Item 1. FINANCIAL STATEMENTS
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Item 1. FINANCIAL STATEMENTS
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS, EXCEPT PER COMMON SHARE DATA) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||
| Revenues | $ | 22,638 | $ | 24,035 | $ | 76,040 | $ | 57,450 | ||||||||||||||||||
| Costs and expenses: | ||||||||||||||||||||||||||
| Cost of sales(a) | 6,063 | 9,932 | 24,696 | 21,085 | ||||||||||||||||||||||
| Selling, informational and administrative expenses(a) | 3,391 | 2,899 | 9,032 | 8,599 | ||||||||||||||||||||||
| Research and development expenses(a) | 2,696 | 2,681 | 7,813 | 6,914 | ||||||||||||||||||||||
| Acquired in-process research and development expenses(b) | 524 | 762 | 880 | 1,000 | ||||||||||||||||||||||
| Amortization of intangible assets | 822 | 968 | 2,478 | 2,743 | ||||||||||||||||||||||
| Restructuring charges and certain acquisition-related costs | 199 | 646 | 580 | 667 | ||||||||||||||||||||||
| Other (income)/deductions––net | (59) | (1,696) | 1,063 | (4,043) | ||||||||||||||||||||||
| Income from continuing operations before provision/(benefit) for taxes on income | 9,001 | 7,843 | 29,498 | 20,484 | ||||||||||||||||||||||
| Provision/(benefit) for taxes on income | 356 | (328) | 3,098 | 1,603 | ||||||||||||||||||||||
| Income from continuing operations | 8,645 | 8,171 | 26,400 | 18,881 | ||||||||||||||||||||||
| Discontinued operations––net of tax | (21) | (13) | 4 | (248) | ||||||||||||||||||||||
| Net income before allocation to noncontrolling interests | 8,623 | 8,159 | 26,404 | 18,633 | ||||||||||||||||||||||
| Less: Net income attributable to noncontrolling interests | 15 | 12 | 27 | 47 | ||||||||||||||||||||||
| Net income attributable to Pfizer Inc. common shareholders | $ | 8,608 | $ | 8,146 | $ | 26,378 | $ | 18,586 | ||||||||||||||||||
| Earnings per common share––basic: | ||||||||||||||||||||||||||
| Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 1.54 | $ | 1.45 | $ | 4.70 | $ | 3.37 | ||||||||||||||||||
| Discontinued operations––net of tax | — | — | — | (0.04) | ||||||||||||||||||||||
| Net income attributable to Pfizer Inc. common shareholders | $ | 1.54 | $ | 1.45 | $ | 4.71 | $ | 3.32 | ||||||||||||||||||
| Earnings per common share––diluted: | ||||||||||||||||||||||||||
| Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 1.51 | $ | 1.43 | $ | 4.60 | $ | 3.31 | ||||||||||||||||||
| Discontinued operations––net of tax | — | — | — | (0.04) | ||||||||||||||||||||||
| Net income attributable to Pfizer Inc. common shareholders | $ | 1.51 | $ | 1.42 | $ | 4.60 | $ | 3.27 | ||||||||||||||||||
| Weighted-average shares––basic | 5,607 | 5,609 | 5,606 | 5,597 | ||||||||||||||||||||||
| Weighted-average shares––diluted | 5,718 | 5,725 | 5,729 | 5,688 |
(a)Exclusive of amortization of intangible assets.
(b)See Note 1D.
See Accompanying Notes.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(UNAUDITED)
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||
| Net income before allocation to noncontrolling interests | $ | 8,623 | $ | 8,159 | $ | 26,404 | $ | 18,633 | ||||||||||||||||||
| Foreign currency translation adjustments, net | (918) | (866) | (2,549) | (366) | ||||||||||||||||||||||
| Unrealized holding gains/(losses) on derivative financial instruments, net | 589 | 213 | 1,443 | 179 | ||||||||||||||||||||||
| Reclassification adjustments for (gains)/losses included in net income(a) | (615) | 48 | (972) | 286 | ||||||||||||||||||||||
| (26) | 261 | 471 | 464 | |||||||||||||||||||||||
| Unrealized holding gains/(losses) on available-for-sale securities, net | (777) | (266) | (1,397) | (128) | ||||||||||||||||||||||
| Reclassification adjustments for (gains)/losses included in net income(b) | 606 | 9 | 1,094 | (172) | ||||||||||||||||||||||
| (171) | (257) | (303) | (300) | |||||||||||||||||||||||
| Reclassification adjustments related to amortization of prior service costs and other, net | (31) | (39) | (99) | (119) | ||||||||||||||||||||||
| Reclassification adjustments related to curtailments of prior service costs and other, net | 2 | (58) | (8) | (62) | ||||||||||||||||||||||
| (29) | (97) | (107) | (181) | |||||||||||||||||||||||
| Other comprehensive income/(loss), before tax | (1,144) | (959) | (2,488) | (382) | ||||||||||||||||||||||
| Tax provision/(benefit) on other comprehensive income/(loss) | (33) | (65) | (149) | (44) | ||||||||||||||||||||||
| Other comprehensive income/(loss) before allocation to noncontrolling interests | $ | (1,111) | $ | (894) | $ | (2,339) | $ | (338) | ||||||||||||||||||
| Comprehensive income/(loss) before allocation to noncontrolling interests | $ | 7,512 | $ | 7,265 | $ | 24,065 | $ | 18,296 | ||||||||||||||||||
| Less: Comprehensive income/(loss) attributable to noncontrolling interests | 10 | 9 | 16 | 48 | ||||||||||||||||||||||
| Comprehensive income/(loss) attributable to Pfizer Inc. | $ | 7,503 | $ | 7,256 | $ | 24,049 | $ | 18,248 |
(a)Reclassified into Other (income)/deductions—net and Cost of sales. See Note 7E.
(b)Reclassified into Other (income)/deductions—net.
See Accompanying Notes.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| (MILLIONS) | October 2, 2022 | December 31, 2021 | ||||||||||||
| (Unaudited) | ||||||||||||||
| Assets | ||||||||||||||
| Cash and cash equivalents | $ | 1,298 | $ | 1,944 | ||||||||||
| Short-term investments | 34,825 | 29,125 | ||||||||||||
| Trade accounts receivable, less allowance for doubtful accounts: 2022—$474; 2021—$492 | 16,076 | 11,479 | ||||||||||||
| Inventories | 9,513 | 9,059 | ||||||||||||
| Current tax assets | 2,544 | 4,266 | ||||||||||||
| Other current assets | 6,149 | 3,820 | ||||||||||||
| Total current assets | 70,403 | 59,693 | ||||||||||||
| Equity-method investments | 9,826 | 16,472 | ||||||||||||
| Long-term investments | 4,062 | 5,054 | ||||||||||||
| Property, plant and equipment, less accumulated depreciation: 2022—$14,931; 2021—$15,074 | 15,441 | 14,882 | ||||||||||||
| Identifiable intangible assets | 28,151 | 25,146 | ||||||||||||
| Goodwill | 49,441 | 49,208 | ||||||||||||
| Noncurrent deferred tax assets and other noncurrent tax assets | 7,136 | 3,341 | ||||||||||||
| Other noncurrent assets | 10,890 | 7,679 | ||||||||||||
| Total assets | $ | 195,350 | $ | 181,476 | ||||||||||
| Liabilities and Equity | ||||||||||||||
| Short-term borrowings, including current portion of long-term debt: 2022—$2,566; 2021—$1,636 | $ | 4,040 | $ | 2,241 | ||||||||||
| Trade accounts payable | 6,267 | 5,578 | ||||||||||||
| Dividends payable | 2,245 | 2,249 | ||||||||||||
| Income taxes payable | 3,071 | 1,266 | ||||||||||||
| Accrued compensation and related items | 2,852 | 3,332 | ||||||||||||
| Deferred revenues | 6,191 | 3,067 | ||||||||||||
| Other current liabilities | 19,647 | 24,939 | ||||||||||||
| Total current liabilities | 44,314 | 42,671 | ||||||||||||
| Long-term debt | 32,629 | 36,195 | ||||||||||||
| Pension benefit obligations | 2,738 | 3,489 | ||||||||||||
| Postretirement benefit obligations | 222 | 235 | ||||||||||||
| Noncurrent deferred tax liabilities | 616 | 349 | ||||||||||||
| Other taxes payable | 9,701 | 11,331 | ||||||||||||
| Other noncurrent liabilities | 12,239 | 9,743 | ||||||||||||
| Total liabilities | 102,459 | 104,013 | ||||||||||||
| Commitments and Contingencies | ||||||||||||||
| Common stock | 476 | 473 | ||||||||||||
| Additional paid-in capital | 91,359 | 90,591 | ||||||||||||
| Treasury stock | (113,945) | (111,361) | ||||||||||||
| Retained earnings | 122,967 | 103,394 | ||||||||||||
| Accumulated other comprehensive loss | (8,225) | (5,897) | ||||||||||||
| Total Pfizer Inc. shareholders’ equity | 92,631 | 77,201 | ||||||||||||
| Equity attributable to noncontrolling interests | 259 | 262 | ||||||||||||
| Total equity | 92,891 | 77,462 | ||||||||||||
| Total liabilities and equity | $ | 195,350 | $ | 181,476 |
See Accompanying Notes.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF EQUITY
(UNAUDITED)
| PFIZER INC. SHAREHOLDERS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Treasury Stock | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS, EXCEPT PER COMMON SHARE DATA) | Shares | Par Value | Add’l Paid-In Capital | Shares | Cost | Retained Earnings | Accum. Other Comp. Loss | Share- holders’ Equity | Non-controlling interests | Total Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance, July 3, 2022 | 9,496 | $ | 476 | $ | 91,183 | (3,903) | $ | (113,939) | $ | 116,608 | $ | (7,119) | $ | 87,208 | $ | 261 | $ | 87,469 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | 8,608 | 8,608 | 15 | 8,623 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income/(loss), net of tax | (1,106) | (1,106) | (5) | (1,111) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends declared, per share: $0.40 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock | (2,245) | (2,245) | (2,245) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Noncontrolling interests | — | (7) | (7) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payment transactions | 20 | — | 172 | — | (6) | (5) | 161 | 161 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of common stock | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other | 4 | — | — | — | 4 | (4) | — | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance, October 2, 2022 | 9,515 | $ | 476 | $ | 91,359 | (3,903) | $ | (113,945) | $ | 122,967 | $ | (8,225) | $ | 92,631 | $ | 259 | $ | 92,891 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PFIZER INC. SHAREHOLDERS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Treasury Stock | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS, EXCEPT PER COMMON SHARE DATA) | Shares | Par Value | Add’l Paid-In Capital | Shares | Cost | Retained Earnings | Accum. Other Comp. Loss | Share- holders’ Equity | Non-controlling interests | Total Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance, July 4, 2021 | 9,450 | $ | 472 | $ | 89,336 | (3,851) | $ | (111,356) | $ | 96,346 | $ | (4,758) | $ | 70,042 | $ | 273 | $ | 70,315 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | 8,146 | 8,146 | 12 | 8,159 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income/(loss), net of tax | (891) | (891) | (3) | (894) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends declared, per share: $0.39 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock | (2,192) | (2,192) | (2,192) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Noncontrolling interests | — | (8) | (8) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payment transactions | 13 | 1 | 637 | — | (3) | (1) | 634 | 634 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of common stock | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other | — | — | — | (47) | (47) | 1 | (46) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance, October 3, 2021 | 9,462 | $ | 473 | $ | 89,973 | (3,851) | $ | (111,359) | $ | 102,252 | $ | (5,649) | $ | 75,691 | $ | 275 | $ | 75,967 |
| PFIZER INC. SHAREHOLDERS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Treasury Stock | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS, EXCEPT PER COMMON SHARE DATA) | 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, 2022 | 9,471 | $ | 473 | $ | 90,591 | (3,851) | $ | (111,361) | $ | 103,394 | $ | (5,897) | $ | 77,201 | $ | 262 | $ | 77,462 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net income | 26,378 | 26,378 | 27 | 26,404 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income/(loss), net of tax | (2,328) | (2,328) | (11) | (2,339) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends declared, per share: $1.20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock | (6,734) | (6,734) | (6,734) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Noncontrolling interests | — | (7) | (7) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payment transactions | 45 | 2 | 760 | (12) | (584) | (71) | 108 | 108 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of common stock | (39) | (2,000) | (2,000) | (2,000) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other | 7 | — | — | — | 7 | (11) | (4) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance, October 2, 2022 | 9,515 | $ | 476 | $ | 91,359 | (3,903) | $ | (113,945) | $ | 122,967 | $ | (8,225) | $ | 92,631 | $ | 259 | $ | 92,891 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PFIZER INC. SHAREHOLDERS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Treasury Stock | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS, EXCEPT PER COMMON SHARE DATA) | 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 | 18,586 | 18,586 | 47 | 18,633 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income/(loss), net of tax | (338) | (338) | — | (338) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash dividends declared, per share: $1.17 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock | (6,569) | (6,569) | (6,569) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Noncontrolling interests | — | (8) | (8) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-based payment transactions | 56 | 3 | 1,300 | (11) | (371) | (77) | 855 | 855 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Purchases of common stock | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other | — | — | — | (81) | (81) | 1 | (79) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance, October 3, 2021 | 9,462 | $ | 473 | $ | 89,973 | (3,851) | $ | (111,359) | $ | 102,252 | $ | (5,649) | $ | 75,691 | $ | 275 | $ | 75,967 |
See Accompanying Notes.
