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(State or other jurisdiction of
incorporation or organization) |
(
I.R.S
Employer
Identification No.)
|
|||||||
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
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Large accelerated filer
☒
|
Accelerated filer
☐
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Non-accelerated filer
☐
|
Smaller reporting company
☐
|
Emerging growth company
☐
|
||||||||||||||||||||||
| PART I—FINANCIAL INFORMATION | |||||
| Item 1. | |||||
| Item 2. | |||||
| Item 3. | |||||
| Item 4. | |||||
| PART II—OTHER INFORMATION | |||||
| Item 1. | |||||
| Item 1A. | |||||
| Item 2. | |||||
| Item 5. | |||||
| Item 6. | |||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| EARNINGS | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Net product sales | $ |
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$ |
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$ |
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$ |
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|||||||||||||||
| Alliance and other revenues |
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|||||||||||||||||||
| Total Revenues |
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Cost of products sold
(a)
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| Marketing, selling and administrative |
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| Research and development |
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| Acquired IPRD |
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|||||||||||||||||||
| Amortization of acquired intangible assets |
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|||||||||||||||||||
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Other (income)/expense, net
|
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(
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(
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|||||||||||||||||||
| Total Expenses |
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|||||||||||||||||||
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Earnings/(loss) before income taxes
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(
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|||||||||||||||||||
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Income tax provision
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|||||||||||||||||||
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Net earnings/(loss)
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(
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|||||||||||||||||||
| Noncontrolling interest |
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|||||||||||||||||||
|
Net earnings/(loss) attributable to BMS
|
$ |
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$ |
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$ |
(
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$ |
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|||||||||||||||
|
Earnings/(Loss) per common share:
|
|||||||||||||||||||||||
| Basic | $ |
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$ |
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$ |
(
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$ |
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|||||||||||||||
| Diluted |
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(
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|||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
|
COMPREHENSIVE INCOME/(LOSS)
|
2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Net earnings/(loss)
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||
| Other comprehensive income/(loss), net of taxes and reclassifications to earnings: | |||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges |
(
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(
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|||||||||||||||||||
| Pension and postretirement benefits |
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(
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|||||||||||||||||||
| Marketable debt securities |
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(
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(
|
|||||||||||||||||||
| Foreign currency translation |
|
(
|
(
|
|
|||||||||||||||||||
| Total Other Comprehensive Income/(Loss) |
(
|
|
|
(
|
|||||||||||||||||||
|
Comprehensive income/(loss)
|
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|
(
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|||||||||||||||||||
| Comprehensive income attributable to noncontrolling interest |
|
|
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|
|||||||||||||||||||
|
Comprehensive income/(loss) attributable to BMS
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||
| ASSETS |
September 30,
2024 |
December 31,
2023 |
|||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ |
|
$ |
|
|||||||
| Marketable debt securities |
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|||||||||
| Receivables |
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|||||||||
| Inventories |
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|||||||||
| Other current assets |
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|||||||||
| Total Current assets |
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|||||||||
| Property, plant and equipment |
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|||||||||
| Goodwill |
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| Other intangible assets |
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|||||||||
| Deferred income taxes |
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|||||||||
|
Marketable debt securities
|
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|||||||||
| Other non-current assets |
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|||||||||
| Total Assets | $ |
|
$ |
|
|||||||
| LIABILITIES | |||||||||||
| Current liabilities: | |||||||||||
| Short-term debt obligations | $ |
|
$ |
|
|||||||
| Accounts payable |
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|||||||||
| Other current liabilities |
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|||||||||
| Total Current liabilities |
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|||||||||
| Deferred income taxes |
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|||||||||
| Long-term debt |
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|||||||||
| Other non-current liabilities |
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|||||||||
| Total Liabilities |
|
|
|||||||||
| Commitments and Contingencies |
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|
|||||||||
| EQUITY | |||||||||||
| BMS 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 BMS Shareholders’ Equity |
|
|
|||||||||
| Noncontrolling interest |
|
|
|||||||||
| Total Equity |
|
|
|||||||||
| Total Liabilities and Equity | $ |
|
$ |
|
|||||||
| Nine Months Ended September 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| Cash Flows From Operating Activities: | |||||||||||
|
Net (loss)/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 |
|
|
|||||||||
| Divestiture gains and royalties |
(
|
(
|
|||||||||
| Acquired IPRD |
|
|
|||||||||
|
Equity investment (gains)/losses
|
(
|
|
|||||||||
| 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 investments |
|
|
|||||||||
| Capital expenditures |
(
|
(
|
|||||||||
| Divestiture and other proceeds |
|
|
|||||||||
| Acquisition and other payments, net of cash acquired |
(
|
(
|
|||||||||
| Net cash used in investing activities |
(
|
(
|
|||||||||
| Cash Flows From Financing Activities: | |||||||||||
|
Proceeds from issuance of short-term debt obligations
|
|
|
|||||||||
|
Repayments of short-term debt obligations
|
(
|
|
|||||||||
|
Other short-term financing obligations, net
|
|
|
|||||||||
|
Proceeds from issuance of long-term debt
|
|
|
|||||||||
|
Repayments of long-term debt
|
(
|
(
|
|||||||||
| Repurchase of common stock |
|
(
|
|||||||||
| Dividends |
(
|
(
|
|||||||||
| Stock option proceeds and other, net |
(
|
|
|||||||||
|
Net cash provided by/(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 | $ |
|
$ |
|
|||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Net product sales | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Alliance revenues |
|
|
|
|
|||||||||||||||||||
|
Other revenues
|
|
|
|
|
|||||||||||||||||||
| Total Revenues | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Gross product sales | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
|
GTN adjustments
(a)
|
|||||||||||||||||||||||
| Charge-backs and cash discounts |
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Medicaid and Medicare rebates |
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Other rebates, returns, discounts and adjustments |
(
|
(
|
(
|
(
|
|||||||||||||||||||
|
Total GTN adjustments
