Bristol Myers Squibb Co 10-Q for FY2022 Q1
Bristol Myers Squibb Co (BMY)
10-Q
2022-04-29
For: 2022-03-31
View Original
Added on
April 02, 2026
About this 10-Q
Bristol Myers Squibb Co filed this 10-Q on April 29, 2022, covering the quarter ended March 31, 2022 (FY2022 Q1).
Headline figures
Quarter ended March 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $11.65B
- up 5.2% from $11.07B a year earlier
- Net income
- $1.28B
- down 36.8% from net income of $2.02B a year earlier
- Diluted EPS
- $0.59
- down 33.7% from $0.89 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________
FORM 10-Q
___________________________
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2022
OR
SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______ to _______
Commission File Number 001-01136
___________________________
(Exact name of registrant as specified in its charter)
___________________________
| (State or other jurisdiction of incorporation or organization) | (I.R.S Employer Identification No.) | |||||||
(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 | ||||||
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 March 31, 2022, there were 2,129,064,271 shares outstanding of the Registrant’s $0.10 par value common stock.
BRISTOL-MYERS SQUIBB COMPANY
INDEX TO FORM 10-Q
March 31, 2022
| PART I—FINANCIAL INFORMATION | |||||
| Item 1. | |||||
| Item 2. | |||||
| Item 3. | |||||
| Item 4. | |||||
| PART II—OTHER INFORMATION | |||||
| Item 1. | |||||
| Item 1A. | |||||
| Item 2. | |||||
| Item 6. | |||||
* 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 March 31, | |||||||||||||||||||||||
| EARNINGS | 2022 | 2021 | |||||||||||||||||||||
| Net product sales | $ | $ | |||||||||||||||||||||
| Alliance and other revenues | |||||||||||||||||||||||
| Total Revenues | |||||||||||||||||||||||
Cost of products sold(a) | |||||||||||||||||||||||
| Marketing, selling and administrative | |||||||||||||||||||||||
| Research and development | |||||||||||||||||||||||
| Acquired IPRD | |||||||||||||||||||||||
| Amortization of acquired intangible assets | |||||||||||||||||||||||
| Other (income)/expense, net | ( | ||||||||||||||||||||||
| Total Expenses | |||||||||||||||||||||||
| Earnings Before Income Taxes | |||||||||||||||||||||||
| Provision for Income Taxes | |||||||||||||||||||||||
| Net Earnings | |||||||||||||||||||||||
| Noncontrolling Interest | |||||||||||||||||||||||
| Net Earnings Attributable to BMS | $ | $ | |||||||||||||||||||||
| Earnings per Common Share | |||||||||||||||||||||||
| Basic | $ | $ | |||||||||||||||||||||
| Diluted | |||||||||||||||||||||||
(a) Excludes amortization of acquired intangible assets .
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
Dollars in Millions
(UNAUDITED)
| Three Months Ended March 31, | |||||||||||||||||||||||
| COMPREHENSIVE INCOME | 2022 | 2021 | |||||||||||||||||||||
| Net Earnings | $ | $ | |||||||||||||||||||||
| Other Comprehensive Income, net of taxes and reclassifications to earnings: | |||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges | |||||||||||||||||||||||
| Pension and postretirement benefits | |||||||||||||||||||||||
| Marketable debt securities | ( | ( | |||||||||||||||||||||
| Foreign currency translation | ( | ( | |||||||||||||||||||||
| Total Other Comprehensive Income | |||||||||||||||||||||||
| Comprehensive Income | |||||||||||||||||||||||
| Comprehensive Income Attributable to Noncontrolling Interest | |||||||||||||||||||||||
| Comprehensive Income Attributable to BMS | $ | $ | |||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
3
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED BALANCE SHEETS
Dollars in Millions
(UNAUDITED)
| ASSETS | March 31, 2022 | December 31, 2021 | |||||||||
| Current Assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Marketable debt securities | |||||||||||
| Receivables | |||||||||||
| Inventories | |||||||||||
| Other current assets | |||||||||||
| Total Current Assets | |||||||||||
| Property, plant and equipment | |||||||||||
| Goodwill | |||||||||||
| Other intangible assets | |||||||||||
| Deferred income taxes | |||||||||||
| Other non-current assets | |||||||||||
| Total Assets | $ | $ | |||||||||
| LIABILITIES | |||||||||||
| Current Liabilities: | |||||||||||
| Short-term debt obligations | $ | $ | |||||||||
| Accounts payable | |||||||||||
| Other current liabilities | |||||||||||
| Total Current Liabilities | |||||||||||
| Deferred income taxes | |||||||||||
| Long-term debt | |||||||||||
| Other non-current liabilities | |||||||||||
| Total Liabilities | |||||||||||
| Commitments and contingencies | |||||||||||
| EQUITY | |||||||||||
| Bristol-Myers Squibb Company Shareholders’ Equity: | |||||||||||
| Preferred stock | |||||||||||
| Common stock | |||||||||||
| Capital in excess of par value of stock | |||||||||||
| Accumulated other comprehensive loss | ( | ( | |||||||||
| Retained earnings | |||||||||||
| Less cost of treasury stock | ( | ( | |||||||||
| Total Bristol-Myers Squibb Company Shareholders’ Equity | |||||||||||
| Noncontrolling interest | |||||||||||
| Total Equity | |||||||||||
| Total Liabilities and Equity | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
4
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF CASH FLOWS
Dollars in Millions
(UNAUDITED)
| Three Months Ended March 31, | |||||||||||
| 2022 | 2021 | ||||||||||
| Cash Flows From Operating Activities: | |||||||||||
| Net earnings | $ | $ | |||||||||
| Adjustments to reconcile net earnings to net cash provided by operating activities: | |||||||||||
| Depreciation and amortization, net | |||||||||||
| Deferred income taxes | ( | ||||||||||
| Stock-based compensation | |||||||||||
| Impairment charges | |||||||||||
| Pension settlements and amortization | |||||||||||
| Divestiture gains and royalties | ( | ( | |||||||||
| Acquired IPRD | |||||||||||
| Equity investment losses/(gains) | ( | ||||||||||
| Contingent consideration fair value adjustments | ( | ||||||||||
| Other adjustments | |||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Receivables | |||||||||||
| Inventories | |||||||||||
| Accounts payable | |||||||||||
| Rebates and discounts | ( | ( | |||||||||
| Income taxes payable | |||||||||||
| Other | ( | ( | |||||||||
| Net Cash Provided by Operating Activities | |||||||||||
| Cash Flows From Investing Activities: | |||||||||||
| Sale and maturities of marketable debt securities | |||||||||||
| Purchase of marketable debt securities | ( | ( | |||||||||
| Proceeds from sales of equity investment securities | |||||||||||
| Capital expenditures | ( | ( | |||||||||
| Divestiture and other proceeds | |||||||||||
| Acquisition and other payments, net of cash acquired | ( | ( | |||||||||
| Net Cash Provided by/(Used in) Investing Activities | ( | ||||||||||
| Cash Flows From Financing Activities: | |||||||||||
| Short-term debt obligations, net | ( | ||||||||||
| Issuance of long-term debt | |||||||||||
| Repayment of long-term debt | ( | ( | |||||||||
| Repurchase of common stock | ( | ( | |||||||||
| Dividends | ( | ( | |||||||||
| Other | |||||||||||
| Net Cash Used in Financing Activities | ( | ( | |||||||||
| Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash | ( | ||||||||||
| Decrease in Cash, Cash Equivalents and Restricted Cash | ( | ( | |||||||||
| Cash, Cash Equivalents and Restricted Cash at Beginning of Period | |||||||||||
| Cash, Cash Equivalents and Restricted Cash at End of Period | $ | $ | |||||||||
The accompanying notes are an integral part of these consolidated financial statements.
5
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 March 31, 2022 and December 31, 2021 and the results of operations and cash flows for the three months ended March 31, 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 goodwill and intangible assets; chargebacks, 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. Up-front 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 statement of earnings. 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. Additionally, Rebates and discounts previously presented in Other changes in operating assets and liabilities in the consolidated statements of cash flows is now presented separately in Rebates and discounts.
Recently Issued Accounting Standards Not Yet Adopted
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 approach. Early adoption is permitted.
6
Note 2. REVENUE
The following table summarizes the disaggregation of revenue by nature:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Net product sales | $ | $ | |||||||||||||||||||||
| Alliance revenues | |||||||||||||||||||||||
| Other revenues | |||||||||||||||||||||||
| Total Revenues | $ | $ | |||||||||||||||||||||
The following table summarizes GTN adjustments:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Gross product sales | $ | $ | |||||||||||||||||||||
GTN adjustments(a) | |||||||||||||||||||||||
| Charge-backs and cash discounts | ( | ( | |||||||||||||||||||||
| Medicaid and Medicare rebates | ( | ( | |||||||||||||||||||||
| Other rebates, returns, discounts and adjustments | ( | ( | |||||||||||||||||||||
| Total GTN adjustments | ( | ( | |||||||||||||||||||||
| Net product sales | $ | $ | |||||||||||||||||||||
(a) Includes adjustments for provisions for product sales made in prior periods resulting from changes in estimates of $74 million and $217 million for the three months ended March 31, 2022, and 2021, respectively.
The following table summarizes the disaggregation of revenue by product and region:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| In-Line Products | |||||||||||||||||||||||
| Eliquis | $ | $ | |||||||||||||||||||||
| Opdivo | |||||||||||||||||||||||
| Pomalyst/Imnovid | |||||||||||||||||||||||
| Orencia | |||||||||||||||||||||||
| Sprycel | |||||||||||||||||||||||
| Yervoy | |||||||||||||||||||||||
| Empliciti | |||||||||||||||||||||||
| Mature and other products | |||||||||||||||||||||||
| New Product Portfolio | |||||||||||||||||||||||
| Reblozyl | |||||||||||||||||||||||
| Abecma | |||||||||||||||||||||||
| Zeposia | |||||||||||||||||||||||
| Breyanzi | |||||||||||||||||||||||
| Inrebic | |||||||||||||||||||||||
| Onureg | |||||||||||||||||||||||
| Opdualag | |||||||||||||||||||||||
Recent LOE Products(a) | |||||||||||||||||||||||
| Revlimid | |||||||||||||||||||||||
| Abraxane | |||||||||||||||||||||||
| Total Revenues | $ | $ | |||||||||||||||||||||
| United States | $ | $ | |||||||||||||||||||||
| Europe | |||||||||||||||||||||||
| Rest of the World | |||||||||||||||||||||||
Other(b) | |||||||||||||||||||||||
| Total Revenues | $ | $ | |||||||||||||||||||||
(a) Recent LOE Products includes 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.
7
Note 3. ALLIANCES
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 March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Revenues from alliances: | |||||||||||||||||||||||
| Net product sales | $ | $ | |||||||||||||||||||||
| Alliance revenues | |||||||||||||||||||||||
| Total Revenues | $ | $ | |||||||||||||||||||||
| Payments to/(from) alliance partners: | |||||||||||||||||||||||
| Cost of products sold | $ | $ | |||||||||||||||||||||
| Marketing, selling and administrative | ( | ( | |||||||||||||||||||||
| Research and development | |||||||||||||||||||||||
| Other (income)/expense, net | ( | ( | |||||||||||||||||||||
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Selected Alliance Balance Sheet information: | |||||||||||
| Receivables – from alliance partners | $ | $ | |||||||||
| Accounts payable – to alliance partners | |||||||||||
Deferred income from alliances(a) | |||||||||||
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 three months ended March 31, 2022 are set forth below.
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 will be discontinued.
8
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).
| Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
Net Proceeds(a) | Divestiture (Gains)/Losses | Royalty Income | |||||||||||||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||||||
| Diabetes Business | $ | $ | $ | $ | $ | ( | $ | ( | |||||||||||||||||||||||||||
| Mature Products and Other | ( | ( | ( | ||||||||||||||||||||||||||||||||
| Total | $ | $ | $ | ( | $ | $ | ( | $ | ( | ||||||||||||||||||||||||||
Mature Products and Other
In the three months ended March 31, 2022, product rights to several mature products were sold to Cheplapharm resulting in cash proceeds of $221 million and divestiture gain of $211 million.
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.
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
Keytruda* royalties | $ | ( | $ | ( | |||||||||||||||||||
Tecentriq* royalties | ( | ( | |||||||||||||||||||||
| Contingent milestone income | ( | ||||||||||||||||||||||
| Amortization of deferred income | ( | ( | |||||||||||||||||||||
| Other royalties | ( | ( | |||||||||||||||||||||
| Total | $ | ( | $ | ( | |||||||||||||||||||
In-license Arrangements
Immatics
In the three months ended March 31, 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 and the trial is planned to commence in the first half of 2022. BMS and Immatics will collaborate on the development and BMS will be responsible for the commercialization of IMA401 and its related products 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 up-front payment of $150 million which was included in Acquired IPRD and 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
In the three months ended March 31, 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.
9
Other
MyoKardia
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 which will result in an Acquired IPRD charge.
Note 5. OTHER (INCOME)/EXPENSE, NET
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Interest expense | $ | $ | |||||||||||||||||||||
| Royalties and licensing income | ( | ( | |||||||||||||||||||||
| Equity investment losses/(gains) | ( | ||||||||||||||||||||||
| Integration expenses | |||||||||||||||||||||||
| Contingent consideration | ( | ||||||||||||||||||||||
| Loss on debt redemption | |||||||||||||||||||||||
| Provision for restructuring | |||||||||||||||||||||||
| Litigation and other settlements | ( | ( | |||||||||||||||||||||
| Transition and other service fees | ( | ( | |||||||||||||||||||||
| Investment income | ( | ( | |||||||||||||||||||||
| Divestiture gains | ( | ||||||||||||||||||||||
| Other | ( | ||||||||||||||||||||||
| Other (income)/expense, net | $ | $ | ( | ||||||||||||||||||||
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 $3.3 billion are expected to be incurred. The majority of the charges are expected to be incurred through 2022. Cumulative charges of approximately $2.7 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 $3.0 billion. Employee workforce reductions were approximately 60 for the three months ended March 31, 2022 and 2021.
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 $120 million have been recognized for these actions to date.
10
The following provides the charges related to restructuring initiatives by type of cost:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Celgene Acquisition Plan | $ | $ | |||||||||||||||||||||
| MyoKardia Acquisition Plan | |||||||||||||||||||||||
| Total charges | $ | $ | |||||||||||||||||||||
| Employee termination costs | $ | $ | |||||||||||||||||||||
| Other termination costs | |||||||||||||||||||||||
| Provision for restructuring | |||||||||||||||||||||||
| Integration expenses | |||||||||||||||||||||||
| Accelerated depreciation | |||||||||||||||||||||||
| Asset impairments | |||||||||||||||||||||||
| Total charges | $ | $ | |||||||||||||||||||||
| Cost of products sold | $ | $ | |||||||||||||||||||||
| Marketing, selling and administrative | |||||||||||||||||||||||
| Other (income)/expense, net | |||||||||||||||||||||||
| Total charges | $ | $ | |||||||||||||||||||||
The following summarizes the charges and spending related to restructuring plan activities:
| Three Months Ended March 31, | |||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||
| Liability at December 31 | $ | $ | |||||||||
Provision for restructuring(a) | |||||||||||
| Foreign currency translation and other | ( | ( | |||||||||
| Payments | ( | ( | |||||||||
Liability at March 31 | $ | $ | |||||||||
(a) Includes a reduction of the liability resulting from changes in estimates of $9 million and $1 million for the three months ended March 31, 2022 and 2021, respectively. Excludes $6 million for the three months ended March 31, 2021 of accelerated stock-based compensation relating to the Celgene Acquisition Plan.
Note 7. INCOME TAXES
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Earnings Before Income Taxes | $ | $ | |||||||||||||||||||||
| Provision for Income Taxes | |||||||||||||||||||||||
| Effective Tax Rate | % | % | |||||||||||||||||||||
Income taxes in interim periods are determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The effective tax rates in 2022 and 2021 were impacted by low jurisdictional tax rates attributed to the unwinding of inventory fair value adjustments and intangible asset amortization and contingent value rights fair value adjustments that were not taxable in 2021. Additional changes to the effective tax rate may occur in future periods due to various reasons, including changes to the estimated pretax earnings mix and tax reserves and revised interpretations or changes to the relevant tax code.
It is reasonably possible that the amount of unrecognized tax benefits at March 31, 2022 could decrease in the range of approximately $450 million to $500 million in the next twelve months as a result of the settlement of certain tax audits and other events. The expected change in unrecognized tax benefits may result in the payment of additional taxes, adjustment of certain deferred taxes and/or recognition of tax benefits.
