(Former name, former address and former fiscal year, if changed since last report)
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 “accelerated filer”, “large accelerated filer”filer,” “accelerated filer,” “smaller reporting company,” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
* Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index.Index at the end of this Quarterly Report on Form 10-Q.
Item 1. FINANCIAL STATEMENTS
The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
Note 1. BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING STANDARDS
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 chief executive officerCEO 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".
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Revenues from alliances | | | | | | | |
Net product sales | $ | 2,762 | | | $ | 2,722 | | | $ | 9,614 | | | $ | 9,234 | |
Alliance revenues | 138 | | | 173 | | | 461 | | | 560 | |
Total alliance revenues | $ | 2,900 | | | $ | 2,895 | | | $ | 10,075 | | | $ | 9,794 | |
| | | | | | | |
To/(from) alliance partners | | | | | | | |
Cost of products sold | $ | 1,330 | | | $ | 1,328 | | | $ | 4,650 | | | $ | 4,456 | |
Marketing, selling and administrative | (52) | | | (53) | | | (190) | | | (160) | |
Research and development | 1 | | | 6 | | | 81 | | | 40 | |
Acquired IPRD | — | | | — | | | 55 | | | 100 | |
Other (income)/expense, net | (10) | | | (18) | | | (37) | | | (41) | |
|
| | | | | | | |
Selected Alliance Balance Sheet information: | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Receivables - from alliance partners | $ | 878 |
| | $ | 903 |
|
Accounts payable - to alliance partners | 634 |
| | 555 |
|
Deferred income from alliances(a) | 1,060 |
| | 1,194 |
|
| |
(a) | Includes unamortized upfront, milestone and other licensing proceeds, revenue deferrals attributed to Atripla* and undelivered elements of diabetes business divestiture proceeds. Amortization of deferred income (primarily related to alliances) was $59 million and $193 million for the nine months ended September 30, 2017 and 2016, respectively.
|
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Selected alliance balance sheet information | | | |
Receivables – from alliance partners | $ | 209 | | | $ | 317 | |
Accounts payable – to alliance partners | 1,288 | | | 1,249 | |
Deferred income – from alliances(a) | 289 | | | 289 | |
(a) Includes unamortized upfront and milestone payments.Specific information pertaining to each of our significant alliances is discussed in our 2016 Form 10-K, including their
The nature, and purpose, the significant rights and obligations of the parties and specific accounting policy elections.elections for each of the Company's significant alliances are discussed in the 2022 Form 10-K. Significant developments and updates related to alliances during the nine months ended September 30, 20172023 and 2022 are set forth below.
AstraZenecaBridgeBio
During the second quarter of 2022, BMS received $100and BridgeBio commenced a collaboration to develop and commercialize BBP-398, a SHP2 inhibitor, in oncology. The transaction included an upfront payment of $90 million from AstraZenecaexpensed to Acquired IPRD during the second quarter of 2022. BridgeBio is eligible to receive contingent development, regulatory and sales-based milestones up to $815 million, as additional contingent considerationwell as royalties on global net sales, excluding certain markets. BridgeBio is responsible for the diabetes business divestiture upon achievement of a regulatory approval milestonefunding and completing ongoing BBP-398 Phase I monotherapy and combination therapy trials. BMS is responsible for leading and funding all other development and commercial activities. BridgeBio has an option to co-develop BBP-398 and receive higher royalties in the first quarter of 2017 (included in other income).U.S.
F-Star Alpha
In the first quarter of 2017, BMS discontinued development of FS102 (an anti-HER2 antibody fragment) which was in Phase I development for the treatment of breast and gastric cancer. BMS will not exercise its option to purchase F-Star Alpha which was previously consolidated by BMS as a variable interest entity. As a result, an IPRD charge of $75 million was included in R&D expense and attributed to noncontrolling interest in the first quarter of 2017.
Note 4. ACQUISITIONS, DIVESTITURES, LICENSING AND LICENSINGOTHER ARRANGEMENTS
Acquisitions
IFM
Mirati
In October 2023, BMS entered into a definitive merger agreement to acquire Mirati, a commercial stage targeted oncology company with a pipeline of clinical and commercial oncology medicines. The acquisition will provide BMS with rights to Krazati* (adagrasib) and MRTX1719, among other assets. Krazati* is a best-in-class inhibitor of KRASG12C mutation, which was approved by the FDA as a second-line treatment for patients with NSCLC and is in clinical development in combination with a PD-1 inhibitor as a first-line therapy for patients with NSCLC, as well as in other indications. MRTX1719, is a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase 1 development. BMS also will gain access to several other promising clinical and pre-clinical stage assets, including additional KRAS inhibitors and enabling programs.
BMS will acquire all of the issued and outstanding shares of Mirati's common stock for $58.00 per share in an all-cash transaction for a total consideration of $4.8 billion, including cash settlements of equity stock awards. Mirati shareholders will also receive one non-tradeable contingent value right for each share of Mirati common stock held, potentially worth $12.00 per share in cash for a total value of approximately $1.0 billion. The payout of the contingent value right is subject to the FDA acceptance of an NDA for MRTX1719 for the treatment of specific indications within seven years of the closing of the transaction. The transaction is expected to be accounted for as a business combination and is anticipated to close by the first half of 2024, subject to fulfillment of customary closing conditions, including approval of Mirati's shareholders and receipt of required regulatory approvals. The acquisition will be funded through a combination of cash-on-hand and debt proceeds.
Turning Point
In the third quarter of 2022, BMS acquired Turning Point for $4.1 billion of cash (or $3.3 billion net of cash acquired). Turning Point was a clinical-stage precision oncology company with a pipeline of investigational medicines designed to target the common mutations and alterations that drive cancer growth. The acquisition provided BMS rights to Turning Point's lead asset, repotrectinib, and other clinical and pre-clinical stage assets.
Divestitures
The following table summarizes the financial impact of divestitures including royalties, which are included in Other (income)/expense, net. Revenue and pretax earnings related to all divestitures were not material in all periods presented (excluding divestiture gains or losses).
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, |
| Net Proceeds | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 | | 2023 | | 2022 |
Diabetes business - royalties | $ | 220 | | | $ | 205 | | | $ | — | | | $ | — | | | $ | (217) | | | $ | (205) | |
Mature products and other | 3 | | | 1 | | | — | | | — | | | — | | | — | |
Total | $ | 223 | | | $ | 206 | | | — | | | $ | — | | | $ | (217) | | | (205) | |
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| Net Proceeds | | Divestiture (Gains)/Losses | | Royalty Income |
Dollars in Millions | 2023 | | 2022 | | 2023 | | 2022 | | 2023 | | 2022 |
Diabetes business - royalties | $ | 621 | | | $ | 562 | | | $ | — | | | $ | — | | | $ | (623) | | | $ | (595) | |
Mature products and other (a) | 10 | | | 229 | | | — | | | (211) | | | — | | | (2) | |
Total | $ | 631 | | | $ | 791 | | | $ | — | | | $ | (211) | | | $ | (623) | | | $ | (597) | |
(a) Includes cash proceeds of $221 million and a divestiture gain of $211 million related to the sale of several mature products to Cheplapharm in the first quarter of 2022.
Mature Products and Other
Manufacturing Operations
During the second quarter of 2022, BMS agreed to sell its manufacturing facility in Syracuse, New York to LOTTE Corporation and accounted for the business as held-for-sale resulting in a $43 million impairment charge recorded to Cost of products sold. Assets and liabilities reclassified to held-for-sale were included within Other current assets and Other current liabilities and were $172 million and $20 million, respectively, as of December 31, 2022. In January 2023, BMS completed the sale resulting in cash proceeds of $159 million, which was received in December 2022.
Licensing and Other Arrangements
The following table summarizes the financial impact of Keytruda* royalties, Tecentriq* royalties, upfront licensing fees and milestones for products that have not obtained commercial approval, which are included in Other (income)/expense, net.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Keytruda* royalties | $ | (315) | | | $ | (268) | | | $ | (878) | | | $ | (732) | |
Tecentriq* royalties | (24) | | | (24) | | | (78) | | | (68) | |
| | | | | | | |
Contingent milestone income | — | | | — | | | (36) | | | (46) | |
Amortization of deferred income | (12) | | | (18) | | | (39) | | | (41) | |
Biohaven sublicense income | — | | | (55) | | | — | | | (55) | |
Other royalties and licensing income | (14) | | | (9) | | | (37) | | | (25) | |
Total | $ | (365) | | | $ | (374) | | | $ | (1,068) | | | $ | (967) | |
LianBio
During October 2023, BMS reacquired the rights for mavacamten in China and certain other Asian territories from LianBio for $350 million in cash. The cost for the reacquired rights will be reflected in Acquired IPRD during the fourth quarter of 2023 as mavacamten is currently in development and not approved for commercial use in China.
Keytruda* Patent License Agreement
In 2017, BMS acquired alland Ono entered a global patent license agreement with Merck related to Merck's PD-1 antibody Keytruda*. In accordance with the agreement, Merck is obligated to pay ongoing royalties on global sales of Keytruda* of 6.5% from January 1, 2017 through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. The companies also granted certain rights to each other under their respective patent portfolios pertaining to PD-1. Payments and royalties are shared between BMS and Ono on a 75/25 percent allocation, respectively after adjusting for each party's legal fees.
Immatics
During the outstanding sharesfirst quarter of IFM,2022, BMS obtained a private biotechnology company focusedglobal exclusive license to Immatics' TCR bispecific IMA401 program, which is being studied in oncology. BMS and Immatics collaborate on developing therapies that modulate novel targetsthe development and BMS will be responsible for the commercialization of IMA401 worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. Immatics has the option to co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the innate immune system to treat cancer, autoimmunity and inflammatory diseases.U.S. The acquisition provides BMS with full rights to IFM's preclinical STING and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer. The consideration includestransaction included an upfront payment of $300$150 million andwhich was expensed to Acquired IPRD in the first quarter of 2022. Immatics is eligible to receive contingent development, regulatory and sales-based milestone paymentsmilestones of up to $1.0 billion for$770 million as well as royalties on global net sales.
Dragonfly
During the first product from eachquarter of 2022, a Phase I development milestone for interleukin-12 ("IL-12") was achieved resulting in a $175 million payment to Dragonfly and an Acquired IPRD charge. During the first quarter of 2023, BMS notified Dragonfly of its termination of the two programsglobal exclusive license related to Dragonfly’s IL-12. All rights to IL-12 were reverted back to Dragonfly effective April 2023.
Other
Nimbus Change of Control Income
During the first quarter of 2022, BMS and Nimbus Therapeutics ("Nimbus") entered into a settlement resolving all legal claims and business interests pertaining to Nimbus' TYK2 inhibitor resulting in $40 million of income included in Other (income)/expense. The settlement also provides for BMS to receive additional amounts for contingent milestone paymentsdevelopment, regulatory approval and sales-based milestones and 10% of any change in control proceeds received by Nimbus related to its TYK2 inhibitor. In February 2023, Takeda acquired 100% ownership of Nimbus' TYK2 inhibitor for approximately $4.0 billion in upfront proceeds plus contingent sales-based milestones aggregating up to $555 million for any subsequent products from these programs. No significant IFM processes were acquired, therefore the transaction was accounted for as an asset acquisition because IFM was determined not to be$2.0 billion. As a business as that term is defined in ASC 805 - Business Combinations. BMS also paid $25 million for certain negotiation rights to collaborate, license or acquire an NLRP3 antagonist program from a newly formed entity established by the former shareholders of IFM. The transactions resulted in $310result, $400 million of R&D income related to the change of control provision was included in Other (income)/expense and $15 millionduring the first quarter of deferred tax assets for net operating losses and tax credit carryforwards.2023.
Flexus
InRoyalty Extinguishment
During the second quarter of 2017,2022, BMS amended the terms of a $100 million milestone was achievedlicense arrangement and paid a third party $295 million, which was expensed to former stockholdersAcquired IPRD, to extinguish a future royalty obligation related to mavacamten prior to its FDA approval in April 2022.
Note 5. OTHER (INCOME)/EXPENSE, NET
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Interest expense (Note 10) | $ | 280 | | | $ | 299 | | | $ | 850 | | | $ | 938 | |
Royalty and licensing income (Note 4) | (365) | | | (374) | | | (1,068) | | | (967) | |
Royalty income - divestiture (Note 4) | (217) | | | (205) | | | (623) | | | (597) | |
Equity investment losses (Note 9) | — | | | 14 | | | 213 | | | 966 | |
Integration expenses (Note 6) | 54 | | | 114 | | | 180 | | | 343 | |
Loss on debt redemption (Note 10) | — | | | — | | | — | | | 266 | |
Divestiture gains (Note 4) | — | | | — | | | — | | | (211) | |
Litigation and other settlements | (61) | | | 44 | | | (393) | | | 32 | |
Investment income | (107) | | | (52) | | | (304) | | | (89) | |
Provision for restructuring (Note 6) | 141 | | | 17 | | | 321 | | | 60 | |
Other | 17 | | | 3 | | | 37 | | | 52 | |
Other (income)/expense, net | $ | (258) | | | $ | (140) | | | $ | (787) | | | $ | 793 | |
Litigation and Other Settlements
BeiGene Settlement
In August 2023, BMS and BeiGene, Ltd. ("BeiGene") entered into an agreement that settled all on-going disputes and claims between the parties, including those related to the Abraxane license and supply agreements and related arbitration proceedings as further described in "—Note 18. Legal Proceedings and Contingencies".
The agreement also provided for the termination of Flexusall contractual relationships between the parties, including the license and supply arrangements pertaining to Revlimid and Vidaza effective as additional contingentof December 31, 2023, subject to BeiGene’s right to continue to sell all remaining inventory beyond that date. In consideration followingfor the commencementabove, BMS agreed to transfer 23.3 million of BeiGene ordinary shares of common stock held under a Phase II clinical studyshare subscription agreement back to BeiGene resulting in $322 million of an anti-cancer IDO inhibitor. The additional considerationexpense that was included in R&D Other (income)/expense, asnet during the Flexus acquisition in 2015three months ended September 30, 2023. The expense was accounted for as an asset acquisition.
Cardioxyl
Indetermined based on the second quarter of 2017, a $100 million milestone was achieved and paid to former stockholders of Cardioxyl as additional contingent consideration following the commencement of a Phase II clinical study of a cardiovascular Nitroxyl Donor. The additional consideration was included in R&D expense as the Cardioxyl acquisition in 2015 was accounted for as an asset acquisition.
Divestitures
SK Biotek
In the second quarter of 2017, BMS agreed to sell its small molecule active pharmaceutical ingredient manufacturing operations in Swords, Ireland to SK Biotek. The divestiture includes the transferclosing price of the facility, the majority of employees at the site, inventories and certain third-party contract manufacturing obligations. The purchase price is expected to be approximately $140 million subject to inventory levelsshares on the date of closing. The transaction is expectedthe transfer. In addition, the remaining BeiGene ordinary shares owned by BMS under the share subscription agreement were converted to closeAmerican Depository Shares, which were subsequently sold during the three months ended September 30, 2023.
AstraZeneca Settlement
In July 2023, BMS entered into an agreement with AZ to settle all outstanding claims between the parties in the fourth quarterCTLA-4 litigation and the two PD-L1 antibody litigations, as further described in "—Note 18. Legal Proceedings and Contingencies". AZ will pay an aggregate of 2017$560 million to BMS in four payments through September 2026, which will be subject to SK Biotek's receiptsharing arrangements with Ono and Dana-Farber. BMS's share is approximately $418 million, of certain environmental permits and other customary closing conditions and will be accounted for as a salewhich the net present value of a business. Net assets of approximately $140$384 million were accounted for as held-for-sale as ofwas reflected in Other (income)/expense during the three months ended September 30, 2017, consisting primarily2023.
Nimbus Change of inventories and property, plant and equipment, and were included in prepaid expenses and other. The assets were reduced to their estimated relative fair value after considering the purchase price resulting in an impairment charge of $128 million that was included in cost of products sold inControl Income
During the nine months ended September 30, 2017. SK Biotek will provide certain manufacturing services for BMS through 2022. Revenues and pretax earnings related to this operation were not material2023, $400 million of income was recorded in 2017 and 2016 (excluding the impairment charge).
Licensing Arrangements
Halozyme
In the third quarter of 2017, BMS and Halozyme announced a global collaboration and license agreement to develop subcutaneously administered BMS IO medicines using Halozyme's ENHANZE* drug-delivery technology. This technology may allow for more rapid delivery of large volume injectable medications, such as medications that are currently delivered intravenously, through subcutaneous delivery. BMS agreed to pay $105 million to Halozyme for access to the technology which will be included in R&D Other (income)/expense in the fourth quarterconnection with Nimbus' TYK2 program change of 2017. BMS has designated multiple IO targets, including PD-1,control provision. Refer to develop using the ENHANZE* technology"—Note 4. Acquisitions, Divestitures, Licensing and has an option to select additional targets within five years from the effective date up to a maximum of 11 targets. BMS may pay up to $160 million upon achievement of contingent development, regulatory and sales-based milestone eventsOther Arrangements" for each of the nominated collaboration targets, additional milestone payments for combination products and future royalties on sales of products using the ENHANZE* technology. The agreement is subject to obtaining customary regulatory and antitrust approvals.further information.
CytomX
In the second quarter of 2017, BMS expanded its strategic collaboration with CytomX to discover novel therapies using CytomX’s proprietary Probody platform. As part of the original May 2014 collaboration to discover, develop and commercialize Probody therapeutics, BMS selected four oncology targets, including CTLA-4. Pursuant to the expanded agreement, CytomX will grant BMS exclusive worldwide rights to develop and commercialize Probody therapeutics for up to eight additional targets. BMS paid CytomX $75 million for the rights to the initial four targets which was expensed as R&D prior to 2017. BMS paid $200 million to CytomX for access to the additional targets which was included in R&D expense in the second quarter of 2017. BMS will also reimburse CytomX for certain research costs over the collaboration period, pay up to $448 million upon achievement of contingent development, regulatory and sales milestone events for each collaboration target and future royalties if a product is approved and commercialized.
Biogen
In the second quarter of 2017, BMS out-licensed to Biogen exclusive rights to develop and commercialize BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy. Biogen paid $300 million to BMS which was included in other income in the second quarter of 2017 as BMS has no further performance obligations as part of the agreement. BMS is also entitled to contingent development, regulatory and sales based milestone payments of up to $410 million if achieved as well as future royalties if the product is ultimately approved and commercialized. BMS originally acquired the rights to this compound in 2014 through its acquisition of iPierian. Biogen assumed all of BMS’s remaining obligations to the former stockholders of iPierian.
Roche
In the second quarter of 2017, BMS out-licensed to Roche exclusive rights to develop and commercialize BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy. Roche paid $170 million to BMS which was included in other income in the second quarter of 2017 as BMS has no further performance obligations as part of the agreement. BMS will also be entitled to contingent development and regulatory milestone payments of up to $205 million if achieved and future royalties if the product is ultimately approved and commercialized.
Note 5. OTHER (INCOME)/EXPENSE
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Interest expense | $ | 48 |
| | $ | 42 |
| | $ | 145 |
| | $ | 127 |
|
Investment income | (37 | ) | | (32 | ) | | (104 | ) | | (81 | ) |
Provision for restructuring | 28 |
| | 19 |
| | 207 |
| | 41 |
|
Litigation and other settlements(a) | — |
| | (1 | ) | | (489 | ) | | 48 |
|
Equity in net income of affiliates | (21 | ) | | (19 | ) | | (59 | ) | | (65 | ) |
Divestiture (gains)/losses | 1 |
| | (21 | ) | | (126 | ) | | (574 | ) |
Royalties and licensing income(b) | (209 | ) | | (158 | ) | | (1,093 | ) | | (579 | ) |
Transition and other service fees | (12 | ) | | (57 | ) | | (32 | ) | | (184 | ) |
Pension charges | 22 |
| | 19 |
| | 91 |
| | 66 |
|
Intangible asset impairments | — |
| | — |
| | — |
| | 15 |
|
Equity investment impairment | — |
| | — |
| | — |
| | 45 |
|
Loss on debt redemption | — |
| | — |
| | 109 |
| | — |
|
Other | (11 | ) | | (16 | ) | | (26 | ) | | (57 | ) |
Other (income)/expense | $ | (191 | ) | | $ | (224 | ) | | $ | (1,377 | ) | | $ | (1,198 | ) |
| |
(a) | Includes BMS's share of a patent-infringement litigation settlement of $481 million related to Merck's PD-1 antibody Keytruda* in the nine months ended September 30, 2017.
|
| |
(b) | Includes upfront licensing fees of $470 million from Biogen and Roche in the nine months ended September 30, 2017. |
Note 6. RESTRUCTURING
2023 Restructuring Plan
In October 2016, the Company announced2023, BMS commenced a restructuring plan to evolveaccelerate the delivery of medicines to patients by evolving and streamlinestreamlining its enterprise operating model in key areas, such as R&D, manufacturing, commercial and other functions, to ensure its operating model supports and expectsis appropriately aligned with the Company’s strategy to incur chargesinvest in connection with employee workforce reductionskey priorities. These changes primarily include (i) transforming R&D operations to accelerate pipeline delivery (ii) enhancing our commercial operating model, and early site exits. The majority(iii) establishing a more responsive manufacturing network and expansion of the chargescell therapy manufacturing capabilities. Charges of approximately $1.0 billion are expected to be incurred through 2020, range between $1.52025, consisting primarily of employee termination costs and to a lesser extent site exit costs, including impairment and accelerated depreciation of property, plant and equipment.
Celgene and Other Acquisition Plans
Restructuring and integration plans were initiated to realize expected cost synergies resulting from cost savings and avoidance from the acquisition of Celgene (2019), MyoKardia (2020) and Turning Point (2022). As part of these plans, the Company expects to incur charges of approximately $3.8 billion. Cumulative charges of approximately $3.5 billion have been recognized to $2.0 billiondate including integration planning and consist ofexecution expenses, employee termination benefit costs and accelerated stock-based compensation, contract termination costs plant and equipment accelerated depreciation and impairment charges and other shutdown costs associated with site shutdown costs. Cash outlays in connection with these actionsexits. The remaining charges related to the acquisition of Celgene are primarily related to IT system integration which are expected to be approximately 40%incurred through 2024.
The following provides the charges related to 50%restructuring initiatives by type of the total charges. Charges of $631cost:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
2023 Restructuring Plan | $ | 149 | | | $ | — | | | $ | 380 | | | $ | — | |
Celgene and Other Acquisition Plans | 131 | | | 131 | | | 269 | | | 409 | |
Total charges | $ | 280 | | | $ | 131 | | | $ | 649 | | | $ | 409 | |
| | | | | | | |
Employee termination costs | $ | 135 | | | $ | 16 | | | $ | 309 | | | $ | 57 | |
Other termination costs | 6 | | | 1 | | | 12 | | | 3 | |
Provision for restructuring | 141 | | | 17 | | | 321 | | | 60 | |
Integration expenses | 54 | | | 114 | | | 180 | | | 343 | |
Accelerated depreciation | 15 | | | — | | | 28 | | | 6 | |
Asset impairments (a) | 70 | | | — | | | 120 | | | — | |
| | | | | | | |
Total charges | $ | 280 | | | $ | 131 | | | $ | 649 | | | $ | 409 | |
| | | | | | | |
Cost of products sold | $ | 16 | | | $ | — | | | $ | 53 | | | $ | — | |
Marketing, selling and administrative | 65 | | | — | | | 85 | | | 6 | |
Research and development | 4 | | | — | | | 10 | | | — | |
Other (income)/expense, net | 195 | | | 131 | | | 501 | | | 403 | |
Total charges | $ | 280 | | | $ | 131 | | | $ | 649 | | | $ | 409 | |
(a)Includes $65 million have been recognizedimpairment charge for these actions since the announcement ($82 million and $534 million fora facility lease that commenced during the three and nine months ended September 30, 2017, respectively). These2023.
The following summarizes the charges include an impairment charge for the manufacturing operations in Swords, Ireland discussed in "—Note 4. Acquisitions, Divestitures and Licensing Arrangements." Restructuring charges are recognized upon meeting certain criteria, including finalization of committed plans, reliable estimates and discussions with local works councils in certain markets.
Other restructuring charges recognized prior to the above actions were primarilyspending related to specialty care transformation initiatives designed to createrestructuring plan activities:
| | | | | | | | | | | |
| Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 |
Beginning balance | $ | 47 | | | $ | 101 | |
Provision for restructuring(a) | 321 | | | 60 | |
Foreign currency translation and other | (3) | | | (10) | |
Payments | (142) | | | (106) | |
Ending balance | $ | 223 | | | $ | 45 | |
(a) Includes a more simplified organization across all functionsreduction of the liability resulting from changes in estimates of $5 million and geographic markets. In addition, accelerated depreciation and other charges were incurred in connection with the expected early exits of a manufacturing site in Ireland and R&D site in the U.S.
Employee workforce reductions were approximately 1,200 and 500$6 million for the nine months ended September 30, 20172023 and 2016, respectively, across all geographic regions for manufacturing, marketing, selling, administrative and R&D personnel.2022, respectively.
