periodic benefit costs due to the extension of the amortization period for the actuarial losses. There was also a greater than expected gain on plan assets due to a higher plan asset base compared to the third quarter and first nine months of 2017. For additional information, see Note 1B andNote 10.
(f) 
For the first nine months of 2018, the net credits primarily representrepresented the reversal of a legal accrual where a loss was no longer deemed probable. In the third quarter and first nine months of 2017, primarily includes a $94 million charge to resolve a class action lawsuit filed by direct purchasers relating to Celebrex, which was approved by the court in April 2018, and a $79 million charge to reflect damages awarded by a jury in a patent matter.
(g) 
InThe first nine months of 2019 include an intangible asset impairment charge of $10 million and the first nine months of 2018, primarily includes a $31 million included an intangible asset impairment charge of $31 million recorded in the second quarter of 2018, which are all related to an IHa finite-lived developed technology right, acquired in connection with our acquisition of Anacor, for the treatment for toenail fungus marketed in the U.S. market only,. The impairment charge recorded in the second quarter of 2018 related to IH reflects, among other things, updated commercial forecasts. In the third quarter and first nine months of 2017, primarily includes an intangible asset impairment charge of $127 million related to developed technology rights, acquired in connection with our acquisition of Hospira, for a generic sterile injectable product for the treatment of edema associated with certain conditions.Biopharma and reflect,


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


among other things, updated commercial forecasts. The first nine months of 2019 also includes intangible asset impairment charges of: (i) $90 million related to WRDM IPR&D, for a pre-clinical stage asset from our acquisition of Bamboo for gene therapies for the potential treatment of patients with certain rare diseases and (ii) $40 million related to a Biopharma developed technology right, acquired in connection with our acquisition of King, for government defense products. The WRDM IPR&D intangible asset impairment charge was the result of a determination to not use certain Bamboo IPR&D acquired in future rare disease development. The intangible asset impairment charge forrelated to the third quarter and first nine months of 2017 is associated with EH andBiopharma developed technology right reflects, among other things, updated commercial forecasts and an increased competitive environment.including manufacturing cost assumptions. In addition, the first nine months of 2019, includes other asset impairments of $48 million.
(h) 
Represents adjustments to amounts previously recordedIn the third quarter and first nine months of 2019, and in 2016 to write down the HIS net assets to fair value lessthird quarter of 2018, represents incremental costs to sell related toassociated with the saledesign, planning and implementation of HIS net assets to ICU Medical on February 3, 2017. For additional information, see Note 2B.
(i)
Representsour new organizational structure, effective in the beginning of 2019, and primarily includes consulting, legal, tax and advisory services. In the first nine months of 2018, mainly represents expenses for changes to our infrastructure to align our commercial operations of our current segments,that existed through December 31, 2018, 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.
(i)
In the first nine months of 2019, represents net losses due to the early retirement of debt in the first quarter of 2019, inclusive of the related termination of cross-currency swaps.
(j) 
InThe third quarter of 2019 includes, among other things, dividend income of $43 million from our investment in ViiV and charges of $121 million for external incremental costs, such as transaction costs and costs to separate our Consumer Healthcare business into a separate legal entity, associated with the formation of the GSK Consumer Healthcare joint venture. The first nine months of 2019 includes, among other things, (i) dividend income of $184 million from our investment in ViiV, (ii) charges of $146 million for external incremental costs, such as transaction costs and costs to separate our Consumer Healthcare business into a separate legal entity, associated with the formation of the GSK Consumer Healthcare joint venture and (iii) $50 million of income from insurance recoveries related to Hurricane Maria. The third quarter and first nine months of 2018, includes included a non-cash $343 million pre-tax gain associated with our transaction with Bain Capital to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and preclinicalpre-clinical stage neuroscience assets primarily targeting disorders of the central nervous system (see Note 2B).system. The third quarter and first nine months of 2018 also include,included, among other things, dividend income of $91 million and $226 million, respectively, from our investment in ViiV, and charges of $122 million, and $257 million, respectively, reflecting the change in the fair value of contingent consideration. The first nine months of 2018 also includeincluded, among other things, (i) dividend income of $226 million from our investment in ViiV, (ii) charges of $257 million, reflecting the change in the fair value of contingent consideration, (iii) a non-cash $50 million pre-tax gain on the contribution of Pfizer’s allogeneic CAR T therapy development program assets obtained from Cellectis S.A. and Les Laboratoires Servier SAS in connection with our contribution agreement entered into with Allogene, in which Pfizer obtained a 25% ownership stake in Allogene (see Note 2B), and (iv) a non-cash $17 million pre-tax gain on the cash settlement of a liability that we incurred in April 2018 upon the EU approval of Mylotarg (see Note 7E). In the third quarter and first nine months of 2017, includes, among other things, dividend income of $54 million and $211 million, respectively, from our investment in ViiV and income of $62 million from resolution of a contract disagreement.
Mylotarg.
The following table provides additional information about the intangible assets that were impaired during 2019 in Other (income)/deductions:
  
Fair Value(a)
 Nine Months Ended September 29, 2019
(MILLIONS OF DOLLARS) Amount Level 1 Level 2 Level 3 Impairment
Intangible assets––IPR&D(b)
 $
 $
 $
 $
 $90
Intangible assets––Developed technology rights(b)
 13
 
 
 13
 50
Total $13
 $
 $
 $13
 $140
The following table provides additional information about the intangible asset that was impaired during 2018 in Other (income)/deductions:
  
Fair Value(a)
 Nine Months Ended September 30, 2018
(MILLIONS OF DOLLARS) Amount Level 1 Level 2 Level 3 Impairment
Intangible assets––Developed technology right, finite-lived(b)
 $35
 $
 $
 $35
 $31

(a) 
The fair value amount is presented as of the date of impairment, as these assets are not measured at fair value on a recurring basis.
(b) 
Reflects an intangible assetassets written down to fair value in the first nine months of 2018.2019. Fair value was determined using the income approach, specifically the multi-period excess earnings method, also known as the discounted cash flow method. We started with a forecast of all the expected net cash flows associated with the asset and then applied an asset-specific discount rate to arrive at a net present value amount. Some of the more significant estimates and assumptions inherent in this approach include: the amount and timing of the projected net cash flows, which includes the expected impact of competitive, legal and/or regulatory forces on the product; the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and the tax rate, which seeks to incorporate the geographic diversity of the projected cash flows.
Note 5. Tax Matters


A. Taxes on Income from Continuing Operations
In
During the fourthsecond quarter of 2017, we recorded an estimate2019, Pfizer reached settlement of certaindisputed issues at the IRS Office of Appeals, thereby settling all issues related to U.S. tax effectsreturns of Pfizer for the TCJA, including the impact on deferred tax assets and liabilities from the reduction in the U.S. Federal corporate tax rate from 35% to 21%, the impact on valuation allowances and other state income tax considerations, the $15.2 billion repatriation tax liability on accumulated post-1986 foreign earnings for which we plan to elect payment over eight years through 2026 (with the first of eight installments due in April 2019) that is reported primarily in Other taxes payable, and deferred taxes on basis differences expected to give rise to future taxes on global intangible low-taxed income. In addition, we had provided deferred tax liabilities in the past on foreign earnings that were not indefinitely reinvested.2009-2010. As a result of the TCJA, we reversed an estimate of the deferred taxes that are no longer expected to be needed due to the change to the territorial tax system. The estimated amounts recorded may changesettling these years, in the future due to uncertain tax positions. With respect to the aforementioned repatriation tax liability related to the TCJA repatriation tax, our obligations may vary as a result of changes in our uncertain tax positions and/or availability of attributes such as foreign tax and other credit carryforwards.
The TCJA subjects a U.S. shareholder to current tax on global intangible low-taxed income earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, states that we are permitted to make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as global intangible low-taxed income in future years or provide for the tax expense related to such income in the year the tax is incurred. We have elected to recognize deferred taxes for temporary differences expected to reverse as global intangible low-taxed income in future years. However, given the complexity of these provisions, we have not finalized our analysis. We were able to make a reasonable estimate of the deferred taxes on the temporary differences expected to reverse in the future and provided a provisional deferred tax liability of approximately $1 billion as of December 31, 2017. The provisional amount is based on the evaluation of certain temporary differences inside each of our foreign subsidiaries that are expected to reverse as global intangible low-taxed income. However, as we continue to evaluate the TCJA’s global intangible low-taxed income provisions during the measurement period, we may revise the methodology used for determining the deferred tax liability associated with such income.
We believe that we have made reasonable estimates with respect to each of the above items, however, all of the amounts recorded remain provisional as we have not completed our analysis of the complex and far reaching effects of the TCJA. Further, we continue to consider our assertions on any remaining outside basis differences in our foreign subsidiaries as of

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

September 30, 2018 and have not completed our analysis. In the thirdsecond quarter of 2018,2019 we recorded a favorable adjustment to the provisional estimatebenefit of the impact of the legislation, primarily related to the remeasurement of deferredapproximately $1.4 billion, representing tax assets and liabilities as well as revised estimates of benefits related to certain tax initiatives. Under guidance issued by the staff of the SEC, we expect to finalize our accounting related to the tax effects of the TCJA on deferred taxes, valuation allowances, state tax considerations, the repatriation tax liability, global intangible low-taxed income, and any remaining outside basis differences in our foreign subsidiaries during the fourth quarter of 2018, as we complete the remainder of our tax return filings and as any interpretations or clarifications of the TCJA occur through further legislation or U.S. Treasury actions or other means.interest.
Our effective tax rate for continuing operations was 28.4% for the third quarter of 2019, compared to 1.6% for the third quarter of 2018 and was 13.4% for the first nine months of 2019, compared to 20.3% for the third quarter of 2017 and was 9.9% for the first nine months of 2018, compared to 20.1% for the first nine months of 2017.
The lowerhigher effective tax rate for the third quarter and first nine months of 20182019 in comparison with the same periodsperiod in 20172018 was primarily due to:
the adoptiontax expense of a territorial system and$2.7 billion associated with the lower U.S. tax rate as a resultgain related to the completion of the December 2017 enactmentConsumer Healthcare joint venture transaction with GSK;
the non-recurrence of the TCJA as well ascertain tax initiatives and favorable adjustments to the provisional estimate of the impact oflegislation commonly referred to as the legislation;
TCJA; and
the favorable changea decrease in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business; as well as
an increase intax 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.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
B. Deferred Taxes

The higher effective tax rate for the first nine months of 2019 in comparison with the same period in 2018 was primarily due to:
We have not completed our analysisthe tax expense of $2.7 billion associated with the gain related to the completion of the TCJA on our prior assertionConsumer Healthcare joint venture transaction with GSK; and
the non-recurrence of indefinitely reinvested earnings. Accordingly, we continue to evaluate our assertion with respect to our accumulated foreign earnings subjectcertain tax initiatives and favorable adjustments to the deemed repatriation tax and we also continue to evaluate the amount of earnings that are indefinitely reinvested. Additionally, we continue to evaluate our assertions on any remaining outside basis differences in our foreign subsidiaries as of September 30, 2018 as we have not finalized our analysisprovisional estimate of the effects of all of the new provisionsTCJA,
partially offset by:
an increase in the TCJA. As of September 30, 2018, it is not practicable to estimate the additional deferred tax liability that would be recorded if the earnings subject to the deemed repatriation tax and any remaining outside basis differences as of September 30, 2018 are not indefinitely reinvested. In accordancebenefits associated with the authoritativeresolution of certain tax positions pertaining to prior years, primarily resulting from the aforementioned favorable settlement with the IRS; and
the tax benefit recorded as a result of additional guidance issued by the SEC Staff Accounting Bulletin 118,U.S. Department of Treasury related to the enactment of the TCJA.
Our estimated $15 billion repatriation tax liability on accumulated post-1986 foreign earnings for which we expect to completeelected, with the filing of our analysis within2018 U.S. Federal Consolidated Income Tax Return, payment over eight years through 2026 is reported in current Incometaxes payable (approximately $750 million) and the measurement period.remaining liability is reported in noncurrent Other taxes payable in our consolidated balance sheet as of September 29, 2019. The first installment of $750 million was paid in April 2019. Our obligations may vary as a result of changes in our uncertain tax positions and/or availability of attributes such as foreign tax and other credit carryforwards.
C.B. Tax Contingencies


We are subject to income tax in many jurisdictions, and a certain degree of estimation is required in recording the assets and liabilities related to income taxes. All of our tax positions are subject to audit by the local taxing authorities in each tax jurisdiction. These tax audits can involve complex issues, interpretations and judgments and the resolution of matters may span multiple years, particularly if subject to negotiation or litigation. Our assessments are based on estimates and assumptions that have been deemed reasonable by management, but our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes, and variation from such estimates could materially affect our financial statements in the period of settlement or when the statutes of limitations expire, as we treat these events as discrete items in the period of resolution.
The U.S. is one of our major tax jurisdictions, and we are regularly audited by the IRS:
During the second quarter of 2019, Pfizer reached settlement of disputed issues at the IRS Office of Appeals, thereby settling all issues related to U.S. tax returns of Pfizer for the years 2009-2010. As a result of settling these years, in the second quarter of 2019 we recorded a benefit of approximately $1.4 billion, representing tax and interest.
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 2011-2015 are currently under audit. Tax years 2016-20182016-2019 are open, but not under audit. All other tax years are closed.
With respect to Hospira, the federal income tax audit of tax year 2014 through short-year 2015 was effectively settled in the second quarter of 2018. All other tax years are closed.
With respect to Anacor and Medivation, the open tax years are not considered material to Pfizer.
In addition to the open audit years in the U.S., we have open audit years in other major tax jurisdictions, such as Canada (2013-2018)(2013-2019), Japan (2017-2018)(2017-2019), Europe (2011-2018,(2011-2019, primarily reflecting Ireland, the United Kingdom,U.K., France, Italy, Spain and Germany), Latin America (1998-2018,(1998-2019, primarily reflecting Brazil) and Puerto Rico (2011-2018)(2015-2019).


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


D. C. Tax Provision/(Benefit)Provision on Other Comprehensive Income/(Loss)Loss
The following table provides the components of Tax provision/(benefit) on other comprehensive income/(loss):
The following table provides the components of Tax provision on other comprehensive loss:
The following table provides the components of Tax provision on other comprehensive loss:
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

 September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Foreign currency translation adjustments, net(a)
 $14
 $(62) $82
 $(192) $86
 $14
 $96
 $82
Unrealized holding gains/(losses) on derivative financial instruments, net 35
 28
 39
 30
Unrealized holding gains on derivative financial instruments, net 31
 35
 37
 39
Reclassification adjustments for (gains)/losses included in net income (28) (29) 36
 (169) (3) (28) (62) 36
Reclassification adjustments of certain tax effects from AOCI to Retained earnings(b)
 
 
 1
 
 
 
 
 1
 7
 (1) 77
 (139) 28
 7
 (24) 77
Unrealized holding gains/(losses) on available-for-sale securities, net 20
 37
 (8) 93
 2
 20
 6
 (8)
Reclassification adjustments for gains included in net income (6) (49) (8) (45)
Reclassification adjustments for (gains)/losses included in net income (1) (6) 4
 (8)
Reclassification adjustments for tax on unrealized gains from AOCI to Retained earnings(c)
 
 
 (45) 
 
 
 
 (45)
 14
 (12) (62) 47
 1
 14
 10
 (62)
Benefit plans: actuarial gains/(losses), net 2
 (37) 27
 (15) (41) 2
 (42) 27
Reclassification adjustments related to amortization 15
 60
 43
 152
 23
 15
 41
 43
Reclassification adjustments related to settlements, net 10
 22
 25
 30
 9
 10
 10
 25
Reclassification adjustments of certain tax effects from AOCI to Retained earnings(b)
 
 
 637
 
 
 
 
 637
Other 11
 (33) 18
 (46) (1) 11
 2
 18
 38
 11
 750
 121
 (10) 38
 12
 750
Benefit plans: prior service costs and other, net 
 
 
 
 
 
 
 
Reclassification adjustments related to amortization (11) (17) (33) (50)
Reclassification adjustments related to curtailments, net (1) (1) (4) (5)
Reclassification adjustments related to amortization of prior service costs and other, net (11) (11) (33) (33)
Reclassification adjustments related to curtailments of prior service costs and other, net (11) (1) (11) (4)
Reclassification adjustments of certain tax effects from AOCI to Retained earnings(b)
 
 
 (144) 
 
 
 
 (144)
Other 1
 1
 1
 1
 1
 1
 1
 1
 (11) (17) (179) (55) (21) (11) (43) (179)
Tax provision/(benefit) on other comprehensive income/(loss) $62
 $(80) $667
 $(218)
Tax provision on other comprehensive loss $84
 $62
 $50
 $667
(a) 
Taxes are not provided for foreign currency translation adjustments relating to investments in international subsidiaries that will be held indefinitely.
(b) 
For additional information on the adoption of a new accounting standard related to reclassification of certain tax effects from AOCI, see Notes to Consolidated Financial Statements––Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards in 2018 in our 2018 Financial Report.
(c) 
For additional information on the adoption of a new accounting standard related to financial assets and liabilities, see Notes to Consolidated Financial Statements––Note 1B.Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards in 2018 in our 2018 Financial Report.
Note 6. Accumulated Other Comprehensive Loss, Excluding Noncontrolling Interests
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, 2017 $(5,180) $(30) $401
 $(5,262) $750
 $(9,321)
Other comprehensive income/(loss) due to the adoption of new accounting standards(a)
 (2) (1) (416) (637) 144
 (913)
Other comprehensive income/(loss)(b)
 (589) 279
 (116) 361
 (118) (183)
Balance, September 30, 2018 $(5,772) $248
 $(131) $(5,538) $776
 $(10,417)
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, 2018 $(6,075) $167
 $(68) $(6,027) $728
 $(11,275)
Other comprehensive income/(loss)(a)
 (443) (107) 68
 94
 (137) (525)
Balance, September 29, 2019 $(6,519) $60
 $
 $(5,933) $591
 $(11,801)
(a) 
Amounts represent the cumulative effect adjustments as of January 1, 2018 from the adoption of new accounting standards related to (i) financial assets and liabilities and (ii) the reclassification of certain tax effects from AOCI. For additional information, see Note 1B.
(b)
Amounts do not include foreign currency translation adjustments attributable to noncontrolling interests of $20$11 million loss for the first nine months of 20182019.
As of September 30, 201829, 2019, with respect to derivative financial instruments, the amount of unrealized pre-tax net gains on derivative financial instruments estimated to be reclassified into income within the next 12 months is approximately $177 million, which is$247 million. The net gains are expected to be offset primarily by net losses resulting from reclassification adjustments related to net losses related to foreign currency exchange-denominated forecasted intercompany inventory sales and available-for-sale debt securities.sales.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Note 7. Financial Instruments


A. Fair Value Measurements


Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

On January 1, 2018, we adopted a new accounting and disclosure standard related to accounting for the recognition of financial assets and liabilities. For additional information see Note 1B.
The following table presents the financial assets and liabilities measured at fair value using a market approach on a recurring basis by balance sheet categories and fair value hierarchy level as defined in Notes to Consolidated Financial Statements––Note 1E. Basis of Presentation and Significant Accounting Policies: Fair Value in Pfizer’s 2017 Financial Report:
The following table presents the financial assets and liabilities measured at fair value using a market approach on a recurring basis by balance sheet categories and fair value hierarchy level as defined in Notes to Consolidated Financial Statements––Note 1E. Basis of Presentation and Significant Accounting Policies: Fair Value in Pfizer’s 2018 Financial Report:
The following table presents the financial assets and liabilities measured at fair value using a market approach on a recurring basis by balance sheet categories and fair value hierarchy level as defined in Notes to Consolidated Financial Statements––Note 1E. Basis of Presentation and Significant Accounting Policies: Fair Value in Pfizer’s 2018 Financial Report:
 September 30, 2018 December 31, 2017 September 29, 2019 December 31, 2018
(MILLIONS OF DOLLARS) Total Level 1 Level 2 Total Level 1 Level 2 Total Level 1 Level 2 Total Level 1 Level 2
Financial assets measured at fair value on a recurring basis:                        
Short-term investments                        
Classified as equity securities:            
Classified as equity securities with readily determinable fair values:            
Money market funds $1,184
 $
 $1,184
 $2,115
 $
 $2,115
 $1,035

$

$1,035

$1,571

$

$1,571
Equity(a)
 29
 17
 12
 35
 16
 19
 19
 7
 12
 29
 17
 11
 1,213
 17
 1,196
 2,150
 16
 2,134
 1,054
 7
 1,047
 1,600
 17
 1,583
Classified as available-for-sale debt securities:                        
Government and agency—non-U.S. 8,336
 
 8,336
 12,242
 
 12,242
 2,498
 
 2,498
 9,609
 
 9,609
Corporate 2,890
 
 2,890
 2,766
 
 2,766
Government—U.S. 8
 
 8
 252
 
 252
Agency asset-backed—U.S. 17
 
 17
 23
 
 23
Other asset-backed 5
 
 5
 79
 
 79
Corporate and other 1,772
 
 1,772
 5,482
 
 5,482
 11,256
 
 11,256
 15,362
 
 15,362
 4,270
 
 4,270
 15,091
 
 15,091
Total short-term investments 12,469
 17
 12,452
 17,512
 16
 17,496
 5,324
 7
 5,317
 16,691
 17
 16,674
Other current assets                        
Derivative assets:                        
Interest rate contracts 88
 
 88
 104
 
 104
 59
 
 59
 97
 
 97
Foreign exchange contracts 488
 
 488
 234
 
 234
 559
 
 559
 477
 
 477
Total other current assets 576
 
 576
 337
 
 337
 618
 
 618
 574
 
 574
Long-term investments                        
Classified as equity securities:            
Equity(a)
 1,563
 1,527
 36
 1,440
 1,398
 42
Classified as trading securities:            
Debt 50
 50
 
 73
 73
 
Equity securities with readily determinable fair values(a)
 1,530

1,506

24

1,273

1,243

30
 1,612
 1,577
 36
 1,514
 1,472
 42
            
Classified as available-for-sale debt securities:                        
Government and agency—non-U.S. 106
 
 106
 387
 
 387
 45
 
 45
 94
 
 94
Corporate 3,210
 
 3,210
 4,172
 36
 4,136
Government—U.S. 421
 
 421
 495
 
 495
Other asset-backed 4
 
 4
 35
 
 35
Corporate and other 363
 
 363
 397
 
 397
 3,742
 
 3,742
 5,090
 36
 5,054
 408
 
 408
 491
 
 491
Total long-term investments 5,354
 1,577
 3,778
 6,603
 1,507
 5,096
 1,937
 1,506
 432
 1,764
 1,243
 521
Other noncurrent assets                        
Derivative assets:                        
Interest rate contracts 246
 
 246
 477
 
 477
 557
 
 557
 335
 
 335
Foreign exchange contracts 220
 
 220
 7
 
 7
 367
 
 367
 232
 
 232
Total other noncurrent assets 467
 
 467
 484
 
 484
 924
 
 924
 566
 
 566
Total assets $18,866
 $1,594
 $17,272
 $24,937
 $1,523
 $23,414
 $8,803
 $1,513
 $7,290
 $19,595
 $1,260
 $18,335
                        
Financial liabilities measured at fair value on a recurring basis:                        
Other current liabilities                        
Derivative liabilities:                        
Interest rate contracts $9
 $
 $9
 $1
 $
 $1
 $
 $
 $
 $5
 $
 $5
Foreign exchange contracts 80
 
 80
 201
 
 201
 133
 
 133
 78
 
 78
Total other current liabilities 89
 
 89
 201
 
 201
 133
 
 133
 82
 
 82
Other noncurrent liabilities                        
Derivative liabilities:                        
Interest rate contracts 653
 
 653
 177
 
 177
 
 
 
 378
 
 378
Foreign exchange contracts 432
 
 432
 313
 
 313
 600
 
 600
 564
 
 564
Total other noncurrent liabilities 1,085
 
 1,085
 490
 
 490
 600
 
 600
 942
 
 942
Total liabilities $1,174
 $
 $1,174
 $691
 $
 $691
 $733
 $
 $733
 $1,024
 $
 $1,024
(a) 
As of September 30, 2018,29, 2019, short-term equity securities of $12 million and long-term equity securities of $35$23 million are held in trust for benefits attributable to the former Pharmacia Savings Plus Plan. As of December 31, 20172018, short-term equity securities of $19$11 million and long-term equity securities of $42$29 million are held in trust for benefits attributable to the former Pharmacia Savings Plus Plan.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Financial Assets and Liabilities Not Measured at Fair Value on a Recurring Basis
The following table presents the financial liabilities not measured at fair value on a recurring basis, including the carrying values and estimated fair values using a market approach:
  September 29, 2019 December 31, 2018
  Carrying Value Estimated Fair Value Carrying Value Estimated Fair Value
(MILLIONS OF DOLLARS)   Total Level 2   Total Level 2
Financial Liabilities            
Long-term debt, excluding the current portion $36,044
 $40,873
 $40,873
 $32,909
 $35,260
 $35,260

The following table presents the financial liabilities not measured at fair value on a recurring basis, including the carrying values and estimated fair values:
  September 30, 2018 December 31, 2017
  Carrying Value Estimated Fair Value Carrying Value Estimated Fair Value
(MILLIONS OF DOLLARS)   Total Level 2   Total Level 2
Financial Liabilities            
Long-term debt, excluding the current portion $33,652
 $36,243
 $36,243
 $33,538
 $37,253
 $37,253
The differences between the estimated fair values and carrying values of held-to-maturity debt securities, restricted stock and private equity securities, at cost, and short-term borrowings not measured at fair value on a recurring basis were not significant as of September 30, 201829, 2019 or December 31, 2017, except for our investment in Allogene (see Note 2B).2018. The fair value measurements of our held-to-maturity debt securities and our short-term borrowings are based on Level 2 inputs. The fair value measurements of our private equity securities, carried at cost, which represent investments in the life sciences sector, are based on Level 3 inputs.inputs using a market approach.


In addition, as of September 30, 201829, 2019 and December 31, 2017,2018, we had long-term receivables whose fair value is based on Level 3 inputs. As of September 30, 201829, 2019 and December 31, 2017,2018, the differences between the estimated fair values and carrying values of these receivables were not significant.
Total Short-Term and Long-Term Investments and Equity-Method Investments
The following table represents our investments by classification type:
(MILLIONS OF DOLLARS) September 29, 2019
 December 31, 2018
Short-term investments    
Equity securities with readily determinable fair values(a)
 $1,054
 $1,600
Available-for-sale debt securities 4,270
 15,091
Held-to-maturity debt securities 978
 1,003
Total Short-term investments $6,302
 $17,694
     
Long-term investments    
Equity securities with readily determinable fair values $1,530
 $1,273
Available-for-sale debt securities 408
 491
Held-to-maturity debt securities 43
 59
Private equity investments at cost 742
 763
Total Long-term investments $2,723
 $2,586
     
Equity-method investments 15,999
 181
Total long-term investments and equity-method investments $18,721
 $2,767
Held-to-maturity cash equivalents $217
 $199

(a)
As of September 29, 2019 and December 31, 2018, equity securities with readily determinable fair values included money market funds primarily invested in U.S. Treasury and government debt.
The following table represents our investments by classification type:
(MILLIONS OF DOLLARS) September 30, 2018
 December 31, 2017
Short-term investments    
Equity securities $1,213
 $2,150
Available-for-sale debt securities 11,256
 15,362
Held-to-maturity debt securities 1,211
 1,138
Total Short-term investments $13,680
 $18,650
     
Long-term investments    
Equity securities $1,563
 $1,440
Trading debt securities 50
 73
Available-for-sale debt securities 3,742
 5,090
Held-to-maturity debt securities 63
 4
Private equity investments carried at equity-method or cost 1,027
 408
Total Long-term investments $6,444
 $7,015
Held-to-maturity cash equivalents $237
 $719

Fair Value Methodology
The following inputs and valuation techniques were used to estimate the fair value of our financial assets and liabilities:
Trading debt securities—quoted market prices.
Available-for-sale debt securities—third-party matrix-pricing model that uses significant inputs derived from or corroborated by observable market data and credit-adjusted interest rate yield curves. Mortgage-backed, loan-backed and receivable-backed securities are valued by third-party models that use significant inputs derived from observable market data like prepayment rates, default rates, and recovery rates.
Equity securities—quoted market prices.
Derivative assets and liabilities (financial instruments)—third-party matrix-pricing model that uses significant inputs derived from or corroborated by observable market data. Where applicable, these models discount future cash flow amounts using market-based observable inputs, including interest rate yield curves, and forward and spot prices for currencies. The credit risk impact to our derivative financial instruments was not significant.
Money market funds—observable net asset value prices.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

We periodically review the methodologies, inputs and outputs of third-party pricing services for reasonableness. Our procedures can include, for example, referencing other third-party pricing models, monitoring key observable inputs (like LIBOR interest rates) and selectively performing test-comparisons of values with actual sales of financial instruments.

B. Investments
At September 30, 2018, the investment securities portfolio consisted of debt securities that were virtually all investment-grade. Information on investments in debt and equity securities at September 30, 2018 and December 31, 2017 is as follows, including, as of September 30, 2018, the contractual maturities, or as necessary, the estimated maturities, of the available-for-sale and held-to-maturity debt securities:
  September 30, 2018 December 31, 2017
    Gross Unrealized   Maturities (in Years)    Gross Unrealized   
(MILLIONS OF DOLLARS) Amortized Cost
 Gains
 Losses
 Fair Value
 Within 1
 
Over 1
to 5

 Over 5
 Total
 Amortized Cost
 Gains
 Losses
 Fair Value
Available-for-sale debt securities                        
Government and agency––non-U.S.
 $8,476
 $9
 $(43) $8,442
 $8,336
 $106
 $
 $8,442
 $12,616
 $61
 $(48) $12,629
Corporate(a)
 6,192
 2
 (94) 6,100
 2,890
 2,356
 854
 6,100
 6,955
 15
 (33) 6,938
Government––U.S. 451
 
 (23) 428
 8
 421
 
 428
 765
 
 (19) 747
Agency asset-backed––U.S. 18
 
 (1) 18
 17
 
 
 18
 24
 
 (1) 24
Other asset-backed(b)
 9
 
 
 9
 5
 3
 2
 9
 114
 
 
 114
Held-to-maturity debt securities                        
Time deposits and other 734
 
 
 734
 670
 23
 40
 734
 1,091
 
 
 1,091
Government and agency––non-U.S. 778
 
 
 778
 778
 
 
 778
 770
 
 
 770
Total debt securities $16,658
 $11
 $(160) $16,509
 $12,704
 $2,909
 $896
 $16,509
 $22,337
 $77
 $(100) $22,313
Available-for-sale equity securities(c)
                        
Money market funds                 $2,115
 $
 $
 $2,115
Equity                 728
 586
 (124) 1,190
Total available-for-sale equity securities                 $2,843
 $586
 $(124) $3,304
At September 29, 2019, the investment securities portfolio consisted of debt securities that were virtually all investment-grade. Information on investments in debt and equity securities at September 29, 2019 and December 31, 2018 is as follows, including, as of September 29, 2019, the contractual maturities, or as necessary, the estimated maturities, of the available-for-sale and held-to-maturity debt securities:
  September 29, 2019 December 31, 2018
    Gross Unrealized   Maturities (in Years)    Gross Unrealized   
(MILLIONS OF DOLLARS) Amortized Cost
 Gains
 Losses
 Fair Value
 Within 1
 Over 1
to 5

 Over 5
 Total
 Amortized Cost
 Gains
 Losses
 Fair Value
Available-for-sale debt securities                        
Government and agency––non-U.S.
 $2,538
 $11
 $(6) $2,543
 $2,498
 $45
 $
 $2,543
 $9,754
 $7
 $(58) $9,703
Corporate and other(a)
 2,140
 1
 (6) 2,135
 1,772
 360
 2
 2,135
 5,905
 
 (27) 5,878
Held-to-maturity debt securities                        
Time deposits and other 636
 
 
 636
 593
 8
 35
 636
 668
 
 
 668
Government and agency––non-U.S.
 601
 
 
 601
 601
 
 
 601
 592
 
 
 592
Total debt securities $5,916
 $11
 $(12) $5,915
 $5,464
 $413
 $38
 $5,915
 $16,920
 $8
 $(85) $16,842
(a) 
IssuedPrimarily issued by a diverse group of corporations.
(b)
Includes mortgage-backed, loan-backed and receivable-backed securities, all of which are in senior positions in the capital structure of the security. Mortgage-backed securities are collateralized by diversified pools of residential and commercial mortgages. Loan-backed securities are collateralized by senior secured obligations of a diverse pool of companies or student loans. Receivable-backed securities are collateralized by credit cards receivables.
(c)
Upon the 2018 adoption of a new accounting standard related to financial assets and liabilities, available-for-sale equity securities were classified as equity securities. For additional information see Note 1B.
The following table presents the net unrealized (gains) and losses for the period that relate to equity securities still held at the reporting date, calculated as follows:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Net gains recognized during the period on investments in equity securities(a)
 $(6) $(85) $(153) $(460)
Less: Net gains recognized during the period on equity securities sold during the period (3) (58) (13) (105)
Net unrealized gains during the reporting period on equity securities still held at the reporting date $(3) $(27) $(140) $(355)
The following table presents the net unrealized gains and losses for the period that relates to equity securities still held at the reporting date, calculated as follows:
(MILLIONS OF DOLLARS) Three Months Ended September 30, 2018
Nine Months Ended September 30, 2018
Net gains recognized during the period on investments in equity securities(a)
 $94
$460
Less: Net gains recognized during the period on equity securities sold during the period (54)(90)
Net unrealized gains during the reporting period on equity securities still held at the reporting date(b)
 $40
$370

(a) 
The net gains on investments in equity securities are reported in Other (income)/deductions––net and, for the third quarter and first nine months of 2018, include unrealized net gains on equity securities reflecting the adoption of a new accounting standard in the first quarter of 2018.net. For additional information, see Note 4.
C. Short-Term Borrowings
Short-term borrowings include:
(MILLIONS OF DOLLARS) September 29,
2019

 December 31,
2018

Commercial paper $12,914
 $3,100
Current portion of long-term debt, principal amount 2,423
 4,781
Other short-term borrowings, principal amount(a)
 1,334
 966
Total short-term borrowings, principal amount 16,671
 8,847
Net fair value adjustments related to hedging and purchase accounting 7
 (5)
Net unamortized discounts, premiums and debt issuance costs (61) (11)
Total Short-term borrowings, including current portion of long-term debt, carried at historical proceeds, as adjusted
 $16,617
 $8,831
(b)(a) 
The third quarter of 2018 includes $8 million of unrealized net gains in Other (income)/deductions––net reflecting the adoption of a new accounting standard in the first quarter of 2018 and $32 million of unrealized gains on other equity securities. The first nine months of 2018 includes $344 million of unrealized net gains in Other (income)/deductions––net reflecting the adoption of a new accounting standard in the first quarter of 2018 and $26 million of unrealized gains on other equity securities.short-term borrowings primarily include cash collateral. For additional information, see Note 1B and Note 47E.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


C. Short-Term BorrowingsD. Long-Term Debt
New Issuances
Short-term borrowings include:
(MILLIONS OF DOLLARS) September 30,
2018

 December 31,
2017

Commercial paper $2,600
 $6,100
Current portion of long-term debt, principal amount 4,260
 3,532
Other short-term borrowings, principal amount(a)
 537
 320
Total short-term borrowings, principal amount 7,396
 9,951
Net fair value adjustments related to hedging and purchase accounting (5) 14
Net unamortized discounts, premiums and debt issuance costs (7) (12)
Total Short-term borrowings, including current portion of long-term debt, carried at historical proceeds, as adjusted
 $7,385
 $9,953
In the first quarter of 2019, we issued the following senior unsecured notes:
    Principal
(MILLIONS OF DOLLARS) Maturity Date As of September 29, 2019
2.800% notes(a)
 March 11, 2022 $500
2.950% notes(a)
 March 15, 2024 750
3.450% notes(a)
 March 15, 2029 1,750
3.900% notes(a)
 March 15, 2039 750
4.000% notes(a)
 March 15, 2049 1,250
Total long-term debt issued in the first quarter of 2019(b)
   $5,000
(a) 
Other short-term borrowings primarily include cash collateral. For additional information, see Note 7F.
D. Long-Term Debt
New Issuances
In the third quarter of 2018, we issued the following senior unsecured notes:
    Principal
(MILLIONS OF DOLLARS) Maturity Date As of September 30, 2018
3.000% notes(a)
 September 15, 2021 $1,000
Floating rate notes (LIBOR plus 0.33%)(b)
 September 15, 2023 300
3.200% notes(a)
 September 15, 2023 1,000
3.600% notes(a)
 September 15, 2028 1,000
4.100% notes(a)
 September 15, 2038 700
4.200% notes(a)
 September 15, 2048 1,000
Total long-term debt issued in the third quarter of 2018   $5,000
(a)
Fixed rate notes may be redeemed by us at any time, in whole, or in part, at varying redemption prices plus accrued and unpaid interest.
(b) 
FloatingThe weighted-average effective interest rate for the notes may not be redeemed by their terms prior to maturity.at issuance was 3.57%.

The following table provides the aggregate principal amount of our senior unsecured long-term debt, and adjustments to report our aggregate long-term debt:
(MILLIONS OF DOLLARS) September 30,
2018

 December 31,
2017

Total long-term debt, principal amount $33,658
 $32,783
Net fair value adjustments related to hedging and purchase accounting 129
 872
Net unamortized discounts, premiums and debt issuance costs (142) (125)
Other long-term debt 7
 8
Total long-term debt, carried at historical proceeds, as adjusted $33,652
 $33,538
Current portion of long-term debt, carried at historical proceeds, as adjusted $4,255
 $3,546
Retirements
E. Other Noncurrent Liabilities

Mylotarg (gemtuzumab ozogamicin)
In April 2018,January 2019, we repurchased all €1.1 billion ($1.3 billion, at exchange rates on settlement) principal amount outstanding of the EU approved Mylotarg for5.75% euro-denominated debt that was due June 2021 before the treatment of acute myeloid leukemia. In connection with the EU approval, we incurred an obligation to make guaranteed fixed annual payments overmaturity date at a ten-year period aggregating $301 million related to a research and development arrangement. We recorded the estimated net presentredemption value of $240 million as a liability and an intangible asset in Developed technology rights as of the approval date. In June 2018, we entered into a transaction with the obligee to buyout the remaining liability for the fixed annual payments for a lump sum payment of $224 million.€1.3 billion ($1.5 billion, at exchange rates on settlement). As a result, in the first quarter of 2019, we recorded a net loss of approximately $138 million, which included the buyout transaction, the liability was extinguishedrelated termination of cross-currency swaps, and we recognized a non-cash $17 million pre-tax gainis reported in Other (income)/deductions––netin the second quartercondensed consolidated statements of 2018 (see income. For additional information, see Note 4).
Bosulif (bosutinib)
In December 2017, the U.S. FDA approved Bosulif for the treatment of patients with newly-diagnosed chronic-phase Ph+ CML. In connection with the U.S. approval, we incurred an obligation to make guaranteed fixed annual payments over a ten-

The following table provides the aggregate principal amount of our senior unsecured long-term debt, and adjustments to report our aggregate long-term debt:
(MILLIONS OF DOLLARS) September 29,
2019

 December 31,
2018

Total long-term debt, principal amount $34,602
 $32,558
Net fair value adjustments related to hedging and purchase accounting 1,614
 479
Net unamortized discounts, premiums and debt issuance costs (179) (136)
Other long-term debt 7
 7
Total long-term debt, carried at historical proceeds, as adjusted $36,044
 $32,909
Current portion of long-term debt, carried at historical proceeds, as adjusted $2,431
 $4,776
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

year period aggregating $416 million related to a research and development arrangement. We recorded the estimated net present value of $364 million as of the approval date as an intangible asset in Developed technology rights. In August 2018, we entered into a transaction with the obligee to buyout a portion of the remaining liability for the fixed annual payments for a lump sum payment of $71 million. As a result of the buyout transaction, the liability was reduced and we recognized a non-cash $9 million pre-tax gain in Other (income)/deductions––net in the third quarter of 2018. The present value of the remaining future payments as of September 30, 2018 is $208 million, of which $23 million is recorded in Other current liabilities and $185 million is recorded in Other noncurrent liabilities.
Besponsa (inotuzumab ozogamicin)
In August 2017, the U.S. FDA approved Besponsa and in June 2017, the EU approved Besponsa as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. In connection with the U.S. approval, we incurred an obligation to make guaranteed fixed annual payments over a nine-year period aggregating $296 million related to a research and development arrangement. We recorded the estimated net present value of $248 million as of the approval date as an intangible asset in Developed technology rights. The present value of the remaining future payments as of September 30, 2018 is $240 million, of which $7 million is recorded in Other current liabilities and $233 million is recorded in Other noncurrent liabilities. In connection with the EU approval, we incurred an obligation to make guaranteed fixed annual payments over a nine-year period aggregating $148 million related to a research and development arrangement. We recorded the estimated net present value of $123 million as of the approval date as an intangible asset in Developed technology rights. The present value of the remaining future payments as of September 30, 2018 is $121 million, of which $3 million is recorded in Other current liabilities and $118 million is recorded in Other noncurrent liabilities.
The differences between the estimated fair values in the Level 2 fair value hierarchy and carrying values of these obligations were not significant as of September 30, 2018.
F. E. Derivative Financial Instruments and Hedging Activities

We adopted a new accounting standard in the first quarter of 2018, as of January 2018. For additional information, see Note 1B.
Foreign Exchange Risk


A significant portion of our revenues, earnings and net investments in foreign affiliates is exposed to changes in foreign exchange rates. We 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. We also manage our foreign exchange risk, depending on market conditions, through fair value, cash flow, and net investment hedging programs through the use of derivative financial instruments and foreign currency debt. These financial instruments serve to protect net income against the impact of remeasurement into another currency, or against the impact of translation into U.S. dollars of certain foreign exchange-denominated transactions.


All derivative financial instruments used to manage foreign currency risk are measured at fair value and are reported as assets or liabilities on the consolidated balance sheet. The derivative financial instruments primarily hedge or offset exposures in the U.K. pound, euro, Japanese yen, U.K. poundChinese renminbi and Swedish krona. Changes in fair value are reported in earnings or in Other comprehensive income/(loss), depending on the nature and purpose of the financial instrument (hedge or offset relationship) and the effectiveness of the hedge relationships, as follows:
Generally, we recognize the gains and losses on foreign exchange contracts that are designated as fair value hedges in earnings upon the recognition of the change in fair value of the hedged risk. Upon the adoption of the new standard in 2018, for certain foreign exchange contracts, we exclude an amount from the assessment of hedge effectiveness and recognize that excluded amount through an amortization approach. We also recognize the offsetting foreign exchange impact attributable to the hedged item in earnings.
Generally, we record in Other comprehensive income/(loss) gains or losses on foreign exchange contracts that are designated as cash flow hedges and reclassify those amounts, as appropriate, into earnings in the same period or periods during which the hedged transaction affects earnings. Upon the adoption of the new standard in 2018, for certain foreign exchange contracts, we exclude an amount from the assessment of hedge effectiveness and recognize that excluded amount through an amortization approach.
Historically, as part of our net investment hedging program, we recognize the gain and loss impact on foreign exchange contracts designated as hedges of our net investments in earnings in three ways: over time––for the periodic net swap payments; immediately––to the extent of any change in the difference between the foreign exchange spot rate and forward rate; and upon sale or substantial liquidation of our net investments––to the extent of change in the foreign exchange spot rates. Upon the adoption of the new standard in 2018, for foreign exchange contracts, we exclude an amount from the

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

assessment of hedge effectiveness and recognize that excluded amount through an amortization approach. We record in Other comprehensive income/(loss) the foreign exchange gains and losses related to foreign exchange-denominated debt designated as a hedge of our net investments in foreign subsidiaries and reclassify those amounts into earnings upon the sale or substantial liquidation of our net investments.
For certain foreign exchange contracts not designated as hedging instruments, we recognize the gains and losses on foreign currency exchange contracts that are used to offset the same foreign currency assets or liabilities immediately into earnings along with the earnings impact of the items they generally offset. These contracts essentially take the opposite currency position of that reflected in the month-end balance sheet to counterbalance the effect of any currency movement.
As a part of our cash flow hedging program, we designate foreign exchange contracts to hedge a portion of our forecasted euro, Japanese yen, Chinese renminbi, Canadian dollar, U.K. pound and Australian dollar-denominated intercompany inventory sales expected to occur no more than two years from the date of each hedge.
For the third quarter and first nine months ended October 1, 2017, any ineffectiveness is recognized immediately into earnings. There is no significant ineffectiveness for these periods.
Interest Rate Risk
Our interest-bearing investments and borrowings are subject to interest rate risk. With respect to our investments, we strive to maintain a predominantly floating-rate basis position, but our strategy may change based on prevailing market conditions. We currently borrow primarily on a long-term, fixed rate basis. Historically, we strove to borrow primarily on a floating-rate basis; but in recent years we borrowed on a long-term, fixed-rate basis. From time to time, depending on market conditions, we will change the profile of our outstanding debt by entering into derivative financial instruments like interest rate swaps. We entered into

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

derivative financial instruments to hedge or offset the fixed interest rates on the hedged item, matching the amount and timing of the hedged item. The derivative financial instruments primarily hedge U.S. dollar fixed-rate debt.

All derivative contracts used to manage interest rate risk are measured at fair value and reported as assets or liabilities on the consolidated balance sheet. Changes in fair value are reported in earnings, as follows:
We recognize the gains and losses on interest rate contracts that are designated as fair value hedges in earnings upon the recognition of the change in fair value of the hedged risk. We also recognize the offsetting earnings impact of fixed-rate debt attributable to the hedged risk in earnings.
For the third quarter and first nine months ended October 1, 2017, any ineffectiveness is recognized immediately into earnings. There is no significant ineffectiveness for these periods.
The following table provides the fair value of the derivative financial instruments and the related notional amounts presented between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments:
(MILLIONS OF DOLLARS) September 30, 2018 December 31, 2017 September 29, 2019 December 31, 2018
   Fair Value   Fair Value   Fair Value   Fair Value
 Notional Asset Liability Notional Asset Liability Notional Asset Liability Notional Asset Liability
Derivatives designated as hedging instruments:                        
Foreign exchange contracts(a)
 $19,955
 $590
 $464
 $18,723
 $179
 $459
 $22,807
 $810
 $621
 $22,984
 $654
 $586
Interest rate contracts 11,300
 335
 661
 12,430
 581
 178
 6,645
 616
 
 11,145
 432
 383
   925
 1,126
   760
 637
   1,425
 621
   1,085
 968
                        
Derivatives not designated as hedging instruments:                        
Foreign exchange contracts $16,798
 118
 48
 $14,300
 62
 54
 $18,112
 116
 112
 $15,154
 55
 55
                        
Total   $1,043
 $1,174
   $822
 $691
   $1,542
 $733
   $1,140
 $1,024
(a) 
As of September 30, 2018, theThe notional amount of outstanding foreign currency forward-exchange contracts hedging our intercompany forecasted inventory sales was $5.4 billion.$6.6 billion as of September 29, 2019 and $5.8 billion as of December 31, 2018.

The following tables provide information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk:
 
Amount of
Gains/(Losses)
Recognized in OID
(a)

Amount of Gains/(Losses)
Recognized in OCI
(a), (b)

Amount of Gains/(Losses)
Reclassified from
OCI into OID and COS
(a), (b)
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Three Months Ended            
Derivative Financial Instruments in Cash Flow Hedge Relationships:            
Foreign exchange contracts(c)
 $
 $
 $131
 $183
 $7
 $198
Amount excluded from effectiveness testing recognized in earnings based on an amortization approach 
 
 21
 39
 22
 36
Derivative Financial Instruments in Fair Value Hedge Relationships:            
Interest rate contracts 378
 (195) 
 
 
 
Hedged item (378) 195
 
 
 
 
Foreign exchange contracts 
 1
 
 
 
 
Hedged item 
 (1) 
 
 
 
Derivative Financial Instruments in Net Investment Hedge Relationships:  
  
  
  
  
  
Foreign exchange contracts 
 
 112
 43
 
 
The portion on foreign exchange contracts excluded from the assessment of hedge effectiveness 
 
 43
 14
 45
 21
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:  
  
  
  
  
  
Foreign currency short-term borrowings(d)
 
 
 45
 8
 
 
Foreign currency long-term debt(d)
 
 
 79
 17
 
 
Derivative Financial Instruments Not Designated as Hedges:            
Foreign exchange contracts (77) 150
 
 
 
 
All other net 
 
 (1) 
 
 
  $(77) $150
 $429
 $304
 $74
 $256


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


The following table provides information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk:
 
Amount of
Gains/(Losses)
Recognized in OID
(a), (b)

Amount of Gains/(Losses)
Recognized in OCI
(a), (c)

Amount of Gains/(Losses)
Reclassified from
OCI into OID and COS
(a), (c)
(MILLIONS OF DOLLARS) Sep 30,
2018

 Oct 1,
2017

 Sep 30,
2018

 Oct 1,
2017

 Sep 30,
2018

 Oct 1,
2017

Three Months Ended            
Derivative Financial Instruments in Cash Flow Hedge Relationships:            
Foreign exchange contracts(d)
 $
 $1
 $183
 $(51) $198
 $(56)
Amount excluded from effectiveness testing recognized in earnings based on an amortization approach 
 
 39
 
 36
 
             
Derivative Financial Instruments in Fair Value Hedge Relationships:            
Interest rate contracts (195) 10
 
 
 
 
Hedged item gain/(loss) 195
 (10) 
 
 
 
Foreign exchange contracts 1
 (11) 
 
 
 
Hedged item gain/(loss) (1) 11
 
 
 
 
             
Derivative Financial Instruments in Net Investment Hedge Relationships:  
  
  
  
  
  
Foreign exchange contracts 
 
 43
 
 
 
The portion of gains/(losses) on foreign exchange contracts excluded from the assessment of hedge effectiveness 
 
 14
 
 21
 
             
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:  
  
  
  
  
  
Foreign currency short-term borrowings(e)
 
 
 8
 
 
 
Foreign currency long-term debt(e)
 
 
 17
 (166) 
 
             
Derivative Financial Instruments Not Designated as Hedges:            
Foreign exchange contracts 150
 33
 
 
 
 
All other net 
 
 
 1
 
 
  $150
 $34
 $304
 $(216) $256
 $(55)

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

 
Amount of
Gains/(Losses)
Recognized in OID
(a), (b)
 
Amount of Gains/(Losses)
Recognized in OCI
(a), (c)
 
Amount of Gains/(Losses)
Reclassified from
OCI into OID and COS
(a), (c)
 
Amount of
Gains/(Losses)
Recognized in OID
(a)
 
Amount of Gains/(Losses)
Recognized in OCI
(a), (b)
 
Amount of Gains/(Losses)
Reclassified from
OCI into OID and COS
(a), (b)
(MILLIONS OF DOLLARS) Sep 30,
2018

 Oct 1,
2017

 Sep 30,
2018

 Oct 1,
2017

 Sep 30,
2018

 Oct 1,
2017

 September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Nine Months Ended                        
Derivative Financial Instruments in Cash Flow Hedge Relationships:  
  
  
  
  
  
  
  
  
  
  
  
Foreign exchange contracts(d)(c)
 $
 $(5) $147
 $(149) $(204) $394
 $
 $
 $137
 $147
 $265
 $(204)
Amount excluded from effectiveness testing recognized in earnings based on an amortization approach 
 
 87
 
 84
 
 



105

87

108

84
            
Derivative Financial Instruments in Fair Value Hedge Relationships:             

 

 

 

 

 

Interest rate contracts (715) 19
 
 
 
 
 1,191
 (715) 
 
 
 
Hedged item gain/(loss) 715
 (19) 
 
 
 
Hedged item (1,191) 715
 
 
 
 
Foreign exchange contracts 5
 (19) 
 
 
 
 
 5
 
 
 
 
Hedged item gain/(loss) (5) 19
 
 
 
 
            
Hedged item 
 (5) 
 
 
 
Derivative Financial Instruments in Net Investment Hedge Relationships:               

   

   

Foreign exchange contracts 
 
 191
 
 
 
 
 
 87
 191
 
 
The portion of gains/(losses) on foreign exchange contracts excluded from the assessment of hedge effectiveness 
 
 41
 
 47
 
            
The portion of foreign exchange contracts excluded from the assessment of hedge effectiveness 



136

41

99

47
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:               

 

 

 

 

Foreign currency short-term borrowings(e)
 
 
 50
 
 
 
Foreign currency long-term debt(e)
 
 
 111
 (518) 
 
            
Foreign currency short-term borrowings(d)
 
 
 65
 50
 
 
Foreign currency long-term debt(d)
 
 
 89
 111
 
 
Derivative Financial Instruments Not Designated as Hedges:               

 

 

   

Foreign exchange contracts 156
 (112) 
 
 
 
 (201) 156
 
 
 
 
All other net 
 
 1
 1
 1
 
 
 
 
 1
 
 1
 $156
 $(117) $629
 $(666) $(72) $394
 $(201) $156
 $617
 $629
 $472
 $(72)
(a) 
OID = Other (income)/deductions—net, included in Other (income)/deductions—net in the condensed consolidated statements of income. COS = Cost of Sales, included in Cost of sales in the condensed consolidated statements of income. OCI = Other comprehensive income/(loss), included in the condensed consolidated statements of comprehensive income.
(b) 
For the third quarter and first nine months ended October 1, 2017, there was no significant ineffectiveness.
(c)
For derivative financial instruments in cash flow hedge relationships, the gains and losses are included in Other comprehensive income/(loss)–income––Unrealized holding gains/(losses)gains on derivative financial instruments, net. For derivative financial instruments in net investment hedge relationships and for foreign currency debt designated as hedging instruments, the effective portion is included in Other comprehensive income/(loss)–income––Foreign currency translation adjustments, net.
(d)(c) 
Based on quarter-end foreign exchange rates that are subject to change, we expect to reclassify a pre-tax gain of $120$252 million within the next 12 months into Cost of sales. The maximum length of time over which we are hedging future foreign exchange cash flow relates to our $1.8 billion U.K. pound debt maturing in 2043.
(e)(d) 
Short-term borrowings include foreign currency short-term borrowings with carrying values of $1.5$1.1 billion as of September 30, 2018,29, 2019, which are used as hedging instruments in net investment hedges. Long-term debt includes foreign currency long-term borrowings with carrying values of $3.2$1.9 billion as of September 30, 2018,29, 2019, which are used as hedging instruments in net investment hedges.
The following table provides the total amount of each income and expense line in which the results of fair value or cash flow hedges are recorded:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS)
September 29,
2019

 September 30,
2018

 September 29
2019

 September 30,
2018

Cost of sales
$2,602
 $2,694
 $7,611
 $8,173
Other (income)/deductions—net
319
 (414) 537
 (1,143)
The following table provides the total amount of each income and expense line in which the results of fair value or cash flow hedges are recorded:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30, 2018
 September 30, 2018
Cost of sales $2,694
 $8,173
Other (income)/deductions—net (414) (1,143)



PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


The following table provides the amounts recorded in our condensed consolidated balance sheet related to cumulative basis adjustments for fair value hedges:
  September 29, 2019 December 31, 2018
    
Cumulative Amount of Fair Value Hedging Adjustment Increase/(Decrease) to
Carrying Amount
   
Cumulative Amount of Fair Value Hedging Adjustment Increase/(Decrease) to
Carrying Amount
(MILLIONS OF DOLLARS)
Carrying Amount of Actively Hedged Assets/Liabilities(a)


Active Hedging Relationships
 Discontinued Hedging Relationships
 
Carrying Amount of Actively Hedged Assets/Liabilities(a)

 Active Hedging Relationships
 Discontinued Hedging Relationships
Long-term investments
$45

$
 $
 $45
 $(1) $
Short-term borrowings, including current portion of long-term debt



 
 1,499
 (5) 
Long-term debt
7,101

557
 700 9,952
 (45) 129

(a)
Carrying amounts exclude the cumulative amount of fair value hedging adjustments.
The following table provides the amounts recorded in our condensed consolidated balance sheet related to cumulative basis adjustments for fair value hedges:
  Carrying Amount of Hedged Assets/Liabilities
 Cumulative Amount of Fair Value Hedging Adjustment Gains/(Losses) Included in the Carrying Amount of the Hedged Assets/Liabilities
(MILLIONS OF DOLLARS) September 30, 2018
 September 30, 2018
Short-term investments $156
 $
Long-term investments 45
 (1)
Short-term borrowings, including current portion of long-term debt 1,490
 8
Long-term debt 9,548
 407
Certain of our derivative instruments are covered by associated credit-support agreements that have credit-risk-related contingent features designed to reduce both counterparties’ exposure to risk of defaulting on amounts owed by the other party. As of September 30, 201829, 2019, the aggregate fair value of these derivative instruments that are in a net liability position was $545$673 million, for which we have posted collateral of $535$661 million in the normal course of business. If there had been a downgrade to below an A rating by S&P or the equivalent rating by Moody’s, we would not have been required to post any additional collateral to our counterparties.
As of September 30, 201829, 2019, we received cash collateral of $472 million$1.3 billion from various counterparties. The collateral primarily supports the approximate fair value of our derivative contracts.contracts that are in a net asset position. With respect to the collateral received, the obligations are reported in Short-term borrowings, including current portion of long-term debt.
G.F. Credit Risk


On an ongoing basis, we review the creditworthiness of counterparties to our foreign exchange and interest rate agreements and do not expect to incur a significant loss from failure of any counterparties to perform under the agreements. There are no significant concentrations of credit risk related to our financial instruments with any individual counterparty, except for certain significant customers. For additional information as toon significant customers, see Notes to Consolidated Financial Statements––Note 18C. Segment, Geographic and Other Revenue Information: Other Revenue Information in Pfizer’s 20172018 Financial Report. As of September 30, 201829, 2019, we had amounts due from a well-diversified, high quality group of banks ($2.12.7 billion) from around the world. For details about our investments, see Note 7B above.


In general, there is no requirement for collateral from customers. However, derivative financial instruments are executed under credit-support agreements that provide for the ability to request to receive cash collateral, depending on levels of exposure, our credit rating and the credit rating of the counterparty, see Note 7F7E above.
Note 8. Inventories
The following table provides the components of Inventories:
(MILLIONS OF DOLLARS) September 29,
2019

 December 31,
2018

Finished goods $2,594
 $2,262
Work-in-process 4,866
 4,701
Raw materials and supplies 762
 546
Inventories(a)
 $8,222
 $7,508
Noncurrent inventories not included above(b)
 $677
 $618
The following table provides the components of Inventories:
(MILLIONS OF DOLLARS) September 30,
2018

 December 31,
2017

Finished goods $2,581
 $2,883
Work-in-process 4,764
 3,908
Raw materials and supplies 839
 788
Inventories(a)
 $8,184
 $7,578
Noncurrent inventories not included above(b)
 $576
 $683

(a) 
The change from December 31, 20172018 reflects increases for certain products to meet targeted levels in the normal course of business, including inventory build for supply recovery, network strategy and new product launches and market demand, partially offset by a decrease due to foreign exchange.exchange and the write off of rivipansel inventory previously expected to be sold (see Note 2C).
(b) 
Included in Other noncurrent assets. There are no recoverability issues associated with these amounts.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Note 9. Identifiable Intangible Assets and Goodwill


A. Identifiable Intangible Assets


Balance Sheet Information
The following table provides the components of Identifiable intangible assets:
  September 29, 2019 December 31, 2018
(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(a)
 $91,212
 $(62,032) $29,180
 $89,430
 $(58,895) $30,535
Brands 922
 (733) 190
 923
 (708) 215
Licensing agreements and other(a)
 1,776
 (1,173) 603
 1,436
 (1,140) 296
  93,910
 (63,938) 29,972
 91,788
 (60,743) 31,045
Indefinite-lived intangible assets            
Brands 1,991
 

 1,991
 1,991
 

 1,991
IPR&D(a)
 5,959
 

 5,959
 2,171
 

 2,171
Licensing agreements and other(a), (b)
 1,073
 

 1,073
 3
 

 3
  9,023
 

 9,023
 4,165
 

 4,165
Identifiable intangible assets(a), (c)
 $102,933
 $(63,938) $38,995
 $95,954
 $(60,743) $35,211
The following table provides the components of Identifiable intangible assets:
  September 30, 2018 December 31, 2017
(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(a)
 $92,123
 $(57,786) $34,337
 $89,550
 $(54,785) $34,765
Brands 2,126
 (1,228) 898
 2,134
 (1,152) 982
Licensing agreements and other 1,938
 (1,160) 777
 1,911
 (1,096) 815
  96,187
 (60,175) 36,012
 93,595
 (57,033) 36,562
Indefinite-lived intangible assets            
Brands and other 6,909
 

 6,909
 6,929
 

 6,929
IPR&D(a)
 2,385
 

 2,385
 5,249
 

 5,249
  9,294
 

 9,294
 12,179
 

 12,179
Identifiable intangible assets(b)
 $105,481
 $(60,175) $45,306
 $105,774
 $(57,033) $48,741

(a) 
The changesincrease in the gross carrying amount of Identifiable intangible assets primarily reflects the impact of the acquisition of Array, including the addition of $1.8 billion of Developed technology rights,and IPR&D primarily reflect (i) the transfer of $2.7 billion from IPR&D to Developed technology rights to reflect the approval of Xtandi in the U.S. for the treatment of men with non-metastatic castration-resistant prostate cancer, which is being developed through a collaboration with Astellas, and (ii) $240 $340 million ofDeveloped technology rights recorded in connection with the EU approvalfinite-lived Licensing agreements, $4.0 billion of Mylotarg (see IPR&D and $1.1 billion of indefinite-lived Licensing agreements(see Note 7E2A).
(b)    The decrease in Identifiable intangible assets, less accumulated amortization, is primarily due to amortization, partially offset by additions, mainly consisting of $240 million of Developed technology rights recorded in connection with the EU approval of Mylotarg (see Note 7E).
Our identifiable intangible assets are associated with the following, as a percentage of total identifiable intangible assets, less accumulated amortization:
  September 30, 2018
  IH EH WRD
Developed technology rights 70% 29% 
Brands, finite-lived 75% 25% 
Brands, indefinite-lived 71% 29% 
IPR&D 64% 21% 15%

Amortization

Total amortization expense for finite-lived intangible assets was $1.3 billion for the third quarter of 2018 and $1.2 billion for the third quarter of 2017, and $3.7 billion for the first nine months of 2018 and $3.6 billion for the first nine months of 2017.
B. Goodwill
The following table provides the components of and changes in the carrying amount of Goodwill:
(MILLIONS OF DOLLARS) IH EH Total
Balance, December 31, 2017 $31,141
 $24,811
 $55,952
Other(a)
 (178) (160) (338)
Balance, September 30, 2018 $30,964
 $24,651
 $55,614
(a)(b) 
Reflects acquired licensing agreements for technology in development.
(c)
Primarily reflects the impact of foreign exchange, as well as the contribution of the allogeneic CAR T developmental programThe increase in Identifiable intangible assets, less accumulated amortization, is primarily due to additions noted in (a) above, partially offset by amortization and operations to Allogene that constituted a businessintangible asset impairment charges. See Note 4 for accounting purposes (see Note 2B).additional information on intangible asset impairments.

Licensing Agreements

Licensing agreements for developed technology and licensing agreements for technology in development primarily relate to out-licensing arrangements acquired from third parties, including the Array acquisition. These intangible assets represent the amortized or unamortized cost associated with the license, where Pfizer has acquired the right to future royalties and/or milestones upon development or commercialization by the licensing partner. A significant component of the licensing arrangements at September 29, 2019 are for out-licensing arrangements with a number of partners for oncology technology in varying stages of development that have not yet received regulatory approval in a major market. Accordingly, during the development period after the date of acquisition, each of these assets is classified as indefinite-lived intangible assets and will not be amortized until approval is obtained in a major market. At that time we will determine the useful life of the asset, reclassify the respective licensing arrangement asset to finite-lived intangible asset and begin amortization. If the development effort is abandoned, the related licensing asset will likely be written-off, and we will record an impairment charge.

