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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| | | | | |
☑ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2021
or
| | | | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 001-37702
Amgen Inc.
(Exact name of registrant as specified in its charter)
| | | | | | | | |
Delaware | | 95-3540776 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| |
One Amgen Center Drive | | 91320-1799 |
Thousand Oaks | |
California | |
(Address of principal executive offices) | | (Zip Code) |
(805) 447-1000
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| | | | | | | | |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common stock, $0.0001 par value | AMGN | The Nasdaq Stock Market LLC |
1.250% Senior Notes due 2022 | AMGN22 | The Nasdaq Stock Market LLC |
2.00% Senior Notes due 2026 | AMGN26 | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | | | | |
Large accelerated filer | ☑ | Accelerated filer | ☐ | Non-accelerated filer | ☐ |
Smaller reporting company | ☐ | Emerging growth company | ☐ | | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☑
As of October 28, 2021, the registrant had 563,265,902 shares of common stock, $0.0001 par value, outstanding.
AMGEN INC.
INDEX
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Item 1. | | |
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Item 2. | | |
Item 3. | | |
Item 4. | | |
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Item 1. | | |
Item 1A. | | |
Item 2. | | |
Item 6. | | |
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| |
PART I — FINANCIAL INFORMATION
| | | | | |
Item 1. | FINANCIAL STATEMENTS |
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per-share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
Revenues: | | | | | | | |
Product sales | $ | 6,320 | | | $ | 6,104 | | | $ | 18,026 | | | $ | 17,906 | |
Other revenues | 386 | | | 319 | | | 1,107 | | | 884 | |
Total revenues | 6,706 | | | 6,423 | | | 19,133 | | | 18,790 | |
| | | | | | | |
Operating expenses: | | | | | | | |
Cost of sales | 1,609 | | | 1,561 | | | 4,736 | | | 4,562 | |
Research and development | 1,422 | | | 1,062 | | | 3,471 | | | 2,978 | |
Acquired in-process research and development | — | | | — | | | 1,505 | | | — | |
Selling, general and administrative | 1,305 | | | 1,346 | | | 3,943 | | | 3,957 | |
Other | (8) | | | 1 | | | 143 | | | 162 | |
Total operating expenses | 4,328 | | | 3,970 | | | 13,798 | | | 11,659 | |
| | | | | | | |
Operating income | 2,378 | | | 2,453 | | | 5,335 | | | 7,131 | |
| | | | | | | |
Other income (expense): | | | | | | | |
Interest expense, net | (296) | | | (302) | | | (862) | | | (944) | |
Other income, net | 73 | | | 55 | | | 97 | | | 69 | |
| | | | | | | |
Income before income taxes | 2,155 | | | 2,206 | | | 4,570 | | | 6,256 | |
| | | | | | | |
Provision for income taxes | 271 | | | 185 | | | 576 | | | 607 | |
| | | | | | | |
Net income | $ | 1,884 | | | $ | 2,021 | | | $ | 3,994 | | | $ | 5,649 | |
| | | | | | | |
Earnings per share: | | | | | | | |
Basic | $ | 3.32 | | | $ | 3.45 | | | $ | 6.98 | | | $ | 9.61 | |
Diluted | $ | 3.31 | | | $ | 3.43 | | | $ | 6.93 | | | $ | 9.54 | |
| | | | | | | |
Shares used in calculation of earnings per share: | | | | | | | |
Basic | 567 | | | 585 | | | 572 | | | 588 | |
Diluted | 570 | | | 589 | | | 576 | | | 592 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In millions)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
Net income | $ | 1,884 | | | $ | 2,021 | | | $ | 3,994 | | | $ | 5,649 | |
Other comprehensive income (loss), net of reclassification adjustments and taxes: | | | | | | | |
(Losses) gains on foreign currency translation | (35) | | | 14 | | | (60) | | | (41) | |
