PFIZER INC - Quarter Report: 2021 April (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 April 4, 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)
Delaware | 13-5315170 | ||||
(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 class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Common Stock, $.05 par value | PFE | New York Stock Exchange | ||||||||||||
0.250% Notes due 2022 | PFE22 | New York Stock Exchange | ||||||||||||
1.000% Notes due 2027 | PFE27 | New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes | x | No | ☐ |
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes | x | No | ☐ |
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).
Yes | ☐ | No | x |
At May 10, 2021, 5,597,693,867 shares of the issuer’s voting common stock were outstanding.
TABLE OF CONTENTS |
Page | |||||
Condensed Consolidated Balance Sheets | |||||
Item 2. | |||||
Item 3. | |||||
Defaults Upon Senior Securities | N/A | ||||
Item 4. | |||||
Mine Safety Disclosures | N/A | ||||
Item 5. | |||||
Other Information | N/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. 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-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2020 | ||||
ACIP | Advisory Committee on Immunization Practices | ||||
ALK | anaplastic lymphoma kinase | ||||
Alliance revenues | Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us | ||||
Allogene | Allogene Therapeutics, Inc. | ||||
AML | Acute Myeloid Leukemia | ||||
Array | Array BioPharma Inc. | ||||
Astellas | Astellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc. | ||||
ATTR-CM | transthyretin amyloid cardiomyopathy | ||||
BioNTech | BioNTech SE | ||||
BLA | Biologics License Application | ||||
BMS | Bristol-Myers Squibb Company | ||||
BNT162b2 | Pfizer-BioNTech COVID-19 Vaccine | ||||
BOD | Board of Directors | ||||
CDC | U.S. Centers for Disease Control and Prevention | ||||
CMA | conditional marketing authorization | ||||
Consumer Healthcare JV | GSK Consumer Healthcare JV | ||||
COVID-19 | novel coronavirus disease of 2019 | ||||
Developed Europe | Includes the following markets: Western Europe, Scandinavian countries and Finland | ||||
Developed Markets | Includes the following markets: U.S., Developed Europe, Japan, Canada, Australia, South Korea and New Zealand | ||||
Developed Rest of World | Includes the following markets: Japan, Canada, Australia, South Korea and New Zealand | ||||
EMA | European Medicines Agency | ||||
Emerging Markets | Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Eastern Europe, Latin America, Central Europe, the Middle East, Africa and Turkey | ||||
EPS | earnings per share | ||||
EU | European Union | ||||
EUA | emergency use authorization | ||||
Exchange Act | Securities Exchange Act of 1934, as amended | ||||
FDA | U.S. Food and Drug Administration | ||||
Form 10-Q | Quarterly Report on Form 10-Q for the quarterly period ended April 4, 2021 | ||||
GAAP | Generally Accepted Accounting Principles | ||||
GIST | gastrointestinal stromal tumors | ||||
GSK | GlaxoSmithKline plc | ||||
Hospira | Hospira, Inc. | ||||
IPR&D | in-process research and development | ||||
IRS | U.S. Internal Revenue Service | ||||
JV | joint venture | ||||
King | King Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.) | ||||
LIBOR | London Interbank Offered Rate | ||||
Lilly | Eli Lilly & Company | ||||
LOE | loss of exclusivity | ||||
MCO | managed care organization | ||||
mCRC | metastatic colorectal cancer | ||||
mCRPC | metastatic castration-resistant prostate cancer | ||||
mCSPC | metastatic castration-sensitive prostate cancer | ||||
MD&A | Management’s Discussion and Analysis of Financial Condition and Results of Operations | ||||
Meridian | Meridian Medical Technologies, Inc. | ||||
MTM | mark-to-market | ||||
Mylan | Mylan N.V. |
3
Mylan-Japan collaboration | a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan that terminated on December 21, 2020 | ||||
Myovant | Myovant Sciences Ltd. | ||||
nmCRPC | non-metastatic castration-resistant prostate cancer | ||||
NSCLC | non-small cell lung cancer | ||||
OPKO | OPKO Health, Inc. | ||||
OTC | over-the-counter | ||||
PBM | pharmacy benefit manager | ||||
PGS | Pfizer Global Supply | ||||
Pharmacia | Pharmacia Corporation | ||||
PsA | psoriatic arthritis | ||||
RA | rheumatoid arthritis | ||||
RCC | renal cell carcinoma | ||||
R&D | research and development | ||||
Sandoz | Sandoz, Inc., a division of Novartis AG | ||||
SEC | U.S. Securities and Exchange Commission | ||||
SI&A | selling, informational and administrative | ||||
UC | ulcerative colitis | ||||
U.K. | United Kingdom | ||||
U.S. | United States | ||||
Upjohn Business | Pfizer’s global, primarily off-patent branded and generics business, which includes 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 | ||||
Viatris | Viatris Inc. |
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 Ended | ||||||||||||||
(MILLIONS, EXCEPT PER COMMON SHARE DATA) | April 4, 2021 | March 29, 2020 | ||||||||||||
Revenues | $ | 14,582 | $ | 10,083 | ||||||||||
Costs and expenses: | ||||||||||||||
Cost of sales(a) | 4,211 | 1,940 | ||||||||||||
Selling, informational and administrative expenses(a) | 2,783 | 2,541 | ||||||||||||
Research and development expenses(a) | 2,014 | 1,672 | ||||||||||||
Amortization of intangible assets | 872 | 849 | ||||||||||||
Restructuring charges and certain acquisition-related costs | 23 | 54 | ||||||||||||
(Gain) on completion of Consumer Healthcare JV transaction | — | (6) | ||||||||||||
Other (income)/deductions––net | (1,004) | 190 | ||||||||||||
Income from continuing operations before provision for taxes on income | 5,683 | 2,842 | ||||||||||||
Provision for taxes on income | 805 | 359 | ||||||||||||
Income from continuing operations | 4,877 | 2,483 | ||||||||||||
Income from discontinued operations––net of tax | 9 | 881 | ||||||||||||
Net income before allocation to noncontrolling interests | 4,886 | 3,364 | ||||||||||||
Less: Net income attributable to noncontrolling interests | 9 | 9 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 4,877 | $ | 3,355 | ||||||||||
Earnings per common share––basic: | ||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.87 | $ | 0.45 | ||||||||||
Income from discontinued operations––net of tax | — | 0.16 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.87 | $ | 0.60 | ||||||||||
Earnings per common share––diluted: | ||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.86 | $ | 0.44 | ||||||||||
Income from discontinued operations––net of tax | — | 0.16 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.86 | $ | 0.60 | ||||||||||
Weighted-average shares––basic | 5,584 | 5,545 | ||||||||||||
Weighted-average shares––diluted | 5,662 | 5,613 |
(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 Ended | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
Net income before allocation to noncontrolling interests | $ | 4,886 | $ | 3,364 | ||||||||||
Foreign currency translation adjustments, net | 465 | (1,256) | ||||||||||||
Unrealized holding gains/(losses) on derivative financial instruments, net | 214 | (501) | ||||||||||||
Reclassification adjustments for (gains)/losses included in net income(a) | 259 | 19 | ||||||||||||