(b)
|
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Net product sales | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Growth Portfolio
|
|||||||||||||||||||||||
| Opdivo | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Orencia |
|
|
|
|
|||||||||||||||||||
| Yervoy |
|
|
|
|
|||||||||||||||||||
| Reblozyl |
|
|
|
|
|||||||||||||||||||
| Opdualag |
|
|
|
|
|||||||||||||||||||
| Abecma |
|
|
|
|
|||||||||||||||||||
| Zeposia |
|
|
|
|
|||||||||||||||||||
| Breyanzi |
|
|
|
|
|||||||||||||||||||
| Camzyos |
|
|
|
|
|||||||||||||||||||
| Sotyktu |
|
|
|
|
|||||||||||||||||||
| Augtyro |
|
|
|
|
|||||||||||||||||||
| Krazati |
|
|
|
|
|||||||||||||||||||
|
Other Growth products
(a)
|
|
|
|
|
|||||||||||||||||||
|
Total Growth Portfolio
|
|
|
|
|
|||||||||||||||||||
|
Legacy Portfolio
|
|||||||||||||||||||||||
| Eliquis |
|
|
|
|
|||||||||||||||||||
| Revlimid |
|
|
|
|
|||||||||||||||||||
| Pomalyst/Imnovid |
|
|
|
|
|||||||||||||||||||
| Sprycel |
|
|
|
|
|||||||||||||||||||
| Abraxane |
|
|
|
|
|||||||||||||||||||
|
Other Legacy products
(b)
|
|
|
|
|
|||||||||||||||||||
|
Total Legacy Portfolio
|
|
|
|
|
|||||||||||||||||||
| Total Revenues | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| United States | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| International |
|
|
|
|
|||||||||||||||||||
|
Other
(c)
|
|
|
|
|
|||||||||||||||||||
| Total Revenues | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Revenues from alliances | |||||||||||||||||||||||
| Net product sales | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Alliance revenues |
|
|
|
|
|||||||||||||||||||
| Total alliance revenues | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| To/(from) alliance partners | |||||||||||||||||||||||
| Cost of products sold | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Marketing, selling and administrative |
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Research and development |
|
|
|
|
|||||||||||||||||||
| Acquired IPRD |
|
|
|
|
|||||||||||||||||||
| Other (income)/expense, net |
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
| Selected alliance balance sheet information | |||||||||||
| Receivables – from alliance partners | $ |
|
$ |
|
|||||||
| Accounts payable – to alliance partners |
|
|
|||||||||
|
Deferred income – from alliances
(a)
|
|
|
|||||||||
| Dollars in millions | |||||
| Cash consideration for outstanding shares | $ |
|
|||
| Cash consideration for equity awards |
|
||||
| Consideration to be paid |
|
||||
|
Less: Charge for unvested stock awards
(a)
|
(
|
||||
| Transaction costs |
|
||||
| Total consideration allocated | $ |
|
|||
| Cash and cash equivalents | $ |
|
|||
| Other assets |
|
||||
| Intangible assets |
|
||||
| Deferred income tax asset |
|
||||
| Deferred income tax liability |
(
|
||||
| Other liabilities |
(
|
||||
|
Total identifiable assets acquired, net
|
|
||||
| Acquired IPRD expense |
|
||||
|
Total consideration allocated
|
$ |
|
|||
| Dollars in millions | |||||
| Cash consideration for outstanding shares | $ |
|
|||
| Cash consideration for equity awards |
|
||||
| Consideration paid |
|
||||
|
Less: Unvested stock awards
(a)
|
(
|
||||
| Total consideration allocated | $ |
|
|||
| Dollars in millions |
Purchase Price Allocation
|
||||
| Cash and cash equivalents | $ |
|
|||
| Other assets |
|
||||
| Intangible assets |
|
||||
| Deferred income tax asset |
|
||||
| Deferred income tax liability |
(
|
||||
| Other liabilities |
(
|
||||
| Identifiable net assets acquired | $ |
|
|||
| Goodwill |
|
||||
| Total consideration allocated | $ |
|
|||
| Dollars in millions | |||||
| Cash consideration for outstanding shares | $ |
|
|||
| Cash consideration for equity awards |
|
||||
| Consideration paid |
|
||||
| Plus: Fair value of CVRs |
|
||||
|
Less: unvested stock awards
(a)
|
(
|
||||
| Total consideration allocated | $ |
|
|||
| Dollars in millions |
Purchase price allocation
|
||||
| Cash and cash equivalents | $ |
|
|||
| Inventories |
|
||||
| Other assets |
|
||||
| Intangible assets |
|
||||
| Deferred income tax assets |
|
||||
| Deferred income tax liabilities |
(
|
||||
| Other liabilities |
(
|
||||
| Identifiable net assets acquired | $ |
|
|||
| Goodwill |
|
||||
| Total consideration allocated | $ |
|
|||
| Three Months Ended September 30, | |||||||||||||||||||||||||||||||||||
| Net Proceeds | Divestiture (Gains)/Losses | Royalty Income | |||||||||||||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||||||||
|
Diabetes business - royalties
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
(
|
$ |
(
|
|||||||||||||||||||||||
| Mature products and other |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Total | $ |
|
$ |
|
$ |
|
$ |
|
$ |
(
|
$ |
(
|
|||||||||||||||||||||||
| Nine Months Ended September 30, | |||||||||||||||||||||||||||||||||||
| Net Proceeds | Divestiture (Gains)/Losses | Royalty Income | |||||||||||||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||||||||
|
Diabetes business - royalties
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
(
|
$ |
(
|
|||||||||||||||||||||||
| Mature products and other |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Total | $ |
|
$ |
|
$ |
|
$ |
|
$ |
(
|
$ |
(
|
|||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Keytruda
* royalties
|
$ |
(
|
$ |
(
|
$ |
(
|
$ |
(
|
|||||||||||||||
|
Tecentriq
* royalties
|
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Contingent milestone income |
(
|
|
(
|
(
|
|||||||||||||||||||
| Amortization of deferred income |
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Other royalties and licensing income |
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Royalty and licensing income | $ |
(
|
$ |
(
|
$ |
(
|
$ |
(
|
|||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Interest expense (Note 10) | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Royalty and licensing income (Note 4) |
(
|
(
|
(
|
(
|
|||||||||||||||||||
|
Royalty income - divestiture (Note 4)
|
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Investment income |
(
|
(
|
(
|
(
|
|||||||||||||||||||
|
Litigation and other settlements
(a)
|
|
(
|
|
(
|
|||||||||||||||||||
| Provision for restructuring (Note 6) |
|
|
|
|
|||||||||||||||||||
| Integration expenses (Note 6) |
|
|
|
|
|||||||||||||||||||
|
Equity investment (gains)/losses (Note 9)
|
(
|
|
(
|
|
|||||||||||||||||||
|
Acquisition expense (Note 4)
|
|
|
|
|
|||||||||||||||||||
|
Intangible asset impairment
|
|
|
|
|
|||||||||||||||||||
|
Other
(b)
|
|
(
|
|
|
|||||||||||||||||||
|
Other (income)/expense, net
|
$ |
|
$ |
(
|
$ |
|
$ |
(
|
|||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| 2023 Restructuring Plan | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Celgene and Other Acquisition Plans |
|
|
|
|
|||||||||||||||||||
| Total charges | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Employee termination costs | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Other termination costs |
|
|
|
|
|||||||||||||||||||
| Provision for restructuring |
|
|
|
|
|||||||||||||||||||
| Integration expenses |
|
|
|
|
|||||||||||||||||||
| Accelerated depreciation |
|
|
|
|
|||||||||||||||||||
|
Asset impairments
(a)
|
|
|
|
|
|||||||||||||||||||
|
Other shutdown costs
|
|
|
|
|
|||||||||||||||||||
| Total charges | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Cost of products sold | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Marketing, selling and administrative |
|
|
|
|
|||||||||||||||||||
| Research and development |
|
|
|
|
|||||||||||||||||||
| Other (income)/expense, net |
|
|
|
|
|||||||||||||||||||
| Total charges | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Nine Months Ended September 30, | |||||||||||
| Dollars in millions | 2024 | 2023 | |||||||||
| Beginning balance | $ |
|
$ |
|
|||||||
| Provision for restructuring |
|
|
|||||||||
| Foreign currency translation and other |
|
(
|
|||||||||
| Payments |
(
|
(
|
|||||||||
| Ending balance | $ |
|
$ |
|
|||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Earnings/(Loss) before income taxes
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||
|
Income tax provision
|
|
|
|
|
|||||||||||||||||||
| Effective tax rate |
|
% |
|
% |
(
|
% |
|
% | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions, except per share data | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Net earnings/(loss) attributable to BMS
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||
| Weighted-average common shares outstanding – basic |
|
|
|
|
|||||||||||||||||||
| Incremental shares attributable to share-based compensation plans |
|
|
|
|
|||||||||||||||||||
| Weighted-average common shares outstanding – diluted |
|
|
|
|
|||||||||||||||||||
|
Earnings/(loss) per common share
|
|||||||||||||||||||||||
| Basic | $ |
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||
| Diluted |
|
|
(
|
|
|||||||||||||||||||
| September 30, 2024 | December 31, 2023 | ||||||||||||||||||||||||||||||||||