Gains (losses) on cash flow hedges | 99 | | | (128) | | | 241 | | | (305) | |
(Losses) gains on available-for-sale securities | (1) | | | 1 | | | (1) | | | (20) | |
Other | (3) | | | (7) | | | (3) | | | (9) | |
Other comprehensive income (loss), net of taxes | 60 | | | (120) | | | 177 | | | (375) | |
Comprehensive income | $ | 1,944 | | | $ | 1,901 | | | $ | 4,171 | | | $ | 5,274 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per-share data)
| | | | | | | | | | | |
| September 30, 2021 | | December 31, 2020 |
| (Unaudited) | | |
ASSETS |
Current assets: | | | |
Cash and cash equivalents | $ | 11,969 | | | $ | 6,266 | |
Marketable securities | 952 | | | 4,381 | |
Trade receivables, net | 4,765 | | | 4,525 | |
Inventories | 4,152 | | | 3,893 | |
Other current assets | 2,542 | | | 2,079 | |
Total current assets | 24,380 | | | 21,144 | |
| | | |
Property, plant and equipment, net | 4,982 | | | 4,889 | |
Intangible assets, net | 14,659 | | | 16,587 | |
Goodwill | 14,665 | | | 14,689 | |
Other noncurrent assets | 6,307 | | | 5,639 | |
Total assets | $ | 64,993 | | | $ | 62,948 | |
| | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: | | | |
Accounts payable | $ | 1,171 | | | $ | 1,421 | |
Accrued liabilities | 9,383 | | | 10,141 | |
Current portion of long-term debt | 4,288 | | | 91 | |
Total current liabilities | 14,842 | | | 11,653 | |
| | | |
Long-term debt | 33,291 | | | 32,895 | |
Long-term tax liabilities | 6,483 | | | 6,968 | |
Other noncurrent liabilities | 2,160 | | | 2,023 | |
| | | |
Contingencies and commitments | | | |
| | | |
Stockholders’ equity: | | | |
Common stock and additional paid-in capital; $0.0001 par value; 2,750.0 shares authorized; outstanding—565.0 shares in 2021 and 578.3 shares in 2020 | 31,989 | | | 31,802 | |
Accumulated deficit | (22,964) | | | (21,408) | |
Accumulated other comprehensive loss | (808) | | | (985) | |
Total stockholders’ equity | 8,217 | | | 9,409 | |
Total liabilities and stockholders’ equity | $ | 64,993 | | | $ | 62,948 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In millions, except per-share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Number of shares of common stock | | Common stock and additional paid-in capital | | Accumulated deficit | | Accumulated other comprehensive loss | | Total |
Balance as of December 31, 2020 | 578.3 | | | $ | 31,802 | | | $ | (21,408) | | | $ | (985) | | | $ | 9,409 | |
| | | | | | | | | |
Net income | — | | | — | | | 1,646 | | | — | | | 1,646 | |
Other comprehensive income, net of taxes | — | | | — | | | — | | | 152 | | | 152 | |
Dividends declared on common stock ($1.76 per share) | — | | | — | | | (1,012) | | | — | | | (1,012) | |
Issuance of common stock in connection with the Company’s equity award programs | 0.7 | | | 6 | | | — | | | — | | | 6 | |
Stock-based compensation expense | — | | | 57 | | | — | | | — | | | 57 | |
Tax impact related to employee stock-based compensation expense | — | | | (59) | | | — | | | — | | | (59) | |
Repurchases of common stock | (3.7) | | | — | | | (865) | | | — | | | (865) | |
Balance as of March 31, 2021 | 575.3 | | | 31,806 | | | (21,639) | | | (833) | | | 9,334 | |
| | | | | | | | | |
Net income | — | | | — | | | 464 | | | — | | | 464 | |
Other comprehensive loss, net of taxes | — | | | — | | | — | | | (35) | | | (35) | |
Issuance of common stock in connection with the Company’s equity award programs | 0.8 | | | 47 | | | — | | | — | | | 47 | |
Stock-based compensation expense | — | | | 100 | | | — | | | — | | | 100 | |
Tax impact related to employee stock-based compensation expense | — | | | (76) | | | — | | | — | | | (76) | |
Repurchases of common stock | (6.5) | | | — | | | (1,592) | | | — | | | (1,592) | |