BMS is currently under examination by a number of tax authorities, which have proposed or are considering proposing material adjustments to tax positions for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. As previously disclosed, BMS received several notices of proposed adjustments from the IRS related to transfer pricing and other tax positions for the 2008 to 2012 tax years. BMS disagrees with the IRS’s positions and continues to work cooperatively with the IRS to resolve these open tax audits. It is reasonably possible that new issues will be raised by tax authorities that may increase unrecognized tax benefits; however, an estimate of such increases cannot reasonably be made at this time. BMS believes that it has adequately provided for all open tax years by tax jurisdiction.
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Note 8. EARNINGS PER SHARE
| Three Months Ended March 31, | |||||||||||||||||||||||
| Amounts in Millions, Except Per Share Data | 2022 | 2021 | |||||||||||||||||||||
| Net Earnings Attributable to BMS Used for Basic and Diluted EPS Calculation | $ | $ | |||||||||||||||||||||
| Weighted-Average Common Shares Outstanding – Basic | |||||||||||||||||||||||
| Incremental Shares Attributable to Share-Based Compensation Plans | |||||||||||||||||||||||
| Weighted-Average Common Shares Outstanding – Diluted | |||||||||||||||||||||||
| Earnings per Common Share | |||||||||||||||||||||||
| Basic | $ | $ | |||||||||||||||||||||
| Diluted | |||||||||||||||||||||||
The total number of potential shares of common stock excluded from the diluted earnings per common share computation because of the antidilutive impact was not material for the three months ended March 31, 2022 and 2021.
Note 9. FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
| March 31, 2022 | December 31, 2021 | ||||||||||||||||||||||||||||||||||
| Dollars in Millions | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |||||||||||||||||||||||||||||
| Cash and cash equivalents - money market and other securities | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||
| Marketable debt securities: | |||||||||||||||||||||||||||||||||||
| Certificates of deposit | |||||||||||||||||||||||||||||||||||
| Commercial paper | |||||||||||||||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||||||||||||||
| Derivative assets | |||||||||||||||||||||||||||||||||||
| Equity investments | |||||||||||||||||||||||||||||||||||
| Derivative liabilities | |||||||||||||||||||||||||||||||||||
| Contingent consideration liability: | |||||||||||||||||||||||||||||||||||
| Contingent value rights | |||||||||||||||||||||||||||||||||||
| Other acquisition related contingent consideration | |||||||||||||||||||||||||||||||||||
As further described in “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements” in the Company’s 2021 Form 10-K, the Company’s fair value estimates use inputs that are either (1) quoted prices for identical assets or liabilities in active markets (Level 1 inputs); (2) observable prices for similar assets or liabilities in active markets or for identical or similar assets or liabilities in markets that are not active (Level 2 inputs); or (3) unobservable inputs (Level 3 inputs).
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Contingent consideration obligations are recorded at their estimated fair values and these obligations are revalued each reporting period until the related contingencies are resolved. The contingent value rights are adjusted to fair value using the traded price of the securities at the end of each reporting period. The fair value measurements for other contingent consideration liabilities are estimated using probability-weighted discounted cash flow approaches that are based on significant unobservable inputs related to product candidates acquired in business combinations and are reviewed quarterly. These inputs include, as applicable, estimated probabilities and timing of achieving specified development and regulatory milestones and the discount rate used to calculate the present value of estimated future payments. Significant changes which increase or decrease the probabilities of achieving the related development and regulatory events or shorten or lengthen the time required to achieve such events would result in corresponding increases or decreases in the fair values of these obligations.
Marketable Debt Securities and Equity Investments
The following table summarizes marketable debt securities:
| March 31, 2022 | December 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||
| Dollars in Millions | Amortized Cost | Gross Unrealized | Amortized Cost | Gross Unrealized | |||||||||||||||||||||||||||||||||||||||||||
| Gains | Losses | Fair Value | Gains | Losses | Fair Value | ||||||||||||||||||||||||||||||||||||||||||
| Certificates of deposit | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
| Commercial paper | |||||||||||||||||||||||||||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||||||||||||||||||||||||||
Total marketable debt securities(a) | $ | $ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
(a) All marketable debt securities mature within one year as of March 31, 2022 and December 31, 2021.
The following summarizes the carrying amount of equity investments:
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Equity investments with readily determinable fair values | $ | $ | |||||||||
| Equity investments without readily determinable fair values | |||||||||||
| Equity method investments | |||||||||||
| Total equity investments | $ | $ | |||||||||
The following summarizes the activity related to equity investments. Changes in fair value of equity investments are included in Other (income)/expense, net.
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
Equity investments with readily determined fair values(a) | |||||||||||||||||||||||
| Net loss/(gain) recognized | $ | $ | ( | ||||||||||||||||||||
| Net loss recognized on investments sold | |||||||||||||||||||||||
| Net unrealized loss/(gain) recognized on investments still held | ( | ||||||||||||||||||||||
| Equity investments without readily determinable fair values | |||||||||||||||||||||||
| Upward adjustments | ( | ( | |||||||||||||||||||||
| Impairments and downward adjustments | |||||||||||||||||||||||
| Cumulative upward adjustments | ( | ||||||||||||||||||||||
| Cumulative impairments and downward adjustments | |||||||||||||||||||||||
| Equity in net (income)/loss of affiliates | ( | ||||||||||||||||||||||
(a) Certain prior year amounts have been reclassified to conform to the current year's presentation.
Qualifying Hedges and Non-Qualifying Derivatives
Cash Flow Hedges — Foreign currency forward contracts are used to hedge certain forecasted intercompany inventory purchases and sales transactions and certain foreign currency transactions. The fair value for contracts designated as cash flow hedges is temporarily reported in Accumulated other comprehensive loss and included in earnings when the hedged item affects earnings. The net gain or loss on foreign currency forward contracts is expected to be reclassified to net earnings (primarily included in Cost of products sold and Other (income)/expense, net) within the next 24 months. The notional amount of outstanding foreign currency forward contracts was primarily attributed to the euro of $5.3 billion and Japanese yen of $1.3 billion at March 31, 2022.
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The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not material during all periods presented. Cash flow hedge accounting is discontinued when the forecasted transaction is no longer probable of occurring within 60 days after the originally forecasted date or when the hedge is no longer effective. Assessments to determine whether derivatives designated as qualifying hedges are highly effective in offsetting changes in the cash flows of hedged items are performed at inception and on a quarterly basis. Foreign currency forward contracts not designated as hedging instruments are used to offset exposures in certain foreign currency denominated assets, liabilities and earnings. Changes in the fair value of these derivatives are recognized in earnings as they occur.
Net Investment Hedges — Non-U.S. dollar borrowings of €950 million ($1.1 billion) at March 31, 2022 are designated as net investment hedges to hedge euro currency exposures of the net investment in certain foreign affiliates and are recognized in long-term debt. The effective portion of foreign exchange gain on the remeasurement of euro debt was included in the foreign currency translation component of Accumulated other comprehensive loss with the related offset in long-term debt.
Cross-currency interest rate swap contracts of $600 million at March 31, 2022 are designated to hedge Japanese yen currency exposure of BMS’s net investment in its Japan subsidiaries. Contract fair value changes are recorded in the foreign currency translation component of Accumulated other comprehensive loss with a related offset in Other non-current assets or Other non-current liabilities.
Fair Value Hedges — Fixed to floating interest rate swap contracts are designated as fair value hedges and used as an interest rate risk management strategy to create an appropriate balance of fixed and floating rate debt. The contracts and underlying debt for the hedged benchmark risk are recorded at fair value. The effective interest rate for the contracts is one-month LIBOR (0.45 % as of March 31, 2022) plus an interest rate spread of 4.6 %. Gains or losses resulting from changes in fair value of the underlying debt attributable to the hedged benchmark interest rate risk are recorded in interest expense with an associated offset to the carrying value of debt. Since the specific terms and notional amount of the swap are intended to align with the debt being hedged, all changes in fair value of the swap are recorded in interest expense with an associated offset to the derivative asset or liability on the consolidated balance sheet. As a result, there was no net impact in earnings. If the underlying swap is terminated prior to maturity, then the fair value adjustment to the underlying debt is amortized as a reduction to interest expense over the remaining term of the debt.
In February 2022, Treasury lock contracts were entered into with a total notional value of $3.0 billion to hedge interest rate risk associated with the anticipated issuance of long-term debt. The Treasury lock contracts were terminated upon the issuance of the aggregate $6.0 billion of unsecured senior notes. These contracts were not designated for hedge accounting. The settlement of these contracts were not material.
In March 2022, Treasury lock contracts were entered into with a total notional value of $2.3 billion to hedge cash payment for the anticipated redemption of long-term debt. The Treasury lock contracts were terminated upon pricing the debt redemption. These contracts were not designated for hedge accounting. The settlement of these contracts were not material.
The following table summarizes the fair value of outstanding derivatives:
| March 31, 2022 | December 31, 2021 | ||||||||||||||||||||||||||||||||||||||||||||||
Asset(a) | Liability(b) | Asset(a) | Liability(b) | ||||||||||||||||||||||||||||||||||||||||||||
| Dollars in Millions | Notional | Fair Value | Notional | Fair Value | Notional | Fair Value | Notional | Fair Value | |||||||||||||||||||||||||||||||||||||||
| Derivatives designated as hedging instruments: | |||||||||||||||||||||||||||||||||||||||||||||||
| Interest rate swap contracts | $ | $ | $ | $ | ( | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||||||
| Cross-currency interest rate swap contracts | ( | ||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Derivatives not designated as hedging instruments: | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | ( | ( | |||||||||||||||||||||||||||||||||||||||||||||
| Other | |||||||||||||||||||||||||||||||||||||||||||||||
(a) Included in Other current assets and Other non-current assets.
(b) Included in Other current liabilities and Other non-current liabilities.
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The following table summarizes the financial statement classification and amount of (gain)/loss recognized on hedging instruments:
| Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | ||||||||||||||||||||||
| Dollars in Millions | Cost of products sold | Other (income)/expense, net | Cost of products sold | Other (income)/expense, net | |||||||||||||||||||
| Interest rate swap contracts | $ | $ | ( | $ | $ | ( | |||||||||||||||||
| Cross-currency interest rate swap contracts | ( | ( | |||||||||||||||||||||
| Foreign currency forward contracts | ( | ( | ( | ||||||||||||||||||||
The following table summarizes the effect of derivative and non-derivative instruments designated as hedging instruments in Other Comprehensive Income:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Derivatives qualifying as cash flow hedges | |||||||||||||||||||||||
| Foreign currency forward contracts gain/(loss): | |||||||||||||||||||||||
Recognized in Other Comprehensive Income(a) | $ | $ | |||||||||||||||||||||
| Reclassified to Cost of products sold | ( | ||||||||||||||||||||||
| Forward starting interest rate swap contract loss: | |||||||||||||||||||||||
| Reclassified to Other (income)/expense, net | ( | ||||||||||||||||||||||
| Derivatives qualifying as net investment hedges | |||||||||||||||||||||||
| Cross-currency interest rate swap contracts gain: | |||||||||||||||||||||||
| Recognized in Other Comprehensive Income | |||||||||||||||||||||||
| Non-derivatives qualifying as net investment hedges | |||||||||||||||||||||||
| Non-U.S. dollar borrowings gain: | |||||||||||||||||||||||
| Recognized in Other Comprehensive Income | |||||||||||||||||||||||
(a) The majority is expected to be reclassified into earnings in the next 18 months.
Debt Obligations
Short-term debt obligations include:
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Non-U.S. short-term borrowings | $ | $ | |||||||||
| Current portion of long-term debt | |||||||||||
| Other | |||||||||||
| Total | $ | $ | |||||||||
15
Long-term debt and the current portion of long-term debt include:
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Principal Value | $ | $ | |||||||||
| Adjustments to Principal Value: | |||||||||||
| Fair value of interest rate swap contracts | ( | ||||||||||
| Unamortized basis adjustment from swap terminations | |||||||||||
| Unamortized bond discounts and issuance costs | ( | ( | |||||||||
| Unamortized purchase price adjustments of Celgene debt | |||||||||||
| Total | $ | $ | |||||||||
| Current portion of long-term debt | $ | $ | |||||||||
| Long-term debt | |||||||||||
| Total | $ | $ | |||||||||
The fair value of long-term debt was $45.8 billion at March 31, 2022 and $49.1 billion at December 31, 2021 valued using Level 2 inputs, which are based upon the quoted market prices for the same or similar debt instruments. The fair value of short-term borrowings approximates the carrying value due to the short maturities of the debt instruments.
In the three months ended March 31, 2022, BMS issued an aggregate principal amount of $6.0 billion of debt consisting of $1.75 billion of 2.950 % Notes due 2032, $1.25 billion of 3.550 % Notes due 2042, $2.0 billion of 3.700 % Notes due 2052 and $1.0 billion of 3.900 % Notes due 2062 with proceeds net of discount and deferred loan issuance costs of $5.9 billion. The notes rank equally in right of payment with all of BMS's existing and future senior unsecured indebtedness and are redeemable at any time, in whole, or in part, at varying specified redemption prices plus accrued and unpaid interest.
Additionally, BMS purchased aggregate principal amount of $5.2 billion of certain of its debt securities for approximately $5.8 billion of cash in tender offers. In connection with these transactions, a $275 million loss on debt redemption was recognized based on the carrying value of the debt and included in Other (income)/expense, net.
In April 2022, BMS purchased aggregate principal amount of $849 million of certain of its debt securities for approximately $880 million of cash pursuant to “make whole” redemptions.
In the three months ended March 31, 2021, BMS purchased aggregate principal amount of $3.5 billion of certain of its debt securities for approximately $4.0 billion of cash in a series of tender offers and “make whole” redemptions. In connection with these transactions, a $281 million loss on debt redemption was recognized based on the carrying value of the debt and included in Other (income)/expense, net. In addition, the $500 million 2.875% Notes matured and were repaid.
Interest payments were $377 million and $435 million for the three months ended March 31, 2022 and 2021, respectively, net of amounts related to interest rate swap contracts.
At December 31, 2021, we had four separate revolving credit facilities totaling $6.0 billion, which consisted of a 364-day $2.0 billion facility which expired in January 2022, a three-year $1.0 billion facility which expired in January 2022 and two five-year $1.5 billion facilities that were extended to September 2025 and July 2026, respectively.
In January 2022, we entered into a five-year $5.0 billion facility expiring in January 2027, which is extendable annually by one year with the consent of the lenders. This facility provides for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings. Concurrently with the entry into this facility, the commitments under our existing five-year $1.5 billion facilities were terminated and the three-year $1.0 billion facility and 364-day $2.0 billion facility expired in accordance with their terms in January 2022. No borrowings were outstanding under any revolving credit facility at March 31, 2022 or December 31, 2021.
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Note 10. RECEIVABLES
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Trade receivables | $ | $ | |||||||||
| Less charge-backs and cash discounts | ( | ( | |||||||||
| Less allowance for expected credit loss | ( | ( | |||||||||
| Net trade receivables | |||||||||||
| Alliance, Royalties, VAT and other | |||||||||||
| Receivables | $ | $ | |||||||||
Non-U.S. receivables sold on a nonrecourse basis were $423 million and $318 million for the three months ended March 31, 2022 and 2021, respectively. Receivables from the three largest customers in the U.S. represented approximately 60 % and 59 % of total trade receivables at March 31, 2022 and December 31, 2021, respectively.
Note 11. INVENTORIES
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Finished goods | $ | $ | |||||||||
| Work in process | |||||||||||
| Raw and packaging materials | |||||||||||
| Total inventories | $ | $ | |||||||||
| Inventories | $ | $ | |||||||||
| Other non-current assets | |||||||||||
Total inventories include fair value adjustments resulting from the Celgene acquisition of $368 million at March 31, 2022 and $508 million at December 31, 2021. Other non-current assets include inventory expected to remain on hand beyond 12 months in both periods.
An out of period adjustment was included in the three months ended March 31, 2022 to reduce the remaining amount of inventory fair value adjustments resulting from the Celgene acquisition by $114 million with a corresponding increase to Cost of products sold of $32 million and Research and development expense of $82 million. The adjustment was not material to previously reported balance sheets or results of operations.
Note 12. PROPERTY, PLANT AND EQUIPMENT
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Land | $ | $ | |||||||||
| Buildings | |||||||||||
| Machinery, equipment and fixtures | |||||||||||
| Construction in progress | |||||||||||
| Gross property, plant and equipment | |||||||||||
| Less accumulated depreciation | ( | ( | |||||||||
| Property, plant and equipment | $ | $ | |||||||||
Depreciation expense was $145 million and $135 million for the three months ended March 31, 2022 and 2021, respectively.
