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PFIZER INC - Quarter Report: 2021 October (Form 10-Q)


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

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

For the quarterly period ended October 3, 2021

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.
(Exact name of registrant as specified in its charter)
Delaware13-5315170
(State of Incorporation)(I.R.S. Employer Identification No.)

235 East 42nd Street, New York, New York  10017
(Address of principal executive offices)  (zip code)
(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
0.250% 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.
YesxNo

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).
YesxNo

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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:

Large Accelerated filer 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).
YesNo
x

At November 8, 2021, 5,612,866,598 shares of the issuer’s voting common stock were outstanding.



TABLE OF CONTENTS
Page
 
 
Item 2.
 
 
 
 
 
 
Item 3. 
Defaults Upon Senior SecuritiesN/A
Item 4. 
Mine Safety DisclosuresN/A
Item 5. 
Other InformationN/A
 
N/A = Not Applicable
2


DEFINED TERMS

Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this Form 10-Q (defined below) refer to Pfizer Inc. and its subsidiaries. Pfizer’s fiscal quarter-end for subsidiaries operating outside the U.S. is as of and for the three and nine months ended August 29, 2021 and August 23, 2020, and for U.S. subsidiaries is as of and for the three and nine months ended October 3, 2021 and September 27, 2020. References to “Notes” in this Form 10-Q are to the notes to the condensed or consolidated financial statements in this Form 10-Q or our 2020 Form 10-K. We also have used several other terms in this Form 10-Q, most of which are explained or defined:
2020 Form 10-KAnnual Report on Form 10-K for the fiscal year ended December 31, 2020
ACIPAdvisory Committee on Immunization Practices
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.
ArrayArray BioPharma Inc.
ArvinasArvinas, Inc.
AstellasAstellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc.
ATTR-CMtransthyretin amyloid cardiomyopathy
BioNTechBioNTech SE
BLABiologics License Application
BMSBristol-Myers Squibb Company
BNT162b2Pfizer BioNTech COVID-19 Vaccine
ComirnatyPfizer-BioNTech COVID-19 Vaccine
BODBoard of Directors
CDCU.S. Centers for Disease Control and Prevention
CMA
conditional marketing authorization
Consumer Healthcare JVGSK Consumer Healthcare JV
COVID-19novel coronavirus disease of 2019
Developed Europe
Includes the following markets: Western Europe, Scandinavian countries and Finland
Developed MarketsIncludes the following markets: U.S., Developed Europe, Japan, Canada, South Korea, Australia and New Zealand
Developed Rest of World
Includes the following markets: Japan, Canada, South Korea, Australia and New Zealand
EMAEuropean Medicines Agency
Emerging Markets
Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Central Europe, Eastern Europe, the Middle East, Africa and Turkey
EPSearnings per share
EUEuropean Union
EUAemergency use authorization
Exchange ActSecurities Exchange Act of 1934, as amended
FDAU.S. Food and Drug Administration
Form 10-QQuarterly Report on Form 10-Q for the quarterly period ended October 3, 2021
GAAPGenerally Accepted Accounting Principles
GISTgastrointestinal stromal tumors
GSKGlaxoSmithKline plc
HospiraHospira, Inc.
IPR&Din-process research and development
IRSU.S. Internal Revenue Service
JVjoint venture
KingKing Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.)
LIBORLondon Interbank Offered Rate
LillyEli Lilly & Company
LOEloss of exclusivity
MCOmanaged care organization
mCRCmetastatic colorectal cancer
mCRPC
metastatic castration-resistant prostate cancer
mCSPC
metastatic castration-sensitive prostate cancer
MD&AManagement’s Discussion and Analysis of Financial Condition and Results of Operations
MeridianMeridian Medical Technologies, Inc.
3


MTMmark-to-market
MylanMylan N.V.
Mylan-Japan collaborationa pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan that terminated on December 21, 2020
MyovantMyovant Sciences Ltd.
nmCRPC
non-metastatic castration-resistant prostate cancer
NSCLCnon-small cell lung cancer
OPKOOPKO Health, Inc.
OTCover-the-counter
PaxlovidPF-07321332 (SARS-CoV-2 3CL protease inhibitor (oral anti-viral)); ritonavir
PBMpharmacy benefit manager
PDUFAPrescription Drug User Fee Act
PGSPfizer Global Supply
PharmaciaPharmacia Corporation
PsApsoriatic arthritis
QTDQuarter-to-date or three months ended
RArheumatoid arthritis
RCCrenal cell carcinoma
R&Dresearch and development
SandozSandoz, Inc., a division of Novartis AG
SECU.S. Securities and Exchange Commission
SI&Aselling, informational and administrative
UCulcerative colitis
U.K.United Kingdom
U.S.United States
Upjohn BusinessPfizer’s former global, primarily off-patent branded and generics business, which included a portfolio of 20 globally recognized solid oral dose brands, including Lipitor, Lyrica, Norvasc, Celebrex and Viagra, as well as a U.S.-based generics platform, Greenstone, that was spun-off on November 16, 2020 and combined with Mylan to create Viatris
ValnevaValneva SE
ViatrisViatris Inc.
YTD
Year-to-date or nine months ended
This Form 10-Q 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.
Some amounts in this Form 10-Q may not add due to rounding. All percentages have been calculated using unrounded amounts. All trademarks mentioned are the property of their owners.
The information contained on our website, our Facebook, YouTube and LinkedIn pages or our Twitter accounts, or any third-party website, is not incorporated by reference into this Form 10-Q.
4


PART I.  FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
 Three Months EndedNine Months Ended
(MILLIONS, EXCEPT PER COMMON SHARE DATA)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Revenues$24,094 $10,277 $57,653 $30,224 
Costs and expenses:
Cost of sales(a)
9,973 2,007 21,232 5,773 
Selling, informational and administrative expenses(a)
2,905 2,658 8,617 7,858 
Research and development expenses(a)
3,447 2,300 7,920 6,050 
Amortization of intangible assets981 862 2,784 2,579 
Restructuring charges and certain acquisition-related costs
646 668 417 
(Gain) on completion of Consumer Healthcare JV transaction
— — — (6)
Other (income)/deductions––net
(1,696)1,878 (3,697)1,114 
Income from continuing operations before provision/(benefit) for taxes on income7,836 570 20,128 6,438 
Provision/(benefit) for taxes on income(331)(347)1,518 434 
Income from continuing operations8,167 917 18,610 6,004 
Income/(loss) from discontinued operations––net of tax(9)560 24 2,334 
Net income before allocation to noncontrolling interests8,159 1,477 18,633 8,338 
Less: Net income attributable to noncontrolling interests12 47 25 
Net income attributable to Pfizer Inc. common shareholders$8,146 $1,469 $18,586 $8,313 
Earnings per common share––basic:
    
Income from continuing operations attributable to Pfizer Inc. common shareholders$1.45 $0.16 $3.32 $1.08 
Income/(loss) from discontinued operations––net of tax— 0.10 — 0.42 
Net income attributable to Pfizer Inc. common shareholders$1.45 $0.26 $3.32 $1.50 
Earnings per common share––diluted:
    
Income from continuing operations attributable to Pfizer Inc. common shareholders$1.42 $0.16 $3.26 $1.06 
Income/(loss) from discontinued operations––net of tax— 0.10 — 0.42 
Net income attributable to Pfizer Inc. common shareholders$1.42 $0.26 $3.27 $1.48 
Weighted-average shares––basic5,609 5,557 5,597 5,552 
Weighted-average shares––diluted5,725 5,633 5,688 5,622 
(a)Exclusive of amortization of intangible assets, except as disclosed in Note 9 in this Form 10-Q and Note 1L in our 2020 Form 10-K.
See Accompanying Notes.
5


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(UNAUDITED)
 Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Net income before allocation to noncontrolling interests$8,159 $1,477 $18,633 $8,338 
Foreign currency translation adjustments, net(866)1,403 (366)(27)
Unrealized holding gains/(losses) on derivative financial instruments, net213 (372)179 (661)
Reclassification adjustments for (gains)/losses included in net income(a)
48 143 286 (25)
 261 (230)464 (685)
Unrealized holding gains/(losses) on available-for-sale securities, net(266)239 (128)231 
Reclassification adjustments for (gains)/losses included in net income(b)
(85)(172)(25)
 (257)155 (300)205 
Reclassification adjustments related to amortization of prior service costs and other, net(39)(45)(119)(134)
Reclassification adjustments related to curtailments of prior service costs and other, net(59)— (59)— 
Other(3)(3)
 (97)(47)(181)(133)
Other comprehensive income/(loss), before tax(959)1,280 (382)(640)
Tax provision/(benefit) on other comprehensive income/(loss)(65)(19)(44)(311)
Other comprehensive income/(loss) before allocation to noncontrolling interests$(894)$1,299 $(338)$(329)
Comprehensive income/(loss) before allocation to noncontrolling interests$7,265 $2,776 $18,296 $8,009 
Less: Comprehensive income/(loss) attributable to noncontrolling interests11 48 16 
Comprehensive income/(loss) attributable to Pfizer Inc.$7,256 $2,766 $18,248 $7,993 
(a)Reclassified into Other (income)/deductions—net and Cost of sales. See Note 7E.
(b)Reclassified into Other (income)/deductions—net.
See Accompanying Notes.
6


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(MILLIONS)October 3,
2021
December 31, 2020
(Unaudited)
Assets
Cash and cash equivalents$1,966 $1,784 
Short-term investments27,730 10,437 
Trade accounts receivable, less allowance for doubtful accounts: 2021—$494; 2020—$508
11,897 7,930 
Inventories8,640 8,046 
Current tax assets3,877 3,264 
Other current assets3,790 3,605 
Total current assets57,900 35,067 
Equity-method investments16,349 16,856 
Long-term investments5,248 3,406 
Property, plant and equipment, less accumulated depreciation: 2021—$15,403; 2020—$14,812
14,436 13,900 
Identifiable intangible assets26,306 28,471 
Goodwill49,489 49,577 
Noncurrent deferred tax assets and other noncurrent tax assets2,755 2,383 
Other noncurrent assets6,705 4,569 
Total assets$179,188 $154,229 
Liabilities and Equity  
Short-term borrowings, including current portion of long-term debt: 2021—$2,663; 2020—$2,002
$3,629 $2,703 
Trade accounts payable4,698 4,309 
Dividends payable2,191 2,162 
Income taxes payable4,496 1,049 
Accrued compensation and related items2,571 3,058 
Deferred revenues3,529 1,113 
Other current liabilities20,690 11,527 
Total current liabilities41,803 25,920 
Long-term debt36,250 37,133 
Pension benefit obligations3,676 4,766 
Postretirement benefit obligations627 645 
Noncurrent deferred tax liabilities328 4,063 
Other taxes payable11,336 11,560 
Other noncurrent liabilities9,201 6,669 
Total liabilities103,221 90,756 
Commitments and Contingencies
Common stock473 470 
Additional paid-in capital89,973 88,674 
Treasury stock(111,359)(110,988)
Retained earnings102,252 90,392 
Accumulated other comprehensive loss(5,649)(5,310)
Total Pfizer Inc. shareholders’ equity75,691 63,238 
Equity attributable to noncontrolling interests275 235 
Total equity75,967 63,473 
Total liabilities and equity$179,188 $154,229 
See Accompanying Notes.
7


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF EQUITY
(UNAUDITED)
PFIZER INC. SHAREHOLDERS
Preferred StockCommon StockTreasury Stock
(MILLIONS, EXCEPT PREFERRED SHARES)SharesStated ValueSharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, July 4, 2021
— $— 9,450 $472 $89,336 (3,851)$(111,356)$96,346 $(4,758)$70,042 $273 $70,315 
Net income8,146 8,146 12 8,159 
Other comprehensive income/(loss), net of tax
(891)(891)(3)(894)
Cash dividends declared, per share: $0.39
Common stock(2,192)(2,192)(2,192)
Preferred stock— — 
Noncontrolling interests— (8)(8)
Share-based payment transactions13 637 — (3)(1)634 634 
Purchases of common stock— — — — 
Preferred stock conversions and redemptions— — — — — — — 
Other— — — (47)(47)(46)
Balance, October 3, 2021
— $— 9,462 $473 $89,973 (3,851)$(111,359)$102,252 $(5,649)$75,691 $275 $75,967 
PFIZER INC. SHAREHOLDERS
Preferred StockCommon StockTreasury Stock
(MILLIONS, EXCEPT PREFERRED SHARES)SharesStated ValueSharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, June 28, 2020
— $— 9,394 $470 $87,886 (3,840)$(110,978)$93,946 $(6,983)$64,342 $228 $64,570 
Net income1,469 1,469 1,477 
Other comprehensive income/(loss), net of tax1,296 1,296 1,299 
Cash dividends declared, per share: $0.38
Common stock (2,113)(2,113)(2,113)
Preferred stock— — 
Noncontrolling interests— (1)(1)
Share-based payment transactions— 275 — (2)273 273 
Purchases of common stock— — — — 
Preferred stock conversions and redemptions— — — — — — — 
Other— — — — — (1)(1)
Balance, September 27, 2020
— $— 9,397 $470 $88,161 (3,840)$(110,980)$93,302 $(5,687)$65,267 $236 $65,503 
See Accompanying Notes.
8



PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF EQUITY
(UNAUDITED)
PFIZER INC. SHAREHOLDERS
Preferred StockCommon StockTreasury Stock
(MILLIONS, EXCEPT PREFERRED SHARES)SharesStated ValueSharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, January 1, 2021
— $— 9,407 $470 $88,674 (3,840)$(110,988)$90,392 $(5,310)$63,238 $235 $63,473 
Net income18,586 18,586 47 18,633 
Other comprehensive income/(loss), net of tax(338)(338)— (338)
Cash dividends declared, per share: $1.17
Common stock(6,569)(6,569)(6,569)
Preferred stock— — 
Noncontrolling interests— (8)(8)
Share-based payment transactions56 1,300 (11)(371)(77)855 855 
Purchases of common stock— — — — 
Preferred stock conversions and redemptions— — — — — — — 
Other— — — (81)(81)(79)
Balance, October 3, 2021
— $— 9,462 $473 $89,973 (3,851)$(111,359)$102,252 $(5,649)$75,691 $275 $75,967 
PFIZER INC. SHAREHOLDERS
Preferred StockCommon StockTreasury Stock
(MILLIONS, EXCEPT PREFERRED SHARES)SharesStated ValueSharesPar ValueAdd’l
Paid-In Capital
SharesCostRetained EarningsAccum. Other Comp.
Loss
Share-
holders’ Equity
Non-controlling interestsTotal Equity
Balance, January 1, 2020
431 $17 9,369 $468 $87,428 (3,835)$(110,801)$91,397 $(5,367)$63,143 $303 $63,447 
Net income8,313 8,313 25 8,338 
Other comprehensive income/(loss), net of tax(319)(319)(9)(329)
Cash dividends declared, per share: $1.14
Common stock (6,408)(6,408)(6,408)
Preferred stock— — — 
Noncontrolling interests— (81)(81)
Share-based payment transactions28 748 (6)(210)539 539 
Purchases of common stock— — — — 
Preferred stock conversions and redemptions(431)(17)(15)31 (1)(1)
Other— — — — — (1)(1)
Balance, September 27, 2020
— $— 9,397 $470 $88,161 (3,840)$(110,980)$93,302 $(5,687)$65,267 $236 $65,503 
See Accompanying Notes.
9


PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
 Nine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
Operating Activities  
Net income before allocation to noncontrolling interests$18,633 $8,338 
Income from discontinued operations—net of tax24 2,334 
Net income from continuing operations before allocation to noncontrolling interests18,610 6,004 
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities:  
Depreciation and amortization3,914 3,573 
Asset write-offs and impairments115 989 
Gain on completion of Consumer Healthcare JV transaction, net of cash conveyed— (6)
Deferred taxes from continuing operations(3,702)(735)
Share-based compensation expense687 468 
Benefit plan contributions in excess of expense/income(1,933)(760)
Other adjustments, net(1,848)(313)
Other changes in assets and liabilities, net of acquisitions and divestitures10,816 (2,856)
Net cash provided by operating activities from continuing operations26,660 6,364 
Net cash provided by operating activities from discontinued operations2,414 
Net cash provided by operating activities26,666 8,778 
Investing Activities  
Purchases of property, plant and equipment(1,718)(1,413)
Purchases of short-term investments(26,280)(9,309)
Proceeds from redemptions/sales of short-term investments15,852 8,397 
Net (purchases of)/proceeds from redemptions/sales of short-term investments with original maturities of three months or less(7,152)671 
Purchases of long-term investments(861)(284)
Proceeds from redemptions/sales of long-term investments569 648 
Other investing activities, net(370)160 
Net cash provided by/(used in) investing activities from continuing operations(19,960)(1,129)
Net cash provided by/(used in) investing activities from discontinued operations— (11,472)
Net cash provided by/(used in) investing activities(19,960)(12,601)
Financing Activities  
Proceeds from short-term borrowings— 12,352 
Principal payments on short-term borrowings(1)(17,449)
Net (payments on)/proceeds from short-term borrowings with original maturities of three months or less
265 1,624 
Proceeds from issuance of long-term debt997 5,222 
Principal payments on long-term debt(1,001)(2,511)
Cash dividends paid(6,540)(6,328)
Other financing activities, net(185)(166)
Net cash provided by/(used in) financing activities from continuing operations(6,465)(7,257)
Net cash provided by/(used in) financing activities from discontinued operations— 11,395 
Net cash provided by/(used in) financing activities(6,465)4,138 
Effect of exchange-rate changes on cash and cash equivalents and restricted cash and cash equivalents
(32)(39)
Net increase/(decrease) in cash and cash equivalents and restricted cash and cash equivalents209 277 
Cash and cash equivalents and restricted cash and cash equivalents, at beginning of period1,825 1,350 
Cash and cash equivalents and restricted cash and cash equivalents, at end of period$2,034 $1,627 
Supplemental Cash Flow Information
Cash paid/(received) during the period for:  
Income taxes
$2,943 $2,445 
Interest paid
1,205 1,297 
Interest rate hedges
(26)(45)
Non-cash transaction:
Right-of-use assets obtained in exchange for lease liabilities$1,552 $157 
See Accompanying Notes.
10


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

We prepared these condensed consolidated financial statements in conformity with U.S. GAAP, consistent in all material respects with those applied in our 2020 Form 10-K, except as disclosed in Note 1C. As permitted under the SEC requirements for interim reporting, certain footnotes or other financial information have been condensed or omitted.

These financial statements include all normal and recurring adjustments that are considered necessary for the fair statement of results for the interim periods presented. The information included in this Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2020 Form 10-K. 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.

Pfizer’s fiscal quarter-end for subsidiaries operating outside the U.S. is as of and for the three and nine months ended August 29, 2021 and August 23, 2020, and for U.S. subsidiaries is as of and for the three and nine months ended October 3, 2021 and September 27, 2020.
Business development activities impacted financial results in the periods presented. See Note 1A in our 2020 Form 10-K, and Note 2. On November 16, 2020, we completed the spin-off and the combination of our Upjohn Business with Mylan to form Viatris. For additional information, see Note 2B in our 2020 Form 10-K. On December 21, 2020, which fell in Pfizer’s international first quarter of 2021, Pfizer and Viatris completed the termination of the Mylan-Japan collaboration pursuant to an agreement dated November 13, 2020, and we transferred related inventories and operations that were part of the Mylan-Japan collaboration to Viatris. As a result, the financial position and results of operations of the Upjohn Business and the Mylan-Japan collaboration are presented as discontinued operations. Prior-period information has been restated to reflect our current organization structure.
B. New Accounting Standard Adopted in 2021
On January 1, 2021, we adopted a new accounting standard for income tax that eliminates certain exceptions to the guidance related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The adoption of this guidance did not have a material impact on our condensed consolidated financial statements.
For information on new accounting standards adopted in 2020, see Note 1B in our 2020 Form 10-K.

C. Change in Accounting Principle

In the first quarter of 2021, we adopted a change in accounting principle to a more preferable policy under U.S. GAAP to immediately recognize actuarial gains and losses arising from the remeasurement of our pension and postretirement plans (MTM Accounting). Under the prior policy, we deferred recognition of these gains and losses in Accumulated other comprehensive loss. The accumulated actuarial gains/losses outside of a “corridor” were then amortized into net periodic benefit costs over the average remaining service period or the average life expectancy of participants. This change has been applied to all pension and postretirement plans on a retrospective basis for all prior periods presented, and as of January 1, 2020, resulted in a cumulative effect decrease to Retained earnings of $6.3 billion, with a corresponding offset to Accumulated other comprehensive loss. Each time a pension or postretirement plan is remeasured, the actuarial gain or loss is recognized immediately and classified as Other (income)/deductions––net.

We believe that MTM Accounting is a more preferable policy as it provides improved transparency of results and performance, better alignment with fair value accounting principles and a better reflection of current economic and interest rate trends on plan investments and assumptions and the actuarial impact of plan remeasurements.