Other | — | | | — | | | 5 | | | — | | | 5 | |
Balance as of June 30, 2021 | 569.6 | | | 31,877 | | | (22,762) | | | (868) | | | 8,247 | |
| | | | | | | | | |
Net income | — | | | — | | | 1,884 | | | — | | | 1,884 | |
Other comprehensive income, net of taxes | — | | | — | | | — | | | 60 | | | 60 | |
Dividends declared on common stock ($1.76 per share) | — | | | — | | | (1,017) | | | — | | | (1,017) | |
Issuance of common stock in connection with the Company’s equity award programs | — | | | 9 | | | — | | | — | | | 9 | |
Stock-based compensation expense | — | | | 111 | | | — | | | — | | | 111 | |
Tax impact related to employee stock-based compensation expense | — | | | (8) | | | — | | | — | | | (8) | |
Repurchases of common stock | (4.6) | | | — | | | (1,069) | | | — | | | (1,069) | |
| | | | | | | | | |
Balance as of September 30, 2021 | 565.0 | | | $ | 31,989 | | | $ | (22,964) | | | $ | (808) | | | $ | 8,217 | |
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)
(In millions, except per-share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Number of shares of common stock | | Common stock and additional paid-in capital | | Accumulated deficit | | Accumulated other comprehensive loss | | Total |
Balance as of December 31, 2019 | 591.4 | | | $ | 31,531 | | | $ | (21,330) | | | $ | (528) | | | $ | 9,673 | |
Cumulative effect of changes in accounting principles, net of taxes | — | | | — | | | (2) | | | — | | | (2) | |
Net income | — | | | — | | | 1,825 | | | — | | | 1,825 | |
Other comprehensive loss, net of taxes | — | | | — | | | — | | | (134) | | | (134) | |
Dividends declared on common stock ($1.60 per share) | — | | | — | | | (938) | | | — | | | (938) | |
Issuance of common stock in connection with the Company’s equity award programs | 0.9 | | | 10 | | | — | | | — | | | 10 | |
Stock-based compensation expense | — | | | 52 | | | — | | | — | | | 52 | |
Tax impact related to employee stock-based compensation expense | — | | | (68) | | | — | | | — | | | (68) | |
Repurchases of common stock | (4.3) | | | — | | | (933) | | | — | | | (933) | |
Balance as of March 31, 2020 | 588.0 | | | 31,525 | | | (21,378) | | | (662) | | | 9,485 | |
| | | | | | | | | |
Net income | — | | | — | | | 1,803 | | | — | | | 1,803 | |
Other comprehensive loss, net of taxes | — | | | — | | | — | | | (121) | | | (121) | |
| | | | | | | | | |
Issuance of common stock in connection with the Company’s equity award programs | 1.0 | | | 65 | | | — | | | — | | | 65 | |
Stock-based compensation expense | — | | | 101 | | | — | | | — | | | 101 | |
Tax impact related to employee stock-based compensation expense | — | | | (81) | | | — | | | — | | | (81) | |
Repurchases of common stock | (2.6) | | | — | | | (591) | | | — | | | (591) | |
Other | — | | | — | | | (2) | | | — | | | (2) | |
Balance as of June 30, 2020 | 586.4 | | | 31,610 | | | (20,168) | | | (783) | | | 10,659 | |
Net income | — | | | — | | | 2,021 | | | — | | | 2,021 | |
Other comprehensive loss, net of taxes | — | | | — | | | — | | | (120) | | | (120) | |
Dividends declared on common stock ($1.60 per share) | — | | | — | | | (952) | | | — | | | (952) | |
Issuance of common stock in connection with the Company’s equity award programs | 0.1 | | | 5 | | | — | | | — | | | 5 | |
Stock-based compensation expense | — | | | 109 | | | — | | | — | | | 109 | |
Tax impact related to employee stock-based compensation expense | — | | | (11) | | | — | | | — | | | (11) | |
Repurchases of common stock | (3.0) | | | — | | | (752) | | | — | | | (752) | |
Balance as of September 30, 2020 | 583.5 | | | $ | 31,713 | | | $ | (19,851) | | | $ | (903) | | | $ | 10,959 | |
See accompanying notes.