473 | (482) | |||||||||||||
Unrealized holding gains/(losses) on available-for-sale securities, net | 79 | (51) | ||||||||||||
Reclassification adjustments for (gains)/losses included in net income(b) | (242) | 15 | ||||||||||||
(163) | (36) | |||||||||||||
Reclassification adjustments related to amortization of prior service costs and other, net | (40) | (45) | ||||||||||||
Other | (3) | (1) | ||||||||||||
(43) | (45) | |||||||||||||
Other comprehensive income/(loss), before tax | 732 | (1,821) | ||||||||||||
Tax provision/(benefit) on other comprehensive income/(loss) | 84 | (380) | ||||||||||||
Other comprehensive income/(loss) before allocation to noncontrolling interests | $ | 647 | $ | (1,441) | ||||||||||
Comprehensive income/(loss) before allocation to noncontrolling interests | $ | 5,533 | $ | 1,923 | ||||||||||
Less: Comprehensive income/(loss) attributable to noncontrolling interests | 10 | 9 | ||||||||||||
Comprehensive income/(loss) attributable to Pfizer Inc. | $ | 5,523 | $ | 1,914 |
(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) | April 4, 2021 | December 31, 2020 | ||||||||||||
(Unaudited) | ||||||||||||||
Assets | ||||||||||||||
Cash and cash equivalents | $ | 1,768 | $ | 1,784 | ||||||||||
Short-term investments | 11,899 | 10,437 | ||||||||||||
Trade accounts receivable, less allowance for doubtful accounts: 2021—$512; 2020—$508 | 9,864 | 7,930 | ||||||||||||
Inventories | 8,493 | 8,046 | ||||||||||||
Current tax assets | 3,419 | 3,264 | ||||||||||||
Other current assets | 4,091 | 3,605 | ||||||||||||
Total current assets | 39,533 | 35,067 | ||||||||||||
Equity-method investments | 16,532 | 16,856 | ||||||||||||
Long-term investments | 3,696 | 3,406 | ||||||||||||
Property, plant and equipment, less accumulated depreciation: 2021—$15,105; 2020—$14,812 | 14,011 | 13,900 | ||||||||||||
Identifiable intangible assets | 27,974 | 28,471 | ||||||||||||
Goodwill | 49,791 | 49,577 | ||||||||||||
Noncurrent deferred tax assets and other noncurrent tax assets | 2,537 | 2,383 | ||||||||||||
Other noncurrent assets | 4,744 | 4,569 | ||||||||||||
Total assets | $ | 158,818 | $ | 154,229 | ||||||||||
Liabilities and Equity | ||||||||||||||
Short-term borrowings, including current portion of long-term debt: 2021—$3,676; 2020—$2,002 | $ | 4,352 | $ | 2,703 | ||||||||||
Trade accounts payable | 4,064 | 4,309 | ||||||||||||
Dividends payable | — | 2,162 | ||||||||||||
Income taxes payable | 1,401 | 1,049 | ||||||||||||
Accrued compensation and related items | 1,985 | 3,058 | ||||||||||||
Deferred revenues | 2,052 | 1,113 | ||||||||||||
Other current liabilities | 12,798 | 11,527 | ||||||||||||
Total current liabilities | 26,652 | 25,920 | ||||||||||||
Long-term debt | 35,347 | 37,133 | ||||||||||||
Pension benefit obligations | 4,526 | 4,766 | ||||||||||||
Postretirement benefit obligations | 635 | 645 | ||||||||||||
Noncurrent deferred tax liabilities | 4,355 | 4,063 | ||||||||||||
Other taxes payable | 11,759 | 11,560 | ||||||||||||
Other noncurrent liabilities | 6,677 | 6,669 | ||||||||||||
Total liabilities | 89,953 | 90,756 | ||||||||||||
Commitments and Contingencies | ||||||||||||||
Common stock | 472 | 470 | ||||||||||||
Additional paid-in capital | 89,002 | 88,674 | ||||||||||||
Treasury stock | (111,349) | (110,988) | ||||||||||||
Retained earnings | 95,158 | 90,392 | ||||||||||||
Accumulated other comprehensive loss | (4,664) | (5,310) | ||||||||||||
Total Pfizer Inc. shareholders’ equity | 68,620 | 63,238 | ||||||||||||
Equity attributable to noncontrolling interests | 245 | 235 | ||||||||||||
Total equity | 68,865 | 63,473 | ||||||||||||
Total liabilities and equity | $ | 158,818 | $ | 154,229 |
See Accompanying Notes.
7
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF EQUITY
(UNAUDITED)
PFIZER INC. SHAREHOLDERS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred Stock | Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(MILLIONS, EXCEPT PREFERRED SHARES) | Shares | Stated Value | Shares | Par Value | Add’l Paid-In Capital | Shares | Cost | Retained Earnings | Accum. Other Comp. Loss | Share- holders’ Equity | Non-controlling interests | Total Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, January 1, 2021 | — | $ | — | 9,407 | $ | 470 | $ | 88,674 | (3,840) | $ | (110,988) | $ | 90,392 | $ | (5,310) | $ | 63,238 | $ | 235 | $ | 63,473 | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net income | 4,877 | 4,877 | 9 | 4,886 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income/(loss), net of tax | 646 | 646 | 1 | 647 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cash dividends declared, per share: $— | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Common stock | (84) | (84) | (84) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred stock | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Noncontrolling interests | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payment transactions | 38 | 2 | 329 | (11) | (361) | (30) | (30) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Purchases of common stock | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred stock conversions and redemptions | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other | — | — | — | (27) | (27) | — | (27) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, April 4, 2021 | — | $ | — | 9,445 | $ | 472 | $ | 89,002 | (3,851) | $ | (111,349) | $ | 95,158 | $ | (4,664) | $ | 68,620 | $ | 245 | $ | 68,865 | |||||||||||||||||||||||||||||||||||||||||||||||||||||
PFIZER INC. SHAREHOLDERS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred Stock | Common Stock | Treasury Stock | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(MILLIONS, EXCEPT PREFERRED SHARES) | Shares | Stated Value | Shares | Par Value | Add’l Paid-In Capital | Shares | Cost | Retained Earnings | Accum. Other Comp. Loss | Share- holders’ Equity | Non-controlling interests | Total Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, January 1, 2020 | 431 | $ | 17 | 9,369 | $ | 468 | $ | 87,428 | (3,835) | $ | (110,801) | $ | 91,397 | $ | (5,367) | $ | 63,143 | $ | 303 | $ | 63,447 | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net income | 3,355 | 3,355 | 9 | 3,364 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income/(loss), net of tax | (1,441) | (1,441) | — | (1,441) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cash dividends declared, per share: $— | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Common stock | (71) | (71) | (71) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred stock | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Noncontrolling interests | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based payment transactions | 23 | 1 | 252 | (6) | (209) | 44 | 44 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Purchases of common stock | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Preferred stock conversions and redemptions | (14) | (1) | (1) | — | — | (1) | (1) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance, March 29, 2020 | 417 | $ | 17 | 9,393 | $ | 470 | $ | 87,680 | (3,841) | $ | (111,010) | $ | 94,680 | $ | (6,808) | $ | 65,028 | $ | 312 | $ | 65,341 | |||||||||||||||||||||||||||||||||||||||||||||||||||||
See Accompanying Notes.