| 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 |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| U.S. Treasury securities |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Derivative assets |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Equity investments |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Derivative liabilities |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Contingent consideration liability | |||||||||||||||||||||||||||||||||||
|
Contingent value rights
(a)
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Other acquisition related contingent consideration |
|
|
|
|
|
|
|||||||||||||||||||||||||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
|
Equity investments with RDFV
|
$ |
|
$ |
|
|||||||
|
Equity investments without RDFV
|
|
|
|||||||||
| Limited partnerships and other equity method investments |
|
|
|||||||||
| Total equity investments | $ |
|
$ |
|
|||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Equity investments with RDFV
|
|||||||||||||||||||||||
|
Net (gain)/loss recognized
|
$ |
(
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||
|
Less: net (gain)/loss recognized on investments sold
|
(
|
(
|
(
|
|
|||||||||||||||||||
|
Net unrealized (gain)/loss recognized on investments still held
|
(
|
|
(
|
|
|||||||||||||||||||
|
Equity investments without RDFV
|
|||||||||||||||||||||||
|
Upward adjustments
|
(
|
(
|
(
|
(
|
|||||||||||||||||||
|
Net realized (gain)/loss recognized on investments sold
|
|
|
(
|
|
|||||||||||||||||||
|
Impairments and downward adjustments
|
|
|
|
|
|||||||||||||||||||
| Limited partnerships and other equity method investments | |||||||||||||||||||||||
|
Equity in net loss/(income) of affiliates
|
|
(
|
(
|
|
|||||||||||||||||||
|
Total equity investment (gains)/losses
|
$ |
(
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||
| September 30, 2024 |
December 31, 2023
|
||||||||||||||||||||||||||||||||||||||||||||||
|
Asset
(a)
|
Liability
(b)
|
Asset
(a)
|
Liability
(b)
|
||||||||||||||||||||||||||||||||||||||||||||
| Dollars in millions | Notional | Fair Value | Notional | Fair Value | Notional | Fair Value | Notional | Fair Value | |||||||||||||||||||||||||||||||||||||||
| Designated as cash flow hedges | |||||||||||||||||||||||||||||||||||||||||||||||
|
Foreign currency exchange contracts
|
$ |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
$ |
|
$ |
|
$ |
(
|
|||||||||||||||||||||||||||||||
| Cross-currency swap contracts |
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||
| Designated as net investment hedges | |||||||||||||||||||||||||||||||||||||||||||||||
|
Foreign currency exchange contracts
|
|
|
|
(
|
|
|
|
(
|
|||||||||||||||||||||||||||||||||||||||
| Cross-currency swap contracts |
|
|
|
(
|
|
|
|
(
|
|||||||||||||||||||||||||||||||||||||||
| Designated as fair value hedges | |||||||||||||||||||||||||||||||||||||||||||||||
| Interest rate swap contracts |
|
|
|
(
|
|
|
|
(
|
|||||||||||||||||||||||||||||||||||||||
| Not designated as hedges | |||||||||||||||||||||||||||||||||||||||||||||||
| Foreign currency exchange contracts |
|
|
|
(
|
|
|
|
(
|
|||||||||||||||||||||||||||||||||||||||
|
Total return swap contracts
(c)
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | |||||||||||||||||||||||||
| Dollars in millions | Cost of products sold | Other (income)/expense, net | Cost of products sold | Other (income)/expense, net | ||||||||||||||||||||||
| Foreign currency exchange contracts | $ |
(
|
$ |
|
$ |
(
|
$ |
(
|
||||||||||||||||||
| Cross-currency swap contracts |
|
(
|
|
(
|
||||||||||||||||||||||
| Interest rate swap contracts |
|
|
|
|
||||||||||||||||||||||
|
Forward interest rate contracts
|
|
(
|
|
(
|
||||||||||||||||||||||
| Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2023 | ||||||||||||||||||||||
| Dollars in millions | Cost of products sold | Other (income)/expense, net | Cost of products sold | Other (income)/expense, net | |||||||||||||||||||
| Foreign currency exchange contracts | $ |
(
|
$ |
(
|
$ |
(
|
$ |
(
|
|||||||||||||||
| Cross-currency swap contracts |
|
|
|
(
|
|||||||||||||||||||
| Interest rate swap contracts |
|
|
|
(
|
|||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Derivatives designated as cash flow hedges | |||||||||||||||||||||||
| Foreign exchange contracts gain/(loss): | |||||||||||||||||||||||
|
Recognized in Other comprehensive (loss)/income
|
$ |
(
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Reclassified to Cost of products sold |
(
|
(
|
(
|
(
|
|||||||||||||||||||
| Cross-currency swap contracts gain/(loss): | |||||||||||||||||||||||
|
Recognized in Other comprehensive (loss)/income
|
|
(
|
|
|
|||||||||||||||||||
| Reclassified to Other (income)/expense, net |
(
|
|
(
|
|
|||||||||||||||||||
|
Forward interest rate contract gain/(loss):
|
|||||||||||||||||||||||
|
Recognized in Other comprehensive (loss)/income
|
|
|
|
|
|||||||||||||||||||
| Reclassified to Other (income)/expense, net |
(
|
|
(
|
|
|||||||||||||||||||
| Derivatives designated as net investment hedges | |||||||||||||||||||||||
| Cross-currency swap contracts gain/(loss): | |||||||||||||||||||||||
|
Recognized in Other comprehensive (loss)/income
|
(
|
|
|
|
|||||||||||||||||||
| Foreign exchange contracts gain/(loss): | |||||||||||||||||||||||
|
Recognized in Other comprehensive (loss)/income
|
(
|
|
(
|
|
|||||||||||||||||||
| Non-derivatives designated as net investment hedges | |||||||||||||||||||||||
|
Non-U.S. dollar borrowings gain/(loss):
|
|||||||||||||||||||||||
|
Recognized in Other comprehensive (loss)/income
|
|
|
|
(
|
|||||||||||||||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
|
Non-U.S. short-term financing obligations
|
$ |
|
$ |
|
|||||||
| Current portion of Long-term debt |
|
|
|||||||||
| Other |
|
|
|||||||||
|
Short-term debt obligations
|
$ |
|
$ |
|
|||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
| 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 | $ |
|
$ |
|
|||||||
|
Principal Amount
(in millions)
|
||||||||
|
Floating rate notes due 2026
(a)
|
$ |
|
||||||
|
|
|
|||||||
|
|
|
|||||||
|
|
|
|||||||
|
|
|
|||||||
|
|
|
|||||||
|
|
|
|||||||
|
|
|
|||||||
|
|
|
|||||||
| Total | $ |
|
||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
| Trade receivables | $ |
|
$ |
|
|||||||
| Less: charge-backs and cash discounts |
(
|
(
|
|||||||||
| Less: allowance for expected credit loss |
(
|
(
|
|||||||||
| Net trade receivables |
|
|
|||||||||
| Alliance, royalties, VAT and other |
|
|
|||||||||
| Receivables | $ |
|
$ |
|
|||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
| Finished goods | $ |
|
$ |
|
|||||||
| Work in process |
|
|
|||||||||
| Raw and packaging materials |
|
|
|||||||||
| Total inventories | $ |
|
$ |
|
|||||||
| Inventories | $ |
|
$ |
|
|||||||
| Other non-current assets |
|
|
|||||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
| Land | $ |
|
$ |
|
|||||||
| Buildings |
|
|
|||||||||
| Machinery, equipment and fixtures |
|
|
|||||||||
| Construction in progress |
|
|
|||||||||
| Gross property, plant and equipment |
|
|
|||||||||
| Less accumulated depreciation |
(
|
(
|
|||||||||
| Property, plant and equipment | $ |
|
$ |
|
|||||||
| Dollars in millions | |||||||||||
| Balance at December 31, 2023 | $ |
|
|||||||||
|
Acquisitions (Note 4)
|
|
||||||||||
| Currency translation and other adjustments |
|
||||||||||
|
Balance at September 30, 2024
|
$ |
|
|||||||||
|
Estimated
Useful Lives |
September 30, 2024 | December 31, 2023 | |||||||||||||||||||||||||||||||||||||||
|
Dollars in millions
|
Gross carrying amounts | Accumulated amortization | Other intangible assets, net | Gross carrying amounts | Accumulated amortization | Other intangible assets, net | |||||||||||||||||||||||||||||||||||
|
R&D technology
(a)
|
|
$ |
|
$ |
(
|
$ |
|
$ |
|
$ |
|
$ |
|
||||||||||||||||||||||||||||
|
Acquired marketed product rights
(a)
|
|
|
(
|
|
|
(
|
|
||||||||||||||||||||||||||||||||||
| Capitalized software |
|
|
(
|
|
|
(
|
|
||||||||||||||||||||||||||||||||||
|
IPRD
(a)
|
|
— |
|
|
— |
|
|||||||||||||||||||||||||||||||||||
| Total | $ |
|
$ |
(
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
|
Cost of goods sold
|
$ |
|
$ |
|
$ |
|
(a) | $ |
|
||||||||||||||
|
Research and development
|
|
|
|
(b) |
|
||||||||||||||||||
|
Other income/(expense)
|
|
|
|
|
|||||||||||||||||||
|
Total
|
$ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Dollars in millions |
September 30,
2024 |
December 31, 2023 | |||||||||
| Income taxes | $ |
|
$ |
|
|||||||
| Research and development |
|
|
|||||||||
| Contract assets |
|
|
|||||||||
|
Restricted cash
(a)
|
|
|
|||||||||
| Other |
|
|
|||||||||
| Other current assets | $ |
|
$ |
|
|||||||
| Dollars in millions |
September 30,
2024 |
December 31, 2023 | |||||||||
| Equity investments (Note 9) | $ |
|
$ |
|
|||||||
| Operating leases |
|
|
|||||||||
|
Inventories (Note 12)
|
|
|
|||||||||
| Pension and postretirement |