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
| | | | | | | | | | | |
| Nine months ended September 30, |
| 2021 | | 2020 |
Cash flows from operating activities: | | | |
Net income | $ | 3,994 | | | $ | 5,649 | |
Depreciation, amortization and other | 2,546 | | | 2,728 | |
Deferred income taxes | (264) | | | (339) | |
Acquired in-process research and development | 1,505 | | | — | |
Other items, net | 187 | | | 270 | |
Changes in operating assets and liabilities, net of acquisitions: | | | |
Trade receivables, net | (269) | | | (31) | |
Inventories | (215) | | | (316) | |
Other assets | (373) | | | 64 | |
Accounts payable | (260) | | | (202) | |
Accrued income taxes, net | (719) | | | (301) | |
Long-term tax liabilities | 102 | | | 110 | |
Other liabilities | 219 | | | 712 | |
Net cash provided by operating activities | 6,453 | | | 8,344 | |
Cash flows from investing activities: | | | |
Cash paid for acquisitions, net of cash acquired | (1,639) | | | — | |
Purchases of marketable securities | (8,901) | | | (5,329) | |
Proceeds from sales of marketable securities | 4,403 | | | 2,597 | |
Proceeds from maturities of marketable securities | 7,927 | | | 2,338 | |
| | | |
Purchases of property, plant and equipment | (593) | | | (435) | |
Purchases of equity method investments | (154) | | | (3,154) | |
Other | (80) | | | (34) | |
Net cash provided by (used in) investing activities | 963 | | | (4,017) | |
Cash flows from financing activities: | | | |
Net proceeds from issuance of debt | 4,946 | | | 8,914 | |
Repayment of debt | — | | | (5,000) | |
| | | |
Repurchases of common stock | (3,532) | | | (2,281) | |
Dividends paid | (3,023) | | | (2,823) | |
| | | |
Other | (104) | | | (87) | |
Net cash used in financing activities | (1,713) | | | (1,277) | |
Increase in cash and cash equivalents | 5,703 | | | 3,050 | |
Cash and cash equivalents at beginning of period | 6,266 | | | 6,037 | |
Cash and cash equivalents at end of period | $ | 11,969 | | | $ | 9,087 | |
See accompanying notes.
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2021
(Unaudited)
1. Summary of significant accounting policies
Business
Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is a global biotechnology pioneer that discovers, develops, manufactures and delivers innovative human therapeutics. We operate in one business segment: human therapeutics.
Basis of presentation
The financial information for the three and nine months ended September 30, 2021 and 2020, is unaudited but includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated), which Amgen considers necessary for a fair presentation of its condensed consolidated results of operations for those periods. Interim results are not necessarily indicative of results for the full fiscal year.
The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2020, and with our condensed consolidated financial statements and the notes thereto contained in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2021 and June 30, 2021.
Principles of consolidation
The condensed consolidated financial statements include the accounts of Amgen as well as its majority-owned subsidiaries. We do not have any significant interests in any variable interest entities. All material intercompany transactions and balances have been eliminated in consolidation.
Use of estimates
The preparation of condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ from those estimates.
Property, plant and equipment, net
Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $9.2 billion and $9.0 billion as of September 30, 2021 and December 31, 2020, respectively.
