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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, 2021
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)
___________________________
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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:
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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 September 30, 2021, there were 2,219,644,935 shares outstanding of the Registrant’s $0.10 par value common stock.
BRISTOL-MYERS SQUIBB COMPANY
INDEX TO FORM 10-Q
September 30, 2021
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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 | 2021 | | 2020 | | 2021 | | 2020 |
Net product sales | $ | 11,243 | | | $ | 10,197 | | | $ | 33,446 | | | $ | 30,555 | |
Alliance and other revenues | 381 | | | 343 | | | 954 | | | 895 | |
Total Revenues | 11,624 | | | 10,540 | | | 34,400 | | | 31,450 | |
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Cost of products sold(a) | 2,291 | | | 2,502 | | | 7,584 | | | 8,863 | |
Marketing, selling and administrative | 1,788 | | | 1,706 | | | 5,336 | | | 4,940 | |
Research and development | 3,251 | | | 2,499 | | | 8,747 | | | 7,393 | |
Amortization of acquired intangible assets | 2,546 | | | 2,491 | | | 7,606 | | | 7,162 | |
Other (income)/expense, net | (409) | | | (915) | | | (1,113) | | | (488) | |
Total Expenses | 9,467 | | | 8,283 | | | 28,160 | | | 27,870 | |
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Earnings Before Income Taxes | 2,157 | | | 2,257 | | | 6,240 | | | 3,580 | |
Provision for Income Taxes | 605 | | | 379 | | | 1,598 | | | 2,548 | |
Net Earnings | 1,552 | | | 1,878 | | | 4,642 | | | 1,032 | |
Noncontrolling Interest | 6 | | | 6 | | | 20 | | | 20 | |
Net Earnings Attributable to BMS | $ | 1,546 | | | $ | 1,872 | | | $ | 4,622 | | | $ | 1,012 | |
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Earnings per Common Share | | | | | | | |
Basic | $ | 0.70 | | | $ | 0.83 | | | $ | 2.08 | | | $ | 0.45 | |
Diluted | 0.69 | | | 0.82 | | | 2.05 | | | 0.44 | |
(a) Excludes amortization of acquired intangible assets.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME/(LOSS)
Dollars in Millions
(UNAUDITED)
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
COMPREHENSIVE INCOME/(LOSS) | 2021 | | 2020 | | 2021 | | 2020 |
Net Earnings | $ | 1,552 | | | $ | 1,878 | | | $ | 4,642 | | | $ | 1,032 | |
Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings: |
Derivatives qualifying as cash flow hedges | 113 | | | (132) | | | 399 | | | (121) | |
Pension and postretirement benefits | 7 | | | (4) | | | 45 | | | 5 | |
Available-for-sale debt securities | (3) | | | (2) | | | (7) | | | 7 | |
Foreign currency translation | (23) | | | (5) | | | (22) | | | (70) | |
Total Other Comprehensive Income/(Loss) | 94 | | | (143) | | | 415 | | | (179) | |
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Comprehensive Income | 1,646 | | | 1,735 | | | 5,057 | | | 853 | |
Comprehensive Income Attributable to Noncontrolling Interest | 6 | | | 6 | | | 20 | | | 20 | |
Comprehensive Income Attributable to BMS | $ | 1,640 | | | $ | 1,729 | | | $ | 5,037 | | | $ | 833 | |
The accompanying notes are an integral part of these consolidated financial statements.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED BALANCE SHEETS
Dollars in Millions
(UNAUDITED)
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ASSETS | September 30, 2021 | | December 31, 2020 |
Current Assets: | | | |
Cash and cash equivalents | $ | 13,540 | | | $ | 14,546 | |
Marketable debt securities | 2,123 | | | 1,285 | |
Receivables | 9,245 | | | 8,501 | |
Inventories | 2,163 | | | 2,074 | |
Other current assets | 4,372 | | | 3,786 | |
Total Current Assets | 31,443 | | | 30,192 | |
Property, plant and equipment | 5,868 | | | 5,886 | |
Goodwill | 20,519 | | | 20,547 | |
Other intangible assets | 44,930 | | | 53,243 | |
Deferred income taxes | 684 | | | 1,161 | |
Marketable debt securities | 46 | | | 433 | |
Other non-current assets | 7,403 | | | 7,019 | |
Total Assets | $ | 110,893 | | | $ | 118,481 | |
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LIABILITIES | | | |
Current Liabilities: | | | |
Short-term debt obligations | $ | 5,065 | | | $ | 2,340 | |
Accounts payable | 2,695 | | | 2,713 | |
Other current liabilities | 13,700 | | | 14,027 | |
Total Current Liabilities | 21,460 | | | 19,080 | |
