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BRISTOL MYERS SQUIBB CO - Quarter Report: 2024 September (Form 10-Q)

Nine Months Ended September 30,
Net ProceedsDivestiture (Gains)/LossesRoyalty Income
Dollars in millions202420232024202320242023
Diabetes business - royalties
$ $ $ $ $()$()
Mature products and other      
Total$ $ $ $ $()$()

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)$()$()$()
Tecentriq* royalties
()()()()Contingent milestone income() ()()Amortization of deferred income()()()()Other royalties and licensing income ()()()()Royalty and licensing income$()$()$()$()

Keytruda* Patent License Agreement

% through December 31, 2023 and is obligated to pay % 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 / percent allocation, respectively, after adjusting for each party's legal fees.

Note 5.
 $ $ $ Royalty and licensing income (Note 4)()()()()
Royalty income - divestiture (Note 4)
()()()()Investment income()()()()
Litigation and other settlements (a)
 () ()Provision for restructuring (Note 6)    Integration expenses (Note 6)    
Equity investment (gains)/losses (Note 9)
() () 
Acquisition expense (Note 4)
    
Intangible asset impairment
    
Other(b)
 ()  
Other (income)/expense, net
$ $()$ $()
(a)    Includes $ million of income related to the Eisai collaboration termination incurred during the nine months ended September 30, 2024 and $ million of income related to Nimbus' TYK2 program change of control provision incurred during the nine months ended September 30, 2023.
(b)    Includes pension settlement charges of $ million during the three months ended September 30, 2024 and $ million during the nine months ended September 30, 2024 incurred in connection with the termination of the Bristol-Myers Squibb Puerto Rico, Inc. Retirement Income pension plan.

Litigation and Other Settlements

BeiGene Settlement

In August 2023, BMS and BeiGene, Ltd. ("BeiGene") entered into an agreement that terminated all contractual relationships and settled all on-going disputes and claims between the parties, including those related to the Abraxane license and supply agreements and related arbitration proceedings that were previously disclosed. As part of this agreement, BMS agreed to transfer million of BeiGene ordinary shares of common stock held under a share subscription agreement back to BeiGene resulting in $ million of expense that was included in Other (income)/expense, net during the three and nine months ended September 30, 2023. The expense was determined based on the closing price of the shares on the date of the transfer.
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PD-L1 antibody litigations. AstraZeneca is to pay an aggregate of $ million to BMS in payments through September 2026, which would be subject to sharing arrangements with Ono and Dana-Farber. BMS's share is approximately $ million, of which the net present value of $ million was reflected in Other (income)/expense during the three and nine months ended September 30, 2023.

Note 6.

 billion. These costs consist 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 acquisitions of Celgene (2019), Turning Point (2022), Mirati (2024), RayzeBio (2024) and Karuna (2024). For these plans, the remaining charges of approximately $ million consist primarily of employee termination costs, IT system integration costs, and to a lesser extent, site exit costs, including impairment and accelerated depreciation of property, plant and equipment.

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 $ $ $ Celgene and Other Acquisition Plans    Total charges$ $ $ $ Employee termination costs$ $ $ $ Other termination costs    Provision for restructuring    Integration expenses    Accelerated depreciation    
Asset impairments (a)
    
Other shutdown costs
    Total charges$ $ $ $ Cost of products sold$ $ $ $ Marketing, selling and administrative    Research and development    Other (income)/expense, net    Total charges$ $ $ $ 
(a)    Includes $ million for a site impairment incurred during the three months ended September 30, 2024 and a $ million impairment charge for a facility lease during the three months ended September 30, 2023.

 $ Provision for restructuring  Foreign currency translation and other ()Payments()()Ending balance$ $ 

Note 7.
 $ $()$ 
Income tax provision
    Effective tax rate % %()% %

Provision for income taxes in interim periods is determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The effective tax rate for the three months ended September 30, 2024 was primarily impacted by changes in previously estimated annual effective tax rates resulting from jurisdictional earnings mix.

The effective tax rate for the nine months ended September 30, 2024 was impacted by a $ billion one-time, non-tax deductible charge for the acquisition of Karuna, as well as the release of income tax reserves of $ million related to the resolution of Celgene's 2017-2019 IRS audit and jurisdictional earnings mix resulting from amortization of acquired intangible assets.

The effective tax rate during the three months ended September 30, 2023 was primarily impacted by the 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 for 2022, which was reflected in the third quarter of 2023, as well as a reduction in the estimated annual effective rates for 2023. Previously estimated income taxes for 2022 were reduced by approximately $ million upon finalization of the U.S. Federal tax return primarily due to the aforementioned revised Section 174 guidance that was issued in the third quarter of 2023.

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million deferred income tax benefit following the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investment, jurisdictional earnings mix resulting from amortization of acquired intangible assets, equity investment losses, litigation and other settlements, as well as releases of income tax reserves of $ million related to the resolution of Celgene's 2009-2011 IRS audit.

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 tax legislation code.

During the nine months ended September 30, 2024 and 2023, income tax payments were $ billion and $ billion, including $ million and $ million, respectively, for the transition tax following the TCJA enactment.

BMS is currently under examination by a number of tax authorities that 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 the amount of unrecognized tax benefits as of September 30, 2024 could decrease in the range of approximately $ million to $ 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.
 $ $()$ Weighted-average common shares outstanding – basic    Incremental shares attributable to share-based compensation plans    Weighted-average common shares outstanding – diluted    
Earnings/(loss) per common share
Basic$ $ $()$ Diluted  () 

The total number of potential shares of common stock excluded from the diluted (loss)/earnings per common share computation because of the antidilutive impact was  million and  million for the three and nine months ended September 30, 2024, respectively, and material for the three and nine months ended September 30, 2023.

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Note 9.

 $ $ $ $ $ Marketable debt securitiesCertificates of deposit      Commercial paper      Corporate debt securities      U.S. Treasury securities      Derivative assets      Equity investments      Derivative liabilities      Contingent consideration liability
Contingent value rights(a)
      Other acquisition related contingent consideration         () ()
Three Months Ended September 30, 2023Nine Months Ended September 30, 2023
Dollars in millionsCost of products soldOther (income)/expense, netCost of products soldOther (income)/expense, net
Foreign currency exchange contracts$()$()$()$()
Cross-currency swap contracts   ()
Interest rate swap contracts   ()
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)$ $ $ Reclassified to Cost of products sold()()()()Cross-currency swap contracts gain/(loss):
Recognized in Other comprehensive (loss)/income
 ()  Reclassified to Other (income)/expense, net() () 
Forward interest rate contract gain/(loss):
  Recognized in Other comprehensive (loss)/income
    Reclassified to Other (income)/expense, net() () Derivatives designated as net investment hedgesCross-currency swap contracts gain/(loss):
Recognized in Other comprehensive (loss)/income
()  Foreign exchange contracts gain/(loss):
Recognized in Other comprehensive (loss)/income
() () Non-derivatives designated as net investment hedges
Non-U.S. dollar borrowings gain/(loss):
Recognized in Other comprehensive (loss)/income
   ()

Note 10.

 $ Current portion of Long-term debt  Other  
Short-term debt obligations
$ $ 
BMS may issue a maximum of $ billion of unsecured notes with maturities of not more than days from the date of issuance under its commercial paper program. BMS issued $ billion of commercial paper during the first quarter of 2024, and such amount was fully repaid by the end of the third quarter of 2024.

 $ Adjustments to principal value:Fair value of interest rate swap contracts ()Unamortized basis adjustment from swap terminations  Unamortized bond discounts and issuance costs()()Unamortized purchase price adjustments of Celgene debt  Total$ $ Current portion of Long-term debt$ $ Long-term debt  Total$ $ 

The fair value of Long-term debt was $ billion as of September 30, 2024 and $ billion as of December 31, 2023 valued using Level 2 inputs, which are based upon the quoted market prices for the same or similar debt instruments. The fair value of Short-term debt obligations approximates the carrying value due to the short maturities of the debt instruments.
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 billion of unsecured senior notes ("2024 Senior Unsecured Notes"), with proceeds, net of discount and loan issuance costs, of $ billion, consisting of:
Principal Amount
(in millions)
Floating rate notes due 2026(a)
$ 
% Notes due 2026
 
% Notes due 2027
 
% Notes due 2029
 
% Notes due 2031
 
% Notes due 2034
 
% Notes due 2044
 
% Notes due 2054
 
% Notes due 2064
 
Total$ 
(a)    As of September 30, 2024, floating rate equals SOFR+%.

The Company used the net proceeds from this offering to partially fund the acquisitions of RayzeBio and Karuna (see "—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information) and used the remaining net proceeds for general corporate purposes. In connection with the issuance of the 2024 Senior Unsecured Notes, the Company terminated the $ billion senior unsecured delayed draw term loan facility, which was entered into in February 2024 to provide bridge financing for the RayzeBio and Karuna acquisitions.

During the nine months ended September 30, 2024, $ billion % Notes and $ million % Notes matured and were repaid.

During the nine months ended September 30, 2023, $ billion of debt matured and was repaid, including $ million % Notes, $ million % Notes and $ million % Notes.

Interest payments were $ billion and $ million for the nine months ended September 30, 2024 and 2023, respectively, net of amounts related to interest rate swap contracts.