Recent accounting pronouncements
In March 2020, the Financial Accounting Standards Board (FASB) issued a new accounting standard to ease the financial reporting burdens caused by the expected market transition from the London Interbank Offered Rate (LIBOR) and other interbank offered rates to alternative reference rates, commonly referred to as reference rate reform. The new standard provides temporary optional expedients and exceptions to current GAAP guidance on contract modifications and hedge accounting. Specifically, a modification to transition to an alternative reference rate is treated as an event that does not require contract remeasurement or reassessment of a previous accounting treatment. Moreover, for all types of hedging relationships, an entity is permitted to change the reference rate without having to dedesignate the hedging relationship. The standard is generally effective for all contract modifications made and hedging relationships evaluated through December 31, 2022. In January 2021, the FASB issued a new accounting standard to expand on the scope of the original March 2020 standard to include derivative instruments on discounting transactions. We are currently evaluating the impacts that the two standards will have on our condensed consolidated financial statements.
2. Acquisitions
On April 16, 2021, Amgen completed its acquisition of Five Prime Therapeutics, Inc. (Five Prime) for total consideration of $1.6 billion, net of cash acquired. The purchase price was funded with cash on hand. This transaction was accounted for as an asset acquisition because substantially all the value of the assets acquired was concentrated in the intellectual property rights of bemarituzumab, a phase 3 trial-ready, first-in-class program for gastric cancer. Five Prime’s operations have been included in our condensed consolidated financial statements commencing after the acquisition date.
We allocated the consideration to acquire Five Prime to: the bemarituzumab in-process research and development (IPR&D) program of $1.5 billion, which was expensed immediately in Acquired IPR&D expense in the Condensed Consolidated Statements of Income; deferred tax assets of $177 million; and other net liabilities of $47 million. The acquired IPR&D expense was not tax deductible.
3. Revenues
We operate in one business segment: human therapeutics. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Revenues by product and by geographic area, based on customers’ locations, are presented below. The majority of rest-of-world (ROW) revenues relates to products sold in Europe.
Revenues were as follows (in millions):
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended September 30, |
| | 2021 | | 2020 |
| | U.S. | | ROW | | Total | | U.S. | | ROW | | Total |
Enbrel® (etanercept) | | $ | 1,263 | | | $ | 26 | | | $ | 1,289 | | | $ | 1,289 | | | $ | 36 | | | $ | 1,325 | |
Prolia® (denosumab) | | 530 | | | 273 | | | 803 | | | 478 | | | 223 | | | 701 | |
Otezla® (apremilast) | | 495 | | | 114 | | | 609 | | | 439 | | | 99 | | | 538 | |
XGEVA® (denosumab) | | 372 | | | 145 | | | 517 | | | 363 | | | 118 | | | 481 | |
Neulasta® (pegfilgrastim) | | 360 | | | 55 | | | 415 | | | 484 | | | 71 | | | 555 | |
Aranesp® (darbepoetin alfa) | | 149 | | | 247 | | | 396 | | | 158 | | | 226 | | | 384 | |
Repatha® (evolocumab) | | 139 | | | 133 | | | 272 | | | 92 | | | 113 | | | 205 | |
KYPROLIS® (carfilzomib) | | 198 | | | 95 | | | 293 | | | 173 | | | 87 | | | 260 | |
Other products | | 1,052 | | | 674 | | | 1,726 | | | 1,142 | | | 513 | | | 1,655 | |
Total product sales(1) | | $ | 4,558 | | | $ | 1,762 | | | 6,320 | | | $ | 4,618 | | | $ | 1,486 | | | 6,104 | |
Other revenues | | | | | | 386 | | | | | | | 319 | |
Total revenues | | | | | | $ | 6,706 | | | | | | | $ | 6,423 | |
| | | | | | | | | | | | |
| | Nine months ended September 30, |