8
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Three Months Ended | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
Operating Activities | ||||||||||||||
Net income before allocation to noncontrolling interests | $ | 4,886 | $ | 3,364 | ||||||||||
Income from discontinued operations—net of tax | 9 | 881 | ||||||||||||
Net income from continuing operations before allocation to noncontrolling interests | 4,877 | 2,483 | ||||||||||||
Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities: | ||||||||||||||
Depreciation and amortization | 1,226 | 1,166 | ||||||||||||
Asset write-offs and impairments | 46 | 44 | ||||||||||||
Gain on completion of Consumer Healthcare JV transaction, net of cash conveyed | — | (6) | ||||||||||||
Deferred taxes from continuing operations | 199 | 82 | ||||||||||||
Share-based compensation expense | 172 | 57 | ||||||||||||
Benefit plan contributions in excess of expense/income | (373) | (276) | ||||||||||||
Other adjustments, net | (291) | 120 | ||||||||||||
Other changes in assets and liabilities, net of acquisitions and divestitures | (1,327) | (1,515) | ||||||||||||
Net cash provided by operating activities from continuing operations | 4,530 | 2,155 | ||||||||||||
Net cash provided by operating activities from discontinued operations | 9 | 978 | ||||||||||||
Net cash provided by operating activities | 4,538 | 3,133 | ||||||||||||
Investing Activities | ||||||||||||||
Purchases of property, plant and equipment | (554) | (449) | ||||||||||||
Purchases of short-term investments | (6,054) | (2,551) | ||||||||||||
Proceeds from redemptions/sales of short-term investments | 5,465 | 3,257 | ||||||||||||
Net (purchases of)/proceeds from redemptions/sales of short-term investments with original maturities of three months or less | (996) | (416) | ||||||||||||
Purchases of long-term investments | (27) | (22) | ||||||||||||
Proceeds from redemptions/sales of long-term investments | 256 | 152 | ||||||||||||
Other investing activities, net | 163 | (24) | ||||||||||||
Net cash provided by/(used in) investing activities from continuing operations | (1,747) | (53) | ||||||||||||
Net cash provided by/(used in) investing activities from discontinued operations | — | (19) | ||||||||||||
Net cash provided by/(used in) investing activities | (1,747) | (71) | ||||||||||||
Financing Activities | ||||||||||||||
Proceeds from short-term borrowings | — | 5,302 | ||||||||||||
Principal payments on short-term borrowings | — | (7,551) | ||||||||||||
Net (payments on)/proceeds from short-term borrowings with original maturities of three months or less | (25) | 3,207 | ||||||||||||
Proceeds from issuance of long-term debt | — | 1,241 | ||||||||||||
Principal payments on long-term debt | — | (2,181) | ||||||||||||
Cash dividends paid | (2,172) | (2,105) | ||||||||||||
Other financing activities, net | (610) | (113) | ||||||||||||
Net cash provided by/(used in) financing activities from continuing operations | (2,807) | (2,200) | ||||||||||||
Effect of exchange-rate changes on cash and cash equivalents and restricted cash and cash equivalents | — | (15) | ||||||||||||
Net increase/(decrease) in cash and cash equivalents and restricted cash and cash equivalents | (15) | 846 | ||||||||||||
Cash and cash equivalents and restricted cash and cash equivalents, at beginning of period | 1,825 | 1,350 | ||||||||||||
Cash and cash equivalents and restricted cash and cash equivalents, at end of period | $ | 1,809 | $ | 2,196 | ||||||||||
Supplemental Cash Flow Information | ||||||||||||||
Cash paid (received) during the period for: | ||||||||||||||
Income taxes | $ | 394 | $ | 239 | ||||||||||
Interest paid | 445 | 472 | ||||||||||||
Interest rate hedges | 10 | (11) |
See Accompanying Notes.
9
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 months ended February 28, 2021 and February 23, 2020, and for U.S. subsidiaries is as of and for the three months ended April 4, 2021 and March 29, 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 falls 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 for all periods presented. 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.
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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 | ||||||||||||||||||||||||||||||||||||||
April 4, 2021 | March 29, 2020 | |||||||||||||||||||||||||||||||||||||
(MILLIONS, EXCEPT PER COMMON SHARE DATA) | Previous Accounting Principle | Impact of Change | As Reported | Previous Accounting Principle | Impact of Change | As Adjusted | ||||||||||||||||||||||||||||||||
Condensed Consolidated Statements of Income: | ||||||||||||||||||||||||||||||||||||||
Other (income)/deductions––net | $ | (857) | $ | (146) | $ | (1,004) | $ | 216 | $ | (25) | $ | 190 | ||||||||||||||||||||||||||
Income from continuing operations before provision for taxes on income | 5,536 | 146 | 5,683 | 2,817 | 25 | 2,842 | ||||||||||||||||||||||||||||||||
Provision for taxes on income | 773 | 32 | 805 | 355 | 4 | 359 | ||||||||||||||||||||||||||||||||
Income from discontinued operations––net of tax | 9 | — | 9 | 948 | (68) | 881 | ||||||||||||||||||||||||||||||||
Net income before allocation to noncontrolling interests | 4,772 | 114 | 4,886 | 3,410 | (47) | 3,364 | ||||||||||||||||||||||||||||||||
Net income attributable to Pfizer Inc. common shareholders | 4,763 | 114 | 4,877 | 3,401 | (47) | 3,355 | ||||||||||||||||||||||||||||||||
Earnings per common share––basic: | ||||||||||||||||||||||||||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.85 | $ | 0.02 | $ | 0.87 | $ | 0.44 | $ | — | $ | 0.45 | ||||||||||||||||||||||||||
Income from discontinued operations––net of tax | — | — | — | 0.17 | (0.01) | 0.16 | ||||||||||||||||||||||||||||||||
Net income attributable to Pfizer Inc. common shareholders | 0.85 | 0.02 | 0.87 | 0.61 | (0.01) | 0.60 | ||||||||||||||||||||||||||||||||
Earnings per common share––diluted: | ||||||||||||||||||||||||||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.84 | $ | 0.02 | $ | 0.86 | $ | 0.44 | $ | — | $ | 0.44 | ||||||||||||||||||||||||||
Income from discontinued operations––net of tax | — | — | — | 0.17 | (0.01) | 0.16 | ||||||||||||||||||||||||||||||||
Net income attributable to Pfizer Inc. common shareholders | 0.84 | 0.02 | 0.86 | 0.61 | (0.01) | 0.60 | ||||||||||||||||||||||||||||||||
Condensed Consolidated Statements of Comprehensive Income: | ||||||||||||||||||||||||||||||||||||||
Foreign currency translation adjustments, net | $ | 546 | $ | (81) | $ | 465 | $ | (1,272) | $ | 16 | $ | (1,256) | ||||||||||||||||||||||||||
Benefit plans: actuarial gains/(losses), net | 47 | (47) | — | (166) | 166 | — | ||||||||||||||||||||||||||||||||
Reclassification adjustments related to amortization | 75 | (75) | — | 66 | (66) | — | ||||||||||||||||||||||||||||||||
Reclassification adjustments related to settlements, net | 19 | (19) | — | 53 | (53) | — | ||||||||||||||||||||||||||||||||
Other | (81) | 81 | — | 16 | (16) | — | ||||||||||||||||||||||||||||||||
Tax provision/(benefit) on other comprehensive income/(loss) | 72 | 12 | 84 | (377) | (3) | (380) | ||||||||||||||||||||||||||||||||
Condensed Consolidated Statements of Cash Flows: | ||||||||||||||||||||||||||||||||||||||
Deferred taxes from continuing operations | $ | 167 | $ | 32 | $ | 199 | $ | 77 | $ | 4 | $ | 82 | ||||||||||||||||||||||||||
Benefit plan contributions in excess of expense/income | (226) | (146) | (373) | (250) | (25) | (276) | ||||||||||||||||||||||||||||||||
April 4, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||||||||||
(MILLIONS) | Previous Accounting Principle | Impact of Change | As Reported | Previous Accounting Principle | Impact of Change | As Adjusted | ||||||||||||||||||||||||||||||||
Condensed Consolidated Balance Sheets: | ||||||||||||||||||||||||||||||||||||||
Noncurrent deferred tax assets and other noncurrent tax assets | $ | 2,569 | $ | (32) | $ | 2,537 | $ | 2,383 | $ | — | $ | 2,383 | ||||||||||||||||||||||||||
Other noncurrent assets | 4,738 | 6 | 4,744 | 4,569 | — | 4,569 | ||||||||||||||||||||||||||||||||
Pension benefit obligations | 4,527 | — | 4,526 | 4,766 | — | 4,766 | ||||||||||||||||||||||||||||||||
Retained earnings | 95,044 | 114 | 95,158 | 96,770 | (6,378) | 90,392 | ||||||||||||||||||||||||||||||||
Accumulated other comprehensive loss | (4,523) | (141) | (4,664) | (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 vaccines 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.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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) | April 4, 2021 | December 31, 2020 | ||||||||||||
Reserve against Trade accounts receivable, less allowance for doubtful accounts | $ | 848 | $ | 861 | ||||||||||
Other current liabilities: | ||||||||||||||
Accrued rebates | 3,211 | 3,017 | ||||||||||||
Other accruals | 449 | 436 | ||||||||||||
Other noncurrent liabilities | 340 | 399 | ||||||||||||
Total accrued rebates and other sales-related accruals | $ | 4,848 | $ | 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, 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 months ended April 4, 2021 and March 29, 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 and Equity-Method Investment
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 first three months of 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 $871 million as of April 4, 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 from discontinued operations––net of tax.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Components of Income from discontinued operations––net of tax: | ||||||||||||||
Three Months Ended(a) | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
Revenues | $ | 27 | $ | 1,946 | ||||||||||
Costs and expenses: | ||||||||||||||
Cost of sales | 14 | 442 | ||||||||||||
Selling, informational and administrative expenses | (8) | 332 | ||||||||||||
Research and development expenses | 1 | 51 | ||||||||||||
Amortization of intangible assets | — | 36 | ||||||||||||
Restructuring charges and certain acquisition-related costs | — | 15 | ||||||||||||
Other (income)/deductions––net | 1 | 70 | ||||||||||||
Pre-tax income from discontinued operations | 19 | 1,000 | ||||||||||||
Provision for taxes on income | 10 | 119 | ||||||||||||
Income from discontinued operations––net of tax | $ | 9 | $ | 881 |
(a)In the three months ended April 4, 2021, Income from discontinued operations—net of tax primarily relates to the Mylan-Japan collaboration, which did not terminate until December 21, 2020 and which falls in Pfizer’s international first quarter of 2021, and adjustments to tax and legal matters directly related to the disposed Upjohn Business. In the three months ended March 29, 2020, Income 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.