Deferred income taxes | 4,956 | | | 5,407 | |
Long-term debt | 39,677 | | | 48,336 | |
Other non-current liabilities | 7,516 | | | 7,776 | |
Total Liabilities | 73,609 | | | 80,599 | |
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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 | 44,292 | | | 44,325 | |
Accumulated other comprehensive loss | (1,424) | | | (1,839) | |
Retained earnings | 22,625 | | | 21,281 | |
Less cost of treasury stock | (28,572) | | | (26,237) | |
Total Bristol-Myers Squibb Company Shareholders’ Equity | 37,213 | | | 37,822 | |
Noncontrolling interest | 71 | | | 60 | |
Total Equity | 37,284 | | | 37,882 | |
Total Liabilities and Equity | $ | 110,893 | | | $ | 118,481 | |
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)
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| Nine Months Ended September 30, |
| 2021 | | 2020 |
Cash Flows From Operating Activities: | | | |
Net earnings | $ | 4,642 | | | $ | 1,032 | |
Adjustments to reconcile net earnings to net cash provided by operating activities: | | | |
Depreciation and amortization, net | 8,107 | | | 7,690 | |
Deferred income taxes | (127) | | | 1,419 | |
Stock-based compensation | 450 | | | 608 | |
Impairment charges | 1,192 | | | 131 | |
Pension settlements and amortization | 30 | | | 34 | |
Divestiture gains and royalties | (462) | | | (486) | |
Asset acquisition charges | 1,071 | | | 603 | |
Equity investment gains | (1,214) | | | (724) | |
Contingent consideration fair value adjustments | (510) | | | (597) | |
Other adjustments | 168 | | | (140) | |
Changes in operating assets and liabilities: | | | |
Receivables | (886) | | | (356) | |
Inventories | 141 | | | 2,571 | |
Accounts payable | 19 | | | 56 | |
Income taxes payable | (841) | | | (2,104) | |
Other | 370 | | | 960 | |
Net Cash Provided by Operating Activities | 12,150 | | | 10,697 | |
Cash Flows From Investing Activities: | | | |
Sale and maturities of marketable debt securities | 2,952 | | | 4,757 | |
Purchase of marketable debt securities | (3,408) | | | (3,148) | |
Proceeds from sales of equity investment securities | 1,058 | | | 14 | |
Capital expenditures | (653) | | | (470) | |
Divestiture and other proceeds | 570 | | | 536 | |
Acquisition and other payments, net of cash acquired | (1,458) | | | (736) | |
Net Cash (Used in)/Provided by Investing Activities | (939) | | | 953 | |
Cash Flows From Financing Activities: | | | |
Short-term debt obligations, net | (46) | | | (264) | |
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Repayment of long-term debt | (6,022) | | | (1,500) | |
Repurchase of common stock | (3,536) | | | (81) | |
Dividends | (3,297) | | | (3,054) | |
Other | 644 | | | 265 | |
Net Cash Used in Financing Activities | (12,257) | | | (4,634) | |
Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash | (48) | | | 24 | |
(Decrease)/Increase in Cash, Cash Equivalents and Restricted Cash | (1,094) | | | 7,040 | |
Cash, Cash Equivalents and Restricted Cash at Beginning of Period | 14,973 | | | 12,820 | |
Cash, Cash Equivalents and Restricted Cash at End of Period | $ | 13,879 | | | $ | 19,860 | |
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” 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 at September 30, 2021 and December 31, 2020, the results of operations for the three and nine months ended September 30, 2021 and 2020, and cash flows for the nine months ended September 30, 2021 and 2020. 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, 2020 included in the 2020 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; sales rebate and return accruals; 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. Cash payments resulting from licensing arrangements, including up-front and contingent milestones previously included in operating activities in the consolidated statements of cash flows are now presented in investing activities. The adjustment resulted in an increase to net cash provided by operating activities and net cash used in investing activities of $315 million in the nine months ended September 30, 2020. Proceeds received from the sale of equity investment securities previously presented in Divestiture and other proceeds in the consolidated statements of cash flows is now presented separately in Proceeds from sales of equity investment securities. These reclassifications did not have an impact on net assets or net earnings.