|
|
|||||||||
| Research and development |
|
|
|||||||||
|
Restricted cash
(a)
|
|
|
|||||||||
|
Receivables and convertible notes
|
|
|
|||||||||
| Other |
|
|
|||||||||
| Other non-current assets | $ |
|
$ |
|
|||||||
| Dollars in millions |
September 30,
2024 |
December 31, 2023 | |||||||||
| Rebates and discounts | $ |
|
$ |
|
|||||||
| Income taxes |
|
|
|||||||||
| Employee compensation and benefits |
|
|
|||||||||
| Research and development |
|
|
|||||||||
| Dividends |
|
|
|||||||||
| Interest |
|
|
|||||||||
| Royalties |
|
|
|||||||||
| Operating leases |
|
|
|||||||||
| Other |
|
|
|||||||||
| Other current liabilities | $ |
|
$ |
|
|||||||
| Dollars in millions |
September 30,
2024 |
December 31, 2023 | |||||||||
| Income taxes | $ |
|
$ |
|
|||||||
| Pension and postretirement |
|
|
|||||||||
| Operating leases |
|
|
|||||||||
| Deferred income |
|
|
|||||||||
| Deferred compensation |
|
|
|||||||||
|
Contingent value rights (Note 9)
|
|
|
|||||||||
| Other |
|
|
|||||||||
| Other non-current liabilities | $ |
|
$ |
|
|||||||
| 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, 2023 |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
|
Net (loss)/earnings
|
— | — | — | — |
(
|
— | — |
|
|||||||||||||||||||||||||||||||||||||||
|
Other comprehensive income/(loss)
|
— | — | — |
|
— | — | — | — | |||||||||||||||||||||||||||||||||||||||
|
Cash dividends declared $
|
— | — | — | — |
(
|
— | — | — | |||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — |
(
|
— | — |
(
|
|
— | |||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2024 |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
| Net earnings | — | — | — | — |
|
— | — |
|
|||||||||||||||||||||||||||||||||||||||
|
Other comprehensive income/(loss)
|
— | — | — |
(
|
— | — | — | — | |||||||||||||||||||||||||||||||||||||||
|
Cash dividends declared $
|
— | — | — | — |
(
|
— | — | — | |||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — |
|
— | — |
|
|
— | |||||||||||||||||||||||||||||||||||||||
| Distributions | — | — | — | — | — | — | — |
(
|
|||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
|
Net earnings
|
— | — | — | — |
|
— | — |
|
|||||||||||||||||||||||||||||||||||||||
|
Other comprehensive income/(loss)
|
— | — | — |
(
|
— | — | — | — | |||||||||||||||||||||||||||||||||||||||
|
Cash dividends declared $
|
— | — | — | — |
(
|
— | — | — | |||||||||||||||||||||||||||||||||||||||
| Stock repurchase program | — | — |
|
— | — |
|
|
— | |||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — |
|
— | — |
(
|
|
— | |||||||||||||||||||||||||||||||||||||||
|
Balance at September 30, 2024
|
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
| 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, 2022 |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
| Net earnings | — | — | — | — |
|
— | — |
|
|||||||||||||||||||||||||||||||||||||||
|
Other comprehensive income/(loss)
|
— | — | — |
(
|
— | — | — | — | |||||||||||||||||||||||||||||||||||||||
|
Cash dividends declared $
|
— | — | — | — |
(
|
— | — | — | |||||||||||||||||||||||||||||||||||||||
| Share repurchase program | — | — | — | — | — |
|
(
|
— | |||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — |
(
|
— | — |
(
|
|
— | |||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2023 |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
| Net earnings | — | — | — | — |
|
— | — |
|
|||||||||||||||||||||||||||||||||||||||
|
Other comprehensive income/(loss)
|
— | — | — |
(
|
— | — | — | — | |||||||||||||||||||||||||||||||||||||||
|
Cash dividends declared $
|
— | — | — | — |
(
|
— | — | — | |||||||||||||||||||||||||||||||||||||||
|
Share repurchase program
|
— | — | — | — | — |
|
(
|
— | |||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — |
|
— | — |
(
|
|
— | |||||||||||||||||||||||||||||||||||||||
| Distributions | — | — | — | — | — | — | — |
(
|
|||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2023 |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
|
Net earnings
|
— | — | — | — |
|
— | — |
|
|||||||||||||||||||||||||||||||||||||||
|
Other comprehensive income/(loss)
|
— | — | — |
|
— | — | — | — | |||||||||||||||||||||||||||||||||||||||
|
Cash dividends declared $
|
— | — | — | — |
(
|
— | — | — | |||||||||||||||||||||||||||||||||||||||
|
Share repurchase program
|
— | — |
(
|
— | — |
|
(
|
— | |||||||||||||||||||||||||||||||||||||||
| Stock compensation | — | — |
|
— | — |
(
|
|
— | |||||||||||||||||||||||||||||||||||||||
|
Convertible debt
|
— | — |
|
— | — | — |
|
— | |||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2023 |
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|
$ |
(
|
$ |
|
|||||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | ||||||||||||||||||||||||||||||||||
| Dollars in millions | Pretax | Tax | After Tax | Pretax | Tax | After Tax | |||||||||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges | |||||||||||||||||||||||||||||||||||
|
Recognized in other comprehensive income/(loss)
|
$ |
(
|
$ |
|
$ |
(
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||||||||||
|
Reclassified to net earnings
(a)
|
(
|
|
(
|
(
|
|
(
|
|||||||||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges |
(
|
|
(
|
|
(
|
|
|||||||||||||||||||||||||||||
| Pension and postretirement benefits | |||||||||||||||||||||||||||||||||||
| Actuarial gains/(losses) |
|
|
|
(
|
|
(
|
|||||||||||||||||||||||||||||
|
Amortization
(b)
|
|
(
|
|
|
(
|
|
|||||||||||||||||||||||||||||
|
Settlements
(b)
|
|
(
|
|
|
(
|
|
|||||||||||||||||||||||||||||
| Pension and postretirement benefits |
|
(
|
|
|
|
|
|||||||||||||||||||||||||||||
|
Marketable debt securities
|
|||||||||||||||||||||||||||||||||||
|
Unrealized gains/(losses)
|
|
(
|
|
|
(
|
|
|||||||||||||||||||||||||||||
| Foreign currency translation |
|
|
|
(
|
|
(
|
|||||||||||||||||||||||||||||
| Other comprehensive income/(loss) | $ |
(
|
$ |
|
$ |
(
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||||||||||
|
Three Months Ended September 30, 2023
|
Nine Months Ended September 30, 2023 | ||||||||||||||||||||||||||||||||||
| Dollars in millions | Pretax | Tax | After Tax | Pretax | Tax | After Tax | |||||||||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges | |||||||||||||||||||||||||||||||||||
|
Recognized in other comprehensive income/(loss)
|
$ |
|
$ |
(
|
$ |
|
$ |
|
$ |
(
|
$ |
|
|||||||||||||||||||||||
|
Reclassified to net earnings
(a)
|
(
|
(
|
(
|
(
|
|
(
|
|||||||||||||||||||||||||||||
| Derivatives qualifying as cash flow hedges |
|
(
|
|
(
|
(
|
(
|
|||||||||||||||||||||||||||||
| Pension and postretirement benefits | |||||||||||||||||||||||||||||||||||
| Actuarial gains/(losses) |
|
(
|
|
(
|
|
(
|
|||||||||||||||||||||||||||||
|
Marketable debt securities
|
|||||||||||||||||||||||||||||||||||
| Unrealized gains/(losses) |
(
|
|
(
|
(
|
|
(
|
|||||||||||||||||||||||||||||
| Foreign currency translation |
|
(
|
(
|
|
(
|
|
|||||||||||||||||||||||||||||
| Other comprehensive income/(loss) | $ |
|
$ |
(
|
$ |
|
$ |
|
$ |
(
|
$ |
(
|
|||||||||||||||||||||||
| Dollars in millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
| Derivatives qualifying as cash flow hedges | $ |
|
$ |
|
|||||||
| Pension and postretirement benefits |
(
|
(
|
|||||||||
| Marketable debt securities |
|
|
|||||||||
|
Foreign currency translation
(a)
|
(
|
(
|
|||||||||
| Accumulated other comprehensive loss | $ |
(
|
$ |
(
|
|||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Cost of products sold | $ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Marketing, selling and administrative |
|
|
|
|
|||||||||||||||||||
| Research and development |
|
|
|
|
|||||||||||||||||||
|
Total stock-based compensation expense
|
$ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
|
Income tax benefit
(a)
|
$ |
|
$ |
|
$ |
|
$ |
|
|||||||||||||||
| Units in millions | Units | Weighted-Average Fair Value | |||||||||
| Restricted stock units |
|
$ |
|
||||||||
| Market share units |
|
$ |
|
||||||||
| Performance share units |
|
$ |
|
||||||||
| Dollars in millions | Restricted Stock Units | Market Share Units | Performance Share Units | ||||||||||||||||||||
| Unrecognized compensation cost | $ |
|
$ |
|
$ |
|
|||||||||||||||||
| Expected weighted-average period in years of compensation cost to be recognized |
|
|
|
||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions, except per share data | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Total Revenues | $ | 11,892 | $ | 10,966 | $ | 35,958 | $ | 33,529 | |||||||||||||||
|
Diluted earnings/(loss) per share
|
|||||||||||||||||||||||
| GAAP | $ | 0.60 | $ | 0.93 | $ | (4.45) | $ | 2.99 | |||||||||||||||
| Non-GAAP | 1.80 | 2.00 | (0.53) | 5.80 | |||||||||||||||||||
| Product | Date | Approval | ||||||
|
Opdivo
|
October 2024
|
FDA approval of
Opdivo
for the treatment of adult patients with resectable (tumors ≥ 4 cm or node positive) NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent
Opdivo
as adjuvant treatment after surgery.