The following tables summarize the charges and activity related to the restructuring actions:
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Employee termination costs | $ | 18 |
| | $ | 17 |
| | $ | 190 |
| | $ | 32 |
|
Other termination costs | 10 |
| | 2 |
| | 17 |
| | 9 |
|
Provision for restructuring | 28 |
| | 19 |
| | 207 |
| | 41 |
|
Accelerated depreciation | 64 |
| | 15 |
| | 216 |
| | 42 |
|
Asset impairments | 1 |
| | — |
| | 144 |
| | — |
|
Other shutdown costs | — |
| | 6 |
| | 3 |
| | 13 |
|
Total charges | $ | 93 |
| | $ | 40 |
| | $ | 570 |
| | $ | 96 |
|
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Cost of products sold | $ | 1 |
| | $ | 7 |
| | $ | 131 |
| | $ | 15 |
|
Research and development | 64 |
| | 14 |
| | 232 |
| | 40 |
|
Other (income)/expense | 28 |
| | 19 |
| | 207 |
| | 41 |
|
Total charges | $ | 93 |
| | $ | 40 |
| | $ | 570 |
| | $ | 96 |
|
|
| | | | | | | |
| Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 |
Liability at January 1 | $ | 114 |
| | $ | 125 |
|
Charges | 233 |
| | 48 |
|
Change in estimates | (26 | ) | | (7 | ) |
Provision for restructuring | 207 |
| | 41 |
|
Foreign currency translation | 17 |
| | 2 |
|
Spending | (179 | ) | | (88 | ) |
Liability at September 30 | $ | 159 |
| | $ | 80 |
|
Note 7. INCOME TAXES
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Earnings before income taxes | $ | 2,137 | | | $ | 2,209 | | | $ | 6,766 | | | $ | 5,854 | |
Income tax provision | 203 | | | 601 | | | 488 | | | 1,534 | |
Effective tax rate | 9.5 | % | | 27.2 | % | | 7.2 | % | | 26.2 | % |
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Earnings Before Income Taxes | $ | 1,183 |
| | $ | 1,559 |
| | $ | 4,433 |
| | $ | 4,829 |
|
Provision for Income Taxes | 327 |
| | 344 |
| | 1,129 |
| | 1,220 |
|
Effective Tax Rate | 27.6 | % | | 22.1 | % | | 25.5 | % | | 25.3 | % |
The effective tax rate is lower than the U.S. statutory rate of 35% which is primarily attributable to undistributed earnings of certain foreign subsidiaries in low tax jurisdictions that have been considered or are expected to be indefinitely reinvested offshore. These undistributed earnings primarily relate to operations in Switzerland, Ireland and Puerto Rico. If these undistributed earnings are repatriated to the U.S. in the future, or if it were determined that such earnings are to be remitted in the foreseeable future, additional tax provisions would be required. Due to complexities in the tax laws and assumptions that would have to be made, it is not practicable to estimate the amounts ofProvision for income taxes that would have to be provided. Reforms to U.S. tax laws related to foreign earnings have been proposed and if adopted, may increase taxes, which could reducein interim periods are determined based on the results of operations and cash flows. BMS operates under a favorable tax grant in Puerto Rico not scheduled to expire prior to 2023.
Jurisdictionalestimated annual effective tax rates and otherthe tax impacts attributed to R&D charges, divestiture transactions and otherimpact of discrete pretax items increasedthat are reflected immediately. The reduction in the effective tax rate during the three months ended September 30, 2023 was primarily due to recently issued Section 174 guidance regarding deductibility of certain non-U.S. research and development expenses. The revised guidance resulted in a reduction of previously estimated income taxes attributed to 2022 which was reflected in the current quarter as well as a reduction in the estimated annual effective rates for 2023. Previously estimated income taxes for 2022 were reduced by 3.7%approximately $240 million upon finalization of the U.S. Federal tax return primarily due to the aforementioned revised Section 174 guidance that was issued during the third quarter of 2023. In addition, the effective tax rate during the first nine months of 2023 was impacted by a $656 million deferred income tax benefit following the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments, jurisdictional earnings mix resulting from amortization of acquired intangible assets, equity investment losses, litigation and 3.1%other settlements, as well as releases of income tax reserves of $89 million related to the resolution of Celgene's 2009-2011 IRS audits, partially offset by the impact of changes in the Puerto Rico tax decree that eliminated a previously creditable excise tax. 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. Income tax payments were $4.1 billion and $3.9 billion for the nine months ended September 30, 20172023 and 2016, respectively, including non-deductible R&D asset acquisition charges and goodwill allocated to business divestitures. The tax impact for discrete items are reflected immediately and are not considered in estimating the annual effective tax rate.2022, respectively.
The adoption of the amended guidance for intra-entity transfers of assets other than inventory and share-based payment transactions reduced the effective tax rate by 2.1% in the nine months ended September 30, 2017. Refer to "—Note 1. Basis of Presentation and Recently Issued Accounting Standards" for additional information.
BMS is currently under examination by a number of tax authorities which havethat 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 issues 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 issues. In the fourth quarter of 2022, BMS entered the IRS administrative appeals process to resolve these matters. Timing of the final resolution of these complex matters is uncertain and could have a material impact on BMS's consolidated financial statements.
It is reasonably possible that new issues will be raised by tax authorities which may require adjustments to the amount of unrecognized tax benefits; however, an estimatebenefits as of such adjustments cannot reasonably be made at this time.
It is also reasonably possible that the total amount of unrecognized tax benefits at September 30, 20172023 could decrease in the range of approximately $255$40 million to $315$60 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.
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 jurisdiction.
Note 8.8. EARNINGS PER SHARE
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions, except per share data | 2023 | | 2022 | | 2023 | | 2022 |
Net earnings attributable to BMS | $ | 1,928 | | | $ | 1,606 | | | $ | 6,263 | | | $ | 4,305 | |
| | | | | | | |
Weighted-average common shares outstanding – basic | 2,057 | | | 2,133 | | | 2,083 | | | 2,137 | |
Incremental shares attributable to share-based compensation plans | 7 | | | 15 | | | 10 | | | 17 | |
Weighted-average common shares outstanding – diluted | 2,064 | | | 2,148 | | | 2,093 | | | 2,154 | |
| | | | | | | |
Earnings per common share | | | | | | | |
Basic | $ | 0.94 | | | $ | 0.75 | | | $ | 3.01 | | | $ | 2.01 | |
Diluted | 0.93 | | | 0.75 | | | 2.99 | | | 2.00 | |
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 and nine months ended September 30, 2023 and 2022.
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Amounts in Millions, Except Per Share Data | 2017 | | 2016 | | 2017 | | 2016 |
Net Earnings Attributable to BMS used for Basic and Diluted EPS Calculation | $ | 845 |
| | $ | 1,202 |
| | $ | 3,335 |
| | $ | 3,563 |
|
| | | | | | | |
Weighted-average common shares outstanding – basic | 1,639 |
| | 1,671 |
| | 1,648 |
| | 1,670 |
|
Incremental shares attributable to share-based compensation plans | 6 |
| | 8 |
| | 7 |
| | 9 |
|
Weighted-average common shares outstanding – diluted | 1,645 |
| | 1,679 |
| | 1,655 |
| | 1,679 |
|
| | | | | | | |
Earnings per Common Share: | | | | | | | |
Basic | $ | 0.52 |
| | $ | 0.72 |
| | $ | 2.02 |
| | $ | 2.13 |
|
Diluted | $ | 0.51 |
| | $ | 0.72 |
| | $ | 2.02 |
| | $ | 2.12 |
|
Note 9.9. FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Dollars in millions | Level 1 | | Level 2 | | Level 3 | | Level 1 | | Level 2 | | Level 3 |
Cash and cash equivalents | | | | | | | | | | | |
Money market and other securities | $ | — | | | $ | 5,545 | | | $ | — | | | $ | — | | | $ | 7,770 | | | $ | — | |
Marketable debt securities | | | | | | | | | | | |
Certificates of deposit | — | | | 2 | | | — | | | — | | | 32 | | | — | |
Commercial paper | — | | | 29 | | | — | | | — | | | 98 | | | — | |
Corporate debt securities | — | | | 442 | | | — | | | — | | | — | | | — | |
U.S. Treasury securities | — | | | 23 | | | — | | | — | | | — | | | — | |
Derivative assets | — | | | 467 | | | — | | | — | | | 305 | | | — | |
Equity investments | 291 | | | 55 | | | — | | | 424 | | | 680 | | | — | |
Derivative liabilities | — | | | 120 | | | — | | | — | | | 213 | | | — | |
Contingent consideration liability | | | | | | | | | | | |
Contingent value rights | 4 | | | — | | | — | | | 5 | | | — | | | — | |
Other acquisition related contingent consideration | — | | | — | | | 9 | | | — | | | — | | | 24 | |
|
| | | | | | | | | | | | | | | |
| September 30, 2017 | | December 31, 2016 |
Dollars in Millions | Level 1 | | Level 2 | | Level 1 | | Level 2 |
Cash and cash equivalents - Money market and other securities | $ | — |
| | $ | 3,915 |
| | $ | — |
| | $ | 3,532 |
|
Marketable securities: | | | | | | | |
Certificates of deposit | — |
| | 176 |
| | — |
| | 27 |
|
Commercial paper | — |
| | 977 |
| | — |
| | 750 |
|
Corporate debt securities | — |
| | 3,725 |
| | — |
| | 3,947 |
|
Equity funds | — |
| | 119 |
| | — |
| | 101 |
|
Fixed income funds | — |
| | 7 |
| | — |
| | 7 |
|
Derivative assets | — |
| | 31 |
| | — |
| | 75 |
|
Equity investments | 90 |
| | — |
| | 24 |
| | — |
|
Derivative liabilities | — |
| | (63 | ) | | — |
| | (30 | ) |
As further described in "Note"Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements" in our 2016the Company's 2022 Form 10-K, ourthe 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). ThereThe fair value of Level 2 equity investments is adjusted for characteristics specific to the security and is not adjusted for contractual sale restrictions. Equity investments subject to contractual sale restrictions were no Level 3 financial assets or liabilitiesnot material as of September 30, 2017 and December 31, 2016.2022 and the restrictions expired in April 2023.
Available-for-saleMarketable Debt Securities
The following table summarizes available-for-salemarketable debt securities:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
Dollars in millions | Amortized Cost | | Gross Unrealized | | | | Amortized Cost | | Gross Unrealized | | |
| Gains | | Losses | | Fair Value | | | Gains | | Losses | | Fair Value |
Certificates of deposit | $ | 2 | | | $ | — | | | $ | — | | | $ | 2 | | | $ | 32 | | | $ | — | | | $ | — | | | $ | 32 | |
Commercial paper | 29 | | | — | | | — | | | 29 | | | 98 | | | — | | | — | | | 98 | |
Corporate debt securities | 445 | | | — | | | (3) | | | 442 | | | — | | | — | | | — | | | — | |
U.S. Treasury securities | 23 | | | — | | | — | | | 23 | | | — | | | — | | | — | | | — | |
Total marketable debt securities(a) | $ | 499 | | | $ | — | | | $ | (3) | | | $ | 496 | | | $ | 130 | | | $ | — | | | $ | — | | | $ | 130 | |
(a) All marketable debt securities mature within three years as of September 30, 2023, and one year as of December 31, 2022.
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2017 | | December 31, 2016 |
Dollars in Millions | Amortized Cost | | Gross Unrealized | | | | Amortized Cost | | Gross Unrealized | | |
| Gains | | Losses | | Fair Value | | | Gains | | Losses | | Fair Value |
Certificates of deposit | $ | 176 |
| | $ | — |
| | $ | — |
| | $ | 176 |
| | $ | 27 |
| | $ | — |
| | $ | — |
| | $ | 27 |
|
Commercial paper | 977 |
| | — |
| | — |
| | 977 |
| | 750 |
| | — |
| | — |
| | 750 |
|
Corporate debt securities | 3,713 |
| | 15 |
| | (3 | ) | | 3,725 |
| | 3,945 |
| | 10 |
| | (8 | ) | | 3,947 |
|
Equity investments | 57 |
| | 34 |
| | (1 | ) | | 90 |
| | 31 |
| | — |
| | (7 | ) | | 24 |
|
| $ | 4,923 |
| | $ | 49 |
| | $ | (4 | ) | | $ | 4,968 |
| | $ | 4,753 |
| | $ | 10 |
| | $ | (15 | ) | | $ | 4,748 |
|
| | | | | | | | | | | | | | | |
Financial assets measured using the fair value option | | | | | | | | | | | | |
Equity and fixed income funds(a) | | | | | | | 126 |
| | | | | | | | 108 |
|
Total | | | | | | | $ | 5,094 |
| | | | | | | | $ | 4,856 |
|
Equity Investments
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Current marketable securities | $ | 2,478 |
| | $ | 2,113 |
|
Non-current marketable securities(b) | 2,526 |
| | 2,719 |
|
Other assets(c) | 90 |
| | 24 |
|
Total | $ | 5,094 |
| | $ | 4,856 |
|
The following summarizes the carrying amount of equity investments: | |
(a) | The fair value option for financial assets was elected for investments in equity and fixed income funds and are included in current marketable securities. |
| |
(b) | All non-current marketable securities mature within five years as of September 30, 2017 and December 31, 2016. |
| |
(c) | Includes equity investments. |
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Equity investments with readily determinable fair values | $ | 346 | | | $ | 1,104 | |
Equity investments without readily determinable fair values | 654 | | | 537 | |
Limited partnerships and other equity method investments | 557 | | | 546 | |
Total equity investments | $ | 1,557 | | | $ | 2,187 | |
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 September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Equity investments with readily determinable fair values | | | | | | | |
Net loss recognized | 15 | | | 75 | | | 203 | | | 927 | |
Less: net (gain) loss recognized on investments sold | (86) | | | (1) | | | 2 | | | (17) | |
Net unrealized loss recognized on investments still held | 101 | | | 76 | | | 201 | | | 944 | |
| | | | | | | |
Equity investments without readily determinable fair values | | | | | | | |
Upward adjustments | (3) | | | (64) | | | (9) | | | (70) | |
Impairments and downward adjustments | 6 | | | — | | | 6 | | | 2 | |
Equity in net (income)/loss of affiliates | (18) | | | 3 | | | 13 | | | 107 | |
| | | | | | | |
Total equity investment losses | — | | | 14 | | | 213 | | | 966 | |
Cumulative upwards adjustments and cumulative impairments and downward adjustments based on observable price changes in equity investments without readily determinable fair values still held as of September 30, 2023 were $189 million and $67 million, respectively.
Qualifying Hedges and Non-Qualifying Derivatives
Cash Flow Hedges
BMS enters into foreign currency forward and purchased local currency put option contracts (foreign exchange contracts) to hedge certain forecasted intercompany inventory sales and certain other foreign currency transactions. The following table summarizesobjective of these foreign exchange contracts is to reduce variability caused by changes in foreign exchange rates that would affect the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro and Japanese yen. The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the consolidated balance sheets. Changes in fair value for these foreign exchange contracts, which are designated as cash flow hedges, are temporarily recorded in Accumulated other comprehensive loss ("AOCL") and reclassified to net earnings when the hedged item affects earnings (typically within the next 24 months). As of September 30, 2023, assuming market rates remain constant through contract maturities, we expect to reclassify pre-tax gains of $179 million into Cost of products sold for our foreign exchange contracts out of AOCL during the next 12 months. The notional amount of outstanding foreign currency exchange contracts was primarily $5.0 billion for the euro contracts and $1.1 billion for Japanese yen contracts as of September 30, 2023.
BMS also enters into cross-currency swap contracts to hedge exposure to foreign currency exchange rate risk associated with its long-term debt denominated in euros. These contracts convert interest payments and principal repayment of the long-term debt to U.S. dollars from euros and are designated as cash flow hedges. The unrealized gains and losses on these contracts are reported in AOCL and reclassified to Other (income)/expense, net, in the same periods during which the hedged debt affects earnings. The notional amount of cross-currency swap contracts associated with long-term debt denominated in euros was $1.2 billion as of September 30, 2023.
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. The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not material during all periods presented. Foreign currency exchange contracts not designated as a cash flow hedge offset exposures in certain foreign currency denominated assets, liabilities and earnings. Changes in the fair value of outstanding derivatives:these derivatives are recognized in earnings as they occur.
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2017 | | December 31, 2016 |
| 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 | $ | — |
| | $ | — |
| | $ | 755 |
| | $ | (3 | ) | | $ | 750 |
| | $ | 1 |
| | $ | 755 |
| | $ | (3 | ) |
Forward starting interest rate swap contracts | — |
| | — |
| | — |
| | — |
| | 500 |
| | 8 |
| | 250 |
| | (11 | ) |
Foreign currency forward contracts | 1,351 |
| | 25 |
| | 548 |
| | (28 | ) | | 967 |
| | 66 |
| | 198 |
| | (9 | ) |
| | | | | | | | | | | | | | | |
Derivatives not designated as hedging instruments: | | | | | | | | | | | | | | | |
Foreign currency forward contracts | 322 |
| | 6 |
| | 1,183 |
| | (32 | ) | | 106 |
| | — |
| | 360 |
| | (7 | ) |
| |
(a) | Included in prepaid expenses and other and other assets. |
| |
(b) | Included in accrued liabilities and pension and other liabilities. |
Net Investment Hedges
Cash Flow Hedges —
Cross-currency swap contracts and foreign currency forward contracts of $1.8 billion as of September 30, 2023 are designated to hedge currency exposure of BMS's net investment in its foreign subsidiaries. Contract fair value changes are recorded in the foreign currency translation component of AOCL with a related offset in derivative asset or liability in the consolidated balance sheets. The notional amount of outstanding cross-currency swap and foreign currency forward contracts was primarily attributed to the euro ($2.2 billion) and Japanese yen ($586 million) atof $650 million and euro of $794 million as of September 30, 2017. BMS terminated forward starting interest rate swap contracts in2023.
During the first quarter of 2017 with an aggregate notional value2023, the Company de-designated its remaining net investment hedge in debt denominated in euros of $750€375 million. The proceeds and related gain were not material.
Net Investment Hedges — Non-U.S. dollar borrowings of €950 million ($1.1 billion) are designatednet investment hedge was entered into to hedge euro currency exposures of the net investment in certain foreign affiliates.affiliates and was recognized in Long-term debt. The effective portion of foreign exchange gain or loss on the remeasurement of debt denominated in euros was included in the foreign currency translation component of AOCL with the related offset in Long-term debt.
During the three and nine months ended September 30, 2023, the amortization of gains related to the portion of our net investment hedges that was excluded from the assessment of effectiveness was not material.
Fair Value Hedges — The notional amount of fixed-to-floating
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. 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 in the consolidated balance sheets. As a result, there was no net impact in earnings. If the underlying swap is terminated was $500 millionprior 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.
Derivative cash flows, with the exception of net investment hedges, are principally classified in 2016 generating proceedsthe operating section of $43 million (including accrued interest).the consolidated statements of cash flows, consistent with the underlying hedged item. Cash flows related to net investment hedges are classified in investing activities.
The following table summarizes the fair value and the notional values of outstanding derivatives:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2023 | | December 31, 2022 |
| 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 | $ | 6,420 | | | $ | 326 | | | $ | 926 | | | $ | (26) | | | $ | 5,771 | | | $ | 271 | | | $ | 2,281 | | | $ | (80) | |
Cross-currency swap contracts | 584 | | | 12 | | | 626 | | | (14) | | | — | | | — | | | 584 | | | (7) | |
Designated as net investment hedges | | | | | | | | | | | | | | | |
Foreign currency exchange contracts | 416 | | | 20 | | | — | | | — | | | — | | | — | | | — | | | — | |
Cross-currency swap contracts | 481 | | | 23 | | | 947 | | | (18) | | | 72 | | | 1 | | | 1,157 | | | (78) | |
Designated as fair value hedges | | | | | | | | | | | | | | | |
Interest rate swap contracts | — | | | — | | | 3,755 | | | (24) | | | — | | | — | | | 255 | | | (18) | |
Not designated as hedges | | | | | | | | | | | | | | | |
Foreign currency exchange contracts | 2,048 | | | 86 | | | 1,486 | | | (21) | | | 1,564 | | | 33 | | | 1,703 | | | (19) | |
Total return swap contracts (c) | — | | | — | | | 359 | | | (17) | | | — | | | — | | | 322 | | | (11) | |
(a) Included in Other current assets and Other non-current assets.
(b) Included in Other current liabilities and Other non-current liabilities.
(c) Total return swap contracts hedge changes in fair value of certain deferred compensation liabilities.
The following table summarizes the financial statement classification and amount of (gain)/loss recognized on hedges:
| | | | | | | | | | | | | | | | | | | | | | | |
| 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 | $ | (51) | | | $ | (40) | | | $ | (261) | | | $ | (100) | |
Cross-currency swap contracts | — | | | 26 | | | — | | | (2) | |
Interest rate swap contracts | — | | | — | | | — | | | (7) | |
| | | | | | | |
| Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2022 |
Dollars in millions | Cost of products sold | | Other (income)/expense, net | | Cost of products sold | | Other (income)/expense, net |
Foreign currency exchange contracts | $ | (195) | | | $ | (61) | | | $ | (408) | | | $ | (136) | |
Cross-currency swap contracts | — | | | 13 | | | — | | | 5 | |
Interest rate swap contracts | — | | | (5) | | | — | | | (23) | |
The following table summarizes the effect of derivative and non-derivative instruments designated as hedges in Other comprehensive income:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Derivatives designated as cash flow hedges | | | | | | | |
Foreign exchange contracts gain/(loss): | | | | | | | |
Recognized in Other comprehensive income | $ | 173 | | | $ | 548 | | | $ | 226 | | | $ | 1,149 | |
Reclassified to Cost of products sold | (51) | | | (195) | | | (261) | | | (408) | |
Cross-currency swap contracts gain/(loss): | | | | | | | |
Recognized in Other comprehensive income | (23) | | | (43) | | | 5 | | | (43) | |
Reclassified to Other (income)/expense, net | 35 | | | 20 | | | 26 | | | 20 | |
Forward starting interest rate swap contract loss: | | | | | | | |
Reclassified to Other (income)/expense, net | — | | | — | | | — | | | (3) | |
Derivatives designated as net investment hedges | | | | | | | |
Cross-currency swap contracts gain/(loss): | | | | | | | |
Recognized in Other comprehensive income | 59 | | | 71 | | | 94 | | | 135 |
Foreign exchange contracts gain/(loss): | | | | | | | |
Recognized in Other comprehensive income | 18 | | | — | | | 18 | | | — | |
Non-derivatives designated as net investment hedges | | | | | | | |
Non-U.S. dollar borrowings gain/(loss): | | | | | | | |
Recognized in Other comprehensive income | — | | | 40 | | | (10) | | | 123 | |
Note 10. FINANCING ARRANGEMENTS
Short-term debt obligations include:
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Non-U.S. short-term debt obligations | $ | 164 | | | $ | 176 | |
Current portion of Long-term debt | 4,873 | | | 3,897 | |
Other | 430 | | | 191 | |
Total | $ | 5,467 | | | $ | 4,264 | |
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Commercial paper | $ | 799 |
| | $ | — |
|
Bank drafts and short-term borrowings | 662 |
| | 243 |
|
Current portion of long-term debt | — |
| | 749 |
|
Total | $ | 1,461 |
| | $ | 992 |
|
The average amount of commercial paper outstanding was $211 million at a weighted-average rate of 1.12% during 2017. The maximum amount of commercial paper outstanding was $1.0 billion with $799 million outstanding at September 30, 2017.
Long-term debt and the current portion of long-termLong-term debt include:
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Principal value | $ | 36,329 | | | $ | 38,234 | |
Adjustments to principal value: | | | |
Fair value of interest rate swap contracts | (24) | | | (18) | |
Unamortized basis adjustment from swap terminations | 85 | | | 97 | |
Unamortized bond discounts and issuance costs | (265) | | | (284) | |
Unamortized purchase price adjustments of Celgene debt | 885 | | | 924 | |
Total | $ | 37,010 | | | $ | 38,953 | |
| | | |
Current portion of Long-term debt | $ | 4,873 | | | $ | 3,897 | |
Long-term debt | 32,137 | | | 35,056 | |
Total | $ | 37,010 | | | $ | 38,953 | |
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Principal Value | $ | 6,834 |
| | $ | 6,261 |
|
Adjustments to Principal Value: | | | |
Fair value of interest rate swap contracts | (3 | ) | | (2 | ) |
Unamortized basis adjustment from swap terminations | 234 |
| | 287 |
|
Unamortized bond discounts and issuance costs | (83 | ) | | (81 | ) |
Total | $ | 6,982 |
| | $ | 6,465 |
|
| | | |
Current portion of long-term debt | $ | — |
| | $ | 749 |
|
Long-term debt | 6,982 |
| | 5,716 |
|
The fair value of Long-term debt was $7.4$31.7 billion atas of September 30, 20172023 and $6.9$34.9 billion atas of December 31, 20162022 valued using Level 2 inputs. Interest payments were $172 million and $140 millioninputs, which are based upon the quoted market prices for the same or similar debt instruments. The fair value of Short-term debt obligations approximates the carrying value due to the short maturities of the debt instruments.
During the nine months ended September 30, 20172023, $1.9 billion of debt matured and 2016, respectively, netwas repaid including $750 million 2.750% Notes, $890 million 3.250% Notes and $239 million 7.150% Notes.
During the nine months ended September 30, 2022, $4.8 billion of amounts related to interest rate swap contracts.debt matured and was repaid including $1.5 billion 2.600% Notes, $500 million Floating Rate Notes, $750 million 2.000% Notes, $1.0 billion 3.250% Notes and $1.0 billion 3.550% Notes.
On February 27, 2017,During the nine months ended September 30, 2022, BMS issued senior unsecured notes in a registered public offering.an aggregate principal amount of $6.0 billion of debt with net proceeds of $5.9 billion. The notes rank equally in right of payment with all of BMS's existing and future senior unsecured indebtedness. BMS may redeem the notes,indebtedness and are redeemable at any time, in whole, or in part, at any time prior to maturity atvarying specified redemption prices plus accrued and unpaid interest. In addition, BMS purchased an aggregate principal amount of $6.0 billion of certain of its debt securities for $6.6 billion of cash in tender offers and "make-whole" redemptions. In connection with these transactions, a predetermined$266 million net loss on debt redemption price. The following table summarizeswas recognized based on the note issuances:
|
| | | |
Dollars in Millions | 2017 |
Principal Value: | |
1.600% Notes due 2019 | $ | 750 |
|
3.250% Notes due 2027 | 750 |
|
Total | $ | 1,500 |
|
| |
Proceeds net of discount and deferred loan issuance costs | $ | 1,488 |
|
During the third quartercarrying value of 2017, $750 million of 0.875% Notes matured and were repaid.
During the second quarter of 2017, the Company repurchased certain long-term debt obligations with interest rates ranging from 5.875% to 6.875%. The following summarizes the debt repurchase activity:and included in Other (income)/expense, net.
Interest payments were $932 million and $1.1 billion for the nine months ended September 30, 2023 and 2022, respectively, net of amounts related to interest rate swap contracts.
Credit Facilities
As of September 30, 2023, BMS had a five-year $5.0 billion revolving credit facility expiring in January 2028, 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. No borrowings were outstanding under the revolving credit facility as of September 30, 2023 and December 31, 2022.