Recently Adopted Accounting Standards
In December 2019, the FASB issued amended guidance on the accounting and reporting of income taxes. The guidance is intended to simplify the accounting for income taxes by removing exceptions related to certain intraperiod tax allocations and deferred tax liabilities; clarifying guidance primarily related to evaluating the step-up tax basis for goodwill in a business combination; and reflecting enacted changes in tax laws or rates in the annual effective tax rate. BMS adopted the new guidance effective January 1, 2021. The amended guidance did not have a material impact on BMS’s results of operations.
Note 2. REVENUE
The following table summarizes the disaggregation of revenue by nature:
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 |
Net product sales | $ | 11,243 | | | $ | 10,197 | | | $ | 33,446 | | | $ | 30,555 | |
Alliance revenues | 194 | | | 184 | | | 495 | | | 452 | |
Other revenues | 187 | | | 159 | | | 459 | | | 443 | |
Total Revenues | $ | 11,624 | | | $ | 10,540 | | | $ | 34,400 | | | $ | 31,450 | |
Products are sold principally to wholesalers, distributors, specialty pharmacies, and to a lesser extent, directly to retailers, hospitals, clinics and government agencies. Customer orders are generally fulfilled within a few days of receipt resulting in minimal order backlog. Contractual performance obligations are usually limited to transfer of control of the product to the customer. The transfer occurs either upon shipment, upon receipt of the product after considering when the customer obtains legal title to the product, or upon infusion for cell therapies and when BMS obtains a right of payment. At these points, customers are able to direct the use of and obtain substantially all of the remaining benefits of the product.
The following table summarizes GTN adjustments:
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 |
Gross product sales | $ | 17,335 | | | $ | 15,211 | | | $ | 49,676 | | | $ | 43,685 | |
GTN adjustments(a) | | | | | | | |
Charge-backs and cash discounts | (1,908) | | | (1,440) | | | (5,214) | | | (4,072) | |
Medicaid and Medicare rebates | (2,625) | | | (2,146) | | | (6,482) | | | (5,126) | |
Other rebates, returns, discounts and adjustments | (1,559) | | | (1,428) | | | (4,534) | | | (3,932) | |
Total GTN adjustments | (6,092) | | | (5,014) | | | (16,230) | | | (13,130) | |
Net product sales | $ | 11,243 | | | $ | 10,197 | | | $ | 33,446 | | | $ | 30,555 | |
(a) Includes adjustments for provisions for product sales made in prior periods resulting from changes in estimates of $10 million and $282 million for the three and nine months ended September 30, 2021, and $(25) million and $91 million for the three and nine months ended September 30, 2020, respectively.
The following table summarizes the disaggregation of revenue by product and region:
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 |
Prioritized Brands | | | | | | | |
Revlimid | $ | 3,347 | | | $ | 3,027 | | | $ | 9,493 | | | $ | 8,826 | |
Eliquis | 2,413 | | | 2,095 | | | 8,091 | | | 6,899 | |
Opdivo | 1,905 | | | 1,780 | | | 5,535 | | | 5,199 | |
Orencia | 870 | | | 826 | | | 2,442 | | | 2,290 | |
Pomalyst/Imnovid | 851 | | | 777 | | | 2,478 | | | 2,235 | |
Sprycel | 551 | | | 544 | | | 1,562 | | | 1,576 | |
Yervoy | 515 | | | 446 | | | 1,481 | | | 1,211 | |
Abraxane | 266 | | | 342 | | | 876 | | | 950 | |
Empliciti | 82 | | | 96 | | | 253 | | | 290 | |
Reblozyl | 160 | | | 96 | | | 400 | | | 159 | |
Inrebic | 22 | | | 13 | | | 54 | | | 40 | |
Onureg | 21 | | | 3 | | | 48 | | | 3 | |
Zeposia | 40 | | | 2 | | | 86 | | | 3 | |
Breyanzi | 30 | | | — | | | 47 | | | — | |
Abecma | 71 | | | — | | | 95 | | | — | |
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Established Brands | | | | | | | |
Vidaza | 36 | | | 106 | | | 135 | | | 390 | |
Baraclude | 105 | | | 100 | | | 327 | | | 343 | |
Other Brands | 339 | | | 287 | | | 997 | | | 1,036 | |
Total Revenues | $ | 11,624 | | | $ | 10,540 | | | $ | 34,400 | | | $ | 31,450 | |
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United States | $ | 7,296 | | | $ | 6,542 | | | $ | 21,694 | | | $ | 19,795 | |
Europe | 2,661 | | | 2,453 | | | 7,903 | | | 7,156 | |
Rest of the World | 1,391 | | | 1,361 | | | 4,172 | | | 4,030 | |
Other(a) | 276 | | | 184 | | | 631 | | | 469 | |
Total Revenues | $ | 11,624 | | | $ | 10,540 | | | $ | 34,400 | | | $ | 31,450 | |
(a) 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 $73 million and $463 million for the three and nine months ended September 30, 2021 and $32 million and $260 million for the three and nine months ended September 30, 2020, respectively, consisting primarily of revised estimates for GTN adjustments related to prior period sales and royalties for out-licensing arrangements. Contract assets were not material at September 30, 2021 and December 31, 2020.