11


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The impacts of the adjustments on our condensed consolidated financial statements are summarized as follows:
Three Months Ended
October 3, 2021
September 27, 2020
(MILLIONS, EXCEPT PER COMMON SHARE DATA)Previous
Accounting
Principle
Impact of ChangeAs ReportedPrevious Accounting PrincipleImpact of ChangeAs Adjusted
Condensed Consolidated Statements of Income:
Other (income)/deductions––net$(641)$(1,055)$(1,696)$889 $989 $1,878 
Income from continuing operations before provision/(benefit) for taxes on income6,782 1,055 7,836 1,559 (989)570 
Provision/(benefit) for taxes on income(561)230 (331)(104)(243)(347)
Income/(loss) from discontinued operations––net of tax(9)— (9)539 21 560 
Net income before allocation to noncontrolling interests7,334 825 8,159 2,202 (724)1,477 
Net income attributable to Pfizer Inc. common shareholders7,322 825 8,146 2,194 (724)1,469 
Earnings per common share––basic:
Income from continuing operations attributable to Pfizer Inc. common shareholders$1.30 $0.15 $1.45 $0.30 $(0.13)$0.16 
Income/(loss) from discontinued operations––net of tax— — — 0.10 — 0.10 
Net income attributable to Pfizer Inc. common shareholders1.30 0.15 1.45 0.39 (0.13)0.26 
Earnings per common share––diluted:
Income from continuing operations attributable to Pfizer Inc. common shareholders$1.27 $0.15 $1.42 $0.29 $(0.13)$0.16 
Income/(loss) from discontinued operations––net of tax— — — 0.10 — 0.10 
Net income attributable to Pfizer Inc. common shareholders1.27 0.15 1.42 0.39 (0.13)0.26 
Condensed Consolidated Statements of Comprehensive Income:
Foreign currency translation adjustments, net$(961)$95 $(866)$1,609 $(206)$1,403 
Benefit plans: actuarial gains/(losses), net836 (836)— (1,211)1,211 — 
Reclassification adjustments related to amortization74 (74)— 67 (67)— 
Reclassification adjustments related to settlements, net139 (139)— 174 (174)— 
Other95 (95)— (206)206 — 
Tax provision/(benefit) on other comprehensive income/(loss)(89)23 (65)(262)243 (19)
Nine Months Ended
October 3, 2021
September 27, 2020
(MILLIONS, EXCEPT PER COMMON SHARE DATA)Previous
Accounting
Principle
Impact of ChangeAs ReportedPrevious Accounting PrincipleImpact of ChangeAs Adjusted
Condensed Consolidated Statements of Income:
Other (income)/deductions––net$(2,414)$(1,283)$(3,697)$232 $881 $1,114 
Income from continuing operations before provision/(benefit) for taxes on income18,845 1,283 20,128 7,320 (881)6,438 
Provision/(benefit) for taxes on income1,237 281 1,518 647 (213)434 
Income/(loss) from discontinued operations––net of tax24 — 24 2,374 (40)2,334 
Net income before allocation to noncontrolling interests17,631 1,002 18,633 9,046 (709)8,338 
Net income attributable to Pfizer Inc. common shareholders17,584 1,002 18,586 9,022 (709)8,313 
Earnings per common share––basic:
Income from continuing operations attributable to Pfizer Inc. common shareholders$3.14 $0.18 $3.32 $1.20 $(0.12)$1.08 
Income/(loss) from discontinued operations––net of tax— — — 0.43 (0.01)0.42 
Net income attributable to Pfizer Inc. common shareholders3.14 0.18 3.32 1.62 (0.13)1.50 
Earnings per common share––diluted:
Income from continuing operations attributable to Pfizer Inc. common shareholders$3.08 $0.18 $3.26 $1.18 $(0.12)$1.06 
Income/(loss) from discontinued operations––net of tax— — — 0.42 (0.01)0.42 
Net income attributable to Pfizer Inc. common shareholders3.09 0.18 3.27 1.60 (0.13)1.48 
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Nine Months Ended
October 3, 2021
September 27, 2020
(MILLIONS)Previous
Accounting
Principle
Impact of ChangeAs ReportedPrevious Accounting PrincipleImpact of ChangeAs Adjusted
Condensed Consolidated Statements of Comprehensive Income:
Foreign currency translation adjustments, net$(354)$(11)$(366)$96 $(123)$(27)
Benefit plans: actuarial gains/(losses), net881 (881)— (1,372)1,372 — 
Reclassification adjustments related to amortization222 (222)— 200 (200)— 
Reclassification adjustments related to settlements, net162 (162)— 240 (240)— 
Other(11)11 — (123)123 — 
Tax provision/(benefit) on other comprehensive income/(loss)(20)(24)(44)(527)215 (311)
Condensed Consolidated Statements of Cash Flows:
Deferred taxes from continuing operations$(3,983)$281 $(3,702)$(522)$(213)$(735)
Benefit plan contributions in excess of expense/income(650)(1,283)(1,933)(1,642)881 (760)
October 3, 2021
December 31, 2020
(MILLIONS)
Previous Accounting Principle
Impact of ChangeAs ReportedPrevious Accounting PrincipleImpact of ChangeAs Adjusted
Condensed Consolidated Balance Sheets:
Noncurrent deferred tax assets and other noncurrent tax assets$3,012 $(257)$2,755 $2,383 $— $2,383 
Other noncurrent assets6,687 18 6,705 4,569 — 4,569 
Pension benefit obligations3,677 — 3,676 4,766 — 4,766 
Retained earnings101,250 1,002 102,252 96,770 (6,378)90,392 
Accumulated other comprehensive loss(4,408)(1,241)(5,649)(11,688)6,378 (5,310)
D. Revenues and Trade Accounts Receivable
Customers––Our prescription pharmaceutical products are sold principally to wholesalers, but we also sell directly to retailers, hospitals, clinics, government agencies and pharmacies. In the U.S., we primarily sell our vaccine products directly to the federal government, CDC, wholesalers, individual provider offices, retail pharmacies and integrated delivery networks. Outside the U.S., we primarily sell our vaccines to government and non-government institutions.
Deductions from Revenues––Our accruals for Medicare, Medicaid and related state program and performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts are as follows:
(MILLIONS)October 3,
2021
December 31, 2020
Reserve against Trade accounts receivable, less allowance for doubtful accounts
$996 $861 
Other current liabilities:
Accrued rebates3,470 3,017 
Other accruals470 436 
Other noncurrent liabilities
503 399 
Total accrued rebates and other sales-related accruals$5,439 $4,712 
Trade Accounts Receivable––Trade accounts receivable are stated at their net realizable value. The allowance for credit losses reflects our best estimate of expected credit losses of the receivables portfolio determined on the basis of historical experience, current information, and forecasts of future economic conditions. In developing the estimate for expected credit losses, trade accounts receivables are segmented into pools of assets depending on market (U.S. versus international), delinquency status, and customer type (high risk versus low risk and government versus non-government), and fixed reserve percentages are established for each pool of trade accounts receivables.
In determining the reserve percentages for each pool of trade accounts receivables, we considered our historical experience with certain customers and customer types, regulatory and legal environments, country and political risk, and other relevant current and future forecasted macroeconomic factors. These credit risk indicators are monitored on a quarterly basis to determine whether there have been any changes in the economic environment that would indicate the established reserve percentages should be adjusted, and are considered on a regional basis to reflect more geographic-specific metrics. Additionally, write-offs and recoveries of customer receivables are tracked against collections on a quarterly basis to determine whether the reserve percentages remain appropriate. When management becomes aware of certain customer-specific factors that impact credit risk,
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
specific allowances for these known troubled accounts are recorded. Trade accounts receivable are written off after all reasonable means to collect the full amount (including litigation, where appropriate) have been exhausted.
During the three and nine months ended October 3, 2021 and September 27, 2020, additions to the allowance for credit losses, write-offs and recoveries of customer receivables were not material to our condensed consolidated financial statements. For additional information on our trade accounts receivable, see Note 1G in our 2020 Form 10-K.
Note 2. Discontinued Operations, Equity-Method Investment and Collaborative Arrangement
A. Discontinued Operations
Upjohn Separation and Combination with Mylan
On November 16, 2020, we completed the spin-off and the combination of the Upjohn Business with Mylan to form Viatris. See Note 1A.
In connection with this transaction, Pfizer and Viatris entered into various agreements to effect the separation and combination to provide a framework for our relationship after the combination, including a separation and distribution agreement, interim operating models, including agency arrangements, manufacturing and supply agreements (MSAs), transition service agreements (TSAs), a tax matters agreement, and an employee matters agreement, among others. The interim agency operating model arrangements primarily include billings, collections and remittance of rebates that we are performing on a transitional basis on behalf of Viatris. Under the MSAs, Pfizer or Viatris, as the case may be, manufactures, labels and packages products for the other party. In the three and nine months ended October 3, 2021, the amounts recorded under the above agreements were not material to our consolidated results of operations. Net amounts due from Viatris under the above agreements were approximately $197 million as of October 3, 2021 and $401 million as of December 31, 2020. The cash flows associated with the above agreements are included in Net cash provided by operating activities from continuing operations, except for a $277 million payment to Viatris made in the first quarter of 2021 pursuant to terms of the separation agreement, which is reported in Other financing activities, net, and was recorded as a payable to Viatris in Other current liabilities as of December 31, 2020. In addition, Pfizer and Mylan had pre-existing arms-length commercial agreements, which are continuing with Viatris and are not material to Pfizer’s consolidated financial statements.
The operating results of the Upjohn Business and the Mylan-Japan collaboration are reported as Income/(loss) from discontinued operations––net of tax.
Components of Income/(loss) from discontinued operations––net of tax:
Three Months Ended(a)
Nine Months Ended(a)
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Revenues$— $1,854 $27 $5,737 
Costs and expenses:
Cost of sales526 18 1,425 
Selling, informational and administrative expenses359 (1)1,061 
Research and development expenses— 60 165 
Amortization of intangible assets — 37 — 109 
Restructuring charges and certain acquisition-related costs— — 18 
Other (income)/deductions––net233 304 
Pre-tax income/(loss) from discontinued operations(10)639 2,654 
Provision/(benefit) for taxes on income(2)79 (21)320 
Income/(loss) from discontinued operations––net of tax$(9)$560 $24 $2,334 
(a)In the third quarter of 2021, Income/(loss) from discontinued operations—net of tax reflects post-closing adjustments directly related to our discontinued operations, including adjustments for legal and tax related matters. In the first nine months of 2021, Income/(loss) from discontinued operations—net of tax includes the operations of the Mylan-Japan collaboration, which terminated during Pfizer’s international first quarter of 2021, and post-closing adjustments directly related to our discontinued operations, including adjustments for tax, benefits and legal related matters. In the three and nine months ended September 27, 2020, Income/(loss) from discontinued operations—net of tax relates to the Upjohn Business and the Mylan-Japan collaboration and includes the change in accounting principle in the first quarter of 2021 to MTM Accounting, which has been applied on a retrospective basis for all prior periods presented. See Note 1C. In the three and nine months ended September 27, 2020, Income/(loss) from discontinued operations—net of tax includes interest expense of $76 million associated with the U.S. dollar and Euro denominated senior unsecured notes issued by Upjohn Inc. and Upjohn Finance B.V. in the second quarter of 2020 and charges of $144 million related to the remeasurement of Euro debt issued by Upjohn Finance B.V. in the second quarter of 2020.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
B. Equity-Method Investment
Formation of Consumer Healthcare JV

On July 31, 2019, we completed a transaction in which we and GSK combined our respective consumer healthcare businesses into a new JV that operates globally under the GSK Consumer Healthcare name. In exchange, we received a 32% equity stake in the new company and GSK owns the remaining 68%.
We are accounting for our interest in the Consumer Healthcare JV as an equity-method investment. The carrying value of our investment in the Consumer Healthcare JV is $16.1 billion as of October 3, 2021 and $16.7 billion as of December 31, 2020 and is reported as a private equity investment in Equity-method investments as of October 3, 2021 and December 31, 2020. The Consumer Healthcare JV is a foreign investee whose reporting currency is the U.K. pound, and therefore we translate its financial statements into U.S. dollars and recognize the impact of foreign currency translation adjustments in the carrying value of our investment and in other comprehensive income. The decrease in the value of our investment from December 31, 2020 is primarily due to $549 million in pre-tax foreign currency translation adjustments (see Note 6), as well as dividends totaling approximately $295 million, partially offset by our share of the JV’s earnings. We record our share of earnings from the Consumer Healthcare JV on a quarterly basis on a one-quarter lag in Other (income)/deductions––net. Our total share of the JV’s earnings generated in the second quarter of 2021, which we recorded in our operating results in the third quarter of 2021, was $106 million. Our total share of the JV’s earnings generated in the fourth quarter of 2020 and first six months of 2021, which we recorded in our operating results in the first nine months of 2021, was $324 million. Our total share of the JV’s earnings generated in the second quarter of 2020, which we recorded in our operating results in the third quarter of 2020, was $166 million. Our total share of the JV’s earnings generated in the fourth quarter of 2019 and first six months of 2020, which we recorded in our operating results in the first nine months of 2020, was $306 million. The total amortization and adjustment of basis differences resulting from the excess of the initial fair value of our investment over the underlying equity in the carrying value of the net assets of the JV is included in Other (income)/deductions––net and was not material to our results of operations in the periods presented. See Note 4.
Summarized financial information for our equity method investee, the Consumer Healthcare JV, for the three and nine months ending June 30, 2021, the most recent period available, and for the three and nine months ending June 30, 2020, is as follows:
Three Months EndedNine Months Ended
(MILLIONS)June 30,
2021
June 30,
2020
June 30,
2021
June 30,
2020
Net sales$3,152 $2,927 $9,428 $9,618 
Cost of sales(1,180)(1,061)(3,536)(4,266)
Gross profit$1,972 $1,866 $5,892 $5,352 
Income from continuing operations348 524 1,064 995 
Net income348 524 1,064 995 
Income attributable to shareholders330 518 1,012 959 
C. Collaboration Arrangement
Collaboration with Arvinas
On July 22, 2021, we announced a global collaboration with Arvinas to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The estrogen receptor is a well-known disease driver in most breast cancers. Under the terms of the collaboration agreement, we made an upfront payment to Arvinas of $650 million in July 2021, which was recorded to Research and development expenses. On September 13, 2021, we made a $350 million equity investment in Arvinas, receiving approximately 3.5 million newly issued shares of Arvinas common stock, priced at a 30% premium to the 30-day volume weighted average price on July 20, 2021, representing an equity ownership stake by Pfizer of approximately 7% as of September 13, 2021. Arvinas is also eligible to receive up to $400 million in approval milestones and up to $1 billion in commercial milestones. The companies will equally share worldwide development costs, commercialization expenses and profits.
Note 3. Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
A. Transforming to a More Focused Company Program
With the formation of the Consumer Healthcare JV in 2019 and the spin-off of our Upjohn Business in the fourth quarter of 2020, Pfizer has transformed into a focused, global leader in science-based innovative medicines and vaccines. We have
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
undertaken efforts to ensure our cost base and support model align appropriately with our new operating structure. While certain direct costs transferred to the Consumer Healthcare JV and to the Upjohn Business in connection with the spin-off, there are indirect costs which did not transfer. This program is primarily composed of the following three initiatives:
We are taking steps to restructure our corporate enabling functions to appropriately support our business, R&D and PGS platform functions. We expect costs, primarily related to restructuring our corporate enabling functions, to total $1.6 billion, with substantially all costs to be cash expenditures. Actions include, among others, changes in location of certain activities, expanded use and co-location of centers of excellence and shared services, and increased use of digital technologies. The associated actions and the specific costs will primarily include severance and benefit plan impacts, exit costs as well as associated implementation costs.
In addition, we are transforming our commercial go-to market model in the way we engage patients and physicians. We expect costs of $1.1 billion, with substantially all costs to be cash expenditures. Actions include, among others, centralization of certain activities and enhanced use of digital technologies. The costs for this effort primarily include severance and associated implementation costs.
We are also optimizing our manufacturing network and incurring certain legacy cost-reduction initiatives related to our manufacturing business. We expect to incur costs of $500 million, with approximately 20% of the costs to be non-cash. The costs for this effort include, among other things, implementation costs, product transfer costs, site exit costs, as well as accelerated depreciation.
The program costs discussed above are expected to be incurred primarily from 2020 through 2022, and may be rounded and represent approximations.
From the start of this program in the fourth quarter of 2019 through October 3, 2021, we incurred costs of $2.0 billion.
B. Key Activities
The following summarizes acquisitions and cost-reduction/productivity initiatives costs and credits, which are composed primarily of the Transforming to a More Focused Company program:
Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Restructuring charges/(credits):    
Employee terminations
$630 $(15)$649 $340 
Asset impairments
10 20 43 
Exit costs/(credits)(11)— (10)
Restructuring charges/(credits)(a)
643 (5)657 374 
Transaction costs(b)
— — — 14 
Integration costs and other(c)
11 29 
Restructuring charges and certain acquisition-related costs
646 668 417 
Net periodic benefit costs/(credits) recorded in Other (income)/deductions––net(d)
(63)— (51)
Additional depreciation––asset restructuring recorded in our condensed consolidated statements of income as follows(e):
    
Cost of sales
23 64 14 
Selling, informational and administrative expenses
— 23 — 
Research and development expenses
— — — (3)
Total additional depreciation––asset restructuring
31 87 10 
Implementation costs recorded in our condensed consolidated statements of income as follows(f):
    
Cost of sales
29 27 
Selling, informational and administrative expenses
142 36 287 114 
Research and development expenses
— 
Total implementation costs
151 47 316 142 
Total costs associated with acquisitions and cost-reduction/productivity initiatives
$764 $52 $1,020 $571 
(a)Primarily represents cost reduction initiatives.
(b)Represents external costs for banking, legal, accounting and other similar services.
(c)Represents 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.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(d)Amounts for the three and nine months ended September 27, 2020 include the impact of a change in accounting principle. See Note 1C.
(e)Represents the impact of changes in the estimated useful lives of assets involved in restructuring actions.
(f)Represents external, incremental costs directly related to implementing our non-acquisition-related cost-reduction/productivity initiatives.
The following summarizes the components and changes in restructuring accruals:
(MILLIONS)Employee
Termination
Costs
Asset
Impairment
Charges
Exit CostsAccrual
Balance, December 31, 2020(a)
$782 $— $15 $798 
Provision649 — 657 
Utilization and other(b)
(306)(9)(5)(319)
Balance, October 3, 2021(c)
$1,125 $— $10 $1,135 
(a)Included in Other current liabilities ($628 million) and Other noncurrent liabilities ($169 million).
(b)Includes adjustments for foreign currency translation.
(c)Included in Other current liabilities ($860 million) and Other noncurrent liabilities ($275 million).
Note 4. Other (Income)/Deductions—Net
Components of Other (income)/deductions––net include:
 Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Interest income$(10)$(15)$(21)$(68)
Interest expense325 345 975 1,102 
Net interest expense
315 330 954 1,034 
Royalty-related income(261)(214)(649)(524)
Net (gains)/losses on asset disposals(1)(2)(99)— 
Net (gains)/losses recognized during the period on equity securities(a)
(400)70 (1,601)(408)
Income from collaborations, out-licensing arrangements and sales of compound/product rights(b)
(65)(30)(317)(245)
Net periodic benefit costs/(credits) other than service costs(c)
(1,132)1,043 (1,635)749 
Certain legal matters, net(d)
38 (17)458 
Certain asset impairments(e)
— 900 — 900 
Consumer Healthcare JV equity method (income)/loss(f)
(105)(103)(307)(196)
Other, net(84)(99)(501)(202)
Other (income)/deductions––net$(1,696)$1,878 $(3,697)$1,114 
(a)The gains in the third quarter and first nine months of 2021 include, among other things, unrealized gains of $420 million and $1.5 billion, respectively, related to investments in BioNTech and Cerevel Therapeutics, LLC. The losses in the third quarter of 2020 included, among other things, unrealized losses of $131 million related to our investment in Allogene. The gains in the first nine months of 2020 included, among other things, unrealized gains of $397 million related to our investments in Allogene and BioNTech.
(b)The first nine months of 2021 includes, among other things, $188 million of net collaboration income from BioNTech in the first quarter of 2021 related to the COVID-19 vaccine. The first nine months of 2020 mainly included, among other things, (i) an upfront payment to us of $75 million from our sale of our CK1 assets to Biogen, Inc., (ii) $40 million of milestone income from Puma Biotechnology, Inc. related to Neratinib regulatory approvals in the EU and (iii) $30 million of milestone income from Lilly related to the first commercial sale in the U.S. of LOXO-292 for the treatment of RET fusion-positive NSCLC.
(c)Amounts include the impact of a change in accounting principle. See Notes 1C and 10.
(d)The first nine months of 2021 primarily includes an amount to resolve a Multi-District Litigation relating to EpiPen pending against the Company in the U.S. District Court for the District of Kansas for $345 million, which remains subject to court approval. See Note 12A5.
(e)The third quarter and first nine months of 2020 included intangible asset impairment charges of $900 million related to IPR&D assets for unapproved indications of certain cancer medicines, acquired in our Array acquisition, and reflected, among other things, updated commercial forecasts.
(f)See Note 2B.
Note 5. Tax Matters
A. Taxes on Income from Continuing Operations
Our effective tax rate for continuing operations was (4.2)% for the third quarter of 2021, compared to (60.9)% for the third quarter of 2020, and was 7.5% for the first nine months of 2021, compared to 6.7% for the first nine months of 2020.
The negative effective tax rate for the third quarter of 2021 was primarily a result of certain initiatives executed in the third quarter of 2021 associated with our investment in the Consumer Healthcare JV with GSK based on estimates and assumptions
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
that we believe to be reasonable. The negative effective tax rate for the third quarter of 2020 was primarily a result of benefits associated with certain intangible asset impairments (see Note 4(e)). The increase in the effective tax rate for the first nine months of 2021, compared to the first nine months of 2020, was due to the change in the jurisdictional mix of earnings primarily related to Comirnaty and the non-recurrence of benefits associated with certain intangible asset impairments, partially offset by certain initiatives executed in the third quarter of 2021 associated with our investment in the Consumer Healthcare JV with GSK.
We elected, with the filing of our 2018 U.S. Federal Consolidated Income Tax Return, to pay our initial estimated $15 billion repatriation tax liability on accumulated post-1986 foreign earnings over eight years through 2026. The third annual installment of this liability was paid by its April 15, 2021 due date. The fourth annual installment is due April 15, 2022 and is reported in current Income taxes payable as of October 3, 2021. The remaining liability is reported in noncurrent Other taxes payable. 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.
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.