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| Nine Months Ended | ||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | ||||||||||||
| Operating Activities | ||||||||||||||
| Net income before allocation to noncontrolling interests | $ | 26,404 | $ | 18,633 | ||||||||||
| Discontinued operations—net of tax | 4 | (248) | ||||||||||||
| Net income from continuing operations before allocation to noncontrolling interests | 26,400 | 18,881 | ||||||||||||
| Adjustments to reconcile net income before allocation to noncontrolling interests to net cash provided by operating activities: | ||||||||||||||
| Depreciation and amortization | 3,545 | 3,856 | ||||||||||||
| Asset write-offs and impairments | 287 | 93 | ||||||||||||
| Deferred taxes from continuing operations | (3,399) | (3,610) | ||||||||||||
| Share-based compensation expense | 508 | 686 | ||||||||||||
| Benefit plan contributions in excess of expense/income | (532) | (1,933) | ||||||||||||
| Other adjustments, net | 1,481 | (1,848) | ||||||||||||
| Other changes in assets and liabilities, net of acquisitions and divestitures | (7,605) | 10,867 | ||||||||||||
| Net cash provided by operating activities from continuing operations | 20,685 | 26,993 | ||||||||||||
| Net cash provided by/(used in) operating activities from discontinued operations | — | (327) | ||||||||||||
| Net cash provided by operating activities | 20,685 | 26,666 | ||||||||||||
| Investing Activities | ||||||||||||||
| Purchases of property, plant and equipment | (2,235) | (1,709) | ||||||||||||
| Purchases of short-term investments | (29,701) | (26,280) | ||||||||||||
| Proceeds from redemptions/sales of short-term investments | 35,087 | 15,852 | ||||||||||||
| Net (purchases of)/proceeds from redemptions/sales of short-term investments with original maturities of three months or less | (10,877) | (7,152) | ||||||||||||
| Purchases of long-term investments | (1,627) | (861) | ||||||||||||
| Proceeds from redemptions/sales of long-term investments | 446 | 569 | ||||||||||||
| Acquisition of business, net of cash acquired | (6,225) | — | ||||||||||||
| Dividends received from Haleon/GSK Consumer Healthcare JV (Note 2C) | 3,960 | — | ||||||||||||
| Other investing activities, net | (200) | (370) | ||||||||||||
| Net cash provided by/(used in) investing activities from continuing operations | (11,373) | (19,951) | ||||||||||||
| Net cash provided by/(used in) investing activities from discontinued operations | — | (8) | ||||||||||||
| Net cash provided by/(used in) investing activities | (11,373) | (19,960) | ||||||||||||
| Financing Activities | ||||||||||||||
| Proceeds from short-term borrowings | 3,887 | — | ||||||||||||
| Payments on short-term borrowings | (3,887) | (1) | ||||||||||||
| Net (payments on)/proceeds from short-term borrowings with original maturities of three months or less | 870 | 265 | ||||||||||||
| Proceeds from issuance of long-term debt | — | 997 | ||||||||||||
| Payments on long-term debt | (1,609) | (1,001) | ||||||||||||
| Purchases of common stock | (2,000) | — | ||||||||||||
| Cash dividends paid | (6,738) | (6,540) | ||||||||||||
| Other financing activities, net | (342) | (185) | ||||||||||||
| Net cash provided by/(used in) financing activities | (9,819) | (6,465) | ||||||||||||
| Effect of exchange-rate changes on cash and cash equivalents and restricted cash and cash equivalents | (139) | (32) | ||||||||||||
| Net increase/(decrease) in cash and cash equivalents and restricted cash and cash equivalents | (646) | 209 | ||||||||||||
| Cash and cash equivalents and restricted cash and cash equivalents, at beginning of period | 1,983 | 1,825 | ||||||||||||
| Cash and cash equivalents and restricted cash and cash equivalents, at end of period | $ | 1,338 | $ | 2,034 | ||||||||||
| Supplemental Cash Flow Information | ||||||||||||||
| Cash paid/(received) during the period for: | ||||||||||||||
| Income taxes | $ | 4,919 | $ | 2,943 | ||||||||||
| Interest paid | 1,121 | 1,205 | ||||||||||||
| Interest rate hedges | 28 | (26) | ||||||||||||
| Non-cash transaction: | ||||||||||||||
| Right-of-use assets obtained in exchange for lease liabilities | $ | 463 | $ | 1,552 |
See Accompanying Notes.
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 2021 Form 10-K. 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 2021 Form 10-K*.* Revenues, expenses, assets and liabilities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year.
Pfizer’s fiscal quarter-end for subsidiaries operating outside the U.S. is as of and for the three and nine months ended August 28, 2022 and August 29, 2021, and for U.S. subsidiaries is as of and for the three and nine months ended October 2, 2022 and October 3, 2021.
Beginning in the fourth quarter of 2021, we reorganized our commercial operations and began to manage our commercial operations through a global structure consisting of two operating segments, each led by a single manager: Biopharma, our innovative science-based biopharmaceutical business, and PC1, our global contract development and manufacturing organization and a leading supplier of specialty active pharmaceutical ingredients. Beginning in the third quarter of 2022, we made several additional organizational changes to further transform our operations to better leverage our expertise in certain areas and in anticipation of potential future new product launches. These changes include establishing a new commercial structure within our Biopharma operating segment and realigning certain enabling and platform functions across the organization to ensure alignment with this new operating structure. Biopharma is the only reportable segment. See Note 17A in our 2021 Form 10-K and Notes 9B and 13A below*.*
Business development activities completed in 2021 and 2022 impacted financial results in the periods presented. Discontinued operations in the periods presented relate to the previously divested Meridian subsidiary and post-closing adjustments for other previously divested businesses. See Notes 1A and 2B in our 2021 Form 10-K, and Note 2B below.
We have made certain reclassification adjustments to conform prior-period amounts to the current presentation for discontinued operations, acquired IPR&D expenses and segment reporting.
B. New Accounting Standard Adopted in 2022
On January 1, 2022, we early adopted a new accounting standard for contract assets and contract liabilities acquired in a business combination. Under the new standard, acquired contract assets and contract liabilities are required to be recognized and measured by the acquirer on the acquisition date in accordance with Accounting Standards Codification 606. This new guidance generally results in the acquirer recognizing contract assets and contract liabilities at the same amounts that were recorded by the acquiree. Previously, these amounts were recognized by the acquirer at fair value as of the acquisition date. We adopted this new standard on a prospective basis and there was no impact to our consolidated financial statements.
C. Revenues and Trade Accounts Receivable
*Revenue Recognition––*We record revenues from product sales when there is a transfer of control of the product from us to the customer. We typically determine transfer of control based on when the product is shipped or delivered and title passes to the customer. For certain contracts, the finished product may temporarily be stored at our or our third-party subcontractors’ locations under a bill-and-hold arrangement. Revenue is recognized on bill-and-hold arrangements at the point in time when the customer obtains control of the product and all of the following criteria have been met: the arrangement is substantive; the product is identified separately as belonging to the customer; the product is ready for physical transfer to the customer; and we do not have the ability to use the product or direct it to another customer. In determining when the customer obtains control of the product, we consider certain indicators, including whether we have a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received.
*Customers––*Our prescription pharmaceutical products, with the exception of Paxlovid, are sold principally to wholesalers, but we also sell directly to retailers, hospitals, clinics, government agencies and pharmacies. We principally sell Paxlovid to
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government agencies. In the U.S., we primarily sell our vaccine products directly to the federal government, CDC, wholesalers, individual provider offices, retail pharmacies and integrated delivery networks. Outside the U.S., we primarily sell our vaccines to government and non-government institutions.
*Deductions from Revenues––*Our accruals for Medicare, Medicaid and related state program and performance-based contract rebates, chargebacks, sales allowances and sales returns and cash discounts are as follows:
| (MILLIONS) | October 2, 2022 | December 31, 2021 | ||||||||||||
| Reserve against Trade accounts receivable, less allowance for doubtful accounts | $ | 1,133 | $ | 1,077 | ||||||||||
| Other current liabilities: | ||||||||||||||
| Accrued rebates | 3,991 | 3,811 | ||||||||||||
| Other accruals | 418 | 528 | ||||||||||||
| Other noncurrent liabilities | 497 | 433 | ||||||||||||
| Total accrued rebates and other sales-related accruals | $ | 6,038 | $ | 5,850 |
*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 and nine months ended October 2, 2022 and October 3, 2021, 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 1H in our 2021 Form 10-K.
D. Acquired In-Process Research and Development Expenses
In the first quarter of 2022, we began reporting acquired IPR&D expense as a separate line item in our consolidated statements of income. Acquired in-process research and development expenses includes costs incurred in connection with (a) all upfront and milestone payments on collaboration and in-license agreements, including premiums on equity securities and (b) asset acquisitions of acquired IPR&D. These costs were previously recorded in Research and development expenses. When we acquire net assets that do not constitute a business, as defined in U.S. GAAP, no goodwill is recognized and acquired IPR&D is expensed. The fair value of IPR&D acquired in connection with a business combination is recorded on the balance sheet as Identifiable intangible assets. See Notes 1E and 10 in our 2021 Form 10-K*.*
Note 2. Acquisitions, Discontinued Operations, Equity-Method Investment and Collaborative Arrangement
A. Acquisitions
ReViral––On June 9, 2022, which fell in our international third quarter of 2022, we acquired ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel antiviral therapeutics that target respiratory syncytial virus, for a total consideration of up to $536 million, including upfront payments of $436 million upon closing (including a base payment of $425 million plus working capital adjustments) and an additional $100 million contingent upon future development milestones.
We accounted for the transaction as an asset acquisition since the lead asset, sisunatovir, represented substantially all of the fair value of the gross assets acquired. At the acquisition date, we recorded a $426 million charge representing an acquired IPR&D asset with no alternative use in Acquired in-process research and development expenses, which is presented as a cash outflow from operating activities. Other assets acquired and liabilities assumed were not significant.
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*Arena––*On March 11, 2022, we acquired Arena, a clinical stage company, for $100 per share in cash. The total fair value of the consideration transferred was $6.6 billion ($6.2 billion, net of cash acquired). In addition, $138 million in payments to Arena employees for the fair value of previously unvested long-term incentive awards was recognized as post-closing compensation expense and recorded in Restructuring charges and certain acquisition-related costs (see Note 3).
Arena’s portfolio includes development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including UC, Crohn’s disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata. In connection with this acquisition, we provisionally recorded: (i) $5.5 billion in Identifiable intangible assets, consisting of $5.0 billion of IPR&D and $460 million of indefinite-lived Licensing agreements and other, (ii) $1.0 billion of Goodwill and (iii) $505 million of net deferred tax liabilities. The allocation of the consideration transferred to the assets acquired and the liabilities assumed has not yet been finalized.
B. Discontinued Operations
*Meridian––*On December 31, 2021, we completed the sale of our Meridian subsidiary. In the three and nine months ended October 2, 2022, the amounts recorded under the interim TSAs and MSA were not material.
*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. In connection with this transaction, Pfizer and Viatris entered into various agreements to effect the separation and combination and to provide a framework for our relationship after the combination, including a separation and distribution agreement, interim operating models, including agency arrangements, MSAs, TSAs, a tax matters agreement, and an employee matters agreement, among others. The amounts recorded under these agreements were not material to our consolidated results of operations in the three and nine months ended October 2, 2022 and October 3, 2021. Net amounts due from Viatris under the agreements were approximately $167 million as of October 2, 2022 and $53 million as of December 31, 2021. The cash flows associated with the 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.
Discontinued operations—net of tax for the three and nine months ended October 3, 2021 reflects pre-tax loss from discontinued operations of $17 million and $353 million, respectively, and primarily includes pre-disposal operations related to our former Meridian subsidiary including a $345 million pre-tax expense in the first nine months of 2021 to resolve a Multi-District Litigation relating to EpiPen against the Company in the U.S. District Court for the District of Kansas (prior to presenting Meridian as discontinued operations, this EpiPen litigation amount was included in Other (income)/deductions––net). For the three and nine months ended October 2, 2022, Discontinued operations—net of tax reflects pre-tax loss of $15 million and pre-tax income of $9 million from discontinued operations, respectively, and relates to post-closing adjustments for previously divested businesses primarily for tax and legal matters.
C. Equity-Method Investment
Haleon/*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 operated globally under the GSK Consumer Healthcare name. In exchange for the contribution of our consumer healthcare business to the JV, we received a 32% equity stake in the new company and GSK owned the remaining 68%. On July 18, 2022, GSK completed a demerger of the Consumer Healthcare JV which became Haleon, an independent, publicly traded company listed on the London Stock Exchange that holds the joint Consumer Healthcare business of GSK and Pfizer following the demerger. We continue to own 32% of the ordinary shares of Haleon after the demerger. We continue to account for our interest in Haleon as an equity-method investment. The carrying value of our investment in Haleon as of October 2, 2022 and in the Consumer Healthcare JV as of December 31, 2021 is $9.6 billion and $16.3 billion, respectively, and is reported in Equity-method investments. The fair value of our investment in Haleon as of October 2, 2022, based on quoted market prices of Haleon stock, was $9.1 billion. Haleon/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, 2021 is primarily due to dividends totaling approximately $4.5 billion, of which cash flows of $4.0 billion are included in Net cash used in investing activities from continuing operations and $584 million are included in Net cash provided by operating activities from continuing operations, as well as $2.4 billion in pre-tax foreign currency translation adjustments (see Note 6), partially offset by our share of the JV’s earnings. We record our share of earnings from Haleon/the Consumer Healthcare JV on a quarterly basis on a one-quarter lag in Other (income)/deductions––net. Our total share of the JV’s earnings generated in the second quarter of 2022, which we recorded in our operating results in the third quarter of 2022, was $67 million. Our total share of the JV’s earnings generated in the fourth quarter of 2021 and first six months of 2022, which we recorded in our operating results in the first nine months of
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2022, was $402 million. Our total share of the JV’s earnings generated in the second quarter of 2021, which we recorded in our operating results in the third quarter of 2021, was $106 million. Our total share of the JV’s earnings generated in the fourth quarter of 2020 and first six months of 2021, which we recorded in our operating results in the first nine months of 2021, was $324 million. In the third quarter and first nine months of 2022, our equity-method income included in Other (income)/deductions––net also includes charges of $118 million and $119 million, respectively, primarily for adjustments to our equity-method basis differences related to the separation of Haleon/the GSK Consumer Healthcare JV from GSK. 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 was not material to our results of operations in the third quarter and first nine months of 2021. See Note 4.
| Summarized financial information for our equity method investee, the Consumer Healthcare JV, for the three and nine months ending June 30, 2022, the most recent period available, and for the three and nine months ending June 30, 2021, is as follows: | ||||||||||||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||
| (MILLIONS) | June 30, 2022 | June 30, 2021 | June 30, 2022 | June 30, 2021 | ||||||||||||||||||||||||||||
| Net sales | $ | 3,218 | $ | 3,152 | $ | 10,164 | $ | 9,428 | ||||||||||||||||||||||||
| Cost of sales | (1,196) | (1,180) | (3,830) | (3,536) | ||||||||||||||||||||||||||||
| Gross profit | $ | 2,022 | $ | 1,972 | $ | 6,334 | $ | 5,892 | ||||||||||||||||||||||||
| Income from continuing operations | 226 | 348 | 1,303 | 1,064 | ||||||||||||||||||||||||||||
| Net income | 226 | 348 | 1,303 | 1,064 | ||||||||||||||||||||||||||||
| Income attributable to shareholders | 210 | 330 | 1,256 | 1,012 |
In connection with GSK’s previously announced planned demerger of at least 80% of GSK’s 68% equity interest in the Consumer Healthcare JV, in March 2022 the Consumer Healthcare JV completed its offering of a total aggregate principal amount of $8.75 billion in U.S. dollar-denominated senior notes of various maturities, €2.35 billion in euro-denominated senior notes of various maturities and £700 million in U.K. pound-denominated senior notes of various maturities (collectively, the “notes”). The notes were guaranteed by GSK generally up to and excluding the date of the demerger (the “Guarantee Assumption Date”). We agreed to indemnify GSK for 32% (representing our pro rata equity interest in the Consumer Healthcare JV) of any amount payable by GSK pursuant to its guarantee of the notes. Our indemnity was provided solely for the benefit of GSK. Neither we nor any of our subsidiaries were an issuer or guarantor of any of the notes.