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.
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 |
Revenues from alliances: | | | | | | | |
Net product sales | $ | 2,452 | | | $ | 2,116 | | | $ | 8,139 | | | $ | 7,040 | |
Alliance revenues | 194 | | | 184 | | | 495 | | | 452 | |
Total Revenues | $ | 2,646 | | | $ | 2,300 | | | $ | 8,634 | | | $ | 7,492 | |
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Payments to/(from) alliance partners: | | | | | | | |
Cost of products sold | $ | 1,181 | | | $ | 1,007 | | | $ | 3,924 | | | $ | 3,363 | |
Marketing, selling and administrative | (43) | | | (25) | | | (140) | | | (103) | |
Research and development | 10 | | | 48 | | | 753 | | | 327 | |
Other (income)/expense, net | 1 | | | (28) | | | (18) | | | (59) | |
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Dollars in Millions | September 30, 2021 | | December 31, 2020 |
Selected Alliance Balance Sheet information: | | | |
Receivables – from alliance partners | $ | 314 | | | $ | 343 | |
Accounts payable – to alliance partners | 1,101 | | | 1,093 | |
Deferred income from alliances(a) | 344 | | | 366 | |
(a) Includes unamortized upfront and milestone payments.
Specific information pertaining to significant alliances including their nature and purpose; the significant rights and obligations of the parties; and specific accounting policy elections are discussed in the 2020 Form 10-K.
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, Russia, Japan, China and certain other countries in the Asia-Pacific region (the “collaboration territory”). Eisai will be responsible for the global manufacturing and supply. Profits, research and development and commercialization costs are shared in the collaboration territories. BMS will be 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 included in Research and development expense in 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. DIVESTITURES, LICENSING AND OTHER ARRANGEMENTS
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).
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| Three Months Ended September 30, |
| Net Proceeds(a) | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 |
Diabetes Business | $ | 153 | | | $ | 129 | | | $ | — | | | $ | — | | | $ | (159) | | | $ | (148) | |
Erbitux* Business | 4 | | | 3 | | | — | | | — | | | — | | | — | |
Manufacturing Operations | 27 | | | — | | | — | | | — | | | — | | | — | |
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Mature Brands and Other | 4 | | | 41 | | | 2 | | | 1 | | | (1) | | | (44) | |
Total | $ | 188 | | | $ | 173 | | | $ | 2 | | | $ | 1 | | | $ | (160) | | | $ | (192) | |
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| Nine Months Ended September 30, |
| Net Proceeds(a) | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 | | 2021 | | 2020 |
Diabetes Business | $ | 449 | | | $ | 409 | | | $ | — | | | $ | — | | | $ | (445) | | | $ | (404) | |
Erbitux* Business | 10 | | | 10 | | | — | | | — | | | — | | | — | |
Manufacturing Operations | 50 | | | 10 | | | — | | | (1) | | | — | | | — | |
Plavix* and Avapro*/Avalide* | 5 | | | 7 | | | — | | | (12) | | | — | | | — | |
Mature Brands and Other | 56 | | | 73 | | | (9) | | | 7 | | | (2) | | | (76) | |
Total | $ | 570 | | | $ | 509 | | | $ | (9) | | | $ | (6) | | | $ | (447) | | | $ | (480) | |
(a) Includes royalties received subsequent to the related sale of the asset or business.