The U.S. is one of our major tax jurisdictions, and we are regularly audited by the IRS. With respect to Pfizer, the IRS has issued Revenue Agent’s Reports (RARs) for tax years 2011-2013 and 2014-2015. We are not in agreement with the RARs and are currently appealing certain disputed issues. Tax years 2016-2018 are currently under audit. Tax years 2019-2021 are open but not under audit. All other tax years are closed. In addition to the open audit years in the U.S., we have open audit years in certain major international tax jurisdictions dating back to 2011.
For additional information, see Note 5D in our 2020 Form 10-K.
C. Tax Provision/(Benefit) on Other Comprehensive Income/(Loss)
Components of Tax provision/(benefit) on other comprehensive income/(loss) include:
Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Foreign currency translation adjustments, net(a)
$(32)$10 $(30)$(167)
Unrealized holding gains/(losses) on derivative financial instruments, net21 (43)28 (126)
Reclassification adjustments for (gains)/losses included in net income13 48 (13)
34 (37)76 (139)
Unrealized holding gains/(losses) on available-for-sale securities, net(33)30 (16)29 
Reclassification adjustments for (gains)/losses included in net income(11)(22)(3)
(32)19 (37)26 
Reclassification adjustments related to amortization of prior service costs and other, net
(22)(11)(39)(32)
Reclassification adjustments related to curtailments of prior service costs and other, net(14)— (14)— 
Other— (1)(1)
(36)(11)(54)(31)
Tax provision/(benefit) on other comprehensive income/(loss)$(65)$(19)$(44)$(311)
(a)Taxes are not provided for foreign currency translation adjustments relating to investments in international subsidiaries that we intend to hold indefinitely.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 6. Accumulated Other Comprehensive Loss, Excluding Noncontrolling Interests
The following summarizes the changes, net of tax, in Accumulated other comprehensive loss:
 Net Unrealized Gains/(Losses)Benefit Plans 
(MILLIONS)Foreign Currency Translation Adjustments Derivative Financial InstrumentsAvailable-For-Sale SecuritiesPrior Service (Costs)/Credits and OtherAccumulated Other Comprehensive Income/(Loss)
Balance, December 31, 2020(a)
$(5,450)$(428)$116 $452 $(5,310)
Other comprehensive income/(loss)(b)
(336)388 (262)(127)(338)
Balance, October 3, 2021$(5,787)$(40)$(146)$325 $(5,649)
(a)Amounts include the impact of a change in accounting principle. See Note 1C.
(b)Amounts do not include foreign currency translation adjustments attributable to noncontrolling interests. Foreign currency translation adjustments include net losses related to our equity method investment in the Consumer Healthcare JV (see Note 2B) and net gains related to the impact of our net investment hedging program.

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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 and Fair Value Hierarchy, using a Market Approach:
October 3, 2021December 31, 2020
(MILLIONS)TotalLevel 1Level 2TotalLevel 1Level 2
Financial assets:
Short-term investments
Classified as equity securities with readily determinable fair values:
Money market funds$2,367 $— $2,367 $567 $— $567 
Classified as available-for-sale debt securities:
Government and agency—non-U.S.
16,826 — 16,826 7,719 — 7,719 
Government and agency—U.S.
4,881 — 4,881 982 — 982 
Corporate and other
1,181 — 1,181 1,008 — 1,008 
22,887 — 22,887 9,709 — 9,709 
Total short-term investments25,254 — 25,254 10,276 — 10,276 
Other current assets
Derivative assets:
Interest rate contracts
— 18 — 18 
Foreign exchange contracts
478 — 478 234 — 234 
Total other current assets484 — 484 251 — 251 
Long-term investments
Classified as equity securities with readily determinable fair values(a)
4,165 4,141 25 2,809 2,776 32 
Classified as available-for-sale debt securities:
Government and agency—non-U.S.
425 — 425 — 
Government and agency—U.S.
— 121 — 121 
Corporate and other
— — — — — — 
434 — 434 128 — 128 
Total long-term investments4,600 4,141 459 2,936 2,776 160 
Other noncurrent assets
Derivative assets:
Interest rate contracts
18 — 18 117 — 117 
Foreign exchange contracts
219 — 219 — 
Total derivative assets236 — 236 122 — 122 
Insurance contracts(b)
762 — 762 693 — 693 
Total other noncurrent assets998 — 998 814 — 814 
Total assets$31,336 $4,141 $27,195 $14,278 $2,776 $11,501 
Financial liabilities:
Other current liabilities
Derivative liabilities:
Foreign exchange contracts
$346 $— $346 $501 $— $501 
Total other current liabilities346 — 346 501 — 501 
Other noncurrent liabilities
Derivative liabilities:
Foreign exchange contracts
477 — 477 599 — 599 
Total other noncurrent liabilities477 — 477 599 — 599 
Total liabilities$823 $— $823 $1,100 $— $1,100 
(a)Long-term equity securities of $191 million as of October 3, 2021 and $190 million as of December 31, 2020 were held in restricted trusts for U.S. non-qualified employee benefit plans.
(b)Includes life insurance policies held in restricted trusts for U.S. non-qualified employee benefit plans. The underlying invested assets in these contracts are marketable securities, which are carried at fair value, with changes in fair value recognized in Other (income)/deductions—net (see Note 4).
20


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
Carrying values and estimated fair values using a market approach:
October 3, 2021December 31, 2020
(MILLIONS)Carrying ValueEstimated Fair Value at Level 2Carrying ValueEstimated Fair Value at Level 2
Financial Liabilities
Long-term debt, excluding the current portion$36,250 $42,228 $37,133 $45,533 
The differences between the estimated fair values and carrying values of held-to-maturity debt securities, private equity securities, long-term receivables and short-term borrowings not measured at fair value on a recurring basis were not significant as of October 3, 2021 and December 31, 2020. The fair value measurements of our held-to-maturity debt securities and short-term borrowings are based on Level 2 inputs. The fair value measurements of our long-term receivables and private equity securities are based on Level 3 inputs.
B. Investments
Total Short-Term, Long-Term and Equity-Method Investments
The following summarizes our investments by classification type:
(MILLIONS)October 3, 2021December 31, 2020
Short-term investments
Equity securities with readily determinable fair values(a)
$2,367 $567 
Available-for-sale debt securities22,887 9,709 
Held-to-maturity debt securities2,476 161 
Total Short-term investments$27,730 $10,437 
Long-term investments
Equity securities with readily determinable fair values$4,165 $2,809 
Available-for-sale debt securities434 128 
Held-to-maturity debt securities32 37 
Private equity securities at cost(b)
616 432 
Total Long-term investments$5,248 $3,406 
Equity-method investments16,349 16,856 
Total long-term investments and equity-method investments$21,596 $20,262 
Held-to-maturity cash equivalents$467 $89 
(a)As of October 3, 2021 and December 31, 2020, includes money market funds primarily invested in U.S. Treasury and government debt.
(b)Represent investments in the life sciences sector.
Debt Securities
At October 3, 2021, our debt investment portfolio consisted of debt securities issued across diverse governments, corporate and financial institutions, which are investment-grade. The contractual or estimated maturities, are as follows:
October 3, 2021December 31, 2020
Gross UnrealizedMaturities (in Years)Gross Unrealized
(MILLIONS)Amortized CostGainsLossesFair ValueWithin 1Over 1
to 5
Over 5Amortized CostGainsLossesFair Value
Available-for-sale debt securities
Government and agency––non-U.S.
$17,414 $16 $(179)$17,251 $16,826 $425 $— $7,593 $136 $(4)$7,725 
Government and agency––U.S.
4,890 — (1)4,889 4,881 — 1,104 — (1)1,103 
Corporate and other1,185 — (4)1,181 1,181 — — 1,006 — 1,008 
Held-to-maturity debt securities
Time deposits and other
986 — — 986 959 16 11 283 — — 283 
Government and agency––non-U.S.
1,988 — — 1,988 1,984 — — 
Total debt securities$26,463 $16 $(183)$26,297 $25,830 $454 $12 $9,991 $138 $(5)$10,124 
Any expected credit losses to these portfolios would be immaterial to our financial statements.
21


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Equity Securities
The following presents the calculation of the portion of unrealized (gains)/losses that relates to equity securities, excluding equity-method investments, held at the reporting date:
Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Net (gains)/losses recognized during the period on equity securities(a)
$(400)$70 $(1,601)$(408)
Less: Net (gains)/losses recognized during the period on equity securities sold during the period(78)(83)(16)
Net unrealized (gains)/losses during the reporting period on equity securities still held at the reporting date(b)
$(322)$68 $(1,518)$(391)
(a)Reported in Other (income)/deductions––net. See Note 4.
(b)Included in net unrealized gains are observable price changes on equity securities without readily determinable fair values. As of October 3, 2021, there were cumulative impairments and downward adjustments of $95 million and upward adjustments of $151 million. Impairments, downward and upward adjustments were not significant in the third quarter and first nine months of 2021 and 2020.
C. Short-Term Borrowings
Short-term borrowings include:
(MILLIONS)October 3,
2021
December 31, 2020
Commercial paper$100 $556 
Current portion of long-term debt, principal amount2,664 2,004 
Other short-term borrowings, principal amount(a)
866 145 
Total short-term borrowings, principal amount
3,630 2,705 
Net unamortized discounts, premiums and debt issuance costs(1)(2)
Total Short-term borrowings, including current portion of long-term debt, carried at historical proceeds, as adjusted
$3,629 $2,703 
(a)Includes cash collateral. See Note 7F.
D. Long-Term Debt
New Issuance
In the third quarter of 2021, we issued the following senior unsecured notes at an effective interest rate of 1.79%:
(MILLIONS)Principal
Interest RateMaturity Date
As of October 3,
2021
1.750%(a)
August 18, 2031
$1,000 
(a)The notes may be redeemed by us at any time, in whole, or in part, at a redemption price plus accrued and unpaid interest.
The following summarizes the aggregate principal amount of our senior unsecured long-term debt, and adjustments to report our aggregate long-term debt:
(MILLIONS)October 3,
2021
December 31, 2020
Total long-term debt, principal amount$34,975 $35,774 
Net fair value adjustments related to hedging and purchase accounting1,470 1,562 
Net unamortized discounts, premiums and debt issuance costs(200)(207)
Other long-term debt
Total long-term debt, carried at historical proceeds, as adjusted$36,250 $37,133 
Current portion of long-term debt, carried at historical proceeds, as adjusted (not included above)
$2,663 $2,002 
E. Derivative Financial Instruments and Hedging Activities
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 principally through the use of derivative financial instruments and
22


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
foreign currency debt. These financial instruments serve to mitigate the impact on net income as a result of remeasurement into another currency, or against the impact of translation into U.S. dollars of certain foreign exchange-denominated transactions.
The derivative financial instruments primarily hedge or offset exposures in the euro, U.K. pound, Japanese yen and Canadian dollar. We hedge a portion of our forecasted intercompany inventory sales denominated in euro, Japanese yen, Canadian dollar, Chinese renminbi, U.K. pound and Australian dollar for up to two years.
Interest Rate Risk
Our interest-bearing investments and borrowings are subject to interest rate risk. Depending on market conditions, we may change the profile of our outstanding debt or investments by entering into derivative financial instruments like interest rate swaps, either to hedge or offset the exposure to changes in the fair value of hedged items with fixed interest rates, or to convert variable rate debt or investments to fixed rates. The derivative financial instruments primarily hedge U.S. dollar fixed-rate debt.
The following summarizes the fair value of the derivative financial instruments and notional amounts (including those reported as part of discontinued operations):
October 3, 2021December 31, 2020
Fair ValueFair Value
(MILLIONS)NotionalAssetLiabilityNotionalAssetLiability
Derivatives designated as hedging instruments:
Foreign exchange contracts(a)
$27,798 $568 $743 $24,369 $145 $1,005 
Interest rate contracts
1,250 24 — 1,950 135 — 
592 743 280 1,005 
Derivatives not designated as hedging instruments:
Foreign exchange contracts
$24,150 129 81 $15,063 94 95 
Total$720 $823 $373 $1,100 
(a)The notional amount of outstanding foreign exchange contracts hedging our intercompany forecasted inventory sales was $4.9 billion as of October 3, 2021 and $5.0 billion as of December 31, 2020.
The following summarizes information about the gains/(losses) incurred to hedge or offset operational foreign exchange or interest rate risk exposures (including those reported as part of discontinued operations):
 
Gains/(Losses)
Recognized in OID
(a)
Gains/(Losses)
Recognized in OCI
(a)
Gains/(Losses)
Reclassified from
OCI into OID and COS(a)
Three Months Ended
(MILLIONS)Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020
Derivative Financial Instruments in Cash Flow Hedge Relationships:
Foreign exchange contracts(b)
$— $— $204 $(379)$(59)$(149)
Amount excluded from effectiveness testing and amortized into earnings(c)
— — 10 10 
Derivative Financial Instruments in Fair Value Hedge Relationships:
Interest rate contracts
(5)(9)— — — — 
Hedged item
— — — — 
Derivative Financial Instruments in Net Investment Hedge Relationships:      
Foreign exchange contracts
— — 177 (257)— — 
The portion of foreign exchange contracts excluded from the assessment of hedge effectiveness(c)
— — 19 26 38 
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:(d)
      
Foreign currency short-term borrowings— — 25 — — — 
Foreign currency long-term debt— — 19 (72)— — 
Derivative Financial Instruments Not Designated as Hedges:
Foreign exchange contracts
(74)255 — — — — 
All other net(c)
— — — — — — 
 $(74)$255 $453 $(692)$(21)$(104)
23


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Gains/(Losses)
Recognized in OID
(a)
Gains/(Losses)
Recognized in OCI
(a)
Gains/(Losses)
Reclassified from
OCI into OID and COS(a)
Nine Months Ended
(MILLIONS)Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020
Derivative Financial Instruments in Cash Flow Hedge Relationships:      
Foreign exchange contracts(b)
$— $— $147 $(721)$(314)$(23)
Amount excluded from effectiveness testing and amortized into earnings(c)
— — 31 49 28 48 
Derivative Financial Instruments in Fair Value Hedge Relationships:
Interest rate contracts
(6)383 — — — — 
Hedged item
(383)— — — — 
Derivative Financial Instruments in Net Investment Hedge Relationships:
Foreign exchange contracts
— — 332 (17)— — 
The portion of foreign exchange contracts excluded from the assessment of hedge effectiveness(c)
— — 54 185 82 122 
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:(d)
Foreign currency short-term borrowings— — 52 — — 
Foreign currency long-term debt— — 66 (69)— — 
Derivative Financial Instruments Not Designated as Hedges:
Foreign exchange contracts
(97)205 — — — — 
All other net(c)
— — 12 (1)
$(97)$205 $683 $(553)$(204)$147 
(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)The amounts reclassified from OCI into COS were:
a net loss of $18 million in the third quarter of 2021;
a net loss of $94 million in the first nine months of 2021;
a net gain of $34 million in the third quarter of 2020; and
a net gain of $184 million in the first nine months of 2020.
The remaining amounts were reclassified from OCI into OID. Based on quarter-end foreign exchange rates that are subject to change, we expect to reclassify a pre-tax gain of $202 million within the next 12 months into income. The maximum length of time over which we are hedging our exposure to the variability in future foreign exchange cash flows is approximately 22 years and relates to foreign currency debt.
(c)The amounts reclassified from OCI were reclassified into OID.
(d)Short-term borrowings and long-term debt include foreign currency borrowings which are used in net investment hedges. The short-term borrowings carrying value as of October 3, 2021 was $1.2 billion. The long-term debt carrying values as of October 3, 2021 and December 31, 2020 were $862 million and $2.1 billion, respectively.
The following summarizes cumulative basis adjustments for fair value hedges to our long-term debt:
October 3, 2021December 31, 2020
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)
Carrying Amount of Hedged Assets/Liabilities(a)
Active Hedging RelationshipsDiscontinued Hedging Relationships
Carrying Amount of Hedged Assets/Liabilities(a)
Active Hedging RelationshipsDiscontinued Hedging Relationships
Long-term debt$1,241 $18 $1,178 $2,016 $117 $1,149 
(a)Carrying amounts exclude the cumulative amount of fair value hedging adjustments.
24


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
F. Credit Risk
A significant portion of our trade accounts receivable balances are due from wholesalers and governments. For additional information on our trade accounts receivables with significant customers, see Note 13B below and Note 17B in our 2020 Form 10-K.

As of October 3, 2021, the largest investment exposures in our portfolio represent primarily sovereign debt instruments issued by the U.S., Canada, Germany, Japan, U.K., France, Australia, Sweden, Denmark, Switzerland, and Finland.

With respect to our derivative financial instrument agreements with financial institutions, we do not expect to incur a significant loss from failure of any counterparty. Derivative financial instruments are executed under International Swaps and Derivatives Association (ISDA) master agreements with credit-support annexes that contain zero threshold provisions requiring collateral to be exchanged daily depending on levels of exposure. As a result, there are no significant concentrations of credit risk with any individual financial institution. As of October 3, 2021, the aggregate fair value of these derivative financial instruments that are in a net payable position was $357 million, for which we have posted collateral of $357 million with a corresponding amount reported in Short-term investments. As of October 3, 2021, the aggregate fair value of our derivative financial instruments that are in a net receivable position was $246 million, for which we have received collateral of $236 million with a corresponding amount reported in Short-term borrowings, including current portion of long-term debt.
Note 8. Other Financial Information
A. Inventories
The following summarizes the components of Inventories:
(MILLIONS)October 3,
2021
December 31, 2020
Finished goods$3,280 $2,878 
Work-in-process4,469 4,430 
Raw materials and supplies891 738 
Inventories(a)
$8,640 $8,046 
Noncurrent inventories not included above(b)
$935 $890 
(a)The change from December 31, 2020 primarily reflects increases for certain products, including inventory build for new product launches (primarily Comirnaty), supply recovery and network strategy, partially offset by decreases due to market demand.
(b)Included in Other noncurrent assets. There are no recoverability issues for these amounts.
B. Other Current Liabilities
Other current liabilities includes, among other things, amounts payable to BioNTech for the gross profit split for Comirnaty, which totaled $7.8 billion as of October 3, 2021 and $25 million as of December 31, 2020.
Note 9. Identifiable Intangible Assets
The following summarizes the components of Identifiable intangible assets:
October 3, 2021December 31, 2020
(MILLIONS)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)
$74,144 $(53,472)$20,673 $73,545 $(50,902)$22,643 
Brands922 (799)123 922 (774)148 
Licensing agreements and other2,284 (1,273)1,011 2,292 (1,186)1,106 
77,350 (55,544)21,807 76,759 (52,862)23,896 
Indefinite-lived intangible assets
Brands827 827 827 827 
IPR&D3,100 3,100 3,175 3,175 
Licensing agreements and other573 573 573 573 
4,500 4,500 4,575 4,575 
Identifiable intangible assets(b)
$81,850 $(55,544)$26,306 $81,334 $(52,862)$28,471 
25


