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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 September 30, 2023
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 001-01136
___________________________
BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)
___________________________
| | | | | | | | |
Delaware | | 22-0790350 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S Employer Identification No.) |
Route 206 & Province Line Road, Princeton, New Jersey 08543
(Address of principal executive offices) (Zip Code)
(609) 252-4621
(Registrant’s telephone number, including area code)
___________________________
(Former name, former address and former fiscal year, if changed since last report)
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, $0.10 Par Value | BMY | New York Stock Exchange |
1.000% Notes due 2025 | BMY25 | New York Stock Exchange |
1.750% Notes due 2035 | BMY35 | New York Stock Exchange |
Celgene Contingent Value Rights | CELG RT | 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 the 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 or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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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 ☒
APPLICABLE ONLY TO CORPORATE ISSUERS:
At October 20, 2023, there were 2,034,757,742 shares outstanding of the Registrant’s $0.10 par value common stock.
BRISTOL-MYERS SQUIBB COMPANY
INDEX TO FORM 10-Q
September 30, 2023
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PART I—FINANCIAL INFORMATION | |
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Item 1. | |
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Item 2. | |
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Item 3. | |
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Item 4. | |
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PART II—OTHER INFORMATION | |
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Item 1. | |
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Item 1A. | |
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Item 2. | |
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Item 5. | |
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Item 6. | |
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* Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index at the end of this Quarterly Report on Form 10-Q.
PART I—FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
Dollars in millions, except per share data
(UNAUDITED)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
EARNINGS | 2023 | | 2022 | | 2023 | | 2022 |
Net product sales | $ | 10,645 | | | $ | 10,813 | | | $ | 32,610 | | | $ | 33,606 | |
Alliance and other revenues | 321 | | | 405 | | | 919 | | | 1,147 | |
Total Revenues | 10,966 | | | 11,218 | | | 33,529 | | | 34,753 | |
| | | | | | | |
Cost of products sold(a) | 2,506 | | | 2,353 | | | 7,948 | | | 7,544 | |
Marketing, selling and administrative | 2,003 | | | 1,930 | | | 5,699 | | | 5,548 | |
Research and development | 2,242 | | | 2,418 | | | 6,821 | | | 6,999 | |
Acquired IPRD | 80 | | | 30 | | | 313 | | | 763 | |
Amortization of acquired intangible assets | 2,256 | | | 2,418 | | | 6,769 | | | 7,252 | |
Other (income)/expense, net | (258) | | | (140) | | | (787) | | | 793 | |
Total Expenses | 8,829 | | | 9,009 | | | 26,763 | | | 28,899 | |
| | | | | | | |
Earnings before income taxes | 2,137 | | | 2,209 | | | 6,766 | | | 5,854 | |
Income tax provision | 203 | | | 601 | | | 488 | | | 1,534 | |
Net earnings | 1,934 | | | 1,608 | | | 6,278 | | | 4,320 | |
Noncontrolling interest | 6 | | | 2 | | | 15 | | | 15 | |
Net earnings attributable to BMS | $ | 1,928 | | | $ | 1,606 | | | $ | 6,263 | | | $ | 4,305 | |
| | | | | | | |
Earnings per common share: | | | | | | | |
Basic | $ | 0.94 | | | $ | 0.75 | | | $ | 3.01 | | | $ | 2.01 | |
Diluted | 0.93 | | | 0.75 | | | 2.99 | | | 2.00 | |
(a) Excludes amortization of acquired intangible assets.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
Dollars in millions
(UNAUDITED)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
COMPREHENSIVE INCOME | 2023 | | 2022 | | 2023 | | 2022 |
Net earnings | $ | 1,934 | | | $ | 1,608 | | | $ | 6,278 | | | $ | 4,320 | |
Other comprehensive income/(loss), net of taxes and reclassifications to earnings: |
Derivatives qualifying as cash flow hedges | 114 | | | 286 | | | (7) | | | 618 | |
Pension and postretirement benefits | 2 | | | 18 | | | (9) | | | 64 | |
Marketable debt securities | (2) | | | — | | | (2) | | | (2) | |
Foreign currency translation | (13) | | | (153) | | | 13 | | | (253) | |
Total Other comprehensive income/(loss) | 101 | | | 151 | | | (5) | | | 427 | |
| | | | | | | |
Comprehensive income | 2,035 | | | 1,759 | | | 6,273 | | | 4,747 | |
Comprehensive income attributable to noncontrolling interest | 6 | | | 2 | | | 15 | | | 15 | |
Comprehensive income attributable to BMS | 2,029 | | | 1,757 | | | 6,258 | | | 4,732 | |
The accompanying notes are an integral part of these consolidated financial statements.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED BALANCE SHEETS
Dollars in millions
(UNAUDITED)
| | | | | | | | | | | |
ASSETS | September 30, 2023 | | December 31, 2022 |
Current assets: | | | |
Cash and cash equivalents | $ | 7,514 | | | $ | 9,123 | |
Marketable debt securities | 171 | | | 130 | |
Receivables | 10,304 | | | 9,886 | |
Inventories | 2,436 | | | 2,339 | |
Other current assets | 7,207 | | | 5,795 | |
Total Current assets | 27,632 | | | 27,273 | |
Property, plant and equipment | 6,481 | | | 6,255 | |
Goodwill | 21,147 | | | 21,149 | |
Other intangible assets | 28,950 | | | 35,859 | |
Deferred income taxes | 1,514 | | | 1,344 | |
Marketable debt securities | 325 | | | — | |
Other non-current assets | 5,214 | | | 4,940 | |
Total Assets | $ | 91,263 | | | $ | 96,820 | |
| | | |
LIABILITIES | | | |
Current liabilities: | | | |
Short-term debt obligations | $ | 5,467 | | | $ | 4,264 | |
Accounts payable | 2,813 | | | 3,040 | |
Other current liabilities | 15,182 | | | 14,586 | |
Total Current liabilities | 23,462 | | | 21,890 | |
Deferred income taxes | 399 | | | 2,166 | |
Long-term debt | 32,137 | | | 35,056 | |
Other non-current liabilities | 6,203 | | | 6,590 | |
Total Liabilities | 62,201 | | | 65,702 | |
| | | |
Commitments and Contingencies | | | |
| | | |
EQUITY | | | |
BMS Shareholders’ equity: | | | |
Preferred stock | — | | | — | |
Common stock | 292 | | | 292 | |
Capital in excess of par value of stock | 44,849 | | | 45,165 | |
Accumulated other comprehensive loss | (1,286) | | | (1,281) | |
Retained earnings | 28,218 | | | 25,503 | |
Less cost of treasury stock | (43,075) | | | (38,618) | |
Total BMS Shareholders’ equity | 28,998 | | | 31,061 | |
Noncontrolling interest | 64 | | | 57 | |
Total Equity | 29,062 | | | 31,118 | |
Total Liabilities and Equity | $ | 91,263 | | | $ | 96,820 | |
The accompanying notes are an integral part of these consolidated financial statements.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF CASH FLOWS
Dollars in millions
(UNAUDITED)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
Cash Flows From Operating Activities: | | | |
Net earnings | $ | 6,278 | | | $ | 4,320 | |
Adjustments to reconcile net earnings to net cash provided by operating activities: | | | |
Depreciation and amortization, net | 7,296 | | | 7,755 | |
Deferred income taxes | (1,961) | | | (2,114) | |
Stock-based compensation | 391 | | | 338 | |
Impairment charges | 226 | | | 144 | |
Divestiture gains and royalties | (639) | | | (820) | |
Acquired IPRD | 313 | | | 763 | |
Equity investment losses | 213 | | | 966 | |
Other adjustments | 260 | | | 179 | |
Changes in operating assets and liabilities: | | | |
Receivables | (487) | | | (557) | |
Inventories | (554) | | | (28) | |
Accounts payable | (246) | | | (296) | |
Rebates and discounts | 1,115 | | | 730 | |
Income taxes payable | (1,647) | | | (310) | |
Other | (950) | | | (1,310) | |
Net cash provided by operating activities | 9,608 | | | 9,760 | |
Cash Flows From Investing Activities: | | | |
Sale and maturities of marketable debt securities | 692 | | 5,205 | |
Purchase of marketable debt securities | (1,057) | | | (3,566) | |
Proceeds from sales of equity investments | 215 | | | 213 | |
Capital expenditures | (879) | | | (772) | |
Divestiture and other proceeds | 668 | | | 815 | |
Acquisition and other payments, net of cash acquired | (588) | | | (4,170) | |
Net cash used in investing activities | (949) | | | (2,275) | |
Cash Flows From Financing Activities: | | | |
Short-term debt obligations, net | 233 | | | 58 | |
Issuance of long-term debt | — | | | 5,926 | |
Repayment of long-term debt | (1,879) | | | (11,431) | |
Repurchase of common stock | (5,155) | | | (5,585) | |
Dividends | (3,584) | | | (3,489) | |
Stock option proceeds and other, net | 2 | | | 805 | |
Net cash used in financing activities | (10,383) | | | (13,716) | |
Effect of exchange rates on cash, cash equivalents and restricted cash | (33) | | | (128) | |
Decrease in cash, cash equivalents and restricted cash | (1,757) | | | (6,359) | |
Cash, cash equivalents and restricted cash at beginning of period | 9,325 | | | 14,316 | |
Cash, cash equivalents and restricted cash at end of period | $ | 7,568 | | | $ | 7,957 | |
The accompanying notes are an integral part of these consolidated financial statements.
Note 1. BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING STANDARDS
Basis of Consolidation
Bristol-Myers Squibb Company ("BMS", "we", "our", "us" or "the Company") prepared these unaudited consolidated financial statements following the requirements of the SEC and U.S. GAAP for interim reporting. Under those rules, certain footnotes and other financial information that are normally required for annual financial statements can be condensed or omitted. The Company is responsible for the consolidated financial statements included in this Quarterly Report on Form 10-Q, which include all adjustments necessary for a fair presentation of the financial position of the Company as of September 30, 2023 and December 31, 2022, the results of operations for the three and nine months ended September 30, 2023 and 2022, and cash flows for the nine months ended September 30, 2023 and 2022. All intercompany balances and transactions have been eliminated. These consolidated financial statements and the related footnotes should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2022 included in the 2022 Form 10-K. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for terms used throughout the document.
Business Segment Information
BMS operates in a single segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines that help patients prevail over serious diseases. A global research and development organization and supply chain organization are responsible for the discovery, development, manufacturing and supply of products. Regional commercial organizations market, distribute and sell the products. The business is also supported by global corporate staff functions. Consistent with BMS's operational structure, the Chief Executive Officer ("CEO"), as the chief operating decision maker, manages and allocates resources at the global corporate level. Managing and allocating resources at the global corporate level enables the CEO to assess both the overall level of resources available and how to best deploy these resources across functions, therapeutic areas, regional commercial organizations and research and development projects in line with our overarching long-term corporate-wide strategic goals, rather than on a product or franchise basis. The determination of a single segment is consistent with the financial information regularly reviewed by the CEO for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting future periods. For further information on product and regional revenue, see "—Note 2. Revenue".
Use of Estimates and Judgments
Revenues, expenses, assets and liabilities can vary during each quarter of the year. Accordingly, the results and trends in these unaudited consolidated financial statements may not be indicative of full year operating results. The preparation of financial statements requires the use of management estimates, judgments and assumptions. The most significant assumptions are estimates used in determining accounting for acquisitions; impairments of intangible assets; charge-backs, cash discounts, sales rebates, returns and other adjustments; legal contingencies; and income taxes. Actual results may differ from estimates.
Reclassifications
Certain reclassifications were made to conform the prior period consolidated financial statements to the current period presentation.
Recently Adopted Accounting Standards
Fair Value Measurements
In June 2022, the FASB issued amended guidance on measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security. The guidance clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. The guidance also clarifies that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction. The amendment requires the following disclosures for equity securities subject to contractual sale restrictions: the fair value of equity securities subject to contractual sale restrictions reflected in the balance sheet; the nature and remaining duration of the restriction(s); and the circumstances that could cause a lapse in the restriction(s). The amended guidance is effective January 1, 2024 on a prospective basis. Early adoption is permitted. The guidance was adopted on January 1, 2023 and the adoption did not have an impact on our consolidated financial statements.
Business Combinations
In October 2021, the FASB issued amended guidance on accounting for contract assets and contract liabilities from contracts with customers in a business combination. The guidance is intended to address inconsistency related to recognition of an acquired contract liability and payment terms and their effect on subsequent revenue recognized. At the acquisition date, an entity should account for the related revenue contracts in accordance with existing revenue recognition guidance generally by assessing how the acquiree applied recognition and measurement in their financial statements. The guidance was adopted on January 1, 2023 and the adoption did not have an impact on our consolidated financial statements.
Note 2. REVENUE
The following table summarizes the disaggregation of revenue by nature:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Net product sales | $ | 10,645 | | | $ | 10,813 | | | $ | 32,610 | | | $ | 33,606 | |
Alliance revenues | 138 | | | 173 | | | 461 | | | 560 | |
Other revenues | 183 | | | 232 | | | 458 | | | 587 | |
Total Revenues | $ | 10,966 | | | $ | 11,218 | | | $ | 33,529 | | | $ | 34,753 | |
The following table summarizes GTN adjustments:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Gross product sales | $ | 18,648 | | | $ | 17,606 | | | $ | 54,047 | | | $ | 51,555 | |
GTN adjustments (a) | | | | | | | |
Charge-backs and cash discounts | (2,373) | | | (1,907) | | | (6,743) | | | (5,420) | |
Medicaid and Medicare rebates | (3,730) | | | (3,295) | | | (9,355) | | | (8,003) | |
Other rebates, returns, discounts and adjustments | (1,900) | | | (1,591) | | | (5,339) | | | (4,526) | |
Total GTN adjustments | (8,003) | | | (6,793) | | | (21,437) | | | (17,949) | |
Net product sales | $ | 10,645 | | | $ | 10,813 | | | $ | 32,610 | | | $ | 33,606 | |
(a) Includes adjustments for provisions for product sales made in prior periods resulting from changes in estimates of $18 million and $116 million for the three and nine months ended September 30, 2023 and $10 million and $207 million for the three and nine months ended September 30, 2022, respectively.
The following table summarizes the disaggregation of revenue by product and region:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
In-Line Products | | | | | | | |
Eliquis | $ | 2,705 | | | $ | 2,655 | | | 9,332 | | | 9,101 | |
Opdivo | 2,275 | | | 2,047 | | | 6,622 | | | 6,033 | |
Pomalyst/Imnovid | 872 | | | 886 | | | 2,551 | | | 2,620 | |
Orencia | 925 | | | 883 | | | 2,616 | | | 2,551 | |
Sprycel | 517 | | | 560 | | | 1,404 | | | 1,587 | |
Yervoy | 579 | | | 523 | | | 1,672 | | | 1,563 | |
Mature and other products | 476 | | | 514 | | | 1,415 | | | 1,563 | |
Total In-Line Products | 8,349 | | | 8,068 | | | 25,612 | | | 25,018 | |
New Product Portfolio | | | | | | | |
Reblozyl | 248 | | | 190 | | | 688 | | | 518 | |
Abecma | 93 | | | 107 | | | 372 | | | 263 | |
Opdualag | 166 | | | 84 | | | 437 | | | 148 | |
Zeposia | 123 | | | 69 | | | 301 | | | 171 | |
Breyanzi | 92 | | | 44 | | | 263 | | | 127 | |
Onureg | 43 | | | 32 | | | 121 | | | 87 | |
Inrebic | 29 | | | 21 | | | 81 | | | 62 | |
Camzyos | 68 | | | 5 | | | 143 | | | 8 | |
Sotyktu | 66 | | | 1 | | | 107 | | | 1 | |
Total New Product Portfolio | 928 | | | 553 | | | 2,513 | | | 1,385 | |
Total In-Line Products and New Product Portfolio | 9,277 | | | 8,621 | | | 28,125 | | | 26,403 | |
Recent LOE Products(a) | | | | | | | |
Revlimid | 1,429 | | | 2,420 | | | 4,647 | | | 7,718 | |
Abraxane | 260 | | | 177 | | | 757 | | | 632 | |
Total Recent LOE Products | 1,689 | | | 2,597 | | | 5,404 | | | 8,350 | |
Total revenues | $ | 10,966 | | | $ | 11,218 | | | $ | 33,529 | | | $ | 34,753 | |
| | | | | | | |
United States | $ | 7,628 | | | $ | 7,941 | | | $ | 23,552 | | | $ | 23,903 | |
International | 3,153 | | | 3,062 | | | 9,462 | | | 10,216 | |
Other(b) | 185 | | | 215 | | | 515 | | | 634 | |
Total revenues | $ | 10,966 | | | $ | 11,218 | | | $ | 33,529 | | | $ | 34,753 | |
(a) Recent LOE Products include products with significant decline in revenue from the prior reporting period as a result of a loss of exclusivity.
(b) Other revenues include royalties and alliance-related revenues for products not sold by BMS's regional commercial organizations.
Revenue recognized from performance obligations satisfied in prior periods was $114 million and $355 million for the three and nine months ended September 30, 2023 and $119 million and $450 million for the three and nine months ended September 30, 2022, respectively, consisting primarily of royalties for out-licensing arrangements and revised estimates for GTN adjustments related to prior period sales.
Note 3. ALLIANCES
BMS enters into collaboration arrangements with third parties for the development and commercialization of certain products. Although each of these arrangements is unique in nature, both parties are active participants in the operating activities of the collaboration and exposed to significant risks and rewards depending on the commercial success of the activities. BMS refers to these collaborations as alliances and its partners as alliance partners.
Selected financial information pertaining to alliances was as follows, including net product sales when BMS is the principal in the third-party customer sale for products subject to the alliance. Expenses summarized below do not include all amounts attributed to the activities for the products in the alliance, but only the payments between the alliance partners or the related amortization if the payments were deferred or capitalized.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Revenues from alliances | | | | | | | |
Net product sales | $ | 2,762 | | | $ | 2,722 | | | $ | 9,614 | | | $ | 9,234 | |
Alliance revenues | 138 | | | 173 | | | 461 | | | 560 | |
Total alliance revenues | $ | 2,900 | | | $ | 2,895 | | | $ | 10,075 | | | $ | 9,794 | |
| | | | | | | |
To/(from) alliance partners | | | | | | | |
Cost of products sold | $ | 1,330 | | | $ | 1,328 | | | $ | 4,650 | | | $ | 4,456 | |
Marketing, selling and administrative | (52) | | | (53) | | | (190) | | | (160) | |
Research and development | 1 | | | 6 | | | 81 | | | 40 | |
Acquired IPRD | — | | | — | | | 55 | | | 100 | |
Other (income)/expense, net | (10) | | | (18) | | | (37) | | | (41) | |
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Selected alliance balance sheet information | | | |
Receivables – from alliance partners | $ | 209 | | | $ | 317 | |
Accounts payable – to alliance partners | 1,288 | | | 1,249 | |
Deferred income – from alliances(a) | 289 | | | 289 | |
(a) Includes unamortized upfront and milestone payments.
The nature, purpose, significant rights and obligations of the parties and specific accounting policy elections for each of the Company's significant alliances are discussed in the 2022 Form 10-K. Significant developments and updates related to alliances during the nine months ended September 30, 2023 and 2022 are set forth below.
BridgeBio
During the second quarter of 2022, BMS and BridgeBio commenced a collaboration to develop and commercialize BBP-398, a SHP2 inhibitor, in oncology. The transaction included an upfront payment of $90 million expensed to Acquired IPRD during the second quarter of 2022. BridgeBio is eligible to receive contingent development, regulatory and sales-based milestones up to $815 million, as well as royalties on global net sales, excluding certain markets. BridgeBio is responsible for funding and completing ongoing BBP-398 Phase I monotherapy and combination therapy trials. BMS is responsible for leading and funding all other development and commercial activities. BridgeBio has an option to co-develop BBP-398 and receive higher royalties in the U.S.
Note 4. ACQUISITIONS, DIVESTITURES, LICENSING AND OTHER ARRANGEMENTS
Acquisitions
Mirati
In October 2023, BMS entered into a definitive merger agreement to acquire Mirati, a commercial stage targeted oncology company with a pipeline of clinical and commercial oncology medicines. The acquisition will provide BMS with rights to Krazati* (adagrasib) and MRTX1719, among other assets. Krazati* is a best-in-class inhibitor of KRASG12C mutation, which was approved by the FDA as a second-line treatment for patients with NSCLC and is in clinical development in combination with a PD-1 inhibitor as a first-line therapy for patients with NSCLC, as well as in other indications. MRTX1719, is a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase 1 development. BMS also will gain access to several other promising clinical and pre-clinical stage assets, including additional KRAS inhibitors and enabling programs.
BMS will acquire all of the issued and outstanding shares of Mirati's common stock for $58.00 per share in an all-cash transaction for a total consideration of $4.8 billion, including cash settlements of equity stock awards. Mirati shareholders will also receive one non-tradeable contingent value right for each share of Mirati common stock held, potentially worth $12.00 per share in cash for a total value of approximately $1.0 billion. The payout of the contingent value right is subject to the FDA acceptance of an NDA for MRTX1719 for the treatment of specific indications within seven years of the closing of the transaction. The transaction is expected to be accounted for as a business combination and is anticipated to close by the first half of 2024, subject to fulfillment of customary closing conditions, including approval of Mirati's shareholders and receipt of required regulatory approvals. The acquisition will be funded through a combination of cash-on-hand and debt proceeds.
Turning Point
In the third quarter of 2022, BMS acquired Turning Point for $4.1 billion of cash (or $3.3 billion net of cash acquired). Turning Point was a clinical-stage precision oncology company with a pipeline of investigational medicines designed to target the common mutations and alterations that drive cancer growth. The acquisition provided BMS rights to Turning Point's lead asset, repotrectinib, and other clinical and pre-clinical stage assets.
Divestitures
The following table summarizes the financial impact of divestitures including royalties, which are included in Other (income)/expense, net. Revenue and pretax earnings related to all divestitures were not material in all periods presented (excluding divestiture gains or losses).
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| Net Proceeds | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 | | 2023 | | 2022 |
Diabetes business - royalties | $ | 220 | | | $ | 205 | | | $ | — | | | $ | — | | | $ | (217) | | | $ | (205) | |
Mature products and other | 3 | | | 1 | | | — | | | — | | | — | | | — | |
Total | $ | 223 | | | $ | 206 | | | — | | | $ | — | | | $ | (217) | | | (205) | |
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| Net Proceeds | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in Millions | 2023 | | 2022 | | 2023 | | 2022 | | 2023 | | 2022 |
Diabetes business - royalties | $ | 621 | | | $ | 562 | | | $ | — | | | $ | — | | | $ | (623) | | | $ | (595) | |
Mature products and other (a) | 10 | | | 229 | | | — | | | (211) | | | — | | | (2) | |
Total | $ | 631 | | | $ | 791 | | | $ | — | | | $ | (211) | | | $ | (623) | | | $ | (597) | |
(a) Includes cash proceeds of $221 million and a divestiture gain of $211 million related to the sale of several mature products to Cheplapharm in the first quarter of 2022.
Mature Products and Other
Manufacturing Operations
During the second quarter of 2022, BMS agreed to sell its manufacturing facility in Syracuse, New York to LOTTE Corporation and accounted for the business as held-for-sale resulting in a $43 million impairment charge recorded to Cost of products sold. Assets and liabilities reclassified to held-for-sale were included within Other current assets and Other current liabilities and were $172 million and $20 million, respectively, as of December 31, 2022. In January 2023, BMS completed the sale resulting in cash proceeds of $159 million, which was received in December 2022.
Licensing and Other Arrangements
The following table summarizes the financial impact of Keytruda* royalties, Tecentriq* royalties, upfront licensing fees and milestones for products that have not obtained commercial approval, which are included in Other (income)/expense, net.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Keytruda* royalties | $ | (315) | | | $ | (268) | | | $ | (878) | | | $ | (732) | |
Tecentriq* royalties | (24) | | | (24) | | | (78) | | | (68) | |
| | | | | | | |
Contingent milestone income | — | | | — | | | (36) | | | (46) | |
Amortization of deferred income | (12) | | | (18) | | | (39) | | | (41) | |
Biohaven sublicense income | — | | | (55) | | | — | | | (55) | |
Other royalties and licensing income | (14) | | | (9) | | | (37) | | | (25) | |
Total | $ | (365) | | | $ | (374) | | | $ | (1,068) | | | $ | (967) | |
LianBio
During October 2023, BMS reacquired the rights for mavacamten in China and certain other Asian territories from LianBio for $350 million in cash. The cost for the reacquired rights will be reflected in Acquired IPRD during the fourth quarter of 2023 as mavacamten is currently in development and not approved for commercial use in China.
Keytruda* Patent License Agreement
In 2017, BMS and Ono entered a global patent license agreement with Merck related to Merck's PD-1 antibody Keytruda*. In accordance with the agreement, Merck is obligated to pay ongoing royalties on global sales of Keytruda* of 6.5% from January 1, 2017 through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. The companies also granted certain rights to each other under their respective patent portfolios pertaining to PD-1. Payments and royalties are shared between BMS and Ono on a 75/25 percent allocation, respectively after adjusting for each party's legal fees.
Immatics
During the first quarter of 2022, BMS obtained a global exclusive license to Immatics' TCR bispecific IMA401 program, which is being studied in oncology. BMS and Immatics collaborate on the development and BMS will be responsible for the commercialization of IMA401 worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. Immatics has the option to co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the U.S. The transaction included an upfront payment of $150 million which was expensed to Acquired IPRD in the first quarter of 2022. Immatics is eligible to receive contingent development, regulatory and sales-based milestones of up to $770 million as well as royalties on global net sales.
Dragonfly
During the first quarter of 2022, a Phase I development milestone for interleukin-12 ("IL-12") was achieved resulting in a $175 million payment to Dragonfly and an Acquired IPRD charge. During the first quarter of 2023, BMS notified Dragonfly of its termination of the global exclusive license related to Dragonfly’s IL-12. All rights to IL-12 were reverted back to Dragonfly effective April 2023.
Other
Nimbus Change of Control Income
During the first quarter of 2022, BMS and Nimbus Therapeutics ("Nimbus") entered into a settlement resolving all legal claims and business interests pertaining to Nimbus' TYK2 inhibitor resulting in $40 million of income included in Other (income)/expense. The settlement also provides for BMS to receive additional amounts for contingent development, regulatory approval and sales-based milestones and 10% of any change in control proceeds received by Nimbus related to its TYK2 inhibitor. In February 2023, Takeda acquired 100% ownership of Nimbus' TYK2 inhibitor for approximately $4.0 billion in upfront proceeds plus contingent sales-based milestones aggregating up to $2.0 billion. As a result, $400 million of income related to the change of control provision was included in Other (income)/expense during the first quarter of 2023.
Royalty Extinguishment
During the second quarter of 2022, BMS amended the terms of a license arrangement and paid a third party $295 million, which was expensed to Acquired IPRD, to extinguish a future royalty obligation related to mavacamten prior to its FDA approval in April 2022.
Note 5. OTHER (INCOME)/EXPENSE, NET
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Interest expense (Note 10) | $ | 280 | | | $ | 299 | | | $ | 850 | | | $ | 938 | |
Royalty and licensing income (Note 4) | (365) | | | (374) | | | (1,068) | | | (967) | |
Royalty income - divestiture (Note 4) | (217) | | | (205) | | | (623) | | | (597) | |
Equity investment losses (Note 9) | — | | | 14 | | | 213 | | | 966 | |
Integration expenses (Note 6) | 54 | | | 114 | | | 180 | | | 343 | |
Loss on debt redemption (Note 10) | — | | | — | | | — | | | 266 | |
Divestiture gains (Note 4) | — | | | — | | | — | | | (211) | |
Litigation and other settlements | (61) | | | 44 | | | (393) | | | 32 | |
Investment income | (107) | | | (52) | | | (304) | | | (89) | |
Provision for restructuring (Note 6) | 141 | | | 17 | | | 321 | | | 60 | |
Other | 17 | | | 3 | | | 37 | | | 52 | |
Other (income)/expense, net | $ | (258) | | | $ | (140) | | | $ | (787) | | | $ | 793 | |
Litigation and Other Settlements
BeiGene Settlement
In August 2023, BMS and BeiGene, Ltd. ("BeiGene") entered into an agreement that settled all on-going disputes and claims between the parties, including those related to the Abraxane license and supply agreements and related arbitration proceedings as further described in "—Note 18. Legal Proceedings and Contingencies".
The agreement also provided for the termination of all contractual relationships between the parties, including the license and supply arrangements pertaining to Revlimid and Vidaza effective as of December 31, 2023, subject to BeiGene’s right to continue to sell all remaining inventory beyond that date. In consideration for the above, BMS agreed to transfer 23.3 million of BeiGene ordinary shares of common stock held under a share subscription agreement back to BeiGene resulting in $322 million of expense that was included in Other (income)/expense, net during the three months ended September 30, 2023. The expense was determined based on the closing price of the shares on the date of the transfer. In addition, the remaining BeiGene ordinary shares owned by BMS under the share subscription agreement were converted to American Depository Shares, which were subsequently sold during the three months ended September 30, 2023.
AstraZeneca Settlement
In July 2023, BMS entered into an agreement with AZ to settle all outstanding claims between the parties in the CTLA-4 litigation and the two PD-L1 antibody litigations, as further described in "—Note 18. Legal Proceedings and Contingencies". AZ will pay an aggregate of $560 million to BMS in four payments through September 2026, which will be subject to sharing arrangements with Ono and Dana-Farber. BMS's share is approximately $418 million, of which the net present value of $384 million was reflected in Other (income)/expense during the three months ended September 30, 2023.
Nimbus Change of Control Income
During the nine months ended September 30, 2023, $400 million of income was recorded in Other (income)/expense in connection with Nimbus' TYK2 program change of control provision. Refer to "—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information.
Note 6. RESTRUCTURING
2023 Restructuring Plan
In 2023, BMS commenced a restructuring plan to accelerate the delivery of medicines to patients by evolving and streamlining its enterprise operating model in key areas, such as R&D, manufacturing, commercial and other functions, to ensure its operating model supports and is appropriately aligned with the Company’s strategy to invest in key priorities. These changes primarily include (i) transforming R&D operations to accelerate pipeline delivery (ii) enhancing our commercial operating model, and (iii) establishing a more responsive manufacturing network and expansion of cell therapy manufacturing capabilities. Charges of approximately $1.0 billion are expected to be incurred through 2025, consisting primarily of employee termination costs and to a lesser extent site exit costs, including impairment and accelerated depreciation of property, plant and equipment.
Celgene and Other Acquisition Plans
Restructuring and integration plans were initiated to realize expected cost synergies resulting from cost savings and avoidance from the acquisition of Celgene (2019), MyoKardia (2020) and Turning Point (2022). As part of these plans, the Company expects to incur charges of approximately $3.8 billion. Cumulative charges of approximately $3.5 billion have been recognized to date including integration planning and execution expenses, employee termination benefit costs and accelerated stock-based compensation, contract termination costs and other shutdown costs associated with site exits. The remaining charges related to the acquisition of Celgene are primarily related to IT system integration which are expected to be incurred through 2024.
The following provides the charges related to restructuring initiatives by type of cost:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
2023 Restructuring Plan | $ | 149 | | | $ | — | | | $ | 380 | | | $ | — | |
Celgene and Other Acquisition Plans | 131 | | | 131 | | | 269 | | | 409 | |
Total charges | $ | 280 | | | $ | 131 | | | $ | 649 | | | $ | 409 | |
| | | | | | | |
Employee termination costs | $ | 135 | | | $ | 16 | | | $ | 309 | | | $ | 57 | |
Other termination costs | 6 | | | 1 | | | 12 | | | 3 | |
Provision for restructuring | 141 | | | 17 | | | 321 | | | 60 | |
Integration expenses | 54 | | | 114 | | | 180 | | | 343 | |
Accelerated depreciation | 15 | | | — | | | 28 | | | 6 | |
Asset impairments (a) | 70 | | | — | | | 120 | | | — | |
| | | | | | | |
Total charges | $ | 280 | | | $ | 131 | | | $ | 649 | | | $ | 409 | |
| | | | | | | |
Cost of products sold | $ | 16 | | | $ | — | | | $ | 53 | | | $ | — | |
Marketing, selling and administrative | 65 | | | — | | | 85 | | | 6 | |
Research and development | 4 | | | — | | | 10 | | | — | |
Other (income)/expense, net | 195 | | | 131 | | | 501 | | | 403 | |
Total charges | $ | 280 | | | $ | 131 | | | $ | 649 | | | $ | 409 | |
(a) Includes $65 million impairment charge for a facility lease that commenced during the three months ended September 2023.
The following summarizes the charges and spending related to restructuring plan activities:
| | | | | | | | | | | |
| Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 |
Beginning balance | $ | 47 | | | $ | 101 | |
Provision for restructuring(a) | 321 | | | 60 | |
Foreign currency translation and other | (3) | | | (10) | |
Payments | (142) | | | (106) | |
Ending balance | $ | 223 | | | $ | 45 | |
(a) Includes a reduction of the liability resulting from changes in estimates of $5 million and $6 million for the nine months ended September 30, 2023 and 2022, respectively.
Note 7. INCOME TAXES
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Earnings before income taxes | $ | 2,137 | | | $ | 2,209 | | | $ | 6,766 | | | $ | 5,854 | |
Income tax provision | 203 | | | 601 | | | 488 | | | 1,534 | |
Effective tax rate | 9.5 | % | | 27.2 | % | | 7.2 | % | | 26.2 | % |
Provision for income taxes in interim periods are determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The reduction in the effective tax rate during the three months ended September 30, 2023 was primarily due to recently issued Section 174 guidance regarding deductibility of certain non-U.S. research and development expenses. The revised guidance resulted in a reduction of previously estimated income taxes attributed to 2022 which was reflected in the current quarter as well as a reduction in the estimated annual effective rates for 2023. Previously estimated income taxes for 2022 were reduced by approximately $240 million upon finalization of the U.S. Federal tax return primarily due to the aforementioned revised Section 174 guidance that was issued during the third quarter of 2023. In addition, the effective tax rate during the first nine months of 2023 was impacted by a $656 million deferred income tax benefit following the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments, jurisdictional earnings mix resulting from amortization of acquired intangible assets, equity investment losses, litigation and other settlements, as well as releases of income tax reserves of $89 million related to the resolution of Celgene's 2009-2011 IRS audits, partially offset by the impact of changes in the Puerto Rico tax decree that eliminated a previously creditable excise tax. Additional changes to the effective tax rate may occur in future periods due to various reasons, including changes to the estimated pretax earnings mix and tax reserves and revised interpretations or changes to the relevant tax code. Income tax payments were $4.1 billion and $3.9 billion for the nine months ended September 30, 2023 and 2022, respectively.
BMS is currently under examination by a number of tax authorities that proposed or are considering proposing material adjustments to tax positions for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. As previously disclosed, BMS received several notices of proposed adjustments from the IRS related to transfer pricing and other tax issues for the 2008 to 2012 tax years. BMS disagrees with the IRS's positions and continues to work cooperatively with the IRS to resolve these issues. In the fourth quarter of 2022, BMS entered the IRS administrative appeals process to resolve these matters. Timing of the final resolution of these complex matters is uncertain and could have a material impact on BMS's consolidated financial statements.
It is reasonably possible that the amount of unrecognized tax benefits as of September 30, 2023 could decrease in the range of approximately $40 million to $60 million in the next twelve months as a result of the settlement of certain tax audits and other events. The expected change in unrecognized tax benefits may result in the payment of additional taxes, adjustment of certain deferred taxes and/or recognition of tax benefits.
It is reasonably possible that new issues will be raised by tax authorities that may increase unrecognized tax benefits, however, an estimate of such increases cannot reasonably be made at this time. BMS believes that it has adequately provided for all open tax years by jurisdiction.
Note 8. EARNINGS PER SHARE
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions, except per share data | 2023 | | 2022 | | 2023 | | 2022 |
Net earnings attributable to BMS | $ | 1,928 | | | $ | 1,606 | | | $ | 6,263 | | | $ | 4,305 | |
| | | | | | | |
Weighted-average common shares outstanding – basic | 2,057 | | | 2,133 | | | 2,083 | | | 2,137 | |
Incremental shares attributable to share-based compensation plans | 7 | | | 15 | | | 10 | | | 17 | |
Weighted-average common shares outstanding – diluted | 2,064 | | | 2,148 | | | 2,093 | | | 2,154 | |
| | | | | | | |
Earnings per common share | | | | | | | |
Basic | $ | 0.94 | | | $ | 0.75 | | | $ | 3.01 | | | $ | 2.01 | |
Diluted | 0.93 | | | 0.75 | | | 2.99 | | | 2.00 | |
The total number of potential shares of common stock excluded from the diluted earnings per common share computation because of the antidilutive impact was not material for the three and nine months ended September 30, 2023 and 2022.
Note 9. FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Dollars in millions | Level 1 | | Level 2 | | Level 3 | | Level 1 | | Level 2 | | Level 3 |
Cash and cash equivalents | | | | | | | | | | | |
Money market and other securities | $ | — | | | $ | 5,545 | | | $ | — | | | $ | — | | | $ | 7,770 | | | $ | — | |
Marketable debt securities | | | | | | | | | | | |
Certificates of deposit | — | | | 2 | | | — | | | — | | | 32 | | | — | |
Commercial paper | — | | | 29 | | | — | | | — | | | 98 | | | — | |
Corporate debt securities | — | | | 442 | | | — | | | — | | | — | | | — | |
U.S. Treasury securities | — | | | 23 | | | — | | | — | | | — | | | — | |
Derivative assets | — | | | 467 | | | — | | | — | | | 305 | | | — | |
Equity investments | 291 | | | 55 | | | — | | | 424 | | | 680 | | | — | |
Derivative liabilities | — | | | 120 | | | — | | | — | | | 213 | | | — | |
Contingent consideration liability | | | | | | | | | | | |
Contingent value rights | 4 | | | — | | | — | | | 5 | | | — | | | — | |
Other acquisition related contingent consideration | — | | | — | | | 9 | | | — | | | — | | | 24 | |
As further described in "Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements" in the Company's 2022 Form 10-K, the Company's fair value estimates use inputs that are either (1) quoted prices for identical assets or liabilities in active markets (Level 1 inputs); (2) observable prices for similar assets or liabilities in active markets or for identical or similar assets or liabilities in markets that are not active (Level 2 inputs); or (3) unobservable inputs (Level 3 inputs). The fair value of Level 2 equity investments is adjusted for characteristics specific to the security and is not adjusted for contractual sale restrictions. Equity investments subject to contractual sale restrictions were not material as of December 31, 2022 and the restrictions expired in April 2023.
Marketable Debt Securities
The following table summarizes marketable debt securities:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Dollars in millions | Amortized Cost | | Gross Unrealized | | | | Amortized Cost | | Gross Unrealized | | |
| Gains | | Losses | | Fair Value | | | Gains | | Losses | | Fair Value |
Certificates of deposit | $ | 2 | | | $ | — | | | $ | — | | | $ | 2 | | | $ | 32 | | | $ | — | | | $ | — | | | $ | 32 | |
Commercial paper | 29 | | | — | | | — | | | 29 | | | 98 | | | — | | | — | | | 98 | |
Corporate debt securities | 445 | | | — | | | (3) | | | 442 | | | — | | | — | | | — | | | — | |
U.S. Treasury securities | 23 | | | — | | | — | | | 23 | | | — | | | — | | | — | | | — | |
Total marketable debt securities(a) | $ | 499 | | | $ | — | | | $ | (3) | | | $ | 496 | | | $ | 130 | | | $ | — | | | $ | — | | | $ | 130 | |
(a) All marketable debt securities mature within three years as of September 30, 2023, and one year as of December 31, 2022.