Note 11. RECEIVABLES
|
| | | |
Dollars in Millions | 2017 |
Principal amount | $ | 337 |
|
Carrying value | 366 |
|
Debt redemption price | 474 |
|
Loss on debt redemption(a) | 109 |
|
| |
(a) | Including acceleration of debt issuance costs, gain on previously terminated interest rate swap contracts and other related fees. |
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Trade receivables | $ | 9,095 | | | $ | 8,848 | |
Less: charge-backs and cash discounts | (661) | | | (675) | |
Less: allowance for expected credit loss | (27) | | | (22) | |
Net trade receivables | 8,407 | | | 8,151 | |
Alliance, royalties, VAT and other | 1,897 | | | 1,735 | |
Receivables | $ | 10,304 | | | $ | 9,886 | |
Note 10. RECEIVABLES
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Trade receivables | $ | 4,564 |
| | $ | 3,948 |
|
Less charge-backs and cash discounts | (184 | ) | | (126 | ) |
Less bad debt allowances | (48 | ) | | (48 | ) |
Net trade receivables | 4,332 |
| | 3,774 |
|
Alliance receivables | 878 |
| | 903 |
|
Prepaid and refundable income taxes | 334 |
| | 627 |
|
Other | 378 |
| | 239 |
|
Receivables | $ | 5,922 |
| | $ | 5,543 |
|
Non-U.S. receivables sold on a nonrecourse basis were $460$769 million and $470 million for the nine months ended September 30, 2017 and 2016, respectively. Receivables from our three largest pharmaceutical wholesalers in the U.S. represented 64% and 66% of total trade receivables at September 30, 2017 and December 31, 2016, respectively.
Note 11. INVENTORIES
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Finished goods | $ | 380 |
| | $ | 310 |
|
Work in process | 956 |
| | 988 |
|
Raw and packaging materials | 224 |
| | 264 |
|
Total inventories | $ | 1,560 |
| | $ | 1,562 |
|
| | | |
Inventories | $ | 1,250 |
| | $ | 1,241 |
|
Other assets | 310 |
| | 321 |
|
Inventories of $120 million are included in assets held-for-sale as of September 30, 2017 due to the expected transfer of manufacturing operations in Swords, Ireland to SK Biotek. Refer to "—Note 4. Acquisitions, Divestitures and Licensing Arrangements" for additional information. Other assets include inventory expected to remain on hand beyond one year in both periods and inventory pending regulatory approval of $54 million at December 31, 2016.
Note 12. PROPERTY, PLANT AND EQUIPMENT
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Land | $ | 105 |
| | $ | 107 |
|
Buildings | 5,188 |
| | 4,930 |
|
Machinery, equipment and fixtures | 3,034 |
| | 3,287 |
|
Construction in progress | 938 |
| | 849 |
|
Gross property, plant and equipment | 9,265 |
| | 9,173 |
|
Less accumulated depreciation | (4,251 | ) | | (4,193 | ) |
Property, plant and equipment | $ | 5,014 |
| | $ | 4,980 |
|
Depreciation expense was $509 million and $319$809 million for the nine months ended September 30, 20172023 and 2016,2022, respectively. Refer to "—Receivables from the three largest customers in the U.S. represented 71% and 66% of total trade receivables as of September 30, 2023 and December 31, 2022, respectively.
Note 4. Acquisitions, Divestitures and Licensing Arrangements" for additional information relating12. INVENTORIES
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Finished goods | $ | 533 | | | $ | 509 | |
Work in process | 2,289 | | | 1,850 | |
Raw and packaging materials | 461 | | | 464 | |
Total inventories | $ | 3,283 | | | $ | 2,823 | |
| | | |
Inventories | $ | 2,436 | | | $ | 2,339 | |
Other non-current assets | 847 | | | 484 | |
The fair value adjustment related to the expected transferCelgene acquisition was $84 million as of manufacturing operationsDecember 31, 2022 and was fully amortized in Swords, Ireland to SK Biotek.the second quarter of 2023.
Note 13. PROPERTY, PLANT AND EQUIPMENT
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Land | $ | 162 | | | $ | 162 | |
Buildings | 6,280 | | | 5,920 | |
Machinery, equipment and fixtures | 3,576 | | | 3,284 | |
Construction in progress | 1,114 | | | 1,053 | |
Gross property, plant and equipment | 11,132 | | | 10,419 | |
Less accumulated depreciation | (4,651) | | | (4,164) | |
Property, plant and equipment | $ | 6,481 | | | $ | 6,255 | |
Depreciation expense was $151 million and $448 million for the three and nine months ended September 30, 2023 and $148 million and $434 million for the three and nine months ended September 30, 2022, respectively.
Note 14. GOODWILL AND OTHER INTANGIBLE ASSETS
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Licenses | $ | 564 |
| | $ | 564 |
|
Developed technology rights | 2,357 |
| | 2,357 |
|
Capitalized software | 1,339 |
| | 1,441 |
|
IPRD | 32 |
| | 107 |
|
Gross other intangible assets | 4,292 |
| | 4,469 |
|
Less accumulated amortization | (3,079 | ) | | (3,084 | ) |
Other intangible assets | $ | 1,213 |
| | $ | 1,385 |
|
Goodwill
The changes in the carrying amounts in Goodwill were as follows:
| | | | | | | |
Dollars in millions | | | |
Balance at December 31, 2022 | $ | 21,149 | | | |
| | | |
Currency translation and other adjustments | (2) | | | |
Balance at September 30, 2023 | $ | 21,147 | | | |
Other Intangible Assets
Other intangible assets consisted of the following:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Estimated Useful Lives | | September 30, 2023 | | December 31, 2022 |
Dollars in millions | | Gross carrying amounts | | Accumulated amortization | | Other intangible assets, net | | Gross carrying amounts | | Accumulated amortization | | Other intangible assets, net |
Licenses | 5 – 15 years | | $ | 363 | | | $ | (144) | | | $ | 219 | | | $ | 400 | | | $ | (128) | | | $ | 272 | |
Acquired marketed product rights | 3 – 15 years | | 59,577 | | | (37,794) | | | 21,783 | | | 60,477 | | | (31,949) | | | 28,528 | |
Capitalized software | 3 – 10 years | | 1,639 | | | (1,171) | | | 468 | | | 1,555 | | | (1,056) | | | 499 | |
IPRD | | | 6,480 | | | — | | | 6,480 | | | 6,560 | | | — | | | 6,560 | |
Total | | | $ | 68,059 | | | $ | (39,109) | | | $ | 28,950 | | | $ | 68,992 | | | $ | (33,133) | | | $ | 35,859 | |
Amortization expense of Other intangible assets was $142$2.3 billion and $6.9 billion during the three and nine months ended September 30, 2023 and $2.5 billion and $7.4 billion for the three and nine months ended September 30, 2022, respectively.
The other intangible assets impairments were as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
IPRD | $ | 60 | | | $ | 58 | | | $ | 80 | | | $ | 98 | |
Licenses | 29 | | | — | | | 29 | | | — | |
Total | $ | 89 | | | $ | 58 | | | $ | 109 | | | $ | 98 | |
IPRD impairment charges were recognized following decisions to discontinue development of investigational compounds in connection with the prioritization of pipeline opportunities and were recorded in Research and development expense. Licenses impairment charges were recognized for out-licensed assets following assessments of future economic benefits and were included in Other Income/(expense), net. The impairments represented full write-downs.
Note 15. SUPPLEMENTAL FINANCIAL INFORMATION
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Income taxes | $ | 4,933 | | | $ | 3,547 | |
Research and development | 714 | | | 579 | |
Contract assets | 410 | | | 504 | |
| | | |
Restricted cash(a) | 54 | | | 148 | |
Other | 1,096 | | | 1,017 | |
Other current assets | $ | 7,207 | | | $ | 5,795 | |
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Equity investments (Note 9) | $ | 1,557 | | | $ | 2,187 | |
Operating leases | 1,367 | | | 1,220 | |
Inventories | 847 | | | 484 | |
Pension and postretirement | 296 | | | 285 | |
Research and development | 427 | | | 496 | |
Restricted cash(a) | — | | | 54 | |
Receivables and convertible notes | 432 | | | — | |
Other | 288 | | | 214 | |
Other non-current assets | $ | 5,214 | | | $ | 4,940 | |
(a) Restricted cash primarily 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. As of September 30, 2022, restricted cash of $223 million was included in Cash, cash equivalents and $134 millionrestricted cash in the consolidated statement of cash flows.
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Rebates and discounts | $ | 7,782 | | | $ | 6,702 | |
Income taxes | 1,458 | | | 942 | |
Employee compensation and benefits | 876 | | | 1,425 | |
Research and development | 1,307 | | | 1,359 | |
Dividends | 1,160 | | | 1,196 | |
Interest | 371 | | | 321 | |
Royalties | 427 | | | 431 | |
Operating leases | 150 | | | 136 | |
| | | |
Other | 1,651 | | | 2,074 | |
Other current liabilities | $ | 15,182 | | | $ | 14,586 | |
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Income taxes | $ | 3,215 | | | $ | 3,992 | |
Pension and postretirement | 386 | | | 402 | |
Operating leases | 1,513 | | | 1,261 | |
Deferred income | 316 | | | 283 | |
Deferred compensation | 384 | | | 349 | |
Other | 389 | | | 303 | |
Other non-current liabilities | $ | 6,203 | | | $ | 6,590 | |
Note 16. EQUITY
The following table summarizes changes in equity for the nine months ended September 30, 2017 and 2016, respectively.2023:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | 2,923 | | | $ | 292 | | | $ | 45,165 | | | $ | (1,281) | | | $ | 25,503 | | | 825 | | | $ | (38,618) | | | $ | 57 | |
Net earnings | — | | | — | | | — | | | — | | | 2,262 | | | — | | | — | | | 5 | |
Other comprehensive loss | — | | | — | | | — | | | (87) | | | — | | | — | | | — | | | — | |
Cash dividends declared $0.57 per share | — | | | — | | | — | | | — | | | (1,197) | | | — | | | — | | | — | |
Share repurchase program | — | | | — | | | — | | | — | | | — | | | 4 | | | (250) | | | — | |
Stock compensation | — | | | — | | | (25) | | | — | | | — | | | (6) | | | 60 | | | — | |
Balance at March 31, 2023 | 2,923 | | | $ | 292 | | | $ | 45,140 | | | $ | (1,368) | | | $ | 26,568 | | | 823 | | | $ | (38,808) | | | $ | 62 | |
Net earnings | — | | | — | | | — | | | — | | | 2,073 | | | — | | | — | | | 4 | |
Other comprehensive loss | — | | | — | | | — | | | (19) | | | — | | | — | | | — | | | — | |
Cash dividends declared $0.57 per share | — | | | — | | | — | | | — | | | (1,192) | | | — | | | — | | | — | |
Share repurchase program | — | | | — | | | — | | | — | | | — | | | 13 | | | (911) | | | — | |
Stock compensation | — | | | — | | | 159 | | | — | | | — | | | (2) | | | 39 | | | — | |
Distributions | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (9) | |
Balance at June 30, 2023 | 2,923 | | | 292 | | | 45,299 | | | (1,387) | | | 27,449 | | | 834 | | | (39,680) | | | 57 | |
Net Earnings | — | | | — | | | — | | | — | | | 1,928 | | | — | | | — | | | 7 | |
Other comprehensive income | — | | | — | | | — | | | 101 | | | — | | | — | | | — | | | — | |
Cash dividends declared $0.57 per share | — | | | — | | | — | | | — | | | (1,159) | | | — | | | — | | | — | |
Stock repurchase program | — | | | — | | | (600) | | | — | | | — | | | 56 | | | (3,433) | | | — | |
Stock compensation | — | | | — | | | 146 | | | — | | | — | | | (1) | | | 27 | | | — | |
Convertible debt | — | | | — | | | 4 | | | — | | | — | | | — | | | 11 | | | — | |
| | | | | | | | | | | | | | | |
Balance at September 30, 2023 | 2,923 | | | $ | 292 | | | $ | 44,849 | | | $ | (1,286) | | | $ | 28,218 | | | 889 | | | $ | (43,075) | | | $ | 64 | |
Note 14. ACCRUED LIABILITIES
|
| | | | | | | | |
Dollars in Millions | | September 30, 2017 | | December 31, 2016 |
Rebates and returns | | $ | 1,901 |
| | $ | 1,680 |
|
Employee compensation and benefits | | 702 |
| | 818 |
|
Research and development | | 689 |
| | 718 |
|
Dividends | | 639 |
| | 660 |
|
Branded Prescription Drug Fee | | 251 |
| | 234 |
|
Royalties | | 249 |
| | 246 |
|
Restructuring | | 121 |
| | 90 |
|
Pension and postretirement benefits | | 41 |
| | 44 |
|
Litigation and other settlements | | 35 |
| | 43 |
|
Other | | 790 |
| | 738 |
|
Accrued liabilities | | $ | 5,418 |
| | $ | 5,271 |
|
Note 15. EQUITY
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 January 1, 2016 | 2,208 |
| | $ | 221 |
| | $ | 1,459 |
| | $ | (2,468 | ) | | $ | 31,613 |
| | 539 |
| | $ | (16,559 | ) | | $ | 158 |
|
Net earnings | — |
| | — |
| | — |
| | — |
| | 3,563 |
| | — |
| | — |
| | 46 |
|
Other comprehensive loss | — |
| | — |
| | — |
| | (267 | ) | | — |
| | — |
| | — |
| | — |
|
Cash dividends declared | — |
| | — |
| | — |
| | — |
| | (1,904 | ) | | — |
| | — |
| | — |
|
Stock repurchase program | — |
| | — |
| | — |
| | — |
| | — |
| | 4 |
| | (231 | ) | | — |
|
Stock compensation | — |
| | — |
| | 191 |
| | — |
| | — |
| | (6 | ) | | (5 | ) | | — |
|
Distributions | — |
| | — |
| | — |
| | — |
| | — |
| | — |
| | — |
| | (36 | ) |
Balance at September 30, 2016 | 2,208 |
| | $ | 221 |
| | $ | 1,650 |
| | $ | (2,735 | ) | | $ | 33,272 |
| | 537 |
| | $ | (16,795 | ) | | $ | 168 |
|
| | | | | | | | | | | | | | | |
Balance at December 31, 2016 | 2,208 |
| | $ | 221 |
| | $ | 1,725 |
| | $ | (2,503 | ) | | $ | 33,513 |
| | 536 |
| | $ | (16,779 | ) | | $ | 170 |
|
Accounting change - cumulative effect(a) | — |
| | — |
| | — |
| | — |
| | (787 | ) | | — |
| | — |
| | — |
|
Adjusted balance at January 1, 2017 | 2,208 |
| | $ | 221 |
| | $ | 1,725 |
| | $ | (2,503 | ) | | $ | 32,726 |
| | 536 |
| | $ | (16,779 | ) | | $ | 170 |
|
Net earnings | — |
| | — |
| | — |
| | — |
| | 3,335 |
| | — |
| | — |
| | 28 |
|
Other comprehensive income | — |
| | — |
| | — |
| | 82 |
| | — |
| | — |
| | — |
| | — |
|
Cash dividends declared | — |
| | — |
| | — |
| | — |
| | (1,920 | ) | | — |
| | — |
| | — |
|
Stock repurchase program | — |
| | — |
| | — |
| | — |
| | — |
| | 40 |
| | (2,226 | ) | | — |
|
Stock compensation | — |
| | — |
| | 120 |
| | — |
| | — |
| | (5 | ) | | 2 |
| | — |
|
Variable interest entity | — |
| | — |
| | — |
| | — |
| | — |
| | — |
| | — |
| | (59 | ) |
Distributions | — |
| | — |
| | — |
| | — |
| | — |
| | — |
| | — |
| | (8 | ) |
Balance at September 30, 2017 | 2,208 |
| | $ | 221 |
| | $ | 1,845 |
| | $ | (2,421 | ) | | $ | 34,141 |
| | 571 |
| | $ | (19,003 | ) | | $ | 131 |
|
| |
(a) | Refer to "—Note 1. Basis of Presentation and Recently Issued Accounting Standards" for additional information. |
BMS has a stock repurchase program authorized by its Board of Directors allowingThe following table summarizes changes in equity for repurchases in the open market or through private transactions, including plans established in accordance with Rule 10b5-1 under the Securities Exchange Act of 1934. The stock repurchase program does not have an 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. BMS repurchased approximately 3.8 million shares for $226 million during the threenine months ended September 30, 2017.2022:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | 2,923 | | | $ | 292 | | | $ | 44,361 | | | $ | (1,268) | | | $ | 23,820 | | | 747 | | | $ | (31,259) | | | $ | 60 | |
Net earnings | — | | | — | | | — | | | — | | | 1,278 | | | — | | | — | | | 5 | |
Other comprehensive income | — | | | — | | | — | | | 39 | | | — | | | — | | | — | | | — | |
Cash dividends declared $0.54 per share | — | | | — | | | — | | | — | | | (1,150) | | | — | | | — | | | — | |
Share repurchase program | — | | | — | | | (750) | | | — | | | — | | | 65 | | | (4,250) | | | — | |
Stock compensation | — | | | — | | | 145 | | | — | | | — | | | (18) | | | 322 | | | — | |
| | | | | | | | | | | | | | | |
Balance at March 31, 2022 | 2,923 | | | $ | 292 | | | $ | 43,756 | | | $ | (1,229) | | | $ | 23,948 | | | 794 | | | $ | (35,187) | | | $ | 65 | |
Net earnings | — | | | — | | | — | | | — | | | 1,421 | | | — | | | — | | | 8 | |
Other comprehensive income | — | | | — | | | — | | | 237 | | | — | | | — | | | — | | | — | |
Cash dividends declared $0.54 per share | — | | | — | | | — | | | — | | | (1,152) | | | — | | | — | | | — | |
Stock repurchase program | — | | | — | | | 300 | | | — | | | — | | | 2 | | | (300) | | | — | |
Stock compensation | — | | | — | | | 319 | | | — | | | — | | | (8) | | | 195 | | | — | |
Distributions | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (12) | |
Balance at June 30, 2022 | 2,923 | | | 292 | | | 44,375 | | | (992) | | | 24,217 | | | 788 | | | (35,292) | | | 61 | |
Net Earnings | — | | | — | | | — | | | — | | | 1,606 | | | — | | | — | | | 2 | |
Other comprehensive income | — | | | — | | | — | | | 151 | | | — | | | — | | | — | | | — | |
Cash dividends declared $0.54 per share | — | | | — | | | — | | | — | | | (1,148) | | | — | | | — | | | — | |
Stock repurchase program | — | | | — | | | 450 | | | — | | | — | | | 12 | | | (1,151) | | | — | |
Stock compensation | — | | | — | | | 131 | | | — | | | — | | | (1) | | | 32 | | | — | |
| | | | | | | | | | | | | | | |
Balance at September 30, 2022 | 2,923 | | | $ | 292 | | | $ | 44,956 | | | $ | (841) | | | $ | 24,675 | | | 799 | | | $ | (36,411) | | | $ | 63 | |
In February 2017,
During the third quarter of 2023, BMS executedentered into accelerated share repurchase ("ASR") agreements to repurchase an aggregate $2amount of $4.0 billion of the Company's common stock. The ASR agreements were funded through a combinationwith cash on-hand and are expected to settle in the fourth quarter of debt and cash. In February 2017, an initial delivery of approximately 28.72023. Approximately 56 million shares of BMS common stock representing approximately 80%(85% of the notional$4.0 billion aggregate repurchase price) were received by BMS and included in treasury stock as of September 30, 2023. 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. In addition, as part of its share repurchase program, BMS repurchased 17 million shares of its common stock for $1.2 billion during the nine months ended September 30, 2023. The remaining share repurchase capacity under the BMS share repurchase program was approximately $2.0 billion as of September 30, 2023.
During the first quarter of 2022, BMS entered into ASR agreements to repurchase an aggregate amount of $5.0 billion of the Company's common stock. The ASR agreements waswere funded with cash on-hand and 65 million shares of common stock (85% of the $5.0 billion aggregate repurchase price) were received by BMS and included in treasury stock. Upon settlementThe remaining amounts in the ASR agreements were settled in two tranches during the second and third quarters of the accelerated share repurchase agreements in May 2017, BMS received an additional 7.82022 and 4 million shares determined using the volume-weighted average price of BMS common stock during the term of the transaction.were received by BMS and transferred to treasury stock.
The componentsfollowing table summarizes the changes in Other comprehensive income by component:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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) | $ | 150 | | | $ | (18) | | | $ | 132 | | | $ | 231 | | | $ | (31) | | | $ | 200 | |
Reclassified to net earnings(a) | (16) | | | (2) | | | (18) | | | (235) | | | 28 | | | (207) | |
Derivatives qualifying as cash flow hedges | 134 | | | (20) | | | 114 | | | (4) | | | (3) | | | (7) | |
| | | | | | | | | | | |
Pension and postretirement benefits | | | | | | | | | | | |
Actuarial gains/(losses) | 3 | | | (1) | | | 2 | | | (10) | | | 1 | | | (9) | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Marketable debt securities | | | | | | | | | | | |
Unrealized losses | (3) | | | 1 | | | (2) | | | (3) | | | 1 | | | (2) | |
| | | | | | | | | | | |
Foreign currency translation | 4 | | | (17) | | | (13) | | | 35 | | | (22) | | | 13 | |
| | | | | | | | | | | |
Other comprehensive income/(loss) | $ | 138 | | | $ | (37) | | | $ | 101 | | | $ | 18 | | | $ | (23) | | | $ | (5) | |
| | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, 2022 | | Nine Months Ended September 30, 2022 |
Dollars in millions | Pretax | | Tax | | After Tax | | Pretax | | Tax | | After Tax |
Derivatives qualifying as cash flow hedges | | | | | | | | | | | |
Recognized in Other comprehensive income | $ | 505 | | | $ | (66) | | | $ | 439 | | | $ | 1,106 | | | $ | (147) | | | $ | 959 | |
Reclassified to net earnings(a) | (175) | | | 22 | | | (153) | | | (391) | | | 50 | | | (341) | |
Derivatives qualifying as cash flow hedges | 330 | | | (44) | | | 286 | | | 715 | | | (97) | | | 618 | |
| | | | | | | | | | | |
Pension and postretirement benefits | | | | | | | | | | | |
Actuarial gains | 14 | | | (4) | | | 10 | | | 54 | | | (11) | | | 43 | |
Amortization(b) | 7 | | | (1) | | | 6 | | | 19 | | | (4) | | | 15 | |
Settlements(b) | 2 | | | — | | | 2 | | | 7 | | | (1) | | | 6 | |
Pension and postretirement benefits | 23 | | | (5) | | | 18 | | | 80 | | | (16) | | | 64 | |
| | | | | | | | | | | |
Marketable debt securities | | | | | | | | | | | |
Unrealized losses | — | | | — | | | — | | | (2) | | | — | | | (2) | |
| | | | | | | | | | | |
Foreign currency translation | (131) | | | (22) | | | (153) | | | (201) | | | (52) | | | (253) | |
| | | | | | | | | | | |
Other comprehensive income | $ | 222 | | | $ | (71) | | | $ | 151 | | | $ | 592 | | | $ | (165) | | | $ | 427 | |
(a)Included in Cost of other comprehensive income/(loss) were as follows:products sold and Other (income)/expense, net. Refer to "—Note 9. Financial Instruments and Fair Value Measurements" for further information.
(b)Included in Other (income)/expense, net. |
| | | | | | | | | | | | | | | | | | | | | | | |
| 2017 | | 2016 |
| Pretax | | Tax | | After tax | | Pretax | | Tax | | After tax |
Three Months Ended September 30, | | | | | | | | | | | |
Derivatives qualifying as cash flow hedges: | | | | | | | | | | | |
Unrealized losses | $ | (28 | ) | | $ | 12 |
| | $ | (16 | ) | | $ | (14 | ) | | $ | 4 |
| | $ | (10 | ) |
Reclassified to net earnings(a) | 21 |
| | (6 | ) | | 15 |
| | 21 |
| | (7 | ) | | 14 |
|
Derivatives qualifying as cash flow hedges | (7 | ) | | 6 |
| | (1 | ) | | 7 |
| | (3 | ) | | 4 |
|
Pension and postretirement benefits: | | | | | | | | | | | |
Actuarial gains/(losses) | (5 | ) | | 2 |
| | (3 | ) | | 72 |
| | (26 | ) | | 46 |
|
Amortization(b) | 19 |
| | (11 | ) | | 8 |
| | 20 |
| | (7 | ) | | 13 |
|
Curtailments and settlements(c) | 21 |
| | (8 | ) | | 13 |
| | 19 |
| | (6 | ) | | 13 |
|
Pension and postretirement benefits | 35 |
| | (17 | ) | | 18 |
| | 111 |
| | (39 | ) | | 72 |
|
Available-for-sale securities: | | | | | | | | | | | |
Unrealized gains/(losses) | 28 |
| | (5 | ) | | 23 |
| | (8 | ) | | 4 |
| | (4 | ) |
Realized gains(c) | (1 | ) | | — |
| | (1 | ) | | (4 | ) | | — |
| | (4 | ) |
Available-for-sale securities | 27 |
| | (5 | ) | | 22 |
| | (12 | ) | | 4 |
| | (8 | ) |
Foreign currency translation | (10 | ) | | 17 |
| | 7 |
| | (2 | ) | | 3 |
| | 1 |
|
| $ | 45 |
| | $ | 1 |
| | $ | 46 |
| | $ | 104 |
| | $ | (35 | ) | | $ | 69 |
|
| | | | | | | | | | | |
Nine Months Ended September 30, | | | | | | | | | | | |
Derivatives qualifying as cash flow hedges: | | | | | | | | | | | |
Unrealized losses | $ | (81 | ) | | $ | 31 |
| | $ | (50 | ) | | $ | (199 | ) | | $ | 66 |
| | $ | (133 | ) |
Reclassified to net earnings(a) | (11 | ) | | — |
| | (11 | ) | | 12 |
| | (5 | ) | | 7 |
|
Derivatives qualifying as cash flow hedges | (92 | ) | | 31 |
| | (61 | ) | | (187 | ) | | 61 |
| | (126 | ) |
Pension and postretirement benefits: | | | | | | | | | | | |
Actuarial losses | (40 | ) | | 17 |
| | (23 | ) | | (453 | ) | | 160 |
| | (293 | ) |
Amortization(b) | 57 |
| | (22 | ) | | 35 |
| | 56 |
| | (19 | ) | | 37 |
|
Curtailments and settlements(c) | 96 |
| | (34 | ) | | 62 |
| | 66 |
| | (23 | ) | | 43 |
|
Pension and postretirement benefits | 113 |
| | (39 | ) | | 74 |
| | (331 | ) | | 118 |
| | (213 | ) |
Available-for-sale securities: | | | | | | | | | | | |
Unrealized gains | 49 |
| | (7 | ) | | 42 |
| | 29 |
| | (13 | ) | | 16 |
|
Realized (gains)/losses(c) | (1 | ) | | — |
| | (1 | ) | | 30 |
| | — |
| | 30 |
|
Available-for-sale securities | 48 |
| | (7 | ) | | 41 |
| | 59 |
| | (13 | ) | | 46 |
|
Foreign currency translation | (8 | ) | | 36 |
| | 28 |
| | 20 |
| | 6 |
| | 26 |
|
| $ | 61 |
| | $ | 21 |
| | $ | 82 |
| | $ | (439 | ) | | $ | 172 |
| | $ | (267 | ) |
| |
(a) | Included in cost of products sold |
| |
(b) | Included in cost of products sold, research and development and marketing, selling and administrative expenses |
| |
(c) | Included in other (income)/expense |
The accumulated balances related to each component of otherOther comprehensive loss,income/(loss), net of taxes, were as follows:
| | | | | | | | | | | |
Dollars in millions | September 30, 2023 | | December 31, 2022 |
Derivatives qualifying as cash flow hedges | $ | 225 | | | $ | 232 | |
Pension and postretirement benefits | (632) | | | (623) | |
Marketable debt securities | (2) | | | — | |
Foreign currency translation(a) | (877) | | | (890) | |
Accumulated other comprehensive loss | $ | (1,286) | | | $ | (1,281) | |
(a)Includes net investment hedge gains of $205 million and $125 million as of September 30, 2023 and December 31, 2022, respectively.