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(a)The increase in the gross carrying amount primarily reflects $500 million of capitalized Comirnaty sales milestones to BioNTech.
(b)The decrease is primarily due to amortization, partially offset by the capitalization of the Comirnaty milestones described above.
Amortization
Total amortization of finite-lived intangible assets was $993 million for the third quarter of 2021 and $873 million for the third quarter of 2020, and $2.8 billion for the first nine months of 2021 and $2.6 billion for the first nine months of 2020.
Note 10. Pension and Postretirement Benefit Plans
As discussed in Note 1C, we adopted a change in accounting principle to a more preferable policy under U.S. GAAP to immediately recognize actuarial gains and losses arising from the remeasurement of pension and postretirement plans. This change has been applied to all pension and postretirement plans on a retrospective basis for all prior periods presented.
The following summarizes the components of net periodic benefit cost/(credit), including in 2020 costs/(credits) reported as part of discontinued operations:
 Pension Plans
 U.S.InternationalPostretirement
Plans
Three Months Ended
(MILLIONS)Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020
Service cost
$— $— $32 $36 $$10 
Interest cost
114 139 37 40 13 
Expected return on plan assets
(261)(251)(83)(79)(10)(9)
Amortization of prior service credits— (1)— (1)(39)(43)
Curtailments— — — — (64)— 
Actuarial (gains)/losses(a)
(836)1,212 — — — — 
Special termination benefits
— — — — — — 
Net periodic benefit cost/(credit) reported in income
$(983)$1,099 $(14)$(3)$(96)$(30)
 Pension Plans
 U.S.InternationalPostretirement
Plans
Nine Months Ended
(MILLIONS)Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020
Service cost
$— $— $98 $108 $27 $29 
Interest cost
341 419 110 122 22 38 
Expected return on plan assets
(782)(754)(246)(238)(29)(27)
Amortization of prior service credits(1)(3)(1)(2)(116)(129)
Curtailments— — (1)— (64)— 
Actuarial (gains)/losses(a)
(881)1,369 — — — 
Special termination benefits
12 — — — 
Net periodic benefit cost/(credit) reported in income
$(1,312)$1,033 $(40)$(7)$(160)$(89)
(a)Mainly reflects interim actuarial remeasurement gains in 2021, primarily due to favorable plan asset performance and an increase in the discount rate, and interim actuarial remeasurement losses in 2020, primarily due to a reduction in the discount rate.
The components of net periodic benefit cost/(credit) other than the service cost component are included in Other (income)/deductions––net (see Note 4).
For the nine months ended October 3, 2021, we contributed $127 million, $259 million, and $35 million to our U.S. Pension Plans, International Pension Plans, and Postretirement Plans, respectively, from our general assets, which include direct employer benefit payments.
26


PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 11. Earnings Per Common Share Attributable to Pfizer Inc. Common Shareholders
The following presents the detailed calculation of EPS:
 Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
EPS Numerator––Basic
Income from continuing operations attributable to Pfizer Inc.
$8,155 $909 $18,563 $5,979 
Less: Preferred stock dividends––net of tax
— — — — 
Income from continuing operations attributable to Pfizer Inc. common shareholders
8,155 909 18,563 5,979 
Income/(loss) from discontinued operations––net of tax(9)560 24 2,334 
Net income attributable to Pfizer Inc. common shareholders
$8,146 $1,469 $18,586 $8,313 
EPS Numerator––Diluted    
Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions
$8,155 $909 $18,563 $5,979 
Income/(loss) from discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions(9)560 24 2,334 
Net income attributable to Pfizer Inc. common shareholders and assumed conversions
$8,146 $1,469 $18,586 $8,313 
EPS Denominator    
Weighted-average number of common shares outstanding––Basic
5,609 5,557 5,597 5,552 
Common-share equivalents: stock options, stock issuable under employee compensation plans, convertible preferred stock and accelerated share repurchase agreements116 76 91 70 
Weighted-average number of common shares outstanding––Diluted
5,725 5,633 5,688 5,622 
Anti-dilutive common stock equivalents(a)
— 
(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.
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. The following outlines our legal contingencies. For a discussion of our tax contingencies, see Note 5B.
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 product, a significant loss of revenues from that product 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 asserted or unasserted matters, which can include acquisition-, licensing-, intellectual property-, collaboration- or co-promotion-related and product-pricing claims and environmental claims and proceedings, can involve complexities that will vary from matter to matter.
27


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 increased expenses and/or 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 matters, which could have a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts are accrued or 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, which result from a complex series of judgments about future events and uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but 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. For proceedings under environmental laws to which a governmental authority is a party, we have adopted a disclosure threshold of $1 million in potential or actual governmental monetary sanctions.
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 to assess materiality, such as, among others, the amount of damages and the nature of other relief sought, if 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. Some of the matters discussed below include those which management believes that the likelihood of possible loss in excess of amounts accrued is remote.
A1. Legal Proceedings––Patent Litigation
We are involved in suits relating to our patents, including but not limited to, those discussed below. Most involve claims by generic drug manufacturers that patents covering our products (or those of our collaboration/licensing partners to which we have licenses or co-promotion rights and to which we may or may not be a party), 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 that are discussed below, patent rights to certain of our products or those of our collaboration/licensing partners are being challenged in various other jurisdictions. For example, some of our collaboration or licensing partners face challenges to the validity of their patent rights in non-U.S. 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.

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 U.S. In 2017, the Patent Trial and Appeal Board (PTAB) initiated proceedings with respect to two of our pneumococcal vaccine patents. However, the PTAB declined to initiate proceedings as to two other pneumococcal vaccine patents; those two patents, and one other patent, were challenged in federal court in Delaware. In September 2021, Pfizer and a challenger entered into a settlement and license agreement, resolving all worldwide legal proceedings involving that challenger, related to our pneumococcal vaccine patents. Other challenges to pneumococcal vaccine patents remain pending at the PTAB and outside the U.S. The invalidation of any of the patents in our pneumococcal portfolio
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could potentially allow additional competitor vaccines into the marketplace. In the event that any of the patents are found valid and infringed, a competitor’s vaccine might be prohibited from entering the market or a competitor might be required to pay us a royalty.
We are also subject to patent litigation pursuant to which one or more third parties seek 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 if we or one of our subsidiaries is found to have willfully infringed valid patent rights of a third party.
Actions In Which We Are The Plaintiff
EpiPen
In 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 (ANDA) 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.
Xeljanz (tofacitinib)
Beginning in 2017, we brought patent-infringement actions against several generic manufacturers that filed separate ANDAs with the FDA seeking approval to market their generic versions of tofacitinib tablets in one or both of 5 mg and 10 mg dosage strengths, and in both immediate and extended release forms. To date, we have settled actions with several manufacturers on terms not material to us. The remaining actions continue in the U.S. District Court for the District of Delaware as described below.
In 2018, we brought a separate patent infringement action against Teva Pharmaceuticals USA, Inc. (Teva) asserting the infringement and validity of our patent covering extended release formulations of tofacitinib that was challenged by Teva in its ANDA seeking approval to market a generic version of tofacitinib 11 mg extended release tablets. In September 2021, we settled the case against Teva on terms not material to us.
In January 2021, we brought a separate patent-infringement action against Aurobindo Pharma Limited (Aurobindo) asserting the infringement and validity of the patent covering the active ingredient expiring in December 2025 and the patent covering a polymorphic form of tofacitinib expiring in 2023, which Aurobindo challenged in its ANDA seeking approval to market a generic version of tofacitinib 5 mg and 10 mg tablets.
In October 2021, we brought a separate patent-infringement action against Sinotherapeutics Inc. (Sinotherapeutics) asserting the infringement and validity of our patent covering extended release formulations of tofacitinib that was challenged by Sinotherapeutics in its ANDA seeking approval to market a generic version of tofacitinib 11 mg extended release tablets.
Inlyta (axitinib)
In 2019, Glenmark Pharmaceuticals Limited (Glenmark) notified us that it had filed an ANDA 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 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.
Ibrance (palbociclib)
In 2019, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Ibrance capsules. The companies asserted the invalidity and non-infringement of two composition of matter patents, one of which expires in 2023 and one of which expires in 2027, as a result of a U.S. Patent Term Extension certificate issued in January 2021, and a method of use patent covering palbociclib, which expires in 2023. In 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. In August 2021, the litigation concluded without settlements or a court decision.
Beginning in September 2020, we received correspondence from several generic companies notifying us that they would seek approval to market generic versions of Ibrance capsules. The generic companies assert the invalidity and non-infringement of our crystalline form patent which expires in 2034. Beginning in October 2020, we brought patent infringement actions against each of these generic companies in various federal courts, asserting the validity and infringement of the crystalline form patent. We have settled with certain of these generic companies on terms not material to the company.
Beginning in January 2021, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Ibrance tablets. The generic companies are challenging some or all of the following patents: (i) the
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composition of matter patent expiring in 2027; (ii) the composition of matter patent expiring in 2023; (iii) the method of use patent expiring in 2023; (iv) the crystalline form patent expiring in 2034; and (v) a tablet formulation patent expiring in 2036. 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.
Eucrisa
Beginning in September 2021, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Eucrisa. The companies assert the invalidity and non-infringement of a composition of matter patent expiring in 2026, two method of use patents expiring in 2027, and one other method of use patent expiring in 2030. In 2021, we brought patent infringement actions against the generic filers in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the patents challenged by the generic companies.
Matter Involving Our Collaboration/Licensing Partners
Eliquis
In 2017, twenty-five generic companies sent BMS Paragraph-IV certification letters informing BMS that they had filed ANDAs seeking approval of generic versions of Eliquis, challenging the validity and infringement of one or more of the three patents listed in the Orange Book for Eliquis. One of the patents expired in December 2019 and the remaining patents currently are set to expire in 2026 and 2031. Eliquis has been jointly developed and is being commercialized by BMS and Pfizer. BMS and Pfizer filed patent-infringement actions against all 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, 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 patent, some challenged both the 2031 and 2026 patent, and one generic company challenged all three patents. In August 2020, the U.S. District Court for the District of Delaware ruled that both the 2026 patent and the 2031 patent are valid and infringed by the proposed generic products. In August and September 2020, the generic filers appealed the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit. Prior to the August 2020 ruling, we and BMS settled with certain of the companies on terms not material to us, and we and BMS may settle with other generic companies in the future. In September 2021, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’s decision.
A2. Legal Proceedings––Product Litigation
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. Warner-Lambert was acquired by Pfizer in 2000 and is a wholly 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 against American Optical, Pfizer and certain of its previously owned subsidiaries are pending 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 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
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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 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 2015, the District Court entered partial final 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 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.
Lipitor
Beginning in 2011, purported class actions relating to Lipitor were filed in various federal courts against, among others, Pfizer, certain Pfizer affiliates, and, in most of the actions, Ranbaxy and certain Ranbaxy affiliates. 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 the U.S. District Court for the District of New Jersey.
In September 2013 and 2014, the District Court dismissed with prejudice the claims of the 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 Court of Appeals. In 2017, the Court of Appeals reversed the District Court’s decisions and remanded the claims to the District Court.
Also, in 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.
EpiPen (Direct Purchaser)
In February 2020, a lawsuit was filed in the U.S. District Court for the District of Kansas against Pfizer, its affiliates King and Meridian, and various Mylan entities, on behalf of a purported U.S. nationwide class of direct purchaser plaintiffs who purchased EpiPen devices directly from the defendants. Plaintiffs in this action generally allege that Pfizer and Mylan conspired to delay market entry of generic EpiPen through the settlement of patent litigation regarding EpiPen, and thereby delayed market entry of generic EpiPen in violation of federal antitrust law. Plaintiffs seek treble damages for alleged overcharges for EpiPen since 2011. In July 2021, the District Court granted defendants’ motion to dismiss the direct purchaser complaint, without prejudice. In September 2021, plaintiffs filed an amended complaint.
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 2017, the federal actions were ordered transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the District of New Jersey. As part of our Consumer Healthcare JV transaction with GSK, the JV 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.
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In 2016, the federal cases were transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the Eastern District of Louisiana.
Mississippi Attorney General Government Action
In 2018, the Attorney General of Mississippi filed a complaint in Mississippi state court against the manufacturer of the branded product and eight 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.
Array Securities Litigation
In 2017, two purported class actions were filed in the U.S. District Court for the District of Colorado alleging that Array, which we acquired in 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 2018, the actions were consolidated into a single proceeding. In March 2021, the parties reached an agreement in principle to resolve the litigation on terms not material to Pfizer.
Zantac
A number of lawsuits have been filed against Pfizer in various federal and state courts alleging that plaintiffs developed various types of cancer, or face an increased risk of developing cancer, purportedly as a result of the ingestion of Zantac. The significant majority of these cases also name other defendants that have historically manufactured and/or sold Zantac. Pfizer has not sold Zantac since 2006, and only sold an OTC version of the product. Plaintiffs seek compensatory and punitive damages.
In February 2020, the federal actions were transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the Southern District of Florida. Plaintiffs in the Multi-District Litigation have filed against Pfizer and many other defendants a master personal injury complaint, a consolidated consumer class action complaint alleging, among other things, claims under consumer protection statutes of all 50 states, and a medical monitoring complaint seeking to certify medical monitoring classes under the laws of 13 states. Plaintiffs previously had filed a consolidated third-party payor class action complaint alleging violation of the RICO statute and seeking reimbursement for payments made for the prescription version of Zantac, but the Multi-District Litigation court dismissed that complaint; Plaintiffs have appealed the dismissal to the U.S. Court of Appeals for the Eleventh Circuit. In addition, (i) Pfizer has received service of two Canadian class action complaints naming Pfizer and other defendants, and seeking compensatory and punitive damages for personal injury and economic loss, allegedly arising from the defendants’ sale of Zantac in Canada; and (ii) the State of New Mexico and the Mayor and City Council of Baltimore separately filed civil actions against Pfizer and many other defendants in state court, alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in those jurisdictions. In April 2021, a Judicial Council Coordinated Proceeding was created in the Superior Court of California in Alameda County to coordinate personal injury actions against Pfizer and other defendants filed in California state court.
Chantix
Beginning in August 2021, a number of putative class actions have been filed against Pfizer in various U.S. federal courts following Pfizer’s voluntary recall of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline. Plaintiffs assert that they suffered economic harm purportedly as a result of purchasing Chantix or generic varenicline medicines sold by Pfizer. Plaintiffs seek to represent nationwide and state-specific classes and seek various remedies, including damages and medical monitoring. Similar putative class actions have been filed in Canada and Israel, where the product brand is Champix.
A3. Legal Proceedings––Commercial and Other Matters
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
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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 spin-off 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 a revised site-wide feasibility study with regard to the Wyeth Holdings Corporation (formerly, American Cyanamid Company) discontinued industrial chemical facility in Bound Brook, New Jersey. In 2011, Wyeth Holdings Corporation executed an Administrative Settlement Agreement and Order on Consent for Removal Action (the 2011 Administrative Settlement Agreement) with the U.S. Environmental Protection Agency (EPA) with regard to the Bound Brook facility. In accordance with the 2011 Administrative Settlement Agreement, we completed construction of an interim remedy. In 2012, the EPA issued a final remediation plan for the Bound Brook facility’s main plant area. In 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 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. The consent decree (which supersedes the 2011 Administrative Settlement Agreement) was entered by the District Court in 2015. In 2018, the EPA issued a final remediation plan for the two adjacent lagoons. In 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. In September 2021, 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 will allow Wyeth Holdings LLC to complete the design and implement the remedy for the two adjacent lagoons.
We have accrued for the estimated costs of the site remedies for the Bound Brook facility.
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 2017, a number of U.S. 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 U.S. 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 2020, the District Court granted defendants’ motions to dismiss and dismissed all of plaintiffs’ claims. The plaintiffs are appealing the District Court’s decision.
Allergan Complaint for Indemnity
In 2019, Pfizer was named as a defendant in a complaint, along with King, filed by Allergan Finance LLC (Allergan) in the Supreme Court of the State of New York, asserting 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. This suit was voluntarily discontinued without prejudice in January 2021.
Breach of Contract––Xalkori/Lorbrena
We are a defendant in a breach of contract action brought by New York University (NYU) in the Supreme Court of the State of New York (Supreme Court). NYU alleges that it is entitled to royalties on Pfizer’s sales of Xalkori under the terms of a Research and License Agreement between NYU and Sugen, Inc. Sugen, Inc. was acquired by Pharmacia in August 1999, and Pharmacia was acquired by Pfizer in 2003 and is a wholly owned subsidiary of Pfizer. The action was originally filed in 2013. In 2015, the Supreme Court dismissed the action and, in 2017, the New York State Appellate Division reversed the decision and remanded the proceedings to the Supreme Court. In January 2020, the Supreme Court denied both parties’ summary judgment motions.
In October 2020, NYU filed a separate breach of contract action against Pfizer alleging that it is entitled to royalties on sales of Lorbrena under the terms of the same NYU-Sugen, Inc. Research and Licensing Agreement.
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A4. Legal Proceedings––Government Investigations
We are subject to extensive regulation by government agencies in the U.S., other developed markets and multiple emerging markets in which we operate. 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.
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 former Greenstone generics business. We believe this is related to an ongoing broader antitrust investigation of the generic pharmaceutical industry. We have produced records relating to this investigation.
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 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. In June 2020, the State Attorneys General filed a new complaint against a large number of companies, including Greenstone and Pfizer, making similar allegations, but concerning a new set of drugs. This complaint was transferred to the Multi-District Litigation in July 2020.
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 have produced 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 Foreign Corrupt Practices Act (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 have produced records pursuant to these requests.
Docetaxel––Mississippi Attorney General Government Investigation
See Legal Proceedings––Product Litigation––Docetaxel––Mississippi Attorney General Government Investigation above for information regarding a government investigation related to Docetaxel marketing practices.
U.S. Department of Justice Inquiries relating to India Operations
In March 2020, we received an informal request from the U.S. Department of Justice's Consumer Protection Branch seeking documents relating to our manufacturing operations in India, including at our former facility located at Irrungattukottai in India. In April 2020, we received a similar request from the U.S. Attorney’s Office for the SDNY regarding a civil investigation concerning operations at our facilities in India. We are producing records pursuant to these requests.
U.S. Department of Justice/SEC Inquiry relating to China Operations
In June 2020, we received an informal request from the U.S. Department of Justice's FCPA Unit seeking documents relating to our operations in China. In August 2020, we received a similar request from the SEC’s FCPA Unit. We are producing records pursuant to these requests.
Zantac––State of New Mexico and Mayor and City Council of Baltimore Civil Actions
See Note 12A2. Contingencies and Certain Commitments: Legal Proceedings––Product Litigation––Zantac above for information regarding civil actions separately filed by the State of New Mexico and the Mayor and City Council of Baltimore alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in those jurisdictions.
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A5. Legal Proceedings––Matters Resolved During the First Nine Months of 2021
During the first nine months of 2021, certain matters, including the matter discussed below, were resolved or became the subject of definitive settlement agreements or settlement agreements-in-principle.
EpiPen
Beginning in 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 former Chief Executive Officer, Heather Bresch. The plaintiffs in these actions 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. Against Pfizer and/or its affiliates, plaintiffs in these actions 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 and various state antitrust laws. At least one lawsuit also alleges that Pfizer and/or Mylan violated the federal Racketeer Influenced and Corrupt Organizations Act (RICO). Plaintiffs also filed various federal antitrust, state 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 2011. In 2017, all of these indirect purchase actions were consolidated for coordinated pre-trial proceedings in a Multi-District Litigation in the U.S. District Court for the District of Kansas with other EpiPen-related actions against Mylan and/or its affiliates to which Pfizer, King and Meridian are not parties. In July 2021, Pfizer and plaintiffs filed a stipulation of settlement to resolve the Multi-District Litigation for $345 million. The settlement is subject to court approval, and the payment has been made in accordance with the terms of the settlement agreement.
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 October 3, 2021, the estimated fair value of these indemnification obligations was not significant.
In addition, in connection with our entry into certain agreements and other transactions, our counterparties may agree to indemnify us. For example, in November 2020, we and Mylan completed the transaction to spin-off our Upjohn Business and combine it with Mylan to form Viatris. As part of the transaction and as previously disclosed, Viatris has agreed to assume, and to indemnify Pfizer for, liabilities arising out of certain matters.
We have also guaranteed the long-term debt of certain companies that we acquired, which are now subsidiaries of Pfizer. See Note 7D.
C. Contingent Consideration for Acquisitions
We may be required to make payments to sellers for certain prior business combinations that are contingent upon future events or outcomes. For additional information, see Note 1D in our 2020 Form 10-K.
Note 13. Product, Geographic and Other Revenue Information
A. Geographic Information
The following summarizes revenues by geographic area:
 Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
%
Change
October 3,
2021
September 27,
2020
%
Change
United States$7,079 $5,425 30 $22,269 $15,827 41 
Developed Europe6,221 1,864 234 13,836 5,437 154 
Developed Rest of World4,498 1,065 322 8,617 2,974 190 
Emerging Markets6,296 1,923 227 12,930 5,986 116 
Revenues$24,094 $10,277 134 $57,653 $30,224 91 
We and our collaboration partner, BioNTech, have entered into agreements to supply pre-specified doses of Comirnaty with multiple developed and emerging nations around the world and are continuing to deliver doses of Comirnaty under such agreements. We currently sell the Comirnaty vaccine directly to government and government sponsored customers. This includes supply agreements entered into in November 2020 and February and May 2021 with the European Commission (EC)
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
on behalf of the different EU member states and certain other countries. Each EU member state submits its own Comirnaty vaccine order to us and is responsible for payment pursuant to terms of the supply agreements negotiated by the EC.
B. Other Revenue Information
Significant Customers
For information on our significant wholesale customers, see Note 17B in our 2020 Form 10-K. Additionally, revenues from the U.S. government represented 10% and 12% of total revenues for the three and nine months ended October 3, 2021, respectively, and primarily represent sales of Comirnaty. Accounts receivable from the U.S. government represented 8% of total trade accounts receivable as of October 3, 2021, and primarily relate to sales of Comirnaty.
Significant Product Revenues
The following provides detailed revenue information for several of our major products:
(MILLIONS)Three Months EndedNine Months Ended
PRODUCTPRIMARY INDICATION OR CLASSOct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020
TOTAL REVENUES(a)
$24,094 $10,277 $57,653 $30,224 
Vaccines$14,583 $1,717 $28,711 $4,574 
Comirnaty direct sales and alliance revenues
Active immunization to prevent COVID-19
12,977 — 24,277 — 
Prevnar family(b)
Pneumococcal disease1,447 1,534 3,971 4,100 
FSME/IMMUN-TicoVacTick-borne encephalitis disease47 77 161 170 
NimenrixMeningococcal ACWY disease51 50 145 180 
TrumenbaMeningococcal B disease52 48 102 85 
All other VaccinesVarious10 55 39 
Oncology$3,085 $2,761 $9,091 $7,843 
IbranceHR-positive/HER2-negative metastatic breast cancer1,381 1,357 4,039 3,955 
Xtandi alliance revenuesmCRPC, nmCRPC, mCSPC309 266 879 741 
InlytaAdvanced RCC256 195 742 559 
SutentAdvanced and/or metastatic RCC, adjuvant RCC, refractory GIST (after disease progression on, or intolerance to, imatinib mesylate) and advanced pancreatic neuroendocrine tumor142 202 537 616 
BosulifPhiladelphia chromosome–positive chronic myelogenous leukemia136 111 395 324 
XalkoriALK-positive and ROS1-positive advanced NSCLC116 122 371 409 
Ruxience(c)
Non-hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis
124 59 343 78 
Retacrit(c)
Anemia110 102 322 278 
Zirabev(c)
Treatment of mCRC; unresectable, locally advanced, recurrent or metastatic NSCLC; recurrent glioblastoma; metastatic RCC; and persistent, recurrent or metastatic cervical cancer
96 48 311 63 
Lorbrena
ALK-positive metastatic NSCLC
67 55 193 142 
AromasinPost-menopausal early and advanced breast cancer56 35 159 107 
BesponsaRelapsed or refractory B-cell acute lymphoblastic leukemia 50 44 145 134 
Braftovi
In combination with Mektovi for metastatic melanoma in patients with a BRAFV600E/K mutation and, in combination with Erbitux® (cetuximab), for the treatment of
BRAFV600E-mutant mCRC after prior therapy
47 42 136 116 
Bavencio alliance revenuesLocally advanced or metastatic urothelial carcinoma; metastatic Merkel cell carcinoma; immunotherapy and tyrosine kinase inhibitor combination for patients with advanced RCC54 21 122 51 
Mektovi
In combination with Braftovi for metastatic melanoma in patients with a BRAFV600E/K mutation
41 34 112 103 
All other OncologyVarious98 69 286 167 
Internal Medicine$2,097 $2,085 $7,093 $6,695 
Eliquis direct sales and alliance revenuesNonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism1,346 1,114 4,470 3,686 
Premarin familySymptoms of menopause148 168 420 471 
Chantix/ChampixAn aid to smoking cessation treatment in adults 18 years of age or older223 409 728 
BMP2Development of bone and cartilage71 70 186 197 
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(MILLIONS)Three Months EndedNine Months Ended
PRODUCTPRIMARY INDICATION OR CLASSOct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020
ToviazOveractive bladder56 59 174 183 
PristiqDepression43 40 144 124 
All other Internal MedicineVarious426 411 1,291 1,305 
Hospital(a)
$2,367 $1,790 $6,968 $5,741 
SulperazonBacterial infections181 143 515 432 
MedrolAnti-inflammatory glucocorticoid109 87 320 295 
ZaviceftaBacterial infections107 49 306 143 
EpiPenEpinephrine injection used in treatment of life-threatening allergic reactions78 75 225 234 
FragminTreatment/prevention of venous thromboembolism74 60 223 178 
VfendFungal infections51 52 204 201 
ZithromaxBacterial infections66 25 198 218 
TygacilBacterial infections56 33 153 115 
PrecedexSedation agent in surgery or intensive care50 55 147 211 
ZyvoxBacterial infections41 51 144 176 
IVIg Products(d)
Various99 88 311 271 
Pfizer CentreOne(e)
Various521 242 1,348 618 
All other Anti-infectivesVarious355 301 1,081 936 
All other HospitalVarious577 529 1,794 1,713 
Inflammation & Immunology (I&I)$1,094 $1,173 $3,200 $3,299 
Xeljanz
RA, PsA, UC, active polyarticular course juvenile idiopathic arthritis
610 654 1,734 1,741 
Enbrel (Outside the U.S. and Canada)
RA, juvenile idiopathic arthritis, PsA, plaque psoriasis, pediatric plaque psoriasis, ankylosing spondylitis and nonradiographic axial spondyloarthritis
283 321 888 1,005 
Inflectra/Remsima(c)
Crohn’s disease, pediatric Crohn’s disease, UC, pediatric UC, RA in combination with methotrexate, ankylosing spondylitis, PsA and plaque psoriasis
172 162 485 471 
All other I&IVarious28 35 93 83 
Rare Disease$869 $752 $2,588 $2,071 
Vyndaqel/VyndamaxATTR-cardiomyopathy and polyneuropathy501 351 1,454 859 
BeneFIXHemophilia B104 107 328 337 
GenotropinReplacement of human growth hormone95 107 284 316 
Refacto AF/XynthaHemophilia A69 92 235 272 
SomavertAcromegaly70 67 203 198 
All other Rare DiseaseVarious30 27 84 89 
Total Alliance revenues$2,068 $1,250 $5,718 $4,036 
Total Biosimilars(c)
$575 $424 $1,663 $1,001 
Total Sterile Injectable Pharmaceuticals(f)
$1,443 $1,192 $4,306 $3,826 
(a)On November 16, 2020, we completed the spin-off and the combination of our Upjohn Business with Mylan to form Viatris. See Note 1A. Beginning in the fourth quarter of 2020, the results of our Meridian subsidiary, which was previously included in our former Upjohn operating segment, are reported in the Hospital therapeutic area for all periods presented.
(b)Prevnar family include revenues from Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20 (adult).
(c)Biosimilars are highly similar versions of approved and authorized biological medicines and primarily include revenues from Inflectra/Remsima, Ruxience, Retacrit and Zirabev.
(d)Intravenous immunoglobulin (IVIg) products include the revenues from Panzyga, Octagam and Cutaquig.
(e)Pfizer CentreOne includes revenues from our contract manufacturing, including certain Comirnaty-related manufacturing activities performed on behalf of BioNTech ($187 million and $274 million for the third quarter and the first nine months of 2021, respectively), and active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with former legacy Pfizer businesses/partnerships, including but not limited to, transitional manufacturing and supply agreements with Viatris following the spin-off of the Upjohn Business.
(f)Total Sterile Injectable Pharmaceuticals represents the total of all branded and generic injectable products in the Hospital therapeutic area, including anti-infective sterile injectable pharmaceuticals.
Deferred Revenues
Our deferred revenues primarily relate to advance payments received or receivable in connection with contracts that we entered into during 2021 and 2020 with various government or government sponsored customers in international markets for supply of Comirnaty. The deferred revenues associated with the advance payments related to Comirnaty total $3.7 billion as of October 3, 2021 and $957 million as of December 31, 2020, with $3.4 billion and $264 million recorded in current liabilities and noncurrent liabilities, respectively as of October 3, 2021, and $957 million recorded in current liabilities as of December 31, 2020. The increase in the Comirnaty deferred revenues during the first nine months of 2021 was the result of additional advance
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
payments received as we entered into new or amended contracts or as we invoiced customers in advance of vaccine deliveries less amounts recognized in Revenues as we delivered doses to our customers. During the third quarter and first nine months of 2021, we recognized revenue of $136 million and $950 million, respectively, that was included in the balance of Comirnaty deferred revenues as of December 31, 2020. The Comirnaty deferred revenues as of October 3, 2021 will be recognized in Revenues proportionately as we deliver doses of the vaccine to our customers and satisfy our performance obligation under the contracts, with the amounts included in current liabilities expected to be recognized in Revenues within the next 12 months, and the amounts included in noncurrent liabilities expected to be recognized in Revenues in the fourth quarter of 2022 and in 2023.
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ITEM 2. MANAGEMENTS’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
OVERVIEW OF OUR PERFORMANCE, OPERATING ENVIRONMENT, STRATEGY AND OUTLOOK
Our Business and Strategy
Most of our revenues come from the manufacture and sale of biopharmaceutical products. With the formation of the Consumer Healthcare JV in 2019 and the completion of the spin-off and combination of our Upjohn Business with Mylan in November 2020, Pfizer has transformed into a focused, global leader in science-based innovative medicines and vaccines. We operate as a single operating segment engaged in the discovery, development, manufacturing, marketing, sale and distribution of biopharmaceutical products worldwide. The financial results of the Upjohn Business and the Mylan-Japan collaboration are reflected as discontinued operations. Prior-period information has been restated to reflect our current organization structure. We expect to incur costs of approximately $700 million in connection with separating Upjohn, of which approximately 75% has been incurred since inception and through the third quarter of 2021. These charges include costs and expenses related to separation of legal entities and transaction costs.
For additional information about our business, strategy and operating environment, see the Item 1. Business section and Overview of Our Performance, Operating Environment, Strategy and Outlook section within MD&A of our 2020 Form 10-K.
References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of our business, they are not within our control and since they can mask positive or negative trends in the business, we believe presenting operational variances excluding these foreign exchange changes provides useful information to evaluate our results.
Our Business Development Initiatives
We are committed to strategically capitalizing on growth opportunities by advancing our own product pipeline and maximizing the value of our existing products, as well as through various business development activities.
Our significant recent business development activities include:
Collaboration with Biohaven––In November 2021, we entered into a collaboration and license agreement and related sublicense agreement with Biohaven Pharmaceutical Holding Company Ltd., Biohaven Pharmaceutical Ireland DAC and Bioshin LTD. (collectively, Biohaven) pursuant to which we will acquire rights to commercialize rimegepant and zavegepant for the treatment and prevention of migraines outside of the U.S., subject to regulatory approval. Rimegepant is currently commercialized in the U.S. under the brand name Nurtec® ODT, with certain applications pending outside of the U.S. Biohaven will continue to lead R&D globally and we have the exclusive right to commercialization globally, outside of the U.S. Under the financial terms of the transaction agreements, we will make an upfront payment of $500 million, consisting of $150 million cash and $350 million in the purchase of Biohaven equity. Biohaven is also eligible to receive up to $740 million in non-U.S. commercialization milestones, in addition to tiered double-digit royalties on net sales outside of the U.S. In addition to the milestones and royalties above, we will also reimburse Biohaven for the portion of certain additional milestones and royalties due to third parties in accordance with preexisting agreements, which are attributed to ex-U.S. sales. The transaction is subject to customary closing conditions, including completion of review under applicable antitrust laws.
Agreement with Altaris Capital Partners, LLC (Altaris)––In November 2021, we entered into an agreement with Altaris, a healthcare investment firm based in New York, for Altaris to purchase Meridian. Meridian was acquired by Pfizer in 2011 as part of the King Pharmaceuticals acquisition and has maintained relative operational autonomy since that time. Meridian’s operations, which generate approximately $300 million in annual revenues, consist of manufacturing and distributing medical countermeasures used by the U.S. Department of Defense, Emergency Medical Services, Homeland Security and foreign ministries of health and defense, as well as rescue auto-injectors for the emergency treatment of allergic reactions including anaphylaxis. The transaction is expected to close in the coming months, subject to customary closing conditions including the receipt of regulatory approvals.
Acquisition of Trillium Therapeutics Inc. (Trillium)––In August 2021, we and Trillium announced that the companies entered into a definitive agreement under which we will acquire Trillium, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. We currently hold a 2% ownership investment in Trillium. Under the terms of the agreement, we will acquire all outstanding shares of Trillium not already owned by us for $18.50 per share, in cash, or an aggregate purchase price of approximately $2.2 billion. The acquisition is expected to close in the fourth quarter of 2021 or first half of 2022, subject to customary closing conditions, including regulatory approvals.
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Collaboration with Arvinas, Inc. (Arvinas)––In July 2021, we announced a global collaboration with Arvinas to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. See Note 2 for additional information.
Acquisition of Amplyx Pharmaceuticals, Inc. (Amplyx)––In April 2021, we announced that we acquired Amplyx, a privately-held company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. Amplyx’s lead compound, Fosmanogepix (APX001), is a novel investigational asset in Phase 2 development for the treatment of invasive fungal infections.
For a discussion of recent significant business development activities, see Note 2. For a description of the more significant recent transactions through February 25, 2021, the filing date of our 2020 Form 10-K, see Note 2 in our 2020 Form 10-K.
Our Third Quarter 2021 and First Nine Months of 2021 Performance