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Note 13. GOODWILL AND OTHER INTANGIBLE ASSETS
| Dollars in Millions | Estimated Useful Lives | March 31, 2022 | December 31, 2021 | ||||||||||||||
| Goodwill | $ | $ | |||||||||||||||
| Other intangible assets: | |||||||||||||||||
| Licenses | |||||||||||||||||
| Acquired marketed product rights | |||||||||||||||||
| Capitalized software | |||||||||||||||||
| IPRD | |||||||||||||||||
| Gross other intangible assets | |||||||||||||||||
| Less accumulated amortization | ( | ( | |||||||||||||||
| Other intangible assets | $ | $ | |||||||||||||||
Amortization expense of other intangible assets was $2.5 billion and $2.6 billion for the three months ended March 31, 2022 and 2021, respectively.
In the three months ended March 31, 2022, a $40 million IPRD impairment charge was recorded in Research and development expense following a decision to discontinue development of an investigational compound in connection with the prioritization of current pipeline opportunities. The compound was obtained in the acquisition of Celgene and was being studied as a potential treatment for autoimmune diseases. The charge represented a full write-down.
In the three months ended March 31, 2021, Inrebic EU regulatory approval milestones of $300 million were achieved resulting in a $385 million increase to the acquired marketed product rights intangible asset, after establishing the applicable deferred tax liability. An impairment charge of $315 million was recognized in Cost of products sold as the carrying value of this asset exceeded the projected undiscounted cash flows of the asset. The charge was equal to the excess of the asset's carrying value over its estimated fair value using discounted cash flow projections.
Note 14. SUPPLEMENTAL FINANCIAL INFORMATION
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Income taxes | $ | $ | |||||||||
| Research and development | |||||||||||
| Contract assets | |||||||||||
| Equity investments | |||||||||||
Restricted cash(a) | |||||||||||
| Other | |||||||||||
| Other current assets | $ | $ | |||||||||
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Equity investments | $ | $ | |||||||||
| Inventories | |||||||||||
| Operating leases | |||||||||||
| Pension and postretirement | |||||||||||
| Research and development | |||||||||||
Restricted cash(a) | |||||||||||
| Other | |||||||||||
| Other non-current assets | $ | $ | |||||||||
(a) Restricted cash consists of funds restricted for annual Company contributions to the defined contribution plan in the U.S. and escrow for litigation settlements. Cash is restricted when withdrawal or general use is contractually or legally restricted.
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| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Rebates and discounts | $ | $ | |||||||||
| Income taxes | |||||||||||
| Employee compensation and benefits | |||||||||||
| Research and development | |||||||||||
| Dividends | |||||||||||
| Interest | |||||||||||
| Royalties | |||||||||||
| Operating leases | |||||||||||
| Other | |||||||||||
| Other current liabilities | $ | $ | |||||||||
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Income taxes payable | $ | $ | |||||||||
| Pension and postretirement | |||||||||||
| Operating leases | |||||||||||
| Deferred income | |||||||||||
| Deferred compensation | |||||||||||
| Other | |||||||||||
| Other non-current liabilities | $ | $ | |||||||||
Note 15. EQUITY
The following table summarizes changes in equity for the three months ended March 31, 2022:
| Common Stock | Capital in Excess of Par Value of Stock | Accumulated Other Comprehensive Loss | Retained Earnings | Treasury Stock | Noncontrolling Interest | ||||||||||||||||||||||||||||||||||||||||||
| Dollars and Shares in Millions | Shares | Par Value | Shares | Cost | |||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2021 | $ | $ | $ | ( | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net Earnings | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Other Comprehensive Income | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Cash dividends declared(a) | — | — | — | — | ( | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Share repurchase program | — | — | ( | — | — | ( | — | ||||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — | — | — | ( | — | |||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2022 | $ | $ | $ | ( | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
(a) Cash dividends declared per common share were $0.54 for the three months ended March 31, 2022.
The following table summarizes changes in equity for the three months ended March 31, 2021:
| Common Stock | Capital in Excess of Par Value of Stock | Accumulated Other Comprehensive Loss | Retained Earnings | Treasury Stock | Noncontrolling Interest | ||||||||||||||||||||||||||||||||||||||||||
| Dollars and Shares in Millions | Shares | Par Value | Shares | Cost | |||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2020 | $ | $ | $ | ( | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
| Net Earnings | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Other Comprehensive Income | — | — | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||
Cash dividends declared(a) | — | — | — | — | ( | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Share repurchase program | — | — | — | — | — | ( | — | ||||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — | ( | — | — | ( | — | ||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2021 | $ | $ | $ | ( | $ | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||
(a) Cash dividends declared per common share were $0.49 for the three months ended March 31, 2021.
BMS has a share repurchase program, authorized by its Board of Directors, allowing for repurchases of its shares. The share repurchase program does not obligate us to repurchase any specific number of shares, does not have a specific expiration date and may be suspended or discontinued at any time. Treasury stock is recognized at the cost to reacquire the shares. Shares issued from treasury are recognized utilizing the first-in first-out method.
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The outstanding share repurchase authorization under the program was approximately $15.2 billion as of December 31, 2021. In the three months ended March, 31, 2022, BMS executed accelerated share repurchase ("ASR") agreements to repurchase an aggregate $5.0 billion of common stock. These ASR agreements were funded with cash on-hand and are expected to settle during the second and third quarters of 2022. Approximately 65 million shares of common stock (85% of the $5.0 billion aggregate repurchase price) were received by BMS and included in treasury stock. The total number of shares to be repurchased under the ASR agreements will be based on volume-weighted average prices of BMS's common stock during the terms of the ASR transactions less a discount and subject to adjustments pursuant to the terms and conditions of the ASR agreements. The remaining share repurchase capacity under the share repurchase program was approximately $10.2 billion as of March 31, 2022.
BMS repurchased 28 million shares of its common stock for $1.8 billion in the three months ended March 31, 2021.
The components of Other Comprehensive Income were as follows:
| 2022 | 2021 | ||||||||||||||||||||||||||||||||||
| Dollars in Millions | Pretax | Tax | After Tax | Pretax | Tax | After Tax | |||||||||||||||||||||||||||||
| Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges: | |||||||||||||||||||||||||||||||||||
| Unrealized gains/(losses) | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
Reclassified to net earnings(a) | ( | ( | ( | ||||||||||||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges | ( | ( | |||||||||||||||||||||||||||||||||
| Pension and postretirement benefits: | |||||||||||||||||||||||||||||||||||
| Actuarial losses | ( | ( | |||||||||||||||||||||||||||||||||
Amortization(b) | ( | ( | |||||||||||||||||||||||||||||||||
Settlements(b) | |||||||||||||||||||||||||||||||||||
| Pension and postretirement benefits | ( | ( | |||||||||||||||||||||||||||||||||
| Marketable debt securities: | |||||||||||||||||||||||||||||||||||
| Unrealized (losses)/gains | ( | ( | ( | ( | |||||||||||||||||||||||||||||||
| Foreign currency translation | ( | ( | ( | ( | ( | ||||||||||||||||||||||||||||||
| Other Comprehensive Income | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
(a)Included in Cost of products sold.
(b)Included in Other (income)/expense, net.
The accumulated balances related to each component of Other Comprehensive Income, net of taxes, were as follows:
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Derivatives qualifying as cash flow hedges | $ | $ | |||||||||
| Pension and postretirement benefits | ( | ( | |||||||||
| Marketable debt securities | |||||||||||
| Foreign currency translation | ( | ( | |||||||||
| Accumulated other comprehensive loss | $ | ( | $ | ( | |||||||
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Note 16. EMPLOYEE STOCK BENEFIT PLANS
Stock-based compensation expense was as follows:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Cost of products sold | $ | $ | |||||||||||||||||||||
| Marketing, selling and administrative | |||||||||||||||||||||||
| Research and development | |||||||||||||||||||||||
| Other (income)/expense, net | |||||||||||||||||||||||
| Total stock-based compensation expense | $ | $ | |||||||||||||||||||||
Income tax benefit(a) | $ | $ | |||||||||||||||||||||
(a) Income tax benefit excludes excess tax benefits from share-based compensation awards that were vested or exercised of $40 million and $17 million for the three months ended March 31, 2022 and 2021, respectively.
The number of units granted and the weighted-average fair value on the grant date for the three months ended March 31, 2022 were as follows:
| Units in Millions | Units | Weighted-Average Fair Value | |||||||||
| Restricted stock units | $ | ||||||||||
| Market share units | |||||||||||
| Performance share units | |||||||||||
| Dollars in Millions | Stock Options | Restricted Stock Units | Market Share Units | Performance Share Units | |||||||||||||||||||
| Unrecognized compensation cost | $ | $ | $ | $ | |||||||||||||||||||
| Expected weighted-average period in years of compensation cost to be recognized | |||||||||||||||||||||||
Note 17. LEGAL PROCEEDINGS AND CONTINGENCIES
BMS and certain of its subsidiaries are involved in various lawsuits, claims, government investigations and other legal proceedings that arise in the ordinary course of business. These claims or proceedings can involve various types of parties, including governments, competitors, customers, suppliers, service providers, licensees, employees, or shareholders, among others. These matters may involve patent infringement, antitrust, securities, pricing, sales and marketing practices, environmental, commercial, contractual rights, licensing obligations, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage, among others. The resolution of these matters often develops over a long period of time and expectations can change as a result of new findings, rulings, appeals or settlement arrangements. Legal proceedings that are significant or that BMS believes could become significant or material are described below.
While BMS does not believe that any of these matters, except as otherwise specifically noted below, will have a material adverse effect on its financial position or liquidity as BMS believes it has substantial defenses in the matters, the outcomes of BMS’s legal proceedings and other contingencies are inherently unpredictable and subject to significant uncertainties. There can be no assurance that there will not be an increase in the scope of one or more of these pending matters or any other or future lawsuits, claims, government investigations or other legal proceedings will not be material to BMS’s financial position, results of operations or cash flows for a particular period. Furthermore, failure to successfully enforce BMS’s patent rights would likely result in substantial decreases in the respective product revenues from generic competition.
Unless otherwise noted, BMS is unable to assess the outcome of the respective matters nor is it able to estimate the possible loss or range of losses that could potentially result for such matters. Contingency accruals are recognized when it is probable that a liability will be incurred and the amount of the related loss can be reasonably estimated. Developments in legal proceedings and other matters that could cause changes in the amounts previously accrued are evaluated each reporting period. For a discussion of BMS’s tax contingencies, see “—Note 7. Income Taxes”.
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INTELLECTUAL PROPERTY
Anti-PD-1 and Anti-PD-L1 Antibody Litigation
In September 2015, Dana-Farber Cancer Institute (“Dana-Farber”) filed a complaint in the U.S. District Court for the District of Massachusetts seeking to correct the inventorship on up to six related U.S. patents directed to methods of treating cancer using PD-1 and PD-L1 antibodies. Specifically, Dana-Farber sought to add two scientists as inventors to these patents. In October 2017, Pfizer was allowed to intervene in the case alleging that one of the scientists identified by Dana-Farber was employed by a company eventually acquired by Pfizer during the relevant period. In May 2019, the District Court issued a decision ruling that the two scientists should be added as inventors to the patents which decision was affirmed on appeal. In June 2019, Dana-Farber filed a new lawsuit in the District of Massachusetts against BMS seeking damages as a result of the decision adding the scientists as inventors. In February 2021, BMS filed a motion to dismiss that complaint. In August 2021, the Court denied the motion to dismiss, but ruled that Dana-Farber’s claims for damages before May 17, 2019—the date of the District Court’s ruling that Dana-Farber was a co-inventor of the patents—are preempted by federal patent law. No trial date has been scheduled.
On March 17, 2022, BMS filed a lawsuit in U.S. District Court for the District of Delaware against AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd ("AZ") alleging that AZ's marketing of the PD-L1 antibody Imfinzi infringes certain claims of U.S. Patent Nos. 9,580,505, 9,580,507, 10,138,299, 10,308,714, 10,266,594, 10,266,595, 10,266,596 and 10,323,092. No trial date has been scheduled.
CAR T
In October 2017, Juno and Sloan Kettering Institute for Cancer Research (“SKI”) filed a complaint for patent infringement against Kite Pharma, Inc. (“Kite”) in the U.S. District Court for the Central District of California. The complaint alleged that Kite’s Yescarta* product infringes certain claims of U.S. Patent No. 7,446,190 (the “’190 Patent”) concerning CAR T cell technologies. Kite filed an answer and counterclaims asserting non-infringement and invalidity of the ’190 Patent. In December 2019, following an eight-day trial, the jury rejected Kite’s defenses, finding that Kite willfully infringed the ’190 Patent and awarding to Juno and SKI a reasonable royalty consisting of a $585 million up-front payment and a 27.6 % running royalty on Kite’s sales of Yescarta* through the expiration of the ’190 Patent in August 2024. In January 2020, Kite renewed its previous motion for judgment as a matter of law and also moved for a new trial, and Juno filed a motion seeking enhanced damages, supplemental damages, ongoing royalties, and prejudgment interest. In March 2020, the Court denied both of Kite’s motions in their entirety. In April 2020, the Court granted in part Juno’s motion and entered a final judgment awarding to Juno and SKI approximately $1.2 billion in royalties, interest and enhanced damages and a 27.6 % running royalty on Kite’s sales of Yescarta* from December 13, 2019 through the expiration of the ’190 Patent in August 2024. In April 2020, Kite appealed the final judgment to the U.S. Court of Appeals for the Federal Circuit and the Court held an oral hearing on July 6, 2021. In August 2021, a Federal Circuit panel reversed the jury verdict and district court decision and found the ’190 Patent to be invalid. In October 2021, Juno and SKI filed a petition with the Federal Circuit for panel and en banc rehearing which the Federal Circuit denied on January 14, 2022. Juno and SKI intend to file a petition for a writ of certiorari with the U.S. Supreme Court.
Eliquis - Europe
In November 2020 and January 2021, Sandoz Limited (“Sandoz”) and Teva Pharmaceutical Industries Ltd. (“Teva Limited”), respectively, filed lawsuits in the United Kingdom seeking revocation of the UK apixaban composition of matter patent and related Supplementary Protection Certificate (“SPC”). BMS subsequently filed counterclaims for infringement in both actions. A trial took place in February 2022 and in a judgement issued on April 7, 2022, the judge found the UK apixaban composition of matter patent and related SPC invalid. We disagree with the ruling and plan to appeal the decision.
There are similar lawsuits filed in France, Italy, the Netherlands, Portugal, the Republic of Ireland, and Sweden seeking revocation of a composition of matter patent relating to Eliquis.
In April 2022, Sandoz informed BMS that it intends to launch its generic apixaban product in the Netherlands as soon as possible. In response, we have requested that the Dutch court issue a preliminary injunction to prevent any infringement of the Dutch apixaban composition of matter patent and related SPC as long as the patent and SPC are in force.
Additional infringement and invalidity actions involving Eliquis patents may be filed in various countries in Europe in the coming months.
Onureg – U.S.
In November 2021, BMS received a Notice Letter from Accord notifying BMS that Accord had filed an aNDA containing a paragraph IV certification seeking approval of a generic version of Onureg in the U.S. and challenging the one FDA Orange Book-listed formulation patent expiring in 2030. In response, BMS filed a patent infringement action against Accord in the U.S. District Court for the District of Delaware. No trial date has been scheduled.
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Plavix* - Australia
Sanofi was notified that, in August 2007, GenRx Proprietary Limited (“GenRx”) obtained regulatory approval of an application for clopidogrel bisulfate 75mg tablets in Australia. GenRx, formerly a subsidiary of Apotex Inc., subsequently changed its name to Apotex (“GenRx-Apotex”). In August 2007, GenRx-Apotex filed an application in the Federal Court of Australia seeking revocation of Sanofi’s Australian Patent No. 597784 (Case No. NSD 1639 of 2007). Sanofi filed counterclaims of infringement and sought an injunction. On September 21, 2007, the Federal Court of Australia granted Sanofi’s injunction. A subsidiary of BMS was subsequently added as a party to the proceedings. In February 2008, a second company, Spirit Pharmaceuticals Pty. Ltd., also filed a revocation suit against the same patent. This case was consolidated with the GenRx-Apotex case. On August 12, 2008, the Federal Court of Australia held that claims of Patent No. 597784 covering clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate salts were valid. The Federal Court also held that the process claims, pharmaceutical composition claims, and claim directed to clopidogrel and its pharmaceutically acceptable salts were invalid. BMS and Sanofi filed notices of appeal in the Full Court of the Federal Court of Australia (“Full Court”) appealing the holding of invalidity of the claim covering clopidogrel and its pharmaceutically acceptable salts, process claims, and pharmaceutical composition claims. GenRx-Apotex appealed. On September 29, 2009, the Full Court held all of the claims of Patent No. 597784 invalid. In March 2010, the High Court of Australia denied a request by BMS and Sanofi to hear an appeal of the Full Court decision. The case was remanded to the Federal Court for further proceedings related to damages sought by GenRx-Apotex. BMS and GenRx-Apotex settled, and the GenRx-Apotex case was dismissed. The Australian government intervened in this matter seeking maximum damages up to 449 million AUD ($337 million), plus interest, which would be split between BMS and Sanofi, for alleged losses experienced for paying a higher price for branded Plavix* during the period when the injunction was in place. BMS and Sanofi dispute that the Australian government is entitled to any damages. A trial was concluded in September 2017. In April 2020, the Federal Court issued a decision dismissing the Australian government’s claim for damages. In May 2020, the Australian government appealed the Federal Court’s decision and an appeal hearing concluded in February 2021.