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Derivatives qualifying as cash flow hedges | $ | (23 | ) | | $ | 38 |
|
Pension and other postretirement benefits | (2,023 | ) | | (2,097 | ) |
Available-for-sale securities | 34 |
| | (7 | ) |
Foreign currency translation | (409 | ) | | (437 | ) |
Accumulated other comprehensive loss | $ | (2,421 | ) | | $ | (2,503 | ) |
Note 16. PENSION AND POSTRETIREMENT17. EMPLOYEE STOCK BENEFIT PLANS
The net periodicStock-based compensation expense was as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Cost of products sold | $ | 14 | | | $ | 11 | | | $ | 38 | | | $ | 30 | |
Marketing, selling and administrative | 55 | | | 48 | | | 162 | | | 144 | |
Research and development | 63 | | | 56 | | | 191 | | | 164 | |
| | | | | | | |
Total Stock-based compensation expense | $ | 132 | | | $ | 115 | | | $ | 391 | | | $ | 338 | |
| | | | | | | |
Income tax benefit(a) | $ | 28 | | | $ | 23 | | | $ | 80 | | | $ | 67 | |
(a) Income tax benefit
cost/(credit)excludes excess tax benefits from share-based compensation awards that were vested or exercised of
defined benefit pension plans includes: |
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Service cost – benefits earned during the year | $ | 7 |
| | $ | 6 |
| | $ | 19 |
| | $ | 19 |
|
Interest cost on projected benefit obligation | 48 |
| | 45 |
| | 142 |
| | 145 |
|
Expected return on plan assets | (104 | ) | | (104 | ) | | (308 | ) | | (314 | ) |
Amortization of prior service credits | (1 | ) | | (1 | ) | | (3 | ) | | (3 | ) |
Amortization of net actuarial loss | 20 |
| | 22 |
| | 61 |
| | 62 |
|
Curtailments and settlements | 22 |
| | 19 |
| | 91 |
| | 66 |
|
Special termination benefits | — |
| | — |
| | — |
| | 1 |
|
Net periodic benefit cost/(credit) | $ | (8 | ) | | $ | (13 | ) | | $ | 2 |
| | $ | (24 | ) |
Pension settlement charges were recognized after determining that the annual lump sum payments will likely exceed the annual interest and service costs for the primary and certain other U.S. pension plans. The charges included the acceleration of a portion of unrecognized actuarial losses. Non-current pension liabilities were $477 million at September 30, 2017 and $600 million at December 31, 2016. Defined contribution plan expense in the U.S. was $46$1 million and $49$21 million for the three and nine months ended September 30, 20172023, and 2016, respectively, and $142$4 million and $141$63 million for the three and nine months ended September 30, 2022, respectively.
The number of units granted and the weighted-average fair value on the grant date for the nine months ended September 30, 2017 and 2016, respectively.2023 were as follows:
| | | | | | | | | | | |
Units in millions | Units | | Weighted-Average Fair Value |
| | | |
Restricted stock units | 9.3 | | | $ | 60.52 | |
Market share units | 1.0 | | | 58.18 | |
Performance share units | 1.5 | | | 64.18 | |
| | | | | | | | | | | | | | | | | | | |
Dollars in millions | | | Restricted Stock Units | | Market Share Units | | Performance Share Units |
Unrecognized compensation cost | | | $ | 893 | | | $ | 63 | | | $ | 115 | |
Expected weighted-average period in years of compensation cost to be recognized | | | 2.8 | | 2.9 | | 1.8 |
Note 17.18. LEGAL PROCEEDINGS AND CONTINGENCIES
The Company
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, partners, suppliers, service providers, licensees, licensors, 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. The Company recognizes accruals for such contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. These matters 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. Legal proceedings that are materialsignificant or that the CompanyBMS believes could become significant or material are described below.
Although the Company
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 claims and/or defenses in thesethe matters, therethe 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 that any other or future lawsuits, claims, government investigations or other legal proceedings will not be material. Unless otherwise noted, the Company is unablematerial to assess the outcomeBMS's financial position, results of the respective litigation nor is it able to provide an estimated range of potential loss.operations or cash flows for a particular period. Furthermore, failure to successfully enforce ourBMS'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."
INTELLECTUAL PROPERTY
Plavix*
Anti-PD-L1 and CTLA-4 — AustraliaU.S.
As previously disclosed, 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 (collectively, "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. On April 25, 2023, BMS filed an additional lawsuit against AZ in U.S. District Court for the District of Delaware alleging that AZ's marketing of the PD-L1 antibody Imfinzi infringes U.S. Patent No. 9,402,899.
On January 23, 2023, BMS filed a lawsuit in U.S. District Court for the District of Delaware against AstraZeneca Pharmaceuticals LP and AstraZeneca AB (collectively, "AZ AB") alleging that AZ AB's marketing of the CTLA-4 antibody Imjudo infringes certain claims of U.S. Patent Nos. 9,320,811 and 9,273,135.
On July 24, 2023, BMS entered into an agreement with AZ and AZ AB to settle all outstanding claims between them in the CTLA-4 litigation and the two PD-L1 antibody litigations described above. Refer to "—Note 5. Other (Income)/Expense, Net" for further information.
Eliquis - Europe
Lawsuits have been filed by generic companies in various countries in Europe seeking revocation of our composition-of-matter patents and Supplementary Protection Certificates ("SPCs") relating to Eliquis, and trials or preliminary proceedings have been held in certain of those cases.
In Finland, the court granted our request for a preliminary injunction prohibiting Teva from offering, storing or selling generic Eliquis products in Finland that have obtained price and reimbursement. A trial regarding Teva's challenge to the validity of the Finnish composition-of-matter patent and related SPC concluded on July 5, 2023, and a decision is expected sometime in the fourth quarter of 2023.
In France, a trial was held regarding Teva's challenge to the validity of the French composition-of-matter patent and related SPC, and a decision was issued on June 8, 2023, confirming their validity and rejecting Teva's claims. Teva has appealed the decision.
In Ireland, the court granted our request for a preliminary injunction prohibiting Teva from making, offering, putting on the market and/or using and/or importing or stocking for the aforesaid purposes, generic Eliquis products. The trial court's preliminary injunction decision was subsequently upheld by the Irish Court of Appeal. A trial regarding Teva's challenge to the validity of the Irish composition-of-matter patent and related SPC concluded on July 28, 2023, and a decision is expected sometime in the fourth quarter of 2023.
In the Netherlands, our requests for preliminary injunctions to prevent at-risk generic launches by Sandoz, Stada and Teva prior to full trials on the validity of the Dutch composition-of-matter patent and SPC were initially denied by the lower courts. However, in a judgment issued on August 15, 2023, the Dutch Court of Appeal overturned the decisions of the lower court, issued preliminary injunctions against Sandoz, Stada and Teva and ordered those companies to recall any generic Eliquis product from the Dutch market. Full trials regarding challenges to the validity of the Dutch composition-of-matter patent and related SPC by Sandoz began on October 13, 2023, and those related to Teva are scheduled to begin on January 12, 2024.
In Norway, a trial was held regarding Teva's challenge to the validity of the Norwegian composition-of-matter patent and related SPC, and a decision was issued on May 23, 2023, confirming their validity and rejecting Teva's claims. Teva has appealed the decision.
In Portugal, there are patent validity and infringement proceedings pending with multiple companies seeking to market generic versions of Eliquis. A trial regarding Mylan's challenge to the validity of the Portuguese composition-of-matter patent is scheduled to conclude November 29, 2023. In early September, Teva launched a generic Eliquis product on the Portuguese market. On September 15, 2023, BMS filed a request for a preliminary injunction against Teva at the Portuguese Intellectual Property Court.
In Spain, a trial regarding Teva's challenge to the validity of the Spanish composition-of-matter patent and related SPC was held on October 18-19, 2023.
In Sweden, a trial was held regarding Teva's challenge to the validity of the Swedish composition-of-matter patent and related SPC, and a decision was issued on November 2, 2022, confirming their validity and rejecting Teva's claims. Teva has appealed the decision.
In Switzerland, a trial regarding Teva's challenge to the validity of the Swiss composition-of-matter patent and related SPC is scheduled to begin on November 29, 2023.
In the UK, Sandoz and Teva filed lawsuits in the United Kingdom seeking revocation of the UK composition-of-matter patent and related SPC. BMS subsequently filed counterclaims for infringement in both actions. A combined trial took place in February 2022, and in a judgment issued on April 7, 2022, the judge found the UK apixaban composition-of-matter patent and related SPC invalid. BMS appealed the judgment and on May 4, 2023, the Court of Appeal upheld the lower court's decision. On June 1, 2023, BMS filed an application to appeal to the UK Supreme Court. Following the first instance decision in the UK, generic manufacturers have begun marketing generic versions of Eliquis in the UK.
In addition to the above, challenges to the validity of the composition-of-matter patent and related SPC are pending in Denmark, Italy, Poland, Czechia, Slovakia, Hungary, Bulgaria, Croatia, Greece and Lithuania.
Generic manufacturers may seek to market generic versions of Eliquis in additional countries in Europe prior to the expiration of our patents, which may lead to additional infringement and invalidity actions involving Eliquis patents being filed in various countries in Europe.
Inrebic - U.S.
In September 2023, BMS received a Notice Letter from Teva notifying BMS that Teva had filed an ANDA containing a paragraph IV certification seeking approval of a generic version of Inrebic in the U.S. and challenging certain patents listed in the Orange Book for Inrebic. In response, in October 2023, BMS filed a patent infringement action against Teva in the U.S. District Court for the District of New Jersey.
Onureg – U.S.
BMS has received Notice Letters from Accord Healthcare, Inc. ("Accord"), MSN Laboratories Private Limited ("MSN"), Teva Pharmaceuticals, Inc. ("Teva") and Natco Pharma Limited ("Natco"), respectively, each notifying BMS that it has filed an ANDA containing a paragraph IV certification seeking approval of a generic version of Onureg in the U.S. and challenging U.S. Patent Nos. 11,571,436 (the "'436 Patent") and 8,846,628 (the "'628 Patent"), FDA Orange Book-listed formulation patents covering Onureg, which expire in 2029 and 2030, respectively. In response, BMS has filed a patent infringement action against Accord, MSN, Teva and Natco in the U.S. District Court for the District of Delaware. In August 2023, the Accord and MSN actions were consolidated, and a trial has been scheduled to begin on September 23, 2024. No trial dates have been scheduled for the Teva or Natco actions.
In February 2023, Apotex Inc. filed a request for inter partes review ("IPR") of the '628 Patent. On July 20, 2023, the USPTO granted Apotex's request to institute an IPR of the '628 Patent.
Plavix* - Australia
Sanofi was notified that, in August 2007, GenRx Proprietary Limited (GenRx)("GenRx") obtained regulatory approval of an application for clopidogrel bisulfate 75mg tablets in Australia. GenRx, formerly a subsidiary of Apotex Inc. (Apotex), has sincesubsequently changed its name to Apotex.Apotex ("GenRx-Apotex"). In August 2007, ApotexGenRx-Apotex filed an application in the Federal Court of Australia (the Federal Court) seeking revocation of Sanofi’sSanofi'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’sSanofi's injunction. A subsidiary of the CompanyBMS 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 Apotex case, and a trial occurred in April 2008.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. The CompanyBMS and Sanofi filed notices of appeal in the Full Court of the Federal Court of Australia (Full Court)("Full Court") appealing the holding of invalidity of the claim covering clopidogrel and its pharmaceutically acceptable salts, process claims, and pharmaceutical composition claims which have stayed the Federal Court’s ruling. Apotex filed a notice of appeal appealing the holding of validity of the clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate claims. A hearing on the appeals occurred in February 2009.GenRx-Apotex appealed. On September 29, 2009, the Full Court held all of the claims of Patent No. 597784 invalid. In November 2009, the Company and Sanofi applied toMarch 2010, the High Court of Australia (High Court) for special leave to appeal the judgment of the Full Court. In March 2010, the High Court denied the Companya request by BMS and Sanofi’s requestSanofi to hear thean appeal of the Full Court decision. The case has beenwas remanded to the Federal Court for further proceedings related to damages sought by Apotex.GenRx-Apotex. BMS and GenRx-Apotex settled, and the GenRx-Apotex case was dismissed. The Australian government has intervened in this matter seeking maximum damages up to 449 million AUD ($289 million), plus interest, which would be split between BMS and is also seeking damagesSanofi, for alleged losses experienced for paying a higher price for branded Plavix* during the period when the injunction was in place. The CompanyBMS and Apotex have settledSanofi dispute that the Apotex case, and the case has been dismissed. The Australian government's claimgovernment is
still pending and a entitled to any damages. A trial was concluded in September 2017. The Company is expectingIn April 2020, the Federal Court issued a decision in 2018. It is not possible at this time to predict the outcome ofdismissing the Australian government’sgovernment's claim or its impact on the Company.
Sprycel - European Union
for damages. In May 2013, Apotex, Actavis Group PTC ehf, Generics [UK] Limited (Mylan)2020, the Australian government appealed the Federal Court's decision and an unnamed company filed oppositionsappeal hearing concluded in February 2021. On June 26, 2023, the EPOappeal court issued a ruling in BMS and Sanofi's favor, upholding the lower court's decision. The Australian government is seeking revocation of European Patent No. 1169038 (the ‘038 patent) covering dasatinib,leave to appeal the active ingredient in Sprycel. The ‘038 patent is scheduled to expire in April 2020 (excluding potential term extensions). On January 20, 2016, the Opposition Division of the EPO revoked the ‘038 patent. In May 2016, the Company appealed the EPO’s decision to the EPO BoardHigh Court of Appeal.Australia.
Revlimid - U.S.
In April 2023, Celgene received a Notice Letter from Deva Holdings A.S. ("Deva") notifying Celgene that Deva has filed an ANDA containing paragraph IV certifications seeking approval to market a generic version of Revlimid in the U.S. In response, on May 31, 2023, Celgene initiated a patent infringement action against Deva in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book listed patents. On October 23, 2023, BMS entered into a confidential settlement agreement with Deva, settling all outstanding claims in the litigation with Deva. In September 2023, Celgene received a Notice Letter from Accord Healthcare, Inc. ("Accord") notifying Celgene that Accord has filed an ANDA containing paragraph IV certifications seeking approval to market a generic version of Revlimid in the U.S. In response, on October 19, 2023, Celgene initiated a patent infringement action against Accord in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book-listed patents. On October 19, 2023, BMS entered into a confidential settlement agreement with Accord, settling all outstanding claims in the litigation with Accord.
Sprycel - U.S.
BMS has received Notice Letters from Xspray Pharma AB ("Xspray"), Nanocopoeia, LLC ("Nanocopoeia"), Handa Oncology, LLC ("Handa") and Zydus Pharmaceuticals ("Zydus"), each notifying BMS that it has filed applications 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 2017, the EPO Board of Appeal upheld the Opposition Division's decision, and revoked the ‘038 patent. Orphan drug exclusivity and data exclusivity for Sprycel2022, BMS filed a patent infringement action against Xspray in the EU expired in November 2016. The EPO BoardU.S. District Court for the District of Appeal's decision does not affect the validity of our other Sprycel patents within and outside Europe, including different patents that cover the monohydrate form of dasatinib and the use of dasatinib to treat CML. Additionally, in February 2017, the EPO Board of Appeal reversed and remanded an invalidity decision on European Patent No. 1610780 and its claim to the use of dasatinib to treat CML, which the EPO's Opposition Division had revoked in October 2012. The Company intends to take appropriate legal actions to protect Sprycel. We may experienceNew Jersey. In May 2022, BMS filed a decline in European revenuespatent infringement action against Nanocopoeia in the eventU.S. District Court for the District of Minnesota. In November 2022, BMS filed a patent infringement action against Handa in the U.S. District Court for the Northern District of California. On March 24, 2023, the Minnesota court denied a motion that generic dasatinib product entersNanocopoeia had filed seeking a judgment based on the market.pleadings. On June 16, 2023, BMS entered into a confidential settlement agreement with Handa, settling all outstanding claims in the litigation. On September 13, 2023, BMS entered into a confidential settlement agreement with XSpray, settling all outstanding claims in the litigation. On October 10, 2023, BMS entered into a confidential settlement agreement with Nanocopoeia, settling all outstanding claims in the litigation. In October 2023, BMS filed a patent infringement action against Zydus in the U.S. District Court for the District of New Jersey.
Anti-PD-1 Antibody Patent Oppositions
Zeposia - U.S.
On October 15, 2021, Actelion Pharmaceuticals LTD and Litigation
In September 2015, Dana-Farber Cancer Institute (Dana-Farber)Actelion Pharmaceuticals US, INC ("Actelion") filed a complaint in Massachusetts federal court seeking to correct the inventorship of five related U.S. patents directed to methods of treating cancer using PD-1 and PD-L1 antibodies. Specifically, Dana-Farber is seeking to add two scientists as inventors to these patents. In September 2017, Pfizer filed a motion seeking to intervene in this case alleging that one of the scientists identified by Dana-Farber was employed by a company eventually acquired by Pfizer. This motion has not been acted upon by the court.
Eliquis Patent Litigation
In February, March and April 2017, twenty-five generic companies sent the Company Paragraph-IV certification letters informing the Company that they had filed abbreviated new drug applications (ANDAs) seeking approval of generic versions of Eliquis. As a result, two Eliquis patents listed in the FDA Orange Book have now been challenged: the composition of matterfor patent claiming apixaban specifically and a formulation patent. In April 2017, the Company, along with its partner Pfizer, initiated patent lawsuits under the Hatch-Waxman Act against all generic filersinfringement in federal district courts in Delaware and West Virginia. In August 2017, 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 Trademark Office granted patent term restoration to the composition of matter patent, thereby restoring the term of the Eliquis composition of matter patent, whichActelion is the Company’s basis for projected loss of exclusivity, from February 2023 to November 2026. In September 2017, the Company settled its lawsuit with Teva Pharmaceuticals USA, Inc.seeking damages and the parties agreed to dismiss the case. The settlement does not impact the Company’s projected loss of exclusivity for Eliquis.injunctive relief. No trial date has been scheduled.
PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION
Plavix* State Attorneys General Lawsuits
The CompanyBMS and certain affiliates of Sanofi entities are defendants in a consumer protection and/or false advertising actionsaction brought by several statesthe attorney general of Hawaii relating to the labeling, sales andand/or promotion of Plavix*Plavix*. It is not possible at this timeIn February 2021, a Hawaii state court judge issued a decision against Sanofi and BMS, imposing penalties in the total amount of $834 million, with $417 million attributed to reasonably assessBMS. Sanofi and BMS appealed the outcome of these lawsuits or their potential impactdecision. On March 15, 2023, the Hawaii Supreme Court issued its decision, reversing in part and affirming in part the trial court decision, vacating the penalty award and remanding the case for a new trial and penalty determination. A new bench trial concluded on the Company.October 16, 2023.
PRODUCT LIABILITY LITIGATION
The Company
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, the CompanyBMS also faces unfiled claims involving its products.
Plavix*
As previously disclosed, the Company and certain affiliates of Sanofi are defendants in a number of individual lawsuits in various state and federal courts claiming personal injury damage allegedly sustained after using Plavix*. Over 5,000 claims involving injury plaintiffs as well as claims by spouses and/or other beneficiaries, have been filed in state and federal courts in various states including California, New Jersey, Delaware and New York. In February 2013, the Judicial Panel on Multidistrict Litigation granted the Company and Sanofi’s motion to establish a multi-district litigation (MDL) to coordinate Federal pretrial proceedings in Plavix* product liability and related cases in New Jersey Federal Court. Following the United States Supreme Court’s June 2017 reversal of a California Supreme Court decision that had held that the California state courts can exercise personal jurisdiction over the claims of non-California residents, over 2,000 out-of-state resident plaintiffs' claims (including spouses and beneficiaries) previously pending in the California state court have been, or are in the process of being dismissed. Some number of these California non-resident plaintiffs’ claims may be re-filed in federal court. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.
Byetta*
Amylin, a former subsidiary of the Company, and Lilly are co-defendants in product liability litigation related to Byetta*. To date, there are over 500 separate lawsuits pending on behalf of approximately 2,000 active plaintiffs (including pending settlements), which include injury plaintiffs as well as claims by spouses and/or other beneficiaries, in various courts in the U.S. The Company has agreed in principle to resolve over 15 of these claims. The majority of these cases have been brought by individuals who allege personal injury sustained after using Byetta*, primarily pancreatic cancer and pancreatitis, and, in some cases, claiming alleged wrongful death. The majority of cases were pending in Federal Court in San Diego in an MDL or in a coordinated proceeding in California Superior Court in Los Angeles (JCCP). In November 2015, the defendants' motion for summary judgment based on federal preemption was granted in both the MDL and the JCCP. The plaintiffs in the MDL have appealed to the U.S. Court of Appeals for the Ninth Circuit and the JCCP plaintiffs have appealed to the California Court of Appeal. Amylin has product liability insurance covering a substantial number of claims involving Byetta* and any additional liability to Amylin with respect to Byetta* is expected to be shared between the Company and AstraZeneca. It is not possible to reasonably predict the outcome of any lawsuit, claim or proceeding or the potential impact on the Company.
Abilify*
The CompanyBMS 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 400 casesCases were filed in state and federal courts in the United States. Pursuant to a previously disclosed master settlement agreement and several additionalsettlement related court orders, the vast majority of the cases are pending in Canada. The Judicial Panel on Multidistrict Litigation has consolidated the federal court cases for pretrial purposes in the United States District Court for the Northern Districtwere resolved or dismissed. Eleven inactive cases remain pending in state courts in New Jersey. There are also eleven cases pending in Canada (four class actions and seven individual injury claims), two of Florida.which are active (the certified class actions in Quebec and Ontario).
Eliquis
Onglyza*
BMS and PfizerAstraZeneca are co-defendants in product liability litigation related to EliquisOnglyza*. Plaintiffs assert claims, including claims for wrongful death, as a result of bleedingheart failure or other cardiovascular injuries they allege waswere caused by their use of EliquisOnglyza*. The majority of these claims are pending inIn February 2018, the Judicial Panel on Multidistrict Litigation ordered all the federal Onglyza* cases to be transferred to an MDL in the United StatesU.S. District Court for the Eastern District of Kentucky. A significant majority of the claims were pending in the MDL, with others pending in a coordinated proceeding in California Superior Court in San Francisco ("JCCP"). The JCCP court granted summary judgment to defendants in March 2022, a decision which was affirmed by the California Court of Appeal. The California Supreme Court declined to review the decision in July 2023. In the MDL, the court granted defendants' motion to exclude plaintiffs' only general causation expert on January 5, 2022 and granted summary judgment on August 2, 2022. Plaintiffs filed their Notice of Appeal on December 2, 2022. The appeal remains pending in the Sixth Circuit. 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.
SECURITIES LITIGATION
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 March 2023, the Court granted the defendants leave to file a motion for summary judgment, the briefing for which was completed in June 2023. On September 8, 2023, the Court granted in part and denied in part defendants' motion for summary judgment.
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 (the "Consolidated Schwab Action"). On October 2, 2023, defendants filed a motion for partial summary judgment in the Consolidated 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 allegedly 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. BMS filed a motion to dismiss the successor trustee's complaint, which was denied on June 24, 2022.
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 (the "Exchange Act") relating to the joint proxy statement. That action later was consolidated with another action filed in the same court, and a consolidated complaint thereafter was filed 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 (the "Securities Act") and sections 10(b), 14(a) and 20(2) of the Exchange Act. The complaint alleged 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 moved to dismiss the complaint. On March 1, 2023, the Court entered an opinion and order granting defendants' motion and dismissed the complaint in its entirety. The claims under Sections 11, 12(a)(2), and 15 of the Securities Act and Section 14(a) of the Exchange Act were dismissed with prejudice. The claims under Sections 10(a) and 20(a) of the Exchange Act were dismissed with leave to file a further amended complaint, which plaintiffs filed on April 14, 2023. Defendants moved to dismiss the amended complaint and briefing on the motion was completed on June 23, 2023. The motion is currently pending before the Court.
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. Defendants have moved to stay the action pending resolution of the federal action or, in the alternative, to dismiss the complaint. In lieu of responding to the motion, the plaintiff filed an amended complaint on June 15, 2023. Defendants again filed a motion to stay or, in the alternative, to dismiss the amended complaint on July 13, 2023. Briefing on that motion was completed on August 24, 2023.