Following its issuance of the notes in March 2022, which fell in our international second quarter of 2022, the Consumer Healthcare JV loaned to us and GSK the net proceeds received from the notes on a pro rata equity ownership basis, for which we received a loan of £2.9 billion ($3.7 billion as of the end of our second quarter of 2022), at an interest rate of 1.365% per annum payable semi-annually in arrears. In conjunction with the demerger, we received £3.5 billion ($4.2 billion) in dividends from the JV in July 2022, of which $4.0 billion related to a one-time pre-separation dividend, which decreased the carrying value of our investment (as discussed above). Simultaneous with the receipt of the dividends, we repaid the £2.9 billion loan from the JV. GSK similarly received pro rata dividends and simultaneously repaid its pro rata loan from the JV. In conjunction with these transactions, our indemnification of GSK’s guarantee discussed above was terminated.
D. Collaborative Arrangement
*Collaboration with Biohaven––*In November 2021, we entered into a collaboration and license agreement and related sublicense agreement with Biohaven and certain of its subsidiaries to commercialize rimegepant and zavegepant for the treatment and prevention of migraines outside of the U.S., subject to regulatory approval. Under the terms of the agreement, Biohaven would lead R&D globally and we would have the exclusive right to commercialization globally, outside of the U.S. Upon the closing of the transaction on January 4, 2022, we paid Biohaven $500 million, including an upfront payment of $150 million and an equity investment of $350 million. We recognized $263 million for the upfront payment and premium paid on our equity investment in Acquired in-process research and development expenses. In October 2022, within our fiscal fourth quarter of 2022, we acquired all outstanding common shares of Biohaven not already owned by us for $148.50 per share, in cash, for payments of approximately $11.5 billion.
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 continue our
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efforts to ensure our cost base and support model align appropriately with our operating structure. While certain direct costs transferred to the Consumer Healthcare JV, and to the Upjohn Business in connection with the spin-off, there are indirect costs which did not transfer. This program is primarily composed of the following three initiatives:
-
We are taking steps to restructure our corporate enabling functions to appropriately support our business, R&D and PGS platform functions. We expect costs, primarily related to restructuring our corporate enabling functions, of $1.8 billion, to be incurred primarily from 2020 through 2022, with substantially all costs to be cash expenditures. Actions include, among others, changes in location of certain activities, expanded use and co-location of centers of excellence and shared services, and increased use of digital technologies. The associated actions and the specific costs primarily include severance and benefit plan impacts, exit costs as well as associated implementation costs.
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In addition, we are transforming our commercial go-to market model in the way we engage patients and physicians. We have also made several organizational changes in the third quarter of 2022 to further transform our operations to better leverage our expertise in certain areas and in anticipation of potential future new product launches (see Note 1A). We expect costs of $1.4 billion to be incurred primarily from 2020 through 2022, with all costs to be cash expenditures. Actions include, among others, centralization of certain activities and enhanced use of digital technologies. The costs for this effort primarily include severance and associated implementation costs.
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We are also optimizing our manufacturing network under this program and incurring one-time costs for cost-reduction initiatives related to our manufacturing operations. We expect to incur costs of $800 million to be incurred primarily from 2020 through 2023, with approximately 25% of the costs to be non-cash. The costs for this effort include, among other things, severance costs, implementation costs, product transfer costs, site exit costs, as well as accelerated depreciation.
The program costs discussed above may be rounded and represent approximations.
From the start of this program in the fourth quarter of 2019 through October 2, 2022, we incurred costs of $2.8 billion, of which $1.1 billion ($862 million of restructuring charges) is associated with Biopharma.
B. Key Activities
| The following summarizes acquisitions and cost-reduction/productivity initiatives costs and credits: | ||||||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||
| Restructuring charges/(credits): | ||||||||||||||||||||||||||
| Employee terminations | $ | 158 | $ | 630 | $ | 293 | $ | 649 | ||||||||||||||||||
| Asset impairments | 17 | 10 | 44 | 7 | ||||||||||||||||||||||
| Exit costs/(credits) | 2 | 3 | 31 | — | ||||||||||||||||||||||
| Restructuring charges/(credits)(a) | 177 | 643 | 368 | 656 | ||||||||||||||||||||||
| Transaction costs(b) | — | — | 42 | — | ||||||||||||||||||||||
| Integration costs and other(c) | 22 | 3 | 170 | 11 | ||||||||||||||||||||||
| Restructuring charges and certain acquisition-related costs | 199 | 646 | 580 | 667 | ||||||||||||||||||||||
| Net periodic benefit costs/(credits) recorded in Other (income)/deductions––net | — | (63) | (5) | (51) | ||||||||||||||||||||||
| Additional depreciation––asset restructuring recorded in our condensed consolidated statements of income as follows(d): | ||||||||||||||||||||||||||
| Cost of sales | 7 | 19 | 22 | 53 | ||||||||||||||||||||||
| Selling, informational and administrative expenses | 1 | 8 | 1 | 23 | ||||||||||||||||||||||
| Total additional depreciation––asset restructuring | 7 | 27 | 22 | 76 | ||||||||||||||||||||||
| Implementation costs recorded in our condensed consolidated statements of income as follows(e): | ||||||||||||||||||||||||||
| Cost of sales | 14 | 8 | 40 | 29 | ||||||||||||||||||||||
| Selling, informational and administrative expenses | 136 | 142 | 344 | 287 | ||||||||||||||||||||||
| Research and development expenses | — | — | — | 1 | ||||||||||||||||||||||
| Total implementation costs | 150 | 151 | 384 | 316 | ||||||||||||||||||||||
| Total costs associated with acquisitions and cost-reduction/productivity initiatives | $ | 357 | $ | 760 | $ | 982 | $ | 1,008 |
(a)Primarily represents cost reduction initiatives. Restructuring charges/(credits) associated with Biopharma: charges of $62 million and $108 million for the three and nine months ended October 2, 2022, respectively, and charges of $616 million and $617 million for the three and nine months ended October 3, 2021, respectively.
(b)Represents external costs for banking, legal, accounting and other similar services.
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(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. In the three and nine months ended October 2, 2022, integration costs and other were mostly related to our acquisition of Arena, including $138 million in payments to Arena employees in the first quarter of 2022 for the fair value of previously unvested long-term incentive awards. See Note 2A.
(d)Represents the impact of changes in the estimated useful lives of assets involved in restructuring actions.
(e)Represents external, incremental costs directly related to implementing our non-acquisition-related cost-reduction/productivity initiatives.
| The following summarizes the components and changes in restructuring accruals: | ||||||||||||||||||||||||||
| (MILLIONS) | Employee Termination Costs | Asset Impairment Charges | Exit Costs | Accrual | ||||||||||||||||||||||
| Balance, December 31, 2021(a) | $ | 1,014 | $ | — | $ | 57 | $ | 1,071 | ||||||||||||||||||
| Provision | 293 | 44 | 31 | 368 | ||||||||||||||||||||||
| Utilization and other(b) | (447) | (44) | (80) | (572) | ||||||||||||||||||||||
| Balance, October 2, 2022(c) | $ | 859 | $ | — | $ | 8 | $ | 867 |
(a)Included in Other current liabilities ($816 million) and Other noncurrent liabilities ($255 million).
(b)Includes adjustments for foreign currency translation.
(c)Included in Other current liabilities ($758 million) and Other noncurrent liabilities ($110 million).
Note 4. Other (Income)/Deductions—Net
| Components of Other (income)/deductions––net include: | ||||||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||
| Interest income | $ | (70) | $ | (10) | $ | (114) | $ | (21) | ||||||||||||||||||
| Interest expense | 311 | 325 | 925 | 975 | ||||||||||||||||||||||
| Net interest expense | 240 | 315 | 811 | 954 | ||||||||||||||||||||||
| Royalty-related income | (239) | (261) | (628) | (649) | ||||||||||||||||||||||
| Net (gains)/losses on asset disposals | 7 | (1) | 6 | (99) | ||||||||||||||||||||||
| Net (gains)/losses recognized during the period on equity securities(a) | 112 | (400) | 1,353 | (1,601) | ||||||||||||||||||||||
| Income from collaborations, out-licensing arrangements and sales of compound/product rights(b) | (4) | (65) | (17) | (317) | ||||||||||||||||||||||
| Net periodic benefit costs/(credits) other than service costs | (306) | (1,132) | (294) | (1,635) | ||||||||||||||||||||||
| Certain legal matters, net | 77 | 38 | 175 | 112 | ||||||||||||||||||||||
| Certain asset impairments(c) | 200 | — | 200 | — | ||||||||||||||||||||||
| Haleon/Consumer Healthcare JV equity method (income)/loss(d) | 51 | (105) | (283) | (307) | ||||||||||||||||||||||
| Other, net | (198) | (84) | (260) | (502) | ||||||||||||||||||||||
| Other (income)/deductions––net | $ | (59) | $ | (1,696) | $ | 1,063 | $ | (4,043) |
(a)The losses in the first nine months of 2022 include, among other things, unrealized losses of $974 million related to investments in BioNTech, Cerevel Therapeutics Holdings, Inc. (Cerevel) and Arvinas. The gains in the third quarter and first nine months of 2021 included, among other things, unrealized gains of $420 million and $1.5 billion, respectively, related to investments in BioNTech and Cerevel.
(b)The first nine months of 2021 included, among other things, $188 million of net collaboration income from BioNTech in the first quarter of 2021 related to Comirnaty.
(c)The amount in the third quarter and first nine months of 2022 represents an intangible asset impairment charge associated with our Biopharma segment, representing an IPR&D asset for the unapproved indication of symptomatic dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA), acquired in our Array BioPharma Inc. acquisition. The intangible asset impairment charge was a result of the Phase 3 trial reaching futility at a pre-planned interim analysis.
(d)See Note 2C.
| Additional information about the intangible asset that was impaired during 2022 (impairment recorded in Other (income)/deductions–net) follows: | ||||||||||||||||||||||||||||||||
| Fair Value(a) | Nine Months Ended October 2, 2022 | |||||||||||||||||||||||||||||||
| (MILLIONS) | Amount | Level 1 | Level 2 | Level 3 | Impairment | |||||||||||||||||||||||||||
| Intangible asset––IPR&D(b) | $ | — | $ | — | $ | — | $ | — | $ | 200 | ||||||||||||||||||||||
(a)The fair value amount is presented as of the date of impairment, as this asset is not measured at fair value on a recurring basis. See also Note 1F in our 2021 Form 10-K*.*
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(b)Reflects an intangible asset written down to fair value in 2022. Fair value was determined using the income approach, specifically the multi-period excess earnings method, also known as the discounted cash flow method. We started with a forecast of all the expected net cash flows for the asset and then applied an asset-specific discount rate to arrive at a net present value amount. Some of the more significant estimates and assumptions inherent in this approach include: the amount and timing of the projected net cash flows, which includes the expected impact of competitive, legal and/or regulatory forces on the product; the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and the tax rate, which seeks to incorporate the geographic diversity of the projected cash flows.
Note 5. Tax Matters
A. Taxes on Income from Continuing Operations
Our effective tax rate for continuing operations was 4.0% for the third quarter of 2022, compared to (4.2)% for the third quarter of 2021, and was 10.5% for the first nine months of 2022, compared to 7.8% for the first nine months of 2021. The higher effective tax rates for the third quarter and first nine months of 2022, compared to the third quarter and first nine months of 2021, were mainly due to the non-recurrence of certain initiatives executed in the third quarter of 2021 associated with our investment in the Consumer Healthcare JV with GSK, partially offset by tax benefits in the third quarter of 2022 related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years that included the closing of U.S. IRS audits covering five tax years.
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 fourth annual installment of this liability was paid by its April 18, 2022 due date. The fifth annual installment is due April 18, 2023 and is reported in current Income taxes payable as of October 2, 2022*.* 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. During the third quarter of 2022, Pfizer reached resolution of disputed issues at the IRS Independent Office of Appeals, thereby settling all issues related to U.S. tax returns of Pfizer for the years 2011-2015. With respect to Pfizer, tax years 2016-2018 are under audit. Tax years 2019-2022 are open but not under audit. All other tax years are closed. In addition to the open audit years in the U.S., we have open audit years in certain major international tax jurisdictions dating back to 2011.