Credit Facilities

As of September 30, 2024, BMS had a $ billion revolving credit facility expiring in January 2029, extendable annually by with the consent of the lenders and a $ billion revolving credit facility expiring in January 2025. The facilities provide for customary terms and conditions with no financial covenants and are used to provide backup liquidity for our commercial paper borrowings. borrowings were outstanding under the revolving credit facilities as of September 30, 2024 and December 31, 2023.

Note 11.
 $ Less: charge-backs and cash discounts()()Less: allowance for expected credit loss()()Net trade receivables  Alliance, royalties, VAT and other  Receivables$ $ 

Non-U.S. receivables sold on a nonrecourse basis were $ million and $ million for the nine months ended September 30, 2024 and 2023, respectively. Receivables from the largest customers in the U.S. represented % of total trade receivables as of September 30, 2024 and December 31, 2023.

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Note 12.
 $ Work in process  Raw and packaging materials  Total inventories$ $ Inventories$ $ Other non-current assets  

Note 13.
 $ Buildings  Machinery, equipment and fixtures  Construction in progress  Gross property, plant and equipment  Less accumulated depreciation()()Property, plant and equipment$ $ 
Depreciation expense was $ million and $ million for the three and nine months ended September 30, 2024 and $ million and $ million for the three and nine months ended September 30, 2023, respectively.

Note 14.

 
Acquisitions (Note 4)
 Currency translation and other adjustments 
Balance at September 30, 2024
$ 

Other Intangible Assets

years $ $()$ $ $ $ 
Acquired marketed product rights(a)
 –  years
 ()  () Capitalized software
 –  years
 ()  () 
IPRD(a)
 —   —  Total$ $()$ $ $()$ 
(a)    Includes assets acquired in connection with Mirati and RayzeBio acquisitions, as further described in "—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements."

Amortization expense of Other intangible assets was $ billion and $ billion during the three and nine months ended September 30, 2024 and $ billion and $ billion during the three and nine months ended September 30, 2023, respectively.
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 $ $ (a)$ 
Research and development
   (b) 
Other income/(expense)
    
Total
$ $ $ $ 
(a) Impairment relates to Inrebic, which resulted from lower revised cash flow projections. The charge represented a partial impairment based on the asset's carrying value over its estimated fair value using discounted cash flow projections.
(b) Impairment relates to alnuctamab, which resulted from portfolio prioritization. The charge represented a full write-down of the asset.

Note 15.
 $ Research and development  Contract assets  
Restricted cash(a)
  Other  Other current assets$ $ 

 $ Operating leases  
Inventories (Note 12)
  Pension and postretirement  Research and development  
Restricted cash(a)
  
Receivables and convertible notes
  Other  Other non-current assets$ $ 
million was included in Cash, cash equivalents and restricted cash in the consolidated statement of cash flows.

 $ Income taxes  Employee compensation and benefits  Research and development  Dividends  Interest  Royalties  Operating leases  Other  Other current liabilities$ $ 

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 $ Pension and postretirement  Operating leases  Deferred income  Deferred compensation  
Contingent value rights (Note 9)
  Other  Other non-current liabilities$ $ 

Note 16.

 $ $ $()$  $()$ 
Net (loss)/earnings
— — — — ()— —  
Other comprehensive income/(loss)
— — —  — — — — 
Cash dividends declared $ per share
— — — — ()— — — Stock compensation— — ()— — () — Balance at March 31, 2024 $ $ $()$  $()$ Net earnings— — — —  — —  
Other comprehensive income/(loss)
— — — ()— — — — 
Cash dividends declared $ per share
— — — — ()— — — Stock compensation— —  — —   — Distributions— — — — — — — ()Balance at June 30, 2024 $ $ $()$  $()$ 
Net earnings
— — — —  — —  
Other comprehensive income/(loss)
— — — ()— — — — 
Cash dividends declared $ per share
— — — — ()— — — Stock repurchase program— —  — —   — Stock compensation— —  — — () — 
Balance at September 30, 2024
 $ $ $()$  $()$ 

The following table summarizes changes in equity during the nine months ended September 30, 2023:
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 $ $ $()$  $()$ Net earnings— — — —  — —  
Other comprehensive income/(loss)
— — — ()— — — — 
Cash dividends declared $ per share
— — — — ()— — — Share repurchase program— — — — —  ()— Stock compensation— — ()— — () — Balance at March 31, 2023 $ $ $()$  $()$ Net earnings— — — —  — —  
Other comprehensive income/(loss)
— — — ()— — — — 
Cash dividends declared $ per share
— — — — ()— — — 
Share repurchase program
— — — — —  ()— Stock compensation— —  — — () — Distributions— — — — — — — ()Balance at June 30, 2023 $ $ $()$  $()$ 
Net earnings
— — — —  — —  
Other comprehensive income/(loss)
— — —  — — — — 
Cash dividends declared $ per share
— — — — ()— — — 
Share repurchase program
— — ()— —  ()— Stock compensation— —  — — () — 
Convertible debt
— —  — — —  — Balance at September 30, 2023 $ $ $()$  $()$ 

During the third quarter of 2023, BMS entered into accelerated share repurchase ("ASR") agreements to repurchase an aggregate amount of $ billion of the Company's common stock. Approximately  million shares of common stock (% of the  billion aggregate repurchase price) were received by BMS and included in treasury stock as of September 30, 2023. In addition, as part of its share repurchase program, BMS repurchased  million shares of its common stock for $ billion during the nine months ended September 30, 2023.

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)$ $()$ $()$ 
Reclassified to net earnings(a)
() ()() ()Derivatives qualifying as cash flow hedges() () () Pension and postretirement benefitsActuarial gains/(losses)   () ()
Amortization(b)
 ()  () 
Settlements(b)
 ()  () Pension and postretirement benefits ()    
Marketable debt securities
Unrealized gains/(losses)
 ()  () Foreign currency translation   () ()Other comprehensive income/(loss)$()$ $()$ $()$ 

Three Months Ended September 30, 2023
Nine Months Ended September 30, 2023
Dollars in millionsPretaxTaxAfter TaxPretaxTaxAfter Tax
Derivatives qualifying as cash flow hedges
Recognized in other comprehensive income/(loss)
$ $()$ $ $()$ 
Reclassified to net earnings(a)
()()()() ()
Derivatives qualifying as cash flow hedges () ()()()
Pension and postretirement benefits
Actuarial gains/(losses) () () ()
Marketable debt securities
Unrealized gains/(losses)() ()() ()
Foreign currency translation ()() () 
Other comprehensive income/(loss)$ $()$ $ $()$()
(a)Included in Cost of 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.

 $ Pension and postretirement benefits()()Marketable debt securities  
Foreign currency translation(a)
()()Accumulated other comprehensive loss$()$()
(a)Includes net investment hedge gains of $ million and $ million as of September 30, 2024 and December 31, 2023, respectively.

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Note 17.

 $ $ $ Marketing, selling and administrative    Research and development    
Total stock-based compensation expense
$ $ $ $ 
Income tax benefit(a)
$ $ $ $ 
(a)    Income tax benefit excludes excess tax (deficiencies)/benefits from share-based compensation awards that were vested or exercised of $() million and $() million for the three and nine months ended September 30, 2024, and $ million and $ million for the three and nine months ended September 30, 2023, respectively.


Note 18.


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 million AUD ($ million), plus interest, which would be split between BMS and Sanofi, for alleged losses experienced for paying a higher price for branded Plavix* during the period when the injunction was in place. BMS and Sanofi dispute that the Australian government is entitled to any damages. A trial was concluded in September 2017. In April 2020, the Federal Court issued a decision dismissing the Australian government's claim for damages. In May 2020, the Australian government appealed the Federal Court's decision and an appeal hearing concluded in February 2021. On June 26, 2023, the appeal court issued a ruling in BMS and Sanofi's favor, upholding the lower court's decision. In December 2023, the Australian government was granted leave to appeal the decision to the High Court of Australia, and the High Court held an appeal hearing on September 4-5, 2024, and a decision is pending.

Zeposia - U.S.
On October 15, 2021, Actelion Pharmaceuticals LTD and Actelion Pharmaceuticals US, INC ("Actelion") filed a complaint for patent infringement in the United States District Court for the District of New Jersey against BMS and Celgene for alleged infringement of U.S. Patent No. 10,251,867 (the "'867 Patent"). The Complaint alleges that the sale of Zeposia infringes certain claims of the '867 Patent and Actelion is seeking damages. No trial date has been scheduled.

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 million, with $ million attributed to BMS. Sanofi and BMS appealed the decision. 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 October 16, 2023. On May 21, 2024, the trial court issued a new decision against Sanofi and BMS, imposing penalties in the total amount of $ million, with $ million attributed to BMS. Sanofi and BMS have appealed the decision.

PRODUCT LIABILITY LITIGATION

BMS is a party to various product liability lawsuits. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss. As previously disclosed, in addition to lawsuits, BMS also faces unfiled claims involving its products.

Abilify*
BMS and Otsuka are co-defendants in product liability litigation related to Abilify*. Plaintiffs allege Abilify* caused them to engage in compulsive gambling and other impulse control disorders. Cases were filed in state and federal courts in the United States. Pursuant to a previously disclosed master settlement agreement and settlement related court orders, the vast majority of the cases in the United States were resolved or dismissed. inactive cases remain pending in state courts in New Jersey. There are also cases pending in Canada ( class actions and individual injury claims), of which are active (the certified class actions in Quebec and Ontario). A settlement in principle has recently been reached in the class actions, subject to Court approval.