Pomalyst - U.S.
In February 2022, Celgene received a Notice Letter from MSN Laboratories Pvt. Ltd. (“MSN”) notifying Celgene that MSN had filed an aNDA containing paragraph IV certifications seeking approval to market a generic version of Pomalyst in the U.S. In response, Celgene initiated a patent infringement action against MSN in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book-listed patents. No trial date has been scheduled.
Revlimid - U.S.
Celgene has received a Notice Letter from Alembic Pharmaceuticals Limited, Alembic Global Holding SA, and Alembic Pharmaceuticals, Inc. (“Alembic”) notifying Celgene that Alembic had filed an aNDA containing paragraph IV certifications seeking approval to market a generic version of Revlimid in the U.S. In response, Celgene initiated a patent infringement action against Alembic in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book-listed patents. Alembic has filed answers and counterclaims alleging that the asserted patents are invalid and/or not infringed. No trial date has been scheduled.
Sprycel - U.S.
In January 2022, BMS received a Notice Letter from Xspray Pharma AB ("Xspray") notifying BMS that Xspray had filed a 505(b)(2) NDA application containing paragraph IV certifications seeking approval of a dasatinib product in the U.S. and challenging two FDA Orange Book-listed monohydrate form patents expiring in 2025 and 2026. In February 2022, BMS filed a patent infringement action against Xspray in the U.S. District Court for the District of New Jersey. No trial date has been scheduled.
Zeposia - U.S.
On October 15, 2021, Actelion Pharmaceuticals LTD and Actelion Pharmaceuticals US, INC (“Actelion”), filed a complaint for patent infringement in the United States District Court for the District of New Jersey against BMS and Celgene for alleged infringement of U.S. Patent No. 10,251,867 (the “’867 Patent”). The Complaint alleges that the sale of Zeposia infringes certain claims of the ’867 Patent and Actelion is seeking damages and injunctive relief. No trial date has been scheduled.
PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION
Plavix* State Attorneys General Lawsuits
BMS and certain Sanofi entities are defendants in consumer protection actions brought by the attorneys general of Hawaii and New Mexico relating to the labeling, sales and/or promotion of Plavix*. A trial in the Hawaii matter occurred in 2020. In February 2021, the Court issued a decision against Sanofi and BMS, imposing penalties in the total amount of $834 million, with $417 million attributed to BMS. Sanofi and BMS disagree with the decision and are appealing it. BMS remains confident in the merits of its case and its likelihood of success on appeal and BMS does not believe establishing a reserve is warranted for this matter. A trial in the New Mexico matter was previously scheduled for April 2022, but was adjourned due to statewide trial delays arising from the COVID-19 pandemic. Trial has been rescheduled for January 2023.
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PRODUCT LIABILITY LITIGATION
BMS is a party to various product liability lawsuits. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss. As previously disclosed, in addition to lawsuits, BMS also faces unfiled claims involving its products.
Abilify*
BMS and Otsuka are co-defendants in product liability litigation related to Abilify*. Plaintiffs allege Abilify* caused them to engage in compulsive gambling and other impulse control disorders. There have been over 2,500 cases filed in state and federal courts and additional cases are pending in Canada. The Judicial Panel on Multidistrict Litigation consolidated the federal court cases for pretrial purposes in the U.S. District Court for the Northern District of Florida. In February 2019, BMS and Otsuka entered into a master settlement agreement establishing a proposed settlement program to resolve all Abilify* compulsivity claims filed as of January 28, 2019 in the MDL as well as various state courts, including California and New Jersey. To date, approximately 2,700 cases, comprising approximately 3,900 plaintiffs, have been dismissed based on participation in the settlement program or failure to comply with settlement related court orders. In the U.S., less than five cases remain pending in state or federal courts (New Jersey and Massachusetts). There are eleven cases pending in Canada (four class actions, seven individual injury claims). Out of the eleven cases, only two are active (the class actions in Quebec and Ontario). Both class actions have now been certified and will proceed separately, subject to a potential further appeal of the Ontario class certification decision.
Byetta*
Amylin, a former subsidiary of BMS, and Lilly are co-defendants in product liability litigation related to Byetta*. This litigation involved lawsuits on behalf of plaintiffs, which include injury plaintiffs as well as claims by spouses and/or other beneficiaries, in various courts in the U.S. The majority of these cases have been brought by individuals who allege personal injury sustained after using Byetta*, primarily pancreatic cancer, and, in some cases, claiming alleged wrongful death. The majority of cases are pending in Federal Court in San Diego in an MDL or in a coordinated proceeding in California Superior Court in Los Angeles (“JCCP”). In April 2020 the defendants filed a motion for summary judgment based on federal preemption and a motion for summary judgment based on the absence of general causation evidence in the MDL and JCCP. Both motions were granted in March 2021 and April 2021, respectively. The orders will result in the dismissal of all claims alleging an injury of pancreatic cancer in the MDL and JCCP. Plaintiffs initially appealed the MDL order, but subsequently filed a motion to dismiss their appeal as to Amylin and Lilly. That motion to dismiss was granted on October 5, 2021 making the MDL decision final as to Amylin and Lilly. Plaintiffs may seek appeals in the JCCP. As of March 2022, Plaintiffs’ counsel have submitted dismissals with prejudice in exchange for a waiver of costs on behalf of approximately 75% of the plaintiffs in the JCCP (including injury plaintiffs and spouse/beneficiary plaintiffs) alleging claims against Amylin and Lilly. Additional dismissals are anticipated. BMS sold Byetta* to AstraZeneca in February 2014 as part of BMS’s global diabetes business divestiture and any additional liability to Amylin with respect to Byetta* is expected to be shared with AstraZeneca.
Onglyza*
BMS and AstraZeneca are co-defendants in product liability litigation related to Onglyza*. Plaintiffs assert claims, including claims for wrongful death, as a result of heart failure or other cardiovascular injuries they allege were caused by their use of Onglyza*. As of April 2022, claims are pending in federal and NY state court on behalf of approximately 252 individuals who allege they ingested the product and suffered an injury. In February 2018, the Judicial Panel on Multidistrict Litigation ordered all federal cases to be transferred to an MDL in the U.S. District Court for the Eastern District of Kentucky. A significant majority of the claims are pending in the MDL, with others pending in a coordinated proceeding in California Superior Court in San Francisco (“JCCP”). In August 2021, the MDL and JCCP courts jointly heard evidence regarding the parties’ motions to exclude general causation experts. On September 24, 2021, the JCCP court granted defendants’ motion to exclude plaintiffs’ only general causation expert and largely denied plaintiffs’ motions to exclude defendants’ general causation experts; on January 5, 2022, the MDL court likewise granted defendants’ motion to exclude plaintiffs’ expert and denied entirely plaintiffs’ motions. On March 30, 2022, the JCCP court granted summary judgment to defendants, thus effectively dismissing the 18 claims previously pending in California state court. As part of BMS’s global diabetes business divestiture, BMS sold Onglyza* to AstraZeneca in February 2014 and any potential liability with respect to Onglyza* is expected to be shared with AstraZeneca.
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SECURITIES LITIGATION
BMS Securities Class Action
Since February 2018, two separate putative class action complaints were filed in the U.S. District for the Northern District of California and in the U.S. District Court for the Southern District of New York against BMS, BMS’s Chief Executive Officer, Giovanni Caforio, BMS’s Chief Financial Officer at the time, Charles A. Bancroft and certain former and current executives of BMS. The case in California was voluntarily dismissed. The remaining complaint alleged violations of securities laws for BMS’s disclosures related to the CheckMate-026 clinical trial in lung cancer. In September 2019, the Court granted BMS’s motion to dismiss, but allowed the plaintiffs leave to file an amended complaint. In October 2019, the plaintiffs filed an amended complaint. In September 2020, the Court granted BMS’s motion to dismiss the amended complaint with prejudice. The plaintiffs appealed the Court’s decision in October 2020. On March 11, 2022, the Second Circuit affirmed the dismissal with prejudice of the amended complaint.
Celgene Securities Litigations
Beginning in March 2018, two putative class actions were filed against Celgene and certain of its officers in the U.S. District Court for the District of New Jersey (the “Celgene Securities Class Action”). The complaints allege that the defendants violated federal securities laws by making misstatements and/or omissions concerning (1) trials of GED-0301, (2) Celgene’s 2020 outlook and projected sales of Otezla*, and (3) the new drug application for Zeposia. The Court consolidated the two actions and appointed a lead plaintiff, lead counsel, and co-liaison counsel for the putative class. In February 2019, the defendants filed a motion to dismiss plaintiff’s amended complaint in full. In December 2019, the Court denied the motion to dismiss in part and granted the motion to dismiss in part (including all claims arising from alleged misstatements regarding GED-0301). Although the Court gave the plaintiff leave to re-plead the dismissed claims, it elected not to do so, and the dismissed claims are now dismissed with prejudice. In November 2020, the Court granted class certification with respect to the remaining claims.
In April 2020, certain Schwab management investment companies on behalf of certain Schwab funds filed an individual action in the U.S. District Court for the District of New Jersey asserting largely the same allegations as the Celgene Securities Class Action against the same remaining defendants in that action (the “Schwab Action”). In July 2020, the defendants filed a motion to dismiss the plaintiffs’ complaint in full. In March 2021, the Court granted in part and denied in part defendants’ motion to dismiss consistent with its decision in the Celgene Securities Class Action.
The California Public Employees’ Retirement System in April 2021 (the “CalPERS Action”); DFA Investment Dimensions Group Inc., on behalf of certain of its funds; and American Century Mutual Funds, Inc., on behalf of certain of its funds, in July 2021 (respectively the “DFA Action” and the “American Century Action”), and GIC Private Limited in September 2021 (the “GIC Action”), filed separate individual actions in the U.S. District Court for the District of New Jersey asserting largely the same allegations as the Celgene Securities Class Action and the Schwab individual action against the same remaining defendants in those actions. In October 2021, these actions were consolidated for pre-trial proceedings with the Schwab Action. The court also consolidated any future direct actions raising common questions of law and fact with the Schwab Action.
No trial dates have been scheduled in any of the above Celgene Securities Litigations.
Contingent Value Rights Litigations
In June 2021, an action was filed against BMS in the U.S. District Court for the Southern District of New York asserting claims of alleged breaches of a Contingent Value Rights Agreement (“CVR Agreement”) entered into in connection with the closing of BMS’s acquisition of Celgene Corporation in November 2019. The successor trustee under the CVR Agreement alleges that BMS breached the CVR Agreement by allegedly failing to use “diligent efforts” to obtain FDA approval of liso-cel (Breyanzi) before a contractual milestone date, thereby avoiding a $6.4 billion potential obligation to holders of the contingent value rights governed by the CVR Agreement and by allegedly failing to permit inspection of records in response to a request by the successor trustee. The successor trustee seeks damages in an amount to be determined at trial and other relief, including interest and attorneys’ fees. BMS disputes the successor trustee’s allegations and filed a Motion to Dismiss on July 23, 2021. All discovery is stayed until there is a decision on the Motion to Dismiss.
25
In October 2021, alleged former Celgene stockholders filed a complaint in the U.S. District Court for the Southern District of New York asserting claims on behalf of a putative class of Celgene stockholders who received CVRs in the BMS merger with Celgene for violations of sections 14(a) and 20(a) of the Securities Exchange Act of 1934 relating to the joint proxy statement. That action later was consolidated with another action filed in the same court asserting claims on behalf of a class of CVR acquirers, whether in the BMS merger with Celgene or otherwise, for violations of sections 11, 12(a)(2), and 15 of the Securities Act of 1933 and sections 10(b), 14(a) and 20(2) of the Securities Exchange Act of 1934. In asserting claims on behalf of a putative class of Celgene stockholders who received CVRs in the merger and persons who purchased CVRs for violations of sections 11, 12(a)(2), and 15 of the Securities Act of 1933 and sections 10(b), 14(a), and 20(a) of the Securities Exchange Act of 1934. The complaint alleges that the February 22, 2019 joint proxy statement was materially false or misleading because it failed to disclose that BMS allegedly had no intention to obtain FDA approval for liso-cel (Breyanzi) by the applicable milestone date in the CVR Agreement and that certain statements made by BMS or certain BMS officers in periodic SEC filings, earnings calls, press releases, and investor presentations between December 2019 and November 2020 were materially false or misleading for the same reason. Defendants have moved to dismiss the complaint.
In November 2021, an alleged purchaser of CVRs filed a complaint in the Supreme Court of the State of New York for New York County asserting claims on behalf of a putative class of CVR acquirers for violations of sections 11(a) and 12(a)(2) of the Securities Act of 1933. The complaint alleges that the registration statement filed in connection with the proposed merger transaction between Celgene and BMS was materially false or misleading because it failed to disclose that allegedly BMS had no intention at the time to obtain FDA approval for liso-cel (Breyanzi) by the contractual milestone date. The complaint asserts claims against BMS, the members of its board of directors at the time of the joint proxy statement, and certain BMS officers who signed the registration statement. BMS removed the action to the U.S. District Court for the Southern District of New York. The plaintiff has filed a motion to remand the action to the state court.
In November 2021, an alleged Celgene stockholder filed a complaint in the Superior Court of New Jersey, Union County asserting claims on behalf of two separate putative classes, one of acquirers of CVRs and one of acquirers of BMS common stock, for violations of sections 11(a), 12(a)(2), and 15 of the Securities Act of 1933. The complaint alleges that the registration statement filed in connection with the proposed merger transaction between Celgene and BMS was materially false or misleading because it failed to disclose that allegedly BMS had no intention at the time to obtain FDA approval for liso-cel (Breyanzi) by the contractual milestone date. The complaint asserts claims against BMS, the members of its board of directors at the time of the joint proxy statement, certain BMS officers who signed the registration statement and Celgene’s former chairman and chief executive officer. BMS removed the action to the U.S. District Court for the District of New Jersey and filed a motion to transfer the action to the U.S. District Court for the Southern District of New York. The plaintiff has filed a motion to remand the action to the state court.
No trial dates have been scheduled in any of the above CVR Litigations.
OTHER LITIGATION
HIV Medication Antitrust Litigations
BMS and two other manufacturers of HIV medications are defendants in related lawsuits pending in the Northern District of California. The lawsuits, filed on behalf of indirect purchasers, allege that the defendants’ agreements to develop and sell fixed-dose combination products for the treatment of HIV, including Atripla* and Evotaz®, violate antitrust laws. In July 2020, the Court granted in part defendants’ motion to dismiss, including dismissing with prejudice plaintiffs’ claims as to an overarching conspiracy and plaintiffs’ theories based on the alleged payment of royalties after patent expiration. Other claims, however, remain. In September and October 2020, two purported class actions were also filed asserting similar claims on behalf of direct purchasers. In March 2021, the Court dismissed one of the direct purchaser cases and limited the claims of the remaining direct purchaser case to those arising in 2016 or later. However, the Court gave plaintiffs leave to amend their complaints, and one plaintiff filed an amended complaint on March 16, 2021. On September 22, 2021, two additional non-class action direct purchaser complaints were filed by a number of retail pharmacy and grocery store chains against BMS and two other manufacturers of HIV medications. These complaints make allegations similar to those raised in the other federal court cases and the New Mexico state court case described below. In October 2021 and March 2022, BMS entered into settlement agreements with the putative class of indirect purchasers and the putative class of direct purchasers, respectively. Both settlements are subject to court approval. In January 2022, BMS reached an agreement to settle the cases filed against it by the retail pharmacy and grocery store chains.
In February 2021, BMS and two other manufacturers of HIV medications were sued in State Court in New Mexico by the Attorney General of the State of New Mexico in a case alleging that the defendants’ agreements to develop and sell various fixed-dose combination products for the treatment of HIV, including Atripla*, and agreements to settle certain patent litigation violate the antitrust laws of the State of New Mexico. No trial date has been scheduled.
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In December 2021, five additional non-class-action indirect purchaser cases were filed in the Northern District of California, and one additional non-class-action indirect purchaser case was filed in California state court naming BMS and two other manufacturers as defendants. These complaints make allegations similar to those in the other federal court cases. In February 2022, BMS reached a settlement agreement with one of the non-class-action indirect purchaser plaintiffs and in April 2022, two additional indirect purchaser plaintiffs filed non-class suits against BMS and other defendants. In total, there are now seven non-class action indirect purchaser cases pending against BMS among others. No trial date has been scheduled for these remaining cases.