Revenues
Revenues increased $13.8 billion, or 134%, in the third quarter of 2021 to $24.1 billion from $10.3 billion in the third quarter of 2020, reflecting an operational increase of $13.4 billion, or 130%, as well as a favorable impact of foreign exchange of $421 million, or 4%. Excluding direct sales and alliance revenues of Comirnaty of $13.0 billion, revenues increased 7% operationally, reflecting strong growth in Eliquis, Vyndaqel/Vyndamax, Inlyta, Xtandi, Biosimilars and the Hospital therapeutic area, partially offset by declines in Chantix/Champix, Prevnar family, Sutent, Xeljanz and Enbrel.
Revenues increased $27.4 billion, or 91%, in the first nine months of 2021 to $57.7 billion from $30.2 billion in the first nine months of 2020, reflecting an operational increase of $26.1 billion, or 86%, as well as a favorable impact of foreign exchange of $1.3 billion, or 4%. Excluding direct sales and alliance revenues of Comirnaty of $24.3 billion, revenues increased 8% operationally, reflecting strong growth in Eliquis, Vyndaqel/Vyndamax, Inlyta, Xtandi, Biosimilars and the Hospital therapeutic area, partially offset by declines in Chantix/Champix, Prevnar family, Enbrel and Sutent.
See the Analysis of the Condensed Consolidated Statements of Income––Revenues by Geography and Revenues––Selected Product Discussion sections for more information, including a discussion of key drivers of our revenue performance. For information regarding the primary indications or class of certain products, see Note 13B.
Income from Continuing Operations Before Provision/(Benefit) for Taxes on Income
The increases in Income from continuing operations before provision/(benefit) for taxes on income of $7.3 billion in the third quarter of 2021 and $13.7 billion in the first nine months of 2021, compared to the same periods in 2020, respectively, were primarily attributable to: (i) higher revenues, (ii) net periodic benefit credits in 2021 versus net periodic benefit costs in 2020, (iii) net gains on equity securities in the third quarter of 2021 versus net losses on equity securities in the third quarter of 2020, and higher net gains on equity securities in the first nine months of 2021 and (iv) the non-recurrence of certain asset impairment charges in 2020, partially offset by (v) increases in: Cost of sales, Research and development expenses, Selling, informational and administrative expenses and Restructuring charges and certain acquisition-related costs.
See the Analysis of the Condensed Consolidated Statements of Income within this MD&A and Note 4 for additional information.
For information on our tax provision and effective tax rate, see the Provision/(Benefit) for Taxes on Income section within MD&A and Note 5.
Our Operating Environment

We, like other businesses in our industry, are subject to certain industry-specific challenges. These include, among others, the topics listed below and in our 2020 Form 10-K.
Intellectual Property Rights and Collaboration/Licensing Rights
The loss, expiration or invalidation of intellectual property rights, patent litigation settlements with manufacturers and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues. Certain of our products have experienced patent-based expirations or loss of regulatory exclusivity in certain markets in the last few years, and we expect certain products to face significantly increased generic competition over the next few years. Examples of products experiencing recent expirations of their basic product patent are Chantix in the U.S. in November 2020 and Sutent in the U.S. in August 2021. While additional patent expiries will continue, we expect a moderate impact of reduced revenues due to patent expiries from 2021 through 2025. Further, legal or regulatory action by various stakeholders or governments could potentially result in us not seeking intellectual property protection for or agreeing not to enforce or being restricted from enforcing intellectual property related to our products. For example, in May 2021, the Brazilian Supreme Court voted to invalidate Article 40 of
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Brazil’s Patent Law, which guaranteed a minimum 10-year patent term from patent grant, and to give retroactive effect to such decision. We continue to vigorously defend our patent rights against infringement, and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking necessary steps to ensure appropriate patient access.

For additional information on patent rights we consider most significant in relation to our business as a whole, see the Item 1. Business––Patents and Other Intellectual Property Rights section of our 2020 Form 10-K. For a discussion of recent developments with respect to patent litigation, see Note 12A1.
Regulatory Environment/Pricing and Access––Government and Other Payer Group Pressures
The pricing of medicines and vaccines by pharmaceutical manufacturers and the cost of healthcare, which includes medicines, vaccines, medical services and hospital services, continues to be important to payers, governments, patients, and other stakeholders. Federal and state governments and private third-party payers in the U.S. continue to take action to manage the utilization of drugs and cost of drugs, including increasingly employing formularies to control costs by taking into account discounts in connection with decisions about formulary inclusion or favorable formulary placement. We consider a number of factors impacting the pricing of our medicines and vaccines. Within the U.S., we often engage with patients, doctors and healthcare plans. We also often provide significant discounts from the list price to insurers, including PBMs and MCOs. The price that patients pay in the U.S. for prescribed medicines and vaccines is ultimately set by healthcare providers and insurers. Governments globally may use a variety of measures to control costs, including proposing pricing reform or legislation, cross country collaboration and procurement, price cuts, mandatory rebates, health technology assessments, forced localization as a condition of market access, “international reference pricing” (i.e., the practice of a country linking its regulated medicine prices to those of other countries), quality consistency evaluation processes and volume-based procurement. In the U.S., we expect to see continued focus by Congress and the Biden Administration on regulating pricing resulting in legislative and regulatory efforts designed to control costs. Congress is currently considering a budget reconciliation package that includes drug pricing changes to Medicare Part B and D. We anticipate that these and similar initiatives will continue to increase pricing pressures globally. For additional information, see the Item 1. Business––Pricing Pressures and Managed Care Organizations and ––Government Regulation and Price Constraints sections in our 2020 Form 10-K.
Product Supply
We periodically encounter supply delays, disruptions and shortages, including due to a voluntary recall of a product. In July and August, Pfizer recalled 16 lots of Chantix in the U.S. due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. In September 2021, Pfizer expanded its voluntary recall in the U.S. to include all lots of Chantix. We currently also have a voluntary recall across multiple markets and a global pause in shipments of Chantix. Nitrosamines are impurities common in water and foods and everyone is exposed to some level of nitrosamines. In response to requests from various regulatory authorities, manufacturers across the pharmaceutical industry, including Pfizer, have been evaluating the potential for the presence or formation of nitrosamines in pharmaceutical products. We are currently undertaking an evaluation of our entire portfolio. For information on risks related to product manufacturing, see the Item 1A. Risk Factors––Product Manufacturing, Sales and Marketing Risks section of our 2020 Form 10-K.