SECURITIES LITIGATION

Celgene Securities Litigations
Beginning in March 2018, 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 NDA for Zeposia. The Court consolidated the 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 plaintiffs' 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 as to the claims regarding statements made by the remaining officer defendants. As to the claims regarding Celgene’s corporate statements, the Court denied the defendants’ motion without prejudice and granted the defendants leave to re-raise the issue. On October 27, 2023, the defendants filed a motion for partial summary judgment as to Celgene’s corporate statements. On July 23, 2024, the Court granted the defendants’ motion as to individual liability for those corporate statements but reserved decision as to the company's liability, noting that another opinion would be forthcoming. On September 4, 2024, the Court granted in part, denied in part, and held in abeyance in part the defendants’ motion for summary judgment as to the Company’s liability for Celgene’s corporate statements and requested supplemental briefing as to the statements the Court did not rule on. Following supplemental briefing, the Court held a hearing on October 10, 2024, where it denied defendants' summary judgment motion as to the remaining statements at issue.

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.
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 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 alleged successor trustee. The plaintiff sought damages in an amount to be determined at trial and other relief, including interest and attorneys' fees. BMS disputes the allegations. BMS filed a motion to dismiss the alleged successor trustee's complaint for failure to state a claim upon which relief can be granted, which was denied on June 24, 2022. On February 2, 2024, BMS filed a motion to dismiss the complaint for lack of subject matter jurisdiction. In an opinion and order entered on September 30, 2024, the court granted BMS’s motion and dismissed the lawsuit for lack of subject matter jurisdiction without prejudice to the refiling of a new lawsuit by a properly appointed trustee. The plaintiff has appealed this order.

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(a) 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. In an opinion and order entered on February 29, 2024, the Court granted that motion in its entirety and dismissed the remaining claims with prejudice. On March 28, 2024, plaintiffs filed a notice of appeal. Briefing has been completed in the appeal, which is pending in the United States Court of Appeals for the Second Circuit. Oral argument took place on October 25, 2024.

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 alleged 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 asserted 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 moved to stay the action pending resolution of the federal action or, in the alternative, to dismiss the complaint and later filed a similar motion in response to an amended complaint. On February 2, 2024, the Court granted defendants’ motion and dismissed the case in its entirety. On February 29, 2024, the plaintiff filed a notice of appeal. The plaintiff’s appeal was not perfected before the deadline for doing so under applicable court rules, and therefore, the appeal is deemed to be dismissed under those rules.

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separate putative classes, of acquirers of CVRs and 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. The Court had temporarily stayed the action pending resolution of the federal action, but lifted the stay on March 21, 2024, following the dismissal of the federal action. On April 4, 2024, defendants moved to dismiss the New Jersey complaint. On June 25, 2024, the Court granted defendants' motion and dismissed the complaint in its entirety without prejudice. The plaintiff filed an amended complaint on August 15, 2024. On September 30, 2024, the defendants filed a motion to dismiss the amended complaint.

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 that necessarily fall below fair market value. BMS also argues that this program violates the First Amendment right to free speech by requiring manufacturers to state that they agree that the price set by the government is the medicine's "maximum fair price" as determined by negotiation, even though there is no true negotiation. On August 16, 2023, BMS filed a motion for summary judgment. On October 16, 2023, the government filed an opposition to BMS’s motion for summary judgment and a cross-motion for summary judgment. The court heard oral argument on the parties' summary judgment motions on March 7, 2024. On April 29, 2024, the court issued an opinion and order that denied BMS's motion for summary judgment and granted the government's cross-motion for summary judgment. BMS appealed to the United States Court of Appeals for the Third Circuit. Oral argument in the Third Circuit took place on October 30, 2024.

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 certain claims of certain entities that opted out of the settlement, and who have since filed new suits advancing related theories. As described below, certain other consolidated or coordinated suits are pending.

In March 2019, Humana Inc. ("Humana"), which opted out of the 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. On June 6, 2024, the Court granted Celgene and BMS's motion to dismiss in its entirety. The Court granted Humana and the other plaintiffs referenced immediately below (other than United HealthCare Services Inc. ("UHS"), which had previously amended) leave to amend their complaints. These plaintiffs filed amended complaints on August 5, 2024.
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of Molina’s claims, which Molina later reasserted in the District of New Jersey as described above, and stayed the remaining 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 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 seeks 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 actions. The motions were fully briefed in May 2023 and administratively terminated in November 2023 pending a ruling on Celgene and BMS's motion to dismiss the Humana amended complaint. In view of the Court's dismissal decision in the Humana action described above, these plaintiffs filed amended complaints on August 5, 2024.

In October and November 2023, healthcare systems—the Mayo Clinic, LifePoint Corporate Services, G.P. and Intermountain Health, Inc.—filed new lawsuits against Celgene, BMS and certain generic manufacturers making 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 seeking injunctive relief and damages under the Sherman Antitrust Act and parallel state laws. In view of the Court's dismissal decision in the Humana action described above, these plaintiffs filed amended complaints on August 5, 2024. Those actions are pending in the U.S. District Court for the District of New Jersey.

No trial dates have been scheduled in any of the above Thalomid and Revlimid Litigations.

Pomalyst Antitrust Class Action
In September 2023, certain health plan entities 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 antitrust, consumer protection, and unjust enrichment laws based on allegations that Celgene and BMS engaged in anticompetitive conduct related to pomalidomide in the U.S., including by allegedly engaging in fraud before the USPTO in the acquisition of patents related to the use of pomalidomide, by filing alleged sham patent litigations against generic pharmaceutical companies seeking to market generic pomalidomide, and by entering into allegedly unlawful patent litigation settlements with certain generic pharmaceutical companies seeking to market generic pomalidomide. In December 2023, the plaintiffs filed an amended complaint that added individual Pomalyst patient as a plaintiff, removed the generic manufacturer defendants, and added individuals as defendants. In March 2024, new plaintiff filed a substantially similar complaint, on behalf of the same putative class and in the same court, which was subsequently consolidated with the first action. In March 2024, BMS and its co-defendants filed motions to dismiss these actions. In September 2024, an additional plaintiff (seeking to proceed solely as a direct purchaser under the federal antitrust laws) filed a separate, substantially similar complaint. No trial dates have been scheduled.

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 million as of September 30, 2024, which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties). The amount includes the estimated costs for any additional probable loss associated with the previously disclosed North Brunswick Township High School Remediation Site.

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Management’s discussion and analysis of financial condition and results of operations 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

Our principal strategy is to combine the resources, scale and capability of a large pharmaceutical company with the speed, agility and focus on innovation typically found in the biotech industry. Our priorities are to (i) focus on transformational medicines where we have a competitive advantage (ii) drive operational excellence and (iii) strategically allocate capital for long-term growth and returns. Our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases in the following core therapeutic areas: oncology and hematology with novel modalities in cell therapies, protein degraders, ADCs and radiopharmaceuticals; immunology with a focus on establishing new standards of care in pulmonology, rapidly advancing cell therapy into immunology diseases and transformational programs to control inflammation, reset immune memory and promote homeostasis in dermatology, rheumatology and gastrointestinal disorders; cardiovascular diseases by leveraging deep expertise across thrombotic diseases, heart failures and cardiomyopathies; and neuroscience with a focus on developing new treatments in neuropsychiatry and neurodegeneration. 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 remain committed to strategic business development, maintaining a strong investment grade credit rating, the dividend and reducing debt. 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 2023 Form 10-K. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for terms used throughout the document.

In September 2024, we received FDA approval for Cobenfy (xanomeline and trospium chloride), formerly known as KarXT, for the treatment of schizophrenia in adults, re-establishing our presence in neuroscience. Cobenfy represents the first new pharmacological approach to treat schizophrenia in decades, with a mechanism of action distinct from current therapies. Registrational studies are planned for Cobenfy in Adjunctive Schizophrenia, Alzheimer's Psychosis, Alzheimer's Agitation, Alzheimer's Cognition, Bipolar I Disorder and autism spectrum disorder irritability. In addition, year-to-date, we have achieved significant advances in CAR-T cell therapy with the approval of Breyanzi in the U.S. and Japan for adults with relapsed or refractory FL and in the U.S. for adults with relapsed or refractory CLL/SLL and MCL; and Abecma in the U.S. and EU for triple-class exposed relapsed and refractory multiple myeloma after two or more prior lines of therapy. Furthermore, Reblozyl received expanded approval to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS in the EU and Japan. In oncology, we continue making advancements with (i) FDA approval of Opdivo for the treatment of adult patients with resectable NSCLC, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery; (ii) accelerated approval in the U.S. of Krazati in combination with cetuximab, for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer; (iii) approval in the U.S. of Augtyro for the treatment of patients with NTRK-positive locally advanced or metastatic solid tumors; (iv) approval in Japan of Augtyro for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC; and (v) both in the U.S. and EU, approval of Opdivo in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic muscle invasive urothelial carcinoma. Refer to "—Product and Pipeline Developments" for additional updates on our pipeline.