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 $16.3 billion as of April 4, 2021 and $16.7 billion as of December 31, 2020 and is reported as a private equity investment in Equity-method investments as of April 4, 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 $126 million in pre-tax foreign currency translation adjustments (see Note 6), as well as dividends totaling approximately $274 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 fourth quarter of 2020, which we recorded in our operating results in the first quarter of 2021, was $71 million. Our total share of the JV’s earnings generated in the fourth quarter of 2019, which we recorded in our operating results in the first quarter of 2020 was $11 million. See Note 4. 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 months ending December 31, 2020, the most recent period available and for the three months ending December 31, 2019, is as follows: | ||||||||||||||
Three Months Ended | ||||||||||||||
(MILLIONS) | December 31, 2020 | December 31, 2019 | ||||||||||||
Net sales | $ | 3,096 | $ | 3,188 | ||||||||||
Cost of sales | (1,188) | (1,811) | ||||||||||||
Gross profit | $ | 1,908 | $ | 1,377 | ||||||||||
Income from continuing operations | 233 | 46 | ||||||||||||
Net income | 233 | 46 | ||||||||||||
Income attributable to shareholders | 221 | 37 |
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 undertaken efforts to ensure our cost base aligns appropriately with our revenue base. 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. In addition, we are taking steps to restructure our corporate enabling functions to appropriately support and drive the purpose of our business and R&D and PGS platform functions. The program costs discussed below are expected to be incurred primarily from 2020 through 2022, and may be rounded and represent approximations.
We expect costs for this program, primarily related to corporate enabling functions, to total $1.6 billion on a pre-tax basis, with substantially all costs to be cash expenditures. Actions will 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.
Also, as part of this program, we expect to incur costs related to manufacturing network optimization, including certain legacy cost-reduction initiatives, of $500 million, with approximately 20% of the costs to be non-cash. The costs for this effort will include, among other things, implementation costs, product transfer costs, site exit costs, as well as accelerated depreciation.
From the start of this program in the fourth quarter of 2019 through April 4, 2021, we incurred costs of $1.0 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 Ended | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
Restructuring charges/(credits): | ||||||||||||||
Employee terminations | $ | 22 | $ | 10 | ||||||||||
Asset impairments | (4) | 31 | ||||||||||||
Restructuring charges/(credits)(a) | 18 | 41 | ||||||||||||
Transaction costs(b) | — | 3 | ||||||||||||
Integration costs and other(c) | 5 | 10 | ||||||||||||
Restructuring charges and certain acquisition-related costs | 23 | 54 | ||||||||||||
Net periodic benefit costs recorded in Other (income)/deductions––net(d) | 8 | 1 | ||||||||||||
Additional depreciation––asset restructuring recorded in our condensed consolidated statements of income as follows(e): | ||||||||||||||
Cost of sales | 10 | 5 | ||||||||||||
Research and development expenses | — | (5) | ||||||||||||
Total additional depreciation––asset restructuring | 10 | — | ||||||||||||
Implementation costs recorded in our condensed consolidated statements of income as follows(f): | ||||||||||||||
Cost of sales | 11 | 8 | ||||||||||||
Selling, informational and administrative expenses | 64 | 15 | ||||||||||||
Total implementation costs | 75 | 22 | ||||||||||||
Total costs associated with acquisitions and cost-reduction/productivity initiatives | $ | 116 | $ | 77 |
(a)Represents acquisition-related costs ($6 million credit in 2021) and cost-reduction/productivity initiatives ($25 million charge in 2021 and a $40 million charge in 2020).
(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.
(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.
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The following summarizes the components and changes in restructuring accruals: | ||||||||||||||||||||||||||
(MILLIONS) | Employee Termination Costs | Asset Impairment Charges | Exit Costs | Accrual | ||||||||||||||||||||||
Balance, December 31, 2020(a) | $ | 782 | $ | — | $ | 15 | $ | 798 | ||||||||||||||||||
Provision | 22 | (4) | — | 18 | ||||||||||||||||||||||
Utilization and other(b) | (102) | 4 | — | (99) | ||||||||||||||||||||||
Balance, April 4, 2021(c) | $ | 702 | $ | — | $ | 15 | $ | 717 |
(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 ($561 million) and Other noncurrent liabilities ($156 million).
Note 4. Other (Income)/Deductions—Net
Components of Other (income)/deductions––net include: | ||||||||||||||
Three Months Ended | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
Interest income | $ | — | $ | (34) | ||||||||||
Interest expense | 336 | 390 | ||||||||||||
Net interest expense | 336 | 356 | ||||||||||||
Royalty-related income | (176) | (119) | ||||||||||||
Net (gains)/losses on asset disposals | (39) | 1 | ||||||||||||
Net (gains)/losses recognized during the period on equity securities(a) | (401) | 255 | ||||||||||||
Income from collaborations, out-licensing arrangements and sales of compound/product rights(b) | (231) | (115) | ||||||||||||
Net periodic benefit costs/(credits) other than service costs(c) | (266) | (103) | ||||||||||||
Certain legal matters, net | 51 | 9 | ||||||||||||
Consumer Healthcare JV equity method (income)/loss(d) | (62) | 33 | ||||||||||||
Other, net | (216) | (126) | ||||||||||||
Other (income)/deductions––net | $ | (1,004) | $ | 190 |
(a)The gains in the first quarter of 2021 include, among other things, unrealized gains of $409 million related to investments in Allogene and BioNTech. The losses in the first quarter of 2020 include, among other things, unrealized losses of $134 million related to our investment in Allogene.
(b)The first quarter of 2021 includes, among other things, $188 million of net collaboration income from BioNTech related to the COVID-19 vaccine. The first quarter of 2020 mainly includes, among other things, an upfront payment to us of $75 million from our sale of our CK1 assets to Biogen, Inc.
(c)Amounts include the impact of a change in accounting principle. See Notes 1C and 10.
(d)See Note 2B.
Note 5. Tax Matters
A. Taxes on Income from Continuing Operations
Our effective tax rate for continuing operations was 14.2% for the first quarter of 2021, compared to 12.6% for the first quarter of 2020. The higher effective tax rate was primarily due to an unfavorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business.
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 and is reported in current Income taxes payable as of April 4, 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
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PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 2010.