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. 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. Defendants moved to stay the action pending resolution of the federal action and, in the alternative, to dismiss the complaint. On February 17, 2023, the Court granted defendants' motion to stay and declined to reach the merits of defendants' motion to dismiss. On October 9, 2023, the plaintiff filed a motion to vacate the stay.
No trial dates have been scheduled in any of the above CVR Litigations.
OTHER LITIGATION
IRA Litigation
On June 16, 2023, BMS filed a lawsuit against the U.S. Department of Health & Human Services and the Centers for Medicare & Medicaid Services, et al., challenging the constitutionality of the drug-pricing program in the IRA. That program requires pharmaceutical companies, like BMS, under the threat of significant penalties, to sell certain of their medicines at government-dictated prices. On August 29, 2023, the government selected Eliquis for this program. In its lawsuit, BMS argues that this program violates the Fifth Amendment, which requires the government to pay just compensation if it takes property for public use, by requiring pharmaceutical manufacturers to provide medicines to third parties at prices set by the government, without any requirement that those prices reflect fair market value. BMS also argues that this program violates the First Amendment right to free speech by requiring manufacturers to state courtpublicly that the government's price setting is a true negotiation that resulted in Delaware.a fair price, even if it was not. On August 16, 2023, BMS filed a motion for summary judgment.
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, and who have since filed new suits advancing related theories. As described below, those suits, together with a suit by certain specialty pharmacies and a new putative class action suit, are pending.
In March 2019, Humana Inc. ("Humana"), which opted out of October 2017, therethe above settlement, 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 now settled 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. In April 2022, the Court issued an order denying Celgene's motion to dismiss. That order addressed only Celgene's argument that certain of Humana's claims were barred by the statute of limitations. The Court's order did not address Celgene's other grounds for dismissal and instead directed Celgene to present those arguments in a renewed motion to dismiss following the filing of amended complaints. In May 2022, Humana filed an amended complaint against Celgene and BMS asserting the same claims based on additional factual allegations. Celgene and BMS subsequently filed a motion to dismiss Humana's amended complaint. On August 18, and September 8, 2023, the Court held argument on Celgene and BMS' motion. No trial date has been scheduled.
United HealthCare Services, Inc. ("UHS"), Blue Cross Blue Shield Association ("BCBSA"), BCBSM Inc., Health Care Service Corporation ("HCSC"), Blue Cross and Blue Shield of Florida Inc., Cigna Corporation ("Cigna"), Molina Healthcare, Inc. ("Molina") and several MSP related entities (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")) filed lawsuits making largely the same claims and allegations as were made in the now-settled class action litigation and in the Humana opt-out action. Certain of the matters have made additional claims related to copay assistance for Thalomid and Revlimid. These cases are over 150 casesnow pending in the MDLU.S. District Court for the District of New Jersey. Celgene and BMS's motion to dismiss the Humana amended complaint applies to these other opt‑out actions as well, and these other opt‑out actions will proceed as described above with respect to that Humana opt-out action. No trial dates have 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 now settled class action litigation. In June 2022, the San Francisco Superior Court dismissed 63 of Molina’s claims, which Molina later reasserted in the District of New Jersey as described above, and stayed the remaining 4 claims. No activity is expected in this case until disposition of the New Jersey actions.
Certain other entities that opted out of the now‑settled class action have also filed summonses related to two actions in the Philadelphia County Court of Common Pleas in connection with the allegations made by Humana and other opt‑out entities. Those actions have been placed in deferred status pending further developments in the above opt‑out cases.
In November 2022, certain specialty pharmacies filed an action as direct purchasers against Celgene, BMS, and certain generic manufacturers in the U.S. District Court for the District of New Jersey. The action makes largely the same claims and allegations against Celgene and BMS as were made with respect to Revlimid in the now settled class action litigation, and seek injunctive relief and damages under the Sherman Antitrust Act. Also in November 2022, a putative class of end-payor plaintiffs filed an action against Celgene, BMS, and certain generic manufacturers in the U.S. District Court for the District of New Jersey. The class complaint brings claims based on Celgene's allegedly anticompetitive settlements of Revlimid patent litigation, seeking damages under state antitrust and consumer protection laws and injunctive relief under federal antitrust law. Celgene, BMS and the generic defendants have filed consolidated motions to dismiss these two actions, and the motions were fully briefed in May 2023. No trial dates have been scheduled.
In October 2023, two healthcare systems—the Mayo Clinic and LifePoint Corporate Services, General Partnership—filed a lawsuit against Celgene, BMS and certain generic manufacturers in the U.S. District Court for the Northern District of California. Plaintiffs pursue claims based on their alleged purchases of and reimbursement for Revlimid and generic lenalidomide, and also claim to proceed based on assignments of claims from their subsidiaries and affiliates. The action makes largely the same claims and allegations against Celgene and BMS as were made with respect to Revlimid in the now-settled class action litigation, and seeks injunctive relief and damages under the Sherman Antitrust Act and parallel state laws. No trial date has been scheduled.
In May 2018, 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 ("NJ RICO"). The complaint seeks, among other things, treble and punitive damages, injunctive relief and attorneys' fees and costs. Humana subsequently dismissed its claims for breach of contract voluntarily. A trial for this matter began on January 31, 2023. On January 25, 2023, the Court granted Celgene's summary judgment motion on Humana's claims for violations of NJ RICO and dismissed those claims. On March 2, 2023, following a multi-week trial, the jury returned a full defense verdict in Celgene's favor on Humana's claims of fraud and negligent misrepresentation. 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. On February 14, 2023, the Court granted summary judgment in favor of Celgene on its breach of contract claims. In July 2023, BMS and Humana entered into a settlement agreement settling all outstanding claims in both the Kentucky and HPI litigations.
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.
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. On August 1, 2023, BMS, Celgene Logistics, and certain of their affiliates entered into a Settlement and Termination Agreement with BeiGene relating to the termination of the parties' ongoing contractual relationships, the arbitration proceeding, other contracts entered into by the parties, as well as resolving other disputes and potential disputes between the parties. The arbitration was subsequently dismissed.
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"). In June 2022, Plaintiffs filed an amended complaint. Plaintiffs allege 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, and filed a motion to dismiss the amended complaint in July 2022. No trial date has been scheduled.
Pomalyst Antitrust Class Action
In September 2023, certain health insurance companies filed an action on behalf of a putative class of end-payor plaintiffs against Celgene, BMS, and certain generic pharmaceutical manufacturers in the U.S. District Court for the Southern District of New York. The class complaint asserts claims under federal antitrust law and state courtsantitrust, consumer protection, and unjust enrichment laws based on allegations that Celgene and BMS engaged in anticompetitive conduct related to pomalidomide in the United States, including by allegedly engaging in fraud before the USPTO in the acquisition of patents that cover the use of pomalidomide, by filing sham patent litigations against generic pharmaceutical companies seeking to market generic pomalidomide, and one pending in Canada. Over 80 cases haveby entering into unlawful patent litigation settlements with certain generic pharmaceutical companies seeking to market generic pomalidomide. No trial date has been dismissed with prejudice by the MDL. Plaintiffs have appealed some of the dismissed cases to the Second Circuit Court of Appeals.scheduled.
SHAREHOLDER DERIVATIVE LITIGATION
Since December 2015, three shareholder derivative lawsuits were filed in New York state court against certain officers and directors of the Company. The plaintiffs allege, among other things, breaches of fiduciary duty surrounding the Company’s previously disclosed October 2015 civil settlement with the Securities and Exchange Commission of alleged Foreign Corrupt Practices Act violations in China in which the Company agreed to a payment of approximately $14.7 million in disgorgement, penalties and interest. As of October 2017, all three of the lawsuits have been dismissed. The Company received a notice of appeal for one of the lawsuits in September 2017.
GOVERNMENT INVESTIGATIONS
Like other pharmaceutical companies, the CompanyBMS and certain of its subsidiaries are subject to extensive regulation by national, state and local government agenciesauthorities in the U.S. and other countries in which BMS operates. As a result, the Company,BMS, from time to time, is subject to various governmental and regulatory inquiries and investigations.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, the CompanyBMS 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 the Company’sBMS's current or former sites or at waste disposal or reprocessing facilities operated by third parties.
CERCLA and Other Remediation Matters
With respect to CERCLA and other remediation matters for which the CompanyBMS is responsible under various state, federal and foreigninternational laws, the CompanyBMS 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"potentially responsible parties,”" and the CompanyBMS accrues liabilities when they are probable and reasonably estimable. The CompanyBMS estimated its share of future costs for these sites to be $63$81 million atas of September 30, 2017,2023, 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.
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 footnotes 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 specialty 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 large pharmaceutical company with the speed, agility and focus on innovation oftypically found in the biotech industry. Our four strategic priorities are to drive business performance, continue to build a strong franchise in IO, maintain a diversifiedrenew and diversify our portfolio both withinthrough launching new medicines, advancing our early, mid and outside of IO,late-stage pipeline, and continue ourexecuting disciplined approach to capital allocation, including establishing partnershipsbusiness development. Our focus is on discovering, developing and collaborations as an essential component of successfully delivering transformational medicines for patients facing serious diseases in the following core therapeutic areas: (i) oncology with a priority in certain tumor types; (ii) hematology with opportunities to patients.broaden our franchise and sustain a leadership position in multiple myeloma; (iii) immunology with priorities in psoriasis, lupus, RA, inflammatory bowel diseases and fibrotic lung diseases; (iv) cardiovascular disease; and (v) neuroscience with a focus on neurodegenerative disease. We are working on accelerating our drug development and delivery of our innovative medicines to patients, enhancing our commercial operating model, as well as enhancing flexibility and reliability of our manufacturing network. We are committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. We remain committed to maintaining a strong investment grade credit rating 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 2022 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.
Our revenues increasedIn 2023, we received approvals for initial and additional indications for the following marketed products in major markets (the U.S., EU and Japan), which further expanded our geographical reach in immunology, hematology and oncology including: (i) U.S. and EC approval of Opdivo expanding upon the existing adjuvant treatment for melanoma patients; (ii) FDA approval of Reblozyl in the first-line setting for the treatment of anemia in MDS and EC approval for an additional indication for anemia associated with non-transfusion-dependent beta thalassemia; (iii) approvals in Japan and by 8%the EC of Opdivo in combination with chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC; (iv) approval of Camzyos for the treatment of symptomatic obstructive HCM by the EC; (v) approval of Breyanzi for the second-line treatment of diffuse large B-cell lymphoma by the EC; and (vi) approval for Sotyktu for moderate-to-severe plaque psoriasis by the EC. We continue expanding our commercial CAR-T manufacturing network through the FDA approval of our Devens, MA facility in June 2023. In October 2023, we entered into a definitive merger agreement to acquire Mirati, a commercial stage targeted oncology company with a pipeline of commercial, clinical and pre-clinical stage oncology medicines and assets, including Krazati*, a best-in-class inhibitor of KRASG12C mutation, which was approved by the FDA as a second-line treatment for patients with NSCLC, and MRTX1719, a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase 1 development, among others.
Revenues decreased by 4% for the nine months ended September 30, 20172023 primarily due to lower Revlimid sales driven by the previously disclosed generic erosion and increase in patients receiving free drug product for Revlimid, and to a lesser extent, Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates product, and foreign exchange impacts of 1% partially offset by higher sales in our New Product Portfolio and In-Line Products (primarily Opdivo). The $0.99 increase in GAAP EPS was primarily driven by the impact of certain specified items, including lower losses on equity investments and amortization of intangible assets, litigation and other settlement income and a deferred income tax benefit related to a non-U.S. tax ruling. After adjusting for specified items, non-GAAP EPS decreased $0.08 primarily as a result of higher demand for our prioritized brands including Opdivo and Eliquislower revenues, partially offset by increased competition for established brands, primarily Daklinza. The $0.10 decrease in GAAP EPS was due to higher license, asset acquisitionlower Acquired IPRD charges, net interest expense, effective income tax rate and restructuring related charges and lower divestiture related income. These items were partially offset by higher revenues, royalties and licensing income and the patent-infringement litigation settlement related to Merck's PD-1 antibody Keytruda* (pembrolizumab). After adjusting for licensing income, litigation settlements, license and asset acquisition charges and other specified items, non-GAAP EPS increased $0.12.weighted average shares outstanding.
| | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, |
| Three Months Ended September 30, | | Nine Months Ended September 30, | |
Dollars in Millions, except per share data | 2017 | | 2016 | | 2017 | | 2016 | |
Dollars in millions, except per share data | | Dollars in millions, except per share data | 2023 | | 2022 | | 2023 | | 2022 |
Total Revenues | $ | 5,254 |
| | $ | 4,922 |
| | $ | 15,327 |
| | $ | 14,184 |
| Total Revenues | $ | 10,966 | | | $ | 11,218 | | | $ | 33,529 | | | $ | 34,753 | |
| | | | | | | | |
Diluted Earnings Per Share | | | | | | | | |
Diluted earnings per share | | Diluted earnings per share | |
GAAP | 0.51 |
| | 0.72 |
| | 2.02 |
| | 2.12 |
| GAAP | $ | 0.93 | | | $ | 0.75 | | | $ | 2.99 | | | $ | 2.00 | |
Non-GAAP | 0.75 |
| | 0.77 |
| | 2.32 |
| | 2.20 |
| Non-GAAP | 2.00 | | | 1.99 | | | 5.80 | | | 5.88 | |
Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items whichthat 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 and reconciliations ofrelating to our non-GAAP financial measures refer to “—"—Non-GAAP Financial Measures.”"
Puerto Rico Update
Like many othersEconomic and Market Factors
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, some of the provisions of the IRA signed into law in August 2022, were as follows: (i) the government requires pharmaceutical industry, we have manufacturingmanufacturers like BMS, under the threat of significant penalties, to sell certain innovative Medicare Part D and commercial operationsPart B medicines at government-set discounted prices, (ii) manufacturers are to pay an inflation-based rebate for Medicare Part B and Part D medicines, and (iii) Medicare Part D redesign. In addition, there were changes made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations, and a (ii) a non-deductible 1% excise tax provision on net stock repurchases, to be applied to repurchases beginning in Puerto Rico2023. Implementation of this legislation is expected to be carried out through upcoming actions by regulatory authorities, the outcome of which were impacted by the recent hurricanes. Our two manufacturing sites sustained some damage but are currently operating at limited capacity.is uncertain. We continue to workevaluate the impact of the IRA on our results of operations and it is possible that these changes may result in a material impact on our business and results of operations. See "Item 1. Financial Statements—Note 18. Legal Proceedings and Contingencies—Other Litigation" for further information. Furthermore, countries are expected to restoremake changes to normal operations. Our first priority wastheir tax laws and updates to ensureinternational tax treaties to implement the safetyagreement by the Organization for Economic Co-operation and well-being of our employees. We have accounted for 100% of our employeesDevelopment to establish a global minimum tax. See 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 provide humanitarian aid as needed. Our business continuity plans have been successfulnegatively affect our revenues and profit margins" and "—Changes to date despite very challenging conditions with no supply disruption to date. In addition, we do not foresee any product supply issues. Althoughtax regulations could negatively impact our financial results for the quarter were not significantly impacted, we will continue to monitor and assess the ongoing effects.earnings" in our 2022 Form 10-K.
Significant Product and Pipeline Approvals
The following is a summary of the significant approvals received in 2017:
2023 as of October 26, 2023: | | | | | | | | |
Opdivo | September 2017October 2023 | FDA approval of Opdivo for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib. |
September 2017 | Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono. |
August 2017 | FDA approval for theadjuvant treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatincompletely resected stages IIB and irinotecan.IIC melanoma. |
| | | | | | | | |
June 2017Reblozyl | August 2023 | FDA approval of Reblozyl as first-line treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk MDS who may also require red blood cell transfusions. |
| | | | | | | | |
Opdivo | August 2023 | EC approval of Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stages IIB and IIC melanoma. |
| | | | | | | | |
Opdivo | June 2023 | EC approval of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable NSCLC at a high risk of recurrence in adult patients with tumor cell PD-L1 expression > 1%. |
| | | | | | | | |
Camzyos | June 2023 | EC approval of Camzyos for the treatment of patients with previously treated locally advanced unresectable or metastatic urothelial carcinoma, a type of bladder cancer,symptomatic (New York Heart Association, class II-III) obstructive HCM in adults after failure of platinum-containing therapy.adult patients. |
| | | | | | | | |
April 2017Breyanzi | May 2023 | EC approval of Breyanzi for the treatment of SCCHN in adults progressing onadult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or after platinum-based therapy.are refractory to, first-line chemoimmunotherapy. |
| | | | | | | | |
Opdivo | March 20172023 | Approval in JapanJapan's Ministry of Health, Labour and Welfare approval of Opdivo plus chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC. |
| | | | | | | | |
Sotyktu | March 2023 | EC approval of Sotyktu for the treatment of recurrent or metastatic HNC, received by our alliance partner, Ono.adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. |
| | | | | | | | |
February 2017Reblozyl | FDAMarch 2023 | EC approval of Reblozyl for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. |
Orencia | July 2017 | EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required. |
July 2017 | FDA approval for the treatment of active PsA in adults. |
March 2017 | FDA approval of a new subcutaneous administration option for use in patients two years of age and older with moderately to severely active polyarticular JIA. |
Yervoy | July 2017 | FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients. |
Hepatitis C Franchise | April 2017 | China FDA approval of the Daklinza and Sunvepra regimen for treatment-naive or experienced patients infected with genotype 1b chronic HCV. In addition, Daklinza was approved in China for combination use with other agents, including sofosbuvir, for adult patients of anemia associated with HCV genotypes 1-6 infection.non-transfusion-dependent beta thalassemia.
|
Refer to "—Product and Pipeline Developments" for all of the developments in our marketed products and late-stage pipeline in 2017.since the start of the third quarter of 2023.
Acquisitions, Divestitures, Licensing and LicensingOther Arrangements
Acquisition and licensing transactions allow us to focus our resources behind our growth opportunities that drive the greatest long-term value. We are focused on the following core therapeutic areas: oncology, including IO, immunoscience, cardiovascular and fibrosis. Significant transactions entered into in 2017 are summarized below.
Refer to "Item 1. Financial Statements—Note 3. Alliances" and "—Note 4. Acquisitions, Divestitures, Licensing and LicensingOther Arrangements" for further information.information on significant acquisitions, divestitures, licensing and other arrangements.
Halozyme
RESULTS OF OPERATIONS
Regional Revenues
The composition of the changes in revenues was as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | % Change | | Foreign Exchange(b) | | 2023 | | 2022 | | % Change | | Foreign Exchange(b) |
United States | $ | 7,628 | | | $ | 7,941 | | | (4) | % | | — | % | | $ | 23,552 | | | $ | 23,903 | | | (1) | % | | — | % |
International | 3,153 | | | 3,062 | | | 3 | % | | 1 | % | | 9,462 | | | 10,216 | | | (7) | % | | (2) | % |
| | | | | | | | | | | | | | | |
Other(a) | 185 | | | 215 | | | (14) | % | | N/A | | 515 | | | 634 | | | (19) | % | | N/A |
Total | $ | 10,966 | | | $ | 11,218 | | | (2) | % | | 1 | % | | $ | 33,529 | | | $ | 34,753 | | | (4) | % | | (1) | % |
(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 decreased 4% during the third quarter of 2017, BMS2023 and Halozyme announced a global collaboration and license agreement to develop subcutaneously administered BMS IO medicines using Halozyme's ENHANZE* drug-delivery technology. This transaction is expected to close in the fourth quarter of 2017 subject to obtaining customary regulatory and antitrust approvals.
IFM
In the third quarter of 2017, BMS acquired all of the outstanding shares of IFM, a private biotechnology company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory diseases. The acquisition provides BMS with full rights to IFM's preclinical STING and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer.
Biogen
In the second quarter of 2017, BMS out-licensed to Biogen exclusive rights to develop and commercialize BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy.
Roche
In the second quarter of 2017, BMS out-licensed to Roche exclusive rights to develop and commercialize BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy.
CytomX
In the second quarter of 2017, BMS and CytomX, a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, expanded their strategic collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.
RESULTS OF OPERATIONS
Regional Revenues
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| Total Revenues | | 2017 vs. 2016 | | Total Revenues | | 2017 vs. 2016 |
Dollars in Millions | 2017 | | 2016 | | Total Change | | Foreign Exchange(b) | | 2017 | | 2016 | | Total Change | | Foreign Exchange(b) |
United States | $ | 2,864 |
| | $ | 2,790 |
| | 3 | % | | — |
| | $ | 8,467 |
| | $ | 8,015 |
| | 6 | % | | — |
|
Europe | 1,262 |
| | 946 |
| | 33 | % | | 5 | % | | 3,596 |
| | 2,855 |
| | 26 | % | | (1 | )% |
Rest of the World | 970 |
| | 1,069 |
| | (9 | )% | | (2 | )% | | 2,858 |
| | 2,922 |
| | (2 | )% | | (1 | )% |
Other(a) | 158 |
| | 117 |
| | 35 | % | | N/A |
| | 406 |
| | 392 |
| | 4 | % | | N/A |
|
Total | $ | 5,254 |
| | $ | 4,922 |
| | 7 | % | | 1 | % | | $ | 15,327 |
| | $ | 14,184 |
| | 8 | % | | (1 | )% |
| |
(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. |
U.S. revenues increased in both periods1% year-to-date, primarily due to higher demandlower Revlimid sales driven by the previously disclosed generic erosion and increase in patients receiving free drug product for EliquisRevlimid, and Opdivo to a lesser extent, Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates product,partially offset by loweran increase in demand for established brands due to increased competition, primarily Daklinzaour In-Line Products and New Product Portfolio. Average U.S. net selling prices were approximately 2% higher after charge-backs, rebates and discounts in the nine months ended September 30, 2017decreased 1% year-to-date compared to the priorsame period a year period. Refer to “—Product Revenues” below for additional information.ago.
Europe
International
•International revenues increased in both periods3% during the third quarter of 2023 primarily due to higher demand for Opdivo and EliquisNew Product Portfolio and foreign exchange, partially offset by lower demand for Daklinzaaverage net selling prices.
•International revenues decreased 7% year-to-date primarily due to increased competition.
Rest of the World revenues decreased in both periods due toRevlimid and Eliquis generic erosion, lower demand for established brands, including Daklinza, due to increased competitionaverage net selling prices and the divestiture of certain other brandsforeign exchange, partially offset by higher demand for Opdivo and Eliquis.New Product Portfolio.
No single country outside the U.S. contributed more than 10% of total revenues during the nine months ended September 30, 2017 or 2016.2023 and 2022. Our business is typically not seasonal.
GTN Adjustments
The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows (excluding alliance and other revenues such as Atripla*):follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | % Change | | 2023 | | 2022 | | % Change |
Gross product sales | $ | 18,648 | | | $ | 17,606 | | | 6 | % | | $ | 54,047 | | | $ | 51,555 | | | 5 | % |
GTN adjustments | | | | | | | | | | | |
Charge-backs and cash discounts | (2,373) | | | (1,907) | | | 24 | % | | (6,743) | | | (5,420) | | | 24 | % |
Medicaid and Medicare rebates | (3,730) | | | (3,295) | | | 13 | % | | (9,355) | | | (8,003) | | | 17 | % |
Other rebates, returns, discounts and adjustments | (1,900) | | | (1,591) | | | 19 | % | | (5,339) | | | (4,526) | | | 18 | % |
Total GTN adjustments | (8,003) | | | (6,793) | | | 18 | % | | (21,437) | | | (17,949) | | | 19 | % |
Net product sales | $ | 10,645 | | | $ | 10,813 | | | (2) | % | | $ | 32,610 | | | $ | 33,606 | | | (3) | % |
| | | | | | | | | | | |
GTN adjustments percentage | 43 | % | | 38 | % | | 5 | % | | 40 | % | | 35 | % | | 5 | % |
U.S. | 49 | % | | 43 | % | | 6 | % | | 45 | % | | 40 | % | | 5 | % |
Non-U.S. | 20 | % | | 18 | % | | 2 | % | | 20 | % | | 17 | % | | 3 | % |
|
| | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | % Change | | 2017 | | 2016 | | % Change |
Gross product sales | $ | 6,555 |
| | $ | 5,698 |
| | 15 | % | | $ | 18,723 |
| | $ | 16,252 |
| | 15 | % |
GTN adjustments: | | | | | | | | | | | |
Charge-backs and cash discounts | (583 | ) | | (427 | ) | | 37 | % | | (1,521 | ) | | (1,174 | ) | | 30 | % |
Medicaid and Medicare rebates | (573 | ) | | (397 | ) | | 44 | % | | (1,474 | ) | | (1,018 | ) | | 45 | % |
Other rebates, returns, discounts and adjustments | (537 | ) | | (382 | ) | | 41 | % | | (1,516 | ) | | (1,172 | ) | | 29 | % |
Total GTN adjustments | (1,693 | ) | | (1,206 | ) | | 40 | % | | (4,511 | ) | | (3,364 | ) | | 34 | % |
Net product sales | $ | 4,862 |
| | $ | 4,492 |
| | 8 | % | | $ | 14,212 |
| | $ | 12,888 |
| | 10 | % |
| | | | | | | | | | | |
GTN adjustments percentage | 26 | % | | 21 | % | | 5 | % | | 24 | % | | 21 | % | | 3 | % |
U.S. | 32 | % | | 26 | % | | 6 | % | | 30 | % | | 26 | % | | 4 | % |
Non-U.S. | 15 | % | | 14 | % | | 1 | % | | 14 | % | | 12 | % | | 2 | % |
Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $65$18 million and $143$116 million infor the three and nine months ended September 30, 20172023 and 2016,$10 million and $207 million for the three and nine months ended September 30, 2022, respectively. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual andor legislative discounts and rebates. U.S. GTN adjustments are increasing at a higher rate than gross product salespercentage increased primarily due to product mix and higher U.S. Eliquis gross product sales, which has a relatively high GTN adjustment percentage.government channel rebates.