Additionally, we completed the following acquisitions in 2024: (i) Karuna, a biopharmaceutical company in the area of developing and delivering medicines, including Cobenfy, for psychiatric and neurological conditions; (ii) RayzeBio, a clinical-stage radiopharmaceutical therapeutics company with a pipeline of potentially first-in-class and best-in-class drug development programs; and (iii) Mirati, a commercial stage targeted oncology company, with a commercialized medicine, Krazati, in addition to a pipeline of clinical and pre-clinical stage oncology assets. BMS also entered into a strategic collaboration with SystImmune, to co-develop and co-commercialize BL-B01D1, a bispecific topoisomerase inhibitor-based anti-body drug conjugate, which is currently being evaluated in a Phase I clinical trial for metastatic or unresectable NSCLC and is also in development for breast cancer and other tumor types. We also entered into a worldwide capacity reservation and supply agreement with Cellares for the manufacturing of CAR-T cell therapies. This agreement is expected to enable us to expand our manufacturing capacity through a platform that is scalable and has the potential to improve turnaround time. For additional information relating to our acquisitions, divestitures, licensing and other arrangements refer to "Item 1. Financial Statements—Note 3. Alliances" and "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements".

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We remain committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. We continue to execute a strategic productivity initiative that will drive approximately $1.5 billion in annual cost savings by the end of 2025, the majority of which are expected to be reinvested to fund innovation and drive growth. As a result, we are focusing resources on R&D programs with the potential to deliver the greatest return on investment, prioritizing investments in key growth brands, and optimizing operations across the organization. The exit costs resulting from these actions are included in our updated 2023 Restructuring Plan.

Financial Highlights
 Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions, except per share data2024202320242023
Total Revenues$11,892 $10,966 $35,958 $33,529 
Diluted earnings/(loss) per share
GAAP$0.60 $0.93 $(4.45)$2.99 
Non-GAAP1.80 2.00 (0.53)5.80 

Revenues increased by 8% during the third quarter of 2024 and 7% year-to-date due to the Growth Portfolio and Eliquis, partially offset by Sprycel due to generic erosion. Year-to-date was also partially offset by Revlimid.

The $0.33 decrease in GAAP EPS and the $0.20 decrease in non-GAAP EPS for the third quarter of 2024 were primarily driven by higher interest expense and a lower effective income tax rate in 2023, partially offset by higher revenues.

The $7.44 decrease in GAAP EPS year-to-date was primarily driven by higher one-time Acquired IPRD charges primarily from the Karuna asset acquisition and SystImmune collaboration ($6.28) and the impact of certain specified items, including intangible asset impairments, as well as the cash settlement of unvested stock awards, partially offset by higher revenues. After adjusting for specified items, the $6.33 decrease in non-GAAP EPS year-to-date was primarily due to the aforementioned Acquired IPRD charges, partially offset by higher revenues.

Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items that represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For further information and reconciliations relating to our non-GAAP financial measures refer to "—Non-GAAP Financial Measures."

Economic and Market Factors

Governmental Actions

As regulators continue to focus on prescription drugs, our products are facing increased pressures across the portfolio. These pressures stem from legislative and policy changes, including price controls, pharmaceutical market access, discounting, changes to tax and importation laws and other restrictions in the U.S., EU and other regions around the world. These pressures have resulted 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. The IRA directs (i) the federal government to “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Part B (beginning in 2028) drugs that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation and (iii) Medicare Part D redesign replacing the current Part D CGDP and establishes a $2,000 cap for out-of-pocket costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached. In August 2024, as part of the first round of government price setting pursuant to the IRA, the U.S. Department of Health and Human Services announced the "maximum fair price" for a 30-day equivalent supply of Eliquis, which applies to the U.S. Medicare channel effective January 1, 2026. It is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections. We continue to evaluate 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.

In addition, in December 2023, the Biden Administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and therefore that the government could exercise “march-in rights” and license it to a third party to manufacture. We cannot predict whether the Biden Administration will finalize the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights or if the government will propose other drug pricing policy changes. If pursued and finalized, these policies could reduce prices and reimbursement for certain of our products and could significantly impact our business and consolidated results of operations.
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At the state level, multiple states have passed, are pursuing or are considering government action via legislation or regulations to change drug pricing and reimbursement (e.g., establishing prescription drug affordability boards, implementing manufacturer mandates tied to the Federal Public Health Service Act drug pricing program, etc.). Some of these state-level actions may also influence federal and other state policies and legislation. Given the current uncertainty surrounding the adoption, timing and implementation of many of these measures, as well as pending litigation challenging such laws, we are unable to predict their full impact on our business. However, such measures could modify or decrease access, coverage, or reimbursement of our products, or result in significant changes to our sales or pricing practices, which could have a material impact on our revenues and results of operations. With respect to the Federal Public Health Service Act drug pricing program, eight states have enacted laws regulating manufacturer pricing obligations under the program to date. Several additional states are considering similar potential legislation or other government actions, and we expect other states may do the same in the future.

Additionally, in connection with the IRA, the following changes have been made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations on adjusted financial statement income beginning in 2023 and (ii) a non-deductible 1% excise tax provision on net stock repurchases, to be applied to repurchases beginning in 2023. Furthermore, countries are in the process of enacting changes to their tax laws to implement the agreement by the OECD 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 negatively affect our revenues and profit margins" and "—Changes to tax regulations could negatively impact our earnings" in our 2023 Form 10-K.

Significant Product and Pipeline Approvals

The following is a summary of the significant approvals received in 2024 as of October 31, 2024:
ProductDateApproval
Opdivo
October 2024
FDA approval of Opdivo for the treatment of adult patients with resectable (tumors ≥ 4 cm or node positive) NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery.
Cobenfy
(KarXT; xanomeline and trospium chloride)
September 2024
FDA approval of Cobenfy for the treatment of schizophrenia in adults.
Augtyro
September 2024
Japan's Ministry of Health, Labour and Welfare approval of Augtyro for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC.
Breyanzi
August 2024
Japan's Ministry of Health, Labour and Welfare approval of Breyanzi for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy.
Krazati
June 2024
FDA accelerated approval for Krazati in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Augtyro
June 2024
FDA accelerated approval of Augtyro for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
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Opdivo
May 2024
EC approval of Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Breyanzi
May 2024
FDA approval of Breyanzi for the treatment of adult patients with relapsed or refractory MCL who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
Breyanzi
May 2024
FDA accelerated approval of Breyanzi for the treatment of adult patients with relapsed or refractory FL who have received at least two prior lines of systemic therapy.
Abecma April 2024
FDA approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Reblozyl
April 2024
EC expanded approval of Reblozyl to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS.
Abecma
March 2024
EC approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Breyanzi
March 2024
FDA accelerated approval of Breyanzi for the treatment of adult patients with relapsed or refractory CLL or SLL who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
Opdivo
March 2024
FDA approval of Opdivo, in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Reblozyl
January 2024
Japan's Ministry of Health, Labour and Welfare approval of Reblozyl for the treatment of anemia associated with myelodysplastic syndrome.

Refer to "—Product and Pipeline Developments" for a listing of other developments in our marketed products and late-stage pipeline since the start of the third quarter of 2024.

Acquisitions, Divestitures, Licensing and Other Arrangements

Refer to "Item 1. Financial Statements—Note 3. Alliances" and "—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for information on significant acquisitions, divestitures, licensing and other arrangements.

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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 millions20242023% Change
Foreign Exchange(b)
20242023% Change
Foreign Exchange(b)
United States$8,232 $7,542 %— %$25,509 $23,298 %— %
International
3,389 3,239 %(4)%9,803 9,716 %(5)%
Other(a)
271 185 46 %N/A646 515 25 %N/A
Total$11,892 $10,966 %(2)%$35,958 $33,529 %(2)%
(a)    Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
(b)    Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.

United States

U.S. revenues increased 9% during the third quarter of 2024 and year-to-date primarily due to higher demand for the Growth Portfolio and higher demand for Eliquis, partially offset by Sprycel due to generic erosion. Average U.S. net selling prices decreased 1% year-to-date compared to the same period a year ago.

International

International revenues increased 5% and 1% during the third quarter of 2024 and year-to-date, respectively, driven by higher demand for the Growth Portfolio, partially offset by lower demand for the Legacy Portfolio and foreign exchange impacts. The negative foreign exchange impacts of 4% and 5% during the third quarter and year-to-date, respectively, were primarily attributed to devaluation of the Argentine peso, which was mostly offset by inflation-related local currency price increases.

Beginning in 2024, Puerto Rico revenues are presented as part of International revenues to align with management's review of the Company's financial results. Prior period amounts have been recast to conform to the current presentation. No single country outside the U.S. contributed more than 10% of total revenues during the nine months ended September 30, 2024 and 2023. 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:
Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Gross product sales$21,223 $18,648 14 %$61,298 $54,047 13 %
GTN adjustments
Charge-backs and cash discounts(2,967)(2,373)25 %(8,366)(6,743)24 %
Medicaid and Medicare rebates(4,577)(3,730)23 %(11,525)(9,355)23 %
Other rebates, returns, discounts and adjustments(2,196)(1,900)16 %(6,440)(5,339)21 %
Total GTN adjustments(9,740)(8,003)22 %(26,331)(21,437)23 %
Net product sales$11,483 $10,645 %$34,967 $32,610 %
GTN adjustments percentage46 %43 %%43 %40 %%
U.S. 52 %49 %%48 %45 %%
Non-U.S.20 %20 %— %20 %20 %— %

Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $42 million and $103 million for the three and nine months ended September 30, 2024 and $18 million and $116 million for the three and nine months ended September 30, 2023, respectively. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S. GTN adjustments percentage increased primarily due to product mix and higher government channel rebates.

