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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, 2020
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) 546-4000
(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 |
Bristol-Myers Squibb Contingent Value Rights | BMY RT | 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 September 30, 2020, there were 2,259,751,518 shares outstanding of the Registrant’s $0.10 par value common stock.
BRISTOL-MYERS SQUIBB COMPANY
INDEX TO FORM 10-Q
September 30, 2020
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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 | 2020 | | 2019 | | 2020 | | 2019 |
Net product sales | $ | 10,197 | | | $ | 5,768 | | | $ | 30,555 | | | $ | 17,512 | |
Alliance and other revenues | 343 | | | 239 | | | 895 | | | 688 | |
Total Revenues | 10,540 | | | 6,007 | | | 31,450 | | | 18,200 | |
| | | | | | | |
Cost of products sold(a) | 2,502 | | | 1,790 | | | 8,863 | | | 5,586 | |
Marketing, selling and administrative | 1,706 | | | 1,055 | | | 4,940 | | | 3,137 | |
Research and development | 2,499 | | | 1,378 | | | 7,393 | | | 4,051 | |
Amortization of acquired intangible assets | 2,491 | | | 25 | | | 7,162 | | | 73 | |
Other (income)/expense, net | (915) | | | 410 | | | (488) | | | 249 | |
Total Expenses | 8,283 | | | 4,658 | | | 27,870 | | | 13,096 | |
| | | | | | | |
Earnings Before Income Taxes | 2,257 | | | 1,349 | | | 3,580 | | | 5,104 | |
Provision/(Benefit) for Income Taxes | 379 | | | (17) | | | 2,548 | | | 584 | |
Net Earnings | 1,878 | | | 1,366 | | | 1,032 | | | 4,520 | |
Noncontrolling Interest | 6 | | | 13 | | | 20 | | | 25 | |
Net Earnings Attributable to BMS | $ | 1,872 | | | $ | 1,353 | | | $ | 1,012 | | | $ | 4,495 | |
| | | | | | | |
Earnings per Common Share | | | | | | | |
Basic | $ | 0.83 | | | $ | 0.83 | | | $ | 0.45 | | | $ | 2.75 | |
Diluted | 0.82 | | | 0.83 | | | 0.44 | | | 2.75 | |
(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 | 2020 | | 2019 | | 2020 | | 2019 |
Net Earnings | $ | 1,878 | | | $ | 1,366 | | | $ | 1,032 | | | $ | 4,520 | |
Other Comprehensive (Loss)/Income, net of taxes and reclassifications to earnings: |
Derivatives qualifying as cash flow hedges | (132) | | | 38 | | | (121) | | | 24 | |
Pension and postretirement benefits | (4) | | | 1,116 | | | 5 | | | 1,204 | |
Available-for-sale debt securities | (2) | | | 4 | | | 7 | | | 43 | |
Foreign currency translation | (5) | | | — | | | (70) | | | 28 | |
Other Comprehensive (Loss)/Income | (143) | | | 1,158 | | | (179) | | | 1,299 | |
| | | | | | | |
Comprehensive Income | 1,735 | | | 2,524 | | | 853 | | | 5,819 | |
Comprehensive Income Attributable to Noncontrolling Interest | 6 | | | 13 | | | 20 | | | 25 | |
Comprehensive Income Attributable to BMS | $ | 1,729 | | | $ | 2,511 | | | $ | 833 | | | $ | 5,794 | |
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, 2020 | | December 31, 2019 |
Current Assets: | | | |
Cash and cash equivalents | $ | 19,435 | | | $ | 12,346 | |
Marketable debt securities | 1,720 | | | 3,047 | |
Receivables | 8,062 | | | 7,685 | |
Inventories | 1,949 | | | 4,293 | |
Other current assets | 3,111 | | | 1,983 | |
Total Current Assets | 34,277 | | | 29,354 | |
Property, plant and equipment | 5,740 | | | 6,252 | |
Goodwill | 20,517 | | | 22,488 | |
Other intangible assets | 56,698 | | | 63,969 | |
Deferred income taxes | 913 | | | 510 | |
Marketable debt securities | 495 | | | 767 | |
Other non-current assets | 6,896 | | | 6,604 | |
Total Assets | $ | 125,536 | | | $ | 129,944 | |
| | | |
LIABILITIES | | | |
Current Liabilities: | | | |
Short-term debt obligations | $ | 3,585 | | | $ | 3,346 | |
Accounts payable | 2,441 | | | 2,445 | |
Other current liabilities | 14,438 | | | 12,513 | |
Total Current Liabilities | 20,464 | | | 18,304 | |
Deferred income taxes | 5,913 | | | 6,454 | |