Product Revenues
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | % Change | | 2023 | | 2022 | | % Change |
In-Line Products | | | | | | | | | | | |
Eliquis | $ | 2,705 | | | $ | 2,655 | | | 2 | % | | $ | 9,332 | | | $ | 9,101 | | | 3 | % |
U.S. | 1,799 | | | 1,729 | | | 4 | % | | 6,693 | | | 6,068 | | | 10 | % |
Non-U.S. | 906 | | | 926 | | | (2) | % | | 2,639 | | | 3,033 | | | (13) | % |
| | | | | | | | | | | |
Opdivo | 2,275 | | | 2,047 | | | 11 | % | | 6,622 | | | 6,033 | | | 10 | % |
U.S. | 1,352 | | | 1,243 | | | 9 | % | | 3,872 | | | 3,547 | | | 9 | % |
Non-U.S. | 923 | | | 804 | | | 15 | % | | 2,750 | | | 2,486 | | | 11 | % |
| | | | | | | | | | | |
Pomalyst/Imnovid | 872 | | | 886 | | | (2) | % | | 2,551 | | | 2,620 | | | (3) | % |
U.S. | 610 | | | 640 | | | (5) | % | | 1,725 | | | 1,813 | | | (5) | % |
Non-U.S. | 262 | | | 246 | | | 7 | % | | 826 | | | 807 | | | 2 | % |
| | | | | | | | | | | |
Orencia | 925 | | | 883 | | | 5 | % | | 2,616 | | | 2,551 | | | 3 | % |
U.S. | 719 | | | 682 | | | 5 | % | | 1,988 | | | 1,928 | | | 3 | % |
Non-U.S. | 206 | | | 201 | | | 2 | % | | 628 | | | 623 | | | 1 | % |
| | | | | | | | | | | |
Sprycel | 517 | | | 560 | | | (8) | % | | 1,404 | | | 1,587 | | | (12) | % |
U.S. | 406 | | | 402 | | | 1 | % | | 1,029 | | | 1,079 | | | (5) | % |
Non-U.S. | 111 | | | 158 | | | (30) | % | | 375 | | | 508 | | | (26) | % |
| | | | | | | | | | | |
Yervoy | 579 | | | 523 | | | 11 | % | | 1,672 | | | 1,563 | | | 7 | % |
U.S. | 362 | | | 322 | | | 12 | % | | 1,045 | | | 959 | | | 9 | % |
Non-U.S. | 217 | | | 201 | | | 8 | % | | 627 | | | 604 | | | 4 | % |
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Mature and other products | 476 | | | 514 | | | (7) | % | | 1,415 | | | 1,563 | | | (9) | % |
U.S. | 191 | | | 191 | | | — | % | | 570 | | | 565 | | | 1 | % |
Non-U.S. | 285 | | | 323 | | | (12) | % | | 845 | | | 998 | | | (15) | % |
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Total In-Line Products | 8,349 | | | 8,068 | | | 3 | % | | 25,612 | | | 25,018 | | | 2 | % |
U.S. | 5,439 | | | 5,209 | | | 4 | % | | 16,922 | | | 15,959 | | | 6 | % |
Non-U.S. | 2,910 | | | 2,859 | | | 2 | % | | 8,690 | | | 9,059 | | | (4) | % |
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| | | | Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | | Dollars in millions | 2023 | | 2022 | | % Change | | 2023 | | 2022 | | % Change |
New Product Portfolio | | New Product Portfolio | | | | | | | | | | | |
Reblozyl | | Reblozyl | 248 | | | 190 | | | 31 | % | | 688 | | | 518 | | | 33 | % |
U.S. | | U.S. | 200 | | | 156 | | | 28 | % | | 537 | | | 434 | | | 24 | % |
Non-U.S. | | Non-U.S. | 48 | | | 34 | | | 41 | % | | 151 | | | 84 | | | 80 | % |
| Abecma | | Abecma | 93 | | | 107 | | | (13) | % | | 372 | | | 263 | | | 41 | % |
U.S. | | U.S. | 69 | | | 75 | | | (8) | % | | 302 | | | 203 | | | 49 | % |
Non-U.S. | | Non-U.S. | 24 | | | 32 | | | (25) | % | | 70 | | | 60 | | | 17 | % |
| Opdualag | | Opdualag | 166 | | | 84 | | | 98 | % | | 437 | | | 148 | | | * |
U.S. | | U.S. | 162 | | | 84 | | | 93 | % | | 430 | | | 148 | | | * |
Non-U.S. | | Non-U.S. | 4 | | | — | | | N/A | | 7 | | | — | | | N/A |
| Zeposia | | Zeposia | 123 | | | 69 | | | 78 | % | | 301 | | | 171 | | | 76 | % |
U.S. | | U.S. | 96 | | | 50 | | | 92 | % | | 223 | | | 119 | | | 87 | % |
Non-U.S. | | Non-U.S. | 27 | | | 19 | | | 42 | % | | 78 | | | 52 | | | 50 | % |
| Breyanzi | | Breyanzi | 92 | | | 44 | | | * | | 263 | | | 127 | | | * |
U.S. | | U.S. | 77 | | | 35 | | | * | | 218 | | | 109 | | | 100 | % |
Non-U.S. | | Non-U.S. | 15 | | | 9 | | | 67 | % | | 45 | | | 18 | | | * |
| Onureg | | Onureg | 43 | | | 32 | | | 34 | % | | 121 | | | 87 | | | 39 | % |
U.S. | | U.S. | 30 | | | 24 | | | 25 | % | | 86 | | | 68 | | | 26 | % |
Non-U.S. | | Non-U.S. | 13 | | | 8 | | | 63 | % | | 35 | | | 19 | | | 84 | % |
| Inrebic | | Inrebic | 29 | | | 21 | | | 38 | % | | 81 | | | 62 | | | 31 | % |
U.S. | | U.S. | 19 | | | 17 | | | 12 | % | | 55 | | | 52 | | | 6 | % |
Non-U.S. | | Non-U.S. | 10 | | | 4 | | | * | | 26 | | | 10 | | | * |
| Camzyos | | Camzyos | 68 | | | 5 | | | * | | 143 | | | 8 | | | * |
U.S. | | U.S. | 67 | | | 5 | | | * | | 142 | | | 8 | | | * |
Non-U.S. | | Non-U.S. | 1 | | | — | | | N/A | | 1 | | | — | | | N/A |
| Sotyktu | | Sotyktu | 66 | | | 1 | | | * | | 107 | | | 1 | | | * |
U.S. | | U.S. | 62 | | | 1 | | | * | | 101 | | | 1 | | | * |
Non-U.S. | | Non-U.S. | 4 | | | — | | | N/A | | 6 | | | — | | | N/A |
| Total New Product Portfolio | | Total New Product Portfolio | 928 | | | 553 | | | 68 | % | | 2,513 | | | 1,385 | | | 81 | % |
U.S. | | U.S. | 782 | | | 447 | | | 75 | % | | 2,094 | | | 1,142 | | | 83 | % |
Non-U.S. | | Non-U.S. | 146 | | | 106 | | | 38 | % | | 419 | | | 243 | | | 72 | % |
| Total In-Line Products and New Product Portfolio | | Total In-Line Products and New Product Portfolio | 9,277 | | | 8,621 | | | 8 | % | | 28,125 | | | 26,403 | | | 7 | % |
U.S. | | U.S. | 6,221 | | | 5,656 | | | 10 | % | | 19,016 | | | 17,101 | | | 11 | % |
Non-U.S. | | Non-U.S. | 3,056 | | | 2,965 | | | 3 | % | | 9,109 | | | 9,302 | | | (2) | % |
| | | Three Months Ended September 30, | | Nine Months Ended September 30, | |
Dollars in Millions | 2017 | | 2016 | | % Change | | 2017 | | 2016 | | % Change | |
Prioritized Brands | | | | | | | | | | | | |
Opdivo | $ | 1,265 |
| | $ | 920 |
| | 38 | % | | $ | 3,587 |
| | $ | 2,464 |
| | 46 | % | |
U.S. | 778 |
| | 712 |
| | 9 | % | | 2,307 |
| | 1,949 |
| | 18 | % | |
Non-U.S. | 487 |
| | 208 |
| | ** |
| | 1,280 |
| | 515 |
| | ** |
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Eliquis | 1,232 |
| | 884 |
| | 39 | % | | 3,509 |
| | 2,395 |
| | 47 | % | |
U.S. | 717 |
| | 512 |
| | 40 | % | | 2,119 |
| | 1,424 |
| | 49 | % | |
Non-U.S. | 515 |
| | 372 |
| | 38 | % | | 1,390 |
| | 971 |
| | 43 | % | |
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Orencia | 632 |
| | 572 |
| | 10 | % | | 1,817 |
| | 1,640 |
| | 11 | % | |
U.S. | 432 |
| | 387 |
| | 12 | % | | 1,243 |
| | 1,109 |
| | 12 | % | |
Non-U.S. | 200 |
| | 185 |
| | 8 | % | | 574 |
| | 531 |
| | 8 | % | |
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Sprycel | 509 |
| | 472 |
| | 8 | % | | 1,478 |
| | 1,330 |
| | 11 | % | |
U.S. | 278 |
| | 259 |
| | 7 | % | | 806 |
| | 702 |
| | 15 | % | |
Non-U.S. | 231 |
| | 213 |
| | 8 | % | | 672 |
| | 628 |
| | 7 | % | |
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Yervoy | 323 |
| | 285 |
| | 13 | % | | 975 |
| | 789 |
| | 24 | % | |
U.S. | 239 |
| | 222 |
| | 8 | % | | 727 |
| | 600 |
| | 21 | % | |
Non-U.S. | 84 |
| | 63 |
| | 33 | % | | 248 |
| | 189 |
| | 31 | % | |
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Empliciti | 60 |
| | 41 |
| | 46 | % | | 168 |
| | 103 |
| | 63 | % | |
U.S. | 39 |
| | 36 |
| | 8 | % | | 112 |
| | 97 |
| | 15 | % | |
Non-U.S. | 21 |
| | 5 |
| | ** |
| | 56 |
| | 6 |
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Established Brands | | | | | | | | | | | | |
Hepatitis C Franchise | 73 |
| | 379 |
| | (81 | )% | | 347 |
| | 1,352 |
| | (74 | )% | |
U.S. | 24 |
| | 192 |
| | (88 | )% | | 96 |
| | 745 |
| | (87 | )% | |
Non-U.S. | 49 |
| | 187 |
| | (74 | )% | | 251 |
| | 607 |
| | (59 | )% | |
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Baraclude | 264 |
| | 306 |
| | (14 | )% | | 819 |
| | 896 |
| | (9 | )% | |
U.S. | 14 |
| | 17 |
| | (18 | )% | | 40 |
| | 49 |
| | (18 | )% | |
Non-U.S. | 250 |
| | 289 |
| | (13 | )% | | 779 |
| | 847 |
| | (8 | )% | |
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Sustiva Franchise | 183 |
| | 275 |
| | (33 | )% | | 555 |
| | 819 |
| | (32 | )% | |
U.S. | 157 |
| | 234 |
| | (33 | )% | | 471 |
| | 689 |
| | (32 | )% | |
Non-U.S. | 26 |
| | 41 |
| | (37 | )% | | 84 |
| | 130 |
| | (35 | )% | |
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Reyataz Franchise | 174 |
| | 238 |
| | (27 | )% | | 555 |
| | 706 |
| | (21 | )% | |
U.S. | 85 |
| | 125 |
| | (32 | )% | | 260 |
| | 367 |
| | (29 | )% | |
Non-U.S. | 89 |
| | 113 |
| | (21 | )% | | 295 |
| | 339 |
| | (13 | )% | |
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Other Brands | 539 |
| | 550 |
| | (2 | )% | | 1,517 |
| | 1,690 |
| | (10 | )% | |
U.S. | 101 |
| | 94 |
| | 7 | % | | 286 |
| | 284 |
| | 1 | % | |
Non-U.S. | 438 |
| | 456 |
| | (4 | )% | | 1,231 |
| | 1,406 |
| | (12 | )% | |
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| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | % Change | | 2023 | | 2022 | | % Change |
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Recent LOE Products(a) | | | | | | | | | | | |
Revlimid | 1,429 | | | 2,420 | | | (41) | % | | 4,647 | | | 7,718 | | | (40) | % |
U.S. | 1,226 | | | 2,170 | | | (44) | % | | 4,004 | | | 6,338 | | | (37) | % |
Non-U.S. | 203 | | | 250 | | | (19) | % | | 643 | | | 1,380 | | | (53) | % |
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Abraxane | 260 | | | 177 | | | 47 | % | | 757 | | | 632 | | | 20 | % |
U.S. | 181 | | | 115 | | | 57 | % | | 532 | | | 464 | | | 15 | % |
Non-U.S. | 79 | | | 62 | | | 27 | % | | 225 | | | 168 | | | 34 | % |
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Total Recent LOE Products | 1,689 | | | 2,597 | | | (35) | % | | 5,404 | | | 8,350 | | | (35) | % |
U.S. | 1,407 | | | 2,285 | | | (38) | % | | 4,536 | | | 6,802 | | | (33) | % |
Non-U.S. | 282 | | | 312 | | | (10) | % | | 868 | | | 1,548 | | | (44) | % |
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Total Revenues | $ | 10,966 | | | $ | 11,218 | | | (2) | % | | $ | 33,529 | | | $ | 34,753 | | | (4) | % |
U.S. | $ | 7,628 | | | $ | 7,941 | | | (4) | % | | $ | 23,552 | | | $ | 23,903 | | | (1) | % |
Non-U.S. | $ | 3,338 | | | $ | 3,277 | | | 2 | % | | $ | 9,977 | | | $ | 10,850 | | | (8) | % |
* 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.
In-Line Products
Eliquis (apixaban)— an oral Factor Xa inhibitor, indicated for the reduction in risk of stroke/systemic embolism in non-valvular atrial fibrillation and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
•U.S. revenuesincreased 4% during the third quarter of 2023 and 10% year-to-date primarily due to higher demand, partially offset by lower average net selling prices, including higher GTN adjustments due to product mix in 2023. A majority of Eliquis patients enter the coverage gap during the third and fourth quarters, which is expected to result in lower revenues during the second half of the year.
•International revenues decreased 2% during the third quarter of 2023 and 13% year-to-date primarily due to lower average net selling price, generic erosion in the UK and Canada partially offset by foreign exchange impact of 4% in the third quarter. Generic erosion had a more significant impact in the first half of 2023. The decrease in international revenues year-to-date included foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues decreased by 6% and 12%, respectively.
•Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe and the court decision in the United Kingdom finding the UK apixaban composition-of-matter patent and related SPC invalid, generic manufacturers have begun marketing generic versions of Eliquis in the UK and in Portugal, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which has led to additional infringement and invalidity actions involving our Eliquis patents being filed in various countries in Europe. Most recently, in France, Norway and Sweden, courts held in BMS's favor, confirming the validity of the composition of matter patent and related SPCs in those countries. 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 18. 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 NKTnatural killer T cells that has been approved for several anti-cancer indications including bladder, blood, colon,CRC, head and neck, kidney, liver,RCC, hepatocellular carcinoma, lung, melanoma, andMPM, stomach and continues to be investigatedesophageal cancer. 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.areas, in monotherapy and in combination with Yervoy and various anti-cancer agents.
•U.S. revenues increased in9% during both periodsthe third quarter of 2023 and year-to-date primarily due to higher demand. We expect increased competitiondemand across multiple indications and to a lesser extent higher average net selling prices. The higher demand was related to the following indications: the Opdivo+Yervoy combinations for Opdivo to continue in the future.
NSCLC, various gastric, esophageal and bladder cancers.
•International revenues increased in both periods15% during the third quarter of 2023 and 11% year-to-date due to higher demand as a result of additional indication launches of additionaland core indications and approvals in new countries.to a lesser extent lower average net selling prices. The year-to-date revenue increase was partially offset by foreign exchange impact of 3%. Excluding foreign exchange impacts, revenues increased 15% and 14%, respectively.
Eliquis(apixaban)
Pomalyst/Imnovid (pomalidomide) — an oral Factor Xa inhibitor, targeted at stroke prevention in adulta 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 non-valvular atrial fibrillationmultiple 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 preventionlast therapy.
•U.S. revenues decreased 5% during both the third quarter of 2023 and treatmentyear-to-date due to an increase in the number of venous thromboembolic disorders.patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, partially offset by higher average net selling prices.
U.S. and international
•International revenues increased in both periods7% during the third quarter of 2023 and 2% year-to-date primarily due to higher demand resulting fromand foreign exchange impacts of 3% partially offset by lower average net selling prices in the third quarter. The year-to-date revenues increase was partially offset by lower average net selling prices and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues increased commercial acceptance of novel oral anticoagulants and market share gains.by 4% in both periods.
Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsApsoriatic arthritis and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.
•U.S. revenues increased in both periods5% during the third quarter of 2023 and 3% year-to-date primarily due to higher demand. Year-to-date was also impacted by lower average net selling prices and demand.prices.
•International revenues increased in both periods2% during the third quarter of 2023 and 1% year-to-date due to higher demand.demand and in the third quarter, foreign exchange impacts of 1%. The year-to-date revenue increase was also partially offset by foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased by 1% and 4%, respectively.
•BMS is not aware of any Orencia biosimilars on the market in the U.S., EU and Japan. Formulation and additional patents expire in 2026 and beyond.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of adultspatients with Philadelphia chromosome-positive chronic myeloid leukemiaCML 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 meslylate).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 in both periods1% during the third quarter of 2023 due to increased demand partially offset by lower average net selling prices.
•U.S. revenues decreased 5% year-to-date due to lower average selling price driven by unfavorable prior period GTN adjustments.
•International revenues decreased 30% during the third quarter of 2023 and 26% year-to-date primarily due to higher demand.lower demand as a result of generic erosion, lower average net selling price and foreign exchange impacts of 1% and 3%, respectively. Excluding foreign exchange impacts, revenues decreased by 29% and 23%, respectively.
International revenues increased
•In the U.S., BMS entered into settlement agreements with certain third parties to sell generic dasatinib products beginning in both periods dueSeptember 2024, or earlier in certain circumstances. In the EU, generic dasatinib products have entered the market. In Japan, the composition of matter patent has been extended to higher demand.2024 for the treatment of non-imatinib-resistant CML, but generics have been approved for other indications.
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, CRC and esophageal cancer.
•U.S. revenues increased in both periods12% during the third quarter of 2023 and 9% year-to-date primarily due to higher demand.demand and average net selling prices.
•International revenues increased in both periods8% during the third quarter of 2023 and 4% year-to-date primarily due to higher demand.demand as a result of additional indication launches and core indications and foreign exchange impacts of 2% during the third quarter of 2023. The year-to-date increase was partially offset by lower average net selling price and foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased by 6% and 7%, respectively.
Empliciti (elotuzumab) — a humanized monoclonal antibody for the treatment of multiple myeloma.
Empliciti was launched in the U.S. in December 2015, in the EU in May 2016Mature and in Japan in September 2016.
Hepatitis C Franchise — Daklinza (daclatasvir) - an NS5A replication complex inhibitor; Sunvepra (asunaprevir) - an NS3 protease inhibitor; and beclabuvir - an NS5B inhibitor. Includes Ximency, a single pill combination of daclatasvir, asunaprevir and beclabuvir in Japan.
U.S. and international revenues decreased in both periods due to lower demand resulting from increased competition.
Baraclude (entecavir) — an oral antiviral agent for the treatment of chronic hepatitis B.
International revenues continued to decrease in both periods due to lower demand resulting from increased competition.
Sustiva (efavirenz)Franchise — a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, which includes Sustiva, an antiretroviral drug, and bulk efavirenz, which is also included in the combination therapy, Atripla*.
U.S. revenues continued to decrease in both periods due to lower demand resulting from increased competition. The loss of exclusivity for Sustiva is expected in December 2017 which may result in the termination of the joint venture agreement with Gilead and further reduce revenues beyond 2017.
Reyataz (atazanavir sulfate) Franchise — Includes Reyataz - a protease inhibitor for the treatment of HIV and Evotaz (atazanavir 300 mg and cobicistat 150 mg) - a combination therapy containing Reyataz and Tybost* (cobicistat).
U.S. revenues continued to decrease due to lower demand resulting from increased competition. The loss of exclusivity is expected in December 2017 and will result in a higher decline in revenues in future periods due to generic competition.
International revenues continued to decrease in both periods due to lower demand.
Other Brandsother products — includes all other products, including those which have lost exclusivity in major markets, OTC brandsproducts, royalty revenue and royalty revenue.mature products.
•International revenues decreased in both periods12% during the third quarter of 2023 and 15% year-to-date primarily due to out-licensing and divestiture of certain other brands and continued generic erosion.erosion, lower average net selling prices and foreign exchange impacts of 1% and 2%, respectively. Excluding foreign exchange impacts, revenues decreased by 11% and 13%, respectively.
New Product Portfolio
Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of ring sideroblast status. Reblozyl was launched in November 2019.
•U.S. revenues increased 28% during the third quarter of 2023 and 24% year-to-date primarily due to higher demand.
Abecma (idecabtagene vicleucel) — is a B-cell maturation antigen-directed ("BCMA") 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-cyclic ADP ribose hydrolase monoclonal antibody. Abecma was launched in May 2021.
•U.S. revenues decreased 8% during the third quarter of 2023 resulting from a planned facility maintenance and lower demand due to increased competition in BCMA targeted therapies, partially offset by higher average net selling prices.
•U.S. revenues increased 49% year-to-date primarily due to higher demand enabled by additional manufacturing capacity.
Opdualag (nivolumab and relatlimab-rmbw) — a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a lymphocyte activation gene-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.
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 one or more lines of systemic therapy. Breyanzi was launched in April 2021.
Onureg (azacitidine) — an oral hypomethylating agent that incorporates into DNA and RNA, indicated for continued treatment of adult patients with acute myeloid leukemia 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.
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.
Camzyos (mavacamten) — a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms. Camzyos was launched in April 2022.
Sotyktu (deucravacitinib) — an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu was launched in September 2022.
Recent LOE Products
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 decreased 44% during the third quarter of 2023 and 37% year-to-date primarily due to generic erosion and an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, and to a lesser extent lower average net selling prices.
•International revenues decreased 19% during the third quarter of 2023 and 53% year-to-date primarily due to generic erosion across several European countries and foreign exchange impacts of 1%. The year-to-date decrease was also impacted by lower average net selling prices. Excluding foreign exchange impacts, revenues decreased by 18% and 52%, respectively.
•In the U.S., certain third parties have been granted volume-limited licenses to sell generic lenalidomide beginning in March 2022 or thereafter. Pursuant to these licenses, several generics have entered or are expected to enter the U.S. market with volume-limited quantities of generic lenalidomide. In the EU, generic lenalidomide products have entered the market. Global revenues for Revlimid are expected to decline to approximately $6.0 billion in 2023.
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 increased 57% during the third quarter of 2023 and 15% year-to-date primarily due to higher branded sales resulting from lower authorized generic sales.
Estimated End-User Demand
Pursuant to the SEC Consent Order described under "— SEC Consent Order" in our 2016 Annual Report on2022 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 productscertain limited exceptions. There were not material to our results of operationsnone as of the dates indicated. No U.S. products had estimated levels of inventory in the distribution channel in excess of one month on hand at September 30, 2017. Below are international products that had estimated levels of inventory in the2023, for our U.S. distribution channel in excess of one month atchannels, and June 30, 2017.2023, for our non-U.S. distribution channels.
Dafalgan, an analgesic product sold principally in Europe, had 1.2 months of inventory on hand internationally at direct customers compared to 1.3 months of inventory on hand at March 31, 2017. The level of inventory on hand was primarily due to the ordering patterns of pharmacists in France.
Fervex, a cold and flu product, had 4.0 months of inventory on hand at direct customers compared to 2.7 months of inventory on hand at March 31, 2017. The level of inventory on hand was attributable to France to support product seasonality.
Perfalgan, an analgesic product, had 1.5 months of inventory on hand internationally at direct customers compared to 1.6 months of inventory on hand at March 31, 2017. The level of inventory on hand was due to extended delivery lead time primarily in the Gulf Countries.
Sunvepra, a Hepatitis C product, had 1.1 months of inventory on hand at direct customers compared to 1.1 months of inventory on hand at March 31, 2017. The level of inventory on hand was attributable to decreasing in-market sales primarily in Japan.
Ximency, a Hepatitis C product, had 1.1 months of inventory on hand at direct customers compared to 2.4 months of inventory on hand at March 31, 2017. The product was launched in February 2017 in Japan.
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, and our distributors. Our three largest wholesalers accountwhich accounted for approximately 95%86% of total gross sales of U.S. products.products during the nine months ended September 30, 2023. 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.
Revlimidand Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide REMS (Revlimid) 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 Revlimidand Pomalyst.Internationally, Revlimidand 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.
Camzyos is only available through a restricted program called the Camzyos REMS Program. Product distribution is limited to REMS certified pharmacies, and enrolled pharmacies must only dispense to patients who are authorized to receive Camzyos.
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 a result,such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. businesses forbusiness during the quarternine months ended September 30, 20172023 is not available prior to the filing of this quarterly reportQuarterly Report on Form 10-Q. We will disclose any product with levels of inventory levels in excess of one month on hand or expected demand for the current quarter, subject to a de minimis exception,certain limited exceptions, in theour next annualquarterly report on Form 10-K.10-Q.
Expenses
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | % Change | | 2023 | | 2022 | | % Change |
Cost of products sold(a) | $ | 2,506 | | | $ | 2,353 | | | 7 | % | | $ | 7,948 | | | $ | 7,544 | | | 5 | % |
Marketing, selling and administrative | 2,003 | | | 1,930 | | | 4 | % | | 5,699 | | | 5,548 | | | 3 | % |
Research and development | 2,242 | | | 2,418 | | | (7) | % | | 6,821 | | | 6,999 | | | (3) | % |
Acquired IPRD | 80 | | | 30 | | | * | | 313 | | | 763 | | | (59) | % |
Amortization of acquired intangible assets | 2,256 | | | 2,418 | | | (7) | % | | 6,769 | | | 7,252 | | | (7) | % |
Other (income)/expense, net | (258) | | | (140) | | | 84 | % | | (787) | | | 793 | | | * |
Total Expenses | $ | 8,829 | | | $ | 9,009 | | | (2) | % | | $ | 26,763 | | | $ | 28,899 | | | (7) | % |
|
| | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | % Change | | 2017 | | 2016 | | % Change |
Cost of products sold | $ | 1,572 |
| | $ | 1,305 |
| | 20 | % | | $ | 4,393 |
| | $ | 3,563 |
| | 23 | % |
Marketing, selling and administrative | 1,147 |
| | 1,144 |
| | — |
| | 3,388 |
| | 3,450 |
| | (2 | )% |
Research and development | 1,543 |
| | 1,138 |
| | 36 | % | | 4,490 |
| | 3,540 |
| | 27 | % |
Other (income)/expense | (191 | ) | | (224 | ) | | (15 | )% | | (1,377 | ) | | (1,198 | ) | | 15 | % |
Total Expenses | $ | 4,071 |
| | $ | 3,363 |
| | 21 | % | | $ | 10,894 |
| | $ | 9,355 |
| | 16 | % |
* In excess of +/- 100%.