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Product Revenues
 Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Growth Portfolio
Opdivo $2,360 $2,275 %$6,825 $6,622 %
U.S.1,366 1,343 %3,927 3,845 %
Non-U.S.994 932 %2,898 2,777 %
Orencia936 925 %2,682 2,616 %
U.S.706 708 — %2,020 1,954 %
Non-U.S.230 217 %662 662 — %
Yervoy642 579 11 %1,855 1,672 11 %
U.S.399 359 11 %1,171 1,039 13 %
Non-U.S.243 220 10 %684 633 %
Reblozyl447 248 80 %1,226 688 78 %
U.S.358 200 79 %999 534 87 %
Non-U.S.89 48 85 %227 154 47 %
Opdualag233 166 40 %674 437 54 %
U.S.216 162 33 %637 429 48 %
Non-U.S.17 >200%37 >200%
Abecma124 93 33 %301 372 (19)%
U.S.77 69 12 %183 302 (39)%
Non-U.S.47 24 96 %118 70 69 %
Zeposia147 123 20 %408 301 36 %
U.S.105 95 11 %288 219 32 %
Non-U.S.42 28 50 %120 82 46 %
Breyanzi224 92 143 %484 263 84 %
U.S.173 77 125 %382 218 75 %
Non-U.S.51 15 >200%102 45 127 %
Camzyos156 68 129 %379 143 165 %
U.S.135 67 101 %342 142 141 %
Non-U.S.21 >200%37 >200%
Sotyktu66 66 — %163 107 52 %
U.S.51 62 (18)%126 101 25 %
Non-U.S.15 >200%37 >200%
Augtyro10 — N/A23 — N/A
U.S.10 — N/A23 — N/A
Non-U.S.— — N/A— — N/A
Krazati34 — N/A87 — N/A
U.S.32 — N/A82 — N/A
Non-U.S.— N/A— N/A
Other Growth Products(a)
433 311 39 %1,093 886 23 %
U.S.172 149 15 %488 455 %
Non-U.S.261 162 61 %605 431 40 %
Total Growth Portfolio
$5,812 $4,946 18 %$16,200 $14,107 15 %
U.S.3,800 3,291 15 %10,668 9,238 15 %
Non-U.S.2,012 1,655 22 %5,532 4,869 14 %
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 Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Legacy Portfolio
Eliquis$3,002 $2,705 11 %$10,138 $9,332 %
U.S.2,045 1,772 15 %7,410 6,610 12 %
Non-U.S.957 933 %2,728 2,722 — %
Revlimid1,412 1,429 (1)%4,434 4,647 (5)%
U.S.1,212 1,209 — %3,830 3,951 (3)%
Non-U.S.200 220 (9)%604 696 (13)%
Pomalyst/Imnovid898 872 %2,722 2,551 %
U.S.697 606 15 %2,010 1,712 17 %
Non-U.S.201 266 (24)%712 839 (15)%
Sprycel 290 517 (44)%1,088 1,404 (23)%
U.S.225 399 (44)%848 1,011 (16)%
Non-U.S.65 118 (45)%240 393 (39)%
Abraxane253 260 (3)%701 757 (7)%
U.S.151 178 (15)%450 526 (14)%
Non-U.S.102 82 24 %251 231 %
Other Legacy Products(b)
225 237 (5)%675 731 (8)%
U.S.102 87 17 %293 250 17 %
Non-U.S.123 150 (18)%382 481 (21)%
Total Legacy Portfolio
$6,080 $6,020 %$19,758 $19,422 %
U.S.4,432 4,251 %14,841 14,060 %
Non-U.S.1,648 1,769 (7)%4,917 5,362 (8)%
Total Revenues
$11,892 $10,966 %$35,958 $33,529 %
U.S.8,232 7,542 %25,509 23,298 %
Non-U.S.(c)
3,660 3,424 %10,449 10,231 %
    
(a)    Includes Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.
(b)    Includes other mature brands.
(c)    Includes International and Other.

Growth Portfolio

Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal 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 registrational studies for Opdivo across other tumor types and disease areas.

U.S. revenues increased 2% during the third quarter of 2024 and year-to-date primarily due to higher average net selling prices, partially offset by lower demand.

International revenues increased 7% during the third quarter of 2024 and 4% year-to-date primarily due to higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 9% and 10%, respectively. Excluding foreign exchange impacts, revenues increased 16% and 14%, respectively.

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Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.

U.S. revenues were relatively flat during the third quarter of 2024 due to higher demand offset by lower average net selling prices.

U.S. revenues increased 3% year-to-date primarily due to higher demand, partially offset by lower average net selling prices.

International revenues increased 6% during the third quarter of 2024 due to higher demand and average net selling price, partially offset by foreign exchange impacts of 7%. Excluding foreign exchange impacts, revenues increased by 13%.

International revenues were flat year-to-date due to higher demand offset by foreign exchange impacts of 8%. Excluding foreign exchange impacts, revenues increased 8%.

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.

Yervoy (ipilimumab) — a CTLA4 immune checkpoint inhibitor. Yervoy is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.

U.S. revenues increased 11% during the third quarter of 2024 and 13% year-to-date due to higher demand and higher average net selling prices.

International revenues increased 10% during the third quarter of 2024 and 8% year-to-date due to higher demand, partially offset by foreign exchange impacts of 7% in both periods. Excluding foreign exchange impacts, revenues increased by 17% and 15%, respectively.

Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in adult patients with lower risk myelodysplastic syndrome and beta thalassemia.

U.S. revenues increased 79% during the third quarter of 2024 and 87% year-to-date driven by higher demand due to a first line label extension in August 2023.

International revenues increased 85% during the third quarter of 2024 and 47% year-to-date due to higher demand, partially offset by foreign exchange impacts of 5% and 3%, respectively. Excluding foreign exchange impacts, revenues increased by 90% and 50%, respectively.

Opdualag (nivolumab and relatlimab-rmbw) — a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

U.S. revenues increased 33% during third quarter of 2024 and 48% year-to-date primarily due to higher demand.

Abecma (idecabtagene vicleucel) — a BCMA genetically modified autologous CAR–T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody.

U.S. revenues increased 12% during the third quarter of 2024 due to higher demand related to third line label extension in April 2024 and decreased 39% year-to-date due to increased competition in BCMA targeted therapies, partially offset by higher demand related to third line label extension.

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.

U.S. revenues increased 11% during the third quarter of 2024 and 32% year-to-date primarily due to higher demand.

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Breyanzi (lisocabtagene maraleucel) — a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory LBCL after one or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, grade 3B FL and relapsed or refractory FL after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL , and relapsed or refractory MCL in patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.

U.S. revenues increased 125% during the third quarter of 2024 and 75% year-to-date primarily due to higher demand enabled by expanded manufacturing capacity and new indication launches.

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.

U.S. revenues increased 101% during the third quarter of 2024 and 141% year-to-date, primarily due to higher demand.

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.

U.S. revenues decreased 18% during the third quarter of 2024 primarily due to comparator sales for use in clinical trials during the third quarter of 2023 and lower average net selling prices, partially offset by higher demand.

U.S. revenues increased 25% year-to-date, primarily due to higher demand, partially offset by comparator sales for use in clinical trials during the third quarter of 2023 and lower average net selling prices.

Augtyro (repotrectinib) a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC and for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. Augtyro was launched in November 2023.

Krazati (adagrasib) — a highly selective and potent oral small-molecule inhibitor of the KRASG12C mutation, indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy and, in combination with cetuximab, for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Krazati was brought into the BMS portfolio as part of the Mirati acquisition completed in 2024.

Cobenfy (xanomeline and trospium chloride) – a combination M1 / M4 muscarinic receptor agonist and muscarinic antagonist indicated for the treatment of schizophrenia in adults. Cobenfy was approved by the FDA in September 2024.

Other Growth Brands — includes Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.

Legacy Portfolio

Eliquis (apixaban) — an oral Factor Xa inhibitor indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.

U.S. revenues increased 15% during third quarter of 2024 and 12% year-to-date primarily due to higher demand and higher average net selling prices.

International revenues increased 3% during the third quarter of 2024 and were flat year-to-date primarily due to foreign exchange impacts of 1% and (1)%, respectively. Excluding foreign exchange impacts, revenues increased 2% and 1%, respectively.

Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe, generic manufacturers have sought to challenge our Eliquis patents and related SPCs and have begun marketing generic versions of Eliquis in certain countries prior to the expiry of our patents and related SPCs, which has led to the filing of infringement and invalidity actions involving our Eliquis patents and related SPCs being filed in various countries in Europe. We believe in the innovative science behind Eliquis and the strength of our intellectual property, which we will defend against infringement. Refer to "Item 1. Financial Statements—Note 18. Legal Proceedings and Contingencies—Intellectual Property" for further information.
44



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. Revlimid has received approvals for several indications in the hematological malignancies including lymphoma and MDS.

U.S. revenues were flat during the third quarter of 2024 and decreased 3% year-to-date primarily due to generic erosion and lower average net selling prices, partially offset by the prior year impact 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.

International revenues decreased 9% during third quarter of 2024 and 13% year-to-date primarily due to generic erosion across several European countries and foreign exchange impacts of 3% and 4%, respectively. Excluding foreign exchange impacts, revenues decreased by 6% and 9%, respectively.

In the U.S., certain third parties were 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 and Japan, generic lenalidomide products have entered the market.