| | 2021 | | 2020 |
| | U.S. | | ROW | | Total | | U.S. | | ROW | | Total |
ENBREL | | $ | 3,270 | | | $ | 87 | | | $ | 3,357 | | | $ | 3,619 | | | $ | 105 | | | $ | 3,724 | |
Prolia® | | 1,569 | | | 806 | | | 2,375 | | | 1,341 | | | 673 | | | 2,014 | |
Otezla® | | 1,284 | | | 335 | | | 1,619 | | | 1,280 | | | 298 | | | 1,578 | |
XGEVA® | | 1,061 | | | 412 | | | 1,473 | | | 1,036 | | | 361 | | | 1,397 | |
Neulasta® | | 1,215 | | | 168 | | | 1,383 | | | 1,538 | | | 219 | | | 1,757 | |
Aranesp® | | 409 | | | 709 | | | 1,118 | | | 489 | | | 704 | | | 1,193 | |
Repatha® | | 421 | | | 423 | | | 844 | | | 331 | | | 303 | | | 634 | |
KYPROLIS® | | 547 | | | 277 | | | 824 | | | 527 | | | 266 | | | 793 | |
Other products | | 3,059 | | | 1,974 | | | 5,033 | | | 3,164 | | | 1,652 | | | 4,816 | |
Total product sales(1) | | $ | 12,835 | | | $ | 5,191 | | | 18,026 | | | $ | 13,325 | | | $ | 4,581 | | | 17,906 | |
Other revenues | | | | | | 1,107 | | | | | | | 884 | |
Total revenues | | | | | | $ | 19,133 | | | | | | | $ | 18,790 | |
| | | | | | | | | | | | |
____________
(1) Hedging gains and losses, which are included in product sales, were not material for the three and nine months ended September 30, 2021 and 2020.
4. Income taxes
The effective tax rate for the three and nine months ended September 30, 2021, was 12.6% for both periods, compared with rates of 8.4% and 9.7%, respectively, for the corresponding periods of the prior year.
The increase in our effective tax rate for the three and nine months ended September 30, 2021, was primarily due to the non-deductible IPR&D expense arising from the acquisition of Five Prime and prior year favorable items partially offset by a change in earnings mix. The effective tax rates differ from the federal statutory rate primarily as a result of foreign earnings from the Company’s operations conducted in Puerto Rico, a territory of the United States treated as a foreign jurisdiction for U.S. tax purposes, that are subject to a tax incentive grant through 2035. In addition, the Company’s operations conducted in Singapore are subject to a tax incentive grant through 2034. These foreign earnings are also subject to U.S. tax at a reduced rate of 10.5%.
The U.S. territory of Puerto Rico imposes an excise tax on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico. The rate of 4% is effective through December 31, 2027. We account for the excise tax as a manufacturing cost that is capitalized in inventory and expensed in cost of sales when the related products are sold. For U.S. income tax purposes, the excise tax results in foreign tax credits that are generally recognized in our provision for income taxes when the excise tax is incurred.
One or more of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely examined by tax authorities in those jurisdictions. Significant disputes may arise with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts. In 2017, we received a Revenue Agent Report (RAR) and a modified RAR from the Internal Revenue Service (IRS) for the years 2010, 2011 and 2012 proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations and pursued a resolution with the IRS administrative appeals office. As previously reported, we were unable to reach resolution with the IRS appeals office. In July 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for 2010, 2011 and 2012 that we received in May and July 2021. The duplicate Notices seek to increase our U.S. taxable income by an amount that would result in additional federal tax of approximately $3.6 billion, plus interest. Any additional tax that could be imposed would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings. In any event, we firmly believe that the IRS’s positions in the Notices are without merit, and we will vigorously contest the Notices through the judicial process.