|
||||||
|
Cobenfy
(KarXT; xanomeline and trospium chloride)
|
September 2024
|
FDA approval of
Cobenfy
for the treatment of schizophrenia in adults.
|
||||||
|
Augtyro
|
September 2024
|
Japan's Ministry of Health, Labour and Welfare approval of
Augtyro
for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC.
|
||||||
|
Breyanzi
|
August 2024
|
Japan's Ministry of Health, Labour and Welfare approval of
Breyanzi
for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy.
|
||||||
| Krazati |
June 2024
|
FDA accelerated approval for
Krazati
in combination with cetuximab as a targeted treatment option for adult patients with KRAS
G12C
-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
|
||||||
| Augtyro |
June 2024
|
FDA accelerated approval of
Augtyro
for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
|
||||||
| Opdivo |
May 2024
|
EC approval of
Opdivo
in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
|
||||||
|
Breyanzi
|
May 2024
|
FDA approval of
Breyanzi
for the treatment of adult patients with relapsed or refractory MCL who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
|
||||||
|
Breyanzi
|
May 2024
|
FDA accelerated approval of
Breyanzi
for the treatment of adult patients with relapsed or refractory FL who have received at least two prior lines of systemic therapy.
|
||||||
| Abecma | April 2024 |
FDA approval of
Abecma
for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
|
||||||
| Reblozyl |
April 2024
|
EC expanded approval of
Reblozyl
to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS.
|
||||||
|
Abecma
|
March 2024
|
EC approval of
Abecma
for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
|
||||||
|
Breyanzi
|
March 2024
|
FDA accelerated approval of
Breyanzi
for the treatment of adult patients with relapsed or refractory CLL or SLL who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
|
||||||
| Opdivo |
March 2024
|
FDA approval of
Opdivo
, in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
|
||||||
|
Reblozyl
|
January 2024
|
Japan's Ministry of Health, Labour and Welfare approval of
Reblozyl
for the treatment of anemia associated with myelodysplastic syndrome.
|
||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | % Change |
Foreign Exchange
(b)
|
2024 | 2023 | % Change |
Foreign Exchange
(b)
|
|||||||||||||||||||||||||||||||||||||||
| United States | $ | 8,232 | $ | 7,542 | 9 | % | — | % | $ | 25,509 | $ | 23,298 | 9 | % | — | % | |||||||||||||||||||||||||||||||
|
International
|
3,389 | 3,239 | 5 | % | (4) | % | 9,803 | 9,716 | 1 | % | (5) | % | |||||||||||||||||||||||||||||||||||
|
Other
(a)
|
271 | 185 | 46 | % | N/A | 646 | 515 | 25 | % | N/A | |||||||||||||||||||||||||||||||||||||
| Total | $ | 11,892 | $ | 10,966 | 8 | % | (2) | % | $ | 35,958 | $ | 33,529 | 7 | % | (2) | % | |||||||||||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | % Change | 2024 | 2023 | % Change | |||||||||||||||||||||||||||||
| Gross product sales | $ | 21,223 | $ | 18,648 | 14 | % | $ | 61,298 | $ | 54,047 | 13 | % | |||||||||||||||||||||||
| GTN adjustments | |||||||||||||||||||||||||||||||||||
| Charge-backs and cash discounts | (2,967) | (2,373) | 25 | % | (8,366) | (6,743) | 24 | % | |||||||||||||||||||||||||||
| Medicaid and Medicare rebates | (4,577) | (3,730) | 23 | % | (11,525) | (9,355) | 23 | % | |||||||||||||||||||||||||||
| Other rebates, returns, discounts and adjustments | (2,196) | (1,900) | 16 | % | (6,440) | (5,339) | 21 | % | |||||||||||||||||||||||||||
| Total GTN adjustments | (9,740) | (8,003) | 22 | % | (26,331) | (21,437) | 23 | % | |||||||||||||||||||||||||||
| Net product sales | $ | 11,483 | $ | 10,645 | 8 | % | $ | 34,967 | $ | 32,610 | 7 | % | |||||||||||||||||||||||
| GTN adjustments percentage | 46 | % | 43 | % | 3 | % | 43 | % | 40 | % | 3 | % | |||||||||||||||||||||||
| U.S. | 52 | % | 49 | % | 3 | % | 48 | % | 45 | % | 3 | % | |||||||||||||||||||||||
| Non-U.S. | 20 | % | 20 | % | — | % | 20 | % | 20 | % | — | % | |||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | % Change | 2024 | 2023 | % Change | |||||||||||||||||||||||||||||
|
Growth Portfolio
|
|||||||||||||||||||||||||||||||||||
| Opdivo | $ | 2,360 | $ | 2,275 | 4 | % | $ | 6,825 | $ | 6,622 | 3 | % | |||||||||||||||||||||||
| U.S. | 1,366 | 1,343 | 2 | % | 3,927 | 3,845 | 2 | % | |||||||||||||||||||||||||||
| Non-U.S. | 994 | 932 | 7 | % | 2,898 | 2,777 | 4 | % | |||||||||||||||||||||||||||
| Orencia | 936 | 925 | 1 | % | 2,682 | 2,616 | 3 | % | |||||||||||||||||||||||||||
| U.S. | 706 | 708 | — | % | 2,020 | 1,954 | 3 | % | |||||||||||||||||||||||||||
| Non-U.S. | 230 | 217 | 6 | % | 662 | 662 | — | % | |||||||||||||||||||||||||||
| Yervoy | 642 | 579 | 11 | % | 1,855 | 1,672 | 11 | % | |||||||||||||||||||||||||||
| U.S. | 399 | 359 | 11 | % | 1,171 | 1,039 | 13 | % | |||||||||||||||||||||||||||
| Non-U.S. | 243 | 220 | 10 | % | 684 | 633 | 8 | % | |||||||||||||||||||||||||||
| Reblozyl | 447 | 248 | 80 | % | 1,226 | 688 | 78 | % | |||||||||||||||||||||||||||
| U.S. | 358 | 200 | 79 | % | 999 | 534 | 87 | % | |||||||||||||||||||||||||||
| Non-U.S. | 89 | 48 | 85 | % | 227 | 154 | 47 | % | |||||||||||||||||||||||||||
| Opdualag | 233 | 166 | 40 | % | 674 | 437 | 54 | % | |||||||||||||||||||||||||||
| U.S. | 216 | 162 | 33 | % | 637 | 429 | 48 | % | |||||||||||||||||||||||||||
| Non-U.S. | 17 | 4 | >200% | 37 | 8 | >200% | |||||||||||||||||||||||||||||
| Abecma | 124 | 93 | 33 | % | 301 | 372 | (19) | % | |||||||||||||||||||||||||||
| U.S. | 77 | 69 | 12 | % | 183 | 302 | (39) | % | |||||||||||||||||||||||||||
| Non-U.S. | 47 | 24 | 96 | % | 118 | 70 | 69 | % | |||||||||||||||||||||||||||
| Zeposia | 147 | 123 | 20 | % | 408 | 301 | 36 | % | |||||||||||||||||||||||||||
| U.S. | 105 | 95 | 11 | % | 288 | 219 | 32 | % | |||||||||||||||||||||||||||
| Non-U.S. | 42 | 28 | 50 | % | 120 | 82 | 46 | % | |||||||||||||||||||||||||||
| Breyanzi | 224 | 92 | 143 | % | 484 | 263 | 84 | % | |||||||||||||||||||||||||||
| U.S. | 173 | 77 | 125 | % | 382 | 218 | 75 | % | |||||||||||||||||||||||||||
| Non-U.S. | 51 | 15 | >200% | 102 | 45 | 127 | % | ||||||||||||||||||||||||||||
| Camzyos | 156 | 68 | 129 | % | 379 | 143 | 165 | % | |||||||||||||||||||||||||||
| U.S. | 135 | 67 | 101 | % | 342 | 142 | 141 | % | |||||||||||||||||||||||||||
| Non-U.S. | 21 | 1 | >200% | 37 | 1 | >200% | |||||||||||||||||||||||||||||
| Sotyktu | 66 | 66 | — | % | 163 | 107 | 52 | % | |||||||||||||||||||||||||||
| U.S. | 51 | 62 | (18) | % | 126 | 101 | 25 | % | |||||||||||||||||||||||||||
| Non-U.S. | 15 | 4 | >200% | 37 | 6 | >200% | |||||||||||||||||||||||||||||
| Augtyro | 10 | — | N/A | 23 | — | N/A | |||||||||||||||||||||||||||||
| U.S. | 10 | — | N/A | 23 | — | N/A | |||||||||||||||||||||||||||||
| Non-U.S. | — | — | N/A | — | — | N/A | |||||||||||||||||||||||||||||