Pomalyst/Imnovid (pomalidomide) — a proprietary, distinct, small molecule that is administered orally and modulates the immune system and other biologically important targets. Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

U.S. revenues increased 15% during the third quarter of 2024 and 17% year-to-date due to higher demand and the prior year impact 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.

International revenues decreased 24% during the third quarter of 2024 and 15% year-to-date primarily due to generic erosion and year-to-date foreign exchange impact of 1%. Excluding foreign exchange impacts, revenues decreased by 24% and 14%, respectively.

In the EU, generic pomalidomide products entered the market in August 2024.

Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML.

U.S. revenues decreased 44% during the third quarter of 2024 primarily due to lower average net selling price and generic erosion.

U.S. revenues decreased 16% year-to-date primarily due to lower average net selling price and generic erosion, partially offset by higher demand during the first half of the year.
International revenues decreased 45% during the third quarter of 2024 and 39% year-to-date primarily due to generic erosion, lower average net selling prices and foreign exchange impacts of 3% and 4%, respectively. Excluding foreign exchange impacts, revenues decreased by 42% and 35%, respectively.

In the U.S. (September 2024) and EU, generic dasatinib products have entered the market. In Japan, the composition of matter patent for the treatment of non-imatinib-resistant CML has expired.
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Abraxane (paclitaxel albumin-bound particles for injectable suspension) a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.

U.S. revenues decreased 15% during the third quarter of 2024 and 14% year-to-date due to lower demand driven by generic erosion.

Other Legacy Portfolio Products — includes other mature brands.

Estimated End-User Demand

Pursuant to the SEC Consent Order described under "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operation— SEC Consent Order" in our 2023 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 disclose products with levels of inventory in excess of one month on hand or expected demand, subject to certain limited exceptions. There were none as of September 30, 2024, for our U.S. distribution channels, and as of June 30, 2024, for our non-U.S. distribution channels.

In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which accounted for approximately 85% of total gross sales of U.S. products during the nine months ended September 30, 2024. Factors that may influence our estimates include generic erosion, 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.

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. Revlimid and 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 Revlimid and Pomalyst. Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities' specifications to provide for the products' safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies.

Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to where we can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data, including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given the difficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and to calculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business during the nine months ended September 30, 2024 is not available prior to the filing of this Quarterly Report on Form 10-Q. We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to certain limited exceptions, in our Annual report on Form 10-K.

46


Expenses
 Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Cost of products sold(a)
$2,957 $2,506 18 %$9,156 $7,948 15 %
Marketing, selling and administrative1,983 2,003 (1)%6,278 5,699 10 %
Research and development2,374 2,242 %7,968 6,821 17 %
Acquired IPRD262 80 *13,343 313 *
Amortization of acquired intangible assets2,406 2,256 %7,179 6,769 %
Other (income)/expense, net234 (258)*588 (787)*
Total Expenses$10,216 $8,829 16 %$44,512 $26,763 66 %
*    In excess of +/- 100%.
(a)    Excludes amortization of acquired intangible assets.

Cost of Products Sold

Cost of products sold increased by $451 million in the third quarter of 2024 and $1.2 billion year-to-date primarily due to higher profit sharing and royalty expense ($246 million and $565 million) and higher sales volume. Year-to-date 2024 also includes a $280 million impairment charge related to Inrebic.

Marketing, Selling and Administrative

Marketing, selling and administrative expense decreased by $20 million in the third quarter of 2024.

Marketing, selling and administrative expense increased by $579 million year-to-date primarily due to the impact of recent acquisitions in 2024, including the cash settlement of unvested stock awards and other related expenses of $372 million.

Research and Development

Research and development expense increased by $132 million in the third quarter of 2024 primarily due to the impact of recent acquisitions.

Research and development expense increased by $1.1 billion year-to-date primarily due to an IPRD impairment charge relating to alnuctamab ($590 million) and the impact of recent acquisitions, including cash settlement of unvested stock awards and other related expenses of $348 million.

Acquired IPRD

Acquired IPRD charges 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 millions2024202320242023
Karuna asset acquisition (Note 4)$— $— $12,122 $— 
RayzeBio rights buy-out
92 — 92 — 
SystImmune upfront fee (Note 3)— — 800 — 
Evotec designation and opt-in license fees
125 — 170 90 
Prothena opt-in license fee— — 80 55 
Other 45 80 79 168 
Acquired IPRD $262 $80 $13,343 $313 

Amortization of Acquired Intangible Assets

Amortization of acquired intangible assets increased by $150 million in the third quarter of 2024 and $410 million year-to-date primarily due to the intangible assets acquired through the RayzeBio acquisition in the first quarter of 2024 and FDA approval of Augtyro in the fourth quarter of 2023.

47


Other (Income)/Expense, Net

Other (income)/expense, net changed by $492 million in the third quarter of 2024 and $1.4 billion year-to-date as discussed below.

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions2024202320242023
Interest expense$505 $280 $1,451 $850 
Royalty and licensing income (180)(365)(532)(1,068)
Royalty income - divestitures(284)(217)(820)(623)
Investment income(94)(107)(364)(304)
Litigation and other settlements— (61)71 (393)
Provision for restructuring78 141 558 321 
Integration expenses 69 54 214 180 
Equity investment (gain)/losses(12)— (221)213 
Acquisition expenses — — 50 — 
Intangible asset impairments
47 29 47 29 
Other105 (12)134 
Other (income)/expense, net
$234 $(258)$588 $(787)

Interest expense increased in the third quarter of 2024 and year-to-date due to additional borrowings. Refer to "Item 1. Financial Statements—Note 10. Financing Arrangements" for further information.
Royalty income decreased in the third quarter of 2024 and year-to-date primarily due to lower royalty rates for Keytruda* starting in 2024, partially offset by higher royalties from diabetes business divestitures in 2024. Refer to "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information.
Investment income is primarily driven by changes in average cash and marketable debt securities balances.
Litigation and other settlements includes amounts related to pricing, sales and promotional practices disputes and securities litigation matters, partially offset by income from the Eisai collaboration termination in 2024. Refer to "Item 1. Financial Statements—Note 3. Alliances" and "Item 1. Financial Statements —Note 18. Legal Proceedings and Contingencies" for further information. Third quarter of 2023 includes income related to the AstraZeneca settlement, partially offset by expense recorded in connection with the BeiGene settlement. Year-to-date 2023 includes income related to the Nimbus' TYK2 program change of control provision and additional settlement costs related to commercial disputes regarding intellectual property matters. Refer to "Item 1. Financial Statements—Note 5. Other (Income)/Expense, Net" for further information.
Provision for restructuring includes exit and other costs primarily related to certain restructuring activities including the plans discussed further in "Item 1. Financial Statements—Note 6. Restructuring".
Integration expenses increased in the third quarter of 2024 and year-to-date primarily due to Celgene and other acquisitions.
Equity investments generated gains year-to-date in 2024 compared to losses in 2023 primarily driven by fair value adjustments for investments that have readily determinable fair value. Refer to "Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements" for more information.
Acquisition expenses primarily includes investment banking and professional advisory fees.
Other includes pension settlement charges of $100 million and $119 million for the third quarter of 2024 and year-to-date, respectively, related to the termination of the Bristol-Myers Squibb Puerto Rico, Inc. Retirement Income pension plan.

48


Income Taxes
 Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions2024202320242023
Earnings/(Loss) before income taxes
$1,676 $2,137 $(8,554)$6,766 
Income tax provision
461 203 455 488 
Effective tax rate27.5 %9.5 %(5.3)%7.2 %
Impact of specified items9.0 %(2.1)%(193.7)%(7.5)%
Effective tax rate excluding specified items18.5 %11.6 %188.4 %14.7 %

Provision for income taxes in interim periods is determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The effective tax rate for the third quarter of 2024 was primarily impacted by changes in previously estimated annual effective tax rates resulting from jurisdictional earnings mix. The effective tax rate for the third quarter of 2023 was primarily impacted by revised guidance regarding deductibility of certain research and development expenses which reduced income taxes by approximately $160 million and was the primary reason for a $240 million reduction to previously estimated income taxes for 2022 upon finalization of the U.S. federal income tax return.

Excluding the impact of specified items, the effective tax rate increased from 11.6% to 18.5% in the third quarter of 2024, primarily due to the aforementioned jurisdictional earnings mix and revised guidance regarding deductibility of certain research and development expenses.

The year-to-date 2024 effective tax rate was primarily impacted by a $12.1 billion one-time, non-tax deductible charge for the acquisition of Karuna and releases of income tax reserves of $644 million related to the resolution of Celgene's 2017-2019 IRS audit. The Karuna non-tax deductible charge affected the effective tax rate as well as the effective tax rate excluding specified items. In addition, the effective tax rate was impacted by jurisdictional earnings mix resulting from amortization of acquired intangible assets, foreign currency changes on certain net operating loss and other carryforwards in 2024, and other specified items.

The year-to-date 2023 effective tax rate was primarily 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 other settlements, as well as releases of income tax reserves of $89 million related to the resolution of Celgene's 2009-2011 IRS audit.

Non-GAAP Financial Measures

Our non-GAAP financial measures, such as non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including (i) amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, (ii) unwinding of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) costs of acquiring a priority review voucher, (vii) divestiture gains or losses, (viii) stock compensation resulting from acquisition-related equity awards, (ix) pension, legal and other contractual 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 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 and release of income tax reserves relating to the Celgene acquisition. 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 31, 2024 and are incorporated herein by reference.