The Global Economic Environment
In addition to the industry-specific factors discussed above, we, like other businesses of our size and global extent of activities, are exposed to the economic cycle. For additional information, please see the Overview of Our Performance, Operating Environment, Strategy and Outlook––The Global Economic Environment section of the MD&A of our 2020 Form 10-K.
COVID-19 Pandemic

The continuation of the COVID-19 pandemic has impacted our business, operations and financial condition and results.
Our Response to COVID-19
We are committed to confronting the public health challenge posed by the pandemic by collaborating with industry partners, global regulators and academic institutions to develop potential approaches to prevent and treat COVID-19. We have made some important advances, including, among others:
COVID-19 Vaccine Development Program:
The FDA has approved Comirnaty in the U.S. to prevent COVID-19 in individuals 16 years of age and older as a two-dose primary series (30 µg per dose). Comirnaty is the first COVID-19 vaccine to be granted approval by the FDA and had previously been available to this patient population in the U.S. under an EUA since December 2020. The vaccine remains available to individuals 12 to 15 years old under an EUA granted by the FDA in May 2021. Emergency use and distribution of this product is subject to the conditions set forth in the EUA, and only for the duration of the declaration by the Department of Health & Human Services that circumstances exist justifying authorization of emergency use of drugs
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and biological products during the COVID-19 pandemic under Section 564 of the U.S. Federal Food, Drug and Cosmetic Act (the Declaration), or until revocation of the EUA by the FDA. The FDA has issued EUAs to certain other companies for products intended for the prevention or treatment of COVID-19 and may continue to do so during the duration of the Declaration. In September 2021, the FDA authorized for emergency use a booster dose of Comirnaty/BNT162b2 for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. In addition, in October 2021, the FDA authorized for emergency use a booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. The FDA also authorized BNT162b2 (10 µg per dose) for emergency use for children 5 through 11 years of age. In November 2021, we and BioNTech submitted a request to the FDA to amend the EUA of a booster dose of Comirnaty/BNT162b2 to include all individuals 18 years of age and older. Comirnaty/BNT162b2 has been granted an approval or a temporary authorization in many other countries around the world in populations varying by country. We continue to evaluate our vaccine, including for potential maternal and additional pediatric indications, and the short- and long-term efficacy of Comirnaty. We are also studying vaccines to potentially prevent COVID-19 caused by new and emerging variants or an updated vaccine as needed.
The companies have entered into agreements to supply pre-specified doses of Comirnaty with multiple developed and emerging countries around the world and are continuing to deliver doses of Comirnaty to governments under such agreements. We also signed agreements with multiple countries to supply Comirnaty doses in 2022 and beyond and are currently negotiating similar potential agreements with multiple other countries.
As of November 2, 2021, we forecasted approximately $36.0 billion in revenues in 2021 from Comirnaty, with gross profit to be split evenly with BioNTech, reflecting approximately 2.3 billion doses that are expected to be delivered in fiscal 2021 based on expected ordering patterns through the end of December 2021 for the U.S. and through the end of November 2021 for the rest of the world. Pfizer and BioNTech continue to expect to manufacture 3 billion doses in total by the end of December 2021. The difference between the number of doses expected to contribute to 2021 revenues versus the number of doses expected to be manufactured by year-end relates to anticipated international deliveries in December 2021, which will be recorded as revenue in 2022 due to our international fiscal calendar, and, to a lesser extent, doses expected to be produced but not yet delivered as of December 31, 2021. We anticipate delivering at least two billion doses to low- and middle-income countries by the end of 2022 - at least one billion to be delivered in 2021 and one billion in 2022, with the possibility to increase those deliveries if more orders are placed by these countries for 2022. One billion of these doses will be supplied to the U.S. government at a not-for-profit price to be donated to the world’s poorest nations at no charge to those countries.
COVID-19 Protease Inhibitors:
In July 2021, we initiated the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) study to evaluate the efficacy, safety and tolerability of Paxlovid (PF-07321332; ritonavir), an investigational, novel oral antiviral therapeutic for COVID-19, which is a SARS-CoV2-3CL protease inhibitor and is co-administered with a low dose of ritonavir, in non-hospitalized, high-risk adult participants with COVID-19. In August 2021, we initiated the pivotal Phase 2/3 EPIC-SR (Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients) study to evaluate Paxlovid (PF-07321332; ritonavir) in patients with a confirmed diagnosis of SARS-CoV-2 infection who are at standard risk (i.e., low risk of hospitalization or death). In September 2021, we initiated the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study to evaluate Paxlovid (PF-07321332; ritonavir) for the prevention of COVID-19 infection in adults living in the same household as someone with a confirmed COVID-19 infection. In November 2021, Pfizer announced the scheduled interim analysis of EPIC-HR, which showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint). Pfizer plans to submit the data as part of its ongoing rolling submission to the FDA for EUA as soon as possible. We have also entered into agreements to supply pre-specified courses of treatment with several countries and are currently in negotiations with other markets to supply the product, if authorized or approved.
In September 2021, the National Institute of Allergy and Infectious Disease initiated a study of our intravenously administered investigational protease inhibitor for COVID-19, PF-07304814, which is a SARS-CoV2-3CL protease inhibitor, in adults hospitalized with COVID-19, as part of the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-3 program.
Despite our significant investments and efforts, any of our ongoing development programs related to COVID-19 may not be successful as the risk of failure is significant, and there can be no certainty these efforts will yield a successful product or that costs will ultimately be recouped.
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Impact of COVID-19 on Our Business and Operations
As part of our on-going monitoring and assessment, we have made certain assumptions regarding the pandemic for purposes of our operational planning and financial projections, including assumptions regarding the duration, severity and the global macroeconomic impact of the pandemic, as well as COVID-19 vaccine supply and contracts, which remain dynamic. Despite careful tracking and planning, we are unable to accurately predict the extent of the impact of the pandemic on our business, operations and financial condition and results due to the uncertainty of future developments. We are focused on all aspects of our business and are implementing measures aimed at mitigating issues where possible, including by using digital technology to assist in operations for our commercial, manufacturing, R&D and corporate enabling functions globally.
As discussed in our 2020 Form 10-K, our business and operations were impacted in 2020 by the pandemic in various ways; certain of those impacts have continued in 2021. For detail on the impact of the COVID-19 pandemic on our products, see the Analysis of the Condensed Consolidated Statements of Income—Revenues by Geography and Revenues—Selected Product Discussion sections within this MD&A. In 2021, engagement with healthcare professionals has started to return to pre-pandemic levels and we continue to review and assess epidemiological data to inform in-person engagements with healthcare professionals and to ensure the safety of our colleagues, customers and communities. As part of our commitment to engaging our customers in the manner they prefer, we are also taking a hybrid approach of virtual and in person engagements and are seeing customer response to both approaches. During the pandemic, we adapted our promotional platform by amplifying our digital capabilities to reach healthcare professionals and customers to provide critical education and information, including increasing the scale of our remote engagement. Also, in 2021, we have continued not to see a significant disruption to our supply chain to date, and all of our manufacturing sites globally have continued to operate at or near normal levels. However, we are seeing an increase in overall demand in the industry for certain components and raw materials potentially constraining available supply, which could have a future impact on our business. We are continuing to monitor and implement mitigation strategies in an effort to reduce any potential impact.
We will continue to pursue efforts to maintain the continuity of our operations while monitoring for new developments related to the pandemic. Future developments could result in additional favorable or unfavorable impacts on our business, operations or financial condition and results. If we experience significant disruption in our manufacturing or supply chains or significant disruptions in clinical trials or other operations, or if demand for our products is significantly reduced as a result of the COVID-19 pandemic, we could experience a material adverse impact on our business, operations and financial condition and results.
For additional information, please see the Item 1A. Risk Factors—COVID-19 Pandemic section and the Overview of Our Performance, Operating Environment, Strategy and Outlook section of the MD&A of our 2020 Form 10-K.
SIGNIFICANT ACCOUNTING POLICIES AND APPLICATION OF CRITICAL ACCOUNTING ESTIMATES AND ASSUMPTIONS
For a description of our significant accounting policies, see Note 1 in our 2020 Form 10-K. 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: Acquisitions (Note 1D); Fair Value (Note 1E); Revenues (Note 1G); Asset Impairments (Note 1L); Tax Assets and Liabilities and Income Tax Contingencies (Note 1P); Pension and Postretirement Benefit Plans (Note 1Q); and Legal and Environmental Contingencies (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 within MD&A in our 2020 Form 10-K. See also Note 1C in our 2020 Form 10-K for a discussion about the risks associated with estimates and assumptions.
For a discussion of a recently adopted accounting standard, a change in accounting principle related to our pension and postretirement plans, and significant accounting policies, see Notes 1B, 1C and 1D.

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ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF INCOME
Revenues by Geography
The following presents worldwide revenues by geography:
Three Months Ended
 WorldwideU.S.InternationalWorld-wideU.S.Inter-national
(MILLIONS)Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020% Change in Revenues
Total revenues$24,094 $10,277 $7,079 $5,425 $17,014 $4,852 134 30 251 
Nine Months Ended
WorldwideU.S.InternationalWorld-wideU.S.Inter-national
(MILLIONS)Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020% Change in Revenues
Total revenues$57,653 $30,224 $22,269 $15,827 $35,384 $14,396 91 41 146 
Third Quarter of 2021 vs. Third Quarter of 2020
The following provides an analysis of the worldwide change in revenues by geographic areas in the third quarter of 2021:
Three Months Ended October 3, 2021
(MILLIONS)WorldwideU.S.International
Operational growth/(decline):
Growth from Comirnaty, Eliquis, Vyndaqel/Vyndamax, Inlyta, Xtandi, Ibrance outside the U.S., Biosimilars and the Hospital therapeutic area, partially offset by declines from Prevnar family and Xeljanz. See the Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion within MD&A for additional analysis
$13,695 $1,877 $11,818 
Lower revenues for Chantix/Champix, Sutent and Enbrel:
The decrease in Chantix/Champix was driven by the voluntary recall across multiple markets and the global pause in shipments of Chantix due to the presence of N-nitroso-varenicline above an acceptable level of intake set by various global regulators, the ultimate timing for resolution of which may vary by country
The decrease in Sutent primarily reflects lower volume demand in the U.S. resulting from its loss of exclusivity in August 2021
The decrease for Enbrel internationally primarily reflects continued biosimilar competition, which is expected to continue
(319)(220)(99)
Other operational factors, net19 (3)22 
Operational growth/(decline), net13,395 1,654 11,741 
Favorable impact of foreign exchange421 — 421 
Revenues increase/(decrease)
$13,817 $1,654 $12,162 
Emerging markets revenues increased $4.4 billion, or 227%, in the third quarter of 2021 to $6.3 billion from $1.9 billion in the third quarter of 2020, reflecting an operational increase of $4.3 billion, or 222%, and a favorable impact from foreign exchange of approximately 5%. The operational increase in emerging markets was primarily driven by revenues from Comirnaty and growth from certain products in the Hospital therapeutic area and Eliquis.
44


First Nine Months of 2021 vs. First Nine Months of 2020
The following provides an analysis of the worldwide change in revenues by geographic areas in the first nine months of 2021:
Nine Months Ended October 3, 2021
(MILLIONS)WorldwideU.S.International
Operational growth/(decline):
Growth from Comirnaty, Eliquis, Vyndaqel/Vyndamax, Inlyta, Xtandi, Ibrance outside the U.S., Biosimilars and the Hospital therapeutic area, partially offset by declines from Prevnar family and Xeljanz. See the Analysis of the Condensed Consolidated Statements of Income––Revenues––Selected Product Discussion within MD&A for additional analysis
$26,647 $6,776 $19,871 
Lower revenues for Chantix/Champix, Enbrel and Sutent:
The decrease in Chantix/Champix was driven by the voluntary recall across multiple markets and the global pause in shipments of Chantix due to the presence of N-nitroso-varenicline above an acceptable level of intake set by various global regulators, the ultimate timing for resolution of which may vary by country and the negative impact of the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventive health purposes
The decrease for Enbrel internationally primarily reflects continued biosimilar competition, which is expected to continue
The decrease in Sutent primarily reflects lower volume demand in the U.S. resulting from its loss of exclusivity in August 2021, as well as continued erosion as a result of increased competition in certain international developed markets
(562)(320)(241)
Other operational factors, net(14)15 
Operational growth/(decline), net26,087 6,442 19,644 
Favorable impact of foreign exchange1,342 — 1,342 
Revenues increase/(decrease)
$27,429 $6,442 $20,987 
Emerging markets revenues increased $6.9 billion, or 116%, in the first nine months of 2021 to $12.9 billion from $6.0 billion in the first nine months of 2020, reflecting an operational increase of $6.7 billion, or 113%, and a favorable impact from foreign exchange of approximately 3%. The operational increase in emerging markets was primarily driven by revenues from Comirnaty and growth from certain products in the Hospital therapeutic area and Eliquis.
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. These deductions represent estimates of related obligations and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting period. Historically, adjustments to these estimates to reflect actual results or updated expectations, have not been material to our overall business and generally have been less than 1% of revenues. Product-specific rebates, however, can have a significant impact on year-over-year individual product revenue growth trends.
The following presents information about revenue deductions:
 Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
October 3,
2021
September 27,
2020
Medicare rebates$175 $163 $546 $489 
Medicaid and related state program rebates252 252 904 832 
Performance-based contract rebates883 616 2,424 1,886 
Chargebacks1,618 1,127 4,567 3,190 
Sales allowances1,218 904 3,575 2,790 
Sales returns and cash discounts267 229 727 668 
Total$4,414 $3,291 $12,743 $9,855 
Revenue deductions are primarily a function of product sales volume, mix of products sold, contractual or legislative discounts and rebates.
For information on our accruals for revenue deductions, including the balance sheet classification of these accruals, see Note 1D.
45


Revenues––Selected Product Discussion
(MILLIONS)Revenue% Change
ProductPeriodGlobal
Revenues
RegionOct. 3, 2021Sept. 27, 2020TotalOper.Operational Results Commentary
Comirnaty(a)
QTD
$12,977

*
U.S.$1,586 $— *Driven by global uptake, following a growing number of regulatory approvals and temporary authorizations.
Int’l.11,391 — **
Worldwide$12,977 $— **
YTD
$24,277

*
U.S.$5,657 $— *
Int’l.18,619 — **
Worldwide$24,277 $— **
EliquisQTD
$1,346

Up 19%

(operationally)
U.S.$629 $557 13 
Global growth driven primarily by continued increased adoption in non-valvular atrial fibrillation and oral anti-coagulant market share gains.
YTD was also impacted by a favorable adjustment related to the Medicare “coverage gap” provision resulting from lower than previously expected discounts in prior periods.
Int’l.717 557 29 25 
Worldwide$1,346 $1,114 21 19 
YTD
$4,470

Up 19%

(operationally)
U.S.$2,440 $2,084 17 
Int’l.2,030 1,602 27 21 
Worldwide$4,470 $3,686 21 19 
IbranceQTD
$1,381

Up 1%
 
(operationally)
U.S.$883 $909 (3)
Growth driven primarily by accelerating demand internationally as the delays in diagnosis and treatment initiations caused by COVID-19 show signs of recovery across several international markets, partially offset by a decline in the U.S., driven by an increase in the proportion of patients accessing Ibrance through our Patient Assistance Program.
 
Int’l.498 448 11 
Worldwide$1,381 $1,357 
YTD
$4,039

Up 1%

(operationally)
U.S.$2,539 $2,689 (6)
Int’l.1,500 1,266 18 14 
Worldwide$4,039 $3,955 
Prevnar familyQTD
$1,447

Down 7%

(operationally)
U.S.$850 $868 (2)
Decline primarily resulting from:
continued impact of the lower remaining unvaccinated eligible adult population in the U.S. and the June 2019 change to the ACIP recommendation for the Prevnar 13 adult indication to shared clinical decision-making; and
the adult indication in the U.S. due to the ongoing prioritization of primary and booster vaccination campaigns for COVID-19 by U.S. health authorities, and a later start to the flu season compared to the prior year.
This decline was partially offset by:
U.S. growth in the pediatric indication, driven by government purchasing patterns.
YTD was also impacted by:
a decline, primarily in developed Europe, reflecting significantly increased adult demand in the prior year in Germany and certain other markets resulting from greater vaccine awareness for respiratory illnesses due to the COVID-19 pandemic.
Int’l.596 665 (10)(13)
Worldwide$1,447 $1,534 (6)(7)
YTD
$3,971

Down 4%

(operationally)
U.S.$2,130 $2,143 (1)
Int’l.1,841 1,957 (6)(8)
Worldwide$3,971 $4,100 (3)(4)
46


(MILLIONS)Revenue% Change
ProductPeriodGlobal
Revenues
RegionOct. 3, 2021Sept. 27, 2020TotalOper.Operational Results Commentary
XeljanzQTD
$610

Down 7%

(operationally)
U.S.$410 $469 (13)
Decline driven by the U.S., reflecting the negative impact of a review by the FDA which resulted in a Drug Safety Communication related to Xeljanz and two competitors’ arthritis medicines in the same drug class, as well as an unfavorable change in channel mix toward lower-priced channels and continued investments to improve formulary positioning and unlock access to additional patient lives. This decline was partially offset by operational growth internationally mainly driven by continued uptake in the UC indication in certain developed markets.
Int’l.201 185 
Worldwide$610 $654 (7)(7)
YTD
$1,734

Down 1%

(operationally)
U.S.$1,132 $1,213 (7)
Int’l.602 528 14 11 
Worldwide$1,734 $1,741 (1)
Vyndaqel/
Vyndamax
QTD
$501

Up 42%

(operationally)
U.S.$228 $158 44 
Growth primarily driven by continued strong uptake of the ATTR-CM indication in the U.S., developed Europe and Japan.
Int’l.273 193 41 40 
Worldwide$501 $351 43 42 
YTD
$1,454

Up 66%

(operationally)
U.S.$658 $431 53 
Int’l.796 429 86 78 
Worldwide$1,454 $859 69 66 
XtandiQTD
$309

Up 16%

(operationally)
U.S.$309 $266 16 
Growth primarily driven by strong demand across the mCRPC, nmCRPC and mCSPC indications.
Int’l.— — 
Worldwide$309 $266 16 16 
YTD
$879

Up 19%

(operationally)
U.S.$879 $741 19 
Int’l.— — 
Worldwide$879 $741 19 19 
InlytaQTD
$256

Up 30%

(operationally)
U.S.$151 $124 22 
Growth primarily reflects continued adoption in the U.S. and developed Europe of combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced RCC.
Int’l.104 71 47 43 
Worldwide$256 $195 31 30 
YTD
$742

Up 31%

(operationally)
U.S.$448 $372 20 
Int’l.294 187 57 51 
Worldwide$742 $559 33 31 
BiosimilarsQTD
$575

Up 34%

(operationally)
U.S.$390 $260 50 Growth primarily driven by recent oncology monoclonal antibody biosimilar launches and continued growth from Retacrit in the U.S.
Int’l.185 164 13 
Worldwide$575 $424 36 34 
YTD
$1,663

Up 62%

(operationally)
U.S.$1,080 $588 84 
Int’l.583 414 41 32 
Worldwide$1,663 $1,001 66 62 
HospitalQTD
$2,367

Up 29%

(operationally)
U.S.$819 $765 
Growth primarily driven by Pfizer CentreOne, our contract manufacturing operation, reflecting certain Comirnaty-related manufacturing activities performed on behalf of BioNTech and manufacturing of legacy Upjohn products for Viatris under manufacturing and supply agreements, as well as growth from international markets, primarily driven by the anti-infectives portfolio.
Int’l.1,548 1,025 51 46 
Worldwide$2,367 $1,790 32 29 
YTD
$6,968

Up 18%

(operationally)
U.S.$2,557 $2,485 
Int’l.4,412 3,256 36 30 
Worldwide$6,968 $5,741 21 18 
(a)Comirnaty includes direct sales and alliance revenues related to sales of the Pfizer-BioNTech COVID-19 vaccine, which are recorded within our Vaccines therapeutic area. It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in the Pfizer CentreOne contract manufacturing operation within the Hospital area. Revenues related to these manufacturing activities totaled $187 million and $274 million for the third quarter and the first nine months of 2021, respectively.
*    Calculation is not meaningful or results are equal to or greater than 100%.
See the Item 1. BusinessPatents and Other Intellectual Property Rights section of our 2020 Form 10-K for information regarding the expiration of various patent rights, Note 12 for a discussion of recent developments concerning patent and product litigation relating to certain of the products discussed above, and Note 13B for information regarding the primary indications or class of the selected products discussed.
Product Developments
A comprehensive update of Pfizer’s development pipeline was published as of November 2, 2021 and is available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of our research and a list of compounds in
47


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 provides information about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.
The table below includes only approvals for products that have occurred in the last twelve months and does not include approvals that may have occurred prior to that time. The table includes filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).
PRODUCTDISEASE AREAAPPROVED/FILED*
U.S.EUJAPAN
Comirnaty/BNT162b2
(PF-07302048)(a)
Immunization to prevent COVID-19 (16 years of age and older)
BLA
Aug.
2021
CMA
Dec.
2020
Approved
Feb.
2021
Immunization to prevent COVID-19 (12-15 years of age)
EUA
May
 2021
CMA
May
 2021
Approved
May
2021
Immunization to prevent COVID-19 (booster, adults)
EUA
Sep.
 2021
CMA
Oct.
 2021
Approved
 Nov.
2021
Immunization to prevent COVID-19 (5-11 years of age)
EUA
Oct.
2021
Filed
Oct.
2021
Filed
Nov.
2021
Bavencio
(avelumab)(b)
First-line maintenance urothelial cancer

Approved
Jan.
2021
Approved
Feb.
2021
Nyvepria
(pegfilgrastim-apgf)
Neutropenia in patients undergoing cancer chemotherapy (biosimilar)

Approved
Nov.
2020
Braftovi (encorafenib)(c)
Second or third-line BRAFv600E-mutant mCRC (combination with Erbitux® (cetuximab))


Approved
Nov.
2020
Braftovi (encorafenib) and Mektovi (binimetinib)(c)
Second or third-line BRAFV600E-mutant mCRC (combination with Erbitux® (cetuximab))
Approved
Nov.
2020
Xtandi
(enzalutamide)(d)
mCSPC
Approved
April
2021