| Krazati | 34 | — | N/A | 87 | — | N/A | |||||||||||||||||||||||||||||
| U.S. | 32 | — | N/A | 82 | — | N/A | |||||||||||||||||||||||||||||
| Non-U.S. | 2 | — | N/A | 5 | — | N/A | |||||||||||||||||||||||||||||
|
Other Growth Products
(a)
|
433 | 311 | 39 | % | 1,093 | 886 | 23 | % | |||||||||||||||||||||||||||
| U.S. | 172 | 149 | 15 | % | 488 | 455 | 7 | % | |||||||||||||||||||||||||||
| Non-U.S. | 261 | 162 | 61 | % | 605 | 431 | 40 | % | |||||||||||||||||||||||||||
|
Total Growth Portfolio
|
$ | 5,812 | $ | 4,946 | 18 | % | $ | 16,200 | $ | 14,107 | 15 | % | |||||||||||||||||||||||
| U.S. | 3,800 | 3,291 | 15 | % | 10,668 | 9,238 | 15 | % | |||||||||||||||||||||||||||
| Non-U.S. | 2,012 | 1,655 | 22 | % | 5,532 | 4,869 | 14 | % | |||||||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | % Change | 2024 | 2023 | % Change | |||||||||||||||||||||||||||||
|
Legacy Portfolio
|
|||||||||||||||||||||||||||||||||||
| Eliquis | $ | 3,002 | $ | 2,705 | 11 | % | $ | 10,138 | $ | 9,332 | 9 | % | |||||||||||||||||||||||
| U.S. | 2,045 | 1,772 | 15 | % | 7,410 | 6,610 | 12 | % | |||||||||||||||||||||||||||
| Non-U.S. | 957 | 933 | 3 | % | 2,728 | 2,722 | — | % | |||||||||||||||||||||||||||
| Revlimid | 1,412 | 1,429 | (1) | % | 4,434 | 4,647 | (5) | % | |||||||||||||||||||||||||||
| U.S. | 1,212 | 1,209 | — | % | 3,830 | 3,951 | (3) | % | |||||||||||||||||||||||||||
| Non-U.S. | 200 | 220 | (9) | % | 604 | 696 | (13) | % | |||||||||||||||||||||||||||
| Pomalyst/Imnovid | 898 | 872 | 3 | % | 2,722 | 2,551 | 7 | % | |||||||||||||||||||||||||||
| U.S. | 697 | 606 | 15 | % | 2,010 | 1,712 | 17 | % | |||||||||||||||||||||||||||
| Non-U.S. | 201 | 266 | (24) | % | 712 | 839 | (15) | % | |||||||||||||||||||||||||||
| Sprycel | 290 | 517 | (44) | % | 1,088 | 1,404 | (23) | % | |||||||||||||||||||||||||||
| U.S. | 225 | 399 | (44) | % | 848 | 1,011 | (16) | % | |||||||||||||||||||||||||||
| Non-U.S. | 65 | 118 | (45) | % | 240 | 393 | (39) | % | |||||||||||||||||||||||||||
| Abraxane | 253 | 260 | (3) | % | 701 | 757 | (7) | % | |||||||||||||||||||||||||||
| U.S. | 151 | 178 | (15) | % | 450 | 526 | (14) | % | |||||||||||||||||||||||||||
| Non-U.S. | 102 | 82 | 24 | % | 251 | 231 | 9 | % | |||||||||||||||||||||||||||
|
Other Legacy Products
(b)
|
225 | 237 | (5) | % | 675 | 731 | (8) | % | |||||||||||||||||||||||||||
| U.S. | 102 | 87 | 17 | % | 293 | 250 | 17 | % | |||||||||||||||||||||||||||
| Non-U.S. | 123 | 150 | (18) | % | 382 | 481 | (21) | % | |||||||||||||||||||||||||||
|
Total Legacy Portfolio
|
$ | 6,080 | $ | 6,020 | 1 | % | $ | 19,758 | $ | 19,422 | 2 | % | |||||||||||||||||||||||
| U.S. | 4,432 | 4,251 | 4 | % | 14,841 | 14,060 | 6 | % | |||||||||||||||||||||||||||
| Non-U.S. | 1,648 | 1,769 | (7) | % | 4,917 | 5,362 | (8) | % | |||||||||||||||||||||||||||
|
Total Revenues
|
$ | 11,892 | $ | 10,966 | 8 | % | $ | 35,958 | $ | 33,529 | 7 | % | |||||||||||||||||||||||
| U.S. | 8,232 | 7,542 | 9 | % | 25,509 | 23,298 | 9 | % | |||||||||||||||||||||||||||
|
Non-U.S.
(c)
|
3,660 | 3,424 | 7 | % | 10,449 | 10,231 | 2 | % | |||||||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | % Change | 2024 | 2023 | % Change | |||||||||||||||||||||||||||||
|
Cost of products sold
(a)
|
$ | 2,957 | $ | 2,506 | 18 | % | $ | 9,156 | $ | 7,948 | 15 | % | |||||||||||||||||||||||
| Marketing, selling and administrative | 1,983 | 2,003 | (1) | % | 6,278 | 5,699 | 10 | % | |||||||||||||||||||||||||||
| Research and development | 2,374 | 2,242 | 6 | % | 7,968 | 6,821 | 17 | % | |||||||||||||||||||||||||||
| Acquired IPRD | 262 | 80 | * | 13,343 | 313 | * | |||||||||||||||||||||||||||||
| Amortization of acquired intangible assets | 2,406 | 2,256 | 7 | % | 7,179 | 6,769 | 6 | % | |||||||||||||||||||||||||||
| Other (income)/expense, net | 234 | (258) | * | 588 | (787) | * | |||||||||||||||||||||||||||||
| Total Expenses | $ | 10,216 | $ | 8,829 | 16 | % | $ | 44,512 | $ | 26,763 | 66 | % | |||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Karuna asset acquisition (Note 4) | $ | — | $ | — | $ | 12,122 | $ | — | |||||||||||||||
|
RayzeBio rights buy-out
|
92 | — | 92 | — | |||||||||||||||||||
| SystImmune upfront fee (Note 3) | — | — | 800 | — | |||||||||||||||||||
|
Evotec designation and opt-in license fees
|
125 | — | 170 | 90 | |||||||||||||||||||
| Prothena opt-in license fee | — | — | 80 | 55 | |||||||||||||||||||
| Other | 45 | 80 | 79 | 168 | |||||||||||||||||||
| Acquired IPRD | $ | 262 | $ | 80 | $ | 13,343 | $ | 313 | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Interest expense | $ | 505 | $ | 280 | $ | 1,451 | $ | 850 | |||||||||||||||
| Royalty and licensing income | (180) | (365) | (532) | (1,068) | |||||||||||||||||||
| Royalty income - divestitures | (284) | (217) | (820) | (623) | |||||||||||||||||||
| Investment income | (94) | (107) | (364) | (304) | |||||||||||||||||||
| Litigation and other settlements | — | (61) | 71 | (393) | |||||||||||||||||||
| Provision for restructuring | 78 | 141 | 558 | 321 | |||||||||||||||||||
| Integration expenses | 69 | 54 | 214 | 180 | |||||||||||||||||||
| Equity investment (gain)/losses | (12) | — | (221) | 213 | |||||||||||||||||||
| Acquisition expenses | — | — | 50 | — | |||||||||||||||||||
|
Intangible asset impairments
|
47 | 29 | 47 | 29 | |||||||||||||||||||
| Other | 105 | (12) | 134 | 8 | |||||||||||||||||||
|
Other (income)/expense, net
|
$ | 234 | $ | (258) | $ | 588 | $ | (787) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Earnings/(Loss) before income taxes
|
$ | 1,676 | $ | 2,137 | $ | (8,554) | $ | 6,766 | |||||||||||||||
|
Income tax provision
|
461 | 203 | 455 | 488 | |||||||||||||||||||
| Effective tax rate | 27.5 | % | 9.5 | % | (5.3) | % | 7.2 | % | |||||||||||||||
| Impact of specified items | 9.0 | % | (2.1) | % | (193.7) | % | (7.5) | % | |||||||||||||||
| Effective tax rate excluding specified items | 18.5 | % | 11.6 | % | 188.4 | % | 14.7 | % | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
| Inventory purchase price accounting adjustments | $ | 13 | $ | — | $ | 34 | $ | 84 | |||||||||||||||
|
Intangible asset impairment
|
— | — | 280 | — | |||||||||||||||||||
| Site exit and other costs | 88 | 16 | 105 | 53 | |||||||||||||||||||
| Cost of products sold | 101 | 16 | 419 | 137 | |||||||||||||||||||
|
Acquisition related charges
(a)
|
— | — | 372 | — | |||||||||||||||||||
| Site exit and other costs | 7 | 65 | 19 | 85 | |||||||||||||||||||
| Marketing, selling and administrative | 7 | 65 | 391 | 85 | |||||||||||||||||||
| IPRD impairments | — | 60 | 590 | 80 | |||||||||||||||||||
| Priority review voucher | — | — | — | 95 | |||||||||||||||||||
|
Acquisition related charges
(a)
|
— | — | 348 | — | |||||||||||||||||||
| Site exit and other costs | 21 | 4 | 36 | 10 | |||||||||||||||||||
| Research and development | 21 | 64 | 974 | 185 | |||||||||||||||||||