In addition, in 2020, we received an RAR and a modified RAR from the IRS for the years 2013, 2014 and 2015 also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico, similar to those proposed for the years 2010, 2011 and 2012. We disagree with the proposed adjustments and calculations and have been pursuing resolution with the IRS administrative appeals office. As a consequence of the Tax Court litigation for the 2010-2012 period, the IRS administrative appeals office recently informed us that it does not plan to engage in discussions at this time regarding the allocation of profits between our entities in the United States and the U.S. territory of Puerto Rico for the 2013-2015 period. We are currently under examination by the IRS for the years 2016, 2017 and 2018. We are also currently under examination by a number of other state and foreign tax jurisdictions.
Final resolution of these complex matters is not likely within the next 12 months. We believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our condensed consolidated financial statements. We are no longer subject to U.S. federal income tax examinations for the years ended on or before December 31, 2009.
During the three and nine months ended September 30, 2021, the gross amounts of our unrecognized tax benefits (UTBs) increased $70 million and $180 million, respectively, as a result of tax positions taken during the current year. Substantially all of the UTBs as of September 30, 2021, if recognized, would affect our effective tax rate.
5. Earnings per share
The computation of basic earnings per share (EPS) is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and dilutive potential common shares, which primarily include shares that may be issued under our stock option, restricted stock and performance unit award programs (collectively, dilutive securities), as determined by using the treasury stock method.
The computations for basic and diluted EPS were as follows (in millions, except per-share data):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, |
| 2021 | | 2020 | | 2021 | | 2020 |
Income (Numerator): | | | | | | | |
Net income for basic and diluted EPS | $ | 1,884 | | | $ | 2,021 | | | $ | 3,994 | | | $ | 5,649 | |
| | | | | | | |
Shares (Denominator): | | | | | | | |
Weighted-average shares for basic EPS | 567 | | | 585 | | | 572 | | | 588 | |
Effect of dilutive securities | 3 | | | 4 | | | 4 | | | 4 | |
Weighted-average shares for diluted EPS | 570 | | | 589 | | | 576 | | | 592 | |
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Basic EPS | $ | 3.32 | | | $ | 3.45 | | | $ | 6.98 | | | $ | 9.61 | |
Diluted EPS | $ | 3.31 | | | $ | 3.43 | | | $ | 6.93 | | | $ | 9.54 | |
For the three and nine months ended September 30, 2021 and 2020, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.
6. Collaborations
On July 30, 2021, we closed our collaboration and licensing agreement with Kyowa Kirin Co., Ltd. (KKC) to jointly develop and commercialize an anti-OX40 fully human monoclonal antibody (AMG 451) worldwide, except in Japan. AMG 451 is for the treatment of atopic dermatitis, with potential in other autoimmune diseases.
Under the terms of the agreement, we will lead the global development, manufacturing and commercialization of AMG 451, except in Japan. KKC will co-promote AMG 451 with Amgen in the United States and have opt-in rights to co-promote AMG 451 in various other markets outside the United States, including in Europe and Asia.
We made an upfront payment of $400 million to KKC that was recognized in Research and development (R&D) expense in the third quarter of 2021. Amgen and KKC will share equally the global development costs, except in Japan, and the U.S. commercialization costs. Outside of the United States and Japan, any commercialization costs incurred by KKC will be reimbursed by Amgen. We may also be required to make milestone payments of up to $850 million contingent upon the achievement of certain regulatory events and commercial thresholds. We will also pay KKC significant double-digit royalties on global sales, except in Japan.
7. Investments
Available-for-sale investments
The amortized cost, gross unrealized gains, gross unrealized losses and fair values of interest-bearing securities, which are considered available-for-sale, by type of security were as follows (in millions):
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Types of securities as of September 30, 2021 | | Amortized cost | | Gross unrealized gains | | Gross unrealized losses | | Fair values |
U.S. Treasury notes | | $ | 51 | | | $ | — | | | $ | — | | | $ | 51 | |
U.S. Treasury bills | | 3,900 | | | — | | | — | | | 3,900 | |
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