Long-term debt | 41,364 | | | 43,387 | |
Other non-current liabilities | 7,565 | | | 10,101 | |
Total Liabilities | 75,306 | | | 78,246 | |
| | | |
Commitments and contingencies | | | |
| | | |
EQUITY | | | |
Bristol-Myers Squibb Company Shareholders’ Equity: | | | |
Preferred stock | — | | | — | |
Common stock | 292 | | | 292 | |
Capital in excess of par value of stock | 44,435 | | | 43,709 | |
Accumulated other comprehensive loss | (1,699) | | | (1,520) | |
Retained earnings | 32,414 | | | 34,474 | |
Less cost of treasury stock | (25,284) | | | (25,357) | |
Total Bristol-Myers Squibb Company Shareholders’ Equity | 50,158 | | | 51,598 | |
Noncontrolling interest | 72 | | | 100 | |
Total Equity | 50,230 | | | 51,698 | |
Total Liabilities and Equity | $ | 125,536 | | | $ | 129,944 | |
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, |
| 2020 | | 2019 |
Cash Flows From Operating Activities: | | | |
Net earnings | $ | 1,032 | | | $ | 4,520 | |
Adjustments to reconcile net earnings to net cash provided by operating activities: | | | |
Depreciation and amortization, net | 7,690 | | | 510 | |
Deferred income taxes | 1,419 | | | (536) | |
Stock-based compensation | 608 | | | 157 | |
Impairment charges | 131 | | | 183 | |
Pension settlements and amortization | 34 | | | 1,683 | |
Divestiture gains and royalties | (486) | | | (1,676) | |
Asset acquisition charges | 278 | | | 25 | |
Equity investment (gains)/losses | (724) | | | 15 | |
Contingent consideration fair value adjustments | (597) | | | — | |
Other adjustments | (140) | | | (21) | |
Changes in operating assets and liabilities: | | | |
Receivables | (356) | | | 434 | |
Inventories | 2,571 | | | (7) | |
Accounts payable | 56 | | | 48 | |
Income taxes payable | (2,104) | | | (4) | |
Other | 970 | | | 698 | |
Net Cash Provided by Operating Activities | 10,382 | | | 6,029 | |
Cash Flows From Investing Activities: | | | |
Sale and maturities of marketable debt securities | 4,757 | | | 2,325 | |
Purchase of marketable debt securities | (3,148) | | | (1,642) | |
Capital expenditures | (470) | | | (585) | |
Divestiture and other proceeds | 550 | | | 2,226 | |
Acquisition and other payments, net of cash acquired | (421) | | | (58) | |
Net Cash Provided by Investing Activities | 1,268 | | | 2,266 | |
Cash Flows From Financing Activities: | | | |
Short-term debt obligations, net | (264) | | | 115 | |
Issuance of long-term debt | — | | | 18,790 | |
Repayment of long-term debt | (1,500) | | | (1,256) | |
Repurchase of common stock | (81) | | | (300) | |
Dividends | (3,054) | | | (2,011) | |
Other | 265 | | | (40) | |
Net Cash (Used in)/Provided by Financing Activities | (4,634) | | | 15,298 | |
Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash | 24 | | | (15) | |
Increase in Cash, Cash Equivalents and Restricted Cash | 7,040 | | | 23,578 | |
Cash, Cash Equivalents and Restricted Cash at Beginning of Period | 12,820 | | | 6,911 | |
Cash, Cash Equivalents and Restricted Cash at End of Period | $ | 19,860 | | | $ | 30,489 | |
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 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, 2020 and December 31, 2019, the results of operations for the three and nine months ended September 30, 2020 and 2019, and cash flows for the nine months ended September 30, 2020 and 2019. All intercompany balances and transactions have been eliminated. BMS’s consolidated financial statements include the assets, liabilities, operating results and cash flows of Celgene from the date of acquisition on November 20, 2019. These financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2019 included in the 2019 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 business combinations; 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 interim consolidated financial statements to the current period presentation.