Our identifiable intangible assets are associated with the following, as a percentage of total identifiable intangible assets, less accumulated amortization:
  September 29, 2019
  Biopharma Upjohn WRDM
Developed technology rights 99% 1% 
Brands, finite-lived 100% 
 
Brands, indefinite-lived 42% 58% 
IPR&D 95% 
 5%
Licensing agreements and other, finite-lived 98% 
 2%
Licensing agreements and other, indefinite-lived 100% 
 



PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Amortization

Total amortization expense for finite-lived intangible assets was $1.2 billion for the third quarter of 2019 and $1.3 billion for the third quarter of 2018, and $3.6 billion for the first nine months of 2019 and $3.7 billion for the first nine months of 2018.
B. Goodwill

Prior to 2019, we managed our commercial operations through 2 distinct business segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). At the beginning of our 2019 fiscal year, we reorganized our commercial operations and our businesses are managed through 3 different operating segments––Biopharma, Upjohn and through July 31, 2019, Pfizer’s Consumer Healthcare business (see Note 10. Pension13 for further information). Our Consumer Healthcare business was classified as held for sale as of December 31, 2018 and Postretirement Benefit Planstherefore, the goodwill attributable to the Pfizer Consumer Healthcare business was not included in the table below (see Note 2B. for further information). Additionally, upon closing of the transaction during the third quarter, we deconsolidated our Consumer Healthcare business and derecognized Consumer Healthcare goodwill.
As a result of the reorganization of our commercial operations, our remaining goodwill was required to be reallocated amongst the then new Biopharma and Upjohn operating segments by determining the fair value of each reporting unit under our old and new management structure and the portions being transferred. We completed this re-allocation based on relative fair value in the second quarter of 2019 and have retrospectively presented goodwill according to the new operating structure.
The following table provides the components of and changes in the carrying amount of Goodwill:
(MILLIONS OF DOLLARS) Biopharma Upjohn Total
Balance, December 31, 2018 $42,927
 $10,484
 $53,411
Additions(a)
 5,378
 
 5,378
Other(b)
 (99) (24) (123)
Balance, September 29, 2019 $48,206
 $10,460
 $58,665
The following table provides the components of net periodic benefit cost/(credit):
  Three Months Ended
  Pension Plans  
  
U.S.
Qualified(a)
 
U.S.
Supplemental
(Non-Qualified)
 International 
Postretirement
Plans
(MILLIONS OF DOLLARS) Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
Net periodic benefit cost/(credit)(b):
                
Service cost(c)
 $
 $67
 $
 $6
 $33
 $44
 $10
 $10
Interest cost 149
 157
 14
 13
 52
 52
 18
 23
Expected return on plan assets (259) (248) 
 
 (89) (87) (9) (9)
Amortization of:  
  
  
  
    
  
  
Actuarial losses(c)
 30
 91
 3
 12
 25
 29
 2
 8
Prior service credits 
 
 
 
 (1) (1) (45) (45)
Curtailments 1
 1
 1
 
 (4) (2) (1) (3)
Settlements 38
 30
 3
 7
 
 
 
 
  $(40) $99
 $20
 $39
 $17
 $35
 $(26) $(17)
 
  Nine Months Ended
  Pension Plans  
  
U.S.
Qualified(a)
 
U.S.
Supplemental
(Non-Qualified)
 International 
Postretirement
Plans
(MILLIONS OF DOLLARS) Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
Net periodic benefit cost/(credit)(b):
                
Service cost(c)
 $
 $202
 $
 $18
 $104
 $127
 $29
 $32
Interest cost 450
 478
 40
 41
 160
 152
 54
 68
Expected return on plan assets (783) (759) 
 
 (274) (256) (28) (27)
Amortization of:                
Actuarial losses(c)
 90
 302
 10
 37
 77
 86
 5
 23
Prior service costs/(credits) 1
 3
 (1) (1) (3) (3) (135) (137)
Curtailments 11
 10
 1
 
 (4) (2) (15) (15)
Settlements 84
 54
 24
 32
 
 3
 
 
  $(147) $292
 $75
 $127
 $61
 $106
 $(89) $(57)

(a) 
In the second quarterBiopharma additions relate to our acquisition of 2017, we settled the remaining obligation associated with the Hospira U.S. qualified defined benefit pension plan. We purchased a group annuity contract on behalf of the remaining plan participants with a third-party insurance provider. As a result, we were relieved of the $156 million net pension benefit obligation and recorded a pre-tax settlement gain of $41 million, partially offset by the recognition of actuarial losses and prior service costs upon plan settlement of approximately $30 million in Other (income)/deductions––net (see Array (see Note 32A).
(b) 
We adopted a new accounting standard on January 1, 2018 that requiresPrimarily reflects the net periodic pension and postretirement benefit costs other than service costs be presented in Other (income)/deductions––net on the condensed consolidated statementsimpact of income. For additional information, see Note 1B and Note 4.
(c)
Effective January 1, 2018, we froze two significant defined benefit pension plans to future benefit accruals in the U.S. and U.K. and as a result, service costs for those plans are eliminated. In addition, due to the plan freeze, the average amortization period for the U.S. qualified plans and U.S. supplemental (non-qualified) plans was extended to the expected life expectancy of the plan participants, whereas the average amortization period in prior years utilized the expected future service period of plan participants.foreign exchange.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Note 10. Pension and Postretirement Benefit Plans
The following tables provide the components of net periodic benefit cost/(credit):
  Three Months Ended
  Pension Plans  
  
U.S.
Qualified
 
U.S. Supplemental
(Non-Qualified)
 International 
Postretirement
Plans
(MILLIONS OF DOLLARS) Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

Net periodic benefit cost/(credit):                
Service cost $
 $
 $
 $
 $31
 $33
 $9
 $10
Interest cost 157
 149
 12
 14
 53
 52
 19
 18
Expected return on plan assets (222) (259) 
 
 (79) (89) (8) (9)
Amortization of:  
  
  
  
    
  
  
Actuarial losses 37
 30
 2
 3
 20
 25
 
 2
Prior service credits (1) 
 
 
 (1) (1) (43) (45)
Curtailments 
 1
 
 1
 
 (4) (47) (1)
Settlements 1
 38
 22
 3
 12
 
 (10) 
Special termination benefits 3
 
 5
 
 
 
 1
 
  $(25) $(40) $41
 $20
 $37
 $17
 $(78) $(26)
  Nine Months Ended
  Pension Plans  
  
U.S.
Qualified
 
U.S. Supplemental
(Non-Qualified)
 International 
Postretirement
Plans
(MILLIONS OF DOLLARS) Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

Net periodic benefit cost/(credit):                
Service cost $
 $
 $
 $
 $94
 $104
 $28
 $29
Interest cost 472
 450
 37
 40
 162
 160
 57
 54
Expected return on plan assets (667) (783) 
 
 (239) (274) (25) (28)
Amortization of:                
Actuarial losses 110
 90
 7
 10
 61
 77
 2
 5
Prior service costs/(credits) (2) 1
 (1) (1) (3) (3) (132) (135)
Curtailments 
 11
 
 1
 
 (4) (47) (15)
Settlements 3
 84
 21
 24
 12
 
 (10) 
Special termination benefits 4
 
 14
 
 
 1
 2
 
  $(80) $(147) $78
 $75
 $88
 $61
 $(124) $(89)

The following table provides the amounts we contributed, and the amounts we expect to contribute during 2018, to our pension and postretirement plans from our general assets for the periods indicated:
  Pension Plans  
(MILLIONS OF DOLLARS) U.S. Qualified U.S. Supplemental (Non-Qualified) International Postretirement Plans
Contributions from our general assets for the nine months ended September 30, 2018 $500
 $118
 $174
 $108
Expected contributions from our general assets during 2018(a)
 500
 137
 229
 149
The following table provides the amounts we contributed, and the amounts we expect to contribute during 2019, to our pension and postretirement plans from our general assets for the periods indicated:
  Pension Plans  
(MILLIONS OF DOLLARS) U.S. Qualified U.S. Supplemental (Non-Qualified) International Postretirement Plans
Contributions from our general assets for the nine months ended September 29, 2019 $8
 $122
 $158
 $103
Expected contributions from our general assets during 2019(a)
 11
 147
 191
 143

(a) 
Contributions expected to be made for 20182019 are inclusive of amounts contributed during the nine months ended September 30, 2018, including the $500 million voluntary contribution that was made in February 2018 for the U.S. qualified plans, which was considered pre-funding for future anticipated mandatory contributions and is also expected to reduce Pension Benefit Guaranty Corporation variable rate premiums.29, 2019. The U.S. supplemental (non-qualified) pension plan, international pension plan and the postretirement plan contributions from our general assets include direct employer benefit payments.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Note 11. Earnings Per Common Share Attributable to Common Shareholders
The following table provides the detailed calculation of EPS:
The following table provides the detailed calculation of EPS:
The following table provides the detailed calculation of EPS:
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(IN MILLIONS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

 September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

EPS Numerator––Basic                
Income from continuing operations $4,111
 $2,858
 $11,562
 $9,064
 $7,680
 $4,111
 $16,625
 $11,562
Less: Net income attributable to noncontrolling interests 8
 18
 25
 32
 4
 8
 19
 25
Income from continuing operations attributable to Pfizer Inc. 4,103
 2,840
 11,537
 9,032
 7,676
 4,103
 16,606
 11,537
Less: Preferred stock dividends––net of tax 
 
 1
 1
 
 
 1
 1
Income from continuing operations attributable to Pfizer Inc. common shareholders 4,103
 2,839
 11,536
 9,032
 7,676
 4,103
 16,605
 11,536
Discontinued operations––net of tax 11
 
 10
 1
 4
 11
 4
 10
Net income attributable to Pfizer Inc. common shareholders $4,114
 $2,839
 $11,546
 $9,033
 $7,680
 $4,114
 $16,609
 $11,546
EPS Numerator––Diluted  
  
  
  
  
  
  
  
Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions $4,103
 $2,840
 $11,537
 $9,032
 $7,676
 $4,103
 $16,606
 $11,537
Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions 11
 
 10
 1
 4
 11
 4
 10
Net income attributable to Pfizer Inc. common shareholders and assumed conversions $4,114
 $2,840
 $11,546
 $9,034
 $7,680
 $4,114
 $16,609
 $11,546
EPS Denominator  
  
  
  
  
  
  
  
Weighted-average number of common shares outstanding––Basic 5,875
 5,951
 5,899
 5,972
 5,545
 5,875
 5,581
 5,899
Common-share equivalents: stock options, stock issuable under employee compensation plans, convertible preferred stock and accelerated share repurchase agreements 112
 89
 99
 85
 104
 112
 110
 99
Weighted-average number of common shares outstanding––Diluted 5,986
 6,041
 5,998
 6,057
 5,649
 5,986
 5,690
 5,998
Stock options that had exercise prices greater than the average market price of our common stock issuable under employee compensation plans(a)
 5
 47
 3
 47
 3
 5
 2
 3
Cash dividends declared per share $0.36
 $0.34
 $1.08
 $1.02
(a) 
These common stock equivalents were outstanding for the periods presented, but were not included in the computation of diluted EPS for those periods because their inclusion would have had an anti-dilutive effect.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Note 12. Contingencies and Certain Commitments


We and certain of our subsidiaries are subject to numerous contingencies arising in the ordinary course of business, including tax and legal contingencies. For a discussion of our tax contingencies, see Note 5C.5B. For a discussion of our legal contingencies, see below.
A. Legal Proceedings


Our legal contingencies include, but are not limited to, the following:
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 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.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

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 jurisdictions.

Certain of these contingencies could result in losses, including damages, fines and/or civil penalties, which could be substantial, and/or criminal charges.


We believe that our claims and defenses in matters in which we are a defendant are substantial, but litigation is inherently unpredictable and excessive verdicts do occur. We do not believe that any of these matters will have a material adverse effect on our financial position. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of certain matters, and such developments could have a material adverse effect on our results of operations in the period in which the amounts are accrued and/or our cash flows in the period in which the amounts are paid.


We have accrued for losses that are both probable and reasonably estimable. Substantially all of our contingencies are subject to significant uncertainties and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to estimate the range of reasonably possible loss in excess of amounts accrued. Our assessments are based on estimates and assumptions that have been deemed reasonable by management, but the assessment process relies heavily on estimates and assumptions that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions.


Amounts recorded for legal and environmental contingencies can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions.


The principal pending matters to which we are a party are discussed below. In determining whether a pending matter is a principal matter, we consider both quantitative and qualitative factors in order to assess materiality, such as, among other things, the amount of damages and the nature of any other relief sought in the proceeding, if such damages and other relief are specified; our view of the merits of the claims and of the strength of our defenses; whether the action purports to be, or is, a class action and, if not certified, our view of the likelihood that a class will be certified by the court; the jurisdiction in which the proceeding is pending; whether related actions have been transferred to multidistrict litigation; any experience that we or, to our knowledge, other companies have had in similar proceedings; whether disclosure of the action would be important to a reader of our financial statements, including whether disclosure might change a reader’s judgment about our financial statements in light of all of the information that is available to the reader; the potential impact of the proceeding on our reputation; and the extent of public interest in the matter. In addition, with respect to patent matters in which we are the plaintiff, we consider, among other things, the financial significance of the product protected by the patent(s) at issue. As a result of considering qualitative factors in our determination of principal matters, there are some matters discussed below with respect to which management believes that the likelihood of possible loss in excess of amounts accrued is remote.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

A1.Legal Proceedings––Patent Litigation

Like other pharmaceutical companies, we are involved in numerous suits relating to our patents, including but not limited to, those discussed below. Most of the suits involve claims by generic drug manufacturers that patents covering our products, processes or dosage forms are invalid and/or do not cover the product of the generic drug manufacturer. Also, counterclaims, as well as various independent actions, have been filed alleging that our assertions of, or attempts to enforce, patent rights with respect to certain products constitute unfair competition and/or violations of antitrust laws. In addition to the challenges to the U.S. patents on a number of our products that are discussed below, patent rights to certain of our products are being challenged in various other jurisdictions. We are also party to patent damages suits in various jurisdictions pursuant to which generic drug manufacturers, payers, governments or other parties are seeking damages from us for allegedly causing delay of generic entry. Additionally, our licensing and collaboration partners face challenges by generic drug manufacturers to patents covering products for which we have licenses or co-promotion rights. We also are often involved in other proceedings, such as inter partes review, post-grant review, re-examination or opposition proceedings, before the U.S. Patent and Trademark Office, the European Patent Office, or other foreign counterparts relating to our intellectual property or the intellectual property rights of others. Also, if one of our patents is found to be invalid by such proceedings, generic or competitive products could be introduced into the market resulting in the erosion of sales of our existing products. For example, several of the patents in our pneumococcal vaccine portfolio were challenged in inter partes review and post-grant review proceedings in the United States.U.S. The Patent Trial and Appeal Board refused to initiate proceedings as to 2 patents. In June 2018, the Patent Trial and Appeal Board ruled on oneanother patent, holding that one1 claim was valid and that all other claims were invalid. The party challenging that patent has appealed the decision. In March and June 2019, an additional patent was found invalid in separate proceedings by the Patent Trial and Appeal Board. We have appealed. Challenges to other patents remain pending beforein jurisdictions outside the U.S. Patent and Trademark Office.The invalidation of theseall of the patents in our pneumococcal portfolio could potentially allow a competitor pneumococcal vaccine into the marketplace. In the event that any of the patents are found valid and infringed, a competitor pneumococcal vaccine

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

might be prohibited from entering the market or required to pay Pfizer a royalty. We are also subject to patent litigation pursuant to which one or more third parties seeks damages and/or injunctive relief to compensate for alleged infringement of its patents by our commercial or other activities. For example, our Hospira subsidiaries are involved in patent and patent-related disputes over their attempts to bring generic pharmaceutical and biosimilar products to market. If one of our marketed products is found to infringe valid patent rights of a third party, such third party may be awarded significant damages, or we may be prevented from further sales of that product. Such damages may be enhanced as much as three-fold in the event that we or one of our subsidiaries, like Hospira, is found to have willfully infringed valid patent rights of a third party.


Actions In Which We Are The Plaintiff
Bosulif (bosutinib)
In December 2016, Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. (collectively, Wyeth)the Wyeth Group) brought a patent-infringement action against Alembic Pharmaceuticals, Ltd, Alembic Pharmaceuticals, Inc. (collectively, Alembic), Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries LimitedLtd. (collectively, Sun), in the U.S. District Court for the District of Delaware in connection with abbreviated new drug applications respectively filed with the FDA by Alembic and Sun, each seeking approval to market generic versions of bosutinib. Alembic is challenging patents, which expire in 2026,a patent covering polymorphic forms of bosutinib, which expires in 2026, and a patent covering methods of treating chronic myelogenous leukemia.leukemia, which expires in 2025. Sun is also challenging the same patent covering polymorphic forms of bosutinib that expires in 2026. In March 2017, the Wyeth Group brought a patent-infringement action against MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. (collectively, MSN), in the U.S. District Court for the District of Delaware in connection with an abbreviated new drug application filed with the FDA by MSN, seeking approval to market a generic version of bosutinib, and challenging a patent expiring in 2026 covering polymorphic forms of bosutinib. In September 2017, the case against MSN was dismissed. Also, in September 2017, the Wyeth Group brought an additional patent-infringement action against Sun in the U.S. District Court for the District of Delaware asserting the infringement and validity of two2 other patents challenged by Sun, which expire in 2025 and 2026, respectively, covering compositions of bosutinib and methods of treating chronic myelogenous leukemia.leukemia, each of which expire in 2025. In October 2019, we settled the cases against each of Alembic and Sun on terms not material to Pfizer.
EpiPen
In July 2010, King, which we acquired in 2011 and is a wholly-owned subsidiary, brought a patent-infringement action against Sandoz in the U.S. District Court for the District of New Jersey in connection with Sandoz’s abbreviated new drug application filed with the FDA seeking approval to market an epinephrine injectable product. Sandoz is challenging patents, which expire in 2025, covering the next-generation autoinjector for use with epinephrine that is sold under the EpiPen brand name.
Precedex Premix
In June 2014,Ben Venue Laboratories, Inc. (Ben Venue)notified our subsidiary, Hospira, that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Hospira’s premix version of Precedex and containing allegations that a patent relatingrelated to the use of Precedex in an intensive care unit setting, which expiresexpired in March 2019, was invalid or not infringed. In August 2014, Hospira and Orion Corporation (co-owner of the patent that is the subject of the lawsuit) filed suit against Ben Venue, Hikma Pharmaceuticals PLC (Hikma), and West-Ward Pharmaceutical Corp. in the U.S. District Court for the District of Delaware asserting the validity and infringement of the patent. In October 2014,

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

Eurohealth International Sarl was substituted for Ben Venue and Hikma. In June 2016, this case was settled on terms not material to Pfizer.
In June 2015, Amneal Pharmaceuticals LLC (Amneal) notified Hospira that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Hospira’s premix version of Precedex and containing allegations that four4 patents relating to the Precedex premix formulations and their use, all of which expire in 2032, were invalid or not infringed. In August 2015, Hospira filed suit against Amneal in the U.S. District Court for the District of Delaware asserting the validity and infringement of the patents that are the subject of the lawsuit. In January 2018, the District Court ruled that one1 of the four4 patents was valid and infringed, and that the other three3 patents were invalid. In February and March 2018, respectively, each of Amneal and Hospira appealed the District Court decision to the U.S. Court of Appeals for the Federal Circuit. In January 2019, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’s decision. 


In December 2015, Fresenius Kabi USA LLC (Fresenius) notified Hospira that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Hospira’s premix version of Precedex and containing allegations that fourcertain patents relating to the Precedex premix formulations and their use, all of which expire in 2032, were invalid or not infringed. In January 2016, Hospira filed suit against Fresenius in the U.S. District Court for the Northern District of Illinois, asserting the validity and infringement of those patents. In December 2018, the District Court ruled that the asserted patents that arewere invalid. Hospira has appealed the subjectDistrict Court’s decision to the U.S. Court of Appeals for the lawsuit.Federal Circuit.


In August 2016, Par Sterile Products, LLC (Par) notified Hospira that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Hospira’s premix version of Precedex and containing allegations that four 4

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patents relating to the Precedex premix formulations and their use, all of which expire in 2032, were invalid or not infringed. In September 2016, Hospira filed suit against Par in the U.S. District Court for the District of Delaware asserting the validity and infringement of the patents that are the subject of the lawsuit. In December 2016, the case was stayed pending the outcome of Hospira’s suit against Amneal (including all appeals). In February 2019, a new stay was entered, extending the stay until the outcome of the appeal in the Fresenius case.


In December 2017, Gland Pharma Limited (Gland) notified Hospira that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Hospira’s premix version of Precedex and containing allegations that six6 patents relating to the Precedex premix formulations and their use, all of which expire in 2032, were invalid or not infringed. In February 2018, Hospira filed suit against Gland in the U.S. District Court for the District of Delaware asserting the validity and infringement of four4 patents that are the subject of the lawsuit. The case against Gland has been stayed pending the outcome of the appeal in the Fresenius case.


In December 2017, Jiangsu Hengrui Medicine Co., Ltd. (Hengrui) notified Hospira that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Hospira’s premix version of Precedex and containing allegations that six6 patents relating to the Precedex premix formulations and their use, all of which expire in 2032, were invalid or not infringed. In February 2018, Hospira filed suit against Hengrui in the U.S. District Court for the District of Delaware asserting the validity and infringement of four4 patents that are the subject of the lawsuit. The case against Hengrui has been stayed pending the outcome of the appeal in the Fresenius case.


In February 2018, Baxter Healthcare Corporation (Baxter) filed a declaratory judgment action against Hospira in the U.S. District Court for the District of Delaware seeking a declaration of non-infringement of four4 patents relating to the Precedex premix formulations and their use. OneNaN of the patents included in the action expiresrelated to the use of Precedex in an intensive care unit setting and expired in 2019 and the other three3 patents expire in 2032. In March 2018, Hospira filed a counterclaim for infringement of the patent expiringthat expired in 2019. In November 2018, the case was dismissed by mutual agreement of the parties.
Xeljanz (tofacitinib)
In February 2017, we brought a patent-infringement action against MicroLabs USA Inc. and MicroLabs Ltd. (collectively, MicroLabs) in the U.S. District Court for the District of Delaware asserting the infringement and validity of three3 patents challenged by MicroLabs in its abbreviated new drug application seeking approval to market a generic version of tofacitinib 5 mg tablets. Of the three patents that are the subjectIn November 2018, we settled all of the lawsuit, one covers the active ingredient and expires in December 2025, the second covers an enantiomer of tofacitinib and expires in 2022, and the third covers a polymorphic form of tofacitinib and expires in 2023. Three other patents for Xeljanz expiring in December 2020 haveour claims against MicroLabs on terms not been challenged by MicroLabs.material to Pfizer.


Separately, also in February 2017, we brought a patent-infringement action against Sun Pharmaceutical Industries Ltd. (Sun Ltd.) in the U.S. District Court for the District of Delaware asserting the infringement and validity of our patent covering a polymorphic form of tofacitinib, expiring in 2023, that was challenged by Sun Pharmaceutical Industries Ltd. in its abbreviated new drug application seeking approval to market a generic version of tofacitinib 11 mg extended release tablets. In November 2017, we brought an additional patent-infringement action against Sun Pharmaceuticals Industries Ltd. in the U.S. District Court for the District of Delaware asserting the infringement and validity of another patent challenged by Sun Pharmaceuticals Industries Ltd,Ltd., which covers the active ingredient and expires in December 2025. In October 2018, we brought a third patent infringement action against Sun Ltd. in the U.S. District Court for the District of Delaware asserting the infringement and validity of our patent covering the extended release formulation of tofacitinib, which expires in 2034. In March and April 2019, the actions against Sun Ltd. were dismissed by mutual agreement of the parties.


In March 2017, we brought a patent-infringement action against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively, Zydus) in the U.S. District Court for the District of Delaware asserting the infringement and validity of 3 patents: the same

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three patents that arepatent covering the subjectactive ingredient expiring in December 2025, the patent covering an enantiomer of tofacitinib expiring in 2022, and the action against MicroLabs,patent covering a polymorphic form of tofacitinib expiring in 2023, which Zydus challenged in its abbreviated new drug application seeking approval to market a generic version of tofacitinib 5 mg tablets.


Also, in March 2017, we brought separate actions in the U.S. District Court for the District of Delaware against Prinston Pharmaceutical Inc., Zhejiang Huahai Pharmaceutical Co., Ltd., Huahai US Inc. and Solco Healthcare US, LLC (collectively, Prinston) and against Breckenridge Pharmaceutical Inc., Pensa Pharma S.A. and Laboratorios Del Dr. Esteve, S.A. (collectively, Breckenridge) on the two2 patents expiring in 2022 and 2023, respectively, that were challenged by Prinston and Breckenridge in their respective abbreviated new drug applications seeking approval to market generic versions of tofacitinib 5 mg tablets. In October 2017, we brought an additional patent-infringement action against Breckenridge in the U.S. District Court for the District of Delaware asserting the infringement and validity of four4 additional patents challenged by Breckenridge, three3 of which expire in December 2020 and one1 of which expires in December 2025. In March 2018, we brought another patent infringement action against Prinston in the U.S. District Court for the District of Delaware asserting the infringement and validity of an additional patent, which had been subsequently challenged by Prinston and which expires in

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December 2025. In May 2018, we settled all of our claims against Breckenridge on terms not material to Pfizer. In January 2019, we settled all of our claims against Prinston on terms not material to Pfizer.

In December 2018, we brought a separate patent infringement action against Teva Pharmaceuticals USA, Inc. (Teva) in the U.S. District Court for the District of Delaware asserting the infringement and validity of our patent covering extended release formulations of tofacitinib that was challenged by Teva in its abbreviated new drug application seeking approval to market a generic version of tofacitinib 11 mg extended release tablets.

In March 2019, we brought a separate patent infringement action against Ajanta Pharma Ltd. and Ajanta Pharma USA Inc. (collectively, Ajanta) in the U.S. District Court for the District of Delaware asserting the infringement and validity of 2 patents: the patent covering the active ingredient that expires in December 2025 and the patent covering a polymorphic form of tofacitinib that expires in 2023, each of which Ajanta challenged in its abbreviated new drug application seeking approval to market a generic version of tofacitinib 5 mg tablets.
Inlyta (axitinib)
In April 2018, Apotex Inc. notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Inlyta. Apotex Inc. asserts the invalidity and non-infringement of the crystalline form patent for Inlyta that expires in 2030. In May 2018, we filed suit against Apotex Inc. in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the crystalline form patent for Inlyta.

In May 2019, Glenmark Pharmaceuticals Limited (Glenmark) notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Inlyta. Glenmark asserts the invalidity and non-infringement of the crystalline form patent for Inlyta that expires in 2030. In June 2019, we filed suit against Glenmark in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the crystalline form patent for Inlyta.
Kerydin (tavaborole)
In September 2018, several generic companies notified us that they had filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Kerydin. The generic companiesassert the invalidity and non-infringement of methods of use and formulation patents for tavaborole that expire in 2026 and 2027, including pediatric exclusivity. In October 2018, Anacor, our wholly-owned subsidiary, filed infringement lawsuits against each of the generic filers in the U.S. District Court for the District of Delaware and the U.S. District Court for the District of West Virginia.

Ibrance (palbociclib)
In March 2019, several generic companies notified us that they had filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Ibrance. The generic companies assert the invalidity and non-infringement of 2 composition of matter patents and a method of use patent covering palbociclib, each of which expire in 2023. In April 2019, we brought patent infringement actions against each of the generic filers in various federal courts, asserting the validity and infringement of the patents challenged by the generic companies.

Matters Involving Our Collaboration/Licensing Partners
Xtandi (enzalutamide)
In December 2016, Medivation and Medivation Prostate Therapeutics, Inc. (collectively, the Medivation Group); Astellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc. (collectively, Astellas); and The Regents of the University of California filed patent-infringement suits in the U.S. District Court for the District of Delaware against Actavis Laboratories FL, Inc. and Actavis LLC (collectively, Actavis); Zydus; and Apotex Inc. and Apotex Corp. (collectively, Apotex) in connection with those companies’ respective abbreviated new drug applications filed with the FDA for approval to market generic versions of enzalutamide. The generic manufacturers are challenging patents, which expire as early as 2026, covering enzalutamide and treatments for prostate cancer. In May 2017, the Medivation Group filed a patent-infringement suit against Roxane Laboratories Inc. (Roxane) in the same court in connection with Roxane’s abbreviated new drug application with the FDA for approval to market a generic version of enzalutamide. In June2018 and July 2018,2019, we settled all of ourpending claims against Actavis and Apotex, respectively,the various generic challengers on terms not material to Pfizer.
Inlyta (axitinib)
In April 2018, Apotex Inc. notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic version of Inlyta. Apotex Inc. asserts the invalidity and non-infringement of the crystalline form patent for Inlyta that expires in 2030. In May 2018, we filed suit against Apotex Inc. in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the crystalline form patent for Inlyta.
Kerydin (tavaborole)
In September 2018, several generic companies notified us that they had filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Kerydin. The generic companiesassert the invalidity and non-infringement of methods of use and formulation patents for tavaborole that expire in 2026 and 2027, including pediatric exclusivity. In October 2018, Anacor, our wholly-owned subsidiary, filed infringement lawsuits against each of the generic filers in the U.S. District Court for the District of Delaware.

Matters Involving Our Collaboration/Licensing Partners
Toviaz (fesoterodine)––Inter-Partes Reviews
In January 2016, Mylan Pharmaceuticals and Mylan Laboratories (collectively, Mylan) filed petitions with the U.S. Patent and Trademark Office requesting inter partes reviews of five of the patents covering fesoterodine, the active ingredient in Toviaz: three composition-of-matter patents and a method-of-use patent that expire in 2019 and a patent covering salts of fesoterodine that expires in 2022. The patents are owned by UCB Pharma GmbH, and we have an exclusive, worldwide license to market Toviaz from UCB Pharma GmbH. In July 2016, the Patent Trial and Appeal Board agreed to institute inter partes reviews of all five patents. Amerigen Pharmaceuticals Limited (Amerigen), Alembic Pharmaceuticals Limited and Torrent Pharmaceuticals Limited joined the inter partes reviews. In July 2017, the U.S. Patent and Trademark Office issued decisions upholding all five patents. In September 2017, Mylan and Amerigen appealed the U.S. Patent and Trademark Office decisions to the U.S. Court of Appeals for the Federal Circuit. In January 2018, Mylan withdrew its appeal. Amerigen’s appeal of the decision upholding the patent covering salts of fesoterodine that expires in 2022 is the only pending appeal.

Eliquis
In February, March, and April 2017, twenty-fiveNaN generic companies sent BMS Paragraph-IV certification letters informing BMS that they had filed abbreviated new drug applications seeking approval of generic versions of Eliquis, challenging the validity and infringement of one or more of the three3 patents listed in the Orange Book for Eliquis. The patents currently are set to expire in 2019, 2026, and 2031. Eliquis has been jointly developed and is being commercialized by BMS and Pfizer. In April 2017, BMS and Pfizer filed patent-infringement actions against all generic filers in the U.S. District Court for the District of

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Delaware and the U.S. District Court for the District of West Virginia, asserting that each of the generic companies’ proposed products would infringe each of the patent(s) that each generic filer challenged. Some generic filers challenged only the 2031

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patent, some challenged both the 2031 and 2026 patent, and one generic company challenged all three3 patents. We and BMS have settled with certain of the generic companies on terms not material to Pfizer, and we and BMS may settle with other generic companies in the future.
Actions In Which We Are The Defendant
Inflectra (infliximab-dyyb)
In March 2015, Janssen and New York University, together, brought a patent-infringement action in the U.S. District Court for the District of Massachusetts against Hospira, Celltrion Healthcare Co. Ltd. and Celltrion Inc. alleging that infliximab-dyyb, to be marketed by Hospira in the U.S. under the brand name Inflectra, would infringe six6 patents relating to infliximab, its manufacture and use. Claims with respect to four4 of the patents were dismissed by the plaintiffs, leaving two2 patents at issue: the infliximab antibody patent and a patent relating to cell culture media. In January 2018, the antibody patent was declared invalid by the Court of Appeals for the Federal Circuit. In July 2018, the U.S. District Court for the District of Massachusetts granted defendants’ motion for summary judgment and ruled that the patent relating to cell culture media was not infringed.
Bavencio (avelumab)
In July 2017, BMS, E.R. Squibb & Sons LLC, Ono Pharmaceutical Co. Ltd., and Tasuku Honjo brought a patent-infringement action in Janssen appealed the District Court’s decision to the U.S. District Court of Appeals for the District of Delaware against Pfizer, Merck KGaA, and EMD Serono, Inc., alleging that Bavencio (avelumab) infringes one patent relating to methods for treating tumors with anti-PD-L1 antibodies, which expires in 2023.Federal Circuit.
A2. Legal Proceedings––Product Litigation

Like other pharmaceutical companies, we are defendants in numerous cases, including but not limited to those discussed below, related to our pharmaceutical and other products. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss.
Asbestos
Between 1967 and 1982, Warner-Lambert owned American Optical Corporation (American Optical), which manufactured and sold respiratory protective devices and asbestos safety clothing. In connection with the sale of American Optical in 1982, Warner-Lambert agreed to indemnify the purchaser for certain liabilities, including certain asbestos-related and other claims. As of September 30, 2018,29, 2019, approximately 56,88046,500 claims naming American Optical and numerous other defendants were pending in various federal and state courts seeking damages for alleged personal injury from exposure to asbestos and other allegedly hazardous materials. Warner-Lambert was acquired by Pfizer in 2000 and is a wholly-ownedwholly owned subsidiary of Pfizer. Warner-Lambert is actively engaged in the defense of, and will continue to explore various means of resolving, these claims.


Numerous lawsuits are pending against Pfizer in various federal and state courts seeking damages for alleged personal injury from exposure to products allegedly containing asbestos and other allegedly hazardous materials sold by Pfizer and certain of its previously owned subsidiaries.
There also are a small number of lawsuits pending in various federal and state courts seeking damages for alleged exposure to asbestos in facilities owned or formerly owned by Pfizer or its subsidiaries.


Effexor
Beginning in May 2011, actions, including purported class actions, were filed in various federal courts against Wyeth and, in certain of the actions, affiliates of Wyeth and certain other defendants relating to Effexor XR, which is the extended-release formulation of Effexor. The plaintiffs in each of the class actions seek to represent a class consisting of all persons in the U.S. and its territories who directly purchased, indirectly purchased or reimbursed patients for the purchase of Effexor XR or generic Effexor XR from any of the defendants from June 14, 2008 until the time the defendants’ allegedly unlawful conduct ceased. The plaintiffs in all of the actions allege delay in the launch of generic Effexor XR in the U.S. and its territories, in violation of federal antitrust laws and, in certain of the actions, the antitrust, consumer protection and various other laws of certain states, as the result of Wyeth fraudulently obtaining and improperly listing certain patents for Effexor XR in the Orange Book, enforcing certain patents for Effexor XR and entering into a litigation settlement agreement with a generic drug manufacturer with respect to Effexor XR. Each of the plaintiffs seeks treble damages (for itself in the individual actions or on behalf of the putative class in the purported class actions) for alleged price overcharges for Effexor XR or generic Effexor XR in the U.S. and its territories since June 14, 2008. All of these actions have been consolidated in the U.S. District Court for the District of New Jersey.
In October 2014, the District Court dismissed the direct purchaser plaintiffs’ claims based on the litigation settlement agreement, but declined to dismiss the other direct purchaser plaintiff claims. In January 2015, the District Court entered partial final

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judgments as to all settlement agreement claims, including those asserted by direct purchasers and end-payer plaintiffs, which plaintiffs appealed to the U.S. Court of Appeals for the Third Circuit. In August 2017, the U.S. Court of Appeals for the Third Circuit reversed the District Court’s decisions and remanded the claims to the District Court.

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Lipitor


Antitrust Actions
Beginning in November 2011, purported class actions relating to Lipitor were filed in various federal courts against, among others, Pfizer, certain affiliates of Pfizer, and, in most of the actions, Ranbaxy, Inc. (Ranbaxy) and certain affiliates of Ranbaxy. The plaintiffs in these various actions seek to represent nationwide, multi-state or statewide classes consisting of persons or entities who directly purchased, indirectly purchased or reimbursed patients for the purchase of Lipitor (or, in certain of the actions, generic Lipitor) from any of the defendants from March 2010 until the cessation of the defendants’ allegedly unlawful conduct (the Class Period). The plaintiffs allege delay in the launch of generic Lipitor, in violation of federal antitrust laws and/or state antitrust, consumer protection and various other laws, resulting from (i) the 2008 agreement pursuant to which Pfizer and Ranbaxy settled certain patent litigation involving Lipitor, and Pfizer granted Ranbaxy a license to sell a generic version of Lipitor in various markets beginning on varying dates, and (ii) in certain of the actions, the procurement and/or enforcement of certain patents for Lipitor. Each of the actions seeks, among other things, treble damages on behalf of the putative class for alleged price overcharges for Lipitor (or, in certain of the actions, generic Lipitor) during the Class Period. In addition, individual actions have been filed against Pfizer, Ranbaxy and certain of their affiliates, among others, that assert claims and seek relief for the plaintiffs that are substantially similar to the claims asserted and the relief sought in the purported class actions described above. These various actions have been consolidated for pre-trial proceedings in a Multi-District Litigation (In re Lipitor Antitrust Litigation MDL-2332) in the U.S. DistrictCourt for the District of New Jersey.


In September 2013 and 2014, the District Court dismissed with prejudice the claims by direct purchasers. In October and November 2014, the District Court dismissed with prejudice the claims of all other Multi-District Litigation plaintiffs. All plaintiffs have appealed the District Court’s orders dismissing their claims with prejudice to the U.S. Court of Appeals for the Third Circuit. In addition, the direct purchaser class plaintiffs appealed the order denying their motion to amend the judgment and for leave to amend their complaint to the U.S. Court of Appeals for the Third Circuit. In August 2017, the U.S. Court of Appeals for the Third Circuit reversed the District Court’s decisions and remanded the claims to the District Court.


Also, in January 2013, the State of West Virginia filed an action in West Virginia state court against Pfizer and Ranbaxy, among others, that asserts claims and seeks relief on behalf of the State of West Virginia and residents of that state that are substantially similar to the claims asserted and the relief sought in the purported class actions described above.
Personal Injury Actions
A number of individual and multi-plaintiff lawsuits have been filed against us in various federal and state courts alleging that the plaintiffs developed type 2 diabetes purportedly as a result of the ingestion of Lipitor. Plaintiffs seek compensatory and punitive damages.
In February 2014, the federal actions were transferred for consolidated pre-trial proceedings to a Multi-District Litigation (In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation (No. II) MDL-2502) in the U.S. District Court for the District of South Carolina. Since 2016, certain cases in the Multi-District Litigation were remanded to certain state courts. In January 2017, the District Court granted our motion for summary judgment, dismissing substantially all of the remaining cases pending in the Multi-District Litigation. In January 2017, the plaintiffs appealed the District Court’s decision to the U.S. Court of Appeals for the Fourth Circuit. In June 2018, the U.S. Court of Appeals for the Fourth Circuit affirmed the District Court’s decision.
Viagra
A number of individual and multi-plaintiff lawsuits have been filed against us in various federal and state courts alleging that the plaintiffs developed melanoma and/or the exacerbation of melanoma purportedly as a result of the ingestion of Viagra. Plaintiffs seek compensatory and punitive damages.
In April 2016, the federal actions were transferred for coordinated pre-trial proceedings to a Multi-District Litigation (In Re: Viagra (Sildenafil Citrate) Products Liability Litigation, MDL-2691) in the U.S. District Court for the Northern District of California. In December 2016, federal actions filed against Lilly and filed against both us and Lilly, were transferred for coordinated pre-trial proceedings to the Multi-District Litigation (In re: Viagra (Sildenafil Citrate) and Cialis (Tadalafil) Products Liability Litigation, MDL-2691).
Intravenous Solutions
Beginning in November 2016, purported class actions were filed in the U.S. District Court for the Northern District of Illinois against Hospira, Hospira Worldwide, Inc. and certain other defendants relating to intravenous saline solution. Plaintiffs seek to

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represent a class consisting of all persons and entities in the U.S. who directly purchased intravenous saline solution sold by any of the defendants from January 1, 2013 until the time the defendants’ allegedly unlawful conduct ceases. Plaintiffs allege that the defendants’ conduct restricts output and artificially fixes, raises, maintains and/or stabilizes the prices of intravenous saline

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solution sold throughout the U.S. in violation of federal antitrust laws. Plaintiffs seek treble damages (for themselves and on behalf of the putative classes) and an injunction against defendants for alleged price overcharges for intravenous saline solution in the U.S. since January 1, 2013. All of these actions have been consolidated in the U.S. District Court for the Northern District of Illinois. In July 2018, the District Court granted defendants’ motions to dismiss the consolidated amended complaint without prejudice. Plaintiffs filed a second amended complaint in September 2018. On February 3, 2017, we completed the sale of our global infusion systems net assets, HIS, which includes intravenous saline solution, to ICU Medical. The litigation is the subject of cross-claims for indemnification by both Pfizer and ICU Medical under the purchase agreement.
Separately, in April 2017, Pfizer, Hospira and two employees of Pfizer received grand jury subpoenas issued by the United States District Court for the Eastern District of Pennsylvania, in connection with an investigation by the U.S. Department of Justice, Antitrust Division. The subpoenas seek documents related to the sale, manufacture, pricing and shortages of intravenous solutions, including saline, as well as communications among industry participants regarding these issues. The Department of Justice investigation is also the subject of cross-claims for indemnification by both Pfizer and ICU Medical under the purchase agreement. In addition, in August 2015, the New York Attorney General issued a subpoena to Hospira for similar information. Hospira has produced records to the New York Attorney General and coordinated with ICU Medical to produce records to the U.S. Department of Justice.
Hormone Therapy Consumer Class Action
A certified consumer class action is pending against Wyeth in the U.S. District Court for the Southern District of California based on the alleged off-label marketing of its hormone therapy products. The case was originally filed in December 2003. The class consists of California consumers who purchased Wyeth’s hormone-replacement products between January 1995 and January 2003 and who do not seek personal injury damages therefrom. The class seeks compensatory and punitive damages, including a full refund of the purchase price.
Eliquis
A number of individual and multi-plaintiff lawsuits have been filed against us and BMS in various federal and state courts pursuant to which plaintiffs seek to recover for personal injuries, including wrongful death, due to bleeding allegedly as a result of the ingestion of Eliquis. Plaintiffs seek compensatory and punitive damages.
In February 2017, the federal actions were transferred for coordinated pre-trial proceedings to a Multi-District Litigation (In Re: Eliquis (Apixaban) Products Liability Litigation MDL-2754) in the U.S. District Court for the Southern District of New York. In July 2017, the District Court dismissed substantially all of the actions that were pending in the Multi-District Litigation. In August 2017, certain plaintiffs appealed the District Court’s dismissal to the U.S. Court of Appeals for the Second Circuit. Additional cases continue to be transferred to the Multi-District Litigation.
EpiPen
Beginning in February 2017, purported class actions were filed in various federal courts by indirect purchasers of EpiPen against Pfizer, and/or its affiliates King and Meridian, and/or various entities affiliated with Mylan, N.V., and Mylan N.V. Chief Executive Officer, Heather Bresch. The plaintiffs in these actions seek to represent U.S. nationwide classes comprising persons or entities who paid for any portion of the end-user purchase price of an EpiPen between 2009 until the cessation of the defendants’ allegedly unlawful conduct. In August 2017, a similar lawsuit brought in the U.S. District Court for the District of New Jersey on behalf of a purported class of direct purchaser plaintiffs against Pfizer, King, Meridian and Mylan was voluntarily dismissed without prejudice. Against Pfizer and/or its affiliates, plaintiffs generally allege that Pfizer’s and/or its affiliates’ settlement of patent litigation regarding EpiPen delayed market entry of generic EpiPen in violation of federal antitrust laws and various state antitrust or consumer protection laws. At least one lawsuit also alleges that Pfizer and/or Mylan N.V. violated the federal Racketeer Influenced and Corrupt Organizations Act. Plaintiffs also filed various consumer protection and unjust enrichment claims against, and relating to conduct attributable solely to, Mylan Pharmaceuticalsand/or its affiliates regarding EpiPen. Plaintiffs seek treble damages for alleged overcharges for EpiPen since 2009. In August 2017, the actions were consolidated for coordinated pre-trial proceedings in a Multi-District Litigation (In re: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation, MDL-2785) in the U.S. District Court for the District of Kansas with other EpiPen-related actions against Mylan N.V. and/or its affiliates to which Pfizer, King and Meridian are not parties.
Nexium 24HR and Protonix
A number of individual and multi-plaintiff lawsuits have been filed against Pfizer, certain of its subsidiaries and/or other pharmaceutical manufacturers in various federal and state courts alleging that the plaintiffs developed kidney-related injuries purportedly as a result of the ingestion of certain proton pump inhibitors. The cases against usPfizer involve Protonix and/or Nexium 24HR and/or Protonix and seek compensatory and punitive damages and, in some cases, treble damages, restitution or disgorgement. In

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August 2017, the federal actions were ordered transferred for coordinated pre-trial proceedings to a Multi-District Litigation (In re: Proton-Pump Inhibitor Products Liability Litigation (No. II)) in the U.S. District Court for the District of New Jersey. On July 31, 2019, we completed the transaction in which we and GSK combined our respective consumer healthcare businesses into a new consumer healthcare joint venture that operates globally under the GSK Consumer Healthcare name. As part of the joint venture transaction, the joint venture has agreed to assume, and to indemnify Pfizer for, liabilities arising out of such litigation to the extent related to Nexium 24HR.
Docetaxel
Personal Injury Actions
A number of lawsuits have been filed against Hospira and Pfizer in various federal and state courts alleging that plaintiffs who were treated with Docetaxel developed permanent hair loss. The significant majority of the cases also name other defendants, including the manufacturer of the branded product, Taxotere. Plaintiffs seek compensatory and punitive damages.
In October 2016, the federal cases were transferred for coordinated pre-trial proceedings to a Multi-District Litigation (In re Taxotere (Docetaxel) Products Liability Litigation, MDL-2740) in the U.S. District Court for the Eastern District of Louisiana.
Mississippi Attorney General Government Investigation
In October 2018, the Attorney General of Mississippi filed a complaint in Mississippi state court against the manufacturer of the branded product and eight8 other manufacturers including Pfizer and Hospira, alleging, with respect to Pfizer and Hospira, a failure to warn about a risk of permanent hair loss in violation of the Mississippi Consumer Protection Act. The action seeks civil penalties and injunctive relief. 

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Adalimumab Biosimilars
Beginning in March 2019, purported class actions relating to Humira and adalimumab biosimilars were filed in the United States District Court for the Northern District of Illinois against AbbVie Inc. (AbbVie), certain affiliates of AbbVie, and other pharmaceutical manufacturers. Pfizer is a named defendant in three of the actions. The plaintiffs seek to represent nationwide and multi-state classes consisting of persons and/or entities who are indirect purchasers of Humira from January 1, 2017 until the allegedly unlawful antitrust effects cease. Against Pfizer, the plaintiffs generally allege that Pfizer’s and AbbVie’s 2018 licensing agreements, resolving all global intellectual property matters for Pfizer’s proposed adalimumab biosimilar, delayed market entry of Pfizer’s biosimilar product in the U.S. in violation of federal antitrust laws, various state antitrust or consumer protection laws, and unjust enrichment laws. Plaintiffs seek injunctive relief and treble damages for alleged overcharges for Humira since 2017. In August 2019, the plaintiffs filed an amended consolidated complaint that superseded the prior complaints and does not name Pfizer as a defendant. As a result, Pfizer is no longer a party to the case.
Array Securities Litigation
In November 2017, 2 purported class actions were filed in the U.S. District Court for the District of Colorado alleging that Array, which we acquired in July 2019 and is our wholly owned subsidiary, and certain of its former officers violated federal securities laws in connection with certain disclosures made, or omitted, by Array regarding the NRAS-mutant melanoma program. In March 2018, the actions were consolidated into a single proceeding.
A3. Legal Proceedings––Commercial and Other Matters
Average Wholesale Price Litigation
Pfizer, certain of its subsidiaries and other pharmaceutical manufacturers were sued in various state courts by a number of states alleging that the defendants provided average wholesale price (AWP) information for certain of their products that was higher than the actual average prices at which those products were sold. The AWP is used to determine reimbursement levels under Medicare Part B and Medicaid and in many private-sector insurance policies and medical plans. All but one1 of those actions have been resolved through settlement, dismissal or final judgment. The plaintiff state, Illinois,in the one1 remaining action, claims that the alleged spread between the AWPs at which purchasers were reimbursed and the actual sale prices was promoted by the defendants as an incentive to purchase certain of their products. The actionalleges, among other things, fraudand violation of the state’s unfair trade practices andconsumer protection statutes and seeks monetary and other relief, including civil penalties and treble damages. In September 2019, we settled the remaining action on terms not material to Pfizer. All actions have now been resolved through settlement, dismissal or final judgment.
Monsanto-Related MattersIntravenous Solutions
In 1997, Monsanto Company (Former Monsanto) contributedBeginning in November 2016, purported class actions were filed in the U.S. District Court for the Northern District of Illinois against Hospira, Hospira Worldwide, Inc. and certain chemical manufacturing operationsother defendants relating to intravenous saline solution. Plaintiffs seek to represent a class consisting of all persons and facilities to a newly formed corporation, Solutia Inc. (Solutia),entities in the U.S. who directly purchased intravenous saline solution sold by any of the defendants from January 1, 2013 until the time the defendants’ allegedly unlawful conduct ceases. Plaintiffs allege that the defendants’ conduct restricts output and spun off the shares of Solutia. In 2000, Former Monsanto merged with Pharmacia & Upjohn Company to form Pharmacia. Pharmacia then transferred its agricultural operations to a newly created subsidiary, named Monsanto Company (New Monsanto), which it spun off in a two-stage process that was completed in 2002. Pharmacia was acquired by Pfizer in 2003 and is a wholly-owned subsidiary of Pfizer.
In connection with its spin-off that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities related to Pharmacia’s former agricultural business. New Monsanto has defendedartificially fixes, raises, maintains and/or is defending Pharmacia in connection with various claims and litigation arising outstabilizes the prices of or related to, the agricultural business, and has been indemnifying Pharmacia when liability has been imposed or settlement has been reached regarding such claims and litigation.
In connection with its spin-off in 1997, Solutia assumed, and agreed to indemnify Pharmacia for, liabilities related to Former Monsanto’s chemical businesses. As the result of its reorganization under Chapter 11 of the U.S. Bankruptcy Code, Solutia’s indemnification obligations relating to Former Monsanto’s chemical businesses are primarily limited to sites that Solutia has owned or operated. In addition, in connection with its spinoff that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities primarily related to Former Monsanto’s chemical businesses, including, but not limited to, any such liabilities that Solutia assumed. Solutia’s and New Monsanto’s assumption of, and agreement to indemnify Pharmacia for, these liabilities apply to pending actions and any future actions related to Former Monsanto’s chemical businesses in which Pharmacia is named as a defendant, including, without limitation, actions asserting environmental claims, including alleged exposure to polychlorinated biphenyls. Solutia and/or New Monsanto are defending Pharmacia in connection with various claims and litigation arising out of, or related to, Former Monsanto’s chemical businesses, and have been indemnifying Pharmacia when liability has been imposed or settlement has been reached regarding such claims and litigation.
Environmental Matters
In 2009, we submitted to the U.S. Environmental Protection Agency (EPA) a corrective measures study report with regard to Pharmacia’s discontinued industrial chemical facility in North Haven, Connecticut. In September 2010, our corrective measures study report was approved by the EPA, and we commenced construction of the site remedy in late 2011 under an Updated Administrative Order on Consent with the EPA.intravenous saline


PFIZER INC. AND SUBSIDIARY COMPANIES
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Also, in 2009, we submitted a revised site-wide feasibility study with regard to Wyeth Holdings Corporation’s (formerly, American Cynamid Company) discontinued industrial chemical facility in Bound Brook, New Jersey. In July 2011, Wyeth Holdings Corporation finalized an Administrative Settlement Agreement with the EPA and Order on Consent for Removal Action (the 2011 Administrative Settlement Agreement) with the EPA with regard to the Bound Brook facility. In May 2012, we completed construction of an interim remedy to address the discharge of impacted groundwater from that facility to the Raritan River. In September 2012, the EPA issued a final remediation plan for the Bound Brook facility’s main plant area, which is generally in accordance with one of the remedies evaluated in our revised site-wide feasibility study. In March 2013, Wyeth Holdings Corporation (now Wyeth Holdings LLC) entered into an Administrative Settlement Agreement and Order on Consent with the EPA to allow us to undertake detailed engineering design of the remedy for the main plant area and to perform a focused feasibility study for two adjacent lagoons. In September 2015,solution sold throughout the U.S., in violation of federal antitrust laws. Plaintiffs seek treble damages (for themselves and on behalf of the EPA, filed a complaintputative classes) and consent decree with the federal District Courtan injunction against defendants for the District of New Jersey that allows Wyeth Holdings LLC to complete the design and to implement the remedyalleged price overcharges for the main plant area. In December 2015, the consent decree (which supersedes the 2011 Administrative Settlement Agreement) was entered by the District Court. We have accrued for the estimated costs of the site remedies for the North Haven and Bound Brook facilities. In September 2018, the EPA issued a final remediation plan for the two adjacent lagoons, which is generally in accordance with one of the remedies evaluated in our focused feasibility study.

We are a party to a number of other proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, and other state, local or foreign laws in which the primary relief sought is the cost of past and/or future remediation.
Contracts with Iraqi Ministry of Health
In October 2017, a number of United States service members, civilians, and their families brought a complaintintravenous saline solution in the Federal District Court for the DistrictU.S. since January 1, 2013. All of Columbia against a number of pharmaceutical and medical devices companies, including Pfizer and certain of its subsidiaries, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health, and seeks monetary relief. In July 2018, the U.S. Department of Justice requested documents related to this matter, which are being provided.
Allergan Complaint for Indemnity
In August 2018, Pfizer was named as a defendant in a third-party complaint for indemnity, along with King Pharmaceuticals LLC, a Pfizer subsidiary (King), filed by Allergan Finance LLC (Allergan) in a Multi-District Litigation (In re National Prescription Opiate Litigation MDL 2804)these actions have been consolidated in the U.S. District Court for the Northern District of Ohio.Illinois. In July 2018, the District Court granted defendants’ motions to dismiss the consolidated amended complaint without prejudice. Plaintiffs filed a second amended complaint in September 2018. On February 3, 2017, we completed the sale of our global infusion systems net assets, HIS, which includes intravenous saline solution, to ICU Medical. The litigation is the subject of cross-claims for indemnification by both Pfizer and ICU Medical under the purchase agreement.
Hormone Therapy Consumer Class Action
A certified consumer class action is pending against Wyeth in the U.S. District Court for the Southern District of California based on the alleged off-label marketing of its hormone therapy products. The case was originally filed in December 2003. The class consists of California consumers who purchased Wyeth’s hormone-replacement products between January 1995 and January 2003 and who do not seek personal injury damages therefrom. The class seeks compensatory and punitive damages, including a full refund of the purchase price.
EpiPen
Beginning in February 2017, purported class actions were filed in various federal courts by indirect purchasers of EpiPen against Pfizer, and/or its affiliates King and Meridian, and/or various entities affiliated with Mylan, and Mylan Chief Executive Officer, Heather Bresch. The plaintiffs in these actions seek to represent U.S. nationwide classes comprising persons or entities who paid for any portion of the end-user purchase price of an EpiPen between 2009 until the cessation of the defendants’ allegedly unlawful conduct. In August 2017, a similar lawsuit assertsbrought in the U.S. District Court for the District of New Jersey on behalf of a purported class of direct purchaser plaintiffs against Pfizer, King, Meridian and Mylan was voluntarily dismissed without prejudice. Against Pfizer and/or its affiliates, plaintiffs generally allege that Pfizer’s and/or its affiliates’ settlement of patent litigation regarding EpiPen delayed market entry of generic EpiPen in violation of federal antitrust laws and various state antitrust or consumer protection laws. At least one lawsuit also alleges that Pfizer and/or Mylan violated the federal Racketeer Influenced and Corrupt Organizations Act. Plaintiffs also filed various consumer protection and unjust enrichment claims against, and relating to conduct attributable solely to, Mylan and/or its affiliates regarding EpiPen. Plaintiffs seek treble damages for indemnity relatedalleged overcharges for EpiPen since 2009. In August 2017, the actions were consolidated for coordinated pre-trial proceedings in a Multi-District Litigation (In re: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation, MDL-2785) in the U.S. District Court for the District of Kansas with other EpiPen-related actions against Mylan and/or its affiliates to Kadian, which was owned for a short period byPfizer, King in 2008, prior to Pfizer's acquisitionand Meridian are not parties.
Nexium 24HR and Protonix
A number of King in 2010.
A4. Legal Proceedings––Government Investigations

Likeindividual and multi-plaintiff lawsuits have been filed against Pfizer, certain of its subsidiaries and/or other pharmaceutical companies, we are subjectmanufacturers in various federal and state courts alleging that the plaintiffs developed kidney-related injuries purportedly as a result of the ingestion of certain proton pump inhibitors. The cases against Pfizer involve Protonix and/or Nexium 24HR and seek compensatory and punitive damages and, in some cases, treble damages, restitution or disgorgement. In August 2017, the federal actions were ordered transferred for coordinated pre-trial proceedings to extensive regulation by government agenciesa Multi-District Litigation (In re: Proton-Pump Inhibitor Products Liability Litigation (No. II)) in the U.S., other developed markets and multiple emerging markets District Court for the District of New Jersey. On July 31, 2019, we completed the transaction in which we operate.and GSK combined our respective consumer healthcare businesses into a new consumer healthcare joint venture that operates globally under the GSK Consumer Healthcare name. As part of the joint venture transaction, the joint venture has agreed to assume, and to indemnify Pfizer for, liabilities arising out of such litigation to the extent related to Nexium 24HR.
Docetaxel
Personal Injury Actions
A number of lawsuits have been filed against Hospira and Pfizer in various federal and state courts alleging that plaintiffs who were treated with Docetaxel developed permanent hair loss. The significant majority of the cases also name other defendants, including the manufacturer of the branded product, Taxotere. Plaintiffs seek compensatory and punitive damages.
In October 2016, the federal cases were transferred for coordinated pre-trial proceedings to a result, we have interactionsMulti-District Litigation (In re Taxotere (Docetaxel) Products Liability Litigation, MDL-2740) in the U.S. District Court for the Eastern District of Louisiana.
Mississippi Attorney General Government Investigation
In October 2018, the Attorney General of Mississippi filed a complaint in Mississippi state court against the manufacturer of the branded product and 8 other manufacturers including Pfizer and Hospira, alleging, with government agencies on an ongoing basis. Criminal charges,respect to Pfizer and substantial fines and/orHospira, a failure to warn about a risk of permanent hair loss in violation of the Mississippi Consumer Protection Act. The action seeks civil penalties as well as limitations on our ability to conduct business in applicable jurisdictions, could result from government investigations. In addition, in a qui tam lawsuit in which the government declines to intervene, the relator may still pursue a suit for the recovery of civil damages and penalties on behalf of the government. Among the investigations by government agencies are the matters discussed below.
Phenytoin Sodium Capsules
In 2012, Pfizer sold the U.K. Marketing Authorisation for phenytoin sodium capsules to a third party, but retained the right to supply the finished product to that third party. In May 2013, the U.K. Competition & Markets Authority (CMA) informed us that it had launched an investigation into the supply of phenytoin sodium capsules in the U.K. market. In August 2015, the CMA issued a Statement of Objections alleging that Pfizer and Pfizer Limited, a U.K. subsidiary, engaged in conduct that violates U.K. and EU antitrust laws. In December 2016, the CMA imposed a £84.2 million fine on Pfizer and Pfizer Limited. Pfizer appealed the CMA decision to The Competition Appeal Tribunal in February 2017. On June 7, 2018, the Competition Appeal Tribunal overturned the CMA decision as well as the associated fine. On June 28, 2018, the CMA sought permission to appeal the Competition Appeal Tribunal’s judgment.
Greenstone Investigations
Since July 2017, the U.S. Department of Justice’s Antitrust Division has been investigating our Greenstone generics business. We believe this is related to an ongoing antitrust investigation of the generic pharmaceutical industry. The government has been obtaining information from Greenstone. In April 2018, Greenstone received requests for information from the Antitrust Department of the Connecticut Office of the Attorney General. We have been providing information pursuant to these requests.injunctive relief. 


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SubpoenaAdalimumab Biosimilars
Beginning in March 2019, purported class actions relating to ManufacturingHumira and adalimumab biosimilars were filed in the United States District Court for the Northern District of Quillivant XRIllinois against AbbVie Inc. (AbbVie), certain affiliates of AbbVie, and other pharmaceutical manufacturers. Pfizer is a named defendant in three of the actions. The plaintiffs seek to represent nationwide and multi-state classes consisting of persons and/or entities who are indirect purchasers of Humira from January 1, 2017 until the allegedly unlawful antitrust effects cease. Against Pfizer, the plaintiffs generally allege that Pfizer’s and AbbVie’s 2018 licensing agreements, resolving all global intellectual property matters for Pfizer’s proposed adalimumab biosimilar, delayed market entry of Pfizer’s biosimilar product in the U.S. in violation of federal antitrust laws, various state antitrust or consumer protection laws, and unjust enrichment laws. Plaintiffs seek injunctive relief and treble damages for alleged overcharges for Humira since 2017. In August 2019, the plaintiffs filed an amended consolidated complaint that superseded the prior complaints and does not name Pfizer as a defendant. As a result, Pfizer is no longer a party to the case.
Array Securities Litigation
In October 2018, we received a subpoena fromNovember 2017, 2 purported class actions were filed in the U.S. Attorney’s OfficeDistrict Court for the Southern District of New York seeking records relatingColorado alleging that Array, which we acquired in July 2019 and is our wholly owned subsidiary, and certain of its former officers violated federal securities laws in connection with certain disclosures made, or omitted, by Array regarding the NRAS-mutant melanoma program. In March 2018, the actions were consolidated into a single proceeding.
A3. Legal Proceedings––Commercial and Other Matters
Average Wholesale Price Litigation
Pfizer, certain of its subsidiaries and other pharmaceutical manufacturers were sued in various state courts by a number of states alleging that the defendants provided average wholesale price (AWP) information for certain of their products that was higher than the actual average prices at which those products were sold. The AWP is used to our relationship with another drug manufacturerdetermine reimbursement levels under Medicare Part B and its productionMedicaid and manufacturingin many private-sector insurance policies and medical plans. All but 1 of drugsthose actions have been resolved through settlement, dismissal or final judgment. The plaintiff state, Illinois,in the 1 remaining action, claims that the alleged spread between the AWPs at which purchasers were reimbursed and the actual sale prices was promoted by the defendants as an incentive to purchase certain of their products. The actionalleges, among other things, fraudand violation of the state’s unfair trade practices andconsumer protection statutes and seeks monetary and other relief, including butcivil penalties and treble damages. In September 2019, we settled the remaining action on terms not limitedmaterial to Quillivant XR. We will be producing records pursuant to the subpoena.Pfizer. All actions have now been resolved through settlement, dismissal or final judgment.
Intravenous Solutions
See Note 12A2. Legal Proceedings––ProductBeginning in November 2016, purported class actions were filed in the U.S. District Court for the Northern District of Illinois against Hospira, Hospira Worldwide, Inc. and certain other defendants relating to intravenous saline solution. Plaintiffs seek to represent a class consisting of all persons and entities in the U.S. who directly purchased intravenous saline solution sold by any of the defendants from January 1, 2013 until the time the defendants’ allegedly unlawful conduct ceases. Plaintiffs allege that the defendants’ conduct restricts output and artificially fixes, raises, maintains and/or stabilizes the prices of intravenous saline

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

solution sold throughout the U.S. in violation of federal antitrust laws. Plaintiffs seek treble damages (for themselves and on behalf of the putative classes) and an injunction against defendants for alleged price overcharges for intravenous saline solution in the U.S. since January 1, 2013. All of these actions have been consolidated in the U.S. District Court for the Northern District of Illinois. In July 2018, the District Court granted defendants’ motions to dismiss the consolidated amended complaint without prejudice. Plaintiffs filed a second amended complaint in September 2018. On February 3, 2017, we completed the sale of our global infusion systems net assets, HIS, which includes intravenous saline solution, to ICU Medical. The litigation is the subject of cross-claims for indemnification by both Pfizer and ICU Medical under the purchase agreement.
Hormone Therapy Consumer Class Action
A certified consumer class action is pending against Wyeth in the U.S. District Court for the Southern District of California based on the alleged off-label marketing of its hormone therapy products. The case was originally filed in December 2003. The class consists of California consumers who purchased Wyeth’s hormone-replacement products between January 1995 and January 2003 and who do not seek personal injury damages therefrom. The class seeks compensatory and punitive damages, including a full refund of the purchase price.
EpiPen
Beginning in February 2017, purported class actions were filed in various federal courts by indirect purchasers of EpiPen against Pfizer, and/or its affiliates King and Meridian, and/or various entities affiliated with Mylan, and Mylan Chief Executive Officer, Heather Bresch. The plaintiffs in these actions seek to represent U.S. nationwide classes comprising persons or entities who paid for any portion of the end-user purchase price of an EpiPen between 2009 until the cessation of the defendants’ allegedly unlawful conduct. In August 2017, a similar lawsuit brought in the U.S. District Court for the District of New Jersey on behalf of a purported class of direct purchaser plaintiffs against Pfizer, King, Meridian and Mylan was voluntarily dismissed without prejudice. Against Pfizer and/or its affiliates, plaintiffs generally allege that Pfizer’s and/or its affiliates’ settlement of patent litigation regarding EpiPen delayed market entry of generic EpiPen in violation of federal antitrust laws and various state antitrust or consumer protection laws. At least one lawsuit also alleges that Pfizer and/or Mylan violated the federal Racketeer Influenced and Corrupt Organizations Act. Plaintiffs also filed various consumer protection and unjust enrichment claims against, and relating to conduct attributable solely to, Mylan and/or its affiliates regarding EpiPen. Plaintiffs seek treble damages for alleged overcharges for EpiPen since 2009. In August 2017, the actions were consolidated for coordinated pre-trial proceedings in a Multi-District Litigation––Intravenous Solutions above (In re: EpiPen (Epinephrine Injection, USP) Marketing, Sales Practices and Antitrust Litigation, MDL-2785) in the U.S. District Court for information regarding government investigationsthe District of Kansas with other EpiPen-related actions against Mylan and/or its affiliates to which Pfizer, King and Meridian are not parties.
Nexium 24HR and Protonix
A number of individual and multi-plaintiff lawsuits have been filed against Pfizer, certain of its subsidiaries and/or other pharmaceutical manufacturers in various federal and state courts alleging that the plaintiffs developed kidney-related injuries purportedly as a result of the ingestion of certain proton pump inhibitors. The cases against Pfizer involve Protonix and/or Nexium 24HR and seek compensatory and punitive damages and, in some cases, treble damages, restitution or disgorgement. In August 2017, the federal actions were ordered transferred for coordinated pre-trial proceedings to a Multi-District Litigation (In re: Proton-Pump Inhibitor Products Liability Litigation (No. II)) in the U.S. District Court for the District of New Jersey. On July 31, 2019, we completed the transaction in which we and GSK combined our respective consumer healthcare businesses into a new consumer healthcare joint venture that operates globally under the GSK Consumer Healthcare name. As part of the joint venture transaction, the joint venture has agreed to assume, and to indemnify Pfizer for, liabilities arising out of such litigation to the extent related to salesNexium 24HR.
Docetaxel
Personal Injury Actions
A number of intravenous solutionlawsuits have been filed against Hospira and Pfizer in various federal and state courts alleging that plaintiffs who were treated with Docetaxel developed permanent hair loss. The significant majority of the cases also name other defendants, including the manufacturer of the branded product, Taxotere. Plaintiffs seek compensatory and punitive damages.
In October 2016, the federal cases were transferred for coordinated pre-trial proceedings to a Multi-District Litigation (In re Taxotere (Docetaxel) Products Liability Litigation, MDL-2740) in the U.S. District Court for the Eastern District of Louisiana.
Mississippi Attorney General Government Investigation
In October 2018, the Attorney General of Mississippi filed a complaint in Mississippi state court against the manufacturer of the branded product and 8 other manufacturers including Pfizer and Hospira, alleging, with respect to Pfizer and Hospira, a failure to warn about a risk of permanent hair loss in violation of the Mississippi Consumer Protection Act. The action seeks civil penalties and injunctive relief. 

