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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended October 2, 2022
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______ to _______
COMMISSION FILE NUMBER 1-3619
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PFIZER INC.
(Exact name of registrant as specified in its charter)
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Delaware | 13-5315170 |
(State of Incorporation) | (I.R.S. Employer Identification No.) |
235 East 42nd Street, New York, New York 10017
(Address of principal executive offices) (zip code)
(212) 733-2323
(Registrant’s telephone number)
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Securities registered pursuant to Section 12(b) of the Act: |
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Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock, $.05 par value | | PFE | | New York Stock Exchange |
1.000% Notes due 2027 | | PFE27 | | New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large Accelerated filer x Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
At November 4, 2022, 5,613,314,537 shares of the issuer’s voting common stock were outstanding.
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Item 2. | |
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Item 3. | |
Defaults Upon Senior Securities | N/A |
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Item 4. | |
Mine Safety Disclosures | N/A |
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Item 5. | |
Other Information | N/A |
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N/A = Not Applicable | |
Unless the context requires otherwise, references to “Pfizer,” “the Company,” “we,” “us” or “our” in this Form 10-Q (defined below) refer to Pfizer Inc. and its subsidiaries. Pfizer’s fiscal quarter-end for subsidiaries operating outside the U.S. is as of and for the three and nine months ended August 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. References to “Notes” in this Form 10-Q are to the Notes to the Condensed or Consolidated Financial Statements in this Form 10-Q or in our 2021 Form 10-K. We also have used several other terms in this Form 10-Q, most of which are explained or defined below:
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2021 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2021 |
ACIP | Advisory Committee on Immunization Practices |
ALK | anaplastic lymphoma kinase |
Alliance revenues | Revenues from alliance agreements under which we co-promote products discovered or developed by other companies or us |
Arena | Arena Pharmaceuticals, Inc. |
Astellas | Astellas Pharma Inc., Astellas US LLC and Astellas Pharma US, Inc. |
Arvinas | Arvinas, Inc. |
ATTR-CM | transthyretin amyloid cardiomyopathy |
Biohaven | Biohaven Pharmaceutical Holding Company Ltd. |
BioNTech | BioNTech SE |
Biopharma | Global Biopharmaceuticals Business |
BLA | Biologics License Application |
BMS | Bristol-Myers Squibb Company |
BOD | Board of Directors |
CDC | U.S. Centers for Disease Control and Prevention |
CGRP | calcitonin gene-related peptide |
CMA | conditional marketing authorisation |
Comirnaty* | Unless otherwise noted, refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), the Comirnaty Original/Omicron BA.1 Vaccine, and Comirnaty Original/Omicron BA.4/BA.5 Vaccine |
Cond. J-NDA | Conditional Japan New Drug Application |
Consumer Healthcare JV | GSK Consumer Healthcare JV |
COVID-19 | novel coronavirus disease of 2019 |
Developed Europe | Includes the following markets: Western Europe, Scandinavian countries and Finland |
Developed Markets | Includes the following markets: U.S., Developed Europe, Japan, Australia, Canada, South Korea and New Zealand |
Developed Rest of World | Includes the following markets: Japan, Australia, Canada, South Korea and New Zealand |
EC | European Commission |
EMA | European Medicines Agency |
Emerging Markets | Includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Central Europe, Eastern Europe, the Middle East, Africa and Turkey |
EPS | earnings per share |
EU | European Union |
EUA | emergency use authorization |
Exchange Act | Securities Exchange Act of 1934, as amended |
FASB | Financial Accounting Standards Board |
FDA | U.S. Food and Drug Administration |
FFDCA | U.S. Federal Food, Drug and Cosmetic Act |
Form 10-Q | This Quarterly Report on Form 10-Q for the quarterly period ended October 2, 2022 |
GAAP | Generally Accepted Accounting Principles |
GIST | gastrointestinal stromal tumors |
GPD | Global Product Development organization |
GSK | GlaxoSmithKline plc |
Haleon | Haleon plc |
HIPAA | Health Insurance Portability and Accountability Act of 1996 |
Hospira | Hospira, Inc. |
IPR&D | in-process research and development |
IRA | Inflation Reduction Act of 2022 |
IRS | U.S. Internal Revenue Service |
JAK | Janus kinase |
JV | joint venture |
King | King Pharmaceuticals LLC (formerly King Pharmaceuticals, Inc.) |
LIBOR | London Interbank Offered Rate |
LOE | loss of exclusivity |
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mCRC | metastatic colorectal cancer |
mCRPC | metastatic castration-resistant prostate cancer |
mCSPC | metastatic castration-sensitive prostate cancer |
MD&A | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
Meridian | Meridian Medical Technologies, Inc. |
mRNA | messenger ribonucleic acid |
MSA | Manufacturing Supply Agreement |
Mylan | Mylan N.V. |
Myovant | Myovant Sciences Ltd. |
NDA | New Drug Application |
nmCRPC | non-metastatic castration-resistant prostate cancer |
NSCLC | non-small cell lung cancer |
ODT | oral disintegrating tablet |
OPKO | OPKO Health, Inc. |
OTC | over-the-counter |
Paxlovid* | an oral COVID-19 treatment (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) |
PC1 | Pfizer CentreOne |
PGS | Pfizer Global Supply |
Pharmacia | Pharmacia Corporation |
| |
PRAC | Pharmacovigilance Risk Assessment Committee |
PsA | psoriatic arthritis |
QTD | Quarter-to-date or three months ended |
RA | rheumatoid arthritis |
RCC | renal cell carcinoma |
R&D | research and development |
ReViral | ReViral Ltd. |
SEC | U.S. Securities and Exchange Commission |
sNDA | supplemental new drug application |
TSAs | transition service arrangements |
UC | ulcerative colitis |
U.K. | United Kingdom |
U.S. | United States |
Upjohn Business | Pfizer’s former global, primarily off-patent branded and generics business, which included a portfolio of 20 globally recognized solid oral dose brands, including Lipitor, Lyrica, Norvasc, Celebrex and Viagra, as well as a U.S.-based generics platform, Greenstone, that was spun-off on November 16, 2020 and combined with Mylan to create Viatris |
Viatris | Viatris Inc. |
ViiV | ViiV Healthcare Limited |
WRDM | Worldwide Research, Development and Medical |
YTD | Year-to-date or nine months ended |
*Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), have not been approved or licensed by the FDA. Paxlovid has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death. Emergency uses of the vaccines have been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1) of the FFDCA unless the declaration is terminated or authorization revoked sooner. Please see the EUA Fact Sheets at www.covid19oralrx.com and www.cvdvaccine-us.com.
This Form 10-Q includes discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.
Some amounts in this Form 10-Q may not add due to rounding. All percentages have been calculated using unrounded amounts. All trademarks mentioned are the property of their owners.
The information contained on our website, our Facebook, Instagram, YouTube and LinkedIn pages or our Twitter accounts, or any third-party website, is not incorporated by reference into this Form 10-Q.
| | |
PART I. FINANCIAL INFORMATION |
ITEM 1. FINANCIAL STATEMENTS
PFIZER INC. AND SUBSIDIARY COMPANIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended |
(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 | | | | | | | | | | | | — | | | — | | | | | | | — | | | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |