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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, 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 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.) |
430 E. 29th Street, 14FL, New York, NY 10016
(Address of principal executive offices) (Zip Code)
(212) 546-4200
(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.
| | | | | | | | | | | | | | | | | | | | | | | | | | |
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 14, 2022, there were 2,126,160,347 shares outstanding of the Registrant’s $0.10 par value common stock.
BRISTOL-MYERS SQUIBB COMPANY
INDEX TO FORM 10-Q
September 30, 2022
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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 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 | 2022 | | 2021 | | 2022 | | 2021 |
Net product sales | $ | 10,813 | | | $ | 11,243 | | | $ | 33,606 | | | $ | 33,446 | |
Alliance and other revenues | 405 | | | 381 | | | 1,147 | | | 954 | |
Total Revenues | 11,218 | | | 11,624 | | | 34,753 | | | 34,400 | |
| | | | | | | |
Cost of products sold(a) | 2,353 | | | 2,291 | | | 7,544 | | | 7,584 | |
Marketing, selling and administrative | 1,930 | | | 1,788 | | | 5,548 | | | 5,336 | |
Research and development | 2,418 | | | 2,980 | | | 6,999 | | | 7,677 | |
Acquired IPRD | 30 | | | 271 | | | 763 | | | 1,070 | |
Amortization of acquired intangible assets | 2,418 | | | 2,546 | | | 7,252 | | | 7,606 | |
Other (income)/expense, net | (140) | | | (409) | | | 793 | | | (1,113) | |
Total Expenses | 9,009 | | | 9,467 | | | 28,899 | | | 28,160 | |
| | | | | | | |
Earnings Before Income Taxes | 2,209 | | | 2,157 | | | 5,854 | | | 6,240 | |
Provision for Income Taxes | 601 | | | 605 | | | 1,534 | | | 1,598 | |
Net Earnings | 1,608 | | | 1,552 | | | 4,320 | | | 4,642 | |
Noncontrolling Interest | 2 | | | 6 | | | 15 | | | 20 | |
Net Earnings Attributable to BMS | $ | 1,606 | | | $ | 1,546 | | | $ | 4,305 | | | $ | 4,622 | |
| | | | | | | |
Earnings per Common Share: | | | | | | | |
Basic | $ | 0.75 | | | $ | 0.70 | | | $ | 2.01 | | | $ | 2.08 | |
Diluted | 0.75 | | | 0.69 | | | 2.00 | | | 2.05 | |
(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 | 2022 | | 2021 | | 2022 | | 2021 |
Net Earnings | $ | 1,608 | | | $ | 1,552 | | | $ | 4,320 | | | $ | 4,642 | |
Other Comprehensive Income, net of taxes and reclassifications to earnings: |
Derivatives qualifying as cash flow hedges | 286 | | | 113 | | | 618 | | | 399 | |
Pension and postretirement benefits | 18 | | | 7 | | | 64 | | | 45 | |
Marketable debt securities | — | | | (3) | | | (2) | | | (7) | |
Foreign currency translation | (153) | | | (23) | | | (253) | | | (22) | |
Total Other Comprehensive Income | 151 | | | 94 | | | 427 | | | 415 | |
| | | | | | | |
Comprehensive Income | 1,759 | | | 1,646 | | | 4,747 | | | 5,057 | |
Comprehensive Income Attributable to Noncontrolling Interest | 2 | | | 6 | | | 15 | | | 20 | |
Comprehensive Income Attributable to BMS | $ | 1,757 | | | $ | 1,640 | | | $ | 4,732 | | | $ | 5,037 | |
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, 2022 | | December 31, 2021 |
Current Assets: | | | |
Cash and cash equivalents | $ | 7,734 | | | $ | 13,979 | |
Marketable debt securities | 1,293 | | | 2,987 | |
Receivables | 9,613 | | | 9,369 | |
Inventories | 2,074 | | | 2,095 | |
Other current assets | 6,082 | | | 4,832 | |
Total Current Assets | 26,796 | | | 33,262 | |
Property, plant and equipment | 6,035 | | | 6,049 | |
Goodwill | 21,112 | | | 20,502 | |
Other intangible assets | 38,179 | | | 42,527 | |
Deferred income taxes | 1,329 | | | 1,439 | |
| | | |
Other non-current assets | 4,745 | | | 5,535 | |
Total Assets | $ | 98,196 | | | $ | 109,314 | |
| | | |
LIABILITIES | | | |
Current Liabilities: | | | |
Short-term debt obligations | $ | 2,132 | | | $ | 4,948 | |
Accounts payable | 2,595 | | | 2,949 | |
Other current liabilities | 14,203 | | | 13,971 | |
Total Current Liabilities | 18,930 | | | 21,868 | |
Deferred income taxes | 2,881 | | | 4,501 | |
Long-term debt | 36,966 | | | 39,605 | |
Other non-current liabilities | 6,685 | | | 7,334 | |
Total Liabilities | 65,462 | | | 73,308 | |
| | | |
Commitments and contingencies | | | |
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EQUITY | | | |
Bristol-Myers Squibb Company Shareholders’ Equity: | | | |
Preferred stock | — | | | — | |
Common stock | 292 | | | 292 | |
Capital in excess of par value of stock | 44,956 | | | 44,361 | |
Accumulated other comprehensive loss | (841) | | | (1,268) | |
Retained earnings | 24,675 | | | 23,820 | |
Less cost of treasury stock | (36,411) | | | (31,259) | |
Total Bristol-Myers Squibb Company Shareholders’ Equity | 32,671 | | | 35,946 | |
Noncontrolling interest | 63 | | | 60 | |
Total Equity | 32,734 | | | 36,006 | |
Total Liabilities and Equity | $ | 98,196 | | | $ | 109,314 | |
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, |
| 2022 | | 2021 |
Cash Flows From Operating Activities: | | | |
Net earnings | $ | 4,320 | | | $ | 4,642 | |
Adjustments to reconcile net earnings to net cash provided by operating activities: | | | |
Depreciation and amortization, net | 7,755 | | | 8,107 | |
Deferred income taxes | (2,114) | | | (127) | |
Stock-based compensation | 338 | | | 450 | |
Impairment charges | 144 | | | 1,192 | |
| | | |
Divestiture gains and royalties | (820) | | | (462) | |
Acquired IPRD | 763 | | | 1,070 | |
Equity investment losses/(income) | 966 | | | (1,214) | |
Contingent consideration fair value adjustments | 1 | | | (510) | |
Other adjustments | 178 | | | 204 | |
Changes in operating assets and liabilities: | | | |
Receivables | (557) | | | (886) | |
Inventories | (28) | | | 141 | |
Accounts payable | (296) | | | 19 | |
Rebates and discounts | 730 | | | 902 | |
Income taxes payable | (310) | | | (841) | |
Other | (1,310) | | | (537) | |
Net Cash Provided by Operating Activities | 9,760 | | | 12,150 | |
Cash Flows From Investing Activities: | | | |
Sale and maturities of marketable debt securities | 5,205 | | | 2,952 | |
Purchase of marketable debt securities | (3,566) | | | (3,408) | |
Proceeds from sales of equity investment securities | 213 | | | 1,058 | |
Capital expenditures | (772) | | | (653) | |
Divestiture and other proceeds | 815 | | | 570 | |
Acquisition and other payments, net of cash acquired | (4,170) | | | (1,458) | |
Net Cash Used in Investing Activities | (2,275) | | | (939) | |
Cash Flows From Financing Activities: | | | |
Short-term debt obligations, net | 58 | | | (46) | |
Issuance of long-term debt | 5,926 | | | — | |
Repayment of long-term debt | (11,431) | | | (6,022) | |
Repurchase of common stock | (5,585) | | | (3,536) | |
Dividends | (3,489) | | | (3,297) | |
Other | 805 | | | 644 | |
Net Cash Used in Financing Activities | (13,716) | | | (12,257) | |
Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash | (128) | | | (48) | |
Decrease in Cash, Cash Equivalents and Restricted Cash | (6,359) | | | (1,094) | |
Cash, Cash Equivalents and Restricted Cash at Beginning of Period | 14,316 | | | 14,973 | |
Cash, Cash Equivalents and Restricted Cash at End of Period | $ | 7,957 | | | $ | 13,879 | |
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" 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 as of September 30, 2022 and December 31, 2021, the results of operations for the three and nine months ended September 30, 2022 and 2021, and cash flows for the nine months ended September 30, 2022 and 2021. All intercompany balances and transactions have been eliminated. These financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2021 included in the 2021 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. Upfront and contingent milestone charges in connection with asset acquisitions or licensing of third-party intellectual property rights previously presented in Research and development are now presented in Acquired IPRD in the consolidated statements of earnings. Additionally, Rebates and discounts previously presented in Other changes in operating assets and liabilities in the consolidated statements of cash flows are now presented separately in Rebates and discounts.
Recently Issued Accounting Standards
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 amended guidance is effective January 1, 2023 on a prospective basis. Early adoption is permitted.
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.
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 | 2022 | | 2021 | | 2022 | | 2021 |
Net product sales | $ | 10,813 | | | $ | 11,243 | | | $ | 33,606 | | | $ | 33,446 | |
Alliance revenues | 173 | | | 194 | | | 560 | | | 495 | |
Other revenues | 232 | | | 187 | | | 587 | | | 459 | |
Total Revenues | $ | 11,218 | | | $ | 11,624 | | | $ | 34,753 | | | $ | 34,400 | |
The following table summarizes GTN adjustments:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2022 | | 2021 | | 2022 | | 2021 |
Gross product sales | $ | 17,606 | | | $ | 17,335 | | | $ | 51,555 | | | $ | 49,676 | |
GTN adjustments(a) | | | | | | | |
Charge-backs and cash discounts | (1,907) | | | (1,908) | | | (5,420) | | | (5,214) | |
Medicaid and Medicare rebates | (3,295) | | | (2,625) | | | (8,003) | | | (6,482) | |
Other rebates, returns, discounts and adjustments | (1,591) | | | (1,559) | | | (4,526) | | | (4,534) | |
Total GTN adjustments | (6,793) | | | (6,092) | | | (17,949) | | | (16,230) | |
Net product sales | $ | 10,813 | | | $ | 11,243 | | | $ | 33,606 | | | $ | 33,446 | |
(a) Includes adjustments for provisions for product sales made in prior periods resulting from changes in estimates of $10 million and $207 million for the three and nine months ended September 30, 2022, and $10 million and $282 million for the three and nine months ended September 30, 2021, 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 | 2022 | | 2021 | | 2022 | | 2021 |
In-Line Products | | | | | | | |
Eliquis | $ | 2,655 | | | $ | 2,413 | | | 9,101 | | | 8,091 | |
Opdivo | 2,047 | | | 1,905 | | | 6,033 | | | 5,535 | |
Pomalyst/Imnovid | 886 | | | 851 | | | 2,620 | | | 2,478 | |
Orencia | 883 | | | 870 | | | 2,551 | | | 2,442 | |
Sprycel | 560 | | | 551 | | | 1,587 | | | 1,562 | |
Yervoy | 523 | | | 515 | | | 1,563 | | | 1,481 | |
Empliciti | 73 | | | 82 | | | 225 | | | 253 | |
Mature and other products | 441 | | | 480 | | | 1,338 | | | 1,459 | |
Total In-Line Products | 8,068 | | | 7,667 | | | 25,018 | | | 23,301 | |
New Product Portfolio | | | | | | | |
Reblozyl | 190 | | | 160 | | | 518 | | | 400 | |
Abecma | 107 | | | 71 | | | 263 | | | 95 | |
Zeposia | 69 | | | 40 | | | 171 | | | 86 | |
Breyanzi | 44 | | | 30 | | | 127 | | | 47 | |
Inrebic | 21 | | | 22 | | | 62 | | | 54 | |
Onureg | 32 | | | 21 | | | 87 | | | 48 | |
Opdualag | 84 | | | — | | | 148 | | | — | |
Camzyos | 5 | | | — | | | 8 | | | — | |
Sotyktu | 1 | | | — | | | 1 | | | — | |
Total New Product Portfolio | 553 | | | 344 | | | 1,385 | | | 730 | |
Total In-Line Products and New Product Portfolio | 8,621 | | | 8,011 | | | 26,403 | | | 24,031 | |
Recent LOE Products(a) | | | | | | | |
Revlimid | 2,420 | | | 3,347 | | | 7,718 | | | 9,493 | |
Abraxane | 177 | | | 266 | | | 632 | | | 876 | |
Total Recent LOE Products | 2,597 | | | 3,613 | | | 8,350 | | | 10,369 | |
Total Revenues | $ | 11,218 | | | $ | 11,624 | | | $ | 34,753 | | | $ | 34,400 | |
| | | | | | | |
United States | $ | 7,941 | | | $ | 7,296 | | | $ | 23,903 | | | $ | 21,694 | |
International | 3,062 | | | 4,052 | | | 10,216 | | | 12,075 | |
Other(b) | 215 | | | 276 | | | 634 | | | 631 | |
Total Revenues | $ | 11,218 | | | $ | 11,624 | | | $ | 34,753 | | | $ | 34,400 | |
(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 $119 million and $450 million for the three and nine months ended September 30, 2022 and $73 million and $463 million for the three and nine months ended September 30, 2021, respectively, consisting primarily of revised estimates for GTN adjustments related to prior period sales and royalties for out-licensing arrangements.
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 may either in-license intellectual property owned by the other party or out-license its intellectual property to the other party. These arrangements also typically include research, development, manufacturing, and/or commercial activities and can cover a single investigational compound or commercial product or multiple compounds and/or products in various life cycle stages. The rights and obligations of the parties can be global or limited to geographic regions. 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 | 2022 | | 2021 | | 2022 | | 2021 |
Revenues from alliances: | | | | | | | |
Net product sales | $ | 2,722 | | | $ | 2,452 | | | $ | 9,234 | | | $ | 8,139 | |
Alliance revenues | 173 | | | 194 | | | 560 | | | 495 | |
Total Revenues | $ | 2,895 | | | $ | 2,646 | | | $ | 9,794 | | | $ | 8,634 | |
| | | | | | | |
Payments to/(from) alliance partners: | | | | | | | |
Cost of products sold | $ | 1,328 | | | $ | 1,181 | | | $ | 4,456 | | | $ | 3,924 | |
Marketing, selling and administrative | (53) | | | (43) | | | (160) | | | (140) | |
Research and development | 6 | | | 10 | | | 40 | | | 17 | |
Acquired IPRD | — | | | — | | | 100 | | | 736 | |
Other (income)/expense, net | (18) | | | 1 | | | (41) | | | (18) | |
| | | | | | | | | | | |
Dollars in Millions | September 30, 2022 | | December 31, 2021 |
Selected Alliance Balance Sheet information: | | | |
Receivables – from alliance partners | $ | 281 | | | $ | 320 | |
Accounts payable – to alliance partners | 1,242 | | | 1,229 | |
Deferred income – from alliances(a) | 304 | | | 330 | |
(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 2021 Form 10-K. Significant developments and updates related to alliances during the nine months ended September 30, 2022, and 2021 are set forth below.
BridgeBio
In May 2022, BMS and BridgeBio commenced an exclusive global collaboration to develop and commercialize BBP-398, a SHP2 inhibitor, in oncology. The transaction included an upfront payment of $90 million, which was 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 will lead and fund all other development and commercial activities. BridgeBio has an option to co-develop BBP-398 and receive higher royalties in the U.S.
Nektar
In April 2022, BMS and Nektar announced that the companies have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo based on results from pre-planned analyses of two late-stage clinical studies in RCC and bladder cancer. These studies and all other ongoing studies in the program are being discontinued.
Eisai
In the second quarter of 2021, BMS and Eisai commenced an exclusive global strategic collaboration for the co-development and co-commercialization of MORAb-202, a selective folate receptor alpha antibody-drug conjugate being investigated in endometrial, ovarian, lung and breast cancers. MORAb-202 is currently in Phase I/II clinical trials for solid tumors.
BMS and Eisai will jointly develop and commercialize MORAb-202 in the U.S., Canada, Europe, Japan, China and certain other countries in the Asia-Pacific region (the “collaboration territory”). Eisai is responsible for the global manufacturing and supply. Profits, research and development and commercialization costs are shared in the collaboration territories. BMS is responsible for development and commercialization outside of the collaboration territory and will pay a royalty on those sales.
A $650 million up-front collaboration fee was expensed to Acquired IPRD during the second quarter of 2021. BMS is also obligated to pay up to $2.5 billion upon the achievement of contingent development, regulatory and sales-based milestones.
Note 4. ACQUISITIONS, DIVESTITURES, LICENSING AND OTHER ARRANGEMENTS
Acquisitions
Turning Point
On August 17, 2022, BMS acquired Turning Point for $4.1 billion of cash (or $3.3 billion net of cash acquired). Turning Point is 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 provides BMS rights to Turning Point's lead asset, repotrectinib, and other clinical and pre-clinical stage assets. The transaction was accounted for as a business combination requiring all assets acquired and liabilities assumed to be recognized at their fair value as of the acquisition date.
The total consideration for the acquisition consisted of the following:
| | | | | |
Dollars in Millions | Total Consideration |
Cash consideration for outstanding shares | $ | 3,811 | |
Cash consideration for equity awards | 302 | |
Consideration paid | 4,113 | |
Less: Unvested stock awards (a) | 153 | |
Total consideration to be allocated | $ | 3,960 | |
(a) Includes unvested equity awards of $73 million expensed in Marketing, selling, and administrative and $80 million expensed in Research and development during the three months ended September 30, 2022.
The purchase price allocation resulted in the following amounts being allocated to the assets acquired and liabilities assumed as of the acquisition date based upon their respective fair values summarized below:
| | | | | |
Dollars in Millions | Purchase Price Allocation |
Cash and cash equivalents | $ | 795 | |
Other current assets | 14 | |
Intangible assets (a) | 2,971 | |
Deferred income tax assets | 229 | |
Other non-current assets | 10 | |
Deferred income tax liabilities | (643) | |
Other current liabilities | (111) | |
Identifiable net assets acquired | $ | 3,265 | |
Goodwill (b) | 695 | |
Total consideration allocated | $ | 3,960 | |
(a) Intangible assets primarily consist of IPRD allocated to repotrectinib ($2.8 billion), a potential best-in-class tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers in NSCLC and other advanced solid tumors. Repotrectinib is currently in registrational Phase II study in adults and a Phase I/II study in pediatric patients. The estimated fair value of IPRD assets was determined using an income approach valuation method.
(b) Goodwill resulted primarily from the recognition of deferred tax liabilities and is not deductible for tax purposes.
The results of Turning Point's operations were included in the consolidated financial statements commencing August 18, 2022, and were not material. Historical financial results of the acquired entity were not significant.
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(a) | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in Millions | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 |
Diabetes Business | $ | 205 | | | $ | 153 | | | $ | — | | | $ | — | | | $ | (205) | | | $ | (159) | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Mature Products and Other | 1 | | | 35 | | | — | | | 2 | | | — | | | (1) | |
Total | $ | 206 | | | $ | 188 | | | $ | — | | | $ | 2 | | | $ | (205) | | | $ | (160) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| Net Proceeds(a) | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in Millions | 2022 | | 2021 | | 2022 | | 2021 | | 2022 | | 2021 |
Diabetes Business | $ | 562 | | | $ | 449 | | | $ | — | | | $ | — | | | $ | (595) | | | $ | (445) | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Mature Products and Other | 229 | | | 121 | | | (211) | | | (9) | | | (2) | | | (2) | |
Total | $ | 791 | | | $ | 570 | | | $ | (211) | | | $ | (9) | | | $ | (597) | | | $ | (447) | |
(a) Includes royalties received subsequent to the related sale of the asset or business.
Mature Products and Other
Manufacturing Operations
In May 2022, BMS agreed to sell its manufacturing facility in Syracuse, New York to LOTTE Corporation for approximately $170 million. The transaction is expected to close during the first quarter of 2023, subject to certain regulatory approvals and other closing conditions and will be accounted for as a sale of a business. The business was accounted for as held-for-sale and its assets were reduced to the estimated relative fair value resulting in a $43 million impairment charge recorded to Cost of products sold during the second quarter of 2022. Assets and liabilities reclassified to held-for-sale and included within Other current assets and Other current liabilities were $155 million and $6 million, respectively, as of September 30, 2022.
Other
During the first quarter of 2022, product rights to several mature products were sold to Cheplapharm, resulting in cash proceeds of $221 million and a divestiture gain of $211 million.