Thalomid and Revlimid Litigations
Beginning in November 2014, certain putative class action lawsuits were filed against Celgene in the U.S. District Court for the District of New Jersey alleging that Celgene violated various antitrust, consumer protection, and unfair competition laws by (a) allegedly securing an exclusive supply contract for the alleged purpose of preventing a generic manufacturer from securing its own supply of thalidomide active pharmaceutical ingredient, (b) allegedly refusing to sell samples of Thalomid and Revlimid brand drugs to various generic manufacturers for the alleged purpose of bioequivalence testing necessary for aNDAs to be submitted to the FDA for approval to market generic versions of these products, (c) allegedly bringing unjustified patent infringement lawsuits in order to allegedly delay approval for proposed generic versions of Thalomid and Revlimid, and/or (d) allegedly entering into settlements of patent infringement lawsuits with certain generic manufacturers that allegedly have had anticompetitive effects. The plaintiffs, on behalf of themselves and putative classes of third-party payers, sought injunctive relief and damages. The various lawsuits were consolidated into a master action for all purposes. In March 2020, Celgene reached a settlement with the class plaintiffs. In October 2020, the Court entered a final order approving the settlement and dismissed the matter. That settlement did not resolve the claims of certain entities that opted out of the settlement.
In May 2018, Humana, Inc. (“Humana”) filed a lawsuit against Celgene in the Pike County Circuit Court of the Commonwealth of Kentucky. Humana’s complaint alleges Celgene engaged in unlawful off-label marketing in connection with sales of Thalomid and Revlimid and asserts claims against Celgene for fraud, breach of contract, negligent misrepresentation, unjust enrichment and violations of New Jersey’s Racketeer Influenced and Corrupt Organizations Act. Humana subsequently dismissed its claims for breach of contract voluntarily. The complaint seeks, among other things, treble and punitive damages, injunctive relief and attorneys’ fees and costs. A trial has been scheduled for January 2023.
In March 2019, Humana filed a lawsuit against Celgene in the U.S. District Court for the District of New Jersey. Humana’s complaint makes largely the same claims and allegations as were made in the Thalomid and Revlimid antitrust class action litigation. The complaint purports to assert claims on behalf of Humana and its subsidiaries in several capacities, including as a direct purchaser and as an indirect purchaser, and seeks, among other things, treble and punitive damages, injunctive relief and attorneys’ fees and costs. In May 2019, Celgene filed a motion to dismiss Humana’s complaint, and the Court has stayed discovery pending adjudication of that motion. No trial date has been scheduled.
In March 2020, United HealthCare Services, Inc. (“UHS”), affiliates of which opted out of the first settlement in the Thalomid and Revlimid antitrust class action litigation, filed a lawsuit against Celgene in the U.S. District Court for the District of Minnesota. UHS’s complaint makes largely the same claims and allegations as were made in the class action litigation in addition to certain claims regarding donations directed to copay assistance. The complaint purports to assert claims on behalf of UHS and its subsidiaries in several capacities, including as a direct purchaser and as an indirect purchaser, and seeks, among other things, treble and punitive damages, injunctive relief and attorneys’ fees and costs. In December 2020, Celgene’s motion to transfer the action to the District of New Jersey was granted and the case is now pending in that Court. In January 2021, Celgene filed a motion to dismiss UHS’s complaint, which the Court administratively terminated in June 2021 pending its decision on Celgene’s pending motion to dismiss Humana’s complaint. No trial date has been scheduled.
In May 2020, Celgene filed suit against Humana Pharmacy, Inc. (“HPI”), a Humana subsidiary, in Delaware Superior Court. Celgene’s complaint alleges that HPI breached its contractual obligations to Celgene by assigning claims to Humana that Humana is now asserting. The complaint seeks damages for HPI’s breach as well as a declaratory judgment. A trial has been scheduled for March 2023.
In July 2020, Blue Cross Blue Shield Association (“BCBSA”) sued Celgene and BMS on behalf of the Federal Employee Program in the U.S. District Court for the District of Columbia. BCBSA’s complaint makes largely the same claims and allegations as were made in the class action litigation. In April 2021, the parties’ joint motion to transfer the action to the District of New Jersey was granted and the case is now pending in that Court. No trial date has been scheduled.
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In August 2020, BCBSM Inc., Health Care Service Corporation (“HCSC”), Blue Cross and Blue Shield of Florida Inc., and Molina Healthcare, Inc. (“Molina”) sued Celgene and BMS in a Minnesota state court. The complaint makes largely the same claims and allegations as were made in the class action litigation but adds allegations on behalf of HCSC only as to alleged off-label marketing of Thalomid and Revlimid. In September 2020, Celgene and BMS removed the action to the U.S. District Court for the District of Minnesota. In March 2021, that Court denied plaintiffs’ motion to remand the action to state court, dismissed Molina for lack of personal jurisdiction and granted defendants’ motion to transfer the action to the District of New Jersey. The case is now pending in the District of New Jersey. No trial date has been scheduled.
In January 2021, Cigna Corporation (“Cigna”) sued Celgene and BMS in the U.S. District Court for the Eastern District of Pennsylvania. Cigna’s complaint makes largely the same claims and allegations as were made in the class action litigation. Cigna’s complaint purports to assert claims on behalf of Cigna and its subsidiaries in several capacities, including as a direct purchaser and as an indirect purchaser. In May 2021, the parties’ joint motion to transfer the action to the District of New Jersey was granted and the case is now pending in that Court. No trial date has been scheduled.
In May 2021, Molina sued Celgene and BMS in San Francisco Superior Court. Molina’s complaint makes largely the same claims and allegations as were made in the class action litigation. In July 2021, Celgene and BMS removed the action to the U.S. District Court for the Northern District of California, and in January 2022, that court granted Molina’s motion to remand to San Francisco Superior Court. No trial date has been scheduled.
In December 2021, a group of plaintiffs—MSP Recovery Claims, Series LLC; MSPA Claims 1, LLC; MAO-MSO Recovery II, LLC, Series PMPI, a segregated series of MAO-MSO Recovery II, LLC; MSP Recovery Claims Series 44, LLC; MSP Recovery Claims PROV, Series LLC; and MSP Recovery Claims CAID, Series LLC (together, “MSP”)—sued Celgene and BMS in the U.S. District Court for the District of New Jersey. MSP’s complaint makes largely the same claims and allegations as were made in the class action litigation. MSP purports to pursue assignments from certain named and unnamed entities that allegedly purchased or otherwise provided reimbursement for Thalomid and/or Revlimid, and purports to bring direct and indirect purchaser claims. In February 2022, MSP filed an amended complaint, adding claims arising from the Company's donations to charitable organizations, and adding those organizations as defendants. No trial date has been scheduled.
BeiGene Arbitration Matter
On July 5, 2017, Celgene Logistics Sàrl (“Celgene Logistics”) and BeiGene, Ltd. (together with its assignees, “BeiGene”), entered into a License and Supply Agreement (the “LSA”) pursuant to which BeiGene was granted, among other things, an exclusive license to distribute and commercialize Revlimid, Vidaza and Abraxane in China.
As has been disclosed publicly, BeiGene initiated an arbitration proceeding against Celgene Logistics and BMS at the International Chamber of Commerce in June 2020, asserting various claims, including breach of contract under the LSA. In October 2021, Celgene Logistics delivered notice to BeiGene terminating the LSA with respect to Abraxane.
MSK Contract Litigation
On April 1, 2022, Memorial Sloan Kettering Cancer Center and Eureka Therapeutics, Inc. (collectively, “Plaintiffs”) filed a complaint against BMS, Celgene and Juno (collectively, “Defendants”) alleging that Defendants breached a license agreement by allegedly failing to use commercially reasonable efforts to develop, manufacture, and commercialize a certain chimeric antigen receptor product and by failing to pay Plaintiffs a running royalty of at least 1.5 % of worldwide sales of Abecma allegedly owed to Plaintiffs under the license agreement. Defendants disagree with plaintiffs’ claims. No trial date has been scheduled.
GOVERNMENT INVESTIGATIONS
Like other pharmaceutical companies, BMS and certain of its subsidiaries are subject to extensive regulation by national, state and local authorities in the U.S. and other countries in which BMS operates. As a result, BMS, from time to time, is subject to various governmental and regulatory inquiries and investigations as well as threatened legal actions and proceedings. It is possible that criminal charges, substantial fines and/or civil penalties, could result from government or regulatory investigations.
ENVIRONMENTAL PROCEEDINGS
As previously reported, BMS is a party to several environmental proceedings and other matters, and is responsible under various state, federal and foreign laws, including CERCLA, for certain costs of investigating and/or remediating contamination resulting from past industrial activity at BMS’s current or former sites or at waste disposal or reprocessing facilities operated by third parties.
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CERCLA Matters
With respect to CERCLA matters for which BMS is responsible under various state, federal and international laws, BMS typically estimates potential costs based on information obtained from the U.S. Environmental Protection Agency, or counterpart state or foreign agency and/or studies prepared by independent consultants, including the total estimated costs for the site and the expected cost-sharing, if any, with other “potentially responsible parties,” and BMS accrues liabilities when they are probable and reasonably estimable. BMS estimated its share of future costs for these sites to be $89 million at March 31, 2022, which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties). The amount includes the estimated costs for any additional probable loss associated with the previously disclosed North Brunswick Township High School Remediation Site.
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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s discussion and analysis of results of operations and financial condition is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q to enhance the understanding of our results of operations, financial condition and cash flows.
EXECUTIVE SUMMARY
Bristol-Myers Squibb Company is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Our principal strategy is to combine the resources, scale and capability of a pharmaceutical company with the speed and focus on innovation of the biotech industry. Our focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where we believe that we have an opportunity to make a meaningful difference: oncology (both solid tumors and hematology), immunology, cardiovascular and neurology. Our priorities are to continue to renew and diversify our portfolio through launching our new product portfolio, advancing our early, mid and late-stage pipeline, and executing disciplined business development. We remain committed to reducing our debt and returning capital to shareholders. For further information on our strategy, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations-Executive Summary-Strategy” in our 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.
In the first quarter of 2022, we received nine approvals for new medicines and additional indications and formulations of currently marketed medicines in major markets (the U.S., EU and Japan), including advancement in oncology through regulatory approval of Opdualag, the first LAG-3 blocking antibody combination, for the treatment of unresectable or metastatic melanoma and of Opdivo in combination with chemotherapy for the treatment of NSCLC in the neoadjuvant setting. We continue to advance and invest in our cell therapy portfolio through the approval of Abecma in Japan for the treatment of multiple myeloma, the approval of Breyanzi in the EU for the third-line treatment of relapsed or refractory diffuse large B-cell lymphoma and the expansion of our manufacturing capabilities through the construction of new state-of-the-art cell therapy manufacturing facilities in Devens, Massachusetts and Leiden, Netherlands. We continue to expand our portfolio in immunology with an important opportunity for deucravacitinib, our TYK2 inhibitor, for the treatment of psoriasis and other diseases. In the cardiovascular space, we broadened our New Product Portfolio with the FDA approval of Camzyos (mavacamten) in April 2022 for patients with symptomatic obstructive HCM.
Our revenues increased by 5% for the three months ended March 31, 2022 due to In-Line Products (primarily Eliquis and Opdivo) and New Product Portfolio (primarily cell therapy products and Reblozyl), partially offset by Recent LOE Products (Revlimid and Abraxane) and foreign exchange impacts. The $0.30 decrease in GAAP EPS primarily resulted from specified items, including equity investment and contingent consideration fair value adjustments, partially offset by lower impairment charges and divestiture gains in 2022. After adjusting for specified items, non-GAAP EPS increased $0.22 as a result of higher revenues and lower weighted-average common shares outstanding, partially offset by Acquired IPRD.
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions, except per share data | 2022 | 2021 | |||||||||||||||||||||
| Total Revenues | $ | 11,648 | $ | 11,073 | |||||||||||||||||||
| Diluted Earnings Per Share | |||||||||||||||||||||||
| GAAP | $ | 0.59 | $ | 0.89 | |||||||||||||||||||
| Non-GAAP | 1.96 | 1.74 | |||||||||||||||||||||
Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items that represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For a detailed listing of all specified items and further information, reconciliations and changes to our non-GAAP financial measures refer to “—Non-GAAP Financial Measures.”
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Economic and Market Factors
COVID-19
In response to the COVID-19 pandemic, international, federal, state and local public health and governmental authorities have taken, and continue to take, a number of actions to limit the spread of COVID-19 and address related disruptions in the U.S. and global economy. While we continue to experience impacts on revenues from COVID-19 primarily due to lower new patient starts and patient visits, the pandemic has not significantly impacted our results of operations. The situation remains dynamic and it is difficult to reasonably assess or predict the full extent of the negative impact that the COVID-19 pandemic may have on our business, financial condition, results of operations and cash flows. The future financial and operational impact of the COVID-19 pandemic on BMS will depend on future developments such as the ultimate duration and the severity of the spread of COVID-19 and any variant strains in the U.S. and globally, the effectiveness and outreach of vaccines, the effectiveness of federal, state, local and international government's mitigation actions, the pandemic's impact on the U.S. and global economies, changes in the behavior of patients and medical professionals and the timing for resumption to our normal operations, as well as developments affecting healthcare and the delivery of medicines to patients. See “Part I—Item 1A. Risk Factors—General Risks—The COVID-19 pandemic is affecting our business and could have a material adverse effect on us” in our 2021 Form 10-K.
As the COVID-19 pandemic affected global healthcare systems as well as major economic and financial markets, we adopted several procedures focused on ensuring the continued supply of our medicines to our patients and protecting the health, wellbeing and safety of our workforce. Additional information on the procedures adopted are available at www.bms.com/about-us/responsibility/coronavirus-updates.
Governmental Actions
Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls and discounting, changes to tax and importation laws and other restrictions in the U.S., the EU and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which can negatively impact our results of operations (including intangible asset impairment charges), operating cash flow, liquidity and financial flexibility. For example, Congress is currently considering a number of different proposals that would potentially: (i) allow the government to set or negotiate prices for prescription drugs, including benchmarking those prices to prices paid in other countries, (ii) penalize manufacturers for price increases beyond inflationary measures, (iii) redesign the Part D benefit with new out of pocket limits for patients and new mandated discounts for manufacturers, and (iv) change U.S. income tax laws resulting in an increase to our income tax expense, including through increased taxation of our international operations. The outcome of these Congressional actions remains highly uncertain. In addition, the Organization for Economic Co-operation and Development recently reached agreement on a global minimum tax pursuant to which countries are expected to implement changes to their tax laws and updates to international tax treaties. See risk factor on the Company’s risk factors on these items included under “Part I—Item 1A. Risk Factors—Product, Industry and Operational Risks—Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins” and “—Changes to tax regulations could negatively impact our earnings” in our 2021 Form 10-K.
In February 2022, the Russian Federation invaded Ukraine. As a result, the U.S. and many other countries have implemented extensive sanctions on the Russian Federation, with which BMS intends to fully comply. The situation remains dynamic, and it is difficult to reasonably assess or predict the full extent of the negative impact that the Russian Federation-Ukraine conflict may have on our business, financial condition, results of operations and cash flows. Although the Russian Federation and Ukraine represent less than 1% of our total revenues, net assets and workforce, the evolving situation could result in significant negative impacts on our business. For example, while the Russia/Ukraine region represents approximately 1% of our overall clinical trial enrollment, as a result of growing operational challenges in the region, we have suspended new enrollment and new clinical trial activations in the region, which could impact our ability to timely complete trials and meet projected regulatory timelines. We also continue to assess our ability to continue operations in Russia, including our ability to provide medicines to patients in this region. For a more complete discussion on the risks we encounter in our business, please refer to “Part I—Item 1A. Risk Factors” in our 2021 Form 10-K.
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Significant Product and Pipeline Approvals
The following is a summary of the significant approvals received as of April 29, 2022:
| Product | Date | Approval | ||||||
Camzyos (mavacamten) | April 2022 | FDA approval of Camzyos (mavacamten) for the treatment of adults with symptomatic obstructive HCM. | ||||||
| Breyanzi | April 2022 | EC approval of Breyanzi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B after two or more lines of systemic therapy. | ||||||
| Opdivo+Yervoy | April 2022 | EC approval of Opdivo plus Yervoy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression > 1%. | ||||||
| Opdivo | April 2022 | EC approval of Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-LI expression > 1% who are at risk of recurrence after undergoing radical resection. | ||||||
| Opdivo | April 2022 | EC approval of Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC with PD-L1 expression > 1%. | ||||||
| Opdualag | March 2022 | FDA approval of Opdualag, a fixed-dose combination of nivolumab and relatlimab, for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma. | ||||||
| Opdivo | March 2022 | FDA approval of Opdivo in combination with platinum-doublet chemotherapy for adult patients with resectable NSCLC in the neoadjuvant setting. | ||||||
| Opdivo | March 2022 | Japan's Ministry of Health, Labour and Welfare approval of Opdivo for the adjuvant treatment of urothelial carcinoma. | ||||||
| Abecma | January 2022 | Japan’s Ministry of Health, Labour and Welfare approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies. | ||||||
Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in 2022.