For additional information, see Note 5D in our 2021 Form 10-K.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
C. Tax Provision/(Benefit) on Other Comprehensive Income/(Loss)
| Components of Tax provision/(benefit) on other comprehensive income/(loss) include: | ||||||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||
| Foreign currency translation adjustments, net(a) | $ | 20 | $ | (32) | $ | (165) | $ | (30) | ||||||||||||||||||
| Unrealized holding gains/(losses) on derivative financial instruments, net | 47 | 21 | 177 | 28 | ||||||||||||||||||||||
| Reclassification adjustments for (gains)/losses included in net income | (72) | 13 | (97) | 48 | ||||||||||||||||||||||
| (25) | 34 | 80 | 76 | |||||||||||||||||||||||
| Unrealized holding gains/(losses) on available-for-sale securities, net | (97) | (33) | (175) | (16) | ||||||||||||||||||||||
| Reclassification adjustments for (gains)/losses included in net income | 76 | 1 | 137 | (22) | ||||||||||||||||||||||
| (21) | (32) | (38) | (37) | |||||||||||||||||||||||
| Reclassification adjustments related to amortization of prior service costs and other, net | (7) | (22) | (23) | (39) | ||||||||||||||||||||||
| Reclassification adjustments related to curtailments of prior service costs and other, net | — | (14) | (3) | (15) | ||||||||||||||||||||||
| (8) | (36) | (26) | (54) | |||||||||||||||||||||||
| Tax provision/(benefit) on other comprehensive income/(loss) | $ | (33) | $ | (65) | $ | (149) | $ | (44) |
(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(a) | Derivative Financial Instruments | Available-For-Sale Securities | Prior Service (Costs)/Credits and Other | Accumulated Other Comprehensive Income/(Loss) | |||||||||||||||||||||||||||||||||
| Balance, December 31, 2021 | $ | (6,172) | $ | 119 | $ | (220) | $ | 377 | $ | (5,897) | ||||||||||||||||||||||||||||
| Other comprehensive income/(loss) | (2,373) | 391 | (265) | (81) | (2,328) | |||||||||||||||||||||||||||||||||
| Balance, October 2, 2022 | $ | (8,545) | $ | 509 | $ | (485) | $ | 296 | $ | (8,225) |
(a)Amounts do not include foreign currency translation adjustments attributable to noncontrolling interests. Foreign currency translation adjustments include net losses related to our equity method investment in Haleon/the Consumer Healthcare JV (see Note 2C) and the impact of our net investment hedging program.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 7. Financial Instruments
A. Fair Value Measurements
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis and Fair Value Hierarchy, using a Market Approach:
| October 2, 2022 | December 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Total | Level 1 | Level 2 | Total | Level 1 | Level 2 | ||||||||||||||||||||||||||||||||||||||
| Financial assets: | ||||||||||||||||||||||||||||||||||||||||||||
| Short-term investments | ||||||||||||||||||||||||||||||||||||||||||||
| Equity securities with readily determinable fair values: | ||||||||||||||||||||||||||||||||||||||||||||
| Money market funds | $ | 12,154 | $ | — | $ | 12,154 | $ | 5,365 | $ | — | $ | 5,365 | ||||||||||||||||||||||||||||||||
| Available-for-sale debt securities: | ||||||||||||||||||||||||||||||||||||||||||||
| Government and agency—non-U.S. | 15,885 | — | 15,885 | 17,318 | — | 17,318 | ||||||||||||||||||||||||||||||||||||||
| Government and agency—U.S. | 2,931 | — | 2,931 | 4,050 | — | 4,050 | ||||||||||||||||||||||||||||||||||||||
| Corporate and other | 1,361 | — | 1,361 | 647 | — | 647 | ||||||||||||||||||||||||||||||||||||||
| 20,176 | — | 20,176 | 22,014 | — | 22,014 | |||||||||||||||||||||||||||||||||||||||
| Total short-term investments | 32,330 | — | 32,330 | 27,379 | — | 27,379 | ||||||||||||||||||||||||||||||||||||||
| Other current assets | ||||||||||||||||||||||||||||||||||||||||||||
| Derivative assets: | ||||||||||||||||||||||||||||||||||||||||||||
| Interest rate contracts | 9 | — | 9 | 4 | — | 4 | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | 1,950 | — | 1,950 | 704 | — | 704 | ||||||||||||||||||||||||||||||||||||||
| Total other current assets | 1,959 | — | 1,959 | 709 | — | 709 | ||||||||||||||||||||||||||||||||||||||
| Long-term investments | ||||||||||||||||||||||||||||||||||||||||||||
| Equity securities with readily determinable fair values(a) | 2,972 | 2,960 | 12 | 3,876 | 3,849 | 27 | ||||||||||||||||||||||||||||||||||||||
| Available-for-sale debt securities: | ||||||||||||||||||||||||||||||||||||||||||||
| Government and agency—non-U.S. | 285 | — | 285 | 465 | — | 465 | ||||||||||||||||||||||||||||||||||||||
| Government and agency—U.S. | — | — | — | 6 | — | 6 | ||||||||||||||||||||||||||||||||||||||
| Corporate and other | 73 | — | 73 | 50 | — | 50 | ||||||||||||||||||||||||||||||||||||||
| 358 | — | 358 | 521 | — | 521 | |||||||||||||||||||||||||||||||||||||||
| Total long-term investments | 3,330 | 2,960 | 370 | 4,397 | 3,849 | 548 | ||||||||||||||||||||||||||||||||||||||
| Other noncurrent assets | ||||||||||||||||||||||||||||||||||||||||||||
| Derivative assets: | ||||||||||||||||||||||||||||||||||||||||||||
| Interest rate contracts | — | — | — | 16 | — | 16 | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | 812 | — | 812 | 242 | — | 242 | ||||||||||||||||||||||||||||||||||||||
| Total derivative assets | 812 | — | 812 | 259 | — | 259 | ||||||||||||||||||||||||||||||||||||||
| Insurance contracts(b) | 631 | — | 631 | 808 | — | 808 | ||||||||||||||||||||||||||||||||||||||
| Total other noncurrent assets | 1,444 | — | 1,444 | 1,067 | — | 1,067 | ||||||||||||||||||||||||||||||||||||||
| Total assets | $ | 39,063 | $ | 2,960 | $ | 36,103 | $ | 33,552 | $ | 3,849 | $ | 29,703 | ||||||||||||||||||||||||||||||||
| Financial liabilities: | ||||||||||||||||||||||||||||||||||||||||||||
| Other current liabilities | ||||||||||||||||||||||||||||||||||||||||||||
| Derivative liabilities: | ||||||||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | $ | 295 | $ | — | $ | 295 | $ | 476 | $ | — | $ | 476 | ||||||||||||||||||||||||||||||||
| Total other current liabilities | 295 | — | 295 | 476 | — | 476 | ||||||||||||||||||||||||||||||||||||||
| Other noncurrent liabilities | ||||||||||||||||||||||||||||||||||||||||||||
| Derivative liabilities: | ||||||||||||||||||||||||||||||||||||||||||||
| Interest rate contracts | 330 | — | 330 | — | — | — | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | 1,153 | — | 1,153 | 405 | — | 405 | ||||||||||||||||||||||||||||||||||||||
| Total other noncurrent liabilities | 1,482 | — | 1,482 | 405 | — | 405 | ||||||||||||||||||||||||||||||||||||||
| Total liabilities | $ | 1,777 | $ | — | $ | 1,777 | $ | 881 | $ | — | $ | 881 |
(a)Long-term equity securities of $139 million as of October 2, 2022 and $194 million as of December 31, 2021 were held in restricted trusts for U.S. non-qualified employee benefit plans.
(b)Includes life insurance policies held in restricted trusts for U.S. non-qualified employee benefit plans. The underlying invested assets in these contracts are marketable securities, which are carried at fair value, with changes in fair value recognized in Other (income)/deductions—net (see Note 4).
*Financial Assets and Liabilities Not Measured at Fair Value on a Recurring Basis––*The carrying value of Long-term debt, excluding the current portion was $33 billion as of October 2, 2022 and $36 billion as of December 31, 2021. The estimated fair value of such debt, using a market approach and Level 2 inputs, was $29 billion as of October 2, 2022 and $42 billion as of December 31, 2021.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The differences between the estimated fair values and carrying values of held-to-maturity debt securities, private equity securities, long-term receivables and short-term borrowings not measured at fair value on a recurring basis were not significant as of October 2, 2022 and December 31, 2021. The fair value measurements of our held-to-maturity debt securities and short-term borrowings are based on Level 2 inputs. The fair value measurements of our long-term receivables and private equity securities are based on Level 3 inputs.
B. Investments
Total Short-Term, Long-Term and Equity-Method Investments
| The following summarizes our investments by classification type: | ||||||||||||||
| (MILLIONS) | October 2, 2022 | December 31, 2021 | ||||||||||||
| Short-term investments | ||||||||||||||
| Equity securities with readily determinable fair values(a) | $ | 12,154 | $ | 5,365 | ||||||||||
| Available-for-sale debt securities | 20,176 | 22,014 | ||||||||||||
| Held-to-maturity debt securities | 2,495 | 1,746 | ||||||||||||
| Total Short-term investments | $ | 34,825 | $ | 29,125 | ||||||||||
| Long-term investments | ||||||||||||||
| Equity securities with readily determinable fair values(b) | $ | 2,972 | $ | 3,876 | ||||||||||
| Available-for-sale debt securities | 358 | 521 | ||||||||||||
| Held-to-maturity debt securities | 36 | 34 | ||||||||||||
| Private equity securities at cost(b) | 696 | 623 | ||||||||||||
| Total Long-term investments | $ | 4,062 | $ | 5,054 | ||||||||||
| Equity-method investments | 9,826 | 16,472 | ||||||||||||
| Total long-term investments and equity-method investments | $ | 13,888 | $ | 21,526 | ||||||||||
| Held-to-maturity cash equivalents | $ | 969 | $ | 268 |
(a)Includes money market funds primarily invested in U.S. Treasury and government debt.
(b)Represent investments in the life sciences sector.
Debt Securities
| At October 2, 2022, our investment portfolio consisted of debt securities issued across diverse governments, corporate and financial institutions, which are investment-grade. The contractual or estimated maturities, are as follows: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| October 2, 2022 | December 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | $ | 16,711 | $ | 26 | $ | (567) | $ | 16,169 | $ | 15,885 | $ | 285 | $ | — | $ | 18,032 | $ | 13 | $ | (263) | $ | 17,783 | |||||||||||||||||||||||||||||||||||||||||||||||||
| Government and agency––U.S. | 2,932 | — | (1) | 2,931 | 2,931 | — | — | 4,056 | — | (1) | 4,055 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Corporate and other | 1,446 | — | (12) | 1,434 | 1,361 | 73 | — | 698 | — | (1) | 697 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Held-to-maturity debt securities | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Time deposits and other | 1,557 | — | — | 1,557 | 1,525 | 20 | 12 | 947 | — | — | 947 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Government and agency*––*non-U.S. | 1,943 | — | — | 1,943 | 1,939 | 3 | 1 | 1,102 | — | — | 1,102 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total debt securities | $ | 24,589 | $ | 26 | $ | (580) | $ | 24,034 | $ | 23,641 | $ | 381 | $ | 13 | $ | 24,835 | $ | 14 | $ | (265) | $ | 24,584 |
Any expected credit losses to these portfolios would be immaterial to our financial statements.
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 | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||
| Net (gains)/losses recognized during the period on equity securities(a) | $ | 112 | $ | (400) | $ | 1,353 | $ | (1,601) | ||||||||||||||||||
| Less: Net (gains)/losses recognized during the period on equity securities sold during the period | (5) | (78) | (84) | (83) | ||||||||||||||||||||||
| Net unrealized (gains)/losses during the reporting period on equity securities still held at the reporting date(b) | $ | 116 | $ | (322) | $ | 1,436 | $ | (1,518) |
(a)Reported in Other (income)/deductions––net. See Note 4.
(b)Included in net unrealized (gains)/losses are observable price changes on equity securities without readily determinable fair values. As of October 2, 2022, there were cumulative impairments and downward adjustments of $148 million and upward adjustments of $201 million. Impairments, downward and upward adjustments were not significant in the third quarter and first nine months of 2022 and 2021.
C. Short-Term Borrowings
| Short-term borrowings include: | ||||||||||||||
| (MILLIONS) | October 2, 2022 | December 31, 2021 | ||||||||||||
| Current portion of long-term debt, principal amount | $ | 2,550 | $ | 1,636 | ||||||||||
| Other short-term borrowings, principal amount(a) | 1,474 | 605 | ||||||||||||
| Total short-term borrowings, principal amount | 4,024 | 2,241 | ||||||||||||
| Net fair value adjustments related to hedging and purchase accounting | 16 | — | ||||||||||||
| Total Short-term borrowings, including current portion of long-term debt, carried at historical proceeds, as adjusted | $ | 4,040 | $ | 2,241 |
(a)Primarily 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) | October 2, 2022 | December 31, 2021 | ||||||||||||
| Total long-term debt, principal amount | $ | 31,831 | $ | 34,948 | ||||||||||
| Net fair value adjustments related to hedging and purchase accounting | 976 | 1,438 | ||||||||||||
| Net unamortized discounts, premiums and debt issuance costs | (178) | (195) | ||||||||||||
| Other long-term debt | — | 4 | ||||||||||||
| Total long-term debt, carried at historical proceeds, as adjusted | $ | 32,629 | $ | 36,195 | ||||||||||
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. Where foreign exchange risk is not offset by other exposures, 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, and Canadian dollar, and include a portion of our forecasted foreign exchange-denominated intercompany inventory sales hedged up to two years. We may seek to protect against possible declines in the reported net investments of our foreign business entities.
*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.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| The following summarizes the fair value of the derivative financial instruments and notional amounts (including those reported as part of discontinued operations): | ||||||||||||||||||||||||||||||||||||||
| October 2, 2022 | December 31, 2021 | |||||||||||||||||||||||||||||||||||||
| Fair Value | Fair Value | |||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Notional | Asset | Liability | Notional | Asset | Liability | ||||||||||||||||||||||||||||||||
| Derivatives designated as hedging instruments: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts(a) | $ | 33,274 | $ | 2,479 | $ | 1,175 | $ | 29,576 | $ | 787 | $ | 717 | ||||||||||||||||||||||||||
| Interest rate contracts | 2,250 | 9 | 330 | 2,250 | 21 | — | ||||||||||||||||||||||||||||||||
| 2,488 | 1,505 | 808 | 717 | |||||||||||||||||||||||||||||||||||
| Derivatives not designated as hedging instruments: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | $ | 26,426 | 283 | 273 | $ | 21,419 | 160 | 164 | ||||||||||||||||||||||||||||||
| Total | $ | 2,771 | $ | 1,777 | $ | 968 | $ | 881 |
(a)The notional amount of outstanding foreign exchange contracts hedging our intercompany forecasted inventory sales was $4.5 billion as of October 2, 2022 and $4.8 billion as of December 31, 2021.