PFIZER INC. AND SUBSIDIARY COMPANIES
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Adalimumab Biosimilars
Beginning in March 2019, purported class actions relating to Humira and adalimumab biosimilars were filed in the United States District Court for the Northern District of Illinois against AbbVie Inc. (AbbVie), certain affiliates of AbbVie, and other pharmaceutical manufacturers. Pfizer is a named defendant in three of the actions. The plaintiffs seek to represent nationwide and multi-state classes consisting of persons and/or entities who are indirect purchasers of Humira from January 1, 2017 until the allegedly unlawful antitrust effects cease. Against Pfizer, the plaintiffs generally allege that Pfizer’s and AbbVie’s 2018 licensing agreements, resolving all global intellectual property matters for Pfizer’s proposed adalimumab biosimilar, delayed market entry of Pfizer’s biosimilar product in the U.S. in violation of federal antitrust laws, various state antitrust or consumer protection laws, and unjust enrichment laws. Plaintiffs seek injunctive relief and treble damages for alleged overcharges for Humira since 2017. In August 2019, the plaintiffs filed an amended consolidated complaint that superseded the prior complaints and does not name Pfizer as a defendant. As a result, Pfizer is no longer a party to the case.
Array Securities Litigation
In November 2017, 2 purported class actions were filed in the U.S. District Court for the District of Colorado alleging that Array, which we acquired in July 2019 and is our wholly owned subsidiary, and certain of its former officers violated federal securities laws in connection with certain disclosures made, or omitted, by Array regarding the NRAS-mutant melanoma program. In March 2018, the actions were consolidated into a single proceeding.
A3. Legal Proceedings––Commercial and Other Matters
Average Wholesale Price Litigation
Pfizer, certain of its subsidiaries and other pharmaceutical manufacturers were sued in various state courts by a number of states alleging that the defendants provided average wholesale price (AWP) information for certain of their products that was higher than the actual average prices at which those products were sold. The AWP is used to determine reimbursement levels under Medicare Part B and Medicaid and in many private-sector insurance policies and medical plans. All but 1 of those actions have been resolved through settlement, dismissal or final judgment. The plaintiff state, Illinois,in the 1 remaining action, claims that the alleged spread between the AWPs at which purchasers were reimbursed and the actual sale prices was promoted by the defendants as an incentive to purchase certain of their products. The actionalleges, among other things, fraudand violation of the state’s unfair trade practices andconsumer protection statutes and seeks monetary and other relief, including civil penalties and treble damages. In September 2019, we settled the remaining action on terms not material to Pfizer. All actions have now been resolved through settlement, dismissal or final judgment.
Monsanto-Related Matters
In 1997, Monsanto Company (Former Monsanto) contributed certain chemical manufacturing operations and facilities to a newly formed corporation, Solutia Inc. (Solutia), and spun off the shares of Solutia. In 2000, Former Monsanto merged with Pharmacia & Upjohn Company to form Pharmacia. Pharmacia then transferred its agricultural operations to a newly created subsidiary, named Monsanto Company (New Monsanto), which it spun off in a two-stage process that was completed in 2002. Pharmacia was acquired by Pfizer in 2003 and is a wholly owned subsidiary of Pfizer.
In connection with its spin-off that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities related to Pharmacia’s former agricultural business. New Monsanto has defended and/or is defending Pharmacia in connection with various claims and litigation arising out of, or related to, the agricultural business, and has been indemnifying Pharmacia when liability has been imposed or settlement has been reached regarding such claims and litigation.
In connection with its spin-off in 1997, Solutia assumed, and agreed to indemnify Pharmacia for, liabilities related to Former Monsanto’s chemical businesses. As the result of its reorganization under Chapter 11 of the U.S. Bankruptcy Code, Solutia’s indemnification obligations relating to Former Monsanto’s chemical businesses are primarily limited to sites that Solutia has owned or operated. In addition, in connection with its spinoff that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities primarily related to Former Monsanto’s chemical businesses, including, but not limited to, any such liabilities that Solutia assumed. Solutia’s and New Monsanto’s assumption of, and agreement to indemnify Pharmacia for, these liabilities apply to pending actions and any future actions related to Former Monsanto’s chemical businesses in which Pharmacia is named as a defendant, including, without limitation, actions asserting environmental claims, including alleged exposure to polychlorinated biphenyls. Solutia and/or New Monsanto are defending Pharmacia in connection with various claims and litigation arising out of, or related to, Former Monsanto’s chemical businesses, and have been indemnifying Pharmacia when liability has been imposed or settlement has been reached regarding such claims and litigation.
Environmental Matters
In 2009, we submitted to the U.S. Environmental Protection Agency (EPA) a corrective measures study report with regard to Pharmacia’s discontinued industrial chemical facility in North Haven, Connecticut. In September 2010, our corrective measures

PFIZER INC. AND SUBSIDIARY COMPANIES
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study report was approved by the EPA, and we commenced construction of the site remedy in late 2011 under an Updated Administrative Order on Consent with the EPA.
Also, in 2009, we submitted a revised site-wide feasibility study with regard to Wyeth Holdings Corporation’s (formerly, American Cyanamid Company) discontinued industrial chemical facility in Bound Brook, New Jersey. In July 2011, Wyeth Holdings Corporation finalized an Administrative Settlement Agreement with the EPA and Order on Consent for Removal Action (the 2011 Administrative Settlement Agreement) with the EPA with regard to the Bound Brook facility. In May 2012, we completed construction of an interim remedy to address the discharge of impacted groundwater from that facility to the Raritan River. In September 2012, the EPA issued a final remediation plan for the Bound Brook facility’s main plant area, which is generally in accordance with one of the remedies evaluated in our revised site-wide feasibility study. In March 2013, Wyeth Holdings Corporation (now Wyeth Holdings LLC) entered into an Administrative Settlement Agreement and Order on Consent with the EPA to allow us to undertake detailed engineering design of the remedy for the main plant area and to perform a focused feasibility study for 2 adjacent lagoons. In September 2015, the U.S., on behalf of the EPA, filed a complaint and consent decree with the federal District Court for the District of New Jersey that allows Wyeth Holdings LLC to complete the design and to implement the remedy for the main plant area. In December 2015, the consent decree (which supersedes the 2011 Administrative Settlement Agreement) was entered by the District Court. In September 2018, the EPA issued a final remediation plan for the 2 adjacent lagoons, which is generally in accordance with one of the remedies evaluated in our focused feasibility study, and in September 2019, Wyeth Holdings LLC entered into an Administrative Settlement Agreement and Order on Consent with the EPA to allow us to undertake detailed engineering design of the remedy for the lagoons. We have accrued for the estimated costs of the site remedies for the North Haven and Bound Brook facilities.

We are a party to a number of other proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, and other state, local or foreign laws in which the primary relief sought is the cost of past and/or future remediation.
Contracts with Iraqi Ministry of Health
In October 2017, a number of United States service members, civilians, and their families brought a complaint in the U.S. District Court for the District of Columbia against a number of pharmaceutical and medical devices companies, including Pfizer and certain of its subsidiaries, alleging that the defendants violated the United States Anti-Terrorism Act. The complaint alleges that the defendants provided funding for terrorist organizations through their sales practices pursuant to pharmaceutical and medical device contracts with the Iraqi Ministry of Health, and seeks monetary relief. In July 2018, the U.S. Department of Justice requested documents related to this matter, which are being provided.
Allergan Complaint for Indemnity
In August 2018, Pfizer was named as a defendant in a third-party complaint for indemnity, along with King, filed by Allergan Finance LLC (Allergan) in a Multi-District Litigation (In re National Prescription Opiate Litigation MDL 2804) in the U.S. District Court for the Northern District of Ohio. The lawsuit asserted claims for indemnity related to Kadian, which was owned for a short period by King in 2008, prior to Pfizer's acquisition of King in 2010. In December 2018, the District Court dismissed the lawsuit. In February 2019, Allergan filed a similar complaint in the Supreme Court of the State of New York, asserting claims for indemnity related to Kadian.
A4. Legal Proceedings––Government Investigations
Like other pharmaceutical companies, we are subject to extensive regulation by government agencies in the U.S., other developed markets and multiple emerging markets in which we operate. As a result, we have interactions with government agencies on an ongoing basis. Criminal charges, substantial fines and/or civil penalties, limitations on our ability to conduct business in applicable jurisdictions, corporate integrity or deferred prosecution agreements, as well as reputational harm and increased public interest in the matter could result from government investigations in the U.S. and other jurisdictions in which we do business. In addition, in a qui tam lawsuit in which the government declines to intervene, the relator may still pursue a suit for the recovery of civil damages and penalties on behalf of the government. Among the investigations by government agencies are the matters discussed below.
Phenytoin Sodium Capsules
In 2012, Pfizer sold the U.K. Marketing Authorisation for phenytoin sodium capsules to a third party, but retained the right to supply the finished product to that third party. In May 2013, the U.K. Competition & Markets Authority (CMA) informed us that it had launched an investigation into the supply of phenytoin sodium capsules in the U.K. market. In August 2015, the CMA issued a Statement of Objections alleging that Pfizer and Pfizer Limited, a U.K. subsidiary, engaged in conduct that violates U.K. and EU antitrust laws. In December 2016, the CMA imposed a £84.2 million fine on Pfizer and Pfizer Limited. Pfizer appealed the CMA decision to The Competition Appeal Tribunal in February 2017. On June 7, 2018, the Competition

PFIZER INC. AND SUBSIDIARY COMPANIES
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Appeal Tribunal overturned the CMA decision as well as the associated fine. The CMA appealed the judgment to the Court of Appeal.
Greenstone Investigations
U.S. Department of Justice Antitrust Division Investigation
Since July 2017, the U.S. Department of Justice's Antitrust Division has been investigating our Greenstone generics business.  We believe this is related to an ongoing broader antitrust investigation of the generic pharmaceutical industry. The government has been obtaining information from Greenstone.
State Attorneys General Generics Antitrust Litigation
In April 2018, Greenstone received requests for information from the Antitrust Department of the Connecticut Office of the Attorney General. In May 2019, Attorneys General of more than 40 states plus the District of Columbia and Puerto Rico filed a complaint against a number of pharmaceutical companies, including Greenstone and Pfizer. The matter has been consolidated with a Multi-District Litigation (In re: Generic Pharmaceuticals Pricing Antitrust Litigation MDL No. 2724) in the Eastern District of Pennsylvania. As to Greenstone and Pfizer, the complaint alleges anticompetitive conduct in violation of federal and state antitrust laws and state consumer protection laws.
Subpoena relating to Manufacturing of Quillivant XR
In October 2018, we received a subpoena from the U.S. Attorney’s Office for the Southern District of New York (SDNY) seeking records relating to our relationship with another drug manufacturer and its production and manufacturing of drugs including, but not limited to, Quillivant XR. We are producing records pursuant to the subpoena.
Government Inquiries relating to Meridian Medical Technologies
In February 2019, we received a civil investigative demand from the U.S. Attorney’s Office for the SDNY. The civil investigative demand seeks records and information related to alleged quality issues involving the manufacture of auto-injectors at our Meridian site. In August 2019, we received a HIPAA subpoena from the U.S. Attorney’s Office for the Eastern District of Missouri seeking similar records and information. We are producing records in response to these requests.
U.S. Department of Justice/SEC Inquiry relating to Russian Operations
In June 2019, we received an informal request from the U.S. Department of Justice’s FCPA Unit seeking documents relating to our operations in Russia. In September 2019, we received a similar request from the SEC’s FCPA unit. We are producing records pursuant to these requests.
Contracts with Iraqi Ministry of Health
See Note 12A3.Contingencies and Certain Commitments: Legal Proceedings––Commercial and Other Matters––Contracts with Iraqi Ministry of Health above for information regarding U.S. government investigations related to contracts with the Iraqi Ministry of Health.

Docetaxel––Mississippi Attorney General Government Investigation
See Note 12A2. Contingencies and Certain Commitments: Legal Proceedings––Product Litigation––Docetaxel––Mississippi Attorney General Government Investigation above for information regarding a government investigation related to Docetaxel marketing practices.

A5. Legal Proceedings--Matters Resolved During the First Nine Months of 2018
During 2018, certain matters, including the matters discussed below, were resolved or were the subject of definitive settlement agreements or settlement agreements-in-principle.
Celebrex
Beginning in July 2014, purported class actions were filed in the U.S. District Court for the Eastern District of Virginia against Pfizer and certain subsidiaries of Pfizer relating to Celebrex. The plaintiffs sought to represent U.S. nationwide or multi-state classes consisting of persons or entities who directly purchased from the defendants, or indirectly purchased or reimbursed patients for some or all of the purchase price of, Celebrex or generic Celebrex from May 31, 2014 until the cessation of the defendants’ allegedly unlawful conduct. The plaintiffs alleged delay in the launch of generic Celebrex in violation of federal antitrust laws or certain state antitrust, consumer protection and various other laws as a result of Pfizer fraudulently obtaining and improperly listing a patent on Celebrex, engaging in sham litigation and prolonging the impact of sham litigation through settlement activity that further delayed generic entry. Each of the actions sought treble damages on behalf of the putative class for alleged price overcharges for Celebrex since May 31, 2014. In December 2014, the District Court granted the parties’ joint motions to consolidate the direct purchaser and end-payer cases, and all such cases were consolidated as of March 2015. In October 2014 and March 2015, we filed motions to dismiss the direct purchasers’ and end-payers’ amended complaints, respectively. In November 2015, the District Court denied in part and granted in part our motion to dismiss the direct purchasers’ amended complaint. In February 2016, the District Court denied in part and granted in part our motion to dismiss the end-payers’ amended complaint, and in August 2016, the District Court dismissed substantially all of the end-payers’ remaining claims. In February 2017, the District Court dismissed with prejudice all of the end-payers’ claims. In March 2017, the end-payers appealed the District Court’s order dismissing their claims with prejudice to the U.S. Court of Appeals for the Fourth Circuit. In August 2017, the District Court granted the direct purchasers’ motion for class certification. In November 2017, Pfizer and the direct purchasers entered into an agreement to resolve the direct purchasers’ class action for $94 million. In April 2018, the court approved the agreement. In November 2017, Pfizer and the end-payers entered into an agreement to resolve the claims of the end-payer plaintiffs on terms not material to Pfizer.
Subpoenas relating to Copayment Assistance Organizations
In December 2015 and July 2016, Pfizer received subpoenas from the U.S. Attorney’s Office for the District of Massachusetts requesting documents related to the Patient Access Network Foundation and other 501(c)(3) organizations that provide financial assistance to Medicare patients. In May 2018, Pfizer entered into a civil settlement to resolve the matter. Pfizer paid $23.85 million to the United States, and entered into a five-year Corporate Integrity Agreement with the Office of the Inspector General of the Department of Health and Human Services.
Civil Investigative Demand relating to Pharmacy Benefit Managers
In March 2016, Pfizer received a Civil Investigative Demand from the U.S. Attorney’s Office for the Southern District of New York (SDNY) related to Pfizer’s contractual relationships with pharmacy benefit managers with respect to certain pharmaceutical products over the period from January 1, 2006 to the present. We have provided information to the government in response to this Civil Investigative Demand. In July 2018, Pfizer was served with a qui tam complaint that appears to be related to the SDNY investigation. The complaint was unsealed following the government’s decision not to intervene in the case.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

B. Guarantees and Indemnifications
In the ordinary course of business and in connection with the sale of assets and businesses and other transactions, we often indemnify our counterparties against certain liabilities that may arise in connection with the transaction or that are related to events and activities prior to or following a transaction. If the indemnified party were to make a successful claim pursuant to the terms of the indemnification, we may be required to reimburse the loss. These indemnifications are generally subject to various restrictions and limitations. Historically, we have not paid significant amounts under these provisions and, as of September 30, 2018,29, 2019, the estimated fair value of these indemnification obligations was not significant.
In addition, in connection with our entry into certain agreements, our counterparties agree to indemnify us. For example, our collaboration agreement with EMD Serono, Inc. to co-promote Rebif in the U.S. expired at the end of 2015 and included certain indemnity provisions. Patent litigation brought by Biogen Idec MA Inc. against EMD Serono Inc. and Pfizer is pending in the U.S. District Court for the District of New Jersey and the United States Court of Appeals for the Federal Circuit. EMD Serono Inc. has acknowledged that it is obligated to satisfy any award of damages.
Pfizer Inc. has also guaranteed the long-term debt of certain companies that it acquired and that now are subsidiaries of Pfizer.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

C. Certain Commitments
Accelerated share repurchase agreement––On March 12, 2018,February 7, 2019, we entered into an accelerated share repurchase agreement with CitibankGS&Co. to repurchase $4.0approximately $6.8 billion of our common stock. Pursuant to the terms of the agreement, on March 14, 2018,February 12, 2019, we paid $4.0approximately $6.8 billion to CitibankGS&Co. and received an initial delivery of approximately 87130 million shares of our common stock from Citibank at a price of $36.61 per share,GS&Co., which represented, based on the closing price of our common stock on the NYSE on March 12, 2018,February 7, 2019, approximately 80% of the notional amount of the accelerated share repurchase agreement. On September 5, 2018,August 1, 2019, the accelerated share repurchase agreement with CitibankGS&Co. was completed, which, per the terms of the agreement, resulted in CitibankGS&Co. owing us a certain number of shares of Pfizer common stock. Pursuant to the agreement’s settlement terms, we received an additional 2133.5 million shares of our common stock from CitibankGS&Co. on September 7, 2018.August 5, 2019. The average price paid for all of the shares delivered under the accelerated share repurchase agreement was $36.86$41.42 per share. The common stock received is included in Treasury stock.stock. This agreement was entered into pursuant to our previously announced share repurchase authorization. After giving effect to the accelerated share repurchase agreement as well asand other share repurchases through September 30, 2018,29, 2019, our remaining share-purchase authorization was approximately $9.2$5.3 billion at on September 30, 2018.
Corporate headquarters lease agreement––In April 2018, we entered an agreement to lease space in an office building in the Hudson Yards neighborhood of New York City. We will relocate our global headquarters to this property with occupancy expected beginning in 2022. Our future minimum rental commitment under this 20-year lease is approximately $1.7 billion. In July 2018, we completed the sale of our current headquarters at 219 and 235 East 42nd Street. We also agreed to lease these properties from the buyer while we complete our relocation.
29, 2019.
Note 13.Segment, Geographic and Other Revenue Information


A. Segment Information


WeAt the beginning of our 2019 fiscal year, we began to manage our commercial operations through twoa new global structure consisting of 3 distinct business segments: Pfizer Innovative Health (IH)Biopharmaceuticals Group (Biopharma), Upjohn and Pfizer Essential Health (EH). The IH and EH segments arethrough July 31, 2019, Pfizer’s Consumer Healthcare business (Consumer Healthcare), each led by a single manager. Each operating segment has responsibility for its commercial activities. Upjohn and Consumer Healthcare are responsible for their own R&D activities while Biopharma receives its R&D services from GPD and for certainWRDM. These services include IPR&D projects for new investigational products and additional indications for in-line products that generally have achieved proof-of-concept.products. Each business has a geographic footprint across developed and emerging markets. Our chief operating decision maker uses the revenues and earnings of the two operating segments, among other factors, for performance evaluation and resource allocation.
Biopharma and Upjohn are the only reportable segments. We regularly reviewhave revised prior-period information (Revenues and Earnings, as defined by management) to conform to the current management structure. As our segments andoperations were not managed under the approach used by management for performance evaluation and resource allocation. In July 2018, we announced that we will reorganize our commercial operations effective atnew structure until the beginning of ourfiscal 2019, fiscal year. We will organize the company into three businesses: a science-based Innovative Medicines business, which will include allcertain costs and expenses could not be directly attributed to one of the current Pfizer Innovative Health medicines and vaccines business units as well as biosimilars andthen new operating segments. As a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer; and a Consumer Healthcare business. We are currently evaluating the impact toresult, our operating segmentssegment results for the third quarter and other costs and activities based on how the businesses will be managed in 2019.
first nine months of 2018 include allocations, which management believes are reasonable. As described in Note 1Aand Note 2B, acquisitions and the February 3, 2017 salecontribution of HISour Consumer Healthcare business to the GSK Consumer Healthcare joint venture have impacted our results of operations in 2017.2019.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Operating Segments
Some additional information about our Biopharma and Upjohn business segments as of September 30, 2018 follows:
innovativehealthrgb.jpgpfizerlogo2816.jpg
Pfizer
Biopharmaceuticals
Group
 
pehlogo.jpgupjohnlogo.jpg
IH focuses on developingBiopharma is a science-based innovative medicines business that includes six business units – Oncology, Inflammation & Immunology, Rare Disease, Hospital, Vaccines and commercializing novel, value-creatingInternal Medicine. The new Hospital unit commercializes our global portfolio of sterile injectable and anti-infective medicines and vaccinesincludes Pfizer’s contract manufacturing operation, Pfizer CentreOne. At the beginning of our 2019 fiscal year, we also incorporated our biosimilar portfolio into our Oncology and Inflammation & Immunology business units and certain legacy established products into the Internal Medicine business unit. Each business unit is committed to delivering breakthroughs that significantly improvechange patients’ lives,lives.Upjohn is a global, primarily off-patent branded and generic medicines business, which includes a portfolio of 20 globally recognized solid oral dose brands, as well as products for consumer healthcare.
Key therapeutic areas include internal medicine, vaccines, oncology, inflammation & immunology, rare disease and consumer healthcare.
EH includes legacy brands that have lost or will soon lose market exclusivity in both developed and emerging markets, branded and generic sterile injectable products, biosimilars, and select branded products including anti-infectives. EH also includes an R&D organization, as well as our contract manufacturing business.
Through February 2, 2017, EH also included HIS.
a U.S.-based generics platform, Greenstone.

Leading brandsSelect products include:

-
Prevnar 13/Prevenar 13

-
Xeljanz
Ibrance
- Eliquis

-
Lyrica (U.S., Japan and certain other markets)
Xeljanz
-
Enbrel (outside the U.S. and Canada)

-
Ibrance
Chantix/Champix
- Xtandi
Sutent
- Several OTC consumer healthcare products (e.g., Advil and
  Centrum)Xtandi
 

Leading brandsSelect products include:

-
Lyrica
-
Lipitor

- Norvasc
- Norvasc
- Lyrica (Europe, Russia, Turkey, Israel and Central Asia countries)
- Celebrex
- Viagra*Viagra
- Inflectra/Remsima
- Sulperazon
- Several other sterile injectable productsCertain generic medicines
*Viagra lost exclusivity in the U.S. in December 2017. Beginning in 2018, revenues for Viagra in the U.S. and Canada, which were reported in IH through 2017, are reported in EH (which reported all other Viagra revenues excluding the U.S. and Canada through 2017). Therefore, beginning in 2018, total Viagra worldwide revenues are reported in EH.
The following organizational change impacted our operating segments in 2018:On July 29, 2019, we announced that we entered into a definitive agreement to combine Upjohn with Mylan, creating a new global pharmaceutical company. For additional information, see Note 1A.
Effective in the first quarter of 2018, certain costsOn July 31, 2019, Pfizer’s Consumer Healthcare business, an over-the-counter medicines business, was combined with GSK’s consumer healthcare business to form a new consumer healthcare joint venture. See Note 1A and Note 2B for Pfizer’s StratCO group, which were previously reported in the operating results of our operating segments and Corporate, are reported in Other Unallocated. StratCO costs primarily include headcount costs, vendor costs and data costs largely in support of Pfizer’s commercial operations. The majority of the StratCO costs reflect additional amounts that our operating segments would have incurred had each segment operated as a standalone company during the periods presented. The reporting change was made to streamline accountability and speed decision making. In the third quarter of 2017, we reclassified approximately $125 million of costs from IH, approximately $36 million of costs from EH and approximately $19 million of costs from Corporate to Other unallocated costs to conform to the current period presentation. In the first nine months of 2017, we reclassified approximately $344 million of costs from IH, approximately $114 million of costs from EH and approximately $40 million of costs from Corporate to Other unallocated costs to conform to the current period presentation.information.
Other Costs and Business Activities
Certain pre-tax costs are not allocated to our operating segment results, such as costs associated with the following:
WRD,WRDM––the R&D and Medical expenses managed by our WRDM organization, which is generally responsible for research projects for our IH businessBiopharma portfolio 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 WRDWRDM organization also has responsibility for certain science-based and other platform-services organizations, which provide end-to-end technical expertise and other services to the various R&D projects, as well as the Worldwide Medical and Safety group, which ensures that Pfizer provides all stakeholders––including EH R&D projects. WRD is also responsible for facilitating all regulatory submissionspatients, healthcare providers, pharmacists, payers and interactions health authorities––with regulatory agencies, including all safety-event activities.complete and up-to-date information on the risks and benefits associated with Pfizer products so that they can make appropriate decisions on how and when to use Pfizer’s medicines.
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.from WRDM in the Biopharma portfolio, including late stage portfolio spend. GPD also provides technical support and other services to Pfizer R&D projects. GPD is responsible for facilitating all regulatory submissions and interactions with regulatory agencies.
Other––the operating results of our Consumer Healthcare business, through July 31, 2019, and costs associated with other commercial activities not managed as part of Biopharma or Upjohn, including all strategy, business development, portfolio management and valuation capabilities, which previously had been reported in various parts of the organization.
Corporate representingand Other Unallocated––the costs associated with platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance, and worldwide procurement), the provision of medical information to healthcare providers, patientspatient advocacy activities 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, as well as certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments. Effective in the first quarter of 2018, certain costs for StratCO, which were previously reported in the operating results of our operating segments and Corporate, are reported in Other Unallocated. For additional information, see note below on Other unallocated costs.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


Other unallocated costs, representinggains and losses on investments, as well as overhead expenses associated with our manufacturing (which include manufacturing variances associated with production) 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). In connection with the StratCO reporting change, in the third quarter of 2017, we reclassified approximately $125 million of costs from IH, approximately $36 million of costs from EH and approximately $19 million of costs from Corporate to Other unallocated costs to conform to the current period presentation. In the first nine months of 2017, we reclassified approximately $344 million of costs from IH, approximately $114 million of costs from EH and approximately $40 million of costs from Corporate to Other unallocated costs to conform to the current period presentation.costs.
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, representing substantive and/or unusual, and in some cases recurring, items (such as gains on the completion of joint venture transactions, restructuring charges, legal charges or legal charges)net gains and losses on investments in equity securities) that are evaluated on an individual basis by management and that, either as a result of their nature or size, would not be expected to occur as part of our normal business on a regular basis. Such items can include, but are not limited to, 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.
Segment Assets


We manage our assets on a total company basis, not by operating segment, as many of our operating assets are shared (such as our plant network assets) or commingled (such as accounts receivable, as many of our customers are served by bothmultiple operating segments). Therefore, our chief operating decision maker does not regularly review any asset information by operating segment and, accordingly, we do not report asset information by operating segment. Total assets were approximately $168$170 billion as of September 30, 201829, 2019 and $172$159 billion as of December 31, 20172018.
Selected Income Statement Information
As described in Note 1A and Note 2B, acquisitions and the contribution of our Consumer Healthcare business to the GSK Consumer Healthcare joint venture have impacted our results of operations in 2019.
The following table provides selected income statement information by reportable segment:
  Three Months Ended
  Revenues 
Earnings(a)
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

Reportable Segments:        
IH(b)
 $8,471
 $8,118
 $5,388
 $5,000
EH(b)
 4,826
 5,050
 2,527
 2,801
Total reportable segments 13,298
 13,168
 7,915
 7,801
Other business activities(c), (d)
 
 
 (736) (759)
Reconciling Items:      
  
Corporate(b), (d)
 
 
 (1,337) (1,363)
Purchase accounting adjustments(d)
 
 
 (1,309) (1,154)
Acquisition-related costs(d)
 
 
 (112) (155)
Certain significant items(e)
 
 
 213
 (449)
Other unallocated(b), (d)
 
 
 (457) (335)
  $13,298
 $13,168

$4,177
 $3,585
 
  Nine Months Ended
  Revenues 
Earnings(a)
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

Reportable Segments:        
IH(b)
 $24,573
 $23,204
 $15,419
 $14,534
EH(b)
 15,097
 15,639
 8,133
 8,672
Total reportable segments 39,670
 38,843
 23,552
 23,206
Other business activities(c), (d)
 
 
 (2,130) (2,205)
Reconciling Items:        
Corporate(b), (d)
 
 
 (3,633) (3,908)
Purchase accounting adjustments(d)
 
 
 (3,665) (3,527)
Acquisition-related costs(d)
 
 
 (221) (347)
Certain significant items(e)
 
 
 (8) (797)
Other unallocated(b), (d)
 
 
 (1,064) (1,070)
  $39,670
 $38,843
 $12,831
 $11,351

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

The following table provides selected income statement information by reportable segment:
  Three Months Ended
  Revenues 
Earnings(a)
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Reportable Segments:        
Biopharma $10,108
 $9,422
 $6,503
 $6,206
Upjohn 2,195
 3,036
 1,353
 2,051
Total reportable segments 12,303
 12,458
 7,856
 8,257
Other business activities 
 
 (1,443) (1,298)
Reconciling Items:      
  
Corporate and other unallocated 377
 839
 (1,431) (1,658)
Purchase accounting adjustments 
 
 (1,141) (1,309)
Acquisition-related costs 
 
 (300) (112)
Certain significant items(b)
 
 
 7,187
 298
  $12,680
 $13,298
 $10,727
 $4,177
 
  Nine Months Ended
  Revenues 
Earnings(a)
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Reportable Segments:        
Biopharma $28,887
 $27,737
 $18,484
 $17,987
Upjohn 8,077
 9,302
 5,577
 6,442
Total reportable segments 36,964
 37,040
 24,062
 24,428
Other business activities 
 
 (3,750) (3,605)
Reconciling Items:        
Corporate and other unallocated 2,098
 2,631
 (4,108) (4,558)
Purchase accounting adjustments 
 
 (3,357) (3,665)
Acquisition-related costs 
 
 (152) (221)
Certain significant items(b)
 
 
 6,495
 452
  $39,062
 $39,670
 $19,190
 $12,831
(a) 
Income from continuing operations before provision for taxes on income. IH’sincome. Biopharma’s earnings include dividend income of $91 million and $54$43 million in the third quarter of 20182019 and 2017$91 million in the third quarter of 2018, respectively, and $226 million and $211$184 million in the first nine months of 20182019 and 2017, respectively,$226 million in the first nine months of 2018 from our investment in ViiV. For additional information, see Note 4.
(b) 
In connection with the StratCO reporting change, in the third quarter of 2017, we reclassified approximately $125 million of costs from IH, approximately $36 million of costs from EH and approximately $19 million of costs from Corporate to Other unallocated costs to conform to the current period presentation. In the first nine months of 2017, we reclassified approximately $344 million of costs from IH, approximately $114 million of costs from EH and approximately $40 million of costs from Corporate to Other unallocated costs to conform to the current period presentation.
(c)
Other business activities includes the costs managed by our WRD and GPD organizations.
(d)
For a description, see the “Other Costs and Business Activities” section above.
(e)
Certain significant items are substantive and/or unusual, and in some cases recurring, items (such as restructuring or legal charges)(as noted above) that, either as a result of their nature or size, would not be expected to occur as part of our normal business on a regular basis.

PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

For Earnings in the third quarter of 20182019, certain significant items includes: (i) restructuring creditscharges and implementation costs associated with our cost-reduction initiativesinitiatives that are not associated with an acquisition of $35$110 million, (ii) net charges for certain legal matters of $37$63 million,, (iii) incomecharges for business and legal entity alignment of $2$89 million, representing an adjustment to amounts previously recorded to write down(iv) net gains recognized during the HIS net assets to fair value less costs to sellperiod on investments in equity securities of $3 million, (v) a pre-tax gain associated with the completion of the GSK Consumer Healthcare joint venture transaction of $8.1 billion and (iv)(vi) other incomecharges of $282$641 million, which includes, among other things, a non-cash $343$337 million pre-tax gaincharge in Other (income)/deductions––net Research and development expenses related to our acquisition of Therachon, a $127 million charge for rivipansel in Cost of sales, primarily for inventory manufactured for expected future sale and charges of $161 million for external incremental costs, such as transaction costs and costs to separate our Consumer Healthcare business into a separate legal entity associated with our transaction with Bain Capital to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and preclinical stage neuroscience assets primarily targeting disordersthe formation of the central nervous system.GSK Consumer Healthcare joint venture. For additional information, see Note 1A, Note 2B, Note 3 and Note 4.
For Earnings in the third quarter of 20172018, certain significant items includes: (i) restructuring credits and implementation costs associated with our cost-reduction initiatives that are not associated with an acquisition of $55$35 million, (ii) net charges for certain legal matters of $37 million, (iii) charges for business and legal entity alignment of $1 million, (iv) net gains recognized during the period on investments in equity securities of $85 million and (v) other income of $286 million, which includes, among other things, a non-cash $343 million pre-tax gain in Other (income)/deductions––net associated with our transaction with Bain Capital to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and pre-clinical stage neuroscience assets primarily targeting disorders of the central nervous system. For additional information, see Note 3 and Note 4.
For Earnings in the first nine months of 2019, certain significant items includes: (i) restructuring charges and implementation costs associated with our cost-reduction initiatives that are not associated with an acquisition of $280 million, (ii) charges for certain legal matters of $183$72 million, (iii) income of $12 million, representing an adjustment to amounts previously recorded to write down the HIS net assets to fair value less costs to sell, (iv) certain asset impairment charges of $127$149 million, (v)(iv) charges for business and legal entity alignment of $16$353 million, (v) net gains recognized during the period on investments in equity securities of $139 million, (vi) a pre-tax gain associated with the completion of the GSK Consumer Healthcare joint venture transaction of $8.1 billion, (vii) net losses on early retirement of debt of $138 million and (vi)(viii) other charges of $81$738 million, which includes, among other things, $55a $337 million charge in inventory losses, overhead costs Research and development expenses related to the periodour acquisition of Therachon, a $127 million chargefor rivipansel in which our Puerto Rico plants were not operational, and incremental costs, all of which resulted from hurricanes in Puerto Rico and are included in Cost of sales., primarily for inventory manufactured for expected future sale and charges of $223 million for external incremental costs, such as transaction costs and costs to separate our Consumer Healthcare business into a separate legal entity associated with the formation of the GSK Consumer Healthcare joint venture. For additional information, see Note 1A, Note 2B,, Note 3 andNote 4.4.
For Earnings in the first nine months of 2018, certain significant items includes: (i) restructuring credits and implementation costs associated with our cost-reduction initiatives that are not associated with an acquisition of $127 million, (ii) net credits for certain legal matters of $70 million, (iii) income of $1 million, representing an adjustment to amounts previously recorded to write down the HIS net assets to fair value less costs to sell, (iv) certain asset impairment charges of $31 million, (v)(iv) charges for business and legal entity alignment of $4$5 million, (v) net gains recognized during the period on investments in equity securities of $460 million, (vi) net losses on early retirement of debt of $3 million and (vi)(vii) other income of $84$89 million, which includes, among other things, a non-cash $343 million pre-tax gain in Other (income)/deductions––net associated with our transaction with Bain Capital to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and preclinicalpre-clinical stage neuroscience assets primarily targeting disorders of the central nervous system, a $119 million charge, in the aggregate, in Selling, informationinformational and administrative expenses, for a special, one-time bonus paid to virtually all Pfizer colleagues, excluding executives, which was one of several actions taken by us after evaluating the expected positive net impact of the December 2017 enactment of the TCJA, on us, and a non-cash $50 million pre-tax gain in Other (income)/deductions––netas a result of the contribution of our allogeneic chimeric antigen receptorCAR T cell therapy development program assets in connection with our contribution agreement entered into with Allogene. For additional information, see Note 2B, Note 3 and Note 4.
For Earnings in the first nine months of 2017, certain significant items includes: (i) restructuring credits and implementation costs associated with our cost-reduction initiatives that are not associated with an acquisition of $133 million, (ii) charges for certain legal matters of $191 million, (iii) charges of $52 million, representing adjustments to amounts previously recorded to write-down the HIS net assets to fair value less costs to sell, (iv) certain asset impairment charges of $127 million, (v) charges for business and legal entity alignment of $54 million and (v) other charges of $239 million, which include, among other things, $55 million in inventory losses, overhead costs related to the period in which our Puerto Rico plants were not operational, and incremental costs, all of which resulted from hurricanes in Puerto Rico and are included in Cost of sales, and a net loss of $30 million related to the sale of our 40% ownership investment in Teuto, including the extinguishment of a put option for the then remaining 60% ownership interest, which is included in Other (income)/deductions––net. For additional information, see Note 2B, Note 3 and Note 4.
Equity in the net income of investees accounted for by the equity method is not significant for any of our operating segments.
The operating segment information does not purport to represent the revenues, costs and income from continuing operations before provision for taxes on income that each of our operating segments would have recorded had each segment operated as a standalone company during the periods presented.
B. Geographic Information
As described in Note 1Aand Note 2B, acquisitions and the February 3, 2017 salecontribution of HISour Consumer Healthcare business to the GSK Consumer Healthcare joint venture have impacted our results of operations in 2017.
2019.
The following table provides revenues by geographic area:

Three Months Ended
Nine Months Ended Three Months Ended
Nine Months Ended
(MILLIONS OF DOLLARS)
September 30,
2018


October 1,
2017


%
Change


September 30,
2018


October 1,
2017


%
Change

 September 29,
2019

 September 30,
2018

 
%
Change


September 29,
2019


September 30,
2018


%
Change

U.S.
$6,361

$6,534

(3)
$18,861

$19,516

(3) $5,850
 $6,361
 (8)
$18,360

$18,861

(3)
Developed Europe(a)

2,231

2,163

3

6,657

6,309

6
 2,135
 2,231
 (4)
6,450

6,657

(3)
Developed Rest of World(b)

1,640

1,632

1

4,795

4,797


 1,585
 1,640
 (3)
4,758

4,795

(1)
Emerging Markets(c)

3,066

2,839

8

9,358

8,222

14
 3,110
 3,066
 1

9,493

9,358

1
Revenues
$13,298

$13,168

1

$39,670

$38,843

2
 $12,680
 $13,298
 (5)
$39,062

$39,670

(2)
(a) 
Developed Europe region includes the following markets: Western Europe, Scandinavian countries and Finland. Revenues denominated in euros were $1.8 billion and $1.7 billion in the third quarter of 20182019 and 2017$1.8 billion in the third quarter of 2018, respectively, and $5.3 billion and $5.0were $5.2 billion in the first nine months of 20182019 and 2017, respectively.$5.3 billion in the first nine months of 2018.
(b) 
Developed Rest of World region includes the following markets: Japan, Canada, Australia, South Korea, Australia and New Zealand.
(c) 
Emerging Markets region includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Eastern Europe, Africa, the Middle East, Africa, Central Europe and Turkey.


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


C. Other Revenue Information
Significant Product Revenues
As described in Note 1Aand Note 2B, acquisitions and the February 3, 2017 salecontribution of HISour Consumer Healthcare business to the GSK Consumer Healthcare joint venture have impacted our results of operations in 2017.2019.
The following table provides detailed revenue information:
(MILLIONS OF DOLLARS)   Three Months Ended Nine Months Ended
PRODUCT PRIMARY INDICATIONS OR CLASS September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

TOTAL REVENUES   $12,680
 $13,298
 $39,062
 $39,670
PFIZER BIOPHARMACEUTICALS GROUP (BIOPHARMA)(a)
 $10,108
 $9,422
 $28,887
 $27,737
Internal Medicine(b)
   $2,207
 $2,182
 $6,754
 $6,529
Eliquis alliance revenues and direct sales Atrial fibrillation, deep vein thrombosis, pulmonary embolism 1,025
 870
 3,121
 2,524
Chantix/Champix An aid to smoking cessation treatment in adults 18 years of age or older 276
 261
 825
 789
Premarin family Symptoms of menopause 182
 204
 542
 605
BMP2 Development of bone and cartilage 66
 54
 212
 206
Toviaz Overactive bladder 61
 67
 186
 197
All other Internal Medicine Various 597
 727
 1,867
 2,208
Oncology(c)
   $2,350
 $1,840
 $6,547
 $5,487
Ibrance Advanced breast cancer 1,283
 1,025
 3,677
 2,985
Sutent Advanced and/or metastatic RCC, adjuvant RCC, refractory GIST (after disease progression on, or intolerance to, imatinib mesylate) and advanced pancreatic neuroendocrine tumor 224
 248
 704
 785
Xtandi alliance revenues Castration-resistant prostate cancer 225
 180
 594
 510
Xalkori ALK-positive and ROS1-positive advanced NSCLC 130
 127
 385
 417
Inlyta Advanced RCC 139
 71
 316
 226
Bosulif Philadelphia chromosome–positive chronic myelogenous leukemia 90
 69
 267
 206
Retacrit(j)
 Anemia 64
 19
 147
 55
All other Oncology Various 194
 101
 456
 302
Hospital(d)
   $1,917
 $1,841
 $5,717
 $5,944
Sulperazon Treatment of infections 163
 145
 505
 464
Medrol(e)
 Steroid anti-inflammatory 109
 110
 348
 369
Vfend Fungal infections 87
 87
 265
 294
Zithromax(e)
 Bacterial infections 77
 61
 254
 243
EpiPen Epinephrine injection used in treatment of life-threatening allergic reactions 92
 68
 238
 215
Zyvox Bacterial infections 61
 50
 195
 184
Fragmin Slows blood clotting 62
 76
 185
 221
Zosyn/Tazocin Antibiotic 49
 56
 153
 176
Tygacil Tetracycline class antibiotic 50
 60
 146
 186
Pfizer CentreOne(f)
 Various 176
 159
 556
 539
All other Anti-infectives Various 335
 300
 961
 929
All other Hospital(d)
 Various 656
 669
 1,910
 2,124
Vaccines   $1,808
 $1,845
 $4,795
 $4,708
Prevnar 13/Prevenar 13 Pneumococcal disease 1,603
 1,660
 4,268
 4,290
FSME/IMMUN-TicoVac Tick-borne encephalitis disease 64
 57
 197
 162
Nimenrix Meningococcal disease 52
 46
 159
 95
Trumenba Meningococcal disease 73
 61
 117
 95
All other Vaccines Various 16
 21
 54
 65
Inflammation & Immunology (I&I)(g)
 $1,226
 $1,184
 $3,482
 $3,419
Xeljanz RA, PsA, UC 599
 432
 1,634
 1,221
Enbrel (Outside the U.S. and Canada) RA, juvenile idiopathic arthritis, PsA, plaque psoriasis, pediatric plaque psoriasis, ankylosing spondylitis and nonradiographic axial spondyloarthritis 415
 531
 1,285
 1,589
Inflectra/Remsima(g), (j)
 Inflammatory diseases 155
 166
 446
 469
Eucrisa Mild-to-moderate atopic dermatitis (eczema) 43
 40
 92
 104
All other I&I Various 15
 14
 24
 36
The following table provides detailed revenue information:
(MILLIONS OF DOLLARS)   Three Months Ended Nine Months Ended 
PRODUCT PRIMARY INDICATIONS OR CLASS September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

TOTAL REVENUES   $13,298
 $13,168
 $39,670
 $38,843
PFIZER INNOVATIVE HEALTH (IH)(a)
 $8,471
 $8,118
 $24,573
 $23,204
Internal Medicine   $2,463
 $2,455
 $7,339
 $7,245
Lyrica IH(b)
 Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury 1,132
 1,150
 3,398
 3,382
Eliquis alliance revenues and direct sales Atrial fibrillation, deep vein thrombosis, pulmonary embolism 870
 644
 2,524
 1,813
Chantix/Champix An aid to smoking cessation treatment in adults 18 years of age or older 261
 240
 789
 727
BMP2 Development of bone and cartilage 54
 79
 206
 198
Toviaz Overactive bladder 67
 62
 197
 187
Viagra IH(c)
 Erectile dysfunction 
 206
 
 711
All other Internal Medicine Various 79
 75
 224
 228
Vaccines   $1,845
 $1,649
 $4,708
 $4,385
Prevnar 13/Prevenar 13 Vaccines for prevention of pneumococcal disease 1,660
 1,522
 4,290
 4,069
FSME/IMMUN-TicoVac Tick-borne encephalitis vaccine 57
 43
 162
 119
Trumenba Meningococcal Group B vaccine 61
 42
 95
 79
All other Vaccines Various 67
 43
 160
 117
Oncology   $1,775
 $1,616
 $5,294
 $4,551
Ibrance Advanced breast cancer 1,025
 878
 2,985
 2,410
Sutent Advanced and/or metastatic RCC, adjuvant RCC, refractory GIST (after disease progression on, or intolerance to, imatinib mesylate) and advanced pancreatic neuroendocrine tumor 248
 276
 785
 805
Xtandi alliance revenues Castration-resistant prostate cancer 180
 150
 510
 422
Xalkori ALK-positive and ROS1-positive advanced NSCLC 127
 146
 417
 442
Inlyta Advanced RCC 71
 84
 226
 256
Bosulif Philadelphia chromosome–positive chronic myelogenous leukemia 69
 57
 206
 163
All other Oncology Various 55
 26
 164
 54
Inflammation & Immunology (I&I)   $1,018
 $1,000
 $2,951
 $2,863
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 531
 613
 1,589
 1,818
Xeljanz Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis 432
 348
 1,221
 935
Eucrisa
Mild-to-moderate atopic dermatitis (eczema) 40
 15
 104
 33
All other I&I Various 15
 23
 37
 78
Rare Disease   $531
 $569
 $1,651
 $1,637
BeneFIX Hemophilia 132
 151
 420
 453
Genotropin Replacement of human growth hormone 143
 136
 416
 375
Refacto AF/Xyntha Hemophilia 117
 140
 388
 409
Somavert Acromegaly 64
 65
 195
 182
All other Rare Disease Various 74
 77
 232
 218
Consumer Healthcare   $839
 $829
 $2,631
 $2,522
PFIZER ESSENTIAL HEALTH (EH)(d)
   $4,826
 $5,050
 $15,097
 $15,639
Legacy Established Products (LEP)(e)
   $2,533
 $2,681
 $7,865
 $7,995
Lipitor Reduction of LDL cholesterol 507
 491
 1,539
 1,341
Norvasc Hypertension 247
 226
 773
 684
Premarin family Symptoms of menopause 204
 238
 605
 711
Xalatan/Xalacom Glaucoma and ocular hypertension 76
 83
 233
 241
Effexor Depression and certain anxiety disorders 78
 76
 228
 215
Zoloft Depression and certain anxiety disorders 72
 78
 223
 215
Zithromax Bacterial infections 54
 61
 216
 202
EpiPen Epinephrine injection used in treatment of life-threatening allergic reactions 68
 82
 215
 253
Xanax Anxiety disorders 52
 58
 163
 164
Sildenafil Citrate Erectile dysfunction 1
 
 72
 
All other LEP Various 1,176
 1,288
 3,599
 3,969



PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)


(MILLIONS OF DOLLARS)   Three Months Ended Nine Months Ended
PRODUCT PRIMARY INDICATIONS OR CLASS September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Rare Disease   $601
 $531
 $1,592
 $1,651
BeneFIX Hemophilia 125
 132
 372
 420
Genotropin Replacement of human growth hormone 124
 143
 357
 416
Refacto AF/Xyntha Hemophilia 104
 117
 319
 388
Vyndaqel ATTR-Cardiomyopathy and Polyneuropathy 156
 37
 259
 108
Somavert Acromegaly 64
 64
 192
 195
All other Rare Disease Various 28
 38
 94
 123
UPJOHN(b), (h)
   $2,195
 $3,036
 $8,077
 $9,302
Lyrica Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury 527
 1,213
 2,888
 3,649
Lipitor Reduction of LDL cholesterol 476
 507
 1,506
 1,539
Norvasc Hypertension 219
 248
 735
 777
Celebrex Arthritis pain and inflammation, acute pain 179
 188
 526
 494
Viagra Erectile dysfunction 120
 137
 379
 509
Effexor Depression and certain anxiety disorders 80
 78
 242
 228
Zoloft Depression and certain anxiety disorders 74
 72
 217
 223
Xalatan/Xalacom Glaucoma and ocular hypertension 68
 76
 201
 233
Xanax Anxiety disorders 50
 52
 147
 163
Revatio Pulmonary arterial hypertension 24
 53
 122
 163
All other Upjohn Various 379
 411
 1,114
 1,325
CONSUMER HEALTHCARE BUSINESS(i)
 $377
 $839
 $2,098
 $2,631
           
Total Alliance revenues Various $1,141
 $977
 $3,418
 $2,820
Total Biosimilars(j)
 Various $236
 $197
 $632
 $558
Total Sterile Injectable Pharmaceuticals(k)
 $1,248
 $1,239
 $3,703
 $3,928
(MILLIONS OF DOLLARS)   Three Months Ended Nine Months Ended 
PRODUCT PRIMARY INDICATIONS OR CLASS September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

Sterile Injectable Pharmaceuticals (SIP)(f)
 $1,239
 $1,273
 $3,928
 $4,270
Sulperazon Treatment of infections 145
 114
 464
 345
Medrol Steroid anti-inflammatory 95
 109
 318
 352
Fragmin Slows blood clotting 76
 79
 221
 221
Tygacil Tetracycline class antibiotic 60
 60
 186
 192
Zosyn/Tazocin Antibiotic 55
 47
 175
 124
Precedex Sedation agent in surgery or intensive care 47
 51
 166
 182
All other SIP Various 761
 814
 2,399
 2,852
Peri-LOE Products(g)
   $698
 $794
 $2,208
 $2,398
Viagra EH(c)
 Erectile dysfunction 137
 102
 509
 285
Celebrex Arthritis pain and inflammation, acute pain 188
 212
 494
 564
Vfend Fungal infections 87
 97
 294
 305
Lyrica EH(b)
 Epilepsy, neuropathic pain and generalized anxiety disorder 81
 134
 251
 428
Zyvox Bacterial infections 50
 68
 184
 220
Revatio Pulmonary arterial hypertension 53
 58
 163
 189
Pristiq Depression 52
 69
 156
 230
All other Peri-LOE Products Various 49
 55
 157
 176
Biosimilars(h)
 Various $197
 $141
 $558
 $367
Inflectra/Remsima Inflammatory diseases 166
 112
 469
 284
All other Biosimilars Various 31
 28
 89
 82
Pfizer CentreOne(i)
   $159
 $161
 $539
 $514
Hospira Infusion Systems (HIS)(j)
 Various $
 $
 $���
 $97
Total Lyrica(b)
 Epilepsy, post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury $1,213
 $1,285
 $3,649
 $3,810
Total Viagra(c)
 Erectile dysfunction $137
 $308
 $509
 $996
Total Alliance revenues Various $977
 $741
 $2,820
 $2,112

(a) 
The IH businessPfizer Biopharmaceuticals Group encompasses Internal Medicine, Oncology, Hospital, Vaccines, Oncology, Inflammation & Immunology and Rare DiseaseDisease. The new Hospital business unit commercializes our global portfolio of sterile injectable and Consumer Healthcare.
(b)
Lyrica revenues from all of Europe, Russia, Turkey, Israelanti-infective medicines, 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.
also includes Pfizer CentreOne(c)(f)
Viagra lost exclusivity in the U.S. in December 2017. Beginning in 2018, revenues for Viagra in the U.S. and Canada, which were reported in IH through 2017, are reported in EH (which reported all other Viagra revenues excluding the U.S. and Canada through 2017). Therefore, beginning in 2018, total Viagra revenues are reported in EH. Total Viagra revenues in 2017 represent the aggregate of worldwide revenues from Viagra IH and Viagra EH.
(d)(b) 
The EHWe reclassified certain products from the LEP category, including Premarin family products, and certain other products from the legacy Peri-LOE category, including Pristiq, to the Internal Medicine category and reclassified Lyrica from the Internal Medicine category to the Upjohn business encompasses Legacy Established Products, Sterile Injectable Pharmaceuticals, Peri-LOE Products, Biosimilars, Pfizer CentreOne and HIS (through February 2, 2017).to conform 2018 product revenues to the current presentation.
(e)(c) 
Legacy Established Products primarily include products that have lost patent protection (excluding Sterile Injectable Pharmaceuticals and Peri-LOE Products). In the fourth quarter of 2017, we sold our equity share in Hisun Pfizer. As a result, effectiveWe performed certain reclassifications in the first quarter ofAll other Oncology category to conform 2018 Hisun Pfizer-relatedproduct revenues previously reported in emerging markets within All Other LEP and All Other SIP, are reported in emerging markets within Pfizer CentreOne.to the current presentation.
(d)
Hospital is a new business unit that commercializes our global portfolio of sterile injectable and anti-infective medicines. We performed certain reclassifications, primarily from the legacy Sterile Injectables Pharmaceuticals (SIP) category (Sulperazon, Medrol, Fragmin, Tygacil, Zosyn/Tazocin and Precedex, among other products), the LEP category (Epipen and Zithromax), and the legacy Peri-LOE category (Vfend and Zyvox) to the Hospital category to conform 2018 product revenues to the current presentation. Hospital also includes Pfizer CentreOne(f)
Sterile Injectable Pharmaceuticals. All other Hospital primarily includes brandedrevenues from legacy SIP products (that are not anti-infective products) and, generic injectables (excluding Peri-LOE Products)to a much lesser extent, solid oral dose products (that are not anti-infective products). In the fourth quarter of 2017, we sold our equity share in Hisun Pfizer. As a result, effective in the first quarter of 2018, Hisun Pfizer-related revenues, previously reported in emerging markets within All Other LEP and All Other SIP are reported in emerging markets within Pfizer CentreOne.
(g)
Peri-LOE Products includesanti-infective products that have recently lost or are anticipated to soon lose patent protection. These products primarily include: Lyricanot individually listed above are recorded in Europe, Russia, Turkey, Israel and Central Asia; worldwide revenues for Celebrex, Pristiq, Zyvox, Vfend, Revatio and Inspra; and beginning in 2018, Viagra revenues for all countries (and Viagra revenues for all countries“All other than the U.S. and Canada in 2017, see note (c) above)Anti-infectives”.
(h)
Biosimilars includes Inflectra/Remsima (biosimilar infliximab) in the U.S. and certain international markets, Nivestim (biosimilar filgrastim) in certain European, Asian and Africa/Middle Eastern markets and in the U.S. and Retacrit (biosimilar epoetin zeta) in certain European and Africa/Middle Eastern markets.
(i)(e) 
2018 revenues for Medrol and Zithromax may not agree to previously disclosed revenues because revenues for those products were previously split between LEP and the legacy SIP categories. All revenues for these products are currently reported in the Hospital category.
(f)
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 Inc. In the fourth quarter of 2017, we sold our equity share in Hisun Pfizer. As a result, effective in the first quarter of 2018, Hisun Pfizer-related revenues, previously reported in emerging markets within legacy All Other LEP and legacy All Other SIP, are reported in emerging markets within Pfizer CentreOne.
(j)(g) 
We reclassified Inflectra/Remsima from the legacy Biosimilars category to the Inflammation & Immunology category to conform 2018 product revenues to the current presentation.
HIS (through February 2, 2017)(h)
Pfizer’s Upjohn business encompasses primarily off-patent branded and generic medicines that includes Medication Management Systems products composeda portfolio of infusion pumps20 globally recognized solid oral dose brands including Lyrica, Lipitor, Norvasc, Celebrex and related software and services,Viagra, as well as IV Infusion Products, including large volume IV solutionsa U.S.-based generics platform, Greenstone.
(i)
On July 31, 2019, Pfizer’s Consumer Healthcare business, an over-the-counter medicines business, was combined with GSK’s consumer healthcare business to form a new consumer healthcare joint venture. For additional information, see Note 1A and their associated administration sets.Note 2B.
(j)
Biosimilars are highly similar versions of approved and authorized biological medicines and primarily include revenues from Inflectra/Remsima and Retacrit.
(k)
Sterile Injectable Pharmaceuticals represents the total of all branded and generic injectable products in the Hospital business, including anti-infective sterile injectable pharmaceuticals.


REVIEW REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Review Report Of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholders of Pfizer Inc.:


Results of Review of Interim Financial Information
We have reviewed the condensed consolidated balance sheet of Pfizer Inc. and Subsidiary companiessubsidiaries (the Company) as of September 30, 2018,29, 2019, the related condensed consolidated statements of income, and comprehensive income and equity for the three-month and nine-month periods ended September 29, 2019 and September 30, 2018, and October 1, 2017, the related condensed consolidated statements of cash flows for the nine-month periods ended September 29, 2019 and September 30, 2018 and October 1, 2017 and the related notes (collectively, the consolidated interim financial information). Based on our reviews, we are not aware of any material modifications that should be made to the consolidated interim financial information for it to be in conformity with U.S. generally accepted accounting principles.
We have previously audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheet of the Company as of December 31, 20172018, and the related consolidated statements of income, comprehensive income, equity, and cash flows for the year then ended (not presented herein); and in our report dated February 22, 2018,28, 2019, we expressed an unqualified opinion on those consolidated financial statements. In our opinion, the information set forth in the accompanying condensed consolidated balance sheet as of December 31, 20172018 is fairly stated, in all material respects, in relation to the consolidated balance sheet from which it has been derived.
Basis for Review Results
This consolidated interim financial information is the responsibility of the Company’s management. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our reviews in accordance with the standards of the PCAOB. A review of consolidated interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with the standards of the PCAOB, the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.






/s/ KPMG LLP
New York, New York
November 8, 20187, 2019


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations


Introduction


See the Glossary of Defined Terms at the beginning of this Quarterly Report on Form 10-Q for terms used throughout this MD&A. Our MD&A is provided in addition to the accompanying condensed consolidated financial statements and footnotes to assist readers in understanding Pfizer’s results of operations, financial condition and cash flows. The MD&A is organized as follows:
Beginning on page 5754
 This section provides information about the following: Our Business; our performance during the third quarter and first nine months of 20182019 and 2017;2018; 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 2018.2019. 
Beginning on page 7169
 
This section discusses updates to our 20172018 Financial Report disclosures for those accounting policies and estimates that we consider important in understanding our consolidated financial statements. For additional discussion of our accounting policies, see Notes to Consolidated Financial Statements—Note 1. Basis of Presentation and Significant Accounting Policies.
 
Beginning on page 7270
 This section includes the following sub-sections: 
 
Beginning on page 7271
 This sub-section provides an overview of revenues by operating segment and geography as well as revenue deductionsdeductions. 
 
Beginning on page 7675
 This sub-section provides an overview of several of our biopharmaceutical products. 
 
Beginning on page 8281
 This sub-section provides an overview of important biopharmaceutical product developments. 
 
Beginning on page 85
 This sub-section provides a discussion about our costs and expenses. 
 
Beginning on page 88
 This sub-section provides a discussion of items impacting our tax provisions. 
 
Beginning on page 88
 This sub-section provides a discussion of an alternative view of performance used by management. 
Beginning on page 94
 This section provides a discussion of the performance of each of our operating segments. 
Beginning on page 102
 This section provides a discussion of changes in certain components of other comprehensive income. 
Beginning on page 102103
 This section provides a discussion of changes in certain balance sheet accounts. 
Beginning on page 104
 This section provides an analysis of our cash flows for the first nine months of 20182019 and 2017.2018. 
Beginning on page 105
 This section provides an analysis of selected measures of our liquidity and of our capital resources as of September 30, 201829, 2019 and December 31, 2017,2018, as well as a discussion of our outstanding debt and other commitments that existed as of September 30, 201829, 2019 and December 31, 2017.2018. 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 109
 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 111110
 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. Also included in this section is a discussion of legal proceedings and contingencies. 
Certain amounts in our MD&A may not add due to rounding. All percentages have been calculated using unrounded amounts.

The following table provides the components of the condensed consolidated statements of income:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS, EXCEPT PER COMMON SHARE DATA) September 30,
2018

 October 1,
2017

 
%
Change

 September 30,
2018

 October 1,
2017

 
%
Change

Revenues $13,298
 $13,168
 1
 $39,670
 $38,843
 2
             
Cost of sales(a)
 2,694
 2,844
 (5) 8,173
 7,972
 3
% of revenues 20.3% 21.6%  
 20.6% 20.5%  
             
Selling, informational and administrative expenses(a)
 3,494
 3,504
 
 10,448
 10,249
 2
% of revenues 26.3% 26.6%  
 26.3% 26.4%  
             
Research and development expenses(a)
 2,008
 1,865
 8
 5,549
 5,367
 3
% of revenues 15.1% 14.2%  
 14.0% 13.8%  
             
Amortization of intangible assets 1,253
 1,177
 6
 3,640
 3,571
 2
% of revenues 9.4% 8.9%  
 9.2% 9.2%  
             
Restructuring charges and certain acquisition-related costs 85
 114
 (26) 172
 267
 (36)
% of revenues 0.6% 0.9%  
 0.4% 0.7%  
             
Other (income)/deductions––net (414) 79
 *
 (1,143) 65
 *
Income from continuing operations before provision for taxes on income 4,177
 3,585
 17
 12,831
 11,351
 13
% of revenues 31.4% 27.2%  
 32.3% 29.2%  
             
Provision for taxes on income 66
 727
 (91) 1,270
 2,287
 (44)
Effective tax rate 1.6% 20.3%  
 9.9% 20.1%  
             
Income from continuing operations 4,111
 2,858
 44
 11,562
 9,064
 28
% of revenues 30.9% 21.7%  
 29.1% 23.3%  
             
Discontinued operations––net of tax 11
 
 *
 10
 1
 *
             
Net income before allocation to noncontrolling interests 4,122
 2,858
 44
 11,571
 9,066
 28
% of revenues 31.0% 21.7%  
 29.2% 23.3%  
             
Less: Net income attributable to noncontrolling interests 8
 18
 (53) 25
 32
 (22)
Net income attributable to Pfizer Inc. $4,114
 $2,840
 45
 $11,546
 $9,034
 28
% of revenues 30.9% 21.6%  
 29.1% 23.3%  
             
Earnings per common share––basic:
  
  
  
  
  
  
Income from continuing operations attributable to Pfizer Inc. common shareholders $0.70
 $0.48
 46
 $1.96
 $1.51
 29
Net income attributable to Pfizer Inc. common shareholders $0.70
 $0.48
 47
 $1.96
 $1.51
 29
             
Earnings per common share––diluted:
      
  
  
  
Income from continuing operations attributable to Pfizer Inc. common shareholders $0.69
 $0.47
 46
 $1.92
 $1.49
 29
Net income attributable to Pfizer Inc. common shareholders $0.69
 $0.47
 46
 $1.92
 $1.49
 29
             
Cash dividends paid per common share $0.34
 $0.32
 6
 $1.02
 $0.96
 6
* Calculation not meaningful or results are equal to or greater than 100%.
(a)
Excludes amortization of intangible assets, except as disclosed in Notes to Condensed Consolidated Financial Statements––Note 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets.



OVERVIEW OF OUR PERFORMANCE, OPERATING ENVIRONMENT, STRATEGY AND OUTLOOK


Our Business


We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products. Our global portfolio includesproducts, including innovative medicines and vaccines, as well as many of the world’s best-known consumer healthcare products.vaccines. We work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. We collaborate with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. Our revenues are derived from the sale of our products and, to a much lesser extent, from alliance agreements, under which we co-promote products discovered or developed by other companies or us (Alliance revenues).


WeAt the beginning of our 2019 fiscal year, we began to manage our commercial operations through two distincta new global structure consisting of three business segments: segments––Pfizer Innovative Health (IH)Biopharmaceuticals Group (Biopharma), Upjohn and Pfizer Essential Health (EH).through July 31, 2019, Consumer Healthcare. Biopharma and Upjohn are the only reportable segments. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Equity-Method Investment and Assets and Liabilities Held for Sale andNote 13A. Segment, Geographic and Other Revenue Information: Segment Information and the “Our Strategy––Commercial Operations” section of this MD&A below, including a discussion of our plans to reorganize our operations into three businesses effective at the beginning of fiscal 2019.below.

In October 2018, we announced our Board of Directors unanimously elected Dr. Albert Bourla, Pfizer Chief Operating Officer, to succeed Ian Read as Chief Executive Officer effective January 1, 2019. Ian Read will transition from his current role as Chairman and Chief Executive Officer to Executive Chairman of Pfizer’s Board of Directors.

The majority of our revenues come from the manufacture and sale of biopharmaceutical products. As explained more fully in our 20172018 Form 10-K, the biopharmaceutical industry is highly competitive and highly regulated. As a result, we face a number of industry-specific factors and challenges, which can significantly impact our results. These factors include, among others: the loss or expiration of intellectual property rights and the expiration of co-promotion and licensing rights, the ability to replenish innovative biopharmaceutical products, healthcare legislation, pipeline productivity, the regulatory environment, pricing and access pressures and competition. We also face challenges as a result of the global economic environment. For additional information about these factors and challenges, see the “Our Operating Environment” and “The Global Economic Environment” sections of this MD&A and of our 20172018 Financial Report and Part I, Item 1A, “Risk Factors” of our 20172018 Form 10-K and Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q.10-K.