Recently Adopted Accounting Standards
Financial Instruments - Measurement of Credit Losses
In June 2016, the FASB issued amended guidance for the measurement of credit losses on financial instruments. Entities are required to use a forward-looking estimated loss model. Available-for-sale debt security credit losses will be recognized as allowances rather than a reduction in amortized cost. BMS adopted the amended guidance on a modified retrospective approach on January 1, 2020. The amended guidance did not impact BMS’s results of operations.
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 | 2020 | | 2019 | | 2020 | | 2019 |
Net product sales | $ | 10,197 | | | $ | 5,768 | | | $ | 30,555 | | | $ | 17,512 | |
Alliance revenues | 184 | | | 143 | | | 452 | | | 418 | |
Other revenues | 159 | | | 96 | | | 443 | | | 270 | |
Total Revenues | $ | 10,540 | | | $ | 6,007 | | | $ | 31,450 | | | $ | 18,200 | |
The following table summarizes GTN adjustments:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2020 | | 2019 | | 2020 | | 2019 |
Gross product sales | $ | 15,211 | | | $ | 8,884 | | | $ | 43,685 | | | $ | 25,697 | |
GTN adjustments(a) | | | | | | | |
Charge-backs and cash discounts | (1,440) | | | (927) | | | (4,072) | | | (2,591) | |
Medicaid and Medicare rebates | (2,146) | | | (1,362) | | | (5,126) | | | (3,252) | |
Other rebates, returns, discounts and adjustments | (1,428) | | | (827) | | | (3,932) | | | (2,342) | |
Total GTN adjustments | (5,014) | | | (3,116) | | | (13,130) | | | (8,185) | |
Net product sales | $ | 10,197 | | | $ | 5,768 | | | $ | 30,555 | | | $ | 17,512 | |
(a) Includes adjustments for provisions for product sales made in prior periods resulting from changes in estimates of $(25) million and $91 million for the three and nine months ended September 30, 2020 and $12 million and $139 million for the three and nine months ended September 30, 2019, 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 | 2020 | | 2019 | | 2020 | | 2019 |
Prioritized Brands | | | | | | | |
Revlimid | $ | 3,027 | | | $ | — | | | $ | 8,826 | | | $ | — | |
Eliquis | 2,095 | | | 1,928 | | | 6,899 | | | 5,895 | |
Opdivo | 1,780 | | | 1,817 | | | 5,199 | | | 5,441 | |
Orencia | 826 | | | 767 | | | 2,290 | | | 2,185 | |
Pomalyst/Imnovid | 777 | | | — | | | 2,235 | | | — | |
Sprycel | 544 | | | 558 | | | 1,576 | | | 1,561 | |
Yervoy | 446 | | | 353 | | | 1,211 | | | 1,104 | |
Abraxane | 342 | | | — | | | 950 | | | — | |
Empliciti | 96 | | | 89 | | | 290 | | | 263 | |
Reblozyl | 96 | | | — | | | 159 | | | — | |
Inrebic | 13 | | | — | | | 40 | | | — | |
Zeposia | 2 | | | — | | | 3 | | | — | |
Onureg | 3 | | | — | | | 3 | | | — | |
| | | | | | | |
Established Brands | | | | | | | |
Baraclude | 100 | | | 145 | | | 343 | | | 433 | |
Vidaza | 106 | | | — | | | 390 | | | — | |
Other Brands(a) | 287 | | | 350 | | | 1,036 | | | 1,318 | |
Total Revenues | $ | 10,540 | | | $ | 6,007 | | | $ | 31,450 | | | $ | 18,200 | |
| | | | | | | |
United States | $ | 6,542 | | | $ | 3,472 | | | $ | 19,795 | | | $ | 10,588 | |
Europe | 2,453 | | | 1,445 | | | 7,156 | | | 4,416 | |
Rest of the World | 1,361 | | | 976 | | | 4,030 | | | 2,838 | |
Other(b) | 184 | | | 114 | | | 469 | | | 358 | |
Total Revenues | $ | 10,540 | | | $ | 6,007 | | | $ | 31,450 | | | $ | 18,200 | |
(a) Includes BMS and Celgene products in 2020.