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 Ended | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
Foreign currency translation adjustments, net(a) | $ | 21 | $ | (247) | ||||||||||
Unrealized holding gains/(losses) on derivative financial instruments, net | 59 | (133) | ||||||||||||
Reclassification adjustments for (gains)/losses included in net income | 34 | 15 | ||||||||||||
93 | (118) | |||||||||||||
Unrealized holding gains/(losses) on available-for-sale securities, net | 10 | (6) | ||||||||||||
Reclassification adjustments for (gains)/losses included in net income | (30) | 2 | ||||||||||||
(20) | (5) | |||||||||||||
Reclassification adjustments related to amortization of prior service costs and other, net | (10) | (11) | ||||||||||||
Other | — | — | ||||||||||||
(10) | (11) | |||||||||||||
Tax provision/(benefit) on other comprehensive income/(loss) | $ | 84 | $ | (380) |
(a)Taxes are not provided for foreign currency translation adjustments relating to investments in international subsidiaries that we intend to hold indefinitely.
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 Instruments | Available-For-Sale Securities | Prior Service (Costs)/Credits and Other | Accumulated Other Comprehensive Income/(Loss) | |||||||||||||||||||||||||||
Balance, December 31, 2020(a) | $ | (5,450) | $ | (428) | $ | 116 | $ | 452 | $ | (5,310) | ||||||||||||||||||||||
Other comprehensive income/(loss)(b) | 442 | 380 | (142) | (33) | 646 | |||||||||||||||||||||||||||
Balance, April 4, 2021 | $ | (5,008) | $ | (48) | $ | (26) | $ | 419 | $ | (4,664) |
(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 primarily include gains from the strengthening of the U.K. pound, euro and Australian dollar against the U.S. dollar, and net gains related to the impact of our net investment hedging program, partially offset by net losses from foreign currency translation adjustments related to our equity-method investment in the Consumer Healthcare JV (see Note 2B).
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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:
April 4, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||||||||||
(MILLIONS) | Total | Level 1 | Level 2 | Total | Level 1 | Level 2 | ||||||||||||||||||||||||||||||||
Financial assets: | ||||||||||||||||||||||||||||||||||||||
Short-term investments | ||||||||||||||||||||||||||||||||||||||
Classified as equity securities with readily determinable fair values: | ||||||||||||||||||||||||||||||||||||||
Money market funds | $ | 1,427 | $ | — | $ | 1,427 | $ | 567 | $ | — | $ | 567 | ||||||||||||||||||||||||||
Classified as available-for-sale debt securities: | ||||||||||||||||||||||||||||||||||||||
Government and agency—non-U.S. | 6,169 | — | 6,169 | 7,719 | — | 7,719 | ||||||||||||||||||||||||||||||||
Government and agency—U.S. | 1,221 | — | 1,221 | 982 | — | 982 | ||||||||||||||||||||||||||||||||
Corporate and other | 902 | — | 902 | 1,008 | — | 1,008 | ||||||||||||||||||||||||||||||||
8,292 | — | 8,292 | 9,709 | — | 9,709 | |||||||||||||||||||||||||||||||||
Total short-term investments | 9,719 | — | 9,719 | 10,276 | — | 10,276 | ||||||||||||||||||||||||||||||||
Other current assets | ||||||||||||||||||||||||||||||||||||||
Derivative assets: | ||||||||||||||||||||||||||||||||||||||
Interest rate contracts | 5 | — | 5 | 18 | — | 18 | ||||||||||||||||||||||||||||||||
Foreign exchange contracts | 389 | — | 389 | 234 | — | 234 | ||||||||||||||||||||||||||||||||
Total other current assets | 394 | — | 394 | 251 | — | 251 | ||||||||||||||||||||||||||||||||
Long-term investments | ||||||||||||||||||||||||||||||||||||||
Classified as equity securities with readily determinable fair values(a) | 3,123 | 3,046 | 77 | 2,809 | 2,776 | 32 | ||||||||||||||||||||||||||||||||
Classified as available-for-sale debt securities: | ||||||||||||||||||||||||||||||||||||||
Government and agency—non-U.S. | 9 | — | 9 | 6 | — | 6 | ||||||||||||||||||||||||||||||||
Government and agency—U.S. | 66 | — | 66 | 121 | — | 121 | ||||||||||||||||||||||||||||||||
Corporate and other | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
75 | — | 75 | 128 | — | 128 | |||||||||||||||||||||||||||||||||
Total long-term investments | 3,198 | 3,046 | 152 | 2,936 | 2,776 | 160 | ||||||||||||||||||||||||||||||||
Other noncurrent assets | ||||||||||||||||||||||||||||||||||||||
Derivative assets: | ||||||||||||||||||||||||||||||||||||||
Interest rate contracts | 21 | — | 21 | 117 | — | 117 | ||||||||||||||||||||||||||||||||
Foreign exchange contracts | 106 | — | 106 | 5 | — | 5 | ||||||||||||||||||||||||||||||||
Total derivative assets | 127 | — | 127 | 122 | — | 122 | ||||||||||||||||||||||||||||||||
Insurance contracts(b) | 726 | — | 726 | 693 | — | 693 | ||||||||||||||||||||||||||||||||
Total other noncurrent assets | 853 | — | 853 | 814 | — | 814 | ||||||||||||||||||||||||||||||||
Total assets | $ | 14,165 | $ | 3,046 | $ | 11,119 | $ | 14,278 | $ | 2,776 | $ | 11,501 | ||||||||||||||||||||||||||
Financial liabilities: | ||||||||||||||||||||||||||||||||||||||
Other current liabilities | ||||||||||||||||||||||||||||||||||||||
Derivative liabilities: | ||||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | $ | 239 | $ | — | $ | 239 | $ | 501 | $ | — | $ | 501 | ||||||||||||||||||||||||||
Total other current liabilities | 239 | — | 239 | 501 | — | 501 | ||||||||||||||||||||||||||||||||
Other noncurrent liabilities | ||||||||||||||||||||||||||||||||||||||
Derivative liabilities: | ||||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | 494 | — | 494 | 599 | — | 599 | ||||||||||||||||||||||||||||||||
Total other noncurrent liabilities | 494 | — | 494 | 599 | — | 599 | ||||||||||||||||||||||||||||||||
Total liabilities | $ | 732 | $ | — | $ | 732 | $ | 1,100 | $ | — | $ | 1,100 |
(a)Long-term equity securities of $168 million as of April 4, 2021 and $190 million as of December 31, 2020 were held in restricted trusts for 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).