| Amortization of acquired intangible assets | 2,406 | 2,256 | 7,179 | 6,769 | |||||||||||||||||||
|
Interest expense
(b)
|
(12) | (12) | (37) | (39) | |||||||||||||||||||
| Litigation and other settlements | — | (62) | 61 | (397) | |||||||||||||||||||
| Provision for restructuring | 78 | 141 | 558 | 321 | |||||||||||||||||||
| Integration expenses | 69 | 54 | 214 | 180 | |||||||||||||||||||
| Equity investment (gain)/losses | (13) | (2) | (222) | 206 | |||||||||||||||||||
| Acquisition expenses | — | — | 50 | — | |||||||||||||||||||
| Intangible asset impairment | 47 | 29 | 47 | 29 | |||||||||||||||||||
| Other | 106 | (1) | 116 | (6) | |||||||||||||||||||
| Other (income)/expense, net | 275 | 147 | 787 | 294 | |||||||||||||||||||
| Increase to pretax income | 2,810 | 2,548 | 9,750 | 7,470 | |||||||||||||||||||
| Income taxes on items above | (371) | (340) | (1,296) | (944) | |||||||||||||||||||
|
Income tax reserve releases
|
— | — | (502) | — | |||||||||||||||||||
| Income taxes attributed to non-U.S. tax ruling | — | — | — | (656) | |||||||||||||||||||
| Income taxes | (371) | (340) | (1,798) | (1,600) | |||||||||||||||||||
| Increase to net earnings | $ | 2,439 | $ | 2,208 | $ | 7,952 | $ | 5,870 | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| Dollars in millions, except per share data | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||
|
Net earnings/(loss) attributable to BMS
|
|||||||||||||||||||||||
| GAAP | $ | 1,211 | $ | 1,928 | $ | (9,020) | $ | 6,263 | |||||||||||||||
| Specified items | 2,439 | 2,208 | 7,952 | 5,870 | |||||||||||||||||||
| Non-GAAP | $ | 3,650 | $ | 4,136 | $ | (1,068) | $ | 12,133 | |||||||||||||||
| Weighted-average common shares outstanding – diluted | 2,031 | 2,064 | 2,026 | 2,093 | |||||||||||||||||||
|
Diluted earnings/(loss) per share attributable to BMS
|
|||||||||||||||||||||||
| GAAP | $ | 0.60 | $ | 0.93 | $ | (4.45) | $ | 2.99 | |||||||||||||||
| Specified items | 1.20 | 1.07 | 3.92 | 2.81 | |||||||||||||||||||
| Non-GAAP | $ | 1.80 | $ | 2.00 | $ | (0.53) | $ | 5.80 | |||||||||||||||
| Dollars in Millions |
September 30,
2024 |
December 31,
2023 |
|||||||||
| Cash and cash equivalents | $ | 7,890 | $ | 11,464 | |||||||
| Marketable debt securities – current | 204 | 816 | |||||||||
| Marketable debt securities – non-current | 324 | 364 | |||||||||
| Total cash, cash equivalents and marketable debt securities | 8,418 | 12,644 | |||||||||
| Short-term debt obligations | (1,078) | (3,119) | |||||||||
| Long-term debt | (48,674) | (36,653) | |||||||||
| Net debt position | $ | (41,334) | $ | (27,128) | |||||||
| Nine Months Ended September 30, | |||||||||||
| Dollars in millions | 2024 | 2023 | |||||||||
| Cash flow provided by/(used in): | |||||||||||
| Operating activities | $ | 10,751 | $ | 9,608 | |||||||
| Investing activities | (21,156) | (949) | |||||||||
| Financing activities | $ | 6,769 | $ | (10,383) | |||||||
| Product | Indication | Date | Developments | ||||||||
|
Abecma
|
Multiple Myeloma
|
September 2024 |
Announced the discontinuation of enrollment in the Phase 3 KarMMa-9 study investigating
Abecma
with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who have suboptimal response after autologous stem cell transplant.
|
||||||||
|
Augtyro
|
NSCLC
|
September 2024 |
Announced that Japan’s Ministry of Health, Labour and Welfare granted manufacturing and marketing approval for
Augtyro
for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC. This approval is based on results from the Phase 1/2 TRIDENT-1 trial.
|
||||||||
|
Breyanzi
|
Follicular Lymphoma (FL) | August 2024 |
Announced that Japan's Ministry of Health, Labour and Welfare approved the supplemental NDA for
Breyanzi
for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy based on results of the TRANSCEND FL study.
|
||||||||
| August 2024 |
Announced EMA validation of the Type II variation application to expand the indication for
Breyanzi
to include the treatment of adult patients with relapsed or refractory FL who have received two or more prior lines of systemic therapy. The application is based on results of the Phase II TRANSCEND FL study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
|
||||||||||
|
Camzyos
|
oHCM
|
September 2024 |
Announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study evaluating
Camzyos
in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy demonstrating that patients experienced consistent and sustained improvements in echocardiographic measures and biomarkers after up to 3.5 years of continuous treatment. Patients experienced an improvement in symptoms and functional capacity as measured by NYHA class and patient-reported outcomes. The safety profile of
Camzyos
for up to 3.5 years remained consistent with the established safety profile and no new safety signals were identified.
|
||||||||
| July 2024 |
Announced that the Japanese New Drug Application for
Camzyos
was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of obstructive hypertrophic cardiomyopathy. This filing is based on results from the global Phase 3 EXPLORER-HCM and Phase 3 VALOR-HCM trials, as well as the Japan Phase 3 HORIZON-HCM study.
|
||||||||||
|
cendakimab
|
Eosinophilic Esophagitis
|
July 2024 |
Announced that the results from the Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with eosinophilic esophagitis met both co-primary endpoints, demonstrating statistically significant reductions versus placebo in symptoms (dysphagia days) and esophageal eosinophil counts after 24 weeks of treatment. The overall safety profile of cendakimab through 48 weeks of treatment in the Phase 3 trial was consistent with previously reported eosinophilic esophagitis Phase 2 trial results, and no new safety signals were identified.
|
||||||||
|
Cobenfy (KarXT; xanomeline and trospium chloride)
|
Schizophrenia
|
September 2024 |
Announced FDA approval of
Cobenfy
for the treatment of schizophrenia in adults. The approval is based on data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of
Cobenfy
for up to one year.
|
||||||||
|
Inrebic
|
Myelofibrosis
|
August 2024 |
Announced that the Japanese New Drug Application for
Inrebic
has been submitted to the Pharmaceuticals and Medical Devices Agency for the treatment of myelofibrosis (MF). This filing is based on results from the global Phase 3 EFC12153 (Jakarta) study for 1L MF, the global Phase 2 ARD12181 (Jakarta-2) study for 2L MF, and the Japan Phase 1/2 FEDR-MF-003 study.
|
||||||||
| Product | Indication | Date | Developments | ||||||||
|
Opdivo
|
NSCLC
|
October 2024 |
Announced FDA approval of
Opdivo
for the treatment of adult patients with resectable (tumors ≥ 4cm or nod positive) NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent
Opdivo
as adjuvant treatment after surgery. The approval is based on results from the Phase 3CheckMate -77T trial.