(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 $32 million and $260 million for the three and nine months ended September 30, 2020 and $78 million and $341 million for the three and nine months ended September 30, 2019, respectively, consisting primarily of royalties for out-licensing arrangements and revised estimates for GTN adjustments related to prior period sales. Contract assets were not material at September 30, 2020 and December 31, 2019.
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 | 2020 | | 2019 | | 2020 | | 2019 |
Revenues from alliances: | | | | | | | |
Net product sales | $ | 2,116 | | | $ | 2,464 | | | $ | 7,040 | | | $ | 7,412 | |
Alliance revenues | 184 | | | 143 | | | 452 | | | 418 | |
Total Revenues | $ | 2,300 | | | $ | 2,607 | | | $ | 7,492 | | | $ | 7,830 | |
| | | | | | | |
Payments to/(from) alliance partners: | | | | | | | |
Cost of products sold | $ | 1,007 | | | $ | 1,017 | | | $ | 3,363 | | | $ | 3,116 | |
Marketing, selling and administrative | (25) | | | (33) | | | (103) | | | (93) | |
Research and development | 48 | | | 11 | | | 327 | | | 32 | |
Other (income)/expense, net | (28) | | | (15) | | | (59) | | | (45) | |
| | | | | | | | | | | |
Dollars in Millions | September 30, 2020 | | December 31, 2019 |
Selected Alliance Balance Sheet information: | | | |
Receivables – from alliance partners | $ | 336 | | | $ | 347 | |
Accounts payable – to alliance partners | 971 | | | 1,026 | |
Deferred income from alliances(a) | 392 | | | 431 | |
(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 2019 Form 10-K. Significant developments and updates related to alliances during the nine months ended September 30, 2020 are set forth below.
Otsuka
Effective January 1, 2020, Otsuka is no longer co-promoting Sprycel in the U.S. and as a result, this arrangement is no longer considered a collaboration under ASC 808. Revenues earned and fees paid to Otsuka in the Oncology Territory in 2020 are not included in the table above.
bluebird
BMS and bluebird jointly develop and commercialize novel disease-altering gene therapy product candidates targeting BCMA. The collaboration arrangement began in 2013 and included (i) a right for BMS to license any anti-BCMA products resulting from the collaboration, (ii) a right for bluebird to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and profit share in the U.S. in exchange for a reduction of milestone payments, and (iii) sales-based milestones and royalties payable to bluebird upon the commercialization of any licensed products resulting from the collaboration if bluebird declined to exercise their co-development and profit sharing rights. The options to license idecabtagene vicleucel (ide-cel, bb2121) and bb21217 were exercised in 2016 and 2017, respectively.
BMS and bluebird share equally in all profits and losses relating to developing, commercializing and manufacturing ide-cel within the U.S. BMS is exclusively responsible for the development and commercialization of ide-cel outside the U.S.
BMS is responsible for the worldwide development, including related funding after the substantial completion by bluebird of the ongoing Phase I clinical trial, and commercialization of bb21217. bluebird has an option to co-develop, co-promote and share equally in all profits and losses in the U.S.
In the second quarter of 2020, BMS and bluebird amended their collaboration arrangement where, among other items, BMS is assuming the contract manufacturing agreements relating to ide-cel adherent lentiviral vector. Over time, BMS is assuming responsibility for manufacturing ide-cel suspension lentiviral vector outside of the U.S., with bluebird responsible for manufacturing ide-cel suspension lentiviral vector in the U.S. The parties were also released from future exclusivity related to BCMA-directed T cell therapies. In addition, BMS agreed to buy out its obligation to pay bluebird future ex-U.S. milestones and royalties on ide-cel and bb21217 for a payment of $200 million, which was included in Research and development expense in the second quarter of 2020.
Note 4. ACQUISITIONS, DIVESTITURES, LICENSING AND OTHER ARRANGEMENTS
Acquisitions
Business Combination
Celgene
On November 20, 2019, BMS completed the Celgene acquisition. The acquisition is expected to further position BMS as a leading biopharmaceutical company for sustained innovation and long-term growth and to address the needs of patients with cancer, inflammatory, immunologic or cardiovascular diseases through high-value innovative medicines and leading scientific capabilities. The transaction was accounted for as a business combination, which requires that assets acquired and liabilities assumed be recognized at their fair value as of the acquisition date. The purchase price allocation is preliminary and subject to change for income tax matters. The amounts recognized will be finalized as the information necessary to complete the analysis is obtained, but no later than one year after the acquisition date.