Licensing and Other Arrangements
The following table summarizes the financial impact of Keytruda* royalties, Tecentriq* royalties 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 | 2022 | | 2021 | | 2022 | | 2021 |
Keytruda* royalties | $ | (268) | | | $ | (215) | | | $ | (732) | | | $ | (611) | |
Tecentriq* royalties | (24) | | | (22) | | | (68) | | | (67) | |
| | | | | | | |
Contingent milestone income | — | | | (10) | | | (46) | | | (12) | |
Amortization of deferred income | (18) | | | 3 | | | (41) | | | (27) | |
Biohaven sublicense income | (55) | | | — | | | (55) | | | — | |
Other royalties and licensing income | (9) | | | (21) | | | (25) | | | (33) | |
Total | $ | (374) | | | $ | (265) | | | $ | (967) | | | $ | (750) | |
In-license Arrangements
Immatics
During the first quarter of 2022, BMS obtained a global exclusive license to Immatics’ TCR bispecific IMA401 program. IMA401 is being studied in oncology and a Clinical Trial Application has been approved by the German federal regulatory authority. The trial commenced in May 2022. 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 interlukin-12 (“IL-12”) was achieved resulting in a $175 million payment to Dragonfly and an Acquired IPRD charge. The parties also amended the terms of three future milestones by requiring the achievement of certain criteria by specified dates unless BMS notifies Dragonfly that it will discontinue development of IL-12. These milestones continue to be considered substantive and contingent because the decision to proceed will be based on an assessment of clinical data prior to the specified dates.
Agenus
During the third quarter of 2021, BMS obtained a global exclusive license to Agenus’ proprietary AGEN1777 bispecific antibody program that blocks TIGIT and an additional target. AGEN1777 is being studied in oncology and a Phase I clinical trial was initiated in October 2021. BMS will be responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. The transaction included an upfront payment of $200 million expensed to Acquired IPRD for the third quarter of 2021. Agenus is eligible to receive contingent development, regulatory and sales-based milestones up to $1.4 billion as well as royalties on global net sales.
Other
Royalty Extinguishment
In April 2022, BMS amended the terms of a license arrangement and paid a third party $295 million to extinguish a future royalty obligation related to mavacamten, prior to its FDA approval in April 2022, resulting in an Acquired IPRD charge during the second quarter of 2022.
Note 5. OTHER (INCOME)/EXPENSE, NET
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2022 | | 2021 | | 2022 | | 2021 |
Interest expense | $ | 299 | | | $ | 328 | | | $ | 938 | | | $ | 1,011 | |
Royalties and licensing income | (579) | | | (425) | | | (1,564) | | | (1,197) | |
Equity investment losses/(income) | 14 | | | (465) | | | 966 | | | (1,214) | |
Integration expenses | 114 | | | 141 | | | 343 | | | 434 | |
Contingent consideration | — | | | — | | | 1 | | | (510) | |
Loss on debt redemption | — | | | — | | | 266 | | | 281 | |
Provision for restructuring | 17 | | | 27 | | | 60 | | | 150 | |
Litigation and other settlements | 44 | | | 13 | | | 32 | | | 49 | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Divestiture losses/(gains) | — | | | 2 | | | (211) | | | (9) | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Other | (49) | | | (30) | | | (38) | | | (108) | |
Other (income)/expense, net | $ | (140) | | | $ | (409) | | | $ | 793 | | | $ | (1,113) | |
Note 6. RESTRUCTURING
Celgene Acquisition Plan
In 2019, a restructuring and integration plan was implemented as an initiative to realize sustainable run rate synergies resulting from cost savings and avoidance from the Celgene acquisition that are currently expected to be approximately $3.0 billion. The synergies are expected to be realized in Cost of products sold (5%), Marketing, selling and administrative expenses (65%) and Research and development expenses (30%). Charges of approximately $3.5 billion are expected to be incurred including cash outlays of approximately $3.1 billion. Cumulative charges of approximately $3.0 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 are primarily related to IT system integration which are expected to be incurred through 2024. Employee workforce reductions were approximately 150 and 320 for the nine months ended September 30, 2022 and 2021, respectively.
Other Restructuring