17
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: | ||||||||||||||||||||||||||
April 4, 2021 | December 31, 2020 | |||||||||||||||||||||||||
(MILLIONS) | Carrying Value | Estimated Fair Value at Level 2 | Carrying Value | Estimated Fair Value at Level 2 | ||||||||||||||||||||||
Financial Liabilities | ||||||||||||||||||||||||||
Long-term debt, excluding the current portion | $ | 35,347 | $ | 40,504 | $ | 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 April 4, 2021 and December 31, 2020. The fair value measurements of our held-to-maturity debt securities and our short-term borrowings are based on Level 2 inputs. The fair value measurements of our 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) | April 4, 2021 | December 31, 2020 | ||||||||||||
Short-term investments | ||||||||||||||
Equity securities with readily determinable fair values(a) | $ | 1,427 | $ | 567 | ||||||||||
Available-for-sale debt securities | 8,292 | 9,709 | ||||||||||||
Held-to-maturity debt securities | 2,180 | 161 | ||||||||||||
Total Short-term investments | $ | 11,899 | $ | 10,437 | ||||||||||
Long-term investments | ||||||||||||||
Equity securities with readily determinable fair values | $ | 3,123 | $ | 2,809 | ||||||||||
Available-for-sale debt securities | 75 | 128 | ||||||||||||
Held-to-maturity debt securities | 31 | 37 | ||||||||||||
Private equity securities at cost(b) | 467 | 432 | ||||||||||||
Total Long-term investments | $ | 3,696 | $ | 3,406 | ||||||||||
Equity-method investments | 16,532 | 16,856 | ||||||||||||
Total long-term investments and equity-method investments | $ | 20,228 | $ | 20,262 | ||||||||||
Held-to-maturity cash equivalents | $ | 60 | $ | 89 |
(a)As of April 4, 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 April 4, 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: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
April 4, 2021 | December 31, 2020 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Gross Unrealized | Maturities (in Years) | Gross Unrealized | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(MILLIONS) | Amortized Cost | Gains | Losses | Fair Value | Within 1 | Over 1 to 5 | Over 5 | Amortized Cost | Gains | Losses | Fair Value | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Available-for-sale debt securities | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Government and agency––non-U.S. | $ | 6,209 | $ | 23 | $ | (54) | $ | 6,178 | $ | 6,169 | $ | 9 | $ | — | $ | 7,593 | $ | 136 | $ | (4) | $ | 7,725 | |||||||||||||||||||||||||||||||||||||||||||||||||
Government and agency––U.S. | 1,288 | — | (1) | 1,287 | 1,221 | 66 | — | 1,104 | — | (1) | 1,103 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Corporate and other | 900 | 3 | — | 903 | 902 | — | — | 1,006 | 2 | — | 1,008 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Held-to-maturity debt securities | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Time deposits and other | 423 | — | — | 423 | 397 | 16 | 10 | 283 | — | — | 283 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Government and agency––non-U.S. | 1,847 | — | — | 1,847 | 1,842 | 4 | 1 | 5 | — | — | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total debt securities | $ | 10,667 | $ | 25 | $ | (55) | $ | 10,637 | $ | 10,531 | $ | 94 | $ | 11 | $ | 9,991 | $ | 138 | $ | (5) | $ | 10,124 |
Any expected credit losses to these portfolios would be immaterial to our financial statements.
18
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 Ended | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
Net (gains)/losses recognized during the period on equity securities(a) | $ | (401) | $ | 255 | ||||||||||
Less: Net (gains)/losses recognized during the period on equity securities sold during the period | (28) | (19) | ||||||||||||
Net unrealized (gains)/losses during the reporting period on equity securities still held at the reporting date(b) | $ | (372) | $ | 274 |
(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. Since January 1, 2018, there were cumulative impairments and downward adjustments of $87 million and upward adjustments of $61 million. Impairments, downward and upward adjustments were not significant in the first quarters of 2021 and 2020.
C. Short-Term Borrowings
Short-term borrowings include: | ||||||||||||||
(MILLIONS) | April 4, 2021 | December 31, 2020 | ||||||||||||
Commercial paper | $ | 416 | $ | 556 | ||||||||||
Current portion of long-term debt, principal amount | 3,679 | 2,004 | ||||||||||||
Other short-term borrowings, principal amount(a) | 260 | 145 | ||||||||||||
Total short-term borrowings, principal amount | 4,355 | 2,705 | ||||||||||||
Net fair value adjustments related to hedging and purchase accounting | — | — | ||||||||||||
Net unamortized discounts, premiums and debt issuance costs | (3) | (2) | ||||||||||||
Total Short-term borrowings, including current portion of long-term debt, carried at historical proceeds, as adjusted | $ | 4,352 | $ | 2,703 |
(a)Includes cash collateral. See Note 7F.
D. Long-Term Debt
The following summarizes the aggregate principal amount of our senior unsecured long-term debt, and adjustments to report our aggregate long-term debt: | ||||||||||||||
(MILLIONS) | April 4, 2021 | December 31, 2020 | ||||||||||||
Total long-term debt, principal amount | $ | 34,032 | $ | 35,774 | ||||||||||
Net fair value adjustments related to hedging and purchase accounting | 1,512 | 1,562 | ||||||||||||
Net unamortized discounts, premiums and debt issuance costs | (200) | (207) | ||||||||||||
Other long-term debt | 4 | 4 | ||||||||||||
Total long-term debt, carried at historical proceeds, as adjusted | $ | 35,347 | $ | 37,133 | ||||||||||
Current portion of long-term debt, carried at historical proceeds, as adjusted (not included above) | $ | 3,676 | $ | 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 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, Swedish krona, Canadian dollar and Chinese renminbi. Additionally, we hedge a portion of our forecasted intercompany inventory sales denominated in euro, Japanese yen, Chinese renminbi, Canadian dollar, U.K. pound and Australian dollar for up to two years.
19
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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): | ||||||||||||||||||||||||||||||||||||||
April 4, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||||||||||
Fair Value | Fair Value | |||||||||||||||||||||||||||||||||||||
(MILLIONS) | Notional | Asset | Liability | Notional | Asset | Liability | ||||||||||||||||||||||||||||||||
Derivatives designated as hedging instruments: | ||||||||||||||||||||||||||||||||||||||
Foreign exchange contracts(a) | $ | 22,799 | $ | 408 | $ | 654 | $ | 24,369 | $ | 145 | $ | 1,005 | ||||||||||||||||||||||||||
Interest rate contracts | 450 | 26 | — | 1,950 | 135 | — | ||||||||||||||||||||||||||||||||
435 | 654 | 280 | 1,005 | |||||||||||||||||||||||||||||||||||
Derivatives not designated as hedging instruments: | ||||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | $ | 14,726 | 86 | 78 | $ | 15,063 | 94 | 95 | ||||||||||||||||||||||||||||||
Total | $ | 521 | $ | 732 | $ | 373 | $ | 1,100 |
(a)The notional amount of outstanding foreign exchange contracts hedging our intercompany forecasted inventory sales was $5.1 billion as of April 4, 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) | April 4, 2021 | March 29, 2020 | April 4, 2021 | March 29, 2020 | April 4, 2021 | March 29, 2020 | ||||||||||||||||||||||||||||||||
Three Months Ended | ||||||||||||||||||||||||||||||||||||||
Derivative Financial Instruments in Cash Flow Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
Foreign exchange contracts(b) | $ | — | $ | — | $ | 202 | $ | (529) | $ | (268) | $ | (46) | ||||||||||||||||||||||||||
Amount excluded from effectiveness testing and amortized into earnings(c) | — | — | 12 | 29 | 9 | 27 | ||||||||||||||||||||||||||||||||
Derivative Financial Instruments in Fair Value Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
Interest rate contracts | (26) | 386 | — | — | — | — | ||||||||||||||||||||||||||||||||
Hedged item | 26 | (386) | — | — | — | — | ||||||||||||||||||||||||||||||||
Derivative Financial Instruments in Net Investment Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | — | — | 154 | 384 | — | — | ||||||||||||||||||||||||||||||||
The portion of foreign exchange contracts excluded from the assessment of hedge effectiveness(c) | — | — | (1) | 147 | 29 | 41 | ||||||||||||||||||||||||||||||||
Non-Derivative Financial Instruments in Net Investment Hedge Relationships:(d) | ||||||||||||||||||||||||||||||||||||||
Foreign currency short-term borrowings | — | — | 38 | 8 | — | — | ||||||||||||||||||||||||||||||||
Foreign currency long-term debt | — | — | 56 | 45 | — | — | ||||||||||||||||||||||||||||||||
Derivative Financial Instruments Not Designated as Hedges: | ||||||||||||||||||||||||||||||||||||||
Foreign exchange contracts | 42 | (59) | — | — | — | — | ||||||||||||||||||||||||||||||||
All other net(c) | — | — | — | (1) | — | — | ||||||||||||||||||||||||||||||||
$ | 42 | $ | (59) | $ | 460 | $ | 83 | $ | (230) | $ | 23 |
(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 .
20
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(b)The amounts reclassified from OCI into COS were:
•a net loss of $45 million in the first quarter of 2021; and
•a net gain of $70 million in the first quarter 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 loss of $20 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 April 4, 2021 was $1.2 billion. The long-term debt carrying values as of April 4, 2021 and December 31, 2020 were $872 million and $2.1 billion, respectively.