Divestitures, Licensing and Other Arrangements
Refer to “Item 1. Financial Statements—Note 3. Alliances” and “—Note 4. Divestitures, Licensing and Other Arrangements” for information on significant divestitures, licensing and other arrangements during the first quarter of 2022.
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RESULTS OF OPERATIONS
Regional Revenues
The composition of the changes in revenues was as follows:
| Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | % Change | Foreign Exchange(b) | |||||||||||||||||||||||||||||||||||||||||||
| United States | $ | 7,694 | $ | 7,010 | 10 | % | — | ||||||||||||||||||||||||||||||||||||||||
| Europe | 2,413 | 2,553 | (5) | % | (6) | % | |||||||||||||||||||||||||||||||||||||||||
| Rest of the World | 1,314 | 1,346 | (2) | % | (4) | % | |||||||||||||||||||||||||||||||||||||||||
Other(a) | 227 | 164 | 38 | % | — | ||||||||||||||||||||||||||||||||||||||||||
| Total | $ | 11,648 | $ | 11,073 | 5 | % | (2) | % | |||||||||||||||||||||||||||||||||||||||
(a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
(b) Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.
United States
•U.S. revenues for the first quarter of 2022 increased due to Eliquis, Opdivo, our New Product Portfolio and Revlimid partially offset by lower demand for Abraxane. Average U.S. net selling prices increased 2% compared to the same period a year ago.
Europe
•Europe revenues for the first quarter of 2022 decreased due to foreign exchange impacts and Revlimid, partially offset by Eliquis. Average net selling prices decreased compared to the same period a year ago.
Rest of the World
•Rest of the World revenues for the first quarter of 2022 decreased due to foreign exchange impacts and Revlimid partially offset by Opdivo. Average net selling prices decreased compared to the same period a year ago.
No single country outside the U.S. contributed more than 10% of total revenues during the first quarter of 2022 and 2021. Our business is typically not seasonal.
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GTN Adjustments
The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows:
| Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | % Change | ||||||||||||||||||||||||||||||||
| Gross product sales | $ | 16,650 | $ | 15,559 | 7 | % | |||||||||||||||||||||||||||||
| GTN adjustments | |||||||||||||||||||||||||||||||||||
| Charge-backs and cash discounts | (1,763) | (1,586) | 11 | % | |||||||||||||||||||||||||||||||
| Medicaid and Medicare rebates | (2,084) | (1,718) | 21 | % | |||||||||||||||||||||||||||||||
| Other rebates, returns, discounts and adjustments | (1,495) | (1,457) | 3 | % | |||||||||||||||||||||||||||||||
| Total GTN adjustments | (5,342) | (4,761) | 12 | % | |||||||||||||||||||||||||||||||
| Net product sales | $ | 11,308 | $ | 10,798 | 5 | % | |||||||||||||||||||||||||||||
| GTN adjustments percentage | 32 | % | 30 | % | 2 | % | |||||||||||||||||||||||||||||
| U.S. | 37 | % | 36 | % | 1 | % | |||||||||||||||||||||||||||||
| Non-U.S. | 16 | % | 17 | % | (1) | % | |||||||||||||||||||||||||||||
Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $74 million and $217 million for the three months ended March 31, 2022 and 2021, respectively. The reductions to provisions was primarily related to Eliquis co-pay and coverage gap discounts. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S. GTN adjustments percentage increased primarily due to higher government channel mix, which has higher GTN adjustment percentages.
Product Revenues
| Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | % Change | ||||||||||||||||||||||||||||||||
| In-Line Products | |||||||||||||||||||||||||||||||||||
| Eliquis | $ | 3,211 | $ | 2,886 | 11 | % | |||||||||||||||||||||||||||||
| U.S. | 2,147 | 1,923 | 12 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 1,064 | 963 | 10 | % | |||||||||||||||||||||||||||||||
| Opdivo | 1,923 | 1,720 | 12 | % | |||||||||||||||||||||||||||||||
| U.S. | 1,099 | 944 | 16 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 824 | 776 | 6 | % | |||||||||||||||||||||||||||||||
| Pomalyst/Imnovid | 826 | 773 | 7 | % | |||||||||||||||||||||||||||||||
| U.S. | 557 | 512 | 9 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 269 | 261 | 3 | % | |||||||||||||||||||||||||||||||
| Orencia | 792 | 758 | 4 | % | |||||||||||||||||||||||||||||||
| U.S. | 592 | 536 | 10 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 200 | 222 | (10) | % | |||||||||||||||||||||||||||||||
| Sprycel | 483 | 470 | 3 | % | |||||||||||||||||||||||||||||||
| U.S. | 305 | 275 | 11 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 178 | 195 | (9) | % | |||||||||||||||||||||||||||||||
| Yervoy | 515 | 456 | 13 | % | |||||||||||||||||||||||||||||||
| U.S. | 311 | 294 | 6 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 204 | 162 | 26 | % | |||||||||||||||||||||||||||||||
| Empliciti | 75 | 85 | (12) | % | |||||||||||||||||||||||||||||||
| U.S. | 47 | 51 | (8) | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 28 | 34 | (18) | % | |||||||||||||||||||||||||||||||
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| Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | % Change | ||||||||||||||||||||||||||||||||
| Mature and other products | 462 | 506 | (9) | % | |||||||||||||||||||||||||||||||
| U.S. | 133 | 152 | (13) | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 329 | 354 | (7) | % | |||||||||||||||||||||||||||||||
| New Product Portfolio | |||||||||||||||||||||||||||||||||||
| Reblozyl | 156 | 112 | 39 | % | |||||||||||||||||||||||||||||||
| U.S. | 134 | 98 | 37 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 22 | 14 | 57 | % | |||||||||||||||||||||||||||||||
| Abecma | 67 | — | N/A | ||||||||||||||||||||||||||||||||
| U.S. | 56 | — | N/A | ||||||||||||||||||||||||||||||||
| Non-U.S. | 11 | — | N/A | ||||||||||||||||||||||||||||||||
| Zeposia | 36 | 18 | 100 | % | |||||||||||||||||||||||||||||||
| U.S. | 21 | 13 | 62 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 15 | 5 | ** | ||||||||||||||||||||||||||||||||
| Breyanzi | 44 | — | N/A | ||||||||||||||||||||||||||||||||
| U.S. | 41 | — | N/A | ||||||||||||||||||||||||||||||||
| Non-U.S. | 3 | — | N/A | ||||||||||||||||||||||||||||||||
| Inrebic | 18 | 16 | 13 | % | |||||||||||||||||||||||||||||||
| U.S. | 15 | 15 | — | ||||||||||||||||||||||||||||||||
| Non-U.S. | 3 | 1 | ** | ||||||||||||||||||||||||||||||||
| Onureg | 23 | 15 | 53 | % | |||||||||||||||||||||||||||||||
| U.S. | 19 | 14 | 36 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 4 | 1 | ** | ||||||||||||||||||||||||||||||||
| Opdualag | 6 | — | NA | ||||||||||||||||||||||||||||||||
| U.S. | 6 | — | NA | ||||||||||||||||||||||||||||||||
| Non-U.S. | — | — | NA | ||||||||||||||||||||||||||||||||
Recent LOE Products(a) | |||||||||||||||||||||||||||||||||||
| Revlimid | 2,797 | 2,944 | (5) | % | |||||||||||||||||||||||||||||||
| U.S. | 2,038 | 1,958 | 4 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 759 | 986 | (23) | % | |||||||||||||||||||||||||||||||
| Abraxane | 214 | 314 | (32) | % | |||||||||||||||||||||||||||||||
| U.S. | 173 | 225 | (23) | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 41 | 89 | (54) | % | |||||||||||||||||||||||||||||||
| Total Revenues | 11,648 | 11,073 | 5 | % | |||||||||||||||||||||||||||||||
| U.S. | 7,694 | 7,010 | 10 | % | |||||||||||||||||||||||||||||||
| Non-U.S. | 3,954 | 4,063 | (3) | % | |||||||||||||||||||||||||||||||
** Change in excess of 100%.
(a) Recent LOE Products includes products with significant decline in revenue from a prior reporting period as a result of a loss of exclusivity.
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Eliquis (apixaban) — an oral Factor Xa inhibitor, indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
•U.S. revenues increased 12% in the first quarter of 2022 due to higher demand and higher average net selling prices.
•International revenues increased 10% in the first quarter of 2022 due to higher demand, partially offset by foreign exchange impacts of 7% and lower average net selling prices. Excluding foreign exchange impacts, revenues increased by 17%.
•Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe, generic manufacturers may seek to market generic versions of Eliquis in Europe prior to the expiration of our patents, which may lead to additional, infringement and invalidity actions involving our Eliquis patents being filed in various countries in Europe. We believe in the innovative science behind Eliquis and the strength of our intellectual property, which we will defend against infringement. Refer to “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies—Intellectual Property” for further information.
Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells that has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM and stomach. The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and various gastric and esophageal cancers. There are several ongoing potentially registrational studies for Opdivo across other tumor types and disease areas, in monotherapy and in combination with Yervoy and various anti-cancer agents.
•U.S. revenues increased 16% in the first quarter of 2022 due to higher demand across multiple indications including the Opdivo+Yervoy combinations for NSCLC, Opdivo+Cabometyx* combination for kidney cancer and various gastric and esophageal cancers, partially offset by declining second-line eligibility across tumor indications and increased competition.
•International revenues increased 6% in the first quarter of 2022 due to higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 7%. Excluding foreign exchange impacts, revenues increased 13%.
Pomalyst/Imnovid (pomalidomide) — a proprietary, distinct, small molecule that is administered orally and modulates the immune system and other biologically important targets. Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
•U.S. revenues increased 9% in the first quarter of 2022 due to higher average net selling prices and higher demand.
•International revenues increased 3% in the first quarter of 2022 due to higher demand, partially offset by foreign exchange impacts of 6% and lower average net selling prices. Excluding foreign exchange impacts, revenues increased by 9%.
Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA.
•U.S. revenues increased 10% in the first quarter of 2022 due to higher demand.
•International revenues decreased 10% in the first quarter of 2022 due to foreign exchange impacts of 6% and lower demand. Excluding foreign exchange impacts, revenues decreased by 4%.
•In the U.S. and EU, estimated LOE dates are based on method of use patents that expired in 2021. Formulation and additional patents expire in 2026 and beyond. There are no Orencia biosimilars on the market in the U.S., EU or Japan.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML.
•U.S. revenues increased 11% in the first quarter of 2022 due to higher average net selling prices and higher demand.
•International revenues decreased 9% in the first quarter of 2022 due to foreign exchange impacts of 7%. Excluding foreign exchange impacts, revenues decreased by 2%.
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Yervoy (ipilimumab) — a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, and CRC.
•U.S. revenues increased 6% in the first quarter of 2022 due to higher average net selling prices and higher demand primarily from the Opdivo+Yervoy combination for NSCLC.
•International revenues increased 26% in the first quarter of 2022 due to higher demand as a result of additional indication launches and core indications, partially offset by lower average net selling prices and foreign exchange impacts of 8%. Excluding foreign exchange impacts, revenues increased by 34%.
Empliciti (elotuzumab) — a humanized monoclonal antibody for the treatment of multiple myeloma.
Mature and other products — includes all other products, including those which have lost exclusivity in major markets, OTC products, royalty revenue and mature products.
•International revenues decreased 7% in the first quarter of 2022 primarily due to continued generic erosion and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues decreased by 5%.
Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions and for the treatment of anemia failing an ESA in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions.
•U.S. revenues increased 37% in the first quarter of 2022 due to higher demand primarily from the launch of Reblozyl in April 2020 for the treatment of adult patients with MDS previously treated with ESA.
Abecma (idecabtagene vicleucel) — is a B-cell maturation antigen-directed genetically modified autologous CAR T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma was launched in May 2021.
Zeposia (ozanimod) — an oral immunomodulatory drug used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults. Zeposia was launched in June 2020.
Breyanzi (lisocabtagene maraleucel) — is a CD19-directed genetically modified autologous CAR T cell therapy indicated for the treatment of adult patients with certain types of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Breyanzi was launched in April 2021.
Inrebic (fedratinib) — an oral kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Inrebic was launched in August 2019.
Onureg (azacitidine) — an oral hypomethylating agent that incorporates into DNA and RNA, indicated for continued treatment of adult patients with AML who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. Onureg was launched in September 2020.
Opdualag (nivolumab and relatlimab-rmbw) — a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag was launched in March 2022.
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Revlimid (lenalidomide) — an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant.
•U.S. revenues increased 4% in the first quarter of 2022 due to higher demand and higher average net selling prices. The impact of generic erosion was not material in the first quarter of 2022.
•International revenues decreased 23% in the first quarter of 2022 due to generic erosion across several EU countries and Canada, foreign exchange impacts of 4% and lower average net selling prices. Excluding foreign exchange impacts, revenues decreased by 19%.
•In the U.S., certain third parties have been granted volume-limited licenses to sell generic lenalidomide beginning in March 2022 or thereafter. In the EU, licenses have been granted to third parties to market generic lenalidomide products prior to expiry of our patent and supplementary protection certificate rights beginning in the UK in January 2022 and in various other major market European countries (e.g. France, Germany, Italy and Spain) where our supplementary protection certificate is in force beginning in February 2022. In Japan, the estimated minimum market exclusivity date is based on a composition of matter patent, which expires in July 2022. Global revenues for Revlimid are expected to decline to approximately $9.0 billion to $9.5 billion in 2022.
Abraxane (paclitaxel albumin-bound particles for injectable suspension) — a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.
•U.S. revenues decreased 23% in the first quarter of 2022 due to lower demand due to manufacturing delays partially offset by higher average selling prices.
•International revenues decreased 54% in the first quarter of 2022 due to generic erosion, lower demand as a result of manufacturing delays and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues decreased by 52%. During the first quarter of 2022, the manufacturing delays experienced in the U.S. and International were substantially resolved.
•In the U.S., based on settlements reached we anticipate generic entry in the second quarter of 2022. In the EU, generics have entered the market. In Japan, the estimated minimum market exclusivity date is 2023 based on a method of use patent. Global revenues for Abraxane are expected to decline by approximately 25% to 30% in 2022.
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Estimated End-User Demand
Pursuant to the SEC Consent Order described in our 2021 Form 10-K, we monitor inventory levels on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We are obligated to disclose products with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception. Estimated levels of inventory in the distribution channel in excess of one month on hand for the following products were not material to our results of operations as of the dates indicated.
Reblozyl had 1.1 months of inventory on hand internationally in the distribution channel at December 31, 2021 compared to 1.0 months of inventory on hand at September 30, 2021 primarily to support the product launch in Saudi Arabia and Israel.
In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which account for approximately 76% of total gross sales of U.S. products for the three months ended March 31, 2022. Factors that may influence our estimates include generic competition, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted by their recordkeeping processes.
Revlimid and Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Revlimid REMS and Pomalyst REMS programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst. Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the products’ safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies.
Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to where we can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data, including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given the difficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and to calculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business for the quarter ended March 31, 2022 is not available prior to the filing of this Quarterly Report on Form 10-Q. We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to a de minimis exception, in our next quarterly report on Form 10-Q.
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Expenses
| Three Months Ended March 31, | |||||||||||||||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | % Change | ||||||||||||||||||||||||||||||||
Cost of products sold(a) | $ | 2,471 | $ | 2,841 | (13) | % | |||||||||||||||||||||||||||||
| Marketing, selling and administrative | 1,831 | 1,666 | 10 | % | |||||||||||||||||||||||||||||||
| Research and development | 2,260 | 2,219 | 2 | % | |||||||||||||||||||||||||||||||
| Acquired IPRD | 333 | 6 | ** | ||||||||||||||||||||||||||||||||
| Amortization of acquired intangible assets | 2,417 | 2,513 | (4) | % | |||||||||||||||||||||||||||||||
| Other (income)/expense, net | 649 | (702) | ** | ||||||||||||||||||||||||||||||||
| Total Expenses | $ | 9,961 | $ | 8,543 | 17 | % | |||||||||||||||||||||||||||||
** In excess of +/- 100%.
(a) Excludes amortization of acquired intangible assets.
Cost of Products Sold
•Cost of products sold decreased by $370 million in the first quarter of 2022, primarily due to the impairment of Inrebic EU regulatory approval milestones ($315 million) in 2021 and foreign exchange, partially offset by higher profit sharing and royalties due to Eliquis revenue growth ($170 million).