(a) Excludes amortization of acquired intangible assets.
Cost of Products Sold
Cost of products sold increased by $153 million in both periodsthe third quarter of 2023 and $404 million year-to-date primarily due to lower hedging settlement gains ($143 million in the quarter and $147 million year-to-date) and higher royalty and profit sharing ($28 million in the quarter and $270 million year-to-date). Year-to-date also included the offsetting impacts of higher CAR-T cell therapy inventory charges and the elimination of the Puerto Rico excise tax ($164 million).
Marketing, Selling and Administrative
Marketing, selling and administrative expense increased by $73 million in the third quarter of 2023 primarily driven by higher advertising and promotion costs to support new product launches, a lease impairment in 2023 ($65 million) and timing of charitable giving ($90 million), partially offset by the cash settlement of Turning Point unvested stock awards ($73 million) in 2022.
Marketing, selling and administrative expense increased by $151 million year-to-date primarily due to higher Eliquis profit sharing (approximately $150advertising and promotion costs to support new product launches, and consulting costs supporting corporate initiatives, a lease impairment in 2023 ($65 million), partially offset by timing of charitable giving ($60 million) and cash settlement of Turning Point unvested stock awards ($73 million).
Research and Development
Research and development expense decreased by $176 million in the third quarter of 2023 and $520$178 million year-to-date, primarily due to lower clinical grants and supplies in 2023 and the cash settlement of Turning Point unvested stock awards ($80 million) in 2022. Year-to-date also included the impacts of the unwinding of inventory purchase price adjustments for clinical use ($130 million) in 2022, partially offset by the three and nine months ended September 30, 2017, respectively) and higher inventorypurchase of a priority review voucher ($95 million) in 2023.
Acquired IPRD
Acquired IPRD charges including a $70 million charge resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights were as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Mavacamten royalty extinguishment | $ | — | | | $ | — | | | $ | — | | | $ | 295 | |
Dragonfly milestone | — | | | — | | | — | | | 175 | |
Prothena opt-in license fee | — | | | — | | | 55 | | | — | |
Immatics upfront license fee | — | | | — | | | 15 | | | 150 | |
Evotec designation and opt-in license fees | — | | | — | | | 90 | | | — | |
BridgeBio upfront license fee | — | | | — | | | — | | | 90 | |
Zenas upfront license fee | 50 | | | — | | | 50 | | | — | |
Other | 30 | | | 30 | | | 103 | | | 53 | |
Acquired IPRD charges | $ | 80 | | | $ | 30 | | | $ | 313 | | | $ | 763 | |
Amortization of Acquired Intangible Assets
Amortization of acquired intangible assets decreased by $162 million in the third quarter of 2023 and $483 million year-to-date primarily due to Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
Other (Income)/Expense, Net
Other (income)/expense, net changed by $118 million in the third quarter of 2023 and $1.6 billion year-to-date primarily litigation and other settlements, equity investments and other items discussed below.
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
Interest expense | $ | 280 | | | $ | 299 | | | $ | 850 | | | $ | 938 | |
Royalty and licensing income | (365) | | | (374) | | | (1,068) | | | (967) | |
Royalty income - divestitures | (217) | | | (205) | | | (623) | | | (597) | |
Equity investment losses | — | | | 14 | | | 213 | | | 966 | |
Integration expenses | 54 | | | 114 | | | 180 | | | 343 | |
Loss on debt redemption | — | | | — | | | — | | | 266 | |
Divestiture gains | — | | | — | | | — | | | (211) | |
Litigation and other settlements | (61) | | | 44 | | | (393) | | | 32 | |
Investment income | (107) | | | (52) | | | (304) | | | (89) | |
Provision for restructuring | 141 | | | 17 | | | 321 | | | 60 | |
Other | 17 | | | 3 | | | 37 | | | 52 | |
Other (income)/expense, net | $ | (258) | | | $ | (140) | | | $ | (787) | | | $ | 793 | |
•Interest expense decreased in the third quarter of 2023 and year-to-date compared to 2022 due to additional debt maturities. Refer to "Item 1. Financial Statements and Supplementary Data—Note 10. Financing Arrangements" for further information.
•Royalties increased in the third quarter of 2023 and year-to-date primarily due to higher Keytruda* and diabetes business divestiture royalties. Refer to "Item 1. Financial Statements and Supplementary Data—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information.
•Equity investments generated lower expected HCV demand requirements. The nine months ended September 30, 2017 also included a $128 million impairment chargelosses in the third quarter of 2023 and year-to-date compared to reduce the carrying2022 primarily driven by fair value of assets held-for-sale to their estimatedadjustments for investments that have readily determinable fair value. Refer to "Item 1. Financial Statements—Note 4. Acquisitions, DivestituresStatements and Licensing Arrangements" for further information.
Research and development expense increased in both periods due to higher license and asset acquisition charges, accelerated depreciation and the expansion of Opdivo development programs. The nine months ended September 30, 2017 also included higher IPRD impairment charges.
The significant license and asset acquisition transactions and other charges included in R&D expense were as follows:
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
IFM | $ | 310 |
| | $ | — |
| | $ | 310 |
| | $ | — |
|
CytomX | — |
| | — |
| | 200 |
| | 10 |
|
Flexus | — |
| | — |
| | 93 |
| | 100 |
|
Cardioxyl | — |
| | — |
| | 100 |
| | — |
|
Padlock | — |
| | — |
| | — |
| | 139 |
|
Cormorant | — |
| | 35 |
| | — |
| | 35 |
|
Other | — |
| | 10 |
| | 50 |
| | 25 |
|
License and asset acquisition charges | 310 |
| | 45 |
| | 753 |
| | 309 |
|
IPRD impairments | — |
| | — |
| | 75 |
| | — |
|
Accelerated depreciation and other | 64 |
| | 14 |
| | 232 |
| | 40 |
|
License and asset acquisition charges include upfront payments for the IFM, CytomX, Padlock and Cormorant arrangements and milestone payments for the CytomX, Flexus and Cardioxyl arrangements. These arrangements were related to certain investigational oncology, cardiovascular and immunoscience compounds.
IPRD impairment charges in the nine months ended September 30, 2017 related to the discontinued development of an investigational compound which was part of our alliance with F-Star Alpha.
Accelerated depreciation and other charges resulted from the expected exit of R&D sites in the U.S. through 2020 primarily due to the reduction in the estimated useful lives of the related assets for each site.
Refer to "Item 1. Financial Statements—Note 3. Alliances, Note 4. Acquisitions, Divestitures and Licensing Arrangements and Note 6. Restructuring" for further information.
Other income increased in the nine months ended September 30, 2017 due to higher royalties and licensing income and litigation and other settlement income partially offset by lower divestiture gains and transition and other service fees and higher restructuring charges. The significant changes included in other income were as follows:
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Provision for restructuring | $ | 28 |
| | $ | 19 |
| | $ | 207 |
| | $ | 41 |
|
Litigation and other settlements | — |
| | (1 | ) | | (489 | ) | | 48 |
|
Divestiture (gains)/losses | 1 |
| | (21 | ) | | (126 | ) | | (574 | ) |
Royalties and licensing income | (209 | ) | | (158 | ) | | (1,093 | ) | | (579 | ) |
Transition and other service fees | (12 | ) | | (57 | ) | | (32 | ) | | (184 | ) |
Restructuring charges relate to changes to the Company's operating model to drive continued success in the near- and long-term through a more focused investment in commercial opportunities for key brands and markets, a competitive and more agile R&D organization that can accelerate the pipeline, streamline operations and realign manufacturing capabilities that broaden biologics capabilities to reflect the current and future portfolio as well as streamline and simplify our small-molecule supply network. The new operating model is expected to enable the Company to deliver the strategic, financial and operational flexibility necessary to invest in the highest priorities across the Company. Aggregate restructuring charges of approximately $250 million are expected to be incurred in 2017 for all actions in addition to accelerated depreciation impacts resulting from early site exits.
Litigation and other settlements include BMS's share of a patent-infringement litigation settlement related to Merck's PD-1 antibody Keytruda* in the first quarter of 2017 as BMS and Ono signed a global patent license agreement with Merck. Merck made an initial payment of $625 million to BMS and Ono, of which BMS received $481 million. Merck is also obligated to pay ongoing royalties on global sales of Keytruda* of 6.5% from January 1, 2017 through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. The companies also granted certain rights to each other under their respective
patent portfolios pertaining to PD-1. Payments and royalties are shared between BMS and Ono on a 75/25 percent allocation, respectively after adjusting for each parties' legal fees.
Divestiture gains include additional contingent consideration for the diabetes business ($100 million) in the first quarter of 2017, an OTC product business in the second quarter of 2016 ($277 million) and the investigational HIV medicines business in the first quarter of 2016 ($272 million).
Royalties and licensing income include upfront licensing fees from Biogen ($300 million) and Roche ($170 million) in the second quarter of 2017 in connection with the out-licensing of certain investigational genetically defined disease compounds.
Transition and other service fees in 2016 included fees resulting from the divestiture of the diabetes business in 2014 and the investigational HIV medicines business in 2016.
Refer to "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures and Licensing Arrangements, Note 5. Other (Income)/Expense, Note 6. Restructuring and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements" for furthermore information.
•Integration expenses decreased in the third quarter of 2023 and year-to-date primarily due to lower consulting fees to implement Celgene integration initiatives related to processes and systems.
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Earnings Before Income Taxes | $ | 1,183 |
| | $ | 1,559 |
| | $ | 4,433 |
| | $ | 4,829 |
|
Provision for Income Taxes | 327 |
| | 344 |
| | 1,129 |
| | 1,220 |
|
Effective Tax Rate | 27.6 | % | | 22.1 | % | | 25.5 | % | | 25.3 | % |
The jurisdictional tax rates and other tax impacts attributed to R&D charges, divestiture transactions and other specified items increased•Loss on debt redemption resulted from the effective tax rate by 3.7% and 3.1% inearly redemption of long-term debt during the nine months ended September 30, 20172022, as further discussed in "Item 1. Financial Statements and 2016, respectively.Supplementary Data—Note 10. Financing Arrangements".
•Divestiture gains resulted from the divestiture of certain mature product rights during the first quarter of 2022.
•Litigation and other settlements include $384 million of income related to the AZ settlement, partially offset by $322 million expense recorded in connection with the BeiGene settlement in 2023. In addition, year-to-date 2023 included $400 million of income related to the adoptionNimbus' TYK2 program change of amended income tax accounting guidance reducedcontrol provision incurred during the effective tax rate by 2.1% in the nine months ended September 30, 2017 which was offset by earnings mix between high and low tax jurisdictions.second quarter. Refer to "Item 1. Financial Statements—Statements and Supplementary Data—Note 1. Basis of Presentation and Recently Issued Accounting Standards and Note 7. Income Taxes"5. Other (Income)/Expense, Net" for further information.
•Investment income increased during the third quarter of 2023 and year-to-date primarily due to higher interest rates.
Comprehensive•Provision for restructuring includes exit and other costs primarily related to certain restructuring activities including a new plan in 2023 discussed further in "Item 1. Financial Statements and Supplementary Data—Note 6. Restructuring".
Income Taxes
| | | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | | 2023 | | 2022 |
Earnings before income taxes | $ | 2,137 | | | $ | 2,209 | | | | $ | 6,766 | | | $ | 5,854 | |
Income tax provision | 203 | | | 601 | | | | 488 | | | 1,534 | |
Effective tax rate | 9.5 | % | | 27.2 | % | | | 7.2 | % | | 26.2 | % |
| | | | | | | | |
Impact of specified items | (2.1) | % | | 10.3 | % | | | (7.5) | % | | 9.6 | % |
Effective tax rate excluding specified items | 11.6 | % | | 16.9 | % | | | 14.7 | % | | 16.6 | % |
Provision for 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 reduction in the effective tax rate during the third quarter of 2023 was primarily due to recently issued Section 174 guidance regarding deductibility of certain non-U.S. research and development expenses. The revised guidance resulted in a reduction of previously estimated income taxes attributed to 2022, which was reflected in the current quarter as well as a reduction in the estimated annual effective rates for 2023. Previously estimated income taxes for 2022 were reduced by approximately $240 million upon finalization of the U.S. Federal tax reform continuesreturn primarily due to be discussedthe aforementioned revised Section 174 guidance that was issued in the third quarter of 2023.
In addition, the effective tax rate during the first nine months of 2023 was impacted by a $656 million deferred income tax benefit following the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments, jurisdictional earnings mix resulting from amortization of acquired intangible assets, equity investment losses, litigation and proposed, including among other items,settlements, as well as releases of income tax reserves of $89 million related to the resolution of Celgene's 2009-2011 IRS audits, partially offset by the impact of changes in the Puerto Rico tax decree that eliminated a previously creditable excise tax. Additional changes to the corporateeffective tax rate a border adjustment tax andmay occur in future periods due to various reasons, including changes to how the U.S. taxes foreign earnings. It is currently uncertain whether anyestimated pretax earnings mix and tax reserves and revised interpretations or changes to the relevant tax code.
The changes in the non-GAAP effective tax rate were due to the changes in the aforementioned changes to Section 174 guidance, Puerto Rico tax decree, jurisdictional earnings mix and the tax reserve releases in the first quarter of these changes will be enacted, and if so, the effective dates. If comprehensive tax reform occurs, our financial condition, results of operations and cash flows could be significantly impacted, however, we are unable to determine the potential impact at this time.2023.
Non-GAAP Financial Measures
Our non-GAAP financial measures, includingsuch 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, R&D charges in connection with the acquisition or licensing(vi) costs of third-party intellectual property rights,acquiring a priority review voucher, (vii) divestiture and debt redemption gains or losses, (viii) stock compensation resulting from acquisition-related equity awards, (ix) pension, charges and legal and other contractual settlements,settlement charges, (x) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), (xi) income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and (xii) 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. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments. 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 99.1 to our Form 8-K filed on October 26, 2023 and are incorporated herein by reference.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investorsinvestors' overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPSthe related financial measures prepared in accordance with GAAP.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 consolidated financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
Specified items were as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 | | 2023 | | 2022 |
| | | | | | | |
Inventory purchase price accounting adjustments | $ | — | | | $ | 86 | | | $ | 84 | | | $ | 240 | |
| | | | | | | |
| | | | | | | |
Site exit and other costs | 16 | | | — | | | 53 | | | 43 | |
Cost of products sold | 16 | | | 86 | | | 137 | | | 283 | |
| | | | | | | |
Employee compensation charges | — | | | 73 | | | — | | | 73 | |
Site exit and other costs | 65 | | | — | | | 85 | | | 6 | |
Marketing, selling and administrative | 65 | | | 73 | | | 85 | | | 79 | |
| | | | | | | |
IPRD impairments | 60 | | | 58 | | | 80 | | | 98 | |
Priority review voucher | — | | | — | | | 95 | | | — | |
Inventory purchase price accounting adjustments | — | | | 22 | | | — | | | 130 | |
Employee compensation charges | — | | | 80 | | | — | | | 80 | |
Site exit and other costs | 4 | | | — | | | 10 | | | — | |
Research and development | 64 | | | 160 | | | 185 | | | 308 | |
| | | | | | | |
Amortization of acquired intangible assets | 2,256 | | | 2,418 | | | 6,769 | | | 7,252 | |
| | | | | | | |
Interest expense(a) | (12) | | | (18) | | | (39) | | | (66) | |
| | | | | | | |
| | | | | | | |
Equity investment (income)/losses | (2) | | | 12 | | | 206 | | | 962 | |
Integration expenses | 54 | | | 114 | | | 180 | | | 343 | |
Loss on debt redemption | — | | | — | | | — | | | 266 | |
Divestiture gains | — | | | — | | | — | | | (211) | |
Litigation and other settlements | (62) | | | 36 | | | (397) | | | (4) | |
Provision for restructuring | 141 | | | 17 | | | 321 | | | 60 | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Other | 28 | | | 28 | | | 23 | | | 70 | |
Other (income)/expense, net | 147 | | | 189 | | | 294 | | | 1,420 | |
| | | | | | | |
Increase to pretax income | 2,548 | | | 2,926 | | | 7,470 | | | 9,342 | |
| | | | | | | |
Income taxes on items above | (340) | | | (268) | | | (944) | | | (987) | |
| | | | | | | |
| | | | | | | |
Income taxes attributed to non-U.S. tax ruling | — | | | — | | | (656) | | | — | |
| | | | | | | |
Income taxes | (340) | | | (268) | | | (1,600) | | | (987) | |
| | | | | | | |
Increase to net earnings | $ | 2,208 | | | $ | 2,658 | | | $ | 5,870 | | | $ | 8,355 | |
(a) Includes amortization of purchase price adjustments to Celgene debt.
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 | | 2017 | | 2016 |
Impairment charges | $ | 1 |
| | $ | — |
| | $ | 128 |
| | $ | — |
|
Accelerated depreciation and other shutdown costs | — |
| | 7 |
| | 3 |
| | 15 |
|
Cost of products sold | 1 |
| | 7 |
| | 131 |
| | 15 |
|
| | | | | | | |
License and asset acquisition charges | 310 |
| | 45 |
| | 753 |
| | 309 |
|
IPRD impairments | — |
| | — |
| | 75 |
| | — |
|
Accelerated depreciation and other | 64 |
| | 14 |
| | 232 |
| | 40 |
|
Research and development | 374 |
| | 59 |
| | 1,060 |
| | 349 |
|
| | | | | | | |
Provision for restructuring | 28 |
| | 19 |
| | 207 |
| | 41 |
|
Litigation and other settlements | — |
| | (3 | ) | | (481 | ) | | 40 |
|
Divestiture gains | — |
| | (13 | ) | | (100 | ) | | (559 | ) |
Royalties and licensing income | — |
| | — |
| | (497 | ) | | — |
|
Pension charges | 22 |
| | 19 |
| | 91 |
| | 66 |
|
Intangible asset impairments | — |
| | — |
| | — |
| | 15 |
|
Loss on debt redemption | — |
| | — |
| | 109 |
| | — |
|
Other (income)/expense | 50 |
| | 22 |
| | (671 | ) | | (397 | ) |
| | | | | | | |
Increase/(decrease) to pretax income | 425 |
| | 88 |
| | 520 |
| | (33 | ) |
Income taxes on specified items | (41 | ) | | (3 | ) | | 51 |
| | 156 |
|
Increase to net earnings | 384 |
| | 85 |
| | 571 |
| | 123 |
|
Noncontrolling interest | — |
| | — |
| | (59 | ) | | — |
|
Increase to net earnings used for Diluted Non-GAAP EPS calculation | $ | 384 |
| | $ | 85 |
| | $ | 512 |
| | $ | 123 |
|
The reconciliations from GAAP to Non-GAAP were as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in millions, except per share data | 2023 | | 2022 | | 2023 | | 2022 |
Net earnings attributable to BMS | | | | | | | |
GAAP | $ | 1,928 | | | $ | 1,606 | | | $ | 6,263 | | | $ | 4,305 | |
Specified items | 2,208 | | | 2,658 | | | 5,870 | | | 8,355 | |
Non-GAAP | $ | 4,136 | | | $ | 4,264 | | | $ | 12,133 | | | $ | 12,660 | |
| | | | | | | |
Weighted-average common shares outstanding – diluted | 2,064 | | | 2,148 | | | 2,093 | | | 2,154 | |
| | | | | | | |
Diluted earnings per share attributable to BMS | | | | | | | |
GAAP | $ | 0.93 | | | $ | 0.75 | | | $ | 2.99 | | | $ | 2.00 | |
Specified items | 1.07 | | | 1.24 | | | 2.81 | | | 3.88 | |
Non-GAAP | $ | 2.00 | | | $ | 1.99 | | | $ | 5.80 | | | $ | 5.88 | |
|
| | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
Dollars in Millions, except per share data | 2017 | | 2016 | | 2017 | | 2016 |
Net Earnings Attributable to BMS used for Diluted EPS Calculation – GAAP | $ | 845 |
| | $ | 1,202 |
| | $ | 3,335 |
| | $ | 3,563 |
|
Specified Items | 384 |
| | 85 |
| | 512 |
| | 123 |
|
Net Earnings used for Diluted EPS Calculation – Non-GAAP | $ | 1,229 |
| | $ | 1,287 |
| | $ | 3,847 |
| | $ | 3,686 |
|
| | | | | | | |
Average Common Shares Outstanding – Diluted | 1,645 |
| | 1,679 |
| | 1,655 |
| | 1,679 |
|
| | | | | | | |
Diluted Earnings Per Share – GAAP | $ | 0.51 |
| | $ | 0.72 |
| | $ | 2.02 |
| | $ | 2.12 |
|
Diluted EPS Attributable to Specified Items | 0.24 |
| | 0.05 |
| | 0.30 |
| | 0.08 |
|
Diluted Earnings Per Share – Non-GAAP | $ | 0.75 |
| | $ | 0.77 |
| | $ | 2.32 |
| | $ | 2.20 |
|
FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES
Our net cashdebt position was as follows:
| | | | | | | | | | | |
Dollars in Millions | September 30, 2023 | | December 31, 2022 |
Cash and cash equivalents | $ | 7,514 | | | $ | 9,123 | |
Marketable debt securities – current | 171 | | | 130 | |
Marketable debt securities – non-current | 325 | | | — | |
Total cash, cash equivalents and marketable debt securities | 8,010 | | | 9,253 | |
Short-term debt obligations | (5,467) | | | (4,264) | |
Long-term debt | (32,137) | | | (35,056) | |
Net debt position | $ | (29,594) | | | $ | (30,067) | |
|
| | | | | | | |
Dollars in Millions | September 30, 2017 | | December 31, 2016 |
Cash and cash equivalents | $ | 4,644 |
| | $ | 4,237 |
|
Marketable securities – current | 2,478 |
| | 2,113 |
|
Marketable securities – non-current | 2,526 |
| | 2,719 |
|
Cash, cash equivalents and marketable securities | 9,648 |
| | 9,069 |
|
Short-term debt obligations | (1,461 | ) | | (992 | ) |
Long-term debt | (6,982 | ) | | (5,716 | ) |
Net cash position | $ | 1,205 |
| | $ | 2,361 |
|
Cash, cash equivalents and marketable securities held in the U.S. were approximately $200 million at September 30, 2017. Most of the remaining $9.4 billion is held primarily in low-tax jurisdictions attributable to earnings expected to be indefinitely reinvested offshore. Cash repatriations are subject to restrictions in certain jurisdictions and may be subject to withholding and additional U.S. income taxes. We believe that our existing cash, cash equivalents and marketable debt securities, together with our ability to generate cash generated from operations and issuance of commercial paper in the U.S. will beour access to short-term and long-term borrowings, are sufficient to satisfy our normalexisting and anticipated cash requirements for at least the next few years,needs, including dividends, capital expenditures, milestone payments, working capital, and maturities of long-term debt.
Management continuously evaluates the Company’s capital structure to ensure the Company is financed efficiently, which may result in theincome taxes, restructuring initiatives, business development, business combinations, asset acquisitions, repurchase of common stock, debt maturities, as well as any debt repurchases through redemptions or tender offers. During the first nine months ended September 30, 2023, our net debt position decreased by $473 million primarily driven by $9.6 billion of cash provided by operations partially offset by $8.7 billion of dividend payments and debt securities, termination of interest rate swap contracts prior to maturity and issuancecommon stock repurchases.
During the first nine months ended September 30, 2023, $1.9 billion of debt securities.
The Company repurchased $2.2 billion of common stock in 2017 through accelerated share repurchase agreements, Rule 10b5-1 plansmatured and open market purchases. The stock repurchases were funded by $1.5 billion of new long-term debt and cash. The Companywas repaid including $750 million of long-term debt at maturity in the third quarter of 20172.750% Notes, $890 million 3.250% Notes and repurchased $337$239 million of long-term debt in the second quarter of 2017. Refer to “Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements and Note 15. Equity" for further information.7.150% Notes.
We issued commercial paper to fund near-term domestic liquidity requirements during 2017. The average amount of commercial paper outstanding was $211 million at a weighted-average rate of 1.12% during 2017. The maximum amount of commercial paper outstanding was $1.0 billion with $799 million outstanding at September 30, 2017.
Dividend payments were $1.9 billion in each ofDuring the nine months ended September 30, 20172023 we repurchased an aggregate $5.2 billion of common stock. Refer to "Item 1. Financial Statements and 2016. Dividends declared per common shareSupplementary Data—Note 16. Equity" for further information.
Dividend payments were $1.17 and $1.14 in$3.6 billion during the nine months ended September 30, 20172023. Dividend paid per common share was $0.57 during each of the first, second and 2016, respectively. Dividend decisions arethird quarters of 2023. The decision to authorize dividends is made on a quarterly basis by our Board of Directors.
Annual capital expenditures were $1.2 billion in 2016 and are expected to be approximately $1.0$1.1 billion and $1.4 billion in 20172023 and $900 million in 2018.2024, respectively. We continue to expandmake capital expenditures in connection with the expansion of our biologics manufacturing capabilities, research and development and other facility-related activities. For example, we are constructing a new large-scale biologics manufacturing facility in Ireland that will produce multiple therapies for our growing biologics portfolio when completed in 2019.
Our investment portfolio includes non-current marketable 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 duration 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.
We currently have three separate revolving credit facilities totaling $5 billion from a syndicate of lenders. The facilities provide for customary terms and conditions withThere were no financial covenants. Our 364 day $2.0 billion facility expires in March 2018 and our two $1.5 billion facilities were extended to October 2021 and July 2022. Our two $1.5 billion, five-year facilities are extendable annually by one year on the anniversary date with the consent of the lenders. No borrowings were outstanding under anyour $5.0 billion revolving credit facility atas of September 30, 2017 or2023 and December 31, 2016.2022.