The following summarizes cumulative basis adjustments for fair value hedges to our long-term debt: | ||||||||||||||||||||||||||||||||||||||
April 4, 2021 | December 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 Relationships | Discontinued Hedging Relationships | Carrying Amount of Hedged Assets/Liabilities(a) | Active Hedging Relationships | Discontinued Hedging Relationships | ||||||||||||||||||||||||||||||||
Long-term debt | $ | 494 | $ | 21 | $ | 1,202 | $ | 2,016 | $ | 117 | $ | 1,149 |
(a)Carrying amounts exclude the cumulative amount of fair value hedging adjustments.
F. Credit Risk
A significant portion of our trade accounts receivable balances are due from drug wholesalers. 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 April 4, 2021, the largest investment exposures in our portfolio represent primarily sovereign debt instruments issued by the U.S., U.K., Germany, France, Japan and Canada.
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 April 4, 2021, the aggregate fair value of these derivative financial instruments that are in a net payable position was $613 million, for which we have posted collateral of $675 million with a corresponding amount reported in Short-term investments. As of April 4, 2021, the aggregate fair value of our derivative financial instruments that are in a net receivable position was $53 million, for which we have received collateral of $124 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) | April 4, 2021 | December 31, 2020 | ||||||||||||
Finished goods | $ | 3,289 | $ | 2,878 | ||||||||||
Work-in-process | 4,364 | 4,430 | ||||||||||||
Raw materials and supplies | 840 | 738 | ||||||||||||
Inventories(a) | $ | 8,493 | $ | 8,046 | ||||||||||
Noncurrent inventories not included above(b) | $ | 981 | $ | 890 |
(a)The change from December 31, 2020 reflects increases for certain products, including inventory build for new product launches and market demand, and an increase due to foreign exchange.
(b)Included in Other noncurrent assets. There are no recoverability issues for these amounts.
B. Other Current Liabilities
Other current liabilities related to the gross margin split with BioNTech for BNT162b2 totaled $1.4 billion as of April 4, 2021 and $25 million as of December 31, 2020.
21
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 9. Identifiable Intangible Assets
The following summarizes the components of Identifiable intangible assets: | ||||||||||||||||||||||||||||||||||||||
April 4, 2021 | December 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) | $ | 74,056 | $ | (51,840) | $ | 22,217 | $ | 73,545 | $ | (50,902) | $ | 22,643 | ||||||||||||||||||||||||||
Brands | 922 | (782) | 140 | 922 | (774) | 148 | ||||||||||||||||||||||||||||||||
Licensing agreements and other | 2,305 | (1,223) | 1,082 | 2,292 | (1,186) | 1,106 | ||||||||||||||||||||||||||||||||
77,284 | (53,845) | 23,439 | 76,759 | (52,862) | 23,896 | |||||||||||||||||||||||||||||||||
Indefinite-lived intangible assets | ||||||||||||||||||||||||||||||||||||||
Brands | 827 | 827 | 827 | 827 | ||||||||||||||||||||||||||||||||||
IPR&D | 3,135 | 3,135 | 3,175 | 3,175 | ||||||||||||||||||||||||||||||||||
Licensing agreements and other | 573 | 573 | 573 | 573 | ||||||||||||||||||||||||||||||||||
4,535 | 4,535 | 4,575 | 4,575 | |||||||||||||||||||||||||||||||||||
Identifiable intangible assets(b) | $ | 81,819 | $ | (53,845) | $ | 27,974 | $ | 81,334 | $ | (52,862) | $ | 28,471 |
(a)The increase in the gross carrying amount primarily reflects $300 million of capitalized BNT162b2 sales milestones due to BioNTech.
(b)The decrease is primarily due to amortization, partially offset by the capitalization of the BNT162b2 milestone payments described above.
Nearly all of our identifiable intangible assets are managed by our commercial organization, with only 9% of total IPR&D assets managed by our R&D organization.
Amortization
Total amortization of finite-lived intangible assets was $883 million for the first quarter of 2021 and $861 million for the first quarter 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. | International | Postretirement Plans | ||||||||||||||||||||||||||||||||||||
Three Months Ended | ||||||||||||||||||||||||||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | April 4, 2021 | March 29, 2020 | April 4, 2021 | March 29, 2020 | ||||||||||||||||||||||||||||||||
Service cost | $ | — | $ | — | $ | 33 | $ | 36 | $ | 9 | $ | 10 | ||||||||||||||||||||||||||
Interest cost | 113 | 141 | 36 | 42 | 7 | 13 | ||||||||||||||||||||||||||||||||
Expected return on plan assets | (261) | (252) | (82) | (81) | (10) | (9) | ||||||||||||||||||||||||||||||||
Amortization of prior service credits | (1) | (1) | — | (1) | (39) | (43) | ||||||||||||||||||||||||||||||||
Actuarial (gains)/losses | (47) | 163 | — | 3 | — | — | ||||||||||||||||||||||||||||||||
Special termination benefits | 7 | 1 | — | — | 1 | — | ||||||||||||||||||||||||||||||||
Net periodic benefit cost/(credit) reported in income | $ | (187) | $ | 53 | $ | (12) | $ | (1) | $ | (32) | $ | (30) | ||||||||||||||||||||||||||
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 three months ended April 4, 2021, we contributed $83 million, $40 million, and $19 million to our U.S. Pension Plans, International Pension Plans, and Postretirement Plans, respectively, from our general assets, which include direct employer benefit payments.
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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 Ended | ||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | ||||||||||||
EPS Numerator––Basic | ||||||||||||||
Income from continuing operations attributable to Pfizer Inc. | $ | 4,868 | $ | 2,474 | ||||||||||
Less: Preferred stock dividends––net of tax | — | — | ||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | 4,868 | 2,474 | ||||||||||||
Income from discontinued operations––net of tax | 9 | 881 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 4,877 | $ | 3,354 | ||||||||||
EPS Numerator––Diluted | ||||||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions | $ | 4,868 | $ | 2,474 | ||||||||||
Income from discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions | 9 | 881 | ||||||||||||
Net income attributable to Pfizer Inc. common shareholders and assumed conversions | $ | 4,877 | $ | 3,355 | ||||||||||
EPS Denominator | ||||||||||||||
Weighted-average number of common shares outstanding––Basic | 5,584 | 5,545 | ||||||||||||
Common-share equivalents: stock options, stock issuable under employee compensation plans, convertible preferred stock and accelerated share repurchase agreements | 78 | 68 | ||||||||||||
Weighted-average number of common shares outstanding––Diluted | 5,662 | 5,613 | ||||||||||||
Anti-dilutive common stock equivalents(a) | 2 | 3 |
(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 drug, a significant loss of revenues from that drug or impairment of the value of associated assets.
•Product liability and other product-related litigation, which can include personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, among others, often involves highly complex issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual, provable injury and other matters.
•Commercial and other 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.
•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
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(UNAUDITED)
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. In August 2020, the SEC amended its disclosure rules regarding the threshold for disclosure of proceedings under environmental laws to which a governmental authority is a party. In accordance with the amended rule, we have adopted a disclosure threshold for such proceedings 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), 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. Additionally, our licensing and collaboration partners face challenges by generic drug manufacturers to patents covering products for which we have licenses or co-promotion rights.