49


Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Specified items were as follows:
Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions2024202320242023
Inventory purchase price accounting adjustments$13 $— $34 $84 
Intangible asset impairment
— — 280 — 
Site exit and other costs88 16 105 53 
Cost of products sold101 16 419 137 
Acquisition related charges(a)
— — 372 — 
Site exit and other costs65 19 85 
Marketing, selling and administrative65 391 85 
IPRD impairments— 60 590 80 
Priority review voucher— — — 95 
Acquisition related charges(a)
— — 348 — 
Site exit and other costs21 36 10 
Research and development21 64 974 185 
Amortization of acquired intangible assets2,406 2,256 7,179 6,769 
Interest expense(b)
(12)(12)(37)(39)
Litigation and other settlements— (62)61 (397)
Provision for restructuring78 141 558 321 
Integration expenses69 54 214 180 
Equity investment (gain)/losses(13)(2)(222)206 
Acquisition expenses— — 50 — 
Intangible asset impairment 47 29 47 29 
Other 106 (1)116 (6)
Other (income)/expense, net275 147 787 294 
Increase to pretax income2,810 2,548 9,750 7,470 
Income taxes on items above(371)(340)(1,296)(944)
Income tax reserve releases
— — (502) 
Income taxes attributed to non-U.S. tax ruling — — — (656)
Income taxes(371)(340)(1,798)(1,600)
Increase to net earnings$2,439 $2,208 $7,952 $5,870 
(a) Includes cash settlement of unvested stock awards, and other related costs incurred in connection with the recent acquisitions.
(b) Includes amortization of purchase price adjustments to Celgene debt.

50


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 data2024202320242023
Net earnings/(loss) attributable to BMS
GAAP$1,211 $1,928 $(9,020)$6,263 
Specified items2,439 2,208 7,952 5,870 
Non-GAAP$3,650 $4,136 $(1,068)$12,133 
Weighted-average common shares outstanding – diluted2,031 2,064 2,026 2,093 
Diluted earnings/(loss) per share attributable to BMS
GAAP$0.60 $0.93 $(4.45)$2.99 
Specified items1.20 1.07 3.92 2.81 
Non-GAAP$1.80 $2.00 $(0.53)$5.80 
51


FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES

Our net debt position was as follows:
Dollars in MillionsSeptember 30,
2024
December 31,
2023
Cash and cash equivalents$7,890 $11,464 
Marketable debt securities – current204 816 
Marketable debt securities – non-current324 364 
Total cash, cash equivalents and marketable debt securities8,418 12,644 
Short-term debt obligations(1,078)(3,119)
Long-term debt(48,674)(36,653)
Net debt position$(41,334)$(27,128)

We believe that our existing cash, cash equivalents and marketable debt securities, together with our ability to generate cash from operations and our access to short-term and long-term borrowings, are sufficient to satisfy our existing and anticipated cash needs, including dividends, capital expenditures, milestone payments, working capital, income 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 nine months ended September 30, 2024, our net debt position increased by $14.2 billion primarily driven by payments for acquisitions, collaborations and milestones of $21.8 billion and $3.6 billion of dividend payments, partially offset by cash provided by operations of $10.8 billion.

During the nine months ended September 30, 2024, we issued the 2024 Senior Unsecured Notes in an aggregate principal amount of $13.0 billion with proceeds, net of discount and loan issuance costs, of $12.9 billion. The proceeds from the 2024 Senior Unsecured Notes were used to partially fund the acquisitions of RayzeBio and Karuna, and the remaining net proceeds were used for general corporate purposes. In connection with the issuance of the 2024 Senior Unsecured Notes, we terminated the $10.0 billion 364-day senior unsecured delayed draw term loan facility entered in February 2024 to provide bridge financing for the RayzeBio and Karuna acquisitions.

During the nine months ended September 30, 2024, $2.5 billion 2.900% Notes and $395 million 3.625% Notes matured and were repaid.

Under our commercial paper program, we may issue a maximum of $7.0 billion of unsecured notes that have maturities of not more than 365 days from the date of issuance. During the first quarter of 2024, we issued $3.0 billion of commercial paper and such amount was fully repaid by the end of the third quarter of 2024.

There were no borrowings outstanding under our $5.0 billion revolving credit facility as of September 30, 2024 and December 31, 2023. This credit facility expires in January 2029 and is extendable annually by one year with the consent of the lenders. Additionally, in February 2024, we entered into a $2.0 billion 364-day revolving credit facility, under which no borrowings were outstanding as of September 30, 2024. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings.

Dividend payments were $3.6 billion during the nine months ended September 30, 2024. The decision to authorize dividends is made on a quarterly basis by our Board of Directors.

Annual capital expenditures are expected to be approximately $1.3 billion for the full year 2024. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities, research and development and other facility-related activities.

During the nine months ended September 30, 2024 and 2023, income tax payments were $3.1 billion and $4.1 billion, including $799 million and $567 million, respectively, for the transition tax following the TCJA enactment.

52


Cash Flows

The following is a discussion of cash flow activities:
Nine Months Ended September 30,
Dollars in millions20242023
Cash flow provided by/(used in):
Operating activities$10,751 $9,608 
Investing activities(21,156)(949)
Financing activities$6,769 $(10,383)

Operating Activities

The $1.1 billion increase in cash provided by operating activities compared to 2023, was primarily due to higher customer collections, net of rebates and discounts and alliance payments ($2.6 billion) and lower income tax payments ($1.0 billion), partially offset by acquisition-related expenses, including cash settlement of unvested stock awards ($1.0 billion), and higher interest payments on debt ($500 million), as well as timing of payments in the ordinary course of business.

Investing Activities

The $20.2 billion increase in cash used in investing activities compared to 2023 was due to higher acquisition-related expenses of $21.2 billion, as well as collaboration and milestone payments, partially offset by changes in the amount of marketable debt securities held of $1.0 billion.

Financing Activities

The $17.2 billion change in cash provided by financing activities compared to 2023 was primarily due to net debt borrowings of $10.5 billion in 2024 primarily to fund our acquisitions compared to $5.2 billion repurchases of common stock and net debt repayments of $1.6 billion in 2023.

53


Product and Pipeline Developments

Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth. Our late-stage R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. The following are the developments in our marketed products and our late-stage pipeline since the start of the third quarter of 2024 as of October 31, 2024:

ProductIndicationDateDevelopments
Abecma
Multiple Myeloma
September 2024
Announced the discontinuation of enrollment in the Phase 3 KarMMa-9 study investigating Abecma with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who have suboptimal response after autologous stem cell transplant.
Augtyro
NSCLC
September 2024
Announced that Japan’s Ministry of Health, Labour and Welfare granted manufacturing and marketing approval for Augtyro for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC. This approval is based on results from the Phase 1/2 TRIDENT-1 trial.
Breyanzi
Follicular Lymphoma (FL)August 2024
Announced that Japan's Ministry of Health, Labour and Welfare approved the supplemental NDA for Breyanzi for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy based on results of the TRANSCEND FL study.
August 2024
Announced EMA validation of the Type II variation application to expand the indication for Breyanzi to include the treatment of adult patients with relapsed or refractory FL who have received two or more prior lines of systemic therapy. The application is based on results of the Phase II TRANSCEND FL study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
Camzyos
oHCM
September 2024
Announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study evaluating Camzyos in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy demonstrating that patients experienced consistent and sustained improvements in echocardiographic measures and biomarkers after up to 3.5 years of continuous treatment. Patients experienced an improvement in symptoms and functional capacity as measured by NYHA class and patient-reported outcomes. The safety profile of Camzyos for up to 3.5 years remained consistent with the established safety profile and no new safety signals were identified.
July 2024
Announced that the Japanese New Drug Application for Camzyos was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of obstructive hypertrophic cardiomyopathy. This filing is based on results from the global Phase 3 EXPLORER-HCM and Phase 3 VALOR-HCM trials, as well as the Japan Phase 3 HORIZON-HCM study.
cendakimab
Eosinophilic Esophagitis
July 2024
Announced that the results from the Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with eosinophilic esophagitis met both co-primary endpoints, demonstrating statistically significant reductions versus placebo in symptoms (dysphagia days) and esophageal eosinophil counts after 24 weeks of treatment. The overall safety profile of cendakimab through 48 weeks of treatment in the Phase 3 trial was consistent with previously reported eosinophilic esophagitis Phase 2 trial results, and no new safety signals were identified.
Cobenfy (KarXT; xanomeline and trospium chloride)
Schizophrenia
September 2024
Announced FDA approval of Cobenfy for the treatment of schizophrenia in adults. The approval is based on data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of Cobenfy for up to one year.
Inrebic
Myelofibrosis
August 2024
Announced that the Japanese New Drug Application for Inrebic has been submitted to the Pharmaceuticals and Medical Devices Agency for the treatment of myelofibrosis (MF). This filing is based on results from the global Phase 3 EFC12153 (Jakarta) study for 1L MF, the global Phase 2 ARD12181 (Jakarta-2) study for 2L MF, and the Japan Phase 1/2 FEDR-MF-003 study.