Cibinqo (abrocitinib)(e)
Atopic dermatitis
Filed
Oct.
2020
Filed
Oct.
2020
Approved
Sep.
2021
Xeljanz
(tofacitinib)(e)
Ankylosing spondylitis
Filed
Aug.
2020
Filed
Feb.
2021
Myfembree
(relugolix fixed dose combination)(f)
Uterine fibroids (combination with estradiol and norethindrone acetate)
Approved
May
2021
Endometriosis (combination with estradiol and norethindrone acetate)
Filed
Sep.
2021
Lorbrena
(lorlatinib)
First- line ALK-positive NSCLC
Approved
Mar.
2021
Filed
Feb.
2021
Filed
Dec.
2020
somatrogon
(PF-06836922)(g)
Pediatric growth hormone deficiency
Filed
Jan.
2021
Filed
Feb.
2021
Filed
Jan.
2021
Prevnar 20
(Vaccine)(h)
Immunization to prevent invasive and non-invasive pneumococcal infections (adults)
Approved
June
2021
Filed
 Feb.
2021
TicoVac
(Vaccine)
Immunization to prevent tick-borne encephalitis
Approved
 Aug.
2021
*For the U.S., the filing date is the date on which the FDA accepted our submission. For the EU, the filing date is the date on which the EMA validated our submission.
(a)Being developed in collaboration with BioNTech. Prior to BLA, Comirnaty/BNT162b2 for ages 16 and up was available pursuant to an EUA from the FDA on December 11, 2020. A booster dose received EUA from the FDA on September 22, 2021 for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. In addition, in October 2021, the FDA authorized for emergency use a booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. A booster dose received conditional marketing authorization from the EMA on October 5, 2021 and approval in Japan on November 10, 2021 for 18 years of age and older. In November 2021, we and BioNTech submitted a request to the FDA to amend the EUA of a booster dose of Comirnaty/BNT162b2 to include all individuals 18 years of age and older.
(b)Being developed in collaboration with Merck KGaA, Germany.
(c)Erbitux® is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono Pharmaceutical Co., Ltd.
(d)Being developed in collaboration with Astellas.
(e)In July 2021, the FDA notified the company that it will not meet the PDUFA goal dates for the New Drug Application for abrocitinib and the supplemental New Drug Application for Xeljanz/Xeljanz XR (tofacitinib). The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a factor for the extensions. In October 2021, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of abrocitinib to treat moderate to severe atopic dermatitis in adults who are candidates for systemic therapy. The CHMP also adopted a positive opinion recommending an extension to the existing indications for Xeljanz (tofacitinib) to include the treatment of adults with active ankylosing spondylitis who have responded inadequately to conventional therapy.
(f)Being developed in collaboration with Myovant.
(g)Being developed in collaboration with OPKO.
(h)In October 2021, the CDC’s ACIP voted to recommend Prevnar 20 for routine use in adults. Specifically, the ACIP voted to recommend the following: (i) adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine
48


(either pneumococcal 20-valent conjugate vaccine (PCV20) or pneumococcal 15-valent conjugate vaccine (PCV15)). If PCV15 is used, this should be followed by a dose of pneumococcal polysaccharide vaccine (PPSV23); and (ii) adults aged 19 years of age or older with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be followed by a dose of PPSV23. The recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and following approval, the recommendations are published in the Morbidity and Mortality Weekly Report.
In October 2021, Pfizer and Lilly discontinued the global clinical development program for tanezumab, an investigational nerve growth factor inhibitor. This decision was made following receipt of a Complete Response Letter from the FDA for the tanezumab application in osteoarthritis (OA) and a negative opinion adopted by the EMA's Committee for Medicinal Products for Human Use on the tanezumab Marketing Authorization Application in OA.
In September 2021, the FDA issued a Drug Safety Communication (DSC) related to Xeljanz/Xeljanz XR and two competitors’ arthritis medicines in the same drug class, based on its completed review of the ORAL Surveillance trial. The DSC stated that the FDA will require revisions to the Boxed Warnings for each of these medicines to include information about the risks of serious heart-related events, cancer, blood clots, and death. In addition, the DSC indicates the FDA’s intention to limit approved uses of these products to certain patients who have not responded or cannot tolerate one or more tumor necrosis factor (TNF) blockers.
The following provides information about additional indications and new drug candidates in late-stage development:
PRODUCT/CANDIDATEPROPOSED DISEASE AREA
LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS
FOR IN-LINE AND IN-REGISTRATION PRODUCTS
Bavencio (avelumab)(a)
First-line NSCLC
Ibrance (palbociclib)(b)
ER+/HER2+ metastatic breast cancer
Xtandi (enzalutamide)(c)
Non-metastatic high-risk castration sensitive prostate cancer
Talzenna (talazoparib)
Combination with Xtandi (enzalutamide) for first-line mCRPC
Combination with Xtandi (enzalutamide) for DNA Damage Repair (DDR)-deficient mCSPC
PF-06482077 (Vaccine)Immunization to prevent invasive and non-invasive pneumococcal infections (pediatric)
somatrogon (PF-06836922)(d)
Adult growth hormone deficiency
Braftovi (encorafenib) and Erbitux® (cetuximab)(e)
First-line BRAFv600E-mutant mCRC
Myfembree
(relugolix fixed dose combination)(f)
Combination with estradiol and norethindrone acetate for contraceptive efficacy
Braftovi (encorafenib) and Mektovi (binimetinib) and Keytruda® (pembrolizumab)(g)
BRAFv600E-mutant metastatic or unresectable locally advanced melanoma
Comirnaty/BNT162b2
(PF-07302048)(h)
Immunization to prevent COVID-19 (children 2 to <5 years of age)
Immunization to prevent COVID-19 (infants 6 months to <24 months)
Immunization to prevent COVID-19 (maternal)
NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENTaztreonam-avibactam
(PF-06947387)
Treatment of infections caused by Gram-negative bacteria
fidanacogene elaparvovec (PF-06838435)(i)
Hemophilia B
giroctocogene fitelparvovec
(PF-07055480)(j)
Hemophilia A
PF-06425090 (Vaccine)Immunization to prevent primary clostridioides difficile infection
PF-06886992 (Vaccine)Immunization to prevent serogroups meningococcal infection (adolescent and young adults)
PF-06928316 (Vaccine)Immunization to prevent respiratory syncytial virus infection (maternal)
Immunization to prevent respiratory syncytial virus infection (older adults)
PF-07265803Dilated cardiomyopathy due to Lamin A/C gene mutation
ritlecitinib (PF-06651600)Alopecia areata
sasanlimab (PF-06801591)Combination with Bacillus Calmette-Guerin for non-muscle-invasive bladder cancer
fordadistrogene movaparvovec (PF-06939926)Duchenne muscular dystrophy
marstacimab (PF-06741086)Hemophilia
Elranatamab (PF-06863135)Multiple Myeloma Double-Class Exposed
Paxlovid (PF-07321332; ritonavir)
COVID-19 Infection (high risk population)
COVID-19 Infection (low risk population)
COVID-19 Infection (post exposure prophylaxis)
(a)Being developed in collaboration with Merck KGaA, Germany.
(b)Being developed in collaboration with the Alliance Foundation Trial.
(c)Being developed in collaboration with Astellas.
(d)Being developed in collaboration with OPKO.
49


(e)Erbitux® is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono Pharmaceutical Co., Ltd.
(f)Being developed in collaboration with Myovant.
(g)Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
(h)Being developed in collaboration with BioNTech.
(i)Being developed in collaboration with Spark Therapeutics, Inc.
(j)Being developed in collaboration with Sangamo Therapeutics, Inc.
For additional information about our R&D organization, see the Item 1. BusinessResearch and Development section of our 2020 Form 10-K.
COSTS AND EXPENSES
Costs and expenses follow:
Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
%
 Change
October 3,
2021
September 27,
2020
%
 Change
Cost of sales$9,973 $2,007 *$21,232 $5,773 *
Percentage of Revenues
41.4 %19.5 %36.8 %19.1 %
Selling, informational and administrative expenses2,905 2,658 8,617 7,858 10 
Research and development expenses3,447 2,300 50 7,920 6,050 31 
Amortization of intangible assets981 862 14 2,784 2,579 
Restructuring charges and certain acquisition-related costs646 *668 417 60 
Other (income)/deductions—net(1,696)1,878 *(3,697)1,114 *
* Indicates calculation not meaningful or results are equal to or greater than 100%.
Cost of Sales
Cost of sales increased $8.0 billion in the third quarter and $15.5 billion in the first nine months of 2021, primarily due to:
the impact of Comirnaty, which includes a charge for the 50% gross profit split with BioNTech and applicable royalty expenses;
increased sales volumes of other products, driven mostly by Pfizer CentreOne; and
the unfavorable impact of foreign exchange and hedging activity on intercompany inventory.
The increase in Cost of sales as a percentage of revenues in the third quarter of 2021, compared to the same period in 2020, was primarily due to all of the factors discussed above, in addition to the unfavorable impact of the voluntary recall and global pause in shipments of Chantix, partially offset by an increase in alliance revenues, which have no associated cost of sales.
The increase in Cost of sales as a percentage of revenues in the first nine months of 2021, compared to the same period in 2020, was primarily due to all of the factors discussed above, partially offset by an increase in alliance revenues, which have no associated cost of sales.
Selling, Informational and Administrative Expenses
SI&A expenses increased $248 million in the third quarter of 2021, mostly due to:
an increase in external, incremental costs directly related to implementing our cost-reduction/productivity initiatives; and
increased product-related spending across multiple therapeutic areas and other costs associated with activity that is closer to pre-pandemic levels as compared to the prior-year quarter.
SI&A expenses increased $759 million in the first nine months of 2021, mostly due to:
increased product-related spending across multiple therapeutic areas and other costs associated with activity that is closer to pre-pandemic levels as compared to the prior-year period;
an increase in external, incremental costs directly related to implementing our cost-reduction/productivity initiatives;
costs related to Comirnaty, driven by a higher provision for healthcare reform fees based on sales;
the unfavorable impact of foreign exchange; and
an increase to expense resulting from the increase in our liability to be paid to participants of our supplemental savings plan,
partially offset by:
lower spending on Chantix following the loss of patent protection in the U.S. in November 2020.
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Research and Development (R&D) Expenses
R&D expenses increased $1.1 billion in the third quarter primarily due to:
an upfront payment related to the global collaboration agreement with Arvinas to develop and commercialize ARV-471; and
increased investments across multiple therapeutic areas, including additional spending related to the development and at-risk manufacturing of the COVID-19 anti-viral programs.
R&D expenses increased $1.9 billion in the first nine months of 2021, primarily due to:
increased investments across multiple therapeutic areas, including additional spending related to the development and at-risk manufacturing of the COVID-19 anti-viral programs;
the upfront payment related to the global collaboration agreement with Arvinas to develop and commercialize ARV-471;
a charge for IPR&D related to an asset acquisition completed in the second quarter of 2021; and
an increase 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,
partially offset by:
the non-recurrence of 2020 upfront payments to Valneva and BioNTech; and
lower spending across the Inflammation & Immunology and Internal medicine portfolios.
Amortization of Intangible Assets
Amortization of intangible assets increased $120 million in the third quarter and $204 million in the first nine months of 2021, primarily as a result of amortization of capitalized Comirnaty sales milestones to BioNTech.
Restructuring Charges and Other Costs Associated with Acquisitions and Cost-Reduction/Productivity Initiatives
Transforming to a More Focused Company Program
For a description of our program, as well as the anticipated and actual costs, see Note 3. The program savings discussed below may be rounded and represent approximations. In connection with restructuring our corporate enabling functions, we expect gross cost savings of $1.0 billion, or net cost savings, excluding merit and inflation growth and certain real estate cost increases, of $700 million to be achieved primarily from 2021 through 2022. In connection with transforming our marketing strategy, we expect net cost savings of $1.3 billion, to be achieved primarily from 2022 through 2024. In connection with manufacturing network optimization, including legacy cost reduction initiatives, we expect net cost savings of $300 million to be achieved primarily from 2020 through 2022.
Certain qualifying costs for this program were recorded in the first three quarters of 2021 and 2020 and are reflected as Certain Significant Items and excluded from our non-GAAP measure of Adjusted Income. See the Non-GAAP Financial Measure: Adjusted Income section of this MD&A.
In addition to this program, 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
Other income—net increased $3.6 billion in the third quarter of 2021, mainly due to:
net periodic benefit credits recorded in the third quarter of 2021 versus net periodic benefit costs recorded in the third quarter of 2020;
the non-recurrence of certain asset impairment charges that were incurred in the third quarter of 2020; and
net gains on equity securities in the third quarter of 2021 versus net losses on equity securities recognized in the third quarter of 2020.
Other income—net increased $4.8 billion in the first nine months of 2021, mainly due to:
net periodic benefit credits recorded in the first nine months of 2021 versus net periodic benefit costs recorded in the first nine months of 2020;
higher net gains on equity securities; and
the non-recurrence of certain asset impairment charges that were incurred in the first nine months of 2020.
See Note 4 for additional information.
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PROVISION/(BENEFIT) FOR TAXES ON INCOME
 Three Months EndedNine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
%
Change
October 3,
2021
September 27,
2020
%
Change
Provision/(benefit) for taxes on income$(331)$(347)(5)$1,518 $434 *
Effective tax rate on continuing operations(4.2)%(60.9)%7.5 %6.7 % 
* Indicates 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, as well as details about discrete elements that impacted our tax provisions, see Note 5.
DISCONTINUED OPERATIONS
For information about our discontinued operations, see Note 2A.
NON-GAAP FINANCIAL MEASURE: ADJUSTED INCOME
Adjusted income is an alternative measure of performance used by management to evaluate our overall performance in conjunction with other performance measures. As such, we believe that investors’ understanding of our performance is enhanced by disclosing this measure. We use Adjusted income, certain components of Adjusted income and Adjusted diluted EPS to present the results of our major operations––the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide––prior to considering certain income statement elements as follows:
MeasureDefinitionIllustrative Use
Adjusted income
Net income attributable to Pfizer Inc. common shareholders(a) before the impact of purchase accounting for acquisitions, acquisition-related items, discontinued operations and certain significant items
Monthly managerial analysis of our operating results and our annual budgets are prepared using these non-GAAP measures
Senior management’s compensation is determined, in part, using these non-GAAP measures(b)
Adjusted cost of sales, Adjusted selling, informational and administrative expenses, Adjusted research and development expenses, Adjusted amortization of intangible assets and Adjusted other (income)/deductions––net
Cost of sales, Selling, informational and administrative expenses, Research and development expenses, Amortization of intangible assets and Other (income)/deductions––net (a), each before the impact of purchase accounting for acquisitions, acquisition-related items, discontinued operations and certain significant items, which are components of the Adjusted income measure
Adjusted diluted EPS
EPS attributable to Pfizer Inc. common shareholders––diluted(a) before the impact of purchase accounting for acquisitions, acquisition-related items, discontinued operations and certain significant items
(a)Most directly comparable GAAP measure.
(b)The short-term incentive plans for substantially all non-sales-force employees worldwide are funded from a pool based on our performance, measured in significant part by three metrics, one of which is Adjusted diluted EPS, which is derived from Adjusted income and accounts for 40% of the bonus pool funding. Additionally, the payout for Performance Share Awards is determined in part by Adjusted net income, which is derived from Adjusted income. Starting with the 2020 performance year and consistent with shareholder feedback received in 2019, the Compensation Committee of the BOD approved adding an R&D pipeline achievement factor to the existing short-term incentive financial metrics.
Adjusted income and its components and Adjusted diluted EPS are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, are limited in their usefulness to investors. Because of their non-standardized definitions, they may not be comparable to the calculation of similar measures of other companies and are presented solely to permit investors to more fully understand how management assesses performance. A limitation of these measures is that they provide a view of our operations without including all events during a period, and do not provide a comparable view of our performance to peers. These measures are not, and should not be viewed as, substitutes for their directly comparable GAAP measures of Net income attributable to Pfizer Inc. common shareholders, components of Net income attributable to Pfizer Inc. common shareholders and EPS attributable to Pfizer Inc. common shareholders—diluted, respectively. See the accompanying reconciliations of certain GAAP reported to non-GAAP adjusted information for the third quarter and first nine months of 2021 and 2020 below.
We also recognize that, as internal measures of performance, these measures have limitations, and we do not restrict our performance-management process solely to these measures. We also use other 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
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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 our incentive compensation plans.
Purchase Accounting Adjustments
Adjusted income excludes certain significant purchase accounting impacts resulting from business combinations and net asset acquisitions. These impacts 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, amortization related to the increase in fair value of acquired debt, and the fair value changes for 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 Items
Adjusted income excludes acquisition-related items, which are comprised of transaction, integration, restructuring charges and additional depreciation costs for business combinations because these costs are unique to each transaction and represent costs that were incurred to restructure and integrate businesses as a result of an acquisition. We have made no adjustments for resulting synergies.
Discontinued Operations
Adjusted income excludes the results of discontinued operations, as well as any related gains or losses on the disposal of such operations. We believe that this presentation is meaningful to investors because, while we review our therapeutic areas and product lines for strategic fit with our operations, we do not build or run our business with the intent to discontinue parts of our business. Restatements due to discontinued operations do not impact compensation or change the Adjusted income measure for the compensation in respect of the restated periods, but are presented for consistency across all periods.