We also are often involved in other proceedings, such as inter partes review, post-grant review, re-examination or opposition proceedings, before the U.S. Patent and Trademark Office, the European Patent Office, or other foreign counterparts relating to our intellectual property or the intellectual property rights of others. Also, if one of our patents is found to be invalid by such proceedings, generic or competitive products could be introduced into the market resulting in the erosion of sales of our existing products. For example, several of the patents in our pneumococcal vaccine portfolio were challenged in inter partes review and post-grant review proceedings in the U.S. In 2017, the Patent Trial and Appeal Board (PTAB) initiated proceedings, which remain pending, 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, are now being challenged in federal court in Delaware. Challenges to other pneumococcal vaccine patents remain pending outside the U.S. The invalidation of all of the patents in our pneumococcal portfolio could potentially allow a competitor’s vaccine 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
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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 2017, we brought a patent-infringement action against Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (collectively, Zydus) asserting the infringement and validity of three patents: the patent covering the active ingredient expiring in December 2025 (the 2025 Patent), the patent covering an enantiomer of tofacitinib expiring in 2022, and the patent covering a polymorphic form of tofacitinib expiring in 2023 (the 2023 Patent), which Zydus challenged in its ANDA seeking approval to market a generic version of tofacitinib 5 mg tablets. In November 2020, we settled the case against Zydus on terms not material to us. In February 2021, we brought a separate patent-infringement action against Zydus asserting the infringement and validity of our composition of matter and crystalline form patents challenged by Zydus in its ANDA seeking approval to market a generic version of tofacitinib 22 mg extended release tablets. In April 2021, we settled our remaining action against Zydus on terms not material to us.
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 January 2021, we brought a separate patent-infringement action against Aurobindo Pharma Limited (Aurobindo) asserting the infringement and validity of the 2025 Patent and the 2023 Patent, which Aurobindo challenged in its ANDA seeking approval to market a generic version of tofacitinib 5 mg and 10 mg 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. The companies assert 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. Beginning in September 2020, we received correspondence from several generic companies notifying us that they would seek approval to market generic versions of Ibrance. 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.
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
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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
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 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
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(UNAUDITED)
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
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 seek to represent U.S. nationwide classes comprising persons or entities who paid for any portion of the end-user purchase price of an EpiPen between 2009 until the cessation of the defendants’ allegedly unlawful conduct. In 2020, a similar lawsuit was filed in the U.S. District Court for the District of Kansas against Pfizer, King, Meridian and the Mylan entities on behalf of a purported U.S. nationwide class of direct purchaser plaintiffs who purchased EpiPen devices directly from the defendants (the 2020 Lawsuit). 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 actions, except for the 2020 Lawsuit, 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 2020, a new lawsuit was filed in the U.S. District Court for the District of Colorado on behalf of indirect purchasers. Plaintiff represents a putative U.S. nationwide class of persons or entities who paid for any portion of the end-user purchase price of certain refill or replacement EpiPens since 2010. Plaintiff alleges that Pfizer and Meridian misrepresented the shelf-life and expiration date of EpiPen, in violation of the federal RICO statute. Plaintiff seeks treble damages for alleged unnecessary replacement or refill purchases of EpiPens by members of the putative class.
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.
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
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(UNAUDITED)
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 us, which is subject to Court approval.
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 and, in some cases, treble damages, restitution or disgorgement.
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. From June to December 2020: (i) plaintiffs in the Multi-District Litigation filed against Pfizer and many other defendants a consolidated consumer class action complaint alleging, among other things, violations of the RICO statute and consumer protection statutes of all 50 states, and 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; (ii) Pfizer 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; (iii) the State of New Mexico filed a civil action against Pfizer and many other defendants, alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in New Mexico; and (iv) Pfizer received service of a suit filed by the Mayor and City Council of Baltimore naming Pfizer and other defendants alleging various claims under Maryland law.
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 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 to the U.S. Environmental Protection Agency (EPA) a corrective measures study report with regard to Pharmacia’s discontinued industrial chemical facility in North Haven, Connecticut. In 2010, our corrective measures study report was approved by the EPA, and we commenced construction of the site remedy in late 2011 under an Updated
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Administrative Order on Consent with the EPA. In 2019, the EPA acknowledged that construction of the site remedy has been completed. In March 2021, the State of Connecticut, Department of Energy & Environmental Protection issued a Stewardship Permit to Pharmacia & Upjohn Company LLC, our wholly-owned subsidiary, that will govern the ongoing operation, maintenance, and management of the North Haven site, and which will not have a material impact on Pfizer.
Also in 2009, we submitted a revised site-wide feasibility study with regard to Wyeth Holdings Corporation’s (formerly, American Cyanamid Company) discontinued industrial chemical facility in Bound Brook, New Jersey. In 2011, Wyeth Holdings Corporation executed an Administrative Settlement Agreement and Order on Consent for Removal Action (the 2011 Administrative Settlement Agreement) with the EPA with regard to the Bound Brook facility. In accordance with the 2011 Administrative Settlement Agreement, we completed construction of an interim remedy to address the discharge of impacted groundwater from the facility to the Raritan River. In 2012, the EPA issued a final remediation plan for the Bound Brook facility’s main plant area, which is generally in accordance with one of the remedies evaluated in our revised site-wide feasibility study. In 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, which is generally in accordance with one of the remedies evaluated in our focused feasibility study, and, 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.
We have accrued for the estimated costs of the site remedies for the North Haven and Bound Brook facilities.
We are a party to a number of other proceedings brought under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended, and other state, local or foreign laws in which the primary relief sought is the cost of past and/or future remediation.
Contracts with Iraqi Ministry of Health
In 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 2018, Pfizer was named as a defendant in a third-party complaint for indemnity, along with King, filed by Allergan Finance LLC (Allergan) in a Multi-District Litigation in the U.S. District Court for the Northern District of Ohio. The lawsuit asserted claims for indemnity related to Kadian, which was owned for a short period by King in 2008, prior to Pfizer's acquisition of King in 2010. In 2018, the District Court dismissed the lawsuit. In 2019, Allergan filed a similar complaint in the Supreme Court of the State of New York, asserting claims for indemnity related to Kadian. That 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.
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
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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 Civil Action
See Note 12A2. Contingencies and Certain Commitments: Legal Proceedings––Product Litigation––Zantac above for information regarding a civil action filed by the State of New Mexico alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in New Mexico.
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
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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 April 4, 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, our collaboration agreement with EMD Serono, Inc. to co-promote Rebif in the U.S. expired at the end of 2015 and included certain indemnity provisions. Patent litigation brought by Biogen Idec MA Inc. against EMD Serono Inc. and Pfizer is pending in the U.S. District Court for the District of New Jersey and the United States Court of Appeals for the Federal Circuit. EMD Serono Inc. has acknowledged that it is obligated to satisfy any award of damages. In addition, 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 and that now are 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 Ended | ||||||||||||||||||||
(MILLIONS) | April 4, 2021 | March 29, 2020 | % Change | |||||||||||||||||
United States | $ | 7,597 | $ | 5,289 | 44 | |||||||||||||||
Developed Europe | 3,038 | 1,708 | 78 | |||||||||||||||||
Developed Rest of World | 1,123 | 919 | 22 | |||||||||||||||||
Emerging Markets | 2,824 | 2,166 | 30 | |||||||||||||||||
Revenues | $ | 14,582 | $ | 10,083 | 45 | |||||||||||||||
We and our collaboration partner, BioNTech, have entered into agreements to supply pre-specified doses of BNT162b2 with multiple developed and emerging nations around the world and are continuing to deliver doses of BNT162b2 under such agreements. We currently sell the BNT162b2 vaccine directly to government and government sponsored customers. This includes supply agreements entered into in November 2020 and February 2021 with the European Commission (EC) on behalf of the different EU member states and certain other countries. Each EU member state submits its own BNT162b2 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 sales of BNT162b2 to the U.S. Government represented 14% of total revenues for the three months ended April 4, 2021. Accounts receivable from sales of BNT162b2 to the U.S. Government represented 12% of total trade accounts receivable as of April 4, 2021.
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Significant Product Revenues
The following provides detailed revenue information for several of our major products:
(MILLIONS) | Three Months Ended | |||||||||||||||||||
PRODUCT | PRIMARY INDICATION OR CLASS | April 4, 2021 | March 29, 2020 | |||||||||||||||||
TOTAL REVENUES(a) | $ | 14,582 | $ | 10,083 | ||||||||||||||||
Vaccines | $ | 4,894 | $ | 1,611 | ||||||||||||||||
BNT162b2 alliance revenues and direct sales |