| 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) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments in Cash Flow Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts(b) | $ | — | $ | — | $ | 528 | $ | 204 | $ | 558 | $ | (59) | ||||||||||||||||||||||||||
| Amount excluded from effectiveness testing and amortized into earnings(c) | — | — | 61 | 10 | 57 | 10 | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments in Fair Value Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
| Interest rate contracts | (124) | (5) | — | — | — | — | ||||||||||||||||||||||||||||||||
| Hedged item | 124 | 5 | — | — | — | — | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments in Net Investment Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | — | — | 680 | 177 | — | — | ||||||||||||||||||||||||||||||||
| Amount excluded from effectiveness testing and amortized into earnings(c) | — | — | 78 | 19 | 32 | 26 | ||||||||||||||||||||||||||||||||
| Non-Derivative Financial Instruments in Net Investment Hedge Relationships:(d) | ||||||||||||||||||||||||||||||||||||||
| Foreign currency short-term borrowings | — | — | — | 25 | — | — | ||||||||||||||||||||||||||||||||
| Foreign currency long-term debt | — | — | 49 | 19 | — | — | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments Not Designated as Hedges: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | (420) | (74) | — | — | — | — | ||||||||||||||||||||||||||||||||
| All other net(c) | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||
| $ | (420) | $ | (74) | $ | 1,396 | $ | 453 | $ | 647 | $ | (21) | |||||||||||||||||||||||||||
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| Gains/(Losses) Recognized in OID(a) | Gains/(Losses) Recognized in OCI(a) | Gains/(Losses) Reclassified from OCI into OID and COS(a) | ||||||||||||||||||||||||||||||||||||
| Nine Months Ended | ||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments in Cash Flow Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts(b) | $ | — | $ | — | $ | 1,339 | $ | 147 | $ | 872 | $ | (314) | ||||||||||||||||||||||||||
| Amount excluded from effectiveness testing and amortized into earnings(c) | — | — | 105 | 31 | 100 | 28 | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments in Fair Value Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
| Interest rate contracts | (346) | (6) | — | — | — | — | ||||||||||||||||||||||||||||||||
| Hedged item | 346 | 6 | — | — | — | — | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments in Net Investment Hedge Relationships: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | — | — | 1,613 | 332 | — | — | ||||||||||||||||||||||||||||||||
| Amount excluded from effectiveness testing and amortized into earnings(c) | — | — | 63 | 54 | 95 | 82 | ||||||||||||||||||||||||||||||||
| Non-Derivative Financial Instruments in Net Investment Hedge Relationships:(d) | ||||||||||||||||||||||||||||||||||||||
| Foreign currency short-term borrowings | — | — | 26 | 52 | — | — | ||||||||||||||||||||||||||||||||
| Foreign currency long-term debt | — | — | 119 | 66 | — | — | ||||||||||||||||||||||||||||||||
| Derivative Financial Instruments Not Designated as Hedges: | ||||||||||||||||||||||||||||||||||||||
| Foreign exchange contracts | (832) | (97) | — | — | — | — | ||||||||||||||||||||||||||||||||
| All other net(c) | — | — | — | 1 | — | 1 | ||||||||||||||||||||||||||||||||
| $ | (832) | $ | (97) | $ | 3,264 | $ | 683 | $ | 1,068 | $ | (204) |
(a)OID = Other (income)/deductions—net, included in Other (income)/deductions—net in the condensed consolidated statements of income*.* COS = Cost of Sales, included in Cost of sales in the condensed consolidated statements of income. OCI = Other comprehensive income/(loss), included in the condensed consolidated statements of comprehensive income*.*
(b)The amounts reclassified from OCI into COS were:
-
a net gain of $125 million in the third quarter of 2022;
-
a net gain of $227 million in the first nine months of 2022;
-
a net loss of $18 million in the third quarter of 2021; and
-
a net loss of $94 million in the first nine months of 2021.
The remaining amounts were reclassified from OCI into OID. Based on quarter-end foreign exchange rates that are subject to change, we expect to reclassify a pre-tax gain of $1 billion 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 21 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 related short-term borrowings’ carrying value as of December 31, 2021 was $1.1 billion. The related long-term debt carrying values as of October 2, 2022 and December 31, 2021 were $726 million and $844 million, respectively.
| The following summarizes cumulative basis adjustments to our debt in fair value hedges: | ||||||||||||||||||||||||||||||||||||||
| October 2, 2022 | December 31, 2021 | |||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| Short-term borrowings, including current portion of long-term debt | $ | — | $ | — | $ | 16 | $ | — | $ | — | $ | — | ||||||||||||||||||||||||||
| Long-term debt | $ | 2,235 | $ | (330) | $ | 1,061 | $ | 2,233 | $ | 16 | $ | 1,154 |
(a)Carrying amounts exclude the cumulative amount of fair value hedging adjustments.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
F. Credit Risk
A significant portion of our trade accounts receivable balances are due from wholesalers and governments. For additional information on our trade accounts receivables with significant customers, see Note 13C below and Note 17C in our 2021 Form 10-K.
As of October 2, 2022, the largest investment exposures in our portfolio represent primarily sovereign debt instruments issued by Germany, the U.S., the Netherlands, Japan, the U.K., France, and Canada, as well as money market funds primarily invested in U.S. Treasury and government debt.
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 master agreements with credit-support annexes that contain zero threshold provisions requiring collateral to be exchanged daily depending on levels of exposure. As a result, there are no significant concentrations of credit risk with any individual financial institution. As of October 2, 2022, the aggregate fair value of these derivative financial instruments that are in a net payable position was $595 million, for which we have posted collateral of $612 million with a corresponding amount reported in Short-term investments. As of October 2, 2022, the aggregate fair value of our derivative financial instruments that are in a net receivable position was $1.5 billion, for which we have received collateral of $1.5 billion with a corresponding amount reported in Short-term borrowings, including current portion of long-term debt.
Note 8. Other Financial Information
A. Inventories
| The following summarizes the components of Inventories: | ||||||||||||||
| (MILLIONS) | October 2, 2022 | December 31, 2021 | ||||||||||||
| Finished goods | $ | 3,159 | $ | 3,641 | ||||||||||
| Work-in-process | 4,540 | 4,424 | ||||||||||||
| Raw materials and supplies | 1,813 | 994 | ||||||||||||
| Inventories(a) | $ | 9,513 | $ | 9,059 | ||||||||||
| Noncurrent inventories not included above(b) | $ | 3,327 | $ | 939 |
(a)The increase from December 31, 2021 primarily reflects higher inventory levels for Paxlovid, partially offset by decreases due to net supply recovery and inventory build, and market demand.
(b)Included in Other noncurrent assets. The increase from December 31, 2021 is primarily due to strategic inventory build related to Paxlovid. There are no recoverability issues for these amounts.
B. Other Current Liabilities
Other current liabilities includes, among other things, amounts payable to BioNTech for the gross profit split for Comirnaty, which totaled $4.5 billion as of October 2, 2022 and $9.7 billion as of December 31, 2021.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 9. Identifiable Intangible Assets
A. Identifiable Intangible Assets
| The following summarizes the components of Identifiable intangible assets: | ||||||||||||||||||||||||||||||||||||||
| October 2, 2022 | December 31, 2021 | |||||||||||||||||||||||||||||||||||||
| (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 | $ | 72,818 | $ | (55,309) | $ | 17,509 | $ | 73,346 | $ | (53,732) | $ | 19,614 | ||||||||||||||||||||||||||
| Brands | 922 | (832) | 90 | 922 | (807) | 115 | ||||||||||||||||||||||||||||||||
| Licensing agreements and other | 2,296 | (1,373) | 923 | 2,284 | (1,299) | 985 | ||||||||||||||||||||||||||||||||
| 76,036 | (57,514) | 18,522 | 76,552 | (55,838) | 20,714 | |||||||||||||||||||||||||||||||||
| Indefinite-lived intangible assets | ||||||||||||||||||||||||||||||||||||||
| Brands | 827 | 827 | 827 | 827 | ||||||||||||||||||||||||||||||||||
| IPR&D(a) | 7,829 | 7,829 | 3,092 | 3,092 | ||||||||||||||||||||||||||||||||||
| Licensing agreements and other(a) | 972 | 972 | 513 | 513 | ||||||||||||||||||||||||||||||||||
| 9,629 | 9,629 | 4,432 | 4,432 | |||||||||||||||||||||||||||||||||||
| Identifiable intangible assets(a), (b) | $ | 85,665 | $ | (57,514) | $ | 28,151 | $ | 80,984 | $ | (55,838) | $ | 25,146 |
(a)The increase in the gross carrying amounts mainly reflect the impact of the acquisition of Arena (see Note 2A), and for IPR&D, is partially offset by an impairment (see Note 4).
(b)The increase is primarily due to the acquisition of Arena, partially offset by amortization expense.
B. Goodwill
| The following summarizes the changes in the carrying amount of Goodwill: | ||||||||||||||||||||||||||||||||
| (MILLIONS) | Total(a) | |||||||||||||||||||||||||||||||
| Balance, January 1, 2022 | $ | 49,208 | ||||||||||||||||||||||||||||||
| Additions(b) | 1,029 | |||||||||||||||||||||||||||||||
| Other(c) | (797) | |||||||||||||||||||||||||||||||
| Balance, October 2, 2022 | $ | 49,441 |
(a)All goodwill is assigned within the Biopharma reportable segment. As a result of the organizational changes to the commercial structure within the Biopharma operating segment effective in the third quarter of 2022 (see Note 1A), our goodwill is required to be reallocated amongst impacted reporting units. The allocation of goodwill is a complex process that requires, among other things, that we determine the fair value of each reporting unit under our old and new organizational structure and the portions being transferred. Therefore, we have not yet completed the allocation, but it will be completed in the current year.
(b)Additions relate to our acquisition of Arena. See Note 2A.
(c)Other represents the impact of foreign exchange.
Note 10. Pension and Postretirement Benefit Plans
| The following summarizes the components of net periodic benefit cost/(credit): | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pension Plans | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| U.S. | International | Postretirement Plans | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Oct. 2, 2022 | Oct. 3, 2021 | Oct. 2, 2022 | Oct. 3, 2021 | Oct. 2, 2022 | Oct. 3, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Service cost | $ | — | $ | — | $ | 29 | $ | 32 | $ | 7 | $ | 9 | ||||||||||||||||||||||||||||||||||||||||||||
| Interest cost | 151 | 114 | 38 | 37 | 7 | 7 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Expected return on plan assets | (195) | (261) | (72) | (83) | (12) | (10) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Amortization of prior service cost/(credit) | — | — | — | — | (31) | (39) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Actuarial (gains)/losses(a) | (193) | (836) | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Curtailments | — | — | — | — | (1) | (64) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Special termination benefits | 1 | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Net periodic benefit cost/(credit) reported in income | $ | (235) | $ | (983) | $ | (6) | $ | (14) | $ | (30) | $ | (96) | ||||||||||||||||||||||||||||||||||||||||||||
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| Pension Plans | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| U.S. | International | Postretirement Plans | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nine Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | Oct. 2, 2022 | Oct. 3, 2021 | Oct. 2, 2022 | Oct. 3, 2021 | Oct. 2, 2022 | Oct. 3, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Service cost | $ | — | $ | — | $ | 89 | $ | 98 | $ | 22 | $ | 27 | ||||||||||||||||||||||||||||||||||||||||||||
| Interest cost | 387 | 341 | 121 | 110 | 21 | 22 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Expected return on plan assets | (685) | (782) | (229) | (246) | (35) | (29) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Amortization of prior service credits | 1 | (1) | (1) | (1) | (99) | (116) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Actuarial (gains)/losses(a) | 231 | (881) | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Curtailments | — | — | — | (1) | (14) | (64) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Special termination benefits | 8 | 12 | — | — | 1 | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Net periodic benefit cost/(credit) reported in income | $ | (57) | $ | (1,312) | $ | (20) | $ | (40) | $ | (106) | $ | (160) |
(a)The third quarter of 2022 mainly reflects interim actuarial remeasurement gains, primarily driven by an increase in the discount rate, partially offset by unfavorable plan asset performance. The first nine months of 2022 mainly reflects interim actuarial remeasurement losses, primarily driven by unfavorable plan asset performance, partially offset by gains due to an increase in the discount rate. In the third quarter and first nine months of 2021, mainly reflects interim actuarial remeasurement gains, primarily due to favorable plan asset performance and an increase in the discount rate.
The components of net periodic benefit cost/(credit) other than the service cost component are primarily included in Other (income)/deductions––net (see Note 4).
For the nine months ended October 2, 2022, we contributed $207 million, $127 million, and $16 million to our U.S. Pension Plans, International Pension Plans, and Postretirement Plans, respectively, from our general assets, which include direct employer benefit payments.
Note 11. Earnings Per Common Share Attributable to Pfizer Inc. Common Shareholders
| The following presents the detailed calculation of EPS: | ||||||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||
| EPS Numerator––Basic | ||||||||||||||||||||||||||
| Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 8,630 | $ | 8,159 | $ | 26,373 | $ | 18,834 | ||||||||||||||||||
| Discontinued operations––net of tax | (21) | (13) | 4 | (248) | ||||||||||||||||||||||
| Net income attributable to Pfizer Inc. common shareholders | $ | 8,608 | $ | 8,146 | $ | 26,378 | $ | 18,586 | ||||||||||||||||||
| EPS Numerator––Diluted | ||||||||||||||||||||||||||
| Income from continuing operations attributable to Pfizer Inc. common shareholders and assumed conversions | $ | 8,630 | $ | 8,159 | $ | 26,373 | $ | 18,834 | ||||||||||||||||||
| Discontinued operations––net of tax, attributable to Pfizer Inc. common shareholders and assumed conversions | (21) | (13) | 4 | (248) | ||||||||||||||||||||||
| Net income attributable to Pfizer Inc. common shareholders and assumed conversions | $ | 8,608 | $ | 8,146 | $ | 26,378 | $ | 18,586 | ||||||||||||||||||
| EPS Denominator | ||||||||||||||||||||||||||
| Weighted-average number of common shares outstanding––Basic | 5,607 | 5,609 | 5,606 | 5,597 | ||||||||||||||||||||||
| Common-share equivalents: stock options and stock issuable under employee compensation plans | 111 | 116 | 124 | 91 | ||||||||||||||||||||||
| Weighted-average number of common shares outstanding––Diluted | 5,718 | 5,725 | 5,729 | 5,688 | ||||||||||||||||||||||
| Anti-dilutive common stock equivalents(a) | 3 | — | 1 | 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.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 12. Contingencies and Certain Commitments
We and certain of our subsidiaries are subject to numerous contingencies arising in the ordinary course of business, including tax and legal contingencies. 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. An adverse outcome could result in loss of patent protection for a product, a significant loss of revenues from a product or impairment of the value of associated assets. We are the plaintiff in the majority of these actions.
-
Product liability and other product-related litigation related to current or former products, which can include personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, among others, and 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, and 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, royalty payments, fines and/or civil penalties, which could be substantial, and/or criminal charges.
We believe that our claims and defenses in matters in which we are a defendant are substantial, but litigation is inherently unpredictable and excessive verdicts do occur. We do not believe that any of these matters will have a material adverse effect on our financial position. However, we could incur judgments, enter into settlements or revise our expectations regarding the outcome of matters, which could have a material adverse effect on our results of operations and/or our cash flows in the period in which the amounts are accrued or paid.
We have accrued for losses that are both probable and reasonably estimable. Substantially all of our contingencies are subject to significant uncertainties and, therefore, determining the likelihood of a loss and/or the measurement of any loss can be complex. Consequently, we are unable to estimate the range of reasonably possible loss in excess of amounts accrued. Our assessments, which result from a complex series of judgments about future events and uncertainties, are based on estimates and assumptions that have been deemed reasonable by management, but that may prove to be incomplete or inaccurate, and unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions.
Amounts recorded for legal and environmental contingencies can result from a complex series of judgments about future events and uncertainties and can rely heavily on estimates and assumptions. For proceedings under environmental laws to which a governmental authority is a party, we have adopted a disclosure threshold of $1 million in potential or actual governmental monetary sanctions.