54


ProductIndicationDateDevelopments
Opdivo
NSCLC
October 2024
Announced FDA approval of Opdivo for the treatment of adult patients with resectable (tumors ≥ 4cm or nod positive) NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery. The approval is based on results from the Phase 3CheckMate -77T trial.
Opdivo + Yervoy
Melanoma
September 2024
Announced 10-year follow-up data from the Phase 3 CheckMate -067 trial that showed continued durable improvement in survival with first-line Opdivo plus Yervoy therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma. With a minimum follow up of 10 years, median overall survival was 71.9 months with Opdivo plus Yervoy, the longest reported median overall survival in a Phase 3 advanced melanoma trial.
HCC
August 2024
Announced FDA acceptance of the supplemental BLA for Opdivo plus Yervoy as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma. The acceptance is based on results from the Phase 3 CheckMate -9DW trial. The FDA assigned a PDUFA goal date of April 21, 2025.
August 2024
Announced that the supplemental Japanese New Drug Application for Opdivo plus Yervoy was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of unresectable first line hepatocellular carcinoma. This filing is based on results from the Phase 3 CheckMate -9DW study.
July 2024
Announced EMA validation of the Type II variation application for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable or advanced HCC who have not received prior systemic therapy. The application is based on results from the Phase 3 CheckMate -9DW trial.
Colorectal Cancer
October 2024
Announced that the Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to Opdivo monotherapy across all lines of therapy as a treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival as assessed by Blinded Independent Central Review at a pre-specified interim analysis. Previously, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy.

Opdivo  plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Opdivo monotherapy across all lines of therapy. The study is ongoing to assess various secondary endpoints, including overall survival. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data, with no new safety signals identified.
September 2024
Announced that the supplemental Japanese New Drug Application for Opdivo plus Yervoy was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of unresectable advanced or recurrent colorectal cancer with frequent microsatellite instability. This filing is based on results from the Phase 3 CheckMate -8HW study.
Urothelial Carcinoma
October 2024
Announced that the Phase 3 CheckMate -901 trial evaluating Opdivo plus Yervoy versus standard-of-care non-cisplatin-based chemotherapy in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy, did not meet its primary endpoint of overall survival. The safety profile for Opdivo and Yervoy was consistent with previously reported data, with no new safety signals identified.
 
Opdivo has previously shown clinical benefit across various stages of urothelial carcinoma. These results do not impact those data or approved indications.
Zeposia
Multiple Sclerosis
September 2024
Announced data from the Phase 3 DAYBREAK trial which demonstrated that decreased rates of brain volume loss were sustained in the open-label extension for patients treated with Zeposia for relapsing forms of multiple sclerosis. A separate DAYBREAK OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events, with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia.
55



Critical Accounting Policies

The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Our critical accounting policies are those that significantly impact our financial condition and results of operations and require the most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates. For a discussion of our critical accounting policies, refer to "Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our 2023 Form 10-K. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2024. 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 Statements

This Quarterly Report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain "forward-looking" statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. You can identify these forward-looking statements by the fact they use words such as "should," "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on 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 our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions, alliances and other business development activities, the impact of any pandemic or epidemic 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. No forward-looking statement can be guaranteed. This Quarterly Report on Form 10-Q, our 2023 Form 10-K, particularly under the section "Item 1A. Risk Factors," and our other filings with the SEC, include additional information on the factors that we believe could cause actual results to differ materially from any forward-looking statement.

Although we believe that we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report on Form 10-Q not to occur. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this Quarterly Report on Form 10-Q.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

For a discussion of our market risk, refer to "Item 7A. Quantitative and Qualitative Disclosures about Market Risk" in our 2023 Form 10-K. There have been no material changes to our market risk during the nine months ended September 30, 2024.

Item 4. CONTROLS AND PROCEDURES

Management carried out an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of its disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that as of September 30, 2024, such disclosure controls and procedures are effective.

There were no changes in the Company's internal control over financial reporting during the quarter ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.

PART II—OTHER INFORMATION
56



Item 1. LEGAL PROCEEDINGS

Information pertaining to legal proceedings can be found in "Item 1. Financial Statements—Note 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 2023 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, 2024: 
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, 202421,409 $41.24 — $5,014 
August 1 to 31, 202440,092 $49.15 — $5,014 
September 1 to 30, 202420,232 $49.81 — $5,014 
Three months ended September 30, 202481,733 — 
(a)Includes 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 in February 2020, January and December 2021 and December 2023, in the amounts of $5.0 billion, $2.0 billion, $15.0 billion and $3.0 billion, respectively, to the share repurchase authorization. The remaining share repurchase capacity under the program was $5.0 billion as of September 30, 2024. Refer to "Item 8. Financial Statements and Supplementary Data—Note 17. Equity" in our 2023 Form 10-K for information on the share repurchase program.

Item 5. OTHER INFORMATION

Rule 10b5-1 Trading Arrangement

During the period covered by this Quarterly Report on Form 10-Q, as each term is defined in Item 408(a) of Regulation S-K.

57


Item 6. EXHIBITS

Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).
Exhibit No.Description
31a.
31b.
32a.
32b.
101.INSXBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCHXBRL Taxonomy Extension Schema Document.
101.CALXBRL Taxonomy Extension Calculation Linkbase Document.
101.DEFXBRL Taxonomy Extension Definition Linkbase Document.
101.LABXBRL Taxonomy Extension Label Linkbase Document.
101.PREXBRL Taxonomy Extension Presentation Linkbase Document.
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

*    Indicates, in this Quarterly Report on Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; Gleevec is a trademark of Novartis AG; Keytruda is a trademark of Merck & Co., Inc., Rahway, NJ, USA; Onglyza is a trademark of AstraZeneca AB; Otezla is a trademark of Amgen Inc.; Plavix is a trademark of Sanofi; and Tecentriq is a trademark of Genentech, Inc. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.

58


SUMMARY OF ABBREVIATED TERMS

Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as Bristol Myers Squibb, BMS, the Company, we, our or us in this Quarterly Report on Form 10-Q, unless the context otherwise indicates. Throughout this Quarterly Report on Form 10-Q we have used terms which are defined below:
2023 Form 10-KAnnual Report on Form 10-K for the fiscal year ended December 31, 2023MiratiMirati Therapeutics, Inc.
2024 Senior Unsecured NotesAggregate principal amount of $13.0 billion of unsecured senior notes issued by BMS in February 2024MPMmalignant pleural mesothelioma
aGVHDacute graft-versus-host diseaseMTAMethylthioadenosine
ANDAAbbreviated New Drug ApplicationNDANew Drug Application
AstraZenecaAstraZeneca PLCNimbusNimbus Therapeutics
BCMAB-cell maturation antigen-directedNKTnatural killer T
BLA Biologics License ApplicationNSCLCnon-small cell lung cancer
CAR-Tchimeric antigen receptor T-cellNTRKNeurotrophic Tropomyosin Receptor Kinase
CelgeneCelgene CorporationNVAFnon-valvular atrial fibrillation
CERCLAU.S. Comprehensive Environmental Response, Compensation and Liability ActOECDOrganization for Economic Co-operation and Development
CGDPCoverage Gap Discount ProgramOnoOno Pharmaceutical Co., Ltd
CLLChronic Lymphocytic LeukemiaOtsukaOtsuka Pharmaceutical Co., Ltd.
CMLchronic myeloid leukemiaPD-1programmed cell death protein 1
CRCcolorectal carcinomaPD-LIprogrammed death-ligand 1
CTLA4Cytotoxic T-lymphocyte Antigen-4PsApsoriatic arthritis
DLBCLDiffuse Large B-cell LymphomaPRMT5protein arginine methyltransferase 5
ECEuropean CommissionQuarterly Report on Form 10-Q
Quarterly Report on Form 10-Q for the quarter ended September 30, 2024
EisaiEisai Co., Ltd.R&Dresearch and development
EPSearnings per shareRArheumatoid arthritis
EUEuropean UnionRayzeBioRayzeBio, Inc.
Exchange Act the Securities Exchange Act of 1934RCCrenal cell carcinoma
FASBFinancial Accounting Standards BoardRDFVreadily determinable fair values
FDAU.S. Food and Drug AdministrationREMSrisk evaluation and mitigation strategy
FLfollicular lymphomaSanofiSanofi S.A.
GAAPgenerally accepted accounting principlesSECU.S. Securities and Exchange Commission
GTNgross-to-netSLLSmall Lymphocytic Lymphoma
HCChepatocellular carcinomaSPCSupplementary Protection Certificate
HCMhypertrophic cardiomyopathySystImmuneSystImmune, Inc.
IPRDin-process research and developmentTakedaTakeda Pharmaceutical Company Limited
IRAInflation Reduction Act of 2022TCJATax Cuts and Jobs Act
IRSInternal Revenue ServiceTurning PointTurning Point Therapeutics, Inc.
JIAjuvenile idiopathic arthritisUCulcerative colitis
KarunaKaruna Therapeutics, Inc.UKUnited Kingdom
KRASKirsten rat sarcomaU.S.United States
LBCLLarge B-cell LymphomaUSPTOU.S. Patent and Trademark Office
MDSmyelodysplastic syndromesVATvalue added tax
MerckMerck & Co.
59


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. 
BRISTOL-MYERS SQUIBB COMPANY
(REGISTRANT)
Date:October 31, 2024By:/s/ Christopher Boerner, Ph.D.
Christopher Boerner, Ph. D.
Chair of the Board and Chief Executive Officer
Date:October 31, 2024By:/s/ David V. Elkins
David V. Elkins
Chief Financial Officer
60

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