Marketing, Selling and Administrative
•Marketing, selling and administrative expenses increased by $165 million in the first quarter of 2022, primarily due to higher charitable giving and expenses to support new product launches.
Research and Development
•Research and development expense increased $41 million in the first quarter of 2022, primarily due to an out of period adjustment relating to the unwinding of inventory purchase price adjustments ($82 million) and an IPRD impairment charge ($40 million), partially offset by timing of spend.
Acquired IPRD
•Acquired IPRD charges resulting from up-front or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights were as follows:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Dragonfly milestone | $ | 175 | $ | — | |||||||||||||||||||
| Immatics up-front license fee | 150 | — | |||||||||||||||||||||
| Other Acquired IPRD charges | 8 | 6 | |||||||||||||||||||||
| Acquired IPRD charges | $ | 333 | $ | 6 | |||||||||||||||||||
Amortization of Acquired Intangible Assets
•Amortization of acquired intangible assets decreased by $96 million in the first quarter of 2022, due to a longer than previously expected market exclusivity period for Pomalyst.
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Other (Income)/Expense, Net
•Other (income)/expense, net changed by $1.4 billion in the first quarter of 2022, primarily due to equity investments, contingent value rights and other items discussed below.
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Interest expense | $ | 326 | $ | 353 | |||||||||||||||||||
| Royalties and licensing income | (477) | (367) | |||||||||||||||||||||
| Equity investment losses/(gains) | 644 | (601) | |||||||||||||||||||||
| Integration expenses | 105 | 141 | |||||||||||||||||||||
| Contingent consideration | 1 | (510) | |||||||||||||||||||||
| Loss on debt redemption | 275 | 281 | |||||||||||||||||||||
| Provision for restructuring | 23 | 45 | |||||||||||||||||||||
| Litigation and other settlements | (37) | (8) | |||||||||||||||||||||
| Transition and other service fees | (1) | (15) | |||||||||||||||||||||
| Investment income | (10) | (9) | |||||||||||||||||||||
| Divestiture gains | (211) | — | |||||||||||||||||||||
| Other | 11 | (12) | |||||||||||||||||||||
| Other (income)/expense, net | $ | 649 | $ | (702) | |||||||||||||||||||
•Royalties and licensing income includes diabetes business royalties, Keytruda* royalties, Tecentriq* royalties, up-front licensing fees and milestones for products that have not obtained commercial approval. Refer to “Item 1. Financial Statements—Note 4. Divestitures, Licensing and Other Arrangements” for further information.
•Equity investment losses/(gains) includes fair value adjustments for investments that have readily determinable fair value and observable price changes for investments without readily determinable fair values resulting primarily from initial public offerings or third-party acquisitions of entities which we held an ownership interest. Our share of income or loss from equity method investments is primarily due to fair value adjustments attributed to limited partnerships. Refer to “Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements” for more information.
•Integration expenses primarily includes consulting fees to implement Celgene integration initiatives related to processes and systems.
•Contingent consideration primarily includes fair value adjustments resulting from the change in the traded price of contingent value rights issued with the Celgene acquisition. The contractual obligation to pay the contingent value rights terminated in January 2021 because the FDA did not approve liso-cel (JCAR017) by December 31, 2020.
•Losses on debt redemption resulted from the early redemption of long-term debt of $5.2 billion in 2022 and $3.5 billion in 2021.
•Provision for restructuring includes exit and other costs primarily related to the Celgene acquisition plan. We are on track to achieve the annualized pre-tax cost savings of approximately $3.0 billion through 2022 as detailed in the restructuring activities. Refer to “Item 1. Financial Statements—Note 6. Restructuring” for further information.
•Litigation and other settlements includes income of $40 million resulting from a settlement resolving all legal claims and business interests pertaining to Nimbus’ TYK2 inhibitor in the first quarter of 2022. The settlement also provides for contingent development, regulatory and sales-based milestones payable to BMS upon the occurrence of certain events.
•Divestiture gains resulted from the divestiture of product rights for several mature products in the first quarter of 2022
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Income Taxes
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Earnings Before Income Taxes | $ | 1,687 | $ | 2,530 | |||||||||||||||||||
| Provision for Income Taxes | 404 | 501 | |||||||||||||||||||||
| Effective Tax Rate | 23.9 | % | 19.8 | % | |||||||||||||||||||
| Impact of Specified Items | 8.0 | % | 3.0 | % | |||||||||||||||||||
| Effective Tax Rate Excluding Specified Items | 15.9 | % | 16.8 | % | |||||||||||||||||||
The tax impact attributed to specified items was primarily due to low jurisdictional tax rates attributed to the unwinding of inventory fair value adjustments and intangible asset amortization and contingent value rights fair value adjustments that were not taxable in 2021. The 0.9% decrease in the effective tax rate excluding specified items during 2022 was due to jurisdictional earnings mix. Refer to “Item 1. Financial Statements—Note 7. Income Taxes” for additional information.
Non-GAAP Financial Measures
Our non-GAAP financial measures, such as non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods including (i) amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, (ii) unwind of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) divestiture gains or losses, (vii) stock compensation resulting from accelerated vesting of Celgene awards and certain retention-related employee compensation charges related to the Celgene transaction, (viii) pension, legal and other contractual settlement charges, (ix) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments) and (x) amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. We also provide international revenues for our priority products excluding the impact of foreign exchange. We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in Exhibit 99.2 to our Form 8-K filed on April 29, 2022 and are incorporated herein by reference.
Beginning with the first quarter of 2022, significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights are no longer excluded from our non-GAAP financial measures. We are making these changes to our presentation of non-GAAP financial measures following comments from and discussions with the SEC. For purposes of comparability, the non-GAAP financial measures for the three months ended March 31, 2021 have been updated to reflect this change.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
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Specified items were as follows:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||||||||||||||
| Inventory purchase price accounting adjustments | $ | 52 | $ | 79 | |||||||||||||||||||
| Intangible asset impairment | — | 315 | |||||||||||||||||||||
| Site exit and other costs | — | 23 | |||||||||||||||||||||
| Cost of products sold | 52 | 417 | |||||||||||||||||||||
| Site exit and other costs | 2 | (1) | |||||||||||||||||||||
| Marketing, selling and administrative | 2 | (1) | |||||||||||||||||||||
| IPRD impairments | 40 | — | |||||||||||||||||||||
| Inventory purchase price accounting adjustments | 87 | — | |||||||||||||||||||||
| Employee compensation charges | — | 1 | |||||||||||||||||||||
| Research and development | 127 | 1 | |||||||||||||||||||||
| Amortization of acquired intangible assets | 2,417 | 2,513 | |||||||||||||||||||||
Interest expense(a) | (27) | (34) | |||||||||||||||||||||
| Equity investment losses/(gains) | 643 | (608) | |||||||||||||||||||||
| Integration expenses | 105 | 141 | |||||||||||||||||||||
| Contingent consideration | — | (510) | |||||||||||||||||||||
| Loss on debt redemption | 275 | 281 | |||||||||||||||||||||
| Provision for restructuring | 23 | 45 | |||||||||||||||||||||
| Litigation and other settlements | (40) | — | |||||||||||||||||||||
| Divestiture gains | (211) | — | |||||||||||||||||||||
| Other (income)/expense, net | 768 | (685) | |||||||||||||||||||||
| Increase to pretax income | 3,366 | 2,245 | |||||||||||||||||||||
| Income taxes on items above | (398) | (303) | |||||||||||||||||||||
| Increase to net earnings | $ | 2,968 | $ | 1,942 | |||||||||||||||||||
(a) Includes amortization of purchase price adjustments to Celgene debt.
The reconciliations from GAAP to Non-GAAP were as follows:
| Three Months Ended March 31, | |||||||||||||||||||||||
| Dollars in Millions, except per share data | 2022 | 2021 | |||||||||||||||||||||
| Net Earnings Attributable to BMS Used for Diluted EPS Calculation – GAAP | $ | 1,278 | $ | 2,021 | |||||||||||||||||||
| Specified Items | 2,968 | 1,942 | |||||||||||||||||||||
| Net Earnings Attributable to BMS Used for Diluted EPS Calculation – Non-GAAP | $ | 4,246 | $ | 3,963 | |||||||||||||||||||
| Weighted-Average Common Shares Outstanding – Diluted | 2,164 | 2,265 | |||||||||||||||||||||
| Diluted Earnings Per Share Attributable to BMS – GAAP | $ | 0.59 | $ | 0.89 | |||||||||||||||||||
| Diluted EPS Attributable to Specified Items | 1.37 | 0.85 | |||||||||||||||||||||
| Diluted EPS Attributable to BMS – Non-GAAP | $ | 1.96 | $ | 1.74 | |||||||||||||||||||
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FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES
Our net debt position was as follows:
| Dollars in Millions | March 31, 2022 | December 31, 2021 | |||||||||
| Cash and cash equivalents | $ | 12,369 | $ | 13,979 | |||||||
| Marketable debt securities – current | 2,599 | 2,987 | |||||||||
| Total cash, cash equivalents and marketable debt securities | 14,968 | 16,966 | |||||||||
| Short-term debt obligations | (7,522) | (4,948) | |||||||||
| Long-term debt | (37,450) | (39,605) | |||||||||
| Net debt position | $ | (30,004) | $ | (27,587) | |||||||
We regularly assess our anticipated working capital needs, debt and leverage levels, debt maturities, capital expenditure requirements, dividend payouts, potential share repurchases and future investments or acquisitions in order to maximize shareholder return, efficiently finance our ongoing operations and maintain flexibility for future strategic transactions. We also regularly evaluate our capital structure to ensure financial risks, adequate liquidity access and lower cost of capital are efficiently managed, which may lead to the issuance of additional debt securities, the repurchase of debt securities prior to maturity or the issuance or repurchase of common stock. Under the Tax Cuts and Jobs Act of 2017, research and development costs are required to be capitalized and amortized for US tax purposes effective January 1, 2022. Absent a change in law, we estimate our US income tax payments will increase by nearly $2.0 billion as compared to 2021. We believe that our existing cash, cash equivalents and marketable debt securities together with cash generated from operations and, if required, from the issuance of commercial paper will be sufficient to satisfy our anticipated cash needs for at least the next few years, including dividends, capital expenditures, milestone payments, working capital, income taxes, restructuring initiatives, business development, repurchase of common stock, debt maturities of approximately $16.3 billion through 2026 as well as any debt repurchases through redemptions or tender offers. The net debt position increased by $2.4 billion due to common stock repurchases and dividends of $6.2 billion, partially offset by cash from operating activities of $3.8 billion.
We have a share repurchase program authorized by our Board of Directors allowing for repurchases of our shares. The specific timing and number of shares repurchased will be determined by our management at its discretion and will vary based on market conditions, securities law limitations and other factors. The share repurchase program does not obligate us to repurchase any specific number of shares, does not have a specific expiration date and may be suspended or discontinued at any time. The repurchases may be effected through a combination of one or more open market repurchases, privately negotiated transactions, transactions structured through investment banking institutions and other derivative transactions, relying on Rule 10b-18 and Rule 10b5-1 under the Exchange Act. The outstanding share repurchase authorization under the program was $15.2 billion as of December 31, 2021. In the first quarter of 2022, we executed ASR agreements to repurchase an aggregate $5.0 billion of common stock. The remaining share repurchase capacity under the share repurchase program was approximately $10.2 billion as of March 31, 2022. Refer to “Item 1. Financial Statements—Note 15. Equity” for additional information.
Dividend payments were $1.2 billion in the first quarter of 2022. Dividends declared per common share were $0.54 in the first quarter of 2022. Dividend decisions are made on a quarterly basis by our Board of Directors.
Annual capital expenditures were approximately $970 million in 2021 and are expected to be approximately $1.2 billion in 2022 and 2023. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities, research and development and other facility-related activities.
In the first quarter of 2022, we issued an aggregate principal amount of $6.0 billion of debt consisting of $1.75 billion of 2.950% Notes due 2032, $1.25 billion of 3.550% Notes due 2042, $2.0 billion of 3.700% Notes due 2052 and $1.0 billion of 3.900% Notes due 2062 with net proceeds of $5.9 billion.
In the first quarter of 2022, we purchased aggregate principal amount of $5.2 billion of certain of our debt securities for approximately $5.8 billion of cash in tender offers.
In April 2022, we purchased aggregate principal amount of $849 million of certain of our debt securities for approximately $880 million of cash pursuant to “make whole” redemptions.
At December 31, 2021, we had four separate revolving credit facilities totaling $6.0 billion, which consisted of a 364-day $2.0 billion facility which expired in January 2022, a three-year $1.0 billion facility which expired in January 2022 and two five-year $1.5 billion facilities that were extended to September 2025 and July 2026, respectively.
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In January 2022, we entered into a five-year $5.0 billion facility expiring in January 2027, which is extendable annually by one year with the consent of the lenders. This facility provides for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings. Concurrently with the entry into this facility, the commitments under our existing five-year $1.5 billion facilities were terminated and the three-year $1.0 billion facility and 364-day $2.0 billion facility expired in accordance with their terms in January 2022. No borrowings were outstanding under revolving credit facilities at March 31, 2022 or December 31, 2021.
Under our commercial paper program, we may issue a maximum of $5.0 billion unsecured notes that have maturities of not more than 366 days from the date of issuance. There were no commercial paper borrowings outstanding as of March 31, 2022.
Our investment portfolio includes non-current marketable debt securities, which are subject to changes in fair value as a result of interest rate fluctuations and other market factors. Our investment policy establishes limits on the amount and time to maturity of investments with any institution. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. Refer to “Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements” for further information.
Credit Ratings
Our current long-term and short-term credit ratings assigned by Moody’s Investors Service are A2 and Prime-1, respectively, with a stable long-term credit outlook, and our current long-term and short-term credit ratings assigned by Standard & Poor’s are A+ and A-1, respectively with a stable long-term credit outlook. The long-term ratings reflect the agencies’ opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. The short-term ratings reflect the agencies’ opinion that we have good to extremely strong capacity for timely repayment. Any credit rating downgrade may affect the interest rate of any debt we may incur, the fair market value of existing debt and our ability to access the capital markets generally.
Cash Flows
The following is a discussion of cash flow activities:
| Three Months Ended March 31, | |||||||||||
| Dollars in Millions | 2022 | 2021 | |||||||||
| Cash flow provided by/(used in): | |||||||||||
| Operating activities | $ | 3,812 | $ | 3,824 | |||||||
| Investing activities | 95 | (143) | |||||||||
| Financing activities | (5,653) | (7,295) | |||||||||
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements from all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash and when the transactions are recognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliance partners; payments to suppliers, alliance partners and employees; customer discounts and rebates; and tax payments in the ordinary course of business. For example, annual employee bonuses are typically paid in the first quarter of the subsequent year.
Cash flow from operating activities decreased by $12 million compared to 2021.
Investing Activities
Cash requirements from investing activities include cash used for acquisitions, manufacturing and facility-related capital expenditures and purchases of marketable securities with original maturities greater than 90 days at the time of purchase, proceeds from business divestitures (including royalties), the sale and maturity of marketable securities, sale of equity investments and upfront and contingent milestones from licensing arrangements.
The $238 million change in cash flow from investing activities compared to 2021 was primarily attributable to changes in the amount of marketable debt securities held of $900 million and higher proceeds from divestitures, partially offset by lower proceeds from sales of equity investments of $400 million and higher Acquired IPRD payments of $330 million.
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Financing Activities
Cash requirements from financing activities include cash used to pay dividends, repurchase common stock and repay long-term debt and other borrowings reduced by proceeds from the exercise of stock options and issuance of long-term debt and other borrowings.
The $1.6 billion change in cash flow from financing activities compared to 2021 was primarily due to changes in the amount of debt securities of $4.7 billion resulting from debt issuances and repayments, partially offset by higher repurchases of common stock ($3.2 billion).