Additional regulations in the U.S. could be passed in the future including additional healthcare reform initiatives, comprehensive tax reform, additional pricing laws and potential importation restrictions which may reduceUnder our results of operations, operating cash flow, liquidity and financial flexibility. We continue to monitor the potential impact of the economic conditions in certain European and other countries and the related impact on prescription trends, pricing discounts and creditworthiness of our customers. We believe these economic conditions will not have a material impact on our liquidity, cash flow or financial flexibility.
Credit Ratings
BMS's long-term and short-term credit ratings assigned by Moody's Investors Service are A2 and Prime-1, respectively, with a negative long-term credit outlook. BMS's 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. BMS's long-term and short-term credit ratings assigned by Fitch are A- and F2, respectively, with a stable long-term credit outlook. Our 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. Our 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 debtcommercial paper program, we may incur,issue a maximum of $5.0 billion unsecured notes that have maturities of not more than 366 days from the fair market valuedate of existing debt and our ability to access the capital markets generally.issuance. There were no commercial paper borrowings outstanding as of September 30, 2023.
Cash Flows
The following is a discussion of cash flow activities:
| | | | | | | | | | | |
| Nine Months Ended September 30, |
Dollars in millions | 2023 | | 2022 |
Cash flow provided by/(used in): | | | |
Operating activities | $ | 9,608 | | | $ | 9,760 | |
Investing activities | (949) | | | (2,275) | |
Financing activities | (10,383) | | | (13,716) | |
|
| | | | | | | |
| Nine Months Ended September 30, |
Dollars in Millions | 2017 | | 2016 |
Cash flow provided by/(used in): | | | |
Operating activities | $ | 4,158 |
| | $ | 1,615 |
|
Investing activities | (1,085 | ) | | 1,464 |
|
Financing activities | (2,725 | ) | | (2,048 | ) |
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, changesThe $152 million decrease 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. In addition, cash collections continue to be impactedprovided by longer payment terms for certain biologic products in the U.S., primarily our newer oncology products including Opdivo, Yervoy and Empliciti (120 days to 150 days). The longer payment terms are used to more closely align with the insurance reimbursement timing for physicians and cancer centers following administration to the patients.
The $2.5 billion change in cash flow from operating activities compared to 20162022 was primarily attributable to the following items in addition to increased sales and the timing of cash collections and payments in the ordinary course of business:
Lower income tax payments of approximately $1.4 billion;
Higher out-license proceeds of approximately $500 million primarily related to the Biogen and Roche transactions; and
BMS's share of litigation settlement proceeds of $481 million related to Merck's PD-1 antibody Keytruda*.
Partially offset by:
Higher R&D licensing payments of approximately $300 million primarily due to the CytomX transaction.lower collections of $700 million (net of rebates and discounts) partially offset by lower non-refundable advance payments for research and development services ($500 million).
Investing Activities
Cash requirements from investing activities includeThe $1.3 billion decrease in cash used for acquisitions, manufacturing and facility-related capital expenditures and purchases of marketable securities with maturities greater than 90 days reduced by proceeds from business divestitures (including royalties) and the sale and maturity of marketable securities.
The $2.5 billion change in cash flow from investing activities compared to 20162022 was primarily attributable to:
Lower net sales of marketable securities with maturities greater than 90 days of $1.6 billion due to higher available cash balances;
Lower business divestiture proceeds of approximately $700 million primarily due to certain OTC products and investigational HIV business divestitures in 2016; and
Higher asset acquisition payments of approximately $400 million primarily due to the acquisition of IFMTurning Point ($3.2 billion net of cash acquired) in 2017.2022 partially offset by changes in the amount of marketable debt securities held ($2.0 billion).
Financing Activities
Cash requirements from financing activities includeThe $3.3 billion decrease in 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 $677 million change in cash flow from financing activities compared to 20162022 was primarily attributable to:
Higher repurchase of common stock of $2.0 billion primarily due to the acceleratedlower net debt borrowings ($3.8 billion), lower share repurchase agreements.repurchases ($430 million) partially offset by lower proceeds from stock option exercises ($803 million).
Partially offset by:
Higher net borrowings of $1.4 billion primarily to fund the repurchase of common stock.
Product and Pipeline Developments
We manage our
Our R&D programs are managed on a portfolio basis investing resources in each stage from early discovery through late-stage development. We continually evaluate our portfolio of R&D assets to ensure that there is an appropriatedevelopment and include a balance of early-early-stage and late-stage programs to support future growth. We consider ourOur late-stage R&D programs that have entered intoin Phase III development to be significant, as these programs constitute our late-stage development pipeline. These programs include both investigational compounds in Phase III development for initial indications and marketed products in Phase III development for additional indications or formulations.formulations for marketed products. The following are the recent developments in our marketed products and our late-stage pipeline:pipeline since the start of the third quarter of 2023:
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| | | | | | | | | | |
Product | Indication | Date | Developments |
| | | | | | | | | | | |
Opdivo | GastricBladder | September 2017October 2023 | ApprovalAnnounced results from the Phase III CheckMate -901 trial in Japan which Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival and progression-free survival as assessed by Blinded Independent Central Review compared to standard-of-care cisplatin-based chemotherapy as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are cisplatin-eligible. With a median follow up of 33 months, treatment with Opdivo in combination with cisplatin-based chemotherapy reduced risk of death by 22%; no new safety signals were identified. |
Melanoma | October 2023 | Announced FDA approval of Opdivo for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono. |
HCC | September 2017 | FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib. |
mCRC | August 2017 | FDA approval for theadjuvant treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatincompletely resected stages IIB and irinotecan.IIC melanoma. The approval is based on the Phase III CheckMate -76K trial. |
Melanoma | October 2017August 2023 | Announced FDA accepted EC approval of Opdivo for priority review the Company's sBLAadjuvant treatment of adult and pediatric patients 12 years and older with completely resected stages IIB and IIC melanoma. The approval is based on results from the Phase III CheckMate -76K trial. |
NSCLC | October 2023 | Announced follow-up results from the Phase III CheckMate -816 trial, demonstrating sustained event-free survival and promising overall survival trends with three cycles of Opdivo in combination with platinum-based chemotherapy for Opdivo to treatthe neoadjuvant treatment of patients with melanoma who are at highresectable NSCLC, regardless of PD-L1 expression levels. Neoadjuvant Opdivo with chemotherapy also showed improvements in pathologic complete response and major pathologic response over chemotherapy alone in PD-L1>1% and <1% patient populations. The safety profile of the Opdivo-based regimen was consistent across all PD-L1 subgroups. |
October 2023 | Announced that the first disclosure of data from the Phase III CheckMate -77T trial evaluating perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB NSCLC showed statistically significant and clinically meaning improvement in the primary efficacy endpoint of event-free survival as assessed by Blinded Independent Central Review compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. Neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo reduced the risk of disease recurrence, following complete surgical resection. The FDA action date is February 14, 2018. |
September 2017 | Announced treatment with Opdivo resulted in significant improvement in recurrence-free survival compared to Yervoyprogression or death by 42% in patients with stage IIIb/c or stage IV melanoma following complete surgical resection.resectable non-small cell lung cancer.
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| | | | | | | | | | | |
Product | Indication | Date | Developments |
| | | | | | | | | | | |
Opdivo | Prostate Cancer | July 20172023 | Announced athat results from the Phase III CheckMate -7DX trial evaluating Opdivo versus Yervoy in patientscombination with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint of recurrence-free survival at a planned interim analysis. |
Multiple Myeloma | September 2017 | Announced the FDA placed a partial clinical hold on CheckMate-602, CheckMate-039 and CA204142, three clinical trials investigating Opdivo based combinations in patients with relapsed or refractory multiple myeloma. This partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma.
|
NSCLC | September 2017 | Announced three-year overall survival data from CheckMate-017 and CheckMate-057, two pivotal Phase III randomized studies evaluating Opdivo vs. docetaxel in patients with previously treated metastatic NSCLC.
|
Various | July 2017 | BMS and Clovis Oncology, Inc. announced a clinical collaboration to evaluate the combination of Opdivo and Rubraca* (rucaparib) in pivotal Phase III trials in advanced ovarian cancer and triple-negative breast cancer as well as a Phase II trial inor metastatic castration-resistant prostate cancer.cancer did not meet the primary endpoints of radiographic progressive free survival at final analysis, nor overall survival at an interim analysis. No safety concerns were reported. Based on the recommendation from the data monitoring committee, the Company has decided to discontinue the study.
|
RCC | October 2023 | Announced FDA acceptedthat the Company's sBLAsPhase III CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo co-formulated with Halozyme Therapeutics’ proprietary recombinant human hyaluronidase (rHPuH20) ("subcutaneous nivolumab") compared to update intravenous (IV) Opdivo dosing in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint. Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications.IV Opdivo, the study’s co-primary endpoints. Additionally, subcutaneous nivolumab showed a noninferior objective response rate as assessed by Blinded Independent Central Review vs. IV Opdivo, a key secondary endpoint. The FDA action date is March 5, 2018.safety profile of subcutaneous nivolumab was consistent with the IV formulation. |
| | | | | | | | | | | |
Opdivo+Yervoy | RCCNSCLC | September 20172023 | Announced CheckMate-214, a Phase III study evaluating Opdivo+Yervoy versus sunitinib in patients with previously untreated advanced or metastatic RCC, met its co-primary endpoint, demonstrating superior overall survival in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved OS in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committee has recommended that the trial be stopped early. |
August 2017 | Announced toplinesix-year results from CheckMate-214. The combination of Opdivo+Yervoy met the co-primary endpoint of objective response rate and was favored in the co-primary endpoint of progression-free survival, however, it did not reach statistical significance.
|
July 2017 | BMS and Exelixis, Inc. announced the initiationPart 1 of the Phase III CheckMate 9ER-227 trial demonstrating long-term, durable survival benefits of Opdivo plus Yervoy compared to evaluate Opdivochemotherapy in combination with Cabometyx* (cabozantinib) or Opdivo and Yervoy in combination with Cabometyx* versus sunitinib inthe first-line treatment of patients with previously untreated, advanced or metastatic RCC.
|
SCLC | October 2017 | Announced data evaluating Opdivo and Opdivo+Yervoy in previously treated SCLC patients whose tumors were evaluable for tumor mutation burden from the Phase I/II CheckMate-032 trial.NSCLC, regardless of PD-L1 expression levels.
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|
| | | | | | | | | | |
ProductReblozyl | IndicationMDS | DateAugust 2023 | DevelopmentsAnnounced FDA approval of Reblozyl as first-line treatment of anemia in adults with lower-risk Myelodysplastic Syndromes (MDS) who may require transfusions. This expanded indication to the first-line setting is based on interim results from the Phase III COMMANDS trial, expanding approved population to ESA-naïve patients, regardless of ring sideroblast status.
|
| | | | | | | | | | | |
EliquisZeposia | NVAFMultiple Sclerosis | August 2017October 2023 | Announced data from the Phase III DAYBREAK and RADIANCE trials showing that after eight years of follow-up, 76% of patients treated with Zeposia for relapsing multiple sclerosis were free of six-month confirmed disability progression. Findings also demonstrated treatment with Zeposia resulted in low rates of progression independent relapse activity and relapse-associated worsening, key drivers of disease progression and permanent disability in multiple sclerosis. Also announced that first interim readout from the Phase IIIb ENLIGHTEN trial showing clinically meaningful improvement in cognitive functioning compared to baseline after one year of Zeposia treatment in almost half of patients with early relapsing multiple sclerosis. |
| | | | | | | | | | | |
Camzyos | Obstructive HCM | August 2023 | Announced long-term follow-up results from the Phase III VALOR-HCM LTE trial demonstrating consistent impact of oral treatment for severely symptomatic obstructive HCM patients by showing that nearly 9 out of 10 patients treated with Camzyos have continued in the trial without septal reduction therapy at either 40 or 56 weeks of treatment. Also announced long-term follow-up results from the Phase III EXPLORER-LTE trial showing sustained improvements in left ventricular outflow tract obstruction, symptoms and NT-proBNP levels in patients with symptomatic obstructive HCM. No new safety signals were observed. |
| | | | | | | | | | | |
Sotyktu | Plaque Psoriasis | October 2023 | Announced results from the POETYK PSO LTE trial of Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis. Clinical response rates were maintained with continuous treatment with modified nonresponder imputation responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75 with 3 years of continuous Sotyktu treatment. Sotyktu had a real-world data analysisconsistent safety profile with no increases in adverse events or serious adverse events and no new safety signals. |
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repotrectinib | NSCLC | October 2023 | Announced the submission of the U.S. Humana database, in whichJapan NDA to the Pharmaceuticals and Medical Devices Agency for repotrectinib, a next-generation ROS1/TRK tyrosine kinase inhibitor, for the treatment of adult patients with Eliquis was associated withlocally advanced or metastatic ROS1-positive NSCLC. The application is based on data from the registrational Phase I/II TRIDENT-1 trial. |
August 2023 | Announced updated results from the registrational Phase I/II TRIDENT-1 trial demonstrating that repotrectinib, a significantly lower risk of stroke/systemic embolismnext-generation ROS1/TRK tyrosine kinase inhibitor, continued to show high response rates and lower rates of major bleeding compared to warfarindurable responses, including robust intracranial responses, in patients aged 65 yearswith ROS1-positive locally advanced or metastatic NSCLC. Based on prior results from the TRIDENT-1 trial, the FDA accepted the NDA for repotrectinib granting Priority Review and older with NVAF.assigned a PDUFA goal date of November 27, 2023. |
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Product | Indication | Date | Developments |
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LPA1 | Progressive Pulmonary Fibrosis | October 2023 | Announced datathat the FDA has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF). The Breakthrough Therapy Designation is based on results from EMANATE, athe global, randomized Phase IV trial, exploringII study that assessed the safety and efficacy of EliquisBMS-986278 treatment versus placebo in patientspeople living with NVAF undergoing cardioversion. |
Announced results from a real-world data analysis pooled from four large U.S. insurance claims databases,idiopathic pulmonary fibrosis (IPF) and PPF. Stable background use of antifibrotics in which treatment with Eliquis was associated with a lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin for the overall population and for each ofIPF cohort and/or select immunosuppressives in the selected high-risk patient sub-populations.
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Orencia | PsA | July 2017 | EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required. |
FDA approval for active PsA in adults, a chronic, inflammatory disease that can affect both the skin and musculoskeletal system. |
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Sprycel | CML | July 2017 | Announced the FDA accepted for priority review a supplemental NDA to treat children with Philadelphia chromosome-positive chronic phase CML, as well as a powder for oral suspension formulation of Sprycel. The FDA action date is November 9, 2017.
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Yervoy | Melanoma | October 2017 | Announced the FDA added five-year overall survival data from the Phase III CA184-029 trial to the prescribing information for Yervoy for the adjuvant treatment of fully resected cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm.
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July 2017 | FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients. |
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Prostvac* | Prostate Cancer | September 2017 | Bavarian Nordic A/S announced an independent Data Monitoring Committee determined that the continuation of the Phase III PROSPECT study of Prostvac* in patients with metastatic castration-resistant prostate cancer is futile. PPF cohort were allowed. |
CRITICAL ACCOUNTING POLICIESCritical 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"Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations”Operations" in our 2016 Annual Report on2022 Form 10-K. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2017.2023. 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."
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSSpecial Note Regarding Forward-Looking Statements
This quarterly reportQuarterly 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”"forward-looking" statements within the meaning of Section 27A of the Securities Act, of 1933 and Section 21E of the Securities Exchange Act of 1934.Act. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”, “guidance”, “intend”, “plan”, “believe”"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 our 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 actual outcomesour future financial results, goals, plans and objectives to differ materially from current expectations.those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and projectionsobjectives 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, our ability to complete the acquisition of Mirati, and in relation to our ability to realize the projected benefits of our acquisitions of Celgene, MyoKardia, Turning Point and Mirati, 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 prices, 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, which are basedresults. No forward-looking statement can be guaranteed. This Quarterly Report on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years. We have included important factors in the cautionary statements included in this report and in the 2016 Annual Report onForm 10-Q, our 2022 Form 10-K, particularly under “Itemthe 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. WeAdditional 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 release publicly update or revise any revisions to forward-looking statementsstatement, whether as a result of new information, future events, changed circumstances or otherwise.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"Item 7A. Quantitative and Qualitative Disclosures Aboutabout Market Risk”Risk" in our 2016 Annual Report on2022 Form 10-K.
Item 4. CONTROLS AND PROCEDURES
Management carried out an evaluation, under the supervision and with the participation of the Chief Executive Officerits chief executive officer and Chief Financial Officer, evaluatedchief financial officer, of the effectiveness of ourthe design and operation of its disclosure controls and procedures. Based on their evaluation,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, the Chief Executive Officer10-Q. Based on this evaluation, our principal executive officer and Chief Financial Officer haveprincipal financial officer concluded that as of September 30, 2023, such disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) are effective.
There were no changes in the Company’sCompany's internal control over financial reporting during the quarter ended September 30, 20172023, that have materially affected, or are reasonably likely to materially affect, the Company’sCompany's internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
Information pertaining to legal proceedings can be found in “Item"Item 1. Financial Statements—Note 17.18. 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 2016 Annual Report onCompany's 2022 Form 10-K.
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 September 30, 2017:2023:
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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, 2023 | 11,032 | | | $ | 63.90 | | | — | | | $ | 6,014 | |
August 1 to 31, 2023(c) | 56,110,995 | | | | | 56,087,101 | | | 2,014 | |
September 1 to 30, 2023 | 57,330 | | | 59.72 | | | — | | | 2,014 | |
Three months ended September 30, 2023 | 56,179,357 | | | | | 56,087,101 | | | |
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(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.
(b)In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of our common stock. Following this authorization, the Board subsequently approved additional authorizations, including most recently, in February 2020, January 2021 and December 2021, in the amounts of $5.0 billion, $2.0 billion and $15.0 billion, respectively, to the share repurchase authorization. The remaining share repurchase capacity under the program was approximately $2.0 billion as of September 30, 2023. Refer to "Item 8. Financial Statements and Supplementary Data—Note 17. Equity" in our 2022 Form 10-K for information on the share repurchase program.
(c)On August 9, 2023, as part of our existing share repurchase program, BMS executed accelerated share repurchase (“ASR”) agreements to repurchase an aggregate $4.0 billion of common stock. Approximately 56 million shares of common stock (85% of the $4.0 billion aggregate purchase price calculated on the basis of a price of $60.62 per share, the closing share price of the Company's common stock on August 9, 2023) 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. The ASR transactions are scheduled to terminate in the fourth quarter of 2023, but each may conclude earlier than its scheduled termination date at the election of the applicable bank.
Item 5. OTHER INFORMATION
Rule 10b5-1 Trading Arrangement
During the period covered by this Quarterly Report on Form 10-Q, no director or officer of the Company adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408(a) of Regulation S-K. During the third quarter of 2023, the Company entered into the ASR agreements which are intended to be Rule 10b5-1 trading arrangements. For more information about the ASR transactions, see "Item 2. Unregistered Sales of Equity Securities and Use of Proceeds."
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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, 2017 | 63,794 |
| | $ | 56.63 |
| | 52,851 |
| | $ | 2,134 |
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August 1 to 31, 2017 | 2,994,306 |
| | $ | 57.68 |
| | 2,985,959 |
| | $ | 1,962 |
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September 1 to 30, 2017 | 812,937 |
| | $ | 62.53 |
| | 803,249 |
| | $ | 1,912 |
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Three months ended September 30, 2017 | 3,871,037 |
| | | | 3,842,059 |
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(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. |
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(b) | In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock and in June 2012 increased its authorization for the repurchase of common stock by an additional $3.0 billion. In October 2016, the Board of Directors approved a new share repurchase program authorizing the repurchase of an additional $3.0 billion of common stock. The stock repurchase program does not have an expiration date. Refer to “Item 1. Financial Statements—Note 15. Equity" for information on the accelerated share repurchase agreements. |
Item 6. EXHIBITS
Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).
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Exhibit No. | | Description |
31a. | | |
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101.101.INS | | The following financial statements fromXBRL Instance Document - the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q forinstance document does not appear in the quarter ended September 30, 2017, formattedInteractive Data File because its XBRL tags are embedded within the Inline XBRL document.
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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 Extensible Business Reporting Language (XBRL):(i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements. 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 Bristol-Myers Squibb and Gilead Sciences, LLC; Byetta is a trademark of Amylin Pharmaceuticals, LLC; Cabometyx is a trademark of Exelixis, Inc.; ENHANZE is a trademark of Halozyme, Inc.; Erbitux is a trademark of ImClone LLC; Gleevec is a trademark of Novartis AG; Keytruda is a trademark of Merck Sharp & Dohme Corp.Corp; Krazati is a trademark Mirati, Therapeutics, Inc.; Onglyza is a trademark of AstraZeneca AB; Otezla is a trademark of Amgen Inc.; and Plavix is a trademark of Sanofi; Prostvac Tecentriqis a trademark of BN ImmunoTherapeuticsGenentech, Inc.; Rubraca is a trademark of Clovis Oncology, Inc. and Tybost is a trademark of Gilead Sciences Ireland UC. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.
SUMMARY OF ABBREVIATED TERMS
Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as Bristol-MyersBristol Myers Squibb, BMS, the Company, we, our or us in this Quarterly Report on Form 10-Q.10-Q, unless the context otherwise indicates. Throughout this Quarterly Report on Form 10-Q we have used terms which are defined below:
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20162022 Form 10-K | Annual Report on Form 10-K for the fiscal year ended December 31, 20162022 | LPA1 | lysophosphatidic acid receptor 1 |
AstraZenecaANDA | AstraZeneca PLCAbbreviated New Drug Application | MDL | multi-district litigation |
BiogenAstraZeneca | Biogen Inc.AstraZeneca PLC | MDS | myelodysplastic syndromes |
CardioxylASR | Cardioxyl Pharmaceuticals, Inc. |
CMLaccelerated share repurchase | chronic myeloid leukemia |
CytomXMirati Therapeutics | CytomXMirati Therapeutics, Inc. |
dMMRBCMA | DNA mismatch repair deficientB-cell maturation antigen-directed | MPM | malignant pleural mesothelioma |
EPOCAR-T | European Patent Officechimeric antigen receptor T-cell | MyoKardia | MyoKardia, Inc. |
EPSCelgene | earnings per share |
EUCelgene Corporation | European Union |
FASBNDA | Financial Accounting Standards Board |
FDA | U.S. Food and Drug Administration |
Flexus | Flexus Biosciences, Inc. |
F-Star Alpha | F-Star Alpha Ltd. |
GAAP | U.S. generally accepted accounting principles |
Gilead | Gilead Sciences, Inc. |
GTN | Gross-to-Net |
Halozyme | Halozyme Therapeutics, Inc. |
HCC | Hepatocellular carcinoma |
HIV | human immunodeficiency virus |
HNC | head and neck cancer |
IFM | IFM Therapeutics, Inc. |
iPierian | iPierian, Inc. |
IO | immuno-oncology |
IPRD | In-process research and development |
JIA | Juvenile Idiopathic Arthritis |
mCRC | metastatic colorectal cancer |
Merck | Merck & Co., Inc. |
MSI-H | microsatellite instability-high |
NDA | New Drug Application |
NKTCelgene and Other Acquisition Plans | natural killer T cells |
NSCLCRestructuring and integration plan implemented as a result of the acquisition of Celgene in 2019, MyoKardia in 2020 and Turning Point in 2022 | NSCLC | non-small cell lung cancer |
NVAFCERCLA | non-valvular atrial fibrillationU.S. Comprehensive Environmental Response, Compensation and Liability Act | Nimbus | Nimbus Therapeutics |
OnoCheplapharm | OnoCheplapharm Arzneimittel GmbH | OTC | over-the-counter |
CML | chronic myeloid leukemia | Otsuka | Otsuka Pharmaceutical Co., Ltd. |
OTCCRC | Over-the-countercolorectal carcinoma | PD-1 | programmed cell death protein 1 |
PadlockDragonfly | PadlockDragonfly Therapeutics, Inc. | PD-L1 | programmed death-ligand 1 |
PD-1EC | programmed death receptor-1European Commission | PDUFA | Prescription Drug User Fee Act |
PsAEPS | active psoriatic arthritisearnings per share | PPF | progessive pulmonary fibrosis |
ESA | erythropoiesis stimulating agent | Quarterly Report on Form 10-Q | Quarterly Report on Form 10-Q for the quarterly periodquarter ended JuneSeptember 30, 20172023 |
RAEU | rheumatoid arthritisEuropean Union | R&D | research and development |
RCCExchange Act | the Securities Exchange Act of 1934 | RA | rheumatoid arthritis |
FASB | Financial Accounting Standards Board | RCC | renal cell carcinoma |
R&DFDA | ResearchU.S. Food and DevelopmentDrug Administration | REMS | risk evaluation and mitigation strategy |
sBLAGAAP | supplemental Biologics License Applicationgenerally accepted accounting principles | Sanofi | Sanofi S.A. |
SCCHNGTN | squamous cell carcinoma of the head and neck |
SCLCgross-to-net | small cell lung cancer |
SEC | U.S. Securities and Exchange Commission |
SK BiotekHCM | SK Biotek Co., Ltd.hypertrophic cardiomyopathy | Section 174 | Guidance on amortization of specified research or experimental expenditures under Section 174 Notice 2023-63 |
UKImmatics | United KingdomImmatics Biotechnologies GmbH. | SPC | Supplementary Protection Certificate |
U.S.IPF | idiopathic pulmonary fibrosis | Takeda | Takeda Pharmaceutical Company Limited |
IPRD | in-process research and development | Turning Point | Turning Point Therapeutics, Inc. |
IRA | Inflation Reduction Act of 2022 | UC | ulcerative colitis |
IRS | Internal Revenue Service | UK | United Kingdom |
IV | intravenous | U.S. | United States |
Juno | Juno Therapeutics, Inc. | USPTO | U.S. Patent and Trademark Office |
LTE | long-term extension | VAT | value added tax |
LOE | loss of exclusivity | | |
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.
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| | | BRISTOL-MYERS SQUIBB COMPANY (REGISTRANT)
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Date: | October 26, 20172023 | By: | By: | /s/ Giovanni Caforio, M.D. |
| | | | Giovanni Caforio, M.D. Chairman of the Board and Chief Executive Officer |
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Date: | October 26, 20172023 | By: | By: | /s/ Charles BancroftDavid V. Elkins |
| | | | Charles BancroftDavid V. Elkins
Chief Financial Officer |