The following table summarizes the provisional amounts recognized for assets acquired and liabilities assumed as of the acquisition date, as well as measurement period adjustments made year-to-date to the amounts initially recorded in 2019. The measurement period adjustments reflected in 2020 primarily resulted from completing valuations of real estate and personal property, revised future cash flow estimates for certain intangible assets, changes in the estimated tax basis of certain intangible assets based upon a tax ruling which reduced deferred income tax liabilities and other changes to certain equity investments, legal contingency and income tax liabilities. The related impact to net earnings that would have been recognized in previous periods if the adjustments were recognized as of the acquisition date is immaterial to the consolidated financial statements.
| | | | | | | | | | | | | | | | | | | | | |
Dollars in Millions | | | | | Amounts Recognized as of Acquisition Date (as previously reported) | | Measurement Period Adjustments | | Amounts Recognized as of Acquisition Date (as adjusted) |
Cash and cash equivalents | | | | | $ | 11,179 | | | $ | — | | | $ | 11,179 | |
Receivables | | | | | 2,652 | | | — | | | 2,652 | |
Inventories | | | | | 4,511 | | | — | | | 4,511 | |
| | | | | | | | | |
| | | | | | | | | |
Property, plant and equipment | | | | | 1,342 | | | (277) | | | 1,065 | |
Intangible assets | | | | | 64,027 | | | (100) | | | 63,927 | |
| | | | | | | | | |
Otezla* assets held-for-sale | | | | | 13,400 | | | — | | | 13,400 | |
Other assets | | | | | 3,408 | | | 45 | | | 3,453 | |
| | | | | | | | | |
Accounts payable | | | | | (363) | | | — | | | (363) | |
| | | | | | | | | |
Income taxes payable | | | | | (2,718) | | | (47) | | | (2,765) | |
Deferred income tax liabilities | | | | | (7,339) | | | 2,350 | | | (4,989) | |
| | | | | | | | | |
Debt | | | | | (21,782) | | | — | | | (21,782) | |
Other liabilities | | | | | (4,017) | | | 15 | | | (4,002) | |
Identifiable net assets acquired | | | | | 64,300 | | | 1,986 | | | 66,286 | |
Goodwill | | | | | 15,969 | | | (1,986) | | | 13,983 | |
Total consideration transferred | | | | | $ | 80,269 | | | $ | — | | | $ | 80,269 | |
Asset Acquisitions
MyoKardia
In the fourth quarter of 2020, BMS entered into a definitive merger agreement under which BMS will acquire MyoKardia, a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious cardiovascular diseases. The acquisition will provide BMS with rights to MyoKardia’s lead asset, mavacamten, a potential first-in-class cardiovascular medicine for the treatment of obstructive hypertrophic cardiomyopathy that has completed Phase III development with an anticipated NDA submission in the first quarter of 2021.
BMS, through a subsidiary, commenced a tender offer to acquire all of the issued and outstanding shares of MyoKardia’s common stock for $225.00 per share, or $13.1 billion. In November 2020, the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (“HSR Act”), as amended, expired. Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the transaction, which remains subject to the satisfaction of the tender of a majority of the outstanding shares of MyoKardia’s common stock, a well as other customary closing conditions and regulatory approvals. BMS intends to close the acquisition of MyoKardia at the earliest possible date after the closing of the tender offer, which it currently expects to be in the fourth quarter of 2020.
BMS anticipates funding the transaction through a combination of cash on hand from its operations and subject to market conditions, net proceeds received in connection with a future debt issuance. BMS expects to account for the transaction as an asset acquisition since mavacamten will represent substantially all of the fair value of the gross assets acquired.
Forbius
In the third quarter of 2020, BMS acquired all of the outstanding shares of Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. The acquisition provides BMS with full rights to Forbius’s TGF-beta program, including the program’s lead investigational asset, AVID200, which is in Phase I development. BMS accounted for the transaction as an asset acquisition since AVID200 represented substantially all of the fair value of the gross assets acquired. The transaction price included an upfront payment of $185 million and contingent development, regulatory and sales-based milestone payments up to $815 million. The up-front payment was included in Research and development expense except for $7 million that was allocated to deferred tax assets.
Other
Research and development expense also includes $100 million in 2020 resulting from the occurrence of a development event attributed to the Cormorant asset acquisition completed in 2016.