The principal pending matters to which we are a party are discussed below. In determining whether a pending matter is a principal matter, we consider both quantitative and qualitative factors to assess materiality, such as, among others, the amount of damages and the nature of other relief sought, if specified; our view of the merits of the claims and of the strength of our defenses; whether the action purports to be, or is, a class action and, if not certified, our view of the likelihood that a class will be certified by the court; the jurisdiction in which the proceeding is pending; whether related actions have been transferred to multidistrict litigation; any experience that we or, to our knowledge, other companies have had in similar proceedings; whether disclosure of the action would be important to a reader of our financial statements, including whether disclosure might change a reader’s judgment about our financial statements in light of all of the information that is available to the reader; the potential impact of the proceeding on our reputation; and the extent of public interest in the matter. In addition, with respect to patent matters in which we are the plaintiff, we consider, among other things, the financial significance of the product protected by the patent(s) at issue. Some of the matters discussed below include those which management believes that the likelihood of possible loss in excess of amounts accrued is remote.
A1. Legal Proceedings––Patent Litigation
We are involved in suits relating to our patents, including but not limited to, those discussed below. Most involve claims by generic drug manufacturers that patents covering our products (or those of our collaboration/licensing partners to which we
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
have licenses or co-promotion rights and to which we may or may not be a party), processes or dosage forms are invalid and/or do not cover the product of the generic drug manufacturer. Also, counterclaims, as well as various independent actions, have been filed alleging that our assertions of, or attempts to enforce, patent rights with respect to certain products constitute unfair competition and/or violations of antitrust laws. In addition to the challenges to the U.S. patents that are discussed below, patent rights to certain of our products or those of our collaboration/licensing partners are being challenged in various other jurisdictions. Some of our collaboration or licensing partners face challenges to the validity of their patent rights in non-U.S. jurisdictions. For example, in April 2022, the U.K. High Court issued a judgment finding invalid a BMS patent related to Eliquis due to expire in 2026. In November 2022, BMS received permission to appeal the High Court’s decision. Additional challenges remain pending in other jurisdictions. Also, for example, in July 2022, CureVac AG (CureVac) brought a patent infringement action against BioNTech and certain of its subsidiaries in the German Regional Court alleging that Comirnaty infringes certain German utility model patents and certain expired and unexpired European patents. Additional challenges involving Comirnaty patents may be filed against us and/or BioNTech in other jurisdictions in the future. In addition, in October 2022, Accord Healthcare Ltd. brought suit in the U.K. against the Regents of the University of California challenging the validity of the U.K. patent covering the active ingredient in Xtandi, which expires in 2028. Adverse decisions in these matters could have a material adverse effect on our results of operations. We are also party to patent damages suits in various jurisdictions pursuant to which generic drug manufacturers, payers, governments or other parties are seeking damages from us for allegedly causing delay of generic entry.
We also are often involved in other proceedings, such as inter partes review, post-grant review, re-examination or opposition proceedings, before the U.S. Patent and Trademark Office, the European Patent Office, or other foreign counterparts relating to our intellectual property or the intellectual property rights of others. Also, if one of our patents is found to be invalid by such proceedings, generic or competitive products could be introduced into the market resulting in the erosion of sales of our existing products. For example, several of the patents in our pneumococcal vaccine portfolio have been challenged in inter partes review and post-grant review proceedings in the U.S. Patent and Trademark Office. In addition, another patent was challenged in federal court in Delaware; and that case was settled in September 2021 on terms not material to the company. Other challenges to pneumococcal vaccine patents remain pending at the Patent Trial and Appeal Board and outside the U.S. The invalidation of any of the patents in our pneumococcal portfolio could potentially allow additional competitor vaccines, if approved, to enter the marketplace earlier than anticipated. In the event that any of the patents are found valid and infringed, a competitor’s vaccine, if approved, 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 products to market. If one of our marketed products is found to infringe valid patent rights of a third party, such third party may be awarded significant damages or royalty payments, 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
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 October 2021, we brought a separate patent-infringement action against Sinotherapeutics Inc. (Sinotherapeutics) asserting the infringement and validity of our patent covering extended release formulations of tofacitinib that was challenged by Sinotherapeutics in its ANDA seeking approval to market a generic version of tofacitinib 11 mg extended release tablets.
In June 2022, we brought a separate patent infringement action against MSN Laboratories Private Ltd. (MSN) asserting the infringement and validity of our compound patent covering the active agreement that was challenged by MSN in its ANDAs seeking approval to market generic versions of tofacitinib immediate release tablets (5 mg, 10 mg) and oral solution 1 mg/mL. In August 2022, we settled our action against MSN on terms not material to us.
Inlyta (axitinib)
In 2019, Glenmark Pharmaceuticals Ltd. (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.
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Ibrance (palbociclib)
Beginning in January 2021, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Ibrance tablets. The generic companies are challenging some or all of the following patents: (i) the composition of matter patent expiring in 2027; (ii) the composition of matter patent expiring in 2023; (iii) the method of use patent expiring in 2023; (iv) the crystalline form patent expiring in 2034; and (v) a tablet formulation patent expiring in 2036. We brought patent infringement actions against each of the generic filers in various U.S. federal courts, asserting the validity and infringement of the patents challenged by the generic companies. We have settled with one of these generic companies on terms not material to us, and we dismissed the patent infringement actions relating to the crystalline form of patent, the composition of matter patent expiring in 2023, the method of use patent, and the tablet formulation patent against the generic companies that had challenged these patents. The composition of matter patent expiring in 2027 remains in suit.
Eucrisa
Beginning in September 2021, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Eucrisa. The companies assert the invalidity and non-infringement of a composition of matter patent expiring in 2026, two method of use patents expiring in 2027, and one other method of use patent expiring in 2030. In September 2021, we brought patent infringement actions against the generic filers in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the patents challenged by the generic companies.
Braftovi (encorafenib)
In August 2022, a generic company notified us that it had filed an ANDA with the FDA seeking approval to market a generic version of Braftovi. The company asserts the invalidity and non-infringement of, among others, a method of use patent expiring in 2033. In September 2022, we brought a patent infringement action against the generic company in the U.S. District Court for the District of Delaware, asserting the validity and infringement of the method of use patent expiring in 2033.
Mektovi (binimetinib)
Beginning in August 2022, several generic companies notified us that they had filed ANDAs with the FDA seeking approval to market generic versions of Mektovi. The companies assert the invalidity and non-infringement of two method of use patents expiring in 2030, a method of use patent expiring in 2031, two method of use patents expiring in 2033, and a product by process patent expiring in 2033. Beginning in September 2022, we brought patent infringement actions against the generic filers in the U.S. District Court for the District of Delaware, asserting the validity and infringement of all six patents.
Actions in Which We are the Defendant
Comirnaty
In March 2022, Alnylam Pharmaceuticals, Inc. (Alnylam) filed a complaint in the U.S. District Court for the District of Delaware against Pfizer and Pharmacia & Upjohn Co. LLC, our wholly owned subsidiary, alleging that Comirnaty infringes U.S. Patent No. 11,246,933, which was issued in February 2022, and seeking unspecified monetary damages. In July 2022, Alnylam filed a second complaint in the U.S. District Court for the District of Delaware against Pfizer, Pharmacia & Upjohn Co. LLC, BioNTech and BioNTech Manufacturing GmbH, alleging that Comirnaty infringes U.S. Patent No. 11,382,979, which was issued in July 2022, and seeking unspecified monetary damages.
In August 2022, ModernaTX, Inc. (ModernaTX) and Moderna US, Inc. (Moderna) sued Pfizer, BioNTech, BioNTech Manufacturing GmbH and BioNTech US Inc. in the U.S. District Court for the District of Massachusetts, alleging that Comirnaty infringes three U.S. patents. In its complaint, Moderna stated that it is seeking damages for alleged infringement occurring only after March 7, 2022.
In August 2022, ModernaTX filed a patent infringement action in Germany against Pfizer and certain subsidiary companies, as well as BioNTech and certain subsidiary companies, alleging that Comirnaty infringes two European patents. In September 2022, ModernaTX filed patent infringement actions in the U.K and in the Netherlands against Pfizer Inc. and certain subsidiary companies, as well as BioNTech and certain subsidiary companies, on the same two patents. In its complaints, Moderna stated that it is seeking damages for alleged infringement occurring only after March 7, 2022. In the U.K., Pfizer and BioNTech have brought an action against ModernaTX seeking to revoke these European patents.
Paxlovid
In June 2022, Enanta Pharmaceuticals, Inc. filed a complaint in the U.S. District Court for the District of Massachusetts against Pfizer alleging that the active ingredient in Paxlovid, nirmatrelvir, infringes U.S. Patent No. 11,358,953, which was issued in June 2022, and seeking unspecified monetary damages.
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Matters Involving Pfizer and its Collaboration/Licensing Partners
Eliquis
In 2017, twenty-five generic companies sent BMS Paragraph-IV certification letters informing BMS that they had filed ANDAs seeking approval of generic versions of Eliquis, challenging the validity and infringement of one or more of the three patents listed in the Orange Book for Eliquis. One of the patents expired in December 2019 and the remaining patents currently are set to expire in 2026 and 2031. Eliquis has been jointly developed and is being commercialized by BMS and Pfizer. BMS and Pfizer filed patent-infringement actions against all generic filers in the U.S. District Court for the District of Delaware and the U.S. District Court for the District of West Virginia, asserting that each of the generic companies’ proposed products would infringe each of the patent(s) that each generic filer challenged. Some generic filers challenged only the 2031 patent, some challenged both the 2031 and 2026 patent, and one generic company challenged all three patents. In August 2020, the U.S. District Court for the District of Delaware ruled that both the 2026 patent and the 2031 patent are valid and infringed by the proposed generic products. In August and September 2020, the generic filers appealed the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit. Prior to the August 2020 ruling, we and BMS settled with certain of the companies on terms not material to us, and we and BMS may settle with other generic companies in the future. In September 2021, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court’s decision.
Comirnaty
In July 2022, Pfizer, BioNTech and BioNTech Manufacturing GmbH filed a declaratory judgment complaint against CureVac in the U.S. District Court for the District of Massachusetts seeking a judgment of non-infringement for the following three patents relating to Comirnaty: U.S. Patent Nos. 11,135,312, 11,149,278, and 11,241,493. Outside of the U.S., in the U.K., Pfizer and BioNTech have sued CureVac seeking a judgment of invalidity of several patents and CureVac has made certain infringement counterclaims.
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
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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 Laboratories Ltd. (Ranbaxy) and certain Ranbaxy affiliates. The plaintiffs in these various actions seek to represent nationwide, multi-state or statewide classes consisting of persons or entities who directly purchased, indirectly purchased or reimbursed patients for the purchase of Lipitor (or, in certain of the actions, generic Lipitor) from any of the defendants from March 2010 until the cessation of the defendants’ allegedly unlawful conduct (the Class Period). The plaintiffs allege delay in the launch of generic Lipitor, in violation of federal antitrust laws and/or state antitrust, consumer protection and various other laws, resulting from (i) the 2008 agreement pursuant to which Pfizer and Ranbaxy settled certain patent litigation involving Lipitor and Pfizer granted Ranbaxy a license to sell a generic version of Lipitor in various markets beginning on varying dates, and (ii) in certain of the actions, the procurement and/or enforcement of certain patents for Lipitor. Each of the actions seeks, among other things, treble damages on behalf of the putative class for alleged price overcharges for Lipitor (or, in certain of the actions, generic Lipitor) during the Class Period. In addition, individual actions have been filed against Pfizer, Ranbaxy and certain of their affiliates, among others, that assert claims and seek relief for the plaintiffs that are substantially similar to the claims asserted and the relief sought in the purported class actions described above. These various actions have been consolidated for pre-trial proceedings in a Multi-District Litigation in the U.S. District Court for the District of New Jersey.
In September 2013 and 2014, the District Court dismissed with prejudice the claims of the direct purchasers. In October and November 2014, the District Court dismissed with prejudice the claims of all other Multi-District Litigation plaintiffs. All plaintiffs appealed the District Court’s orders dismissing their claims with prejudice to the U.S. Court of Appeals for the Third Circuit. In addition, the direct purchaser class plaintiffs appealed the order denying their motion to amend the judgment and for leave to amend their complaint to the Court of Appeals. In 2017, the Court of Appeals reversed the District Court’s decisions and remanded the claims to the District Court.
Also, in 2013, the State of West Virginia filed an action in West Virginia state court against Pfizer and Ranbaxy, among others, that asserts claims and seeks relief on behalf of the State of West Virginia and residents of that state that are substantially similar to the claims asserted and the relief sought in the purported class actions described above.
EpiPen (Direct Purchaser)
In February 2020, a lawsuit was filed in the U.S. District Court for the District of Kansas against Pfizer, its current and former affiliates King and Meridian, and various Mylan entities, on behalf of a purported U.S. nationwide class of direct purchaser plaintiffs who purchased EpiPen devices directly from the defendants. Plaintiffs in this action generally allege that Pfizer and Mylan conspired to delay market entry of generic EpiPen through the settlement of patent litigation regarding EpiPen, and thereby delayed market entry of generic EpiPen in violation of federal antitrust law. Plaintiffs seek treble damages for alleged overcharges for EpiPen since 2011. In July 2021, the District Court granted defendants’ motion to dismiss the direct purchaser complaint, without prejudice. In September 2021, plaintiffs filed an amended complaint. In August 2022, the District Court granted Pfizer’s motion to dismiss the complaint.
Nexium 24HR and Protonix
A number of individual and multi-plaintiff lawsuits have been filed against Pfizer, certain of its subsidiaries and/or other pharmaceutical manufacturers in various federal and state courts alleging that the plaintiffs developed kidney-related injuries purportedly as a result of the ingestion of certain proton pump inhibitors. The cases against Pfizer involve Protonix and/or Nexium 24HR and seek compensatory and punitive damages and, in some cases, treble damages, restitution or disgorgement. In 2017, the federal actions were ordered transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the District of New Jersey. As part of our Consumer Healthcare JV transaction with GSK, the JV has agreed to assume, and to indemnify Pfizer for, liabilities arising out of such litigation to the extent related to Nexium 24HR.
Docetaxel
*•*Personal Injury Actions
A number of lawsuits have been filed against Hospira and Pfizer in various federal and state courts alleging that plaintiffs who were treated with Docetaxel developed permanent hair loss. The significant majority of the cases also name other defendants, including the manufacturer of the branded product, Taxotere. Plaintiffs seek compensatory and punitive damages. Additional lawsuits have been filed in which plaintiffs allege they developed blocked tear ducts following their treatment with Docetaxel.
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. In 2022, the eye injury 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.