The financial information included in our condensed consolidated financial statements for our subsidiaries operating outside the U.S. is as of and for the three and nine months ended August 26, 201825, 2019 and August 27, 2017.26, 2018. The financial information included in our condensed consolidated financial statements for U.S. subsidiaries is as of and for the three and nine months ended September 29, 2019 and September 30, 2018 and October 1, 2017.
References to developed and emerging markets in this MD&A include:
Developed marketsU.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, Eastern Europe, Africa, the Middle East, Central Europe and Turkey
References to operational variances in this MD&A pertain to period-over-period growth rates that exclude the impact of foreign exchange. The operational variances are determined by multiplying or dividing, as appropriate, our current period U.S. dollar results by the current period average foreign exchange rates and then multiplying or dividing, as appropriate, those amounts by the prior-year period average foreign exchange rates. Although exchange rate changes are part of our business, they are not within our control. Exchange rate changes, however, can mask positive or negative trends in the business; therefore, we believe presenting operational variances provides useful information in evaluating the results of our business.

On December 22, 2017, the U.S. enactedOur significant changes to U.S. tax law following the passage and signing of the TCJA. The TCJA is complex and significantly changes the U.S. corporate income tax system by, among other things, reducing the U.S. Federal corporate tax rate from 35% to 21%, transitioning U.S. international taxation from a worldwide tax system to a territorial tax system and imposing a repatriation tax on deemed repatriated accumulated post-1986 earnings of foreign subsidiaries. For information on estimates and assumptions in connection with the TCJA, see Notes to Condensed Consolidated Financial Statements––Note 5A. Tax Matters: Taxes on Income from Continuing Operations.
We continue to review strategic options for our Consumer Healthcare business. We remain disciplined regarding our capital allocation, and at this time we have not received an acceptable offer for the sale of this business. We will continue our

management of this strong business as we explore other alternatives, which could include everything from a full or partial separation of the business to ultimately deciding to retain the business. We continue to expect that any decision regarding strategic alternatives for our Consumer Healthcare business will be made during the fourth quarter of 2018.

Our other significantrecent business development activities include:
Formation of a New Consumer Healthcare Joint Venture––On July 31, 2019, we completed the transaction in which we and GSK combined our respective consumer healthcare businesses into a new consumer healthcare joint venture that operates globally under the GSK Consumer Healthcare name. The joint venture is a category leader in pain relief, respiratory and vitamins, minerals and supplements, and therapeutic oral health and is the largest global OTC consumer healthcare business.
Acquisition of Array BioPharma Inc.––On July 30, 2019, we acquired Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need, for $48 per share in cash. The total fair value of the consideration transferred for Array was approximately $11.2 billion ($10.9 billion, net of cash acquired). Our financial statements for the third quarter and first nine months of 2019 reflect the assets, liabilities, operating results and cash flows of Array, commencing from the acquisition date.
Agreement to Combine Upjohn with Mylan N.V.––On July 29, 2019, we announced that we entered into a definitive agreement to combine Upjohn with Mylan, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, Upjohn is expected to be spun-off or split-off to Pfizer’s shareholders and, immediately thereafter, combined with Mylan. Pfizer shareholders would own 57% of the combined new company, and former Mylan shareholders would own 43%. The transaction is expected to be tax free to Pfizer and Pfizer shareholders. The transaction is anticipated to close in mid-2020, subject to Mylan shareholder approval and satisfaction of other customary closing conditions, including receipt of regulatory approvals.

Acquisition of Therachon Holding AG––On July 1, 2019, we acquired all the remaining shares of Therachon for $340 million upfront, plus potential milestone payments of up to $470 million, contingent on the achievement of key milestones in the development and commercialization of the lead asset. The total fair value of the consideration transferred for Therachon was approximately $322 million. Our financial statements for the third quarter and first nine months of 2019 reflect the assets, liabilities, operating results and cash flows of Therachon, commencing from the acquisition date and, in accordance with our international reporting period, reflect two months of Therachon operations and cash flows.
On February 3, 2017, we completed the sale of Pfizer’s global infusion systems 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 initially valued at approximately $428 million (a portion of which we sold in August 2018), 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 our condensed consolidated statement of income and EH’s operating results through February 2, 2017 and, therefore, our financial results, and EH’s operating results, for the third quarter of 2017 do not reflect any contribution from HIS global operations, while our financial results, and EH’s operating results, for the first nine months of 2017 reflect approximately one month of HIS domestic operations and approximately two months of HIS international operations. Our financial results, and EH’s operating results, for 2018 do not reflect any contribution from HIS global operations.
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. for $1,040 million, composed of cash and contingent consideration. 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 financial results, EH’s operating results, and cash flows for the third quarter and first nine months of 2017 reflect approximately three months and eight months, respectively, of the small molecule anti-infectives business acquired from AstraZeneca. Our financial results, EH’s operating results, and cash flows for the third quarter and first nine months of 2018 reflect three months and nine months, respectively, of the small molecule anti-infective business acquired from AstraZeneca.
For additional information, see Notes to Condensed Consolidated Financial Statements––Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation, Notes to Condensed Consolidated Financial Statements––Note 2. Acquisition, Divestitures, Licensing Arrangements, Collaborative ArrangementsAcquisitions, Equity-Method Investment and PrivatelyAssets and Liabilities Held Investmentfor Sale and Research and Development Arrangement, and the “Our Strategy”Strategy––Commercial Operations” and the “Our Strategy––Our Business Development Initiatives” sections of this MD&A below.

Impact of Hurricanes in Puerto Rico

We have manufacturing and commercial operations in Puerto Rico, which were impacted by the hurricanes toward the end of the third quarter in 2017. While our three manufacturing sites sustained some damage and became inoperable due to issues impacting Puerto Rico overall, all three sites have resumed operations and remediation activities will continue through the remainder of the year. Given prior inoperability along with ongoing remediation of our sites, there could be certain product shortages in the coming months. Our commercial sales offices in Puerto Rico have been operational since October 2017.
Product Manufacturing

We periodically encounter difficulties or delays in manufacturing, including due to suspension of manufacturing or voluntary recall of a product, or legal or regulatory actions such as warning letters. For example, Hospira’s manufacturing facility in McPherson, Kansas is currently under the FDA inspection classification of Official Action Indicated (OAI). As a result of this classification, the FDA may refuse to grant premarket approval of applications and/or the FDA may refuse to grant export certificates related to products manufactured at our McPherson site until the site status is upgraded, which upgrade would be based on a re-inspection by the FDA. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of corrections implemented at the site. Communication with the FDA on the status of the McPherson site is ongoing. For additional information regarding the FDA inspection of the McPherson site, see Part I, Item 1A, “Risk Factors––Product Manufacturing, Sales and Marketing Risks” of our 2018 Form 10-K.

The product shortages we have been experiencing within our Essential Health portfolio are primarily for products from the legacy Hospira portfolio and are largely driven by capacity constraints, technical issues and supplier quality concerns. We continue to remediate issues at legacy Hospira facilities manufacturing sterile injectables within our Essential Health portfolio.injectables. Any continuing product shortage interruption at these manufacturing facilities could negatively impact our financial results, specifically in our SIPHospital portfolio. We continue to make progress on our comprehensive remediation plan to upgrade and modernize these facilities, and we expect our supply issues to be significantlysubstantially improved by the end of 2019.



Our Third Quarter 2019 Performance
Our 2018 Performance


Revenues


Revenues in the third quarter of 2018 increased $1302019 decreased $618 million, or 1%5%, compared to the same period in 20172018, which reflects an operational increasedecrease of $243$403 million, or 2%3%, partially offset byas well as the unfavorable impact of foreign exchange of $113$215 million, or 1%2%. Revenues in the first nine months of 2018 increased $8272019 decreased $609 million, or 2%, compared to the same period in 20172018, which reflects a favorablean unfavorable impact of foreign exchange of $693 million,$1.2 billion, or 2%3%, andpartially offset by an operational increase of $134 million.$586 million, or 1%.

The following provides an analysis of the changes in revenues for the third quarter and first nine months of 20182019:
(MILLIONS OF DOLLARS) Three Months
 Nine Months
Revenues, for the three and nine months ended October 1, 2017
 $13,168
 $38,843
  

  
Operational growth/(decline):    
Continued growth from key brands(a) and from recently launched products(b), as well as growth from Biosimilars(c)
 768
 2,172
Declines from the SIP portfolio (primarily in the U.S.), the Peri-LOE Products portfolio (excluding Viagra EH(d), which was impacted by the shift in the reporting of U.S. and Canada Viagra revenues to EH), total Viagra(d) (primarily in the U.S.), Enbrel (driven by declines in most developed Europe markets) and the LEP portfolio (primarily in developed markets)
 (508) (1,971)
Disposition-related impact of the February 2017 sale of HIS(e)
 
 (97)
Other operational factors, net (18) 29
Operational growth, net 243
 134
     
Operational revenues 13,410
 38,977
(Unfavorable)/favorable impact of foreign exchange (113) 693
Revenues, for the three and nine months ended September 30, 2018
 $13,298
 $39,670
(MILLIONS OF DOLLARS) Three Months
 Nine Months
Revenues, for the three and nine months ended September 30, 2018
 $13,298
 $39,670
  

  
Operational growth/(decline):    
Continued growth from certain key brands(a)
 621
 1,978
Higher revenues for Biosimilars, certain rare disease products and Inlyta primarily in the U.S.; and, in the nine months ended September 29, 2019, volume growth from Celebrex and Effexor, primarily in Japan and China
 200
 284
Decline from Lipitor and Norvasc in the third quarter of 2019 and growth from Lipitor in the first nine months of 2019, partially offset by decline from Norvasc (35) 37
Declines from Viagra and Pfizer’s authorized generic for Viagra in the U.S.; Enbrel internationally; Lyrica, primarily in the U.S., reflecting significant lower volume associated with multi-source generic competition that began in July 2019; Revatio and Relpax primarily in the U.S.; and in the third quarter of 2019, Prevnar 13/Prevenar 13 (897) (1,215)
Decline from Consumer Healthcare reflecting the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK (451) (462)
Growth/(decline) from the Hospital business 112
 (46)
Other operational factors, net 47
 10
Operational growth/(decline), net (403) 586
     
Operational revenues 12,895
 40,256
Unfavorable impact of foreign exchange (215) (1,194)
Revenues, for the three and nine months ended September 29, 2019
 $12,680
 $39,062
(a) 
Key brands represent Ibrance, Eliquis Ibrance,and Xeljanz Prevnar 13/Prevenar 13 and Xtandi, as well as, for the first nine months of 2018, Chantix/Champix.2019, Prevnar 13/Prevenar 13.
(b)
Growth from recently launched products include Eucrisa in the U.S., as well as Besponsa and Bavencio, primarily in the U.S. and developed Europe.
(c)
Growth from Biosimilars, primarily from Inflectra in certain channels in the U.S., as well as in developed Europe.
(d)
Viagra lost exclusivity in the U.S. in December 2017. Beginning in 2018, revenues for Viagra in the U.S. and Canada, which were reported in IH through 2017, are reported in EH (which reported all other Viagra revenues excluding the U.S. and Canada through 2017). Therefore, beginning in 2018, total Viagra revenues are reported in EH. Total Viagra revenues in 2017 represent the aggregate of worldwide revenues from Viagra IH and Viagra EH.
(e)
Impact on financial results for the sale of HIS in February 2017. The first nine months of 2018 do not reflect any contribution from HIS global operations, compared to approximately one month of HIS domestic operations and approximately two months of HIS international operations in the same period in 2017.
For worldwide revenues and revenues by geography, for selected products, see the discussion in the “Analysis of the Condensed Consolidated Statements of Income––Revenues and Product Developments––Revenues––Selected Product Discussion” section of this MD&A. For additional information regarding the primary indications or class of certain products, see Notes to Condensed Consolidated Financial Statements––Note 13C. Segment, Geographic and Other Revenue Information: Other Revenue Information.
See the “Analysis of the Condensed Consolidated Statements of Income––Revenues and Product Developments––Revenues by Operating Segment and Geography” section below for more information, including a discussion of key drivers of our revenue performance.


Income from Continuing Operations Before Provision for Taxes on Income
The following provides an analysis of the increase in Income from continuing operations before provision for taxes on income for the third quarter and first nine months of 20182019:
(MILLIONS OF DOLLARS) Three Months
 Nine Months
Income from continuing operations before provision for taxes on income, for the three and nine months ended October 1, 2017
 $3,585
 $11,351
Favorable change in revenues 130
 827
Favorable/(unfavorable) changes:  

Higher net gains recognized during the period on investments in equity securities(a)
 49
 349
Impact of net periodic benefit costs/(credits) other than service costs(a)
 93
 313
Higher income from collaborations, out-licensing arrangements and sales of compound/product rights(a)
 61
 292
Impact of certain legal matters, net(a)
 146
 264
Lower certain asset impairments(a)
 131
 103
Impact of Cost of sales(b)
 149
 (202)
Impact of Selling, information and administrative expenses(c)
 10
 (198)
Higher Research and development expenses(d)
 (144) (182)
Higher Amortization of intangible assets(e)
 (76) (69)
All other items, net 43

(17)
Income from continuing operations before provision for taxes on income, for the three and nine months ended September 30, 2018
 $4,177

$12,831
(MILLIONS OF DOLLARS) Three Months
 Nine Months
Income from continuing operations before provision for taxes on income, for the three and nine months ended September 30, 2018
 $4,177
 $12,831
Unfavorable change in revenues (618) (609)
Favorable/(unfavorable) changes:  

Gain on completion of Consumer Healthcare JV transaction in 2019 8,087
 8,087
Lower Cost of sales(a)
 92
 562
Lower Selling, information and administrative expenses(b)
 234
 338
Favorable change in the fair value of contingent consideration(c)
 101
 226
Higher royalty-related income(c)
 12
 115
Lower Amortization of intangible assets(c)
 42
 61
Income from insurance recoveries related to Hurricane Maria(c)
 
 50
Non-recurrence of gain on equity investment in Cerevel(c)
 (343) (343)
Higher business and legal entity alignment costs(c)
 (86) (337)
Lower income from collaborations, out-licensing arrangements and sales of compound/product rights(c)
 (119) (331)
Lower net gains recognized during the period on investments in equity-securities(c)
 (79) (307)
Higher Research and development expenses(d)
 (275) (278)
Higher net interest expense(c)
 (120) (267)
Unfavorable change in certain legal matters, net(c)
 (28) (154)
Higher asset impairment charges(c)
 (28) (148)
Higher net losses on early retirement of debt(c)
 
 (134)
Higher Restructuring charges and certain acquisition-related costs(e)
 (280) (123)
Lower net periodic benefit credits other than service costs(c)
 (46) (121)
Higher transaction and advisory costs to separate our Consumer Healthcare business(c)
 (81) (58)
Non-recurrence of gain on the contribution of Pfizer’s CAR T assets(c)
 
 (50)
All other items, net 83

180
Income from continuing operations before provision for taxes on income, for the three and nine months ended September 29, 2019
 $10,727

$19,190
(a) 
See the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions—Net.
(b)
See the “Costs and Expenses––Cost of Sales” section of this MD&A.
(c)(b) 
See the “Costs and Expenses––Selling, Informational and Administrative (SI&A) Expenses” section of this MD&A.
(c)
See the Notes to Condensed Consolidated Financial Statements––Note 4. Other (Income)/Deductions—Net.
(d) 
See the “Costs and Expenses––Research and Development (R&D) Expenses” section of this MD&A.
(e) 
See the “Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” section of this MD&A.
(f)
See the “Costs and Expenses––Amortization of Intangible Assets” section of this MD&A.
For information on our tax provision and effective tax rate see the “Provision for Taxes on Income” section of this MD&A and Notes to Condensed Consolidated Financial Statements––Note 5. Tax Matters.


Our Operating Environment
Industry-Specific Challenges


Intellectual Property Rights and Collaboration/Licensing Rights


The loss, expiration or invalidation of intellectual property rights, patent litigation settlements with generic manufacturers and the expiration of co-promotion and licensing rights can have a significant adverse effect on our revenues. Many of our branded products have multiple patents that expire at varying dates, thereby strengthening our overall patent protection. However, once patent protection has expired or has been lost prior to the expiration date as a result of a legal challenge, we typically lose exclusivity on these products, and generic and biosimilar pharmaceutical manufacturers generally produce similar products and sell them for a lower price. The date at which generic competition commences may be different from the date that the patent or regulatory exclusivity expires. However, when generic competition does commence, the resulting price competition can

substantially decrease our revenues for the impacted products, often in a very short period of time. Also, if one of our patents is found to be invalid by judicial, court or administrative proceedings, such as inter partesreview, post-grant review, re-examination or opposition proceedings, before the U.S. Patent and Trademark Office, the European Patent Office, or other foreign counterparts, generic or competitive products could be introduced into the market resulting in the erosion of sales of our existing products. For example, several of the patents in our pneumococcal vaccine portfolio were challenged in inter partes review and post-grant review proceedings in the U.S. The Patent Trial and Appeal Board refused to initiate proceedings as to two patents. In June 2018, the Patent Trial and Appeal Board ruled on oneanother patent, holding that one claim was valid and that all other claims were invalid. The party challenging that patent has appealed the decision. In March and June 2019, an additional patent was found invalid in separate proceedings by the Patent Trial and Appeal Board. We have appealed. Challenges to other patents remain pending beforein jurisdictions outside the U.S. Patent and Trademark Office. The invalidation of theseall of the patents in our pneumococcal portfolio could potentially allow a competitor pneumococcal vaccine into the marketplace. In the event that any of the patents are found valid and infringed, a competitor pneumococcal vaccine might be prohibited from entering the market or required to pay Pfizer a royalty.
AsA number of our current products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years. For example, as a result of a patent litigation settlement, Teva Pharmaceuticals USA, Inc. launched a generic version of Viagra (a product in our Upjohn business) in the U.S. in December 2017. Lyrica (a product in our Upjohn business) lost patent protection in the U.S. in June 2019 and multi-source generic competition began in July 2019. Additional patent expiries will continue over several years, and we expect the impact of reduced revenues due to patent expiries will be significant in the rest of 2019 and in 2020, then moderating downward to a much lower level from 2021 through 2025.

Our biologic products, including BeneFIX, ReFacto, Xyntha, Bavencio, Prevnar 13/Prevenar 13 and Enbrel (we market Enbrel outside the U.S. and Canada), may face in the future, or already face, competition from biosimilars (also referred to as follow-on biologics). If competitors are able to obtain marketing approval for biosimilars referencing our biologic products, our biologic products may become subject to competition from these biosimilars, with attendant competitive pressure, and price reductions could follow. For example, Enbrel faces ongoing biosimilar competition in most developed Europe markets. The expiration or successful challenge of applicable patent rights could trigger this competition, assuming any relevant regulatory exclusivity period has expired.
See the “Intellectual Property Rights and Collaboration/Licensing Rights” section of our 20172018 Financial Report for additional information about (i) recent losses and expected losses of product exclusivity in the U.S., Europe and/or Japan impacting product revenues and (ii) recent losses of collaborationrevenues.

For additional information, including the patent rights impacting alliance revenues.


We lost or expectwe consider most significant in relation to lose exclusivity for various other productsour business as a whole, together with the year in various markets over the next few years, including, among others, the expiration ofwhich the basic product patent for Lyrica in the U.S. in December 2018. Pfizer is currently pursuing a six-month patent-term extension for pediatric exclusivity for Lyrica in the U.S. with the FDA.

For additional information,expires, see the “Patents and Other Intellectual Property Rights” section in Part I, Item 1, “Business” of our 20172018 Form 10-K.
We will continue to aggressivelyvigorously defend our patent rights whenever we deem appropriate. For a discussion of certain recent developments with respect to patent litigation, see Notes to Condensed Consolidated Financial Statements––Note 12A1. Contingencies and Certain Commitments: Legal Proceedings––Patent Litigation.
Regulatory Environment/Pricing and Access––U.S. Healthcare Legislation


In March 2010, the ACA was enacted in the U.S. For additional information, see the “Government Regulation and Price Constraints” section in Part I, Item 1, “Business” of our 20172018 Form 10-K.
We recorded the following amounts as a result of the U.S. Healthcare Legislation:
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

 September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Reduction to Revenues, related to the Medicare “coverage gap” discount provision
 $217
 $157
 $435
 $296
 $307
 $217
 $596
 $435
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. The first nine months of 2018 also reflected a favorable true-up associated with the updated 2017 invoice received from the federal government, which reflected a lower expense than what was previously estimated for invoiced periods.
 43
 87
 118
 218
 52
 43
 173
 118


Regulatory Environment/Pricing and Access––Government and Other Payer Group Pressures
The pricing of medicines by pharmaceutical manufacturers and the cost of healthcare, which includes medicines, medical services and hospital services, continues to be important to payers, governments, patients, and other stakeholders. We believe that medicines are amongst the most powerful tooltools for patients in curing, treating and preventing illness and disability, and that all patients should have appropriate access to the medicines their doctors prescribe. We may consider a number of factors when determining a medicine’s price, including, for example, its impact on patients and their disease, other available treatments, the medicine’s potential to reduce other healthcare costs (such as hospital stays), and affordability. Within the U.S., in particular, we may also engage with patients, doctors and healthcare plans regarding their views. We also negotiate with insurers, including PBMs and MCOs, often providing significant discounts to them from the initiallist price. The price that patients pay in the U.S. for the medicines their physicians prescribe is ultimately set by healthcare providers and insurers. On average, in the U.S., insurers coverimpose a much lower share of prescription drug costs than medical services, which results in a greater proportion ofhigher out-of-pocket costs being passedburden on to patients for prescription medicines thereby making them less accessible and affordable.than for comparably-priced medical services. We will continue to work with insurance providers, governments and others to improve access to today’s innovative treatments.
Governments, MCOs and other payer groups continue to seek increasing discounts on our products through a variety of means, such as leveraging their purchasing power, implementing price controls, and demanding price cuts (directly or by rebate actions). In Europe, Japan, China, Canada, South Korea and some other international markets, governments provide healthcare at low-to-zero direct cost to consumers at the point of care and have significant power as large single payers to regulate pharmaceutical prices or patient reimbursement levels to control costs for the government-sponsored healthcare system, particularly under recent global economic pressures.
In response to the evolving U.S. and global healthcare spending landscape, we continue to work with health authorities, health technology assessment and quality measurement bodies and major U.S. payers throughout the product-development process to better understand how these entities value our compounds and products. Further, we seek to develop stronger internal capabilities focused on demonstrating the value of the medicines that we discover or develop, register and manufacture, by recognizing patterns of usage of our medicines and competitor medicines along with patterns of healthcare costs.

U.S.––In the U.S., government action to reduce federal spending on entitlement programs including Medicare and Medicaid may affect payment for our products or services provided using our products. Any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented could have an adverse impact on our results of operations. Significant Medicare reductions could also result if Congress proceeds with certain proposals to convert the Medicare fee-for-service program into a premium support program, or Congress chooses to implement the recommendations made annually by the Medicare Payment Advisory Commission, which are primarily intended to extend the fiscal solvency of the Medicare program.
Consolidation among MCOs has increased the negotiating power of MCOs and other private insurers.third-party payers. Private third-party insurers,payers, as well as governments, increasingly employ formularies to control costs by negotiating discounted pricestaking into account discounts in exchange

forconnection with decisions about formulary inclusion.inclusion or favorable formulary placement. Failure to obtain or maintain timely or adequate pricing or favorable formulary placement for our products, or obtainingfailure to obtain such pricing orformulary placement at unfavorablefavorable pricing, could adversely impact revenue.
Efforts by government officials or legislators to implement measures to regulate prices or payment for pharmaceutical products, including legislation on drug importation, could adversely affect our business if implemented. Recently, there has beenThere continues to be considerable public and government scrutiny of pharmaceutical pricing and proposalsmeasures to address the perceived high cost of pharmaceuticals. Therepharmaceuticals are being considered by Congress, the Presidential Administration and select states. In addition to new state transparency laws and the introduction of several Federal pricing bills, we have also been state legislative efforts to address drug costs, which generally have focused on increasing transparency around drug costs or limiting drug prices. Certain state legislation has been subject to legal challenges.
Adoptionseen the inclusion of new pricing rules in continuing resolutions such as the treatment of authorized generics in the calculation of average manufacturer price. We expect to see continued focus in regulating pricing resulting in additional legislation at the federal or state levelthat could further affect demand for, or pricing of, our products. adversely impact revenue.
We believe medicines are the most efficient and effective use of healthcare dollars based on the value they deliver to the overall healthcare system. We will continue to work with law makers and advocate for solutions that effectively improve patient health outcomes, lower costs to the healthcare system, and ensure access to medicines within an efficient and affordable healthcare system.
There have been significant efforts at the federal and state levels to reform the healthcare system by enhancing access to healthcare, improving the delivery of healthcare and further rationalizing payment for healthcare. We face uncertainties due to federal legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the ACA. The likelihood of such a repeal currently appears lowThere is additional uncertainty given the recentDecember 2018 ruling in Texas v. Azar to invalidate the law as unconstitutional, and the subsequent decision by the U.S. Department of Justice not to defend the law. At this time, the law remains in effect pending appeals of the decision. Given the outcomes of the 2018 U.S. midterm elections which resulted in Democratic control ofwith Democrats taking over the U.S. House of Representatives. AlthoughRepresentatives and Republicans growing their majority in the U.S. Senate, we believe it is unlikely Congress will find bipartisan consensus to advance any significant changes to the ACA until the legal process unfolds. The revenues generated for Pfizer by the health insurance exchanges and Medicaid expansion under the ACA are minor, therenot material, so the impact of the change in law and similar recent Presidential Administration actions is no assurance that anyexpected to be limited. Any future replacement,

modification or repeal of the ACA will notmay adversely affect our business and financial results, particularly if the legislation reduces incentives for employer-sponsored insurance coverage. We also may face uncertainties if our industry is looked to for savings to fund certain legislation, such as lifting the debt ceiling. One recentAs another example, is the Bipartisan Budget Act of 2018, which increased the discount we pay in the Medicare Part D “coverage gap” from 50% to 70%, which will modestly reduceincrease our future Medicare Part D revenues.
In May 2018, President Trump released his Blueprint to Lower Drug Pricesrebates. Any future healthcare reform efforts may adversely affect our business and Reduce Out-of-Pocket Costs (Blueprint). Pfizer communicated a formal response to the request for information that accompanied the Blueprint, and is participating in the subsequent rule-making process to advance the proposals that are most likely to bring meaningful out-of-pocket cost relief to patients. Certain proposals in the Blueprint, and related drug pricing measures proposed since the Blueprint, could cause significant operational and reimbursement changes for the pharmaceutical industry. On July 10, 2018, Pfizer decided to defer price increases that were effective July 1, 2018, and return those prices to their pre-July 1, 2018 levels. In addition, the price declines that we took as of July 1, 2018 remain in effect.financial results.
The potential for additional pricing and access pressures in the commercial sector continues to be significant. SomeMany employers seeking to avoid the tax on high-cost health insurance in the ACA to be imposed in 2022, are already scaling back healthcare benefits and an increasing number are implementinghave adopted high deductible benefit designs.health plans, which can increase out-of-pocket costs for medicines. This is a trend that is likely to continue. Private third-party payers, such as health plans, increasingly challenge pharmaceutical product pricing, which could result in lower prices, lower reimbursement rates and a reduction in demand for our products. Pricing pressures for our products may occur as a result of highly competitive insurance markets. Healthcare provider purchasers, directly or through group purchasing organizations, are seeking enhanced discounts or implementing more rigorous bidding or purchasing review processes.
Overall, there is increasing pressure on U.S. providers to deliver healthcare at a lower cost and to ensure that those expenditures deliver demonstrated value in terms of health outcomes. Longer term, we are seeing a shift in focus away from fee-for-service payments towards outcomes-based payments and risk-sharing arrangements that reward providers for cost reductions.reductions and improved patient outcomes. These new payment models can, at times, lead to lower prices for, and restricted access to, new medicines. At the same time, these models can also expandpromote utilization of drugs by encouraging physicians to screen and diagnose and focus on outcomes.consider drugs as a means of forestalling more costly medical interventions.
Outside the U.S.,U.S.––Certain governments, including the different EU Member States, China, Japan, Canada and Canada,South Korea, have significant power as large single payers to regulate prices and may use a variety of cost-containment measures for our pharmaceutical products, including price cuts, mandatory rebates, public or private health technology assessments, forced localization as a condition of market access and international reference pricing (i.e., the practice of a country linking its regulated medicine prices to those of other countries). ThisAs a result, we expect that such pressures on the pricing component of operating results will continue. In addition, the international patchwork of price regulation and differing economic conditions and incomplete value assessments across countries has led to different prices in different countries, varying health outcomes and some third-party trade in our products between countries.
In particular, international reference pricing adds to the regional impact of price cuts in individual countries and hinders patient access and innovation. Price variations, exacerbated by international reference pricing systems, also have resulted from exchange rate fluctuations. The downward pricing pressure resulting from this dynamic can be expected to continue as a result of reforms to international reference pricing policies and measures targeting pharmaceuticals in some European countries.
In addition, several important multilateral organizations, such as the United Nations (UN), including the World Health Organization (WHO), and the Organization for Economic Cooperation and Development (OECD), are increasing scrutiny of international pharmaceutical pricing through issuing reports and policy recommendations (e.g.recommendations. In 2019, the WHO continued exerting pressure on pharmaceutical pricing practices by supporting strategies to reduce medicine prices, including calling for greater transparency around the cost of research and development and production of medicines, as well as disclosure of net prices.
In China, healthcare is largely driven by a public payer system, with public medical insurance as the largest single payer for pharmaceuticals, and pricing pressures have increased in recent years. Government officials have consistently emphasized the importance of improved health outcomes, the need for healthcare reform and decreased drug prices as key indicators of progress towards reform. While the government provides basic health insurance for the vast majority of Chinese citizens, that insurance is not adequate to cover many innovative medicines, and alternative funding sources for innovative medicines remain suboptimal.

In 2017 and 2018, China’s government negotiated with companies to add approximately 60 innovative drugs (mainly oncology medicines) to the National Reimbursement Drug List. Prices for drugs were reduced dramatically through this government-led process. While these negotiations included a path to access for companies, market access is not assured. In addition, significant questions about the processes and negotiations for provincial tendering remain, as well as the need for multi-layered negotiations across provincial, municipal and hospital levels.

In the off-patent space, in 2013, China began to implement a quality consistency evaluation (QCE) process in order to improve the quality of domestically-manufactured generic drugs, primarily by requiring such drugs to pass a test to assess their bioequivalence to a qualified reference drug (typically the originator drug). In 2018, numerous local generics were officially deemed bioequivalent under QCE. A pilot project for centralized volume-based procurement was then initiated including 25 molecules of drugs covering 11 major Chinese cities. Under this procurement model, a tender process has been established where a certain portion of included molecule volumes are guaranteed to tender winners. The program is intended to contain

healthcare cost by driving utilization of generics that have passed QCE, which has resulted in dramatic price cuts for off-patent medicines.

Upjohn and most off-patent originators were not successful in the first bidding process, which was finalized in December 2018 and implemented in March 2019, and those contracts went to local generic companies. The first bidding process resulted in significant price cuts by the successful bidders, with some reducing the price of their products by as much as 96%, 2016 UN High Level Panel Reportas companies attempted to secure volumes of the Chinese pharmaceutical market. The drugs which lost the bidding were also requested to reduce their selling price up to 30% based on Accessthe price difference with the successful bidder. In July 2019, China’s government announced a plan for a nationwide expansion of the volume-based procurement model, which was finalized in September 2019 and will be implemented in late 2019 or early 2020. The expanded model allows for as many as three successful bidders and includes an additional 25 provinces and regions, and applies to Medicines certain drugs that are purchased for public hospitals as well as some military and 2017 OECD Report private medical institutions. Our Upjohn business unit and most originator brands were not successful in the bidding process for this nationwide expansion, and those contracts mostly went to local Chinese generic companies. The QCE-qualified generic makers of atorvastatin and amlodipine bid aggressively, lowering prices even further from the March 2019 tender. Our Upjohn business unit continues to take steps to mitigate the revenue impact of these initiatives but anticipates that they will continue to affect our Upjohn business in China going forward. We expect to utilize our presence in the retail channel and tendering capabilities to mitigate some of these pricing pressures. In addition, we believe that our geographic expansion to under-penetrated and lower-tiered cities and counties and additional focus on New Health Technologies––Managing Access, Valuenon-tendered products will increase sales volumes in greater China and Sustainability).partially mitigate pressures from QCE.

Furthermore, the Chinese government has discussed moving toward efforts to unify the reimbursement price between QCE-approved generic medicines and the applicable original medicines. The recommendations from these reportsgovernment currently plans to implement this universal reimbursement price initiative within the next two to three years. If this policy is implemented, the new reimbursement level for Upjohn’s products will likely be lower than the current reimbursement level, placing additional pressures on price and/or patient copays. There remains uncertainty as to whether, when and how this policy may be officially implemented. The Chinese government could also enact other policies that may increase pricing pressures or have the effect of reducing the volume of sales available to Upjohn’s products. This potential policy, and any other recommendationspolicies like it that could increase pricing and copay pressures on Upjohn’s drug products in China, could have an adverse effect on our business, financial condition and results of operations. The government has indicated that additional post-LOE drugs could be subjected to QCE qualification in future rounds, which could also be tied to volume-based procurement. The scope of future QCE products is currently unknown and while it may impact our business in China, we do not believe it will be made in the futuresignificant to Pfizer’s business and financial condition. We will continue to exert additional pricing pressures.monitor the market for developments.

In response to the evolving U.S. and global healthcare spending landscape, we are continuing to work with health authorities, health technology assessment and quality measurement bodies and major U.S. payers throughout the product-development process to better understand how these entities value our compounds and products. Further, we are seeking to develop stronger internal capabilities focused on demonstrating the value of the medicines that we discover or develop, register and manufacture, by recognizing patterns of usage of our medicines and competitor medicines along with patterns of healthcare costs.
For additional information, see the “Regulatory Environment––Pipeline Productivity” and “Competition” sections of our 20172018 Financial Report.Report and the “Government Regulation and Price Constraints” section in Part I, Item 1, “Business” of our 2018 Form 10-K.
The Global Economic Environment


In addition to the industry-specific factors discussed above, we, like other businesses of our size, are exposed to the economic cycle, which impacts our biopharmaceutical operations globally.
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 or biosimilar products, delay treatments, skip doses or use less effective treatments. GovernmentAs discussed above, 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,the different EU Member States, 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.
Significant portions of our revenues, costs and expenses, 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 earnings, and our overall expenses would increase, having a negative impact on earnings. Conversely, if the U.S. dollar were to strengthen against another currency, assuming all other variables remained constant, our revenues would decrease, having a negative

impact on earnings, and our overall expenses would decrease, having a positive impact on earnings. Therefore, significant changes in foreign exchange rates can impact our results and our financial guidance.
The impact of possible currency devaluations in countries experiencing high inflation rates or significant exchange fluctuations, including Venezuela and Argentina, can impact our results and financial guidance. For further information about our exposure to foreign currency risk, see the “Analysis of Financial Condition, Liquidity and Capital Resources” and the “Our Financial Guidance for 20182019” sections of this MD&A.
In June 2016, the U.K. electorate voted in a referendum to leave the EU, which is commonly referred to as “Brexit”. 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. Formal negotiations officially started in June 2017. ThisAfter multiple votes in the British Parliament in 2019 failing to approve a Brexit withdrawal agreement with the EU, the EU has agreed in principle to extend the date of the U.K.’s withdrawal until January 31, 2020, or earlier in the event the current proposed Brexit withdrawal agreement is agreed and approved by both U.K. and EU parliaments. A General Election will now be held on December 12, 2019. The outcome of the election on the Brexit process, continuesand the consequences of the U.K. leaving the EU (when or if that happens), also continue to be highly complex and the end result of these negotiationsuncertain, which may pose certain implications to our research, commercial and general business operations in the U.K. and the EU, including the approval and supply of our products. The EMA announced in November 2017 thatAt present, it is still unclear whether and to what extent the U.K. will remain within or aligned to the EU system of medicines regulation, depending on the ultimate outcome of the negotiations. However, both the U.K. and the EU have issued detailed guidance for the industry on how medicines, medical devices and clinical trials will be relocating from London, U.K. to Amsterdam, Netherlands byseparately regulated in their respective territories in the expected dateevent of Brexit in March 2019.a ‘hard Brexit’, meaning an outcome where no negotiated settlement is reached.
We generated approximately 2% of our worldwide revenues from the U.K. in 20172018 and in the first nine months of 20182019, including the foreign currency exchange impact from the weakening U.K. pound relative to the U.S. dollar to date. We recognize that there are still significant uncertainties surrounding the ultimate resolution of Brexit negotiations, and we will continue to monitor any changes that may arise and assess their potential impact on our business.
Pfizer’s preparations for Brexit, including for a ‘hard Brexit’, are well advanced to make the changes necessary to meet all relevant requirements in the EU legal requirements afterand the U.K. is no longer a member state,after Brexit, especially in the regulatory, research, manufacturing and supply chain areas. The principal aim is to ensure the continuity of supply to patients in Europe (EU and the U.K.) and other global markets impacted by these changes. TheBetween 2018 and 2021, we now expect to spend up to approximately $60 million in one-time costs of makingto make these adaptations are currently estimated at approximately $100 million.
On December 22, 2017, the U.S. enacted significant changes to U.S. tax law following the passage and signing of the TCJA. The TCJA is complex and significantly changes the U.S. corporate income tax system by, among other things, reducing the U.S. Federal corporate tax rate from 35% to 21%, transitioning U.S. international taxation from a worldwide tax system to a

territorial tax system and imposing a repatriation tax on deemed repatriated accumulated post-1986 earnings of foreign subsidiaries. Given the significant changes resulting from and complexities associated with the TCJA, the estimated financial impacts for 2017, as well as the estimated impact on 2018 financial guidance for the effective tax rate on adjusted income remain provisional and subject to further analysis, interpretation and clarification of the TCJA, which could result in further changes to these estimates during the fourth quarter of 2018. For additional information, see the “Our Financial Guidance for 2018”, “Provision for Taxes on Income” and “Analysis of Financial Condition, Liquidity and Capital Resources” sections of this MD&A and Notes to Condensed Consolidated Financial Statements––Note 5A. Tax Matters: Taxes on Income from Continuing Operations.adaptations.
Pfizer maintains a strong financial position while operating in a complex global environment. Due to our significant operating cash flows, financial assets, access to capital markets and available lines of credit and revolving credit agreements, we continue to believe that we have, and will maintain, the ability to meet our liquidity needs for the foreseeable future. Our long-term debt is rated high quality by both S&P and Moody’s. As market conditions change, we continue to monitor our liquidity position. We have taken and will continue to take a conservative approach to our financial investments. Both short-term and long-term investments consist primarily of high-quality, highly liquid, well-diversified, available-for-sale debt securities. For further discussion of our financial condition and credit ratings, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this MD&A.
These and other industry-wide factors that may affect our businesses should be considered along with information presented in the “Forward-Looking Information and Factors That May Affect Future Results” section of this MD&A and in Part I, Item 1A, “Risk Factors” of our 20172018 Form 10-K and Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q.10-K.


Our Strategy


We believe that our medicines provide significant value for both healthcare providers and patients, not only from the improved treatment of diseases but also from a reduction in other healthcare costs, such as emergency room or hospitalization costs, as well as improvements in health, wellness and productivity. We continue to actively engage in dialogues about the value of our medicines and how we can best work with patients, physicians and payers to prevent and treat disease and improve outcomes. We continue to work within the current legal and pricing structures, as well as continue to review our pricing arrangements and contracting methods with payers, to maximize patient access and minimize any adverse impact on our revenues. We remain firmly committed to fulfilling our companys purpose of innovating to bring therapies to patientscompany’s purpose: Breakthroughs that extend and significantly improve their lives.change patients’ lives. By doing so, we expect to create value for the patients we serve and for our colleagues and shareholders.
Organizing for Growth
We believe we have one of the strongest pipelines in over a decade, and believe we are well positioned for future growth. Additional patent expiries will continue over several years, and we expect higherthe impact of reduced revenues due to patent expiries will be significant in the rest of 2019 and more sustained growth post-2020 after our near-term patent expirations occur. Therefore, in July 2018,2020, then moderating downward to a much lower level from 2021 through 2025. This confluence of events has given us an opportunity to look at and refine how we announced that we will organize our company into three businesses effective atbusiness to best achieve sustainable growth and to deliver our medicines and vaccines to the maximum number of people who need them.

At the beginning of our fiscal year 2019, fiscal year. we began to manage our commercial operations through a new global structure consisting of three businesses, each led by a single manager—Pfizer Biopharmaceuticals Group (Biopharma), Upjohn and, through July 31, 2019, Pfizer’s Consumer Healthcare business. We designed this new global structure to take advantage of new growth opportunities driven by the evolving and unique dynamics of relevant markets.
See the “Commercial Operations” section below for additional information about each business.
We also reorganized our R&D operations as part of our Organizing for Growth reorganization:
The former Worldwide, Research and Development organization is renamed Worldwide Research, Development and Medical (WRDM) as we have created a new Worldwide Medical & Safety organization in WRDM that incorporates the former Chief Medical Office as well as the Worldwide Safety function;
The R&D organization within our former Essential Health business has been integrated into the WRDM, GPD and Upjohn organizations, including moving biosimilars into WRDM and GPD and realigning them with the relevant therapeutic areas (e.g., Oncology and Inflammation & Immunology);
The Regulatory function has been moved from the WRDM organization into the GPD organization; and
Late-stage portfolio spend has been moved from our former Innovative Health business to GPD and from our former Essential Health business to GPD and Upjohn.
We re-aligned our commercial operations in 2019 for a number of reasons, including:
Bringing biosimilars into our Oncology and Inflammation & Immunology therapeutic categories gives us the potential to leverage our R&D, regulatory and commercial infrastructure within the Biopharma business to more efficiently bring those assets to market;
Creating a business unit (i.e., the Hospital unit within Biopharma) that is solely focused on medicines that are used in hospitals can potentially bring greater focus and attention to serving those customers and developing those relationships;
Giving Upjohn more autonomy with a focus on maximizing the value of its products, particularly in emerging markets, provides it the opportunity to operate as a standalone business within Pfizer with the potential for sustainable modest growth; and
We believe thethis new structure better positions each business to achieve its growth potential:
potential as we transition to a science-based Innovative Medicines business, which will include allperiod post-2020 where we expect higher and more sustained revenue growth due to declining LOEs and the potential of our current Innovative Healthlate-stage pipeline.
Biopharma seeks to leverage a strong pipeline, organize around operational growth drivers, and capitalize on trends creating long-term growth opportunities, including:
an aging global population that is generating increased demand for innovative medicines that address patients’ unmet needs;
advances in both biological science and vaccinesdigital technology that are enhancing the delivery of breakthrough new medicines; and
the increasingly significant role of hospitals in healthcare systems.
Urbanization and the rise of the middle class in emerging markets, particularly in Asia, provide growth opportunities for the Upjohn business. Our ability to work collaboratively within local markets and to be fast, focused and flexible is intended to position this business unitsto seize these opportunities. Upjohn has distinct and dedicated manufacturing, marketing, regulatory and, subject to limited exceptions, enabling functions that report directly into the business providing autonomy and positioning Upjohn to operate as well as biosimilarsa true stand-alone division. We created this new structure to, among other things, position Upjohn to optimize its distinct growth potential and provide us with the flexibility to access further opportunities to enhance value.
Subsequent to the re-alignment of our commercial operations in 2019, on July 29, 2019, we announced that we entered into a definitive agreement to combine Upjohn with Mylan, creating a new Hospital Medicines business unit thatglobal pharmaceutical company. We believe the new company will commercialize our globaltransform and accelerate Upjohn’s and Mylan’s ability to serve patients’ needs and expand their capabilities across more than 165 markets. The combination will drive a sustainable, diverse and differentiated portfolio of sterile injectableprescription medicines, complex generics, over-the-counter products and anti-infective medicines;
an off-patent brandedbiosimilars supported by commercial and generic Established Medicines business;regulatory expertise, established infrastructure, R&D capabilities and
a Consumer Healthcare business, for which we continue to evaluate strategic alternatives, with a decision expected in the fourth quarter of 2018.
These changes will not be effective until the beginning of our 2019 fiscal year to allow for the necessary internal transition process. We are currently evaluating the impact to our operating segments manufacturing and other costs and activities based on how the businesses will be managed in 2019. Beginning with our first-quarter 2019 financial results, our financial reporting will reflect the new organizational structure.supply chain excellence.
As we prepare for expected growth, we are focused on creating a simpler, more efficient structureorganization by streamlining structures, processes and governance within each business and the functions that support them. Further, asAs our innovative pipeline matures with thebased on anticipated progression of current trials and the initiation of new pivotal trials, including new trials for medicines we may acquire or in-license, we will need to increase our R&D investments. In addition, as our pipeline potentially delivers new commercialization opportunities, we will need to increase our investments in new-market-creation activities. We have initiated an enterprise-wide digital effort to accelerate drug development, enhance experiences (patient and physician), and leverage technology and robotics to simplify and automate our processes.
To partially offset these incremental cost increases,
In the fourth quarter of 2018, we expect to generate cost reduction opportunities, particularly in SI&A. We are takingtook steps to simplify the organization, increase spans of control and reduce organizational layers. As such, we expectlayers, which impacted some managerial roles and responsibilities to be impacted. Enhancementsresponsibilities. We also offered enhancements to certain employee benefits are being offered for a short period of time. We doThe expenses related to these enhancements for certain employee benefits did not yet know thehave a material impact on our 2018 results of operations and any expected future impact of these voluntary and involuntary plans, but expect to record a special termination benefit as well as severance in the fourth quarter of 2018. Such benefits will beenhancements are reflected as Certain Significant Items and excluded from our non-GAAP measure of Adjusted Income. We do not expect the expenses related to these

enhancements to change our current full year 2018 guidance. Any future impact will be considered in the totality of our annual guidance for 2019. To partially offset the incremental cost increases of increased R&D investments and marketing activities in future periods, we expect to generate cost reduction opportunities, particularly in indirect SI&A.


Commercial Operations


We currentlyAs discussed under “Organizing for Growth”, at the beginning of our 2019 fiscal year, we began to manage our commercial operations through two distincta new global structure consisting of three business segments: Pfizer Innovative Health (IH)segments––Biopharma, Upjohn and Pfizer Essential Health (EH). The IH and EH operating segments arethrough July 31, 2019, Consumer Healthcare, each led by a single manager. Each operating segment has responsibility for its commercial activities. Upjohn and Consumer Healthcare are responsible for their own R&D activities while Biopharma receives its R&D services from GPD and for certainWRDM. These services include IPR&D projects for new investigational products and additional indications for in-line products that generally have achieved proof-of-concept.products. Each business has a geographic footprint across developed and emerging markets.
Some additional information about our Biopharma and Upjohn business segments as of September 30, 2018 follows:
pfizerlogo2816.jpg
innovativehealthrgb.jpgPfizer
Biopharmaceuticals
Group

 
pehlogo.jpgupjohnlogo.jpg
IH focuses on developingBiopharma is a science-based innovative medicines business that includes six business units – Oncology, Inflammation & Immunology, Rare Disease, Hospital, Vaccines and commercializing novel, value-creatingInternal Medicine. The new Hospital unit commercializes our global portfolio of sterile injectable and anti-infective medicines and vaccinesincludes Pfizer’s contract manufacturing operation, Pfizer CentreOne. At the beginning of our 2019 fiscal year, we also incorporated our biosimilar portfolio into our Oncology and Inflammation & Immunology business units and certain legacy established products into the Internal Medicine business unit. Each business unit is committed to delivering breakthroughs that significantly improvechange patients’ lives,lives.
Upjohn is a global, primarily off-patent branded and generic medicines business, which includes a portfolio of 20 globally recognized solid oral dose brands, as well as products for consumer healthcare.a U.S.-based generics platform, Greenstone.
Key therapeutic areas include internal medicine, vaccines, oncology, inflammation & immunology, rare disease and consumer healthcare.
EH includes legacy brands that have lost or will soon lose market exclusivity in both developed and emerging markets, branded and generic sterile injectable products, biosimilars, and select branded products including anti-infectives. EH also includes an R&D organization, as well as our contract manufacturing business.
Through February 2, 2017, EH also included HIS.
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. We have also expanded our pipeline in high priority therapeutic areas such as inflammation and immunology and oncology with select business development transactions.
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 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 systems net assets, representing the infusion systems net assets that we acquired as part of the Hospira transaction, HIS, to ICU Medical.

Leading brandsSelect products include:

-
Prevnar 13/Prevenar 13

-
Xeljanz
Ibrance
- Eliquis

-
Lyrica (U.S., Japan and certain other markets)
Xeljanz
-
Enbrel (outside(outside the U.S. and Canada)

-
Ibrance
Chantix/Champix
- Xtandi
Sutent
- Several OTC consumer healthcare products (e.g., Advil and
Centrum)Xtandi
 

Leading brandsSelect products include:

-
Lipitor
Lyrica
-
Norvasc
Lipitor
-
Lyrica (Europe, Russia, Turkey, Israel and Central Asia
countries)
-
Celebrex
- Viagra*
- Inflectra/Remsima
- SulperazonNorvasc
- Several other sterile injectable productsCelebrex
- Viagra
- Certain generic medicines
*Viagra lost exclusivity inOn July 29, 2019, we announced that we entered into a definitive agreement to combine Upjohn with Mylan, creating a new global pharmaceutical company. For additional information, see the U.S. in December 2017. Beginning in 2018, revenues“Our Strategy––Our Business Development Initiatives” section of this MD&A below.
On July 31, 2019, Pfizer’s Consumer Healthcare business, an over-the-counter medicines business, was combined with GSK’s consumer healthcare business to form a new consumer healthcare joint venture. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation and Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Viagra in the U.S.Sale and Canada, which were reported in IH through 2017, are reported in EH (which reported all other Viagra revenues excluding the U.S.Research and Canada through 2017)Development Arrangement:Equity-Method Investment and Assets and Liabilities Held for Sale. Therefore, beginning in 2018, total Viagra worldwide revenues are reported in EH.
For additional information about our operating structure, see Notes to Condensed Consolidated Financial Statements—Note 13A. Segment, Geographic and Other Revenue Information: Segment Information.
For additional information about the2018 performance for each of our operating segments, see the “Analysis of Operating Segment Information” section of this MD&A.




Description of Research and Development Operations

The following description of R&D operations reflects operations as of September 30, 2018.
Innovation is critical to the success of our company, and drug discovery and development isare time-consuming, expensive and unpredictable. Our goalPfizer’s purpose is to discover, developdeliver breakthroughs that change patients’ lives. R&D is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and bring to market innovative productstechnologies into the therapies that address major unmet medical needs.matter most. Our R&D priorities include:
delivering a pipeline of highly differentiated therapiesmedicines and vaccines withwhere Pfizer has a unique opportunity to bring the greatest medical and commercial potential;most important new therapies to patients in need;
advancing our capabilities that can position Pfizer for long-term R&D leadership; and
creatingadvancing new models for biomedical collaboration that will expedite the pace of partnerships with creativity, flexibility and urgency to deliver innovation and productivity.to patients as quickly as possible.
To that end, our R&D primarily focuses on:
Biosimilars;Oncology;
Inflammation and Immunology;
Internal Medicine;
Oncology;
Rare Diseases;
Hospital;
Vaccines; and
Vaccines.Internal Medicine.
In January 2018,2019, we announced our decision to end internal neuroscience discovery and early development efforts and re-allocate funding to other areas where we have stronger scientific leadership. The development of tanezumab and potential treatments for rare neuromuscular disorders is not impacted by this decision. In June 2018, we announced our plan to invest $600 million in biotechnology and other emerging growth companies through Pfizer Ventures, our venture investment vehicle. Pfizer Ventures will seek to invest approximately 25% of its available capital ($150 million) in promising early-stage neuroscience companies. In addition to increased funding, we will extend our leadership as a venture capital investor with an expanded team that leverages expertise across venture capital investing, business development, drug discovery and clinical development. The new organization consolidates R&D Innovate, Pfizer’s R&D equity investment vehicle, with Pfizer Venture Investments, our long-standing venture investment group. In September 2018, we and Bain Capital entered into a transaction to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and preclinical stage neuroscience assets primarily targeting disorders of the central nervous system including Parkinson’s disease, epilepsy, Alzheimer’s disease, schizophrenia and addiction. For additional information on the transaction with Bain Capital, see the Notes to Condensed Consolidated Financial Statements––Note 2B.Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangements and Privately Held Investment: Divestitures.

We continue to strengthen our global R&D organization and pursue strategies intended to improve innovation and overall productivity in R&D to achieve a sustainable pipeline that willis positioned to deliver value in the near term and over time.

Our R&D spending is conducted through a number of matrix organizations:
Research Units within our WRDWRDM organization are generally responsible for research and early-stage development assets for our IHBiopharma business (assets that have not yet achieved proof-of-concept). Our Research Units are organized by therapeutic area to enhance flexibility, cohesiveness and focus. Because of our structure, we canare able to rapidly redeploy resources within a Research Unit between various projects as necessary because in many instances 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 operational execution of 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.
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 WRDWRDM organization), such as Pharmaceutical Sciences, Medicinal Chemistry, Regulatory and Drug Safety,Medicine Design, and non-science-based functions, such as Facilities, Business TechnologyDigital 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. In addition, the Worldwide Medical and Safety group ensures that Pfizer provides all stakeholders, including patients, healthcare providers, pharmacists, payers and health authorities with complete and up-to-date information on the risks and benefits associated with Pfizer products so that they can make appropriate decisions on how and when to use Pfizer’s medicines.

Our R&D organization within the Upjohn business supports the off-patent branded and generic established medicines and helps develop product enhancements, new indications and new market registrations based on these medicines.
Our GPD organization is a unified center for clinical development and regulatory activities that is generally responsible for the clinical development strategy and operational execution of clinical trials for both early-stage assets in the WRDM portfolio as well as late-stage assets in the Biopharma portfolio. For WRDM assets, GPD works in close collaboration with the Early Clinical Development group, which has expertise in various disciplines such as Biostatistics, Clinical Pharmacology and Digital Medicine. GPD enables more efficient and effective development and enhances our ability to accelerate and progress assets through our pipeline. GPD also provides operational support to Upjohn for select clinical development and regulatory activities.
We manage R&D operations on a total-company basis through our matrix organizations described above. Specifically, a singleportfolio governance committee, with representation from the R&D groups and the IH commercial organizationcomprised of senior executives, is accountable for aligning resources among all of our WRD,WRDM, GPD and IHBiopharma R&D projects and for seeking to ensure optimal capital allocation across the Innovative

innovative R&D portfolio. We believe that this approach also serves to maximize accountability and flexibility. Our EHUpjohn R&D organization manages its resources separately from the WRDWRDM and GPD organizations.

Generally, we do not disaggregate total R&D expense by development phase or by therapeutic area since, as described above, we do not manage a significant portion of our R&D operations by development phase or by therapeutic area. Further, as we are able to adjust a significant portion of our spending quickly, as conditions change, we believe that any prior-period information about R&D expense by development phase or by therapeutic area would not necessarily be representative of future spending.

While a significant portion of R&D is done internally, we continue to seek out promising chemical and biological lead molecules and innovative technologies developed by third parties to incorporate into our discovery and development processes or projects, as well as our product lines, by entering into collaborations, alliancescollaboration, alliance and license agreements with other companies, as well as leveraging acquisitions and equity- or debt-based investments. These agreements enable us to co-develop, license or acquire promising compounds, technologies or capabilities. We also enter into agreements pursuant to which a third party agrees to fund a portion of the development costs of one or more of our pipeline products in exchange for rights to receive potential milestone payments, revenue sharing payments, profit sharing payments and/or royalties. Collaboration, alliance, license and funding agreements and equity- or debt-based investments allow us to share risk and cost and to access external scientific and technological expertise, and enableprovide us the opportunity to advance our own products as well as the in-licensed or acquired products.

For additional information about R&D by operating segment, see the “Analysis of Operating Segment Information” section of this MD&A. For additional information about our pending new drug applications and supplemental filings, see the “Analysis of the Condensed Consolidated Statements of Income––Product Developments––Biopharmaceutical” section of this MD&A. For additional information about recent transactions and strategic investments that we believe have the potential to advance our pipeline, see the “Our Strategy––Our Business Development Initiatives” section of this MD&A.

Intellectual Property Rights
We continue to aggressivelyvigorously defend our patent rights against increasingly aggressive infringement, whenever appropriate, and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking necessary steps to ensure appropriate patient access. In addition, we will continue to employ innovative approaches designed to prevent counterfeit pharmaceuticals from entering the supply chain and to achieve greater control over the distribution of our products, and we will continue to participate in the generics market, for our products, whenever appropriate, once they lose exclusivity.appropriate. Also, the pursuit of valid business opportunities may require us to challenge intellectual property rights held by other companies that we believe were improperly granted. Such challenges may include negotiation and litigation, which may not always be successful. For additional information about our current efforts to enforce our intellectual property rights and certain other patent proceedings, see Notes to Condensed Consolidated Financial Statements––Note 12A1. Contingencies and Certain Commitments: Legal Proceedings––Patent Litigation. For information on risks related to patent protection and intellectual property claims by third parties, see “RisksPart I, Item 1A, “Risk Factors––Risks Related to Intellectual Property” in Part I, Item 1A, “Risk Factors” of our 20172018 Form 10-K.
Capital Allocation and Expense Management
We seek to maintain a strong balance sheet and robust liquidity so that we continue to have the financial resources necessary to take advantage of prudent commercial, research and business development opportunities and to directly enhance shareholder value through share repurchases and dividends. For additional information about our financial condition, liquidity, capital resources, share repurchases (including accelerated share repurchases) and dividends, see the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this MD&A. For additional information about our recent business development activities, see the “Our Strategy––Our Business Development Initiatives” section of this MD&A.
We remain focused on achieving an appropriate cost structure for our company. For additional information about our cost-reduction and productivity initiatives, see the “Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” section of this MD&A and Notes to Condensed Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.


Increasing Investment in the U.S.––After evaluating the expected positive net impact the TCJA will have on us, in early 2018, we decided to take several actions:
Over the next five years,five-year period from 2018 through 2022, we plan to invest approximately $5.0 billion in capital projects in the U.S., including the strengthening of our manufacturing presence in the U.S. As part of this plan, in July 2018, we announced that we will increase our commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan. This U.S. investment will strengthen our capability to produce and supply critical, life-saving injectable medicines for patients around the world.plan:

Known as Modular Aseptic Processing, the new, multi-story, 400,000-square-foot production facility will also support the area economy by creating an estimated 450 new jobs over the next several years.
in July 2018, we announced that we will increase our commitment to U.S. manufacturing with a $465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in the world in Portage, Michigan. This U.S. investment will strengthen our capability to produce and supply critical, life-saving injectable medicines for patients around the world, creating an estimated 450 new jobs over the next several years; and
in August 2019, we announced an additional half billion dollar investment for the construction of a state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. This facility is anticipated to support our continuing investment in gene therapy R&D, similar to Pfizer’s Chapel Hill and Kit Creek, North Carolina R&D sites. This facility would expand our presence in North Carolina. The expanded facility is projected to add approximately 300 new jobs.
We made a $500 million voluntary contribution to ourthe U.S. pension planPfizer Consolidated Pension Plan in February 2018.
In the fourth quarter of 2017, we made a $200 million charitable contribution to the Pfizer Foundation, an organization that provides grant and investment funding to support organizations and social entrepreneurs in an effort to improve healthcare delivery.
In the first quarter of 2018, we paid a special, one-time bonus to virtually all Pfizer colleagues, excluding executives, of $119 million in the aggregate.
Our Business Development Initiatives


We are committed to capitalizing on growth opportunities by advancing our own pipeline and maximizing the value of our in-line products, as well as through various forms of business development, which can include alliances, licenses, joint ventures, collaborations, equity- or debt-based investments, dispositions, mergers and acquisitions. We view our business development activity as an enabler of our strategies, and we seek to generate earnings growth and enhance shareholder value by pursuing a disciplined, strategic and financial approach to evaluating business development opportunities. We continue to evaluate business development transactions that have the potential to strengthen our businesses and their capabilities, such as our recently-announced agreement to combine Upjohn with Mylan, our acquisitions of Hospira,Array, Medivation, Anacor and AstraZeneca’s small molecule anti-infectives business, as well as collaborations, and alliance and license agreements with other companies. We assess our businesses, assets and scientific capabilities/portfolio as part of our regular, ongoing portfolio review process and also continue to consider business development activities that will advance our businesses.

We continue to review strategic options for our Consumer Healthcare business. We remain disciplined regarding our capital allocation, and at this time we have not received an acceptable offer for the sale of this business. We will continue our management of this strong business as we explore other alternatives, which could include everything from a full or partial separation of the business to ultimately deciding to retain the business. We continue to expect that any decision regarding strategic alternatives for our Consumer Healthcare business will be made during the fourth quarter of 2018.

For additional information on our business development activities, see Notes to Condensed Consolidated Financial Statements––Note 2. Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangements and Privately Held Investment.
The more significant recent transactions and events are described below:
License Agreement with Akcea Therapeutics, Inc.––In October 2019, we announced that we entered into a worldwide exclusive licensing agreement for AKCEA-ANGPTL3-LRx, an investigational antisense therapy being developed to treat patients with certain cardiovascular and metabolic diseases, with Akcea, a majority-owned affiliate of Ionis. Under the terms of the agreement, Akcea and Ionis will split equally a $250 million upfront license fee and will split equally development, regulatory and sales milestone payments of up to $1.3 billion and tiered, double-digit royalties on annual worldwide net sales upon marketing approval of AKCEA-ANGPTL3-LRx, if any. Pfizer is responsible for all development and regulatory activities and costs beyond those associated with the ongoing Phase 2 study. This transaction is expected to close in the fourth quarter of 2019 and is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act as well as satisfaction of other customary closing conditions.
Formation of a New Consumer Healthcare Joint Venture––On July 31, 2019, we completed the transaction in which we and GSK combined our respective consumer healthcare businesses into a new consumer healthcare joint venture that operates globally under the GSK Consumer Healthcare name. The joint venture is a category leader in pain relief, respiratory and vitamins, minerals and supplements, and therapeutic oral health and is the largest global OTC consumer healthcare business. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation andNotes to Condensed Consolidated Financial Statements––Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement:Equity-Method Investment and Assets and Liabilities Held for Sale.
Acquisition of Array BioPharma Inc.––On July 30, 2019, we acquired Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need, for $48 per share in cash. The total fair value of the consideration transferred for Array was approximately $11.2 billion ($10.9 billion, net of cash acquired). Array’s portfolio includes the approved combined use of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of BRAFV600E- or BRAFV600K-mutant unresectable or metastatic melanoma. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation and Notes to Condensed Consolidated Financial Statements––Note 2A. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions.
Agreement to Combine Upjohn with Mylan N.V.––On July 29, 2019, we announced that we entered into a definitive agreement to combine Upjohn with Mylan, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, Upjohn is expected to be spun-off or split-off to Pfizer’s shareholders and, immediately thereafter, combined with Mylan. Pfizer shareholders would own 57% of the combined new company, and former Mylan shareholders would own 43%. The transaction is expected to be tax free to Pfizer and Pfizer shareholders. The transaction is anticipated to close in mid-2020, subject to Mylan shareholder approval and satisfaction of other customary closing conditions, including receipt of regulatory approvals. See the “Analysis of Financial Condition, Liquidity and Capital Resources” section of this MD&A for additional information.
Acquisition of Therachon Holding AG––On July 1, 2019, we acquired all the remaining shares of Therachon, a privately-held clinical-stage biotechnology company focused on rare diseases, with assets in development for the treatment of achondroplasia, a genetic condition and the most common form of short-limbed dwarfism. We acquired Therachon for $340 million upfront, plus potential milestone payments of up to $470 million, contingent on the achievement of key milestones in the development and commercialization of the lead asset. The total fair value of the consideration transferred for Therachon was approximately $322 million. For additional information, see Notes to Condensed Consolidated Financial Statements––

Note 2A. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale of Hospira Infusion Systems Net Assets to ICU Medical, Inc. (EH)––On February 3, 2017, we completed the sale of our global infusion systems net assets, HIS, to ICU Medical. In connection with this transaction, we recognized pre-tax income of $2 million in the third quarter of 2018and pre-tax income of $1 million in the first nine months of 2018, and we recognized pre-tax income of approximately $12 million in the third quarter of 2017 and a pre-tax loss of approximately $52 million in the first nine months of 2017 in Other (income)/deductions––net, representing adjustments to amounts previously recorded in 2016 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, 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 fell 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. The total fair value of the consideration transferred for this business was approximately $555 million in cash plus the fair value of contingent consideration of $485 million.
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 3 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 12 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 third quarter of 2018totaled $12.9 million and for the first nine months of 2018 totaled $44.2 million. The reduction to Research and development expenses for the third quarter of 2017 totaled $16.8 million and for the first nine months of 2017 totaled $48.8 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
: Acquisitions.