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Product and Pipeline Developments
Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth. Our late stage R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. The following are the developments in our marketed products and our late-stage pipeline since the start of the first quarter:
| Product | Indication | Date | Developments | ||||||||
| Opdivo | Bladder | April 2022 | Announced EC approval of Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-LI expression > 1% who are at risk of recurrence after undergoing radical resection. The approval is based on results from the Phase III CheckMate -274 trial. | ||||||||
| March 2022 | Ono, our alliance partner for Opdivo in Japan, announced that the Japan's Ministry of Health, Labour and Welfare approved Opdivo for the adjuvant treatment of urothelial carcinoma, for partial change in approved items of the manufacturing and marketing approval. The approval is based on results from the Phase III CheckMate-274 (ONO-4538-33) trial. | ||||||||||
| Esophageal | April 2022 | Announced EC approval of Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC with PD-L1 expression > 1%. The approval is based on results from the Phase III CheckMate -648 trial. | |||||||||
| Melanoma | March 2022 | Announced that the Phase III PIVOT IO-001 trial did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) in patients with previously untreated unresectable or metastatic melanoma who were treated with bempegaldesleukin in combination with Opdivo compared to Opdivo monotherapy. The DMC notified the companies that the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis. The trial was conducted in collaboration with Nektar. The trial will be unblinded and no additional analyses for the OS endpoint will be performed. Based on subsequent results from pre-planned analyses of two late-stage clinical studies in RCC and bladder cancer, coupled with the results of PIVOT IO-001 noted above, BMS and Nektar have jointly decided to end the global clinical development program for bempegaldesleukin in combination with Opdivo. | |||||||||
| NSCLC | April 2022 | Announced results from the Phase III CheckMate-816 trial which showed that neoadjuvant treatment with Opdivo in combination with chemotherapy significantly improved event-free survival, a primary endpoint, compared to chemotherapy alone in patients with resectable NSCLC. Opdivo in combination with chemotherapy reduced the risk of disease recurrence, progression or death by 37%, and demonstrated favorable early overall survival trend. | |||||||||
| March 2022 | Announced that the EMA validated the Type II Variation application for Opdivo in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA NSCLC. The application is based on results from the Phase III CheckMate-816 trial. | ||||||||||
| March 2022 | Announced FDA approval of Opdivo in combination with platinum-doublet chemotherapy for the treatment of adult patients with resectable NSCLC in the neoadjuvant setting. The approval is based on the Phase III CheckMate-816 trial. | ||||||||||
| RCC | April 2022 | Announced, with our alliance partner Nektar, that based on results from pre-planned analysis of two late-stage clinical studies of bempegaldesleukin in combination with Opdivo in RCC and bladder cancer, to jointly end the global clinical development program for bempegaldesleukin in combination with Opdivo. These studies and all other ongoing studies in the program will be discontinued. | |||||||||
| February 2022 | Announced two-year follow-up results from analysis of the Phase III CheckMate-9ER trial, demonstrating sustained survival, response rate benefits, and health-related quality of life improvements, with the combination of Opdivo and CABOMETYX* versus sunitinib in the first-line treatment of advanced RCC. | ||||||||||
| Opdivo + Yervoy | Esophageal | April 2022 | Announced EC approval of Opdivo plus Yervoy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression > 1%. The approval is based on results from the Phase III CheckMate -648 trial. | ||||||||
| Reblozyl | Beta Thalassemia | March 2022 | Announced that the FDA has extended the review of the sBLA for Reblozyl for the treatment of anemia in adults with non-transfusion dependent beta thalassemia to June 27, 2022 to allow sufficient time to review a written response to an information request. The sBLA was based on results from the Phase II BEYOND trial. | ||||||||
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| Product | Indication | Date | Developments | ||||||||
| Abecma | Multiple Myeloma | January 2022 | Announced Japan's Ministry of Health, Labour and Welfare approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have either experienced disease progression on the last therapy or relapse after the last therapy. The approval is based on results from the Phase II BB2121-MM-001 and Phase I CRB-401 trials. | ||||||||
| Zeposia | UC | February 2022 | Announced interim results from the Phase III True North open-label extension trial evaluating the long-term efficacy and safety profile of Zeposia in patients with moderately to severely active UC through Week 142. Findings show that the percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained. | ||||||||
| Breyanzi | Lymphoma | April 2022 | Announced EC approval of Breyanzi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after two or more lines of systemic therapy. The approval is based on results from the TRANSCEND WORLD and TRANSCEND NHL 001 trials. | ||||||||
| March 2022 | Announced that Japan's Ministry of Health, Labour and Welfare has accepted the sNDA for Breyanzi for the second-line treatment of patients with relapsed or refractory large B-cell lymphoma. The acceptance is based on results from the Phase III TRANSFORM trial and other studies. | ||||||||||
| February 2022 | Announced that the FDA has accepted for priority review the sBLA to expand its current indication to include earlier use of Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after failure of first-line therapy. The FDA has assigned a PDUFA goal date of June 24, 2022. The sBLA is based on results from the Phase III TRANSFORM trial. | ||||||||||
Opdualag (nivolumab and relatlimab-rmbw) | Melanoma | March 2022 | Announced FDA approval of Opdualag (nivolumab and relatlimab-rmbw), a fixed-dose combination of nivolumab and relatlimab, a novel LAG-3 inhibitor, for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approval is based on results from the Phase II/III RELATIVITY-047 trial. | ||||||||
Camzyos (mavacamten) | Obstructive HCM | April 2022 | Announced FDA approval of Camzyos (mavacamten) for the treatment of adults with symptomatic New York Heart Association class II-III obstructive HCM to improve functional capacity and symptoms. The approval is based on results from the Phase III EXPLORER-HCM trial. | ||||||||
| mavacamten | Obstructive HCM | April 2022 | Announced that Phase 3 VALOR-HCM trial met its primary and secondary endpoints, significantly reducing the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive HCM who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association Guidelines at baseline, after 16 weeks of treatment with mavacamten. | ||||||||
| April 2022 | Announced that interim results from the EXPLORER-LTE cohort of the MAVA-LTE trial in patients with symptomatic obstructive HCM showed sustained improvements in cardiovascular outcomes at 48 and 84-weeks, no new safety signals were observed. | ||||||||||
| February 2022 | Announced that VALOR-HCM, the Phase III randomized, double-blind, placebo-controlled trial evaluating mavacamten in adults with symptomatic obstructive HCM who are eligible for septal reduction therapy, met its primary endpoint at Week 16. | ||||||||||
Critical Accounting Policies
The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Our critical accounting policies are those that significantly impact our financial condition and results of operations and require the most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates. For a discussion of our critical accounting policies, refer to “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2021 Form 10-K. There have been no material changes to our critical accounting policies during the three months ended March 31, 2022. For information regarding the impact of recently adopted accounting standards, refer to “Item 1. Financial Statements—Note.1 Basis of Presentation and Recently Issued Accounting Standards.”
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Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. You can identify these forward-looking statements by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions of Celgene and MyoKardia, the impact of the COVID-19 pandemic on our operations and the development and commercialization of our products, potential laws and regulations to lower drug costs, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about our ability to retain marketing exclusivity of certain products, and the outcome of contingencies such as legal proceedings and financial results. No forward-looking statement can be guaranteed. This Quarterly Report on Form 10-Q, our 2021 Form 10-K, particularly under the section “Item 1A. Risk Factors,” and our other filings with the SEC, include additional information on the factors that we believe could cause actual results to differ materially from any forward-looking statement.
Although we believe that we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report on Form 10-Q not to occur. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this Quarterly Report on Form 10-Q.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
For a discussion of our market risk, refer to “Item 7A. Quantitative and Qualitative Disclosures about Market Risk” in our 2021 Form 10-K.
Item 4. CONTROLS AND PROCEDURES
Management carried out an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of its disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that as of March 31, 2022, such disclosure controls and procedures are effective.
There were no changes in the Company’s internal control over financial reporting during the quarter ended March 31, 2022 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
Information pertaining to legal proceedings can be found in “Item 1. Financial Statements—Note 17. Legal Proceedings and Contingencies,” to the interim consolidated financial statements, and is incorporated by reference herein.
Item 1A. RISK FACTORS
There have been no material changes from the risk factors disclosed in the Company’s 2021 Form 10-K.
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Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
The following table summarizes the surrenders of our equity securities during the three months ended March 31, 2022:
| Period | Total Number of Shares Purchased(a) | Average Price Paid per Share(a) | Total Number of Shares Purchased as Part of Publicly Announced Programs(b) | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs(b) | |||||||||||||||||||
| Dollars in Millions, Except Per Share Data | |||||||||||||||||||||||
| January 1 to 31, 2022 | 840,489 | $ | 64.75 | — | $ | 15,169 | |||||||||||||||||
February 1 to 28, 2022(c) | 64,583,226 | 64,501,440 | 10,169 | ||||||||||||||||||||
| March 1 to 31, 2022 | 2,330,783 | 68.44 | — | 10,169 | |||||||||||||||||||
| Three months ended March 31, 2022 | 67,754,498 | 64,501,440 | |||||||||||||||||||||
(a)Includes shares repurchased as part of publicly announced programs and shares of common stock surrendered to the Company to satisfy tax-withholding obligations in connection with the vesting of awards under our long-term incentive program. Shares surrendered for tax-withholding included 840,489 in January, 81,786 in February and 2,330,783 in March, with average prices of $64.75, $66.13 and $68.44, respectively.
(b)In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of our common stock and in June 2012 increased its authorization for the repurchase of our common stock by an additional $3.0 billion. The Board of Directors approved a new share repurchase program authorizing the repurchase of an additional $3.0 billion of our common stock in October 2016 and further increased its authorization for the repurchase of our common stock by approximately $7.0 billion in November 2019 and $5.0 billion in February 2020. In January and December 2021, the Board of Directors approved an increase of $2.0 billion and $15.0 billion, respectively, to the share repurchase authorization for our common stock. The remaining share repurchase capacity under the program is approximately $10.2 billion as of March 31, 2022. Refer to “Item 1. Financial Statements-Note 15. Equity” for information on the share repurchase program.
(c)On February 8, 2022, as part of our existing share repurchase program, BMS executed accelerated share repurchase (“ASR”) agreements to repurchase an aggregate $5.0 billion of common stock. Approximately 65 million shares of common stock (85% of the $5.0 billion aggregate purchase price calculated on the basis of a price of $65.89 per share, the closing share price of the Company's common stock on February 8, 2022) were received by BMS and included in treasury stock. The total number of shares to be repurchased under the ASR agreements, and the average price paid per share, will be determined at the settlement of the ASR agreements and will be based on volume-weighted average prices of BMS's common stock during the terms of the ASR transactions less a discount and subject to adjustments pursuant to the terms and conditions of the ASR agreements.
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Item 6. EXHIBITS
Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).
| Exhibit No. | Description | |||||||
| 4a. | ||||||||
| 4b. | ||||||||
| 4c. | ||||||||
| 4d. | ||||||||
| 4e. | ||||||||
| 31a. | ||||||||
| 31b. | ||||||||
| 32a. | ||||||||
| 32b. | ||||||||
| 101.INS | XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |||||||
| 101.SCH | XBRL Taxonomy Extension Schema Document. | |||||||
| 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | |||||||
| 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. | |||||||
| 101.LAB | XBRL Taxonomy Extension Label Linkbase Document. | |||||||
| 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. | |||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | |||||||
* Indicates, in this Quarterly Report on Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; Atripla is a trademark of Gilead Sciences, LLC.; Byetta is a trademark of Amylin Pharmaceuticals, LLC; Cabometyx is a trademark of Exelixis, Inc.; Onglyza is a trademark of AstraZeneca AB; Keytruda is a trademark of Merck Sharp & Dohme Corp; Otezla is a trademark of Amgen Inc.; Tecentriq is a trademark of Genentech, Inc.; and Yescarta is a trademark of Kite Pharma, Inc. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.
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SUMMARY OF ABBREVIATED TERMS
Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as Bristol Myers Squibb, BMS, the Company, we, our or us in this Quarterly Report on Form 10-Q, unless the context otherwise indicates. Throughout this Quarterly Report on Form 10-Q we have used terms which are defined below:
| 2021 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2021 | LIBOR | London Interbank Offered Rate | ||||||||
| Agenus | Agenus Inc. | Lilly | Eli Lilly and Company | ||||||||
| AML | acute myeloid leukemia | LOE | loss of exclusivity | ||||||||
| Amylin | Amylin Pharmaceuticals, Inc. | MAA | marketing authorization application | ||||||||
| aNDA | abbreviated new drug application | MDL | multi-district litigation | ||||||||
| AstraZeneca | AstraZeneca PLC | MDS | myelodysplastic syndromes | ||||||||
| BLA | biologics license application | MPM | malignant pleural mesothelioma | ||||||||
| bluebird | bluebird bio, Inc. | MyoKardia | MyoKardia, Inc. | ||||||||
| CAR T | chimeric antigen receptor T-cell | NDA | new drug application | ||||||||
| Celgene | Celgene Corporation | NKT | natural killer T cells | ||||||||
| CERCLA | U.S. Comprehensive Environmental Response, Compensation and Liability Act | NSCLC | non-small cell lung cancer | ||||||||
| CHMP | Committee for Medicinal Products for Human Use | NVAF | non-valvular atrial fibrillation | ||||||||
| CML | chronic myeloid leukemia | OTC | over-the-counter | ||||||||
| CRC | Colorectal carcinoma | Otsuka | Otsuka Pharmaceutical Co., Ltd. | ||||||||
| CVR | contingent value rights | PD-1 | programmed cell death protein 1 | ||||||||
| EC | European Commission | PD-L1 | programmed death-ligand 1 | ||||||||
| Eisai | Eisai Co., Ltd. | PDUFA | The Prescription Drug User Fee Act | ||||||||
| EMA | European Medicines Agency | Pfizer | Pfizer, Inc. | ||||||||
| EPS | earnings per share | PsA | psoriatic arthritis | ||||||||
| ESCC | esophageal squamous cell carcinoma | Quarterly Report on Form 10-Q | Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022 | ||||||||
| EU | European Union | R&D | research and development | ||||||||
| FASB | Financial Accounting Standards Board | RA | rheumatoid arthritis | ||||||||
| FDA | U.S. Food and Drug Administration | RBC | red blood cell | ||||||||
| GAAP | U.S. generally accepted accounting principles | RCC | renal cell carcinoma | ||||||||
| GILTI | Global intangible low-taxed income | REMS | risk evaluation and mitigation strategy | ||||||||
| GTN | gross-to-net | Sanofi | Sanofi S.A. | ||||||||
| HCC | hepatocellular carcinoma | sBLA | supplemental Biologics License Application | ||||||||
| HCM | hypertrophic cardiomyopathy | SEC | Securities and Exchange Commission | ||||||||
| HIV | human immunodeficiency viruses | sNDA | supplemental new drug application | ||||||||
| IO | immuno-oncology | UC | ulcerative colitis | ||||||||
| IPRD | in-process research and development | U.S. | United States | ||||||||
| IRS | Internal Revenue Service | UK | United Kingdom | ||||||||
| JIA | juvenile idiopathic arthritis | VAT | value added tax | ||||||||
| Juno | Juno Therapeutics, Inc. | ||||||||||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BRISTOL-MYERS SQUIBB COMPANY (REGISTRANT) | |||||||||||
| Date: | April 29, 2022 | By: | /s/ Giovanni Caforio, M.D. | ||||||||
Giovanni Caforio, M.D. Chairman of the Board and Chief Executive Officer | |||||||||||
| Date: | April 29, 2022 | By: | /s/ David V. Elkins | ||||||||
David V. Elkins Chief Financial Officer | |||||||||||
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EXHIBIT 31a
CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Giovanni Caforio, certify that:
1.I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022;
2.Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3.Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
b.designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
a.all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.
Date: April 29, 2022
| /s/ Giovanni Caforio, M.D. | ||
Giovanni Caforio, M.D. Chairman of the Board and Chief Executive Officer | ||
EXHIBIT 31b
CERTIFICATION BY THE CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, David V. Elkins, certify that:
1.I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022;
2.Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3.Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
b.designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
a.all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.
Date: April 29, 2022
| /s/ David V. Elkins | ||
David V. Elkins Chief Financial Officer | ||
EXHIBIT 32a
Certification by the Chief Executive Officer Pursuant to 18 U. S. C. Section 1350, as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to 18 U.S.C. Section 1350, I, Giovanni Caforio, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 (the "Report"), as filed with the Securities and Exchange Commission on April 29, 2022, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.
| /s/ Giovanni Caforio, M.D. | ||
Giovanni Caforio, M.D. Chairman of the Board and Chief Executive Officer | ||
April 29, 2022
This written statement is being furnished to the Securities and Exchange Commission as an exhibit to the Report. A signed original of this written statement required by Section 906 has been provided to Bristol-Myers Squibb Company and will be retained by Bristol-Myers Squibb Company and furnished to the Securities and Exchange Commission or its staff upon request.
EXHIBIT 32b
Certification by the Chief Financial Officer Pursuant to 18 U. S. C. Section 1350, as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
Pursuant to 18 U.S.C. Section 1350, I, David V. Elkins, hereby certify that, to the best of my knowledge, Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 (the "Report"), as filed with the Securities and Exchange Commission on April 29, 2022, fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Bristol-Myers Squibb Company.
| /s/ David V. Elkins | ||
David V. Elkins Chief Financial Officer | ||
April 29, 2022
This written statement is being furnished to the Securities and Exchange Commission as an exhibit to the Report. A signed original of this written statement required by Section 906 has been provided to Bristol-Myers Squibb Company and will be retained by Bristol-Myers Squibb Company and furnished to the Securities and Exchange Commission or its staff upon request.