Equity Investments
The following summarizes the carrying amount of equity investments:
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Equity investments with readily determinable fair values | $ | 346 | | | $ | 1,104 | |
Equity investments without readily determinable fair values | 654 | | | 537 | |
Limited partnerships and other equity method investments | 557 | | | 546 | |
Total equity investments | $ | 1,557 | | | $ | 2,187 | |
The following summarizes the activity related to equity investments. Changes in fair value of equity investments are included in Other (income)/expense, net.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Equity investments with readily determinable fair values | | | | | | | |
Net loss recognized | 15 | | | 75 | | | 203 | | | 927 | |
Less: net (gain) loss recognized on investments sold | (86) | | | (1) | | | 2 | | | (17) | |
Net unrealized loss recognized on investments still held | 101 | | | 76 | | | 201 | | | 944 | |
| | | | | | | |
Equity investments without readily determinable fair values | | | | | | | |
Upward adjustments | (3) | | | (64) | | | (9) | | | (70) | |
Impairments and downward adjustments | 6 | | | — | | | 6 | | | 2 | |
Equity in net (income)/loss of affiliates | (18) | | | 3 | | | 13 | | | 107 | |
| | | | | | | |
Total equity investment losses | — | | | 14 | | | 213 | | | 966 | |
Cumulative upwards adjustments and cumulative impairments and downward adjustments based on observable price changes in equity investments without readily determinable fair values still held as of September 30, 2023 were $189 million and $67 million, respectively.
Qualifying Hedges and Non-Qualifying Derivatives
Cash Flow Hedges
BMS enters into foreign currency forward and purchased local currency put option contracts (foreign exchange contracts) to hedge certain forecasted intercompany inventory sales and certain other foreign currency transactions. The objective of these foreign exchange contracts is to reduce variability caused by changes in foreign exchange rates that would affect the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro and Japanese yen. The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the consolidated balance sheets. Changes in fair value for these foreign exchange contracts, which are designated as cash flow hedges, are temporarily recorded in Accumulated other comprehensive loss ("AOCL") and reclassified to net earnings when the hedged item affects earnings (typically within the next 24 months). As of September 30, 2023, assuming market rates remain constant through contract maturities, we expect to reclassify pre-tax gains of $179 million into Cost of products sold for our foreign exchange contracts out of AOCL during the next 12 months. The notional amount of outstanding foreign currency exchange contracts was primarily $5.0 billion for the euro contracts and $1.1 billion for Japanese yen contracts as of September 30, 2023.
BMS also enters into cross-currency swap contracts to hedge exposure to foreign currency exchange rate risk associated with its long-term debt denominated in euros. These contracts convert interest payments and principal repayment of the long-term debt to U.S. dollars from euros and are designated as cash flow hedges. The unrealized gains and losses on these contracts are reported in AOCL and reclassified to Other (income)/expense, net, in the same periods during which the hedged debt affects earnings. The notional amount of cross-currency swap contracts associated with long-term debt denominated in euros was $1.2 billion as of September 30, 2023.
Cash flow hedge accounting is discontinued when the forecasted transaction is no longer probable of occurring within 60 days after the originally forecasted date or when the hedge is no longer effective. Assessments to determine whether derivatives designated as qualifying hedges are highly effective in offsetting changes in the cash flows of hedged items are performed at inception and on a quarterly basis. The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not material during all periods presented. Foreign currency exchange contracts not designated as a cash flow hedge offset exposures in certain foreign currency denominated assets, liabilities and earnings. Changes in the fair value of these derivatives are recognized in earnings as they occur.
Net Investment Hedges
Cross-currency swap contracts and foreign currency forward contracts of $1.8 billion as of September 30, 2023 are designated to hedge currency exposure of BMS's net investment in its foreign subsidiaries. Contract fair value changes are recorded in the foreign currency translation component of AOCL with a related offset in derivative asset or liability in the consolidated balance sheets. The notional amount of outstanding cross-currency swap and foreign currency forward contracts was primarily attributed to the Japanese yen of $650 million and euro of $794 million as of September 30, 2023.
During the first quarter of 2023, the Company de-designated its remaining net investment hedge in debt denominated in euros of €375 million. The related net investment hedge was entered into to hedge euro currency exposures of the net investment in certain foreign affiliates and was recognized in Long-term debt. The effective portion of foreign exchange gain or loss on the remeasurement of debt denominated in euros was included in the foreign currency translation component of AOCL with the related offset in Long-term debt.
During the three and nine months ended September 30, 2023, the amortization of gains related to the portion of our net investment hedges that was excluded from the assessment of effectiveness was not material.
Fair Value Hedges
Fixed to floating interest rate swap contracts are designated as fair value hedges and used as an interest rate risk management strategy to create an appropriate balance of fixed and floating rate debt. The contracts and underlying debt for the hedged benchmark risk are recorded at fair value. Gains or losses resulting from changes in fair value of the underlying debt attributable to the hedged benchmark interest rate risk are recorded in interest expense with an associated offset to the carrying value of debt. Since the specific terms and notional amount of the swap are intended to align with the debt being hedged, all changes in fair value of the swap are recorded in interest expense with an associated offset to the derivative asset or liability in the consolidated balance sheets. As a result, there was no net impact in earnings. If the underlying swap is terminated prior to maturity, then the fair value adjustment to the underlying debt is amortized as a reduction to interest expense over the remaining term of the debt.
Derivative cash flows, with the exception of net investment hedges, are principally classified in the operating section of the consolidated statements of cash flows, consistent with the underlying hedged item. Cash flows related to net investment hedges are classified in investing activities.
The following table summarizes the fair value and the notional values of outstanding derivatives:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
| Asset(a) | | Liability(b) | | Asset(a) | | Liability(b) |
Dollars in millions | Notional | | Fair Value | | Notional | | Fair Value | | Notional | | Fair Value | | Notional | | Fair Value |
Designated as cash flow hedges | | | |