Certain Significant Items
Adjusted income excludes certain significant items representing substantive and/or unusual items that are evaluated individually on a quantitative and qualitative basis. 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, although major non-acquisition-related cost-reduction/productivity programs are specific to an event or goal with a defined term, we may have subsequent programs based on reorganizations of the business, cost-reduction/productivity or in response to LOE 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 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. For a non-inclusive list of certain significant items see Details of Income Statement Items Included in GAAP Reported but Excluded from Non-GAAP Adjusted Income below.
Beginning in 2021, we exclude pension and postretirement actuarial remeasurement gains and losses from our measure of Adjusted income because of their inherent market volatility, which we do not control and cannot predict with any level of certainty and because we do not believe including these gains and losses assists investors in understanding our business or is reflective of our core operations and business.
Also, see the Non-GAAP Financial Measure: Adjusted Income section of the MD&A of our 2020 Form 10-K for additional information.
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Reconciliations of GAAP Reported to Non-GAAP Adjusted Information––Certain Line Items
 Three Months Ended October 3, 2021
(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$24,094 $— $— $— $— $24,094 
Cost of sales9,973 — — (42)9,937 
Selling, informational and administrative expenses2,905 (1)— — (173)2,732 
Research and development expenses3,447 — — (708)2,740 
Amortization of intangible assets981 (813)— — — 169 
Restructuring charges and certain acquisition-related costs646 — (1)— (645)— 
(Gain) on completion of Consumer Healthcare JV transaction — — — — — 
Other (income)/deductions––net(1,696)(47)— — 1,174 (569)
Income from continuing operations before provision/(benefit) for taxes on income7,836 852 — 395 9,084 
Provision/(benefit) for taxes on income(b)
(331)127 — 1,587 1,385 
Income from continuing operations8,167 725 (1)— (1,192)7,699 
Income/(loss) from discontinued operations––net of tax(9)— — — — 
Net income attributable to noncontrolling interests12 — — — — 12 
Net income attributable to Pfizer Inc. common shareholders8,146 725 (1)(1,192)7,687 
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted1.42 0.13 — — (0.21)1.34 
 Nine Months Ended October 3, 2021
(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$57,653 $— $— $— $— $57,653 
Cost of sales21,232 17 — — (138)21,112 
Selling, informational and administrative expenses8,617 (2)— — (432)8,183 
Research and development expenses7,920 — — (899)7,026 
Amortization of intangible assets2,784 (2,338)— — — 446 
Restructuring charges and certain acquisition-related costs668 — (3)— (666)— 
(Gain) on completion of Consumer Healthcare JV transaction
 — — — — — 
Other (income)/deductions––net(3,697)(31)— — 1,984 (1,744)
Income from continuing operations before provision/(benefit) for taxes on income20,128 2,349 — 151 22,631 
Provision/(benefit) for taxes on income(b)
1,518 482 — 1,549 3,551 
Income from continuing operations18,610 1,868 — — (1,398)19,080 
Income/(loss) from discontinued operations––net of tax24 — — (24)— — 
Net income attributable to noncontrolling interests47 — — — — 47 
Net income attributable to Pfizer Inc. common shareholders18,586 1,868 — (24)(1,398)19,033 
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted3.27 0.33 — — (0.25)3.35 
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 Three Months Ended September 27, 2020
(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$10,277 $— $— $— $— $10,277 
Cost of sales2,007 — — (24)1,989 
Selling, informational and administrative expenses2,658 (1)— — (95)2,562 
Research and development expenses2,300 — — (3)2,298 
Amortization of intangible assets862 (789)— — — 73 
Restructuring charges and certain acquisition-related costs2 — (11)— — 
(Gain) on completion of Consumer Healthcare JV transaction — — — — — 
Other (income)/deductions––net1,878 (4)— — (2,271)(397)
Income from continuing operations before provision/(benefit) for taxes on income570 787 11 — 2,384 3,752 
Provision/(benefit) for taxes on income(b)
(347)190 — 596 441 
Income from continuing operations917 596 — 1,789 3,311 
Income/(loss) from discontinued operations––net of tax560 — — (560)— — 
Net income attributable to noncontrolling interests8 — — — — 
Net income attributable to Pfizer Inc. common shareholders1,469 596 (560)1,789 3,303 
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted0.26 0.11 — (0.10)0.32 0.59 
 Nine Months Ended September 27, 2020
(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$30,224 $— $— $— $— $30,224 
Cost of sales5,773 14 — — (86)5,701 
Selling, informational and administrative expenses7,858 (1)— — (318)7,540 
Research and development expenses6,050 — — (242)5,812 
Amortization of intangible assets2,579 (2,365)— — — 214 
Restructuring charges and certain acquisition-related costs417 — (46)— (371)— 
(Gain) on completion of Consumer Healthcare JV transaction(6)— — — — 
Other (income)/deductions––net1,114 (89)— — (2,126)(1,101)
Income from continuing operations before provision/(benefit) for taxes on income6,438 2,437 46 — 3,137 12,057 
Provision/(benefit) for taxes on income(b)
434 546 11 — 719 1,710 
Income from continuing operations6,004 1,891 35 — 2,417 10,347 
Income/(loss) from discontinued operations––net of tax2,334 — — (2,334)— — 
Net income attributable to noncontrolling interests25 — — — — 25 
Net income attributable to Pfizer Inc. common shareholders8,313 1,891 35 (2,334)2,417 10,322 
Earnings per common share attributable to Pfizer Inc. common shareholders––diluted1.48 0.34 0.01 (0.42)0.43 1.84 
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(a)For details of adjustments, see Details of Income Statement Items Included in GAAP Reported but Excluded from Non-GAAP Adjusted Income.
(b)The effective tax rate on Non-GAAP Adjusted income was 15.3% in the third quarter of 2021, compared to 11.8% in the third quarter of 2020. The effective tax rate on Non-GAAP Adjusted income was 15.7% in the first nine months of 2021, compared to 14.2% in the first nine months of 2020. The increases were due to a change in the jurisdictional mix of earnings, primarily related to Comirnaty.
Details of Income Statement Items Included in GAAP Reported but Excluded from Non-GAAP Adjusted Income
Three Months EndedNine Months Ended
(MILLIONS)Oct. 3, 2021Sept. 27, 2020Oct. 3, 2021Sept. 27, 2020
Purchase accounting adjustments  
Amortization, depreciation and other(a)
$859 $792 $2,367 $2,451 
Cost of sales
(6)(5)(17)(14)
Total purchase accounting adjustments––pre-tax852 787 2,349 2,437 
Income taxes(b)
(127)(190)(482)(546)
Total purchase accounting adjustments––net of tax725 596 1,868 1,891 
Acquisition-related items   
Restructuring charges/(credits)(c)
(2)(9)
Transaction costs(c)
— — — 14 
Integration costs and other(c)
11 29 
Total acquisition-related items––pre-tax11 46 
Income taxes(b)
(2)(3)(3)(11)
Total acquisition-related items––net of tax(1)— 35 
Discontinued operations   
Income/(loss) from discontinued operations––net of tax(d)
(560)(24)(2,334)
Certain significant items   
Restructuring charges/(credits)––cost reduction initiatives(e)
645 (9)666 371 
Implementation costs and additional depreciation––asset restructuring(f)
181 50 403 153 
Net (gains)/losses on asset disposals(g)
— (57)— 
Net (gains)/losses recognized during the period on equity securities(g)
(400)73 (1,597)(429)
Certain legal matters, net(g)
64 (17)438 
Certain asset impairments(g)
— 900 — 900 
Business and legal entity alignment costs(h)
31 63 156 212 
Actuarial valuation and other pension and postretirement plan (gains)/losses(i)
(899)1,230 (932)1,306 
(Gain) on completion of Consumer Healthcare JV transaction(j)
— — — (6)
Other(k)
772 94 1,075 624 
Total certain significant items––pre-tax395 2,384 151 3,137 
Income taxes(l)
(1,587)(596)(1,549)(719)
Total certain significant items––net of tax(1,192)1,789 (1,398)2,417 
Total purchase accounting adjustments, acquisition-related items, discontinued operations and certain significant items––net of tax, attributable to Pfizer Inc.$(460)$1,834 $446 $2,009 
(a)Included primarily in Amortization of intangible assets.
(b)Included in Provision/(benefit) for taxes on income. Includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying the applicable tax rate.
(c)Included in Restructuring charges and certain acquisition-related costs. See Note 3.
(d)Included in Income/(loss) from discontinued operations––net of tax. See Note 2A.
(e)Includes 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 Note 3.
(f)Relates to our cost-reduction and productivity initiatives not related to acquisitions (see Note 3). For the third quarter of 2021, primarily included in Cost of sales ($31 million) and Selling, informational and administrative expenses ($150 million). For the first nine months of 2021, primarily included in Cost of sales ($93 million) and Selling, informational and administrative expenses ($310 million). For the third quarter of 2020, primarily included in Cost of sales ($13 million) and Selling, informational and administrative expenses ($36 million). For the first nine months of 2020, primarily included in Cost of sales ($40 million) and Selling, informational and administrative expenses ($114 million).
(g)Included in Other (income)/deductionsnet. See Note 4.
(h)Mainly represents costs for consulting, legal, tax and advisory services associated with the internal reorganization of legal entities. For the third quarter of 2021, primarily included in Cost of sales ($11 million) and Selling, informational and administrative expenses ($20 million), and for the first nine months of 2021, primarily included in Cost of sales ($43 million) and Selling, informational and administrative expenses ($107 million). For the third quarter of 2020, primarily included in Cost of sales ($12 million) and Selling, informational and administrative expenses ($50 million), and for the first nine months of 2020, primarily included in Cost of sales ($42 million), Selling, informational and administrative expenses ($157 million) and Research and development expenses ($13 million).
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(i)Included in Other (income)/deductions––net. Primarily includes pension plan interim actuarial remeasurement pre-tax gains of $836 million in the third quarter of 2021 and $881 million in the first nine months of 2021, and pension plan interim actuarial remeasurement pre-tax losses of $1.2 billion in the third quarter of 2020 and $1.3 billion in the first nine months of 2020. See Note 1C.
(j)Included in (Gain) on completion of Consumer Healthcare JV transaction. See Note 2B.
(k)For the third quarter of 2021, primarily included in Research and development expenses ($707 million) and Other (income)/deductions––net ($61 million). For the first nine months of 2021, primarily included in Selling, informational and administrative expenses ($15 million), Research and development expenses ($892 million) and Other (income)/deductions––net ($165 million). For the third quarter of 2020, primarily included in Other (income)/deductions––net ($86 million). For the first nine months of 2020, primarily included in Selling, informational and administrative expenses ($46 million), Research and development expenses ($231 million) and Other (income)/deductions––net ($343 million). Among other things, the third quarter and first nine months of 2021 include an upfront payment of $650 million to Arvinas, which was recorded to Research and development expenses, and the first nine months of 2021 include a charge of $186 million for IPR&D related to an asset acquisition completed in the second quarter of 2021. Also, the third quarter of 2021 includes charges of $55 million and the first nine months of 2021 include charges of $136 million recorded in Other (income)/deductions––net, primarily representing our pro rata share of accounting charges related to restructuring costs and costs of preparing for separation from GSK that were recorded by the Consumer Healthcare JV. Among other things, the first nine months of 2020 included (i) charges of $297 million recorded in Other (income)/deductions––net, primarily representing our pro rata share of restructuring and business combination accounting charges recorded by the Consumer Healthcare JV, partially offset by gains from the divestiture of certain of the JV’s brands recorded by the Consumer Healthcare JV, and our write-off and amortization of equity method basis differences primarily related to those brand divestitures and to inventory and (ii) upfront payments of $130 million to Valneva and $72 million to BioNTech, which were recorded to Research and development expenses.
(l)Included in Provision/(benefit) for taxes on income. Includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying the applicable tax rate. The third quarter and first nine months of 2021 were favorably impacted by benefits associated with certain initiatives executed in the third quarter of 2021 associated with our investment in the Consumer Healthcare JV with GSK (see Note 5A). The third quarter and first nine months of 2020 were favorably impacted by benefits associated with certain intangible asset impairment charges (see Note 4).
ANALYSIS OF THE CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Cash Flows from Continuing Operations
 Nine Months Ended
(MILLIONS)October 3,
2021
September 27,
2020
Drivers of change
Cash provided by/(used in):
Operating activities from continuing operations$26,660 $6,364 
The change is driven primarily by higher net income and advance payments in 2021 for Comirnaty recorded in deferred revenue and the impact of timing of receipts and payments in the ordinary course of business, including a $7.8 billion accrual for the gross profit split due to BioNTech, partially offset by a non-cash change in Other Adjustments, net, primarily resulting from an increase in unrealized gains on equity securities.
Investing activities from continuing operations$(19,960)$(1,129)
The change is driven mainly by a $17.0 billion increase in purchases of short-term investments with original maturities of greater than three months and a $7.8 billion increase in net purchases of short-term investments with original maturities of three months or less, partially offset by a $7.5 billion increase in redemptions of short-term investments with original maturities of greater than three months.
Financing activities from continuing operations$(6,465)$(7,257)
The change is driven mostly by a $5.1 billion net reduction in repayments of short-term borrowings with maturities of greater than three months and a $1.5 billion reduction in repayments of long-term debt, partially offset by a $4.2 billion decrease in proceeds from issuances of long-term debt and a $1.4 billion net decrease in proceeds from short-term borrowings with maturities of three months or less.
Cash Flows from Discontinued Operations
Cash flows from discontinued operations primarily relate to our former Upjohn Business and the Mylan-Japan collaboration (see Note 2A). In 2020, investing and financing activities from discontinued operations primarily reflect investments in money market funds with proceeds from issuances of long-term debt.
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ANALYSIS OF FINANCIAL CONDITION, LIQUIDITY, CAPITAL RESOURCES AND MARKET RISK

We rely largely on operating cash flows, short-term investments or commercial paper borrowings and long-term debt to provide for our liquidity requirements. We strive to improve cash inflows through working capital efficiencies. 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. We have taken and will continue to take a conservative approach to our financial investments and monitoring of our liquidity position in response to market changes. Our debt investments consist primarily of high-quality, highly liquid, well-diversified available-for-sale debt securities.

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 October 3, 2021, we had access to a $7 billion U.S. revolving credit facility expiring in 2025. In addition, our lenders have provided us an additional $377 million in lines of credit, of which $336 million expire within one year. Essentially all lines of credit were unused as of October 3, 2021.
Selected Measures of Liquidity and Capital Resources
The following presents certain relevant measures of our liquidity and capital resources:
(MILLIONS, EXCEPT RATIOS)October 3,
2021
December 31, 2020
Selected financial assets(a):
  
Cash and cash equivalents$1,966 $1,784 
Short-term investments27,730 10,437 
Long-term investments, excluding private equity securities at cost4,632 2,973 
 34,328 15,195 
Debt:  
Short-term borrowings, including current portion of long-term debt3,629 2,703 
Long-term debt36,250 37,133 
 39,878 39,835 
Selected net financial liabilities$(5,551)$(24,641)
Working capital(b)
$16,097 $9,147 
Ratio of current assets to current liabilities1.39:11.35:1
(a)See Note 7 for a description of certain assets held and for a description of credit risk related to our financial instruments held.
(b)The increase in working capital was primarily driven by an increase in short-term investments due to operating cash flow generation, partially offset by the timing of accruals, cash receipts and payments in the ordinary course of business and capital expenditures.
In August 2021, we completed a public offering of $1 billion aggregate principal amount of senior unsecured sustainability notes. We are using the net proceeds to finance or refinance, in whole or in part as follows: R&D expenses related to our COVID-19 vaccine, capital expenditures in connection with the manufacture and distribution of COVID-19 vaccines and other projects that have environmental and/or social benefits. For additional information, see Note 7D.
For information about the sources and uses of our funds, see the Analysis of the Condensed Consolidated Statements of Cash Flows section within MD&A.
For information about credit ratings, LIBOR, global economic conditions, and market risk, see the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk—Selected Measures of Liquidity and Capital Resources section within MD&A in our 2020 Form 10-K.
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 the transaction or that are related to events and activities. For more information on guarantees and indemnifications, see Note 12B.
Additionally, 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.
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Share-Purchase Plans and Accelerated Share Repurchase Agreements
At October 3, 2021, our remaining share-purchase authorization was approximately $5.3 billion, with no repurchases in the first nine months of 2021. See Note 12 in our 2020 Form 10-K for more information on our publicly announced share-purchase plans.
Dividends on Common Stock
In September 2021, our BOD declared a dividend of $0.39 per share, payable on December 6, 2021, to shareholders of record at the close of business on November 5, 2021. Our current and projected dividends provide a return to shareholders while maintaining sufficient capital to invest in growing our business. Our dividends are not restricted by debt covenants. While the dividend level remains a decision of Pfizer’s BOD and will continue to be evaluated in the context of future business performance, we currently believe that we can support future annual dividend increases, barring significant unforeseen events.
NEW ACCOUNTING STANDARDS
Recently Adopted Accounting Standard
See Note 1B.
Recently Issued Accounting Standard, Not Adopted as of October 3, 2021
Standard/DescriptionEffective DateEffect on the Financial Statements
Reference rate reform provides temporary optional expedients and exceptions to the guidance for contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued after 2021 because of reference rate reform.
The new guidance provides the following optional expedients:
1.Simplify accounting analyses under current U.S. GAAP for contract modifications.
2.Simplify the assessment of hedge effectiveness and allow hedging relationships affected by reference rate reform to continue.
3.Allow a one-time election to sell or transfer debt securities classified as held to maturity that reference a rate affected by reference rate reform.
Elections can be adopted prospectively at any time through December 31, 2022.We are assessing the impact of the provisions of this new guidance on our consolidated financial statements.
Accounting for contract assets and contract liabilities from contracts with customers requires contract assets and contract liabilities acquired in a business combination to be recognized and measured by the acquirer on the acquisition date in accordance with ASC 606. This new guidance will generally result in the acquirer recognizing contract assets and contract liabilities at the same amounts that were recorded by the acquiree. Previously, these amounts were recognized by the acquirer at fair value as of the acquisition date.
January 1, 2023. Early adoption is permitted.We do not expect this new guidance to have a material impact on our consolidated financial statements.
FORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTS
This Form 10-Q contains forward-looking statements. We also provide forward-looking statements in other materials we release to the public, as well as public oral statements. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions.
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,” “seek” and other words and terms of similar meaning or by using future dates.
We include forward-looking information in our discussion of the following, among other topics:
our anticipated operating and financial performance, reorganizations, 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, clinical trial results and other developing data, revenue contribution, growth, performance, timing of exclusivity and potential benefits;
strategic reviews, capital allocation objectives, dividends and share repurchases;
plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities;
sales, expenses, interest rates, foreign exchange rates and the outcome of contingencies, such as legal proceedings;
expectations for impact of or changes to existing or new government regulations or laws;
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our ability to anticipate and respond to macroeconomic, geopolitical, health and industry trends, pandemics, acts of war and other large-scale crises; and
manufacturing and product supply.
In particular, forward-looking information in this Form 10-Q includes statements relating to specific future actions and effects, including, among others, our efforts to respond to COVID-19, including our development of a vaccine to help prevent COVID-19 and our investigational protease inhibitors, the forecasted revenue contribution of Comirnaty and the potential number of doses that we and BioNTech believe can be manufactured; our expectations regarding the impact of COVID-19 on our business; the expected impact of patent expiries and competition from generic manufacturers; the benefits expected from our business development transactions; our anticipated liquidity position; the anticipated costs and savings from certain of our initiatives, including our Transforming to a More Focused Company program; anticipated study starts; our planned capital spending; and the expectations for our quarterly dividend payments.
Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. Actual outcomes may vary materially from past results and those anticipated, estimated, implied or projected. These forward-looking statements may be affected by underlying assumptions that may prove inaccurate or incomplete, or by known or unknown risks and uncertainties, including those described in this section and in the Item 1A. Risk Factors section in our 2020 Form 10-K.
Therefore, you are cautioned not to unduly rely on forward-looking statements, which speak only as of the date of this Form 10-Q. We undertake no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. You are advised, however, to consult any further disclosures we make on related subjects.
Some of the factors that could cause actual results to differ are identified below, as well as those discussed in the Item 1A. Risk Factors section in our 2020 Form 10-K and within this MD&A. We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. The occurrence of any of the risks identified below or in the Item 1A. Risk Factors section in our 2020 Form 10-K, or other risks currently unknown, could have a material adverse effect on our business, financial condition or results of operations, or we may be required to increase our accruals for contingencies. It is not possible to predict or identify all such factors. Consequently, you should not consider the following to be a complete discussion of all potential risks or uncertainties:
Risks Related to Our Business, Industry and Operations, and Business Development:
the outcome of R&D activities, including, the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, and/or regulatory approval and/or launch dates; the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data; the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; and whether and when additional data from our pipeline programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations;
our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA, or obtain approval for new products and indications from regulators on a timely basis or at all; regulatory decisions impacting labeling including the scope of indicated patient populations, product dosage, manufacturing processes, safety and/or other matters, including decisions relating to emerging developments regarding potential product impurities; the impact of recommendations by technical or advisory committees; and the timing of pricing approvals and product launches;
claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the outcome of post-approval clinical trials, which could impact marketing approval, product labeling, and/or availability or commercial potential, including uncertainties regarding the commercial or other impact of the results of the Xeljanz ORAL Surveillance (A3921133) study or any potential actions by regulatory authorities based on analysis of ORAL Surveillance or other data, including on other Janus kinase (JAK) inhibitors in our portfolio;
the success and impact 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 in the anticipated time frame or at all; the potential need for and impact of additional equity or debt financing to pursue these opportunities, which could result in increased leverage and/or a downgrade of our credit ratings; challenges integrating the businesses and operations; disruption to business and operations relationships; risks related to growing revenues for certain acquired products; significant transaction costs; and unknown liabilities;
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competition, including from 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 products and product candidates;
the ability to successfully market both new and existing products, including biosimilars;
difficulties or delays in manufacturing, sales or marketing; supply disruptions, shortages or stock-outs at our or our third party suppliers’ facilities; and legal or regulatory actions;
the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic), including the impact of vaccine mandates where applicable, on our business, operations and financial condition and results, including impacts on our employees, manufacturing, supply chain, sales and marketing, R&D and clinical trials;
risks and uncertainties related to our efforts to develop a vaccine to help prevent COVID-19 and potential treatments for COVID-19, as well as challenges related to their manufacturing, supply and distribution;
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;
interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates;
any significant issues involving our largest wholesale distributors or government customers, which account for a substantial portion of our revenues;
the impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain;
any significant issues related to the outsourcing of certain operational and staff functions to third parties; and any significant issues related to our JVs and other third-party business arrangements;
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;
any changes in business, political and economic conditions due to actual or threatened terrorist activity, civil unrest or military action;
the impact of product recalls, withdrawals and other unusual items, including uncertainties related to regulator-directed risk evaluations and assessments;
trade buying patterns;
the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments;
the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, 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;
Risks Related to Government Regulation and Legal Proceedings:
the impact of any U.S. healthcare reform or legislation or 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;
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 or restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals and other industry stakeholders; as well as pricing pressures for our products as a result of highly competitive insurance markets;
legislation or regulatory action in markets outside of 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 globally 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;
legal defense costs, insurance expenses, settlement costs and contingencies, including those related to actual or alleged environmental contamination;
the risk and impact of an adverse decision or settlement and the adequacy of reserves related to legal proceedings;
the risk and impact of tax related litigation;
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governmental laws and regulations affecting our operations, including, without limitation, changes in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations, including, among others, any potential changes to the existing tax law by the current U.S. Presidential administration and Congress increasing the corporate tax rate and/or the tax rate on foreign earnings;
Risks Related to Intellectual Property, Technology and Security:
any significant breakdown or interruption of our information technology systems and infrastructure;
any business disruption, theft of confidential or proprietary information, extortion or integrity compromise resulting from a cyberattack;
the risk that our currently pending or future patent applications may not be granted on a timely basis or at all, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; and
our ability to protect our patents and other intellectual property, including against claims of invalidity that could result in LOE, unasserted intellectual property claims and in response to any pressure, or legal or regulatory action by, various stakeholders or governments that could potentially result in us not seeking intellectual property protection for or agreeing not to enforce or being restricted from enforcing intellectual property related to our products, including our vaccine to help prevent COVID-19 and potential treatments for COVID-19.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Information required by this item is incorporated by reference from the discussion in the Analysis of Financial Condition, Liquidity, Capital Resources and Market Risk—Selected Measures of Liquidity and Capital Resources—Market Risk section within MD&A of our 2020 Form 10-K.
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

Certain legal proceedings in which we are involved are discussed in Note 12A.
ITEM 1A. RISK FACTORS
We refer to the “Our Operating Environment”, “The Global Economic Environment”, “COVID-19 Pandemic” and “Forward-Looking Information and Factors That May Affect Future Results” sections of the MD&A of this Form 10-Q and to Part I, Item 1A, “Risk Factors” of our 2020 Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

The following summarizes purchases of our common stock during the third quarter of 2021:
Period
Total Number of
Shares Purchased(a)
Average Price
Paid per Share(a)
Total Number of Shares Purchased as Part of Publicly Announced Plan
Approximate Value of Shares That May Yet Be Purchased Under the Plan(b)
July 5 through August 1, 2021
2,792 $39.78 — $5,292,881,709 
August 2 through August 29, 2021
40,687 $43.01 — $5,292,881,709 
August 30 through October 3, 2021
24,743 $45.01 — $5,292,881,709 
Total68,222 $43.60 — 
(a)Represents (i) 65,860 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 2,362 shares of common stock in connection with the reinvestment of dividends paid on common stock held in trust for employees who deferred receipt of performance share awards.
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(b)See Note 12 in our 2020 Form 10-K.
ITEM 6. EXHIBITS
 -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.INSXBRL 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.
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 12, 2021/s/ Jennifer B. Damico
 Jennifer B. Damico, Senior Vice President and
Controller
(Principal Accounting Officer and
Duly Authorized Officer)
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