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- Mississippi Attorney General Government Action
In 2018, the Attorney General of Mississippi filed a complaint in Mississippi state court against the manufacturer of the branded product and eight other manufacturers including Pfizer and Hospira, alleging, with respect to Pfizer and Hospira, a failure to warn about a risk of permanent hair loss in violation of the Mississippi Consumer Protection Act. The action seeks civil penalties and injunctive relief.
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. In 2006, Pfizer sold the consumer business that included its Zantac OTC rights to Johnson & Johnson and transferred the assets and liabilities related to Zantac OTC to Johnson & Johnson in connection with the sale. Plaintiffs in these cases seek compensatory and punitive damages.
In February 2020, the federal actions were transferred for coordinated pre-trial proceedings to a Multi-District Litigation in the U.S. District Court for the Southern District of Florida. Plaintiffs in the Multi-District Litigation have filed against Pfizer and many other defendants a master personal injury complaint, asserting a consolidated consumer class action alleging, among other things, claims under consumer protection statutes of all 50 states, and a medical monitoring complaint seeking to certify medical monitoring classes under the laws of 13 states. In addition, (i) Pfizer has received service of Canadian class action complaints naming Pfizer and other defendants, and seeking compensatory and punitive damages for personal injury and economic loss, allegedly arising from the defendants’ sale of Zantac in Canada; and (ii) the State of New Mexico and the Mayor and City Council of Baltimore separately filed civil actions against Pfizer and many other defendants in state courts, alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in those jurisdictions. In April 2021, a Judicial Council Coordinated Proceeding was created in the Superior Court of California in Alameda County to coordinate personal injury actions against Pfizer and other defendants filed in California state court. Coordinated proceedings have also been created in other state courts.
Chantix
Beginning in August 2021, a number of putative class actions have been filed against Pfizer in various U.S. federal courts following Pfizer’s voluntary recall of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline. Plaintiffs assert that they suffered economic harm purportedly as a result of purchasing Chantix or generic varenicline medicines sold by Pfizer. Plaintiffs seek to represent nationwide and state-specific classes and seek various remedies, including damages and medical monitoring. Similar putative class actions have been filed in Canada and Israel, where the product brand is Champix.
A3. Legal Proceedings––Commercial and Other Matters
Monsanto-Related Matters
In 1997, Monsanto Company (Former Monsanto) contributed certain chemical manufacturing operations and facilities to a newly formed corporation, Solutia Inc. (Solutia), and spun off the shares of Solutia. In 2000, Former Monsanto merged with Pharmacia & Upjohn Company to form Pharmacia. Pharmacia then transferred its agricultural operations to a newly created subsidiary, named Monsanto Company (New Monsanto), which it spun off in a two-stage process that was completed in 2002. Pharmacia was acquired by Pfizer in 2003 and is a wholly owned subsidiary of Pfizer.
In connection with its spin-off that was completed in 2002, New Monsanto assumed, and agreed to indemnify Pharmacia for, any liabilities related to Pharmacia’s former agricultural business. New Monsanto has defended and/or is defending Pharmacia in connection with various claims and litigation arising out of, or related to, the agricultural business, and has been indemnifying Pharmacia when liability has been imposed or settlement has been reached regarding such claims and litigation.
In connection with its spin-off in 1997, Solutia assumed, and agreed to indemnify Pharmacia for, liabilities related to Former Monsanto’s chemical businesses. As the result of its reorganization under Chapter 11 of the U.S. Bankruptcy Code, Solutia’s 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.
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Environmental Matters
In 2009, as part of our acquisition of Wyeth, we assumed responsibility for environmental remediation at the Wyeth Holdings LLC (formerly known as, Wyeth Holdings Corporation and American Cyanamid Company) discontinued industrial chemical facility in Bound Brook, New Jersey. Since that time, we have executed or have become a party to a number of administrative settlement agreements, orders on consent, and/or judicial consent decrees, with the U.S. Environmental Protection Agency and/or New Jersey Department of Environmental Protection to perform remedial design, removal and remedial actions, and related environmental remediation activities at the Bound Brook facility. We have accrued for the currently estimated costs of these activities.
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. In January 2022, the Court of Appeals reversed the District Court’s decision. In February 2022, the defendants filed for en banc review of the Court of Appeals’ decision.
Allergan Complaint for Indemnity
In 2019, Pfizer was named as a defendant in a complaint, along with King, filed by Allergan Finance LLC (Allergan) in the Supreme Court of the State of New York, asserting claims for indemnity related to Kadian, which was owned for a short period by King in 2008, prior to Pfizer's acquisition of King in 2010. This suit was voluntarily discontinued without prejudice in January 2021.
Viatris Securities Litigation
In October 2021, a putative class action was filed in the Court of Common Pleas of Allegheny County, Pennsylvania on behalf of former Mylan N.V. shareholders who received Viatris common stock in exchange for Mylan shares in connection with the spin-off of the Upjohn Business and its combination with Mylan (the Transactions). Viatris, Pfizer, and certain of each company’s current and former officers, directors and employees are named as defendants. The complaint alleges that the defendants violated certain provisions of the Securities Act of 1933 in connection with certain disclosures made in or omitted from the registration statement and related prospectus issued in connection with the Transactions. Plaintiff seeks damages, costs and expenses and other equitable and injunctive relief.
A4. Legal Proceedings––Government Investigations
We are subject to extensive regulation by government agencies in the U.S., other developed markets and multiple emerging markets in which we operate. Criminal charges, substantial fines and/or civil penalties, limitations on our ability to conduct business in applicable jurisdictions, corporate integrity or deferred prosecution agreements, as well as reputational harm and increased public interest in the matter could result from government investigations in the U.S. and other jurisdictions in which we do business. These matters often involve government requests for information on a voluntary basis or through subpoenas after which the government may seek additional information through follow-up requests or additional subpoenas. 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 and Multi-District 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
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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. The Multi-District Litigation also includes civil complaints filed by private plaintiffs and state counties against Pfizer, Greenstone and a significant number of other defendants asserting allegations that generally overlap with those asserted by the State Attorneys General.
Subpoena & Civil Investigative Demand relating to Tris Pharma/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 responded to that subpoena in full and have had no communication with the SDNY in connection with the subpoena since June 2019. Additionally, in September 2020, we received a Civil Investigative Demand (CID) from the Texas Attorney General’s office seeking records of a similar nature to those requested by the SDNY. We are producing records in response to this request.
Government Inquiries relating to Meridian Medical Technologies
In February 2019, we received a CID from the U.S. Attorney’s Office for the SDNY. The CID seeks records and information related to alleged quality issues involving the manufacture of auto-injectors at the 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 have produced records pursuant to these requests.
Zantac––State of New Mexico and Mayor and City Council of Baltimore Civil Actions
See Legal Proceedings––Product Litigation––Zantac above for information regarding civil actions separately filed by the State of New Mexico and the Mayor and City Council of Baltimore alleging various state statutory and common law claims in connection with the defendants’ alleged sale of Zantac in those jurisdictions.
Government Inquiries relating to Biohaven
In June 2022, the U.S. Department of Justice's Commercial Litigation Branch and the U.S. Attorney’s Office for the Western District of New York issued a CID relating to Biohaven. The CID seeks records and information related to, among other things, engagements with health care professionals and co-pay coupons cards. Biohaven is a wholly-owned subsidiary that we acquired in October 2022. We are producing records in response to these requests.
B. Guarantees and Indemnifications
In the ordinary course of business and in connection with the sale of assets and businesses and other transactions, we often indemnify our counterparties against certain liabilities that may arise in connection with the transaction or that are related to events and activities prior to or following a transaction. If the indemnified party were to make a successful claim pursuant to the terms of the indemnification, we may be required to reimburse the loss. These indemnifications are generally subject to various
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restrictions and limitations. Historically, we have not paid significant amounts under these provisions and, as of October 2, 2022, the estimated fair value of these indemnification obligations is not material to Pfizer. See Note 2C for a description of the March 2022 indemnity provided by Pfizer to GSK in connection with the issuance of notes by the Consumer Healthcare JV. In conjunction with the completion of GSK’s demerger transactions in July 2022, GSK’s guarantee and our related indemnification of GSK’s guarantee were terminated.
In addition, in connection with our entry into certain agreements and other transactions, our counterparties may be obligated to indemnify us. For example, in November 2020, we and Mylan completed the transaction to spin-off our Upjohn Business and combine it with Mylan to form Viatris. As part of the transaction and as previously disclosed, each of Viatris and Pfizer has agreed to assume, and to indemnify the other for, liabilities arising out of certain matters. Also, our global agreement with BioNTech to co-develop a mRNA-based coronavirus vaccine program aimed at preventing COVID-19 infection, includes certain indemnity provisions pursuant to which each of BioNTech and Pfizer has agreed to indemnify the other for certain liabilities that may arise in connection with certain third-party claims relating to Comirnaty.
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 1E in our 2021 Form 10-K.
Note 13. Segment, Geographic and Other Revenue Information
A. Segment Information
We manage our commercial operations through two operating segments, Biopharma and PC1, which are each led by a single manager. Biopharma is the only reportable segment. Each operating segment has responsibility for its commercial activities. Regional commercial organizations market, distribute and sell our products and are supported by global platform functions that are responsible for the research, development, manufacturing and supply of our products and global corporate enabling functions. Biopharma receives its R&D services from WRDM and GPD. These services include IPR&D projects for new investigational products and additional indications for in-line products. Each operating segment has a geographic footprint across developed and emerging markets. Our chief operating decision maker uses the revenues and earnings of the operating segments, among other factors, for performance evaluation and resource allocation.
After the organizational changes in the third quarter of 2022 (see Note 1A), the new commercial structure within Biopharma is designed to better support and optimize performance across three broad therapeutic areas:
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Primary Care consists of the former Internal Medicine and Vaccines product portfolios, as well as COVID-19 products and potential future mRNA products.
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Specialty Care consists of the former Inflammation & Immunology, Rare Disease and Hospital (excluding Paxlovid) product portfolios.
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Oncology consists of the former Oncology product portfolio.
*Other Costs and Business Activities––*Certain pre-tax costs are not allocated to our operating segment results, such as costs included in Other business activities that are associated with: (i) R&D and medical expenses managed by our WRDM and GPD organizations; (ii) corporate enabling functions and other corporate costs; (iii) overhead costs primarily associated with our manufacturing operations; and (iv) our share of earnings from Haleon/the Consumer Healthcare JV. Additionally, all amortization of intangible assets, acquisition-related items, and certain significant items, representing substantive and/or unusual, and in some cases recurring, items that are evaluated on an individual basis by management and that, either as a result of their nature or size, would not be expected to occur as part of our normal business on a regular basis, are not allocated to our operating segment results. Beginning in the first quarter of 2022, acquisition-related items may now include purchase accounting impacts that previously were included as part of a reconciling item entitled “Purchase accounting adjustments” that we no longer separately present, such as the incremental charge to cost of sales from the sale of acquired inventory that was written up to fair value, depreciation related to the increase/decrease in fair value of acquired fixed assets, amortization related to the increase in fair value of acquired debt, and the fair value changes for contingent consideration. The operating results of PC1 are included in Other business activities.
*Segment Assets––*We manage our assets on a total company basis, not by operating segment, as our operating assets are shared or commingled. Therefore, our chief operating decision maker does not regularly review any asset information by operating
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segment and, accordingly, we do not report asset information by operating segment. Total assets were $195 billion as of October 2, 2022 and $181 billion as of December 31, 2021.
Selected Income Statement Information
| The following provides selected income statement information by reportable segment: | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||
| Revenues | Earnings(a) | Revenues | Earnings(a) | |||||||||||||||||||||||||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | October 2, 2022 | October 3, 2021 | ||||||||||||||||||||||||||||||||||||||||||
| Reportable Segment: | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Biopharma | $ | 22,319 | $ | 23,513 | $ | 14,665 | $ | 11,848 | $ | 75,066 | $ | 56,101 | $ | 45,222 | $ | 29,952 | ||||||||||||||||||||||||||||||||||
| Other business activities(b) | 319 | 521 | (4,007) | (3,303) | 974 | 1,348 | (9,820) | (7,778) | ||||||||||||||||||||||||||||||||||||||||||
| Reconciling Items: | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Amortization of intangible assets | — | — | (822) | (980) | — | — | (2,478) | (2,778) | ||||||||||||||||||||||||||||||||||||||||||
| Acquisition-related items | — | — | (62) | (41) | — | — | (331) | (14) | ||||||||||||||||||||||||||||||||||||||||||
| Certain significant items(c) | — | — | (773) | 318 | — | — | (3,095) | 1,102 | ||||||||||||||||||||||||||||||||||||||||||
| $ | 22,638 | $ | 24,035 | $ | 9,001 | $ | 7,843 | $ | 76,040 | $ | 57,450 | $ | 29,498 | $ | 20,484 | |||||||||||||||||||||||||||||||||||
(a)I**ncome from continuing operations before provision/(benefit) for taxes on income. Biopharma’s earnings include dividend income from our investment in ViiV of $112 million in the third quarter of 2022 and $38 million in the third quarter of 2021, and $237 million in the first nine months of 2022 and $127 million in the first nine months of 2021. In connection with the organizational changes effective in the third quarter of 2022, certain functions transferred between Biopharma and corporate enabling functions and certain activities were realigned within the GPD organization. We have reclassified $105 million of costs for the first six months of 2022, $57 million of costs in the third quarter of 2021 and $153 million of costs in the first nine months of 2021 from corporate enabling functions, which are included in Other business activities, to Biopharma to conform to the current period presentation.
(b)Other business activities include revenues and costs associated with PC1 and costs that we do not allocate to our operating segments, per above, including acquired IPR&D expenses in the periods presented. In the third quarter and first nine months of 2022, earnings include $426 million of acquired IPR&D expenses for an upfront payment related to the closing of the acquisition of ReViral, as well as a charge to Cost of sales of approximately $400 million related to excess raw materials for Paxlovid. Earnings in the first nine months of 2022 also include write-offs to Cost of sales of inventory, related to COVID-19 products that have exceeded or are expected to exceed their approved shelf-lives prior to being used, of $516 million. In the third quarter and first nine months of 2021, earnings include $706 million of acquired IPR&D expenses associated with our collaboration with Arvinas.