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 3 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 third quarter of 2018 totaled $27.1 million and for the first nine months of 2018 totaled $78.7 million. The reduction to Research and development expenses for the third quarter of 2017 totaled $27.6 million and for the first nine months of 2017 totaled $54.4 million. 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.
For a description of the more significant recent transactions through February 22, 2018,28, 2019, the filing date of our 20172018 Form 10-K, see the “Our Strategy––Our Business Development Initiatives” section of our 20172018 Financial Report.
Our Financial Guidance for 20182019
On October 30, 2018,29, 2019, we updated our 20182019 financial guidance primarily to reflect our performance to date as well asfinancial results through the first nine months of 2019 and our outlook forconfidence in the remainder ofbusiness going forward. We raised the year. The midpoint of our 2019 guidance range for Adjusted diluted EPS was unchanged from our July 2018 guidance update.
The guidance range for Revenues was narrowed from a range of $53.0 to $55.0 billionrevenues by $200 million to a range of $53.0$51.2 to $53.7$52.2 billion, primarily reflecting:
lower-than-anticipated Essential Health revenues, primarily due to continued legacy Hospira Sterile Injectable Pharmaceuticals (SIP) product shortages in the U.S.; and
recentcomposed of $400 million of operational revenue improvement, partially offset by a $200 million unfavorable impact from changes in foreign exchange rates since mid-July 2019. We also increased the midpoint of our 2019 guidance range for Adjusted Diluted EPS by $0.16 to a range of $2.94 to $3.00, reflecting an $0.18 operational improvement, partially offset by a $0.02 unfavorable impact from changes in relation toforeign exchange rates. The operational improvement primarily reflects the U.S. dollar from mid-July 2018 to mid-October 2018, primarily the weakeningaforementioned improved revenue outlook as well as an improved outlook for Adjusted cost of certain emerging markets currencies and the euro.sales as a percentage of revenues, driven by a more favorable product mix than previously anticipated.
Pfizer’s updated 20182019 financial guidance is presented below(a), (b):
Revenues$53.051.2 to $53.7$52.2 billion
 (previously $53.0$50.5 to $55.0$52.5 billion)
Adjusted cost of sales as a percentage of revenues20.8%19.3% to 21.3%19.8%
 (previously 20.5%20.1% to 21.5%21.1%)
Adjusted selling, informational and administrative expenses$14.013.5 to $14.5$14.0 billion
 (previously $14.0$13.0 to $15.0$14.0 billion)
Adjusted research and development expenses$7.7 to $8.1 billion
(previously $7.9 to $8.3 billion)
Adjusted other (income)/deductionsApproximately $1.3 billion$200 million of income
(previously approximately $1.0 billion of income)
Effective tax rate on adjusted incomeApproximately 16.0%
Adjusted diluted EPS$2.982.94 to $3.02$3.00
 (previously $2.95$2.76 to $3.05)$2.86)
(a) 
The 2018The 2019 financial guidance reflects the following:
Does not assume the completion of any business development transactions not completed as of September 29, 2019.
A full year contribution from Consumer Healthcare. Pfizer continues to expect that any decision regarding strategic alternatives forIncludes revenues and expenses associated with Pfizer’s Consumer Healthcare wouldbusiness through July 31, 2019 as well as Pfizer’s pro rata share of anticipated earnings from the Consumer Healthcare JV with GSK from August 1, 2019, which will be made duringrecorded on a quarterly basis in Adjusted other (income)/deductions. Pfizer will record its share of the fourth quarter of 2018.
Does not assume the completion of any business development transactions not completed as of September 30, 2018, including any one-time upfront payments associated with such transactions.
GuidanceJV’s anticipated earnings on a one-quarter lag; therefore, 2019 financial guidance for Adjusted other (income)/deductions does not attempt to forecast unrealized net gains or losses on equity securities. Pfizer is unable to predict with reasonable certainty unrealized gains or losses on equity securities in a given period. Net unrealized gains and losses on equity securities are now recorded in Adjusted other (income)/deductions during each quarter, reflecting the adoptiondiluted EPS reflects Pfizer’s share of a new accounting standard in the first quarter of 2018 (see Notes to Condensed Consolidated Financial Statements—Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards). Prior to the adoptiontwo months of the new standard, net unrealized gains and losses on virtually all equity securities with readily determinable fair values were reportedJV’s earnings that are expected to be generated in Accumulated other comprehensive income.
third-quarter 2019, which will be recorded by Pfizer in fourth-quarter 2019.
Exchange rates assumed are a blend of the actual exchange rates in effect through third-quarter 2018 and mid-October 2018 exchange rates for the remainder of the year.

Reflects an anticipated negative revenue impact of $1.8$2.1 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. Assumes no generic competition
Exchange rates assumed are a blend of the actual exchange rates in effect through third-quarter 2019 and mid-October 2019 rates for Lyrica in the U.S. until June 2019, which is contingent upon a six-month patent-term extension granted byremainder of the FDA for pediatric exclusivity, which the company is currently pursuing.
year. Reflects the anticipated favorableunfavorable impact of approximately $350 million$1.4 billion on revenues and approximately $0.02$0.10 on adjusted diluted EPS as a result of favorable changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2017.
2018.
Guidance for adjusted diluted EPS assumes diluted weighted-average shares outstanding of approximately 6.05.7 billion shares, which reflects anticipatedthe weighted-average impact of share repurchases totaling approximately $12.0$8.9 billion in 2018, including $9.0 billion of share repurchases already completed through October 30, 2018.in 2019. Dilution related to share-based employee compensation programs is currently expected to offset the reduction in shares associated with these share repurchases by approximately half.
(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.
Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of pending litigation, unusual gains and losses, acquisition-related expenses, net gains or losses on investments in equity securities and potential future asset impairments without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
For information about our actual costs and anticipated costs and cost savings associated with our three-year cost-reduction initiative entered into in the fourth quarter of 2016, the Hospira acquisition, our recent business development activities,2017-2019 initiatives and our current global commercial structure,Organizing for Growth, see the “Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” section of this MD&A and Notes to Condensed Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.
Our 20182019 financial guidance is subject to a number of factors and uncertainties as described in the “Our Operating Environment”, “The Global Economic Environment”, “Our Strategy” and “Forward-Looking Information and Factors That May Affect Future Results” sections of this MD&A; and Part I, Item 1A, “Risk Factors” of our 20172018 Form 10-K and Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q.10-K.


SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS


For a description of our significant accounting policies, see Notes to Consolidated Financial Statements––Note 1. Basis of Presentation and Significant Accounting Policies in our 20172018 Financial Report and Notes to Condensed Consolidated Financial Statements––Note 1C. Basis of Presentation and Significant Accounting Policies: Revenues. Of these policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and the most complex judgments: (i) Acquisitions (2017 Financial Report Note(Note 1D); (ii) Fair Value (2017 Financial Report Note(Note 1E); (iii) Revenues (Note 1C in this Quarterly Report on Form 10-Q); (iv)1G ); Asset Impairments (2017 Financial Report Note 1K)(Note 1L); (v) Income Tax Assets and Liabilities and Income Tax Contingencies (2017 Financial Report Note 1O)(Note 1P); (vi) Pension and Postretirement Benefit Plans (2017 Financial Report Note 1P)(Note 1Q); and Legal and Environmental Contingencies (2017 Financial Report Note 1Q)(Note 1R).
For a discussion about the critical accounting estimates and assumptions impacting our consolidated financial statements, see the “Significant Accounting Policies and Application of Critical Accounting Estimates and Assumptions” section of our 20172018 Financial Report. See also Notes to Consolidated Financial Statements––Note 1C. Basis of Presentation and Significant Accounting Policies: Estimates and Assumptions in our 20172018 Financial Report for a discussion about the risks associated with estimates and assumptions.
For a discussion of recently adopted accounting standards and significant accounting policies, see Notes to Condensed Consolidated Financial Statements––Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards, Note 1C. Basis of Presentation and Significant Accounting Policies: Revenues and Trade Accounts Receivable and Note 1D. Basis of Presentation and Significant Accounting Policies: Collaborative Arrangements.
Revenues
Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, sales allowances and sales returns. These deductions represent estimates of the related obligations and, as such, knowledge and judgment is required when estimating the impact of these revenue deductions on gross sales for a reporting period.

Historically, our adjustments of estimates, to reflect actual results or updated expectations, have not been material to our overall business. On a quarterly basis, our adjustments of estimates to reflect actual results generally have been less than 1% of revenues, and have resulted in either a net increase or a net decrease in revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product growth trends. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate predictors of our future experience, our results could be materially affected. The sensitivity of our estimates can vary by program, type of customer and geographic location. However, estimates associated with U.S. Medicare, Medicaid and performance-based contract rebates are most at risk for material adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally range up to one year. Because of this time lag, in any given quarter, our adjustments to actual can incorporate revisions of several prior quarters.
Income Tax Assets and Liabilities

In the fourth quarter of 2017, we recorded an estimate of certain tax effects of the TCJA, including the impact on deferred tax assets and liabilities from the reduction in the U.S Federal corporate tax rate from 35% to 21%, the impact on valuation allowances and other state income tax considerations, a repatriation tax liability on accumulated post-1986 foreign earnings for which we plan to elect payment over eight years through 2026 that is reported primarily in Other taxes payable, and deferred taxes on basis differences expected to give rise to future taxes on global intangible low-taxed income. In addition, we had provided deferred tax liabilities in the past on foreign earnings that were not indefinitely reinvested. As a result of the TCJA, in the fourth quarter of 2017, we reversed an estimate of the deferred taxes that are no longer expected to be needed due to the change to the territorial tax system. The estimated amounts recorded may change in the future due to uncertain tax positions.
The TCJA subjects a U.S. shareholder to current tax on global intangible low-taxed income earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, states that we are permitted to make an accounting policy election to either recognize deferred taxes for temporary basis differences expected to reverse as global intangible low-taxed income in future years or provide for the tax expense related to such income in the year the tax is incurred. We have elected to recognize deferred taxes for temporary differences expected to reverse as global intangible low-taxed income in future years. However, given the complexity of these provisions, we have not finalized our analysis. We were able to make a reasonable estimate of the deferred taxes on the temporary differences expected to reverse in the future and provided a provisional deferred tax liability as of December 31, 2017. The provisional amount is based on the evaluation of certain temporary differences

inside each of our foreign subsidiaries that are expected to reverse as global intangible low-taxed income. However, as we continue to evaluate the TCJA’s global intangible low-taxed income provisions during the measurement period, we may revise the methodology used for determining the deferred tax liability associated with such income.
We believe that we have made reasonable estimates with respect to each of the above items, however, all of the amounts recorded remain provisional as we have not completed our analysis of the complex and far reaching effects of the TCJA. Further, we continue to consider our assertions on any remaining outside basis differences in our foreign subsidiaries as of September 30, 2018 and have not completed our analysis. In the third quarter of 2018, we recorded a favorable adjustment to the provisional estimate of the impact of the legislation, primarily related to the remeasurement of deferred tax assets and liabilities as well as revised estimates of benefits related to certain tax initiatives. Under guidance issued by the staff of the SEC, we expect to finalize our accounting related to the tax effects of the TCJA on deferred taxes, valuation allowances, state tax considerations, the repatriation tax liability, global intangible low-taxed income, and any remaining outside basis differences in our foreign subsidiaries during the fourth quarter of 2018, as we complete the remainder of our tax return filings and as any interpretations or clarifications of the TCJA occur through further legislation or U.S. Treasury actions or other means.

Income tax assets and liabilities also include income tax valuation allowances and accruals for uncertain tax positions. For additional information, see Notes to Consolidated Financial Statements—Note 1C.Basis of Presentation and Significant Accounting Policies: Estimates and Assumptions; Note 1O. Basis of Presentation and Significant Accounting Policies: Tax Assets and Liabilities and Income Tax Contingencies and Note 5A. Tax Matters: Taxes on Income from Continuing Operations in our 2017 Form 10-K, as well as the “Analysis of Financial Condition, Liquidity and Capital Resources––Selected Measures of Liquidity and Capital Resources—Contractual Obligations” section of our 2017 Financial Report.Leases.

ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF INCOME
The following table provides the components of the condensed consolidated statements of income:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS, EXCEPT PER COMMON SHARE DATA) September 29,
2019

 September 30,
2018

 
%
Change

 September 29,
2019

 September 30,
2018

 
%
Change

Revenues $12,680
 $13,298
 (5) $39,062
 $39,670
 (2)
             
Cost of sales(a)
 2,602
 2,694
 (3) 7,611
 8,173
 (7)
% of revenues 20.5% 20.3%  
 19.5% 20.6%  
             
Selling, informational and administrative expenses(a)
 3,260
 3,494
 (7) 10,110
 10,448
 (3)
% of revenues 25.7% 26.3%  
 25.9% 26.3%  
             
Research and development expenses(a)
 2,283
 2,008
 14
 5,827
 5,549
 5
% of revenues 18.0% 15.1%  
 14.9% 14.0%  
             
Amortization of intangible assets 1,212
 1,253
 (3) 3,578
 3,640
 (2)
% of revenues 9.6% 9.4%  
 9.2% 9.2%  
             
Restructuring charges and certain acquisition-related costs 365
 85
 *
 295
 172
 72
% of revenues 2.9% 0.6%  
 0.8% 0.4%  
             
(Gain) on completion of Consumer Healthcare JV transaction (8,087) 
 *
 (8,087) 
 *
% of revenues 63.8% 
 *
 20.7% 
 *
             
Other (income)/deductions––net 319
 (414) *
 537
 (1,143) *
Income from continuing operations before provision for taxes on income 10,727
 4,177
 *
 19,190
 12,831
 50
% of revenues 84.6% 31.4%  
 49.1% 32.3%  
             
Provision for taxes on income 3,047
 66
 *
 2,566
 1,270
 *
Effective tax rate 28.4% 1.6%  
 13.4% 9.9%  
             
Income from continuing operations 7,680
 4,111
 87
 16,625
 11,562
 44
% of revenues 60.6% 30.9%  
 42.6% 29.1%  
             
Discontinued operations––net of tax 4
 11
 (66) 4
 10
 (61)
             
Net income before allocation to noncontrolling interests 7,684
 4,122
 86
 16,628
 11,571
 44
% of revenues 60.6% 31.0%  
 42.6% 29.2%  
             
Less: Net income attributable to noncontrolling interests 4
 8
 (56) 19
 25
 (23)
Net income attributable to Pfizer Inc. $7,680
 $4,114
 87
 $16,609
 $11,546
 44
% of revenues 60.6% 30.9%  
 42.5% 29.1%  
             
Earnings per common share––basic:
  
  
  
  
  
  
Income from continuing operations attributable to Pfizer Inc. common shareholders $1.38
 $0.70
 98
 $2.98
 $1.96
 52
Net income attributable to Pfizer Inc. common shareholders $1.38
 $0.70
 98
 $2.98
 $1.96
 52
             
Earnings per common share––diluted:
      
  
  
  
Income from continuing operations attributable to Pfizer Inc. common shareholders $1.36
 $0.69
 98
 $2.92
 $1.92
 52
Net income attributable to Pfizer Inc. common shareholders $1.36
 $0.69
 98
 $2.92
 $1.92
 52
* Calculation not meaningful or results are equal to or greater than 100%.
(a)
Excludes amortization of intangible assets, except as disclosed in Notes to Condensed Consolidated Financial Statements––Note 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets.

Revenues by Operating Segment and Geography

The following graphs show revenues by operating segment and geography:
Third Quarter
q32019revenuesbysegment.jpgq32018revenuesbysegment.jpg
2019 Revenues by Geography% of Total
U.S.46%
International54%
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF INCOME

2018 Revenues by Geography
% of Total
U.S.48%
REVENUES AND PRODUCT DEVELOPMENTSInternational52%

First Nine Months
firstninemonths2019byseg.jpgfirstninemonths2018byseg.jpg
2019 Revenues by Segment and Geography% of Total
U.S.47%
International53%
qtdrevbysegandgeo.jpgytdrevbysegandgeo.jpg

2018 Revenues by Geography% of Total
U.S.48%
International52%

The following tables provide worldwide revenues by operating segment and geography:
 Three Months Ended Three Months Ended
 Worldwide U.S. International World-wide U.S. Inter-national Worldwide U.S. International World-wide U.S. Inter-national
(MILLIONS OF DOLLARS) Sep 30,
2018

 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 % Change in Revenues Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 % Change in Revenues
Operating Segments(a):
                                    
IH $8,471
 $8,118
 $4,881
 $4,777
 $3,590
 $3,341
 4
 2
 7
EH 4,826
 5,050
 1,480
 1,756
 3,347
 3,294
 (4) (16) 2
Biopharma $10,108
 $9,422
 $5,218
 $4,684
 $4,890
 $4,738
 7
 11
 3
Upjohn 2,195
 3,036
 509
 1,231
 1,686
 1,805
 (28) (59) (7)
Consumer Healthcare 377
 839
 124
 445
 253
 394
 (55) (72) (36)
Total revenues $13,298
 $13,168
 $6,361
 $6,534
 $6,937
 $6,634
 1
 (3) 5 $12,680
 $13,298
 $5,850
 $6,361
 $6,830
 $6,937
 (5) (8) (2)
 Nine Months Ended Nine Months Ended
 Worldwide U.S. International World-wide U.S. Inter-national Worldwide U.S. International World-wide U.S. Inter-national
(MILLIONS OF DOLLARS) Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 Sep 30, 2018
 Oct 1, 2017
 % Change in Revenues Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 Sept. 29,
2019

 Sept. 30,
2018

 % Change in Revenues
Operating Segments(a):
    
    
    
  
  
      
    
    
  
  
  
IH $24,573
 $23,204
 $14,002
 $13,708
 $10,572
 $9,496
 6
 2
 11
EH 15,097
 15,639
 4,859
 5,808
 10,238
 9,831
 (3) (16) 4
Biopharma $28,887
 $27,737
 $14,481
 $13,582
 $14,406
 $14,155
 4
 7
 2
Upjohn 8,077
 9,302
 2,891
 3,921
 5,186
 5,381
 (13) (26) (4)
Consumer Healthcare 2,098
 2,631
 988
 1,357
 1,110
 1,273
 (20) (27) (13)
Total revenues $39,670
 $38,843
 $18,861
 $19,516
 $20,810
 $19,327
 2
 (3) 8 $39,062
 $39,670
 $18,360
 $18,861
 $20,701
 $20,810
 (2) (3) (1)
(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.
Revenues––
Third Quarterof20182019 vs. Third Quarter of 20172018
The following provides an analysis of the worldwide change in revenues by geographic areas in the third quarter of 2018:
  Three Months Ended September 30, 2018
(MILLIONS OF DOLLARS) Worldwide U.S. International
Operational growth/(decline):      
Continued growth from certain key brands(a)
 $660
 $287
 $373
Growth from Biosimilars, primarily from Inflectra in certain channels in the U.S., as well as in developed Europe 56
 38
 18
Growth from recently launched products, including Eucrisa in the U.S., as well as Besponsa and Bavencio, primarily in the U.S. and developed Europe 52
 40
 12
Lower revenues for total Viagra(b), primarily in the U.S. due to generic competition that began in December 2017
 (169) (165) (4)
Decline from the Peri-LOE Products portfolio, driven by lower revenues in developed markets (excluding Viagra EH(b)), primarily due to expected declines in Lyrica in developed Europe
 (125) (61) (64)
Decline in the LEP portfolio primarily driven by lower revenues in developed markets (121) (180) 59
Lower revenues for Enbrel, primarily in most developed Europe markets due to continued biosimilar competition (65) 
 (65)
Decline from the SIP portfolio, driven by lower revenues in developed markets, primarily due to continued legacy Hospira product shortages in the U.S. (28) (58) 31
Other operational factors, net (18) (73) 55
Operational growth/(decline), net 243
 (173) 415
       
Unfavorable impact of foreign exchange (113) 
 (113)
Revenues increase/(decrease)
 $130
 $(173) $302
The following provides an analysis of the worldwide change in revenues by geographic areas in the third quarter of 2019:
  Three Months Ended September 29, 2019
(MILLIONS OF DOLLARS) Worldwide U.S. International
Operational growth/(decline):      
Continued growth from certain key brands(a)
 $621
 $323
 $298
Higher revenues for the Hospital products business, primarily driven by continued growth from anti-infective products in China as well as the November 2018 U.S. launch of Panzyga 112
 54
 58
Higher revenues for rare disease products driven by Vyndaqel following the U.S. launch in May 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM); and in international markets, primarily driven by continued uptake for the transthyretin amyloid polyneuropathy indication, primarily in developed Europe, as well as the March 2019 launch of the ATTR-CM indication in Japan, partially offset by lower revenues for the hemophilia franchises (Refacto AF/Xyntha and BeneFIX), primarily due to competitive pressures, and Genotropin in developed markets, mainly due to unfavorable channel mix in the U.S. 86
 65
 21
Higher revenues for Inlyta, primarily in the U.S. driven by increased demand resulting from the second quarter of 2019 U.S. FDA approvals for the combinations of certain checkpoint inhibitors plus Inlyta for the first-line treatment of patients with advanced RCC, partially offset by the decline in other developed markets due to increased competition 70
 65
 4
Growth from Biosimilars, primarily in the U.S. 44
 51
 (7)
Lower worldwide revenues for Lyrica, primarily in the U.S., reflecting the expected significantly lower volumes associated with multi-source generic competition that began in July 2019 (687) (675) (12)
Lower revenues for Consumer Healthcare reflecting the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK. As a result, third-quarter 2019 revenues reflect one month of Consumer Healthcare domestic operations and two months of Consumer Healthcare international operations (451) (321) (130)
Lower revenues for Enbrel internationally, reflecting continued biosimilar competition in most developed Europe markets (99) 
 (99)
Decline in revenues for Revatio driven by lower U.S. Oral Suspension formulation sales and pricing pressures due to a recent generic entry, and for Relpax, driven by continued generic competition across developed markets (53) (39) (14)
Lower revenues for Prevnar 13 in the U.S., primarily reflecting lower government purchases for the pediatric indication as well as the continued decline in revenues for the adult indication due to a declining “catch up” opportunity compared to the prior year quarter, partially offset by an increase in international revenues mostly due to higher volumes reflecting continued uptake following the 2017 launch in China, partially offset by the unfavorable impact of timing associated with government purchases for the pediatric indication in certain emerging markets (43) (81) 37
Decline from Norvasc and Lipitor, primarily in China, driven by pricing pressures from the March 2019 government implementation of the VBP in certain cities. The decline in Lipitor was also due to discontinued sales in Saudi Arabia and lower volumes in Japan. The decline in Norvasc was also due to lower volumes in Japan and South Korea. These declines were partially offset by volume growth and geographic expansion in provinces in China where the VBP has not yet been implemented (35) 1
 (36)
Lower revenues for Viagra primarily in the U.S. resulting from the loss of exclusivity in December 2017 (14) (11) (3)
Other operational factors, net 47
 57
 (9)
Operational growth/(decline), net (403) (510) 107
       
Unfavorable impact of foreign exchange (215) 
 (215)
Revenues decrease
 $(618) $(510) $(107)
(a) 
Certain key brands represent Ibrance, Eliquis Ibrance, Prevnar 13/Prevenar 13, Xeljanz and Xtandi.Xeljanz. See the “Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion"Discussion” section of this MD&A for product analysis information.
(b)
Viagra lost exclusivity in the U.S. in December 2017. Beginning in 2018, revenues for Viagra in the U.S. and Canada, which were reported in IH through 2017, are reported in EH (which reported all other Viagra revenues excluding the U.S. and Canada through 2017). Therefore, beginning in 2018, total Viagra revenues are reported in EH. Total Viagra revenues in 2017 represent the aggregate of worldwide revenues from Viagra IH and Viagra EH.
Emerging markets revenues increased $226$44 million, or 8%1%, in the third quarter of 20182019 to $3.1 billion from $2.8 billion, reflecting an operational increase of $356$180 million, or 13%. Foreign exchange had6%, partially offset by an unfavorable impact from foreign exchange of approximately 5% on emerging markets revenues.4%. The operational increase in emerging markets was primarily driven by our EH segment, primarily by the Legacy Established Products portfolio and Sterile Injectable Pharmaceuticals portfolio, as well asIbrance, Prevenar 13 and Eliquis in our IHBiopharma segment.


Revenues––First Nine Months of 20182019 vs. First Nine Months of 20172018
The following provides an analysis of the change in worldwide revenues by geographic areas in the first nine months of 2018:
  Nine Months Ended September 30, 2018
(MILLIONS OF DOLLARS) Worldwide U.S. International
Operational growth/(decline):      
Continued growth from certain key brands(a)
 $1,835
 $822
 $1,013
Growth from recently launched products, including Eucrisa in the U.S., as well as Besponsa and Bavencio, primarily in the U.S. and developed Europe 172
 145
 27
Growth from Biosimilars, primarily from Inflectra in certain channels in the U.S., as well as in developed Europe 165
 115
 50
Lower revenues for total Viagra(b), primarily in the U.S. due to generic competition that began in December 2017
 (495) (491) (4)
Decline from the Peri-LOE Products portfolio, driven by lower revenues in developed markets (excluding Viagra EH(b)), primarily due to expected declines in Lyrica in developed Europe and Pristiq in the U.S. due to generic competition
 (463) (156) (307)
Decline from the SIP portfolio, driven by lower revenues in developed markets, primarily due to continued legacy Hospira product shortages in the U.S. (419) (480) 61
Decline in the LEP portfolio, primarily driven by lower revenues in developed markets (314) (460) 145
Lower revenues for Enbrel, primarily in most developed Europe markets due to continued biosimilar competition (279) 
 (279)
Impact on financial results for the sale of HIS in February 2017. The first nine months of 2018 do not reflect any contribution from HIS global operations, compared to approximately one month of HIS domestic operations and approximately two months of HIS international operations in the same period in 2017 (97) (64) (33)
Other operational factors, net 29
 (88) 117
Operational growth/(decline), net 134
 (655) 790
       
Favorable impact of foreign exchange 693
 
 693
Revenues increase/(decrease)
 $827
 $(655) $1,483
The following provides an analysis of the change in worldwide revenues by geographic areas in the first nine months of 2019:
  Nine Months Ended September 29, 2019
(MILLIONS OF DOLLARS) Worldwide U.S. International
Operational growth/(decline):      
Continued growth from certain key brands(a)
 $1,978
 $761
 $1,216
Higher revenues for Inlyta, primarily in the U.S. driven by increased demand resulting from the second quarter of 2019 U.S. FDA approvals for the combinations of certain checkpoint inhibitors plus Inlyta for the first-line treatment of patients with advanced RCC, partially offset by the decline in other developed markets due to increased competition 100
 97
 3
Higher revenues for Biosimilars, primarily in the U.S. 95
 112
 (18)
Volume-driven growth from Celebrex and Effexor, primarily in Japan and China 68
 (6) 74
Growth from Lipitor, primarily due to volume growth and geographic expansion in provinces in China where the VBP has not yet been implemented, partially offset by pricing pressures for Lipitor and Norvasc from the implementation of the VBP in certain cities in China, lower volumes in Japan for Norvasc and the discontinued sales of Lipitor in Saudi Arabia 37
 (7) 44
Higher revenues for rare disease products driven by Vyndaqel following the U.S. launch in May 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM); and in international markets, primarily driven by continued uptake for the transthyretin amyloid polyneuropathy indication, primarily in developed Europe, as well as the March 2019 launch of the ATTR-CM indication in Japan, partially offset by lower revenues for certain rare disease products, including the hemophilia franchises (Refacto AF/Xyntha and BeneFIX), primarily due to competitive pressures, and Genotropin in developed markets, mainly due to unfavorable channel mix 21
 26
 (5)
Lower worldwide revenues for Lyrica, primarily in the U.S., reflecting the expected significantly lower volumes associated with multi-source generic competition that began in July 2019 (736) (719) (17)
Lower revenues for Consumer Healthcare reflecting the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK. As a result, the first nine months of 2019 revenues reflect seven months of Consumer Healthcare domestic operations and eight months of Consumer Healthcare international operations (462) (370) (93)
Lower revenues for Enbrel internationally, reflecting continued biosimilar competition in most developed Europe markets (200) 
 (200)
Lower revenues for Viagra and Upjohn’s authorized generic for Viagra in the U.S. resulting from increased generic competition (181) (191) 9
Decline in revenues for Revatio driven by lower U.S. Oral Suspension formulation sales and pricing pressures due to a recent generic entry, and for Relpax, driven by continued generic competition across developed markets (98) (67) (31)
Lower revenues for the Hospital products business, primarily reflecting declines in developed markets, mostly due to the continued expected negative impact from generic competition for products that have previously lost marketing exclusivity, partially offset by continued growth from anti-infective products in China as well as the 2018 U.S. launches of our immune globulin intravenous products (Panzyga and Octagam) (46) (91) 45
Other operational factors, net 10
 (47) 56
Operational growth/(decline), net 586
 (500) 1,085
       
Unfavorable impact of foreign exchange (1,194) 
 (1,194)
Revenues decrease
 $(609) $(500) $(108)
(a) 
Certain key brands represent Ibrance, Eliquis, Ibrance, Xeljanz and Prevnar 13/Prevenar 13, Xtandi and Chantix/Champix.13. See the “Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion"Discussion” section of this MD&A for product analysis information.
(b)
Viagra lost exclusivity in the U.S. in December 2017. Beginning in 2018, revenues for Viagra in the U.S. and Canada, which were reported in IH through 2017, are reported in EH (which reported all other Viagra revenues excluding the U.S. and Canada through 2017). Therefore, beginning in 2018, total Viagra revenues are reported in EH. Total Viagra revenues in 2017 represent the aggregate of worldwide revenues from Viagra IH and Viagra EH.information.
Emerging markets revenues increased $1.1 billion,$135 million, or 14%1%, in the first nine months of 20182019 to $9.4$9.5 billion from $8.2$9.4 billion, reflecting an operational increase of $1.1 billion,$839 million, or 13%9%. Foreign exchange had a favorablean unfavorable impact of approximately 1%8% on emerging markets revenues. The operational increase in emerging markets was primarily driven by our EH segment, primarily by the Legacy Established Products portfolio and the Sterile Injectable Pharmaceuticals portfolio, as well as Prevenar 13, Ibrance and Eliquis in our IHBiopharma segment and Lipitor, Viagra, Celebrex and Norvasc in our Upjohn segment.

Revenue Deductions
Our gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, sales allowances and sales returns. These deductions represent estimates of the related obligations and, as such, knowledge and judgment is required when estimating the impact of these revenue deductions on gross sales for a reporting period. Historically, our adjustments of estimates, to reflect actual results or updated expectations, have not been material to our overall business. On a quarterly basis, our adjustments of estimates to reflect actual results generally have been less than 1% of revenues, and have resulted in either a net increase or a net decrease in revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product growth trends. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 1C. Basis of Presentation and Significant Accounting Policies: Revenues.

The following table provides information about revenue deductions:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Medicare rebates(a)
 $295
 $443
 $1,080
 $1,266
Medicaid and related state program rebates(a)
 503
 502

1,531
 1,500
Performance-based contract rebates(a), (b)
 923
 854

2,784
 2,467
Chargebacks(c)
 1,328
 1,654

4,252
 4,850
Sales allowances(d)
 1,350
 1,448

4,164
 4,142
Sales returns and cash discounts 262
 358
 1,065
 1,067
Total(e)
 $4,660
 $5,259
 $14,875
 $15,292
The following table provides information about revenue deductions:
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

Medicare rebates(a)
 $443
 $355
 $1,266
 $931
Medicaid and related state program rebates(a)
 502
 439

1,500
 1,335
Performance-based contract rebates(a), (b)
 854
 773

2,467
 2,321
Chargebacks(c)
 1,654
 1,608

4,850
 4,585
Sales allowances(d)
 1,448
 1,419

4,142
 3,718
Sales returns and cash discounts 358
 329
 1,067
 1,025
Total(e)
 $5,259
 $4,923
 $15,292
 $13,916
(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 September 29, 2019, associated with the following segments: Biopharma ($3.0 billion), Upjohn ($1.6 billion) and Other ($0.1 billion). For the three months ended September 30, 2018, associated with the following segments: IHBiopharma ($2.32.6 billion), Upjohn ($2.5 billion) and EHOther ($2.90.2 billion). For the threenine months ended October 1, 2017,September 29, 2019, associated with the following segments: IHBiopharma ($2.48.7 billion);, Upjohn ($5.8 billion) and EHOther ($2.50.4 billion). For the nine months ended September 30, 2018, associated with the following segments: IHBiopharma ($6.57.4 billion), Upjohn ($7.4 billion) and EHOther ($8.8 billion). For the nine months ended October 1, 2017, associated with the following segments: IH ($6.4 billion) and EH ($7.50.5 billion).
Total revenue deductions for the third quarter of 2018 increased 7%2019 decreased 11% compared to the third quarter of 20172018, and total revenue deductions for the first nine months of 2018 increased 10%2019 decreased 3%, compared to the first nine months of 20172018, primarily as a result of:
an increasea decrease in sales allowances as chargebacks, primarily related to Upjohn products, including Viagra and Lyrica; and
a result of sales growth, primarily in international markets;
an increasedecrease in Medicare rebates, driven by increaseda significant decrease in Lyrica sales of IH products through this channel;in the U.S., due to multi-source generic competition that began in July 2019,
higher chargebacks to U.S. wholesalers on certain IH and EH products, partially offset by decreases in chargebacks as a result of decreases in sales of sterile injectable products; andby:
an increase in Medicaid and related state programperformance-based contract rebates, primarily as a result ofin the U.S. due to increased sales of IHcertain Biopharma products, through these programs.slightly offset by decreased Lyrica sales.
For information on our accruals for Medicare rebates, Medicaid and related state program rebates, performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts, including the balance sheet classification of these accruals, see Notes to Condensed Consolidated Financial Statements––Note 1C. Basis of Presentation and Significant Accounting Policies: Revenues and Trade Accounts Receivable.

Revenues––Selected Product Discussion
The tables below provide worldwide revenues and revenues by geography, for selected products. References to total change pertain to period-over-period growth rates that include foreign exchange. The difference between the total change and operational change represents the impact of foreign exchange. Amounts may not add due to rounding. All percentages have been calculated using unrounded amounts. An asterisk (*) indicates the calculation is not meaningful or results are equal to or greater than 100%.
•Prevnar 13/Prevenar 13 (IH):
Prevnar 13/Prevenar 13 (Biopharma):
 Three Months Ended Nine Months Ended
Three Months Ended
Nine Months Ended
     % Change     % Change






% Change




% Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper.
September 29,
2019


September 30,
2018


Total

Oper.

September 29,
2019


September 30,
2018


Total

Oper.
U.S. $1,089
 $971
 12   $2,597
 $2,554
 2  
$1,008

$1,089

(7)



$2,498

$2,597

(4)

International 571
 551
 4 6 1,694
 1,515
 12 10
595

571

4

7

1,770

1,694

4

9
Worldwide revenues $1,660
 $1,522
 9 10 $4,290
 $4,069
 5 5
$1,603

$1,660

(3)
(3)
$4,268

$4,290

(1)
1
The growthdeclines in the third quarter and first nine months of 20182019 in the U.S. was primarily due to higherreflect lower government purchases for the pediatric indication partially offset byas well as the continued decline in revenues for the adult indication due to a high initial capture rate of the eligible population following its successful fourth-quarter 2014 launch, which resulted in a smaller remaining “catch up” opportunity (i.e., the opportunity to reach adults aged 65 years and older who have not been previously vaccinated with Prevnar 13), compared to the prior-year period..
The operational growth in the third quarter of 20182019 internationally was primarilymostly due to higher volumes reflecting continued uptake following the 2017 launch in China, partially offset by the unfavorable impact of timing associated with government purchases for the pediatric indication resulting from increased orders associated with Gavi, the Vaccine Alliance and from the second-quarter 2017 launch in China. certain emerging markets.
The international operational growth in the first nine months of 20182019 internationally was primarily due tohigher volumes for the pediatric indication resulting from the second-quarter 2017 launch in China and increased ordersshipments associated with Gavi, the Vaccine Alliance.Alliance, and higher volumes reflecting continued uptake following the second quarter 2017 launch in China, partially offset by the non-recurrence of volumes associated with an adult national immunization program in first quarter of 2018.
In 2014, the ACIP voted to recommend Prevnar 13 for routine use to help protect adults aged 65 years and older against pneumococcal disease, which for adults includes pneumonia caused by the 13 pneumococcal serotypes included in the vaccine. These ACIP recommendations were subsequently approved by the directors at the CDC and U.S. Department of Health and Human Services, and were published in the Morbidity and Mortality Weekly Report in September 2014 by the CDC. As with other vaccines, theThe CDC regularly monitors the impact of vaccination and reviews the recommendations. During the recently held October 2018February 2019 ACIP meeting, the CDC presented initial data and indicateda formal evaluation of evidence to the recommendation framework (grading) for ACIP’s input. On June 26, 2019, the ACIP voted to revise the pneumococcal vaccination guidelines and a potential voterecommend Prevnar 13 for adults 65 and older based on the maintenanceshared clinical decision making of the provider and patient, which means the decision to vaccinate should be made at the individual level between health care providers and their patients, maintaining reimbursement. This revised recommendation reaffirms that there remains vaccine preventable pneumococcal disease in the population of adults 65 years or older, which may be prevented through direct vaccination, and olderwe expect the ACIP’s provisional recommendation would likely happen in 2019. A potential adverse changeto be approved by the directors at the CDC and U.S. Department of Health and Human Services, and is expected to be published by the CDC in the ACIPMorbidity and Mortality Weekly Report in the fourth quarter of 2019. We do not expect the ACIP’s latest recommendation could negativelywill have a significant impact futureon Prevnar 13 revenues. We continue to generate and publish data and communicate withrevenues for the ACIP on the burdenremainder of pneumococcal disease and Prevnar 13 vaccine effectiveness and safety.2019.
Ibrance (Biopharma):
We announced in September 2018 that our next generation 20-Valent Pneumococcal Vaccine candidate has received Breakthrough Therapy designation from the U.S. FDA.
•Lyrica (EH (revenues from all of Europe, Russia, Turkey, Israel and Central Asia)/IH (revenues from all other geographies)):
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total Oper. September 29,
2019

 September 30,
2018

 Total Oper.
U.S. $875
 $877
 
   $2,643
 $2,602
 2
   $832
 $708
 18   $2,405
 $2,178
 10  
International 338
 408
 (17) (17) 1,006
 1,208
 (17) (19) 451
 317
 42 48 1,273
 807
 58 70
Worldwide revenues $1,213
 $1,285
 (6) (5) $3,649
 $3,810
 (4) (5) $1,283
 $1,025
 25 27 $3,677
 $2,985
 23 27
Operational growth in international markets reflects the continued strong uptake in developed Europe and Japan as well as in certain emerging markets following launches. The relatively flat performance in the third quarter of 2018growth in the U.S. was primarily due to sustained demand. The growth in the first nine months of 2018 in the U.S. was primarilymainly driven by sustained demandcyclin-dependent kinase (CDK) class share growth and positive price impact.
The operational declineIbrance’s continued CDK class share leadership in the third quarter of 2018 internationally was primarily due to losses of exclusivity in developed Europe markets, Australia and South Korea. The operational decline in the first nine months of 2018 internationally was primarily due to losses of exclusivity in developed Europe markets, Australia and South Korea, partially offset by growth in the orally dissolving tablet formulation in Japan.its approved metastatic breast cancer indications.
Eliquis alliance revenues and direct sales (Biopharma): Eliquis 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 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. 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.


The following table provides worldwide revenues for Lyrica in our IH segment, by geography:
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total Oper. September 29,
2019

 September 30,
2018

 Total Oper.
U.S. $875
 $877
 
   $2,643
 $2,602
 2
   $541
 $455
 19   $1,768
 $1,371
 29  
International 257
 274
 (6) (6) 755
 779
 (3) (5) 484
 416
 16 20 1,353
 1,153
 17 24
Worldwide revenues $1,132
 $1,150
 (2) (2) $3,398
 $3,382
 
 
 $1,025
 $870
 18 20 $3,121
 $2,524
 24 27
Worldwide Lyrica revenues in our IH segment in the third quarter of 2018 decreased operationally, primarily due to losses of exclusivity in Australia in July 2017 and in South Korea in August 2017. The relatively flat performance in worldwide Lyrica revenues in our IH segment in the first nine months of 2018 was primarily due to losses of exclusivity in Australia and South Korea, offset by growth in the orally dissolving tablet formulation in Japan.
The following table provides worldwide revenues for Lyrica in our EH segment, by geography:
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
U.S. $
 $
 
   $
 $
 
  
International 81
 134
 (40) (39) 251
 428
 (41) (45)
Worldwide revenues $81
 $134
 (40) (39) $251
 $428
 (41) (45)
The worldwide operational declines in our EH segment in the third quarter and first nine months of 2018 were primarily due to losses of exclusivity in developed Europe markets.
Ibrance (IH):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper. September 30,
2018

 October 1,
2017

 Total Oper.
U.S. $708
 $713
 (1)   $2,178
 $2,048
 6  
International 317
 165
 93
 98 807
 362
 * *
Worldwide revenues $1,025
 $878
 17
 18 $2,985
 $2,410
 24 23
The worldwide operational growth in the third quarter and first nine months of 2018 reflects an uptake in international markets,2019 was mostly driven by key European markets where we secured access and reimbursement in 2017 and the December 2017 launch in Japan as well as Ibrance class leadership among cyclin-dependent kinase inhibitors in major markets, supported by our scientific/clinical data and continued positive patient experience. The decline in the third quarter of 2018 in the U.S. was primarily due to the impact of competition and increased rebates. The growth in the first nine months of 2018 in the U.S. was primarily due to continued demand growth partially offset by uptake of competitors and increased rebates.
Eliquis alliance revenues and direct sales (IH): Eliquis 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 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. 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.
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper.
U.S. $455
 $352
 29   $1,371
 $1,041
 32  
International 416
 291
 43 44 1,153
 772
 49 42
Worldwide revenues $870
 $644
 35 36 $2,524
 $1,813
 39 36
The worldwide operational growth in the third quarter and first nine months of 2018 was primarily driven by continued increased adoption in non-valvular atrial fibrillation, as well as oral anti-coagulant market share gain.gains, partially offset by a higher Medicare “coverage gap” discount provision on U.S. revenues compared to the prior year.
Lyrica (Upjohn):

•Lipitor (EH):
 Three Months Ended Nine Months Ended
Three Months Ended
Nine Months Ended
     % Change     % Change






% Change




% Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper. September 30,
2018

 October 1,
2017

 Total
 Oper.
September 29,
2019


September 30,
2018


Total

Oper.

September 29,
2019


September 30,
2018


Total

Oper.
U.S. $25
 $60
 (58)   $86
 $125
 (32)  
$200

$875

(77)



$1,924

$2,643

(27)


International 482
 431
 12
 11 1,453
 1,215
 20
 14
326

338

(4)
(4)
964

1,006

(4)
(2)
Worldwide revenues $507
 $491
 3
 3 $1,539
 $1,341
 15
 10
$527

$1,213

(57)
(57)
$2,888

$3,649

(21)
(20)
The worldwidedeclines in the third quarter and first nine months of 2019 in the U.S. were due to the expected significantly lower volumes driven by multi-source generic competition which began in July 2019.
The operational growthdecline internationally in the third quarter of 20182019 was mostly due to generic competition in developed Europe markets. The operational decline internationally in the first nine months of 2019 was primarily driven by increased demanddue to generic competition in China,developed Europe markets and pricing pressures across international markets, partially offset by increased volumes in Japan attributable to growth in the orally dissolving tablet formulation, and increased volumes in Russia and China.
Xeljanz (Biopharma):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 Total Oper. September 29,
2019

 September 30,
2018

 Total Oper.
U.S. $444
 $332
 34   $1,201
 $964
 25  
International 154
 100
 54 61 434
 256
 69 83
Worldwide revenues $599
 $432
 38 40 $1,634
 $1,221
 34 37
The growth in the U.S. in the third quarter and first nine months of 2019 was primarily due to continued growth in the RA indication driven by access improvements, and by volume growth from the launches of the UC and PsA indications in 2018, partially offset by higher rebating from new commercial contracts. The third quarter of 2019 also benefited from the non-recurrence of favorablea one-time true-up payment in the prior year quarter for improved access with one customer.
The operational growth internationally in the third quarter and first nine months of 2019 was mainly driven by continued uptake in the RA indication in developed Europe, emerging markets, Japan and Canada as well as from the recent launch of the UC indication in certain developed markets.
In July 2019, the FDA updated the U.S. rebates that occurredprescribing information for Xeljanz to include two additional boxed warnings as well as changes to the indication and dosing for UC. These updates were based on the FDA’s review of data from the ongoing post-marketing requirement RA study A3921133. While we expect these updates to have an impact on prescribing, we expect Xeljanz to continue to grow globally across all indications due to improved access and reimbursement and due to the high unmet need for these disease states. See the “Analysis of Condensed Consolidated Statements of Income—Product Development—Biopharmaceuticals” section of this MD&A.
Lipitor (Upjohn):
 
Three Months Ended
Nine Months Ended








% Change




% Change
(MILLIONS OF DOLLARS)
September 29,
2019


September 30,
2018


Total

Oper.

September 29,
2019


September 30,
2018


Total

Oper.
U.S.
$25

$25

1




$76

$86

(12)

International
451

482

(6)
(3)
1,430

1,453

(2)
4
Worldwide revenues
$476

$507

(6)
(3)
$1,506

$1,539

(2)
3

The worldwide operational decline in the third quarter of 2017 and2019 was primarily driven by pricing pressures in China.China resulting from the March 2019 government implementation of the VBP in certain cities, discontinued sales in Saudi Arabia and lower volumes in Japan, partially offset by volume growth and geographic expansion in provinces in China where the VBP has not yet been implemented. The worldwide operational growth in the first nine months of 20182019 was primarily driven bymostly due to overall increased demand in China in the first quarter of 2019 and certain Middle Eastern markets,continued geographic expansion during the third quarter in provinces where the VBP program has not yet been implemented, partially offset by pricing pressures in China resulting from the non-recurrence of favorable U.S. rebates that occurredVBP implementation in the third quarter of 2017certain cities and generic competitiondiscontinued sales in Japan.Saudi Arabia.
Enbrel (Biopharma, outside the U.S. and Canada):
Enbrel (IH, outside the U.S. and Canada):
 Three Months Ended Nine Months Ended
Three Months Ended
Nine Months Ended
     % Change     % Change






% Change




% Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.

September 29,
2019


September 30,
2018


Total

Oper.

September 29,
2019


September 30,
2018


Total

Oper.
U.S. $
 $
 
   $
 $
 
  
$

$






$

$





International 531
 613
 (13) (11) 1,589
 1,818
 (13) (15)
415

531

(22)
(19)
1,285

1,589

(19)
(13)
Worldwide revenues $531
 $613
 (13) (11) $1,589
 $1,818
 (13) (15)
$415

$531

(22)
(19)
$1,285

$1,589

(19)
(13)
The worldwide operational declines in the third quarter and first nine months of 20182019 were primarily due to ongoing biosimilar competition in most developed Europe markets, which is expected to continue.
Chantix/Champix (Biopharma):
•Xeljanz (IH):
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper. September 29,
2019

 September 30,
2018

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total
 Oper.
U.S. $332
 $291
 14   $964
 $793
 22   $227
 $197
 15
   $666
 $602
 11
  
International 100
 57
 76 84 256
 142
 81 81 49
 64
 (22) (20) 159
 187
 (15) (10)
Worldwide revenues $432
 $348
 24 26 $1,221
 $935
 31 31 $276
 $261
 6
 7
 $825
 $789
 5
 6
The growth in the U.S. in the third quarter and first nine months of 20182019 was primarily driven by increased adoption among rheumatologists, growing awareness among patients and improvements in payer access, as well as launches of the psoriatic arthritis (PsA) indication in the first quarter of 2018 and ulcerative colitis indication in the third quarter of 2018.
due to favorable channel mix. The operational growthdeclines internationally in the third quarter and first nine months of 20182019 were mainly driven by generic entry in South Korea and Canada.
Norvasc (Upjohn):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total
 Oper.
U.S. $9
 $9
 5
   $30
 $27
 11
  
International 209
 239
 (12) (9) 704
 750
 (6) (1)
Worldwide revenues $219
 $248
 (12) (9) $735
 $777
 (6) (1)
The worldwide operational decline in the third quarter of 2019 was primarily driven by pricing pressures in China resulting from the 2017 approval of the rheumatoid arthritis indicationVBP implementation in certain European markets, as well as continued uptakecities and lower volumes in Japan Canada and emerging markets.South Korea, partially offset by volume growth and geographic expansion in provinces in China where the VBP has not yet been implemented. The worldwide operational decline in the first nine months of 2019 was primarily due to pricing pressures in China resulting from the VBP implementation in certain cities and lower volumes in Japan, partially offset by overall increased demand in China in the first quarter of 2019 and continued geographic expansion during the third quarter of 2019 in provinces where the VBP has not yet been implemented.
Sutent (Biopharma):
•Sutent (IH):
 Three Months Ended Nine Months Ended
Three Months Ended
Nine Months Ended
     % Change     % Change






% Change




% Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.

September 29,
2019


September 30,
2018


Total

Oper.

September 29,
2019


September 30,
2018


Total

Oper.
U.S. $80
 $87
 (7)   $262
 $277
 (6)  
$64

$80

(20)



$217

$262

(17)


International 168
 189
 (11) (9) 524
 527
 (1) (5)
160

168

(5)


488

524

(7)

Worldwide revenues $248
 $276
 (10) (9) $785
 $805
 (2) (5)
$224

$248

(10)
(7)
$704

$785

(10)
(5)

The worldwide operational declines in the third quarter and first nine months of 2018 were primarily due to lower volumes driven by competitive pressure2019 reflect continued erosion as a result of increased competition in the U.S. and certainkey developed and emerging Europe markets.

•Norvasc (EH):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper. September 30,
2018

 October 1,
2017

 Total
 Oper.
U.S. $9
 $9
 (2)   $27
 $28
 (4)  
International 238
 217
 10
 10 745
 656
 14
 9
Worldwide revenues $247
 $226

9
 10 $773
 $684
 13
 9
The worldwide operational growth in the third quarter and the first nine months of 2018 was primarily driven by increased demand in China,markets, partially offset by generic competitiongrowth in Japan and pricing pressures in China.certain emerging markets.
Xtandi alliance revenues (Biopharma): Xtandi 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).
Chantix/Champix (IH):
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper.
 September 29,
2019

 September 30,
2018

 Total Oper. September 29,
2019

 September 30,
2018

 Total Oper.
U.S. $197
 $180
 10   $602
 $542
 11   $225
 $180
 25   $594
 $510
 17  
International 64
 60
 6 7 187
 184
 2 (2) 
 
   
 
  
Worldwide revenues $261
 $240
 9 9 $789
 $727
 9 8
 $225
 $180
 25 25 $594
 $510
 17 17
The growth in the U.S. in the third quarter and first nine months of 20182019 was primarily due todriven by increased volume, improveddemand for Xtandi in metastatic (mCRPC) and non-metastatic (nmCRPC) castration-resistant prostate cancer, partially offset by higher patient access and, forassistance programs (PAP) utilization in the first nine months of 20182019, positive price impact.compared to the same period in 2018.
The Premarin family of products (Biopharma):
•The Premarin family of products (EH):
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total
 Oper.
U.S. $191
 $224
 (15)   $569

$670
 (15)   $170
 $191
 (11)   $510
 $569
 (10)  
International 12
 14
 (14) (12) 36
 41
 (13) (14) 11
 12
 (8) (5) 32
 36
 (10) (5)
Worldwide revenues $204
 $238
 (15) (15) $605
 $711
 (15) (15) $182
 $204
 (11) (11) $542
 $605
 (10) (10)
The worldwide operational declines in the third quarter and first nine months of 20182019 were primarily driven by generic competitioncompetitive pressures in the U.S.
Celebrex (Upjohn):
•Viagra (EH): Viagralost exclusivity in the U.S. in December 2017. Beginning in 2018, revenues for Viagra in the U.S. and Canada, which were reported in IH through 2017, are reported in EH (which reported all other Viagra revenues excluding the U.S. and Canada through 2017). Therefore, beginning in 2018, total Viagra revenues are reported in EH.
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total
 Oper.
U.S. $32
 $198
 (84)   $196
 $687
 (71)   $14
 $16
 (17)   $44
 $50
 (13)  
International 105
 111
 (5) (3) 313
 309
 1
 (1) 166
 171
 (3) (3) 482
 444
 9
 12
Worldwide revenues $137
 $308
 (55) (55) $509
 $996
 (49) (50) $179
 $188
 (5) (4) $526
 $494
 7
 9
The declines in the U.S. in the third quarter and first nine months of 2018 were primarily due to the loss of exclusivity in December 2017.
Theworldwide operational decline in the third quarter of 2018 internationally2019 was primarily driven bydue to lower volumes in Russia and Turkey and pricing pressures in certain emerging markets. The worldwide operational growth in the first nine months of 2019 was mainly due to higher volumes in Japan and in China, driven by investments in geographic expansion, partially offset by increased demandpricing pressures in China and Saudi Arabia.certain emerging markets.
Sulperazon (Biopharma):
•Sulperazon (EH):
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper. September 29,
2019

 September 30,
2018

 Total Oper. September 29,
2019

 September 30,
2018

 Total Oper.
U.S. $
 $
    $
 $
    $
 $
    $
 $
   
International 145
 114
 28 26 464
 345
 34 28 163
 145
 12 16 505
 464
 9 15
Worldwide revenues $145
 $114
 28 26 $464
 $345
 34 28 $163
 $145
 12 16 $505
 $464
 9 15

The international operational growth in the third quarter and first nine months of 20182019 was primarilymostly due to increased demand in China.
•Xtandi alliance
Inflectra/Remsima (Biopharma):
 
Three Months Ended
Nine Months Ended








% Change




% Change
(MILLIONS OF DOLLARS)
September 29,
2019


September 30,
2018


Total

Oper.

September 29,
2019


September 30,
2018


Total

Oper.
U.S.
$77

$71

8




$208

$189

10



International
78

95

(18)
(15)
238

280

(15)
(10)
Worldwide revenues
$155

$166

(7)
(5)
$446

$469

(5)
(2)
The worldwide operational revenues (IH): Xtandi is being developed and commercialized through a collaboration with Astellas. The two companies share equallydeclined in the gross profits (losses) relatedthird quarter and first nine months of 2019 due to U.S. net sales of Xtandi. Subject topricing pressures globally as well as competitive pressures internationally, partially offset by continued volume growth in certain exceptions, Pfizerchannels in the U.S., as well as in certain developed markets in Europe 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).
Canada.
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper.
U.S. $180
 $150
 20   $510
 $422
 21  
International 
 
   
 
  
Worldwide revenues $180
 $150
 20 20 $510
 $422
 21 21
The growth in the U.S. in the third quarter and first nine months of 20182019 was primarily driven by continued growth of Xtandidemand in metastatic castration-resistant prostate cancer. While enrollment rates in patient assistance programs (PAP), which provide free medicines to patients, fluctuate throughout the year, we have observed a reduction in PAP utilization in the third quarter and first nine months of 2018, compared to the same periods in 2017.
•Xalkori (IH):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
U.S. $34
 $49
 (31)   $118
 $170
 (31)  
International 93
 96
 (4) (2) 299
 272
 10
 5
Worldwide revenues $127
 $146
 (13) (12) $417
 $442
 (6) (9)
The worldwide operational declines in the third quarter and first nine months of 2018 were primarily due to volume declines in the ALK indication across certain developed markets, primarily in the U.S. and certain markets in developed Europe, due to competitive pressure. The declines wereopen systems, partially offset by a continued increaseprice erosion. While Inflectra has achieved parity access to Remicade® (infliximab) in diagnostic rates for the ALK gene mutation across key markets and share in first-line ALK treatment outside the U.S., primarily in certain emerging markets, as well as uptake in treatmentMedicare Part B, nearly half of all commercial patients with metastatic NSCLC whose tumors are ROS1-positive.
Celebrex (EH):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
U.S. $16
 $61
 (73)   $50
 $117
 (57)  
International 171
 150
 14
 14
 444
 448
 (1) (4)
Worldwide revenues $188
 $212
 (11) (11) $494
 $564
 (12) (15)
The worldwide operational decline in the third quarter of 2018 was primarily driven by the non-recurrence of the favorable U.S. rebates that occurred in the third quarter of 2017 and lower volumes in the U.S., as well as pricing pressure in Mexico, partially offset by increased demand in China and Japan. The worldwide operational decline in the first nine months of 2018 was primarily driven by the non-recurrence of the favorable U.S. rebates that occurred in the third quarter of 2017, lower volumes in the U.S., Japan and certain Middle Eastern markets, as well as pricing pressure in Mexico, partially offset by increased demand in China.
Inflectra/Remsima (EH):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper.
U.S. $71
 $34
 *   $189
 $74
 *  
International 95
 78
 22 22 280
 210
 33 24
Worldwide revenues $166
 $112
 48 48 $469
 $284
 65 58

The worldwide operational growth in the third quarter and first nine months of 2018 wasnot able to access Inflectra due to continued uptake in certain channels in the U.S., as well as in developed markets in Europe, partially offsetexclusionary contracting practices by pricing pressures in these markets.
Inflectra uptake in the U.S. is being driven by a number of factors including Inflectra’s clinical data package, price and the access/reimbursement environment. To date, reimbursement coverage has been mixed. While we achieved 100% Medicare coverage, we have experienced access challenges among commercial payers where our lower priced product has not received access at parity to the innovator product and remains in a disadvantaged position despite the higher price of innovator product. We will look at all relevant factors impacting reimbursement given our extensive experience working with commercial payers to enable greater access for Inflectra. Additionally, inJ&J. In September 2017, Pfizer filed suit in the U.S. District Court for the Eastern District of Pennsylvania against J&J alleging that J&J’s exclusionary contracts and other anticompetitive practices concerning Remicade® (infliximab) violate federal antitrust laws. In June 2019, Pfizer received a Civil Investigative Demand from the Federal Trade Commission (FTC) seeking documents and information relating to the alleged conduct and market conditions at issue in Pfizer’s lawsuit against J&J. Pfizer understands that the FTC’s investigation is focused on J&J’s alleged conduct at issue in Pfizer’s lawsuit against J&J.
Xalkori (Biopharma):
•Inlyta (IH):
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
     % Change     % Change     % Change     % Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 30,
2018

 October 1,
2017

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total Oper. September 29,
2019

 September 30,
2018

 Total
 Oper.
U.S. $27
 $30
 (10)   $88
 $95
 (7)   $36
 $34
 7   $111
 $118
 (6)  
International 44
 53
 (18) (15) 138
 161
 (14) (16) 94
 93
 1 4 274
 299
 (8) (3)
Worldwide revenues $71
 $84
 (15) (13) $226
 $256
 (12) (13) $130
 $127
 2 5 $385
 $417
 (8) (4)
The worldwide operational declinegrowth in the third quarter of 20182019 was primarily due to increased volumes in China following the impact of inclusion of Xalkori in the 2019 National Reimbursement Drug Listing (NRDL) in China, partially offset by volume declines in the ALK indication due to competitive pressure primarily across developed Europe and pricing pressures in China. In the first nine months of 2019, the worldwide operational decline in revenues primarily resulted from erosion due to competition in developed Europe and in the U.S., partially offset by growth in China, following the impact of inclusion of Xalkori in the NRDL.
Viagra (Upjohn):
  Three Months Ended Nine Months Ended
      % Change     % Change
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 Total
 Oper.
 September 29,
2019

 September 30,
2018

 Total
 Oper.
U.S. $20
 $32
 (37)   $72
 $196
 (63)  
International 99
 105
 (5) (3) 306
 313
 (2) 3
Worldwide revenues $120
 $137
 (13) (11) $379
 $509
 (26) (22)
The declines in the U.S. in the third quarter and first nine months of 2019 were driven by the loss of exclusivity in December 2017.
The operational decline internationally in the third quarter of 2019 was primarily due to lower volumes across developed markets. The worldwide operational declinegrowth internationally in the first nine months of 2018 2019 was primarilymostly due to increased competitiondemand in China driven by investments in geographic expansion, partially offset by pricing pressures in China and lower volumes across developed markets, as well as China.and certain emerging markets.
•Eucrisa (IH):
Inlyta (Biopharma):
 Three Months Ended Nine Months Ended
Three Months Ended
Nine Months Ended
     % Change     % Change






% Change




% Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper.
September 29,
2019


September 30,
2018


Total
Oper.
September 29,
2019


September 30,
2018


Total

Oper.
U.S. $40
 $15
 *   $104
 $33
 *  
$92

$27

*


$185

$88

*


International 
 
   
 
  
46

44

6
10
131

138

(5)
2
Worldwide revenues $40
 $15
 * * $104
 $33
 * *
$139

$71

95
98
$316

$226

40

44

The worldwide operational growth in the third quarter and first nine months of 20182019 was primarily drivendue to increased demand in the U.S. as a result of the FDA approvals in the second quarter of 2019 for combinations of certain checkpoint inhibitors plus Inlyta for the first-line treatment of patients with advanced RCC. The growth was partially offset by broader prescriber trial and adoption, as well as growing patient awareness and interest.the decline in other developed markets due to increased competition.
Eucrisa (Biopharma):
•Alliance revenues (IH/EH):
 Three Months Ended Nine Months Ended
Three Months Ended
Nine Months Ended
     % Change     % Change






% Change




% Change
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 Total Oper. September 30,
2018

 October 1,
2017

 Total Oper.
September 29,
2019


September 30,
2018


Total
Oper.
September 29,
2019


September 30,
2018


Total

Oper.
U.S. $642
 $507
 26   $1,901
 $1,487
 28  
$42

$40

5


$90

$104

(14)


International 336
 234
 44 43 919
 624
 47 39
1



*
*
2



*

*
Worldwide revenues $977
 $741
 32 32 $2,820
 $2,112
 34 31
$43

$40

7
7
$92

$104

(12)
(12)
The worldwide operational growth in the U.S. in the third quarter of 2019 was driven by volume growth that was partially offset by higher rebating and unfavorable channel mix. The decline in the U.S. in the first nine months of 20182019 was driven by volume growth that was more than offset by higher rebating and unfavorable channel mix, in addition to favorable rebate adjustments in 2018.
Alliance revenues (Biopharma):
 
Three Months Ended
Nine Months Ended








% Change




% Change
(MILLIONS OF DOLLARS)
September 29,
2019


September 30,
2018


Total
Oper.
September 29,
2019


September 30,
2018


Total
Oper.
U.S.
$773

$642

20


$2,383

$1,901

25

International
368

336

10
13
1,034

919

13
18
Worldwide revenues
$1,141

$977

17
18
$3,418

$2,820

21
23
The worldwide operational growth was mainly due to increases in Eliquis and Xtandi alliance revenues discussed above.included in the above discussion.
Bavencio (IH) (Biopharma) is being developed and commercialized in collaboration with Merck KGaA. Both companies jointly fund allthe majority of development and commercialization costs, and split equally any profits generated from selling any anti-PD-L1 or anti-PD-1 products containing avelumab from this collaboration. Bavencio is currently approved in metastatic MCC in the U.S., Europe and Japan and selectedselect other markets, as well as in second line treatment of locally advanced or metastatic urothelial carcinoma and first-line treatment of patients with advanced RCC in combination with Inlyta in the U.S.
See Notes to Condensed Consolidated Financial Statements––Note 13C.Segment, Geographic and Other Revenue Information: Other Revenue Information for additional information regarding the primary indications or class of the selected products discussed above.
See Notes to Condensed Consolidated Financial Statements—Note 12.Contingencies and Certain Commitments for a discussion of recent developments concerning patent and product litigation relating to certain of the products discussed above.

Product Developments—Biopharmaceutical

We continue to invest in R&D to provide potential future sources of revenues through the development of new products, as well as through additional uses for in-line and alliance products. Notwithstanding our efforts, there are no assurances as to when, or if, we will receive regulatory approval for additional indications for existing products or any of our other products in development.
We continue to strengthen our global R&D organization and pursue strategies intended to improve innovation and overall productivity in R&D to achieve a sustainable pipeline that will deliver value in the near term and over time.

For additional information about our R&D organization, see the “Overview of Our Performance, Operating Environment, Strategy and Outlook—Our Strategy—Organizing for Growth” and “—Description of Research and Development Operations” sections of this MD&A.
A comprehensive update of Pfizer’s development pipeline was published as of October 30, 201829, 2019 and is available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of our research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
The following series of tables provides information about significant regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan, as well as additional indications and new drug candidates in late-stage development.
RECENT FDA APPROVALS
PRODUCTINDICATIONDATE APPROVED
Ruxience™ (rituximab-pvvr)(a)
A biosimilar to Rituxan® (rituximab) for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis
July 2019
Zirabev (bevacizumab-bvzr)(b)
A biosimilar to Avastin® (bevacizumab) for the treatment of mCRC; unresectable, locally advanced, recurrent or metastatic NSCLC; recurrent glioblastoma; metastatic RCC; and persistent, recurrent or metastatic cervical cancer
June 2019
Bavencio (avelumab)Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced RCC, which is being developed in collaboration with Merck KGaA, GermanyMay 2019
Vyndaqel (tafamidis meglumine)Treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalizationMay 2019
Vyndamax (tafamidis)Treatment of the cardiomyopathy of wild-type or hereditary ATTR-CM in adults to reduce cardiovascular mortality and cardiovascular-related hospitalizationMay 2019
Trazimera (trastuzumab-qyyp)(c)
A biosimilar to Herceptin® (trastuzumab) for all eligible indications of the reference product
March 2019
Daurismo (glasdegib)Treatment of newly-diagnosed acute myeloid leukemia in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapyNovember 2018
Lorbrena (lorlatinib)Treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic diseaseNovember 2018
Talzenna (talazoparib)
Treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer
October 2018
Vizimpro (dacomitinib)First-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test, which is being developed in collaboration with SFJSeptember 2018
Nivestym (filgrastim-aafi)(a)
A biosimilar to Neupogen® (filgrastim) for all eligible indications of the reference productJuly 2018
Xtandi (enzalutamide)Treatment of men with non-metastatic castration-resistant prostate cancer, which is being developed through a collaboration with AstellasJuly 2018
Xeljanz (tofacitinib)Treatment of adult patients with moderately to severely active ulcerative colitisMay 2018
Retacrit (epoetin alfa-epbx)(b)
A biosimilar to Epogen® and Procrit® (epoetin alfa) for all indications of the reference productMay 2018
Steglatro (ertugliflozin)An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, which is being developed in collaboration with MerckDecember 2017
Segluromet (ertugliflozin and metformin)An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin, which is being developed in collaboration with MerckDecember 2017
Steglujan (ertugliflozin and sitagliptin)An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate, which is being developed in collaboration with MerckDecember 2017
Bosulif (bosutinib)Treatment of adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive Ph+ CML, which is being developed in collaboration with AvillionDecember 2017
Xeljanz (tofacitinib) and Xeljanz XRXeljanz 5 mg twice daily and Xeljanz XR extended release 11 mg once daily for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugsDecember 2017
Sutent (sunitinib)Adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma following nephrectomy (surgical removal of the cancerous kidney)November 2017
(a) 
Neupogen®
Rituxan® is a registered trademark of AmgenBiogen MA Inc.
(b) 
Epogen®
Avastin® is a registered U.S. trademark of AmgenGenentech, Inc.; Procrit®
(c)
Herceptin® is a registered U.S. trademark of J&J.Genentech, Inc.
PENDING U.S. NDAs AND SUPPLEMENTAL FILINGS
PRODUCTPROPOSED INDICATIONDATE FILED*
Xtandi (enzalutamide)Treatment of metastatic hormone-sensitive prostate cancer, which is being developed through a collaboration with AstellasAugust 2019
PF-05280586PF-06881894(a)
A potential biosimilar to Rituxan® (rituximab)Neulasta®(pegfilgrastim)
September 2018August 2019
PF-06439535PF-06410293(b)
A potential biosimilar to Avastin® (bevacizumab)Humira® (adalimumab)
August 2018
glasdegibTreatment of adult patients with previously untreated acute myeloid leukemia in combination with low-dose cytarabine, a type of chemotherapyJune 2018January 2019
PF-05280014Vyndaqel (tafamidis meglumine)(c)
A potential biosimilar to Herceptin® (trastuzumab)August 2017
tafamidis meglumine(d)
Treatment of transthyretin familial amyloid polyneuropathyFebruary 2012
*The dates set forth in this column are the dates on which the FDA accepted our submissions.
(a) 
RituxanNeulasta®is a registered U.S. trademark of Biogen MAAmgen Inc.
(b) 
AvastinHumira® is a registered trademark of Genentech, Inc.AbbVie Biotechnology Ltd.
(c) 
Herceptin® is a registered trademark of Genentech, Inc. In April 2018, we received a “complete response” letter from the FDA with respect to our biologics license application (BLA) for PF-05280014, our proposed biosimilar to trastuzumab, which was submitted for all indications of the reference product. The FDA highlighted the need for additional technical information, which does not relate to safety or clinical data submitted in the application. In October 2018, the FDA acknowledged for review our BLA resubmission.