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 and assets held-for-sale were not material in all periods presented (excluding divestiture gains or losses).
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| Net Proceeds(a) | | Divestiture (Gains)/Losses | | Royalty and Milestone Income |
Dollars in Millions | 2020 | | 2019 | | 2020 | | 2019 | | 2020 | | 2019 |
UPSA Business | $ | — | | | $ | 1,510 | | | $ | — | | | $ | (1,176) | | | $ | — | | | $ | — | |
Diabetes Business | 129 | | | 163 | | | — | | | — | | | (148) | | | (171) | |
Erbitux* | 3 | | | 3 | | | — | | | — | | | — | | | — | |
Manufacturing Operations | — | | | — | | | — | | | 1 | | | — | | | — | |
| | | | | | | | | | | |
Mature Brands and Other | 41 | | | 7 | | | 1 | | | (4) | | | (44) | | | (6) | |
Total | $ | 173 | | | $ | 1,683 | | | $ | 1 | | | $ | (1,179) | | | $ | (192) | | | $ | (177) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, |
| Net Proceeds(a) | | Divestiture (Gains)/Losses | | Royalty and Milestone Income |
Dollars in Millions | 2020 | | 2019 | | 2020 | | 2019 | | 2020 | | 2019 |
UPSA Business | $ | — | | | $ | 1,510 | | | $ | — | | | $ | (1,160) | | | $ | — | | | $ | — | |
Diabetes Business | 409 | | | 491 | | | — | | | — | | | (404) | | | (497) | |
Erbitux* | 10 | | | 11 | | | — | | | — | | | — | | | — | |
Manufacturing Operations | 10 | | | 3 | | | (1) | | | 1 | | | — | | | — | |
Plavix* and Avapro*/Avalide* | 7 | | | — | | | (12) | | | — | | | — | | | — | |
Mature Brands and Other | 73 | | | 9 | | | 7 | | | (12) | | | (76) | | | (8) | |
Total | $ | 509 | | | $ | 2,024 | | | $ | (6) | | | $ | (1,171) | | | $ | (480) | | | $ | (505) | |
(a) Includes royalties received subsequent to the related sale of the asset or business.
UPSA Business
In the third quarter of 2019, the Company sold its UPSA consumer health business, including the shares of UPSA SAS and BMS’s assets and liabilities relating to the UPSA product portfolio. The transaction was accounted for as the sale of a business.
Manufacturing Operations
In the second quarter of 2019, BMS agreed to sell its manufacturing and packaging facility in Anagni, Italy to Catalent. The transaction was accounted for as the sale of a business and the sale was completed in the fourth quarter of 2019. The assets were reduced to their relative fair value after considering the purchase price resulting in an impairment charge of $113 million for the nine months ended September 30, 2019 that was included in Cost of products sold.
Licensing and Other Arrangements
The following table summarizes the financial impact of Keytruda* royalties, up-front and milestone licensing fees 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 | 2020 | | 2019 | | 2020 | | 2019 |
Keytruda* royalties | $ | (176) | | | $ | (132) | | | $ | (492) | | | $ | (373) | |
Up-front licensing fees | — | | | (24) | | | (30) | | | (24) | |
Contingent milestone income | (16) | | | (6) | | | (62) | | | (15) | |
Amortization of deferred income | (14) | | | (14) | | | (44) | | | (44) | |
Other royalties | (5) | | | (3) | | | (16) | | | (6) | |
Total | $ | (211) | | | $ | (179) | | | $ | (644) | | | $ | (462) | |
Dragonfly
In the fourth quarter of 2020, BMS obtained a global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002. BMS will be responsible for the development and any subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. Dragonfly will continue to be involved in the development of DF6002 in current and certain future Phase I/II clinical trials. The transaction included an upfront payment of $400 million and Dragonfly is eligible to receive contingent consideration comprised of development, regulatory and sales-based milestone payments up to $2.8 billion. Dragonfly will also receive royalties on global net sales.
Note 5. OTHER (INCOME)/EXPENSE, NET
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2020 | | 2019 | | 2020 | | 2019 |
Interest expense | $ | 346 | | | $ | 209 | | | $ | 1,065 | | | $ | 377 | |
Pension and postretirement | — | | | 1,537 | | | (6) | | | 1,607 | |
|