(c)Certain significant items are substantive and/or unusual, and in some cases recurring, items (as noted above). Earnings in the first nine months of 2022 includes, among other items: (i) net losses on equity securities of $1.3 billion recorded in Other (income)/deductions––net and (ii) restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring of $701 million ($344 million recorded in Selling, informational and administrative expenses and the remaining amounts primarily recorded in Restructuring charges and certain acquisition-related costs). Earnings in the first nine months of 2021 includes, among other items: (i) net gains on equity securities of $1.6 billion recorded in Other (income)/deductions––net and (ii) actuarial valuation and other pension and postretirement plan gains of $932 million recorded in Other (income)/deductions––net, partially offset by (iii) restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring of $1.1 billion ($310 million recorded in Selling, informational and administrative expenses and the remaining amount primarily recorded in Restructuring charges and certain acquisition-related costs). Earnings in the third quarter of 2021 includes, among other items: (i) actuarial valuation and other pension and postretirement plan gains of $899 million recorded in Other (income)/deductions––net, partially offset by (ii) restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring of $823 million ($150 million recorded in Selling, informational and administrative expenses and the remaining amount primarily recorded in Restructuring charges and certain acquisition-related costs). For additional information, see Notes 3 and 4.
B. Geographic Information
| The following summarizes revenues by geographic area: | ||||||||||||||||||||||||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||||||||||||||
| (MILLIONS) | October 2, 2022 | October 3, 2021 | % Change | October 2, 2022 | October 3, 2021 | % Change | ||||||||||||||||||||||||||||||||
| United States | $ | 13,851 | $ | 7,020 | 97 | $ | 33,991 | $ | 22,066 | 54 | ||||||||||||||||||||||||||||
| Developed Europe | 3,136 | 6,221 | (50) | 14,705 | 13,836 | 6 | ||||||||||||||||||||||||||||||||
| Developed Rest of World | 2,351 | 4,498 | (48) | 10,671 | 8,617 | 24 | ||||||||||||||||||||||||||||||||
| Emerging Markets | 3,300 | 6,296 | (48) | 16,673 | 12,930 | 29 | ||||||||||||||||||||||||||||||||
| Revenues | $ | 22,638 | $ | 24,035 | (6) | $ | 76,040 | $ | 57,450 | 32 | ||||||||||||||||||||||||||||
C. Other Revenue Information
*Significant Customers––*For information on our significant wholesale customers, see Note 17C in our 2021 Form 10-K. Additionally, revenues from the U.S. government represented 38% and 27% of total revenues for the three and nine months ended October 2, 2022, respectively, and primarily represent sales of Paxlovid and Comirnaty. Accounts receivable from the
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
U.S. government represented 44% of total trade accounts receivable as of October 2, 2022, and primarily relate to sales of Paxlovid and Comirnaty.
Significant Product Revenues
The following provides detailed revenue information for several of our major products:
| (MILLIONS) | Three Months Ended | Nine Months Ended | ||||||||||||||||||||||||||||||
| PRODUCT | PRIMARY INDICATION OR CLASS | Oct. 2, 2022 | Oct. 3, 2021 | Oct. 2, 2022 | Oct. 3, 2021 | |||||||||||||||||||||||||||
| TOTAL REVENUES(a) | $ | 22,638 | $ | 24,035 | $ | 76,040 | $ | 57,450 | ||||||||||||||||||||||||
| GLOBAL BIOPHARMACEUTICALS BUSINESS (BIOPHARMA)(a), (b) | $ | 22,319 | $ | 23,513 | $ | 75,066 | $ | 56,101 | ||||||||||||||||||||||||
| Primary Care | $ | 15,846 | $ | 16,680 | $ | 55,676 | $ | 35,804 | ||||||||||||||||||||||||
| Comirnaty direct sales and alliance revenues(c) | Active immunization to prevent COVID-19 | 4,402 | 12,977 | 26,477 | 24,277 | |||||||||||||||||||||||||||
| Paxlovid | COVID-19 infection (high risk population) | 7,514 | — | 17,099 | — | |||||||||||||||||||||||||||
| Eliquis alliance revenues and direct sales | Nonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism | 1,464 | 1,346 | 5,001 | 4,470 | |||||||||||||||||||||||||||
| Prevnar family(d) | Pneumococcal disease | 1,607 | 1,447 | 4,601 | 3,971 | |||||||||||||||||||||||||||
| Premarin family | Symptoms of menopause | 110 | 148 | 327 | 420 | |||||||||||||||||||||||||||
| Nimenrix | Meningococcal ACWY disease | 79 | 51 | 221 | 145 | |||||||||||||||||||||||||||
| BMP2 | Development of bone and cartilage | 58 | 71 | 201 | 186 | |||||||||||||||||||||||||||
| FSME-IMMUN/TicoVac | Tick-borne encephalitis disease | 67 | 47 | 177 | 161 | |||||||||||||||||||||||||||
| Toviaz | Overactive bladder | 30 | 56 | 130 | 174 | |||||||||||||||||||||||||||
| Trumenba | Meningococcal B disease | 60 | 52 | 108 | 102 | |||||||||||||||||||||||||||
| Chantix/Champix | An aid to smoking cessation treatment in adults 18 years of age or older | 4 | 7 | 8 | 409 | |||||||||||||||||||||||||||
| All other Primary Care | Various | 451 | 479 | 1,326 | 1,490 | |||||||||||||||||||||||||||
| Specialty Care | $ | 3,404 | $ | 3,749 | $ | 10,267 | $ | 11,205 | ||||||||||||||||||||||||
| Vyndaqel/Vyndamax | ATTR-CM and polyneuropathy | 602 | 501 | 1,766 | 1,454 | |||||||||||||||||||||||||||
| Xeljanz | RA, PsA, UC, active polyarticular course juvenile idiopathic arthritis, ankylosing spondylitis | 502 | 610 | 1,304 | 1,734 | |||||||||||||||||||||||||||
| Enbrel (Outside the U.S. and Canada) | RA, juvenile idiopathic arthritis, PsA, plaque psoriasis, pediatric plaque psoriasis, ankylosing spondylitis and nonradiographic axial spondyloarthritis | 230 | 283 | 767 | 888 | |||||||||||||||||||||||||||
| Sulperazon | Bacterial infections | 178 | 181 | 598 | 515 | |||||||||||||||||||||||||||
| Inflectra | Crohn’s disease, pediatric Crohn’s disease, UC, pediatric UC, RA in combination with methotrexate, ankylosing spondylitis, PsA and plaque psoriasis | 131 | 172 | 403 | 485 | |||||||||||||||||||||||||||
| Ig Portfolio(e) | Various | 124 | 99 | 356 | 311 | |||||||||||||||||||||||||||
| BeneFIX | Hemophilia B | 99 | 104 | 325 | 328 | |||||||||||||||||||||||||||
| Zavicefta | Bacterial infections | 98 | 107 | 302 | 306 | |||||||||||||||||||||||||||
| Genotropin | Replacement of human growth hormone | 90 | 95 | 261 | 284 | |||||||||||||||||||||||||||
| Zithromax | Bacterial infections | 71 | 66 | 250 | 198 | |||||||||||||||||||||||||||
| Medrol | Anti-inflammatory glucocorticoid | 79 | 109 | 235 | 320 | |||||||||||||||||||||||||||
| Fragmin | Treatment/prevention of venous thromboembolism | 60 | 74 | 202 | 223 | |||||||||||||||||||||||||||
| Somavert | Acromegaly | 70 | 70 | 202 | 203 | |||||||||||||||||||||||||||
| Refacto AF/Xyntha | Hemophilia A | 58 | 69 | 188 | 235 | |||||||||||||||||||||||||||
| Vfend | Fungal infections | 51 | 51 | 171 | 204 | |||||||||||||||||||||||||||
| All other Anti-infectives | Various | 374 | 455 | 1,123 | 1,384 | |||||||||||||||||||||||||||
| All other Specialty Care | Various | 586 | 702 | 1,816 | 2,134 | |||||||||||||||||||||||||||
| Oncology | $ | 3,070 | $ | 3,085 | $ | 9,124 | $ | 9,091 | ||||||||||||||||||||||||
| Ibrance | HR-positive/HER2-negative metastatic breast cancer | 1,283 | 1,381 | 3,841 | 4,039 | |||||||||||||||||||||||||||
| Xtandi alliance revenues | mCRPC, nmCRPC, mCSPC | 320 | 309 | 878 | 879 | |||||||||||||||||||||||||||
| Inlyta | Advanced RCC | 252 | 256 | 760 | 742 | |||||||||||||||||||||||||||
| Zirabev | Treatment of mCRC; unresectable, locally advanced, recurrent or metastatic NSCLC; recurrent glioblastoma; metastatic RCC; and persistent, recurrent or metastatic cervical cancer | 146 | 96 | 432 | 311 | |||||||||||||||||||||||||||
| Bosulif | Philadelphia chromosome–positive chronic myelogenous leukemia | 141 | 136 | 425 | 395 | |||||||||||||||||||||||||||
| Xalkori | ALK-positive and ROS1-positive advanced NSCLC | 118 | 116 | 362 | 371 | |||||||||||||||||||||||||||
| Ruxience | Non-hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis | 120 | 124 | 357 | 343 |
PFIZER INC. AND SUBSIDIARY COMPANIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
| (MILLIONS) | Three Months Ended | Nine Months Ended | ||||||||||||||||||||||||||||||
| PRODUCT | PRIMARY INDICATION OR CLASS | Oct. 2, 2022 | Oct. 3, 2021 | Oct. 2, 2022 | Oct. 3, 2021 | |||||||||||||||||||||||||||
| Retacrit | Anemia | 87 | 110 | 308 | 322 | |||||||||||||||||||||||||||
| Sutent | Advanced and/or metastatic RCC, adjuvant RCC, refractory GIST (after disease progression on, or intolerance to, imatinib mesylate) and advanced pancreatic neuroendocrine tumor | 75 | 142 | 287 | 537 | |||||||||||||||||||||||||||
| Lorbrena | ALK-positive metastatic NSCLC | 99 | 67 | 247 | 193 | |||||||||||||||||||||||||||
| Bavencio alliance revenues | Locally advanced or metastatic urothelial carcinoma; metastatic Merkel cell carcinoma; immunotherapy and tyrosine kinase inhibitor combination for patients with advanced RCC | 73 | 54 | 198 | 122 | |||||||||||||||||||||||||||
| Aromasin | Post-menopausal early and advanced breast cancer | 66 | 56 | 187 | 159 | |||||||||||||||||||||||||||
| Besponsa | Relapsed or refractory B-cell acute lymphoblastic leukemia | 55 | 50 | 164 | 145 | |||||||||||||||||||||||||||
| Braftovi | In combination with Mektovi for metastatic melanoma in patients with a BRAFV600E/K mutation and, in combination with Erbitux® (cetuximab)(f), for the treatment of BRAFV600E -mutant mCRC after prior therapy | 58 | 47 | 156 | 136 | |||||||||||||||||||||||||||
| Trazimera | HER-positive breast cancer and metastatic stomach cancers | 51 | 45 | 149 | 131 | |||||||||||||||||||||||||||
| Mektovi | In combination with Braftovi for metastatic melanoma in patients with a BRAFV600E/K mutation | 45 | 41 | 129 | 112 | |||||||||||||||||||||||||||
| All other Oncology | Various | 80 | 53 | 243 | 155 | |||||||||||||||||||||||||||
| PFIZER CENTREONE(b) | $ | 319 | $ | 521 | $ | 974 | $ | 1,348 | ||||||||||||||||||||||||
| Total Alliance revenues included above | $ | 1,689 | $ | 2,068 | $ | 6,320 | $ | 5,718 |
(a)On December 31, 2021, we completed the sale of our Meridian subsidiary. Prior to its sale, Meridian was managed as part of the former Hospital therapeutic area (see footnote (b) below). Beginning in the fourth quarter of 2021, the financial results of Meridian are reflected as discontinued operations. See Note 1A.
(b)See Note 1A for information about our recent organizational changes. PC1 includes revenues from our contract manufacturing, including certain Comirnaty-related manufacturing activities performed on behalf of BioNTech ($7 million and $108 million for the third quarter and the first nine months of 2022, respectively, and $187 million and $274 million for the third quarter and the first nine months of 2021, respectively), and revenues from our active pharmaceutical ingredient sales operation, as well as revenues related to our manufacturing and supply agreements with former legacy Pfizer businesses/partnerships, including but not limited to, transitional manufacturing and supply agreements with Viatris following the spin-off of the Upjohn Business. Prior to the fourth quarter of 2021, PC1 was managed within our former Hospital product portfolio.
(c)Excludes revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech, which are included in the PC1 contract development and manufacturing organization.
(d)Prevnar family include revenues from Prevnar 13/Prevenar 13 (pediatric and adult) and Prevnar 20/Apexxnar (adult).
(e)Immunoglobulin (Ig) portfolio includes the revenues from Panzyga, Octagam and Cutaquig.
(f)Erbitux® is a registered trademark of ImClone LLC.
*Remaining Performance Obligations––*Contracted revenue expected to be recognized from remaining performance obligations for firm orders in long-term contracts to supply Comirnaty to our customers totaled approximately $22 billion as of October 2, 2022, which includes amounts received in advance and deferred, as well as amounts that will be invoiced as we deliver these products to our customers in future periods. Of this amount, we expect to recognize revenue of approximately $9 billion in 2022, $13 billion in 2023 and $200 million in 2024. Remaining performance obligations are based on foreign exchange rates as of the end of the third quarter of 2022 and exclude arrangements with an original expected contract duration of less than one year.
*Deferred Revenues––*Our deferred revenues primarily relate to advance payments received or receivable from various government or government sponsored customers in international markets for supply of Comirnaty and Paxlovid. The deferred revenues related to Comirnaty and Paxlovid total $6.2 billion as of October 2, 2022, with $6.1 billion and $126 million recorded in current and noncurrent liabilities, respectively. The deferred revenues related to Comirnaty total $3.3 billion as of December 31, 2021, with $3.0 billion and $249 million recorded in current liabilities and noncurrent liabilities, respectively. There were no deferred revenues associated with Paxlovid as of December 31, 2021. The increase in Comirnaty and Paxlovid deferred revenues during the first nine months of 2022 was primarily the result of additional advance payments received as we entered into new or amended contracts, including new advance payments received for Paxlovid contracts, less amounts recognized in Revenues as we delivered the products to our customers and the impact of foreign exchange. During the third quarter and first nine months of 2022, we recognized revenue of $68 million and $2.5 billion, respectively, that was included in the balance of Comirnaty deferred revenues as of December 31, 2021. The Comirnaty and Paxlovid deferred revenues as of October 2, 2022 will be recognized in Revenues proportionately as we transfer control of the products to our customers and satisfy our performance obligation under the contracts, with the amounts included in current liabilities expected to be recognized in Revenues within the next 12 months, and the amounts included in noncurrent liabilities expected to be recognized in Revenues in the last three months of 2023 and in the first quarter of 2024. Deferred revenues associated with contracts for other products were not significant as of October 2, 2022 or December 31, 2021.
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