(d)
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 thethis 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 has completed study B3461028, a global Phase 3 study to support a potentialthe new indication inof transthyretin amyloid cardiomyopathy, which includes patients with wild type and variant transthyretin. This study has achieved its primary endpoint, and weWe are working with the FDA to identify next steps.

REGULATORY APPROVALS AND FILINGS IN THE EU AND JAPAN
PRODUCTDESCRIPTION OF EVENTDATE APPROVEDDATE FILED*
Vyndaqel (tafamidis meglumine)Braftovi (encorafenib) and Mektovi (binimetinib)
Application filed in Japanthe EU for second-or-third-line treatment of transthyretin amyloid cardiomyopathy (ATTR-CM)BRAF-mutant mCRC, which is being developed in collaboration with the Pierre Fabre Group
November 20182019
Xtandi (enzalutamide)Bavencio (avelumab)Application approved in the EU for Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of adult menadvanced RCC, which is being developed in collaboration with high-risk non-metastatic castration-resistantMerck KGaA, GermanyOctober 2019
PF-06881894(a)
Application filed in the EU for a potential biosimilar to Neulasta® (pegfilgrastim)October 2019
Rituximab Pfizer (rituximab)(b)
Application approved in Japan for a biosimilar to Rituxan® (rituximab) for the treatment of CD20-positive, B-cell non-Hodgkin’s Lymphoma, CD20-positive, B-cell lymphoproliferative disease under immunosuppression, and Granulomatosis with polyangiitis, and microscopic polyangiitis
September 2019
Bosulif (bosutinib)Application filed in Japan for the treatment of chronic myelogenous leukemia (CML), which is being developed in collaboration with Avillion LLPJuly 2019
Xtandi (enzalutamide)Application filed in the EU for the treatment of metastatic hormone-sensitive prostate cancer, which is being developed through a collaboration with AstellasOctober 2018July 2019
Talzenna (talazoparib)
Application approved in the EU for monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer
June 2019
Trastuzumab BS for I.V. Infusion 60mg/150mg “Pfizer”Bevacizumab Pfizer (bevacizumab)(a)(c)
Application approved in Japan for a biosimilar to Herceptin® (trastuzumab)

September 2018
Lorbrena (lorlatinib)Application approved in JapanAvastin® (bevacizumab) for the treatment of patients with ALK-positive metastatic non-small cell lungcolorectal cancer previously treated with one or more ALK inhibitorSeptember 2018June 2019
PF-05280586(b)
Daurismo (glasdegib)
Application filed in the EU for a potential biosimilar to Rituxan® (rituximab)

treatment of newly-diagnosed acute myeloid leukemia in adult patients who are 75 years or older or who have co-morbidities that preclude use of intensive induction chemotherapy
August 2018May 2019
Xeljanz (tofacitinib)Lorviqua (lorlatinib)
Application approved in the EU as monotherapy, for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response,ALK- positive advanced non-small cell lung cancer whose disease has progressed after:
alectinib or were intolerant to either conventional therapyceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or a biologic agent
crizotinib and at least one other ALK TKI
July 2018May 2019
Trazimera(a)
Vizimpro (dacomitinib)
Application approved in the EU for a biosimilar to Herceptin® (trastuzumab) for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinomaJuly 2018
Infliximab BS for I.V. Infusion 100mg “Pfizer”(c)
Application approved in Japan for a biosimilar to Remicade® (infliximab)July 2018
Xeljanz (tofacitinib)Application approved in the EU for Xeljanz in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapyJune 2018
talazoparibApplication filed in the EU for the treatment of patients with germline BRCA-mutated advanced breast cancerJune 2018
Xeljanz (tofacitinib)Application approved in Japan for the treatment of ulcerative colitisMay 2018
dacomitinibApplication filed in Japan for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations, which is being developed in collaboration with SFJMay 2018
crisaboroleApplication filed in the EU for the treatment of mild-to-moderate atopic dermatitisMay 2018
Mylotarg (gemtuzumab ozogamicin)Application approved in the EU for treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia, except acute promyelocytic leukemia
April 2018

Bosulif (bosutinib)Application approved in the EU for the treatment of adults with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), which is being developed in collaboration with AvillionApril 2018
dacomitinibApplication filed in the EUas monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations, which is being developed in collaboration with SFJApril 2019
Vyndaqel (tafamidis meglumine)Application approved in Japan for treatment of transthyretin amyloid cardiomyopathyMarch 20182019
Steglatro (ertugliflozin)
Zirabev(c)
ApprovalApplication approved in the EU as an adjunctfor a biosimilar to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus:
as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications; and
in addition to other medicinal productsAvastin® (bevacizumab) for the treatment of diabetes,metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent NSCLC, advanced and/or metastatic renal cell cancer and persistent, recurrent, or metastatic carcinoma of the cervix
February 2019
Vyndaqel (tafamidis free acid)Application filed in the EU for the treatment of adults with transthyretin amyloid cardiomyopathyJanuary 2019
Bavencio (avelumab)Application filed in Japan for Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of advanced RCC, which is being developed in collaboration with MerckMarch 2018 KGaA, GermanyJanuary 2019
Segluromet (ertugliflozin and metformin)Vizimpro (dacomitinib)
ApprovalApplication approved in the EU as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus:
in patients not adequately controlled on their maximally tolerated dose of metformin alone;
in patients on their maximally tolerated doses of metformin in addition to other medicinal productsJapan for the treatment of diabetes; and
in patients already being treated with the combination of ertugliflozin and metformin as separate tablets,locally advanced or metastatic non-small cell lung cancer with EGFR mutations, which is being developed in collaboration with Merck
SFJ
March 2018
Steglujan (ertugliflozin and sitagliptin)
Approval in the EU as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus:
when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control; and
in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets, which is being developed in collaboration with Merck
March 2018January 2019
PF-06439535PF-06410293(d)
Application filed in the EU for a potential biosimilar to Avastin® (bevacizumab)Humira® (adalimumab)
MarchNovember 2018
PF-05280586(b)
Application filed in the EU for a potential biosimilar to Rituxan® (rituximab)
August 2018
crisaboroleApplication filed in the EU for the treatment of mild-to-moderate atopic dermatitisMay 2018
Xeljanz (tofacitinib)Application filed in the EU for modified release 11mg tablet for rheumatoid arthritisRAMarch 2018
lorlatinib (PF-06463922)Application filed in the EU for the treatment of patients with ALK-positive metastatic non-small cell lung cancer, previously treated with one or more ALK inhibitorsFebruary 2018
Besponsa (inotuzumab ozogamicin)Approval in Japan for the treatment of relapsed or refractory CD 22- positive acute lymphoblastic leukemiaJanuary 2018
*For applications in the EU, the dates set forth in this column are the dates on which the EMA validated our submissions.
(a) 
HerceptinNeulasta® is a registered trademark of Genentech,Amgen Inc.
(b) 
Rituxan® is a registered trademark of Biogen MA Inc.

(c)
Remicade® is a registered Japan 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.
(d)(c) 
Avastin®
Avastin® is a registered trademark of Genentech, Inc.
(d)
Humira® is a registered trademark of AbbVie Biotechnology Ltd.

LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS

FOR IN-LINE AND IN-REGISTRATION PRODUCTS
PRODUCTPROPOSED 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, in combination with talazoparib in patients with previously untreated advanced 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 stage IIIb/IV non-small cell lung
cancer, which is being developed in collaboration with Merck KGaA, Germany
Bavencio (avelumab)(a)
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 treatment of locally advanced squamous cell carcinoma of the
head and neck, which is being developed in collaboration with Merck KGaA, Germany
Braftovi (encorafenib) and Mektovi (binimetinib)
Second-or-third-line treatment of BRAF-mutant mCRC (ex-EU)
Daurismo (glasdegib)A smoothened inhibitor, in combination with azacitidine, for the treatment of acute myeloid leukemia
Ibrance (palbociclib)Treatment of HER2+ advanced breast cancer, in collaboration with the Alliance Foundation Trials, LLC
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
Lorbrena (lorlatinib)Treatment of patients with metastatic non-small cell lung cancer whose tumors are ALK-positive as detected by an FDA-approved test
Xeljanz (tofacitinib)Treatment of ankylosing spondylitis
Xtandi (enzalutamide)Treatment of non-metastatic high risk hormone-sensitive prostate cancer, which is being developed through a collaboration with Astellas
Talzenna (talazoparib)An oral PARP inhibitor, in combination with Xtandi (enzalutamide)Treatment, for the treatment of metastatic hormone-sensitivecastration-resistant prostate cancer which is being developed through a collaboration with Astellas
Vyndaqel (tafamidis meglumine)Adult symptomatic transthyretin cardiomyopathy (ex-Japan)
(a)
In February 2019, the company took steps to transition rheumatoid arthritis study patients who were on tofacitinib 10 mg twice daily to tofacitinib 5 mg twice daily in the ongoing FDA post-marketing requirement study A3921133, a study performed in patients considered to be at high risk for certain side effects. This action was taken as the result of notification from the tofacitinib Rheumatology Data Safety Monitoring Board of a safety signal regarding the tofacitinib 10 mg twice daily treatment arm in study A3921133. The 5 mg twice daily dose is the FDA approved dose in the U.S. for adult patients with moderate to severe rheumatoid arthritis. In July 2019, the FDA updated the U.S. prescribing information for Xeljanz to include two additional boxed warnings as well as changes to the indication and dosing for UC. These updates were based on the FDA’s review of data from the ongoing post-marketing requirement RA study A3921133. In addition, the EU product labeling (SmPC) for Xeljanz was updated in July 2019 to reflect provisional measures required by the EMA’s pharmacovigilance committee (PRAC) while a review was conducted. The PRAC has completed its review and has recommended to the EMA’s scientific committee (CHMP) that caution should be utilized in treating patients with Xeljanz who are at risk for certain side effects. This recommendation will be reviewed by the CHMP who will issue a final opinion; this is expected during November 2019. The CHMP opinion will be provided to the European Commission to issue a legally-binding decision; this procedure is expected to be completed in early 2020.
In February 2018, we and our partner Merck KGaA, Darmstadt, Germany, announced that the Bavencio Phase 3 trial in second-line NSCLC did not meet its pre-specified primary endpoint. We are continuing to further evaluate the detailed results.
NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT
CANDIDATEPROPOSED INDICATION
glasdegib (PF-0444913)aztreonam-avibactam
(PF-06947387)
A smoothenedbeta lactam/beta lactamase inhibitor for the treatment of acute myeloid leukemia
lorlatinib (PF-06463922)A next generation ALK/ROS1 tyrosine kinase inhibitor for the first-line treatment of patients with ALK-positive advanced non-small cell lung cancerinfections caused by Gram-negative bacteria, including those that produce metallo-beta-lactamases, for which there are limited or no treatment options
fidanacogene elaparvovec (PF-06838435)An investigational gene therapy for the treatment of hemophilia B
PF-04965842PF-06482077
A 20-Valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumonia caused by Streptococcus pneumoniae serotypes covered by the vaccine in adults 18 years of age and older
PF-06651600A selective dual Janus kinase 3 (JAK3) and Tyrosine kinase Expressed in hepatocellular Carcinoma (TEC) family inhibitor for the treatment of patients with moderate to severe alopecia areata
abrocitinib (PF-04965842)A Janus kinase 1 (JAK1) inhibitor for the treatment of moderate-to-severe atopic dermatitis
PF-06425090A prophylactic vaccine for active immunization to preventprevention of primary clostridium difficile colitisinfection (CDI) in individuals
PF-06410293(a)
PF-06802861
A potential biosimilar to Humira® (adalimumab)
rivipansel (GMI-1070)A pan-selectinAn oral inhibitor of p38 mitogen-activated protein kinase for the treatment of patients with symptomatic dilated cardiomyopathy due to a Lamin A/C gene mutation
rivipansel (GMI-1070)(a)
A triple selectin inhibitor, with highest potency for E-selectin for the treatment of acute vaso-occlusive crisis in hospitalized individualscrises associated with sickle cell disease in patients aged 6 years and above, which was licensed from GlycoMimetics Inc.
somatrogon (PF-06836922)A long-acting hGH-CTP for the treatment of growth hormone deficiency in children, which is being developed in collaboration with OPKO
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 metastatic castration-resistant prostate cancer
tanezumab(b)
An anti-nerve growth factor monoclonal antibody for the treatment of pain, which is being developed in collaboration with Lilly
(a) 
In August 2019, we announced that the Phase 3 RESET (Rivipansel Evaluating Safety, Efficacy and Time to Discharge) pivotal study did not meet its primary or key secondary efficacy endpoints. The objective of the trial was to evaluate the efficacy and safety of rivipansel in patients aged six and older with sickle cell disease who were hospitalized for a vaso-occlusive crisis and required treatment with IV opioids. The primary endpoint was time to readiness-for-discharge and the key secondary efficacy endpoints were time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids. Detailed analyses of the RESET study, including additional data on efficacy and safety endpoints, which are not available at this time, will be submitted for presentation at a future scientific meeting. We are awaiting additional data to determine next steps.
Humira®(b)
In April 2019, Pfizer and Lilly announced top-line results from a Phase 3 study (A4091058) evaluating subcutaneous (SC) administration of tanezumab 2.5 mg and 5 mg. The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee. During additional routine quality-control activities that occurred after the study was completed and the database was locked, an adverse event of osteonecrosis, which required adjudication was identified in a patient treated with tanezumab 2.5 mg SC. Accounting for the one additional adjudicated case of osteonecrosis in the tanezumab 2.5 mg arm, the incidence of the primary joint safety endpoint for the 2.5 mg SC arm is a registered trademark of AbbVie Biotechnology Ltd.3.9

percent (vs. 3.8 percent, reported in the top-line report). This additional finding does not change the conclusion of the study. Detailed results from this study will be presented at the 2019 American College of Rheumatology and the Association of Rheumatology Professionals Annual Meeting on November 11 and 12, 2019.
Additional product-related programs are in various stages of discovery and development. Also, see the discussion in the “Our Strategy––Our Business Development Initiatives” section of this MD&A.

COSTS AND EXPENSESCosts and Expenses

The changes in expenses below reflect, among other things, a decline in expenses resulting from the favorable impactJuly 31, 2019 completion of the February 2017 sale of HIS. The operatingConsumer Healthcare JV transaction with GSK. Our financial results, of HIS are included inand our operating results through February 2, 2017 and, therefore,Consumer Healthcare segment’s operating results, for the third quarter of 2017 do not2019 reflect any contribution from HIS globalonly one month of Consumer Healthcare segment domestic operations whileand two months of Consumer Healthcare segment international operations. Likewise, our financial results, and our Consumer Healthcare segment’s operating results, for the first nine months of 20172019 reflect approximately one monthseven months of HISConsumer Healthcare segment domestic operations and approximately twoeight months of HISConsumer Healthcare segment international operations. Our operating results for 2018 do not reflect any HIS global operations.For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation.
Cost of Sales
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 
%
 Change

 September 30,
2018

 October 1,
2017

 
%
 Change
 September 29,
2019

 September 30,
2018

 
%
 Change

 September 29,
2019

 September 30,
2018

 
%
 Change

Cost of sales $2,694
 $2,844
 (5) $8,173
 $7,972
 3 $2,602
 $2,694
 (3) $7,611
 $8,173
 (7)
As a percentage of Revenues
 20.3% 21.6%   20.6% 20.5%  20.5% 20.3%   19.5% 20.6%  
Cost of sales decreased 5%$92 million, or 3%, in the third quarter of 20182019, compared to the same period in 20172018, primarily due to:
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
lower royalty expense for Lyrica due to the June 2019 loss of exclusivity in the U.S.,
partially offset by:
a $127 million charge for rivipansel, primarily for inventory manufactured for expected future sale (see Notes to Condensed Consolidated Financial Statements––Note 2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement).
Cost of sales decreased$562 million, or 7%, in the first nine months of 2019, compared to the same period in 2018, primarily due to:
the favorable impact of foreign exchange of $212 million and $341 million;
the favorable impact of hedging activity on intercompany inventory of $18$216 million;
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
lower volumes driven by the SIP portfolio, primarilyroyalty expense for Lyrica due to legacy Hospira product shortagesthe June 2019 loss of exclusivity in the U.S., as well as generic competition in developed markets; and
the non-recurrence of $55 million in inventory losses, overhead costs, and incremental costs related to the period in 2017 during which our Puerto Rico plants were not operational due to hurricanes,
partially offset by:
increased sales volumes for various key products within ouran unfavorable change in product portfolio;
higher costs across the SIP portfolio, as a result of the complexity of high quality product manufacture across the legacy Hospira plants;mix; and
a $127 million charge for rivipansel, primarily for inventory manufactured for expected future sale (see Notes to Condensed Consolidated Financial Statements––Note 2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement).
anThe slight increase in royalty expenses based on the mix of products sold.
Cost of salesincreased3% in the first nine months of 2018, compared to the same period in 2017, primarily due to:
the unfavorable impact of foreign exchange of $157 million and the unfavorable impact of hedging activity on intercompany inventory of $114 million;
increased sales volumes for various key products within our product portfolio; and
an increase in royalty expenses based on the mix of products sold,
partially offset by:
lower volumes driven by the SIP portfolio, primarily due to legacy Hospira product shortages in the U.S., as well as generic competition in developed markets;
the non-recurrence of $55 million in inventory losses, overhead costs, and incremental costs related to the period in 2017 during which our Puerto Rico plants were not operational due to hurricanes; and
the non-recurrence of charges related to a product recall that occurred in 2017.
The decrease in Cost of sales as a percentage of revenues in the third quarter of 2018 and the slight increase in Cost of sales as a percentage of revenues for the first nine months of 2018,2019, compared to the same periodsperiod in 20172018, was primarily due to all of the factors discussed above, as well as the impact of the loss of exclusivity of Lyrica in the U.S., partially offset by an increase in alliance revenues, which have no associated cost of sales.
The decrease in Cost of sales as a percentage of revenues in the first nine months of 2019, compared to the same period in 2018, was primarily due to all of the factors discussed above, as well an increase in alliance revenues, which have no associated cost of sales, partially offset by the impact of the loss of exclusivity of Lyrica in the U.S.
Selling, Informational and Administrative (SI&A) Expenses
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 %
 Change

 September 30,
2018

 October 1,
2017

 %
 Change
 September 29,
2019

 September 30,
2018

 %
 Change

 September 29,
2019

 September 30,
2018

 %
 Change

Selling, informational and administrative expenses $3,494
 $3,504
 
 $10,448
 $10,249
 2 $3,260
 $3,494
 (7) $10,110
 $10,448
 (3)
As a percentage of Revenues
 26.3% 26.6%   26.3% 26.4%  25.7% 26.3%   25.9% 26.3%  

SI&A expenses remained relatively flatdecreased $234 million, or 7%, in the third quarter of 20182019, compared to the same period in 20172018, primarily due to:
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK;
lower advertising, promotional and field force expenses reflectingin developed markets, primarily related to Lyrica in the benefits of cost-reductionU.S., and productivity initiatives;
lower general and administrative expenses;
lower healthcare reform expenses as a result of a true up of the prior year amount; and

the favorable impact of foreign exchange of $24$48 million,
largelypartially offset by:
additional investment across several of our key products, primarily Xeljanz, Eucrisa, Eliquis and Prevnar 13/Prevenar 13 (pediatric indication); andproducts.
additional investments in China.
SI&A expenses increased 2%decreased $338 million, or 3%, in the first nine months of 2018, 2019, compared to the same period in 20172018, primarily due to:
additional investment across several of our key products, primarily Xeljanz, Eucrisa, Ibrance, Prevnar 13/Prevenar 13 (pediatric indication) and Eliquis;
the unfavorablefavorable impact of foreign exchange of $152$254 million;
lower advertising, promotional and field force expenses in developed markets, primarily related to Lyrica in the U.S.;
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
the non-recurrence of a special, one-time bonus paid to virtually all Pfizer colleagues, excluding executives, of $119 million, in the aggregate, in the first quarter of 2018;2018,
partially offset by:
additional investment across several of our key products; and
additional investments in China
partially offset by:
lower advertising, promotional and field force expenses, reflecting the benefits of cost-reduction and productivity initiatives;
lower general and administrative expenses;
lower healthcare reform expenses as a result of a true up of the prior year amount; and
decreased investment in Enbrel due to loss of exclusivity across developed Europe.key brands.
Research and Development (R&D) Expenses
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 %
Change
 September 30,
2018

 October 1,
2017

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Research and development expenses $2,008
 $1,865
 8 $5,549
 $5,367
 3 $2,283
 $2,008
 14 $5,827
 $5,549
 5
As a percentage of Revenues
 15.1% 14.2% 14.0% 13.8% 
 18.0% 15.1% 14.9% 14.0% 
R&D expenses increased 8%$275 million, or 14%, in the third quarter of 2019, compared to the same period in 2018, and 3%increased $278 million, or 5%, in the first nine months of 20182019, compared to the same periodsperiod in 2017,2018 primarily due to:
increased costs associated with:
our Oncology portfolio, including costs associated with Bavencio studies;
our Phase 3 clinical trial relatedinvestments in newly acquired Therachon and Array products (see Notes to our JAK1 inhibitor (which was initiated in December 2017), as well as, in the first nine months of 2018, our Phase 3 clinical trial related to the C. difficile vaccine program (which was initiated in March 2017)Condensed Consolidated Financial Statements––Note 2A. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions);
an increaseincreased investments towards building new capabilities and driving automation; and
increased spending on our Inflammation & Immunology and Rare Disease portfolios due to several phase 3 programs and
investment in gene therapy,
partially offset by:
a decrease in the value of the portfolio performance share grants reflecting changes in the price of Pfizer’s common stock, as well as management’s assessment of the probability that the specifiedspecific performance criteria will be achieved;
decreased spending across the Oncology, Vaccines and Internal Medicine portfolios, as select programs have reached completion; and
the timing of milestone activity; and
increased spend on our rare disease portfolio,
partially offset by:
decreased spending for biosimilars as several programs have reached completion;
lower costs due to the completion of certain tanezumab studies;
the phase out of the Lyrica clinical studies; and
the impact of our decision to end internal neuroscience discovery and early development efforts.activity.
For additional information on Cost of sales, SI&A and R&D expenses by operating segment, see the “Analysis of Operating Segment Information” section of this MD&A.
Amortization of Intangible Assets
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 %
Change
 September 30,
2018

 October 1,
2017

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change

 September 29,
2019

 September 30,
2018

 %
Change

Amortization of intangible assets $1,253
 $1,177
 6 $3,640
 $3,571
 2 $1,212
 $1,253
 (3) $3,578
 $3,640
 (2)
As a percentage of Revenues
 9.4% 8.9% 9.2% 9.2%  9.6% 9.4%   9.2% 9.2%  
See also
Amortization of intangible assets decreased $42 million, or 3%, in the third quarter of 2019, compared to the same period in 2018, primarily due to the non-recurrence of amortization expense resulting from the impairment of sterile injectable products

in the fourth quarter of 2018 and the contribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with GSK, partially offset by an increase in amortization expense of intangible assets as a result of our acquisition of Array.

Amortization of intangible assets decreased $61 million, or 2%, in the first nine months of 2019, compared to same period in 2018, primarily due to the non-recurrence of amortization expense resulting from the impairment of sterile injectable products in 2018 and the contribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with GSK, partially offset by an increase in amortization expense of assets recorded as a result of the approval of an additional indication for Xtandi in the U.S., and amortization of intangible assets as a result of our acquisition of Array.
For additional information, see Notes to Condensed Consolidated Financial Statements—Note 2A.Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions, Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Equity-Method Investment and Assets and Liabilities Held for Sale andNote 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets.

Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) Sep 30,
2018

 Oct 1,
2017

 %
Change

 Sep 30,
2018

 Oct 1,
2017

 %
Change

 Sept. 29,
2019

 Sept. 30,
2018

 %
Change

 Sept. 29,
2019

 Sept. 30,
2018

 %
Change

Restructuring charges—acquisition-related costs(a)
 $24
 $70
 (66) $5
 $80
 (94)
Restructuring credits—cost reduction initiatives(b)
 (22) (15) 54
 (37) (52) (29)
Restructuring charges/(credits)—acquisition-related costs(a)
 $19
 $24
 (20) $(196) $5
 *
Restructuring charges/(credits)—cost reduction initiatives(b)
 64
 (22) *
 145
 (37) *
Restructuring charges/(credits) 1
 56
 (98) (32) 28
 *
 83
 1
 *
 (50) (32) 58
Transaction costs(c)
 1
 (14) *
 1
 4
 (59) 65
 1
 *
 65
 1
 *
Integration costs(c)
 82
 73
 13
 202
 235
 (14)
Integration costs and other(c)
 217
 82
 *
 281
 202
 39
Restructuring charges and certain acquisition-related costs 85
 114
 (26) 172
 267
 (36) 365
 85
 *
 295
 172
 72
Net periodic benefit costs(d)
 41
 35
 16
 103
 110
 (7) 9
 41
 (78) 19
 103
 (81)
Additional depreciation—asset restructuring 12
 39
 (69) 43
 74
 (42) 6
 12
 (50) 29
 43
 (33)
Total implementation costs 48
 57
 (16) 130
 150
 (13) 40
 48
 (17) 109
 130
 (17)
Costs associated with acquisitions and cost-reduction/productivity initiatives(e)(d)
 $186
 $245
 (24) $447
 $601
 (26) $420
 $186
 *
 $452
 $447
 1
* Calculation not meaningful or results are equal to or greater than 100%.
(a) 
Restructuring charges–charges/(credits)––acquisition-related costs include employee termination costs, asset impairments and other exit costs associated with business combinations. Charges for the third quarter of 2019 represent employee termination costs related to our acquisition of Array. Credits for the first nine months of 2019 were mostly due to the reversal of certain accruals related to our acquisition of Wyeth upon the effective favorable settlement of a U.S. IRS audit for multiple tax years. See Notes to Condensed Consolidated Financial Statements—Note 5B. Tax Matters: Tax Contingencies. Charges for the third quarter of 2018 were primarily due to accruals for exit costs and asset write downs related to our acquisition of Hospira, and charges for the first nine months of 2018 were primarilymainly due to asset write downs related to our acquisition of Hospira, partially offset by the reversal of previously recorded accruals for employee termination costs related to our acquisition of Hospira. Restructuring charges for the third quarter and first nine months of 2017 were mainly related to our acquisitions of Hospira and Medivation..
(b) 
Restructuring credits–charges/(credits)––cost reduction initiatives relate to employee termination costs, asset impairments and other exit costs not associated with acquisitions. For the third quarter of 2019, the charges were mainly composed of employee termination costs, and for the first nine months of 2019, the charges were mostly related to employee termination costs and exit costs. For the third quarter and first nine months of 2018, and 2017, the credits arewere mostly related to the reversal of previously recorded accruals for employee termination costs.
(c) 
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) 
For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards and Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.
(e)
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,Selling, informational and administrative expenses and/or Other (income)/deductions––net as appropriate. 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.
In connection with2017-2019 Initiatives and Organizing for Growth
During 2018, as we reviewed our acquisition of Hospira in September 2015, we focused our efforts on achieving an appropriate cost structure for the combined company. We achieved our $1 billion of annual cost savings in connection with the Hospira acquisition, 25% more than our initial cost savings target of $800 million. The one-time costs to generate the savings are expected to be approximately $1 billion (not including costs of $215 million associated with the return of acquired IPR&D rights),business opportunities and challenges and the majority of these costs were incurred within the three-year period post-acquisition.
New Cost-Reduction/Productivity Initiatives2017 through 2019 Activities
As a result of the evaluation performedway in connection with our decision in September 2016 to not pursue, at that time, splitting IH and EH into two separate publicly-traded companies, we identified new opportunities to potentially achieve greater optimization and efficiency to become more competitive in our business. Therefore, in early 2017, we initiated new enterprise-wide cost-reduction/productivity initiatives, which we expect to substantially complete bythink about our business operations, we determined that at the end of 2019. These initiatives encompass all areasstart of our cost base2019 fiscal year, we would begin operating under our new commercial structure, which reorganized our operations into three businesses––Biopharma,a science-based innovative medicines business; Upjohn, a global, primarily off-patent branded and include further centralization of our corporategeneric established medicines business; and platform functionsthrough July 31, 2019, a Consumer Healthcare business. To operate effectively in this structure and optimization of our manufacturing plant network to support IH and EH products and pipelines,position ourselves for future growth, we are focused on creating a simpler, more efficient operating structure within each business as well as activitiesthe functions that support them. Beginning in other areas where opportunities are identified. The action plans related to thesethe fourth quarter of 2018, we reviewed previously planned initiatives and new initiatives are underwayto ensure that there was alignment around our new structure and in orderhave combined the 2017-2019 initiatives with our current Organizing for Growth initiatives to form one cohesive plan. For the combined programs, to achieve targeted savings of approximately $1.4$2.0 billion, by 2020, we expect to incur totalapproximately $2.0 billion in costs of approximately $1.2 billion over the three-year period 2017-2019.2017-2019, and approximately $500 million beyond 2019, primarily on manufacturing activities. Of this amount,the total $2.5 billion, we expect about 60%approximately 50% to be related to

manufacturing operations, related and we expect aboutapproximately 20% of the total charges to be non-cash. We expect anticipated savings through 2020 associated with the Organizing for Growth initiatives of approximately $500 million will be non-cash.reinvested in our R&D pipeline and in selling and marketing to support our current and recently launched products and indications. For additional information about these programs and expected and actual total costs, see Notes to Condensed Consolidated Financial Statements—Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives. The expected cost savings in 2018 associated with these activities are reflected in our 2018 financial guidance.



In addition to these major initiatives, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of the losses of exclusivity and the expiration of collaborative arrangements for various products.


Other (Income)/Deductions—Net
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 %
Change
 September 30,
2018

 October 1,
2017

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Other (income)/deductions––net $(414) $79
 * $(1,143) $65
 * $319
 $(414) * $537
 $(1,143) *
* Calculation not meaningful or results are equal to or greater than 100%.
For information about the components of Other (income)/deductions—net, see Notes to Condensed Consolidated Financial Statements—Note 4. Other (Income)/Deductions—Net.
See also the “Analysis of Operating Segment Information” section of this MD&A.
PROVISION FOR TAXES ON INCOMEProvision for Taxes on Income
 Three Months Ended Nine Months Ended   Three Months Ended Nine Months Ended 
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 %
Change

 September 30,
2018

 October 1,
2017

 %
Change

 September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Provision for taxes on income $66
 $727
 (91) $1,270
 $2,287
 (44) $3,047
 $66
 * $2,566
 $1,270
 *
Effective tax rate on continuing operations 1.6% 20.3%   9.9% 20.1%  
 28.4% 1.6% 13.4% 9.9%  
* Calculation not meaningful or results are equal to or greater than 100%.* Calculation not meaningful or results are equal to or greater than 100%.
For information about our effective tax rate and the events and circumstances contributing to the changes between periods, see Notes to Condensed Consolidated Financial Statements—Note 5. Tax Matters.
NON-GAAP FINANCIAL MEASURE (ADJUSTED INCOME)Non-GAAP Financial Measure (Adjusted Income)
General Description of Non-GAAP Financial Measure (Adjusted Income)


Adjusted income is an alternative view of performance used by management. We measure the performance of the overall Company on this basis in conjunction with other performance metrics. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our performance is enhanced by disclosing this performance measure. We report Adjusted income, certain components of Adjusted income, and Adjusted diluted earnings per share in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of prescription medicines vaccines and consumer healthcare (OTC) products–vaccines––prior to considering certain income statement elements. We have defined Adjusted income as Net income attributable to Pfizer Inc. before the impact of purchase accounting for acquisitions, acquisition-related costs, discontinued operations and certain significant items, which are described below. Also, see the “Non-GAAP Financial Measure (Adjusted Income)––General Description of Non-GAAP Financial Measure (Adjusted Income)” section of our 20172018 Financial Report for additional information. Similarly, we have defined the Adjusted income components as Cost of sales, Selling, informational and administrative expenses, Research and development expenses, Amortization of intangible assets and Other (income)/deductions––net each before the impact of purchase accounting for acquisitions, acquisition-related costs and certain significant items. We have defined Adjusted diluted earnings per share as Earnings per common share attributable to Pfizer Inc.––dilutedbefore the impact of purchase accounting for acquisitions, acquisition-related costs, discontinued operations and certain significant items. The Adjusted income measure, the Adjusted income component measures and the Adjusted diluted earnings per share measure are not, and should not be viewed as, substitutes for U.S. GAAP net income, U.S. GAAP net income components or U.S. GAAP diluted earnings per share.


The following are examples of how the Adjusted income and Adjusted diluted earnings per share measures are utilized:
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 20172018 Financial Report for additional information.
Adjusted income and its components and Adjusted diluted earnings per share are non-GAAP financial measures that have no standardized meaning prescribed by U.S. GAAP and, therefore, are limited in their usefulness to investors. Because of their

non-standardized definitions, Adjusted income and its components (unlike U.S. GAAP net income and its components) and Adjusted diluted earnings per share (unlike U.S. GAAP diluted earnings per share) may not be comparable to the calculation of similar measures of other companies. Adjusted income and its components and Adjusted diluted earnings per share are presented solely to permit investors to more fully understand how management assesses performance.


We also recognize that, as internal measures of performance, the Adjusted income and its components and Adjusted diluted earnings per share measures have limitations, and we do not restrict our performance-management process solely to these metrics. A limitation of these measures is that they provide a view of our operations without including all events during a period, such as the effects of an acquisition or amortization of purchased intangibles, and do not provide a comparable view of our performance to other companies in the biopharmaceutical industry. We also use other specifically tailored tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a publicly-traded pharmaceutical index, plays a significant role in determining payouts under certain of Pfizer’s long-term incentive compensation plans.


See the accompanying reconciliations of certain GAAP reported to non-GAAP adjusted information for the third quarter and first nine months of 20182019 and 20172018 below.
Purchase Accounting AdjustmentsCosts and Expenses

Adjusted income is calculated prior to considering certain significant purchase accounting impactsThe changes in expenses below reflect, among other things, a decline in expenses resulting from business combinationsthe July 31, 2019 completion of the Consumer Healthcare JV transaction with GSK. Our financial results, and net asset acquisitions. These impacts,our Consumer Healthcare segment’s operating results, for the third quarter of 2019 reflect only one month of Consumer Healthcare segment domestic operations and two months of Consumer Healthcare segment international operations. Likewise, our financial results, and our Consumer Healthcare segment’s operating results, for the first nine months of 2019 reflect seven months of Consumer Healthcare segment domestic operations and eight months of Consumer Healthcare segment international operations. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation.
Cost of Sales
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 
%
 Change

 September 29,
2019

 September 30,
2018

 
%
 Change

Cost of sales $2,602
 $2,694
 (3) $7,611
 $8,173
 (7)
As a percentage of Revenues
 20.5% 20.3%   19.5% 20.6%  
Cost of sales decreased $92 million, or 3%, in the third quarter of 2019, compared to the same period in 2018, primarily due to:
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
lower royalty expense for Lyrica due to the June 2019 loss of exclusivity in the U.S.,
partially offset by:
a $127 million charge for rivipansel, primarily for inventory manufactured for expected future sale (see Notes to Condensed Consolidated Financial Statements––Note 2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement).
Cost of sales decreased$562 million, or 7%, in the first nine months of 2019, compared to the same period in 2018, primarily due to:
the favorable impact of foreign exchange of $341 million;
the favorable impact of hedging activity on intercompany inventory of $216 million;
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
lower royalty expense for Lyrica due to the June 2019 loss of exclusivity in the U.S.,
partially offset by:
an unfavorable change in product mix; and
a $127 million charge for rivipansel, primarily for inventory manufactured for expected future sale (see Notes to Condensed Consolidated Financial Statements––Note 2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement).
The slight increase in Cost of sales as a percentage of revenues in the third quarter of 2019, compared to the same period in 2018, was primarily due to all of the factors discussed above, as well as the impact of the loss of exclusivity of Lyrica in the U.S., partially offset by an increase in alliance revenues, which have no associated with Wyeth (acquiredcost of sales.
The decrease in 2009)Cost of sales as a percentage of revenues in the first nine months of 2019, compared to the same period in 2018, Hospira (acquiredwas primarily due to all of the factors discussed above, as well an increase in 2015), Anacor (acquired in June 2016) and Medivation (acquired in September 2016), can include the incremental charge toalliance revenues, which have no associated cost of sales, frompartially offset by the saleimpact of acquired inventory that was written upthe loss of exclusivity of Lyrica in the U.S.
Selling, Informational and Administrative (SI&A) Expenses
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
 Change

 September 29,
2019

 September 30,
2018

 %
 Change

Selling, informational and administrative expenses $3,260
 $3,494
 (7) $10,110
 $10,448
 (3)
As a percentage of Revenues
 25.7% 26.3%   25.9% 26.3%  

SI&A expenses decreased $234 million, or 7%, in the third quarter of 2019, compared to fair value, amortizationthe same period in 2018, primarily due to:
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK;
lower advertising, promotional and field force expenses in developed markets, primarily related to Lyrica in the increaseU.S., and
the favorable impact of foreign exchange of $48 million,
partially offset by:
additional investment across several of our products.
SI&A expenses decreased $338 million, or 3%, in fairthe first nine months of 2019, compared to the same period in 2018, primarily due to:
the favorable impact of foreign exchange of $254 million;
lower advertising, promotional and field force expenses in developed markets, primarily related to Lyrica in the U.S.;
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
the non-recurrence of a special, one-time bonus paid to virtually all Pfizer colleagues, excluding executives, of $119 million, in the aggregate, in the first quarter of 2018,
partially offset by:
additional investment across several of our key products; and
additional investments in China across key brands.
Research and Development (R&D) Expenses
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Research and development expenses $2,283
 $2,008
 14 $5,827
 $5,549
 5
As a percentage of Revenues
 18.0% 15.1%   14.9% 14.0% 
R&D expenses increased $275 million, or 14%, in the third quarter of 2019, compared to the same period in 2018, and increased $278 million, or 5%, in the first nine months of 2019, compared to the same period in 2018 primarily due to:
investments in newly acquired Therachon and Array products (see Notes to Condensed Consolidated Financial Statements––Note 2A. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions);
increased investments towards building new capabilities and driving automation; and
increased spending on our Inflammation & Immunology and Rare Disease portfolios due to several phase 3 programs and
investment in gene therapy,
partially offset by:
a decrease in the value of the acquired finite-livedportfolio performance share grants reflecting changes in the price of Pfizer’s common stock, as well as management’s assessment of the probability that the specific performance criteria will be achieved;
decreased spending across the Oncology, Vaccines and Internal Medicine portfolios, as select programs have reached completion; and
the timing of milestone activity.
For additional information on Cost of sales, SI&A and R&D expenses by operating segment, see the “Analysis of Operating Segment Information” section of this MD&A.
Amortization of Intangible Assets
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change

 September 29,
2019

 September 30,
2018

 %
Change

Amortization of intangible assets $1,212
 $1,253
 (3) $3,578
 $3,640
 (2)
As a percentage of Revenues
 9.6% 9.4%   9.2% 9.2%  

Amortization of intangible assets and to a much lesser extent, depreciation relateddecreased $42 million, or 3%, in the third quarter of 2019, compared to the increase/decreasesame period in fair value of the acquired fixed assets (primarily manufacturing facilities), amortization related2018, primarily due to the non-recurrence of amortization expense resulting from the impairment of sterile injectable products

in the fourth quarter of 2018 and the contribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with GSK, partially offset by an increase in fair valueamortization expense of acquired debt,intangible assets as a result of our acquisition of Array.

Amortization of intangible assets decreased $61 million, or 2%, in the first nine months of 2019, compared to same period in 2018, primarily due to the non-recurrence of amortization expense resulting from the impairment of sterile injectable products in 2018 and the fair value changes associatedcontribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with contingent consideration. Therefore, the Adjusted income measure includes the revenues earned upon the saleGSK, partially offset by an increase in amortization expense of the acquired products without considering the acquisition cost of those products.
Acquisition-Related Costs

Adjusted income is calculated prior to considering transaction, integration, restructuring and additional depreciation costs associated with business combinations because these costs are unique to each transaction and represent costs that were incurred to restructure and integrate two businessesassets recorded as a result of the acquisition decision. Forapproval of an additional clarity, only transaction costs, additional depreciationindication for Xtandi in the U.S., and restructuring and integration activities that are associated with a business combination or a net-asset acquisition are included in acquisition-related costs. We have made no adjustments for the resulting synergies.

Discontinued Operations

Adjusted income is calculated prior to considering the resultsamortization of operations included in discontinued operations, as well as any related gains or losses on the disposal of such operations.

Certain Significant Items

Adjusted income is calculated prior to considering certain significant items. Certain significant items represent substantive and/or unusual items that are evaluated on an individual basis. Such evaluation considers both the quantitative and the qualitative aspects of their nature. Certain significant items may be highly variable and difficult to predict. Furthermore, in some cases it is reasonably possible that they could reoccur in future periods. For example, major non-acquisition-related cost-reduction programs stand on their own as they are specific to an event or goal with a defined term, but we may have subsequent programs based on reorganizations of the business, cost productivity or in response to loss of exclusivity or economic conditions. Legal charges to resolve litigation are also related to specific cases, which are facts and circumstances specific and, in some cases, may also be the result of litigation matters at acquired companies that were inestimable, not probable or unresolved at the date of acquisition. Unusual items may represent items that are not part of our ongoing business; items that, eitherintangible assets as a result of their nature or size, we would not expect to occur as partour acquisition of our normal business on a regular basis; items that would be non-recurring; or items that relate to products we no longer sell. While not all-inclusive, examples of items that could be included as certain significant items would be a major non-acquisition-related restructuring charge and associated implementation costs; amounts related to certain disposals of businesses, products or facilities that do not qualify as discontinued operations under U.S. GAAP; certain intangible asset impairments; adjustments related to the resolution of certain tax positions; the impact of adopting certain significant, event-driven tax legislation, such as the TCJA discussed inArray.
For additional information, see Notes to Condensed Consolidated Financial Statements—Note 5A. Tax Matters: Taxes on Income from Continuing Operations;or charges related to certain legal matters, such as certain of those discussed in Notes to Condensed Consolidated Financial Statements—2A.Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions, Note 12A. Contingencies2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Equity-Method Investment and Assets and Liabilities Held for Sale andNote 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets.

Restructuring Charges and Certain Commitments: Legal Proceedings, included in Part I, Item 1 of this Quarterly Report on Form 10-Q. Normal, ongoing defense costs of the Company or settlements ofOther Costs Associated with Acquisitions and accruals for legal matters made in the normal course of our business would not be considered certain significant items.

Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line ItemsCost-Reduction/Productivity Initiatives
  Three Months Ended September 30, 2018
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 $13,298
 $
 $
 $
 $
 $13,298
Cost of sales 2,694
 1
 (3) 
 (19) 2,673
Selling, informational and administrative expenses 3,494
 
 
 
 (23) 3,471
Research and development expenses 2,008
 1
 
 
 (11) 1,998
Amortization of intangible assets 1,253
 (1,182) 
 
 
 71
Restructuring charges and certain acquisition-related costs 85
 
 (107) 
 22
 
Other (income)/deductions––net (414) (130) (2) 
 244
 (302)
Income from continuing operations before provision for taxes on income 4,177
 1,309
 112
 
 (213) 5,386
Provision for taxes on income(b)
 66
 263
 21
 
 367
 716
Income from continuing operations 4,111
 1,047
 91
 
 (580) 4,669
Discontinued operations––net of tax 11
 
 
 (11) 
 
Net income attributable to noncontrolling interests 8
 
 
 
 
 8
Net income attributable to Pfizer Inc. 4,114
 1,047
 91
 (11) (580) 4,661
Earnings per common share attributable to Pfizer Inc.––diluted 0.69
 0.17
 0.02
 
 (0.10) 0.78
  Nine Months Ended September 30, 2018
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 $39,670
 $
 $
 $
 $
 $39,670
Cost of sales 8,173
 (2) (9) 
 (77) 8,086
Selling, informational and administrative expenses 10,448
 1
 
 
 (185) 10,264
Research and development expenses 5,549
 3
 
 
 (26) 5,526
Amortization of intangible assets 3,640
 (3,428) 
 
 
 212
Restructuring charges and certain acquisition-related costs 172
 
 (209) 
 37
 
Other (income)/deductions––net (1,143) (238) (4) 
 242
 (1,143)
Income from continuing operations before provision for taxes on income 12,831
 3,665
 221
 
 8
 16,725
Provision for taxes on income(b)
 1,270
 735
 40
 
 500
 2,544
Income from continuing operations 11,562
 2,930
 182
 
 (492) 14,181
Discontinued operations––net of tax 10
 
 
 (10) 
 
Net income attributable to noncontrolling interests 25
 
 
 
 
 25
Net income attributable to Pfizer Inc. 11,546
 2,930
 182
 (10) (492) 14,156
Earnings per common share attributable to Pfizer Inc.––diluted 1.92
 0.49
 0.03
 
 (0.08) 2.36
See end of tables for notes (a) and (b).

  Three Months Ended October 1, 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 $13,168
 $
 $
 $
 $
 $13,168
Cost of sales 2,844
 (28) (26) 
 (92) 2,696
Selling, informational and administrative expenses 3,504
 
 
 
 (22) 3,482
Research and development expenses 1,865
 1
 
 
 (9) 1,857
Amortization of intangible assets 1,177
 (1,120) 
 
 
 57
Restructuring charges and certain acquisition-related costs 114
 
 (129) 
 15
 
Other (income)/deductions––net 79
 (7) 
 
 (340) (268)
Income from continuing operations before provision for taxes on income 3,585
 1,154
 155
 
 449
 5,343
Provision for taxes on income(b)
 727
 306
 72
 
 161
 1,267
Income from continuing operations 2,858
 848
 83
 
 288
 4,077
Discontinued operations––net of tax 
 
 
 
 
 
Net income attributable to noncontrolling interests 18
 
 
 
 
 18
Net income attributable to Pfizer Inc. 2,840
 848
 83
 
 288
 4,059
Earnings per common share attributable to Pfizer Inc.––diluted 0.47
 0.14
 0.01
 
 0.05
 0.67
  Nine Months Ended October 1, 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 $38,843
 $
 $
 $
 $
 $38,843
Cost of sales 7,972
 (45) (38) 
 (168) 7,720
Selling, informational and administrative expenses 10,249
 (15) 
 
 (67) 10,167
Research and development expenses 5,367
 7
 
 
 (26) 5,348
Amortization of intangible assets 3,571
 (3,438) 
 
 
 133
Restructuring charges and certain acquisition-related costs 267
 
 (319) 
 52
 
Other (income)/deductions––net 65
 (35) 10
 
 (588) (547)
Income from continuing operations before provision for taxes on income 11,351
 3,527
 347
 
 797
 16,023
Provision for taxes on income(b)
 2,287
 990
 137
 
 263
 3,677
Income from continuing operations 9,064
 2,537
 211
 
 534
 12,345
Discontinued operations––net of tax 1
 
 
 (1) 
 
Net income attributable to noncontrolling interests 32
 
 
 
 
 32
Net income attributable to Pfizer Inc. 9,034
 2,537
 211
 (1) 534
 12,313
Earnings per common share attributable to Pfizer Inc.––diluted 1.49
 0.42
 0.03
 
 0.09
 2.03
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) Sept. 29,
2019

 Sept. 30,
2018

 %
Change

 Sept. 29,
2019

 Sept. 30,
2018

 %
Change

Restructuring charges/(credits)—acquisition-related costs(a)
 $19
 $24
 (20) $(196) $5
 *
Restructuring charges/(credits)—cost reduction initiatives(b)
 64
 (22) *
 145
 (37) *
Restructuring charges/(credits) 83
 1
 *
 (50) (32) 58
Transaction costs(c)
 65
 1
 *
 65
 1
 *
Integration costs and other(c)
 217
 82
 *
 281
 202
 39
Restructuring charges and certain acquisition-related costs 365
 85
 *
 295
 172
 72
Net periodic benefit costs 9
 41
 (78) 19
 103
 (81)
Additional depreciation—asset restructuring 6
 12
 (50) 29
 43
 (33)
Total implementation costs 40
 48
 (17) 109
 130
 (17)
Costs associated with acquisitions and cost-reduction/productivity initiatives(d)
 $420
 $186
 *
 $452
 $447
 1
* Calculation not meaningful or results are equal to or greater than 100%.
(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 13.3% in the third quarter of 2018, compared to 23.7% in the third quarter of 2017. The effective tax rate on Non-GAAP Adjusted income was 15.2% in the first nine months of 2018, compared to 22.9% in the first nine months of 2017. The decreases were primarily due to tax benefits associated with the December 2017 enactment of the TCJA, a favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business, as well as an increase 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.

Details of Income Statement Items Included in GAAP Reported but Excluded from Non-GAAP Adjusted Income
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 30,
2018

 October 1,
2017

 September 30,
2018

 October 1,
2017

Purchase accounting adjustments        
Amortization, depreciation and other(a)
 $1,310
 $1,126
 $3,662
 $3,482
Cost of sales (1) 28
 2
 45
Total purchase accounting adjustments––pre-tax 1,309
 1,154
 3,665
 3,527
Income taxes(b)
 (263) (306) (735) (990)
Total purchase accounting adjustments––net of tax 1,047
 848
 2,930
 2,537
Acquisition-related costs    
  
  
Restructuring charges(c)
 24
 70
 5
 80
Transaction costs(c)
 1
 (14) 1
 4
Integration costs(c)
 82
 73
 202
 235
Net periodic benefit costs/(credits) other than service costs(d)
 2
 
 4
 (10)
Additional depreciation––asset restructuring(e)
 3
 26
 9
 38
Total acquisition-related costs––pre-tax 112
 155
 221
 347
Income taxes(f)
 (21) (72) (40) (137)
Total acquisition-related costs––net of tax 91
 83
 182
 211
Discontinued operations    
  
  
Total discontinued operations––net of tax, attributable to Pfizer Inc.(g)
 (11) 
 (10) (1)
Certain significant items    
  
  
Restructuring credits––cost reduction initiatives(h)
 (22) (15) (37) (52)
Implementation costs and additional depreciation––asset restructuring(i)
 57
 69
 164
 185
Certain legal matters, net(j)
 37
 183
 (70) 191
Adjustments to loss on sale of HIS net assets(j)
 (2) (12) (1) 52
Certain asset impairments(j)
 
 127
 31
 127
Business and legal entity alignment costs(j)
 
 16
 4
 54
Other(k)
 (282) 81
 (84) 239
Total certain significant items––pre-tax (213) 449
 8
 797
Income taxes(l)
 (367) (161) (500) (263)
Total certain significant items––net of tax (580) 288
 (492) 534
Total purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items––net of tax, attributable to Pfizer Inc. $547
 $1,219
 $2,610
 $3,280
(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 charges/(credits)––acquisition-related costs. Restructuring charges include employee termination costs, asset impairments and other exit costs associated with business combinations. Restructuring chargesCharges for the threethird quarter of 2019 represent employee termination costs related to our acquisition of Array. Credits for the first nine months ended September 30,of 2019 were mostly due to the reversal of certain accruals related to our acquisition of Wyeth upon the effective favorable settlement of a U.S. IRS audit for multiple tax years. See Notes to Condensed Consolidated Financial Statements—Note 5B. Tax Matters: Tax Contingencies. Charges for the third quarter of 2018 were primarily due to accruals for exit costs and asset write downs related to our acquisition of Hospira,, and charges for the first nine months ended September 30,of 2018 were primarilymainly due to asset write downs related to our acquisition of Hospira, partially offset by the reversal of previously recorded accruals for employee termination costs related to our acquisition of Hospira.Restructuring charges for the third quarter and first nine months of 2017 were mainly related to our acquisitions of Hospira and Medivation. Transaction costs 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)(b) 
Amounts for the three and nine months ended October 1, 2017 represent the net periodic benefit credits, excluding service costs, reclassified to Other (income)/deductions–Restructuring charges/(credits)net as a result of the retrospective adoption of a new accounting standard in the first quarter of 2018. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards. These credits included a net settlement gain, partially offset by accelerated amortization of actuarial losses and prior service costs upon the settlement of the remaining obligation associated with the Hospira U.S. qualified defined benefit pension plan.
(e)
Included in Cost of sales. Represents the impact of changes in estimated useful lives of assets involved in restructuring actions related to acquisitions.

(f)
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.
(g)
Included in Discontinued operations–net of tax.
(h)
Amountscost reduction initiatives relate to employee termination costs, asset impairments and other exit costs not associated with acquisitions, which are included in Restructuringacquisitions. For the third quarter of 2019, the charges were mainly composed of employee termination costs, and certain acquisition-related cost (for the first nine months of 2019, the charges were mostly related to employee termination costs and exit costs. For the third quarter and first nine months of 2018, the credits were mostly related to the reversal of previously recorded accruals for employee termination costs.
(c)
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). For the three and nine months ended September 30, 2018 and October 1, 2017, the credits are mostly related to the reversal of previously recorded accruals for employee termination costs.
(i)(d) 
Amounts relate toComprises Restructuring charges and certain acquisition-related costs as well as costs associated with our cost-reduction/productivity initiatives not related to acquisitions (seeincluded in Cost of sales, Research and development expenses,Selling, informational and administrative expenses and/or Other (income)/deductions––net as appropriate. 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). For the three months ended September 30, 2018, included in Cost of sales ($30 million), Selling, informational and administrative expenses ($17 million) and Research and development expenses ($9 million). For the three months ended October 1, 2017, included in Cost of sales ($38 million), Selling, informational and administrative expenses ($22 million) and Research and development expenses ($9 million). For the nine months ended September 30, 2018, included in Cost of sales ($91 million), Selling, informational and administrative expenses ($51 million) and Research and development expenses ($22 million). For the nine months ended October 1, 2017, included in Cost of sales ($113 million), Selling, informational and administrative expenses ($46 million) and Research and development expenses ($26 million).
(j)
Included in Other (income)/deductionsnet (see Notes to Condensed Consolidated Financial Statements—Note 4. Other (Income)/Deductions—Net).
(k)
For the three months ended September 30, 2018, primarily included in Cost of sales ($12 millionincome), Selling, informational and administrative expenses ($6 million) and Other (income)/deductions––net ($279 million income). For the nine months ended September 30, 2018, primarily included in Cost of sales ($14 millionincome), Selling, informational and administrative expenses ($134 million) and Other (income)/deductions––net ($206 million income). For the third quarter and first nine months of 2018, includes, among other things, a non-cash $343 million pre-tax gain in Other (income)/deductions––net associated with our transaction with Bain Capital to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and preclinical stage neuroscience assets primarily targeting disorders of the central nervous system. The first nine months of 2018 also includes (i) a $119 million charge, in the aggregate, in Selling, informational and administrative expenses for a special, one-time bonus paid to virtually all Pfizer colleagues, excluding executives, which was one of several actions taken by us after evaluating the expected positive net impact of the December 2017 enactment of the legislation commonly referred to as the TCJA on us and (ii) a non-cash $50 million pre-tax gain in Other (income)/deductions––net as a result of the contribution of our allogeneic chimeric antigen receptor T cell therapy development program assets in connection with our contribution agreement entered into with Allogene (see Notes to Condensed Consolidated Financial Statements—Note 2B. Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangements and Privately Held Investment: Divestitures). For the three months ended October 1, 2017, included in Cost of sales ($54 million) and Other (income)/deductions––net ($26 million). For the nine months ended October 1, 2017, included in Cost of sales ($55 million), Selling, informational and administrative expenses ($21 million) and Other (income)/deductions––net ($163 million). For the third quarter and first nine months of 2017, includes $55 million in inventory losses, overhead costs related to the period in which our Puerto Rico plants were not operational, and incremental costs, all of which resulted from hurricanes in Puerto Rico and are included in Cost of sales. For the nine months ended October 1, 2017, also includes a net loss of $30 million related to the sale of our 40% ownership investment in Teuto, including the extinguishment of a put option for the then remaining 60% ownership interest, which is 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 and nine months ended September 30, 2018 were favorably impacted by the December 2017 enactment of the TCJA, primarily related to certain tax initiatives, as well as favorable adjustments to the provisional estimate of the impact of the legislation. Given the significant changes resulting from and complexities associated with the TCJA, the estimated financial impacts recorded in 2017 remain provisional and are subject to further analysis, interpretation and clarification of the TCJA, which could result in further changes to these estimates in the fourth quarter of 2018. Under guidance issued by the staff of the SEC, we expect to finalize our accounting related to the tax effects of the TCJA on deferred taxes, valuation allowances, state tax considerations, the repatriation tax liability, global intangible low-taxed income, and any remaining outside basis differences in our foreign subsidiaries during the fourth quarter of 2018, as we complete the remainder of our tax return filings and as any interpretations or clarifications of the TCJA occur through legislation or U.S. Treasury actions or other means.

2017-2019 Initiatives and Organizing for Growth
ANALYSIS OF OPERATING SEGMENT INFORMATION

The following tablesDuring 2018, as we reviewed our business opportunities and associated notes provide additional informationchallenges and the way in which we think about our business operations, we determined that at the performancestart of our two2019 fiscal year, we would begin operating segments—under our new commercial structure, which reorganized our operations into three businesses––Biopharma,a science-based innovative medicines business; Upjohn, a global, primarily off-patent branded and generic established medicines business; and through July 31, 2019, a Consumer Healthcare business. To operate effectively in this structure and position ourselves for future growth, we are focused on creating a simpler, more efficient operating structure within each business as well as the IH segmentfunctions that support them. Beginning in the fourth quarter of 2018, we reviewed previously planned initiatives and new initiatives to ensure that there was alignment around our new structure and have combined the EH segment.2017-2019 initiatives with our current Organizing for Growth initiatives to form one cohesive plan. For the combined programs, to achieve targeted savings of approximately $2.0 billion, we expect to incur approximately $2.0 billion in costs over the three-year period 2017-2019, and approximately $500 million beyond 2019, primarily on manufacturing activities. Of the total $2.5 billion, we expect approximately 50% to be related to

manufacturing operations, and we expect approximately 20% of the charges to be non-cash. We expect anticipated savings through 2020 associated with the Organizing for Growth initiatives of approximately $500 million will be reinvested in our R&D pipeline and in selling and marketing to support our current and recently launched products and indications. For additional information about each operating segment,these programs and expected and actual total costs, see the “Our Strategy––Commercial Operations” section of this MD&A and Notes to Condensed Consolidated Financial Statements—Note 13. Segment, Geographic3. Restructuring Charges and Other Revenue Information, as well as the “Selected Balance Sheet Information by Operating Segment” sectionCosts Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.

In addition to these major initiatives, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of the MD&A in our Quarterly Report on Form 10-Qlosses of exclusivity and the expiration of collaborative arrangements for various products.

Other (Income)/Deductions—Net
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Other (income)/deductions––net $319
 $(414) * $537
 $(1,143) *
* Calculation not meaningful or results are equal to or greater than 100%.
For information about the quarterly period ended April 1, 2018.
As described in thecomponents of Other (income)/deductions—net, see Notes to Condensed Consolidated Financial Statements—Note 1A.Basis4. Other (Income)/Deductions—Net.
See also the “Analysis of Presentation and Significant Accounting Policies: BasisOperating Segment Information” section of Presentation, the February 3, 2017 sale of HIS impacted our results of operations in 2017.this MD&A.
Provision for Taxes on Income
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:
  Third Quarter of 2018
(MILLIONS OF DOLLARS) 
Innovative Health (IH)(a)

 
Essential Health (EH)(a)

 
Other(b)

 
Non-GAAP
Adjusted(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $8,471
 $4,826
 $
 $13,298
 $
 $13,298
Cost of sales 981
 1,413
 279
 2,673
 21
 2,694
% of revenue 11.6%
29.3%
*

20.1%
*

20.3%
Selling, informational and administrative expenses 1,695
 663
 1,114
 3,471
 23
 3,494
Research and development expenses 695
 225
 1,078
 1,998
 10
 2,008
Amortization of intangible assets 57
 20
 (6) 71
 1,182
 1,253
Restructuring charges and certain acquisition-related costs 
 
 
 
 85
 85
Other (income)/deductions––net (345) (22) 65
 (302) (112) (414)
Income/(loss) from continuing operations before provision for taxes on income $5,388
 $2,527
 $(2,530) $5,386
 $(1,208) $4,177
  Three Months Ended Nine Months Ended  
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Provision for taxes on income $3,047
 $66
 * $2,566
 $1,270
 *
Effective tax rate on continuing operations 28.4% 1.6%   13.4% 9.9%  
* Calculation not meaningful or results are equal to or greater than 100%.
  Nine Months Ended September 30, 2018
(MILLIONS OF DOLLARS) 
Innovative Health (IH)(a)

 
Essential Health (EH)(a)

 
Other(b)

 
Non-GAAP
Adjusted
(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $24,573
 $15,097
 $
 $39,670
 $
 $39,670
Cost of sales 3,049
 4,442
 595
 8,086
 87
 8,173
% of revenue 12.4% 29.4% *
 20.4% *
 20.6%
Selling, informational and administrative expenses 4,967
 1,909
 3,388
 10,264
 183
 10,448
Research and development expenses 1,882
 683
 2,961
 5,526
 23
 5,549
Amortization of intangible assets 165
 47
 
 212
 3,428
 3,640
Restructuring charges and certain acquisition-related costs 
 
 
 
 172
 172
Other (income)/deductions––net (909) (117) (117) (1,143) 
 (1,143)
Income/(loss) from continuing operations before provision for taxes on income $15,419
 $8,133
 $(6,827) $16,725
 $(3,894) $12,831
  Third Quarter of 2017
(MILLIONS OF DOLLARS) 
Innovative Health (IH)(a)

 
Essential Health (EH)(a)

 
Other(b)

 
Non-GAAP
Adjusted
(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $8,118
 $5,050
 $
 $13,168
 $
 $13,168
Cost of sales 1,082
 1,448
 167
 2,696
 147
 2,844
% of revenue 13.3%
28.7%
*

20.5%
*

21.6%
Selling, informational and administrative expenses 1,619
 693
 1,171
 3,482
 22
 3,504
Research and development expenses 634
 250
 973
 1,857
 8
 1,865
Amortization of intangible assets 40
 17
 
 57
 1,120
 1,177
Restructuring charges and certain acquisition-related costs 
 
 
 
 114
 114
Other (income)/deductions––net (256) (158) 147
 (268) 347
 79
Income/(loss) from continuing operations before provision for taxes on income $5,000
 $2,801
 $(2,457) $5,343
 $(1,759) $3,585
See end of tables for notes (a) through (d).