|
||||||||
|
Opdivo + Yervoy
|
Melanoma
|
September 2024 |
Announced 10-year follow-up data from the Phase 3 CheckMate -067 trial that showed continued durable improvement in survival with first-line
Opdivo
plus
Yervoy
therapy and
Opdivo
monotherapy, versus
Yervoy
alone, in patients with previously untreated advanced or metastatic melanoma. With a minimum follow up of 10 years, median overall survival was 71.9 months with
Opdivo
plus
Yervoy
, the longest reported median overall survival in a Phase 3 advanced melanoma trial.
|
||||||||
|
HCC
|
August 2024 |
Announced FDA acceptance of the supplemental BLA for
Opdivo
plus
Yervoy
as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma. The acceptance is based on results from the Phase 3 CheckMate -9DW trial. The FDA assigned a PDUFA goal date of April 21, 2025.
|
|||||||||
| August 2024 |
Announced that the supplemental Japanese New Drug Application for
Opdivo
plus
Yervoy
was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of unresectable first line hepatocellular carcinoma. This filing is based on results from the Phase 3 CheckMate -9DW study.
|
||||||||||
| July 2024 |
Announced EMA validation of the Type II variation application for
Opdivo
plus
Yervoy
as a potential first-line treatment option for adult patients with unresectable or advanced HCC who have not received prior systemic therapy. The application is based on results from the Phase 3 CheckMate -9DW trial.
|
||||||||||
|
Colorectal Cancer
|
October 2024 |
Announced that the Phase 3 CheckMate -8HW trial evaluating
Opdivo
plus
Yervoy
compared to
Opdivo
monotherapy across all lines of therapy as a treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival as assessed by Blinded Independent Central Review at a pre-specified interim analysis. Previously,
Opdivo
plus
Yervoy
demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy.
Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to
Opdivo
monotherapy across all lines of therapy. The study is ongoing to assess various secondary endpoints, including overall survival. The safety profile for the combination of
Opdivo
plus
Yervoy
remained consistent with previously reported data, with no new safety signals identified.
|
|||||||||
| September 2024 |
Announced that the supplemental Japanese New Drug Application for
Opdivo
plus
Yervoy
was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of unresectable advanced or recurrent colorectal cancer with frequent microsatellite instability. This filing is based on results from the Phase 3 CheckMate -8HW study.
|
||||||||||
|
Urothelial Carcinoma
|
October 2024 |
Announced that the Phase 3 CheckMate -901 trial evaluating
Opdivo
plus
Yervoy
versus standard-of-care non-cisplatin-based chemotherapy in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy, did not meet its primary endpoint of overall survival. The safety profile for
Opdivo
and
Yervoy
was consistent with previously reported data, with no new safety signals identified.
Opdivo
has previously shown clinical benefit across various stages of urothelial carcinoma. These results do not impact those data or approved indications.
|
|||||||||
|
Zeposia
|
Multiple Sclerosis
|
September 2024 |
Announced data from the Phase 3 DAYBREAK trial which demonstrated that decreased rates of brain volume loss were sustained in the open-label extension for patients treated with
Zeposia
for relapsing forms of multiple sclerosis. A separate DAYBREAK OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events, with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with
Zeposia
.
|
||||||||
| 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 | |||||||||||||||||||||||
| July 1 to 31, 2024 | 21,409 | $ | 41.24 | — | $ | 5,014 | |||||||||||||||||
| August 1 to 31, 2024 | 40,092 | $ | 49.15 | — | $ | 5,014 | |||||||||||||||||
| September 1 to 30, 2024 | 20,232 | $ | 49.81 | — | $ | 5,014 | |||||||||||||||||
| Three months ended September 30, 2024 | 81,733 | — | |||||||||||||||||||||
| Exhibit No. | Description | |||||||
| 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). | |||||||
| 2023 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 2023 | Mirati | Mirati Therapeutics, Inc. | ||||||||||||||||||||
| 2024 Senior Unsecured Notes | Aggregate principal amount of $13.0 billion of unsecured senior notes issued by BMS in February 2024 | MPM | malignant pleural mesothelioma | ||||||||||||||||||||
| aGVHD | acute graft-versus-host disease | MTA | Methylthioadenosine | ||||||||||||||||||||
| ANDA | Abbreviated New Drug Application | NDA | New Drug Application | ||||||||||||||||||||
| AstraZeneca | AstraZeneca PLC | Nimbus | Nimbus Therapeutics | ||||||||||||||||||||
| BCMA | B-cell maturation antigen-directed | NKT | natural killer T | ||||||||||||||||||||
| BLA | Biologics License Application | NSCLC | non-small cell lung cancer | ||||||||||||||||||||
| CAR-T | chimeric antigen receptor T-cell | NTRK | Neurotrophic Tropomyosin Receptor Kinase | ||||||||||||||||||||
| Celgene | Celgene Corporation | NVAF | non-valvular atrial fibrillation | ||||||||||||||||||||
| CERCLA | U.S. Comprehensive Environmental Response, Compensation and Liability Act | OECD | Organization for Economic Co-operation and Development | ||||||||||||||||||||
| CGDP | Coverage Gap Discount Program | Ono | Ono Pharmaceutical Co., Ltd | ||||||||||||||||||||
| CLL | Chronic Lymphocytic Leukemia | Otsuka | Otsuka Pharmaceutical Co., Ltd. | ||||||||||||||||||||
| CML | chronic myeloid leukemia | PD-1 | programmed cell death protein 1 | ||||||||||||||||||||
| CRC | colorectal carcinoma | PD-LI | programmed death-ligand 1 | ||||||||||||||||||||
| CTLA4 | Cytotoxic T-lymphocyte Antigen-4 | PsA | psoriatic arthritis | ||||||||||||||||||||
| DLBCL | Diffuse Large B-cell Lymphoma | PRMT5 | protein arginine methyltransferase 5 | ||||||||||||||||||||
| EC | European Commission | Quarterly Report on Form 10-Q |
Quarterly Report on Form 10-Q for the quarter ended September 30, 2024
|
||||||||||||||||||||
| Eisai | Eisai Co., Ltd. | R&D | research and development | ||||||||||||||||||||
| EPS | earnings per share | RA | rheumatoid arthritis | ||||||||||||||||||||
| EU | European Union | RayzeBio | RayzeBio, Inc. | ||||||||||||||||||||
| Exchange Act | the Securities Exchange Act of 1934 | RCC | renal cell carcinoma | ||||||||||||||||||||
| FASB | Financial Accounting Standards Board | RDFV | readily determinable fair values | ||||||||||||||||||||
| FDA | U.S. Food and Drug Administration | REMS | risk evaluation and mitigation strategy | ||||||||||||||||||||
| FL | follicular lymphoma | Sanofi | Sanofi S.A. | ||||||||||||||||||||
| GAAP | generally accepted accounting principles | SEC | U.S. Securities and Exchange Commission | ||||||||||||||||||||
| GTN | gross-to-net | SLL | Small Lymphocytic Lymphoma | ||||||||||||||||||||
| HCC | hepatocellular carcinoma | SPC | Supplementary Protection Certificate | ||||||||||||||||||||
| HCM | hypertrophic cardiomyopathy | SystImmune | SystImmune, Inc. | ||||||||||||||||||||
| IPRD | in-process research and development | Takeda | Takeda Pharmaceutical Company Limited | ||||||||||||||||||||
| IRA | Inflation Reduction Act of 2022 | TCJA | Tax Cuts and Jobs Act | ||||||||||||||||||||
| IRS | Internal Revenue Service | Turning Point | Turning Point Therapeutics, Inc. | ||||||||||||||||||||
| JIA | juvenile idiopathic arthritis | UC | ulcerative colitis | ||||||||||||||||||||
| Karuna | Karuna Therapeutics, Inc. | UK | United Kingdom | ||||||||||||||||||||
| KRAS | Kirsten rat sarcoma | U.S. | United States | ||||||||||||||||||||
| LBCL | Large B-cell Lymphoma | USPTO | U.S. Patent and Trademark Office | ||||||||||||||||||||
| MDS | myelodysplastic syndromes | VAT | value added tax | ||||||||||||||||||||
| Merck | Merck & Co. | ||||||||||||||||||||||
|
BRISTOL-MYERS SQUIBB COMPANY
(REGISTRANT) |
|||||||||||
| Date: | October 31, 2024 | By: | /s/ Christopher Boerner, Ph.D. | ||||||||
|
Christopher Boerner, Ph. D.
Chair of the Board and Chief Executive Officer
|
|||||||||||
| Date: | October 31, 2024 | By: | /s/ David V. Elkins | ||||||||
|
David V. Elkins
Chief Financial Officer
|
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No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
Customers
Suppliers
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
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