Licensing and Other Arrangements
The following table summarizes the financial impact of Keytruda* royalties, Tecentriq* royalties, up-front licensing fees and milestones for products that have not obtained commercial approval, which are included in Other (income)/expense, net.
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 |
Keytruda* royalties | $ | (215) | | | $ | (176) | | | $ | (611) | | | $ | (492) | |
Tecentriq* royalties | (22) | | | — | | | (67) | | | — | |
Up-front licensing fees | — | | | — | | | — | | | (30) | |
Contingent milestone income | (10) | | | (16) | | | (12) | | | (62) | |
Amortization of deferred income | 3 | | | (14) | | | (27) | | | (44) | |
Other royalties | (21) | | | (5) | | | (33) | | | (16) | |
Total | $ | (265) | | | $ | (211) | | | $ | (750) | | | $ | (644) | |
Agenus
In 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 up-front payment of $200 million which was included in Research and development expense and 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.
Note 5. OTHER (INCOME)/EXPENSE, NET
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2021 | | 2020 | | 2021 | | 2020 |
Interest expense | $ | 328 | | | $ | 346 | | | $ | 1,011 | | | $ | 1,065 | |
Contingent consideration | — | | | (988) | | | (510) | | | (597) | |
Royalties and licensing income | (425) | | | (403) | | | (1,197) | | | (1,124) | |
Equity investment gains | (465) | | | (244) | | | (1,214) | | | (724) | |
Integration expenses | 141 | | | 195 | | | 434 | | | 535 | |
Provision for restructuring | 27 | | | 176 | | | 150 | | | 451 | |
Litigation and other settlements | 13 | | | 10 | | | 49 | | | 41 | |
Transition and other service fees | (6) | | | (18) | | | (43) | | | (129) | |
Investment income | (12) | | | (13) | | | (33) | | | (99) | |
Reversion excise tax | — | | | — | | | — | | | 76 | |
Divestiture losses/(gains) | 2 | | | 1 | | | (9) | | | (6) | |
Intangible asset impairment | — | | | — | | | — | | | 21 | |
| | | | | | | |
Loss on debt redemption | — | | | — | | | 281 | | | — | |
| | | | | | | |
| | | | | | | |
Other | (12) | | | 23 | | | (32) | | | 2 | |
Other (income)/expense, net | $ | (409) | | | $ | (915) | | | $ | (1,113) | | | $ | (488) | |
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 (10%), Marketing, selling and administrative expenses (55%) and Research and development expenses (35%). Charges of approximately $3.0 billion are expected to be incurred through 2022. Cumulative charges of approximately $2.4 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. Cash outlays in connection with these actions are expected to be approximately $2.5 billion. Employee workforce reductions were approximately 320 and 1,400 for the nine months ended September 30, 2021 and 2020, respectively.
MyoKardia Acquisition Plan
In 2020, a restructuring and integration plan was initiated to realize expected cost synergies resulting from cost savings and avoidance from the MyoKardia acquisition. Charges of approximately $150 million are expected to be incurred through 2022, and consist of integration planning and execution expenses, employee termination benefit costs and other costs. Cumulative charges of approximately $113 million have been recognized for these actions to date.
Company Transformation
In 2016, a restructuring plan was announced to evolve and streamline BMS’s operating model. Cumulative charges of approximately $1.5 billion were recognized for these actions since the announcement. Actions under the plan were completed as of December 31, 2020.
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 | 2021 | | 2020 | | 2021 | | 2020 |
Celgene Acquisition Plan | $ | 153 | | | $ | 373 | | | $ | 526 | | | $ | 1,014 | |
MyoKardia Acquisition Plan | 18 | | | — | | | 74 | | | — | |
Company Transformation | — | | | 10 | | | — | | | 115 | |
Total charges | $ | 171 | | | $ | 383 | | | $ | 600 | | | $ | 1,129 | |
| | | | | | | |
Employee termination costs | $ | 24 | | | $ | 133 | | | $ | 143 | | | $ | 389 | |
Other termination costs | 3 | | | 43 | | | 7 | | | 62 | |
Provision for restructuring | 27 | | | 176 | | | 150 | | | 451 | |
Integration expenses | 141 | | | 195 | | | 434 | | | |