  Nine Months Ended October 1, 2017
(MILLIONS OF DOLLARS) 
Innovative Health (IH)(a)

 
Essential Health (EH)(a)

 
Other(b)

 
Non-GAAP
Adjusted
(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $23,204
 $15,639
 $
 $38,843
 $
 $38,843
Cost of sales 2,912
 4,319
 489
 7,720
 252
 7,972
% of revenue 12.6% 27.6% *
 19.9% *
 20.5%
Selling, informational and administrative expenses 4,598
 2,103
 3,467
 10,167
 82
 10,249
Research and development expenses 1,694
 760
 2,894
 5,348
 20
 5,367
Amortization of intangible assets 90
 43
 
 133
 3,438
 3,571
Restructuring charges and certain acquisition-related costs 
 
 
 
 267
 267
Other (income)/deductions––net (623) (258) 334
 (547) 613
 65
Income/(loss) from continuing operations before provision for taxes on income $14,534
 $8,672
 $(7,183) $16,023
 $(4,671) $11,351
*Indicates calculation not meaningful or result is equal to or greater than 100%.
(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.
The following organizational change impactedFor information about our operating segments in 2018:
Effective ineffective tax rate and the first quarter of 2018, certain costs for Pfizer’s StratCO group, which were previously reported in the operating results of our operating segmentsevents and Corporate, are reported in Other Unallocated. StratCO costs primarily include headcount costs, vendor costs and data costs largely in support of Pfizer’s commercial operations. The majority of the StratCO costs reflect additional amounts that our operating segments would have incurred had each segment operated as a standalone company during the periods presented. The reporting change was made to streamline accountability and speed decision making. In the third quarter of 2017, we reclassified approximately $125 million of costs from IH, approximately $36 million of costs from EH and approximately $19 million of costs from Corporate to Other unallocated costs to conformcircumstances contributing to the current period presentation. In the first nine months of 2017, we reclassified approximately $344 million of costs from IH, approximately $114 million of costs from EH and approximately $40 million of costs from Corporate to Other unallocated costs to conform to the current period presentation.
(b)
Other comprises the costs included in our Adjusted income components (see footnote (c) below) that are managed outside of our two operating segmentsand includes the following:
  Third Quarter of 2018
  Other Business Activities   
(MILLIONS OF DOLLARS) 
WRD(i)

 
GPD(ii)

 
Corporate(iii)

 
Other Unallocated(iv)

 Total
Revenues $
 $
 $
 $
 $
Cost of sales 
 
 21
 258
 279
Selling, informational and administrative expenses 
 
 950
 164
 1,114
Research and development expenses 550
 193
 318
 16
 1,078
Amortization of intangible assets 
 
 
 (6) (6)
Restructuring charges and certain acquisition-related costs 
 
 
 
 
Other (income)/deductions––net (6) (1) 47
 26
 65
Loss from continuing operations before provision for taxes on income $(543) $(192) $(1,337) $(457) $(2,530)
  Nine Months Ended September 30, 2018
  Other Business Activities    
(MILLIONS OF DOLLARS) 
WRD(i)

 
GPD(ii)

 
Corporate(iii)

 
Other Unallocated(iv)

 Total
Revenues $
 $
 $
 $
 $
Cost of sales 
 
 149
 446
 595
Selling, informational and administrative expenses 
 
 2,881
 507
 3,388
Research and development expenses 1,664
 579
 672
 46
 2,961
Amortization of intangible assets 
 
 
 
 
Restructuring charges and certain acquisition-related costs 
 
 
 
 
Other (income)/deductions––net (110) (4) (69) 65
 (117)
Loss from continuing operations before provision for taxes on income $(1,554) $(575) $(3,633) $(1,064) $(6,827)

  Third Quarter of 2017
  Other Business Activities    
(MILLIONS OF DOLLARS) 
WRD(i)

 
GPD(ii)

 
Corporate(iii)

 
Other Unallocated(iv)

 Total
Revenues $
 $
 $
 $
 $
Cost of sales 
 
 27
 139
 167
Selling, informational and administrative expenses 
 
 980
 191
 1,171
Research and development expenses 570
 195
 189
 20
 973
Amortization of intangible assets 
 
 
 
 
Restructuring charges and certain acquisition-related costs 
 
 
 
 
Other (income)/deductions––net (4) (1) 167
 (15) 147
Loss from continuing operations before provision for taxes on income $(566) $(193) $(1,363) $(335) $(2,457)
  Nine Months Ended October 1, 2017
  Other Business Activities    
(MILLIONS OF DOLLARS) 
WRD(i)

 
GPD(ii)

 
Corporate(iii)

 
Other Unallocated(iv)

 Total
Revenues $
 $
 $
 $
 $
Cost of sales 
 
 (4) 493
 489
Selling, informational and administrative expenses 
 (1) 2,965
 502
 3,467
Research and development expenses 1,680
 565
 609
 39
 2,894
Amortization of intangible assets 
 
 
 
 
Restructuring charges and certain acquisition-related costs 
 
 
 
 
Other (income)/deductions––net (36) (4) 338
 36
 334
Loss from continuing operations before provision for taxes on income $(1,644) $(561) $(3,908) $(1,070) $(7,183)
(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.
(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.
(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), 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, as well as certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments. Effective in the first quarter of 2018, certain costs for StratCO, which were previously reported in the operating results of our operating segments and Corporate, are reported in Other Unallocated. For additional information, see note (iv) below.
We recognized a $14 million loss in the third quarter of 2018 and a $47 million gain in the first nine months of 2018 as an offset to Cost of sales primarily related to euro-denominated forward-exchange contracts designated as cash flow hedges of a portion of our foreign exchange-denominated forecasted intercompany inventory sales. We recognized a $4 million loss in the third quarter of 2017 and a $67 million gain in the first nine months of 2017 as a reduction to Cost of sales related to euro, Japanese yen and U.K. pound-denominated forward-exchange contracts designated as cash flow hedges of a portion of our foreign exchange-denominated forecasted intercompany inventory sales. For additional information,changes between periods, see Notes to Condensed Consolidated Financial Statements––Statements—Note 7F.5. Tax Matters.
Non-GAAP Financial Instruments: DerivativeMeasure (Adjusted Income)
General Description of Non-GAAP Financial Instruments and Hedging Activities.Measure (Adjusted Income)
(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). In connection with the StratCO reporting change, in the third quarter of 2017, we reclassified approximately $125 million of costs from IH, approximately $36 million of costs from EH and approximately $19 million of costs from Corporate to Other unallocated costs to conform to the current period presentation. In the first nine months of 2017, we reclassified approximately $344 million of costs from IH, approximately $114 million of costs from EH and approximately $40 million of costs from Corporate to Other unallocated costs to conform to the current period presentation.
For information purposes only,
Adjusted income is an alternative view of performance used by management. We measure the following tables present reconciliationsperformance of the overall Company on this basis in conjunction with other performance metrics. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our segmentperformance is enhanced by disclosing this performance measure. We report Adjusted income, certain components of Adjusted income, and Adjusted diluted earnings per share in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of prescription medicines and vaccines––prior to considering certain income statement elements. We have defined Adjusted income as Net income attributable to Pfizer Inc. before the impact of purchase accounting for acquisitions, acquisition-related costs, discontinued operations and certain significant items, which are described below. Also, see the “Non-GAAP Financial Measure (Adjusted Income)––General Description of Non-GAAP Financial Measure (Adjusted Income)” section of our 2018 Financial Report for additional information. Similarly, we have defined the Adjusted income components as Cost of sales, Selling, informational and administrative expenses, Research and development expenses, Amortization of intangible assets and Other (income)/deductions––net each before the impact of purchase accounting for acquisitions, acquisition-related costs and certain significant items. We have defined Adjusted diluted earnings per share as Earnings per common share attributable to Pfizer Inc.––dilutedbefore the impact of purchase accounting for acquisitions, acquisition-related costs, discontinued operations and certain significant items. The Adjusted income measure, the Adjusted income component measures and the Adjusted diluted earnings per share measure are not, and should not be viewed as, substitutes for U.S. GAAP net income, U.S. GAAP net income components or U.S. GAAP diluted earnings per share.

The following are examples of how the Adjusted income and Adjusted diluted earnings per share measures are utilized:
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 2018 Financial Report for additional information.
Adjusted income and its components and Adjusted diluted earnings per share are non-GAAP financial measures that have no standardized meaning prescribed by U.S. GAAP and, therefore, are limited in their usefulness to segment operating results including estimated Other costs generally associated with each segment. Whileinvestors. Because of their non-standardized definitions, Adjusted income and its components (unlike U.S. GAAP net income and its components) and Adjusted diluted earnings per share (unlike U.S. GAAP diluted earnings per share) may not be comparable to the calculation of similar measures of other companies. Adjusted income and its components and Adjusted diluted earnings per share are presented solely to permit investors to more fully understand how management assesses performance.

We also recognize that, as internal measures of performance, the Adjusted income and its components and Adjusted diluted earnings per share measures have limitations, and we do not managerestrict our segmentsperformance-management process solely to these metrics. A limitation of these measures is that they provide a view of our operations without including all events during a period, such as the effects of an acquisition or have performance goals under such an allocated manner, we believe that some investors may find this information useful in their analyses.
The estimated Other costs generally associated with our operating segmentsamortization of purchased intangibles, and do not purport to reflect the additional amounts that eachprovide a comparable view of our operating segments would have incurred had each segment operated asperformance to other companies in the biopharmaceutical industry. We also use other specifically tailored tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a standalone company duringpublicly-traded pharmaceutical index, plays a significant role in determining payouts under certain of Pfizer’s long-term incentive compensation plans.

See the period presented.

Foraccompanying reconciliations of certain GAAP reported to non-GAAP adjusted information purposes only, for the third quarter and first nine months of 2018, we estimate that Other costs, as described above, for combined WRD2019 and GPD costs of $2.1 billion, and combined Corporate and Other Unallocated costs of $4.4 billion after excluding (i) net interest-related expense not attributable to an operating segment included in Corporate (approximately $730 million for the first nine months of 2018 in Other (income)/deductions––net); and (ii) net income from investments and other assets not attributable to an operating segment included in Corporate (approximately $442 million for the first nine months of 2018 in Other(income)/deductions––net), are generally associated with our operating segments, as follows: below.


Nine Months Ended September 30, 2018




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
$24,573

$

$

$24,573
Cost of sales
3,049



81

3,130
Selling, informational and administrative expenses
4,967



1,918

6,886
Research and development expenses
1,882

2,219

658

4,760
Amortization of intangible assets
165



(4)
161
Restructuring charges and certain acquisition-related costs







Other (income)/deductions––net
(909)
(113)
(213)
(1,235)
Income from continuing operations before provision for taxes on income
15,419

(2,106)
(2,441)
10,872


Nine Months Ended September 30, 2018




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
$15,097

$

$

$15,097
Cost of sales
4,442



514

4,956
Selling, informational and administrative expenses
1,909



1,469

3,379
Research and development expenses
683

24

60

767
Amortization of intangible assets
47



4

51
Restructuring charges and certain acquisition-related costs







Other (income)/deductions––net
(117)


(78)
(195)
Income from continuing operations before provision for taxes on income
8,133

(24)
(1,969)
6,141
(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.
The estimated Other costs generally associated with our operating segments do not purport to reflect the additional amounts that each of our operating segments would have incurred had each segment operated as a standalone company during the period presented.
(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.

Third Quarter of 2018 vs. Third Quarter of 2017
Innovative Health Operating Segment
Revenues
IH Revenues increased $353 million, or 4%, to $8.5 billion, reflecting an operational increase of $426 million, or 5%, partially offset by the unfavorable impact of foreign exchange of $73 million, or 1%.
The following provides an analysis of the increase in IH worldwide Revenues:
(MILLIONS OF DOLLARS)  
IH Revenues, for the three months ended October 1, 2017
 $8,118
   
Operational growth/(decline):  
Continued growth from certain key brands(a)
 660
Growth from recently launched products, including Eucrisa in the U.S., as well as Besponsa and Bavencio, primarily in the U.S. and developed Europe 52
Negative impact of the loss of exclusivity of Viagra in the U.S. in December 2017 and the resulting shift in the reporting of U.S. and Canada Viagra revenues from IH to EH at the beginning of 2018 (206)
Lower revenues for Enbrel, primarily in most developed Europe markets due to continued biosimilar competition (65)
Other operational factors, net (15)
Operational growth, net 426
   
Unfavorable impact of foreign exchange (73)
IH Revenues increase
 353
IH Revenues, for the three months ended September 30, 2018
 $8,471
(a)
Certain key brands represent Eliquis, Ibrance, Prevnar 13/Prevenar 13, Xeljanz and Xtandi. See the “Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion” section of this MD&A for product analysis information.
Total IH revenues from emerging markets increased $78 million, or 7%, to $1.2 billion from $1.1 billion, reflecting 14% operational growth. Foreign exchange had an unfavorable impact of 7% on total IH revenues from emerging markets.
Costs and Expenses
The changes in expenses below reflect, among other things, a decline in expenses resulting from the July 31, 2019 completion of the Consumer Healthcare JV transaction with GSK. Our financial results, and our Consumer Healthcare segment’s operating results, for the third quarter of 2019 reflect only one month of Consumer Healthcare segment domestic operations and two months of Consumer Healthcare segment international operations. Likewise, our financial results, and our Consumer Healthcare segment’s operating results, for the first nine months of 2019 reflect seven months of Consumer Healthcare segment domestic operations and eight months of Consumer Healthcare segment international operations. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation.
Cost of Sales
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 
%
 Change

 September 29,
2019

 September 30,
2018

 
%
 Change

Cost of sales $2,602
 $2,694
 (3) $7,611
 $8,173
 (7)
As a percentage of Revenues
 20.5% 20.3%   19.5% 20.6%  
Cost of salesas a percentage decreased $92 million, or 3%, in the third quarter of Revenues decreased 1.7 percentage points,2019, compared to the same period in 2018, primarily driven by due to:
the favorable impact of foreign exchange.
the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
The decreaselower royalty expense for Lyrica due to the June 2019 loss of exclusivity in Cost of sales of 9% was primarily driven by the favorable impact of foreign exchange, partially offset by an increase in sales volumes for various key products within our product portfolio and an increase in royalty expenses based on the mix of products sold.U.S.,
The increase in Selling, informational and administrativeexpenses of 5% was primarily driven by additional investment across several of our key products, primarily Xeljanz, Eucrisa, Eliquis and Prevnar 13/Prevenar 13 (pediatric indication), partially offset by lower healthcare reform expenses as a result of a true up of a prior year amount, and the favorable impact of foreign exchange.
The increase in Research and developmentexpenses of 10% primarily reflects:
increased costs for our rare disease portfolio;
increased costs associated with our Phase 3 clinical trial related to our JAK1 inhibitor (which was initiated in December 2017); and
increased costs across the Oncology portfolio, including costs associated with Bavencio studies,
partially offset by:
lower costs due
a $127 million charge for rivipansel, primarily for inventory manufactured for expected future sale (see Notes to the completion of certain tanezumab studies.Condensed Consolidated Financial Statements––Note 2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement).
Cost of sales decreased$562 million, or 7%, in the first nine months of 2019, compared to the same period in 2018, primarily due to:
Thethe favorable impact of foreign exchange of $341 million;
the favorable impact of hedging activity on intercompany inventory of $216 million;
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
lower royalty expense for Lyrica due to the June 2019 loss of exclusivity in the U.S.,
partially offset by:
an unfavorable change in Other (income)/deductions––net primarily reflects:
product mix; and
a $36$127 million charge for rivipansel, primarily for inventory manufactured for expected future sale (see Notes to Condensed Consolidated Financial Statements––Note 2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement).
The slight increase in Cost of sales as a percentage of revenues in the third quarter of 2019, compared to the same period in 2018, was primarily due to all of the factors discussed above, as well as the impact of the loss of exclusivity of Lyrica in the U.S., partially offset by an increase in alliance revenues, which have no associated cost of sales.
The decrease in Cost of sales as a percentage of revenues in the first nine months of 2019, compared to the same period in 2018, was primarily due to all of the factors discussed above, as well an increase in alliance revenues, which have no associated cost of sales, partially offset by the impact of the loss of exclusivity of Lyrica in the U.S.
Selling, Informational and Administrative (SI&A) Expenses
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
 Change

 September 29,
2019

 September 30,
2018

 %
 Change

Selling, informational and administrative expenses $3,260
 $3,494
 (7) $10,110
 $10,448
 (3)
As a percentage of Revenues
 25.7% 26.3%   25.9% 26.3%  

SI&A expenses decreased $234 million, or 7%, in the third quarter of 2019, compared to the same period in 2018, primarily due to:
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK;
lower advertising, promotional and field force expenses in developed markets, primarily related to Lyrica in the U.S., and
the favorable impact of foreign exchange of $48 million,
partially offset by:
additional investment across several of our products.
SI&A expenses decreased $338 million, or 3%, in the first nine months of 2019, compared to the same period in 2018, primarily due to:
the favorable impact of foreign exchange of $254 million;
lower advertising, promotional and field force expenses in developed markets, primarily related to Lyrica in the U.S.;
the favorable impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK; and
the non-recurrence of a special, one-time bonus paid to virtually all Pfizer colleagues, excluding executives, of $119 million, in the aggregate, in the first quarter of 2018,
partially offset by:
additional investment across several of our key products; and
additional investments in China across key brands.
Research and Development (R&D) Expenses
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Research and development expenses $2,283
 $2,008
 14 $5,827
 $5,549
 5
As a percentage of Revenues
 18.0% 15.1%   14.9% 14.0% 
R&D expenses increased $275 million, or 14%, in the third quarter of 2019, compared to the same period in 2018, and increased $278 million, or 5%, in the first nine months of 2019, compared to the same period in 2018 primarily due to:
investments in dividend incomenewly acquired Therachon and Array products (see Notes to Condensed Consolidated Financial Statements––Note 2A. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions);
increased investments towards building new capabilities and driving automation; and
increased spending on our Inflammation & Immunology and Rare Disease portfolios due to several phase 3 programs and
investment in gene therapy,
partially offset by:
a decrease in the value of the portfolio performance share grants reflecting changes in the price of Pfizer’s common stock, as well as management’s assessment of the probability that the specific performance criteria will be achieved;
decreased spending across the Oncology, Vaccines and Internal Medicine portfolios, as select programs have reached completion; and
the timing of milestone activity.
For additional information on Cost of sales, SI&A and R&D expenses by operating segment, see the “Analysis of Operating Segment Information” section of this MD&A.
Amortization of Intangible Assets
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change

 September 29,
2019

 September 30,
2018

 %
Change

Amortization of intangible assets $1,212
 $1,253
 (3) $3,578
 $3,640
 (2)
As a percentage of Revenues
 9.6% 9.4%   9.2% 9.2%  

Amortization of intangible assets decreased $42 million, or 3%, in the third quarter of 2019, compared to the same period in 2018, primarily due to the non-recurrence of amortization expense resulting from the impairment of sterile injectable products

in the fourth quarter of 2018 and the contribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with GSK, partially offset by an increase in amortization expense of intangible assets as a result of our acquisition of Array.

Amortization of intangible assets decreased $61 million, or 2%, in the first nine months of 2019, compared to same period in 2018, primarily due to the non-recurrence of amortization expense resulting from the impairment of sterile injectable products in 2018 and the contribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with GSK, partially offset by an increase in amortization expense of assets recorded as a result of the approval of an additional indication for Xtandi in the U.S., and amortization of intangible assets as a result of our acquisition of Array.
For additional information, see Notes to Condensed Consolidated Financial Statements—Note 2A.Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions, Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Equity-Method Investment and Assets and Liabilities Held for Sale andNote 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets.
Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) Sept. 29,
2019

 Sept. 30,
2018

 %
Change

 Sept. 29,
2019

 Sept. 30,
2018

 %
Change

Restructuring charges/(credits)—acquisition-related costs(a)
 $19
 $24
 (20) $(196) $5
 *
Restructuring charges/(credits)—cost reduction initiatives(b)
 64
 (22) *
 145
 (37) *
Restructuring charges/(credits) 83
 1
 *
 (50) (32) 58
Transaction costs(c)
 65
 1
 *
 65
 1
 *
Integration costs and other(c)
 217
 82
 *
 281
 202
 39
Restructuring charges and certain acquisition-related costs 365
 85
 *
 295
 172
 72
Net periodic benefit costs 9
 41
 (78) 19
 103
 (81)
Additional depreciation—asset restructuring 6
 12
 (50) 29
 43
 (33)
Total implementation costs 40
 48
 (17) 109
 130
 (17)
Costs associated with acquisitions and cost-reduction/productivity initiatives(d)
 $420
 $186
 *
 $452
 $447
 1
* Calculation not meaningful or results are equal to or greater than 100%.
(a)
Restructuring charges/(credits)––acquisition-related costs include employee termination costs, asset impairments and other exit costs associated with business combinations. Charges for the third quarter of 2019 represent employee termination costs related to our investment in ViiV;acquisition of Array. Credits for the first nine months of 2019 were mostly due to the reversal of certain accruals related to our acquisition of Wyeth upon the effective favorable settlement of a U.S. IRS audit for multiple tax years. See Notes to Condensed Consolidated Financial Statements—Note 5B. Tax Matters: Tax Contingencies. Charges for the third quarter of 2018 were primarily due to accruals for exit costs and asset write downs related to our acquisition of Hospira, and charges for the first nine months of 2018 were mainly due to asset write downs related to our acquisition of Hospira, partially offset by the reversal of previously recorded accruals for employee termination costs related to our acquisition of Hospira.
(b)
a $33 million increase in income from collaborations, out-licensing arrangements
Restructuring charges/(credits)––cost reduction initiatives relate to employee termination costs, asset impairments and salesother exit costs not associated with acquisitions. For the third quarter of compound/product rights;2019, the charges were mainly composed of employee termination costs, and for the first nine months of 2019, the charges were mostly related to employee termination costs and exit costs. For the third quarter and first nine months of 2018, the credits were mostly related to the reversal of previously recorded accruals for employee termination costs.
(c)
a $14 million increase
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)
Comprises Restructuring charges and certain acquisition-related costs as well as costs associated with our cost-reduction/productivity initiatives included in Xtandi royalty income.Cost of sales, Research and development expenses,Selling, informational and administrative expenses and/or Other (income)/deductions––net as appropriate. 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.

2017-2019 Initiatives and Organizing for Growth
Essential HealthDuring 2018, as we reviewed our business opportunities and challenges and the way in which we think about our business operations, we determined that at the start of our 2019 fiscal year, we would begin operating under our new commercial structure, which reorganized our operations into three businesses––Biopharma,a science-based innovative medicines business; Upjohn, a global, primarily off-patent branded and generic established medicines business; and through July 31, 2019, a Consumer Healthcare business. To operate effectively in this structure and position ourselves for future growth, we are focused on creating a simpler, more efficient operating structure within each business as well as the functions that support them. Beginning in the fourth quarter of 2018, we reviewed previously planned initiatives and new initiatives to ensure that there was alignment around our new structure and have combined the 2017-2019 initiatives with our current Organizing for Growth initiatives to form one cohesive plan. For the combined programs, to achieve targeted savings of approximately $2.0 billion, we expect to incur approximately $2.0 billion in costs over the three-year period 2017-2019, and approximately $500 million beyond 2019, primarily on manufacturing activities. Of the total $2.5 billion, we expect approximately 50% to be related to

manufacturing operations, and we expect approximately 20% of the charges to be non-cash. We expect anticipated savings through 2020 associated with the Organizing for Growth initiatives of approximately $500 million will be reinvested in our R&D pipeline and in selling and marketing to support our current and recently launched products and indications. For additional information about these programs and expected and actual total costs, see Notes to Condensed Consolidated Financial Statements—Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.

In addition to these major initiatives, we continuously monitor our operations for cost reduction and/or productivity opportunities, especially in light of the losses of exclusivity and the expiration of collaborative arrangements for various products.

Other (Income)/Deductions—Net
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Other (income)/deductions––net $319
 $(414) * $537
 $(1,143) *
* Calculation not meaningful or results are equal to or greater than 100%.
For information about the components of Other (income)/deductions—net, see Notes to Condensed Consolidated Financial Statements—Note 4. Other (Income)/Deductions—Net.
See also the “Analysis of Operating Segment Information” section of this MD&A.
Provision for Taxes on Income
  Three Months Ended Nine Months Ended  
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 %
Change
 September 29,
2019

 September 30,
2018

 %
Change
Provision for taxes on income $3,047
 $66
 * $2,566
 $1,270
 *
Effective tax rate on continuing operations 28.4% 1.6%   13.4% 9.9%  
* Calculation not meaningful or results are equal to or greater than 100%.
For information about our effective tax rate and the events and circumstances contributing to the changes between periods, see Notes to Condensed Consolidated Financial Statements—Note 5. Tax Matters.
Non-GAAP Financial Measure (Adjusted Income)
General Description of Non-GAAP Financial Measure (Adjusted Income)

Adjusted income is an alternative view of performance used by management. We measure the performance of the overall Company on this basis in conjunction with other performance metrics. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our performance is enhanced by disclosing this performance measure. We report Adjusted income, certain components of Adjusted income, and Adjusted diluted earnings per share in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of prescription medicines and vaccines––prior to considering certain income statement elements. We have defined Adjusted income as Net income attributable to Pfizer Inc. before the impact of purchase accounting for acquisitions, acquisition-related costs, discontinued operations and certain significant items, which are described below. Also, see the “Non-GAAP Financial Measure (Adjusted Income)––General Description of Non-GAAP Financial Measure (Adjusted Income)” section of our 2018 Financial Report for additional information. Similarly, we have defined the Adjusted income components as Cost of sales, Selling, informational and administrative expenses, Research and development expenses, Amortization of intangible assets and Other (income)/deductions––net each before the impact of purchase accounting for acquisitions, acquisition-related costs and certain significant items. We have defined Adjusted diluted earnings per share as Earnings per common share attributable to Pfizer Inc.––dilutedbefore the impact of purchase accounting for acquisitions, acquisition-related costs, discontinued operations and certain significant items. The Adjusted income measure, the Adjusted income component measures and the Adjusted diluted earnings per share measure are not, and should not be viewed as, substitutes for U.S. GAAP net income, U.S. GAAP net income components or U.S. GAAP diluted earnings per share.

The following are examples of how the Adjusted income and Adjusted diluted earnings per share measures are utilized:
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 2018 Financial Report for additional information.
Adjusted income and its components and Adjusted diluted earnings per share are non-GAAP financial measures that have no standardized meaning prescribed by U.S. GAAP and, therefore, are limited in their usefulness to investors. Because of their non-standardized definitions, Adjusted income and its components (unlike U.S. GAAP net income and its components) and Adjusted diluted earnings per share (unlike U.S. GAAP diluted earnings per share) may not be comparable to the calculation of similar measures of other companies. Adjusted income and its components and Adjusted diluted earnings per share are presented solely to permit investors to more fully understand how management assesses performance.

We also recognize that, as internal measures of performance, the Adjusted income and its components and Adjusted diluted earnings per share measures have limitations, and we do not restrict our performance-management process solely to these metrics. A limitation of these measures is that they provide a view of our operations without including all events during a period, such as the effects of an acquisition or amortization of purchased intangibles, and do not provide a comparable view of our performance to other companies in the biopharmaceutical industry. We also use other specifically tailored tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a publicly-traded pharmaceutical index, plays a significant role in determining payouts under certain of Pfizer’s long-term incentive compensation plans.

See the accompanying reconciliations of certain GAAP reported to non-GAAP adjusted information for the third quarter and first nine months of 2019 and 2018 below.
Purchase Accounting Adjustments

Adjusted income is calculated prior to considering certain significant purchase accounting impacts resulting from business combinations and net asset acquisitions. These impacts, primarily associated with Wyeth (acquired in 2009), Hospira (acquired in 2015), Anacor (acquired in 2016), Medivation (acquired in 2016) and Array (acquired in 2019), can include the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value, amortization related to the increase in fair value of the acquired finite-lived intangible assets, and to a much lesser extent, depreciation related to the increase/decrease in fair value of the acquired fixed assets (primarily manufacturing facilities), amortization related to the increase in fair value of acquired debt, and the fair value changes associated with contingent consideration. Therefore, the Adjusted income measure includes the revenues earned upon the sale of the acquired products without considering the acquisition cost of those products.
Acquisition-Related Costs

Adjusted income is calculated prior to considering transaction, integration, restructuring and additional depreciation costs associated with business combinations because these costs are unique to each transaction and represent costs that were incurred to restructure and integrate two businesses as a result of the acquisition decision. For additional clarity, only transaction costs, additional depreciation and restructuring and integration activities that are associated with a business combination or a net-asset acquisition are included in acquisition-related costs. We have made no adjustments for the resulting synergies.

Discontinued Operations

Adjusted income is calculated prior to considering the results of operations included in discontinued operations, as well as any related gains or losses on the disposal of such operations.

Certain Significant Items

Adjusted income is calculated prior to considering certain significant items. Certain significant items represent substantive and/or unusual items that are evaluated on an individual basis. Such evaluation considers both the quantitative and the qualitative aspects of their nature. Certain significant items may be highly variable and difficult to predict. Furthermore, in some cases it is reasonably possible that they could reoccur in future periods. For example, major non-acquisition-related cost-reduction programs stand on their own as they are specific to an event or goal with a defined term, but we may have subsequent programs based on reorganizations of the business, cost productivity or in response to loss of exclusivity or economic conditions. Legal charges to resolve litigation are also related to specific cases, which are facts and circumstances specific and, in some cases, may also be the result of litigation matters at acquired companies that were inestimable, not probable or unresolved at the date

of acquisition. Unusual items may represent items that are not part of our ongoing business; items that, either as a result of their nature or size, we would not expect to occur as part of our normal business on a regular basis; items that would be non-recurring; or items that relate to products we no longer sell. While not all-inclusive, examples of items that could be included as certain significant items would be gains on the completion of joint venture transactions such as the gain on the completion of the Consumer Healthcare joint venture transaction discussed in Notes to Condensed Consolidated Financial Statements—Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Equity-Method Investment and Assets and Liabilities Held for Sale, a major non-acquisition-related restructuring charge and associated implementation costs; amounts related to certain disposals of businesses, products or facilities that do not qualify as discontinued operations under U.S. GAAP; certain intangible asset impairments; adjustments related to the resolution of certain tax positions; the impact of adopting certain significant, event-driven tax legislation, such as the TCJA discussed in Notes to Condensed Consolidated Financial Statements—Note 5A. Tax Matters: Taxes on Income from Continuing Operations;or charges related to certain legal matters, such as certain of those discussed in Notes to Condensed Consolidated Financial Statements—Note 12A. Contingencies and Certain Commitments: Legal Proceedings, included in Part I, Item 1 of this Quarterly Report on Form 10-Q. Normal, ongoing defense costs of the Company or settlements of and accruals for legal matters made in the normal course of our business would not be considered certain significant items.
Beginning in 2019, we exclude the net gains and losses on investments in equity securities from our measure of Adjusted income because of their inherent volatility, which we do not control and cannot predict with any level of certainty and because we do not believe that including these gains and losses assists investors in understanding our business or is reflective of our core operations and business. We have revised Adjusted income and Adjusted diluted EPS for the third quarter and first nine months of 2018 to conform with our 2019 presentation.

Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items
  Three Months Ended September 29, 2019
IN MILLIONS, EXCEPT PER COMMON SHARE DATA GAAP Reported
 
Purchase Accounting Adjustments(a)

 
Acquisition-Related Items(a)

 
Discontinued Operations(a)

 
Certain Significant Items(a)

 Non-GAAP Adjusted
Revenues $12,680
 $
 $
 $
 $
 $12,680
Cost of sales 2,602
 4
 
 
 (147) 2,459
Selling, informational and administrative expenses 3,260
 1
 
 
 (64) 3,196
Research and development expenses 2,283
 1
 
 
 (343) 1,940
Amortization of intangible assets 1,212
 (1,140) 
 
 
 72
Restructuring charges and certain acquisition-related costs 365
 
 (300) 
 (64) 
(Gain) on completion of Consumer Healthcare JV transaction (8,087) 
 
 
 8,087
 
Other (income)/deductions––net 319
 (6) 
 
 (281) 32
Income from continuing operations before provision for taxes on income 10,727
 1,141
 300
 
 (7,187) 4,981
Provision for taxes on income(b)
 3,047
 239
 58
 
 (2,581) 763
Income from continuing operations 7,680
 902
 242
 
 (4,606) 4,218
Discontinued operations––net of tax 4
 
 
 (4) 
 
Net income attributable to noncontrolling interests 4
 
 
 
 
 4
Net income attributable to Pfizer Inc. 7,680
 902
 242
 (4) (4,606) 4,214
Earnings per common share attributable to Pfizer Inc.––diluted 1.36
 0.16
 0.04
 
 (0.82) 0.75
See end of tables for notes (a) and (b).

  Nine Months Ended September 29, 2019
IN MILLIONS, EXCEPT PER COMMON SHARE DATA GAAP Reported
 
Purchase Accounting Adjustments(a)

 
Acquisition-Related Items(a)

 
Discontinued Operations(a)

 
Certain Significant Items(a)

 Non-GAAP Adjusted
Revenues $39,062
 $
 $
 $
 $
 $39,062
Cost of sales 7,611
 15
 
 
 (196) 7,430
Selling, informational and administrative expenses 10,110
 2
 (2) 
 (139) 9,971
Research and development expenses 5,827
 3
 
 
 (372) 5,458
Amortization of intangible assets 3,578
 (3,377) 
 
 
 201
Restructuring charges and certain acquisition-related costs 295
 
 (150) 
 (145) 
(Gain) on completion of Consumer Healthcare JV transaction (8,087) 
 
 
 8,087
 
Other (income)/deductions––net 537
 
 
 
 (740) (203)
Income from continuing operations before provision for taxes on income 19,190
 3,357
 152
 
 (6,495) 16,204
Provision for taxes on income(b)
 2,566
 685
 69
 
 (759) 2,560
Income from continuing operations 16,625
 2,673
 83
 
 (5,737) 13,644
Discontinued operations––net of tax 4
 
 
 (4) 
 
Net income attributable to noncontrolling interests 19
 
 
 
 
 19
Net income attributable to Pfizer Inc. 16,609
 2,673
 83
 (4) (5,737) 13,625
Earnings per common share attributable to Pfizer Inc.––diluted 2.92
 0.47
 0.01
 
 (1.01) 2.39
  Three Months Ended September 30, 2018
IN MILLIONS, EXCEPT PER COMMON SHARE DATA GAAP Reported
 
Purchase Accounting Adjustments(a)

 
Acquisition-Related Items(a)

 
Discontinued Operations(a)

 
Certain Significant Items(a)

 Non-GAAP Adjusted
Revenues $13,298
 $
 $
 $
 $
 $13,298
Cost of sales 2,694
 1
 (3) 
 (19) 2,673
Selling, informational and administrative expenses 3,494
 
 
 
 (23) 3,471
Research and development expenses 2,008
 1
 
 
 (11) 1,998
Amortization of intangible assets 1,253
 (1,182) 
 
 
 71
Restructuring charges and certain acquisition-related costs 85
 
 (107) 
 22
 
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
 
Other (income)/deductions––net (414) (130) (2) 
 329
 (217)
Income from continuing operations before provision for taxes on income 4,177
 1,309
 112
 
 (298) 5,300
Provision for taxes on income(b)
 66
 263
 21
 
 363
 712
Income from continuing operations 4,111
 1,047
 91
 
 (661) 4,588
Discontinued operations––net of tax 11
 
 
 (11) 
 
Net income attributable to noncontrolling interests 8
 
 
 
 
 8
Net income attributable to Pfizer Inc. 4,114
 1,047
 91
 (11) (661) 4,580
Earnings per common share attributable to Pfizer Inc.––diluted 0.69
 0.17
 0.02
 
 (0.11) 0.77

  Nine Months Ended September 30, 2018
IN MILLIONS, EXCEPT PER COMMON SHARE DATA GAAP Reported
 
Purchase Accounting Adjustments(a)

 
Acquisition-Related Items(a)
 
Discontinued Operations(a)

 
Certain Significant Items(a)

 Non-GAAP Adjusted
Revenues $39,670
 $
 $
 $
 $
 $39,670
Cost of sales 8,173
 (2) (9) 
 (77) 8,086
Selling, informational and administrative expenses 10,448
 1
 
 
 (185) 10,264
Research and development expenses 5,549
 3
 
 
 (26) 5,526
Amortization of intangible assets 3,640
 (3,428) 
 
 
 212
Restructuring charges and certain acquisition-related costs 172
 
 (209) 
 37
 
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
 
Other (income)/deductions––net (1,143) (238) (4) 
 702
 (683)
Income from continuing operations before provision for taxes on income 12,831
 3,665
 221
 
 (452) 16,265
Provision for taxes on income(b)
 1,270
 735
 40
 
 468
 2,513
Income from continuing operations 11,562
 2,930
 182
 
 (921) 13,752
Discontinued operations––net of tax 10
 
 
 (10) 
 
Net income attributable to noncontrolling interests 25
 
 
 
 
 25
Net income attributable to Pfizer Inc. 11,546
 2,930
 182
 (10) (921) 13,727
Earnings per common share attributable to Pfizer Inc.––diluted 1.92
 0.49
 0.03
 
 (0.15) 2.29
(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 15.3% in the third quarter of 2019, compared to 13.4% in the third quarter of 2018. The increase was primarily due to a decrease in tax benefits associated with the resolution of certain tax positions pertaining to prior years primarily with foreign tax authorities. The effective tax rate on Non-GAAP Adjusted income was 15.8% in the first nine months of 2019, compared to 15.4% in the first nine months of 2018. The increase was primarily due to a decrease in tax benefits associated with the resolution of certain tax positions pertaining to prior years primarily with foreign tax authorities, partially offset by the favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business.

Details of Income Statement Items Included in GAAP Reported but Excluded from Non-GAAP Adjusted Income
  Three Months Ended Nine Months Ended
(MILLIONS OF DOLLARS) September 29,
2019

 September 30,
2018

 September 29,
2019

 September 30,
2018

Purchase accounting adjustments        
Amortization, depreciation and other(a)
 $1,145
 $1,310
 $3,372
 $3,662
Cost of sales (4) (1) (15) 2
Total purchase accounting adjustments––pre-tax 1,141
 1,309
 3,357
 3,665
Income taxes(b)
 (239) (263) (685) (735)
Total purchase accounting adjustments––net of tax 902
 1,047
 2,673
 2,930
Acquisition-related items    
  
  
Restructuring charges/(credits)(c)
 19
 24
 (196) 5
Transaction costs(c)
 65
 1
 65
 1
Integration costs and other(c)
 217
 82
 281
 202
Net periodic benefit costs other than service costs 
 2
 
 4
Additional depreciation––asset restructuring(d)
 
 3
 2
 9
Total acquisition-related items––pre-tax 300
 112
 152
 221
Income taxes(e)
 (58) (21) (69) (40)
Total acquisition-related items––net of tax 242
 91
 83
 182
Discontinued operations    
  
  
Total discontinued operations––net of tax, attributable to Pfizer Inc.(f)
 (4) (11) (4) (10)
Certain significant items    
  
  
Restructuring charges/(credits)––cost reduction initiatives(g)
 64
 (22) 145
 (37)
Implementation costs and additional depreciation––asset restructuring(h)
 46
 57
 135
 164
Certain legal matters, net(i)
 63
 37
 72
 (70)
Certain asset impairments(i)
 
 
 149
 31
Business and legal entity alignment costs(i)
 89
 1
 353
 5
Net gains recognized during the period on investments in equity securities(i)
 (3) (85) (139) (460)
(Gain) on completion of Consumer Healthcare JV transaction(j)
 (8,087) 
 (8,087) 
Net losses on early retirement of debt(i)
 
 
 138
 3
Other(k)
 641
 (286) 738
 (89)
Total certain significant items––pre-tax (7,187) (298) (6,495) (452)
Income taxes(l)
 2,581
 (363) 759
 (468)
Total certain significant items––net of tax (4,606) (661) (5,737) (921)
Total purchase accounting adjustments, acquisition-related items, discontinued operations and certain significant items––net of tax, attributable to Pfizer Inc. $(3,466) $466
 $(2,984) $2,181
(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/(credits) includes employee termination costs, asset impairments and other exit costs associated with business combinations. Transaction costs represent external costs for banking, legal, accounting and other similar services. Integration costs and other represent external, incremental costs directly related to integrating acquired businesses, such as expenditures for consulting and the integration of systems and processes, and certain other qualifying costs. For additional information, see the “Costs and Expenses—Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiativessection of this MD&A and Notes to Condensed Consolidated Financial Statements—Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives.
(d)
Included in Selling, informational and administrative expenses for the nine months ended September 29, 2019 and in Cost of sales for the three and nine months ended September 30, 2018. 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 nine months of 2019 include the impact of the non-taxable reversal of certain accruals related to our acquisition of Wyeth upon the effective favorable settlement of a U.S. IRS audit for multiple tax years.
(f)
Included in Discontinued operations––net of tax.
(g)
Amounts relate to employee termination costs, asset impairments and other exit costs not associated with acquisitions, which are included in Restructuring charges and certain acquisition-related costs (see the “Costs and Expenses—Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiativessection of this MD&A and 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 September 29, 2019, included in Cost of sales ($20 million), Selling, informational and administrative expenses ($23 million) and Research and development expenses ($3 million). For the nine months ended September 29, 2019, included in Cost of sales ($65 million), Selling, informational and administrative expenses ($48 million) and Research and development expenses ($21 million). For the three months ended September 30, 2018, included in Cost of sales ($30 million), Selling, informational and administrative expenses ($17 million) and Research and development expenses ($9 million). For the nine months ended September 30, 2018, included in Cost of sales ($91 million), Selling, informational and administrative expenses ($51 million) and Research and development expenses ($22 million).
(i)
Included in Other (income)/deductionsnet except for business and legal entity alignment costs that are primarily included in Other (income)/deductionsnet (see Notes to Condensed Consolidated Financial Statements—Note 4. Other (Income)/Deductions—Net).
(j)
Included in (Gain) on completion of Consumer Healthcare JV transaction (see notes to Condensed Consolidated Financial Statements––Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement:Equity-Method Investment and Assets and Liabilities Held for Sale).
(k)
For the three months ended September 29, 2019, included in Cost of sales ($128 million), Selling, informational and administrative expenses ($39 million), Research and development expenses ($340 million) and Other (income)/deductions––net ($134 million). For the nine months ended September 29, 2019, included in Cost of sales ($130 million), Selling, informational and administrative expenses ($80 million), Research and development expenses ($351 million) and Other (income)/deductions––net ($178 million). For the three months ended September 30, 2018, included in Cost of sales ($12 million income), Selling, informational and administrative expenses ($6 million), Research and development expenses ($2 million) and Other (income)/deductions––net ($282 million income). For the nine months ended September 30, 2018, included in Cost of sales ($14 million income), Selling, informational and administrative expenses ($134 million), Research and development expenses ($3 million), and Other (income)/deductions––net ($212 million income). The third quarter and first nine months of 2019 include, among other things, (i) a $337 million charge in Research and development expenses related to our acquisition of Therachon and (ii) a $127 million charge for rivipansel in Cost of sales, primarilyfor inventory manufactured for expected future sale. In addition, the third quarter of 2019 includes charges of $161 million and the first nine months of 2019 include charges of $223 million, primarily in Other (income)/deductions––net and Selling, informational and administrative expenses, for external incremental costs, such as transaction costs and costs to separate our Consumer Healthcare business into a separate legal entity associated with the formation of the GSK Consumer Healthcare joint venture. The third quarter and first nine months of 2018 include, among other things, a non-cash $343 million pre-tax gain in Other (income)/deductions––net associated with our transaction with Bain Capital to create a new biopharmaceutical company, Cerevel, to continue development of a portfolio of clinical and pre-clinical stage neuroscience assets primarily targeting disorders of the central nervous system. The first nine months of 2018 also includes (i) a $119 million charge, in the aggregate, in Selling, informational and administrative expenses for a special, one-time bonus paid to virtually all Pfizer colleagues, excluding executives, which was one of several actions taken by us after evaluating the expected positive net impact of the December 2017 enactment of the legislation commonly referred to as the TCJA and (ii) a non-cash $50 million pre-tax gain in Other (income)/deductions––net as a result of the contribution of our allogeneic chimeric antigen receptor T cell therapy development program assets in connection with our asset contribution agreement entered into with Allogene.
(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 third quarter and first nine months of 2019 were impacted by the tax expense associated with the gain related to the completion of the Consumer Healthcare joint venture transaction with GSK. The first nine months of 2019 were favorably impacted by a benefit of $1.4 billion, representing tax and interest, resulting from the favorable settlement of a U.S. IRS audit for multiple tax years, as well as the tax benefit recorded as a result of additional guidance issued by the U.S. Department of Treasury related to the TCJA. The third quarter and nine months ended September 30, 2018 were favorably impacted by the December 2017 enactment of the TCJA, primarily related to certain tax initiatives, as well as favorable adjustments to the provisional estimate of the impact of the legislation.
Analysis of Operating Segment Information

The following tables and associated notes provide additional information about the performance of each of our two reportable operating segments—Biopharma and Upjohn and our Consumer Healthcare operating segment through July 31, 2019. For additional information about each operating segment, see the “Overview of Our Performance, Operating Environment, Strategy and Outlook—Our Strategy—Organizing for Growth” and “—Commercial Operations” sections of this MD&A and Notes to Condensed Consolidated Financial Statements—Note 13. Segment, Geographic and Other Revenue Information.
Acquisitions and the contribution of our Consumer Healthcare business to the GSK Consumer Healthcare joint venture have impacted our results of operations in 2019. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1A.Basis of Presentation and Significant Accounting Policies: Basis of Presentation.

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:
  Third Quarter of 2019
(MILLIONS OF DOLLARS) 
Biopharma(a)

 
Upjohn(a)

 
Other(b)

 
Non-GAAP
Adjusted(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $10,108
 $2,195
 $377
 $12,680
 $
 $12,680
Cost of sales 1,869
 425
 164
 2,459
 143
 2,602
% of revenue 18.5%
19.4%
*

19.4%
*

20.5%
Selling, informational and administrative expenses 1,602
 360
 1,234
 3,196
 64
 3,260
Research and development expenses 256
 57
 1,628
 1,940
 343
 2,283
Amortization of intangible assets 71
 
 
 72
 1,140
 1,212
Restructuring charges and certain acquisition-related costs 
 
 
 
 365
 365
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 (8,087) (8,087)
Other (income)/deductions––net (193) 
 226
 32
 287
 319
Income/(loss) from continuing operations before provision for taxes on income 6,503
 1,353
 (2,874) 4,981
 5,746
 10,727
See end of tables for notes (a) through (d).
  Nine Months Ended September 29, 2019
(MILLIONS OF DOLLARS) 
Biopharma(a)

 
Upjohn(a)

 
Other(b)

 
Non-GAAP
Adjusted
(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $28,887
 $8,077
 $2,098
 $39,062
 $
 $39,062
Cost of sales 5,488
 1,268
 674
 7,430
 181
 7,611
% of revenue 19.0% 15.7% *
 19.0% *
 19.5%
Selling, informational and administrative expenses 4,821
 1,064
 4,087
 9,971
 139
 10,110
Research and development expenses 623
 169
 4,667
 5,458
 369
 5,827
Amortization of intangible assets 201
 1
 
 201
 3,377
 3,578
Restructuring charges and certain acquisition-related costs 
 
 
 
 295
 295
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 (8,087) (8,087)
Other (income)/deductions––net (729) (2) 528
 (203) 740
 537
Income/(loss) from continuing operations before provision for taxes on income 18,484
 5,577
 (7,857) 16,204
 2,986
 19,190
  Third Quarter of 2018
(MILLIONS OF DOLLARS) 
Biopharma(a)

 
Upjohn(a)

 
Other(b)

 
Non-GAAP
Adjusted
(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $9,422
 $3,036
 $839
 $13,298
 $
 $13,298
Cost of sales 1,673
 476
 524
 2,673
 21
 2,694
% of revenue 17.8%
15.7%
*

20.1%
*

20.3%
Selling, informational and administrative expenses 1,626
 439
 1,406
 3,471
 23
 3,494
Research and development expenses 215
 67
 1,717
 1,998
 10
 2,008
Amortization of intangible assets 66
 
 5
 71
 1,182
 1,253
Restructuring charges and certain acquisition-related costs 
 
 
 
 85
 85
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
 
Other (income)/deductions––net (364) 3
 144
 (217) (197) (414)
Income/(loss) from continuing operations before provision for taxes on income 6,206
 2,051
 (2,956) 5,300
 (1,123) 4,177



  Nine Months Ended September 30, 2018
(MILLIONS OF DOLLARS) 
Biopharma(a)

 
Upjohn(a)

 
Other(b)

 
Non-GAAP
Adjusted
(c)

 
Reconciling Items(d)

 GAAP Reported
Revenues $27,737
 $9,302
 $2,631
 $39,670
 $
 $39,670
Cost of sales 5,242
 1,453
 1,391
 8,086
 87
 8,173
% of revenue 18.9% 15.6% *
 20.4% *
 20.6%
Selling, informational and administrative expenses 4,765
 1,239
 4,261
 10,264
 183
 10,448
Research and development expenses 583
 173
 4,770
 5,526
 23
 5,549
Amortization of intangible assets 177
 
 34
 212
 3,428
 3,640
Restructuring charges and certain acquisition-related costs 
 
 
 
 172
 172
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
 
Other (income)/deductions––net (1,016) (4) 337
 (683) (460) (1,143)
Income/(loss) from continuing operations before provision for taxes on income 17,987
 6,442
 (8,163) 16,265
 (3,434) 12,831
*Indicates calculation not meaningful or result is equal to or greater than 100%.
(a)
Amounts represent the revenues and costs managed by each of the Biopharma and Upjohn reportable operating segments for the periods presented. The expenses generally include only those costs directly attributable to the operating segment.
(b)
Other comprises the revenues and costs included in our Adjusted income components (see footnote (c) below) that are managed outside Biopharma and Upjohn and includes the following:
  Third Quarter of 2019
  Other Business Activities   
(MILLIONS OF DOLLARS) 
WRDM(i) 

 
GPD(ii)

 
Other(iii)

 
Corporate and Other Unallocated(iv)

 Total
Revenues $
 $
 $377
 $
 $377
Cost of sales 
 
 113
 51
 164
Selling, informational and administrative expenses 34
 
 263
 936
 1,234
Research and development expenses 582
 816
 19
 210
 1,628
Amortization of intangible assets 
 
 
 
 
Restructuring charges and certain acquisition-related costs 
 
 
 
 
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
Other (income)/deductions––net (9) 1
 
 234
 226
Income/(loss) from continuing operations before provision for taxes on income (608) (817) (19) (1,431) (2,874)
  Nine Months Ended September 29, 2019
  Other Business Activities  
(MILLIONS OF DOLLARS) 
WRDM(i)

 
GPD(ii)

 
Other(iii)

 
Corporate and Other Unallocated(iv)

 Total
Revenues $
 $
 $2,098
 $
 $2,098
Cost of sales 
 1
 663
 9
 674
Selling, informational and administrative expenses 84
 
 1,058
 2,944
 4,087
Research and development expenses 1,662
 2,306
 82
 617
 4,667
Amortization of intangible assets 
 
 
 
 
Restructuring charges and certain acquisition-related costs 
 
 
 
 
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
Other (income)/deductions––net (11) 
 
 538
 528
Income/(loss) from continuing operations before provision for taxes on income (1,736) (2,308) 294
 (4,108) (7,857)

  Third Quarter of 2018
  Other Business Activities    
(MILLIONS OF DOLLARS) 
WRDM(i)

 
GPD(ii)

 
Other(iii)

 
Corporate and Other Unallocated(iv)

 Total
Revenues $
 $
 $839
 $
 $839
Cost of sales 
 3
 281
 240
 524
Selling, informational and administrative expenses 35
 
 416
 955
 1,406
Research and development expenses 546
 806
 42
 323
 1,717
Amortization of intangible assets 
 
 11
 (6) 5
Restructuring charges and certain acquisition-related costs 
 
 
 
 
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
Other (income)/deductions––net (3) (8) 9
 146
 144
Income/(loss) from continuing operations before provision for taxes on income (578) (801) 80
 (1,658) (2,956)
  Nine Months Ended September 30, 2018
  Other Business Activities    
(MILLIONS OF DOLLARS) 
WRDM(i)

 
GPD(ii)

 
Other(iii)

 
Corporate and Other Unallocated(iv)

 Total
Revenues $
 $
 $2,631
 $
 $2,631
Cost of sales 
 
 870
 521
 1,391
Selling, informational and administrative expenses 98
 
 1,250
 2,913
 4,261
Research and development expenses 1,644
 2,318
 130
 678
 4,770
Amortization of intangible assets 
 
 34
 
 34
Restructuring charges and certain acquisition-related costs 
 
 
 
 
(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
 
Other (income)/deductions––net (107) (10) 8
 446
 337
Income/(loss) from continuing operations before provision for taxes on income (1,636) (2,308) 339
 (4,558) (8,163)
(i)
WRDM—the R&D and Medical expenses managed by our WRDM organization, which is generally responsible for research projects for our Biopharma portfolio until proof-of-concept is achieved and then for transitioning those projects to the GPD organization for possible clinical and commercial development. R&D spending may include upfront and milestone payments for intellectual property rights. The WRDM organization also has responsibility for certain science-based and other platform-services organizations, which provide end-to-end technical expertise and other services to the various R&D projects, as well as the Worldwide Medical and Safety group, which ensures that Pfizer provides all stakeholders––including patients, healthcare providers, pharmacists, payers and health authorities––with complete and up-to-date information on the risks and benefits associated with Pfizer products so that they can make appropriate decisions on how and when to use Pfizer’s medicines.
(ii)
GPD––the costs associated with our GPD organization, which is generally responsible for clinical trials from WRDM in the Biopharma portfolio, including late stage portfolio spend. GPD also provides technical support and other services to Pfizer R&D projects. GPD is responsible for facilitating all regulatory submissions and interactions with regulatory agencies.
(iii)
Other—the operating results of our Consumer Healthcare business, through July 31, 2019, and costs associated with other commercial activities not managed as part of Biopharma or Upjohn, including all strategy, business development, portfolio management and valuation capabilities, which previously had been reported in various parts of the organization.
(iv)
Corporate and Other Unallocated––the costs associated with platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance and worldwide procurement), patient advocacy activities and certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments, as well as overhead expenses associated with our manufacturing (which include manufacturing variances associated with production) and commercial operations that are not directly assessed to an operating segment, as business unit (segment) management does not manage these costs.
We recognized the following amounts in Cost of sales related to forward-exchange contracts designated as cash flow hedges of a portion of our foreign exchange-denominated forecasted intercompany inventory sales:
a $66 million gain in the third quarter of 2019;
a $169 million gain in the first nine months of 2019;
a $14 million gain in the third quarter of 2018; and
a $47 million loss in the first nine months of 2018.
For additional information, see Notes to Condensed Consolidated Financial Statements––Note 7E. Financial Instruments: Derivative Financial Instruments and Hedging Activities.

For information purposes only, the following tables present reconciliations of the Biopharma segment operating results and Upjohn segment operating results to Biopharma and Upjohn operating results including estimated Other costs generally associated with the Biopharma and Upjohn operating segments. While we do not manage our segments or have performance goals under such an allocated manner, we believe that some investors may find this information useful in their analyses.
The estimated Other costs generally associated with our operating segments do not purport to reflect the additional amounts that each of our operating segments would have incurred had each segment operated as a standalone company during the periods presented.
For information purposes only, for the first nine months of 2019, we estimate that Other costs attributable to our Biopharma and Upjohn segments, as described above, for combined WRDM, GPD and other business activities costs are $4.4 billion, and combined Corporate and Other Unallocated costs are $3.2 billion, which excludes income and costs associated with our Consumer Healthcare business. The combined Corporate and Other Unallocated costs also exclude (i) net interest-related expense not attributable to an operating segment included in Corporate (approximately $987 million for the first nine months of 2019 in Other (income)/deductions––net); and (ii) net income from investments and other assets not attributable to an operating segment included in Corporate (approximately $127 million for the first nine months of 2019 in Other(income)/deductions––net). The remaining costs have been attributed to our Biopharma and Upjohn operating segments, as follows:


Nine Months Ended September 29, 2019




Estimated Other Costs Associated with Biopharma(ii)


(MILLIONS OF DOLLARS)
Biopharma Non-GAAP Adjusted(i), (iii)


Estimated WRDM/
GPD/Other
Business Activities
(ii)


Estimated Corporate/Other Unallocated(ii)


Biopharma with
Estimated Other Costs
Associated with
Biopharma
Non-GAAP Adjusted
(ii), (iii)

Revenues
$28,887

$

$

$28,887
Cost of sales
5,488

1

6

5,495
Selling, informational and administrative expenses
4,821

400

2,183

7,403
Research and development expenses
623

3,977

582

5,182
Amortization of intangible assets
201





201
Restructuring charges and certain acquisition-related costs







(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
Other (income)/deductions––net
(729)
(9)
(255)
(992)
Income/(loss) from continuing operations before provision for taxes on income
18,484

(4,369)
(2,517)
11,598


Nine Months Ended September 29, 2019




Estimated Other Costs Associated with Upjohn(ii)


(MILLIONS OF DOLLARS)
Upjohn
Non-GAAP Adjusted
(i), (iii)


Estimated WRDM/
GPD/Other
Business Activities
(ii)


Estimated Corporate/Other Unallocated(ii)


Upjohn with
Estimated Other Costs
Associated with
Upjohn
Non-GAAP Adjusted
(ii), (iii)

Revenues
$8,077

$

$

$8,077
Cost of sales
1,268



(19)
1,249
Selling, informational and administrative expenses
1,064

24

599

1,687
Research and development expenses
169

1

20

190
Amortization of intangible assets
1





1
Restructuring charges and certain acquisition-related costs







(Gain) on completion of Consumer Healthcare JV transaction 
 
 
 
Other (income)/deductions––net
(2)


(44)
(46)
Income/(loss) from continuing operations before provision for taxes on income
5,577

(25)
(556)
4,996
(i)
Amount represents the revenues and costs managed by the 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.
WRDM/GPD/Other Business Activities––The information provided for WRDM, GPD and Other Business Activities was substantially all derived from our estimates of the costs incurred in connection with the R&D projects associated with the Biopharma and Upjohn operating segments as well as specific identification and estimates of costs incurred in connection with activities associated with the Biopharma and Upjohn operating segments.
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.
The estimated Other costs generally associated with our Biopharma and Upjohn operating segments do not purport to reflect the additional amounts that each of the operating segments would have incurred had each segment operated as a standalone company during the period presented.
(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 gains on the completion of joint venture transactions, restructuring charges, legal charges or net gains and losses on investment in equity securities), 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.
Third Quarter of 2019 vs. Third Quarter of 2018
Biopharma Operating Segment
Revenues
EH Biopharma Revenues decreased $223 increased $686 million, or 4%7%, to $4.8$10.1 billion, reflecting an operational decreaseincrease of $183$852 million, or 4%9%, andpartially offset by the unfavorable impact of foreign exchange of $40 million, or 1%.
The following provides an analysis of the decrease in EH worldwide Revenues:
(MILLIONS OF DOLLARS)


EH Revenues, for the three months ended October 1, 2017

$5,050




Operational growth/(decline):


Decline from the Peri-LOE Products portfolio, driven by lower revenues in developed markets (excluding Viagra EH), primarily due to expected declines in Lyrica in developed Europe
(125)
Decline in the LEP portfolio primarily driven by lower revenues in developed markets (121)
Decline from the SIP portfolio, driven by lower revenues in developed markets, primarily due to continued legacy Hospira product shortages in the U.S. (28)
Positive impact of Viagra, mostly driven by the shift in the reporting of U.S. and Canada Viagra revenues from IH to EH at the beginning of 2018 (due to the loss of exclusivity of Viagra in the U.S. in December 2017), partially offset by lower revenues in emerging markets and developed Europe markets (previously reported in EH) 37
Growth from Biosimilars, primarily from Inflectra in certain channels in the U.S., as well as in developed Europe
56
Other operational factors, net (2)
Operational decline, net
(183)
 


Unfavorable impact of foreign exchange
(40)
EH Revenues decrease

(223)
EH Revenues, for the three months ended September 30, 2018

$4,826
Total EH revenues from emerging markets increased $149 million, or 9%, to $1.9 billion from $1.7 billion, reflecting 11% operational growth, primarily driven by 11% operational growth from the LEP portfolio and 14% operational growth from the SIP portfolio, partially offset by a 2% operational decline from the Peri-LOE Products portfolio. Foreign exchange had an unfavorable impact of 3% on total EH revenues from emerging markets.
Costs and Expenses
Cost of sales as a percentage of Revenues increased 0.6 percentage points, primarily due to:
higher sales volumes of Inflectra in the U.S. and developed Europe, which carry higher product costs; and
lower sales volumes and margins as a result of product losses of exclusivity and generic competition in developed markets,
partially offset by:
the favorable impact of foreign exchange; and
lower sales volumes in the SIP portfolio, which carries a higher cost to produce, in developed markets, primarily due to continued legacy Hospira product shortages in the U.S.
The decrease in Cost of sales of 2% was primarily due to:
the favorable impact of foreign exchange; and
lower sales volumes driven by product losses of exclusivity and generic competition in developed markets,
partially offset by:
higher sales volumes of Inflectra in the U.S. and developed Europe, which carry higher product costs; and
higher costs across the SIP portfolio, as a result of the complexity of high quality product manufacturing across the legacy Hospira plants.
Selling, informational and administrativeexpenses decreased 4% mainly due to lower general and administrative expenses, as well as lower advertising, promotional and field force expenses, reflecting the benefits of cost-reduction and productivity initiatives, and the favorable impact of foreign exchange, partially offset by additional investments in China.
Research and developmentexpenses decreased 10% primarily due to decreased spending for biosimilars as several programs have reached completion.
The unfavorable change in Other (income)/deductions––netprimarily reflects the non-recurrence of income from resolution of a contract disagreement, the unfavorable impact of foreign exchange and the non-recurrence of a gain on the redemption of an acquired bond in 2017, partially offset by an increase in income from collaborations, out-licensing arrangements and sales of compound/product rights.

First Nine Months of 2018 vs. First Nine Months of 2017
Innovative Health Operating Segment
Revenues
IH Revenues increased $1.4 billion, or 6%, to $24.6 billion, reflecting an operational increase of $1.0 billion, or 4%, and the favorable impact of foreign exchange of $342$166 million, or 2%.
The following provides an analysis of the increase in IHBiopharma worldwide Revenues:
(MILLIONS OF DOLLARS)  
IH Revenues, for the nine months ended October 1, 2017
 $23,204
   
Operational growth/(decline):  
Continued growth from certain key brands(a)
 1,835
Growth from recently launched products, including Eucrisa in the U.S., as well as Besponsa and Bavencio, primarily in the U.S. and developed Europe 172
Negative impact of the loss of exclusivity of Viagra in the U.S. in December 2017 and the resulting shift in the reporting of U.S. and Canada Viagra revenues from IH to EH at the beginning of 2018 (711)
Lower revenues for Enbrel, primarily in most developed Europe markets due to continued biosimilar competition (279)
Other operational factors, net 11
Operational growth, net 1,028
   
Favorable impact of foreign exchange 342
IH Revenues increase
 1,370
IH Revenues, for the nine months ended September 30, 2018
 $24,573
(MILLIONS OF DOLLARS)  
Biopharma Revenues, for the three months ended September 30, 2018
 $9,422
   
Operational growth/(decline):  
Continued worldwide growth from certain key brands(a)
 621
Higher revenues for the Hospital products business, primarily driven by continued growth from anti-infective products in China as well as the November 2018 U.S. launch of Panzyga 112
Higher revenues for rare disease products driven by Vyndaqel following the U.S. launch in May 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM); and in international markets, primarily driven by continued uptake for the transthyretin amyloid polyneuropathy indication, primarily in developed Europe, as well as the March 2019 launch of the ATTR-CM indication in Japan, partially offset by lower revenues for the hemophilia franchises (Refacto AF/Xyntha and BeneFIX), primarily due to competitive pressures, and Genotropin in developed markets, mainly due to unfavorable channel mix in the U.S. 86
Higher revenues for Inlyta, primarily in the U.S. driven by increased demand resulting from the second quarter of 2019 U.S. FDA approvals for the combinations of certain checkpoint inhibitors plus Inlyta for the first-line treatment of patients with advanced RCC, partially offset by the decline in other developed markets due to increased competition 70
Growth from Biosimilars, primarily in the U.S. 44
Lower revenues for Enbrel internationally, reflecting continued biosimilar competition in most developed Europe markets (99)
Lower revenues for Prevnar 13 in the U.S., primarily reflecting lower government purchases for the pediatric indication as well as the continued decline in revenues for the adult indication due to a declining “catch up” opportunity compared to the prior year quarter, partially offset by an increase in international revenues mostly due to higher volumes reflecting continued uptake following the 2017 launch in China, partially offset by the unfavorable impact of timing associated with government purchases for the pediatric indication in certain emerging markets (43)
Other operational factors, net 62
Operational growth, net 852
Unfavorable impact of foreign exchange (166)
Biopharma Revenues increase
 686
Biopharma Revenues, for the three months ended September 29, 2019
 $10,108
(a) 
Certain key brands represent Ibrance, Eliquis Ibrance, Xeljanz, Prevnar 13/Prevenar 13, Xtandi and Chantix/Champix.Xeljanz. See the “Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion” section of this MD&A for product analysis information.information.
Total IHBiopharma revenues from emerging markets increased $456$174 million, or 15%9%, to $3.6$2.0 billion from $3.1$1.8 billion, reflecting a 16%15% operational increase.growth. Foreign exchange had an unfavorable impact of 1%5% on Total IHtotal Biopharma revenues from emerging markets.
Costs and Expenses
Cost of sales as a percentage of Revenues decreased 0.1 percentage points, primarily driven by the favorable impact of foreign exchange, partially offset by an unfavorable change in product mix. The unfavorable product mix, which includes the unfavorable impact of the reclassification of Viagra IH to EH in 2018, is partially offset by anoperational increase in alliance revenues, which have no associated cost of sales.
The increase in Cost of sales of 5%emerging markets was primarily driven by an increase in sales volumes for various key products within our product portfolio,Ibrance, Eliquis and an increase in royalty expenses based on the mix of products sold, partially offset by the favorable impact of foreign exchange.
Prevenar 13.

The increase in Selling, informationalCosts and administrativeexpenses of 8% was primarily driven by additional investment across several of our key products, primarily Xeljanz, Eucrisa, Ibrance, Prevnar 13/Prevenar 13 (pediatric indication) and Eliquis, partially offset by lower healthcare reform expenses as a result of a true up of a prior year amount and decreased investment in Enbrel due to loss of exclusivity across developed Europe.
The increase in Research and developmentexpenses of 11% primarily reflects:
Expenses
Cost of sales as a percentage of Revenues increased costs associated with our Phase 3 clinical trials related to our JAK1 inhibitor (which was initiated0.7 percentage points driven by an unfavorable impact of foreign exchange and higher royalty expenses, partially offset by a favorable change in December 2017) and the C. difficile vaccine program (which was initiated in March 2017);product mix.
increased costs across
The increase in Cost of sales of 12% was mainly driven by the Oncologyunfavorable impact of foreign exchange, as well as an increase in royalty expenses based on the mix of products sold, an increase in sales volumes for various products within our product portfolio including costs associated with Bavencio studies; and an unfavorable change in product mix.
increased costs for
The decrease in Selling, informational and administrativeexpenses of 1% was mostly driven by lower investment in certain products and a favorable impact of foreign exchange, partially offset by additional investment across several of our rare disease portfolio,products, including recently acquired Array products.
partially offset by:
lower costs due to the completion
The increasein Research and developmentexpenses of certain clinical studies, including tanezumab and Lyrica.19% was mostly driven by investment in newly acquired Array products.
The favorable change in Other (income)/deductions––net primarily reflects:
The unfavorable change in Other (income)/deductions––net primarily reflects a $188$96 million increasedecrease in income from collaborations, out-licensing arrangements and sales of compound/product rights;
rights, and a $45$47 million increase in Xtandi royalty income; and
a $14 million increasedecrease in dividend income from our investment in ViiV.ViiV, partially offset by a favorable impact of foreign exchange.


Essential HealthUpjohn Operating Segment
Revenues
EH Upjohn Revenues decreased $542$841 million, or 3%28%, to $15.1$2.2 billion, reflecting an operational decrease of $894$804 million, or 6%26%, partially offset byand the favorableunfavorable impact of foreign exchange of $352$37 million, or 2%1%.
The following provides an analysis of the decrease in EHUpjohn worldwide Revenues:
(MILLIONS OF DOLLARS)  
EH Revenues, for the nine months ended October 1, 2017
 $15,639
   
Operational growth/(decline):  
Decline from the Peri-LOE Products portfolio, driven by lower revenues in developed markets (excluding Viagra EH), primarily due to expected declines in Lyrica in developed Europe and Pristiq in the U.S. due to generic competition (463)
Decline from the SIP portfolio, driven by lower revenues in developed markets, primarily due to continued legacy Hospira product shortages in the U.S. (419)
Decline in the LEP portfolio primarily driven by lower revenues in developed markets (314)
Impact on financial results for the sale of HIS in February 2017. The first nine months of 2018 do not reflect any contribution from HIS global operations, compared to approximately one month of HIS domestic operations and approximately two months of HIS international operations in the same period in 2017 (97)
Positive impact of Viagra, mostly driven by the shift in the reporting of U.S. and Canada Viagra revenues from IH to EH at the beginning of 2018 (due to the loss of exclusivity of Viagra in the U.S. in December 2017), partially offset by lower revenues in developed Europe markets (previously reported in EH) 216
Growth from Biosimilars, primarily from Inflectra in certain channels in the U.S., as well as in developed Europe 165
Other operational factors, net 19
Operational decline, net (894)
   
Favorable impact of foreign exchange 352
EH Revenues decrease
 (542)
EH Revenues, for the nine months ended September 30, 2018
 $15,097
(MILLIONS OF DOLLARS)


Upjohn Revenues, for the three months ended September 30, 2018

$3,036




Operational decline:


Lower worldwide revenues for Lyrica, primarily in the U.S., reflecting the expected significantly lower volumes associated with multi-source generic competition that began in July 2019 (687)
Decline in revenues for Revatio driven by lower U.S. Oral Suspension formulation sales and pricing pressures due to a recent generic entry, and for Relpax, driven by continued generic competition across developed markets (53)
Decline from Norvasc and Lipitor, primarily in China, driven by pricing pressures from the March 2019 government implementation of the VBP in certain cities. The decline in Lipitor was also due to discontinued sales in Saudi Arabia and lower volumes in Japan. The decline in Norvasc was also due to lower volumes in Japan and South Korea. These declines were partially offset by volume growth and geographic expansion in provinces in China where the VBP has not yet been implemented (35)
Lower revenues for Viagra primarily in the U.S. resulting from the loss of exclusivity in December 2017
(14)
Other operational factors, net (14)
Operational decline, net
(804)
Unfavorable impact of foreign exchange
(37)
Upjohn Revenues decrease

(841)
Upjohn Revenues, for the three months ended September 29, 2019

$2,195
Total EHUpjohn revenues from emerging markets increased $680decreased $46 million, or 13%5%, to $5.8$955 million from $1.0 billion, reflecting a 1% operational decline. Foreign exchange had an unfavorable impact of 3% on total Upjohn revenues from $5.1 billion,emerging markets. The operational decrease in emerging markets was primarily driven by 11% operational growth from the LEP portfolioLipitor and 13% operational growth from the SIP portfolio, partially offset by a 2% operational decline from the Peri-LOE Products portfolio. Foreign exchange had a favorable impact of 2% on total EH revenues from emerging markets.Norvasc.
Costs and Expenses
The changes in EH expenses below reflect, among other things, the favorable impact of the February 2017 sale of HIS. The operating results of HIS are included in EH’s operating results through February 2, 2017 and, therefore, operating results for EH for the first nine months of 2017 include approximately one month of HIS domestic operations and approximately two months of HIS international operations. Operating results for EH for the first nine months of 2018 do not reflect any contribution from HIS global operations.
Cost of sales as a percentage of Revenues increased 1.8 percentage points, primarily due to:
higher
Cost of sales volumeas a percentage of InflectraRevenues increased 3.7 percentage points driven by lower Lyrica revenues in developed markets, primarily related to the June 2019 loss of exclusivity for Lyrica in the U.S. and developed Europe, and higher Pfizer CentreOne sales volumes, both, as well as an unfavorable impact of which carry higher product costs;foreign exchange, partially offset by lower royalty expense for Lyrica due to the patent expiration.
The decreasein Cost of sales of 11% was driven by lower sales volumes and margins as a result of product lossesroyalty expense resulting from the June 2019 loss of exclusivity and generic competitionfor Lyrica in developed markets; andthe U.S., as well as lower volumes for certain products, partially offset by an unfavorable impact of foreign exchange.
the unfavorable impact of foreign exchange,
partially offset by:
lower sales volumes
Selling, informational and administrativeexpenses decreased 18% mostly driven by a reduction in the SIP portfolio, which carries a higher cost to produce,field force expense as well as advertising and promotion expenses in developed markets, primarily duerelated to continued legacy Hospira product shortagesLyrica in the U.S.;, partially offset by the non-recurrence of a one-time general and administrative expense reversal in the third quarter of 2018.
the non-recurrence of charges related to a product recall that occurred in 2017.
Research and developmentexpenses and Other (income)/deductions––netwere relatively unchanged.

First Nine Months of 2019 vs. First Nine Months of 2018
Biopharma Operating Segment
Revenues
Biopharma Revenues increased $1.1 billion, or 4%, to $28.9 billion, reflecting an operational increase of $2.0 billion, or 7%, and an unfavorable impact of foreign exchange of $891 million, or 3%.
The following provides an analysis of the increase in Cost of sales of 3% was primarily due to:Biopharma worldwide Revenues:
(MILLIONS OF DOLLARS)  
Biopharma Revenues, for the nine months ended September 30, 2018
 $27,737
   
Operational growth/(decline):  
Continued worldwide growth from certain key brands(a)
 1,978
Higher revenues for Inlyta, primarily in the U.S. driven by increased demand resulting from the second quarter of 2019 U.S. FDA approvals for the combinations of certain checkpoint inhibitors plus Inlyta for the first-line treatment of patients with advanced RCC, partially offset by the decline in other developed markets due to increased competition 100
Growth from Biosimilars, primarily in the U.S. 95
Higher revenues for rare disease products driven by Vyndaqel following the U.S. launch in May 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM); and in international markets, primarily driven by continued uptake for the transthyretin amyloid polyneuropathy indication, primarily in developed Europe, as well as the March 2019 launch of the ATTR-CM indication in Japan, partially offset by lower revenues for certain rare disease products, including the hemophilia franchises (Refacto AF/Xyntha and BeneFIX), primarily due to competitive pressures, and Genotropin in developed markets, mainly due to unfavorable channel mix 21
Lower revenues for Enbrel internationally, reflecting continued biosimilar competition in most developed Europe markets (200)
Lower revenues for the Hospital products business, primarily reflecting declines in developed markets, mostly due to the continued expected negative impact from generic competition for products that have previously lost marketing exclusivity, partially offset by continued growth from anti-infective products in China as well as the 2018 U.S. launches of our immune globulin intravenous products (Panzyga and Octagam) (46)
Other operational factors, net 92
Operational growth, net 2,040
Unfavorable impact of foreign exchange (891)
Biopharma Revenues increase
 1,150
Biopharma Revenues, for the nine months ended September 29, 2019
 $28,887
(a)
higher
Certain key brands represent Ibrance, Eliquis, Xeljanz and Prevnar/Prevenar 13. See the “Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion” section of this MD&A for product analysis information.
Total Biopharma revenues from emerging markets increased $288 million, or 5%, to $5.9 billion from $5.7 billion, reflecting 14% operational growth. Foreign exchange had unfavorable impact of 9% on total Biopharma revenues from emerging markets. The operational increase in emerging markets was primarily driven by Prevenar 13, Ibrance and Eliquis.
Costs and Expenses
Cost of sales volumesas a percentage of Inflectra in the U.S. and developed Europe, and higher Pfizer CentreOne sales volumes, both of which carry higher product costs; andRevenues was relatively flat.
The increase in Cost of sales of 5% was mainly driven by an unfavorable change in product mix, an increase in royalty expenses based on the unfavorablemix of products sold and an increase in sales volumes for various products within our product portfolio, partially offset by a favorable impact of foreign exchange,
partially offset by:exchange.
lower sales volumes driven by product losses of exclusivity and generic competition in developed markets; and
The increase in Selling, informational and administrativeexpenses of 1% was mostly driven by additional investment across several of our products, including recently acquired Array products, as well as the non-recurrence of charges relateda favorable true-up of healthcare reform expenses in the first quarter of 2018, partially offset by a favorable impact of foreign exchange and decreased investment in certain products.
Research and developmentexpenses of 7% was mostly driven by investment in newly acquired Array products, partially offset by a favorable impact of foreign exchange.
The unfavorable change in Other (income)/deductions––net primarily reflects a $301 million decrease in income from collaborations, out-licensing arrangements and sales of compound/product rights and a $42 million decrease in dividend income from our investment in ViiV, partially offset by an increase in royalty-related income mainly due to a product recall that occurredone-time favorable resolution in 2017.the second quarter of 2019 of a legal dispute for $82 million.


Upjohn Operating Segment
Selling, informational and administrativeexpensesRevenues
Upjohn Revenues decreased 9% mainly due$1.2 billion, or 13%, to lower advertising, promotional and field force expenses,$8.1 billion, reflecting the benefitsan operational decrease of cost-reduction and productivity initiatives, and lower general and administrative expenses, partially offset by additional investments in China and the unfavorable impact of foreign exchange.
Research and developmentexpenses decreased 10%$992 million, or 11%, primarily due to decreased spending for biosimilars as several programs have reached completion.
The unfavorable change in Other (income)/deductions––net primarily reflects the non-recurrence of income from resolution of a contract disagreement, the non-recurrence of a gain on the redemption of an acquired bond in 2017 and the unfavorable impact of foreign exchange partiallyof $233 million, or 2%.
The following provides an analysis of the decrease in Upjohn worldwide Revenues:
(MILLIONS OF DOLLARS)  
Upjohn Revenues, for the nine months ended September 30, 2018 $9,302
   
Operational growth/(decline):  
Lower worldwide revenues for Lyrica, primarily in the U.S., reflecting the expected significantly lower volumes associated with multi-source generic competition that began in July 2019 (736)
Lower revenues for Viagra and Upjohn’s authorized generic for Viagra in the U.S. resulting from increased generic competition following Viagra's December 2017 patent expiration (181)
Decline in revenues for Revatio driven by lower U.S. Oral Suspension formulation sales and pricing pressures due to a recent generic entry, and for Relpax, driven by continued generic competition across developed markets (98)
Volume-driven growth from Celebrex and Effexor, primarily in Japan and China 68
Growth from Lipitor, primarily due to volume growth and geographic expansion in provinces in China where the VBP has not yet been implemented, partially offset by pricing pressures for Lipitor and Norvasc from the implementation of the VBP in certain cities in China, lower volumes in Japan for Norvasc and the discontinued sales of Lipitor in Saudi Arabia 37
Other operational factors, net (82)
Operational decline, net (992)
Unfavorable impact of foreign exchange (233)
Upjohn Revenues decrease
 (1,225)
Upjohn Revenues, for the nine months ended September 29, 2019
 $8,077
Total Upjohn revenues from emerging markets decreased $52 million, or 2%, to $3.0 billion, reflecting 4% operational growth more than offset by anthe unfavorable impact of foreign exchange of 6% on total Upjohn revenues from emerging markets. The operational increase in income from collaborations, out-licensing arrangementsemerging markets was primarily driven by Lipitor, Viagra, Celebrex and sales of compound/product rights.Norvasc.
Costs and Expenses
Cost of sales as a percentage of Revenues increased 0.1 percentage points driven by lower Lyrica revenues in developed markets, primarily related to the June 2019 loss of exclusivity for Lyrica in the U.S., partially offset by lower royalty expense for Lyrica due to the patent expiration, and a favorable impact of foreign exchange.
The decrease in Cost of sales of 13% was primarily driven by lower royalty expense due to the June 2019 loss of exclusivity for Lyrica in the U.S., a favorable impact of foreign exchange, as well as lower atorvastatin active product ingredients import duties in China.
Selling, informational and administrativeexpenses decreased 14% driven by a reduction in field force expense as well as advertising and promotion expenses in developed markets, primarily related to Lyrica in the U.S., as well as a favorable impact of foreign exchange, partially offset by the non-recurrence of one-time general and administrative expense reversals in the second and third quarters of 2018, and investments in China across key brands.
Research and developmentexpenses and Other (income)/deductions––net were relatively unchanged.
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME


Changes in the components of Accumulated other comprehensive loss for the third quarter and first nine months of2018 reflect the following:
For Foreign currency translation adjustments, net, the third quarter and first nine months of2019 primarily reflect the reclassification resulting from the contribution of our Consumer Healthcare business to the Consumer Healthcare joint venture with GSK, and the strengthening of the U.S. dollar against the euro, partially offset by the weakening of the U.S. dollar against the Japanese yen and the results of our net investment hedging program. The first nine months of 2019 also reflect the strengthening of the U.S. dollar against the Australian dollar. For additional information, see Notes to Consolidated Financial Statements—Note 2B. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Equity-Method Investment and Assets and Liabilities Held for Sale.
For Unrealized holding gains on derivative financial instruments, net and Unrealized holding gains/(losses) on available-for-sale securities, net, thethird quarter and first nine months of2019reflect the impact of fair value remeasurements and the reclassification of amounts into income. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 7. Financial Instruments.
For Foreign currency translation adjustments, net,the third quarter of 2018 primarily reflects the strengthening of the U.S. dollar against the Chinese renminbi, U.K. pound and Australian dollar, and for the first nine months of 2018, primarily reflects the strengthening of the U.S. dollar against the U.K. pound, Turkish lira and Brazilian real, partially offset by the weakening of the U.S. dollar against the Japanese yen.
For Unrealized holding gains/(losses) on derivative financial instruments, net and Unrealized holding gains/(losses) on available-for-sale securities, net, reflects the impact of fair value re-measurements and the reclassification of amounts into income. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1B. Basis of Presentation and Significant Accounting Policies––Adoption of New Accounting Standards and Notes to Condensed Consolidated Financial Statements—Note 7. Financial Instruments.
For Benefit plans: actuarial gains/(losses), net, the third quarter of 2018 primarily reflects (i) the amortization of changes in the pension benefit obligation previously recognized in Other comprehensive income, (ii) the favorable impact of foreign exchange, (iii) settlement activity and (iv) an $8 million reduction in the plan liability due to an interim re-measurement. For the first nine months of 2018, primarily reflects (i) the amortization of changes in the pension benefit obligation previously recognized in Other comprehensive income, (ii) a $92 million reduction in the plan liability due to an interim re-measurement, (iii) settlement activity and (iv) the favorable impact of foreign exchange. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 10.Pension and Postretirement Benefit Plans.
For Benefit plans: prior service costs and other, net, the third quarter and the first nine months of 2018 reflect the reclassification into income of amounts related to (i) amortization of changes in prior service costs and credits previously recognized in Other comprehensive income and (ii) curtailment activity. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 10. Pension and Postretirement Benefit Plans.
For Tax provision/(benefit) on other comprehensive income/(loss), the first nine months of 2018 reflect the reclassification of the stranded tax amounts related to the TCJA from AOCI to Retained earnings, which was recorded in the first quarter of 2018. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 1B. Basis of Presentation and Significant Accounting Policies––Adoption of New Accounting Standards and Notes to Condensed Consolidated Financial Statements—Note 5D.Tax Matters: Tax Provision/(Benefit) on Other Comprehensive Income/(Loss).
For Benefit plans: actuarial gains/(losses), net, mainly reflects for the third quarter and the first nine months of 2019 (i) the amortization of changes in the pension benefit obligation previously recognized in Other comprehensive income, (ii) the favorable impact of foreign exchange, (iii) settlement activity and (iv) a $194 million increase in the plan liability due to interim plan remeasurements. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 10.Pension and Postretirement Benefit Plans.
For Benefit plans: prior service costs and other, net, the third quarter and the first nine months of 2019 reflect the reclassification into income of amounts related to amortization of changes in prior service costs and credits previously recognized in Other comprehensive income. For additional information, see Notes to Condensed Consolidated Financial Statements—Note 10. Pension and Postretirement Benefit Plans.
ANALYSIS OF THE CONDENSED CONSOLIDATED BALANCE SHEETS
For information about certain of our financial assets and liabilities, including Cash and cash equivalents, Short-term investments, Equity-method investments, Long-term investments, Short-term borrowings, including current portion of long-term debt, and Long-term debt, see the “Analysis of the Condensed Consolidated Statements of Cash Flows” section of this MD&A, the “Analysis of Financial Condition, Liquidity and Capital Resources: Selected Measures of Liquidity and Capital Resources” section of this MD&A and Notes to Condensed Consolidated Financial Statements—Note 7. Financial Instruments.
For information about events and circumstances impacting our tax-related accounts, see Notes to Condensed Consolidated Financial Statements—Note 5. Tax Matters.
For a description of changes in Total Equity, see the consolidated statements of equity.
For information related to changes in Accumulated other comprehensive loss, see the “Analysis of the Condensed Consolidated Statements of Comprehensive Income” section of this MD&A and Notes to Condensed Consolidated Financial Statements—Note 6. Accumulated Other Comprehensive Loss, Excluding Noncontrolling Interests.


The changes in our asset and liability accounts as of September 30, 2018,29, 2019, compared to December 31, 20172018, generally reflect, among other things,and the following explanations exclude, fluctuations in foreign currency exchange rates, as well as the impact of the adoption of new accounting standards in the first quarter of 2018. The following explanations exclude the impact2019, our Consumer Healthcare business joint venture with GSK, and our acquisitions of foreign exchangeArray and the impact of the adoption of new accounting standards in the first quarter of 2018Therachon (see Notes to Condensed Consolidated Financial Statements—

Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards and Note 2. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangementfor additional information).
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 increases for certain products to meet targeted levels in the normal course of business, including inventory build for supply recovery, network strategy and new product launches.
For Other current assets, the change reflects an increase in receivables associated with derivative financial instruments, partially offset by the receipt of a milestone payment related to the first marketing authorization for ertugliflozin (see Notes to Condensed Consolidated Financial Statements—Note 2D. Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangements and Privately Held Investment: Collaborative Arrangements).
For PP&E,the change primarily reflects capital additions in the normal course of business, partially offset by depreciation during the period.
For Identifiable intangible assets, less accumulated amortization, the change primarily reflects amortization for the period, partially offset by an intangible asset recorded in connection with the EU approval of Mylotarg (see Notes to Condensed Consolidated Financial Statements—Note 9A. Identifiable Intangible Assets and Goodwill: Identifiable Intangible Assets).
For Trade accounts payable, the change reflects the timing of purchases and payments in the normal course of business.
For Other current liabilities, the change reflects a decrease in liabilities associated with:
payments
For Trade accounts receivable, less allowance for contingent consideration obligations;doubtful accounts, the change reflects the timing of sales and collections in the normal course of business.
payments to settle certain legal and product liability obligations;
payments for restructuring activities;
paymentsFor Inventories, the change reflects the increases for certain products to meet targeted levels in the current portionnormal course of obligations recorded in connection withbusiness, including inventory build for supply recovery, new product launches and market demand, partially offset by the U.S. approvalwrite off of Bosulif, and the EU and U.S. approvals of Besponsarivipansel inventory previously expected to be sold (see Notes to Condensed Consolidated Financial Statements—Note 7E. Financial Instruments: Other Noncurrent Liabilities);2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement for additional information).
payables related
For Other current assets, the change reflects increases in receivables in the normal course of business.
For PP&E,the change primarily reflects capital additions in the normal course of business, partially offset by depreciation during the period.
For Identifiable intangible assets, less accumulated amortization, the change primarily reflects amortization for the period and intangible asset impairment charges (see Notes to Condensed Consolidated Financial Statements—Note 4. Other (Income)/DeductionsNet), partially offset by additions for the period.
For Other noncurrent assets, the change reflects a net increase in assets in the normal course of business, and an increase in receivables associated with derivative financial instruments,instruments.
partially offset by increases related to:
For Trade accounts payable, the change reflects the timing of purchases and payments in the normal course of business.
For Other current liabilities, the change reflects a decrease in liabilities associated with:
payments and accruals in the normal course of business;
payments for restructuring activities; and
reclassifications from noncurrent liabilities.payments for contingent consideration obligations,
For Pension benefit obligations, net, the decrease primarily reflects a voluntary pension contribution, direct employer benefit payments, and an interim re-measurement in a U.S. non-qualified plan.
For Other noncurrent liabilities, the change reflects an increase in liabilities associated with:
partially offset by:
an increase due to reclassifications from noncurrent to current.
For Pension benefit obligations, net, the change reflects pension contributions and direct employer benefit payments, partially offset by interim plan remeasurements.

For Other noncurrent liabilities, the change reflects:
a decrease in payables associated with derivative financial instruments;
an increasea decrease in restructuring liabilities associated withrelated to the sale-leasebackreversal of certain accruals related to our New York headquartersacquisition of Wyeth upon the effective favorable settlement of a U.S. IRS audit for multiple tax years (see Notes to Condensed Consolidated Financial Statements—Note 12C.5B. Tax Contingencies and Certain Commitments: Certain Commitments for additional information)); and
a change in the fair value of contingent consideration (see Notesdecrease due to Condensed Consolidated Financial Statements—Note 4. Other (Income)/Deductions—Net),
reclassifications from noncurrent to current,
partially offset by:
reclassificationsan increase in accruals in the normal course of business.
For Treasury stock, the change reflects $8.9 billion of share repurchases, composed of $6.8 billion paid to current liabilities.GS&Co. in February 2019 pursuant to the terms of an accelerated share repurchase agreement as well as $2.1 billion of open-market share repurchases. See Notes to Condensed Consolidated Financial Statements—Note 12C. Contingencies and Certain Commitments: Certain Commitments for additional information.
For Treasury stock, the change reflects $4.0 billion paid to Citibank in March 2018 pursuant to the terms of an accelerated share repurchase agreement as well as open market share repurchases. See Notes to Condensed Consolidated Financial Statements—Note 12C. Contingencies and Certain Commitments: Certain Commitments for additional information.

ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 Nine Months Ended   Nine Months Ended  
(MILLIONS OF DOLLARS)
September 30,
2018

 October 1,
2017

 %
Change

September 29,
2019

 September 30,
2018

 %
Change

Cash provided by/(used in):
     
     
Operating activities
$11,089
 $9,713
 14
$8,819
 $11,089
 (20)
Investing activities
5,289
 19
 *
(1,112) 5,289
 *
Financing activities
(14,034) (9,607) 46
(6,045) (14,034) (57)
Effect of exchange-rate changes on cash and cash equivalents and restricted cash and cash equivalents (116) 67
 * (41) (116) (65)
Net increase in Cash and cash equivalents and restricted cash and cash equivalents
 $2,227
 $193
 * $1,620
 $2,227
 (27)
* Calculation not meaningful or results are equal to or greater than 100%.
In the condensed consolidated statements of cash flows, the line item Other changes in assets and liabilities, net of acquisitions and divestitures is presented excluding the effects of changes in foreign currency exchange rates, as these changes do not reflect actual cash inflows or outflows, and excluding any other significant non-cash movements. Accordingly, the amounts shown will not necessarily agree with the changes in the assets and liabilities that are presented in our condensed consolidated balance sheets.
Operating Activities


Our net cash provided by operating activities was $11.1$8.8 billion in the first nine months of 20182019, compared to $9.7$11.1 billion in the same period in 20172018. The increasedecrease in net cash provided by operating activities reflects an increase in net cash generated from net income. The net cash generated reflects the timing of receipts from customers and payments to vendors in the ordinary course of business.business, and the upfront cash payment associated with our acquisition of Therachon (see Notes to Condensed Consolidated Financial Statements––Note 2A. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions), partially offset by an increase in net income and a decrease in benefit plan contributions.
In the first nine months of 20182019, the change in the line item Other adjustments, net primarily reflects, among other items:
unrealized net gains on equity securities resulting from the adoptionnon-recurrence of a new accounting standard on January 1, 2018 related to financial assets and liabilities (see Notes to Condensed Consolidated Financial Statements—Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards);
a non-cash gain associated with our transaction with Bain Capital to create a new biopharmaceutical company to continue development of a portfolio of clinical and preclinicalpre-clinical stage neuroscience assets (see Notes to Condensed Consolidated Financial Statements––Note 2B. Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangementsin 2018;
a reduction in net unrealized gains on equity securities;
a reduction in net realized gains on equity securities; and Privately Held Investment: Divestitures); and
the non-recurrence of a non-cash gain on the contribution of Pfizer’s allogeneic CAR T developmental program assets, in connection with our contribution agreement with Allogene (see Notes to Condensed Consolidated Financial Statements—Note 2B. Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangements and Privately Held Investment: Divestitures),
in 2018,
partially offset by:
net lossesgains on foreign exchange contracts hedging a portion of our forecasted intercompany inventory sales (that fixes the cost of inventory sold later to customers); and.
a decrease in gains on the sale of property, plant and equipment.
In the first nine monthscondensed consolidated statements of 2018 and 2017,cash flows, the line item Other changes in assets and liabilities, net of acquisitions and divestitures is presented excluding the effects of changes in foreign currency exchange rates, as these changes do not reflect actual cash inflows or outflows, and excluding any other significant non-cash movements. Accordingly, the amounts shown will not necessarily agree with the changes in the assets and liabilities that are presented in our condensed consolidated balance sheets. In the first nine months of 2019 and 2018, the line item Other changes in assets and liabilities, net of acquisitions and divestitures, primarily reflects changes, in the normal course of business, in trade accounts receivable, inventories, other current assets, other noncurrent assets, trade accounts payable, accrued compensation, and other current and noncurrent liabilities.liabilities, as well as in the first nine months of 2019, the adjustment necessary to reflect the non-cash nature of a favorable settlement of a U.S. IRS audit for multiple tax years (see Notes to Condensed Consolidated Financial Statements––Note 5A. Tax Matters: Taxes on Income from Continuing Operations).

For additional information about changes in other assets and liabilities account balances, see the “Analysis of the Condensed Consolidated Balance Sheets” in this MD&A.
Investing Activities
Our net cash provided byused in investing activities was $5.3$1.1 billion in the first nine months of 20182019, compared to net cash provided by investing activities of $19 million$5.3 billion in the same period in 20172018. The increasechange in net cash provided byby/(used in) investing activities was primarily attributable to:
an increase in net proceeds generated from the sale of investments of $4.5 billion in 2018 for cash needs; and
a decrease in cash used for acquisitions,the acquisition of Array, net of cash acquired, of $1.0$10.9 billion due toin the acquisitionthird quarter of the development and commercialization rights to AstraZeneca’s small molecule anti-infectives business and substantially all of the remaining consideration for the Medivation acquisition in 2017 (see Notes to Condensed Consolidated Financial Statements—Note 2A.
2019,

partially offset by:
Acquisition, Divestitures, Licensing Arrangements, Collaborative Arrangements and Privately Held Investment: Acquisition).
an increase in net proceeds generated from the sale of investments of $5.0 billion for cash needs, including financing the acquisition of Array (see Notes to Condensed Consolidated Financial Statements––Note 2A. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Acquisitions).
Financing Activities
Our net cash used inby financing activities was $14.0$6.0 billion in the first nine months of 20182019, compared to $9.6$14.0 billion in the same period in 20172018. The increasedecrease in net cash used in financing activities was primarily attributable to:
$10.1 billion net proceeds raised from short-term borrowings in the first nine months of 2019, primarily in connection with the acquisition of Array, compared to net payments on short-term borrowings of $3.3 billion in the first nine months of 2018,
partially offset by:
$3.2 billion less proceeds raised from short-term borrowings in the first nine monthshigher repayments on long-term debt of 2018, compared to the first nine months of 2017; and
$2.7 billion;
higher purchases of common stock of $2.2 billion,
partially offset by:$1.7 billion; and
lower repayments on long-term debtproceeds from the exercise of $1.4 billion.stock options of $796 million.
ANALYSIS OF FINANCIAL CONDITION, LIQUIDITY AND CAPITAL RESOURCES


We rely largely on operating cash flows, short-term investments, short-term commercial paper borrowings and long-term debt to provide for our liquidity requirements. We continue our efforts to improve cash inflows through working capital efficiencies. We target specific areas of focus including accounts receivable, inventories, accounts payable, and other working capital, which allows us to optimize our operating cash flows. Due to our significant operating cash flows as well as our financial assets, access to capital markets and available lines of credit and revolving credit agreements, we believe that we have, and will maintain, the ability to meet our liquidity needs for the foreseeable future, which include:
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.


Our long-term debt is rated high-quality by both S&P and Moody’s. See the “Credit Ratings” section below. As market conditions change, we continue to monitor our liquidity position. We have taken and will continue to take a conservative approach to our financial investments. Both short-term and long-term investments consist primarily of high-quality, highly liquid, well-diversified available-for-sale debt securities.


Selected Measures of Liquidity and Capital Resources
The following table provides certain relevant measures of our liquidity and capital resources:
(MILLIONS OF DOLLARS, EXCEPT RATIOS AND PER COMMON SHARE DATA) September 30,
2018

 December 31,
2017

 September 29,
2019

 December 31,
2018

Selected financial assets:    
Selected financial assets(a):
    
Cash and cash equivalents(a)
 $3,559
 $1,342
 $2,785
 $1,139
Short-term investments(a)
 13,680
 18,650
 6,302
 17,694
Long-term investments(a)
 6,444
 7,015
Long-term investments, excluding private equity investments at cost
 1,981
 1,823
 23,684
 27,007
 11,067
 20,656
Debt:  
  
  
  
Short-term borrowings, including current portion of long-term debt 7,385
 9,953
 16,617
 8,831
Long-term debt 33,652
 33,538
 36,044
 32,909
 41,037
 43,491
 52,662
 41,740
Selected net financial liabilities(b)
 $(17,353) $(16,484) $(41,595) $(21,084)
        
Working capital(c)
 $12,569
 $10,714
 $(3,515) $18,068
Ratio of current assets to current liabilities 1.43:1
 1.35:1
 0.90:1
 1.57:1
Total Pfizer Inc. shareholders’ equity per common share(d)
 $12.21
 $11.93
 $11.77
 $11.09
(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 was primarily driven by thea decrease in short-term investments usedand a net increase in short-term debt, mainly as a result of cash paid for cash needs, partially offset by the repaymentacquisition of debt.Array. 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. For additional information, see the “Credit Ratings” section of this MD&A.

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 increasedecrease in working capital was primarily due to:
a decrease in Short-term investments mainly driven by the financing requirements for the acquisition of Array, share repurchase activities, dividend payments, capital expenditures and debt repayment, partially offset by operating cash flow generation, cash from employee stock option exercises and the long-term debt issuance;
the impact of the deconsolidation of the Consumer Healthcare business as a result of the completion of the Consumer Healthcare joint venture transaction;
an increase in short-term borrowings as a result of the issuance of commercial paper, mostly to finance the acquisition of Array; and
the net impact of foreign currency exchange,
partially offset by:
the timing of accruals, cash receipts and payments in the ordinary course of business;
a decrease in short-term borrowings as a result of repayments of commercial paper; and
an increase in inventory related to increases for certain products to meet targeted levels in the normal course of business, including inventory build for supply recovery, network strategy and new product launches,
partially offset by:
a decrease in Short-term investments mainly driven by the financing requirements for share repurchase activities, dividend payments, capital expenditures and debt repayment, partially offset by operating cash flow generation, cash from employee stock option exercises and reclassification of long-term to short-term investments;
an increase in income taxes payable related to the timing of accruals in certain major markets in the ordinary course of business and the reclassification of the first federal installment of transition tax previously recorded in noncurrent liabilities; and
the net impact of foreign currency exchange.
an increase in inventory related to increases for certain products to meet targeted levels in the normal course of business, including inventory build for supply recovery, new product launches and market demand, partially offset by the write off of rivipansel inventory previously expected to be sold (see Notes to Condensed Consolidated Financial Statements—Note 2C. Acquisitions, Equity-Method Investment and Assets and Liabilities Held for Sale and Research and Development Arrangement: Research and Development Arrangement for additional information).
(d) 
Represents total Pfizer Inc. shareholders’ equity divided by the actual number of common shares outstanding (which excludes treasury stock).


On September 7, 2018,In March 2019, we completed a public offering of $5.0 billion aggregate principal amount of senior unsecured notes (see Notes to Condensed Consolidated Financial Statements–Statements–Note 7D.Financial7D. Financial Instruments: Long-Term Debt).

On October 6, 2016, we announced that we entered into a definitive agreement under which ICU Medical agreed to acquire all of our global infusion systems net assets, HIS. The revised transaction closed on February 3, 2017. At closing, we received 3.2 million newly issued shares of ICU Medical common stock (as originally agreed). In August 2018, we sold 700,000 shares of ICU Medical common stock. We continue to hold 2.5 million shares of ICU Medical common stock. The lock-up period under the shareholder agreement that we entered into with ICU Medical in connection with these shares expired on August 3, 2018 and the shares are registrable upon our request subject to the terms thereof. Given that the shares were received in connection with our divestiture of the HIS business, and that our business model is generally not to invest in equities, we are evaluating our options to monetize the shares subject to market conditions and other relevant factors.

For additional information about the sources and uses of our funds, see the “Analysis of the Condensed Consolidated Balance Sheets” and the “Analysis of the Condensed Consolidated Statements of Cash Flows” sections of this MD&A.

Domestic and International Selected Financial Assets


Many of our operations are conducted outside the U.S., and significant portions of our selected financial assets are held internationally. The amount of funds held in U.S. tax jurisdictions can fluctuate due to the timing of receipts and payments in the ordinary course of business and due to other reasons, such as business-development activities. As part of our ongoing liquidity assessments, we regularly monitor the mix of domestic and international cash flows (both inflows and outflows). Given the recentThe changes in tax law under the TCJA, which includes transitioning U.S. international taxation from a worldwide tax system to a territorial tax system, in the fourth quarter of 2017, we recorded an estimated repatriation tax on deemed repatriated accumulated post-1986 earnings of foreign subsidiaries for which we plan to elect payment over eight years through 2026. These changes will also allow us to more easily access our selected financial assets globally. As a result of the enactment of the TCJA, in 2018 we repatriated theThe majority of our cash we held internationally as of year-end 2017.2017 was repatriated in 2018.
Agreement to Combine Upjohn with Mylan
In connection with the recently-announced agreement to combine Upjohn with Mylan discussed in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Business” and “––Our Strategy––Our Business Development Initiatives” sections of this MD&A, Upjohn will incur $12 billion of debt prior to the closing of the transaction. Immediately prior to the separation, Upjohn will make a cash distribution of $12 billion to Pfizer, which will be funded by the proceeds of such debt. Following the separation, Upjohn will remain the obligor with respect to the debt.

Credit Ratings


Two major corporate debt-rating organizations, Moody’s and S&P, assign ratings to our short-term and long-term debt. A security rating is not a recommendation to buy, sell or hold securities and the rating is subject to revision or withdrawal at any time by the rating organization. Each rating should be evaluated independently of any other rating.
In June 2019, S&P placed Pfizer on “CreditWatch Negative” following the announcement of Pfizer’s intention to acquire Array. The CreditWatch placement was resolved with a one-notch downgrade of Pfizer’s debt rating to ‘AA-’ upon the consummation of the transaction. In July 2019, we announced that we entered into a definitive agreement to combine Upjohn with Mylan, which resulted in actions from both Moody’s and S&P. Moody’s placed Pfizer’s long-term rating under review for downgrade (limited to one-notch, or ‘A2’ upon close of the Mylan transaction) while S&P lowered Pfizer’s rating to ‘AA-’ (as a result of the Array transaction) and confirmed it will still remain on CreditWatch Negative (with the expectation the rating will be lowered one additional notch to ‘A+’ upon close of the Mylan transaction).
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
Outlook/WatchDate of Last Rating Change
 Rating Rating 
Moody’s(a)
 P-1 A1 Under Review for DowngradeOctober 2009
S&P(b)
 A-1+ AAAA- October 2009CreditWatch NegativeJuly 2019
(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.

Debt Capacity––Lines of Credit


We have available lines of credit and revolving credit agreements with a group of banks and other financial intermediaries. We typically maintain cash and cash equivalent balances and short-term investments which, together with our available revolving credit facilities, are in excess of our commercial paper and other short-term borrowings. As of September 30, 2018, 29, 2019,we had access to $7.6a total of $15.0 billion of lines of credit, of which $571 million expire within one year. Of these lines of credit, $7.6 billion were unused, of which our lenders have committed to loan us $7.1 billion at our request, primarily under ourin U.S. revolving credit facilities consisting of a $7.0 billion facility expiring in 2022,2023 and an $8.0 billion facility expiring in September 2020, which may be used to support our commercial paper borrowings. In addition to the U.S. revolving credit facilities, our lenders have provided us an additional $526 million lines of credit, of which $497 million expire within one year. Of these total lines of credit, $15.5 billion were unused as of September 29, 2019. In connection with the recently-announced agreement to combine Upjohn with Mylan discussed in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Business” and “––Our Strategy––Our Business Development Initiatives” sections of this MD&A, Upjohn entered into a fully underwritten, 364-day senior unsecured bridge facility for up to $12 billion. This bridge facility is expected to terminate upon the issuance of $12 billion of debt securities, loans or a combination of the two by Upjohn prior to the transaction close.


LIBOR

From time to time, we issue variable rate debt based on LIBOR, or undertake interest rate swaps that contain a variable element based on LIBOR. Banks currently reporting information used to set LIBOR will stop doing so after 2021. Various parties, including government agencies, are seeking to identify an alternative rate to replace LIBOR. We are monitoring their efforts, and we will likely amend contracts to accommodate any replacement rate where it is not already provided.
Global Economic Conditions––General


The global economic environment has not had, nor do we anticipate it will have, a material impact on our liquidity or capital resources. Due to our significant operating cash flows, financial assets, access to capital markets and available lines of credit and revolving credit agreements, we continue to believe that we have, and will maintain, the ability to meet our liquidity needs for the foreseeable future. We monitor our liquidity position continuously in the face of evolving economic conditions. For additional information see the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Operating Environment––The Global Economic Environment” section in this MD&A.
Global Economic Conditions––Venezuela and Argentina Operations


Our Venezuela operations continue to operate with the U.S. dollar as the functional currency due to the hyperinflationary status of the Venezuelan economy.

We used the Venezuelan bolivar soberano rate of 60.27 as our best estimate to revalue our Venezuelan bolivar denominated net monetary assets. The current DICOM rate is about 64.89. Future actions by the Venezuelan government in response to economic uncertainties could impact the recoverability of our investment in Venezuela, which could result in an impairment charge and under extreme circumstances, could impact our ability to continue to operate in the country in the same manner as we have historically. We have in Venezuela a few net monetary assets and $46 million of non-monetary assets, and $11 million of deferred foreign exchange losses reported in the balance sheet in Accumulated other comprehensive loss––Foreign currency translation adjustments at August 26, 2018, our international quarter-end.
Global Economic Conditions––Argentina Operations
Our Argentina operations function in a hyperinflationary economy.economies. The impact to Pfizer is not considered material.

Off-Balance Sheet Arrangements


In the ordinary course of business and in connection with the sale of assets and businesses and other transactions, we often indemnify our counterparties against certain liabilities that may arise in connection with a transaction or that are related to events and activities prior to or following a transaction. If the indemnified party were to make a successful claim pursuant to the terms of the indemnification, we may be required to reimburse the loss. These indemnification obligations generally are subject to various restrictions and limitations. Historically, we have not paid significant amounts under these provisions and, as of September 30, 2018,29, 2019, the estimated fair value of our indemnity obligations was not significant.


Certain of our co-promotion or license agreements give our licensors or partners the rights to negotiate for, or in some cases to obtain under certain financial conditions, co-promotion or other rights in specified countries with respect to certain of our products.


Share-Purchase Plans and Accelerated Share Repurchase Agreements


Our December 2015 $112017 $10 billion share repurchase program was exhausted in the thirdfirst quarter of 2018.2019.
In December 2017,2018, the Board of Directors authorized an additionala new $10 billion share repurchase program to be utilized over time (the 2018 program) and share repurchases commenced thereunder in the thirdfirst quarter of 2018 (the 2017 program).2019.
On March 12, 2018,February 7, 2019, we entered into an accelerated share repurchase agreement with CitibankGS&Co. to repurchase $4.0approximately $6.8 billion of our common stock.stock, and on August 1, 2019, the accelerated share repurchase agreement with GS&Co. was completed. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 1212C. Contingencies and Certain Commitments: Certain Commitments 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.

The following table provides the number of shares of our common stock purchased and the cost of purchases under our publicly announced share purchase plans, including our accelerated share repurchase agreements:
 Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended
(SHARES IN MILLIONS, DOLLARS IN BILLIONS) 
September 30, 2018(a)

 October 1, 2017
 
September 30, 2018(a)

 
October 1, 2017(b)

 
September 29, 2019(a)

 
September 30, 2018(b)

 
September 29, 2019(a)

 
September 30, 2018(b)

Shares of common stock purchased 47
 
 192
 150
 34
 47
 213
 192
Cost of purchase $1.1
 $
 $7.2
 $5.0
 $
 $1.1
 $8.9
 $7.2
(a) 
Represents shares purchased pursuant to an accelerated share repurchase agreement with GS&Co. entered into on February 7, 2019, as well as other share repurchases. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 12C. Contingencies and Certain Commitments: Certain Commitments 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 with Citibank entered into on March 12, 2018, as well as other share repurchases. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 12. Contingencies and Certain Commitments 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 and the Quarterly Report on Form 10-Q for the quarterly period ended April 1, 2018.
(b)
Represents shares purchased pursuant to an accelerated share repurchase agreement entered into on February 2, 2017. For additional information, see Notes to Consolidated Financial Statements––Note 12. Equity in our 20172018 Financial Report.


AtAfter giving effect to the accelerated share repurchase agreement and other share repurchases through September 30, 2018,29, 2019, our remaining share-purchase authorization under the 2017 program was approximately $9.2 billion.$5.3 billion on September 29, 2019.


Dividends on Common Stock


In September 2018,2019, our Board of Directors declared a dividend of $0.34$0.36 per share, payable on December 3, 20182, 2019, to shareholders of record at the close of business on November 9, 20188, 2019.




NEW ACCOUNTING STANDARDS


Recently Adopted Accounting Standards


See Notes to Condensed Consolidated Financial Statements––Note 1B. Basis of Presentation and Significant AccountingPolicies: Adoption of New Accounting Standards.
Recently Issued Accounting Standards, Not Adopted as of September 30, 201829, 2019
Standard/Description Effective Date Effect on the Financial Statements or Other Significant Matters
In February 2016, the FASB issued new guidance on accounting for 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. Since its issuance, the FASB has issued several ASUs, including amending the guidance to offer an additional transition method.
January 1, 2019. Earlier application is permitted.We have made substantial progress in completing our review of the impact of this new guidance. We anticipate recognition of approximately $2 billion of additional assets and corresponding liabilities on our balance sheet. We have also assessed the potential impact of embedded leases on our consolidated financial statements, given our manufacturing outsourcing, service arrangements and other agreements. In connection with this guidance we are currently designing new global processes and technological solutions to provide the appropriate financial accounting and disclosure data. We continue to monitor changes, modifications, clarifications or interpretations undertaken by the FASB, which may impact our conclusions.
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 do not have any investments with features subject to this standard and do not expect this new guidance to have a material impact on our consolidated financial statements.
In July 2017, the FASB issued new guidance on accounting for certain financial instruments with characteristics of liabilities and equity, and accounting for certain financial instruments with down round features (a feature in a financial instrument that reduces the strike price of an issued financial instrument if the issuer sells shares of its stock for an amount less than the currently stated strike price of the issued financial instrument or issues an equity-linked financial instrument with a strike price below the currently stated strike price of the issued financial instrument).
January 1, 2019. Earlier application is permitted.We do not have any financial instruments with features subject to this standard and do not expect this new guidance to have a material impact on our consolidated financial statements.
In June 2018, the FASB issued new guidance to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. Under the guidance, the measurement of equity-classified nonemployee awards will be fixed at the grant date.
January 1, 2019. Early adoption is permitted, including in interim periods.

We do not have any share-based awards issued to nonemployees and do not expect this new guidance to have a material impact on our consolidated financial statements.



Standard/DescriptionEffective DateEffect on the Financial Statements or Other Significant Matters
In June 2016, the FASB issued new guidance on accounting for credit losses of financial instruments. The new guidance replaces the probable initial recognition threshold for incurred loss estimates in current GAAP with a methodology that reflects expected credit loss estimates.
 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. This standard includes our financial instruments, such as accounts receivable, and investments that are generally of high credit quality.
Previously, when credit losses were measured under GAAP, an entity generally only considered past events and current conditions in measuring the incurred loss.
The new guidance requires us to identify, analyze, document and support new methodologies for quantifying expected credit loss estimates for our financial instruments, using information such as historical experience and current economic environmental conditions, plus the use of reasonable supportable forecast information. We do not expect this new guidance to have a material impact 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 do not expect this new guidance to have a material impact on our consolidated financial statements.
In August 2018, the FASB issued new guidance related to customers’ accounting for implementation costs incurred in a cloud computing arrangement that is considered a service contract. The new guidance aligns the requirements for capitalizing implementation costs in such arrangements with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The new guidance can be adopted either prospectively or retrospectively.
 January 1, 2020. Earlier application is permitted. 
We are assessing the impact of the provisions of this new guidance on our consolidated financial statements. We do not expect this new guidance to have a material impact on our consolidated financial statements.


In November 2018, the FASB issued new guidance clarifying the interaction between the accounting guidance for collaboration agreements and revenue from contracts with customers.
 January 1, 2020. Earlier application is permitted We are assessinghave assessed the impact of the provisions of this new guidance and do not expect it will have a material impact on our consolidated financial statements.


FORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTS


This report and other written or oral statements that we make from time to time contain forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties. We have tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim”“aim,” “seek” and other words and terms of similar meaning or by using future dates in connection with any discussion of, among other things, our anticipated operating and financial performance, business plans and prospects, expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, revenue contribution, growth, performance, timing of exclusivity and potential benefits, of Pfizer’s products and product candidates, strategic reviews, capital allocation business-developmentobjectives, plans the benefits expected from our plans to organize our commercial operations into three businesses effective at the beginningfor and prospects of the company's 2019 fiscal year, our acquisitions and other business developmentbusiness-development activities, benefits anticipated from the reorganization of our commercial operations in 2019, sales efforts, expenses, interest rates, foreign exchange rates, the outcome of contingencies, such as legal proceedings, government regulation, our ability to successfully capitalize on growth opportunities or prospects, manufacturing and product supply and plans relating to share repurchases and dividends. In particular, these include statements relating to future actions, business plans and prospects, our acquisitions and other business development activities, the disposition of the HIS net assets, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, interest rates, foreign exchange rates, the outcome of contingencies, such as legal proceedings, plans relating to share repurchases and dividends, government regulation and financial results, including, in particular,among others, the anticipated progress in remediation efforts at certain of our Hospira manufacturing facilities and the expectations related to our supply issues set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Business––Product Manufacturing” section of this MD&A, the expected impact of patent expiries on our plansbusiness set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Operating Environment––Industry-Specific Challenges––Intellectual Property Rights and Collaboration/Licensing Rights” section of this MD&A, the expected pricing pressures on our products in the U.S. and internationally and the anticipated impact to organize our company into three businesses effective atbusiness set forth in the beginning“Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Operating Environment––Industry-Specific Challenges––Regulatory Environment/Pricing and Access––Government and Other Payer Group Pressures” section of this MD&A, the benefits expected from the reorganization of our commercial operations in 2019 fiscal year and our expectations regarding growth set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Strategy––Organizing for Growth” section of this MD&A, the anticipated timeframe for any decision regarding strategic alternatives for Pfizer Consumer Healthcareexpected timing and benefits of our agreement to combine Upjohn with Mylan to create a new global pharmaceutical company set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Business”Business,” and “––Our Strategy––Our Business Development Initiatives” sections of this MD&A, the anticipated costs related to our preparations for Brexit set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Operating Environment––The Global Economic Environment” section of this MD&A, our anticipated liquidity position set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Operating Environment––The Global Economic Environment” and the “Analysis of Financial Condition, Liquidity and Capital Resources” sections of this MD&A, our plans for increasing investment in the U.S. set forth in the “Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Strategy––Capital Allocation and Expense Management––Increasing Investment in the U.S.” section of this MD&A, the financial guidance set forth in the “Our“Overview of Our Performance, Operating Environment, Strategy and Outlook––Our Financial Guidance for 20182019 section of this MD&A, the expected impact of ACIP’s latest recommendation for Prevnar 13 for adults 65 and older on Prevnar 13’s revenues set forth in the “Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion––Prevnar 13/Prevenar 13” section of this MD&A, the expected impact of updates to the prescribing information for Xeljanz on its prescribing and growth set forth in the “Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion––Xeljanz” section of this MD&A, the anticipated costs and cost savings including from our acquisition of Hospira2017-2019 initiatives and our cost-reduction/productivity initiativesOrganizing for Growth initiative, set forth in the “Costs and Expenses––Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives” section of this MD&A and in Notes to Condensed Consolidated Financial Statements––Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives, the benefits expected from our business development transactions and the contributions that we expect to make from our general assets to ourthe company’s pension and postretirement plans during 20182019 set forth in Notes to Condensed Consolidated Financial Statements––Note 10. Pension and Postretirement Benefit Plans. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:
the outcome of research and developmentR&D activities, including, without limitation, the ability to meet anticipated pre-clinical andor clinical trialendpoints, commencement andand/or completion dates for our pre-clinical or clinical trials, regulatory submission anddates, regulatory approval dates andand/or launch dates, for product candidates, as well as the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new clinical data and additionalfurther analyses of existing clinical data;
decisions by regulatory authorities regarding whether and whenthe risk we may not be able to approve our drug applications, which will depend on the assessment by such regulatory authoritiessuccessfully address all 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; uncertainties regarding our ability to address the comments received by us from regulatory authorities such as the FDA andor the EMA, with respector obtain approval from regulators, which will depend on myriad factors, including such regulator making a determination as to certainwhether a product’s benefits outweigh its known risks and a determination of our drug applications to the satisfaction of those authorities;product’s efficacy; regulatory decisions impacting labeling, manufacturing processes, safety and/or other matters; and recommendations by technical or advisory committees, such as ACIP, that may impact the use of our vaccines;

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 theproduct labeling, for, and/or increasednew or newincreased concerns about the safetyside effects or efficacy of, a product that could affect its availability or commercial potential;

risks associated with preliminary, early stage or interim data, includingpotential, such as the risk that final results of studiesupdate to the U.S. prescribing information for which preliminary, early stage or interim data have been provided and/or additional clinical trials may be different from (including less favorable than) the preliminary, early stage or interim data resultsXeljanz and may not support further clinical development of the applicable product candidate or indication;Xeljanz extended release;
the success of external business-development activities, including the ability to identify and execute on potential business development opportunities, the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all, the ability to realize the anticipated benefits of any such transactions, and the potential need to obtain additional equity or debt financing to pursue these opportunities, which could result in increased leverage and impact our credit ratings;
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, and access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to the innovator product;
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 delays caused by natural events, such as hurricanes; supply shortages at our facilities; and legal or regulatory actions, such as warning letters, suspension of manufacturing, seizure of product, debarment, injunctions, ordebarment, voluntary recall of a product;product or failure to secure product approvals;
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 favorable 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;
the impact of any U.S. healthcare reform or legislation, including any replacement, repeal, modification or invalidation of some or all of the provisions of the U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act;
U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, 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; general budget control actions; the importation of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries; revisions to reimbursement of biopharmaceuticals under government programs; restrictions on U.S. 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., including China, affecting pharmaceutical product pricing, intellectual property, 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, economic conditions, 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, such as claims that our patents are invalid and/or do not cover the product of the generic drug manufacturer or where one or more third parties seeks damages and/or injunctive relief to compensate for alleged infringement of its patents by our commercial or other activities, 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;
the risk that our currently pending or future patent applications may not result in issued patents, or be granted on a timely basis, or any patent-term extensions that we seek may not be granted on a timely basis, if at all;
our ability to protect our patents and other intellectual property, both domestically and internationally;
interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates;
governmental laws and regulations affecting domestic and foreign operations, including, without limitation, tax obligations and changes affecting the tax treatment by the U.S. of income earned outside the U.S. that may result from pending and possible future proposals, including further clarifications and/or interpretations of the recently passed TCJA;TCJA enacted in 2017;
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, including the approval and supply of our products;
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 or regulatory 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;
further clarifications and/or 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; the related risk that our allowance for doubtful accounts may not be adequate; and the risks related to volatility of our income due to changes in the market value of equity investments;
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 and internal reorganizations, including our plans to organizethe reorganization of our commercial operations in 2019, the transaction with GSK which combined our respective consumer healthcare businesses into three businesses effective at the beginning of the company’s 2019 fiscal year,a new consumer healthcare joint venture and our agreement to combine Upjohn with Mylan, as well as any other corporate strategic initiatives, and cost-reduction and productivity initiatives, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs or organizational disruption;
the impact of product recalls, withdrawals and other unusual items;
the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;

risks related to internal control over financial reporting;

risks and uncertainties related to our acquisitions, such as the acquisition of Hospira, Anacor, Medivation and AstraZeneca’s small molecule anti-infectives business,Array, including, among other things, the ability to realize the anticipated benefits of those acquisitions, including the possibility that the expected cost savings and/or accretion related to thefrom certain of those 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; risks related to our ability to grow revenues for Xtandi;certain acquired products; significant transaction costs; and unknown liabilities;
risks and uncertainties related to our transaction with GSK, which combined our respective consumer healthcare businesses into a new consumer healthcare joint venture, including, among other things, risks related to the ability to realize the anticipated benefits of the transaction, including the possibility that the expected benefits and cost synergies from the transaction will not be realized or will not be realized within the expected time period, the risk that the businesses will not be integrated successfully, the possibility that a future separation of the joint venture as an independent company via a demerger of GSK’s equity interest to GSK’s shareholders and a listing of the joint venture on the U.K. equity market may not occur, disruption from the transaction making it more difficult to maintain business and operational relationships, negative effects of the transaction on the market price of Pfizer’s common stock and on Pfizer’s operating results, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the transaction, other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates, changes in tax and other laws, regulations, rates and policies, future business combinations or disposals and competitive developments; and
risks and uncertainties related to our evaluation of strategic alternatives for our Consumer Healthcare business,agreement to combine Upjohn with Mylan to create a new global pharmaceutical company, including, among other things, risks related to the satisfaction of the conditions to closing the transaction (including the failure to obtain necessary shareholder and regulatory approvals) in the anticipated timeframe or at all and the possibility that the transaction does not close, risks related to the ability to realize the anticipated benefits of any strategic alternatives we may pursue for our Consumer Healthcare business; the potential for disruption to our business and diversion of management’s attention from other aspects of our business;transaction, including the possibility that such strategic alternativesthe expected benefits and cost synergies from the proposed transaction will not be completedrealized or will not be realized within the expected time period, the risk that the businesses will not be integrated successfully, disruption from the transaction making it more difficult to maintain business and operational relationships, negative effects of the announcement or the consummation of the proposed transaction on terms that are advantageousthe market price of Pfizer’s common stock, Pfizer’s credit ratings and/or on Pfizer’s or the combined company’s operating results, significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to Pfizer; the possibility that we may be unable to realize a higher value for Pfizer Consumer Healthcare through strategic alternatives;proposed transaction, other business effects, including the effects of industry, market, economic, political or regulatory conditions, future exchange and unknown liabilities.interest rates, changes in tax and other laws, regulations, rates and policies, future business combinations or disposals and competitive developments.
We cannot guarantee that any forward-looking statement will be realized. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors should bear this in mind as they consider forward-looking statements, and are cautioned not to put undue reliance on forward-looking statements.


We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law or by the rules and regulations of the SEC. You are advised, however, to consult any further disclosures we make on related subjects.


Our 2017Additional discussion regarding certain risks, uncertainties and assumptions described above, as well as other material risks to our business, is included under the heading entitled “Risk Factors” in Part I, Item 1A. of our 2018 Form 10-K listed various important factors that10-K. These risks could cause actual results to differ materially from past and projected future results. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. Readers can find them in Part I, Item 1A, of that filing under the heading “Risk Factors.” We incorporate that section of thatthe 2018 Form 10-K in this filing and investors should refer to it. Reference is also made to Part II, Item 1A, “Risk Factors,” of this Quarterly Report on Form 10-Q. You should understand that it is not possible to predict or identify all such factors. Consequently, you should not consider any such list to be a complete set of all potential risks or uncertainties.


The operating segment information provided in this report does not purport to represent the revenues, costs and income from continuing operations before provision for taxes on income that each of our operating segments would have recorded had each segment operated as a standalone company during the periods presented.


This report includes discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.


Financial Risk Management

Interest Rate Risk

With respect to our investments, we strive to maintain a predominantly floating–rate basis position, but our strategy may change based on prevailing market conditions.

We currently borrow primarily on a long-term, fixed-rate basis. Historically, we strove to borrow primarily on a floating-rate basis; but in recent years we borrowed on a long-term, fixed-rate basis. From time to time, depending on market conditions, we will change the profile of our outstanding debt by entering into derivative financial instruments like interest rate swaps.

Legal Proceedings and Contingencies


Information with respect to legal proceedings and contingencies required by this Item is incorporated herein by reference to Notes to Condensed Consolidated Financial Statements––Note 12A. Contingencies and Certain Commitments: Legal Proceedings in Part I, Item 1, of this Quarterly Report on Form 10-Q.


Item 3. Quantitative and Qualitative Disclosures About Market Risk


Information required by this item is incorporated by reference from the discussion under the heading Financial Risk Management in our 20172018 Financial Report and Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q.

Report.
Item 4. Controls and Procedures


As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective in alerting them in a timely manner to material information required to be disclosed in our periodic reports filed with the SEC.


During our most recent fiscal quarter, there has not been any change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


PART II - OTHER INFORMATION


Item 1. Legal Proceedings


The information required by this Item is incorporated herein by reference to Notes to Condensed Consolidated Financial Statements––Note 12A. Contingencies and Certain Commitments: Legal Proceedings in Part I, Item 1, of this Quarterly Report on Form 10-Q.


Tax Matters


Additional information with respect to tax matters required by this Item is incorporated herein by reference to Notes to Condensed Consolidated Financial Statements––Note 5C.5B. Tax Matters: Tax Contingencies in Part I, Item 1, of this Quarterly Report on Form 10-Q.


We account for income tax contingencies using a benefit recognition model. If our initial assessment fails to result in the recognition of a tax benefit, we regularly monitor our position and subsequently recognize the tax benefit: (i) if there are changes in tax law, analogous case law or there is new information that sufficiently raise the likelihood of prevailing on the technical merits of the position to “more likely than not”; (ii) if the statute of limitations expires; or (iii) if there is a completion of an audit resulting in a favorable settlement of that tax year with the appropriate agency. We regularly re-evaluate our tax positions based on the results of audits of federal, state and foreign income tax filings, statute of limitations expirations, changes in tax law or receipt of new information that would either increase or decrease the technical merits of a position relative to the “more-likely-than-not” standard.


Our assessments are based on estimates and assumptions that have been deemed reasonable by management, but our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes, and variation from such estimates could materially affect our financial statements in the period of settlement or when the statutes of limitations expire, as we treat these events as discrete items in the period of resolution. Finalizing audits with the relevant taxing authorities can include formal administrative and legal proceedings, and, as a result, it is difficult to estimate the timing and range of possible changes related to our uncertain tax positions, and such changes could be significant.
Item 1A. Risk Factors
TheWe refer to the “Our Operating Environment”, “The Global Economic Environment” and “Forward-Looking Information and Factors That May Affect Future Results” sections of the MD&A of this Quarterly Report on Form 10-Q and Part I, Item 1A, “Risk Factors”, of our 20172018 Form 10-K are incorporated by reference herein. We are including10-K. There have been no material changes from the following risk factor which should be read in conjunction with our description of risk factors discussed in Part I, Item 1A, “Risk Factors” of our 20172018 Form 10-K.
MARKET FLUCTUATIONS IN OUR EQUITY INVESTMENTS
In the first quarter of 2018, we adopted a new accounting standard whereby certain equity investments are measured at fair value with changes in fair value now recognized in net income. We expect the adoption of this new accounting standard may increase the volatility of our income in future periods due to changes in the fair value of equity investments. For additional information, see Notes to Condensed Consolidated Financial Statements––Note 1B. Basis of Presentation and Significant Accounting Policies: Adoption of New Accounting Standards.



Item 2. Unregistered Sales of Equity Securities and Use of Proceeds


The following table provides certain information with respect to our purchases of shares of the Company’s common stock during the third fiscal quarter of 20182019:


Issuer Purchases of Equity Securities(a) 
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)

July 2, 2018 through July 29, 2018 7,765
 $36.43
 
 $10,292,715,228
July 30, 2018 through August 26, 2018 10,626
 $40.45
 
 $10,292,715,228
August 27, 2018 through September 30, 2018 46,671,505
 $40.36
 46,652,993
 $9,187,715,502
Total 46,689,896
 $40.36
 46,652,993
  
Period 
Total Number of
Shares Purchased(a), (b)

 
Average Price
Paid per Share(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)

July 1, 2019 through July 28, 2019 30,230
 $43.28
 
 $5,292,881,709
July 29, 2019 through August 25, 2019 33,620,322
 $41.42
 33,501,384
 $5,292,881,709
August 26, 2019 through September 29, 2019 23,422
 $37.78
 
 $5,292,881,709
Total 33,673,974
 $41.41
 33,501,384
  
(a) 
Our December 2015 $112017 $10 billion share repurchase program was exhausted in the thirdfirst quarter of 2018.2019. In December 2017,2018, the Board of Directors authorized an additionala new $10 billion share repurchase program to be utilized over time (the 2018 program) and share repurchases commenced thereunder in the thirdfirst quarter of 2018 (the 2017 program).2019. On March 12, 2018,February 7, 2019, we entered into an accelerated share repurchase agreement with CitibankGS&Co. to repurchase $4.0approximately $6.8 billion of our common stock and on September 5, 2018,August 1, 2019, the accelerated share repurchase agreement with CitibankGS&Co. was completed. For additional information, see the Notes to Condensed Consolidated Financial Statements––Note 12.12C. Contingencies and Certain Commitments: Certain Commitments. At September 30, 2018,29, 2019, our remaining share-purchase authorization under the 20172018 program was approximately $9.2$5.3 billion.
(b) 
In addition to the amounts purchased under our share repurchase program, including amounts purchased33.5 million shares received under the accelerated share repurchase agreement with Citibank, GS&Co. (see the Notes to Condensed Consolidated Financial Statements––Note 12C. Contingencies and Certain Commitments: Certain Commitments),these columns represent (i) 32,041166,539 shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive programs and (ii) the open market purchase by the trustee of 4,8626,051 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.
Item 3. Defaults Upon Senior Securities


None.
Item 4. Mine Safety Disclosures


Not applicable.

Item 5. Other Information


None.




Item 6. Exhibits
 -AmendmentBusiness Combination Agreement, dated July 29, 2019, by and among Pfizer Inc., Upjohn Inc., Utah Acquisition Sub Inc., Mylan N.V., Mylan I B.V. and Mylan II B.V. is incorporated by reference from our Current Report on Form 8-K filed on July 29, 2019 (File No. 3 to the Pfizer Supplemental Savings Plan.001-03619)*
 -Separation and Distribution Agreement, dated as of July 29, 2019, by and among Pfizer Inc. and Upjohn Inc. is incorporated by reference from our Current Report on Form 8-K filed on July 29, 2019 (File No. 001-03619)*
-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
 
Inline XBRL Taxonomy Extension Schema
Inline XBRL Taxonomy Extension Calculation Linkbase
Inline XBRL Taxonomy Extension Label Linkbase
Inline XBRL Taxonomy Extension Presentation Linkbase
Inline XBRL Taxonomy Extension Definition Document
Exhibit 104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
*Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Pfizer agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request.




SIGNATURE


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


  Pfizer Inc.
  (Registrant)
   
   
Dated:November 8, 20187, 2019/s/ Loretta V. Cangialosi
  
Loretta V. Cangialosi, Senior Vice President and
Controller
(Principal Accounting Officer and
Duly Authorized Officer)


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